Source: https://patents.google.com/patent/US20090306768A1/en
Timestamp: 2018-02-26 03:21:41
Document Index: 581331408

Matched Legal Cases: ['Application No. 60', 'application No. 20050137691', 'Application No. 2003', 'Application No. 2003', 'Application No. 2005', 'Application No. 2005', 'Application No. 2005', 'Application No. 2005', 'Application No. 2006', 'art 132', 'art 132', 'art 132', 'art 132', 'arts 132', 'art 132', 'arts 132', 'application No. 60', 'Application No. 60']

US20090306768A1 - Percutaneous valve prosthesis and system and method for implanting same - Google Patents
US20090306768A1
US20090306768A1 US12309680 US30968007A US2009306768A1 US 20090306768 A1 US20090306768 A1 US 20090306768A1 US 12309680 US12309680 US 12309680 US 30968007 A US30968007 A US 30968007A US 2009306768 A1 US2009306768 A1 US 2009306768A1
US12309680
The present patent application is based on, and claims priority from, U.S. provisional Application No. 60/833,791, filed Jul. 28, 2006, which is incorporated herein by reference in its entirety.
In recent years, advancements in minimally invasive, endoaortic, surgery interventional cardiology, and intervention radiology have encouraged some investigators to pursue percutaneous replacement of the aortic heart valve. Percutaneous Valve Technologies (“PVT”) of Fort Lee, N. J., has developed a balloon-expandable stent integrated with a bioprosthetic valve, which is the subject of U.S. Pat. Nos. 5,411,552, 5,840,081, 6,168,614, and 6,582,462 to Anderson et al. The stent/valve device is deployed across the native diseased valve to permanently hold the valve open, thereby alleviating a need to excise the native valve and to position the bioprosthetic valve in place of the native valve. PVT's device is designed for delivery in a cardiac catheterization laboratory under local anesthesia using fluoroscopic guidance, thereby avoiding general anesthesia and open-heart surgery. The device was first implanted in a patient in April of 2002.
Another drawback of the PVT device is its relatively large cross-sectional delivery profile. This is largely due to fabricating the tri-leaflet pericardial valve inside a robust stainless steel stent. Considering they have to be durable, the materials for the valve and the stent are very bulky, thus increasing the profile of the device. The PVT system's stent/valve combination is mounted onto a delivery balloon, making retrograde delivery through the aorta challenging. An antegrade transseptal approach may therefore be needed, requiring puncture of the septum and routing through the mitral valve, which significantly increases complexity and risk of the procedure. Very few cardiologists are currently trained in performing a transseptal puncture, which is a challenging procedure by itself.
Sadra et al (U.S. published application No. 20050137691) describes a system with two pieces, a valve piece and an anchor piece. The valve piece connects to the anchor piece in such a fashion that it will reduce the effective valve area considerably. Valve area, i.e., the inner diameter of the channel after the valve leaflets open, is of prime importance when considering an aortic valve replacement in a stenotic valve. Garrison's valve is also implanted in the inner portion of the stent, compromising the effective valve outflow area. Sadra et al's and Garrison's valves overlook this very critically important requirement.
The technologies described above and other technologies (for example, those disclosed in U.S. Pat. No. 4,908,028 to Colon et al.; U.S. Published Application No. 2003/0014104, U.S. Published Application No. 2003/0109924, U.S. Published Application No. 2005/0251251, U.S. Published Application No. 2005/0203616, and U.S. Pat. No. 6,908,481 to Cribier; U.S. Pat. No. 5,607,469 to Frey; U.S. Pat. No. 6,723,123 to Kazatchkov et al.; Germany Patent No. DE 3,128,704 A1 to Kuepper; U.S. Pat. No. 3,312,237 to Mon et a).; U.S. Published Application No. 2005/0182483 to Osbourne et al.; U.S. Pat. No. 1,306,391 to Romanoff; U.S. Published Application No. 2005/0203618 to Sharkcawy et al.; U.S. Published Application No. 2006/0052802 to Sterman et al.; U.S. Pat. No. 5,713,952; and U.S. Pat. No. 5,876,437 to Vanney et al.) also use various biological, or other synthetic materials for fabrication of the prosthetic valve. The duration of function and physical deterioration of these new valves have not been addressed. Their changeability has not been addressed, in the percutaneous situation.
Referring now to FIGS. 2A-2H, the bi-leaflet tissue valve 130 comprises a two-part (that is, a two-leaflet) frame 132 made from a memory metal wire or strip and a tissue cover 133. As best shown in FIG. 2A, each part 132 a and 132 b of the frame 132 is substantially semicircular. Portions of each part 132 a and 132 b of the frame 132 (for example, the straight side and the center portion of the curved side) are configured (for example, by having a sinusoidal configuration, shown by broken lines in FIGS. 2A and 2C) so that each part 132 a and 132 b of the frame 132, as well as the frame 132 as a whole, is expandable and compressible, while the remaining portions of the frame 132 are not expandable and compressible.
Each part 132 a and 132 b of the frame 132 includes a slot 134 for receiving a hinge 135 having a shape when deployed that is similar to a lower-case “t”, as shown in FIGS. 2D and 2E, having two aims 135 a and 135 b and a stem 135 c. The slot 134 is formed unitarily with the frame 132. The “t”-shaped hinge 135 is stamped out of memory metal (for example, nitinol) sheeting so that it is deformable. The arms 135 and 135 b of the hinge 135 have projections 135 d at their ends, which function as stops for the leaflets. The stem 135 c of the hinge 135 has a snap-on or screw-in mechanism 141 for attachment to a valve mount 142 (shown in FIGS. 2I-2L), as described below.
The tissue cover 133 (shown in FIG. 2B) is made, for example, of equine or bovine pericardium, or various synthetic materials, for example, or medical grade silicone, fabric, or other compressible, materials, and is configured to cover the two parts 132 a and 132 b of the frame 132 with their straight sides in spaced apart relation, with a central aperture 133 a in the center for receiving the stem of the “t”-shaped hinge 135 and two side apertures 133 b in alignment with the slots 134 for receiving the arms 135 a and 135 b of the hinge 135. The tissue cover 133 is sewn to each part 132 a and 132 b of the frame 132, as shown in FIGS. 2C and 2F-2H, and thus connects the two parts 132 a and 132 b of the frame 132 in spaced-apart relation.
As discussed in greater detail below, in use, the bi-leaflet valve 130 is detachably connected to a valve mount 142 (shown in FIGS. 2I and 21) via the “t”-shaped hinge 135, as shown in FIGS. 2K-2N, 4D-4G, and 5G-5I. The valve mount 142 is also made from a memory metal so that it is collapsible. More specifically, the valve mount 142 has arms 142 a and 142 b on either side of a receptacle 142 c, which are folded up vertically when the valve cage stent 120 is in its compressed (undeployed) condition, the ends of the arms 142 a and 142 b being affixed to the valve cage stent 120.
Referring now to FIGS. 3A-3C, the tri-leaflet tissue valve 230 comprises an expandable and compressible valve frame 232 (shown in FIG. 3A) made from a memory metal wire or strip and a tissue cover 233 (shown in FIG. 3B and 3C). The tissue cover 233 is made from the individual cusps of a porcine aortic valve sewn to appropriate fabric. Three identical cusps are selected. Two or more pigs are used to get ideal sized aortic cusps. The muscle bar cusp is preferably not used; and all of the sinus and surrounding tissue is S discarded. The commissural height is maintained at all cost. The tissue cover 233 (that is, the cusps sewn to the fabric) is fitted and sewn to the valve frame 232. The valve frame 232 has three cannulated commissural posts 240 a, 240 b, and 240 c mounted thereon, and the tissue cover 233 is sewn to the commissural posts 240 a, 240 b, and 240 c to complete the tri-leaflet valve 230 (FIG. 3C).
As shown in FIGS. 3A-3C, the tri-leaflet valve 230 is mounted on commissural pins 240 aa, 240 bb, and 240 cc provided on a valve cage stent 220 of the type disclosed in provisional application No. 60/735,221, Attorney Docket P70721US0, which is incorporated herein by reference in its entirety. More specifically, the commissural posts 240 a, 240 b, and 240 c of the valve frame 232 are cannulated to receive the commissural pins 240 aa, 240 bb, and 240 cc, respectively, of the valve cage stent 220, thereby connecting the valve frame 232 (and thus the valve 230) to the valve cage stent 220. As described below, the heart valve prosthesis 210 incorporating the tri-leaflet valve 230 is delivered using a catheter.
As shown in FIG. 3G, the valve cage stent 220 for use with the tri-leaflet valve 230 has three different zones 221, 222, and 223 along its longitudinal axis, the different zones having different geometric configurations so as to perform different functions. The first, or center, zone 221 functions as the stent connector, which is identical to the stent disclosed in Int'al Patent Application No. PCT/US2006/043526, filed Nov. 9, 2006 (which is based on U.S. Provisional Application No. 60/735,221), and which connects to the native valve annulus. The second and third zones 222 and 223, at either end of the center zone 221, function respectively as the superior valve rim carrying the commissural pins in the tri-leaflet valve prosthesis 210 or the valve mount in the bi-leaflet valve prosthesis 110, and the inferior valve skirt. The valve skirt 223 provides additional support, as well as a fabric/tissue attachment area to minimize leaking.
The valve cage stent 20 has provisions for the attachment of the prosthetic valve, depending on the type of prosthetic valve contemplated to be used. For example, in the case of a bi-leaflet valve, the valve is attached to the valve cage stent 120 via a valve mount affixed to the valve cage stent 120, as shown in FIGS. 4D-4G and 5G-5I. In the case of a tri-leaflet valve, the valve is attached to the valve cage stent 220 via engagement of the valve commissural posts 240 a, 240 b, and 240 c with the commissural pins 240 aa, 240 bb, and 240 cc of the valve cage stent 220, as shown in FIGS. 6H-6J.
The delivery system employs a two stage procedure, both stages of which can be performed at the same session, only minutes apart. The first stage is insertion of the valve cage stent 20. In the case of a bi-leaflet valve, as shown in FIG. 4A, the valve cage stent 120 has a valve mount connected thereto and a guide wire connected to the valve mount. In the case of a tri-leaflet valve, as shown in FIGS. 6A-6G and as described above, the valve cage stent 220 has three commissural pins 240 aa, 240 bb, and 240 cc provided thereon and guide wires connected thereto.
an expandable and compressible, cylindrical valve cage stent constructed to be implanted endovascularly in the planar axis of a native valve annulus, the valve cage stent having a superior rim;
an elastic and compressible, multi-leaflet valve insertable endovascularly into the body, the valve including an expandable and compressible valve frame and a tissue cover attached to the valve frame; and
attachment means for attaching the valve to the superior rim of the valve cage.
the valve cage stent has a fabric covering on the interior surfaces thereof and on parts of the exterior surfaces thereof to provide a complete seal and prevent leakage of blood when the valve cage stent is expanded; and
the valve cage stent has first, second, and third zones along its longitudinal axis, the first zone being between the second and third zones, the first zone being configured to connect the valve cage stent to the native valve annulus, the second zone being configured as the superior valve rim, and the third zone being configured as an inferior valve skirt for providing additional support and as an attachment area for the fabric covering and surrounding tissue to minimize leaking.
5. The heart valve prosthesis of claim 4, wherein the tissue cover has a central aperture and the two parts of the frame have respective slots, and wherein the heart valve prosthesis further comprises a deformable hinge having oppositely extending arms extending through the slots and a stem received through the aperture, and
wherein the attachment means comprises a valve mount affixed to the superior rim of the valve cage stent and a mating part on the hinge receivable in the valve mount.
11. A method for implanting the percutaneous valve prostheses of claim 1 in a body, comprising the steps of:
endovascularly inserting the valve cage stent in the planar axis of a native valve annulus; and
endovascularly attaching the valve to the superior rim of the valve cage stent so that the valve is in a supra annular position.
US12309680 2006-07-28 2007-07-27 Percutaneous valve prosthesis and system and method for implanting same Abandoned US20090306768A1 (en)
US83379106 true 2006-07-28 2006-07-28
US12309680 US20090306768A1 (en) 2006-07-28 2007-07-27 Percutaneous valve prosthesis and system and method for implanting same
PCT/US2007/016855 WO2008013915A9 (en) 2006-07-28 2007-07-27 Percutaneous valve prosthesis and system and method for implanting same
US20090306768A1 true true US20090306768A1 (en) 2009-12-10
US12309680 Abandoned US20090306768A1 (en) 2006-07-28 2007-07-27 Percutaneous valve prosthesis and system and method for implanting same
US15221435 Pending US20160331532A1 (en) 2006-07-28 2016-07-27 Percutaneous valve prosthesis and system and method for implanting the same
WO (1) WO2008013915A9 (en)
US20120179239A1 (en) * 2005-11-10 2012-07-12 Cardiaq Valve Technologies, Inc. Vascular prosthesis connecting stent
US20130138203A1 (en) * 2005-11-10 2013-05-30 Cardiaq Valve Technologies, Inc. Prosthesis having a plurality of distal and proximal prongs
US20140172085A1 (en) * 2009-04-15 2014-06-19 Cardiaq Valve Technologies, Inc. Vascular implant
WO2008013915A3 (en) 2008-07-03 application
WO2008013915A9 (en) 2008-08-21 application
WO2008013915A2 (en) 2008-01-31 application
US20160331532A1 (en) 2016-11-17 application
Owner name: CARDIAQ VALVE TECHNOLOGIES, INC., MAINE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:QUADRI, ARSHAD;REEL/FRAME:023123/0062