# Patent

## Title
Invertible filter for embolic protection

## Abstract

A medical device including a guiding member and a filter portion is disclosed. The guiding member includes a lumen configured to slidably engage the filter portion. The filter portion forms a tubular geometry that extends distally from the guiding member. The filter portion is configured to evert to form a proximally facing concave geometry for capturing emboli. Further, the filter portion includes filter openings that are sized to allow blood cells to pass therethrough while preventing the passage of emboli.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Application Ser. No. 60/727,770, filed on Oct. 18, 2005, entitled “INVERTIBLE FILTER FOR EMBOLIC PROTECTION,” the entire contents of which are incorporated herein by reference.


BACKGROUND
1. Field of the Invention
The present invention generally relates to a medical device for embolic protection.
2. Description of Related Art
With the continuing advance of medical techniques, interventional procedures are more commonly being used to actively treat stenosis, occlusions, lesions, or other defects within a patient's blood vessels. Often the treated regions are in the coronary, carotid or even cerebral arteries. One procedure for treating an occluded or stenosed blood vessel is angioplasty. During angioplasty, an inflatable balloon is introduced into the occluded region. The balloon is inflated, pushing against the plaque or other material of the stenosed region and increasing the intralumenal diameter of the vessel. As the balloon presses against the material, portions of the material may inadvertently break free from the plaque deposit. These emboli may travel along the vessel and become trapped in a smaller blood vessel restricting blood flow to a vital organ, such as the brain.
Other methods for removing plaque or thrombus from arteries may include mechanical ablation, or non-contact ablation using light waves, sound waves, ultrasonics, or other radiation. Each of these methods are subject to the risk that some thrombogenic material may dislodge from the wall of the vessel and occlude a smaller blood vessel. The occlusion may cause damage to the patient, including an ischemic stroke in the cerebral arteries.
To prevent the risk of damage from emboli, many devices have been used to restrict the flow of emboli downstream from the stenosed area. One method includes inserting a balloon that may be expanded to occlude the flow of blood through the artery downstream of the stenosed area. An aspirating catheter may be located between the balloon and stenosed area and used to remove emboli that may be caused by the treatment. However, because the balloon completely blocks blood flow through the vessel, the vessel may be occluded only for short periods of time, limiting use of the procedure.
As an alternative to occluding flow through the blood vessel, various filtering devices have been proposed. Such devices typically have elements that form legs or a mesh that would capture embolic material, but allow blood cells to flow between the elements. Capturing the emboli in the filter device prevents the material from being lodged downstream in a smaller blood vessel. The filter may then be removed along with the embolic material after the procedure has been performed and the risk from emboli has decreased.
Challenges also exist with filtering devices. Often it is desirable to deploy filter devices from the proximal side of a stenosis. Therefore, the profile of the filtering device should be significantly smaller than the opening in the stenosed vessel. If the profile of the filtering device is not significantly smaller than the opening, there is an increased risk of dislodging emboli during insertion of the device. Further, if the filter portion is not held against the inside of the vessel wall, there is a risk that embolic material may pass between the filter and the vessel wall. In addition, if the filtering device becomes filled with particles blood flow through the filtering device may be compromised.
In view of the above, it is apparent that there exists a need for an improved medical device for embolic protection.
SUMMARY
In satisfying the above need, as well as overcoming the enumerated drawbacks and other limitations of the related art, the present invention provides an improved medical device for embolic protection. Further, the medical device being applicable to blood vessel, renal, and other applications, similar in nature.
The medical device includes a guiding member and a filter portion. The guiding member includes a lumen configured to slidably engage the filter portion. The filter portion has a tubular geometry that extends distally from the  guiding member. The filter portion is configured to evert to form a proximally facing concave geometry for capturing emboli. Further, the filter portion includes filter openings that are sized to allow blood cells to pass therethrough while preventing the passage of emboli. Due to the everted shape, collected emboli arrange themselves in a ring shaped collection area that is spaced from the vessel wall to improve blood flow.
The filter portion may be made of a mesh material having a plurality of interwoven elements. The elements are interwoven such that the filter portion may expand to circumferentially engage the inner wall of the blood vessel when the filter portion is everted. The elements with the mesh material define the filter openings formed in the filter portion. The filter portion including the mesh material may be made of a shape memory alloy to facilitate the everting of the filter portion into the proximally facing concave geometry.
The medical device also includes control wires attached to the filter portion. The control wires may be used to facilitate eversion of the filter material. For example, the core wires may be attached to the distal end of the filter portion and pulled proximally forcing the distal end of the filter portion to evert back over the rest of the filter portion. In addition, the control wires may extend through the tubular geometry to support the filter portion and provide a frame structure for the mesh material. In addition, the control wires may be comprised of a shape memory material and the shape memory characteristics may be used to facilitate eversion or retrieval of the medical device. Further objects, features and advantages of this invention will become readily apparent to persons skilled in the art after a review of the following description, with reference to the drawings and claims that are appended to and form a part of this specification.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial sectional view of a medical device in accordance with the present invention;
FIG. 2 is a sectional view of a blood vessel including a stenosis and illustrating the introduction of the medical device of FIG. 1, in accordance with the present invention;
FIG. 3 is a sectional view of the blood vessel illustrating deployment of the medical device in FIG. 1;
FIG. 4 is a sectional view of the blood vessel illustrating the medical device of FIG. 1 in a fully deployed state;
FIG. 5 is a sectional view of the blood vessel illustrating the medical device prior to removal;
FIG. 6 is a sectional view of a blood vessel illustrating another embodiment of a medical device in accordance with the present invention;
FIG. 7 is a sectional view of the blood vessel illustrating the medical device of FIG. 6 prior to removal; and
FIG. 8 is a sectional view of a the medical device of FIG. 6 during removal from the vessel.



DETAILED DESCRIPTION
Referring now to FIG. 1, a medical device embodying the principles of the present invention is denoted by reference numeral 10. The medical device 10 includes a flexible filter portion 12 and a guiding member 16. The filter portion 12 extends distally from the guiding member 16.
In the embodiment shown, the filter portion 12 is made from a mesh material. The mesh material has a tubular geometry including a first opening at the first end 13 of the filter portion 12 and a second opening at the second end of the filter portion 12. The first end 13 extends distally from the guiding member 16 and the second end is engaged by a lumen formed in the guiding member 16. The mesh material includes a plurality of interwoven elements 19. The elements 19 are interwoven such that the diameter of the filter portion 12 can expand or contract while maintaining its generally tubular geometry. To facilitate deployment of the medical device 10, the filter portion 12 may be biased to expand. However, when contracted, the tubular geometry provides a very small profile during insertion of the medical device and facilitates passing the medical device 10 through the stenosis.
The elements 19 may be comprised of any suitable material such as a superelastic material, stainless steel wire, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chrome alloy. Alternatively, the elements 19 may be formed of a synthetic material. For example, Nylon, Dacron, Thorolon, or ePTFE may be used. Depending on the application, the mesh material may include multiple layers or a composite mesh of elements 19, such as a nano fiber mesh. In addition, the elements 19 may include an agent bonded thereto for release in the vessel, such as an anticoagulant. Further, it is understood that the elements 19 may be formed of any other suitable material that will result in a flexible everting geometry, such as shape memory alloys. The mesh material includes openings 18 between the strands that are large enough to allow the flow of blood therethrough, but small enough to capture emboli. Accordingly, the weave of the elements 19 may be configured such that the openings 18 between the strands are between about 30 and 100 microns, although other size openings may be used. Openings of this size in the filter portion 12 will allow blood cells to pass through the openings 18 while larger emboli are constrained by the elements 19.
When deployed, the filter portion 12 is configured to evert thereby forming a proximally facing concave geometry 20. Accordingly, the first end 13 of the filter portion 12 forms a proximally facing opening. The proximally facing concave geometry 20 is adapted to span the diameter of the vessel, such that the filter portion 12 is radially biased against the wall of the vessel. In the everted state, blood flows into the proximally facing opening and through the openings in the mesh material. However, emboli are trapped in the distal most region of the filter portion 12 where the mesh material everts over itself. The distal most portion of the proximally facing concave geometry 20 serves as an annular collection region that is spaced from the wall of the vessel. Accordingly, the emboli form a ring in the annular collection region allowing blood to flow both around the outside and through the middle of the ring.
To control the filter portion 12, the medical device 10 may include control wires 14 attached to the filter portion 12. The control wires 14 may be attached to the filter portion 12 by any suitable means including sonic bonding, thermal bonding, or adhesive bonding. The control wires 14 are moved proximally relative to the guiding member 16 to cause the filter portion 12 to evert. The control wires 14 extends proximally from the first end 13 of the filter portion 12 and are received by the guiding member 16 through control wire openings 15. During retrieval, of the medical device 10 the control wires 14 may be used to pull the filter portion 12 tightly against the guiding member 16, thereby trapping the emboli inside the filter portion 12.
As discussed above, in alternative embodiments the mesh material can be made from a shape memory alloy. Shape memory alloys have the desirable property of becoming rigid, that is, returning to a remembered state, when heated above a transition temperature. A shape memory alloy suitable for the present invention is Ni—Ti available under the more commonly known name Nitinol. When this material is heated above the transition temperature, the material undergoes a phase transformation from martensite to austenite, such that material returns to its. remembered state. The transition temperature is dependent on the relative proportions of the alloying elements Ni and Ti and the optional inclusion of alloying additives.
In one embodiment, the filter portion 12 is made from Nitinol with a transition temperature that is slightly below normal body temperature of humans, which is about 98.6° F. Thus, when the medical device 10 is deployed in a body vessel and exposed to normal body temperature, the alloy of the filter portion 12 will transform to austenite, that is, the remembered state, which for one embodiment of the present invention is the everted state when the filter portion 12 is deployed in the body vessel. To remove the medical device 10, the filter portion 12 is cooled to transform the material to martensite which is more ductile than austenite, making the filter portion 12 more malleable. As such, the medical device 10 can be more easily collapsed and pulled into a lumen of a catheter for removal.
In another alternate embodiment, the filter portion 12 is made from Nitinol with a transition temperature that is above normal body temperature of humans, which is about 98.6°F. Thus, when the medical device 10 is deployed in a body vessel and exposed to normal body temperature, the filter portion 12 is in the martensitic state so that the filter portion 12 is sufficiently ductile to bend or form into a desired shape, which for the present invention is an everted shape. To remove the medical device 10, the filter portion 12 is heated to transform the alloy to austenite so that the medical device becomes rigid and returns to a remembered state, which for the filter portion 12 of this alternate embodiment is a non-everted configuration.
Now referring to FIGS. 2-5, a method and system for deploying the medical device 10 is provided. A sectional view of a vessel 21 is provided in FIG. 2, illustrating insertion of the medical device 10. A stenosis 22 is located against the wall of the vessel 21 and would be the subject of an interventional procedure, such as angioplasty, to increase blood flow through the vessel 21. The medical device 10 can be deployed to contain emboli that may break free from the stenosis 22 during the interventional procedure.
The medical device 10 is advanced through the blood vessel 21 distal the stenosis 22. The filter portion 12 is contained within the guiding member 16 along with an advancement member 17. The second end of filter portion 12 is attached to the distal end 26 of advancement member 17 through any suitable means including sonic bonding, thermal bonding, or adhesive bonding. While contained within the guiding member 16, the tubular geometry of the filter portion 12 is collapsed allowing the guiding member 16 to retain a very small profile. As previously mentioned, maintaining a small profile reduces the risk of dislodging emboli during deployment of the medical device 10.
Now referring to FIG. 3, the advancement member 17 is moved distally relative to the guiding member 16, such that the filter portion 12 extends from the distal end 24 of the guiding member 16. As the filter portion 12 is advanced from the guiding member 16, the filter portion 12 may be biased to expand while retaining its tubular geometry.
Now referring to FIG. 4, the filter portion is then everted to form a proximally facing concave geometry. The filter portion 12 may be everted by moving the control wires 14 proximally, thereby pulling the first end 13 of the filter portion 12 back over the rest of the filter portion 12. Further, the filter portion 12 may also be made of a shape memory material such that the filter portion 12 has two defined geometries. For example, the mesh material may be made of a shape memory alloy so that the mesh material 20 is biased into a straight tubular geometry in a non-everting state at a first temperature. The first temperature being controlled, for example, by fluid flowing through the guiding member 16 across the medical device 10. At a second temperature, such as the ambient temperature inside the vessel 21, the filter portion 12 is biased into a proximally facing concave geometry. When the filter portion 12 is biased into the proximally facing concave geometry, the filter portion 12 everts causing the filter portion 12 to expand against the inner wall of the vessel 21. While the medical device 10 is expanded against the inner wall of the vessel 21, the filter portion 12 serves to collect emboli that may break free from the stenosed area preventing such emboli from blocking smaller vessels downstream of the medical device 10.
When everted, the first end 13 of the filter portion 12 is biased against the inner wall of the vessel 21 forcing the fluid to flow through the proximally facing concave geometry formed by the filter portion 12. Therefore, emboli 34 are trapped in the distal region of the proximally facing concave geometry. The medical device 10 remains in this expanded state during the interventional procedure to capture any emboli that break free from the stenosis 22. After the interventional procedure is completed, the medical device 10 may be removed as shown in FIG. 5. To trap the emboli 34 in the filter portion 12, the control wires 14 may be pulled further proximally drawing the filter portion 12 against the guiding member 16.
Another embodiment of the present invention is shown in FIG. 6. The medical device 40 is depicted with a guiding member 16 and filter portion 12 as described above in connection with the medical device 10. However, the control wires 42 extend through the tubular geometry of the filter portion 12. Accordingly, the control wires 42 form a frame structure along the length of the filter portion 12. The control wires 42 may be made of a synthetic material, a stainless steel, or a shape memory alloy, such as Nitinol. The shape memory characteristics of the control wire 42 may be used to support the first end 13 of the filter portion 12 against the inner wall of the vessel 21. Supporting the filter portion 12 against the wall of the vessel ensures that the fluid will flow through the proximally facing concave geometry formed by the everted filter portion 12, thereby causing emboli to be trapped by the medical device 40.
If the control wires 42 are made of a shape memory material, the control wires 42 may have a low profile geometry defined at a first temperature and an expanded geometry defined at a second temperature. Accordingly, the first temperature inside the guiding member 16 may be controlled to maintain a non-everted state. For example, a fluid may be passed through the guiding member to manipulate the temperature of the control wires 42 thereby controlling the state of the shape memory material in the control wires 42. As the medical device 40 is pushed out of the distal opening 44 of the guiding member 16, the temperature of the shape memory material of the control wire will change according to the temperature of the vessel 21. The second temperature inside the vessel 21 causes the control wires 42 to force outwardly against the inner wall of the vessel 21.
In addition, the control wires 42 extend from the first end 13 of the filter portion 12 through the distal opening 44 in the guiding member 16. Accordingly, no control wire openings are provided in the guiding member 16 as were provided with previous embodiment of the medical device 10. After the interventional procedure is complete, the medical device 40 may be removed from the vessel 21. To trap emboli 34 in the filter portion 12 the control wires 42 are pulled proximally into the guiding member 16. Accordingly, the first end 13 of the filter portion may also be pulled into the guiding member 16 thereby sealing the emboli 34 within the filter portion 12. To further secure the emboli within the medical device 40, the guiding member 16 may be configured to retract the entire filter portion and emboli 34 within the guiding member lumen 46 prior to removal from the vessel.
As a person skilled in the art will readily appreciate, the above description is meant as an illustration of implementation of the principles this invention. This description is not intended to limit the scope or application of this invention in that the invention is susceptible to modification, variation and change, without departing from spirit of this invention, as defined in the following claims.

## Claims

1. A medical device for capturing emboli in a blood vessel, the medical device comprising:
a guiding member including a lumen sized to receive an advancement member, an outer surface, a distal end, and a plurality of control wire openings proximal to the distal end;
a filter portion having a tubular geometry and a plurality of filter openings, the tubular geometry having a first end opening at a first end and a second end opening at a second end, the first end extending distally from the guiding member, the second end being fixedly attached to the advancement member;
a plurality of control wires attached to the filter portion and extending proximally from the first end of the filter portion, wherein the plurality of control wires are received into the lumen of the guiding member through the plurality of control wire openings; and
wherein the filter portion has a non-everted state and an everted state, the filter portion being configured to evert by pulling the first end back over the filter portion so that the filter portion forms a proximally facing concave geometry with the first end forming a proximally facing opening; and
wherein the everted state of the filter portion has an expanded state and a collapsed state, wherein the first end of the filter portion is drawn against the outer surface of the guiding member by proximal movement of the control wires and the second end of the filter portion is disposed within the lumen of the guiding member when the filter portion is in the collapsed state, such that the distal end of the guiding member is disposed within the concave geometry of the filter portion when the filter portion is in the collapsed state.

2. The medical device according to claim 1, wherein the filter portion includes a plurality of elements, the elements being interwoven such that the filter portion expands to circumferentially engage an inner wall of the blood vessel when everted.

3. The medical device according to claim 2, wherein the plurality of elements define the plurality of filter openings.

4. The medical device according to claim 3, the plurality of filter openings are sized to allow blood cells to pass through the filter openings and prevent the passage of emboli.

5. The medical device according to claim 1, wherein the filter portion is comprised of a shape memory material.

6. The medical device according to claim 1, wherein the plurality of control wires are comprised of a shape memory material.

7. The medical device according to claim 1, wherein the proximally facing concave geometry has an annular collection region.

8. The medical device according to claim 7, wherein the annular collection region is spaced from the blood vessel.

9. A medical device for capturing emboli in a blood vessel, the medical device comprising:
a guiding member including a lumen sized to receive an advancement member, an outer surface, a distal end, and a plurality of control wire openings proximal to the distal end;
a filter portion having a tubular geometry and a plurality of filter openings, the tubular geometry having a first and second end, the first end extending distally from the guiding member; the second end being fixedly attached to the advancement member;
a plurality of control wires attached to the filter portion and extending proximally from the first end of the filter portion, wherein the plurality of control wires are received into the lumen of the guiding member through the plurality of control wire openings; and
wherein the filter portion has a non-everted state and an everted state, the filter portion being configured to evert by proximal movement of the control wires, the proximal movement of the control wires pulling the first end back over the filter portion so that the filter portion forms a proximally facing concave geometry with the first end forming a proximally facing opening, the filter portion including a plurality of elements interwoven such that the filter portion expands to circumferentially engage an inner wall of the blood vessel when everted, the plurality of elements defining the plurality of filter openings; and
wherein the everted state of the filter portion has an expanded state and a collapsed state, wherein the first end of the filter portion is drawn against the outer surface of the guiding member by proximal movement of the control wires and the second end of the filter portion is disposed within the lumen of the guiding member when the filter portion is in the collapsed state, such that the distal end of the guiding member is disposed within the concave geometry of the filter portion when the filter portion is in the collapsed state.

10. The medical device according to claim 9, the plurality of filter openings are sized to allow blood cells to pass through the filter openings and prevent the passage of emboli.

11. The medical device according to claim 9, wherein the filter portion is comprised of a shape memory material.

12. The medical device according to claim 9, wherein the plurality of control wires are comprised of a shape memory material.

13. The medical device according to claim 9, wherein the proximally facing concave geometry has an annular collection region and the annular collection region is spaced from the blood vessel.