IP Library › Granted Patent US 12,569,330
Granted Patent B2
US 12,569,330 · App. 17/708,147 · Granted Mar 10, 2026

Percutaneous Potts shunt devices and related methods

Inventors: Nasser Rafiee (Andover, MA); Alexis Balcom (Andover, MA); Mai Le Diep (Andover, MA)
Assignee: Transmural Systems LLC
A61F2/064A61L27/16A61L27/507A61F2250/0029A61F2250/0069A61F2250/0098
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,569,330
App. No.
17/708,147
Granted
Mar 10, 2026
Kind
B2
Abstract

The disclosure provides various embodiments of prostheses and delivery systems to permit an interventional cardiologist to create shunts between various blood vessels. Moreover, the disclosed shunts can be used to shunt between various hollow organs, as set forth in the present disclosure.

Claims (27)

1 . A prosthesis having a proximal end, a distal end, and defining an axial direction from the proximal end to the distal end, the prosthesis comprising:

a proximal sealing flange configured and arranged to facilitate seating a proximal end portion of the prosthesis against an interior concave surface of a wall of a first vessel, wherein the prosthesis is configured to extend outwardly through an ostium formed through the wall of the first vessel when deployed, wherein the proximal sealing flange remains inside the ostium after deployment;

a distal sealing flange displaceable from the proximal sealing flange along the axial direction, the distal sealing flange being configured and arranged to facilitate seating a distal end portion of the prosthesis against an interior concave surface of a wall of a second vessel, wherein the prosthesis is configured to extend outwardly through an ostium formed through the wall of the second vessel when deployed, wherein the distal sealing flange remains inside the ostium after deployment; and

a first circumferential undulating strut ring formed from a first undulating filament disposed axially between the proximal sealing flange and the distal sealing flange;

a second circumferential undulating strut ring formed from a second undulating filament disposed axially between the proximal sealing flange and the distal sealing flange, the filament of the second circumferential undulating strut ring being woven and wrapped around the filament of the first circumferential undulating strut ring about a circumference of the prosthesis, wherein the filament of the first circumferential undulating strut ring and the filament of the second circumferential undulating strut ring are configured to slide over each other along the axial direction to permit the prosthesis to collapse along the axial direction into a nested configuration.

2 . The prosthesis of claim 1 , further comprising at least one tension coil spring connecting the proximal sealing flange to the distal sealing flange to cause the prosthesis to collapse into the nested configuration, the at least one tension coil spring being disposed adjacent to each of the first circumferential undulating strut ring and the second circumferential undulating strut ring.

3 . The prosthesis of claim 2 , wherein the at least one tension coil spring includes a plurality of coil springs spaced circumferentially apart from each other about a circumference of the prosthesis.

4 . The prosthesis of claim 1 , further comprising a membrane covering the prosthesis.

5 . The prosthesis of claim 4 , wherein the proximal sealing flange and the distal sealing flange are each formed from an undulating wire forming a star shape, the undulating wire forming a plurality of radially outwardly extending lobes interspersed by a plurality of radially inwardly extending vertices, and further wherein each radially outwardly extending lobe is covered by the membrane material.

6 . The prosthesis of claim 5 , wherein a pair of laterally opposing lobes on each of the proximal sealing flange and the distal sealing flange are larger than other lobes on each said respective sealing flange disposed between the pair of laterally opposing lobes.

7 . The prosthesis of claim 5 , wherein each said flange includes six lobes, wherein each said flange includes three relatively long lobes mutually separated by an angular displacement of about 120 degrees that are interdigitated with three relatively short lobes mutually separated by an angular displacement of about 120 degrees.

8 . The prosthesis of claim 5 , wherein each the proximal sealing flange and the distal sealing flange each includes a further pair of laterally opposing radially outwardly directed projections, wherein each said further pair of projections is formed from a wire loop that is not covered by the membrane material.

9 . The prosthesis of claim 8 , wherein the further pair of projections coupled to the proximal sealing flange are located in an orientation that is rotated 90 degrees about a central axis of the prosthesis with respect to further pair of projections coupled to the distal sealing flange.

10 . A prosthesis having a proximal end, a distal end, and defining an axial direction from the proximal end to the distal end, the prosthesis comprising:

a proximal sealing flange configured and arranged to facilitate seating a proximal end portion of the prosthesis against an interior concave surface of a wall of a first vessel, wherein the prosthesis is configured to extend outwardly through an ostium formed through the wall of the first vessel when deployed, wherein the proximal sealing flange remains inside the ostium after deployment;

a distal sealing flange displaceable from the proximal sealing flange along the axial direction, the distal sealing flange being configured and arranged to facilitate seating a distal end portion of the prosthesis against an interior concave surface of a wall of a second vessel, wherein the prosthesis is configured to extend outwardly through an ostium formed through the wall of the second vessel when deployed, wherein the distal sealing flange remains inside the ostium after deployment;

a plurality of undulating circumferential strut rings disposed axially between the proximal sealing flange and the distal sealing flange; and

at least one tension coil spring connecting the proximal sealing flange to the distal sealing flange to cause the prosthesis to collapse into an axially shortened configuration, the at least one tension coil spring being disposed along an axial direction alongside and radially displaced with respect to each of the plurality of undulating strut rings.

11 . The prosthesis of claim 10 , further comprising a membrane covering the prosthesis.

12 . The prosthesis of claim 11 , wherein the proximal sealing flange and the distal sealing flange are each formed from a plurality of radially outwardly extending lobes, and further wherein each radially outwardly extending lobe is covered by the membrane material.

13 . The prosthesis of claim 11 , wherein each the proximal sealing flange and the distal sealing flange each includes a further plurality of radially outwardly directed projections, each said further plurality of radially outwardly directed projections being formed from a wire loop that is not covered by the membrane material.

14 . The prosthesis of claim 13 , wherein the further plurality of radially outwardly directed projections coupled to the proximal sealing flange are located in an orientation that is rotated about a central axis of the prosthesis with respect to the further plurality of radially outwardly directed projections coupled to the distal sealing flange.

15 . The prosthesis of claim 1 , wherein the filament of the first circumferential undulating strut ring is adjacent and coupled to the proximal sealing flange, and the second circumferential undulating strut ring is adjacent and coupled to the distal sealing flange.

16 . The prosthesis of claim 2 , wherein the at least one tension coil spring is disposed radially inwardly with respect to the first circumferential undulating strut ring.

17 . The prosthesis of claim 2 , wherein the at least one tension coil spring is disposed radially outwardly with respect to the first circumferential undulating strut ring.

18 . The prosthesis of claim 10 , wherein the at least one tension coil spring is disposed radially inwardly with respect to the plurality of undulating circumferential strut rings.

19 . The prosthesis of claim 10 , wherein the at least one tension coil spring is disposed radially outwardly with respect to the plurality of undulating circumferential strut rings.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2022
From: RAFIEE, NASSER; BALCOM, ALEXIS; DIEP, MAI LE
To: TRANSMURAL SYSTEMS LLC
Reel/Frame 060959/0328 →
Continuity (3)
Continuation PCTUS2022018806 · Mar 3, 2022
Provisional Application 63155732 · Mar 3, 2021
Related Publication 20220323196A1 · Oct 13, 2022
References Cited (173)
US 4106129A · Carpentier et al. · 1978 [cited by applicant]
US 4259753A · Liotta et al. · 1981 [cited by applicant]
US 4666442A · Arru et al. · 1987 [cited by applicant]
US 4692164A · Dzemeshkevich et al. · 1987 [cited by applicant]
US 5411552A · Andersen et al. · 1995 [cited by applicant]
US 5449384A · Johnson · 1995 [cited by applicant]
US 5606928A · Religa et al. · 1997 [cited by applicant]
US 5639278A · Dereume et al. · 1997 [cited by applicant]
US 5749921A · Lenker et al. · 1998 [cited by applicant]
US 5788715A · Watson, Jr. et al. · 1998 [cited by applicant]
US 5861028A · Angell · 1999 [cited by applicant]
US 5876432A · Lau · 1999 [cited by examiner]
US 5895410A · Forber et al. · 1999 [cited by applicant]
US 5928281A · Huynh et al. · 1999 [cited by applicant]
US 6059769A · Lunn et al. · 2000 [cited by applicant]
US 6090136A · McDonald · 2000 [cited by applicant]
US 6106510A · Lunn et al. · 2000 [cited by applicant]
US 6238430B1 · Klumb et al. · 2001 [cited by applicant]
US 6375774B1 · Lunn et al. · 2002 [cited by applicant]
US 6599303B1 · Peterson · 2003 [cited by applicant]
US 6602271B2 · Adams et al. · 2003 [cited by applicant]
US 6716231B1 · Rafiee et al. · 2004 [cited by applicant]
US 6733525B2 · Yang et al. · 2004 [cited by applicant]
US 6790229B1 · Berreklouw · 2004 [cited by applicant]
US 6797000B2 · Simpson et al. · 2004 [cited by applicant]
US 6800081B2 · Parodi · 2004 [cited by applicant]
US 6866677B2 · Douk et al. · 2005 [cited by applicant]
US 6911036B2 · Douk et al. · 2005 [cited by applicant]
US 6926690B2 · Renati · 2005 [cited by applicant]
US 6953476B1 · Shalev · 2005 [cited by applicant]
US 6960217B2 · Bolduc · 2005 [cited by applicant]
US 7044958B2 · Douk et al. · 2006 [cited by applicant]
US 7066946B2 · Douk et al. · 2006 [cited by applicant]
US 7137993B2 · Acosta · 2006 [cited by applicant]
US 7189259B2 · Simionescu et al. · 2007 [cited by applicant]
US 7195641B2 · Palmaz et al. · 2007 [cited by applicant]
US 7201772B2 · Schwammenthal et al. · 2007 [cited by applicant]
US 7294135B2 · Stephens et al. · 2007 [cited by applicant]
US 7316706B2 · Bloom et al. · 2008 [cited by applicant]
US 7399315B2 · Iobbi · 2008 [cited by applicant]
US 7425219B2 · Quadri · 2008 [cited by applicant]
US 7442204B2 · Schwammenthal et al. · 2008 [cited by applicant]
US 7442207B2 · Rafiee · 2008 [cited by applicant]
US 7445631B2 · Salahieh et al. · 2008 [cited by applicant]
US 7481838B2 · Carpentier et al. · 2009 [cited by applicant]
US 7491232B2 · Bolduc et al. · 2009 [cited by applicant]
US 7524330B2 · Berreklouw · 2009 [cited by applicant]
US 7655040B2 · Douk et al. · 2010 [cited by applicant]
US 7682352B2 · Rafiee et al. · 2010 [cited by applicant]
US 7699892B2 · Rafiee et al. · 2010 [cited by applicant]
US 7716801B2 · Pouk et al. · 2010 [cited by applicant]
US 7753840B2 · Simionescu et al. · 2010 [cited by applicant]
US 7753949B2 · Lamphere et al. · 2010 [cited by applicant]
US 7780726B2 · Seguin · 2010 [cited by applicant]
US 7799069B2 · Bailey et al. · 2010 [cited by applicant]
US 7806917B2 · Xiao · 2010 [cited by applicant]
US 7806919B2 · Bloom et al. · 2010 [cited by applicant]
US 7815673B2 · Bloom et al. · 2010 [cited by applicant]
US 7947072B2 · Yang et al. · 2011 [cited by applicant]
US 7955384B2 · Rafiee et al. · 2011 [cited by applicant]
US 7972370B2 · Douk et al. · 2011 [cited by applicant]
US 7998188B2 · Zilla et al. · 2011 [cited by applicant]
US 8002825B2 · Letac et al. · 2011 [cited by applicant]
US 8052750B2 · Tuval et al. · 2011 [cited by applicant]
US 8062355B2 · Figulla et al. · 2011 [cited by applicant]
US 8070802B2 · Lamphere et al. · 2011 [cited by applicant]
US 8092518B2 · Schreck · 2012 [cited by applicant]
US 8092520B2 · Quadri · 2012 [cited by applicant]
US 8092524B2 · Nugent et al. · 2012 [cited by applicant]
US 8226710B2 · Nguyen et al. · 2012 [cited by applicant]
US 8252051B2 · Chau et al. · 2012 [cited by applicant]
US 8308798B2 · Pintor et al. · 2012 [cited by applicant]
US 8337541B2 · Quadri et al. · 2012 [cited by applicant]
US 8348995B2 · Tuval et al. · 2013 [cited by applicant]
US 8348996B2 · Tuval et al. · 2013 [cited by applicant]
US 8353954B2 · Cai et al. · 2013 [cited by applicant]
US 8353955B2 · Styrc et al. · 2013 [cited by applicant]
US 8518096B2 · Nelson · 2013 [cited by applicant]
US 10426482B2 · Rafiee · 2019 [cited by examiner]
US 20010021872A1 · Bailey et al. · 2001 [cited by applicant]
US 20020032481A1 · Gabbay · 2002 [cited by applicant]
US 20020138138A1 · Yang · 2002 [cited by applicant]
US 20030055495A1 · Pease et al. · 2003 [cited by applicant]
US 20030065386A1 · Weadock · 2003 [cited by applicant]
US 20030097172A1 · Shalev et al. · 2003 [cited by applicant]
US 20040087998A1 · Lee et al. · 2004 [cited by applicant]
US 20040127916A1 · Bolduc et al. · 2004 [cited by applicant]
US 20050038508A1 · Gabbay · 2005 [cited by applicant]
US 20050043790A1 · Seguin · 2005 [cited by applicant]
US 20050049675A1 · Wallace · 2005 [cited by applicant]
US 20050055082A1 · Ben-Muvhar et al. · 2005 [cited by applicant]
US 20050137769A1 · Salahieh et al. · 2005 [cited by applicant]
US 20050143809A1 · Salahieh et al. · 2005 [cited by applicant]
US 20050177180A1 · Kaganov et al. · 2005 [cited by applicant]
US 20050288706A1 · Widomski et al. · 2005 [cited by applicant]
US 20060085012A1 · Dolan · 2006 [cited by applicant]
US 20060106449A1 · Ben-Muvhar · 2006 [cited by applicant]
US 20060106450A1 · Ben-Muvhar · 2006 [cited by applicant]
US 20060173537A1 · Yang et al. · 2006 [cited by applicant]
US 20070043435A1 · Seguin et al. · 2007 [cited by applicant]
US 20070067029A1 · Gabbay · 2007 [cited by applicant]
US 20070250160A1 · Rafiee · 2007 [cited by applicant]
US 20070255398A1 · Yang et al. · 2007 [cited by applicant]
US 20070288089A1 · Gurskis et al. · 2007 [cited by applicant]
US 20070293942A1 · Mizraee · 2007 [cited by applicant]
US 20080015687A1 · Lashinski et al. · 2008 [cited by applicant]
US 20080021537A1 · Ben-Muvhar et al. · 2008 [cited by applicant]
US 20080065191A1 · Bolduc et al. · 2008 [cited by applicant]
US 20080077234A1 · Styrc · 2008 [cited by applicant]
US 20080125860A1 · Webler et al. · 2008 [cited by applicant]
US 20080208328A1 · Antocci et al. · 2008 [cited by applicant]
US 20080221672A1 · Lamphere et al. · 2008 [cited by applicant]
US 20090005863A1 · Goetz et al. · 2009 [cited by applicant]
US 20090062841A1 · Amplatz et al. · 2009 [cited by applicant]
US 20090270966A1 · Douk et al. · 2009 [cited by applicant]
US 20090270976A1 · Douk et al. · 2009 [cited by applicant]
US 20090306768A1 · Quadri · 2009 [cited by applicant]
US 20090319038A1 · Gurskis et al. · 2009 [cited by applicant]
US 20100036479A1 · Hill · 2010 [cited by examiner]
US 20100082094A1 · Quadri et al. · 2010 [cited by applicant]
US 20100100167A1 · Bortlein et al. · 2010 [cited by applicant]
US 20100174363A1 · Castro · 2010 [cited by applicant]
US 20100179648A1 · Richter et al. · 2010 [cited by applicant]
US 20100179649A1 · Richter et al. · 2010 [cited by applicant]
US 20100185275A1 · Richter et al. · 2010 [cited by applicant]
US 20100249923A1 · Alkhatib et al. · 2010 [cited by applicant]
US 20100262232A1 · Annest · 2010 [cited by applicant]
US 20100280606A1 · Naor · 2010 [cited by applicant]
US 20100298931A1 · Quadri et al. · 2010 [cited by applicant]
US 20110112632A1 · Chau et al. · 2011 [cited by applicant]
US 20110137409A1 · Yang et al. · 2011 [cited by applicant]
US 20110172784A1 · Richter et al. · 2011 [cited by applicant]
US 20110282438A1 · Drews et al. · 2011 [cited by applicant]
US 20110313515A1 · Quadri et al. · 2011 [cited by applicant]
US 20110319988A1 · Schankereli · 2011 [cited by examiner]
US 20110319989A1 · Lane et al. · 2011 [cited by applicant]
US 20120022639A1 · Hacohen · 2012 [cited by applicant]
US 20120059450A1 · Chiang et al. · 2012 [cited by applicant]
US 20120065652A1 · Cully et al. · 2012 [cited by applicant]
US 20120078353A1 · Quadri et al. · 2012 [cited by applicant]
US 20120078360A1 · Rafiee · 2012 [cited by applicant]
US 20120179244A1 · Schankereli et al. · 2012 [cited by applicant]
US 20120215303A1 · Quadri et al. · 2012 [cited by applicant]
US 20120316642A1 · Yu et al. · 2012 [cited by applicant]
US 20120323316A1 · Chau · 2012 [cited by examiner]
US 20140018906A1 · Rafiee · 2014 [cited by applicant]
US 20140039083A1 · Krepski et al. · 2014 [cited by applicant]
US 20140128965A1 · Rafiee · 2014 [cited by applicant]
US 20140163668A1 · Rafiee · 2014 [cited by applicant]
US 20140358223A1 · Rafiee et al. · 2014 [cited by applicant]
US 20150134051A1 · Donadio et al. · 2015 [cited by applicant]
US 20190231510A1 · Rafiee · 2019 [cited by examiner]
EP 2412397A1 · 2012 [cited by applicant]
JP 2015519969A · 2015 [cited by applicant]
KR 20130110413A1 · 2013 [cited by applicant]
KR 101501614B1 · 2015 [cited by applicant]
RU 100718U1 · 2010 [cited by applicant]
WO WO2007121314A2 · 2007 [cited by applicant]
WO WO2012061809A2 · 2012 [cited by applicant]
WO WO2013131069A1 · 2013 [cited by applicant]
WO WO2015069947A1 · 2015 [cited by applicant]
WO WO2015148821A1 · 2015 [cited by applicant]
International Search Report dated Jun. 16, 2022 in International Patent Application No. PCT/US2022/018806. [cited by applicant]
Written Opinion of the International Searching Authority dated May 17, 2022 in International Patent Application No. PCT/US2022/018806. [cited by applicant]
International Search Report, for related application No. PCT/US2011/059586, mailed May 25, 2012. [cited by applicant]
International Preliminary Report on Patentability and Written Opinion, or related application No. PCT/US2011/059586, mailed May 25, 2012. [cited by applicant]
BioIntegral Surgical, Mitral Valve Restoration System. [cited by applicant]
International Search Report for co-pending international application No. PCT/US2013/028774, mailed Jun. 14, 2013. [cited by applicant]
International Preliminary Report on Patentability and Written Opinion, on related application No. PCT/US2014/064431 mailed Mar. 26, 2015. [cited by applicant]
International Search Report, for related application No. PCT/US2015/022782, mailed Jun. 18, 2015. [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/US2016/052005, mailed Dec. 29, 2016. [cited by applicant]
International Search Report and Written Opinion in Application No. PCT/US2018/049373, mailed Dec. 6, 2018. [cited by applicant]
Office Action in related Japanese Patent Application No. JP2018-514884 dated Jun. 30, 2020 with English language translation. [cited by applicant]