JP2023545853A - Blood clot collection system - Google Patents

Abstract

A device platform is provided for removing occlusions and other objects inside blood vessels or other lumens of an animal. The system can include a cage that includes an aspiration catheter that can be deployed into the lumen from the catheter and includes one or more aspiration openings for drawing clots or other objects into the interior of the cage. TIFF2023545853000004.tif53170

Description

The present invention relates to a deployable system for removing blood clots or other objects from the lumen of an animal.

BACKGROUND OF THE INVENTION Acute ischemic stroke occurs when a blood clot (thrombus) blocks an artery that supplies blood to the brain. Of course, when a blood clot creates such an occlusion, time for removal of the clot is critical.

Removal of an intracranial obstruction depends on several factors, such as the distance of the intracranial obstruction from the femoral access site, the tortuosity of the cervical and proximal intracranial vasculature (the twists and turns), the small size of the vessels and the extremely thin walls of intracranial vessels (without significant muscle layer). These limitations are small enough that the device can be navigated through tortuous blood vessels in guide catheters and microcatheters, delivered to the site of occlusion, and then expanded and retrieved into the microcatheter. It needs to be flexible, yet strong enough to forcefully dislodge attached thrombus from the vessel wall. In addition, the device should trap or confine the thrombus distally to prevent embolization to other vessels and completely remove the occlusion. The device should be retrievable without requiring proximal occlusion of the vessel with the risk of further ischemia and vessel damage. The device should be easy to use and allow multiple uses within the same patient procedure. The device should not be abrasive and should not have sharp corners that expose the endothelial layer of the vessel wall.

Currently available intravascular thrombus and foreign body removal devices lack some of these features. Currently available devices include the MERCI™ RETRIEVER clot retrieval device, marketed by Concentric Medical, Inc. (Mountainview, CA); the clot retrieval device, marketed by Penumbra Inc. (Alameda, CA); and the newer stent retrieval devices TREVO(TM) (Stryker, Kalamazoo, MI) and SOLITAIRE(TM) (eV3 Endovascular Inc., Plymouth, MA (a subsidiary of Covidien)). All of these devices are ineffective in removing organized hard thrombi that form emboli from the heart and atherosclerotic proximal vessels to the brain. These "hard" thrombi are resistant to medical treatment and therefore constitute the majority of strokes referred for removal by mechanical means via endovascular techniques. The MERCI retrieval system consists of a coiled spring-like metal and a corresponding suture material. The method of use is deployment distal to the thrombus, and by pulling the device through the thrombus, the thrombus becomes entangled in the coil and mesh and then retrieved. The MERCI system requires occlusion of the proximal vessel with a balloon catheter and simultaneous aspiration of blood while the thrombus is removed. More often than not, the device is unable to dislodge the thrombus from the wall of the blood vessel, and often, even when a thrombus is successfully removed, a thrombus forms in another blood vessel or in the same blood vessel due to the open nature of the device.

The next attempt at a thrombus removal system was PENUMBRA. PENUMBRA is a suction catheter with a separator that breaks up the clot (which is then removed by suction). This device is ineffective at removing hard organized thrombi that form occlusions from the heart, removing cholesterol plaque from proximal feeding arteries, and removing other foreign bodies.

The SOLITAIRE and TREVO systems are self-expanding, non-detachable stents. After the device is delivered past the thrombus, the thrombus becomes entangled in the mesh of the stent and then removed in a manner similar to the MERCI system. Again, these devices are ineffective at treating hard blood clots. In fact, blood clots are often pressed against the blood vessel wall by a stent that temporarily widens the blood vessel by pushing the clot outward and against the blood vessel wall. When the device is retrieved, the clot remains or breaks up into several pieces that form further emboli along the blood vessel.

Accordingly, there is a need for a new, safe, easy-to-use, easy-to-manufacture surgical device for the timely removal of obstructions, such as blood clots, from the internal lumens of humans and other animals.

SUMMARY The present disclosure provides several systems for removing occlusions and other objects within blood vessels or other lumens of an animal. The system may be deployed from the distal end of the catheter into the lumen, and in some embodiments includes a pull wire having a proximal end and a distal end; a distal body attached to the pull wire, the distal body having an interior and an exterior. , a proximal end, a distal end, a plurality of proximal shape memory metal strips located at the proximal end, a proximal hub/junction located within the distal body, and a distal end to the proximal hub/junction. and a distal hub/junction located on the side. The distal body has a relaxed state in which the distal body has a first height and a width, and a relaxed state in which the distal body has a second height and width and the second height is less than the first height. and a deflated state in which the second width is less than the first width. The system further includes a catheter having an interior, a proximal end communicating with the interior, and a distal end communicating with the interior; It is constructed to wrap around the body. Each proximal shape memory metal strip has a proximal end and a distal end, and preferably, in the relaxed state, each proximal end of the proximal shape memory metal strip is proximal to the proximal hub/junction. Located in Preferably, in the relaxed state, the proximal end of the proximal shape memory metal strip is compressed when the operator moves the proximal hub/junction distally toward the fixed distal hub/junction (i.e., when the operator moves the proximal hub/junction distally toward the fixed distal hub/junction). (when reducing the distance between the junctions), they are configured to move toward each other and the pull wires. Preferably, in the relaxed state, the proximal end of the proximal shape memory metal strip is moved by moving the proximal hub/junction proximally away from the fixed distal hub/junction (i.e., when the operator when increasing the distance between the junctions), they are configured to move away from each other and the pull wires.

Optionally, the system further includes a plurality of shape memory metal connector strips, each of the plurality of shape memory metal connector strips having a proximal end attached to the proximal shape memory metal strip and a proximal hub/ and a tip attached to the junction. Optionally, the connector strip is integral with the proximal hub/junction (i.e., optionally, the connector strip and the proximal/junction are formed from the same piece of memory metal). Optionally, the proximal hub/junction is a tube with an opening through which the pull wire passes. Optionally, in the relaxed state, the proximal hub/junction is slidable along the pull wire (ie, at least a section of the pull wire). Optionally, in the relaxed state, the proximal shape memory metal strips are substantially evenly distributed around the circumference of the distal body. Optionally, the distal hub/junction is a tube with an opening. Optionally, the distal hub/junction is attached to the pull wire such that it cannot slide along the pull wire. Optionally, the distal body further includes a lead wire extending distally from the distal hub/junction. Optionally, the distal body includes a basket comprised of a plurality of shape memory metal strips distal to the proximal shape memory metal strip. Optionally, the distal hub/junction, proximal hub/junction and distal basket are constructed of nitinol having the same material composition. Optionally, the distal body further includes an x-ray marker. Optionally, the proximal shape memory metal strip forms a pawl, the pawl having a closable proximal end formed by the proximal end of the proximal shape memory metal strip. Optionally, two to four proximal shape memory metal strips form the pawl. Optionally, the distal body has a tapered shape in the relaxed state, with the distal body height and width decreasing from the proximal end to the distal end. Optionally, the distal body has a bullet shape in the relaxed state. Optionally, the proximal hub/junction and the distal hub/junction are generally cylindrical and each have an outer diameter and an inner diameter, the inner diameter of which is the opening of the proximal hub/junction and the distal hub/junction. , the proximal hub/junction and the distal hub/junction have an outer diameter of substantially the same size, and the proximal hub/junction and the distal hub/junction have inner diameters of substantially the same size. . Optionally, the proximal hub/junction and the distal hub/junction have an outer diameter of about 0.011 inch to about 0.054 inch, and the proximal hub/junction and the distal hub/junction have an inner diameter of about 0.008 inch to about 0.051 inch. Inches. Optionally, the pull wire is generally cylindrical, and the pull wire has a diameter of about 0.008 inch to about 0.051 inch. Optionally, the proximal shape memory metal strip has a length of about 10 to about 60 millimeters. Optionally, the first height and first width of the distal body are about 2 millimeters (mm) to about 6 millimeters. Optionally, the proximal shape memory metal strip is configured to detach the clot from the vessel wall.

The present invention also provides a method for removing an object from a lumen of an animal having an inner wall forming the lumen. In some embodiments, the method comprises:
a)
i) a pull wire having a proximal end and a distal end;
ii) a distal body attached to the pull wire, the distal body including a proximal end, a distal end, and a pawl comprised of a plurality of shape memory metal strips, the distal body having a first height and width; in a relaxed state, the distal body has a second height and a second width, the second height is less than the first height, and the second width is less than the first width; the distal body having a deflated state; and
iii) a catheter having an interior, a proximal end communicating with the interior, and a distal end communicating with the interior, the catheter being constructed of a biocompatible material and surrounding the distal body when the distal body is in the deflated state; providing a system including a catheter configured to
b) placing the system into the lumen;
c) Deploying the distal body from the tip of the catheter;
d) increasing the height and width of the distal body; and
e) moving the shape memory metal strips towards each other and the pull wire to capture the obstruction. Optionally, a pawl and a shape memory metal strip are located proximally of the distal body, and the distal body is deployed distally relative to the object. Optionally, the proximal shape memory metal strips have a proximal end forming a proximal end of the pawl and a distal end, and the method includes moving the proximal sides of the shape memory metal strips toward each other and the pull wire. and trapping the obstruction. Optionally, the distal body further includes a proximal hub/junction located within the distal body and a distal hub/junction located distal to the proximal hub/junction, the proximal Each of the shape memory metal strips has a proximal end and a distal end, each proximal end of the shape memory metal strip being located proximally with respect to the proximal hub/junction, and the proximal end of the shape memory metal strip having a , the proximal ends of the shape memory metal strips are configured to move toward each other and the pull wire by moving the proximal hub/junction distally closer to the distal hub/junction; The method is configured to move the hub/junction proximally and away from the distal hub/junction to separate them from each other and the pull wire; The step includes trapping the blockage in the pawl as it approaches the hub/junction. Optionally, the lumen is an intracranial artery and the occlusion is a blood clot. Optionally, the method further includes using the clot to move the proximal hub/junction toward the distal hub/junction and apply tension to the proximal shape memory metal strip. Optionally, the method further includes using the tube to move the proximal hub/junction toward the distal hub/junction and apply tension to the proximal shape memory metal strip.

The present invention also provides a method of manufacturing a system for removing objects within the lumen of an animal. In some embodiments, the method comprises:
a) an exterior, a hollow interior, a wall separating the exterior from the hollow interior, a proximal portion including an opening leading to the hollow interior, a distal portion including an opening leading to the hollow interior, and a proximal portion; providing a tube constructed of shape memory metal having a section and an intermediate section between the distal section;
b) Cutting the wall of the middle part by laser;
c) removing the laser-cut intermediate section fragments to separate the proximal tube, the intermediate section including a plurality of shape memory metal strips attached to the proximal tube, and the distal tube; a step of forming;
d) changing the shape of the intermediate part;
e) expanding the intermediate section relative to the distal and proximal canals;
f) cutting the shape memory metal strip into a first section including a proximal tube and a proximal section of the shape memory metal strip; and a distal tube and a distal section of the shape memory metal strip; a second section comprising; and
g) joining the proximal section to the distal section, the distal section forming the proximal end of the distal body, the proximal tube being located inside the interior of said distal body; the tube is positioned distally relative to the proximal end.

Optionally, the method further includes positioning the pull wire through the proximal tube such that the proximal tube is slidable along at least a section of the pull wire. Optionally, the method further includes attaching a pull wire to the distal tube. Optionally, joining the proximal section to the distal section includes welding or soldering the proximal section to the distal section. Optionally, after joining the proximal section to the distal section, the proximal end forms a pawl comprised of two to four shape memory metal strips, the pawl shape memory metal strips being The proximal tube is configured to move toward each other by moving the proximal tube distally toward the distal tube, and the pawl shape memory metal strip moves the proximal tube proximally. The tubes are separated from each other by being separated from the distal tube. Optionally, the method further includes not changing the shape of the proximal and distal portions when changing the shape of the intermediate portion. Optionally, the method further includes cooling the proximal portion, the intermediate portion, and the distal portion after step (D), and after cooling, the proximal portion and the distal portion are cooled in step (A). It has substantially the same size as the proximal and distal portions previously had. Optionally, the method of expanding the intermediate section includes heating the intermediate section. Optionally, the method of changing the shape of the intermediate portion includes using a mandrel. Optionally, the mandrel is tapered. Optionally, the proximal portion and the distal portion are not cut by the laser. Optionally, before cutting the shape memory metal tube, the shape memory metal tube has an outer diameter of about 0.011 inch to about 0.054 inch and an inner diameter of about 0.008 inch to about 0.051 inch.

In an alternative aspect, the present disclosure provides
a pull wire having a proximal end and a distal end;
an interior, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, and a proximal hub/junction (preferably in the form of a tube) forming the proximal end of the distal body; A basket comprising a plurality of compartments formed by a plurality of basket strips, a plurality of proximal strips, and optionally a distal hub/junction (preferably in the form of a tube) forming the distal end of the basket. ), the basket including a basket interior, each proximal strip having a proximal end attached to the proximal hub/junction and a distal body attached to the compartment; a relaxed state in which the distal body has a first height and a first width; the distal body has a second height and a second width; the distal body having a deflated state with a second height less than the first height and a second width less than the first width; and an interior and a proximal end communicating with the interior; a catheter having a distal end communicating with the interior, the catheter being constructed of a biocompatible material and configured to wrap around the distal body when the distal body is in a deflated state;
In a relaxed state, the basket includes a first pair of distal apices that are not attached to another compartment of the basket and are oriented generally distally, the first pair of distal apices being in contact with the proximal hub. / located at approximately the same distance from the junction and at approximately 180° to each other (e.g., from about 150° to about 180° to each other), and the basket is further not attached to another compartment of the basket and approximately at the tip. a second pair of distal apices oriented in a direction, the second pair of distal apices being distal to the first pair of distal apices and relative to the first pair of distal apices of the first pair; (e.g., each distal apex of the second pair of distal apices is located at approximately 60° to 90° with respect to the distal apex of the first pair of distal apices) , the distal crests on the distal crests of the second pair are located approximately the same distance from the proximal hub/junction, and further each of the distal crests on the distal crests of the first and second pairs are located approximately the same distance from the proximal hub/junction; including an X-ray marker, the X-ray marker being visible under X-rays compared to the basket strip when the distal body is located in a cephalic blood vessel inside the human body and the X-ray image is taken from outside the human body; To provide a system for easily removing objects from the lumen of an animal. Optionally, the basket includes an open tip in place of the distal hub/junction.

Optionally, the X-ray marker is constructed of a different material than the material forming the basket strip. Optionally, the interior of the basket is substantially hollow in the relaxed state. Optionally, in the relaxed state, the distal body does not have another X-ray marker located approximately the same distance from the proximal hub/junction as the first pair of X-ray markers, and the distal body It does not have another X-ray marker located approximately the same distance from the end hub/junction as the second pair of X-ray markers. In other words, the first and second pairs of X-ray markers are the only markers at each distance from the proximal hub/junction. Optionally, each distal apex in the first and second pairs of distal apices forms part of an enlarged section, and further, the surface area of each enlarged section in the relaxed state is equal to or greater than that of each other individual section of the basket. larger than the surface area, and further configured to allow the thrombus to pass therethrough and into the interior of the basket. Optionally, in the relaxed state, the distal body does not have another free distally facing apex located approximately the same distance from the proximal hub/junction as the distal apex of the first pair; The side body does not have another free distally facing top located approximately the same distance from the proximal hub/junction as the second pair of distal tops. Optionally, the basket strip is constructed of shape memory metal. Optionally, each of the distal apices of the first pair and the second pair of distal apices curves radially inward toward the interior of the basket in a relaxed state; The lateral apexes touch each other when an external compressive force (e.g., a blood clot) is applied to the distal apices of the first pair when the distal bodies are in a relaxed state. The distal apices of the second pair of distal apices are configured to contact each other, and the distal apices of the second pair of distal apices are configured such that when the distal body is in a relaxed state, an external surface compressive force (e.g., a thrombus) is applied to the distal apex of the second pair. They are configured to contact each other when applied to the distal apex of the distal apex. Optionally, the proximal hub/junction is approximately centered between the first height and the first width in the relaxed state. For example, preferably the proximal hub/junction is located within 0.5 mm of the center of the first width and first height. Optionally, the catheter is constructed from a polymeric material (ie, one or more polymeric materials such as silicone, PVC, latex rubber, or braided nylon). Optionally, the pull wire is constructed of a biocompatible metallic material (eg, a biocompatible metal or biocompatible alloy). Optionally, the proximal end of the first proximal strip is located at at least about 65° (e.g., about 65° to about 180°) relative to the distal end of the first proximal strip, and The proximal end of the distal strip is located at least about 65° (e.g., from about 65° to about 180°) to the distal end of the second proximal strip; The strips intersect proximal to and distal to the proximal hub/junction (eg, within about 0 and about 4 mm from the proximal hub/junction). Optionally, each distal apex forms part of a section, the section further oriented generally proximally and including a shape memory metal strip (e.g., a proximal strip or shape constructed of shape memory metal). a proximal top connected to a basket strip (basket strip) constructed of memory metal. In other words, the proximal apex is not free. Optionally, the basket, the proximal hub/junction and the proximal strip are constructed of shape memory metal, the proximal hub/junction including a proximal end and a distal end, and the proximal strip including a proximal end. It is integrated with the tip of the end hub/junction. Optionally, the length of the distal body from the proximal hub/junction to the distal hub/junction (not including any lead wires) is about 20 mm to about 65 mm. Optionally, the system includes a method for removing a blood clot from a blood vessel in an animal, the system comprising:
a) The process of providing the system;
b) placing the system into the lumen;
c) Deploying the distal body from the tip of the catheter;
d) increasing the height and width of the distal body;
e) Step of irradiating the distal body with X-rays;
f) placing the clot inside the distal basket; and
g) moving the distal body proximally out of the blood vessel.

Optionally, the method further includes irradiating the distal body with X-rays at at least two different angles. Optionally, at least one x-ray marker attached to the distal top is distal to the clot when the distal body is deployed from the tip of the catheter. Optionally, the method further includes applying a contrast agent proximally and distally to the clot. Optionally, the method further includes providing an aspiration catheter having a proximal end and a distal end, and applying suction to the aspiration catheter to apply the tip of the aspiration catheter to the blood clot. Optionally, the method further includes manually aspirating a predetermined amount of fluid from the aspiration catheter using the syringe, and then locking the syringe at the predetermined amount. Optionally, the method further includes delivering the aspiration catheter adjacent the clot by advancing the aspiration catheter over the pull wire.

In yet another aspect, the system includes:
a pull wire having a proximal end and a distal end;
an interior, a proximal end, a distal end, a distal body length extending from said proximal end to the distal end, a proximal hub/junction (preferably in the form of a tube) forming a proximal end of the distal body; a basket comprising a plurality of compartments formed by basket strips, a plurality of proximal strips and, optionally, a distal hub/junction (preferably in the form of a tube) forming the distal end of the basket; a distal body attached to a pull wire, the basket including a basket interior, each proximal strip having a proximal end attached to the proximal hub/junction, and a distal body attached to the compartment; the distal body has a relaxed state in which the distal body has a first height and a first width; the distal body has a second height and a second width; a deflated state having a second height less than the first height and a second width less than the first width; and an interior, and a proximal end communicating with the interior; a catheter having a distal end communicating with the interior, the catheter being constructed of a biocompatible material and configured to wrap around the distal body when the distal body is in a deflated state;
In a relaxed state, the basket includes a first pair of distal apexes that are not attached to another compartment of the basket and are oriented generally distally, the first pair of distal apexes being proximal to the hub. / located at approximately the same distance from the junction and at approximately 180° to each other (e.g., from about 150° to about 180° to each other), and the baskets are not attached to another compartment of the basket and are generally at the tip further comprising a second pair of distal crests oriented distally with respect to the first pair of distal crests and with the second pair of distal crests oriented distally relative to the first pair of distal crests; (e.g., each distal apex of the second pair of distal apices is located at approximately 60° to 90° relative to the distal apex of the first pair of distal apices) ), the distal apices of the second pair of distal apices are located approximately the same distance from the proximal hub/junction, and each distal apex of the first and second pair of distal apices form a compartment. and each compartment further includes a proximal apex oriented generally proximally and connected to the shape memory metal strip, each of the distal apexes of the first pair and the second pair of distal apices curves radially inward toward the interior of the basket in the relaxed state, and the distal apex of the first pair of distal apexes is curved radially inwardly toward the interior of the basket when the distal body is in the relaxed state. The distal apices of the first pair of distal apices are configured to contact each other when applied to the distal apices of the distal apices of the second pair; The second pair of distal apices are configured to contact each other when an external surface compressive force (e.g., a thrombus) is applied to the distal apices of the second pair when the distal apices are in a relaxed state. "Proximal apex oriented generally proximally and connected to a shape memory metal strip" means that the proximal apex is composed of a shape memory metal (e.g., Nitinol) and is connected to a basket strip or proximal strip; It means that it is connected to. Optionally, the basket includes an open tip in place of the distal hub/junction.

Optionally, the proximal hub/junction is approximately centered between the first height and the first width in the relaxed state. For example, preferably the proximal hub/junction is located within 0.5 mm of the center of the first width and first height. Optionally, the catheter is constructed from a polymeric material (ie, one or more polymeric materials such as silicone, PVC, latex rubber, or braided nylon). Optionally, the pull wire is constructed of a biocompatible metallic material (eg, a biocompatible metal or biocompatible alloy). Optionally, the interior of the basket is substantially hollow in the relaxed state. Optionally, the proximal end of the first proximal strip is located at least about 65° (e.g., from about 65° to about 180°) to the distal end of the first proximal strip; the proximal end of the lateral strip is located at at least about 65° (e.g., from about 65° to about 180°) to the distal end of the second proximal strip; intersect proximal to the proximal hub/junction and distal to the proximal hub/junction (eg, within about 0 mm and about 4 mm from the proximal hub/junction). Optionally, each distal apex in the first and second pairs of distal apices forms part of an enlarged section, and further, the surface area of each enlarged section in the relaxed state is greater than that of each other individual section of the basket. The enlarged compartment is at least twice as large as the surface area and further configured to allow the thrombus to pass therethrough and enter the interior of the basket. Optionally, a pull wire is attached to the proximal hub/junction. Optionally, the basket, the proximal hub/junction and the proximal strip are constructed of shape memory metal, the proximal hub/junction including a proximal end and a distal end, and the proximal strip including a proximal end. It is integrated with the tip of the end hub/junction. Optionally, the distal body further includes a lead wire extending distally from the distal hub/junction, the lead wire having a length of about 3 mm to about 10 mm. Optionally, the distal hub/junction, the proximal hub/junction, and the basket are constructed of Nitinol having the same material composition, and further, the proximal hub/junction and the distal hub/junction are tubular and generally cylindrical. shaped and each having an outer diameter and an inner diameter, the inner diameters forming the openings of the proximal hub/junction and the distal hub/junction, and the proximal hub/junction and the distal hub/junction The outer diameters of the proximal hub/junction and the distal hub/junction are substantially the same size, and the inner diameters of the proximal hub/junction and the distal hub/junction are substantially the same size. Optionally, the length of the distal body from the proximal hub/junction to the distal hub/junction (not including any lead wires) is about 20 mm to about 65 mm.

Optionally, the system includes a method for removing a blood clot from a blood vessel in an animal, the system comprising:
a) The process of providing the system;
b) placing the system into the lumen;
c) Deploying the distal body from the tip of the catheter;
d) increasing the height and width of the distal body;
e) Step of irradiating the distal body with X-rays;
f) placing the clot inside the distal basket; and
g) moving the distal body proximally out of the blood vessel.

Optionally, the method further includes irradiating the distal body with X-rays at at least two different angles.

In yet a further aspect, the present disclosure provides yet another aspect of a system for removing objects from a lumen of an animal. The system may include a pull wire having a proximal end and a distal end. The system may also include a distal body attached to the pull wire (the tip of the pull wire). The distal body includes an interior, an outer periphery, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, a proximal junction forming the proximal end of the distal body, and a plurality of proximal ends. The basket may include a side strip, a basket comprised of a plurality of compartments formed by a plurality of basket strips, and a distal junction forming a distal end of the basket. The basket may include a basket interior. Each proximal strip may have a distal end attached to the compartment and a proximal end, and the proximal ends of the proximal strips may converge at a proximal junction. The distal body has a relaxed state in which the distal body has a first height and a first width, and a relaxed state in which the distal body has a second height and a second width and the second height has a second height. and a deflated state, wherein the second width is less than the first width. Optionally, in the relaxed state, the basket has a distal body having a proximal apex oriented generally proximally and attached to the shape memory metal strip, and a free distal apex oriented generally distally. It includes a series of at least three pairs of compartments located on the outer periphery. Optionally, the most proximal free distal apices in the series are located at the 12 o'clock and 6 o'clock positions and approximately the same distance from the proximal junction (i.e., the same distance +/-5 millimeters (mm)), and the next most proximal free distal apex is located at the 3 o'clock and 9 o'clock positions and approximately the same distance from the proximal junction (i.e., the same distance +/- 5 mm) and then the proximal-most free distal apex is located at the 12 o'clock and 6 o'clock positions and approximately the same distance from the proximal junction (i.e., the same distance +/-5 mm). To position. Each free distal apex may form part of a different expansion section configured to allow thrombus to enter the interior of the basket. Optionally, in the relaxed state, the basket includes a plurality of distal compartments distal to the distal-most free distal apex of said series. The plurality of distal compartments can have a proximal apex attached to another compartment of the basket and oriented generally proximally, and a distal apex oriented generally distally and attached to the distal junction. . Optionally, each expansion section has a proximal end, a distal end including a generally distally oriented distal apex, and a length extending from the proximal end to the distal end of the respective expansion section. Optionally, in the relaxed state, each distal section has a length extending from a proximal apex to a distal apex of the respective distal section. Optionally, in the relaxed state, each of the enlarged sections is longer than each of the distal sections. Optionally, for some, most, or each of the expansion sections, the distance from the proximal end of the expansion section to the free distal apex of the expansion section is equal to the distance from the free distal apex of the expansion section to the distal end of the expansion section. less than the distance. Optionally, in the relaxed state, the basket does not have any free apex oriented generally proximally. Optionally, the distal body includes a distal tapered region in which, in the relaxed state, the distal body height and width decrease as the basket approaches the distal junction. Optionally, each enlarged section is longer than each of its paired sections in said series. Optionally, in the relaxed state, each of the enlarged sections extends from the 6 o'clock position to the 12 o'clock position or from the 3 o'clock position to the 9 o'clock position. Optionally, in the relaxed state, the basket further includes a plurality of proximal compartments proximal to the proximal-most free distal apex of said series. Optionally, the plurality of proximal compartments include a proximal apex attached to the proximal junction and oriented generally proximally, and a distal apex oriented generally distally and attached to another compartment of the basket. and has. Optionally, the proximal apex of the section, including the proximal-most free distal apex, is attached to the distal end of the proximal strip. Optionally, in the relaxed state, for each expansion section, two basket strips intersect to form a distal apex located at the distal end of the expansion section. Optionally, each basket strip has a proximal basket strip end, a distal basket strip end, and a basket strip length extending from the proximal end to the distal end. Optionally, for at least some, most or each of the enlarged sections, the maximum angle between two basket strips at the same location along the distal body length is at least 90 degrees. Optionally, in the relaxed state, for said at least some, most or each of the enlarged sections, two basket strips intersect to form a free distal top of the enlarged section, and each basket strip one proximal end, a basket strip distal end, and a basket strip length extending from the proximal end to the distal end, and further, the maximum angle between the two basket strips at the same location along the distal body length is , less than 40°. Optionally, for at least some, most or each of the expansion sections, the average angle between the two basket strips is at least 90°. Optionally, for at least some, most or each of the enlarged sections, each basket strip length is approximately equal to one half of the distal body height and width. Optionally, from at least the proximal apex of the compartment containing the next most proximal free distal apex to the proximal end of the enlarged compartment formed by the subsequent free distal apex, the basket includes an enlarged compartment and a free distal apex. It does not have any compartments other than the compartment including the distal apex. Optionally, at least from the most proximal free distal apex to the proximal end of the enlarged compartment formed by the subsequent free distal apex, the basket includes a compartment other than the enlarged compartment and the free distal apex. does not have. Optionally, the distal top of the enlarged section is attached to another section of the basket. Optionally, in the relaxed state, the basket further has approximately the same distance from the proximal junction (i.e., the same Contains an additional pair of compartments located at a distance of +/-5mm). Optionally, each compartment of the additional pair of compartments has a proximal apex attached to the shape memory metal strip and a distal apex attached to another compartment of the basket. Optionally, additional pairs of compartments are adjacent to the enlarged compartment formed by the proximal-most free distal apex. Optionally, from at least the distal apex of the additional pair of compartments to the proximal end of the enlarged compartment formed by the subsequent free distal apex, the basket includes the enlarged compartment, the compartment containing the free distal apex, and the compartment. It has no compartments other than an additional pair of . Optionally, in the relaxed state, the basket includes a series of bridging shape memory metal strips having a proximal end attached to the distal apex of the compartment and a distal end attached to the proximal apex of the distally located compartment. Including pieces. Optionally, a proximal pair of bridge memory metal strips are located at the 3 o'clock and 9 o'clock positions. Optionally, a pair of more distal bridge memory metal strips are located at the 12 o'clock and 6 o'clock positions. Optionally, each of the pair of bridging shape memory metal strips forms part of at least one enlarged section. Optionally, the bridge memory metal strips include a single distally extending basket strip attached to each proximal top and a single proximally extending basket strip attached to each distal top. It's a piece. Optionally, in the relaxed state, each of the pair of bridging shape memory metal strips forms part of two enlarged sections. Optionally, the bridge shape memory metal strip is substantially parallel to the distal body length. Optionally, the plurality of distal compartments is comprised of four compartments located approximately the same distance from the proximal junction (ie, the same distance +/-5 mm). Optionally, each compartment has a center, and the centers of the compartments are spaced approximately 90 degrees apart around the distal body circumference. Optionally, each of said four compartments is adjacent to two others of said four compartments. Optionally, each of the four sections includes two lateral apexes oriented generally perpendicular to the distal body length, and each lateral apex of one of the four sections includes: Adjacent to the lateral top of an adjacent one of the four sections. Optionally, the distal body has four or fewer compartments anywhere along the length of the distal body. Optionally, each of the enlarged sections is approximately the same size. Optionally, in the relaxed state, the interior of the basket is substantially hollow. Optionally, the basket has a proximal apex oriented generally proximally and attached to the shape memory metal strip, and a free distal apex oriented generally distally on the distal body periphery. comprising a series of at least five pairs of compartments located at the 3 o'clock and 9 o'clock The most distal free distal apex is located at the 12 o'clock and 6 o'clock positions and approximately the same distance from the proximal junction (same distance +/-5 mm) Located approximately the same distance from the end junction (same distance +/-5mm). Optionally, the enlarged sections formed by the proximal-most free distal apex are adjacent, and the enlarged sections formed by the next most proximal free distal apex are adjacent and subsequent The enlarged sections formed by the free distal apices of are adjacent. Optionally, each of the enlarged sections formed by the next most proximal-most free distal apex is the enlarged section formed by the proximal-most free distal apex, and the subsequent free distal apex. adjacent to the enlarged section formed by. Optionally, the distal body further includes a lead wire extending distally from the distal junction. Optionally, the system further has an interior, a proximal end communicating with the interior, and a distal end communicating with the interior, the system being constructed of a biocompatible material and configured to wrap around the distal body when the distal body is in a deflated state. comprising a catheter. Optionally, for each expansion section, the free distal apex is aligned with the distal apex located at the distal end of the expansion section. Optionally, the distal body includes a proximal tapered region in which the distal body height and width decrease as the proximal strip approaches the proximal junction in the relaxed state. Optionally, the system provides a method for removing a blood clot from a blood vessel in an animal comprising: a) providing the system; b) positioning the system within the blood vessel; c) determining the height and width of the distal body. d) moving the clot into the interior of the basket; and e) moving the distal body proximally out of the blood vessel.

Optionally, in place of the three pairs of compartments in said series, the series includes a proximal apex section oriented generally proximally and attached to a shape memory metal strip, and a free section oriented generally distally. may include only two pairs of compartments located on the distal body periphery with free distal apexes, of which the most proximal free distal apexes are at 12 o'clock and 6 o'clock. and approximately the same distance from the proximal junction (same distance +/-5mm), with the next most proximal free distal apex at the 3 o'clock and 9 o'clock positions. and approximately the same distance from the proximal junction (same distance +/-5 mm). In such embodiments, the distal body and system may have any of the features described above in connection with the distal body having at least three pairs of compartments with free distal tops.

FIG. 1A shows a side (elevation) view of a shape memory metal tube before being cut by a laser. FIG. 1B shows a side (elevation) view of the shape memory metal tube of FIG. 1A being cut by a laser. FIG. 2A shows a side (elevation) view of the shape memory metal tube of FIG. 1B after it has been cut by the laser. In Figure 2A, the tube is shown as if it were flat just to show the cut pattern. FIG. 2B shows a side perspective view of the shape memory metal tube of FIG. 1B after being cut by the laser. Figure 2C shows another side perspective view of the shape memory metal tube of Figure 1B after being cut by the laser. In Figure 2C, the tube has been rotated compared to Figure 2B. 3A-3H illustrate a method of manufacturing the distal body of one embodiment of the invention using the laser cut shape memory metal tube of FIGS. 1 and 2. FIG. For simplicity, the basket portion of the distal body is not shown in Figures 3A-3H. 4A to 4D show the welding process of the manufacturing method shown in FIG. 3. For simplicity, the basket portion of the distal body is not shown in FIGS. 4A-4D. FIG. 7 illustrates different locations where the connector strip may be welded to the proximal shape memory metal strip. FIG. 7 illustrates different locations where the connector strip may be welded to the proximal shape memory metal strip. Figure 7 shows a side (elevation) view of the catheter and distal body of Figure 6; 1 shows a side (elevation) view of a deployable system of one embodiment of the invention being used to capture blood clots. FIG. For simplicity, the basket portion of the distal body is not shown in FIG. 8. FIG. 3 shows a side (elevation) view of a pawl of one embodiment of the invention closed by a pawl actuator tube. For simplicity, the basket portion of the distal body is not shown in FIG. 9. 1 shows a side (elevation) view of a deployable system of one embodiment of the invention being used to capture blood clots. FIG. For simplicity, the basket portion of the distal body is not shown in FIG. 10. FIG. 6 shows a first perspective view of a distal body of an alternative embodiment of the invention. The distal body is in what is referred to herein as "orientation 1." FIG. 12A shows a second perspective view of the distal body of FIG. 11. The distal body is in what is referred to herein as "orientation 2." FIG. 12B shows a proximal elevation view of the proximal strip of the distal body of FIG. 11; FIG. 12 shows an enlarged perspective view of the two distally facing non-securing peaks of the distal body of FIG. 11; FIG. 14A shows the original shape memory metal tube used to manufacture the distal body of FIG. 11. The original tube was rolled flat and the lines in the tube indicate where the tube was cut by the laser. FIG. 14B shows a first perspective view of the distal body manufactured from the original tube of FIG. 14A. The distal body is in orientation 1. FIG. 14C shows a second perspective view of the distal body manufactured from the original tube of FIG. 14A. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 1. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows the step-by-step use of the distal body of Figure 11 in retrieving a soft clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. Figure 12 shows step-by-step use of the distal body of Figure 11 in retrieving a hard clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 12 shows stepwise use of the distal body of FIG. 11 in retrieving a deformable sticky clot. The distal body is in orientation 2. FIG. 20A shows a diagram of the original shape memory metal tube used to manufacture the distal body of yet another embodiment of the invention. The original tube was rolled flat, the lines in the tube indicate where the tube was cut by the laser, and the distal body in Figures 20A-20C is slightly smaller than the distal body in Figures 11-19. Intended for use in short, tortuous vessels. FIG. 20B shows a first perspective view of the distal body manufactured from the original tube of FIG. 20A. The distal body is in orientation 1. FIG. 20C shows a second perspective view of the distal body manufactured from the original tube of FIG. 20A. The distal body is in orientation 2. 20B-C shows a perspective view of a clot retrieval system including the distal body of FIGS. 20B-C being delivered into a blood vessel using a delivery catheter. FIG. Figure 22 shows a perspective view of the distal body of Figure 21 after it has been deployed and the delivery catheter has been retracted into the blood vessel. 22 shows a perspective view of the distal body of FIG. 21. FIG. Compared to Figure 22, the distal body has been moved proximally and tension is applied to the pull wire. 22 shows a perspective view of the aspiration catheter being delivered over the pull wire of the system of FIG. 21. FIG. Figure 25 shows a perspective view of the tip of the aspiration catheter of Figure 24 being pushed into a blood clot. The user has pulled back on the syringe lever so that the syringe is aspirating the clot into the suction catheter. Figure 25 shows a perspective view of the tip of the aspiration catheter of Figure 24 being pushed into a blood clot. In Figure 26, the user has locked the syringe lever to the desired amount. Figure 25 shows a perspective view of the system of Figure 24; In Figure 27, the aspiration catheter has aspirated the distal body and clot partially into the aspiration catheter. Figure 25 shows a perspective view of the system of Figure 24; In Figure 28, the suction catheter has suctioned the distal body and clot completely into the suction catheter. Figure 25 shows a perspective view of the system of Figure 24; The system and captured clot are being removed proximally from the blood vessel. Figure 3 shows a right side perspective view of a mandrel used to prepare an unattached, distally facing top that curves radially towards the interior of the basket. Figure 31 shows a right side elevation view of the mandrel of Figure 30; 32 shows an alternative embodiment of the distal body; in the distal body of FIG. 32, the proximal strips converge and are soldered or welded at the proximal hub/junction, with the basket strip located at the distal end of the basket; converge and are soldered or welded at the distal hub/junction. FIG. 33A shows a raw shape memory metal tube used to fabricate the distal body of another embodiment of the invention; the raw tube is stretched flat and the lines within the tube are shows the location where the laser was cut. FIG. 33B shows a first perspective view of a distal body made from the raw tube of FIG. 33A; in FIG. 33B, the distal body is in Orientation 1. FIG. 33C shows a second perspective view of a distal body made from the raw tube of FIG. 33A; in FIG. 33C, the distal body is in Orientation 2. FIG. 34A shows a first perspective view of the distal body of another embodiment of the invention; in FIG. 34A, the distal body is in Orientation 1. FIG. 34B shows a second perspective view of the distal body of FIG. 34A; in FIG. 34B, the distal body is in Orientation 2. FIG. 35A shows a first perspective view of the proximal portion of the distal body of another embodiment of the invention; in FIG. 35A, the distal body is in Orientation 1. FIG. 35B shows a second perspective view of the proximal portion of the distal body of FIG. 35A; in FIG. 35B, the distal body is in Orientation 2. FIG. 36A shows a front perspective view of the distal body of another embodiment of the invention; in FIG. 36A, the distal body is in a relaxed state. FIG. 36B shows another front perspective view of the distal body of FIG. 36A without the proximal and distal hubs/junctions and pull wires. FIG. 36C shows an enlarged front perspective view of the distal body of FIG. 36A. FIG. 36D shows an enlarged front perspective view of the area labeled 36D in FIG. 36C. FIG. 36E shows an enlarged front perspective view of the area labeled 36E in FIG. 36C. FIG. 36F shows an enlarged front perspective view of the area labeled 36F in FIG. 36C. FIG. 36G shows an enlarged front perspective view of the area labeled 36G in FIG. 36E. FIG. 36H shows an enlarged front perspective view of the area labeled 36H in FIG. 36F. FIG. 36I shows a top plan view of the distal body of FIG. 36A. FIG. 36J shows a front elevational view of the distal body of FIG. 36A. FIG. 36K shows a bottom plan view of the distal body of FIG. 36A. FIG. 36L shows a rear elevational view of the distal body of FIG. 36A. FIG. 36M shows a proximal elevational view of the distal body of FIG. 36A; in FIG. 36M, the miniature clock face shows the 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions. FIG. 36N shows a distal elevation view of the distal body of FIG. 36A; in FIG. 36N, the miniature clock face shows the 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions. FIG. 37A shows a front perspective view of the distal body of another embodiment of the invention; in FIG. 37A, the distal body is in a relaxed state. FIG. 37B shows another front perspective view of the distal body of FIG. 37A without the proximal and distal hubs/junctions and pull wires. FIG. 37C shows a top plan view of the distal body of FIG. 37A. FIG. 37D shows a front elevational view of the distal body of FIG. 37A. FIG. 37E shows a bottom plan view of the distal body of FIG. 37A. FIG. 37F shows a rear elevational view of the distal body of FIG. 37A. FIG. 37G shows an enlarged front elevation view of the area labeled 37G in FIG. 37A. FIG. 37H shows a proximal elevational view of the distal body of FIG. 37A; in FIG. 37H, the miniature clock face shows the 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions. FIG. 37I shows a distal elevation view of the distal body of FIG. 37A; in FIG. 37I, the miniature clock face shows the 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions. FIG. 37J shows an enlarged front perspective view of the area labeled 37J in FIG. 37A. FIG. 37K shows an enlarged rear elevation view of the area labeled 37K in FIG. 37F. FIG. 38 shows a side elevational view of the distal body and expandable suction catheter of another embodiment of the invention. FIG. 39 shows a side elevational view of a non-expandable aspiration catheter of another embodiment of the invention with the aspiration catheter transparent to show the inner blocking catheter. Figure 39A shows a side elevational view of the tip of a suction catheter of another embodiment of the invention. FIG. 39B shows a side elevational view of the tip of a suction catheter of another embodiment of the invention. FIG. 40 shows a side perspective view of the distal body and expandable suction catheter of another embodiment of the invention. FIG. 41 shows a side perspective view of the distal body and expandable suction catheter of another embodiment of the invention. FIG. 42 shows a side perspective view of a distal body, a portion of an expandable suction catheter, and a guide catheter of another embodiment of the invention. FIG. 43 shows a side perspective view of the distal body and suction catheter of FIG. 42. Figure 44A shows a side perspective view of the distal body and suction catheter of Figure 42 being used to capture a blood clot in a pulmonary blood vessel; It has expanded into the clot; the suction force is pulling the clot toward the suction catheter, as shown by the arrow pointing toward the suction catheter. Figure 44B shows a side perspective view of the distal body and suction catheter of Figure 44A being used to capture a clot; as compared to Figure 44A, in Figure 44B the distal body is fully expanded. (i.e. in its fully relaxed state). 45A-45G show side perspective views of the distal body and stepwise sequence of the suction catheter of FIG. 42 being used to capture a blood clot in a pulmonary vessel, with the guide catheter also shown in FIGS. 45B-45G. 45G shows how the clot is forced proximally out of the blood vessel. See description of Figure 45A. See description of Figure 45A. See description of Figure 45A. See description of Figure 45A. See description of Figure 45A. See description of Figure 45A. FIG. 46A shows a side perspective view of the distal body and expandable suction catheter of another embodiment of the invention. FIG. 46B shows a close-up side perspective view of the distal body and expandable suction catheter of FIG. 46A.

DETAILED DESCRIPTION Referring to FIGS. 1-10, the present disclosure provides a method for removing an obstruction or other object, such as a blood clot 12, from a blood vessel 14 or other lumen of an animal, generally designated by the reference numeral 10. Provides a deployable system. In addition to blood clots12, occlusions may include, for example, coils extruded during aneurysm procedures, intravascular emboli such as onyx or other vasculature requiring mechanical endovascular removal from small distal vessels. May be an obstruction. For clarity, not all reference numbers in the figures have been included in each figure.

Still referring to FIGS. 1-10, deployable system 10 includes a pullwire 16 having a proximal end (not shown) and a distal end 20. As shown in FIGS. Optionally, the diameter of the pull wire is about 0.008 inch to about 0.051 inch. Preferably, pull wire 16 is constructed from a biocompatible metallic material.

System 10 further includes a distal body 22 attached to pull wire 16. Distal body 22 has a proximal end 24, a distal end 26, an interior 28, and an exterior 30. The distal body 22 has a deflated state, in which the distal body 22 has a first height and a width, and is configured to fit within the catheter 50 (see FIG. 10A); have different heights 32 and widths and are configured to expand to approximately the height and width of the human blood vessel 14 when the distal body 22 is deployed from the catheter 50 (see FIGS. 10B-G). and has. Distal body 22 further includes a proximal hub/junction 74 and a distal hub/junction 76 located distal to proximal hub/junction 74. In some embodiments, the distal body 22 includes a plurality of strips 40 comprised of a shape memory metal (eg, a shape memory alloy such as Nitinol) forming the proximal end 24 of the distal body 22. Optionally, the proximal shape memory metal strips 40 each have a distal end 44 and a proximal end 42 forming a retractable pawl 46. Optionally, proximal shape memory metal strip 40 is attached to proximal hub/junction 74 via connector shape memory metal strip 48. In such embodiments, the proximal hub/junction 74 is optionally fixed to the pull wire 16 and extends along at least a section of the pull wire 16, as opposed to the distal hub/junction 76 that cannot slide along the pull wire 16. may be slidable. Moving the proximal hub/junction 74 distally toward the distal hub/junction 76 (i.e., moving the proximal hub/junction 74 distally while keeping the distal hub/junction 76 fixed) (by reducing the distance 88 between the proximal hub/junction 74 and the distal hub/junction 76), tension is applied to the connector shape memory metal strip 48 and thus the proximal shape memory metal strip 40. This tension, in turn, moves the proximal ends 42 of the proximal shape memory metal strips 40 radially toward each other and the pull wire 16. As the proximal ends 42 of the proximal shape memory metal strips 40 move radially toward each other and the pull wire 16, the pawls 46 (formed by the proximal shape memory metal strips 40) move at least Moved to a partially closed position, it in turn separates the obstruction 12 from the wall of the human lumen 14 and captures the obstruction 12. See Figures 3H, 8, 9F and 10F and 10G. Conversely, movement of the proximal hub/junction 74 proximally away from the distal hub/junction 76 (i.e., increasing the distance 88 between the hub/junction 74 and the hub/junction 76) preferably The tension in the proximal shape memory metal strips 40 is released, which in turn forces the proximal ends 42 of the proximal shape memory metal strips 40 away from each other and from the pull wire 16, causing the pawls 46 to open. Pawl 46 and proximal hub/junction 74 serve several functions. First, as described above, closure of pawl 46 captures obstruction 12. Second, closure of pawl 46 retracts pawl 46 from the wall of lumen 14 so that pawl 46 does not scratch (and damage) the lumen wall while capturing the obstruction 12. do. Third, closure of pawl 46 reduces the height and width of distal body 22, which allows distal body 22 to be repositioned within catheter 50. This may occur, for example, if the operator wishes to deploy the distal body 22 again at a different location within the body (if the operator initially deploys the distal body 22 at the wrong location in the lumen 14; applicable) and may be desirable. In the context of the present invention, "closing the pawl" includes partially closing the pawl 46 (the proximal end 42 of the proximal shape memory metal strip 40 does not contact the pull wire 16) and fully closing the pawl 46 ( proximal end 42 contacts pull wire 16).

Pawl 46 may be comprised of any number of proximal shape memory metal strips 40. However, preferably two to four proximal shape memory metal strips 40 constitute pawl 46 (if connector strip 48 is present, it simply connects pawl 46 to proximal hub/junction 74). ). Preferably, proximal shape memory metal strip 40 has a length of about 10 to about 60 millimeters. The proximal shape memory metal strip 40 can be thought of as the arm of the pawl 46.

In some embodiments, connector strip 48 is integral (ie, formed from the same piece of shape memory metal) with proximal hub/junction 74. In other embodiments, proximal hub/junction 74 may be welded or soldered to connector strip 48. Optionally, in the relaxed state, the proximal shape memory metal strips 42 are substantially evenly distributed around the circumference of the distal body 22.

Optionally, distal body 22 includes a lead wire 52 extending distally from distal body 22. Optionally, lead wire 52 extends distally from distal hub/junction 76. If present, lead wire 52 may be used to facilitate movement of system 10 within lumen 14.

Optionally, the distal body 22 includes a basket 54 distal to the proximal shape memory metal strip 40, the basket 54 being distal to the proximal shape memory metal strip 40. It is composed of a plurality of shape memory metal strips 56. Distal shape memory metal strip 56 may, for example, form a basket 54 having a plurality of mesh openings 58. Optionally, the size of the mesh apertures 58 in the basket 54 when the distal body 22 is in its relaxed state is an average size to prevent clots 12 from slipping out of the distal basket 54 after being captured by the distal body 22. smaller (preferably significantly smaller) than the diameter of the ischemic clot 12. Optionally, the basket 54 has an open proximal end 60 and a substantially closed distal end 62 formed by a distal tube 76. Optionally, distal hub/junction 74 and proximal hub/junction 76 and distal basket 54 are constructed of Nitinol having the same material composition. Optionally, the size of the mesh openings 58 decreases from the proximal end 60 to the distal end 62 of the basket 54. The distal basket 54 is best seen in FIG. 2 and can be configured with different numbers of compartment patterns. Distal basket 54 is not shown in FIGS. 3-10 to facilitate illustration of other components in system 10.

Optionally, proximal hub/junction 74 and distal hub/junction 76 are cylindrical tubes containing substantially circular openings spanning the length of hub/junctions 74 and 76, and hub/junctions 74 and 76 are They have approximately the same inner diameter 72 and the same outer diameter 70. Preferably, the inner diameter 72 is at least slightly larger than the diameter of the pull wire 16 so that the pull wire 16 can slide within the proximal hub/junction 74. In some embodiments, the outer diameter 70 of proximal hub/junction 74 and distal hub/junction 76 can be about 0.011 inch to about 0.054 inch, and proximal hub/junction 74 and distal hub/junction 76 The inner diameter 72 of can be about 0.008 inch to about 0.051 inch.

Optionally, the distal body 22 further includes a proximal shape memory metal strip under X-rays when the distal body 22 is positioned in a cranial blood vessel within the human body and an X-ray image is taken from outside the human body. Contains an X-ray marker 64 that is easier to see than the piece 40. If the connector strip 48 is welded or soldered to the proximal shape memory metal strip 40, the x-ray marker 64 may be located at the weld or solder site, for example. In some cases, the increased thickness of the weld or soldering site itself may constitute the X-ray marker 64. Preferably, X-ray marker 64 is constructed from a radiopaque material. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Preferably, proximal shape memory metal strip 40 is constructed of Nitinol and X-ray marker 64 is constructed of a material having a higher density than Nitinol.

A catheter 50 having an open proximal end (not shown) and an open distal end 66 initially encloses the system 10. The term "catheter" as used herein generally refers to any suitable tube through which system 10 can be deployed. Preferably, the catheter 50 is sterile and made of biocompatible materials (i.e., does not irritate the human body during the 45 minute surgical process, which includes removing the clot 12 from the intracranial blood vessel 14 using the system 10). material). Catheter 50 can be any suitable shape, including but not limited to being generally cylindrical. Preferably, catheter 50 is a microcatheter. In the context of the present invention, reference to catheter 50 encasing system 10 is understood to mean that catheter 50 encases at least one component of system 10 (preferably distal body 22, lead wire 52 and pull wire 16). Ru. In some embodiments, catheter 50 is approximately 2.5 French in diameter. Optionally, catheter 50 is delivered to the region of lumen 14 having occlusion 12 as follows. A guidewire is delivered to the area of the obstruction and past the obstruction 12; a catheter 50 is delivered over the guidewire; the guidewire is withdrawn; the system 10, along with its pull wire 16 and lead wire 52, is Deliver through 50. Optionally, pull wire 16 is used to push system 10 through catheter 50 and retrieve distal body 22 after capturing occlusion 14 as described below. The system 10 includes a plurality of catheters 50, such as a wider catheter that travels to the brain and a highly flexible, smaller diameter microcatheter that is delivered from the first catheter and travels through small arteries in the brain. It can be used. Preferably, catheter 50 is constructed from a biocompatible polymeric material (ie, one or more polymeric materials, such as silicone, PVC, latex rubber, or braided nylon).

Optionally, the distal body 22 or only the distal basket 54 tapers from the proximal end of the distal body 22 or the distal basket 54 to the distal end, such that in the relaxed state with the pawl open, The side bodies 22, or optionally only the distal basket 54, have a tapered shape (eg, substantially conical or bullet-shaped).

The proximal end of system 10 is shown at the left end of FIGS. 1 and 3-10, and the distal end of system 10 is shown at the right end of FIGS. 1 and 3-10. This is because the primary use of system 10 is to remove blood clots 12 from human intracranial arteries 14, in which case system 10 typically has a catheter 50 at its proximal end that a surgeon uses to remove blood clots 12 from human intracranial arteries 14. This is because by entering the patient's body and pushing towards the brain, it enters the artery 14. The diameter of human artery 14 generally decreases from its proximal end to its distal end. However, when used with other types of lumens, when the terms "proximal" and "distal" are used with that lumen, the distal body 22 is defined as proximal to the catheter 50. may be located.

The surgeon may deploy the distal body 22, for example, by moving the catheter 50 proximally to cause the distal body 22 to exit the sheath or by pushing the distal body 22 out of the catheter 50.

Although the use of system 10 is described below with respect to removing a blood clot 12 from an intracranial artery 14 of a human ischemic stroke patient, system 10 may also be used to remove other objects from other lumens. It will be understood that this can be done.

A catheter 50 including a deflated distal body 22 is positioned within the lumen 14 distal to the clot 12. See Figure 10A.

When distal body 22 is deployed from catheter 50, the height and width of distal body 22 increases to approximately the height and width of blood vessel 14. See Figure 10B.

Catheter 50 is withdrawn proximally and pawl actuator tube 90 is placed into blood vessel 14. See Figure 10C.

Distal body 22 is moved proximally so that clot 12 is located within interior 28 of distal body 22. See Figures 10D and 10E.

As pawl actuator tube 90 is moved distally, it pushes proximal hub/junction 74 distally, causing proximal hub/junction 74 and distal hub/junction 76 (which is secured to pull wire 16 and (maintained in a fixed state) is reduced. Distal movement of the proximal hub/junction 74 tensions the connector and proximal shape memory metal strips 40 and 48, which in turn cause the pawl 46 to close. Referring to FIG. 10F, the pawl actuator tube 90 should float over the pull wire 16, i.e., have an opening extending the length of the tube with a diameter larger than the diameter of the pull wire 16, and the opening of the pawl actuator tube 90 should be smaller than the diameter of the proximal hub/junction 74 so that the pawl actuator tube 90 pushes against the proximal hub/junction 74).

System 10 is withdrawn proximally and removed from the body. See Figure 10G.

To test the efficacy of the system 10, a distal basket 54, a proximal hub/junction 74 and a distal hub/junction 76, and a pawl 46 comprised of three proximal shape memory metal strips 42 were used. The distal body 22 with a 100 mm diameter was tested in a flow model that included a tube and moist cotton wool located within the tube. Cotton wool was used to mimic a blood clot. System 10 was deployed distally against cotton wool. By moving the proximal hub/junction 74 distally, the pawl 46 was closed and the cotton wool was captured. System 10 and cotton wool were withdrawn proximally in the tube.

In some embodiments, distal body 22 is prepared by a method that includes one or more of the following steps, as illustrated in FIGS. 1-4.
a) providing a tube 68 constructed of a shape memory metal such as Nitinol, the tube 68 having an exterior, a substantially hollow interior, an exterior and a substantially hollow interior; (See FIG. 1A) having a wall separating the two, an open proximal end 74, an open distal end 76, and an intermediate portion 78 between the open proximal end 74 and the open distal end 76;
b) cutting the wall of the intermediate section 78 by a laser 80 (see Figure 1B);
c) a plurality of shape memory metal strips attached to proximal tube 74, distal tube 76, and proximal tube 74 by removing fragments of intermediate portion 78 cut by laser 80; forming an intermediate portion 78 including 82;
d) using a mandrel to change the shape of intermediate section 78 to allow intermediate section 78 to expand relative to distal tube 76 and proximal tube 74 to form distal basket 54; ;
e) cooling the intermediate section 78 to room temperature;
f) removing the mandrel from the intermediate section 78 (see Figures 2 and 3A);
g) mechanically or chemically electropolishing the intermediate portion 78 to remove oxides;
h) cutting the shape memory metal strip 82 to form a first section 84 including the proximal tube 74 and the proximal section of the shape memory metal strip 82 and the distal tube 76 and the shape memory metal strip; forming a second section 86 including a distal section of piece 82 (see FIG. 3B); and
i) joining the proximal section to the distal section such that the distal section forms the proximal end 24 of the distal body 22 and the proximal tube 74 is located inside the interior 28 of the distal body 22; , so that the proximal tube 74 is located distally relative to the distal body proximal end 24 (see FIGS. 3C-3E).

In some embodiments, the method further includes passing the pull wire 16 into the proximal tube 74 such that the proximal tube 74 is slidable along at least a section of the pull wire 16. include.

In some embodiments, the method further includes attaching the pull wire 16 to the distal tube 76 such that the distal tube 76 cannot slide along the pull wire 16 and instead moves with the pull wire 16. Includes installation process.

In some embodiments, after step i, the proximal end 24 of the distal body 22 forms a pawl 46 comprised of two to four proximal shape memory metal strips 40, such that the proximal end becomes the pawl. The side shape memory metal strips 40 are moved together by moving the proximal tube 74 distally toward the distal tube 76 (i.e., reducing the distance 88 between the tubes 74 and 76). and the detent memory metal strip 40 is configured to move toward the pull wire 16 and pull the proximal tube 76 proximally away from the distal tube 76 (i.e., between the tube 74 and the tube 76). and (as described above) (as described above).

In some embodiments, the intermediate section 78 is expanded by heating the mandrel and intermediate section 78, for example, by placing the mandrel and intermediate section 78 in a fluidized sand bath at about 500° C. for about 3 to about 7 minutes. . When intermediate section 78 is heated, the heating rearranges the crystal structure of shape memory metal tube 68. Preferably, the mandrel is tapered (eg, substantially conical or bullet-shaped) such that the distal basket 54 formed from the intermediate portion 78 tapers from the proximal end 60 to the distal end 62. Preferably, the proximal and distal ends of tubes 74 and 76 are not shaped by a mandrel or cut by laser 80, and proximal and distal ends 74 and 76 do not change shape and expand slightly in size under heating. After the heat is removed, the tube returns to its original size. Preferably, the laser cut is programmed by a computer. To ensure that the laser cuts only one side of the tube wall at a time (and not the diametrically opposite side to the desired cut surface), the laser 80 is preferably placed at the inner diameter of the desired cut surface. and the outside diameter, and the coolant is passed through the shape memory metal tube 68 to allow the laser 80 to cool before reaching the surface directly opposite the desired cut surface.

The portions of the wall not cut by laser 80 create distal basket 53, proximal tube 74 and distal tube 76 and shape memory metal strips 40, 48 and 56, as described above.

Preferably, the shape memory metal selected for the original tube 68 is designed to have sufficient elasticity and flexibility so that the distal body 22 has sufficient elasticity and flexibility after deployment from the catheter 50 in the human blood vessel 14. It has a heat of transition less than ℃).

In some embodiments, original tube 68 (and thus distal tube 74 and proximal tube 76) has an outer diameter of less than about 4 French, such as a diameter of about 1 to about 4 French. In some embodiments, the diameter of the pull wire 16 is from about 0.008 inches to about 0.051 inches, as described above, and in such embodiments, the diameter of the pull wire 16 may be approximately equal to the inner diameter 72 of the original Nitinol tube 68. good.

Without being bound by any particular theory, fabricating the distal body 22 from a single shape memory metal tube 68 provides ease of manufacture and safety from mechanical breakage, and provides rigid clot 12 and It is believed to provide the necessary tensile strength for system 10 to clear other obstructions.

Embodiment of FIGS. 11-29 FIGS. 11-29 illustrate an alternative embodiment 200 that includes one or more of the following additional features: a twisted proximal strip/tether 252, optionally curved inwardly. , an unsecured/free distally facing apex 258 with an X-ray marker 244, and a distal end in the basket 246 that allows an obstruction or other object 270 to enter the distal basket interior 222. Enlarged aperture/drop zone 262 immediately distal to side facing unfixed apex 258.

More specifically, as shown in FIGS. 11-29, the system 200 includes a pull wire 202 having a proximal end 204 and a distal end 206, as described above; a distal body 216 attached to the pull wire 202; a proximal hub forming the proximal end 218 of the distal body 216; a proximal end 218; a distal end 220; /junction 228 (preferably in the form of a tube and having a proximal end 230 and a distal end 232) and a plurality of compartments/openings 248 formed by a plurality of basket strips 291, preferably constructed of shape memory metal. a configured basket 246 and, optionally, a distal hub/junction 236 (preferably in the form of a tube having a proximal end 238 and a distal end 240) forming the distal end 220 of the basket 246, and each proximal strip. 252 is attached to the proximal end 254 attached to the proximal hub/junction/tube 228 and to the compartment 248 (more specifically, to the proximally facing top of the compartment 248 located at the proximal end of the basket 246). a distal body 216 including a plurality of proximal strips 252 (preferably the proximal strips 252 are constructed of shape memory metal) having a distal end 256 (the basket includes a basket interior 292; The distal body 216 has a relaxed state in which the distal body 216 has a first height and width, and a relaxed state in which the distal body 216 has a second height and width and the second height has a first height. and a deflated state in which the second width is less than the first width); a delivery catheter for delivering distal body 216 as described above, constructed of a compatible (preferably polymeric) material and configured to wrap around distal body 216 when distal body 216 is in a deflated state; 208. Optionally, basket interior 292 is substantially hollow. That is, unlike US Patent Publication No. 2013/0345739, the basket interior 292 does not include an elongated inner body. Optionally, basket 246 includes an open tip in place of distal hub/junction 236. Optionally, the at least two sections 250 of the basket 246 include a proximal apex 260 oriented generally proximally and a distal apex 258 oriented generally distally; 258 is not attached to another compartment 248 of basket 246. In other words, the distal tops 258 of the at least two compartments 250 are free floating and are not attached to any strip except for the strip forming part of the at least two compartments 250. Hereinafter, such a distal end side apex 258 will be referred to as a non-fixed apex 258 facing toward the distal end. Preferably, the distal tip of the distally facing non-anchored apex 258 terminates in an Referring to at least two sections including a proximal oriented apex 260 and a distally oriented non-anchored apex 258, the sections labeled with reference numbers 262, 262A, 262B, 262C and 262D refer to a distally oriented non-anchored apex 258; Refers to the expansion compartment/drop zone adjacent to (preferably immediately distal to) the fixed apex 258, and the compartment designated by reference numeral 248 generally refers to the compartment of the basket 246) (the expansion compartment/drop zone When we say that 262 is immediately distal to the preferably distally facing free apex 258, we mean that because of the shape of the expansion zone/drop zone 262, as shown in FIGS. At least a portion of the drop zone 262 is immediately distal to the distally facing unanchored apex 258 and a portion of the expansion section/drop zone 262 is proximal to the distally facing unanchored apex 258. (understood as being on the side). It will be appreciated that part number 250 generally refers to one or more of the at least two compartments, while part numbers 250A, 250B, 250C, and 250D refer to a specific one of the at least two compartments. Similarly, it is understood that part number 262 generally refers to one or more of the expansion compartments/drop zones, while part numbers 262A, 262B, 262C and 262D refer to a specific one of the expansion compartments/drop zones. It will be. Similarly, part number 258 generally refers to one or more of the distally facing non-securing peaks, while part numbers 258A, 258B, 258C and 258D refer to a specific one of the distally facing non-securing peaks. It can be understood that it refers to

Optionally, as best shown in FIG. 12A, at least two of the distally facing non-securing peaks 258 are approximately 180° relative to each other (e.g., about 150° to about 180°) and at the proximal hub/junction. / located approximately the same distance from tube 228. Optionally, the basket 246 includes a first pair of distally facing non-secure peaks 258A and 258B, each of the first pair of distally facing non-secure peaks 258A and 258B having a proximal hub/ Located approximately the same distance from junction/tube 228 and at approximately 180° relative to each other, basket 246 is further distal to and relative to the first pair of distally facing non-anchored peaks 258A and 258B. A second pair of distally facing free peaks 258C and 258D are located at approximately 90° (eg, from about 60° to about 90°). Optionally, the second pair of distally facing non-secure peaks 258C and 258D are adjacent to the sections 250A and 250B formed by the first pair of distally facing non-secure peaks 258A and 258B; forming compartments 250C and 250D offset therefrom (in other words, optionally, the center of compartment 250A is approximately 90° to the center of compartments 250C and 250D, and optionally the center of compartment 250B is also It is also approximately 90° to the center of sections 250C and 250D). Optionally, at least one (preferably all) of the distally facing free peaks 258A, 258B, 258C or 258D include an X-ray marker 244, which indicates that the distal body 216 is located within the human body. It is located in the head blood vessel 266 and is easier to see under X-rays than the basket strip 291 when an X-ray image is taken from outside the human body. Preferably, X-ray marker 244 is a radiopaque material. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Preferably, basket strip 291 is constructed of Nitinol and X-ray marker 244 is constructed of a material having a higher density than Nitinol. In some embodiments, the X-ray marker 244 includes heavy metal welded or soldered to a distally facing free top 258. Optionally, the distally facing free apex 258 is slightly curved towards the interior 222 of the distal basket 246, which allows the distally facing free apex 258 to rub against the vessel wall 268 and cause reduce the risk of damage. Optionally, the basket 246 includes at least two compartments proximal to at least two compartments 250 including a distally facing free top 258. Optionally, the distally facing free top 258 is located at least about 5 mm (eg, about 5 to about 30 mm) from the proximal hub/junction/tube 228. Optionally, the distally facing free apex 258 is located at least about 5 mm from the distal hub/junction/tube 236. Optionally, the distally facing free peaks 258 of at least two compartments 250 also each have a portion (i.e. , a portion of the proximal border), and furthermore, the surface area of enlarged section 262 in the relaxed state is greater than the surface area of the other sections of basket 246 in the relaxed state. Optionally, the distally facing free top 258 serves several functions. 1) forming a bend point in the basket 246 that makes it easier to navigate the system 200 through the curves of the cerebral blood vessels 266; 2) an X-ray marker at the distally facing free apex 258 244 allows the operator to locate the enlarged section 262 of the basket 246 that forms the point where the hard thrombus 270B enters the basket 246; Moving 258 proximally and distally relative to object 270 allows object 270 to be ratcheted or pushed into basket 246 (as explained below, reference numeral 270 generally refers to blood Refers to clots/thrombus and other objects, 270A refers to soft clots, 270B refers to hard clots, 270C refers to deformable sticky clots). Optionally, as best shown in FIG. 12B, the proximal end 254 of the proximal strip 252 is approximately 65 to 180° (preferably approximately 180°) relative to the distal end 256 of that same proximal strip 252. ) located at In other words, preferably the proximal end 254 of the first proximal strip 252 is attached to the 12 o'clock position on the proximal tube 228 and the distal end 256 of the first proximal strip 252 is attached to the 12 o'clock position on the proximal tube 228. (terminating in the proximal section 248 of the basket 246) is located at the 6 o'clock position (i.e., 180° from the starting position) and the proximal end 254 of the second proximal strip 252 is located in the proximal tube. attached at the 6 o'clock position on 228, and the distal end 254 of the second proximal strip 252 (terminating in section 248 of basket 246) is located at the 12 o'clock position (i.e., 180° from the starting position) . This twisting feature serves two functions. 1) allows the proximal strip 252 to enclose the object 270; 2) allows the manufacturer to insert the mandrel into the basket 246 during the shaping procedure. Optionally, pull wire 202 is attached to proximal tube 228 (eg, by gluing, welding, soldering, etc.). Preferably, pull wire 202 does not extend through distal basket interior 222. Optionally, the proximal strip 252 is integral with the distal end 232 of the proximal tube 228 such that the entire distal body 216 is made from a single shape memory metal tube 264. Optionally, the proximal tops 260 of the at least two sections 250 including the distally facing free tops 258 are each attached to another section 248 of the basket 246. In other words, basket 246 preferably does not have any free floating top facing proximally. This is because a free floating apex pointing proximally may damage blood vessel 266 when distal body 216 is pulled proximally. Optionally, system 200 further includes a lead wire 286 extending distally from distal tube 236, lead wire 286 having a length of about 3 mm to about 10 mm. Optionally, distal hub/junction/tube 236, proximal hub/junction/tube 228 and basket 246 are constructed of Nitinol having the same material composition. In other words, as with the previous embodiments of FIGS. 1-10, the entire distal body 216 is optionally fabricated from a single piece of nitinol tubing 264. Optionally, the proximal and distal hubs/junctions/tubes 228 and 236 are configured to be It includes an X-ray marker 244 that is easier to see under the line than the basket strip 291. Preferably, X-ray marker 244 is a radiopaque material. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Preferably, basket strip 291 is constructed of Nitinol and X-ray marker 244 is constructed of a material having a higher density than Nitinol. In some embodiments, the proximal and distal hub/junction/tube interiors 234 and 242 are welded or otherwise welded to the interiors 234 and 242 of the proximal and distal hub/junction/tubes 228 and 236. May include attached tantalum. Optionally, the proximal and distal tubes 228 and 236 are generally cylindrical and each have an outer diameter and an inner diameter, the inner diameter of the openings of the proximal and distal tubes 228 and 236. furthermore, the outer diameters of the proximal and distal tubes 228 and 236 are substantially the same size, and further the inner diameters of the proximal and distal tubes 228 and 236 are substantially the same size. It is. Optionally, proximal and distal tubes 228 and 236 have an outer diameter of about 0.011 inch to about 0.054 inch, and further, proximal and distal tubes 228 and 236 have an inner diameter of about 0.008 inch to about 0.051 inch. Inches. Optionally, pull wire 202 is generally cylindrical, and further, pull wire 202 has a diameter of about 0.008 inch to about 0.051 inch. Optionally, distal body 216 has a length of about 10 to about 60 millimeters. Optionally, the first height 224 and first width 226 of the distal body 216 are about 2 millimeters to about 6 millimeters.

The present disclosure also provides a method of removing a blood clot or other object 270 from a lumen 266 of an animal, comprising:
a) at least two compartments 250 of basket 246 include a proximal apex 260 oriented generally proximally and a distal apex 258 oriented generally distally; is not attached (i.e., free floating) to another compartment 248 of the basket 246, and further, at least one of the distally facing free tops 258 includes an X-ray marker 244, FIGS. Process of providing 29 systems 200;
b) placing system 200 within lumen 266;
c) deploying the distal body 216 from the distal end 214 of the delivery catheter 208;
d) increasing the height 224 and width 226 of the distal body 216;
e) irradiating the X-ray marker 244 with X-rays; and
f) placing the object 270 into the distal basket interior 222.

Optionally, the object 270 is located within the distal basket interior 222 , i.e., the expansion section/drop zone 262 adjacent to (preferably adjacent to and immediately distal to) at least one of the distally facing non-anchored peaks 258 . enter. In some embodiments, the distal body 216 is configured such that at least one of the distally facing free apexes 258 (e.g., preferably the two proximal sides 258A and 258B) is distal to the object 270. Let it unfold. The x-ray marker 244 on the distally facing free top 258 is used to locate the distal body 216 relative to the clot or other object 270, as described below. Blood clots 270 are typically detected, for example, by injecting a contrast agent into blood vessels 266 proximal and distal to the area where the obstruction is thought to be, and then X-ray images show where the fluid stops moving in blood vessels 266. It will be appreciated that its location in blood vessel 266 can be found by looking at . It will also be appreciated that if object 270 is not a blood clot but is a radiopaque object, object 270 may be visible on the X-ray image.

11 and 14B show a twisted proximal strip 252, a distally facing free top 258 that is slightly inwardly curved and has an X-ray marker 244, and an obstruction or other object 270. FIG. 12 shows a first perspective view of one embodiment of the distal body 216 having an enlarged opening/drop zone 262 in the basket 246 to allow entry of the distal body 216. 11 and 14B, the distal body 216 is in orientation 1 (to prepare a basket 246 with a distally facing free top 258 that curves inward toward the basket interior 292, FIGS. 63 and 64 may be used. The mandrel 900 includes a generally cylindrical body 901 having a tapered proximal end 902 and a distal end 903 that slope like the tip of a pencil. , includes two grooves 904 extending around a cylindrical body 901. The grooves 904 include a tapered portion 905 that slopes toward a distal end 903, which tapers toward a distally facing free apex 258. (Groove 904 is generally truncated conical in shape, as shown in Figures 30-31). The two proximal distal facing free peaks 258A and 258B are located approximately the same distance from the proximal hub/junction/tube 228 and are oriented at approximately 180° with respect to each other. The two distal, distally facing non-anchored peaks 258C and 258D are approximately the same distance from the proximal hub/junction/tube 228 (and the two proximal, distally facing non-anchored peaks 258C and 258D 258A and 258B) and oriented at approximately 180° with respect to each other, and oriented approximately 90° with respect to the proximal, distally facing free apices 258A and 258B. There is. For example, for purposes of FIGS. 11-29, "approximately the same distance from the proximal hub/junction/tube 228" means that one free distal peak 258A of the first pair of distal peaks 258A/258B is When located at a distance Minus (+/-) means located at 3 millimeters (mm). Similarly, if one free distal peak 258C of the second pair of distal peaks 258C/258D is located a distance Y from the proximal hub/junction/tube 228, then the second pair of distal peaks 258C The other distal top 258D of /258D is located a distance Y plus or minus (+/-) 3 mm from the proximal hub/junction/tube 228. In a preferred embodiment, first free distal apices 258A and 258B are located the same distance from proximal hub/junction/tube 228 +/-0.5 mm. Similarly, in a preferred embodiment, second free distal apex 258C and 258D are located the same distance +/-0.5 mm from proximal hub/junction/tube 228.

The two proximal enlarged apertures/drop zones 262A and 262B distal to the proximal, distally facing free peaks 258A and 258B are approximately identical from the proximal hub/junction/tube 228. located at a distance, the centers of the two proximal enlargement apertures/drop zones 262A and 262B are oriented at approximately 180° with respect to each other (as described above, preferably proximally, distally oriented The free apices 258A and 258B form part of the proximal enlarged aperture/drop zone 262A and 262B, and the distal, distally facing free apices 258C and 258C form part of the proximal enlarged aperture/drop zone 262A and 262B. forming the proximal border of zones 262C and 262D). Two distal enlarged apertures/drop zones 262C and 262D distal to the distal, distally facing free apices 258C and 258D are located approximately the same distance from the proximal hub/junction/tube 228 and the centers of distal enlarged aperture/drop zones 262C and 262D are oriented at approximately 180° to each other and approximately 90° to proximal enlarged aperture/drop zones 262A and 262B. . 12A and 14C show a second view (orientation 2) of the distal body 216 of FIG. 11. FIG. 13 is an enlarged view of the two non-fixed tops 262 facing forward. The lines in FIG. 14 show how the Nitinol tube 264 is laser cut to create the distal body 216 shown in FIGS. 14B and 14C. It will be appreciated that FIG. 14B is a schematic illustration of the distal body 216 and the orientation shown in FIG. 11, and FIG. 14C is a schematic illustration of the distal body 216 and the orientation shown in FIG. 12A.

As described below, FIGS. 15-19 illustrate using a distal body 216 to retrieve a soft clot 270A, a hard clot 270B, and a deformable sticky clot 270C in a human intracranial artery 266. The method is shown (in Figures 15-19, the center of the artery 266 is indicated by a dashed line). As described below, the distal body 216 includes four rows of X-ray markers, namely: 1) one X-ray marker located inside the proximal tube, indicated by reference numerals 228, 244; first row; 2) a second row of two X-ray markers located on the two proximal distally facing unfixed tops, designated by reference numbers 258A, 244 and 258B, 244; (the two markers are oriented at 180° with respect to each other); 3) two a third row of line markers (these two markers are oriented at 180° to each other and 90° to the two proximal distally facing free apices); and 4) having a fourth row of one X-ray marker located inside the distal tube, indicated by reference numbers 236, 244 (the first number in the number row indicates the position of the X-ray marker). It will be understood that the second number 244 indicates that the item is an X-ray marker). As described below, when the distal body 216 is deployed so that the two proximal distally facing non-anchored peaks 258A, 244 and 258B, 244 are immediately distal to the clot 270, the interface The surgeon interventionalist (i.e., the operator of the distal body 216) uses X-rays from a first perspective and a second perspective that is offset (e.g., 90°) from the first perspective. , detect four rows of X-ray markers. The surgeon then moves the distal body 216 proximally relative to the clot 270 and takes additional x-ray images from the first and second viewpoints. As will be described in more detail below, the surgeon identifies the proximal and distal X-ray markers on the distally facing unfixed apex, i.e. 258A, 244; 258B, 244; 258C, 244 and 258D, 244 (More specifically, the convergence of the proximal and distal, distally facing non-anchored apices 258A, 244; 258B, 244; 258C, 244 and 258D, 244 as shown on the X-ray image) (or the lack thereof) is used to determine whether the clot 270 is located inside the distal body interior 222 or whether the clot 270 is deflating the distal body 216.

More specifically, FIGS. 15A-G illustrate the stepwise use of distal body 216 in retrieving a soft clot 270A in a human intracranial artery 266 (distal body 216 in FIGS. 15A-15G is in orientation 1). First, as usual, the surgeon determines the location of the clot 270A in the blood vessel 266 using, for example, a contrast agent injected proximally and distally to the clot 270A. Delivery catheter 208 encasing distal body 216 is then inserted into blood vessel 266 such that the two proximal, distally facing, loose peaks 258A and 258B are immediately distal to clot 270A. Deploy. See Figure 15B. Distal body 216 is then deployed from delivery catheter 208 by moving catheter 208 proximally. Then, the soft blood clot 270A that cannot deflate the distal body 216 enters the interior 222 of the distal body. See Figure 15C. However, at this point, the surgeon does not know that the clot 270A has entered the distal body interior 222. Thus, the surgeon can view the four rows of X-ray markers from a first perspective (i.e., from the proximal side of the distal body 216 in the orientation shown in FIGS. 15A-G; i.e., in the plane of the paper) without moving the distal body 216. to) add irradiation. As shown in Figure 15D, the first view shows four rows of X-ray markers. The first row is a single point representing the x-ray marker 228, 244 located in the proximal tube; the proximal tube x-ray marker 228, 244 is always visible as a single point. The second row is a single point representing the X-ray marker 258B, 244 located on the anterior proximal, distally facing unfixed apex; this second row of markers is a single point. This is because the rear X-ray markers 258A, 244 in the second row are directly behind the front X-ray markers 258B, 244 in the second row and are hidden from view. The third row is two points representing the two X-ray markers 258C, 244 and 258D, 244 located on the distal, distally facing unfixed top; The reason for having two points is that none of the markers 258C, 244 and 258D, 244 in the third row are hidden on the X-ray image at this angle. On the contrary, one marker 258C, 244 is located above the other marker 258D, 244, and the distal body 216 has a distal, distally facing free top 258C, 244 and a 258D, 244 and not deflated. The fourth column is a single point representing the x-ray marker 236, 244 located in the distal tube; the distal tube x-ray marker 236, 244 is always visible as a single point. Without moving the distal body 216, the surgeon approaches the four rows of X-ray markers from a second perspective that is 90° offset from the first perspective (i.e., below the distal body 216 in the orientation shown in FIG. 15A). ) add irradiation. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second row has two points representing two X-ray markers 258A, 244 and 258B, 244 located on the proximal, distally facing free top; appears as two dots because none of the markers 258A, 244 and 258B, 244 in the second row are hidden on the X-ray image at this offset angle. On the contrary, one marker 258B, 244 is located above the other marker 258A, 244, and the distal body 216 is deflated at the proximal, distally facing free apex 258A, 244 and 258B, 244. Not there. The third row is a single point representing the underlying, distal, distally facing, unfixed apical X-ray marker 258D, 244; This is because the upper X-ray markers 258C, 244 in the third row are directly behind the lower X-ray markers 258D, 244 in the third row, and are therefore hidden from view. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. Therefore, the surgeon may select the second row of X-ray markers 258A, 244 and 258B, 244 or the third row of X-ray markers 258C, 244 and 258D, 244 (i.e., both proximally and distally, It is inferred that none of the X-ray markers (on the unfixed top facing the surface) are concentrated at one point. The surgeon then moves the distal body 216 proximally relative to the soft clot 270A to remove the distal, distally facing non-securing peaks 258C, 244 and 258D, as shown in FIG. 244 is immediately distal to the clot 270A, and then the four rows of X-ray markers are reirradiated from the first and second viewpoints. As shown in Figure 15F, the results are the same as in Figure 15D. From the results in Figures 15D and 15F, the surgeon can determine whether the second row of X-ray markers 258A, 244 and 258B, 244 or the third row of X-ray markers 258C, 244 and 258D, 244 (i.e. proximal and distal X-ray marker on the distally facing unfixed top of both sides) either in the initial position of the distal body 216 (FIGS. 15C and 15D) or after moving the distal body 216 proximally. position (FIGS. 15E and 15F), thus inferring that the distal body 216 is deployed in both positions in the vessel 266. Therefore, the surgeon infers that the clot is a soft clot 270A that has entered the distal body interior 222 and moves the distal body 216 proximally to move it out of the blood vessel 266, as shown in FIG. 15G. By taking out the distal body 216 and the soft blood clot 270A captured by the distal body 216.

Figures 16A-H illustrate the stepwise use of distal body 216 in retrieving a hard clot 270B in a human intracranial artery 266 (in Figures 16A-H, distal body 216 is in orientation 1). First, as usual, the surgeon determines the location of the clot 270B in the blood vessel 266 using, for example, a contrast agent injected proximally and distally to the clot 270B. The delivery catheter 208, which wraps around the distal body 216, is then inserted into the blood vessel 266 so that the two proximal, distally facing, loose peaks 258A and 258B are immediately distal to the clot 270B. Deploy. See Figure 16B. Distal body 216 is then deployed from delivery catheter 208 by moving catheter 208 proximally. As shown in FIG. 16C, hard blood clot 270B located on top of distal body 216 causes distal body 216 to deflate. However, at this point, the surgeon does not know that clot 270B has deflated distal body 216. Thus, the surgeon illuminates the X-ray marker from a first perspective (ie, from the proximal side of the distal body 216; ie, into the plane of the page) without moving the distal body 216. As shown in Figure 16D, the first view shows four rows of X-ray markers. The first column is, as usual, a single point representing the X-ray marker located in the proximal tube, ie 228, 244. The second row is a single point representing the X-ray marker 258B, 244 located on the anterior proximal, distally facing unfixed apex; this second row of markers is a single point. This is because the rear X-ray markers 258A, 244 in the second row are directly behind the front X-ray markers 258B, 244 in the second row and are hidden from view. The third row has two points representing the two X-ray markers 258C, 244 and 258D, 244 located on the distal, distally facing unfixed top; The reason for having two points is that none of the markers in the third row are hidden on the X-ray image at this angle. Rather, one marker 258C, 244 is located above the other marker 258D, 244, and as shown in FIG. and 258D, 244 undeflated. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon then illuminates the marker from a second perspective that is 90 degrees offset from the first perspective (ie, from below the distal body 216) without moving the distal body 216. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second row has two points representing two X-ray markers 258A, 244 and 258B, 244 located on the proximal, distally facing free top; appears as two dots because none of the markers in the second row are hidden on the X-ray image at this offset angle. On the contrary, one marker 258B, 244 is located above the other marker 258A, 244. The distal body 216 is deflated at the proximal, distally facing unfixed top, as shown in FIG. 16C, because the clot 270B is over the second row of X-ray markers. The X-ray markers in the second row are not concentrated at one point. The third row is a single point representing the underlying, distal, distally facing, unfixed apical X-ray marker 258D, 244; This is because the upper X-ray markers 258C, 244 in the third row are directly behind the lower X-ray markers 258D, 244 in the third row, and are therefore hidden from view. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. Therefore, the surgeon may select the second row of X-ray markers 258A, 244 and 258B, 244 or the third row of X-ray markers 258C, 244 and 258D, 244 (i.e., both proximally and distally, It is inferred that none of the X-ray markers (on the unfixed top facing the surface) are concentrated at one point. The surgeon then moves the distal body 216 proximally so that the distal, distally facing free peaks 258C, 244 and 258D, 244 are positioned against the clot 270B, as shown in FIG. 16E. Then, irradiate the X-ray marker again from the first viewpoint. As shown in FIG. 16F, the first column is, as an example, a single point representing the X-ray marker 228, 244 located in the proximal canal. The second row is a single point representing the X-ray marker 258B, 244 located on the anterior proximal, distally facing unfixed apex; this second row of markers is a single point. This is because the rear X-ray markers 258A, 244 in the second row are directly behind the front X-ray markers 258B, 244 in the second row and are hidden from view. The third column has only one point. The reason is that the clot 270B above the third row of X-ray markers 258C, 244 and 258D, 244 (i.e., the markers on the distal, distally facing, unfixed top) This is because the X-ray markers 258C, 244 and 258D, 244 were pressed together. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon then illuminates the marker from a second perspective that is 90 degrees offset from the first perspective (ie, from below the distal body) without moving the distal body 216. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second row has two points representing two X-ray markers 258A, 244 and 258B, 244 located on the proximal, distally facing free top; appears as two dots because none of the markers in the second row are hidden at this offset angle on the This is because the top portions 258A, 244 and 258B, 244 are not deflated. The third row is a single point representing the underlying, distal, distally facing, unfixed apical X-ray marker 258D, 244; The reason is that the lower X-ray markers 258D, 244 in the third row are directly behind the upper X-ray markers 258C, 244 in the third row, and therefore the upper X-ray markers 258C, 244 in the third row This is because it is hidden and cannot be seen. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. When the surgeon moves the distal body 216 proximally, knowing that the distal, distally facing free peaks 258C, 244 and 258D, 244 have converged as shown in FIG. 16F, The hard clot 270B drops into the distal body interior 222 at an expansion zone/drop zone 262C immediately distal to the overlying, distal, distally facing unfixed apex 258C. See Figure 16G. To confirm that the hard clot 270B has entered the distal body interior 222, the surgeon takes X-ray images from the first and second viewpoints. The results are shown in Figure 16H. Compared to 16F, the frontal X-ray projection of FIG. It is inferred that the blood clot 270B entered the inside of the distal body 222. The surgeon then removes the distal body 216 and the hard clot 270B captured by the distal body 216 by moving the distal body 216 proximally out of the blood vessel 266.

Figures 17A-G show the stepwise use of distal body 216 in retrieving a soft blood clot 270A in a human intracranial artery 266 (in Figures 17A-G, distal body 216 is in orientation 2). First, as usual, the surgeon determines the location of the clot 270A in the blood vessel 266 using, for example, a contrast agent injected proximally and distally to the clot 270A. Delivery catheter 208 encasing distal body 216 is then inserted into blood vessel 266 such that the two proximal, distally facing, loose peaks 258A and 258B are immediately distal to clot 270A. Deploy. See Figure 17B. The distal body 216 is then deployed from the catheter 208 by moving the catheter 208 proximally. Then, the soft blood clot 270A that cannot deflate the distal body 216 enters the interior 222 of the distal body. See Figure 17C. However, at this point, the surgeon does not know that the clot 270A has entered the distal body interior 222. Thus, the surgeon illuminates the X-ray marker from a first perspective (ie, from the proximal side of the distal body; into the plane of the paper) without moving the distal body 216. As shown in Figure 17D, the first view shows four rows of X-ray markers. The first column is, as usual, a single point representing the x-ray marker 228, 244 located in the proximal tube. The second row has two points representing two X-ray markers 258A, 244 and 258B, 244 located on the proximal, distally facing free top; has two points because none of the markers in the second row are hidden on the X-ray image at this angle. Rather, one marker 258A, 244 is located above the other marker 258B, 244, and as shown in FIG. 244 and 258B, 244 not deflated. The third row has one point representing the X-ray marker 258C, 244 located in the proximal (orientation 2), distal, distally facing unfixed top; the markers of this third row The reason why is one point is that the X-ray markers 258D, 244 behind the third column (orientation 2) are directly behind the X-ray markers 258C, 244 in front of the third column, and are hidden and cannot be seen. It is from. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. Next, without moving the distal body, the surgeon illuminates the marker from a second perspective that is 90° offset from the first perspective (i.e., from below the distal body, as shown in this figure). Add. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second row is a single dot representing the lower (orientation 2), proximal, distally facing, unfixed apex lower X-ray marker 258B, 244; The reason why the markers in the second column are one point is that the top (orientation 2) This is because it cannot be seen. The third row has two points representing the two X-ray markers 258C, 244 and 258D, 244 located on the distal, distally facing unfixed top; The reason why they appear as two dots is that none of the markers in the third row are hidden on the X-ray image at this offset angle, and the distal body 216 is located at the distal, distally facing unfixed apex 258C. , 244 and 258D, 244 are not deflated. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. Therefore, the surgeon may select the second row of X-ray markers 258A, 244 and 258B, 244 or the third row of X-ray markers 258C, 244 and 258D, 244 (i.e., both proximally and distally, It is inferred that none of the X-ray markers (on the unfixed top facing the surface) are concentrated at one point. The surgeon then moves the distal body 216 proximally relative to the clot 270A to remove the distal, distally facing free peaks 258C, 244 and 258D, 244, as shown in FIG. 17E. is immediately distal to the clot 270A, and then the X-ray marker is irradiated again from the first and second viewpoints. As shown in Figure 17F, the results are the same as in Figure 17D. From the results in Figures 17D and 17F, the surgeon can determine whether the second row of X-ray markers 258A, 244 and 258B, 244 or the third row of X-ray markers 258C, 244 and 258D, 244 (i.e. proximal and distal X-ray marker on the distally facing unfixed top of both sides) either in the initial position of the distal body 216 (FIGS. 17C and 17D) or after moving the distal body 216 proximally. position (FIGS. 17E and 17F), thus inferring that the distal body 216 is deployed in both positions in the vessel 266. Therefore, the surgeon infers that the clot 270A is a soft clot 270A that has entered the distal body interior 222, and the surgeon moves the distal body 216 proximally to remove the blood vessel from the blood vessel, as shown in FIG. 17G. 266, the distal body 216 and the soft blood clot 270A captured by the distal body 216 are removed.

Figures 18A-G illustrate the stepwise use of distal body 216 in retrieving a hard clot 270B in a human intracranial artery 266 (in Figures 18A-G, distal body 216 is in orientation 2) ( As noted below, the main difference between FIGS. 18A-G and FIGS. 16A-G is that the clot 270B is just distal to one of the distal, distally facing non-securing peaks 258C. 16A-G, where the clot 270B enters the distal body interior 222 at the enlarged compartment/drop zone 262C, whereas in FIGS. (Entering the distal body interior 222 with an enlarged compartment/drop zone 262A located just distal). First, as usual, the surgeon determines the location of the clot 270B in the blood vessel 266 using, for example, a contrast agent injected proximally and distally to the clot 270B. The delivery catheter 208, which wraps around the distal body 216, is then inserted into the blood vessel 266 so that the two proximal, distally facing, loose peaks 258A and 258B are immediately distal to the clot 270B. Deploy. See Figure 18B. The distal body 216 is then deployed from the catheter 208 by moving the catheter 208 proximally. As shown in FIG. 18C, hard blood clot 270B located on top of distal body 216 causes distal body 216 to deflate. However, at this point, the surgeon does not know that clot 270B has entered distal body 216. Thus, the surgeon illuminates the X-ray marker from a first perspective (ie, from the proximal side of the distal body in orientation 2; into the plane of the paper) without moving the distal body 216. As shown in Figure 18D, the first view shows four rows of X-ray markers. The first column is, as usual, a single point representing the x-ray marker 228, 244 located in the proximal tube. The second column has only one point. The reason is that clots 270B above the second row of X-ray markers 258A, 244 and 258B, 244 (i.e., the proximal, distally facing non-fixated top X-ray marker) This is because they were pressed together. The third column has only one point representing the X-ray marker 258C, 244 located on the proximal (orientation 2), proximal, distally facing unfixed top; The reason why the marker is one point is that after the third column (in this diagram) That's because there isn't. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon then illuminates the marker from a second perspective that is 90 degrees offset from the first perspective (ie, from below the distal body 216) without moving the distal body. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second column has only one point. The reason is that the X-ray markers 258A, 244 on the top of the second column (orientation 2) are located behind the X-ray markers 258B, 244 on the bottom (orientation 2), and therefore the top X of the second column This is because the line markers 258A and 244 are hidden and cannot be seen. The third row has two points representing X-ray markers 258C, 244 and 258D, 244 located on the distal, distally facing unfixed top; in this X-ray projection view, the third None of the X-ray markers in the column are obscured. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. Therefore, the surgeon deduces that the second row of X-ray markers 258A, 244 and 258B, 244 (ie, the proximal, distally facing, free top X-ray markers) have converged. Next, as shown in FIG. 18E, the surgeon moves the distal body 216 proximally so that the distal, distally facing free peaks 258C, 244 and 258D, 244 are positioned against the clot 270B. Make sure that it is right on the tip side. Unbeknownst to the surgeon, the clot 270B enters the distal body interior 222 immediately distal to the overlying (orientation 2), proximal, distally facing unfixed apex 258A, and The side bodies 216 are no longer deflated. The surgeon then reirradiates the X-ray marker from the first perspective. As shown in FIG. 18F, the first column is, as an example, a single point representing the X-ray marker 228, 244 located in the proximal canal. The second column has two X-ray markers. The reason is that the distal body 216 is not deflated and the second row of over (orientation 2) X-ray markers 258A, 244 or under (orientation 2) X-ray markers 258B, 244 (i.e. proximal This is because none of the markers on the non-fixed apex facing the distal side are hidden. The third column has only one point. The reason is that the back (orientation 2), distal side, non-fixed apex 258D, 244 facing the distal side is the front (orientation 2), distal side, non-fixed apex 258C, 244 facing the distal side. This is because it is hidden in The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon then illuminates the marker from a second perspective that is 90 degrees offset from the first perspective (ie, from below the distal body 216) without moving the distal body 216. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second column has one point. The reason is that the X-ray markers 258A, 244 on the top (orientation 2), proximal, distally facing unfixed apex are on the bottom (orientation 2), proximally, distally facing. This is because it is hidden behind the non-fixed top portions 258B and 244. The third column has two points. This is because neither the front X-ray marker nor the rear X-ray marker 258C, 244 and 258D, 244 of the non-fixed top portion facing the distal side on the distal side are hidden. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon concludes that the clot 270B has entered the distal body interior 222 based on the information from FIGS. 18D and 18F. The surgeon then removes the hard clot 270B captured by the distal body 216 and the distal body 216 by moving the distal body 216 proximally and out of the blood vessel 266, as shown in FIG. 18G. Take out. Comparing FIGS. 16A-G with FIGS. 18A-G, the orientation of expansion compartments/drop zones 262A-D relative to the orientation of hard clot 270B shows that the orientation of expansion compartments/drop zones 262A-D through which expansion compartments/drop zones 262A, 262B, 262C, or 262D is hard It will be appreciated that determining whether the clot 270 enters the distal body interior 222. For example, in FIG. 16C, hard clot 270B is located above the distal body 216, and therefore, hard clot 270B must enter through the expansion compartment/drop zone located above the distal body. , whose enlarged compartment/drop zone is immediately distal to the distal body orientation shown in FIGS. Drop zone 262C. In FIG. 18C, hard clot 270B is again located on top of the distal body, so hard clot 270B must enter through the enlarged compartment/drop zone located on top of the distal body. It won't happen. However, in the orientation of the distal body 216 shown in FIGS. 18A-G, the enlarged compartment/drop zone located above the distal body 216 in FIG. Immediately distal to the unfixed apex 258A is an enlarged section/drop zone 262A.

19A-N depict the stages of distal body 216 during retrieval of a deformable sticky clot 270C (i.e., a clot that is difficult to disassemble and adheres to the vessel wall 268) in a human intracranial artery 266. Use is shown (in FIGS. 19A-N, distal body 216 is in orientation 2). First, as usual, the surgeon determines the location of the clot 270C in the blood vessel 266 using, for example, a contrast agent injected proximally and distally to the clot 270C. The delivery catheter 208, which envelops the distal body 216, is then inserted into the blood vessel 266 so that the two proximal, distally facing, loose apexes 258A and 258B are immediately distal to the clot 270C. Deploy. See Figure 19B. Distal body 216 is then deployed from catheter 208 by moving catheter 208 proximally. As shown in FIG. 19C, a deformable sticky clot 270C located on top of the distal body 216 deflates the distal body 216. However, at this point, the surgeon does not know that clot 270C has deflated distal body 216. Thus, the surgeon illuminates the X-ray marker from a first perspective (ie, from the proximal side of the distal body; into the plane of the paper) without moving the distal body 216. As shown in Figure 19D, the first view shows four rows of X-ray markers. The first column is, as usual, a single point representing the x-ray marker 228, 244 located in the proximal tube. The second row is proximal, distally directed, above (orientation 2) and below (orientation 2), converging as the clot 270C deflates the distal body 216. It has one point corresponding to the free tops 258A, 244 and 258B, 244. The third column has one point representing the X-ray marker 258C, 244 located on the proximal (orientation 2), distal, distally facing unfixed top; the back, distal, The X-ray markers 258D and 244 located at the non-fixed top facing the distal end are hidden and cannot be seen. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon then illuminates the marker from a second perspective that is 90 degrees offset from the first perspective (ie, from below the distal body) without moving the distal body 216. As shown, the first column is, as an example, a single point representing the x-ray marker 228, 244 located in the proximal canal. The second row has one point corresponding to the underlying (orientation 2), proximal, distally facing unanchored apex 258B, 244; the upper (orientation 2), proximal The side, distally facing non-securing peaks 258A, 244 are located behind the underlying, proximal, distally facing non-securing peaks 258B, 244 and are hidden from view. The third row includes front (orientation 2), distal, distally facing non-anchored peaks 258C, 244 and back (orientation 2), distal, distal-facing non-anchored peaks 258D, 244, neither of which is hidden in this figure. The fourth column is, as usual, a single point representing the X-ray marker 236, 244 located in the distal tube. The surgeon then moves distal body 216 proximally (ie, pulls distal body 216 slightly), as shown in FIG. 19E. The surgeon then reirradiates the X-ray marker from the first and second viewpoints. As shown in Figure 19F, the results are exactly the same as those shown in Figure 19D. The surgeon determines that the proximal, distally facing free peaks 258A, 244 and 258B, 244 are in the initial position (the proximal, distally facing free peaks 258A, 244 and 258B, 244 are in the blood Based on the observation that clot 270C converged in both the immediately distal position (Figs. 19C and 19D) and the second position (Figs. 19E and 19F), clot 270C is a changeable sticky clot 270C. I infer that there is. The surgeon then rocks the distal body 216 proximally and distally within the blood vessel 266 by a small distance (eg, about 1 mm to about 2 mm), and the clot 270C disintegrates, as shown in FIG. 19G. It begins to enter the tip side body 216. The surgeon then reirradiates the X-ray marker from the first and second viewpoints. The results are as shown in Figure 19H, except that the second row of markers 258A, 244 and 258B, 244 (on the proximal, distally facing unfixed apex) are beginning to separate. and is exactly the same as the result in Figure 19F. The surgeon then moves the distal body 216 proximally again, as shown in FIG. 19I. The surgeon then reirradiates the X-ray marker from the first and second viewpoints. As shown in FIG. 19J, the results are exactly the same as those in FIGS. 19D and 19F because clot 270C refocused the second row of markers 258A, 244 and 258B, 244. The surgeon then rocks the distal body 216 proximally and distally within the blood vessel 266 a small distance (e.g., about 1 mm to about 2 mm), and the clot 270C disintegrates, as shown in FIG. 19K. It begins to further enter the inside of the body 222 on the tip side. The surgeon then reirradiates the X-ray marker from the first and second viewpoints. As shown in Figure 19L, the results are exactly the same as those in Figure 19H. Then, when the surgeon moves the distal body 216 proximally again, the clot 270C, instead of deflating the second row of markers 258A, 244 and 258B, 244, as shown in FIG. 19M, Completely enters the inside of the body 222 on the tip side. The surgeon then reirradiates the X-ray marker from the first and second viewpoints. As shown in FIG. 19N, the results show that the second row of markers 258A, 244 and 258B, 244 (on the proximal, distally facing unfixed apex) are separated. The X-ray markers 258A, 244 and 258B, 244 in the second row (on the proximal, distally facing unfixed top) are far enough apart that the X-ray markers in the third row (on the proximal, distally facing unfixed top) Satisfied that 258C, 244 and 258D, 244 (on the distally facing non-fixated apex of the The blood clot 270C captured by the distal body 216 and the distal body 216 is removed by moving the distal body 216 proximally and out of the blood vessel 266. Take it out.

As mentioned above, several observations can be made from Figures 15-19. For example, the x-ray markers at the proximal and distal distally facing free peaks 258A-D, 244 provide feedback regarding the interaction between the distal body 216 and the clot 270 in the blood vessel 266. Provide to surgeon. In addition, the soft clot 270A guideline indicates that the soft clot 270A will not deflate the distal body 216 and therefore the X-ray marker 258A on the proximal and distal, distally facing non-fixated apex. D, 244 is that a marker is always visible as two points, except when it is hidden behind another marker (depending on how you look at it). Regarding the hard clot 270B, the hard clot 270B can generally enter the distal body interior 222 without the need to rock the distal body 216 proximally and distally (deformable sticky blood (different from Mochi 270C). However, in order to capture a hard clot 270B, the hard clot 270B must be properly oriented relative to the expansion compartment/drop zone 262A, 262B, 262C, or 262D (this is because the distal body 216 Expansion Zone/Drop Zone: 1 Expansion Zone/Drop Zone 262B at 0°, 1 Expansion Zone at 90°/Drop Zone 262C, 1 Expansion Zone at 180°/Drop Zone 262A and 1 Expansion Zone at 270°/ That's why we have a drop zone 262D). As a guide, the magnification section/drop zone 262A, 262B, 262C or 262D can be used with X-ray markers 258A, 244 and 258B, 244 on the proximal, distally facing unfixed top or distally, distally facing. X-ray markers 258C, 244 and 258D, 244 on the oriented free top are seen together in both the first X-ray image and the second X-ray image at 90° to the first X-ray image When properly oriented relative to clot 270B, hard clot 270B can enter expansion compartment/drop zone 262A, 262B, 262C, or 262D by moving distal body 216 proximally. See Figures 16F and 18D. Finally, the guideline for collecting the deformable sticky clot 270C is that the rocking of the distal body 216 gradually causes the deformable sticky clot 270C to enter the distal basket interior 222 over time. It is.

FIGS. 20A, 20B, and 20C show that the distal body 216 of FIGS. 20A, 20B, and 20C is slightly shorter, and its distally facing free peaks 258A, 258B, 258C, and 258D are more proximal to the tube 228. A distal body 216 is shown that is similar to the distal body 216 of FIGS. 14A, 14B, and 14C, except that it is closer. The shortened distal body 216 of FIGS. 20A, 20B and 20C is specifically adapted for tortuous blood vessels 266. FIGS. 21-29 illustrate FIGS. 20A, 20B and 20B when used with a manual (i.e. manual) volume dependent (i.e. fixed volume) suction catheter 272 locked between about 10 and about 60 cubic centimeters (cc). The staged deployment of the distal body 216 of 20C is shown. Optionally, aspiration catheter 272 has an outer diameter of about 0.05 inch to about 0.09 inch, which outer diameter is substantially larger than the outer diameter of delivery catheter 208. Clot 270 is located in blood vessel 266, for example, through the use of a contrast agent injected proximally and distally to clot 270. As shown in FIG. 21, a delivery catheter 208, including the distal body 216 of FIGS. 20A, 20B, and 20C, is placed in a tortuous blood vessel 266 distal to a blood clot 270. When delivery catheter 208 is withdrawn, distal body 216 is deployed. See Figure 22. Distal body 216 is moved proximally relative to clot 270 and tension is applied to pull wire 202. See Figure 23. While maintaining tension on the pull wire 202, an aspiration catheter 272 having a proximal end 274 and a distal end 276 is delivered over the pull wire 202 attached to the distal body 216. See FIG. 24 (the reason for applying tension to pull wire 202 is that pull wire 202 acts as a guide/track for movement of suction catheter 272; without tension, suction catheter 272 and pull wire 202 would stop in ophthalmic artery 288). (This is because there is a risk.) A tip 276 of aspiration catheter 272 is applied to blood clot 270. A syringe 278 is attached to the aspiration catheter 272 using a rotary hemostasis valve 290 that allows the surgeon to aspirate when the pull wire 202 is in the system. The surgeon aspirates syringe 278 by pulling lever 280 back to a mark on base 282 that corresponds to about 10 to about 60 cubic centimeters of fluid. The surgeon then locks the lever 280 (and attached plunger) in place, leaving the suction catheter 272 under suction. The surgeon captures the clot 270 into the distal body 216 using the techniques described in FIGS. 15-19. Distal body 216 and clot 270 are captured by suction catheter 272. See Figures 27 and 28. The surgeon then moves suction catheter 272 proximally out of blood vessel 266 to remove clot 270 captured by suction catheter 272 and distal body 216 and suction catheter 272 . See Figure 29. Suction catheter 272 may be helpful if a small portion of clot 270 breaks off when distal body 216 is used to retrieve clot 270.

To test the effectiveness of the system 200, soft clots 270A and hard clots were induced in pigs weighing 30-50 kg using the system 200 of Figures 11-20 without the use of a suction catheter 272. 270B was recovered. The weight of the pig was chosen such that the size of its vessels 266 approximated the size of human vessels. The pig was anesthetized. Several hard clots 270B were prepared by mixing pig blood and barium and incubating the mixture for 2 hours. Several soft clots 270A were prepared by mixing pig blood, thrombin and barium and incubating the mixture for 1 hour. Clots 270A and 270B, each having a width of 4-6 mm and a length of 10-40 mm, were then inserted into a blood vessel 266 with a diameter of 2-4 mm (only one clot 270A and 270B was inserted into blood vessel 266 at a time). ). Angiography was then performed to confirm the occlusion. Then, 10 minutes after confirming occlusion, the distal body 216 of FIGS. 11-20 is delivered distally to the clots 270A and 270B as described above, and the distal body 216 of FIGS. Blood clots 270A and 270B were recovered using the same procedure. In both cases, distal body 216 successfully retrieved clots 270A and 270B. As shown, the relaxed distal body height tapers/reduces as the proximal strip 252 approaches the proximal hub/junction/tube 228 and the distal body height of the basket 246. The basket strips 291 located at the distal hub/junction/tube 236 taper/reduce as they converge at the distal hub/junction/tube 236.

Alternative Embodiment to FIG. 32 FIG. 32 shows that the proximal strip proximal end 254 converges and is soldered or welded at the proximal hub/junction 228, and that the basket strip 291 located at the distal end 220 of the basket 246 The distal body 216 is shown converging and soldered or welded at the distal hub/junction 236. To create such an embodiment, the distal body 216 can be prepared from a single tube as described above, and the proximal and distal tubes can be clipped together (and optionally to the pull wire 202) with solder. The proximal end 254 of the attached or welded proximal strip 252 and the basket strip 291 located at the distal end 220 of the basket 246 may also be welded or soldered or welded together. Optionally, proximal and distal hubs/junctions 228 and 236 may include x-ray markers 244 as described above.

Alternative Embodiments to Figures 33-35 Figures 33A-33C and 34A-34B (as well as the close-up views shown in Figures 35A and 35B) show proximal-most sections 250A and 250B having free distal apexes 258A and 258B. An alternative embodiment is shown in which there is no compartment proximally to the. (Figures 33A-35B do not show pull wires or catheters, both of which are preferably used with the distal body 216 and are shown elsewhere, such as in Figures 11-20), and Figures 33B-33C and 35A-35B do not show proximal hub 228). 33A-33C have four pairs of compartments with free distally facing peaks 258A-258H creating four pairs of enlarged apertures 262A-262H (only a few such compartments are 250 or 250B). marked and visible). Figures 34A-34B have five pairs of compartments (also not all labeled) with free distally facing peaks 258A-258J creating five pairs of enlarged apertures 262A-262J. More specifically, in FIGS. 33A-33C and 34A-34B, as in FIGS. 11-20, the distal body 216 has an X-ray marker 244 and a 150 having a proximal pair of free distal apices 258A and 258B located 180° apart and an X-ray marker 244 and distal to a proximal pair of free distal apices 258A and 258B. and a second pair of free distal apices 258C and 258D located at the sides. As in FIGS. 11-20, in FIGS. 33A-33C and 34A-34B, the second pair of distal apices 258C and 258D are located approximately the same distance from the proximal junction 228 and are 150° to 180° Spaced apart and at about 60° to about 90° with respect to the proximal pair of free distal apexes 258A and 258B.

The embodiments of FIGS. 33A-33C, 34A-34B, and 35A-35B have several additional features. For example, in FIGS. 33A-33C, 34A-34B, and 35A-35B, the proximal pair of sections 250A and 250B, each having a free distal apex 258A and 258B, are attached to the proximal strip 252. It has proximal apex portions 297A and 297B. 33A-33C and 34A-34B, distal to the second pair of free distal apices 258C and 258D, the distal body 216 has an X-ray marker 244 and a proximal junction 228. a third pair of frees located approximately the same distance from and 150° to 180° apart and at about 60° to about 90° with respect to the second pair of free distal apices 258C and 258D; It has a tip side apex 258E and 258F. 33A-33C, 34A-34B, distal to the third pair of free distal apices 258E and 258F, the distal body 216 also has an X-ray marker 244 and a proximal junction. a fourth pair located approximately the same distance from 228 and 150° to 180° apart and at about 60° to about 90° with respect to the free distal apices 258E and 258F of the third pair; It has free distal tops 258G and 258H. 34A-34B, distal to the fourth pair of free distal apices 258G and 258H, the distal body 216 also has an X-ray marker 244 and about the same distance from the proximal junction 228. and a fifth pair of free distal apices located 150° to 180° apart and at about 60° to about 90° with respect to the fourth pair of free distal apices 258G and 258H. Has 258I and 258J. 8 sequentially offset unattached distal facing peaks 258A-258H (as in Figures 33A-33C) and 10 sequentially offset unattached distal facing peaks 258A-258J (as in FIGS. 34A-34B) is that each free distal apex 258A-258J creates an enlarged section 262A-262J. Thus, in FIGS. 33A-33C and 34A-34B, eight and ten sequentially offset enlarged sections 262A-262H, respectively, are formed to create multiple clot entry points. 34A-34B, sections 250A and 250B have a proximal pair of free distal apexes 258A and 258B, except for enlarged sections 262A-262H (250A is hidden in FIGS. 34A-34B, but FIGS. 35A- 35B) and the most distal pair of sections with free distal apices 258I and 258J all have free distal apices. In fact, with the exception of enlarged sections 262A-262H, all of the sections located between the proximal-most free distal apex 258A and 258B and the distal-most free apex 258I and 258J are It has a top part 258C to 258H. In contrast, the distal body 216 of FIGS. 33A-33C has a crippled distal apex (basket strip) between the second pair of enlarged apertures 262C and 262D and the third pair of enlarged apertures 262E and 262F. 291) with an intermediate group of sections 248 (i.e., stent-like structures). 34A-34B, all of the compartments 248 with distal tops attached to the basket strips 291 are located distally of the distal body 216 (i.e., distally relative to the distal-most enlarged openings 262G and 262H). side), creating a substantially closed end of the basket 246 to capture the clot.

Additionally, in FIGS. 33A-33C, 34A-34B, and 35A-35B, the distal bodies 216 are spaced 180 degrees apart, as best seen in the close-up views of FIGS. 33C and 34A and 35A and 35B. It has two proximal three-dimensional openings 293 located at the same position. (The proximal three-dimensional openings 293 are aligned to create a continuous void). One such three-dimensional aperture 293 has a proximal end at the intersection 294 of the proximal strip 252 and a distal end from the proximal hub/junction 228 to the free distal apex of the first pair. The distal apex 299 is attached to the first strut 295 and is located approximately the same distance (in the longitudinal direction) as the distal apexes 258A and 258B. The other such three-dimensional opening 293 is on the other side of the distal body 216 with a proximal end at the intersection 294 of the proximal strip 252 and a distal end at the intersection 294 of the proximal strip 252 and the distal end from the proximal hub/junction 228. Another distal apex 298 attached to a second strut 296 is similarly located (in the longitudinal direction) at approximately the same distance as the free distal apices 258A and 258B of the first pair of free distal apices. have The second post 296 is located 180° from the first post 295. As shown in FIG. 35A, the intersection 294 of the proximal strips 252 may be located approximately at the width and height center of the distal body 216, with the most The proximal apices 297A and 297B of proximal compartments 250A and 250B are approximately 150° to 180° apart (e.g., at the 12 o'clock and 6 o'clock positions as shown in Figure 35A and at the 3 o'clock and 3 o'clock positions in Figure 35B). 9 o'clock position) and at the maximum height/width of the distal body 216. The proximal tops 297A and 297B of the proximal-most sections 250A and 250B with free distal tops 258A and 258B are also attached to the proximal strip 252 as shown in FIGS. 35A and 35B. Similarly, the bridge memory metal strips (distal struts) 295 and 296 are approximately 150° to 180° apart (e.g., at the 3 o'clock and 9 o'clock positions as shown in Figure 35A, and at the 12 o'clock position in Figure 35B). and 6 o'clock position), at the maximum height/width of the distal body 216, and at approximately 60° to 90° relative to the free distal apex 258A and 258B.

Embodiments of FIGS. 36-37 FIGS. 36A-36N and 37A-37K (also referred to herein as FIGS. 36-37 for brevity) illustrate alternative embodiments of the distal body 216 that are similar to the embodiments of FIGS. 11-35. . Distal body 216 may be fabricated by any method known in the art, including, but not limited to, that described in US Pat. No. 9,566,412, the entire contents of which are incorporated herein by reference.

Figures 36-37 are CAD drawings drawn to scale. However, it will be recognized that other dimensions are possible.

More specifically, FIGS. 36-37 provide a system for removing objects from the lumen of an animal. The system may include a pull wire 202 having a proximal end (not shown in FIGS. 36-37) and a distal end 206, as previously described. The system of FIGS. 36-37 also includes a distal body 216 that can be attached to the pull wire 202, preferably the pull wire tip 206. As in the previous embodiment of FIGS. 11-35, the distal body 216 includes an interior 222, an outer circumference 300, a proximal end 218, a distal end 220, and a distal body length 226 extending from the proximal end 218 to the distal end 220. and a proximal junction/hub/tube 228 that may be attached to the pull wire 202 and form the proximal end 218 of the distal body 216, a plurality of proximal strips 252, and a plurality of basket strips 291. The basket 246 may include a plurality of shaped compartments and a distal junction/hub/tube 236 forming a distal end 302 of the basket 246. As in the previous embodiments of FIGS. 11-35, the basket 246 may include a basket interior 346, and each proximal strip 252 may have a distal end 256 attached to a compartment and a proximal end 254; Proximal ends 254 of proximal strips 252 may converge at proximal junction 228. As in the previous embodiment of FIGS. 11-35, the distal body 216 is configured to have a relaxed state in which the distal body 216 has a first height 224 and a first width 225 and a relaxed state in which the distal body 216 has a second height. a deflated state (FIGS. 36-37) having a height and a second width, the second height being less than the first height 224 and the second width being less than the first width 225; (not shown). As in the previous embodiment, in the embodiment of FIGS. 36-37, proximal strip 252 and basket strip 291 are preferably constructed of shape memory metal.

33-35, in the embodiment of FIGS. 36-37, in the relaxed state, the basket 246 is oriented generally proximally and the shape memory metal strip (proximal strip 252 or basket strip 291) a series of at least three pairs located on the distal body periphery 300, each having a proximal apex 260 attached to a proximal apex 260 and free distal apexes 258A-258F oriented generally distally; May include sections 250A-250F. Optionally, as shown in FIGS. 36-37, the most proximal free distal peaks 258A, 258B of the series are located at the 12 o'clock and 6 o'clock positions, and the proximal Located approximately the same distance from junction 228, the next most proximal free distal peaks 258C, 258D are located at the 3 o'clock and 9 o'clock positions and approximately the same distance from proximal junction 228. and then the proximal-most free distal crests 258E, 258F are substantially aligned with the 12 o'clock and 6 o'clock positions (i.e., substantially aligned with the proximal-most free distal crests 258A, 258B). and approximately the same distance from proximal junction 228. Optionally, each free distal apex 250A-250F forms part of a different enlarged section 262A-262F that is configured to allow thrombus to enter the basket interior 346. In other words, as in the previous embodiment, the enlarged sections 262A-262F are designed to capture blood clots/thrombus. In the proximal and distal views of Figures 36M, 36N, 37H and 37I, a small clock with clock hands is used to illustrate the 12 o'clock, 3 o'clock, 6 o'clock and 9 o'clock positions.

For purposes of FIGS. 36-37, when we say that components such as free distal apices 258A-258J are located "approximately the same distance from proximal junction 228," we mean one component (e.g., the most proximal of a pair). If one free distal apex 258A of the distal free distal apices 258A/258B is located a distance X from the proximal junction 228, then the other part (e.g. The other free distal apex 258B of the distal apices 258A/258B is located a distance X plus or minus (+/-) 5 millimeters (mm) from the proximal junction 228. In a preferred embodiment, the other component is located at a distance X plus or minus (+/-) 3 mm from the proximal junction 228, and more preferably at a distance X plus or minus (+/-) 0.5 mm from the proximal junction 228. do. (The same relationship would apply to other pairs of free distal apices 258C-258F in the series - for example, one of the next most proximal pair of free distal apices 258C/258D) If the free distal apex 258C of is located a distance Y from the proximal junction 228, then the other free distal apex 258D of the next most proximal pair of free distal apexes 258C/258D is Located at a distance Y plus or minus (+/-) 5 mm from the proximal junction 228. Again, more preferably, the other part is located at a distance Y plus or minus (+/-) from the proximal junction 228. 3 mm, more preferably a distance Y plus or minus (+/-) 0.5 mm from proximal junction 228. The same relationship applies to 258E and 258F.

In FIG. 37, as in the embodiment of FIG. 34, the series is oriented generally proximally and attached to a shape memory metal strip (either proximal strip 252 or basket strip 291). of the series, including at least five pairs of compartments 250A-250J located on the distal body circumference 300 having a proximal apex 260 and a generally distally oriented free distal apex 258A-258J; Therein, after the subsequent free distal apex 258E, 258F, the next most proximal free distal apex 258G, 258H are located at the 3 o'clock and 9 o'clock positions, and the proximal junction 228 The distal-most free distal peaks 258I, 258J, which are located approximately the same distance from and form enlarged sections 262G, 262H, are located at the 12 o'clock and 6 o'clock positions and from the proximal junction 228. Enlarged sections 262I and 262J are formed which are located at approximately the same distance and located at the most distal side. Again, approximately the same distance from the proximal hub 228 means the same distance +/-5 mm from the proximal junction 228. In a preferred embodiment, the 258G/258H are located the same distance +/-3 mm from the proximal junction 228, and more preferably the same distance +/-0.5 mm from the proximal junction. The same relationship applies to 258I and 258J.

As in the previous embodiment, FIGS. 36-37 show the proximal apex attached to another compartment of the basket 246 and oriented generally proximally, and the distal junction 236 oriented generally distally, in a relaxed state. a plurality of distal compartments 248D distal to the most distal free distal apices (i.e., 258E, 258F in FIG. 36 and 258I, 258J in FIG. 37) with a distal apex attached to a distal apex; illustrates that basket 246 may include. In other words, the distal compartment 248D is designed to retain the clot/thrombus within the basket interior 346.

As in the previous embodiment, FIGS. 36-37 show that in a relaxed state, each enlarged section 262A-262J may be comprised of two proximal apexes oriented generally proximally and a proximal end 308 oriented generally distally. and a length 312 extending from the proximal end 308 of each enlarged section 262A-262J to the distal end 310.

As in the previous embodiment, FIGS. 36-37 show that in the relaxed state, each distal segment 248D may have a length 314 extending from the proximal apex of the respective distal segment 248D to the distal apex 307. exemplify.

As in previous embodiments, FIGS. 36-37, and in particular FIG. 36J, illustrate that in the relaxed state, each of the enlarged sections 262A-262J may be longer than each of the distal sections 248D.

As in the previous embodiment, FIGS. 36-37, and in particular FIG. 36J, show, for each of the enlarged sections 262A-262J, from the proximal end 308 of the enlarged sections 262A-262J to the free distal side of the enlarged sections 262A-262J in the relaxed state. Illustratively, the distance 316 to the apices 258A-258J can be less than the distance 318 from the free distal apex 258A-258J of the enlarged sections 262A-262J to the tip 310 of the enlarged sections 262A-262J. In other words, the free distal apex 258A-258J does not protrude into the enlarged compartments 262A-262J enough to prevent clots from entering the basket interior 346 through the enlarged compartments 262A-262J. not present.

As in the previous embodiment, FIGS. 36-37 illustrate that the distal body 216 may further include a lead wire 286 extending distally from the distal junction 236. Although not shown in FIGS. 36-37, as in the previous embodiment, the distal body 216 has an interior, a proximal end communicating with the interior, and a distal end communicating with the interior, and is constructed of a biocompatible material and The system may further include a catheter configured to wrap around the distal body 216 when the catheter is in a deflated state. Deployment and use of the system may be as shown in FIGS. 15-29.

As in the previous embodiment, FIGS. 36-37 show that in the relaxed state, the basket 246 is preferably oriented generally proximally, since a free proximal apex can damage the blood vessel as described above. Illustratively, it does not have any free top.

As in the previous embodiment, FIGS. 36-37 show a distal taper in which the distal body 216 decreases in height 224 and width 225 as the basket 246 approaches the distal junction 236 in the relaxed state. For example, the area 322 may include a shaped area 322.

As in the previous embodiment, FIGS. 36-37 show that the distal body height 224 and width 225 decrease as the proximal strip 252 approaches the proximal junction 228 when the distal body 216 is in a relaxed state. The proximal tapered region 320 may include a proximal tapered region 320. It will be appreciated that the taper of proximal region 320 can take a variety of shapes, as shown in FIGS. 36 and 37.

As in the previous embodiment, FIGS. 36-37 illustrate that in the relaxed state, each of the enlarged sections 262A-262J may be longer than each of the paired sections 250A-250J.

As with the previous embodiment, FIGS. 36-37 are best seen in close-up views in FIGS. 36C, 36E and 36F and 37G, but also shown in FIGS. , illustrates that in the relaxed state, each of the enlarged sections 262A-262J may extend from the 6 o'clock position to the 12 o'clock position, or from the 3 o'clock position to the 9 o'clock position.

As with the previous embodiments of FIGS. 11-19 and 21-32, FIG. 36 shows that in the relaxed state, the basket 246 has multiple The proximal section 342 may further include a proximal top section 342 attached to the proximal junction 228 and oriented generally proximally, and a proximal top section 342 oriented generally distally and separated from the basket 246 . and a distal top section attached to the section of the section. However, such a proximal section 342 is optional and is not shown in FIG. 37 due to the length of the basket 246, which includes ten enlarged sections 262A-262J. If proximal section 342 is not included, then optionally, as in the previous embodiments of FIGS. 20 and 33-35, FIG. It is illustrated that the proximal tops of the containing sections 250A, 250B can be attached to the distal end 256 of the proximal strip 252. Without being bound to any particular theory, the purpose of proximal compartment 342 may be to allow blood clots to rest on proximal compartment 342 before entering through expansion compartments 262A-262J. .

In preliminary clot capture animal studies using a porcine thrombectomy model, the distal body 216 of Figure 37 was observed to be particularly adept at capturing blood clots. (Preliminary clot capture animal studies are described in Ulm et al., Preclinical Evaluation of the NeVaTM Stent Retriever: Safety and Efficacy in the Swine Thrombectomy Model, Interv Neurol. 2018 Apr; 7(5):205-217 (performed using similar conditions to the original). Without being bound by any particular theory, the clot capture ability of the distal body 216 of FIG. It is thought that it spreads in a flare shape at the top of the distal end located at the distal end 310).

Thus, as shown in FIG. 37, in the relaxed state, for at least some enlarged sections 262A-262J (preferably for most, more preferably for each enlarged section 262A-262J), the two basket strips 291 The two basket strips 291 intersect to form a distal apex located at the distal end 310 of the enlarged sections 262A-262J, and the two basket strips 291 extend from 65° at their respective distal apices located at the distal end 310 of the enlarged sections 262A-262J. larger, more preferably larger than 70°, more preferably larger than 75°, more preferably larger than 80°, more preferably larger than 85°, more preferably larger than 90°, more preferably larger than 95°, More preferably, an angle 328 is formed that is greater than 100°. Preferably angle 328 is less than 150°. It is believed that the flared features of the basket strips 291 that meet at the distal apices at the distal ends 310 of the enlarged sections 250A-250J assist in allowing blood clots to enter the basket interior 346. By comparison, assuming that compartments 250A-250J are not intended to be clot capture compartments, the basket strips 291 that intersect to form free distal apexes 258A-258J are It can have a much smaller angle 326 at ~258J. For example, the angle 326 at each free distal apex 258A-258J can be less than 50°, more preferably less than 45°, and more preferably less than 40°. In other words, for some, most or all enlarged sections 262A-262J, the angle 328 at the distal apex at the tip 310 is at least twice (more than) the angle 326 at the free distal apex 258A-258J. (preferably at least 2.5 times, more preferably at least 3 times) larger. Preferably, angle 328 is less than or equal to five times as large as angle 326. Due to the symmetry of the distal body 216, the angle 326 at the free distal apex 258A can be substantially the same as the angle 326 at the free distal apex 258B and the angle 326 at the free distal apex 258C. The angle 326 of can be substantially the same as the angle 326 at the free distal apex 258D, and the angle 326 at the free distal apex 258E can be substantially the same as the angle 326 at the free distal apex 258F. The angle 326 at the free distal apex 258G may be substantially the same as the angle 326 at the free distal apex 258H and the angle 326 at the free distal apex 258I may be the same as the angle 326 at the free distal apex 258G. The angle 326 at the distal apex 258J may be substantially the same. Similarly, the angle 328 at the distal apex of the distal end 310 of the enlarged section 262A can be substantially the same as the angle 328 at the distal apex of the enlarged section 262B and the distal apex angle 328 at the distal end 310 of the enlarged section 262C. The angle 328 at the distal apex of the enlarged section 262D may be substantially the same as the angle 328 at the distal apex of the enlarged section 262E at the distal tip 310 of the enlarged section 262E. The angle 328 at the distal apex of the enlarged section 262G at the distal end 310 may be substantially the same as the angle 328 at the distal apex of the enlarged section 262H and The angle 328 at the distal top of the distal end 310 of can be substantially the same as the angle 328 at the distal top of the enlarged section 262J.

Because basket strips 291 may be non-linear, angles 326 and 328 may be determined as if basket strips 291 were in a straight line from their proximal ends 330 to their distal ends 332. (See dashed lines 350 and 355 in Figure 37K). In other words, angles 326 and 328 may be the average (intermediate) angle between basket strips 291 along the basket strip length. In such measurements, angles 326 and 328 are measured by drawing an arc between points on each basket strip 291 at the same location along distal body length 226. Alternatively, angles 326 and 328 define basket strips along the basket strip length that arc between points on each of the two basket strips 291 at the same location along the distal body length 226. The maximum angle between pieces 291 can be. See Figures 37A, 37E, 37F, 37G to show how the arcs are drawn and how the maximum angles 326 and 328 are measured.

As an example, as illustrated in FIGS. 37E-37G, the maximum angle 328 between the basket strips 291 forming the distal apex at the distal end 310 of enlarged sections 262C, 262F, and 262G is approximately 100°, whereas By comparison, as illustrated in FIGS. 37E-37G, the maximum angle 326 between the basket strips 291 forming free distal apexes 258C, 258F, and 258G is approximately 40°. (As illustrated in FIG. 37E, the maximum angle 328 between the basket strips 291 forming the distal apex at the tip 310 of the most distal enlarged section 262J is approximately 80°, which is similar to the angles 326, 328 It should be noted that this indicates that there may be variability).

Relatedly, optionally, in the relaxed state, each of the basket strips 291 that intersect at the distal apex at the distal end 310 of some or all of the enlarged sections 250A-250J may at least 32.5°, more preferably at least 35°, more preferably at least 37.5°, more preferably at least 40°, and more preferably from a line bisecting each distal apex parallel to body length 226. Extending proximally from the respective distal apex at the distal end 310 at an angle 348 of at least 42.5°, more preferably at least 45°, more preferably at least 47.5°, and more preferably at least 50°. Angle 348 may be determined by measuring basket strip 291 as if it were a straight line from proximal end 330 to distal end 332. Thus, for example, each basket strip length, as measured by drawing a straight line from the proximal end 330 to the distal end 332 of the basket strip 291, is equal to the distal body length 226 (as well as as described herein). at least 32.5° to a line bisecting each distal apex parallel to an adjacent bridge memory metal strip 336, which may be substantially parallel to the distal body length 226; Preferably it may be at least 35°, more preferably at least 37.5°, more preferably at least 40°, more preferably at least 42.5°, more preferably at least 45°, more preferably at least 47.5°, more preferably at least 50°. . See FIG. 36K (dashed line 350 represents the basket strip length, dashed line 226 is drawn through each distal apex parallel to the distal body length 226, and lines 350 and 226 The angle between 348 is 45°). Relatedly, for some, most or all of the free distal apices 258A-258J, the basket strip length as measured by drawing a straight line from the proximal end 330 of the basket strip 291 to the distal end 332 is: It may be less than 25°, more preferably less than 22.5°, more preferably less than 20° relative to a line bisecting the free distal apex 258A-258J and parallel to the distal body length 226. See FIG. 36K (dashed line 355 represents the basket strip length, dashed line 226 is drawn through the distal apex 258H parallel to the distal body length 226, and between lines 355 and 226). The angle 354 is 18° at the free distal apex 258H). Thus, for some, most or each enlarged section 262A-262J, the angle 348 at the free distal apex 258A-258J is twice the magnitude of angle 354, more preferably 2.5 times, more preferably 3 It can be double.

Relatedly, in FIG. 37E, which shows a top plan view, the tip 332 of the basket strip 291 forming the distal top of the enlarged section 262J is located approximately in the center of the distal body width 225 and The proximal end 330 is located approximately at the front and back of the distal body 216. The proximal end 330 and distal end 332 of the basket strip 291 intersecting to form a distal apex located at the distal end 310 of the enlarged section 262H are also shown in the perspective view of FIG. 37G. Optionally, the length of each basket strip 291 that intersects at the distal apex at the distal end 310 of some or all of the enlarged sections 250A-250J is the length of the distal body when measured from their proximal end 330 to their distal end 332. It may be approximately equal to 1/2 of the width 225 and height 224.

Relatedly, optionally for at least some enlarged segments 262A-262J (preferably for each enlarged segment 262A-262J) in the relaxed state, as shown in the embodiment of FIG. 37 and best seen in FIGS. 37G and 37K. ), in the relaxed state, the two basket strips 291 that intersect to form the distal apices located at the distal ends 310 of the enlarged sections 262A-262J intersect at their respective distal apices and are approximately at the distal body height 224 Alternatively, it may have a distal end 332 located in the center of the width 225 and a proximal end 330 attached to another section of the basket 246 and located generally above, below, or on the front or back side of the distal body 216. In other words, in FIGS. 37F and 37K showing front and rear elevations, the tip 332 of the basket strip 291 forming the distal top of the enlarged sections 262G and 262H is located approximately at the center of the distal body height 224. , and the proximal end 330 of the basket strip 291 is located generally above or below the distal body 216.

As in the previous embodiment of FIGS. 34A-34B, in the distal body 216 of FIG. 37, in the relaxed state, as seen for example in FIGS. 37E-37F, the space occupied by the ten enlarged sections 250A-250J is Therefore, from at least the proximal apex 260 of the section 250C, 250D, which includes the proximal-most free distal apex 258C, 258D, formed by the distal-most pair of free distal apexes 258I, 258J Up to the proximal end 308 of enlarged sections 262I, 262J, which are expanded, basket 246 has no sections other than sections 250C-250J, which include enlarged sections 262A-262J and free distal tops 258C-258J.

In the distal body 216 of FIG. 36, in the relaxed state, due to the space occupied by the six enlarged sections 250A-250F, the next most proximal free section is removed, as seen for example in FIGS. 37E-37F. from at least the proximal apex 260 of the sections 250C, 250D containing the free distal apexes 258B, 258C to the proximal end 308 of the enlarged section 262E, 262F formed by the subsequent pair of free distal apexes 258E, 258F; 246 has no sections other than sections 262C-262F, which include enlarged sections 250A-250F and free distal apexes 258C-258F.

The distal body 216 can be substantially symmetrical from front to back and from bottom to top, as shown, for example, in FIGS. 36I-36L and 37C-37F.

As with the previous embodiment, FIGS. 36-37 show that in the relaxed state, the distal apex located at the distal end 310 of the enlarged sections 250A-250J can be attached to another section of the basket 246 (i.e., free floating). example).

Optionally, as in the previous embodiment, in the embodiment of FIG. 36, as best seen in FIGS. 36J and 36L, in the relaxed state, the basket 246 extends from the proximal junction 228 to the proximal-most pair. further comprising an additional pair of compartments 344 including free distal apices 258A, 258B and located approximately the same distance as compartments 250A, 250B located at the 9 o'clock and 3 o'clock positions; Each compartment has a proximal apex attached to a shape memory metal strip (either basket strip 291 or proximal strip 252) and a distal apex attached to another segment of basket 246 (i.e. and a distal top that is not freely floating. Again, about the same distance means the same distance +/-5mm from the proximal hub 228. (In a preferred embodiment, the additional pair of compartments 344 are located the same distance +/-3 mm, more preferably the same distance +/-0.5 mm from the proximal hub 228). As best seen in FIGS. 36J and 36L, the additional pair of compartments 344 may be adjacent to the enlarged compartments 262A, 262B formed by the proximal-most free distal apex 258A, 258B. Optionally, from at least the distal apex of the additional pair of compartments 344 to the proximal end of the enlarged compartments 262E, 262F formed by the subsequent free distal apex 258E, 258F, the basket 246 includes enlarged compartments 262A-262F; It has no compartments other than compartments 250A-250F, including free distal apices 258A-258F, and an additional pair of compartments 344.

As in the previous embodiment, FIGS. 36-37 show that in the relaxed state, the basket 246 is attached to the proximal end 334 of the distal compartment and the proximal apex of the distally located compartment. A series of strut/bridge shape memory metal strips 295 having tips 336 may be included. The most proximal pair of bridge memory metal strips 295 may be located at the 3 o'clock and 9 o'clock positions, and the next most proximal pair of bridge memory metal strips 295 may be located at the 12 o'clock and 6 o'clock positions. The bridge memory metal strips 295 may be located at the o'clock position, followed by the proximal-most pair of bridge memory metal strips at the 3 o'clock and 9 o'clock positions, such that the bridge memory metal strips 295 are free. The distal apices 258A-258J are staggered along the distal body length 226. Each of the pair of bridge shape memory metal strips 295 may form part of at least one enlarged section 262A-262J. Optionally, the bridge memory metal strips 295 include a single distally extending basket strip 291 attached to each proximal apex, and a single proximally extending basket strip 291 attached to each distal apex. Basket strip 291.

As in the previous embodiment, FIGS. 36-37 illustrate that in a relaxed state, each of the pair of bridge shape memory metal strips 295 may form part of two enlarged sections 262A-262J. As in the previous embodiment, FIGS. 36 and 37 illustrate that in the relaxed state, the bridge shape memory metal strip 295 can be substantially parallel to the distal body length 226.

As in the previous embodiment, FIGS. 36-37 show that in the relaxed state, the plurality of distal segments 248D are located approximately the same distance from the proximal junction 228, as best seen in FIGS. 36C and 36D. The four distal sections 248D may be configured with each section having a center 340, and the centers 340 of the sections 248D may be spaced approximately 90 degrees around the distal body perimeter 300, and the four distal sections 248D may be configured with It is illustrated that each of the side sections 248D may be adjacent to the other two of the four distal sections 248D. Again, about the same distance means the same distance +/-5mm from the proximal hub 228. (In a preferred embodiment, the four distal sections 248D are located the same distance +/-3 mm, more preferably the same distance +/-0.5 mm from the proximal hub 228). Optionally, in the relaxed state, as best seen in FIGS. 36C and 36D, each of the four distal sections 248D includes two lateral sections oriented generally perpendicular to the distal body length 226. Each lateral apex 338 of one of the four sections 248D is adjacent to the lateral apex 338 of an adjacent one of the four sections 248D.

As in the previous embodiment, FIGS. 36-37 illustrate that the distal body 216 has no more than four sections anywhere along the distal body length 226.

As in the previous embodiment, FIGS. 36-37 illustrate that each of the enlarged sections 260A-260J can be approximately the same size.

As in the previous embodiment, FIGS. 36-37 illustrate that in the relaxed state, the basket interior 346 can be substantially hollow.

As in the previous embodiment, FIGS. 36-37 show that in the relaxed state, the enlarged sections 262A, 262B formed by the proximal-most free distal peaks 258A, 258B may be adjacent, then the most Enlarged sections 262C, 262D formed by proximal free distal apices 258C, 258D may be adjacent, and enlarged sections 262E, 262F formed by subsequent free distal apices 258E, 258F may be adjacent. This is an example of what may be compatible. Optionally, as shown in the views of FIGS. 36-37, in the relaxed state, each of the enlarged sections 262C, 262D formed by the next most proximal free distal apex 258C, 258D is Adjacent to enlarged sections 262A, 262B formed by side free distal apexes 258A, 258B and enlarged sections 262E, 262F formed by subsequent free distal apexes 258E, 258F.

As in the previous embodiment, FIGS. 36-37 show that, in a relaxed state, the free distal apex 258A-262J for at least some enlarged segments 262A-262J (preferably for each enlarged segment as shown) 258J may be aligned with the distal apex 307 located at the distal end 310 of the enlarged sections 262A-262J.

As in the previous embodiment, FIGS. 36-37 show that in the relaxed state, the distal section 248D can be substantially the same size, with the proximal and distal ends attached to the distal top of the distal section 248D. The basket strip 291 has a distal end attached to the junction 236.

As in the previous embodiment, FIGS. 36-37 illustrate that in the relaxed state, sections 250A-250J, including free distal apexes 258A-258J, can be substantially the same size.

As in the previous embodiment, the system of Figures 36-37 is a method for removing a blood clot from a blood vessel in an animal, comprising the steps of: a) providing the system; b) placing the system within the blood vessel; c) increasing the height 224 and width 225 of the distal body 216; d) moving the clot into the basket interior 346; and e) moving the distal body 216 proximally out of the blood vessel. can be used in methods including.

As in the previous embodiment, in FIGS. 36-37, not all parts are labeled in any drawing for clarity.

The embodiments of FIGS. 36-37 may include any features described or shown in previous embodiments. For example, as illustrated in FIGS. 36-37, proximal junction 228 and distal junction 236 may be located approximately at the center of distal body width 225 and distal body height 224 in the relaxed state. Additionally, as illustrated in FIGS. 36-37, each pair of enlarged sections 262A/262B; 262C/262D; 262E/262F; 262G/262H; 262I/262J; 262C/262D; 262E/262F; 262G/262H; 262I/262J and substantially hollow interior 346 to create a void extending from one side of basket 246 through substantially hollow interior 346 to the opposite side of basket 246. may be substantially aligned. Additionally, FIGS. 36-37 illustrate the twisted proximal strip 252 described and shown above. For example, the proximal end 254 of the first proximal strip 252 can be positioned at at least about 65° relative to the distal end 256 of the first proximal strip 252 and the second proximal strip 252 The proximal end 254 of the second proximal strip 252 may be positioned at at least about 65° to the distal end 256 of the second proximal strip 252, and the first and second proximal strips 252 may be at a proximal junction 228. It may intersect distally to the adjacent proximal junction 228, and the intersection may be located approximately at the center of the first height 224 and first width 225 in the relaxed state. Additionally, FIG. 37 shows that the distal body 216 can have a gap located between the proximal junction 228 and the sections 250A, 250B that include the proximal-most free distal apex 258A, 258B. Additionally, FIGS. 36-37 illustrate that the basket 246 has a non-uniform outward radial force from the proximal strip 252 to the basket tip 302. As in the previous embodiment, in the embodiment of FIGS. 36-37, the free distal apex of each pair of free distal apexes 258A/258B; 258C/258D; 258E/258F; 258G/258H; 258I/258J is When an external compressive force from the outside is applied to the free distal tops 258A-258J when the distal body 216 is in a relaxed state, they may be configured to contact each other. As in the previous embodiment, in the embodiment of FIGS. 36-37, proximal junction 228 and distal junction 236 may be in the form of a tube. Additionally, distal body 216 may include the three-dimensional aperture 293 described above. As in the previous embodiment, in the embodiment of FIGS. 36 and 37, some or all of the free distal apices 258A-258J and the proximal and distal junctions 228 and 236 are marked with X-ray markers as previously described. may include.

Embodiments of FIGS. 38-46 FIGS. 38-46 illustrate yet another clot collection system 400 in accordance with the present invention. The system 400 of FIGS. 38-46 is particularly adapted for capturing blood clots 402 (eg, pulmonary thrombus formations) within pulmonary vessels 404 that taper more gently in diameter than cranial vessels. Suction catheter 436 includes a suction source (e.g., suction opening 444 When a surgeon uses suction opening 444 to remove clot 402 from cage 408 when the surgeon is connected to The system 400 optionally advances into the interior 422 of the cage 408 and includes an aspiration catheter (also known as an evacuation catheter) that can be retracted into the interior 422 and includes one or more suction openings 444. Contains 436. However, the systems of Figures 38-46 may also be used to retrieve other objects within other lumens of the body.

38-46, the system 400 includes a cage proximal end 410 that may include a proximal junction 412, a cage distal end 414, a cage length 416 extending from the cage proximal end 410 to the cage distal end 414, and a cage length 416 that extends from the cage proximal end 410 to the cage distal end 414. a cage height 418 perpendicular to 416; a cage width perpendicular to cage length 416 and cage height 418; a cage interior 422; and a cage periphery comprised of a plurality of memory metal strips 426. (not specifically labeled but designated by the numeral 300 in other embodiments), which can be in the form of a cage 408. Optionally, the cage 408 has a relaxed state in which the cage has a first height 428 and a first width and a second state in which the cage has a second height 432 and a second width. and a deflated state in which the height 432 is less than the first height 428 of the cage 408 and the second width of the cage 408 is less than the first width of the cage 408. In some embodiments, as shown in FIGS. 38 and 40 to 41 and 46, the cage 408 is in the form of a stent retriever having multiple compartments 480 and is similar in design to the distal body of the previous embodiments. . In other embodiments, the cage 408 may have a slightly different design, as shown in FIGS. 42-45.

System 400 may also include an aspiration catheter 436 that includes a generally hollow interior 438, a proximal end 440 located proximal to cage proximal end 410, and a distal end 442. A suction catheter 436 may be attached to the proximal end of the cage 410 and may advance into the cage interior 422. In some embodiments, an aspiration catheter 436 can be attached to the cage tip 414, as shown in FIG. 38. In other embodiments, the suction catheter tip 442 can be proximal to the cage tip 414, as shown in FIGS. 40-46. Inside cage interior 422, suction catheter 436 may include at least one suction opening 444, preferably located between cage proximal end 410 and cage distal end 414, and leading to a generally hollow interior 438 of the suction catheter. For example, as shown in FIGS. 44A-44B, at least one suction opening 444 allows suction catheter 436 to apply suction to draw blood clot 402 from outside cage interior 422 into cage interior 422.

In some embodiments, as shown in FIG. 39, suction catheter 436 is not expandable. In other embodiments, aspiration catheter 436 may include an expandable distal tip 446 that may be constructed of shape memory metal. In such embodiments, the aspiration catheter 436 includes an expandable distal tip 446 located adjacent to the aspiration catheter tip 442 and comprised of a shape memory metal framework 448 and, optionally, a shape memory metal framework 448. and a film/coating 450 attached to the. Optionally, as best seen by comparing FIG. 45E and FIG. the expandable distal tip 446 has a second height 456 and a second width; and a deflated state that is less than one height 452. Optionally, as shown in FIGS. 38 and 40-45, the first height 452 of the expandable distal tip 446 is less than the first height 428 of the cage 408 and the expandable distal tip 446 is less than the first height 428 of the cage 408. The first width of chip 446 is less than the first width of cage 408.

Optionally, in the relaxed state, the expandable distal tip 446 of the aspiration catheter 436 is tapered in shape (eg, funnel-shaped) in the relaxed state, as shown in FIGS. 40-45. Optionally, the tip 442 of the suction catheter 436 forms a maximum height and width of the expandable distal tip 446 in the relaxed state, as shown in FIGS. 40-45. Optionally, the tip 442 of the suction catheter 436 is flared inwardly, as shown in FIGS. 39A and 39B.

Optionally, cage 408 includes a width and height 418 of about 15 to about 35 millimeters in the relaxed state. Optionally, the suction catheter 436 includes a non-expandable proximal section 460 constructed of a different material than the expandable distal tip 446 and located immediately proximal to the expandable distal tip 446. The non-expandable proximal section 460 is configured to maintain substantially the same height and the same width as the expandable distal tip 446 moves between the deflated and relaxed states. be done. Optionally, the expandable distal tip 446 includes a maximum width in the relaxed state that is about 2 times to about 6 times greater than the width of the proximal section. Optionally, the expandable distal tip 446 includes a maximum height in the relaxed state that is about 2 times to about 6 times greater than the height of the proximal section.

46A and 46B show prototype drawings (drawn to scale) of certain embodiments of the expandable distal tip 446 that were fabricated. In FIGS. 46A and 46B, the proximal end 474 of the proximal shape memory metal strip 470 is attached to the outer wall/outer perimeter of the non-expandable proximal section 460. In addition, the expandable distal tip 446 chemically attaches to the proximal shape memory metal strip 470 at least partially along the length of the proximal shape memory metal strip 470 (e.g., a distance of at least 2 millimeters). It consists of a film 450 that is bonded together. The apparatus of FIGS. 46A and 46B involves dipping a proximal shape memory metal strip 470 (made of Nitinol) and a film 450 into the same polymer and then brushing the solvent onto the proximal shape memory metal strip 470 and film 450. fabricated by attaching/chemically bonding the proximal shape memory metal strip 470 and film 450. This process occurs within the expandable distal tip portion 474 whose height 452 and width 456 can expand and collapse with the cage 408, i.e. as the height of the cage expands and collapses. It created several advantages, including having coverage. In other words, as shown in FIGS. 46A and 46B, film 450 covers a portion of cage length 416 (e.g., about 5% to about 50%, more preferably about 5% to about 33%, more preferably about (5% to about 25%, more preferably about 15% to about 25%), the expandable distal tip 446 can be coextensive with the proximal portion of the cage 408. For example, the film 450 may have a length 451 ( parallel to the cage length 416). In addition, the cage 408 has a larger compartment 480A distally relative to the expandable distal tip 446 to prevent captured clots from escaping outside the cage tip 414 (to prevent clots from entering the cage interior 422). ), and the distal portion of the cage 408 was designed with a smaller compartment 480B. In an exemplary embodiment, larger compartment 480A has a surface area in the relaxed state that is about 150% to about 500% of the surface area of smaller compartment 480B. However, other dimensions are also possible. In practice, a suction aperture 444 is located at the distal end of the expandable distal tip 446 (and proximal to the large compartment 480A and distal to the cage proximal end 410) to accommodate the syringe to be applied. or allow suction from other suction sources to draw the clot through the large compartment 480A. Additionally, as can be seen from viewing FIGS. 46A and 46B shown in the relaxed state, the first height 452 of the expandable distal tip 446 is equal to the first height 428 of the cage 408. , the first width of the expandable distal tip 446 is equal to the first width of the cage 408.

Optionally, shape memory metal framework 448 is comprised of woven/braided linear shape memory metal strands 462, as shown in FIGS. 38 and 40-46. Examples of woven/braided linear shape memory metal strands with films/coatings are known in the art. For example, an Anaconda suction catheter with such a framework and film/coating is sold by Anaconda Biomed SL (Barcelona, Spain) and is described in European patent application EP3634768, which includes a woven/braided wire. It is stated that the shaped strands can be dipped into or sprayed onto the polymer coating and that the film/coating can create a water-resistant compartment. Woven/braided linear strands are also described, for example, in applicant's own US Pat. Nos. 10,321,925 and 10,226,268. The contents of the aforementioned European patent applications and US patents are incorporated herein by reference. Optionally, each woven linear strand may be rotated multiple times in a helical manner around the distal portion periphery relative to the cage length/longitudinal axis. Optionally, the expandable distal tip 446 of the aspiration catheter can be flexible and reversible, such as in the Anaconda aspiration catheter.

Optionally, at least one suction opening 444 is located at the tip 442 of the suction catheter 436, as shown in FIGS. 39B and 40-46. Alternatively, the tip 442 of the aspiration catheter 436 may be closed, as shown in FIGS. 38-39 and 39A.

Optionally, as shown in FIGS. 38-40, at least one suction opening 444 is located in the film 450 proximal to the suction catheter tip 442. It is understood that the term "at least one suction opening" allows the suction catheter 436 to have a plurality of suction openings 444 inside the cage interior 422, as shown, for example, in FIGS. 38, 39B and 40. Will. Optionally, as best seen in FIGS. 38 and 39B, if one side (e.g., the top) of the suction catheter 436 includes a suction aperture 444, preferably the opposite side (e.g., the bottom) also includes an aligned suction aperture 444. including. This can also be inferred since, for example in FIG. 40, there is no visible film 450 opposite the suction opening 444. In other words, the centers of suction apertures 444 are optionally aligned longitudinally and located 150-180° apart.

Optionally, cage 408 includes a plurality of x-ray markers 524 located between suction catheter tip 442 and cage tip 414, as best seen in FIGS. 42-44. Optionally, as best seen in FIGS. 42-44, the X-ray markers 524 are vertically aligned (i.e., each of the X-ray markers 524 is located approximately the same distance from the proximal end of the cage 410). . Without being bound by any particular theory, the plurality of X-ray markers 524 inform the operator/surgeon of the position of the cage 408 relative to the clot 402, thereby allowing the operator to correctly position the cage 408 within the blood vessel 404. Can be expanded.

Optionally, the proximal end 440 of the suction catheter 436 is connected to a syringe or pump, not shown but well known in the art.

Optionally, the cage 408 is not freely floating over the aspiration catheter 436; instead, attachment of the aspiration catheter 436 to the cage 408 is accomplished by an operator pulling the aspiration catheter 436 proximally. is configured to allow the cage 408 to be pulled proximally by the pump and to push the cage 408 distally by pushing the suction catheter 436 distally. In other words, the surgeon may move cage 408 proximally and distally by moving suction catheter 436 proximally and distally.

Optionally, the proximal end 440 of the suction catheter 436 has a tapered (e.g., funnel-shaped) configuration configured to connect the proximal end 440 to a source of suction, such as shown in FIGS. shape) of the hub/coupler 468.

Optionally, as shown in FIGS. 38 and 40-46, in the relaxed state, the cage 408 increases in cage height as the shape memory metal strip 426 located at the proximal end of the cage 408 approaches the cage proximal end 410. 418 and a tapered proximal region 528 where the cage width is reduced.

Optionally, as shown in FIGS. 38 and 40-46, in the relaxed state, the cage 408 increases in cage height 418 and Includes a tapered distal region 530 where the cage width is reduced.

Optionally, cage 408 further includes a cage proximal junction 412 located at cage proximal end 410 and a plurality of proximal strips 470, each proximal strip 470 having a distal end 472 and a proximal end 474. , the proximal ends of the proximal strips 470 converge at the cage proximal junction 412, and the suction catheter 436 passes through the cage proximal junction 412, as shown in FIG.

Optionally, as shown in FIGS. 38 and 40-45, the cage 408 further includes a cage distal junction 532 located at the cage distal end 414 and a plurality of distal strips 534, each distal strip 534 Having a distal end 536 and a proximal end 538, the distal end 536 of the distal strip 534 converges at a cage distal junction 532.

Optionally, a suction catheter 436 is attached to the cage distal junction 532, as shown in FIG. 38. Optionally, suction catheter tip 442 may extend distally beyond cage tip 414. Optionally, suction catheter 436 is not attached to cage tip 414.

Optionally, suction catheter 436 has a length of about 60 centimeters to about 150 centimeters.

Optionally, suction catheter 436 includes a plurality of suction apertures 444, at least some of which are located proximal to aspiration catheter tip 442, as shown in FIGS. 38-40. .

Optionally, as shown in FIGS. 38 and 40-41, the cage 408 is comprised of a framework 478 that includes a plurality of compartments 480 formed by a plurality of shape memory metal strips 426. Optionally, in the relaxed state, at least one of the suction openings 444 located proximally to the suction catheter tip 442 is aligned with compartment 480 so that the operator can use suction opening 444 to compartmentalize the clot. 480 into the cage interior 422. For example, as shown in FIGS. 38 and 40-41, the height center of the suction opening 422 may be aligned with the height center of the compartment 480 such that the suction force is centered on the compartment 480. Optionally, in a relaxed state, the framework 478 includes at least a pair of distal peaks 482 that are not attached to another compartment 480 and are oriented generally distally, as shown in FIGS. 38 and 40-41. , the distal apexes 482 of at least one pair of distal apexes 482 are located approximately the same distance from the cage proximal end 410 and are located at 150° to 180° with respect to each other. Optionally, each distal apex in the at least one pair of distal apices 482 forms part of a different enlarged section 484, and each enlarged section 484 has a center. Optionally, the centers of the enlarged sections 484 for at least one pair of distal apices 482 are between 150° and 180° with respect to each other. Optionally, expansion compartment 484 is configured to allow blood clot 402 to pass therethrough and into cage interior 422. Optionally, one or more of the suction openings 444 located proximally to the suction catheter tip 442 are aligned with the enlarged section 484. Optionally, as shown in FIG. 38, as in the previous embodiment, the enlargement sections 484 are sequentially offset (e.g., the proximal-most pair of enlargement sections 484 (60-90° offset from the pair of enlarged compartments 484, which in turn is 60-90° offset from the proximal-most pair of enlarged compartments, etc.), the suction apertures 444 are similarly sequentially offset. has been done.

Optionally, as shown in FIG. 38, the cage 408 further includes a cage proximal junction 412 located at the proximal end 410 of the cage, and a plurality of proximal strips 470, each proximal strip 470 has a distal end 472 attached to the proximal top 540 of the compartment of the cage 408 and a proximal end 474, with the proximal ends of the proximal strips 470 converging at the cage proximal junction 412.

Optionally, as shown in FIG. 45E, the system 400 further includes a delivery catheter 488 having an interior, a proximal end (not shown) communicating with the interior, and a distal end 494 communicating with the interior. Constructed of biocompatible material and configured to encase cage 408 and suction catheter 436 prior to deployment from delivery catheter 488. System 400 may also include a guide catheter 542, as shown in FIGS. 42 and 45E and 45F.

Optionally, as shown in FIG. 39, an inner blocking catheter located within the generally hollow interior 438 of the aspiration catheter and movable proximally and distally within the generally hollow interior 438 of the aspiration catheter. 498, the system 400 may include an inner blocking catheter 498 including an open proximal end 500, an open distal end 502, and a generally hollow interior. Without being bound to any particular theory, inner blocking catheter 498 is used to block suction hole 444 in suction catheter 436, as shown in FIG. 39, where proximal suction hole 444 is blocked. obtain. Optionally, inner blocking catheter 498 and aspiration catheter 436 each include an outer diameter and an inner diameter, and further, the outer diameter of inner blocking catheter 498 is about 85% to about 99.9% as large as the inner diameter of aspiration catheter 436.

Optionally, the height/width center of suction catheter 436 is located approximately at the height/width center of cage 408 in the relaxed state, as shown in FIGS. 38 and 40-45.

Optionally, although not shown, the cage 408 further includes a scaffolding memory metal strip extending inwardly from the cage periphery to the suction catheter 436 to help maintain the suction catheter 436 centered in the cage 408. 426.

Optionally, in the relaxed state, the cage 408 has a minimum height 418 and width at the proximal end 410 of the cage, as shown in FIGS. 40-46.

Optionally, cage interior 422 is hollow except for suction catheter 436.

Optionally, as shown in FIG. 38, the cage proximal end 410 is in the form of a tube.

Optionally, as shown in FIGS. 38-46, a suction catheter 436 is fixedly attached to at least some of the cage shape memory metal strips 426.

Optionally, as shown in FIGS. 38 and 40-41 and 46, in the relaxed state, the cage 408 is configured with a plurality of compartments 480, but with any free proximal apex 540 oriented in a generally proximal direction. However, it does have a free distal apex 482 that points generally in the distal direction.

Optionally, the system further includes a lead wire 512 extending distally from the cage tip 414.

Generally, as illustrated in FIGS. 44A and 44B and FIGS. 45A-45G, system 400 includes:
a) providing a delivery catheter 488 having an interior, a proximal end, and a distal end 494 and surrounding the cage 408 (see FIG. 45C);
b) deploying cage 408 from delivery catheter tip 494 such that cage 408 moves from a deflated state to a relaxed state (see FIGS. 45D and 45E);
c) applying suction to suction catheter 436 to move clot 402 into cage interior 422 (see FIG. 45F and FIGS. 44A and 44B); and
d) moving cage 408 and clot 402 proximally out of the animal, for example by pulling suction catheter 436 proximally (see Figure 45G);
can be used in a method of removing a blood clot 402 from an animal, including.

Optionally, the method further includes connecting a syringe or pump (not shown but known in the art) to the suction catheter proximal end 440 and using the syringe or pump to suction into the suction catheter 436. Including adding.

Optionally, as shown in FIG. 39, the method further includes, prior to step c), providing an inner blocking catheter 498 located within the generally hollow interior 438 of the aspiration catheter; including moving proximally or distally within the generally hollow interior 438 of the aspiration catheter to cover the aspiration opening 444 in the aspiration catheter 436 .

Optionally, steps b) and c) occur in the animal's lungs.

Without being bound to any particular theory, Figures 44A and 44B and 45D and 45E illustrate how cage 408 can gradually move from a deflated state to a relaxed state. Unlike the previous embodiment, best seen in FIG. 22, where the distal body is deployed distally to the clot 402, in the embodiments of FIGS. 44A-44B and 45D and 45E, where the cage tip 414 is distal to the proximal end and the cage tip 414 is proximal to the tip of the clot 402. It can be deployed at the site of In addition to delivery catheter 488, a guide catheter 542 having a larger diameter than delivery catheter 488 may also be used, as best seen in FIGS. 45C-45G. After capture of clot 402, aspiration catheter 436, cage 408 and clot 402 may be moved (fully or partially) into guide catheter 542, as shown in FIG. 45G.

parts list

Although the invention has been described in accordance with the requirements of the patent laws, those skilled in the art will recognize how to make changes and modifications to the disclosed embodiments to meet their own requirements or conditions. Changes and modifications may be made without departing from the scope and spirit of the invention, which is defined and limited only by the following claims. In particular, although the system has been illustrated for use in retrieving blood clots, the system may be used to retrieve other objects from an animal's lumen. Additionally, the steps of any method described herein may be performed in any suitable order, and steps may be performed simultaneously, if desired.

As used herein, words such as "substantially," "about," and "approximately" are modified by a reasonable amount of the word so that the final result does not change significantly. means a deviation from For example, these words can be interpreted to include a deviation of at least ±5% from the word they modify (provided such deviation does not negate the meaning of the word it modifies).

Optionally, in place of the three pairs of compartments in said series, the series includes a proximal apex section oriented generally proximally and attached to a shape memory metal strip, and a free section oriented generally distally. may include only two pairs of compartments located on the distal body periphery with free distal apexes, of which the most proximal free distal apexes are at 12 o'clock and 6 o'clock. and approximately the same distance from the proximal junction (same distance +/-5mm), with the next most proximal free distal apex at the 3 o'clock and 9 o'clock positions. and approximately the same distance from the proximal junction (same distance +/-5 mm). In such embodiments, the distal body and system may have any of the features described above in connection with the distal body having at least three pairs of compartments with free distal tops.
[Invention 1001]
a cage proximal end, a cage distal end, a cage length extending from the cage proximal end to the cage distal end, a cage height perpendicular to the cage length, and a cage length perpendicular to the cage height. a distal body including a cage including a cage width, a cage interior, and a cage perimeter configured with a plurality of shape memory metal strips, the cage having a first height and a first height; the cage has a second height and a second width, the second height of the cage is less than the first height of the cage; the distal body has a deflated condition, the second width of the cage being less than the first width of the cage; and
an aspiration catheter that is attached to and extends into the cage, the aspiration catheter including a generally hollow interior, a proximal end located proximal to the cage proximal end, and a distal end; the suction catheter including at least one suction opening in the cage interior located between an end and the cage tip and communicating with the generally hollow interior;
A system for removing blood clots from human blood vessels, including:
[Present invention 1002]
The present invention 1001, wherein the suction opening is configured to allow an operator to draw a clot from outside the cage interior into the cage interior when a proximal suction force is applied to the suction catheter. system.
[Present invention 1003]
1002 of the present invention, wherein the suction catheter is connected to a syringe or pump, the syringe or pump configured to apply a proximal suction force to the suction opening to draw the clot into the interior of the cage. system.
[Present invention 1004]
1001. The system of the invention 1001, wherein the proximal end of the aspiration catheter includes a tapered hub configured to connect the proximal end of the aspiration catheter to a source of suction.
[Present invention 1005]
1001. The system of the invention 1001, wherein the cage is comprised of a framework that includes a plurality of compartments formed by a plurality of shape memory metal strips.
[Present invention 1006]
1005. The system of the invention 1005, wherein in the relaxed state, the suction opening is aligned with the compartment.
[Present invention 1007]
1006. The system of the present invention, wherein in the relaxed state, the suction opening is aligned with the longitudinal center of the compartment.
[Present invention 1008]
In the relaxed state, the framework includes at least one pair of distal apices that are not attached to another compartment and are oriented generally distally, the distal apices of the at least one pair of distal apices being in a cage. each distal apex of the at least one pair of distal apices forming a part of a different enlarged segment, each distal apex being located approximately the same distance from the proximal end and between 150° and 180° with respect to each other; has a center,
the centers of the enlarged sections for the at least one pair of distal apices are 150° to 180° with respect to each other; the suction opening is aligned with the expansion compartment;
System of the present invention 1005.
[Present invention 1009]
1008. The system of the present invention, wherein the vertical center of the suction opening is aligned with the vertical center of the expansion compartment.
[Present invention 1010]
Within the cage interior, the suction catheter includes at least one pair of suction apertures proximal to the aspiration catheter tip, each of the at least one pair of suction apertures having a center; The system of the invention 1001, wherein the centers are located at 150° to 180° with respect to each other.
[Present invention 1011]
1010. The system of the invention 1010, wherein the suction catheter tip is open.
[Invention 1012]
The aspiration catheter includes an expandable distal tip located adjacent to the aspiration catheter tip and configured with a shape memory metal framework, and a film attached to the shape memory metal framework, the expandable The distal tip is in a relaxed state, the expandable distal tip having a first height and a first width, and the expandable distal tip having a second height and a second width. , the second height of the expandable distal tip is less than the first height of the expandable distal tip, and the second width of the expandable distal tip is less than the first height of the expandable distal tip; the first width of the expandable distal tip is less than the first width of the expandable distal tip; and the first height of the expandable distal tip is less than the first height of the cage. , the first width of the expandable distal tip is less than the first width of the cage.
[Present invention 1013]
In the relaxed state, the expandable distal tip of the aspiration catheter is tapered, and the distal end of the aspiration catheter has a maximum height of the expandable distal tip in the relaxed state and The system of the present invention 1012 for forming a width.
[Present invention 1014]
the cage includes a maximum width and a maximum height of about 15 mm to about 35 mm in the relaxed state, and the suction catheter includes a non-expandable proximal section immediately proximal to the expandable distal tip; , such that the non-expandable proximal section maintains substantially the same height and the same width as the expandable distal tip moves between the deflated state and the relaxed state. configured, further comprising: the expandable distal tip having a maximum width in the relaxed state that is about 2 times to about 6 times greater than the width of the proximal section; has a maximum height in the relaxed state that is about 2 times to about 6 times greater than the height of the proximal section.
[Present invention 1015]
1013. The system of the invention 1012, wherein the shape memory metal framework is comprised of woven linear shape memory metal strands forming a plurality of braided mesh apertures, and wherein the film covers the mesh apertures.
[Invention 1016]
The suction catheter includes at least one pair of suction apertures located in the film proximal to the aspiration catheter tip, each of the at least one pair of suction apertures having a center, the center of the at least one pair of suction apertures; are located at 150° to 180° with respect to each other.
[Invention 1017]
The system of the present invention 1001, wherein a suction catheter is attached to the proximal end of the cage.
[Invention 1018]
Attachment of an aspiration catheter to a cage is performed by an operator pulling the cage proximally by pulling the aspiration catheter proximally and pushing the cage distally by an operator pushing the aspiration catheter distally. The system of the invention 1001 configured to allow pushing.
[Invention 1019]
The present invention 1001, wherein within the cage interior, the suction catheter includes a plurality of suction openings leading into the generally hollow interior, at least some of the plurality of suction openings being located proximal to the tip of the suction catheter. system.
[Invention 1020]
The invention 1001 further includes a delivery catheter having an interior, a proximal end communicating with the interior, and a distal end communicating with the interior, the delivery catheter being constructed of a biocompatible material and enclosing the cage and the suction catheter. system.
[Invention 1021]
1001. The system of the invention 1001, wherein the tip of the aspiration catheter extends distally beyond the cage tip and is not attached to the cage tip.
[Invention 1022]
further comprising an inner blocking catheter located within the generally hollow interior of the aspiration catheter and movable proximally and distally within the generally hollow interior of the aspiration catheter, the inner blocking catheter having an open 1001. The system of the invention 1001, comprising a proximal end, an open distal end, and a generally hollow interior.
[Invention 1023]
The present invention wherein the inner blocking catheter and the aspiration catheter each include an outer diameter and an inner diameter, and the outer diameter of the inner blocking catheter is about 85% to about 99.9% of the size of the inner diameter of the aspiration catheter. 1022 systems.
[Invention 1024]
The system of the present invention 1001, wherein the height and width centers of the suction catheter are located approximately at the height and width centers of the cage in the relaxed state.
[Invention 1025]
1001. The system of the present invention 1001, wherein the interior of the cage is hollow except for the suction catheter, and the system further includes a lead wire extending distally from the distal end of the cage.
[Invention 1026]
a cage proximal end, a cage distal end, a cage length extending from the cage proximal end to the cage distal end, a cage height perpendicular to the cage length, and a cage length perpendicular to the cage height. a distal body including a cage including a cage width, a cage interior, and a cage perimeter configured with a plurality of shape memory metal strips, the cage having a first height and a first height; the cage has a second height and a second width, the second height of the cage is less than the first height of the cage; the distal body has a deflated condition, the second width of the cage being less than the first width of the cage; and
an aspiration catheter including a generally hollow interior, a proximal end disposed proximally to the cage proximal end, and a distal end attached to at least some of the cage shape memory metal strips; the suction catheter including at least one suction opening leading into the hollow interior;
A system for removing blood clots from human blood vessels, including:
[Invention 1027]
1026. The system of the invention 1026, wherein the suction catheter is fixedly attached to at least some of the plurality of shape memory metal strips.
[Invention 1028]
The aspiration catheter includes an expandable distal tip located adjacent to the aspiration catheter tip, the expandable distal tip having a first height and a first width. the expandable distal tip has a second height and a second width, and the second height of the expandable distal tip is a relaxed state of the expandable distal tip; and a deflated state, wherein the second width of the expandable distal tip is less than the first width of the expandable distal tip. Any system from 1026 to 1027.
[Invention 1029]
1028. The system of the present invention, wherein the expandable distal tip is comprised of a film chemically bonded to at least some of the shape memory metal strips.
[Invention 1030]
Inventions 1028-1029, wherein the first height of the expandable distal tip is equal to the first height of the cage, and the first width of the expandable distal tip is equal to the first width of the cage. any system.
[Present invention 1031]
an expandable distal tip comprised of a film, the aspiration catheter including a non-expandable proximal section immediately proximal to the expandable distal tip; a side section configured to maintain substantially the same height and width as the expandable distal tip moves between the deflated state and the relaxed state, and includes an outer wall; , at least some of the shape memory metal strips are proximal shape memory metal strips including a proximal end, a distal end attached to the outer wall of the non-expandable proximal section; is attached to the proximal shape memory metal strip.
[Invention 1032]
The system of the invention 1031, wherein the film has a film length parallel to the cage length, the film length being about 5 millimeters to about 25 millimeters.
[Present invention 1033]
In the relaxed state, the expandable distal tip of the aspiration catheter is tapered, and the distal end of the aspiration catheter has a maximum height of the expandable distal tip in the relaxed state and The system of any of the inventions 1028-1032, forming a width.
[Present invention 1034]
1034. The system of any of the inventions 1028-1033, wherein the cage includes a plurality of compartments adjacent the cage tip.
[Invention 1035]
The cage includes a plurality of small compartments adjacent to the cage tip and a plurality of large compartments located between the plurality of small compartments and the suction catheter tip, the large compartments having a lower volume than the smaller compartments in the relaxed state. The system of any of the inventions 1028-1033, having a large surface area.
[Invention 1036]
1035. The system of the invention 1035, wherein the large compartment has a surface area in the relaxed state that is between 150% and 500% of the surface area of the small compartment.
[Present invention 1037]
The invention 1028 wherein the suction opening is configured to allow an operator to draw a clot from outside the cage interior into the cage interior when a proximal suction force is applied to the suction catheter. Any system from ~1036.
[Invention 1038]
The present invention 1028-, wherein the suction catheter is connected to a syringe or pump, the syringe or pump configured to apply a proximal suction force to the suction opening to draw the clot into the interior of the cage. 1037 any system.
[Invention 1039]
1038. The system of any of the inventions 1026-1038, wherein the at least one suction opening is located between the proximal end of the cage and the distal end of the cage.
[Invention 1040]
1039. The system of any of the inventions 1026-1039, wherein the at least one suction opening is located at the tip of the suction catheter.
[Present invention 1041]
1040. The system of any of the inventions 1026-1040, wherein the cage shape memory metal strip located at the cage tip converges at a cage tip side junction.
[Present invention 1042]
1042. The system of the invention 1041, wherein the cage shape memory metal strip located at the cage tip is soldered or welded to the cage tip junction.

Claims (42)

a cage proximal end, a cage distal end, a cage length extending from the cage proximal end to the cage distal end, a cage height perpendicular to the cage length, and a cage length perpendicular to the cage height. a distal body including a cage including a cage width, a cage interior, and a cage perimeter configured with a plurality of shape memory metal strips, the cage having a first height and a first height; the cage has a second height and a second width, the second height of the cage is less than the first height of the cage; the distal body having a deflated condition, the second width of the cage being less than the first width of the cage; an aspiration catheter, the suction catheter having a proximal end and a distal end attached to the cage and advancing into the interior of the cage, the catheter being located between the proximal end of the cage and the distal end of the cage and communicating with the generally hollow interior; A system for removing blood clots from a human blood vessel, including a suction catheter that includes at least one suction opening within the cage interior. 10. The suction opening is configured to allow an operator to draw a clot from outside the cage interior into the cage interior when a proximal suction force is applied to the aspiration catheter. The system described. 3. The suction catheter is connected to a syringe or pump, and the syringe or pump is configured to apply proximal suction to the suction opening to draw the clot into the interior of the cage. system. 2. The system of claim 1, wherein the proximal end of the aspiration catheter includes a tapered hub configured to connect the proximal end of the aspiration catheter to a source of suction. 2. The system of claim 1, wherein the cage is comprised of a framework that includes a plurality of compartments formed by a plurality of shape memory metal strips. 6. The system of claim 5, wherein in the relaxed state, the suction opening is aligned with the compartment. 7. The system of claim 6, wherein in the relaxed state the suction opening is aligned with the longitudinal center of the compartment. In the relaxed state, the framework includes at least one pair of distal apices that are not attached to another compartment and are oriented generally distally, the distal apices of the at least one pair of distal apices being in a cage. each distal apex of the at least one pair of distal apices forming a part of a different enlarged segment, each distal apex being located approximately the same distance from the proximal end and between 150° and 180° with respect to each other; has a center,
the centers of the enlarged sections for the at least one pair of distal apices are 150° to 180° with respect to each other; the suction opening is aligned with the expansion compartment;
6. The system according to claim 5. 9. The system of claim 8, wherein the vertical center of the suction opening is aligned with the vertical center of the expansion section. Within the cage interior, the suction catheter includes at least one pair of suction apertures proximal to the aspiration catheter tip, each of the at least one pair of suction apertures having a center; The system of claim 1, wherein the centers are located at 150° to 180° with respect to each other. 11. The system of claim 10, wherein the suction catheter tip is open. The aspiration catheter includes an expandable distal tip located adjacent to the aspiration catheter tip and configured with a shape memory metal framework, and a film attached to the shape memory metal framework, the expandable The distal tip is in a relaxed state, wherein the expandable distal tip has a first height and a first width, and the expandable distal tip has a second height and a second width. , the second height of the expandable distal tip is less than the first height of the expandable distal tip, and the second width of the expandable distal tip is less than the expandable distal tip. the first width of the expandable distal tip is less than the first width of the expandable distal tip; and the first height of the expandable distal tip is less than the first height of the cage. , wherein the first width of the expandable distal tip is less than the first width of the cage. In the relaxed state, the expandable distal tip of the aspiration catheter is tapered, and the distal end of the aspiration catheter has a maximum height of the expandable distal tip in the relaxed state and 13. The system of claim 12, forming a width. the cage includes a maximum width and a maximum height of about 15 mm to about 35 mm in the relaxed state, and the suction catheter includes a non-expandable proximal section immediately proximal to the expandable distal tip; , such that the non-expandable proximal section maintains substantially the same height and the same width as the expandable distal tip moves between the deflated state and the relaxed state. configured, further comprising: the expandable distal tip having a maximum width in the relaxed state that is about 2 times to about 6 times greater than the width of the proximal section; 13. The system of claim 12, wherein: comprises a maximum height in the relaxed state that is about 2 times to about 6 times greater than the height of the proximal section. 13. The system of claim 12, wherein the shape memory metal framework is comprised of woven linear shape memory metal strands forming a plurality of braided mesh apertures, and wherein the film covers the mesh apertures. The suction catheter includes at least one pair of suction apertures located in the film proximal to the aspiration catheter tip, each of the at least one pair of suction apertures having a center, the center of the at least one pair of suction apertures; are located at 150° to 180° with respect to each other. 2. The system of claim 1, wherein the suction catheter is attached to the proximal end of the cage. Attachment of an aspiration catheter to a cage is performed by an operator pulling the cage proximally by pulling the aspiration catheter proximally and pushing the cage distally by an operator pushing the aspiration catheter distally. 2. The system of claim 1, wherein the system is configured to allow pressing. 12. Within the cage interior, the suction catheter includes a plurality of suction openings leading into the generally hollow interior, at least some of the plurality of suction openings being located proximal to the tip of the suction catheter. The system described. 2. The delivery catheter of claim 1, further comprising a delivery catheter having an interior, a proximal end communicating with the interior, and a distal end communicating with the interior, the delivery catheter being constructed of a biocompatible material and enclosing the cage and the suction catheter. system. 2. The system of claim 1, wherein the tip of the aspiration catheter extends distally beyond the cage tip and is not attached to the cage tip. further comprising an inner blocking catheter located within the generally hollow interior of the aspiration catheter and movable proximally and distally within the generally hollow interior of the aspiration catheter, the inner blocking catheter having an open 2. The system of claim 1, comprising a proximal end, an open distal end, and a generally hollow interior. 10. An inner blocking catheter and an aspiration catheter each include an outer diameter and an inner diameter, and further wherein the outer diameter of the inner blocking catheter is about 85% to about 99.9% of the size of the inner diameter of the aspiration catheter. System described in 22. 2. The system of claim 1, wherein the height and width centers of the suction catheter are located approximately at the height and width centers of the cage in the relaxed state. 2. The system of claim 1, wherein the interior of the cage is hollow except for the suction catheter, and the system further includes a lead wire extending distally from a distal end of the cage. a cage proximal end, a cage distal end, a cage length extending from the cage proximal end to the cage distal end, a cage height perpendicular to the cage length, and a cage length perpendicular to the cage height. a distal body including a cage including a cage width, a cage interior, and a cage perimeter configured with a plurality of shape memory metal strips, the cage having a first height and a first height; the cage has a second height and a second width, the second height of the cage is less than the first height of the cage; the distal body having a deflated condition, the second width of the cage being less than the first width of the cage; an aspiration catheter, the aspiration catheter having at least one aspiration opening attached to at least some of the cage shape memory metal strips and communicating with the generally hollow interior; , a system for removing blood clots from human blood vessels. 27. The system of claim 26, wherein the aspiration catheter is fixedly attached to at least some of the plurality of shape memory metal strips. The aspiration catheter includes an expandable distal tip located adjacent to the aspiration catheter tip, the expandable distal tip having a first height and a first width. the expandable distal tip has a second height and a second width, and the second height of the expandable distal tip is a relaxed state of the expandable distal tip; and a deflated state, wherein the second width of the expandable distal tip is less than the first width of the expandable distal tip. The system according to any one of paragraphs 26 to 27. 29. The system of claim 28, wherein the expandable distal tip is comprised of a film chemically bonded to at least some of the shape memory metal strips. Claims 28-29 wherein the first height of the expandable distal tip is equal to the first height of the cage and the first width of the expandable distal tip is equal to the first width of the cage. A system according to any one of the following. an expandable distal tip comprised of a film, the aspiration catheter including a non-expandable proximal section immediately proximal to the expandable distal tip; a side section configured to maintain substantially the same height and width as the expandable distal tip moves between the deflated state and the relaxed state, and includes an outer wall; , at least some of the shape memory metal strips are proximal shape memory metal strips including a proximal end, a distal end attached to the outer wall of the non-expandable proximal section; is attached to the proximal shape memory metal strip. 32. The system of claim 31, wherein the film has a film length parallel to the cage length, the film length being about 5 millimeters to about 25 millimeters. In the relaxed state, the expandable distal tip of the aspiration catheter is tapered, and the distal end of the aspiration catheter has a maximum height of the expandable distal tip in the relaxed state and System according to any one of claims 28 to 32, forming a width. 34. The system of any one of claims 28-33, wherein the cage includes a plurality of compartments adjacent the cage tip. The cage includes a plurality of small compartments adjacent to the cage tip and a plurality of large compartments located between the plurality of small compartments and the suction catheter tip, the large compartments having a lower volume than the smaller compartments in the relaxed state. System according to any one of claims 28 to 33, having a large surface area. 36. The system of claim 35, wherein the large compartment has a surface area in the relaxed state that is between 150% and 500% of the surface area of the small compartment. 28. The suction opening is configured to allow an operator to draw a clot from outside the cage interior into the cage interior when a proximal suction force is applied to the suction catheter. The system described in any one of ~36. 28-28, wherein the suction catheter is connected to a syringe or pump, the syringe or pump being configured to apply proximal suction to the suction opening to draw the clot into the interior of the cage. 37. The system according to any one of paragraph 37. 39. The system of any one of claims 26 to 38, wherein the at least one suction opening is located between the proximal end of the cage and the distal end of the cage. 40. The system of any one of claims 26-39, wherein the at least one suction opening is located at the tip of the suction catheter. 41. The system of any one of claims 26 to 40, wherein the cage shape memory metal strips located at the cage tip converge at a cage tip junction. 42. The system of claim 41, wherein the cage shape memory metal strip located at the cage tip is soldered or welded to the cage tip junction.

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