Patent Publication Number: US-11642511-B2

Title: Method and apparatus for long-term assisting a left ventricle to pump blood

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/535,865 filed Aug. 8, 2019, which is a continuation of U.S. patent application Ser. No. 13/185,974 filed Jul. 19, 2011, issued as U.S. Pat. No. 10,413,648, which is a continuation of U.S. patent application Ser. No. 11/202,795 filed Aug. 12, 2005, issued as U.S. Pat. No. 8,012,079, which claims the benefit and priority of U.S. Provisional Patent Application Ser. Nos. 60/601,733 filed Aug. 13, 2004, and 60/653,015 filed Feb. 15, 2005. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The invention relates to a method and apparatus for long-term assisting the left ventricle of a heart to pump blood. A left ventricle assist device and associated methods are disclosed. 
     Description of the Related Art 
     With the advent of new drugs, percutaneous transluminal coronary angioplasty, commonly known as “balloon angioplasty” and the use of stents in combination with balloon angioplasty, effective treatments are available for heart disease, as it relates to coronary arteries. The major problem currently in treatment of heart disease is treating individuals having congestive heart failure or who may require a heart transplant. In this regard, it is believed that only certain very ill patients may require a heart transplant, whereas many other individuals with heart disease could benefit from a less complicated, costly, and invasive procedure, provided the individual&#39;s heart can be somehow assisted in its function to pump blood through a person&#39;s body. 
     To this end, left ventricle assist devices (“LVAD”) are in current use that can boost the heart&#39;s pumping ability, without replacing the patient&#39;s heart by way of a heart transplant. While presently available left ventricle assist devices do provide a benefit to patients with heart disease who require either a heart transplant or assistance in pumping blood throughout the body, it is believed that currently available devices have certain disadvantages associated with them. Conventional left ventricle assist devices generally require surgery upon the heart itself, including surgical incisions into the heart, which may weaken the heart, as well as requires a complicated procedure to implant the left ventricle assist device. 
     Most LVAD implantations require a midline sternotomy of the chest and utilization of cardiopulmonary bypass. Newer devices can be implanted through a lateral thoracotomy and can be done without using cardiopulmonary bypass; however, large loss of blood may occur during this procedure. It is also important to note the fact that all current long term LVAD devices require operation on the heart itself and disruption of the myocardium, which can lead to further problems, including arrhythmias, and left and right ventricular dysfunction, which can lead to poor outcomes in the patients. The major disadvantage in treating patients with chronic congestive heart failure through a surgical approach is that there is a significant risk of the surgery itself, including just the use of general anesthesia itself and the use of the heart lung machine. Patients with chronic congestive heart failure have impaired liver, renal, pulmonary and other organ function, and therefore, are prone to multiple complications following surgery. As a result, current long-term implantable left ventricular assist devices have a one-year mortality rate of greater than 30%. 
     Currently available left ventricle assist devices may include pumps placed within the left ventricle of the heart. Currently available devices typically include relatively long conduits, or fluid passageways, in fluid communication with the heart, and through which the person&#39;s blood must flow and be pumped therethrough. It is believed that the long conduits may become sites for thrombosis, or blood clots, which can possibly lead to strokes and other complications. During many of the procedures to implant such currently available devices, blood transfusions are required due to excessive bleeding by the patient. Additionally, the surgery upon the heart may lead to Right Heart Failure, which is the leading cause of early death in present patients receiving implanted left ventricle assist devices. Presently available left ventricle assist devices, which are connected to the aorta of the patient, can lead to unbalanced blood flow to certain branch vessels as compared to others. For example, the blood flow from the aorta to certain blood vessels that branch off the aorta, such as the coronary or carotid arteries, may be diminished. Lastly, present LVADs, which are implanted without chest surgery (percutaneous LVADs), are typically only used for a relatively short period of time, generally on the order of 7-10 days, whereas it would be desirable for a long-term treatment—on the order of months or even years—for patients with severe chronic congestive heart failure who cannot withstand conventional surgery. 
     Accordingly, prior to the development of the present invention, there has been no method and apparatus for long-term assisting the left ventricle of the heart to pump blood which: does not require surgery upon the heart itself; does not require long conduits, or fluid passageways, to connect the device to the heart; supplies a balanced and normal blood flow, or physiologic blood supply, to branch vessels, such as the coronary and carotid arteries; can be implanted without the use of general anesthesia; can be implanted and used for a long period of time; and can be transluminally delivered and implanted in a cardiac catheterization lab setting with minimal blood loss and relatively low risk of morbidity and mortality. Therefore, the art has sought a method and apparatus for long term assisting the left ventricles of the heart to pump blood, which: does not require surgery, or incisions upon the heart itself; does not require open chest surgery; does not require lengthy conduits, or fluid passageways, through which the blood must flow and be pumped through; is believed to provide a normal and balanced blood flow or physiologic blood supply, to branch vessels such as the coronary and carotid arteries; can be transluminally delivered and implanted without the use of general anesthesia; can be implanted and used for a long period of time; and can be implanted in a cardiac catheterization lab setting by a cardiologist with minimal blood loss and relatively low risk of morbidity and mortality. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention, the foregoing advantages are believed to have been achieved through the present long-term left ventricle assist device for assisting a left ventricle of a heart in pumping blood. The present invention may include a transluminally deliverable pump and a deliverable support structure, which may be implanted in the catheterization laboratory. 
     The method and apparatus for assisting the left ventricle of the heart to pump blood of the present invention, when compared to previously proposed methods and apparatus, is believed to have the advantages of: not requiring surgery, or incisions, upon the heart itself; not requiring the use of lengthy conduits, or fluid passageways, through which blood must pass through and be pumped through; supplying a normal and a balanced blood flow, or physiologic blood supply, to branch vessels, such as the coronary and carotid arteries; can be implanted without the use of general anesthesia; not requiring a chest surgery; can be implanted and used for a long period of time; and can be transluminally implanted in a cardiac catheterization lab setting with minimal blood loss and relatively low risk of morbidity and mortality. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       In the drawing: 
         FIG.  1    is a front view of a current left ventricle assist device, illustrating its location within a patient&#39;s body; 
         FIG.  2    is a partial cross-sectional view of a heart, to illustrate its functions and anatomy; 
         FIG.  3    is a partial cross-sectional view of the left ventricle assist device of the present invention in a first transluminal delivery configuration, the device being enlarged for clarity; 
         FIG.  4    is a partial cross-sectional view of the left ventricle assist device in accordance with the present invention in a second deployed configuration; 
         FIG.  4 A  is a partial cross-sectional view of another embodiment of the left ventricle assist device in accordance with the present invention in a second deployed configuration; 
         FIG.  5    is perspective view of a power connection for the left ventricle assist device in accordance with the present invention; 
         FIG.  6    is a perspective view of another embodiment of a power connection for the left ventricle assist device in accordance with the present invention; 
         FIG.  7    is a side view of a connection flange in accordance with the present invention; 
         FIG.  8    is a front view of the connection flange of  FIG.  7   ; 
         FIG.  9    is a partial cross-sectional view of an embodiment of the left ventricle assist device in accordance with the present invention, similar to that of  FIGS.  3  and  4   , including a one-way valve; 
         FIG.  10    is a partial cross-sectional view of the left ventricle assist device of the present invention being deployed in the ascending aorta; 
         FIG.  11    is a partial cross-sectional view of another embodiment of the left ventricle assist device of the present invention in a first transluminal delivery configuration, the device being enlarged for clarity; and 
         FIG.  12    is a partial cross-sectional view of another embodiment of the left ventricle assist device in accordance with the present invention in a second deployed configuration; 
     
    
    
     While the invention will be described in connection with the preferred embodiments shown herein, it will be understood that it is not intended to limit the invention to those embodiments. On the contrary, it is intended to cover all alternatives, modifications, and equivalents, as may be included within the spirit and the scope of the invention as defined by the appended claims. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In  FIG.  1   , a currently available left ventricle assist device  70  is shown to include: an inflow conduit, or fluid passageway,  71 , disposed between the lower portion of the left ventricle  72  of heart  73  and a device housing  74 ; and an outflow conduit  75  disposed between the device housing  74  and a portion of the ascending aorta  76  of heart  73 . Device  70  also includes an associated source  77  of suitable power and related sensors  78 , all operatively associated with device housing  74  in a known manner. 
     As previously discussed, the implantation of left ventricle assist device  70  within the body  79  requires surgery incisions upon the heart  73 , where the inflow conduit  71  is attached to heart  73 . As also previously discussed, although left ventricle assist devices presently in use, such as device  70  illustrated in  FIG.  1   , do provide the best presently available level of care for patients awaiting a heart transplant, by assisting the patient&#39;s heart  73  to pump his or her blood through the patient&#39;s body, such currently available left ventricle assist devices are believed to have certain previously discussed disadvantages. These disadvantages relate to: the use of the lengthy conduits, or flow passageways, and the particularly long outflow conduit  75 ; and the requirement of an actual incision and surgery upon the heart muscle, including blood loss and use of general anesthesia in order to connect the inflow conduit to the left ventricle  72  of heart  73 . In the regard, some devices also include implanting components thereof within left ventricle  72  of heart  73 . The currently available left ventricle assist devices, such as device  70  of  FIG.  1   , although suffering from the previously described disadvantages, is also an acceptable device for helping patients who may not need a heart transplant, or cannot withstand the rigors of such a surgery, but who may similarly benefit from having assistance provided in pumping blood through their body. 
     With reference to  FIGS.  3 - 4   , a left ventricle assist device  80  in accordance with the present invention is illustrated in conjunction with a patient&#39;s heart  73 . Before describing the left ventricle assist device  80  of the present invention, a brief description of the functioning of heart  73  and associated arteries will help in understanding the left ventricle assist device  80  as will be hereinafter described. 
     In general, the heart  73  consists of two pumps lying side by side. Each pump has an upper chamber, or atrium, and a lower chamber, or ventricle, as will hereinafter be described. Heart  73  functions to provide a person&#39;s body  79  ( FIG.  1   ) with a continuous supply of blood as illustrated by arrows  81  throughout  FIGS.  2 - 6   . In general, the right side of heart  73  receives “used” blood from the veins (not shown) of a person&#39;s body, and this blood is pumped to the lungs (not shown) of the person&#39;s body to be oxygenated. The oxygen-rich blood from the lungs is then returned to the left side of the heart, which pumps it through the various arteries. Heart  73  requires its own supply of blood to keep it beating. Oxygen-rich blood is pumped to the chambers, or ventricles, of the heart through the coronary arteries, as will be hereinafter described. Once the blood has been used, it is returned to the right side of heart  73  through a network of veins. 
     The functioning of these elements of heart  73  may be described in connection with  FIGS.  2  and  5   . Deoxygenated blood flows from veins, such as vein  82  into the right atrium, or right upper chamber,  85  of heart  73 , as illustrated by arrows  81 ′. Deoxygenated blood  81 ′ then flows through the one-way tricuspid valve, or right atrioventricular valve,  86 ′ into the right lower chamber, or right ventricle,  86  of heart  73 . Contraction of the muscle surrounding right ventricle  86  pumps the blood through the semilunar valve, or pulmonary valve  87 , and along the pulmonary arteries  88  through the lungs (not shown), where the deoxygenated blood  81 ′ receives oxygen. The ascending pulmonary artery is designated  89 , from which pulmonary arteries  88  branch. Oxygenated blood, as represented by arrows  81 ″ flows from the lungs into the left upper chamber, or left atrium,  90  and then passes downwardly through mitral valve, or left atrioventricular valve,  91  into the left lower chamber, or left ventricle,  72 . Muscle surrounding the left ventricle  72  contracts and pumps the blood  81 ″ through the semilunar valve, or aortic valve,  92  into the aorta, or ascending aorta,  76 , and descending aorta  98 . The oxygenated blood  81 ″ is then circulated through the body&#39;s arteries and ultimately returned as deoxygenated blood  81 ′ to the right side of heart  73  as previously described. As previously described, oxygen-rich blood  81 ″ is pumped to the left and right sides of heart  73  through the left coronary artery  95  and right coronary artery  96 . As previously described, once the oxygen-rich blood  81 ″ has been used, the blood is returned to the right side of the heart through a network of veins  97 . 
     With reference to  FIGS.  3  and  4   , the left ventricle assist device  80  of the present invention includes: a pump  110  which is percutaneously and transluminally delivered to a portion of the descending aorta  98  ( FIGS.  2  and  4   ) of a patient  79  via the femoral artery  10  ( FIG.  3   ) of a patient  79 ; and a transluminally deliverable support structure  120  which secures, or anchors, pump  110  within the descending aorta  98 . Left ventricle assist device  80  is disposed within a portion of the descending aorta  98 , preferably in a central portion of the descending aorta  98 . Pump  110  pumps, or pulls, blood  81 ″ downward from the ascending aorta  76 , and thereafter the oxygenated blood  81 ″ from left ventricle  72  is then circulated through the various arteries of the patient&#39;s body. 
     Still with reference to  FIGS.  3  and  4   , pump  110  is a rotary pump and preferably is an axial flow pump  111  having first and second ends  112 ,  113 , and pump  110  is preferably disposed within a housing  114 . At least one spiral vane, or impeller,  115  is disposed within housing  114 . Housing  114  may be approximately 20 French diameter in size, although other sizes may be selected. Pump  110  is preferably powered by a motor  116 , such as an electric motor  116 ′, which rotates impeller  115 . Impeller  115  may be mounted on bearings, or magnetically levitated, for rotation within housing  114 . A power wire  117  is associated with motor  116 , and as will hereinafter described in greater detail, it extends from left ventricle assist device  80  to a point at which it may be associated with a power source, such a battery (not shown). Housing  114  may be provided with a fluid port, e.g., a top cover, or inflow cage,  155 , which permits the passage of blood  81 ″ into housing  114 , as it is drawn into, pumped, or pulled into housing  114  by the rotation of impeller  115 . Housing  114  is preferably made of a suitable metallic or plastic material, such as stainless steel, which is a bio-compatible material. Alternatively, other bio-compatible materials, including plastic materials, having the requisite strength and bio-compatibility characteristics which permit the desired use in a person&#39;s aorta may be utilized. If pump  110  is an axial flow pump  111 , impeller  115  would rotate about the longitudinal axis  119  of housing  114 . 
     Still with reference to  FIGS.  3  and  4   , support structure  120  of left ventricle assist device  80  includes a plurality of support members  121  associated with pump  110 , which are preferably associated with housing  114 . Support members  121  may be secured to the outer surface, or outer wall surface,  114 ′ of housing  114  in any suitable manner, such as by welding or adhesive bonding. Support structure  120  supports pump  110  within the descending aorta  98 , preferably in a generally, centrally spaced relationship from the interior wall surface  98 ′ of descending aorta  98 . As will be hereinafter described in greater detail, support structure  120  anchors pump  110  within descending aorta  98  for long-term use to assist the pumping of blood  81 ″ from ascending aorta  76  downwardly through descending aorta  98 . At least two support members, or struts,  121  are disposed toward the upper end  112  of pump  110  and toward the lower end  113  of pump  110 . Preferably, at least three support members, or struts  121 , are substantially equidistantly disposed around each of the upper and lower ends  112 ,  113  of pump  110 . Preferably, the support members  121  have are formed of a suitable bio-compatible material, such as stainless steel. Alternatively, other bio-compatible materials, including plastic materials, having the requisite strength, expansion or spring, and bio-compatible characteristics to function in the manner hereinafter described in a person&#39;s aorta  98  may also be utilized. As shown in  FIG.  3   , the support structure  120 , or plurality of support members  121  are disposed in a first configuration for percutaneous transluminal delivery to the desired portion of the descending aorta  98 , as will be hereinafter described. In the first configuration, support members  121  are disposed substantially adjacent the outer wall surface  114 ′ of housing  114 , and are disposed substantially parallel to the longitudinal axis  119  of housing  114 . In this first configuration, the overall diameter of pump  110 , housing  114 , and support structure  120  is reduced to permit the percutaneous transluminal delivery of the left ventricle assist device  80  through the femoral or iliac artery  10  of the patient to the desired location within the descending aorta  98 . 
     The support members, or struts  121 , may be disposed in the configuration shown in  FIG.  3    as by a sheath  130  or annular bands (not shown), which may be subsequently removed, or alternatively, the struts, or support members  121 , when initially attached to the outer wall surface  114 ′ of housing  114 , have the disposition shown in  FIG.  3   . 
     Upon the left ventricle assist device  80  being positioned within the desired portion of the descending aorta  98 , the support members, or struts,  121 , have a second, expanded configuration wherein the outer ends  122  of the support members  121  contact the inner wall surface  98 ′ of descending aorta  98 . The second disposition of the support members  121  shown in  FIG.  4    may be achieved in a variety of ways. For example, the support members  121  may be formed as leaf springs, or spring members, wherein the support members  121  are biased to spring outwardly into the configuration shown in  FIG.  4   . If support members  121  are in the form of leaf springs which bias outwardly toward descending aorta  98 , they may be initially restrained into the configuration shown in  FIG.  3   , by a sheath  130  or band-like member, as previously described, which may be removed when left ventricle assist device  80  has been delivered to its desired location within the descending aorta  98 , whereby the support members, or struts,  121  would move outwardly into the configuration illustrated in  FIG.  4   . Alternatively, support members  121  could be formed of a material, such as nitinol, whereby the support members  121  would initially have the configuration shown in  FIG.  3   , and upon being heated by the blood flowing within aorta  98  would spring outwardly into the configuration illustrated in  FIG.  4   . 
     Other devices and structures could be utilized for support structure  120 , provided they permit the percutaneous transluminal delivery of the left ventricle assist device  80 , and that after such delivery, the support structure  120  permits the disposition of the left ventricle assist device within the descending aorta for long-term use, as shown in  FIG.  4   . By use of the terms “long term” and “long-term use”, it is meant to be more than the relatively short period of time that conventional percutaneous LVADS are used for (e.g. greater than 7-10 days, as previously described), and preferably on the order of at least a month and perhaps even a year or more. For example, a self-expanding stent  200 , or stents, as are known in the art could be used for supportive structure  120 , to support pump  110  in a substantially, centrally spaced relationship from the interior wall surface  98 ′ of aorta  98 , as shown in  FIGS.  11  and  12   . The stent, or stents,  200 , schematically shown in  FIGS.  11  and  12   , could have pump  110  centrally disposed therein with support members, or struts  121 , being attached to the interior of the stent as shown in  FIG.  11   . The stent  200  with the pump, and struts disposed therein, could be compressed and disposed within a sheath  130 , as hereinafter discussed and transluminally delivered as seen in  FIGS.  11  and  12   , in a manner similar to and as shown as described with reference to  FIG.  3   . Upon removal of sheath  130  the self-expanding stent  200  with pump  10  and struts  121  would expand outwardly as seen in  FIG.  12   , similar to  FIG.  4   , whereby the pump  110  would be supported in a generally centrally spaced relationship from the interior wall surface  98 ′ of aorta  98 . 
     With reference to  FIGS.  3  and  4   , preferably, the outer end  122  of at least one strut  121 , and preferably each of the outer ends of the support members, or struts,  121  are provided with an anchor element, such as a small hook  123 , or similar structure, which serves to anchor each of the struts  121  at the desired location within descending aorta  98 . If desired, a plurality of anchor elements may be used. Preferably, the left ventricle assist device  80  of the present invention is initially sheathed in a sheath  130  of approximately 22 to 23 French size in diameter in its undeployed configuration, as show in  FIG.  3   . If the struts  121  are of a spring-type design, the sheath  130  retains the support members  121  in the desired configuration illustrated in  FIG.  3   . Housing  114  preferably has a diameter of approximately 20 French. The strut system, or struts  121 , may also be deployed as a separate unit from the pump and initially deployed, and thereafter the pump  110  can then be deployed into the center of the strut system utilizing a locking mechanism, so that the pump may be removed and replaced at a later date so as to allow the ability to replace the pump if it should fail. Additionally, two or more pumps  110 ,  110 ′ may be placed in parallel in the descending aorta with one pump being designed in a more cranial position and the other pump in a more caudal position, so as to allow for redundancy of the pumps in case one fails and to allow for more pumping capability while utilizing the same French size sheath for delivery, as shown in  FIG.  4 A . 
     It should be apparent to one of ordinary skill in the art that other pumps  110  could be utilized in lieu of axial flow pump  111 , provided pump  110  is bio-compatible and capable of operating in the environment of the body, specifically the aorta, and able to pump blood  81 ″. Pump  110  may be powered by an implanted power device, or transformer, and may receive electric power from either an implanted power source or from a source of power located outside the patient&#39;s body  79 . It should be readily apparent to one of ordinary skill that if desired other types of power could be utilized to power pump  110 , such as hydraulic power or other types of power sources. The implanted power device, not shown, could be a conventional battery or a plutonium, or other nuclear material, power source. 
     With reference to  FIG.  5   , a power connection  135  for left ventricle assist device  80  is shown, with power wire  117  extending from the left ventricle assist device  80  being associated with a tubular shaped graft  131 . The power wire  117  extends into the interior  132  of graft  131  and passes outwardly of the graft  131  through the wall surface of the graft  131  and includes a portion  118  of power wire  117  extending outwardly from graft  131 . As will be hereinafter described in greater detail, the graft  131  is connected or anastamosed to the patient&#39;s femoral artery  10  ( FIG.  3   ), or other suitable body passageway, and it is desirable that blood flowing within graft  131  does not leak from graft  131  at the location through which power wire  117  passes through graft  131 . Graft  131  may be formed as a woven Dacron graft, as are known in the art. To provide the desired sealing about power wire  117 , the individual wires  117 ′ forming the composite power wire  117  may be woven into the interior surface of graft  131  and passed outwardly through the wall surface of the graft  131  at which point the individual wires  117  are recombined into the portion  118  of power wire  117  extending outwardly of graft  131 . Graft  131  may have an approximate length of 2-3 cm. The external portion  118  of power wire  117  may then be connected to a transcutaneous energy transmission coil (not shown), which may be placed just under the skin in the patient&#39;s thigh region. The transcutaneous energy transmission coils may then receive electrical energy from another transcutaneous energy transmission coil, or antenna, worn by the patient in close proximity or remotely to the implanted transcutaneous energy transmission coil. Thus, power may be supplied to pump  110  via power wire  117 . Alternatively, power wire  117  could pass through Dacron graft  131  or the vessel wall itself and a suitable bio-compatible sealant could be used to provide the requisite seal between power wire  117  and graft  131 . 
     Alternatively, the power wire  117  could be surrounded by standard felt material, and the power wire  117  is exteriorized through the skin midway down the patient&#39;s thigh, approximate the vastous medialus or lateralus muscle. The exiting power wire  117 , or portion  118 , could then be connected directly to an external battery and a controller device (not shown). The controller (not shown) could be a standard power delivery device, delivering proper wattage to allow for a variable range of operation of pump  110 , whereby pump  110  could pump blood at a rate of from approximately 0.5 liters/minute to as high as 5 liters/minute, depending upon the needs of the patient. The battery may be connected to the controller or incorporated within it, with one primary battery and a second auxiliary battery being utilized. The controller and batteries could be worn on the patient&#39;s belt or up on a holster-type system, or strapped to the patient&#39;s leg via a Velcro type attachment means, or other suitable attachment structure. The transcutaneous energy transmission coil could also be operated to provide varying amounts of power to pump  110  so as to also provide for the variable pumping of blood at a rate of from approximately 0.5 liters/minute to as high as 5 liters/minute. 
     The controller for either system could vary pump speed either in synchronization with the heart rhythm or paced rhythm, or out of synchronization with the heart rhythm or paced rhythm to provide optimal flow to the body. The device controller may also have the ability to sense the native electrocardiogram of the patient or the paced rhythm, and thus vary pump speed based upon it, and it may also communicate directly or indirectly with an implanted pacemaker, or defibrillator device, to optimize flow in this manner. The device controller may also be able to sense when the patient is supine or lying down and decrease or increase overall pump speed to compensate for decreased need while supine. The device controller may also sense other physiologic parameters such as bioimpedence, body motion or cardiac performance parameters and adjust pump speed to optimize flow of blood to the body. 
     The method, or procedure to transluminally implant the LVAD  80  of the present invention may include some, or all, of the following steps. First, the patient is prepared in a catheterization lab in a standard fashion. Under conscious sedation, local anesthesia is applied to the femoral area, similar to the manner in which a standard heart catheterization is performed. A small 3 cm incision is made in the vertical plane overlying the femoral artery  10 , just below the inguinal ligament. The femoral artery is exposed, and may then be entered by the Seldinger technique over a guide-wire and is successively dilated to allow entry of a sheath  140 , having a preferred diameter of 23 French ( FIG.  3   ). The sheath  140  is then passed over a guide-wire and then placed into position in the descending aorta  98 , with the tip  141  ( FIG.  3   ) in the mid thoracic aorta, approximately 4 cm below the take off of the left subclavian artery. The sheath  140  is then de-aired. Sheath  140  contains at its external end, outside the patient&#39;s body, a one-way valve and a side arm for de-airing. The LVAD  80  is then passed through the one-way valve into the sheath  140  to the tip  141  at the mid thoracic area. The passage of the LVAD  80  through the sheath  140  is made possible with an obturator (not shown). As the obturator is held in place, the sheath  130  is then withdrawn, which in the case of a spring type support structure  120 , the support members, or struts  121  then spring open and anchor the pump  110  in the descending aorta  98 , or alternatively, if support structure  120  is a self-expanding stent  200 , stent  200  springs open and anchors the pump  110  in the aorta  98 . The obturator is then removed, and the sheath  140  is then pulled back with the power wire  117  still passing through, or disposed within, the sheath  140 . 
     The graft  131  ( FIG.  5   ) that contains the transarterial wire system, or power connection  135 , is then passed through the one-way valve into the sheath  140 , and the sheath  140  is successively withdrawn until the sheath exits the femoral or iliac artery. Just prior to it exiting the femoral, or iliac, artery, a clamp is placed proximal to the entry site to prevent excessive bleeding. Thereafter, a small section approximately 1.5 cm of the femoral artery is excised, and the graft  131  is anastamosed in an end-to-end fashion in an interposition technique to the femoral or iliac artery. It is then de-aired. This leaves the transarterial wire, or portion  118  ( FIG.  5   ) of wire  117  external to the artery  10 , which is then tunneled to a drive line exit site or tunneled under the skin to a transcutaneous energy transmission coil, which is placed under the skin. The skin is then closed with suture. 
     Alternatively, with reference to  FIGS.  6 - 9   , after the sheath  140  is removed, a clamp is applied to prevent excessive bleeding. At the site of entry of the power wire  117  into the artery  10 , a tubular graft, or a small flange member  160  is placed via a small delivery tool, which is passed over the power wire  117 . The graft, or flange,  160  is put into position and the small delivery tool is removed and any excessive bleeding is observed. The flange member  160  may be made of either Dacron graft material or an inert polyurethane compound, or other bio-compatible material, and flange  160  may also be a thrombin plug with a central hole  161  to allow passage of the wire  117 . The flange member  160  is preferably two small, circular shaped members joined by a central portion  162 , which has a central hole  161  through which the wire passes. The flange  160  is preferably 25 French in diameter, whereby it is large enough to occlude the hole in the artery  10 , which was made by the large sheath  140 . This flange system allows for externalization of the power wire  117  from the artery  10  without excessive bleeding while preventing formation of an arterial fistula. The power wire is now external to the artery  10  and can be attached to an internal implanted transcutaneous energy transmission coil or exteriorized through a drive line as previously described. 
     After access to the artery  10  is gained, anti-coagulation with a short term intravenous anti-coagulant is provided during the procedure, and immediately thereafter, until long-term oral anti-coagulation can be instituted, if needed. 
     With reference to  FIG.  9   , a figure similar to  FIG.  4   , the left ventricle assist device  80  is provided with a one-way valve  170 , and is shown disposed in the descending aorta  98 . The same reference numerals are used for the same components shown and described in connection with  FIGS.  3  and  4   . One-way valve  170  may be provided to prevent backflow of blood  81 ″ from flowing upwardly back into descending aorta  98 . One-way valve  170  may be provided in any suitable manner, such as by supporting one-way valve  170  by a strut system  171  associated with housing  114 . Strut system  171  may include a plurality of strut members  172  which may be deployed in a similar manner to strut members  121  of strut system  120  to bring the circumferential end, or lip,  172  of one-way valve  170  into a sealing relationship with the interior surface  98 ′ of descending aorta  98 . The other, smaller diameter circumferential end, or lip,  174  of one-way valve  170  is shown in  FIG.  9    disposed in its sealed relationship with respect to housing  114 , whereby backflow of blood  81 ″ upwardly into descending aorta  98  is prevented. As blood  81 ″ is pumped to flow downwardly into descending aorta  98 , one-way valve  170  may open as shown by dotted lines  170 ′, whereby one-way valve  170  opens as shown in the direction of arrows  175 , whereby the circumferential lip  174  of one-way valve  170  moves outwardly from housing  114  to permit blood  81 ″ to flow not only through pump  110 , but from outside housing  114  and into descending aorta  98 . 
     One-way valve  170  may be made of any suitable bio-compatible, or biomaterial, including plastic materials, having the requisite strength and bio-compatibility characteristics which permit the desired use in a person&#39;s aorta and permits the function of one-way valve  170 . Rigid biomaterials, or flexible biomaterials may be utilized for the construction of one-way valve  170 . 
     With reference to  FIG.  10   , the left ventricle assist device  80  of the present invention, having the same general construction as illustrated in connection with  FIGS.  3  and  4    is shown disposed, not in the descending aorta  98 , but rather in the ascending aorta  76 , with oxygenated blood  81 ″ being pumped by pump  110  from the left ventricle  72  and outwardly into the aortic root, or ascending aorta,  76 . In this embodiment of the left ventricle assist device  80 , the housing  114 ′ is lengthened to include an inflow cannula  180 , which may be provided with a plurality of openings, or ports,  181  formed in the side walls of cannula  180 . Similar ports  181  may also be provided in the upper end of housing  114 ′, which ports  181  assist in the passage of blood  81 ″ through housing  114 ′. As shown in  FIG.  10   , housing  114 ′ is anchored within ascending aorta  76  by a plurality of strut members  121 , and housing  114 ′ is disposed within aortic valve  92 . When the left ventricle assist device  80 , shown in  FIG.  10   , is deployed within the ascending aorta  76 , the aortic valve  92  functions as the one-way valve which may be provided, as discussed in connection with the embodiment of LVAD  80  of  FIG.  9   . It is believed that by disposing the left ventricle assist device  80  within the ascending aorta  76 , direct unloading of the left ventricle  72  will be provided, so that more efficient afterload reduction may be accomplished. It is also believed that deployment of the left ventricle assist device in the ascending aorta  76  will also permit better perfusion of the cerebral circulation. In the embodiment of left ventricle assist device  80  of  FIG.  10   , power wire  117  may be associated with the upper, or first end,  112  of pump  110 . 
     Alternatively, rather than transluminally implanting the LVAD  80  of the present invention through the femoral artery, as previously described, LVAD  80  may be transluminally implanted and delivered through the left or right subclavian artery, and the power source or battery and controller may be placed in the pectoral area of the patient. This type of implant technique would be similar to the implantation of a cardiac pacemaker or defibrillator, with the exception that access would be obtained through the subclavian artery, rather than the subclavian vein. The power source, and/or its controller, may be incorporated in a device such as a cardiac pacemaker or defibrillator, if used in this manner. 
     Alternatively, if desired, the pump  110  and support structure  120 , including support members  121 , could be designed whereby pump  110  and support structure  120  could be removed with a catheter based removal device (not shown) which could collapse support members  121  and disengage them from their anchored configuration to permit the removal of them and pump  110 , if desired, such as to replace or repair pump  110 . Such a catheter based removal device could be similar to those presently used with inferior vena cava filters. 
     The present invention has been described and illustrated with respect to a specific embodiment. It will be understood to those skilled in the art that changes and modifications may be made without departing from the spirit and scope of the invention as set forth in the appended claims.