The present invention relates generally to devices and methods for the treatment of heart failure and, more particularly, to devices and methods for the relief of high pressure in the cardiovascular system to alleviate symptoms of cardiovascular disease.
Heart failure is a common and potentially lethal condition affecting humans, with sub-optimal clinical outcomes often resulting in symptoms, morbidity and/or mortality, despite maximal medical treatment. In particular, “diastolic heart failure” refers to the clinical syndrome of heart failure occurring in the context of preserved left ventricular systolic function (ejection fraction) and in the absence of major valvular disease. This condition is characterised by a stiff left ventricle with decreased compliance and impaired relaxation, which leads to increased end-diastolic pressure. Approximately one third of patients with heart failure have diastolic heart failure and there are very few, if any, proven effective treatments.
Symptoms of diastolic heart failure are due, at least in a large part, to an elevation in pressure in the left atrium. In addition to diastolic heart failure, a number of other medical conditions, including systolic dysfunction of the left ventricle and valve disease, can lead to elevated pressures in the left atrium. Increased left atrial pressure often causes acute or chronic breathlessness amongst other problems. In addition, a variety of heart conditions can lead to “right heart failure”, which can result in enlargement of the liver (hepatomegaly), fluid accumulation in the abdomen (ascites) and/or swelling of the lower limbs.
In the past, strategies have been described for the relief of high pressure in the right atrium, such as the creation of hole(s) in the native or surgically created septum between the left and right atria. These have been designed for the rare conditions of pulmonary hypertension or cavopulmonary connections for certain complex congenital heart diseases. O'Loughlin et al. recently described a fenestrated atrial septal defect closure device for the palliation of advanced pulmonary hypertension. However, this device allows bidirectional flow, and the passage of thrombi, and was shown to be closed over within 6 months of insertion. Thus a need still exists for devices to relieve high pressure in the left atrium and which will prevent or minimize the chance of the passage of thrombi.
Accordingly, there exists a need for devices and methods to treat heart failure particularly diastolic and/or systolic failure of the left ventricle and its consequences.
According to a first aspect of the invention, there is provided a device for treating heart failure in a patient, the device comprising:
a body;
at least one passage through the body;
at least one one way valve in the passage; and
a mounting means adapted for mounting the body in an opening provided in the patient's atrial septum,
wherein, in use, the device is oriented such that, when the patient's left atrial pressure exceeds the patient's right atrial pressure by a predetermined amount, the one way valve(s) opens to allow blood flow through the passage(s) from the left atrium to the right atrium to thereby reduce the left atrial pressure.
According to a second aspect of the invention, there is provided a device for treating heart failure or pulmonary venous hypertension in a patient, the device comprising:
a body;
at least one passage through the body;
at least one one way valve in the passage; and
a mounting means adapted for mounting the body in the patient's venous system,
wherein, in use, the device is oriented such that the one way valve(s) prevents blood flow through the passage(s) in a direction opposite to that of the natural flow direction.
The device is preferably adapted to be fitted into a blood vessel in the patient's venous system, such as the inferior vena cava, superior vena cava, the hepatic vein, an iliac vein, or one or more pulmonary veins.
According to a third aspect of the invention, there is provided a device for treating lower limb venous hypertension in a patient, the device comprising:
a body;
at least one passage through the body;
at least one one way valve in the passage; and
a mounting means adapted for mounting the body in the patient's lower limb venous system,
wherein, in use, the device is oriented such that the one way valve(s) prevents blood flow through the passage(s) in a direction opposite to that of the natural flow direction.
The above device is also suitable for treating varicose veins.
The body is preferably in the form of a stent, most preferably an expandable stent.
The valve is preferably a duckbill valve, a leaflet valve, a flap valve, a disc in cage type valve or a ball in cage type valve. The valve is preferably biased to a closed position, most preferably by the inherent resilience of the valve material. The valve preferably opens when the predetermined amount of pressure differential is at least approximately 2 mm Hg, preferably approximately 5 to 25 mm Hg, even more preferably 5 to 15 mm Hg.
In one form, the device has a single passage through the body, most preferably centrally located in relation to the body. In another form, the device has a single passage through the body, most preferably eccentrically located in relation to the body. In yet another form, the device has a plurality of passages through the body, each with a one way valve therein, most preferably each eccentrically located in relation to centre of the body.
According to a fourth aspect of the invention, there is provided a device for treating heart failure in a patient, the device comprising:
a body;
at least one passage through the body;
a mesh or grill arrangement within the passage and having apertures therein of a size permitting flow of blood, whilst substantially excluding thrombi, therethrough;
a mounting means adapted for mounting the body in an opening provided in the patient's atrial septum,
wherein, in use, the device allows blood flow through the passage(s) from the left atrium to the right atrium when the patient's left atrial pressure exceeds the patient's right atrial pressure to thereby reduce the patient's left atrial pressure.
The device preferably includes a mesh or grill arrangement across one or both ends of the passage(s).
The apertures preferably have a maximum dimension of less than 4 mm, most preferably less than 2 mm. The mesh or grill is preferably coated or impregnated with one or more drugs, adapted for preventing thrombosis or endothelialisation of the opening in the patient's atrial septum, including an anticoagulant substance, such as heparin, or an inhibitor of re-endothelialisation, such as sirolimus or paclitaxel.
In one form, the device has a single passage through the body, most preferably centrally located in relation to the body. In another form, the device has a plurality of passages through the body, each with a mesh or grill arrangement therein, most preferably each eccentrically located in relation to centre of the body.
The device is preferably flexible, most preferably formed from a material which can be deformed but later return to its original shape. An example of such a material is Nitinol.
The device is preferably collapsible and adapted for implanting via a catheter, although it could be inserted at surgery.
The device is preferably collapsible to a size able to pass through an opening made in the patient's atrial septum (or an enlargement of a pre-existing communication, by standard methods) and adapted to return to a shape where at least some of the device would have been unable to pass through the opening in the patient's atrial septum. The device is preferably formed from a Nitinol mesh, or any other material which can be deformed but later return to its original shape.
The mounting means preferably comprises at least one flange having a dimension larger than the opening in the patient's septum. More preferably, the mounting means preferably comprises a pair of spaced apart flanges having a dimension larger than the opening in the patient's septum.
The external dimension of the body, remote the flange(s), is preferably substantially equal to the opening in the patient's atrial septum.
In one embodiment, the flanges are adapted for gluing, suturing, stapling or pinning to the patient's septum.
In another embodiment, the flanges are spaced apart by about the thickness of the patient's atrial septum and are adapted to locate, most preferably by gripping, the patient's atrial septum therebetween.
According to a fifth aspect of the invention, there is provided a method for treating heart failure in a patient, the method comprising the steps of:
forming an opening in the patient's atrial septum;
inserting at least one one way valve in the opening that is oriented such that the one way valve(s) allows blood flow through the passage from the left atrium to the right atrium when the patient's left atrial pressure exceeds the patient's right atrial pressure; and
securing the one way valve(s) relative to the patient's atrial septum,
whereby, when the patient's left atrial pressure exceeds the patient's right atrial pressure by a predetermined amount, the valve opens to allow blood flow through the passage(s) from the left atrium to the right atrium to thereby reduce the patient's left atrial pressure.
The above method is particularly suited for treating cardiovascular disease manifest by left atrial hypertension, such as that due to left ventricular systolic or diastolic dysfunction.
The predetermined amount of pressure differential is at preferably least approximately 3 mm Hg, preferably approximately 5 to 25 mm Hg, even more preferably 5 to 15 mm Hg.
According to a sixth aspect of the invention, there is provided a method for treating heart failure in a patient, the method comprising the steps of:
forming an opening in the patient's atrial septum;
inserting a mesh or grill arrangement within the opening having apertures therein of a size permitting passage of blood, whilst substantially excluding passage of thrombi, therethrough; and
securing the mesh or grill arrangement relative to the patient's atrial septum.
The mesh or grill arrangement is preferably provided within a passage in a body, and the method preferably includes the step of securing the body relative to the patient's atrial septum.
The above method is particularly suited for treating cardiovascular disease manifest by left atrial hypertension, such as that due to left ventricular systolic or diastolic dysfunction.
According to a seventh aspect of the invention, there is provided a method for treating heart failure in a patient, the method comprising the steps of:
inserting at least one one way valve in the patient's venous system that is oriented such that the one way valve(s) prevents blood flow through the said venous system in a direction opposite to that of the natural flow direction; and
securing the one way valve(s) relative to the patient's venous system.
The method preferably includes the steps of inserting and securing the one way valve in the patient's blood vessel, such as the inferior vena cava, superior vena cava, the hepatic vein, an iliac vein, or one or more pulmonary veins.
The method preferably includes a step of inserting and securing, most preferably by expanding, a stent with the one way valve(s) therein.
According to an eighth aspect of the invention, there is provided a device for treating heart failure in a patient, the device comprising:
a tube having first and second ends in fluid communication with the left and right atriums of the heart respectively; and
a valve between the first and second ends and adapted to selectively prevent or allow fluid flow through the tube,
wherein, in use, when the patient's left atrial pressure exceeds the patient's right atrial pressure by a predetermined amount, the valve opens to allow blood flow through the tube from the left atrium to the right atrium to thereby reduce the left atrial pressure.
The valve opens when the predetermined amount of pressure differential is at preferably least approximately 2 mm Hg, preferably approximately 5 to 25 mm Hg, even more preferably approximately 5 to 15 mm Hg.
According to an ninth aspect of the invention, there is provided a device for treating heart failure or pulmonary venous hypertension in a patient, the device comprising:
a tube having first and second ends in fluid communication with the left and right atriums of the heart respectively; and
a one way valve in the tube,
wherein, in use, the one way valve prevents blood flow through the tube from the right atrium to the left atrium.
According to a tenth aspect of the invention, there is provided a method for treating heart failure in a patient, the method comprising the steps of:
connecting a tube externally between the patient's left and right atriums; and
inserting a one way valve in the tube that is oriented such that the one way valve allows blood flow through the passage from the left atrium to the right atrium when the patient's left atrial pressure exceeds the patient's right atrial pressure,
whereby, when the patient's left atrial pressure exceeds the patient's right atrial pressure, by a predetermined amount, the valve open to allow blood flow through the passage(s) from the left atrium to the right atrium to thereby reduce the patient's left atrial pressure.
The predetermined amount of pressure differential is at preferably least approximately 2 mm Hg, preferably approximately 5 to 25 mm Hg, even more preferably approximately 5 to 15 mm Hg.
Preferred embodiments of the invention will now be described, by way of examples only, with reference to the accompanying drawings in which:
The external diameters of the body 12, the flanges 14 and internal diameter of the passage 18 are approximately 18, 38 and 12 mm respectively. In other embodiments (not shown), the diameter of the body 12 ranges from 8 to 25 mm, the diameter of the flanges 14 ranges from 20 to 50 mm, and the diameter of the passage 18 ranges from 4 to 15 mm.
The device 10 can be implanted during open heart surgery or percutaneously using a catheter. In either case, the opening 30 is firstly fashioned in the patient's atrial septum 28. Some or all of the device 10 is then collapsed to a size able to pass through the opening 30 and subsequently expanded to the configuration shown in
The device 10 is orientated during implanting with the one way valve 20 only allowing blood flow through the passage 18 from the left atrium 24 to the right atrium 26, as indicated by arrows 32. More particularly, when the left atrial pressure exceeds the right atrial pressure by about 5-15 mm Hg, the valve leaflets 20a to c separate and thus open the passage 18 to blood flow from the left atrium 24 to the right atrium 26.
The leaflets 20a to 20c are formed from biological, mechanical or engineered tissue and are inherently biased towards a closed position. Further, the patient's right atrial pressure exceeding the left atrial pressure also assists in the closing, and the maintaining closed, of the valve 20.
The relief and/or avoidance of the left atrial pressure significantly exceeding the right atrial pressure is beneficial in alleviating the adverse consequences of left atrial hypertension complicating cardiovascular diseases, including left ventricular systolic and/or diastolic dysfunction and/or valvular diseases.
As best seen in
To implant the device 10, it is firstly collapsed inside a catheter. When the catheter is correctly positioned adjacent the opening 30, the cable is used to push the device 10 out of the catheter, whereafter it expands to the shape shown in
The device 10 can also be adapted to allow later removal by a percutaneous route, for example by the placement of small hooks (not shown) on a surface of the device 10 that is closest to a nearby venous access site.
More particularly, the device 70 is collapsed and introduced in the venous system within a sheath, and removed from the sheath to expand when correctly positioned.
The device 80 is also suitable for placement in the venous system of the lower limb or iliac system to relieve the signs or symptoms of lower limb hypertension (e.g., peripheral oedema and/or varicose veins).
More particularly, as shown in
As shown in
In other similar embodiments (not shown) the catheter 142 has a diameter of 4-6 mm and the device 140 is initially attached to the head 146 by one or two releasable pins 148.
Although the invention has been described with reference to the specific examples it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.
Number | Date | Country | Kind |
---|---|---|---|
2006906202 | Nov 2006 | AU | national |
This application is a continuation of pending U.S. application Ser. No. 12/447,617, filed Apr. 28, 2009, which is the national phase filing of International Application No. PCT/AU2007/001704, filed Nov. 7, 2007, which application claims priority to Australian Application No. 2006906202, filed Nov. 7, 2006, each of which is herein incorporated by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
3837345 | Matar | Sep 1974 | A |
3874388 | King et al. | Apr 1975 | A |
4018228 | Goosen | Apr 1977 | A |
4373216 | Klawitter | Feb 1983 | A |
4491986 | Gabbay | Jan 1985 | A |
4655217 | Reed | Apr 1987 | A |
4705507 | Boyles | Nov 1987 | A |
5100423 | Fearnot | Mar 1992 | A |
5108420 | Marks | Apr 1992 | A |
5171233 | Amplatz et al. | Dec 1992 | A |
5284488 | Sideris | Feb 1994 | A |
5332402 | Teitelbaum | Jul 1994 | A |
5334217 | Das | Aug 1994 | A |
5387219 | Rapper | Feb 1995 | A |
5413599 | Imachi et al. | May 1995 | A |
5429144 | Wilk | Jul 1995 | A |
5433727 | Sideris | Jul 1995 | A |
5464449 | Ryan et al. | Nov 1995 | A |
5478353 | Yoon | Dec 1995 | A |
5488958 | Topel et al. | Feb 1996 | A |
5556386 | Todd | Sep 1996 | A |
5556408 | Farhat | Sep 1996 | A |
5599295 | Rosen et al. | Feb 1997 | A |
5672153 | Lax et al. | Sep 1997 | A |
5693090 | Unsworth et al. | Dec 1997 | A |
5702412 | Popov et al. | Dec 1997 | A |
5725552 | Kotula et al. | Mar 1998 | A |
5741297 | Simon | Apr 1998 | A |
5824071 | Nelson et al. | Oct 1998 | A |
5846261 | Kotula et al. | Dec 1998 | A |
5876436 | Vanney et al. | Mar 1999 | A |
5893369 | Lemole | Apr 1999 | A |
5911725 | Boury et al. | Jun 1999 | A |
5916214 | Cosio et al. | Jun 1999 | A |
5944738 | Amplatz et al. | Aug 1999 | A |
5964754 | Osypka | Oct 1999 | A |
6016452 | Kasevich | Jan 2000 | A |
6050936 | Schweich et al. | Apr 2000 | A |
6056744 | Edwards | May 2000 | A |
6059827 | Fenton | May 2000 | A |
6068635 | Gianotti | May 2000 | A |
6077257 | Edwards et al. | Jun 2000 | A |
6120534 | Ruiz | Sep 2000 | A |
6123682 | Knudson et al. | Sep 2000 | A |
6123715 | Amplatz | Sep 2000 | A |
6152937 | Peterson et al. | Nov 2000 | A |
6156055 | Ravenscroft | Dec 2000 | A |
6168622 | Mazzocchi | Jan 2001 | B1 |
6190353 | Makower et al. | Feb 2001 | B1 |
6193734 | Bolduc et al. | Feb 2001 | B1 |
6210338 | Afremov et al. | Apr 2001 | B1 |
6214029 | Thill et al. | Apr 2001 | B1 |
6241678 | Afremov et al. | Jun 2001 | B1 |
6258119 | Hussein et al. | Jul 2001 | B1 |
6283983 | Makower et al. | Sep 2001 | B1 |
6286512 | Loeb et al. | Sep 2001 | B1 |
6334864 | Amplatz et al. | Jan 2002 | B1 |
6350277 | Kocur | Feb 2002 | B1 |
6355052 | Neuss et al. | Mar 2002 | B1 |
6355056 | Pinheiro | Mar 2002 | B1 |
6357735 | Haverinen | Mar 2002 | B2 |
6383195 | Richard | May 2002 | B1 |
6391036 | Berg et al. | May 2002 | B1 |
6395017 | Dwyer et al. | May 2002 | B1 |
6402777 | Globerman et al. | Jun 2002 | B1 |
6409716 | Sahatjian et al. | Jun 2002 | B1 |
6440152 | Gainor et al. | Aug 2002 | B1 |
6454795 | Chuter | Sep 2002 | B1 |
6458153 | Bailey et al. | Oct 2002 | B1 |
6468301 | Amplatz et al. | Oct 2002 | B1 |
6468303 | Amplatz et al. | Oct 2002 | B1 |
6527746 | Oslund et al. | Mar 2003 | B1 |
6572652 | Shaknovich | Jun 2003 | B2 |
6579311 | Makower | Jun 2003 | B1 |
6599308 | Amplatz | Jul 2003 | B2 |
6626936 | Stinson | Sep 2003 | B2 |
6638257 | Amplatz | Oct 2003 | B2 |
6645143 | Vantassel et al. | Nov 2003 | B2 |
6666885 | Moe | Dec 2003 | B2 |
6695877 | Brucker et al. | Feb 2004 | B2 |
6699256 | Logan et al. | Mar 2004 | B1 |
6712836 | Berg et al. | Mar 2004 | B1 |
6719768 | Cole et al. | Apr 2004 | B1 |
6719934 | Stinson | Apr 2004 | B2 |
6837901 | Rabkin et al. | Jan 2005 | B2 |
6866679 | Kusleika | Mar 2005 | B2 |
6911037 | Gainor et al. | Jun 2005 | B2 |
6913614 | Marino et al. | Jul 2005 | B2 |
6932837 | Amplatz et al. | Aug 2005 | B2 |
6936058 | Forde et al. | Aug 2005 | B2 |
6979343 | Russo et al. | Dec 2005 | B2 |
7033372 | Cahalan | Apr 2006 | B1 |
7037329 | Martin | May 2006 | B2 |
7044134 | Khairkhahan et al. | May 2006 | B2 |
7097653 | Freudenthal et al. | Aug 2006 | B2 |
7105024 | Richelsoph | Sep 2006 | B2 |
7144410 | Marino et al. | Dec 2006 | B2 |
7226466 | Opolski | Jun 2007 | B2 |
7309341 | Ortiz et al. | Dec 2007 | B2 |
7317951 | Schneider et al. | Jan 2008 | B2 |
7338514 | Wahr et al. | Mar 2008 | B2 |
7350995 | Rhodes | Apr 2008 | B1 |
7419498 | Opolski et al. | Sep 2008 | B2 |
7445630 | Lashinski et al. | Nov 2008 | B2 |
7473266 | Glaser | Jan 2009 | B2 |
7485141 | Majercak et al. | Feb 2009 | B2 |
7530995 | Quijano et al. | May 2009 | B2 |
7611534 | Kapadia et al. | Nov 2009 | B2 |
7625392 | Coleman et al. | Dec 2009 | B2 |
7658747 | Forde et al. | Feb 2010 | B2 |
7678123 | Chanduszko | Mar 2010 | B2 |
7691144 | Chang et al. | Apr 2010 | B2 |
7699297 | Cicenas et al. | Apr 2010 | B2 |
7704268 | Chanduszko | Apr 2010 | B2 |
7722629 | Chambers | May 2010 | B2 |
7758589 | Ortiz et al. | Jul 2010 | B2 |
7842026 | Cahill et al. | Nov 2010 | B2 |
7860579 | Goetzinger et al. | Dec 2010 | B2 |
7871419 | Devellian et al. | Jan 2011 | B2 |
7905901 | Corcoran et al. | Mar 2011 | B2 |
7967769 | Faul et al. | Jun 2011 | B2 |
7976564 | Blaeser et al. | Jul 2011 | B2 |
8010186 | Ryu | Aug 2011 | B1 |
8021359 | Auth et al. | Sep 2011 | B2 |
8034061 | Amplatz et al. | Oct 2011 | B2 |
8043360 | McNamara et al. | Oct 2011 | B2 |
8048147 | Adams | Nov 2011 | B2 |
8052750 | Tuval et al. | Nov 2011 | B2 |
8157860 | McNamara et al. | Apr 2012 | B2 |
8172896 | McNamara et al. | May 2012 | B2 |
8216256 | Raschdorf et al. | Jul 2012 | B2 |
8252042 | McNamara et al. | Aug 2012 | B2 |
8303623 | Melzer et al. | Nov 2012 | B2 |
8313505 | Amplatz et al. | Nov 2012 | B2 |
8361138 | Adams | Jan 2013 | B2 |
8398670 | Amplatz et al. | Mar 2013 | B2 |
8460372 | McNamara et al. | Jun 2013 | B2 |
8740962 | Finch et al. | Jun 2014 | B2 |
8745845 | Finch et al. | Jun 2014 | B2 |
8752258 | Finch et al. | Jun 2014 | B2 |
8777974 | Amplatz et al. | Jul 2014 | B2 |
8778008 | Amplatz et al. | Jul 2014 | B2 |
8864822 | Spence et al. | Oct 2014 | B2 |
8882697 | Celermajer et al. | Nov 2014 | B2 |
8951223 | McNamara et al. | Feb 2015 | B2 |
8979923 | Spence et al. | Mar 2015 | B2 |
9005155 | Sugimoto | Apr 2015 | B2 |
9205236 | McNamara et al. | Dec 2015 | B2 |
9232997 | Sugimoto et al. | Jan 2016 | B2 |
9277995 | Celermajer et al. | Mar 2016 | B2 |
9358371 | McNamara et al. | Jun 2016 | B2 |
9456812 | Finch et al. | Oct 2016 | B2 |
9642993 | McNamara et al. | May 2017 | B2 |
9649480 | Sugimoto et al. | May 2017 | B2 |
9681948 | Levi et al. | Jun 2017 | B2 |
9724499 | Rottenberg et al. | Aug 2017 | B2 |
9757107 | McNamara et al. | Sep 2017 | B2 |
9775636 | Fazio et al. | Oct 2017 | B2 |
9937036 | Sugimoto et al. | Apr 2018 | B2 |
10045766 | McNamara et al. | Aug 2018 | B2 |
10188375 | McNamara et al. | Jan 2019 | B2 |
10398421 | Celermajer et al. | Sep 2019 | B2 |
10413284 | McNamara et al. | Sep 2019 | B2 |
10413286 | McNamara et al. | Sep 2019 | B2 |
10463477 | Forcucci et al. | Nov 2019 | B2 |
10568751 | McNamara | Feb 2020 | B2 |
10588611 | Magin et al. | Mar 2020 | B2 |
10610210 | Finch et al. | Apr 2020 | B2 |
10624621 | Celermajer | Apr 2020 | B2 |
10632292 | Forcucci et al. | Apr 2020 | B2 |
10675450 | Finch | Jun 2020 | B2 |
20010027287 | Shmulewitz et al. | Oct 2001 | A1 |
20010029368 | Berube | Oct 2001 | A1 |
20010053932 | Phelps et al. | Dec 2001 | A1 |
20020033180 | Solem | Mar 2002 | A1 |
20020077698 | Peredo | Jun 2002 | A1 |
20020082525 | Oslund et al. | Jun 2002 | A1 |
20020082613 | Hathaway et al. | Jun 2002 | A1 |
20020087208 | Kobiish et al. | Jul 2002 | A1 |
20020095172 | Mazzocchi et al. | Jul 2002 | A1 |
20020120277 | Hauschild et al. | Aug 2002 | A1 |
20020133148 | Daniel et al. | Sep 2002 | A1 |
20020143289 | Ellis et al. | Oct 2002 | A1 |
20020161424 | Rapacki et al. | Oct 2002 | A1 |
20020161432 | Mazzucco et al. | Oct 2002 | A1 |
20020165606 | Wolf et al. | Nov 2002 | A1 |
20020169377 | Khairkhahan et al. | Nov 2002 | A1 |
20020173742 | Keren et al. | Nov 2002 | A1 |
20020177894 | Acosta et al. | Nov 2002 | A1 |
20020183786 | Girton | Dec 2002 | A1 |
20020183826 | Dorn et al. | Dec 2002 | A1 |
20030009165 | Edwards et al. | Jan 2003 | A1 |
20030032967 | Park et al. | Feb 2003 | A1 |
20030055455 | Yang et al. | Mar 2003 | A1 |
20030093072 | Friedman | May 2003 | A1 |
20030125798 | Martin | Jul 2003 | A1 |
20040044351 | Searle | Mar 2004 | A1 |
20040078950 | Schreck | Apr 2004 | A1 |
20040087937 | Eggers et al. | May 2004 | A1 |
20040093075 | Kuehne | May 2004 | A1 |
20040102719 | Keith et al. | May 2004 | A1 |
20040102797 | Golden et al. | May 2004 | A1 |
20040111095 | Gordon et al. | Jun 2004 | A1 |
20040133236 | Chanduszko | Jul 2004 | A1 |
20040143261 | Hartley et al. | Jul 2004 | A1 |
20040143262 | Visram et al. | Jul 2004 | A1 |
20040143292 | Marino et al. | Jul 2004 | A1 |
20040162514 | Alferness et al. | Aug 2004 | A1 |
20040176788 | Opolski | Sep 2004 | A1 |
20040193152 | Sutton et al. | Sep 2004 | A1 |
20040193261 | Berreklouw | Sep 2004 | A1 |
20040206363 | McCarthy et al. | Oct 2004 | A1 |
20040220653 | Borg et al. | Nov 2004 | A1 |
20040236308 | Herweck et al. | Nov 2004 | A1 |
20040243143 | Corcoran et al. | Dec 2004 | A1 |
20040267306 | Blaeser et al. | Dec 2004 | A1 |
20050015953 | Keidar | Jan 2005 | A1 |
20050049692 | Numamoto et al. | Mar 2005 | A1 |
20050049697 | Sievers | Mar 2005 | A1 |
20050065507 | Hartley et al. | Mar 2005 | A1 |
20050065546 | Corcoran et al. | Mar 2005 | A1 |
20050065548 | Marino et al. | Mar 2005 | A1 |
20050070934 | Tanaka et al. | Mar 2005 | A1 |
20050075655 | Bumbalough et al. | Apr 2005 | A1 |
20050075665 | Brenzel et al. | Apr 2005 | A1 |
20050080400 | Corcoran et al. | Apr 2005 | A1 |
20050080430 | Wright et al. | Apr 2005 | A1 |
20050096735 | Hojeibane et al. | May 2005 | A1 |
20050113868 | Devellian et al. | May 2005 | A1 |
20050131503 | Solem | Jun 2005 | A1 |
20050137609 | Guiraudon | Jun 2005 | A1 |
20050137686 | Salahieh et al. | Jun 2005 | A1 |
20050148925 | Rottenberg et al. | Jul 2005 | A1 |
20050159738 | Visram et al. | Jul 2005 | A1 |
20050165344 | Dobak | Jul 2005 | A1 |
20050187616 | Realyvasquez | Aug 2005 | A1 |
20050222604 | Schaeffer | Oct 2005 | A1 |
20050234537 | Edin | Oct 2005 | A1 |
20050240205 | Berg et al. | Oct 2005 | A1 |
20050251063 | Basude | Nov 2005 | A1 |
20050251187 | Beane et al. | Nov 2005 | A1 |
20050267524 | Chanduszko | Dec 2005 | A1 |
20050273075 | Krulevitch et al. | Dec 2005 | A1 |
20050273124 | Chanduszko | Dec 2005 | A1 |
20050288722 | Eigler et al. | Dec 2005 | A1 |
20060004323 | Chang et al. | Jan 2006 | A1 |
20060009800 | Christianson et al. | Jan 2006 | A1 |
20060009832 | Fisher | Jan 2006 | A1 |
20060041183 | Massen et al. | Feb 2006 | A1 |
20060052821 | Abbott et al. | Mar 2006 | A1 |
20060085060 | Campbell | Apr 2006 | A1 |
20060095066 | Chang et al. | May 2006 | A1 |
20060111704 | Brenneman et al. | May 2006 | A1 |
20060122646 | Corcoran et al. | Jun 2006 | A1 |
20060122647 | Callaghan et al. | Jun 2006 | A1 |
20060135990 | Johnson | Jun 2006 | A1 |
20060136043 | Cully et al. | Jun 2006 | A1 |
20060155305 | Freudenthal et al. | Jul 2006 | A1 |
20060184088 | Van Bibber et al. | Aug 2006 | A1 |
20060210605 | Chang et al. | Sep 2006 | A1 |
20060217761 | Opolski | Sep 2006 | A1 |
20060224153 | Fischell et al. | Oct 2006 | A1 |
20060224183 | Freudenthal | Oct 2006 | A1 |
20060241675 | Johnson et al. | Oct 2006 | A1 |
20060241745 | Solem | Oct 2006 | A1 |
20060247680 | Amplatz et al. | Nov 2006 | A1 |
20060253184 | Amplatz | Nov 2006 | A1 |
20060259121 | Osypka | Nov 2006 | A1 |
20060265004 | Callaghan et al. | Nov 2006 | A1 |
20060276882 | Case et al. | Dec 2006 | A1 |
20070005127 | Boekstegers et al. | Jan 2007 | A1 |
20070010851 | Chanduszko et al. | Jan 2007 | A1 |
20070021739 | Weber | Jan 2007 | A1 |
20070027528 | Agnew | Feb 2007 | A1 |
20070038295 | Case et al. | Feb 2007 | A1 |
20070043431 | Melsheimer | Feb 2007 | A1 |
20070088375 | Beane et al. | Apr 2007 | A1 |
20070088388 | Opolski et al. | Apr 2007 | A1 |
20070118207 | Amplatz et al. | May 2007 | A1 |
20070123934 | Whisenant et al. | May 2007 | A1 |
20070129755 | Abbott et al. | Jun 2007 | A1 |
20070168018 | Amplatz et al. | Jul 2007 | A1 |
20070185513 | Woolfson et al. | Aug 2007 | A1 |
20070197952 | Stiger | Aug 2007 | A1 |
20070198060 | Devellian et al. | Aug 2007 | A1 |
20070209957 | Glenn et al. | Sep 2007 | A1 |
20070225759 | Thommen et al. | Sep 2007 | A1 |
20070244517 | Callaghan | Oct 2007 | A1 |
20070250115 | Opoiski et al. | Oct 2007 | A1 |
20070265658 | Nelson et al. | Nov 2007 | A1 |
20070270741 | Hassett et al. | Nov 2007 | A1 |
20070282157 | Rottenberg et al. | Dec 2007 | A1 |
20080015619 | Figulla et al. | Jan 2008 | A1 |
20080033425 | Davis et al. | Feb 2008 | A1 |
20080033478 | Meng | Feb 2008 | A1 |
20080033543 | Gurskis et al. | Feb 2008 | A1 |
20080039804 | Edmiston et al. | Feb 2008 | A1 |
20080039881 | Greenberg | Feb 2008 | A1 |
20080039922 | Miles et al. | Feb 2008 | A1 |
20080058940 | Wu et al. | Mar 2008 | A1 |
20080071135 | Shaknovich | Mar 2008 | A1 |
20080086168 | Cahill | Apr 2008 | A1 |
20080103508 | Karakurum | May 2008 | A1 |
20080109069 | Coleman et al. | May 2008 | A1 |
20080119891 | Miles et al. | May 2008 | A1 |
20080125861 | Webler et al. | May 2008 | A1 |
20080154250 | Makower et al. | Jun 2008 | A1 |
20080154302 | Opolski et al. | Jun 2008 | A1 |
20080154351 | Leewood et al. | Jun 2008 | A1 |
20080154355 | Benichou et al. | Jun 2008 | A1 |
20080161901 | Heuser et al. | Jul 2008 | A1 |
20080172123 | Yadin | Jul 2008 | A1 |
20080177381 | Navia et al. | Jul 2008 | A1 |
20080183279 | Bailey et al. | Jul 2008 | A1 |
20080188880 | Fischer et al. | Aug 2008 | A1 |
20080188888 | Adams et al. | Aug 2008 | A1 |
20080215008 | Nance et al. | Sep 2008 | A1 |
20080221582 | Gia et al. | Sep 2008 | A1 |
20080228264 | Li et al. | Sep 2008 | A1 |
20080249397 | Kapadia | Oct 2008 | A1 |
20080249562 | Cahill | Oct 2008 | A1 |
20080249612 | Osborne et al. | Oct 2008 | A1 |
20080262592 | Jordan et al. | Oct 2008 | A1 |
20080269662 | Vassiliades et al. | Oct 2008 | A1 |
20080312679 | Hardert et al. | Dec 2008 | A1 |
20090018570 | Righini et al. | Jan 2009 | A1 |
20090030495 | Koch | Jan 2009 | A1 |
20090054805 | Boyle | Feb 2009 | A1 |
20090054982 | Cimino | Feb 2009 | A1 |
20090054984 | Shortkroff et al. | Feb 2009 | A1 |
20090062841 | Amplatz et al. | Mar 2009 | A1 |
20090076541 | Chin et al. | Mar 2009 | A1 |
20090082803 | Adams et al. | Mar 2009 | A1 |
20090099647 | Glimsdale et al. | Apr 2009 | A1 |
20090112050 | Farnan et al. | Apr 2009 | A1 |
20090112244 | Freudenthal | Apr 2009 | A1 |
20090112251 | Qian et al. | Apr 2009 | A1 |
20090177269 | Kalmann et al. | Jul 2009 | A1 |
20090234443 | Ottma et al. | Sep 2009 | A1 |
20100030259 | Pavcnik et al. | Feb 2010 | A1 |
20100114140 | Chanduszko | May 2010 | A1 |
20100131053 | Agnew | May 2010 | A1 |
20100268316 | Brenneman et al. | Oct 2010 | A1 |
20110004296 | Lutter et al. | Jan 2011 | A1 |
20110040374 | Goetz et al. | Feb 2011 | A1 |
20110106149 | Ryan et al. | May 2011 | A1 |
20110130784 | Kusleika | Jun 2011 | A1 |
20110213364 | Davis et al. | Sep 2011 | A1 |
20110218479 | Rottenberg et al. | Sep 2011 | A1 |
20110257723 | McNamara | Oct 2011 | A1 |
20110295183 | Finch et al. | Dec 2011 | A1 |
20120022639 | Hacohen et al. | Jan 2012 | A1 |
20120290062 | McNamara et al. | Nov 2012 | A1 |
20130178784 | McNamara et al. | Jul 2013 | A1 |
20140277054 | McNamara et al. | Sep 2014 | A1 |
20150039084 | Levi et al. | Feb 2015 | A1 |
20150119796 | Finch | Apr 2015 | A1 |
20160022423 | McNamara et al. | Jan 2016 | A1 |
20160051800 | Vassiliades et al. | Feb 2016 | A1 |
20160120550 | McNamara et al. | May 2016 | A1 |
20180256865 | Finch et al. | Sep 2018 | A1 |
20190021861 | Finch | Jan 2019 | A1 |
20190269392 | Celermajer et al. | Sep 2019 | A1 |
20190336163 | McNamara et al. | Nov 2019 | A1 |
Number | Date | Country |
---|---|---|
1218379 | Jun 1999 | CN |
1556719 | Dec 2004 | CN |
1582136 | Feb 2005 | CN |
1780589 | May 2006 | CN |
101035481 | Sep 2007 | CN |
101035488 | Sep 2007 | CN |
101292889 | Oct 2008 | CN |
101426431 | May 2009 | CN |
1264582 | Feb 2002 | EP |
1480565 | Sep 2003 | EP |
1470785 | Oct 2004 | EP |
1849440 | Oct 2007 | EP |
2827153 | Jan 2003 | FR |
58-27935 | Jun 1983 | JP |
H02-277459 | Nov 1990 | JP |
2003530143 | Oct 2003 | JP |
WO9527448 | Oct 1995 | WO |
WO9808456 | Mar 1998 | WO |
WO9842403 | Oct 1998 | WO |
WO0115618 | Mar 2001 | WO |
WO02094363 | Nov 2002 | WO |
WO2004019811 | Mar 2004 | WO |
WO2005048881 | Jun 2005 | WO |
WO2005048883 | Jun 2005 | WO |
WO2006127765 | Nov 2006 | WO |
WO2007054116 | May 2007 | WO |
WO2007083288 | Jul 2007 | WO |
WO2008058940 | May 2008 | WO |
Entry |
---|
U.S. Appl. No. 10/292,690, filed May 21, 2019, Celermajer et al. |
Ad et al.; A one way valved atrial septal patch: A new surgical technique and its clinical application; The Journal of Thoracic and Cardiovascular Surgery; 111; pp. 841-848; Apr. 1996. |
Althoff et al.; Long-term follow up of a fenestrated amplatzer atrial septal occluder in pulmonary arterial hypertension; Chest; 133(1); pp. 183-185; Jan. 2008. |
Atz et al.; Preoperative management of pulmonary venous hypertension in hypoplastic left heart syndrome with restrictive atrial septal defect; the American Journal of Cardiology; 83; pp. 1224-1228; Apr. 15, 1999. |
Bailey, Steven R.; Nanotechnology in prosthetic heart valves (presentation); 31 pgs.; (year of pub. sufficiently earlier than effective US filing date and any foreign priority date) 2005. |
Bolling, Steven; Direct flow medical—My valve is better (presentation); 21 pgs.; Apr. 23, 2009. |
Cheatham, John P.; Intervention in the critically ill neonate and infant with hypoplastic left heart syndrome and intact atrial septum; Journal of Interventional Cardiology; 14(3); pp. 357-366; Jun. 2001. |
Coselli, Joseph S.; No! Valve replacement: Patient prosthetic mismatch rarely occurs (presentation); 75 pgs.; Apr. 25, 2009. |
Design News; Low power piezo motion; retrieved from the internet (http://www.designnews.com/document.asp?doc_id=229053&dfpPParams=ht_13,aid_229053&dfpLayout=article); 3 pgs.; May 14, 2010. |
Gaudiani et al.; A philosophical approach to mirral valve repair (presentation); 28 pgs.; Apr. 24, 2009. |
Hijazi, Zayad M.; Valve implantation (presentation); 36 pgs.; May 10, 2007. |
Larios et al.; The use of an artificial foraminal valve prosthesis in the closure of interatrial and interventricular septal defects; Chest; 36(6); pp. 631-641; Dec. 1959. |
Leon, Martin B.; Transcatheter aortic valve therapy: Summary thoughts (presentation); 19 pgs.; Jun. 24, 2009. |
Moses, Jeffrey W.; The good, the bad and the ugly of transcatheter AVR (presentation); 28 pgs.; Jul. 10, 2009. |
O'Loughlin et al.; Insertion of a fenestrated amplatzer atrial sestosotomy device for severe pulmonary hypertension; Heart Lung Circ.; 15(4); pp. 275-277; Aug. 2006. |
Park et al.; Blade atrial septostomy: Collaborative study; Circulation; 66(2); pp. 258-266; Aug. 1982. |
Pedra et al.; Stent implantation to create interatrial communications in patients with complex congenital heart disease; Catheterization and Cardiovascular Interventions; 47; pp. 310-313; Jan. 27, 1999. |
Perry et al.; Creation and maintenance of an adequate interatrial communication in left atrioventricular valve atresia or stenosis; The American Journal of Cardiology; 58; pp. 622-626; Sep. 15, 1986. |
Philips et al.; Ventriculofemoroatrial shunt: A viable alternative for the treatment of hydrocephalus; J. Neurosurg.; 86; pp. 1063-1066; Jun. 1997. |
Physik Instrumente; Piezo for Motion Control in Medical Design and Drug Research (product information); Physik Instrumente (PI) GmbH & Co. KG; 22 pgs.; © Nov. 21, 2010. |
Roven et al.; Effect of compromising right ventricular function in left ventricular failure by means of interatrial and other shunts; Am J Cardiol.; 24(2); pp. 209-219; Aug. 1969. |
Sambhi et al.; Pathologic Physiology of Lutembacher Syndrome; Am J Cardiol.; 2(6); pp. 681-686; Dec. 1958. |
Sommer et al.; Transcatheter creation of atrial septai defect and fontan fenestration with “butterfly” stent technique; Journal of the American college of Cardiology; 33(2); Suppl. A; 3 pgs.; Feb. 1999. |
Stone, Gregg W.; Transcatheter devices for mirral valve repair, surveying the landscape (presentation); 48 pgs.: Jul. 10, 2009. |
Stormer et al.; Comparative study of in vitro flow characteristics between a human aortic valve and a designed aortic valve and six corresponding types of prosthetic heart valves; Eur Surg Res; 8(2); pp. 117-131; (year of pub. sufficiently earlier than effective US filing date and any foreign priority date) 1976. |
Watterson et al.; Very small pulmonary arteries: Central end-to-side shunt; Ann. Thorac. Surg.; 52(5); pp. 1132-1137; Nov. 1991. |
Celermajer et al.; U.S. Appl. No. 14/498,903 entitled “Apparatus and methods to create and maintain an intra-atrial pressure relief opening,” filed Sep. 26, 2014. |
McNamara; U.S. Appl. No. 16/801,046 entitled “Devices and methods for coronary sinus pressure relief,” filed Feb. 25, 2020. |
McNamara et al.; U.S. Appl. No. 17/454,019 entitled “Intra-atrial implants made of non-braided material,” filed Nov. 5, 2021. |
Number | Date | Country | |
---|---|---|---|
20200245991 A1 | Aug 2020 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 12447617 | US | |
Child | 16854100 | US |