# Patent

## Title
Expandable device for treatment of a stricture in a body vessel

## Abstract

An expandable and retrievable device for treatment of a stenotic lesion in a body vessel is disclosed. The device comprises a tubular portion including a proximal end and a distal end extending from the proximal end. The tubular portion has a lumen formed therethrough between the proximal and distal ends. The device further comprises an expandable member formed helically about the tubular portion. The expandable member is configured to helically close, defining a collapsed state for delivery of the device. The expandable member is configured to helically open, defining an expanded state for treatment of the stenotic lesion in the body vessel. The expandable member has at least one filter portion that helically extends from the tubular portion at a predetermined angle. This defines a proximally faced opening when the expandable member is in the expanded state.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a Divisional of U.S. patent application Ser. No. 11/855,611, filed Sep. 14, 2007, entitled “EXPANDABLE DEVICE FOR TREATMENT OF A STRICTURE IN A BODY VESSEL”. The entire contents of which are incorporated herein by reference.


BACKGROUND OF THE INVENTION
The present invention relates to medical devices and particularly the present invention relates to an expandable device for treating a stricture in a body vessel.
Treatments for a stenotic lesion are continuously being improved. One example is the treatment for carotid artery stenosis. Generally, carotid artery stenosis is the narrowing of the carotid arteries, the main arteries in the neck that supply blood to the brain. Carotid artery stenosis (also called carotid artery disease) is a relatively high risk factor for ischemic stroke. The narrowing is usually caused by plaque build-up in the carotid artery. Plaque forms when cholesterol, fat and other substances form in the inner lining of an artery. This formation process is called atherosclerosis.
Depending on the degree of stenosis and the patient's overall condition, carotid artery stenosis has been treated with surgery. The procedure (with its inherent risks) is called carotid endarterectomy, which removes the plaque from the arterial walls. Carotid endarterectomy has proven to benefit patients with arteries substantially narrowed, e.g., by about 70% or more. For people with less narrowed arteries, e.g., less than about 50%, an anti-clotting drug may be prescribed to reduce the risk of ischemic stroke. Examples of these drugs are anti-platelet agents and anticoagulants.
Carotid angioplasty is a more recently developed treatment for carotid artery stenosis. This treatment uses balloons and/or stents to open a narrowed artery. Carotid angioplasty is a procedure that can be performed via a standard percutaneous transfemoral approach with the patient anesthetized using light intravenous sedation. At the stenosis area, an angioplasty balloon is delivered to predilate the stenosis in preparation for stent placement. The balloon is then removed and exchanged via catheter for a stent delivery device. Once in position, a stent is deployed across the stenotic area. If needed, an additional balloon can be placed inside the deployed stent for post-dilation to make sure the struts of the stent are pressed firmly against the inner surface of the vessel wall.
Currently, devices such as stents used for treatment of a stenosis are typically permanent devices when deployed in a body vessel. In many situations, when a stenosis condition has passed, the deployed stent can not be removed from the patient. Thus, there is a need to provide a retrievable device, e.g., a stent, for treatment of a stenosis or stricture in a body vessel without compromising the cross-sectional profile of the device.
BRIEF SUMMARY OF THE INVENTION
The present invention generally provides an expandable and retrievable device for treatment of a stricture in a body vessel. The device has a reduced cross-sectional profile and is configured to conform to the tortuosity of blood vessels. This provides the ability for retrieval and an enhanced flexibility for access to more tortuous lumen areas with a body vessel.
In one embodiment, the present invention provides an expandable device for treatment of a stenotic lesion in a body vessel. The device comprises a tubular portion including a proximal end and a distal end extending from the proximal end. The tubular portion has a lumen formed therethrough between the proximal and distal ends. The device further comprises an expandable member formed helically about the tubular portion. The expandable member is configured to helically close, defining a collapsed state for delivery of the device. The expandable member is configured to helically open, defining an expanded state for treatment of the stenotic lesion in the body vessel. The expandable member has at least one filter portion that helically extends from the tubular portion at a predetermined angle. This defines a proximally faced opening when the expandable member is in the expanded state.
In another embodiment, the present invention provides an assembly for treatment of a stricture in a body vessel. The assembly comprises an inner catheter having a tubular body portion. The assembly further comprises an outer catheter having a distal end through which the inner catheter is disposed for deployment in the body vessel. The assembly further comprises the expandable device coaxially disposed within the inner catheter for treatment of the stricture in the body vessel.
In another example, the present invention provides a method for treating a stricture in a body vessel. The method comprises percutaneously introducing an inner catheter in the body vessel. The inner catheter has a tubular body portion. The method further comprises disposing the expandable device for treatment of the stricture in the body vessel. The device is in a collapsed state and is coaxially within the inner catheter. The method further comprises deploying the device in the expanded state at the stricture of the body vessel to treat the stricture.
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. 1 is a side view of an expandable device for treating a stricture of a body vessel in accordance with one embodiment of the present invention.
FIG. 2 is an enlarged view of the device of FIG. 1.
FIG. 3a is a side view of an assembly for treating a stricture 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 flowchart of a method for treating a stricture in a body vessel in accordance with one example of the present invention.
FIGS. 5a-5d are environmental views of treating a stricture with the expandable device.
FIG. 5e is an enlarged view of the expandable device in FIG. 5d. 



DETAILED DESCRIPTION OF THE INVENTION
The present invention generally provides an expandable device, e.g., a stent, having a reduced cross-sectional profile and configured to conform to tortuosity of blood vessels, allowing for the device to be more easily advanced through body vessels and providing an enhanced flexibility for access to more tortuous lumen areas within the body vessels. The device has a tubular portion and an expandable member formed helically about the tubular portion. The expandable member has at least one member portion, preferably a plurality of separate member portions, helically extending from the tubular portion at a predetermined angle. The separate member portions allow the tubular portion to maintain its flexibility as it is disposed through a tortuous body vessel. When helically closed, the device may be delivered through a body vessel. Upon deployment in a body vessel, the expandable member self-expands and helically opens.
FIG. 1 illustrates an expandable device 10 for treating a stricture in a body vessel in accordance with one embodiment of the present invention. As shown, the device 10 comprises a tubular portion 12 about which an expandable member 20 is formed. The expandable member 20 may be helically closed to define a collapsed state and helically opened to define an opened state.
As mentioned above, the device 10 comprises a tubular portion 12 having a first diameter D1. As illustrated in FIG. 1, the tubular portion 12 includes a proximal portion 14 and a distal portion 16 extending from the proximal portion 14. The tubular portion 12 is preferably a tubular member for enhanced flexibility and to allow for a wire guide to be advanced therethrough.
This may be accomplished by any suitable means such as by machining the expandable member 20 helically around the tubular portion 12 disposed about a mandrel. However, any other way of forming the expandable member 20 helically about the tubular portion 12 may be used without falling beyond the scope or spirit of the present invention.
FIGS. 1 and 2 depict the device 10 further comprising an expandable member 20 formed helically about the tubular portion 12. In this embodiment, the expandable member 20 is configured to helically close, defining a collapsed state for delivery and retrieval of the device 10. Moreover, the expandable member 20 is configured to helically open to define an expanded state for treating a stricture in the body vessel. The expandable member 20 occupies a second diameter D2 that varies based on the expanded and collapsed state thereof.
As shown in FIG. 2, the expandable member 20 comprises at least one member portion 30, preferably a plurality of member portions 30, each of which is integrally formed with another member portion 30. Each member portion 30 is helically formed and outwardly extends separately from the tubular portion 12 at a predetermined angle defining a proximally faced opening when the member is in an expanded state. In one 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 member portions 30 is in coaxial alignment with each other about the tubular portion 12. Preferably, each member portion 30 is helically formed integrally with the tubular portion 12 and separately extends therefrom. This allows the tubular portion 12 to maintain its flexibility with the first diameter D1 for advancement through tortuous areas within a body vessel.
FIGS. 1 and 2 illustrate that the expandable member 20 and the tubular portion 12 are formed along a longitudinal axis. The expandable member 20 may be helically closed in the collapsed state when the tubular portion 12 or the expandable member 20 is rotated about the longitudinal axis in a first direction. The expandable member 20 may be helically opened in the expanded state when the tubular portion 12 or the expandable member 20 is rotated about the longitudinal axis in a second direction.
As mentioned above, the device 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 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 alloying elements Ni and Ti and the optional inclusion of alloying 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 pulled into a lumen of a catheter for removal.
FIGS. 3a and 3b depict an assembly 40 for treatment of a stricture in a body vessel in accordance with another embodiment of the present invention. As shown, the assembly 40 comprises an inner catheter 42 having a tubular body 44. In this embodiment, the assembly 40 comprises the expandable 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 catheter 42 includes an inner lumen. The inner lumen is formed therethrough for percutaneous guidance through the body vessel.
As shown, the assembly 40 further includes an outer catheter 52 having a distal end 54 through which the inner catheter 42 is disposed for deployment in the body vessel. The outer catheter 52 is preferably made of a soft, flexible material such as silicon or any other suitable material. Generally, the outer catheter 52 further has a proximal end 56 and a plastic adaptor or hub 58 to receive the expandable device and inner catheter 42 to be advanced therethrough. The size of the outer catheter 52 is based on the size of the body vessel in which it percutaneously inserts, and the size of the inner 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 outer catheter 52 to a location proximal to a stricture in a body vessel. The wire guide 60 provides the outer catheter 52 (and inner 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 outer catheter 52.
As shown, the expandable device is coaxially disposed through the inner lumen of the inner catheter 42 prior to treatment of the stricture in the body vessel. The expandable device is guided through the inner lumen preferably from the hub 58 and distally beyond the inner catheter 42, exiting from the distal end of the inner catheter 42 to a location within the vasculature upstream of the stricture to be stented.
In this embodiment, the apparatus further includes a polytetrafluoroethylene (PTFE) introducer sheath 64 for percutaneously introducing the wire guide 60 and the outer 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 inner catheters 42 to be percutaneously inserted to a desired location in the body vessel. The introducer sheath 64 receives the outer 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 outer catheter 52, as the outer catheter 52 is advanced through the introducer sheath 64 to a dilatation area in the vasculature.
When the distal end 54 of the outer catheter 52 is at a location downstream of the dilatation area in the body vessel, the inner catheter 42 is inserted therethrough to the dilatation area. The device 10 is then loaded at the proximal end of the inner 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 110 for treating a stricture in a body vessel (see FIG. 5a), implementing the assembly mentioned above. The method comprises percutaneously introducing an inner catheter in the body vessel in box 112. Introduction of the inner 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 inner catheter. For example, the wire guide may be percutaneously inserted through the introducer sheath to the stricture in the body vessel. The inner catheter may then be place over the wire guide for percutaneous guidance and introduction to the stricture.
The method 110 further comprises disposing the expandable device coaxially within the inner catheter in box 114. The device may be disposed coaxially within the inner catheter before or after percutaneous insertion of the inner catheter. Preferably, the expandable member is disposed along a longitudinal axis. For example, once the inner catheter is placed at the stricture of the body vessel, the wire guide may be removed therefrom, and the device may then be disposed within the inner catheter for guidance and introduction in the body vessel. In the collapsed state, the device may then be advanced distally past the inner catheter in the body vessel (see FIG. 5b).
As mentioned above, the expandable member is helically closed in the collapsed state when the tubular portion is rotated about the longitudinal axis in a first direction and the expandable member is helically opened in the expanded state when the tubular portion is rotated about the longitudinal axis in a second direction.
The method 110 further includes deploying the device in the expanded state in box 116 (see also FIG. 5c). This may be accomplished by pushing the device by any suitable means such as a pusher. In this example, the device is self-expanding and is configured to turn about a first direction relative to the tubular portion to helically open and treat the stricture in the body vessel. In the expanded state, the open end of each member portion is expanded to a proximally facing concave shape to engage the body vessel for stenting. In this embodiment, each member portion extends from the tubular portion at an angle between about 40 and 70 degree (see FIGS. 5d and 5e). As desired, additional inner catheters may be used for primary and post-dilatation treatment of the stricture.
The method 110 further comprises closing the device in the collapsed state in the body vessel by rotating the tubular portion in the first direction and retrieving the device in the collapsed state in the inner catheter.
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 expandable device for treatment of a stenotic lesion in a body vessel, the device comprising:
a tubular portion including a proximal end and a distal end extending from the proximal end, the tubular portion having a lumen formed therethrough between the proximal and distal ends; and
an expandable member formed helically about the tubular portion, the expandable member being configured to helically close defining a collapsed state for delivery of the device, the expandable member being configured to helically open defining an expanded state, in which the expandable member forms an outermost periphery of the expandable device, for treatment of the stenotic lesion in the body vessel, the expandable member having at least one member portion helically extending from the tubular portion at a predetermined angle at the outermost periphery, defining a proximally faced opening having a concave shape with the predetermined angle forming a greater opening angle than an opening angle adjacent the tubular member when the expandable member is in the expanded state, the predetermined angle being between about 40 and 70 degrees.

2. The device of claim 1 wherein the predetermined angle is between about 55 and 65 degrees.

3. The device of claim 1 wherein the at least one member portion is a plurality of member portions.

4. The device of claim 3 wherein each of the plurality of member portions is in coaxial alignment with each other about the tubular portion.

5. The device of claim 1 wherein the expandable member is disposed along a longitudinal axis, the expandable member being helically closed in the collapsed state when the tubular portion is rotated about the longitudinal axis in a first direction and the expandable member is helically opened in the expanded state when the tubular portion is rotated about the longitudinal axis in a second direction.

6. The device of claim 1 wherein the expandable member comprises at least one of the following materials:
superelastic material, nitinol, polymeric material.