Aortic pathologies, including aortic aneurysms, can be treated by open surgical reconstruction, or alternatively, endovascular repair, which is a minimally invasive alternative to open surgical repair. Optimizing a successful outcome of endovascular repair, however, requires assessment of the patient's anatomy and, in the case of an aortic aneurysm, an appropriate stent graft that spans the proximal and distal ends of the aneurysm to insure complete exclusion of the aneurysm sac, anchoring of the stent graft in the aorta, and minimal endoleaks. Also, endoleaks and post-surgical enlargement of the aneurysm can require additional repair to seal any expansion of the aneurysm sac, and, generally, must be done without significantly compromising blood flow through the surgical site to surrounding viscera and associated structures.
Therefore, a need exists for new and improved delivery devices, endovascular repair devices for implanting stent grafts, and methods of their use, to treat aortic pathologies, in particular aortic aneurysms.
The present invention relates to stent graft systems for use in treating and repairing aortic vascular damage, such as vascular damage associated with aortic aneurysms, for example, in regions of the aorta having arterial branches to vital organs and tissues, such as, thoracic aortic aneurysms, abdominal aortic aneurysms, and thoracoabdominal aortic aneurysms, including juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms.
In one embodiment, the invention is a stent graft system that includes a stent graft having a luminal and flexible graft component defining a proximal open end, a distal open end, and having an outside surface and inside surface extending from the proximal open end to the distal open end, the inside surface defining a lumen having a longitudinal axis. The stent graft also includes a plurality of stents distributed longitudinally along the luminal flexible graft component and a plurality of suture loops spaced radially and longitudinally along the luminal flexible graft component in an arrangement that causes the stent graft to be in a radially constricted position when the suture loops are substantially aligned along the longitudinal axis of the stent graft. The stent graft system also includes at least one ligature having a proximal end and a distal end. The at least one ligature extends through the suture loops, wherein tension on the ligature or stiffness of the ligature substantially aligns the suture loops, thereby at least partially radially constricting the stent graft.
In another embodiment of the invention, a stent graft is delivered to an aneurysm site of a subject by a method that includes directing a stent graft to an aneurysm site by maintaining at least one of a plurality of stents of the stent graft in a constricted position with a ligature extending through a plurality of suture loops spaced longitudinally along a flexible luminal graft component, a luminal flexible graft component including a proximal open end, a distal open end, and outside and inside surfaces of the luminal wall extending from the proximal open end to the distal open end. The stent graft is released from the constricted position by movement of the ligature relative to the suture loops, thereby implanting the stent graft at the aneurysm site of the subject.
This invention has many advantages. For example, the physician can rotate the stent graft after it has been partially deployed, such as by only partially removing the radial constraint, or withdrawing only a portion of a plurality of radial restraints. Further, in certain embodiments, tension on a flexible ligature reversibly aligns the suture loops to thereby reversibly and radially collapse the stent graft. As a consequence, the stent graft system of the invention provides greater control relative to delivery systems that are only able to align a stent graft prior to full radial expansion of a stent graft. Accordingly, a stent graft can be deployed at a surgical site with more accuracy, less risk of injury to the vasculature of the subject, and without significant risk of distorting the intended shape of the stent graft when implanted at the surgical site.
The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments. The same number present in different figures represents the same item.
The invention is generally directed to stent graft systems for use in treating and repairing aortic vascular damage, such as vascular damage associated with arterial aneurysms in, for example, regions of the aorta having arterial branches to vital organs and tissues, such as thoracic aortic aneurysms, abdominal aortic aneurysms and thoracoabdominal aortic aneurysms, including a juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms. The same number in different figures represents the same item.
The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the invention.
A description of example embodiments of the invention follows.
When reference is made herein to a prosthesis, also referred to herein as “vascular prosthesis,” “stent graft,” or “stent graft prosthesis,” to be delivered, or implanted in a patient, the word “proximal” means that portion of the prosthesis or component of the prosthesis that is relatively close to the heart of the patient and “distal” means that portion of the prosthesis or component of the prosthesis that is relatively far from the heart of the patient. A “longitudinal axis,” as that term is defined herein, means an axis along a lengthwise direction of a body that also passes through a center of gravity of the body.
When, however, reference is made to a delivery system or a component of a delivery system employed to deliver, or implant, a prosthesis, the word, “proximal,” as employed herein, means closer to the clinician using the delivery system. When reference is made to a delivery system or a component of a delivery system, “distal,” as that term is employed herein, means, further away from the clinician using the delivery system.
For clarity, the word “proximate” means “close to,” as opposed to the meanings ascribed to “proximal” or “distal” described above with respect to either the prosthesis or a delivery system.
One embodiment of a stent graft system of the invention is shown in
Ligature 42 extends through suture loops 36 in longitudinal sequence along longitudinal axis 26. Stabilizing suture loop 41 is located at distal portion 40 of luminal flexible graft component 14 to stabilize ligature 42 along flexible luminal graft component 14. Ligature 42 includes proximal end 44 and distal end 46. In an embodiment, at least a portion of suture loops are between an opening of struts of a stent, referred to herein as “nested,” as shown in
Ligature suture loops 36 are distributed along proximal portion 38 of luminal flexible graft component 14 and are distributed laterally and longitudinally relative to each other in an arrangement that causes the stent graft to be in a radially constricted position when suture loops 36 are substantially longitudinally aligned, thereby at least partially radially constricting stent graft 12, as shown in
Luminal flexible graft component 14 is formed of a suitable material, such as is known in the art. Examples of such materials include at least one member selected from the group consisting of polytetrafluoroethylene (PTFE), such as expanded (ePTFE), and polyethylene terephthalate (PET), such as woven polyester. Suture loops 36 are fabricated of a suitable material, such as is known in the art, including, for example polyester, nylon and polypropylene. Ligature 42 is sufficiently flexible to allow stents 28, when radially self-expanding, to radially expand in the absence of longitudinal tension on ligature 42. Examples of material suitable for use in ligature are known to those skilled in the art, such as wire, thread and cords.
In another embodiment, shown in
It is to be understood that additional ligatures (not shown) can be employed, along with additional distinct sets of suture loops distributed longitudinally along luminal flexible graft component. For example, the stent graft system of the invention can include three ligatures, as shown in
For example, in another alternative embodiment, shown in
The embodiment shown in
In yet another embodiment, shown in
In another embodiment, shown in
Another embodiment of a stent graft system of the invention is shown in
In one embodiment of a method of the invention, and as shown in the transition from
Alternatively, as shown in
In a method of the invention, stent graft system 200 is delivered through an artery to aneurysm site 246 having arterial branch 245. Stent graft 228 spans aneurysm site 246, as shown in
In one embodiment of the method, control handle 224 is advanced in distal direction 250, from proximal handle 210 to distal handle 242, as shown in the transition from
Similarly, as shown in the transition from
As shown in the transition from
It is also to be understood that, as with the embodiments shown in
Further, stent graft can include a fenestration in the embodiments of the method wherein the stent graft is to be placed at an aneurysm spanning a branch artery. Also, it is to be understood, that as described in earlier embodiments, a ligature, whether wires or threads of the embodiment shown in
Vascular prostheses implanted by the stent graft systems and methods of the invention can be implanted, for example, by transfemoral access. Additional branch prostheses that are directed into the vascular prostheses of the invention can be implanted, for example, by supraaortic vessel access (e.g., through the brachial artery), or by transfemoral access, or access from some other branch or branch of major blood vessels, including peripheral blood vessels.
The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. The relevant teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. The relevant teachings of U.S. Pat. Nos. 8,292,943; 7,763,063; 8,308,790; 8,070,790; 8,740,963; 8,007,605; 9,320,631; 8,062,349; 9,198,786; 8,062,345; 9,561,124; 9,173,755; 8,449,595; 8,636,788; 9,333,104; 9,408,734; 9,408,735; 8,500,792; 9,220,617; 9,364,314; 9,101,506; 8,998,970; 9,554,929; 9,439,751; 9,592,112; 9,655,712, 9,827,123, 9,877,857, 9,907,686; U.S. patent application Ser. Nos. 14/575,673; 15/166,818; 15/167,055; 14/272,818; 14/861,479; 15/478,424; 15/478,737; 15/587,664; 15/604,032; 15/672,404; 15/816,772; 15/839,272; 15/417,467; PCT/US2017/025844; PCT/US2017/025849; PCT/US2017/025912; PCT/US2017/034223 and PCT/US2017/046062, are also incorporated by reference in their entirety.
The relevant teachings of the “Delivery System For Radially Constricting a Stent Graft and Method of Use,” by Eduardo Alejandro Garcia, International Application No. PCT/US2018/019355, filed on Feb. 23, 2018; “Delivery System and Method to Radially Constrict a Stent Graft,” by Timothy Lostetter, International Application No. PCT/US2018/019349, filed on Feb. 23, 2018; “Vascular Prosthesis with Moveable Fenestration,” by Samuel Arbefeuille, International Application No. PCT/US2018/019353, filed on Feb. 23, 2018; “Stent Graft Delivery System with Constricted Sheath and Method of Use,” by Timothy Lostetter, International Application No. PCT/US2018/019354, filed on Feb. 23, 2018; “Stent Graft with Fenestration Lock,” by Timothy Lostetter, International Application No. PCT/US2018/019352, filed on Feb. 23, 2018; “Constrainable Stent Graft, Delivery System and Methods of Use,” by Samuel Arbefeuille and Nico Bahar, International Application No. PCT/US2018/019342, filed on Feb. 23, 2018; “Vascular Prosthesis with Crimped Adapter and Methods of Use,” by Samuel Arbefeuille, International Application No. PCT/US2018/019350, filed on Feb. 23, 2018; “Radially Adjustable Stent Graft Delivery System,” by Samuel Arbefeuille, Eduardo Alejandro Garcia and Scott L. Rush, International Application No. PCT/US2018/019356, filed on Feb. 23, 2018; “Vascular Prosthesis with Fenestration Ring and Methods of Use,” by Timothy Lostetter, International Application No. PCT/US2018/019351, filed on Feb. 23, 2018; “Distal Torque Component, Delivery System and Method of Using Same,” by Samuel Arbefeuille, International Application No. PCT/US2018/019510, filed on Feb. 23, 2018, are also incorporated by reference in their entirety.
While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended claims.
This application is a continuation of International Application No. PCT/US2018/019344, which designated the United States and was filed on Feb. 23, 2018, published in English, which claims the benefit of U.S. Provisional Application No. 62/463,031, filed on Feb. 24, 2017. The entire teachings of the above applications are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
5123917 | Lee | Jun 1992 | A |
5242452 | Inoue | Sep 1993 | A |
5507769 | Marin et al. | Apr 1996 | A |
5755769 | Richard et al. | May 1998 | A |
5873906 | Lau et al. | Feb 1999 | A |
6113623 | Sgro | Sep 2000 | A |
6171334 | Cox | Jan 2001 | B1 |
6280464 | Hayashi | Aug 2001 | B1 |
6395018 | Castaneda | May 2002 | B1 |
6610087 | Zarbatany et al. | Aug 2003 | B1 |
6776791 | Stallings et al. | Aug 2004 | B1 |
7435253 | Hartley et al. | Oct 2008 | B1 |
7637940 | Kocur et al. | Dec 2009 | B2 |
7763063 | Arbefeuille et al. | Jul 2010 | B2 |
8007605 | Arbefeuille et al. | Aug 2011 | B2 |
8062346 | Quigley et al. | Nov 2011 | B2 |
8128686 | Paul, Jr. et al. | Mar 2012 | B2 |
8137393 | Ishimaru et al. | Mar 2012 | B2 |
8172895 | Anderson et al. | May 2012 | B2 |
8236040 | Mayberry et al. | Aug 2012 | B2 |
8333800 | Bruszewski et al. | Dec 2012 | B2 |
8480725 | Rasmussen et al. | Jul 2013 | B2 |
8486129 | Lautherjung | Jul 2013 | B2 |
8500792 | Berra | Aug 2013 | B2 |
8641752 | Holm et al. | Feb 2014 | B1 |
8808351 | Osborne | Aug 2014 | B2 |
8915955 | West et al. | Dec 2014 | B2 |
8926693 | Duffy et al. | Jan 2015 | B2 |
9101455 | Roeder et al. | Aug 2015 | B2 |
9101506 | Arbefeuille et al. | Aug 2015 | B2 |
9226814 | Jensen et al. | Jan 2016 | B2 |
9259336 | Schaeffer et al. | Feb 2016 | B2 |
9278018 | Roeder | Mar 2016 | B2 |
9364314 | Berra et al. | Jun 2016 | B2 |
9375308 | Norris | Jun 2016 | B2 |
9439751 | White et al. | Sep 2016 | B2 |
9592112 | Arbefeuille et al. | Mar 2017 | B2 |
9770322 | Burkart et al. | Sep 2017 | B2 |
9827123 | Arbefeuille et al. | Nov 2017 | B2 |
9861503 | Barthold et al. | Jan 2018 | B2 |
9877857 | Arbefeuille et al. | Jan 2018 | B2 |
9913743 | Arbefeuille et al. | Mar 2018 | B2 |
10005269 | Hall et al. | Jun 2018 | B2 |
10080674 | Yuan et al. | Sep 2018 | B2 |
10245137 | Scutti et al. | Apr 2019 | B2 |
10292850 | Vad et al. | May 2019 | B2 |
10299951 | Arbefeuille et al. | May 2019 | B2 |
10390930 | Arbefeuille et al. | Aug 2019 | B2 |
10478320 | Shahriari | Nov 2019 | B2 |
10617542 | Chakfe et al. | Apr 2020 | B2 |
10702406 | Swift et al. | Jul 2020 | B2 |
10744012 | Bonsignore et al. | Aug 2020 | B2 |
10898357 | Arbefeuille et al. | Jan 2021 | B2 |
10987235 | Eubanks et al. | Apr 2021 | B2 |
11000359 | Torrance et al. | May 2021 | B2 |
11219540 | Arbefeuille | Jan 2022 | B2 |
11291572 | Garcia | Apr 2022 | B2 |
11376145 | Arbefeuille et al. | Jul 2022 | B2 |
11491003 | Arbefeuille et al. | Nov 2022 | B2 |
20020062133 | Gilson et al. | May 2002 | A1 |
20020151956 | Chobotov et al. | Oct 2002 | A1 |
20020177890 | Lenker | Nov 2002 | A1 |
20020188344 | Bolea et al. | Dec 2002 | A1 |
20020193872 | Trout et al. | Dec 2002 | A1 |
20030233140 | Hartley et al. | Dec 2003 | A1 |
20040059406 | Cully et al. | Mar 2004 | A1 |
20040073289 | Hartley | Apr 2004 | A1 |
20050049674 | Berra et al. | Mar 2005 | A1 |
20050131517 | Hartley et al. | Jun 2005 | A1 |
20050131518 | Hartley et al. | Jun 2005 | A1 |
20050131519 | Hartley | Jun 2005 | A1 |
20050131523 | Bashiri et al. | Jun 2005 | A1 |
20050154444 | Quadri | Jul 2005 | A1 |
20060004433 | Greenberg et al. | Jan 2006 | A1 |
20060015171 | Armstrong | Jan 2006 | A1 |
20060020319 | Kim et al. | Jan 2006 | A1 |
20060155359 | Watson | Jul 2006 | A1 |
20060184226 | Austin | Aug 2006 | A1 |
20070043425 | Hartley et al. | Feb 2007 | A1 |
20070055360 | Hanson et al. | Mar 2007 | A1 |
20070135904 | Eidenschink et al. | Jun 2007 | A1 |
20070213805 | Schaeffer et al. | Sep 2007 | A1 |
20070233223 | Styrc | Oct 2007 | A1 |
20080082154 | Tseng et al. | Apr 2008 | A1 |
20080091260 | Pomeranz et al. | Apr 2008 | A1 |
20080132988 | Jordan | Jun 2008 | A1 |
20080269867 | Johnson | Oct 2008 | A1 |
20080294234 | Hartley et al. | Nov 2008 | A1 |
20090043377 | Greenberg et al. | Feb 2009 | A1 |
20090163994 | Quigley et al. | Jun 2009 | A1 |
20090248135 | Bruszewski et al. | Oct 2009 | A1 |
20090264990 | Bruszewski et al. | Oct 2009 | A1 |
20100004730 | Benjamin et al. | Jan 2010 | A1 |
20100234932 | Arbefeuille et al. | Sep 2010 | A1 |
20100268319 | Bruszewski et al. | Oct 2010 | A1 |
20100316830 | Hartley et al. | Dec 2010 | A1 |
20110077730 | Fenster | Mar 2011 | A1 |
20110190862 | Bashiri et al. | Aug 2011 | A1 |
20110257720 | Peterson et al. | Oct 2011 | A1 |
20110270378 | Bruszewski et al. | Nov 2011 | A1 |
20120035714 | Ducke et al. | Feb 2012 | A1 |
20120172965 | Kratzberg | Jul 2012 | A1 |
20120221096 | Roeder et al. | Aug 2012 | A1 |
20120271401 | Bruszewski et al. | Oct 2012 | A1 |
20120296360 | Norris et al. | Nov 2012 | A1 |
20120323302 | Brinser | Dec 2012 | A1 |
20130116773 | Roeder et al. | May 2013 | A1 |
20130116775 | Roeder et al. | May 2013 | A1 |
20130123900 | Eblacas et al. | May 2013 | A1 |
20130158648 | Hartley et al. | Jun 2013 | A1 |
20130184806 | Arbefeuille et al. | Jul 2013 | A1 |
20130282102 | Peterson | Oct 2013 | A1 |
20130289713 | Pearson | Oct 2013 | A1 |
20140039597 | Arbefeuille et al. | Feb 2014 | A9 |
20140046428 | Cragg et al. | Feb 2014 | A1 |
20140046429 | Cragg et al. | Feb 2014 | A1 |
20140180378 | Roeder | Jun 2014 | A1 |
20140324150 | Stephens et al. | Oct 2014 | A1 |
20140336745 | Barthold et al. | Nov 2014 | A1 |
20150051691 | Zukowski et al. | Feb 2015 | A1 |
20150105819 | Becking et al. | Apr 2015 | A1 |
20150105849 | Cohen et al. | Apr 2015 | A1 |
20150202065 | Shalev et al. | Jul 2015 | A1 |
20150202067 | Barrand et al. | Jul 2015 | A1 |
20150265444 | Kitaoka | Sep 2015 | A1 |
20150272755 | Arbefeuille et al. | Oct 2015 | A1 |
20150335452 | Rao et al. | Nov 2015 | A1 |
20160100969 | Lesmeister et al. | Apr 2016 | A1 |
20160120667 | Bolduc et al. | May 2016 | A1 |
20160184078 | Choubey et al. | Jun 2016 | A1 |
20160199207 | Treacy et al. | Jul 2016 | A1 |
20160250050 | Lim et al. | Sep 2016 | A1 |
20160278910 | Kelly | Sep 2016 | A1 |
20160296353 | Skender | Oct 2016 | A1 |
20160302950 | Marmur et al. | Oct 2016 | A1 |
20170135807 | Arbefeuille et al. | May 2017 | A1 |
20170281382 | Lostetter et al. | Oct 2017 | A1 |
20180071123 | Arbefeuille et al. | Mar 2018 | A1 |
20180153680 | Greenberg et al. | Jun 2018 | A1 |
20180296374 | Chakfe et al. | Oct 2018 | A1 |
20190328556 | Eubanks et al. | Oct 2019 | A1 |
20190350694 | Arbefeuille et al. | Nov 2019 | A1 |
20200246165 | Arbefeuille et al. | Aug 2020 | A1 |
20200352700 | Torrance et al. | Nov 2020 | A1 |
20210100669 | Arbefeuille et al. | Apr 2021 | A1 |
20210236262 | Torrance et al. | Aug 2021 | A1 |
20220160529 | Arbefeuille et al. | May 2022 | A1 |
20220192851 | Garcia | Jun 2022 | A1 |
20220313464 | Arbefeuille et al. | Oct 2022 | A1 |
Number | Date | Country |
---|---|---|
2016256777 | Apr 2017 | AU |
203815663 | Sep 2014 | CN |
105832447 | Aug 2016 | CN |
105943213 | Sep 2016 | CN |
0786972 | Jan 2004 | EP |
1847234 | Oct 2007 | EP |
1847236 | Oct 2007 | EP |
2471498 | Jul 2012 | EP |
2501334 | Sep 2012 | EP |
2517672 | Oct 2012 | EP |
2735283 | May 2014 | EP |
2740440 | Jun 2014 | EP |
2745812 | Jun 2014 | EP |
2745813 | Jun 2014 | EP |
2749250 | Jul 2014 | EP |
2749251 | Jul 2014 | EP |
2606851 | Nov 2015 | EP |
3040054 | Jul 2016 | EP |
3068339 | Sep 2016 | EP |
3146993 | Mar 2017 | EP |
3187155 | Jul 2017 | EP |
3272319 | Jan 2018 | EP |
3320881 | May 2018 | EP |
3395302 | Oct 2018 | EP |
3733124 | Nov 2020 | EP |
2932979 | Jan 2010 | FR |
2464978 | May 2010 | GB |
WO-9703624 | Feb 1997 | WO |
WO-9725002 | Jul 1997 | WO |
WO-9929262 | Jun 1999 | WO |
WO-9934749 | Jul 1999 | WO |
WO-0160285 | Aug 2001 | WO |
WO-02083038 | Oct 2002 | WO |
WO-03099108 | Dec 2003 | WO |
WO-2005034809 | Apr 2005 | WO |
WO-2006037086 | Apr 2006 | WO |
WO-2009148594 | Dec 2009 | WO |
WO-2010024880 | Mar 2010 | WO |
WO-2010030370 | Mar 2010 | WO |
WO-2010105195 | Sep 2010 | WO |
WO-2010127040 | Nov 2010 | WO |
WO-2012116368 | Aug 2012 | WO |
WO-2012145823 | Nov 2012 | WO |
WO-2014149022 | Sep 2014 | WO |
WO-2014162306 | Oct 2014 | WO |
WO-2015059019 | Apr 2015 | WO |
WO-2015070792 | May 2015 | WO |
WO-2016122862 | Aug 2016 | WO |
WO-2017106156 | Jun 2017 | WO |
WO-2017218474 | Dec 2017 | WO |
WO-2018026768 | Feb 2018 | WO |
WO-2018183563 | Oct 2018 | WO |
WO-2019040326 | Feb 2019 | WO |
Entry |
---|
International Preliminary Report on Patentability for International Application No. PCT/US2018/019344 dated Aug. 27, 2019. |
International Search Report and Written Opinion for International Application No. PCT/US2018/019344 dated May 16, 2018. |
Extended European Search Report for EP Application No. 21153107.4 dated May 18, 2021. |
Luo et al., “Stent-grafts for the treatment of TIPS dysfunction: Fluency stent vs. Wallgrent stent,” World J Gastroenterol, 19(30): 5000-5005 (2013). |
Number | Date | Country | |
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20190231514 A1 | Aug 2019 | US |
Number | Date | Country | |
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62463031 | Feb 2017 | US |
Number | Date | Country | |
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Parent | PCT/US2018/019344 | Feb 2018 | US |
Child | 16379490 | US |