Abstract:
A device for treating a heart condition in a patient. The device has a body adapted and configured to self-expand from a radially collapsed configuration to an expanded configuration. In its expanded configuration, the device has a first section at a first end, a second section at a second end and a central portion extending between the first and second sections, the first and second sections each having diameters that increase with distance from the central portion toward the first and second ends, respectively. The body is configured to be delivered percutaneously to a patient&#39;s heart and allowed to self-expand in an opening in a septum of the heart to dispose the first end in the left atrium, the second end in the right atrium and the central portion in the opening to permit blood to flow through the body from the left atrium to the right atrium.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    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. 
     
    
     FIELD OF THE INVENTION 
       [0002]    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. 
       BACKGROUND OF THE INVENTION 
       [0003]    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. 
         [0004]    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. 
         [0005]    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&#39;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. 
         [0006]    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. 
       SUMMARY OF THE INVENTION 
       [0007]    According to a first aspect of the invention, there is provided a device for treating heart failure in a patient, the device comprising: 
         [0008]    a body; 
         [0009]    at least one passage through the body; 
         [0010]    at least one one way valve in the passage; and 
         [0011]    a mounting means adapted for mounting the body in an opening provided in the patient&#39;s atrial septum, 
         [0012]    wherein, in use, the device is oriented such that, when the patient&#39;s left atrial pressure exceeds the patient&#39;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. 
         [0013]    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: 
         [0014]    a body; 
         [0015]    at least one passage through the body; 
         [0016]    at least one one way valve in the passage; and 
         [0017]    a mounting means adapted for mounting the body in the patient&#39;s venous system, 
         [0018]    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. 
         [0019]    The device is preferably adapted to be fitted into a blood vessel in the patient&#39;s venous system, such as the inferior vena cava, superior vena cava, the hepatic vein, an iliac vein, or one or more pulmonary veins. 
         [0020]    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: 
         [0021]    a body; 
         [0022]    at least one passage through the body; 
         [0023]    at least one one way valve in the passage; and 
         [0024]    a mounting means adapted for mounting the body in the patient&#39;s lower limb venous system, 
         [0025]    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. 
         [0026]    The above device is also suitable for treating varicose veins. 
         [0027]    The body is preferably in the form of a stent, most preferably an expandable stent. 
         [0028]    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. 
         [0029]    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. 
         [0030]    According to a fourth aspect of the invention, there is provided a device for treating heart failure in a patient, the device comprising: 
         [0031]    a body; 
         [0032]    at least one passage through the body; 
         [0033]    a mesh or grill arrangement within the passage and having apertures therein of a size permitting flow of blood, whilst substantially excluding thrombi, therethrough; 
         [0034]    a mounting means adapted for mounting the body in an opening provided in the patient&#39;s atrial septum, 
         [0035]    wherein, in use, the device allows blood flow through the passage(s) from the left atrium to the right atrium when the patient&#39;s left atrial pressure exceeds the patient&#39;s right atrial pressure to thereby reduce the patient&#39;s left atrial pressure. 
         [0036]    The device preferably includes a mesh or grill arrangement across one or both ends of the passage(s). 
         [0037]    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&#39;s atrial septum, including an anticoagulant substance, such as heparin, or an inhibitor of re-endothelialisation, such as sirolimus or paclitaxel. 
         [0038]    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. 
         [0039]    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. 
         [0040]    The device is preferably collapsible and adapted for implanting via a catheter, although it could be inserted at surgery. 
         [0041]    The device is preferably collapsible to a size able to pass through an opening made in the patient&#39;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&#39;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. 
         [0042]    The mounting means preferably comprises at least one flange having a dimension larger than the opening in the patient&#39;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&#39;s septum. 
         [0043]    The external dimension of the body, remote the flange(s), is preferably substantially equal to the opening in the patient&#39;s atrial septum. 
         [0044]    In one embodiment, the flanges are adapted for gluing, suturing, stapling or pinning to the patient&#39;s septum. 
         [0045]    In another embodiment, the flanges are spaced apart by about the thickness of the patient&#39;s atrial septum and are adapted to locate, most preferably by gripping, the patient&#39;s atrial septum therebetween. 
         [0046]    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: 
         [0047]    forming an opening in the patient&#39;s atrial septum; 
         [0048]    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&#39;s left atrial pressure exceeds the patient&#39;s right atrial pressure; and 
         [0049]    securing the one way valve(s) relative to the patient&#39;s atrial septum, 
         [0050]    whereby, when the patient&#39;s left atrial pressure exceeds the patient&#39;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&#39;s left atrial pressure. 
         [0051]    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. 
         [0052]    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. 
         [0053]    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: 
         [0054]    forming an opening in the patient&#39;s atrial septum; 
         [0055]    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 
         [0056]    securing the mesh or grill arrangement relative to the patient&#39;s atrial septum. 
         [0057]    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&#39;s atrial septum. 
         [0058]    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. 
         [0059]    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: 
         [0060]    inserting at least one one way valve in the patient&#39;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 
         [0061]    securing the one way valve(s) relative to the patient&#39;s venous system. 
         [0062]    The method preferably includes the steps of inserting and securing the one way valve in the patient&#39;s blood vessel, such as the inferior vena cava, superior vena cava, the hepatic vein, an iliac vein, or one or more pulmonary veins. 
         [0063]    The method preferably includes a step of inserting and securing, most preferably by expanding, a stent with the one way valve(s) therein. 
         [0064]    According to an eighth aspect of the invention, there is provided a device for treating heart failure in a patient, the device comprising: 
         [0065]    a tube having first and second ends in fluid communication with the left and right atriums of the heart respectively; and 
         [0066]    a valve between the first and second ends and adapted to selectively prevent or allow fluid flow through the tube, 
         [0067]    wherein, in use, when the patient&#39;s left atrial pressure exceeds the patient&#39;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. 
         [0068]    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. 
         [0069]    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: 
         [0070]    a tube having first and second ends in fluid communication with the left and right atriums of the heart respectively; and 
         [0071]    a one way valve in the tube, 
         [0072]    wherein, in use, the one way valve prevents blood flow through the tube from the right atrium to the left atrium. 
         [0073]    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: 
         [0074]    connecting a tube externally between the patient&#39;s left and right atriums; and 
         [0075]    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&#39;s left atrial pressure exceeds the patient&#39;s right atrial pressure, 
         [0076]    whereby, when the patient&#39;s left atrial pressure exceeds the patient&#39;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&#39;s left atrial pressure. 
         [0077]    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. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0078]    Preferred embodiments of the invention will now be described, by way of examples only, with reference to the accompanying drawings in which: 
           [0079]      FIG. 1  is a front view of a first embodiment of a device for treating heart failure; 
           [0080]      FIG. 2  is a cross sectional side view of the device shown in  FIG. 1 ; 
           [0081]      FIG. 3  is a cross sectional side view of the device shown in  FIGS. 1 and 2  implanted in a human heart; 
           [0082]      FIG. 4  is a rear view of the device shown in  FIG. 1 ; 
           [0083]      FIG. 5  is a front view of a second embodiment of a device for treating heart failure; 
           [0084]      FIG. 6  is a front view of a third embodiment of a device to treat heart failure; 
           [0085]      FIG. 7  is a cross sectional side view of the device shown in  FIG. 6 ; 
           [0086]      FIG. 8  is a front view of a fourth embodiment of a device to treat heart failure; 
           [0087]      FIG. 9  is a cross sectional side view of the device shown in  FIG. 8 ; 
           [0088]      FIG. 10  is a cross sectional side view of a fifth embodiment of a device for treating heart failure; 
           [0089]      FIG. 11  is a cross sectional side view of the device shown in  FIG. 10  implanted in a patient&#39;s inferior vena cava; 
           [0090]      FIG. 12  is a cross sectional side view of a first embodiment of a delivery mechanism for the device shown in  FIG. 10 ; 
           [0091]      FIG. 13  is a cross sectional side view of a second embodiment of a delivery mechanism for the device shown in  FIG. 10 ; 
           [0092]      FIG. 14  is a cross sectional side view of a sixth embodiment of a device for treating heart failure implanted in a patient&#39;s hepatic vein; 
           [0093]      FIG. 15  is a cross sectional side view of a pair of the devices shown in  FIG. 14  implanted in a patient&#39;s iliac veins; 
           [0094]      FIG. 16  is a front view of a seventh embodiment of a device for treating heart failure; 
           [0095]      FIG. 17  is a front view of an eighth embodiment of a device for treating heart failure; 
           [0096]      FIG. 18  is a cross sectional side view of the device shown in  FIG. 17 ; 
           [0097]      FIG. 19   a  is a front view of a ninth embodiment of a device for treating heart failure; 
           [0098]      FIG. 19   b  is a cross sectional side view the device shown in  FIG. 19   a;    
           [0099]      FIG. 20  is a front view of a tenth embodiment of a device for treating heart failure, 
           [0100]      FIG. 21   a  is a cross sectional side view of an eleventh embodiment of a device for treating heart failure, collapsed within a catheter; 
           [0101]      FIG. 21   b  is a cross sectional perspective view of the device shown in  FIG. 21   a , collapsed within a catheter; 
           [0102]      FIG. 22   a  is a cross sectional side view of the device shown in  FIG. 21   a , partially deployed from the catheter; 
           [0103]      FIG. 22   b  is a cross sectional perspective view of the device shown in  FIG. 21   a , partially deployed from the catheter; 
           [0104]      FIG. 22   c  is an enlarged, partial cross sectional side view of the device shown in  FIG. 21   a , partially deployed from the catheter; 
           [0105]      FIG. 23   a  is a side view of the device shown in  FIG. 21   a , deployed from the catheter; 
           [0106]      FIG. 23   b  is a cross sectional side view of the device shown in  FIG. 21   a , deployed from the catheter; and 
           [0107]      FIG. 24  is a cross sectional side view of a twelfth embodiment of a device for treating heart failure. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0108]      FIGS. 1 to 4  show a first embodiment of a device  10  for treating heart failure. The device  10  includes a generally cylindrical body  12  with a mounting means, in the form of a pair of annular flanges  14  at either end with an annular gap  16  therebetween. The body  12  has a centrally located passage or duct  18  within which is provided a one way valve  20 , in the form of three flexible valve leaflets  20   a  to  20   c.    
         [0109]    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. 
         [0110]      FIG. 3  shows a patient&#39;s heart  22  with a left atrium  24  and a right atrium  26  separated by an atrial septum  28 . The device  10  is mounted within a generally circular opening  30  made in the septum  28  and with the edges of the septum  28  adjacent the opening  30  positioned in the gap  16  between the flanges  14 . The opening  30  has an internal diameter approximately equal to the external diameter of the body  12 . The device  10  is retained adjacent the opening  30  in the septum  28  as the flanges  14  are larger, and thus cannot pass through, the opening  30 . Alternatively, or in addition, one or both of the flanges  14  can be glued, sutured, stapled or pinned to the patient&#39;s septum  28  to secure the device  10  thereto. 
         [0111]    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&#39;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  FIG. 3 . Forming the s body  12  and the flanges  14  of the device  10  from a Nitinol wire mesh result in it being suitable for implanting in a manner similar to the implanting of the AMPLATZER (Trade Mark) septal occluder produced by AGA Medical Corp. More particularly, the exterior faces of the flanges  14  are pulled away from one another which causes the device  10  to lengthen and simultaneously reduce in diameter for fitting within a catheter able to pass through the opening  30 . When the separating force is then removed the flanges  14  return to the (expanded) configuration in  FIGS. 1 to 4 . 
         [0112]    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  20   a  to  c  separate and thus open the passage  18  to blood flow from the left atrium  24  to the right atrium  26 . 
         [0113]    The leaflets  20   a  to  20   c  are formed from biological, mechanical or engineered tissue and are inherently biased towards a closed position. Further, the patient&#39;s right atrial pressure exceeding the left atrial pressure also assists in the closing, and the maintaining closed, of the valve  20 . 
         [0114]    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. 
         [0115]    As best seen in  FIG. 4 , the device  10  includes four thin collapsible struts  34  connected to a central fixture or boss  36  having an internally threaded opening. A cable (not shown) is threadedly attachable to the fixture  36 . The fixture  36  is accessible from the left atrium. 
         [0116]    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  FIG. 3 . The cable is then unscrewed from the fixture  36  and removed from the patient with the catheter. 
         [0117]    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. 
         [0118]      FIG. 5  shows a second embodiment of a device  40  for treating heart failure. The construction, function and implanting of the device  40  is similar to that of the device  10  and like reference numerals are used to indicate like features between the two embodiments. However, the device  40  has four eccentrically located passages  18  through the body  12  and blood flow therethrough is controlled by four corresponding sets of valve leaflets  20 . 
         [0119]      FIGS. 6 and 7  show a third embodiment of a device  50  for treating heart failure. The construction, operation and implantation of the device  50  is similar to that of the device  10  and like reference numerals are used to indicate like features between the two embodiments. However, the device  50  has only one collapsible strut  34  connected to a central fixture  36 , to which a cable  52  can be attached. The fixture  36  is also accessible from the left atrium. In a variation of this embodiment, the fixture is accessible from the right atrium. 
         [0120]      FIGS. 8 and 9  show a fourth embodiment of a device  60  for treating heart failure. The construction, function and implanting of the device  60  is similar to that of the device  10  and like reference numerals are used to indicate like features between the two embodiments. However, the device  60  has three fixtures  36  attached to the body  12 , adjacent the passage  18 , to which three respective cables  62  (see  FIG. 9 ) can be attached. The fixtures  36  are accessible from the right atrium. 
         [0121]      FIGS. 10 and 11  show a fifth embodiment of a device  70  for treating heart failure, in a manner similar to that of the device  10 . However, unlike the earlier embodiments, the device  70  only has a single mounting flange  14  which, as shown in  FIG. 11 , makes it suitable for implanting in the inferior vena cava  72  at or near the junction with the right atrium  74 . The device  70  is preferably produced from a deformable material that can resume its preformed shape (such as Nitinol) and may be implanted by a percutaneous approach. 
         [0122]    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. 
         [0123]      FIGS. 12 and 13  show two mechanisms suitable for delivering the device  70  to the inferior vena cava. The mechanism shown in  FIG. 12  is similar to that shown in  FIGS. 6 and 7  and the mechanism shown in  FIG. 13  is similar to that shown in  FIGS. 8 and 9 . 
         [0124]      FIG. 14  is a cross sectional side view of a sixth embodiment of a device  80  for treating heart failure, implanted in a patient&#39;s hepatic vein  82 . The device  80  does not include any mounting flanges and its body is instead an expandable stent  84  with a one way valve  20  therein. 
         [0125]      FIG. 15  shows an alternative implanting of the device  80  in a patient&#39;s iliac veins  84  and  86 . 
         [0126]    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). 
         [0127]      FIG. 16  shows a seventh embodiment of a device  90  for treating heart failure. The construction, function and implanting of the device  90  is similar to that of the device  40  and like reference numerals are used to indicate like features between the two embodiments. However, the device  90  has only two eccentrically located passages  18  through the body  12  and blood flow therethrough is controlled by two corresponding sets of valve leaflets  20 . 
         [0128]      FIG. 17  shows an eighth embodiment of a device  100  for treating heart failure. This embodiment is constructed and implanted in a similar manner to that previously described. However, the device  100  has a passage  18  therethrough with a mesh or grill arrangement  102  across each end of the passage  18 . The mesh  102  has apertures  104  therein of a maximum dimension of less than 4 mm which permit the flow of blood from the left to the right atrium through the passage  18 , whilst substantially excluding thrombi. The mesh  102  is coated or impregnated with one or more drugs, adapted for preventing thrombosis or endothelialisation of the opening in the patient&#39;s atrial septum, including an anticoagulant substance, such as heparin, or an inhibitor of re-endthelialisation, such as sirolimus or paclitaxel. 
         [0129]      FIGS. 19   a  and  19   b  show a ninth embodiment of a device  110  for treating heart failure. The construction, operation and implantation of the device  110  is similar to that of the device  10  and like reference numerals are used to indicate like features between the two embodiments. The device  110  utilizes a strut/fixture arrangement similar to that shown in  FIGS. 6 and 7 . 
         [0130]      FIG. 20  shows a tenth embodiment of a device  130  for treating heart failure. The construction, operation and implantation of the device  130  is similar to that of the device  10  and like reference numerals are used to indicate like features between the two embodiments. The device  130  has a helical groove  132  for releasably engaging a corresponding fitting on the end of a catheter cable during implantation. 
         [0131]      FIGS. 21   a  to  23   b  show an eleventh embodiment of a device  140  for treating heart failure. The construction, operation and implantation of the device  100  is similar to that of the device  10  and like reference numerals are used to indicate like features between the two embodiments. The body  12  and the flanges  14  of the device  140  are formed from a Nitinol wire mesh which result in it being suitable for implanting in a manner similar to the implanting of the AMPLATZER (Trade Mark) septal occluder produced by AGA Medical Corp. The device  140  is collapsed by pulling the exterior faces of the flanges  14  away from one another which causes the device  140  to lengthen and simultaneously reduce in diameter. When the separating force is removed the flanges  14  return to the (expanded) configuration. 
         [0132]    More particularly, as shown in  FIGS. 21   a  and  21   b , the device  140  is initially collapsed within a catheter  142  of about 5 mm in diameter, which is able to pass through an opening in the septum. As shown in  FIGS. 22   a  to  22   c , the device  140  is then partially deployed from the catheter  142  by movement of wire  144 , and thus head  146 , relative to the catheter  142 . This results in part of the device  140  expanding to form the first flange  14 . 
         [0133]    As shown in  FIGS. 23   a  and  23   b , fall deployment of the device  140  by further relative movement of the wire  144  and the head  146 , relative to the catheter  142 , results in the remainder of the device  140  expanding to form the second flange  14 . The device  140  is initially attached to the head  146  by three pins  148 , which are remotely released after the device has been deployed from the catheter  142 . 
         [0134]    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 . 
         [0135]      FIG. 20  shows a twelfth embodiment of a device  150  for treating heart failure. In this embodiment, a tube  152  of about 8 mm internal diameter provides an external fluid communication path between the heart&#39;s left and right atriums  154  and  156  respectively. A valve  158  is adapted to selectively occlude the tube  152 . As with earlier embodiments, when the left atrial pressure exceeds the right atrial pressure by about 5-15 mm Hg, the valve  158  is released to open the interior of the tube  152  and allow blood flow from the left atrium  24  to the right atrium  26 . In a variation of this embodiment, the valve  158  is a one way valve that prevents blood flow from the right atrium  156  to the left atrium  154 . 
         [0136]    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.