Abstract
A calcification treatment device includes a catheter with proximal and distal ends. The catheter has at its distal end a non-occluding expansion element movable from a closed to an open position. In the open position, the expansion element is configured to apply force to leaflets of a valve so as to forcefully open the leaflets.
Claims
1. A calcification treatment device comprising: a catheter with proximal and distal ends, said catheter having at its distal end a non-occluding expansion element movable from a closed to an open position, wherein in said open position, said expansion element is configured to apply force to leaflets of a valve so as to forcefully open said leaflets, said expansion element being constructed of a mesh or struts with openings formed therein that allow blood and fluids to flow therethrough.
2. The calcification treatment device according to claim 1, wherein said catheter comprises at its distal end a locating element which provides axial and/or radial positioning relative to the valve.
3. The calcification treatment device according to claim 1, wherein the expansion device comprises an internal valve element, located inwards of said mesh or struts, configured to control valve opening during expansion.
4. A method of treating calcification of a heart valve comprising: placing the device of claim 1 near leaflets of a heart valve; and expanding said expansion element against the leaflets.
5. The method according to claim 4, comprising using said expansion element to stretch the leaflets, thereby increasing leaflet compliance by breaking a calcium layer that is on the leaflets.
6. The method according to claim 4, wherein said expansion device comprises an internal valve element, located inwards of said mesh or struts, configured to control valve opening during expansion, and the method comprises closing said prosthetic valve element during a diastolic part of a heart cycle and opening said prosthetic valve element during a systolic part of the heart cycle.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
[0037] FIG. 1 is a simplified illustration of the valve leaflet treatment device positioned in the aortic valve complex such that the locating elements are located within the Valsalva sinuses and the expansion element is located within the leaflet portion of the aortic valve. The expansion element is in its unopened position.
[0038] FIG. 2 is a simplified illustration of the device in its location as described in FIG. 1, with the expansion element in its open position, forcing the valve leaflets to open.
[0039] FIG. 3 is a simplified illustration of the valve leaflet catheter located within the aortic valve complex, in a configuration not having a supporting element.
[0040] FIG. 4 is a simplified illustration of the distal end of the catheter, specifically its expansion element in its closed position. In this representation, the distal end of the catheter is shown without the positioning element.
[0041] FIG. 5 is a simplified illustration of the distal end of the catheter, similar to FIG. 3. The expansion element is in its closed position. Again, in this representation, the distal end of the catheter is shown without the positioning element.
[0042] FIG. 6A is a simplified illustration of the expansion element of the valve leaflet treatment catheter in its normally closed yet unsheathed state. An inner polymeric material to control valve opening area during expansion is shown schematically in its closed position within the expansion element. This polymeric material may be formed in a shape of prosthetic valve element as shown in FIGS. 6B and 6C. This configuration does not show the locating element.
[0043] FIG. 6B is a simplified illustration of the expansion element of the catheter in its open position. The prosthetic valve element is closed during the diastolic part of the heart cycle. The valve element is closed so as to prevent aortic insufficiency during diastole. The closing of the valve element allows the physician to keep the expansion element in its open position without loading of the left ventricle during diastole.
[0044] FIG. 6C is a simplified illustration of the expansion element of the catheter in its open position. The prosthetic valve element is open during the systolic part of the heart cycle. The valve element is open so as to allow forward blood flow during diastole. The opening of the valve element allows the physician to keep the expansion element in its open position without having the left ventricle contract against a complete occlusion, thus eliminating the need for rapid pacing.
DETAILED DESCRIPTION OF EMBODIMENTS
[0045] Reference is now made to FIG. 1, which illustrates a valve leaflet treatment device 30 positioned in the aortic valve complex such that locating (positioning or supporting) elements 34 are located within the Valsalva sinuses and an expansion element 32 is located within the leaflet portion of the aortic valve. The expansion element 32 is in its unopened position. The expansion element 32 is constructed of a mesh or struts with openings formed therein (such as apertures formed in the mesh or gaps between the struts), these openings ensuring that the expansion element 32 is non-occluding, i.e., blood is not impeded from flowing therethrough.
[0046] The device is shown after introduction into the vasculature 10 in the aortic arch near the carotid takeoffs 22. The device may include a first (e.g., proximal) shaft 12 and a second (e.g., distal) shaft 14. First shaft 12 may slide over second shaft 14. Both shafts may be delivered over a catheter 16, which in the illustrated embodiment is a pigtail catheter having a proximal portion 18 and a distal portion 20. In one embodiment, catheter 16 passes through the lumen of the second shaft 14 and second shaft 14 passes through the lumen of the first shaft 12. Other arrangements are in the scope of the invention.
[0047] The distal portion 20 includes the valve leaflet treatment device 30 positioned against one of the cusps of the aortic valve 24.
[0048] Reference is now made to FIG. 2, which illustrates the device 30 in its location as described in FIG. 1, with the expansion element 32 in its open position, forcing the valve leaflets to open.
[0049] Reference is now made to FIG. 3, which illustrates the valve leaflet catheter 16 located within the aortic valve complex, in a configuration not having a supporting element.
[0050] Reference is now made to FIG. 4, which illustrates the distal end of the catheter 16, specifically its expansion element 32 in its closed position. In this representation, the distal end of the catheter 16 is shown without the positioning element.
[0051] Reference is now made to FIG. 5, which illustrates the distal end of the catheter 16, similar to FIG. 3. The expansion element 32 is in its closed position. Again, in this representation, the distal end of the catheter 16 is shown without the positioning element.
[0052] Reference is now made to FIG. 6A, which illustrates the expansion element 32 of the valve leaflet treatment catheter 16 in its normally closed yet unsheathed state. An inner valve element 36 (which may be made of a polymeric material, metallic material or other suitable materials) to control valve opening area during expansion is shown in its closed position within the expansion element 32. Valve element 36 may be formed in a shape of prosthetic valve as shown in FIGS. 6B and 6C. This configuration does not show the locating element.
[0053] Reference is now made to FIG. 6B, which illustrates the expansion element 32 of the catheter 16 in its open position. The prosthetic valve element 36 is closed during the diastolic part of the heart cycle. The valve element 36 is closed so as to prevent aortic insufficiency during diastole. The closing of the valve element 36 allows the physician to keep the expansion element 32 in its open position without loading of the left ventricle during diastole.
[0054] Reference is now made to FIG. 6C, which illustrates the expansion element of the catheter in its open position. The prosthetic valve element 36 is open during the systolic part of the heart cycle. The valve element 36 is open so as to allow forward blood flow during diastole. The opening of the valve element 36 allows the physician to keep the expansion element 32 in its open position without having the left ventricle contract against a complete occlusion, thus eliminating the need for rapid pacing.
