The present invention relates generally to vascular connector devices and methods of using the same. More specifically, the invention relates to an endovascular anastomotic connector, a delivery system, and a method of delivery.
The circulatory system of the human body transports blood containing chemicals, such as metabolites and hormones, and cellular waste products to and from the cells. This organ system includes the heart, blood, and a vascular network. Veins are vessels that carry blood toward the heart while arteries carry blood away from the heart. The human heart consists of two atrial chambers and two ventricular chambers. Atrial chambers receive blood from the veins and the ventricular chambers, which include larger muscular walls, pump blood from the heart. Movement of the blood is as follows: blood enters the right atrium from either the superior or the inferior vena cava and moves into the right ventricle. From the right ventricle, blood is pumped to the lungs via pulmonary arteries to become oxygenated. Once the blood has been oxygenated, the blood returns to the heart by entering the left atrium, via the pulmonary veins, and flows into the left ventricle. Finally, the blood is pumped from the left ventricle into the aorta and the vascular network.
In some instances, it becomes necessary to maintain fluidic communication with the vascular network. For example, a circulatory assist system uses a pump to aid in moving blood through the vascular network, thereby relieving the symptoms associated with congestive heart failure (commonly referred to as heart disease). The pump of the circulatory assist system includes inflow and outflow cannulae. Often the inflow cannula connects the left atrium of the heart to the pump; the outflow cannula connects the pump to a peripheral artery. The outflow cannula must be stabilized within the peripheral artery to ensure proper functioning of the circulatory assist system and reduce the risk of bleeding. Accordingly, it would be beneficial to have devices that can be delivered and secured to a peripheral vessel but are also capable of being attached to an auxiliary device.
In one illustrative embodiment of the present invention, an anastomotic connector is described. The anastomotic connector includes a vascular conduit and a supply conduit. The vascular conduit has proximal and distal ends that reside within a vascular structure. The supply conduit extends at an angle from the vascular conduit. The proximal end of the supply conduit is configured to extend from the vascular structure and attach to an auxiliary device.
In another illustrative embodiment of the present invention, a delivery system is described and includes the anastomotic connector and a delivery subassembly. The delivery subassembly includes a multi-lumen hub, a multi-lumen delivery shaft, and a secondary delivery shaft. The multi-lumen delivery shaft extends from the multi-lumen hub, through the lumen of the supply conduit, and out from the distal end of the vascular conduit. The secondary delivery shaft extends from the multi-lumen hub, into the proximal end of the vascular conduit, and out from the distal end of the vascular conduit. A proximal portion of the secondary delivery shaft extending from the distal end of the vascular conduit is received by a first lumen of the multi-lumen delivery shaft.
With respect to the implanted circulatory assist system 10, a flexible cannula body 48 extends from within the left atrium 18, through the intra-atrial septum 50, and percutaneously to a vascular access site 52 in the right subclavian vein 26. The flexible cannula body 48 is attached to an input port 54 of an implantable pump 56. An endovascular anastomotic connector 58 connects an output port 60 of the implantable pump 56 to a suitable superficial artery, such as the right subclavian artery 44. The physician can position the implantable pump 56 subcutaneously and, optionally, submuscularly in a pump pocket 57 located near the vascular access site 52 or maintain the pump 56 externally.
The endovascular anastomotic connector 58 is shown in greater detail in
The vascular and supply conduits 62, 64 can each include support structures 67, 68, 69 constructed from continuous wire or laser cut from a hypotube or rolled sheet stock. The support structures 67, 68, 69 are then encapsulated within an expandable material. The expandable material can be superelastic and self-expanding, such as nickel titanium (NiTi). Alternatively, a balloon-expandable material, such as nickel cobalt (NiCo) or chromium cobalt (CrCo) can be used. The expandable material can then be coated with a porous material to allow for the migration of endothelial cells, and to secure the conduits 62, 64 to the wall of the vessel. Suitable porous materials can include expanded polytetrafluoroethylene (ePTFE), woven polyester, velour, or DACRON brand of synthetic polyester fabric. In some embodiments, the wall thickness of the vascular conduit 62 can be thinner than the wall thickness of the supply conduit 64 to allow the vascular conduit 62 to conform to the lumen of the blood vessel while not obstructing the flow of blood through the vessel. This is more preferred over the reverse because the vascular conduit 62 is implanted within the vessel and the profile should be minimized so as to not interfere with blood flow.
The bifurcated joint 66 should be flexible and replicate the vessel's native compliance. The bifurcated joint 66 can form an angle, θ, which can vary from about 5° to about 90° (i.e., perpendicular) depending on the intended use of the endovascular anastomotic connector 58 and the local anatomy.
Turning now to
The multi-lumen delivery shaft 76, illustrated alone in
In
The endovascular anastomotic connector 58 can be folded about the delivery subassembly 74 to minimize the delivery system profile. One manner of folding the endovascular anastomotic connector 58 includes collapsing the support structures 67, 69 (
After assembly, the delivery system 100 is back-loaded into a delivery sheath 102, as shown in
One manner of inserting the endovascular anastomotic connector 58 into a vessel can now be described with reference to
The physician can then create a secondary incision site (not shown) that is remotely located from the incision 103 in the right subclavian artery 44. For the incision 103 in the right subclavian artery 44, a suitable secondary incision site could be, for example, near the right femoral vein (not shown). A first guide-wire 114 is then directed percutaneously from the secondary incision site to the right subclavian artery 44 and through the introducer 104. The first guide-wire 114 is then directed into the distal end of the secondary delivery shaft 78. In some embodiments, the physician can direct the first guide-wire 114 through the entire length of the secondary delivery shaft 78, alternatively the first guide-wire 114 is advanced about 10 mm to about 20 mm into the secondary delivery shaft 78.
As shown in
With the guide-wires 114, 116 in position, the delivery system 100 with the delivery sheath 102 can be advanced, as a unit, into the introducer 104, as shown in
Once the delivery sheath 102 is sufficiently removed, the endovascular anastomotic connector 58 automatically deploys within the right subclavian artery 44. The proximal end 70 of the vascular conduit 62 is unfolded from around the supply conduit 64 and radially expanded against the inner wall of the right subclavian artery 44 by the support structure 67 (
As illustrated in
The physician can then pull proximally on the multi-lumen delivery shaft 76 and the supply conduit 64 to reposition the vascular conduit 62 and bridge the incision 103 in the wall of the right subclavian artery 44. Repositioning is structurally supported by the multi-lumen delivery shaft 76. The introducer 104 and the multi-lumen delivery shaft 76 can then be retracted from the right subclavian artery 44 leaving the endovascular anastomotic connector 58, as shown in
Once the sheath 106 of the introducer 104 is removed, the support structure 69 (
Though not shown, the physician can ensure full radial expansion of the support structures 67, 68, 69 (
To fully expand the bifurcation joint 66, the physician directs a balloon dilation catheter over the second guide-wire 116. Inflation of the balloon dilation catheter causes the bifurcation joint 66 to expand and seal the incision 103 in the wall of the right subclavian artery 44. In some embodiments, the physician can inflate and deflate the balloon dilation catheter multiple times, in the same or different positions, within the bifurcation joint 66 to ensure a complete expansion.
The balloon dilation catheter and guide-wires 114, 116 are then removed. The physician can then cap or clamp (not shown) the proximal end of the supply conduit 64 to prevent bleeding through its lumen. When attaching the auxiliary device to the supply conduit 64, the physician can deair the supply conduit 64 by back bleeding or inserting a needle through the cap to draw out the air.
While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims.
This application is a divisional of U.S. patent application Ser. No. 14/713,380, filed May 15, 2015, now patent Ser. No. 10/136,893, issued Nov. 27, 2018, which application is a divisional of U.S. patent application Ser. No. 12/829,425, filed Jul. 2, 2010, now U.S. Pat. No. 9,050,419, issued Jun. 9, 2015, which claims priority to U.S. Provisional Application Ser. No. 61/242,153, filed Sep. 14, 2009 the entirety of all of which are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3496939 | Odiaga et al. | Feb 1970 | A |
3683926 | Suzuki | Aug 1972 | A |
4142528 | Whelan et al. | Mar 1979 | A |
4230119 | Blum | Oct 1980 | A |
4503568 | Madras | Mar 1985 | A |
4512761 | Raible | Apr 1985 | A |
4712551 | Rayhanabad | Dec 1987 | A |
4822341 | Colone | Apr 1989 | A |
5041101 | Seder et al. | Aug 1991 | A |
5054484 | Hebeler, Jr. | Oct 1991 | A |
5254097 | Schock | Oct 1993 | A |
5425765 | Tiefenbrun et al. | Jun 1995 | A |
5443497 | Venbrux | Aug 1995 | A |
5449342 | Hirose et al. | Sep 1995 | A |
5456712 | Maginot | Oct 1995 | A |
5474540 | Miller | Dec 1995 | A |
5486159 | Mahurkar | Jan 1996 | A |
5522880 | Barone et al. | Jun 1996 | A |
5613980 | Chauhan | Mar 1997 | A |
5628783 | Quiachon et al. | May 1997 | A |
5669924 | Shaknovich | Sep 1997 | A |
5676670 | Kim | Oct 1997 | A |
5676696 | Mardcade | Oct 1997 | A |
5676697 | McDonald | Oct 1997 | A |
5693087 | Parodi | Dec 1997 | A |
5693088 | Lazarus | Dec 1997 | A |
5720735 | Dorros | Feb 1998 | A |
5755773 | Evans et al. | May 1998 | A |
5755778 | Kleshinski | May 1998 | A |
5807311 | Palestrant | Sep 1998 | A |
5807356 | Finch et al. | Sep 1998 | A |
5824036 | Lauterjung | Oct 1998 | A |
5921971 | Agro et al. | Jul 1999 | A |
6017363 | Hojeibane | Jan 2000 | A |
6019788 | Butters | Feb 2000 | A |
6030395 | Nash et al. | Feb 2000 | A |
6042569 | Finch, Jr. | Mar 2000 | A |
6053901 | Finch, Jr. | Apr 2000 | A |
6099497 | Adams | Aug 2000 | A |
6129738 | Lashinski | Oct 2000 | A |
6162196 | Hart | Dec 2000 | A |
6183509 | Dibie | Feb 2001 | B1 |
6210430 | Solem | Apr 2001 | B1 |
6210435 | Piplani et al. | Apr 2001 | B1 |
6293955 | Houser et al. | Sep 2001 | B1 |
6293965 | Berg et al. | Sep 2001 | B1 |
6319278 | Quinn | Nov 2001 | B1 |
6361544 | Wilson | Mar 2002 | B1 |
6428567 | Wilson et al. | Aug 2002 | B2 |
6451033 | Berg et al. | Sep 2002 | B1 |
6468300 | Freidberg | Oct 2002 | B1 |
6475232 | Babbs et al. | Nov 2002 | B1 |
6475234 | Richter et al. | Nov 2002 | B1 |
6482211 | Choi | Nov 2002 | B1 |
6494889 | Fleischman et al. | Dec 2002 | B1 |
6506202 | Dutta et al. | Jan 2003 | B1 |
6508836 | Wilson et al. | Jan 2003 | B2 |
6517558 | Gittings et al. | Feb 2003 | B2 |
6524334 | Thompson | Feb 2003 | B1 |
6558414 | Layne | May 2003 | B2 |
6579312 | Wilson et al. | Jun 2003 | B2 |
6579314 | Lombardi et al. | Jun 2003 | B1 |
6585756 | Strecker | Jul 2003 | B1 |
6592544 | Mooney | Jul 2003 | B1 |
6645242 | Quinn | Nov 2003 | B1 |
6652544 | Houser et al. | Nov 2003 | B2 |
6669708 | Nissenbaum et al. | Dec 2003 | B1 |
6719749 | Schweikert | Apr 2004 | B1 |
6733522 | Schmitt et al. | May 2004 | B2 |
6736838 | Richter | May 2004 | B1 |
6740101 | Houser et al. | May 2004 | B2 |
6740115 | Lombardi et al. | May 2004 | B2 |
6770087 | Layne et al. | Aug 2004 | B2 |
6786920 | Shannon et al. | Sep 2004 | B2 |
6790225 | Shannon et al. | Sep 2004 | B1 |
6808533 | Goodwin et al. | Oct 2004 | B1 |
6843795 | Houser et al. | Jan 2005 | B1 |
6860899 | Rivelli, Jr. | Mar 2005 | B1 |
6866805 | Hong et al. | Mar 2005 | B2 |
6875229 | Wilson et al. | Apr 2005 | B2 |
6887265 | Richter et al. | May 2005 | B2 |
6896699 | Wilson et al. | May 2005 | B2 |
6899730 | Rivelli, Jr. | May 2005 | B1 |
6911040 | Johnson et al. | Jun 2005 | B2 |
6955688 | Wilson et al. | Oct 2005 | B2 |
6969395 | Eskuri | Nov 2005 | B2 |
6979338 | Loshakove et al. | Dec 2005 | B1 |
6984243 | Dwyer et al. | Jan 2006 | B2 |
6989071 | Kocur et al. | Jan 2006 | B2 |
6994713 | Berg et al. | Feb 2006 | B2 |
7014628 | Bousquet | Mar 2006 | B2 |
7022131 | Derowe et al. | Apr 2006 | B1 |
7063711 | Loshakove et al. | Jun 2006 | B1 |
7083640 | Lombardi et al. | Aug 2006 | B2 |
7094248 | Bachinski et al. | Aug 2006 | B2 |
7108717 | Freidberg | Sep 2006 | B2 |
7141060 | Metz | Nov 2006 | B1 |
7285235 | Rapacki | Oct 2007 | B2 |
7699864 | Kick et al. | Apr 2010 | B2 |
7713193 | Nance et al. | May 2010 | B2 |
7722568 | Lenker et al. | May 2010 | B2 |
7780692 | Nance et al. | Aug 2010 | B2 |
8500620 | Lu | Aug 2013 | B2 |
20010003149 | Utterberg et al. | Jun 2001 | A1 |
20010041902 | Lepulu et al. | Nov 2001 | A1 |
20020019665 | Dehdashtian et al. | Feb 2002 | A1 |
20020052648 | McGuckin et al. | May 2002 | A1 |
20020099394 | Houser | Jul 2002 | A1 |
20020169495 | Gifford et al. | Nov 2002 | A1 |
20030195535 | Swanson et al. | Oct 2003 | A1 |
20040153112 | Nissenbaum et al. | Aug 2004 | A1 |
20040153143 | Quachon et al. | Aug 2004 | A1 |
20040167478 | Mooney | Aug 2004 | A1 |
20040168691 | Sharkawy | Sep 2004 | A1 |
20040243095 | Nimkar | Dec 2004 | A1 |
20050070933 | Leiboff | Mar 2005 | A1 |
20050096585 | Schon | May 2005 | A1 |
20050124937 | Kick et al. | Jun 2005 | A1 |
20050165428 | Franco | Jul 2005 | A1 |
20050251187 | Beane | Nov 2005 | A1 |
20060052750 | Lenker et al. | Mar 2006 | A1 |
20060135962 | Kick et al. | Jun 2006 | A1 |
20060135963 | Kick et al. | Jun 2006 | A1 |
20060135981 | Lenker et al. | Jun 2006 | A1 |
20060200189 | Nance et al. | Sep 2006 | A1 |
20060253102 | Nance et al. | Nov 2006 | A1 |
20070179591 | Baker et al. | Aug 2007 | A1 |
20070203572 | Heuser et al. | Aug 2007 | A1 |
20080109058 | Greenberg et al. | May 2008 | A1 |
20080172118 | Johnson et al. | Jul 2008 | A1 |
20080195125 | Hoffman | Aug 2008 | A1 |
20080200943 | Barker et al. | Aug 2008 | A1 |
20080215008 | Nance et al. | Sep 2008 | A1 |
20080243081 | Nance et al. | Oct 2008 | A1 |
20090093873 | Navia | Apr 2009 | A1 |
20090182188 | Marseille et al. | Jul 2009 | A1 |
20090287182 | Bishop et al. | Nov 2009 | A1 |
20090287183 | Bishop et al. | Nov 2009 | A1 |
20100145267 | Bishop et al. | Jun 2010 | A1 |
20100228077 | Lenker et al. | Sep 2010 | A1 |
Number | Date | Country |
---|---|---|
10033720 | Jan 2002 | DE |
0838486 | Feb 1996 | JP |
9511409 | Nov 1997 | JP |
2002301083 | Oct 2002 | JP |
2002534208 | Oct 2002 | JP |
2003019137 | Jan 2003 | JP |
2003250819 | Sep 2003 | JP |
2003290233 | Oct 2003 | JP |
2005517502 | Jun 2005 | JP |
2008511419 | Apr 2008 | JP |
2008513155 | May 2008 | JP |
2009525128 | Jul 2009 | JP |
9514442 | Jun 1995 | WO |
0041633 | Jul 2000 | WO |
0049951 | Aug 2000 | WO |
2004043519 | May 2004 | WO |
2006028925 | Mar 2006 | WO |
2007089500 | Aug 2007 | WO |
2008027869 | Mar 2008 | WO |
2008027869 | Mar 2008 | WO |
2009082718 | Jul 2009 | WO |
2009082718 | Jul 2009 | WO |
Entry |
---|
Japanese Patent Office, Notice of Reasons for Rejection in JP Application No. 2012-528794, dated Feb. 24, 2014. |
Japanese Patent Office, Notice of Reasons for Rejection in JP Application No. 2014-206184, dated Aug. 31, 2015. |
Japanese Patent Office, Decision of Rejection in JP Application No. 2014-206184, dated May 9, 2016. |
U.S. Patent and Trademark Office, International Preliminary Report on Patentability in related International Application No. PCT/US10/048082, dated Dec. 6, 2011, 4 pages. |
U.S. Patent and Trademark Office, International Preliminary Report on Patentability in related International Application No. PCT/US10/039782, dated Mar. 2, 2012, 9 pages. |
Canadian Intellectual Property Office, Office Action in Canadian Application No. 2,768,567, dated Jan. 26, 2016. |
European Patent Office, Supplementary Partial European Search Report in EP Application No. 10815780, dated Aug. 26, 2014. |
Atrium Medical Corp., “Atrium iCAST Covered Stent Brochure,” at http://www.atriummed.com/EN/interventional/Dcouments/iCAST%20Brochure$2003603G.pdf (last visited Oct. 13, 2010). |
Boston Scientific Corp., “Boston Scientific Announces CE Mark for SYMBIOT covered stent system: Symbiot II clinical trial results reported at PCR,” at http://www.ptca.org/press_rel/20020528pr_boston.html (last visited Oct. 13, 2010). |
Cook Medical, “Aortic Intervention,” at http://www.cookmedical.com/ai/home.do (last visited Oct. 13, 2010). |
Atrium Medical Corp., “FLIXENE IFG: The Best Engineered Dialysis Access Graft . . . There Can Only Be One,” at http://wwww.atriummed.com/en/vascular/Documents/FlixeneIFG%202-sidedflyer.pdf (last visited Dec. 3, 2010). |
U.S. Patent and Trademark Office, International Search Report and Written Opinion in PCT Application No. PCT/US10/048082, dated Oct. 25, 2010. |
U.S. Patent and Trademark Office, International Search Report and Written Opinion in PCT Application No. PCT/US10/39782, dated Aug. 10, 2010. |
Number | Date | Country | |
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20190069898 A1 | Mar 2019 | US |
Number | Date | Country | |
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61242153 | Sep 2009 | US |
Number | Date | Country | |
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Parent | 14713380 | May 2015 | US |
Child | 16178729 | US | |
Parent | 12829425 | Jul 2010 | US |
Child | 14713380 | US |