PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DEVICE WITH INTEGRAL EMBOLIC FILTER
A percutaneous transluminal angioplasty device having an embolic filter mounted to the catheter shaft at a location distal to the angioplasty balloon and downstream from the blockage to capture embolic particles that may be set loose into the blood stream as the angioplasty procedure is performed. The embolic filter is normally collapsed against the catheter shaft to facilitate introduction and withdrawal of the device to and from the operative site. Once the angioplasty balloon is properly positioned, however, means operatively associated with the embolic filter are actuated to erect the filter to operatively position a filter mesh across the lumen of the vessel.
This application is a Continuation of U.S. application Ser. No. 13/850,782, filed Mar. 26, 2013, now U.S. Pat. No. 8,758,424 issued Jun. 24, 2014; which is a Continuation of U.S. application Ser. No. 10/997,803, filed Nov. 24, 2004, now U.S. Pat. No. 8,403,976 issued Mar. 26, 2013, which claims benefit of U.S. Provisional Application No. 60/560,934, filed Apr. 8, 2004, which applications are herein incorporated by reference in their entirety.
FIELD OF THE INVENTIONThe present invention relates generally to surgical devices and relates more specifically to a percutaneous transluminal angioplasty device.
BACKGROUND OF THE INVENTIONThe vascular bed supplies a constant flow of oxygen-rich blood to the organs. If plaque builds up in these vessels, blockages can develop, reducing blood flow to the organs and causing adverse clinical symptoms, up to and including fatality.
Angioplasty is a catheter-based procedure performed by a physician to open up a blocked vessel and restore blood flow. An entry site is opened, for example in the patient's groin, arm, or hand, and a guide wire and catheter are advanced under fluoroscopic guidance to the location of the blockage. A catheter having a small balloon adjacent its distal end is advanced under fluoroscopic guidance until the balloon lies within the stenosed region. The balloon is then inflated and deflated one or more times to expand the stenosed region of the artery.
Since diseased vessels are comprised of a range of material from early-stage thrombosis to late-stage calcified plaque, angioplasty can release embolic particles downstream from the stenosed location. These embolic particles can result in adverse clinical consequences. It has been shown that it is beneficial to trap these embolic particles to prevent them from traveling downstream with blood flow to the capillary bed (e.g., Bairn D S, Wahr D, George B, et al., Randomized Trial of a Distal Embolic Protection Device During Percutaneous Intervention of Saphenous Vein Aorto-Coronary Bypass Grafts, Circulation 2002; 105:1285-90).
In addition to balloon angioplasty, stenoses may also be treated with stents and with mechanical thrombectomy devices. These devices are also prone to releasing embolic particles downstream from the stenosed location.
There are systems available today that are used to catch these embolic particles. They are primarily filter systems or occlusion balloon systems built on a guidewire. These systems have shortcomings related to simplicity of use and crossing tight lesions with a filter or balloon guidewire that is larger in diameter than the guide wire which is normally used. These embolic protection guidewires also have flexibility and stability problems that make the protected angioplasty procedure difficult in many cases. In the case of saphenous vein grafts, the problems relate specifically to aorto-ostial lesions, where the guidewire may not be long enough to provide support, or distal vein graft lesions, where there is not enough of a landing zone for the filter. The latter is a problem as currently available filter systems have a considerable distance between the treatment balloon and the distal filter. This distance is a problem not only in distal vein graft lesions, but also in arterial stenoses in which there is a side branch immediately after the stenosis. In such cases, the filter can often be deployed only distal to the side branch, thus leaving the side branch unprotected from embolic particles.
SUMMARYStated generally, the present invention comprises a percutaneous transluminal angioplasty device with integral embolic filter. Because the filter is integral with the catheter of the angioplasty device, there is no need to insert a separate device into the vessel. Further, proper placement of the angioplasty balloon assures proper placement of the embolic filter.
Stated somewhat more specifically, the percutaneous transluminal angioplasty device of the present invention comprises an embolic filter mounted to the catheter shaft at a location distal to the angioplasty balloon, stent, or mechanical thrombectomy device. Thus the filter is downstream from the blockage and is properly positioned to capture embolic particles that may be set loose into the blood stream as the angioplasty procedure is performed. The embolic filter is normally collapsed against the catheter shaft to facilitate introduction and withdrawal of the device to and from the operative site. Once the angioplasty balloon, stent, or mechanical thrombectomy device is properly positioned, however, means operatively associated with the embolic filter are actuated to erect the filter to position a filter mesh across the lumen of the coronary artery.
In some embodiments the means for erecting the filter comprises a balloon which longitudinally displaces one end of the filter toward the other, causing longitudinal ribs to bow outward, thus erecting the filter mesh. In other embodiments the means for erecting the filter comprises a balloon interposed within the proximal and distal ends of the filter, whereby inflating the balloon will bias the ribs away from the catheter shaft, causing the ribs to bow outwardly to erect the filter mesh. In still other embodiments the means for erecting the filter comprises a pull wire attached to one end of the filter, such that pulling on the wire longitudinally displaces one end of the filter toward the other, causing longitudinal ribs to bow outward, thus erecting the filter mesh.
In one embodiment of the invention, a reservoir is provided at the distal tip of the filter so that when the device collapses for withdrawal, debris does not get pushed out of the filter.
Additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and together with the description, serve to explain the principles of the invention.
The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.
The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in limitation thereof.
As used throughout, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “lumen” can include two or more such lumens unless the context indicates otherwise.
Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
The present invention can be understood more readily by reference to the following detailed description of preferred embodiments of the invention and the examples included therein and to the Figures and their previous and following description.
Referring now to the drawings,
Located between the angioplasty balloon 18 and the distal tip 14 of the catheter 12 is a collapsible filter 20. The filter 20 includes a proximal ring portion 22 and a distal ring portion 24. A plurality of elongated ribs 26 extend generally longitudinally between the proximal and distal rings 22, 24. These ribs can be made of a shape memory material, such as nitinol, and in their baseline position, these ribs are collapsed. A filter mesh 28 overlies the distal portion of the ribs 26. In the embodiment of
Means 34 are included for erecting and collapsing the filter 20 of the device 10 shown in
Referring now to
Referring now to
Referring now to
The embodiment 610 shown in
In the device 710 shown in
The device 810 shown in
The operation of the device 10 will now be explained with respect to
In
Referring now to
In
Of interest in
When removing the device 10 from the coronary artery, the preferred procedure is to deflate the angioplasty balloon 18 to first, prior to collapsing the embolic filter 20. In this way, any embolic particles that are broken loose as the angioplasty balloon 18 deflates will be captured by the filter 20. The embolic filter balloon 20 is then deflated; permitting the ribs 26 and filter mesh 28 to collapse against the shaft 14 of the catheter 12. Any embolic particles captured by the mesh 28 are trapped against the shaft 14. The device 10 is then withdrawn over the guide wire 908 and removed from the patient's body.
In various peripheral vascular applications, it may be necessary to insert the catheter against the direction of blood flow (e.g., the aorta).
While the embodiment 1000 of
In
To retract the embolic filter 1120, a second, outer catheter 1190 is advanced over the catheter 1112, as shown in
To use the percutaneous angioplasty device 1210, the inner catheter is inserted into the outer catheter so that the embolic filter 1220 is collapsed within the distal end of the device, as shown in
When the angioplasty procedure has been completed, the angioplasty balloon 1218 is deflated, and the embolic filter 1220 is withdrawn back into the forward end of the outer catheter 1294. The outer and inner catheters 1294, 1295 are then withdrawn together from the patient.
In the foregoing embodiment a wire can be substituted for the inner catheter 1295 as a means for carrying the embolic filter 1220.
In each of the foregoing examples, it will be appreciated that an angioplasty balloon is but one means for relieving a stenosis in a vessel. Stents, mechanical thrombectomy devices, or other suitable apparatus may be substituted for the angioplasty balloon and positioned on the catheter at a location proximal to the embolic filter. Thus any emboli loosened by the stent or mechanical thrombectomy device will be captured by the embolic filter in the same manner as described above with respect to the angioplasty balloon.
While the foregoing disclosed embodiments comprise filter ribs of a shape memory metal such as nitinol, it will be appreciated that similar results can be obtained by using any suitable resilient material. The ribs would be formed straight, forced open by the balloon, and return to their normal shape as a result of the resiliency of the structure. Or, in the case of the embodiment of
Variations in the design of the filter are also contemplated. For example, while both ends of the ribs 26 of the filter 20 are mounted to rings 22, 24, it will be appreciated that the ends of the ribs at the fixed end of the filter can be secured directly to the catheter shaft.
It will be appreciated that the present invention permits the placement of the embolic filter very close to the means for treating the stenosis. This has the effect of minimizing the “landing area” of the filter and also permits the protection of side branches, as shown in
Finally, it will be understood that the foregoing embodiments have been disclosed by way of example, and that other modifications may occur to those killed in the art without departing from the scope and spirit of the appended claims. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
Claims
1. A percutaneous transluminal angioplasty device, comprising:
- an elongated catheter having proximal and distal ends and an outer side wall;
- a filter attached to the elongated catheter, the filter being collapsible for insertion of the distal end of the catheter into a blood vessel, and the filter being expandable to an expanded position, wherein the filter comprises: a movable ring portion movably attached to the catheter; a fixed ring portion immovably attached to the catheter such that the movable ring portion is movable relative to the fixed ring portion, wherein the movable ring portion is distal to the fixed ring portion; a plurality of elongated ribs attached to the fixed and movable ring portions, wherein the ribs are formed of a shape memory material that urges the ribs into a collapsed position and
- a filter mesh overlying a portion of the ribs;
- wherein the catheter further comprises a lumen and a port in communication with the lumen, the port comprising an aperture in the outer side wall of the catheter located distal to the fixed ring portion and proximal to the movable ring portion, and the lumen extending from a location proximate the proximal end of the catheter to the port; and
- an actuator wire having proximal and distal ends, the actuator wire extending through the lumen of the catheter, and the distal end of the actuator wire exiting the lumen of the catheter through the port, the distal end of the actuator wire being attached to the movable ring portion;
- wherein, when the filter is in the collapsed position, pulling on the proximal end of the wire exerts a force on the movable ring portion in the proximal direction that moves the movable ring portion toward the fixed ring portion and causes the ribs to bow outward to expand the filter to the expanded position;
- wherein, when the filter is in the expanded position, releasing tension on the wire permits the shape memory of the ribs to return the ribs to their normal, collapsed position, collapsing the filter.
2. The percutaneous transluminal angioplasty device of claim 1, further comprising an interventional device attached to the catheter adjacent the distal end thereof, wherein the filter is positioned between the interventional device and the distal end of the catheter.
3. The percutaneous transluminal angioplasty device of claim 2, wherein the interventional device comprises an angioplasty balloon.
4. The percutaneous transluminal angioplasty device of claim 2, wherein the interventional device comprises a stent.
5. The percutaneous transluminal angioplasty device of claim 2, wherein the interventional device comprises a mechanical thrombectomy device.
6. The percutaneous transluminal angioplasty device of claim 1, wherein the shape memory material comprises nitinol.
7. The percutaneous transluminal angioplasty device of claim 1, wherein filter mesh overlies a distal portion of the ribs, and wherein, in the expanded position, the ribs bow outward, radially expanding the filter mesh.
8. The percutaneous transluminal angioplasty device of claim 1, wherein the filter mesh extends beyond the ribs in a longitudinal direction relative to the longitudinal axis of the catheter, such that a sac is formed to retain embolic particles when the filter is in the collapsed position.
9. The percutaneous transluminal angioplasty device of claim 1, wherein filter mesh overlies a distal portion of the ribs, and wherein, in the expanded position, the ribs bow outward, radially expanding the filter mesh.
10. A percutaneous transluminal angioplasty device, comprising:
- an elongated catheter having proximal and distal ends;
- an interventional device attached to the catheter adjacent the distal end thereof,
- a filter attached to the elongated catheter, the filter being collapsible for insertion and removal of the distal end of the catheter into a blood vessel, and the filter being expandable to an expanded position to capture emboli released into a bloodstream, wherein the filter comprises: a movable ring portion movably attached to the catheter; a fixed ring portion immovably attached to the catheter such that the movable ring portion is movable relative to the fixed ring portion; a plurality of elongated ribs extending longitudinally between and attached to the fixed and movable ring portions; and a filter mesh overlying a portion of the ribs, wherein the ribs are formed of a shape memory material that urges the ribs into a collapsed position;
- wherein the catheter further comprises a lumen extending from a location proximate the proximal end of the catheter, to a location distal to the interventional device; and
- an actuator wire having proximal and distal ends, the actuator wire extending through the lumen of the catheter, the proximal end of the actuator wire extending to a location proximate the proximal end of the catheter and the distal end of the actuator wire exiting the lumen through the side wall of the catheter at the location distal to the interventional device, the distal end of the actuator wire being attached to the movable ring portion;
- wherein when the filter is in a collapsed condition, manipulating the proximal end of the wire exerts a force on the movable ring portion that moves the movable ring portion toward the fixed ring portion and causes the ribs to bow outward to the expanded position.
11. The percutaneous transluminal angioplasty device of claim 10, wherein the filter is positioned between the interventional device and the distal end of the catheter.
12. The percutaneous transluminal angioplasty device of claim 10, wherein the movable ring portion is the distal ring portion.
13. The percutaneous transluminal angioplasty device of claim 12, wherein the distal end of the actuator wire exits the lumen through the catheter side wall at a location distal to the proximal ring portion.
14. The percutaneous transluminal angioplasty device of claim 13, wherein the distal end of the actuator wire is operatively connected to the distal ring portion.
15. The percutaneous transluminal angioplasty device of claim 14, wherein pulling on the proximal end of the actuator wire draws the distal ring portion toward the fixed proximal ring portion.
16. The percutaneous transluminal angioplasty device of claim 10, wherein the movable ring portion is the proximal ring portion.
17. The percutaneous transluminal angioplasty device of claim 16, wherein the distal end of the actuator wire exits the lumen through the catheter side wall at a location proximal to the proximal ring portion.
18. The percutaneous transluminal angioplasty device of claim 17, wherein the distal end of the actuator wire is operatively connected to the proximal ring portion.
19. The percutaneous transluminal angioplasty device of claim 18, wherein pushing on the proximal end of the actuator wire moves the proximal ring portion toward the fixed distal ring portion.
20. The percutaneous transluminal angioplasty device of claim 16, wherein the distal end of the actuator wire exits the lumen through the catheter side wall at a location distal to the proximal ring portion.
21. The percutaneous transluminal angioplasty device of claim 20, wherein the distal end of the actuator wire passes through an opening defined by the fixed distal ring portion and then returns to be is operatively connected to the proximal ring portion.
22. The percutaneous transluminal angioplasty device of claim 21, wherein pulling on the proximal end of the actuator wire moves the proximal ring portion toward the fixed distal ring portion.
23. The percutaneous transluminal angioplasty device of claim 10, wherein the interventional device comprises an angioplasty balloon.
24. The percutaneous transluminal angioplasty device of claim 10, wherein the interventional device comprises a stent.
25. The percutaneous transluminal angioplasty device of claim 10, wherein the interventional device comprises a mechanical thrombectomy device.
26. The percutaneous transluminal angioplasty device of claim 10, wherein the shape memory material comprises nitinol.
Type: Application
Filed: Jun 24, 2014
Publication Date: Jan 15, 2015
Inventors: RAVISH SACHAR (Raleigh, NC), GREGG SUTTON (Maple Grove, MN), LARRY A. ROBERTS (Atlanta, GA)
Application Number: 14/313,667
International Classification: A61F 2/01 (20060101); A61M 25/10 (20060101); A61F 2/958 (20060101);