# Patent

## Title
Foam embolic protection device

## Abstract

An embolic protection device includes a foam body attached to a plurality of flexible struts. The foam body has a generally conical geometry and the bottom of the conical geometry having a generally conical recess. The filter portion has pores sized such that blood cells can pass through the foam body, but larger material such as objects would be trapped in the recess. Each strut is attached along the periphery of the foam body and extend from the first end of the foam body to a connection point located proximate the first end.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Application Ser. No. 60/737,480 filed on Nov. 17, 2005, entitled “FOAM EMBOLIC PROTECTION DEVICE”, 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 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 smaller than the opening in the stenosed vessel. Further, the smaller the profile of the filtering device the less risk of dislodging emboli during deployment of the device. In addition, 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. The filter portion should also be durable and firmly secured to the medical device, since any damage caused to the medical device during deployment increases the risk that emboli might breach the medical device.
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.
The embolic protection device includes a foam body attached to a plurality of flexible struts. The foam body has a generally conical geometry and the bottom of the conical geometry includes a generally conical recess. The filter portion has pores sized such that blood cells can pass through the foam body, but larger material such as emboli are trapped in the recess. Each strut is attached along the periphery of the foam body and extend from the first end of the foam body to a connection point located proximate the first end. The struts are attached to one another to form a cannula extending proximally from the filter portion.
The struts are biased into an expanded state such that the filter portion is forced against an inner wall of the vessel. The embolic protection device also includes a core wire extending between the first and second ends of the basket. The core wire may be moved relative to the struts forcing the basket into a collapsed state.
Folds are provided in the filter portion to facilitate insertion and removal of the medical device. The folds extend radially from the apex along the side of the conical shape. The folds form an accordion-like alternating pattern of periodically spaced inward and outward folds.
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 side view of a medical device in accordance with the present invention;
FIG. 2 is an perspective view of the medical device in FIG. 1;
FIG. 3a is a side view of an embolic protection assembly for capturing emboli during treatment of a stenotic lesion in accordance with one embodiment of the present invention;
FIG. 3b is an exploded side view of the assembly in FIG. 3a; 
FIG. 4 is a sectional view of a blood vessel illustrating insertion of the medical device of FIG. 1 in the collapsed state;
FIG. 5 is a sectional view of the blood vessel illustrating the medical device of FIG. 1 in a fully deployed state;
FIG. 6 is a sectional view of the blood vessel illustrating removal of the medical device from the vessel;
FIG. 7 is a side view of another embodiment of the present invention including a floppy tip;
FIG. 8 is a side view of yet another embodiment of the present invention including a guide wire adapter.



DETAILED DESCRIPTION
Referring now to FIGS. 1 and 2, the medical device 10 includes a basket 12 formed from a filter portion 14 and a plurality of struts 16. The filter portion 14 has a foam body that forms a generally conical geometry. A conical recess 26 is provided in the bottom of the conical geometry allowing fluid and emboli to be contained within the recess 26. The opening 25 of recess 26 is enlarged when the basket 12 is in the expanded state for capturing emboli. As such, the opening 25 and recess 26 are configured to face toward the stenotic lesion. Accordingly, the filter portion 14 forms a proximally facing concave shape. The foam body is porous such that blood cells may be allowed to permeate and flow through the filter portion 14, while larger material such as emboli would be trapped within the recess 26. Accordingly, the size of the pores may be between about 80 and 100 micrometers, thereby allowing objects the size of blood cells to traverse through the pores.
The foam body may be made of any polymeric material, metal, shape memory alloy, mixtures thereof, or any suitable material to be used for capturing emboli from the stenotic lesion during treatment thereof without falling beyond the scope or spirit of the present invention. Preferably, the foam body is comprised of a shape memory material. More preferably, the foam body is comprised of a porous Nitinol foam. As described in more detail below, the super elastic and shape memory characteristics will facilitate the expansion and collapse of the filter portion 14 as the medical device 10 is deployed or retrieved.
A plurality of folds 28 are also formed in the filter portion 14. The folds 28 extend radially from the apex of the conical geometry and along the sides of the conical geometry. The folds 28 include a plurality of inward and outward folds in an alternating pattern. One example, of an alternating pattern of inward and outward folds is often illustrated by an accordion. The folds 28 minimize the profile of the foam body when it assumes the collapsed state. As previously discussed, minimizing the profile of the medical device 10 reduces the risk of dislodging emboli during insertion of the medical device 10.
The struts 16 are attached to the second end of the filter portion 14 and are radially spaced about the opening 25 in the bottom of the conical geometry. The struts 16 may be attached to the filter portion 14 by any suitable means, including but not limited to sonic bonding, thermal bonding, or adhesive bonding. The struts 16 extend proximally from the second end of the filter portion 14 and are attached to one another at a point proximate and concentrically aligned with the conical geometry. The struts 16 cooperate to form a tubular portion 15 that further extends proximally relative to the filter portion 14. A core wire 24 runs through the basket 12 and extends to the apex of the conical geometry. The tubular portion 15 includes a lumen that slidably engages the core wire 24. The struts 16 and core wire 24 may be used to facilitate the transition of the filter portion 14 between an expanded state and a collapsed state.
The struts 16 may be comprised of any suitable material, for example a superelastic material such as Nitinol, stainless steel wire, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chrome alloy. It is understood that the struts 16 may be formed of any other suitable material that will result in a self-opening or self-expanding basket, such as shape memory alloys. 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 struts 16 and filter portion 14 are made from Nitinol with a transition temperature that is slightly below normal body temperature of humans, which is about 98.6° F. Although not necessarily a preferred embodiment, when the basket 12 is deployed in a body vessel and exposed to normal body temperature, the alloy of the struts 16 and filter portion 14 will transform to austenite, that is, the remembered state, which for one embodiment of the present invention is the expanded configuration when the basket 12 is deployed in the body vessel. To facilitate removal of the basket 12, the struts 16 and filter portion 14 are cooled to transform the material to martensite which is more ductile than austenite, making the struts 16 and filter portion 14 more malleable. As such, the basket 12 can be more easily collapsed and pulled into a lumen of a catheter for removal.
In another alternate embodiment, the struts 16 and filter portion 14 are made from Nitinol with a transition temperature that is above normal body temperature of humans, which is about 98.6° F. Although not necessarily a preferred embodiment, when the basket 12 is deployed in a body vessel and exposed to normal body temperature, the struts 16 and filter portion 14 are in the martensitic state so that the basket 12 is sufficiently ductile to bend or form into a desired shape, which for the present invention is an expanded configuration. To facilitate removal of the basket 12, the struts 16 and filter portion 14 are heated to transform the alloy to austenite so that the basket 12 becomes rigid and returns to a remembered state, which for the basket 12 of this alternate embodiment is a collapsed configuration.
In one embodiment of the medical device 10, the core wire 24 extends from the tubular portion 15 and is attached to the filter portion 14 at the apex of the conical geometry. The struts 16 and filter portion 14 are biased into an expanded state providing a radial force to support the filter portion 14 against an inner wall of the vessel. Accordingly, the core wire 24 may be moved distally relative to the struts 16, such that the struts 16 will be pulled tight against the core wire 24 causing the filter portion 14 to collapse along the pattern of alternating inward and outward folds 28 in the foam body. Drawing the filter portion 14 tightly against the core wire 24, minimizes the diameter of the medical device 10 for insertion. As previously discussed, minimizing the profile of the medical device 10 during insertion reduces the risk of dislodging emboli as the medical device 10 is inserted.
In use, the device 10 expands from the collapsed state to the expanded state, engaging the body vessel with the filter portion 14. In turn, the filter portion 14 expands to open the recess 26 in the conical geometry for capturing emboli during treatment of the stenotic lesion. After the need for such device 10 in the vasculature passes, the device 10 may be retrieved.
FIGS. 3a and 3b depict an embolic protection assembly 40 for capturing emboli during treatment of a stenotic lesion in a body vessel in accordance with another embodiment of the present invention. As shown, the assembly 40 comprises a balloon catheter 42 having a tubular body 44 and an expandable balloon 46 attached to and in fluid communication with the tubular body 44 for angioplasty at a stenotic lesion. In this embodiment, the assembly 40 comprises the embolic protection device mentioned above. The tubular body 44 is preferably made of soft flexible material such as silicon or any other suitable material. In this embodiment, the balloon catheter 42 includes an outer lumen and an inner lumen. The outer lumen is in fluid communication with the balloon 46 for inflating and deflating the balloon 46. The inner lumen is formed therethrough for percutaneous guidance through the body vessel.
As shown, the assembly 40 further includes an inner catheter 52 having a distal end 54 through which the balloon catheter 42 is disposed for deployment in the body vessel. The inner catheter 52 is preferably made of a soft, flexible material such as silicon or any other suitable material. Generally, the inner catheter 52 further has a proximal end 56 and a plastic adaptor or hub 58 to receive the embolic protection device and balloon catheter 42 to be advanced therethrough. The size of the inner catheter 52 is based on the size of the body vessel in which it percutaneously inserts, and the size of the balloon catheter 42.
As shown, the assembly 40 may also include a wire guide 60 configured to be percutaneously inserted within the vasculature to guide the inner catheter 52 to a location adjacent a stenotic lesion. The wire guide 60 provides the inner catheter 52 (and balloon catheter 42) a path during insertion within the body vessel. The size of the wire guide 60 is based on the inside diameter of the inner catheter 52.
In one embodiment, the balloon catheter 42 has a proximal fluid hub 62 in fluid communication with the balloon 46 via the outer lumen for fluid to be passed therethrough for inflation and deflation of the balloon 46 during treatment of the stenotic lesion.
As shown, the embolic protection device is coaxially disposed through the inner lumen of the balloon catheter 42 prior to treatment of the stenotic lesion in the body vessel. The distal protection device is guided through the inner lumen preferably from the hub 58 and distally beyond the balloon 46 of the balloon catheter 42, exiting from the distal end of the inner or balloon catheter 42 to a location within the vasculature downstream of the stenotic lesion.
In this embodiment, the apparatus further includes a polytetrafluoroethylene (PTFE) introducer sheath 64 for percutaneously introducing the wire guide 60 and the inner catheter 52 in a body vessel. Of course, any other suitable material may be used without falling beyond the scope or spirit of the present invention. The introducer sheath 64 may have any suitable size, e.g., between about three-french to eight-french. The introducer serves to allow the inner and balloon catheters 42 to be percutaneously inserted to a desired location in the body vessel. The introducer sheath 64 receives the inner catheter 52 and provides stability to the inner catheter at a desired location of the body vessel. For example, the introducer sheath 64 is held stationary within a common visceral artery, and adds stability to the inner catheter 52, as the inner catheter 52 is advanced through the introducer sheath 64 to a dilatation area in the vasculature.
When the distal end 54 of the inner catheter 52 is at a location downstream of the dilatation area in the body vessel, the balloon catheter 42 is inserted therethrough to the dilatation area. The device 10 is then loaded at the proximal end of the balloon catheter 42 and is advanced through the inner lumen thereof for deployment through its distal end. In this embodiment, the proximal stem is used to mechanically advance or push the device 10 through the catheter.
Now referring to FIG. 4, a cutaway view of a vessel 70 is provided illustrating insertion of the medical device 10. The medical device 10 is inserted with the basket 12 in a collapsed state, allowing the medical device 10 to navigate through the narrow opening formed by the stenosed area 72. Accordingly, during insertion, the profile of the medical device 10 should be minimized. As such, the core wire 24 is moved distally relative to the struts 16 drawing the struts 16 and the filter portion 14 tightly against the core wire 24, thereby forming a collapsed state. The medical device 10 is inserted into the vessel 70 past the stenosis 72 as denoted by the distally pointing arrow 74.
Once the basket portion 12 of the medical device 10 is located distal the stenosis 72, the basket portion 12 can be expanded against the inner wall of the blood vessel 70 as shown in FIG. 5. As previously discussed, the filter portion 14 may also be made of a shape memory material such that the filter portion 14 has two defined geometries. For example, the mesh material may be made of a shape memory alloy so that the foam body is biased into a collapsed state at a first temperature. The first temperature being controlled, for example, by fluid flowing through a guiding catheter 16 across the medical device 10. At a second temperature, such as the ambient temperature inside the vessel 70, the filter portion 14 is biased into a proximally facing concave geometry.
In the expanded state, the struts 16 and filter portion 14 provide a radial force against the inner wall of the vessel 70. The radial force eliminates gaps between the filter portion 14 and the vessel 70 forcing embolic material that is released from the stenosis 72 to be trapped downstream in the recess 26 of the filter portion 14. After a procedure is performed on the stenosis 72, the core wire 24 is moved distally relative to the struts 16 to collapse the struts 16 and filter portion 14 tightly against the core wire 24, as shown in FIG. 6. In the collapsed state, the emboli are trapped within the filter portion 14 and a catheter is slid over the medical device 10. The medical device 10 in the collapsed state, may then be removed proximally as denoted by proximally pointing arrow 76.
Now referring to FIG. 7, the medical device 10 may include a floppy tip 80 located distal the second end 20 of the basket 12 to provide additional guidance during insertion. The floppy tip 80 may extend from the second end 20 and may include a hydrophilic or other lubricious coating to facilitate easy advancement of the medical device to and through the stenosed region of the blood vessel during insertion. The floppy tip 80 is attached to the second end 20, for example by adhesive bonding, and may be made of nylon, polymeric material, silicone, Teflon, or other commonly known material without falling beyond the scope or spirit of the present invention. The flexibility provided by the floppy tip 80, aids in advancement of the medical device through the vessel while minimizing any trauma caused during the advancement.
Now referring to FIG. 8, another embodiment of a medical device in accordance with the present invention is provided. A tubular member 90 may be located on a tip 92 or in lieu of the tip extending distally from the second end 20 of the basket portion 12. The tubular member 90 may be made of nylon, polymeric material, Teflon, superelastic metal or other commonly known material without falling beyond the scope or spirit of the present invention. The tubular member 90 may include a first opening 94 and a second opening 96 such that a wire guide 98 may extend through the first and second opening 94, 96 of the tubular member 90. Accordingly, the tubular member 90 allows the medical device 10 to be guided along the wire guide 98 or alternatively allowing the wire guide 98 to be advanced together with the medical device 10 during insertion.
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. An embolic protection device for use in a vessel, the embolic protection device comprising:
a filter portion including a porous foam body comprised of a shape memory alloy foam, pores of the porous foam body being sized to allow blood to flow through the foam body; and
a plurality of struts attached to the filter portion and extending proximally therefrom, the filter portion and the plurality of struts forming a basket, where the basket is configured to have an expanded and collapsed state;
wherein the foam body has a generally conical geometry and wherein the struts are radially spaced around the circumference of the generally conical geometry; and a plurality of folds in the generally conical geometry, each fold extending radially from an apex of the generally conical geometry and along a side of the generally conical geometry.

2. The embolic protection device according to claim 1, wherein the filter portion is comprised of a Nitinol foam.

3. The embolic protection device according to claim 1, further comprising a core wire attached to a distal end of the filter portion and extending proximally through the basket.

4. The embolic protection device according to claim 1, wherein the basket is biased into an expanded state.

5. The embolic protection device according to claim 1, wherein the filter portion includes a recess configured to trap emboli.

6. The embolic protection device according to claim 1, wherein the plurality of folds form an alternating pattern of inward and outward folds periodically spaced around a circumference of the generally conical geometry.

7. The embolic protection device according to claim 1, further comprising a floppy tip attached to the distal end of the basket.

8. The embolic protection device according to claim 1, further comprising a tubular portion attached to the distal end of the basket, the tubular portion being configured to receive a wire guide through the tubular portion.

9. An embolic protection device according to claim 1, wherein the pores are between about 80 and 100 micrometers.

10. An embolic protection device for use in a vessel, the embolic protection device comprising:
a filter portion including a porous Nitinol foam body having a conical geometry, pores of the porous Nitinol foam body being sized to allow blood to flow through the foam body;
a plurality of struts attached to the filter portion and extending proximally therefrom, the filter portion and the plurality of struts forming a basket, where the basket is configured to have an expanded and collapsed state; and
a plurality of folds in the conical geometry, the plurality of folds extending radially from an apex of the conical geometry and along a side of the conical geometry, wherein the plurality of folds form an alternating pattern of inward and outward folds periodically spaced around a circumference of the conical geometry.

11. The embolic protection device according to claim 10, wherein the basket is biased into an expanded state.

12. The embolic protection device according to claim 10, wherein the struts are radially spaced around the circumference of the conical geometry.

13. The embolic protection device according to claim 10, wherein the filter portion includes a recess configured to trap emboli.

14. The embolic protection device according to claim 13, wherein the recess has a generally conical geometry.

15. An embolic protection device according to claim 10, wherein the pores are between about 80 and 100 micrometers.

16. An embolic protection device for use in a vessel, the embolic protection device comprising:
a filter portion including a porous foam body, the foam body having a generally conical geometry including a plurality of folds, each fold extending radially from an apex of the generally conical geometry and along a side of the generally conical geometry; and
a plurality of struts attached to the filter portion and extending proximally therefrom, the filter portion and the plurality of struts forming a basket, where the basket is configured to have an expanded and collapsed state.