The present disclosure relates to prosthetic heart valves and, more specifically, to prosthetic heart valves having an angled stent frame.
A healthy aortic valve acts as a one-way valve, opening to allow blood to flow out of the left ventricle of the heart, and then closing to prevent blood from flowing back into the heart. Diseased or damaged aortic valves may not close properly and thus allow blood to flow back into the heart. Damage to aortic valves may occur due to congenital defects, the natural aging process, infection or scarring. Diseased or damaged aortic valves sometimes need to be replaced to prevent heart failure. In such cases, collapsible prosthetic heart valves may be used to replace the native aortic valve.
Current collapsible prosthetic heart valve designs may be used in high-risk patients who may need a cardiac valve replacement, but who are not appropriate candidates for conventional open-chest, open-heart surgery. These collapsible and re-expandable prosthetic heart valves can be implanted transapically or percutaneously through the arterial system. One percutaneous delivery method entails introducing a collapsible prosthetic heart valve through a patient's femoral artery. This delivery method is referred to as a transfemoral approach.
With reference to
The present disclosure relates to prosthetic heart valves and the use of the same to treat patients. In one embodiment, the prosthetic heart valve includes a stent and a valve assembly attached to the stent. The stent has a proximal end adapted to reside adjacent the aortic annulus, a distal end, a first side having a first length between the proximal end and the distal end, and a second side having a second length between the proximal end and the distal end. The second length is less than the first length.
In another embodiment, the prosthetic heart valve includes a stent and a valve assembly attached to the stent. The stent has a longitudinal axis, a distal end, and a proximal end adapted to reside adjacent the aortic annulus. The proximal end of the stent is oriented at a first oblique angle to the longitudinal axis. The first oblique angle may be between about 5° and about 25°. Preferably, the first oblique angle is about 15°. The valve assembly may be attached to the stent at a second oblique angle to the longitudinal axis. The second oblique angle may be substantially equal to the first oblique angle.
The prosthetic heart valve has a first side having a first length between the proximal end and the distal end and a second side having a second length between the proximal end and the distal end. The second length may be less than the first length.
In some embodiments, the distal end of the stent may be oriented substantially orthogonally to the longitudinal axis. Alternatively, the distal end of the stent may be oriented at a second oblique angle to the longitudinal axis. The second oblique angle may be between about 5° and about 25°, and preferably is about 15°. The second oblique angle may be about equal to the first oblique angle. In these embodiments, the valve assembly may be attached to the stent at a third oblique angle to the longitudinal axis. The first oblique angle, the second oblique angle and the third oblique angle may be substantially equal.
The present disclosure further relates to methods of replacing a native heart valve of a patient, the native heart valve having a valve annulus and valve leaflets. The method may include providing a prosthetic heart valve including a stent and a valve assembly attached to the stent, the stent having a longitudinal axis, a distal end, and a proximal end oriented at an oblique angle to the longitudinal axis; and implanting the prosthetic heart valve in the patient so that the proximal end of the stent is substantially parallel with the valve annulus. The implanting step may include deploying the prosthetic heart valve using a transapical procedure, a transfemoral procedure or a transseptal procedure. The implanting step may further include implanting the prosthetic heart valve so that the valve assembly is substantially parallel with the valve annulus.
Various embodiments of the present invention will now be described with reference to the appended drawings. It is appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope.
As used herein, the term “proximal,” when used in connection with a prosthetic heart valve, refers to the end of the prosthetic heart valve closest to the heart when the heart valve is implanted in a patient, whereas the term “distal,” when used in connection with a prosthetic heart valve, refers to the end of the heart valve farthest from the heart when the prosthetic valve is implanted in a patient. The term “proximal,” when used herein in connection with a delivery device for a prosthetic heart valve, refers to the end of the delivery device closest to the operator, and the term “distal,” when used herein in connection with a prosthetic heart valve delivery device, refers to the end of the delivery device farthest from the operator.
In all the embodiments disclosed herein, the stents are part of a collapsible prosthetic heart valve. The prosthetic heart valve has an expanded condition in which the stent is held in place in the aortic annulus primarily by outward radial forces.
Prosthetic heart valve 100 also includes a valve assembly 200 supported by stent 101. Valve assembly 200 may include a cuff 201 and a plurality of leaflets 202 which collectively function as a one-way valve. Valve assembly 200 may be wholly or partly formed of tissue or any suitable polymer. U.S. Patent Application Publication Nos. 2008/0228264, filed Mar. 12, 2007 and 2008/0147179, filed Dec. 19, 2007, the entire disclosures of which are hereby incorporated by reference, describe suitable valve assemblies. Briefly, as described in these publications, each of leaflets 202 has one edge attached to stent 101 and a free edge. When the blood pressure on an inflow side of prosthetic heart valve 100 exceeds the blood pressure on the outflow side of the valve, the free edges of leaflets 202 can move away from one another to allow blood to flow through the valve. When the blood pressure on the inflow side of prosthetic heart valve 100 is no longer greater than the blood pressure on the outflow side of the valve, the free edges of leaflets 202 coapt to prevent blood from flowing in an opposite direction through the valve.
Stent 101 is formed with a plurality of cells 109 which define an annulus section 106 and an aorta section 108. In the expanded condition of stent 101, aorta section 108 may have a larger perimeter or circumference than annulus section 106. Cells 109 may have a substantially diamond shape when stent 101 is in the expanded condition, and may be arranged in one or more annular rows extending around the perimeter of stent 101. The cellular structure of stent 101 allows stent 101 to move from a collapsed condition for maneuvering to the proper position in the patient to an expanded condition for engagement in the annulus N of the patient's aortic valve. Stent 101 may include various other structures, such as features for attaching the commissure points of valve assembly 200, commissure posts, elongated struts for joining the cells of annulus section 106 to the cells of aorta section 108, and the like (none of which are shown).
The valve assembly 200 may be attached to the stent 101 at an oblique angle λ to the longitudinal axis Y of between about 5° and about 25°. Angle λ may be substantially similar to the angle θ formed by the proximal end 104 of the stent 101 with longitudinal axis Y. An angle λ of about 15° is highly preferred.
Stent 101 may additionally include any suitable marker (not shown) to aid the operator in aligning or orienting prosthetic heart valve 100 properly in the aortic annulus. The marker may help the operator position prosthetic heart valve 100 in the aortic annulus so that the second side 122 of stent 101 is situated closer to the mitral valve than the first side 120. The marker may constitute a band or other region of radiopaque material positioned on one or more commissure posts or on any other portions of stent 101. In some embodiments, the marker may be situated on second, side 122 of stent 101. Alternatively or additionally, a marker may be positioned in the delivery system to assist the operator in properly aligning the delivery system, and thus the prosthetic heart valve 100, in the aortic annulus.
The aorta section 108 of stent 101 terminates in a stent distal end 102 which is oriented substantially orthogonal to the longitudinal axis Y of stent 101. The annulus section 106 of stent 101, on the other hand, terminates in a stent proximal end 104 which is oriented at an oblique angle to the stent longitudinal axis Y. Preferably, the proximal end 104 of the stent 101 forms an angle θ with longitudinal axis Y of between about 5° and about 25°. An angle θ of about 15° is highly preferred.
A length or height H1 in the direction of longitudinal axis Y is defined between distal end 102 and proximal end 104 on the first side 120 of stent 101. Similarly, a length or height H2 in the longitudinal direction is defined between distal end 102 and proximal end 104 on the second side 122 of stent 101. As seen in
Using minimally invasive surgical procedures, the prosthetic heart valve 100 may be implanted in the valve annulus N of the patient's native aortic valve. In particular, the annulus section 106 of stent 101 is positioned in aortic valve annulus N, whereas the aorta section 108 of stent 101 is positioned in the aorta A, typically downstream (in the direction of blood flow) from the patient's valsalva sinus.
An operator may implant prosthetic heart valve 100 in a patient using any suitable delivery system. Various delivery systems can be utilized to deliver and deploy the prosthetic heart valve 100 at the intended target site. The delivery system may depend to some extent on the desired valve implantation approach; for example, whether transapical, transseptal or transfemoral techniques are used. Although the delivery systems may include certain variations depending on the delivery approach, all such delivery systems may have similar valve interface mechanisms for retaining the valve in a collapsed condition during delivery to a target site and subsequently deploying it in a controlled manner.
The prosthetic heart valve 100 is assembled to the delivery system in a collapsed condition. The delivery system maintains the prosthetic heart valve 100 in the collapsed condition until the operator actuates a deployment mechanism of the delivery system. Typically, the delivery system includes a sheath which surrounds the prosthetic heart valve 100 and maintains it in the collapsed condition.
To deploy the prosthetic heart valve 100, the operator may slide the sheath of the delivery system in either a proximal (toward the operator) or distal (away from the operator) direction to uncover the prosthetic heart valve 100. As the sheath is removed, the uncovered portions of prosthetic heart valve 100 will begin to expand radially.
With reference to
With stent 101 properly implanted in a patient, the proximal end 104 of stent 101 will preferably be substantially parallel to and slightly upstream of the aortic annulus N, with leaflets 202 appropriately positioned relative to the aortic annulus. Due to the angled feature of stent 101, the leaflets 202 can be more accurately positioned relative to the patient's aortic annulus N, thereby improving the overall functioning of the prosthetic heart valve 100. As discussed above, the valve assembly 200 may be attached to the stent 101 at an oblique angle λ to the longitudinal axis Y. As such, the prosthetic heart valve 100 may be implanted adjacent the valve annulus N of a patient so that the valve assembly 200 is substantially parallel with the valve annulus.
The angled proximal end 104 of stent 101 of prosthetic heart valve 100 makes it easier for the operator to align the prosthetic heart valve with the native aortic leaflets or aortic annulus. The improved positioning capability of prosthetic heart valve 100 minimizes the need for repositioning the prosthetic heart valve once it has been deployed. As discussed above, an operator can cover or uncover the prosthetic heart valve 100 with the sheath of the delivery system to expand or collapse the prosthetic heart valve. When using a conventional prosthetic heart valve 10, the operator might need to collapse the prosthetic heart valve after deployment to reposition it in the aortic annulus. In the case of prosthetic heart valve 100, however, the operator may not need to reposition the prosthetic heart valve because of its improved positioning capability. Thus, the operator may not need to cover stent 101 again with the sheath of the delivery system. As a consequence, it may be possible to form the sheath of the delivery system of more flexible materials.
Stent 301 has a length or height J in the direction of longitudinal axis Z between distal end 302 and proximal end 304 on a first side 320 of the stent. Similarly, a second side 322 of stent 301 has a length or height K in the direction of longitudinal axis Z between distal end 302 and proximal end 304. Height J may be greater than or less than height K depending on the relative sizes of angles α and β. Where angles α and β are about the same, heights J and K will be substantially equal.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.
The present application is a national phase entry under 35 U.S.C. §171 of International Application No. PCT/US2011/001070, filed Jun. 14, 2011, published in English, which claims priority from U.S. Provisional Application No. 61/355,639, filed Jun. 17, 2010, all of which are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2011/001070 | 6/14/2011 | WO | 00 | 2/27/2013 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2011/159342 | 12/22/2011 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3657744 | Ersek | Apr 1972 | A |
4275469 | Gabbay | Jun 1981 | A |
4491986 | Gabbay | Jan 1985 | A |
4759758 | Gabbay | Jul 1988 | A |
4878906 | Lindemann et al. | Nov 1989 | A |
4922905 | Strecker | May 1990 | A |
4994077 | Dobben | Feb 1991 | A |
5411552 | Andersen et al. | May 1995 | A |
5480423 | Ravenscroft et al. | Jan 1996 | A |
5800520 | Fogarty | Sep 1998 | A |
5843167 | Dwyer et al. | Dec 1998 | A |
5855601 | Bessler et al. | Jan 1999 | A |
5935163 | Gabbay | Aug 1999 | A |
5961549 | Nguyen et al. | Oct 1999 | A |
6077297 | Robinson et al. | Jun 2000 | A |
6083257 | Taylor et al. | Jul 2000 | A |
6090140 | Gabbay | Jul 2000 | A |
6214036 | Letendre et al. | Apr 2001 | B1 |
6264691 | Gabbay | Jul 2001 | B1 |
6267783 | Letendre et al. | Jul 2001 | B1 |
6299637 | Shaolian | Oct 2001 | B1 |
6368348 | Gabbay | Apr 2002 | B1 |
6419695 | Gabbay | Jul 2002 | B1 |
6468660 | Ogle et al. | Oct 2002 | B2 |
6488702 | Besselink | Dec 2002 | B1 |
6517576 | Gabbay | Feb 2003 | B2 |
6533810 | Hankh et al. | Mar 2003 | B2 |
6582464 | Gabbay | Jun 2003 | B2 |
6610088 | Gabbay | Aug 2003 | B1 |
6623518 | Thompson et al. | Sep 2003 | B2 |
6685625 | Gabbay | Feb 2004 | B2 |
6719789 | Cox | Apr 2004 | B2 |
6730118 | Spenser et al. | May 2004 | B2 |
6783556 | Gabbay | Aug 2004 | B1 |
6790230 | Beyersdorf et al. | Sep 2004 | B2 |
6814746 | Thompson et al. | Nov 2004 | B2 |
6830584 | Seguin | Dec 2004 | B1 |
6869444 | Gabbay | Mar 2005 | B2 |
6893460 | Spenser et al. | May 2005 | B2 |
6908481 | Cribier | Jun 2005 | B2 |
7018406 | Seguin et al. | Mar 2006 | B2 |
7025780 | Gabbay | Apr 2006 | B2 |
7137184 | Schreck | Nov 2006 | B2 |
7160322 | Gabbay | Jan 2007 | B2 |
7247167 | Gabbay | Jul 2007 | B2 |
7267686 | DiMatteo et al. | Sep 2007 | B2 |
7311730 | Gabbay | Dec 2007 | B2 |
7374573 | Gabbay | May 2008 | B2 |
7381218 | Schreck | Jun 2008 | B2 |
7452371 | Pavcnik et al. | Nov 2008 | B2 |
7510572 | Gabbay | Mar 2009 | B2 |
7524331 | Birdsall | Apr 2009 | B2 |
RE40816 | Taylor et al. | Jun 2009 | E |
7585321 | Cribier | Sep 2009 | B2 |
7682390 | Seguin | Mar 2010 | B2 |
7731742 | Schlick et al. | Jun 2010 | B2 |
7803185 | Gabbay | Sep 2010 | B2 |
7846203 | Cribier | Dec 2010 | B2 |
7846204 | Letac et al. | Dec 2010 | B2 |
7914569 | Nguyen et al. | Mar 2011 | B2 |
7972378 | Tabor et al. | Jul 2011 | B2 |
D648854 | Braido | Nov 2011 | S |
D652926 | Braido | Jan 2012 | S |
D652927 | Braido et al. | Jan 2012 | S |
D653341 | Braido et al. | Jan 2012 | S |
D653342 | Braido et al. | Jan 2012 | S |
D653343 | Ness et al. | Jan 2012 | S |
D654169 | Braido | Feb 2012 | S |
D654170 | Braido et al. | Feb 2012 | S |
D660432 | Braido | May 2012 | S |
D660433 | Braido et al. | May 2012 | S |
D660967 | Braido et al. | May 2012 | S |
20020036220 | Gabbay | Mar 2002 | A1 |
20030023303 | Palmaz et al. | Jan 2003 | A1 |
20030050694 | Yang et al. | Mar 2003 | A1 |
20030130726 | Thorpe et al. | Jul 2003 | A1 |
20030167089 | Lane | Sep 2003 | A1 |
20040049262 | Obermiller et al. | Mar 2004 | A1 |
20040093075 | Kuehne | May 2004 | A1 |
20040210304 | Seguin et al. | Oct 2004 | A1 |
20050096726 | Sequin et al. | May 2005 | A1 |
20050137695 | Salahieh et al. | Jun 2005 | A1 |
20050137697 | Salahieh et al. | Jun 2005 | A1 |
20050256566 | Gabbay | Nov 2005 | A1 |
20060008497 | Gabbay | Jan 2006 | A1 |
20060074484 | Huber | Apr 2006 | A1 |
20060122692 | Gilad et al. | Jun 2006 | A1 |
20060149360 | Schwammenthal et al. | Jul 2006 | A1 |
20060173532 | Flagle et al. | Aug 2006 | A1 |
20060178740 | Stacchino et al. | Aug 2006 | A1 |
20060206202 | Bonhoeffer et al. | Sep 2006 | A1 |
20060241744 | Beith | Oct 2006 | A1 |
20060241745 | Solem | Oct 2006 | A1 |
20060259120 | Vongphakdy et al. | Nov 2006 | A1 |
20060259137 | Artof et al. | Nov 2006 | A1 |
20060265056 | Nguyen et al. | Nov 2006 | A1 |
20060276813 | Greenberg | Dec 2006 | A1 |
20070010876 | Salahieh et al. | Jan 2007 | A1 |
20070021816 | Rudin | Jan 2007 | A1 |
20070027534 | Bergheim et al. | Feb 2007 | A1 |
20070043435 | Seguin et al. | Feb 2007 | A1 |
20070055358 | Krolik et al. | Mar 2007 | A1 |
20070067029 | Gabbay | Mar 2007 | A1 |
20070093890 | Eliasen et al. | Apr 2007 | A1 |
20070100435 | Case et al. | May 2007 | A1 |
20070118210 | Pinchuk | May 2007 | A1 |
20070213813 | Von Segesser et al. | Sep 2007 | A1 |
20070233228 | Eberhardt et al. | Oct 2007 | A1 |
20070244545 | Birdsall et al. | Oct 2007 | A1 |
20070244552 | Salahieh et al. | Oct 2007 | A1 |
20070288087 | Fearnot et al. | Dec 2007 | A1 |
20080021552 | Gabbay | Jan 2008 | A1 |
20080039934 | Styrc | Feb 2008 | A1 |
20080071369 | Tuval et al. | Mar 2008 | A1 |
20080082164 | Friedman | Apr 2008 | A1 |
20080097595 | Gabbay | Apr 2008 | A1 |
20080114452 | Gabbay | May 2008 | A1 |
20080125853 | Bailey et al. | May 2008 | A1 |
20080140189 | Nguyen et al. | Jun 2008 | A1 |
20080147183 | Styrc | Jun 2008 | A1 |
20080154355 | Benichou et al. | Jun 2008 | A1 |
20080154356 | Obermiller et al. | Jun 2008 | A1 |
20080183273 | Mesana et al. | Jul 2008 | A1 |
20080183279 | Bailey et al. | Jul 2008 | A1 |
20080243245 | Thambar et al. | Oct 2008 | A1 |
20080255662 | Stacchino et al. | Oct 2008 | A1 |
20080262602 | Wilk et al. | Oct 2008 | A1 |
20080269879 | Sathe et al. | Oct 2008 | A1 |
20090112309 | Jaramillo et al. | Apr 2009 | A1 |
20090138079 | Tuval et al. | May 2009 | A1 |
20100004740 | Seguin et al. | Jan 2010 | A1 |
20100036484 | Hariton et al. | Feb 2010 | A1 |
20100049306 | House et al. | Feb 2010 | A1 |
20100087907 | Lattouf | Apr 2010 | A1 |
20100131055 | Case et al. | May 2010 | A1 |
20100168778 | Braido | Jul 2010 | A1 |
20100168839 | Braido et al. | Jul 2010 | A1 |
20100185277 | Braido et al. | Jul 2010 | A1 |
20100191326 | Alkhatib | Jul 2010 | A1 |
20100204781 | Alkhatib | Aug 2010 | A1 |
20100204785 | Alkhatib | Aug 2010 | A1 |
20100217382 | Chau et al. | Aug 2010 | A1 |
20100249911 | Alkhatib | Sep 2010 | A1 |
20100249923 | Alkhatib et al. | Sep 2010 | A1 |
20100286768 | Alkhatib | Nov 2010 | A1 |
20100298931 | Quadri et al. | Nov 2010 | A1 |
20110029072 | Gabbay | Feb 2011 | A1 |
Number | Date | Country |
---|---|---|
19857887 | Jul 2000 | DE |
10121210 | Nov 2002 | DE |
202008009610 | Dec 2008 | DE |
0850607 | Jul 1998 | EP |
1000590 | May 2000 | EP |
1360942 | Nov 2003 | EP |
1584306 | Oct 2005 | EP |
1598031 | Nov 2005 | EP |
2047824 | Apr 2009 | EP |
2847800 | Jun 2004 | FR |
2850008 | Jul 2004 | FR |
9117720 | Nov 1991 | WO |
9716133 | May 1997 | WO |
9832412 | Jul 1998 | WO |
9913801 | Mar 1999 | WO |
0128459 | Apr 2001 | WO |
0149213 | Jul 2001 | WO |
0154625 | Aug 2001 | WO |
0156500 | Aug 2001 | WO |
0176510 | Oct 2001 | WO |
0236048 | May 2002 | WO |
0247575 | Jun 2002 | WO |
03047468 | Jun 2003 | WO |
2006073626 | Jul 2006 | WO |
2007071436 | Jun 2007 | WO |
2008070797 | Jun 2008 | WO |
2009045338 | Apr 2009 | WO |
2009132187 | Oct 2009 | WO |
2010008548 | Jan 2010 | WO |
2010008549 | Jan 2010 | WO |
2010096176 | Aug 2010 | WO |
2010098857 | Sep 2010 | WO |
Entry |
---|
International Search Report & Written Opinion dated Sep. 23, 2011 for Application No. PCT/US2011/001070. |
Ruiz, Carlos, Overview of PRE-CE Mark Transcatheter Aortic Valve Technologies, Euro PCR, dated May 25, 2010. |
Percutaneous aortic valve replacement: resection before implantation, 836-840, Quaden, Rene et al., European J. of Cardio-thoracic Surgery, 27 (2005). |
Catheter-implanted prosthetic heart valves, Knudsen, L.L., et al., The International Journal of Artificial Organs, vol. 16, No. 5 1993, pp. 253-262. |
Transluminal Aortic Valve Placement, Moazami, Nader, et al., ASAIO Journal, 1996; 42:M381-M385. |
Transluminal Catheter Implanted Prosthetic Heart Valves, Andersen, Henning Rud, International Journal of Angiology 7:102-106 (1998). |
Transluminal implantation of artificial heart valves, Andersen, H. R., et al., European Heart Journal (1992) 13, 704-708. |
Is It Reasonable to Treat All Calcified Stenotic Aortic Valves With a Valved Stent?, 579-584, Zegdi, Rachid, MD, PhD et al., J. of the American College of Cardiology, vol. 51, No. 5, Feb. 5, 2008. |
U.S. Appl. No. 29/375,243, filed Sep. 20, 2010. |
U.S. Appl. No. 29/375,260, filed Sep. 20, 2010. |
Number | Date | Country | |
---|---|---|---|
20130166023 A1 | Jun 2013 | US |
Number | Date | Country | |
---|---|---|---|
61355639 | Jun 2010 | US |