Intravascular Filter With Debris Entrapment Mechanism
Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris generated during a percutaneous heart procedure includes deploying a filter mechanism orthogonal to the axis of an artery and performing a percutaneous heart procedure. in the vascular accumulated debris from the vascular system.
This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 60/215,542, filed Jun. 30, 2000 by Richard B. Streeter et al. for INTRAVASCULAR FILTER WITH DEBRIS ENTRAPMENT MECHANISM, which patent application is hereby incorporated herein by reference, and of pending prior U.S. Provisional Patent Application Ser. No. 60/231,101, filed Sep. 8, 2000 by Richard B. Streeter et al. for INTRAVASCULAR FILTER WITH DEBRIS ENTRAPMENT MECHANISM, which patent application is hereby incorporated herein by reference.
FIELD OF THE INVENTIONThis invention relates to intravascular filtering apparatus and methods in general, and more particularly to apparatus and methods for filtering and irreversibly entrapping embolic debris from the vascular system during an intravascular or intracardiac procedure.
BACKGROUND OF THE INVENTIONIntracardiac and intravascular procedures, whether performed percutaneously or in an open, surgical, fashion, may liberate particulate debris. Such debris, once free in the vascular system, may cause complications including vascular occlusion, end-organ ischemia, stroke, and heart attack. Ideally, this debris is filtered from the vascular system before it can travel to distal organ beds.
Using known filter mechanisms deployed in the arterial system, debris is captured during systole. There is a danger, however, that such debris may escape the filter mechanism during diastole or during filter removal. Apparatus and methods to reduce debris escape during diastole or during filter removal may be desirable to reduce embolic complications.
SUMMARY OF THE INVENTIONAn object of the invention is to provide a filtering mechanism that irreversibly entraps debris therein.
Another object of the invention is to provide a filtering mechanism that permanently captures debris from the intravscular system of a patient.
A further object of the invention is to provide a filtering mechanism with greater ability to collect debris in the intravascular system of a patient to decrease the number of complications attributable to such debris.
Another further object of this invention is to provide a filter holding mechanism suitable to be secured to a retractor used to create access to the heart and surrounding structures during heart surgery procedures.
A still further object is to provide a method for using a filtering mechanism in the intravascular system of a patient to permanently capture debris therefrom.
Another still further object of the present invention is to provide a method for introducing a filtering device in the aorta downstream of the aortic valve to restrict the passage of emboli while allowing blood to flow through the aorta during cardiovascular procedures, and to entrap debris collected in the filter so as to prevent its escape during cardiac diastole or during manipulation, repositioning or removal of the device from the aorta.
With the above and other objects in view, as will hereinafter appear, there is provided apparatus for debris removal from the vascular system of a patient, said apparatus comprising: a filtering device having a proximal side and a distal side said filter being sized to allow blood flow therethrough and to restrict debris therethrough and said filter having a first given perimeter, wherein blood flow in a first direction passes from the proximal side to the distal side of the filtering device; an entrapment mechanism having a proximal side and a distal side, the entrapment mechanism forming a selective opening to allow debris and blood flow passage in the first direction from the proximal side to the distal side therethrough, the selective opening having a restriction mechanism to debris passage in a second direction opposite to said first direction the selective opening having a second given perimeter, the first given perimeter and the second given perimeter being deployed within the vascular system so as to form a chamber between the distal side of the entrapment mechanism and the proximal side of the filtering device, wherein the entrapment mechanism allows blood flow and debris to pass therethrough in the first direction, the filtering device allows blood flow to pass therethrough in the first direction, the restriction mechanism prevents debris from passing back through said selective opening in a second direction opposite to the first direction and the chamber contains the debris received through the entrapment mechanism so as to prevent the escape of the debris therein by said filtering device in the first direction and said restriction mechanism in said second direction.
In accordance with another further feature of the invention there is provided a method for filtering and entrapping debris from the vascular system of a patient, the method comprising: providing apparatus for filtering and entrapping debris from the vascular system of a patient, the apparatus comprising: a filter device being sized to allow blood flow therethrough and to restrict passage of debris therethrough, and the filter device having a first given perimeter, a proximal side and a distal side; and wherein the filtering device captures debris carried in a first direction of blood flow from the proximal side to the distal side thereof on the proximal side of the filter device; an entrapment mechanism having a proximal side and a distal side, the entrapment mechanist including a selective opening to allow passage of blood and debris therethrough, the selective opening being configured to allow passage of blood and debris carried therein therethrough in the first direction of blood flow from the proximal side to the distal side of the entrapment mechanism, the selective opening having a restriction mechanism to prevent debris passage from the distal side to the proximal side of the entrapment mechanism in a second direction opposite to the first direction, the selective opening forming a second given perimeter, and the first given perimeter and the second given perimeter being deployed witin the vascular system so as to form a chamber between the distal side of the entrapment mechanism and the proximal side of the filtering device; wherein the entrapment mechanism allows blood and debris carried therein therethrough in the first direction of blood flow, the filtering device allows blood therethrough in the first direction of blood flow, and the restriction mechanism prevents debris back through the selective opening in the second direction of blood flow opposite to the first direction of blood flow such that the chamber entraps the filtered debris received therein for debris removal from the vascular system of the patient; inserting said apparatus into the vascular system of the patient; allowing blood and debris carried therein to flow through the entrapment mechanism, and into the chamber; and removing the apparatus from the vascular system of the patient.
The above and other features of the invention, including various novel details of construction and combinations of parts and method steps will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular devices and method steps embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.
These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:
A filtration and entrapment apparatus 5 is shown in
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It should also be appreciated that, while in the foregoing description the apparatus shown in
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In addition, it should also be appreciated that soft outer cuff 135 may comprise a radially expandable mechanism (e.g., a balloon, a decompressed sponge, a spring loaded leaflet, etc.) for sealing filtration and entrapment apparatus 105 against the inner wall of vascular structure 122.
As noted above, entrapment leaflets 140 are preferably formed out of a fine filter mesh. This filter mesh is sized so that it will pass blood therethrough but not debris. Furthermore, this filter mesh is sized so that it will provide a modest resistance to blood flow, such that the entrapment leaflets will open during systole and close during diastole. By way of example but not limitation, the filter mesh may have a pore size of between about 40 microns, and about 300 microns.
It should also be appreciated that with bidirectional flow filtration and entrapment apparatus 105 of
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In addition, it should also be appreciated that soft outer cuff 235 may comprise a radially expandable mechanism (e.g., a balloon, a decompressed sponge, a spring loaded leaflet, etc.) for sealing deployable valve/filter apparatus 205 against the inner wall of vascular structure 222.
It should also be appreciated that with valve/filter apparatus 205 shown in
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In addition, it should also be appreciated that soft outer cuff 335 may comprise a radially expandable mechanism (e.g., a balloon, a decompressed sponge, a spring loaded leaflet, etc.) for sealing orthogonally deployable valve/filter apparatus 305 against the inner wall of vascular structure 322.
In addition, it should also be appreciated that valve entrapment mechanism 315 may be mounted for blood flow in either direction within vascular structure 322.
It should also be appreciated that with valve/filter apparatus 305 shown in
The filter design as described herein to prevent the escape of captured debris during diastole or filter removal may also be applied to all intravascular filters. Such a filter design may comprise a one-way valve and a filtering mesh in series. Liberated debris may pass through the one-way valve and come to rest in the filtering mesh. The one-way valve ensures permanent entrapment of debris. Potential applications of such an apparatus extend to all percutaneous and surgical procedures on the heart and vascular system, including open heart surgery, balloon dilatation of cardiac valves and arteries, deployment of stents in arteries, diagnostic catheterizations and other cardiac and vascular procedures. Advantages of such a system include more complete collection of liberated debris, with a resulting decrease in the complications attributable to such debris.
Claims
1-20. (canceled)
21. A method for filtering and entrapping debris generated during a percutaneous heart procedure comprising:
- deploying a filter mechanism substantially orthogonal to an axis of an artery, the filter mechanism mounted to an elongate cannula; and
- performing a percutaneous heart procedure comprising a stent-based device;
- wherein the elongate cannula extends proximally and distally from the filter mechanism in proximal and distal directions.
22. The method of claim 21, wherein performing a percutaneous heart procedure includes balloon dilation of a heart valve.
23. The method of claim 21, wherein performing a percutaneous heart procedure includes deployment of a stent.
24. The method of claim 21, wherein the filter mechanism is deployed at a location different than the location of the percutaneous heart procedure.
25. The method of claim 21, wherein the stent-based device is mounted to the elongate cannula.
26. The method of claim 21, wherein the filter mechanism further comprises a filter device having a proximal side and a distal side, the filter mechanism adapted to allow blood flow and prevent passage of debris in a first direction from the proximal side to the distal side of the filter device.
27. The method of claim 26, wherein the filter mechanism further comprises an entrapment device having a proximal side and a distal side;
- wherein the entrapment device comprises a selective opening to allow passage of blood and debris therethrough in a first direction from a proximal side to a distal side of the entrapment device.
28. The method of claim 26, wherein the entrapment device further comprises a blocking element;
- wherein the blocking element is adapted to allow the passage of debris and blood in the first direction through the selective opening and prevent the passage of debris and blood in a second direction through the selective opening by blocking the selective opening.
29. The method of claim 26, wherein the filtering device forms a first given perimeter and the entrapment device forms a second given perimeter;
- wherein the first given perimeter and the second given perimeter form a chamber between the distal side of the entrapment device and the proximal side of the filtering device; and
- wherein the chamber entraps the filtered debris.
30. The method of claim 27, wherein the first and second directions are different from each other.
31. The method of claim 21, wherein the filter mechanism is deployed substantially orthogonal to an axis of the elongate cannula.
Type: Application
Filed: Jun 4, 2014
Publication Date: Sep 25, 2014
Inventors: Robert B. Streeter (Winchester, MA), Gregory B. Lambrecht (Natick, MA), John R. Liddicoat (Minneapolis, MA), Robert Kevin Moore (Natick, MA), Todd F. Davenport (Andover, MA)
Application Number: 14/295,715
International Classification: A61F 2/01 (20060101);