# Patent

## Title
Stent retriever having an expandable fragment guard

## Abstract

A stent retriever assembly having a proximal end and a distal end, and including a mesh tube having a distal and proximal end, and being connected to a first wire. Also, a blood-porous fragment guard is at the distal end of the mesh tube, the fragment guard including spokes joined at a central hub and extending radially and proximally from the central hub, and wherein a second wire is connected to the central hub so that when the second wire is pulled proximally relative to the first wire, the hub is pulled proximally, causing the spokes to spread out and causing the fragment guard to widen.

## Background
BACKGROUND
The medical arts have advanced rapidly in the area of stroke treatment. Until recently, only medicinal treatment could be offered. Then, stents capable of retrieving the clot material blocking a blood vessel in an ischemic stroke were developed. Now, if a patient is seen quickly after onset the clot material can be swiftly removed, thereby saving a great deal of brain function, that would otherwise be lost.
Still, many challenges remain, in the removal of a clot that blocks a cerebral artery. One of these challenges is the tendency of fragments of material to break off of the clot as it is being removed, flow in the direction of blood flow, and lodge anew in some narrow cerebral artery, causing a secondary stroke, which can be damaging.
SUMMARY
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other improvements.
In a first separate aspect, the present invention may take the form of a stent retriever assembly having a proximal end and a distal end, and including a mesh tube having a distal and proximal end, and being connected to a first wire. Also, a blood-porous fragment guard is at the distal end of the mesh tube, the fragment guard including spokes joined at a central hub and extending radially and proximally from the central hub, and wherein a second wire is connected to the central hub so that when the second wire is pulled proximally relative to the first wire, the hub is pulled proximally, causing the spokes to spread out and causing the fragment guard to widen.
In a second separate aspect, the present invention may take the form of a method of removing a clot from an artery, utilizing a stent retriever assembly having a proximal end and a distal end. The stent retriever includes a mesh tube having a distal and proximal end, and being connected to a first wire. A blood-porous fragment guard at the distal end of the mesh tube, the fragment guard including spokes joined at a central hub and extending radially and proximally from the central hub, and wherein a second wire is connected to the central hub so that when the second wire is pulled proximally relative to the first wire, the hub is pulled proximally, causing the spokes to spread out and causing the fragment guard to widen. In the method, this stent retriever is deployed to a proximal side of the clot and pushed through the clot. Then the second wire is pulled, relative to the first wire, thereby widening the fragment guard, and the stent retriever is pulled proximally to pull material from the clot proximally.
In a third separate aspect, the present invention may take the form of a stent retriever catheter assembly having a proximal end and a distal end, and including a catheter, including a flexible tube sized to fit through the arterial system of a person, and to reach a blood clot in an artery. A first and a second wire extend through the tube, and a handle is connected to the first and second wires, permitting the first and second wires to be advanced and retracted with at least 1 cm of independence relative to each other. Also, a mesh tube having a distal and proximal end, is connected to the first wire and a blood-porous fragment guard is positioned at the distal end of the mesh tube. This fragment guard includes spokes joined at a central hub and extending radially and proximally from the central hub, and wherein the second wire is connected to the central hub so that when the second wire is pulled proximally relative to the first wire, the hub is pulled proximally, causing the spokes to spread out and causing the fragment guard to widen.
In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an isometric view of a stent retriever according to the present invention.
FIG. 2 is a sectional view of an artery clogged by a clot, with the stent retriever of FIG. 1 piercing the clot.
FIG. 3 is the sectional view of FIG. 2, with the stent retriever of FIG. 1 deployed.
FIG. 4 is the sectional view of FIG. 2, with the stent retriever of FIG. 1 further expanded and in the process of removing the clot.
FIG. 5 is an isometric view of a catheter assembly, including a handle assembly, that could be used to control the stent retriever of FIGS. 1-4.



Exemplary embodiments are illustrated in referenced drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIGS. 1 and 2, In a preferred embodiment, a stent retriever 10 includes a wire mesh 12 and a woven fragment guard 14. it is controlled by a pair of wires 18A and 18B, which must be separately advanceable for the stent retriever 10 to work correctly. The stent retriever 10 is positioned in an artery 20, near a clot 22 by introduction of a catheter 16. After a distal end of catheter 16 is positioned near clot 22, the stent retriever 10 is deployed by pushing wires 18A and 18B forward. A system for permitting this action is shown and described in U.S. Pat. No. 8,876,863. After or during deployment the stent retriever 10 is pushed through clot 22, so that at least the fragment guard 14 is pushed all the way through.
Referring also to FIG. 3, wire 18B is advanced relative to wire 18A. Fragment guard 14 is made of a set of spokes 24 that meet in an apex 26, and are all covered by a fabric 28. When wire 18B is advanced, or wire 18A is retracted, then spokes 24 are spread apart (much as the spokes of an umbrella). The stent retriever is now pulled proximally, bringing the clot 22 with it, and with fragment guard 14 protecting the artery 20 further on in the direction of blood flow, from fragments that could break off from clot 22. Referring to FIG. 4, as the stent retriever 10 is pulled toward the incision where catheter 16 was introduced, artery 20 will typically widen. Wire 18A may be pulled further back relative to wire 18B, thereby widening out fragment guard 14. Wires 18B and 18A each support a radiopaque marker 40 and 42, respectively, to aid a surgeon in locating the stent retriever during a procedure. The two markers 40 and 42 are spaced apart and mutually distinguishable, to aid a surgeon in determining the orientation of stent retriever 10. In an alternative preferred embodiment, marker 42 is closer to the distal tip of retriever 10.
In one preferred embodiment, wire mesh 12 and spokes 24 are made of nitinol. In another preferred embodiment mesh 12 and spokes 24 are made of a titanium alloy. In one embodiment, fabric 28 is made of woven strands of expanded polytetrafluoroethylene (ePTFE). In one embodiment, the weave is loose, to permit blood to flow through the interstices of the threads. In still another embodiment, the fabric 28 is made of threads arranged in a circular manner about said spokes, to form a pattern similar to that of a spider web.
Referring to FIG. 5, catheter 16 is connected to a handle 44, having separately positionable positioners 46A and 46B, for wires 18A and 18B. Handle 44 permits a user to separately move wire 18A and 18B, for deployment and control of the fragment guard 14.
While a number of exemplary aspects and embodiments have been discussed above, those possessed of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

## Claims

1. A stent retriever assembly having a proximal end and a distal end, and comprising:
(a) a mesh tube having a distal and proximal end, and being connected to a first wire; and
(b) a blood-porous fragment guard mounted at said distal end of said mesh tube, said fragment guard including spokes joined at a central hub and extending radially and proximally from said central hub, and wherein a second wire is connected to said central hub so that when said second wire is pulled proximally relative to said first wire, said hub is pulled proximally, causing said spokes to spread out and causing said fragment guard to widen, and wherein said first wire and said second wire are spaced apart laterally.

2. The stent retriever assembly of claim 1, wherein said mesh tube is made, at least in part, of a metal mesh that is stiff, so that when said second wire is pulled proximally, said metal mesh resists being pulled proximally, due to said stiffness.

3. The stent retriever assembly of claim 1, wherein said fragment guard, in addition to said spokes, includes threads extending across and between said spokes, to create a finer mesh, better able to hold clot material.

4. The stent retriever assembly of claim 1, wherein said mesh tube is collapsible, to be placed into a narrow state for penetrating through a clot.

5. The stent retriever assembly of claim 1, wherein when said second wire is pulled proximally relative to said first wire, said mesh tube expands outwardly with said fragment guard.

6. A method of removing a clot from an artery, comprising:
(a) providing a stent retriever assembly having a proximal end and a distal end, and including:
(i) a mesh tube having a distal and proximal end, and being connected to a first wire; and
(ii) a blood-porous fragment guard mounted at said distal end of said mesh tube, said fragment guard including spokes joined at a central hub and extending radially and proximally from said central hub, and wherein a second wire is connected to said central hub so that when said second wire is pulled proximally relative to said first wire, said hub is pulled proximally, causing said spokes to spread out and causing said fragment guard to widen, and wherein said first wire and said second wire are spaced apart laterally;

(b) deploying said stent retriever to a proximal side of said clot;
(c) pushing said stent retriever through said clot;
(d) pulling said second wire relative to said first wire, thereby widening said fragment guard; and
(e) pulling said stent retriever proximally to pull material from said clot proximally.

7. The method of claim 6, wherein said blood clot is in a narrow artery, and wherein as said stent retriever is pulled proximally through said artery, said artery widens and said second wire is pulled further proximally relative to said first wire causing said fragment guard to widen further to more closely conform to the wider arterial walls.

8. The method of claim 6, wherein said blood clot is in a cranial artery.

9. The method of claim 6, wherein said stent retriever assembly includes a radiopaque element, and wherein during performance of the method location of said stent retriever assembly is monitored by means of said radiopaque element.

10. A stent retriever catheter assembly having a proximal end and a distal end, and comprising:
(a) a catheter, including a flexible tube sized to fit through the arterial system of a person, and to reach a blood clot in an artery;
(b) a first and second wire, extending through said tube;
(c) a handle connected to said first and second wires, and wherein said first and second wires can be advanced and retracted with at least 1 cm of independence relative to each other,
(d) a mesh tube having a distal and proximal end, and being connected at said proximal end to said first wire; and
(e) a blood-porous fragment guard mounted at said distal end of said mesh tube, said fragment guard including spokes joined at a central hub and extending radially and proximally from said central hub, and wherein said second wire is connected to said central hub so that when said second wire is pulled proximally relative to said first wire, said hub is pulled proximally, causing said spokes to spread out and causing said fragment guard to widen, and wherein said first wire and said second wire are spaced apart laterally.

11. The stent retriever catheter assembly of claim 10, wherein said mesh tube is made, at least in part, of a metal mesh that is stiff, so that when said second wire is pulled proximally, said metal mesh resists being pulled proximally, due to said stiffness.

12. The stent retriever catheter assembly of claim 10, wherein said fragment guard, in addition to said spokes, includes threads extending across and between said spokes, to create a finer mesh, better able to hold clot material.

13. The stent retriever catheter assembly of claim 10, wherein said mesh tube is collapsible, to be placed into a narrow state for penetrating through a clot.

14. The stent retriever catheter assembly of claim 10, wherein when said second wire is pulled proximally relative to said first wire, said mesh tube expands outwardly with said fragment guard.