# Patent

## Title
Helical embolic protection device

## Abstract

An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel is disclosed. The device comprises an elongated shaft having a proximal portion and a distal portion extending from the proximal portion. The device further comprises an expandable filter formed helically about the distal portion of the elongated shaft. The expandable filter is configured to helically close defining a collapsed state for delivery and retrievable of the device. The expandable filter is configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel. The expandable filter has at least one filter portion helically extending from the elongated shaft at a predetermined angle defining an opening when the filter is in the expanded state.

## Background
BACKGROUND OF THE INVENTION
The present invention generally relates to medical devices. Particularly, the present invention relates to medical devices for embolic protection.
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. Although adequate, many devices have various components connected together. In some situations, the number of components may add to the cross-section profile and the flexibility of the device. In view of the current challenges, it is apparent that there exists a need for an improved medical device for embolic protection.
BRIEF SUMMARY OF THE INVENTION
The present invention generally provides an embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel. The present invention provides a device having a relatively small cross-sectional profile when being delivered or retrieved in a body vessel. Moreover, the present invention provides an emboli protection device that more effectively maintains trapped emboli therein during retrieval of the device.
In one embodiment, the present invention provides an embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel comprising an elongated shaft. The elongated shaft has a proximal portion and a distal portion extending from the proximal portion. The device further comprises an expandable filter formed helically about the distal portion of the elongated shaft. The expandable filter is configured to helically close defining a collapsed state for delivery and retrieval of the device. The expandable filter is configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel. The expandable filter has at least one filter portion helically extending from the elongated shaft at a predetermined angle defining an opening when the filter is in the expanded state.
In another embodiment, the present invention provides an embolic protection assembly for capturing emboli during treatment of a stenotic lesion in a body vessel. The assembly comprises the emboli protection device mentioned above. The assembly further comprises a balloon catheter having a tubular body portion and an expandable balloon. The expandable balloon is attached to and in fluid communication with the tubular body portion for angioplasty at the stenotic lesion. The expandable balloon has distal and proximal portions.
In another example, the present invention provides a method for embolic protection during treatment of a stenotic lesion in a body vessel. The method comprises percutaneously introducing the balloon catheter in the body vessel. The method further comprises disposing the embolic protection device in the collapsed state coaxially within the balloon catheter. The method further comprises deploying the device in the expanded state by turning the elongated shaft about a first direction relative to the elongated shaft downstream from the stenotic lesion to helically open the expandable filter and capture emboli during treatment of the stenotic lesion.
Further objects, features, and advantages of the present invention will become apparent from consideration of the following description and the appended claims when taken in connection with the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1a is an environmental view of an emboli protection device for capturing emboli during treatment of a stenotic lesion in a body vessel in accordance with one embodiment of the present invention.
FIG. 1b is an enlarged environmental view of the device shown in FIG. 1a. 
FIG. 2a is a side view of the embolic protection device depicted in FIGS. 1a and 1b. 
FIG. 2b is an enlarged view of the device in circle 2b of FIG. 2a. 
FIG. 2c is an end view of the device in FIG. 2a. 
FIG. 2d is a side view of the device being partially deployed to an expanded state.
FIG. 3a is a side view of an embolic protection assembly for capturing emboli during treatment of a stenotic lesion in a body vessel in accordance with one embodiment of the present invention.
FIG. 3b is an exploded view of the assembly in FIG. 3a. 
FIG. 4 is a flow chart of a method for embolic protection during treatment of a stenotic lesion in a body vessel in accordance with one example of the present invention.
FIG. 5a is an environmental view of a body vessel in which the embolic protection assembly may be introduced.
FIG. 5b is an environmental view of the embolic protection device in a collapsed state disposed in the body vessel of FIG. 4.
FIG. 5c is an environmental view of the embolic protection device in an expanded state disposed in the body vessel of FIG. 5.
FIG. 5d is an enlarged view of the device shown in circle 6b of FIG. 6a. 
FIG. 6 is an embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel in accordance with another embodiment of the present invention.



DETAILED DESCRIPTION OF THE INVENTION
The present invention generally provides an embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel. Embodiments of the present invention provide a device having a reduced cross-sectional profile for delivery of the device during predilitation of the stenotic lesion, and a more simple design of an integral device for capturing emboli from the body vessel. In one embodiment, the device includes an elongated shaft and an expandable filter formed helically about the distal portion of the elongated shaft. By rotation of the shaft, the expandable filter may be helically closed and helically opened, defining a collapsed state for delivery (and retrieval), and an expanded state for capturing emboli. The expandable filter has at least one filter portion, preferably a plurality thereof, that helically extends from the elongated shaft at a predetermined angle to define a proximally faced opening when the filter is in the expanded state.
FIG. 1a illustrates an embolic protection device 10 for capturing emboli during treatment of a stenotic lesion in a body vessel 11 in accordance with one embodiment of the present invention. As shown, the device 10 comprises an elongated shaft 12 having a proximal portion 14 and a distal portion 16 extending distally from the proximal portion. In this embodiment, the elongated shaft 12 is tubular but may take on any other configuration such as having a core center without falling beyond the scope or spirit of the present invention. In this embodiment, the tubular shape of the elongated shaft 12 allows for a wire guide, for example, to be disposed therethrough for guidance during percutaneous introduction of the device in a body vessel. In this embodiment, the elongated shaft 12 has a first diameter D1. As illustrated in FIGS. 2a-2b, the elongated shaft 12 includes a proximal portion 14 and a distal portion 16 extending from the proximal portion 14.
FIGS. 2a-2b further depict the device 10 further comprising an expandable filter 20 formed helically about the distal portion 16 of the elongated shaft 12. In this embodiment, the expandable filter 20 is formed integrally with the elongated shaft 12. This may be accomplished by any suitable means such as by machining a tubular body disposed about a mandrel to form the expandable filter about the elongated shaft. Other ways of forming the expandable filter about the elongated shaft may be used without falling beyond the scope or spirit of the present invention.
As shown in FIGS. 2a-2b, the expandable filter 20 has at least one filter portion 22, preferably a plurality of filter portions 22, that helically extends from the elongated shaft 12. In this embodiment, there is a plurality of filter portions 22 comprising the expandable filter 20. Each filter portion 22 helically extends from the elongated shaft at a predetermined angle, defining a proximally faced opening 24 when the filter 20 is in the expanded state. Each filter portion 22 defines a conical shape and overlaps with an adjacent filter portion 22. In this embodiment, the predetermined angle is between about 40 and 70 degrees, and preferably between about 55 and 65 degrees.
As shown, each of the plurality of filter portions 22 is in coaxial alignment with each other about the elongated shaft 12. Preferably, each filter portion 22 is helically formed integrally with the elongated shaft 12 and separately extends therefrom. This allows the elongated shaft 12 to maintain its flexibility with the first diameter D1 for advancement through tortuous areas within a body vessel.
FIGS. 2a-2d illustrate that the expandable filter 20 and the elongated shaft 12 are formed along a longitudinal axis X. As mentioned, the expandable filter may be helically closed in the collapsed state when the elongated shaft 12 or the expandable filter 20 is rotated about the longitudinal axis in a first direction Y. The expandable filter 20 may be helically opened in the expanded state when the elongated shaft 12 or the expandable filter 20 is rotated about the longitudinal axis X in a second direction Z. The formation of the plurality of filter portions 22 provides the device 10 to more easily conform to the blood vessel tortuosity thereby allowing the device 10 to be more flexible. In this embodiment, each filter portion 22 comprises filter holes 23 formed therethrough to permit blood flow through the filter portion while restricting larger particles from passing therethrough. The holes 23 may have any size or shape without falling beyond the scope or spirit of the present invention.
As mentioned above, the device 10 may be made of shape memory material, or may be configured to have shape memory defining the predetermined shape thereof in the deployed state. For example, the device 10 may be comprised of any suitable material such as a pre-configured polymeric material, superelastic material, stainless steel wire, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chrome alloy. In one example, the device may be made of pre-configured polymeric material which takes on a predetermined shape, e.g. helical, when in the expanded state.
It is understood that the device may be formed of any other suitable material that may result in a self-opening or self-expanding device, such as shape memory materials or alloys. Shape memory alloys have the desirable property of becoming rigid, i.e., 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 austenic, such that material returns to its remembered state. The transition temperature is dependent on the relative proportions of the alloy elements Ni and Ti and the optional inclusion of alloy additives.
In one example, the device is made from material including Nitinol with a transition temperature that is slightly below normal body temperature of humans, which is about 98.6° F. Thus, when the device 10 is deployed and exposed to normal body temperature, the alloy of the device will transform to austenite, that is, the remembered state, which for one embodiment of the present invention is the expanded state when deployed in the body vessel. To remove the device, the device is cooled to transform the material to martensite which is more ductile than austenite, making the device more malleable. As such, the device can be more easily collapsed and advanced or pulled into a lumen of a catheter for embolic protection.
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.
FIG. 4 illustrates a flow chart depicting one method 210 for capturing emboli during treatment of a stenotic lesion in a body vessel (see FIG. 5a), implementing the assembly mentioned above. The method comprises percutaneously introducing a balloon catheter having an expandable balloon for angioplasty of the stenotic lesion in the body vessel in box 212. Introduction of the balloon catheter may be performed by any suitable means or mechanism. As mentioned above, an introducer sheath and a wire guide may be used to provide support and guidance to the balloon catheter. For example, the wire guide may be percutaneously inserted through the introducer sheath to the stenotic lesion in the body vessel. The balloon catheter may then be place over the wire guide for percutaneous guidance and introduction to the stenotic lesion.
The method 210 further comprises disposing the embolic protection device coaxially within the balloon catheter in box 214. The device may be disposed coaxially within the balloon catheter before or after percutaneous insertion of the balloon catheter. For example, once the balloon catheter is placed at the stenotic lesion, the wire guide may be removed therefrom, and the device may then be disposed within the balloon catheter for guidance and introduction in the body vessel. In the collapsed state, the device may then be advanced distally past the balloon catheter in the body vessel (see FIG. 5b). In this example, the expandable balloon is positioned at the stenotic lesion and the device, in its collapsed state, is disposed through the distal end of the balloon catheter downstream from the expandable balloon.
The method 210 further includes deploying the embolic protection device in the expanded state in box 216 (see also FIG. 5c). This may be accomplished by turning the elongated shaft about a first direction relative to the elongated shaft downstream from the stenotic lesion to helically open the expandable filter and capture emboli during treatment of the stenotic lesion in box 116. In the expanded state, the open end of each filter portion is expanded to a proximally facing concave shape to engage the body vessel for capturing emboli during angioplasty. In this embodiment, each filter portion extends from the elongated shaft at an angle between about 40 and 70 degree (see FIG. 5d).
The method may further include treating the stenotic lesion in the body vessel with the balloon catheter. As desired, additional balloon catheters may be used for primary and post-dilatation treatment of the stenotic lesion while the device is in its expanded state within the body vessel.
FIG. 6 illustrates an embolic protection device 110 having a varying second or outer diameter D2 in accordance with another embodiment of the present invention. As shown, the device 110 has similar components as the device 10 mentioned above. For example the device 110 comprises an elongated shaft 112, a proximal portion 114, a distal portion 116, and an expandable filter 120 similar to the shaft 12, the proximal portion 14, the distal portion 16, and the expandable filter 20 of device 10. In this embodiment, each filter portion 122 includes a proximally faced opening having an outer diameter D2 that increases distally. That is, the outer diameter D2 increases distally longitudinally relative to the elongated shaft 112 to define the expandable filter 120 having a distally flared profile.
While the present invention has been described in terms of preferred embodiments, it will be understood, of course, that the invention is not limited thereto since modifications may be made to those skilled in the art, particularly in light of the foregoing teachings.

## Claims

1. An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel, the device comprising:
an elongated shaft having a proximal portion and a distal portion extending from the proximal portion; and
an expandable filter formed helically about the distal portion of the elongated shaft, the expandable filter formed integrally with the elongated shaft such that the elongated shaft and the expandable filter have a one-piece construction, the expandable filter being configured to helically close defining a collapsed state for delivery and retrieval of the device, the expandable filter being configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel, the expandable filter having a plurality of filter portions each helically and separately extending from the elongated shaft, the filter portions being directly adjacent to each other, each of the plurality of filter portions defining a proximally faced opening when the expandable filter is in the expanded state, the plurality of filter portions being of a one-piece construction with the elongated shaft and having filter holes formed therethrough, wherein each of the plurality of filter portions defines a conical shape and overlaps with an adjacent filter portion.

2. The device of claim 1 wherein the opening of each filter portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the elongated shaft to define the expandable filter having a distally flared profile.

3. The device of claim 1 wherein the expandable filter extends along a longitudinal axis, the expandable filter being helically closed in the collapsed state when the elongated shaft is rotated about the longitudinal axis in a first direction, the expandable filter being helically opened in the expanded state when the elongated shaft is rotated about a second direction.

4. The device of claim 1 wherein the expandable filter comprises at least one of the following materials:
nitinol, elastomeric materials, polymeric materials.

5. The embolic protection device of claim 1 wherein the filter portions are not in direct contact with each other.

6. The embolic protection device of claim 5 wherein the plurality of filter portions comprises at least three filter portions.

7. The embolic protection device of claim 5 wherein the plurality of filter portions comprises at least four filter portions.

8. The embolic protection device of claim 1 wherein the plurality of filter portions comprises at least three filter portions.

9. The embolic protection device of claim 1 wherein the plurality of filter portions comprises at least four filter portions.

10. An embolic protection assembly for capturing emboli during treatment of a stenotic lesion in a body vessel, the assembly comprising
a balloon catheter having a tubular body portion and an expandable balloon attached to and in fluid communication with the tubular body portion for angioplasty at the stenotic lesion, the expandable balloon having distal and proximal portions; and
an embolic protection device coaxially disposed within the balloon catheter during treatment of the stenotic lesion in the body vessel, the device comprising:
an elongated shaft having a proximal portion and a distal portion extending from the proximal portion; and
an expandable filter formed helically about the distal portion of the elongated shaft, the expandable filter formed integrally with the elongated shaft such that the elongated shaft and the expandable filter have a one-piece construction, the expandable filter being configured to helically close defining a collapsed state for delivery and retrieval of the device, the expandable filter being configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel, the expandable filter having a plurality of filter portions each helically and separately extending from the elongated shaft at a predetermined angle relative to the elongated shaft, the filter portions being directly adjacent to each other, each of the plurality of filter portions defining a proximally faced opening when the expandable filter is in the expanded state, each of the plurality of filter portions having filter holes formed therethrough, each of the plurality of filter portions having a proximal end and a distal end, wherein the proximal end defines the opening in the expanded state, the proximal end being an open end free from contact of any other structure, wherein each of the plurality of filter portions defines a conical shape and overlaps with an adjacent filter portion.

11. The assembly of claim 10 wherein the balloon catheter includes an outer lumen and an inner lumen, the outer lumen being in fluid communication with the balloon for inflating and deflating the balloon, the inner lumen formed therethrough for percutaneous guidance through the body vessel.

12. The assembly of claim 10 further comprising:
an inner catheter having a distal end throughwhich the balloon catheter is disposed for deployment in the body vessel;
a wire guide configured to be disposed through the inner lumen of the balloon catheter for percutaneous guidance through the body vessel; and
an introducer sheath throughwhich the inner catheter is inserted for percutaneous insertion to the body vessel.

13. The assembly of claim 10 wherein the inner catheter further includes a proximal end, the proximal end having a hub in fluid communication with the balloon for fluid to be passed therethrough for inflation and deflation of the balloon during treatment of the stenotic lesion.

14. The device of claim 10 wherein the opening of each filter portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the elongated shaft to define the expandable filter having a distally flared profile.

15. The device of claim 10 wherein the expandable filter extends along a longitudinal axis, the expandable filter being helically closed in the collapsed state when the elongated shaft is rotated about the longitudinal axis in a first direction, the expandable filter being helically opened in the expanded state when the elongated shaft is rotated about a second direction.

16. The device of claim 10 wherein the expandable filter comprises at least one of the following materials:
nitinol, elastomeric materials, polymeric materials.

17. The embolic protection assembly of claim 10 wherein the filter portions are not in direct contact with each other.

18. The embolic protection assembly of claim 10 wherein the plurality of filter portions comprises at least three filter portions.

19. A method for embolic protection during treatment of a stenotic lesion in a body vessel, the method comprising:
percutaneously introducing a balloon catheter in the body vessel, the balloon catheter having a tubular body portion and an expandable balloon attached to and in fluid communication with the tubular body portion for angioplasty at the stenotic lesion;
disposing an embolic protection device in a collapsed state coaxially within the balloon catheter, the device comprising:
an elongated shaft having a proximal portion and a distal portion extending from the proximal portion; and
an expandable filter formed helically about the distal portion of the elongated shaft, the expandable filter formed integrally with the elongated shaft such that the elongated shaft and the expandable filter have a one-piece construction, the expandable filter being configured to helically close defining the collapsed state for delivery and retrieval of the device, the expandable filter being configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel, the expandable filter having a plurality of filter portions each helically and separately extending from the elongated shaft at a predetermined angle relative to the elongated shaft, the filter portions being directly adjacent to each other, each of the plurality of filter portions defining a proximally faced opening when the expandable filter is in the expanded state, the plurality of filter portions being of a one-piece construction with the elongated shaft and having filter holes formed therethrough, wherein each of the plurality of filter portions defines a conical shape and overlaps with an adjacent filter portion; and
deploying the device in the expanded state by turning the elongated shaft about a first direction relative to the elongated shaft downstream from the stenotic lesion to helically open the expandable filter and capture emboli during treatment of the stenotic lesion.

20. The method of claim 19 wherein the opening of each filter portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the elongated shaft to define the expandable filter having a distally flared profile.

21. The method of claim 19 wherein the filter portions are not in direct contact with each other.