Abstract:
A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a divisional of U.S. application Ser. No. 10/436,959 filed on May 12, 2003 now U.S. Pat. No. 8,257,428 which is a continuation-in-part of abandoned U.S. patent application Ser. No. 09/635,511, filed on Aug. 9, 2000, which claims priority from expired U.S. Provisional Patent Application No. 60/147,894 filed on Aug. 9, 1999, and are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     Embodiments of this invention relate to a method and device for improving cardiac function. 
     2. Discussion of Related Art 
     Congestive heart failure annually leads to millions of hospital visits internationally. Congestive heart failure is the description given to a myriad of symptoms that can be the result of the heart&#39;s inability to meet the body&#39;s demand for blood flow. In certain pathological conditions, the ventricles of the heart become ineffective in pumping the blood, causing a back-up of pressure in the vascular system behind the ventricle. 
     The reduced effectiveness of the heart is usually due an enlargement of the heart. A myocardial ischemia may, for example, cause a portion of a myocardium of the heart to lose its ability to contract. Prolonged ischaemia can lead to infarction of a portion of the myocardium (heart muscle) wherein the heart muscle dies and becomes scar tissue. Once this tissue dies it no longer functions as a muscle and cannot contribute to the pumping action of the heart. When the heart tissue is no longer pumping effectively, that portion of the myocardium is said to be hypokinetic, meaning that it is less contractile than the uncompromised myocardial tissue. As this situation worsens, the local area of compromised myocardium may in fact bulge out as the heart contracts, further decreasing the heart&#39;s ability to move blood forward. When local wall motion moves in this way, it is said to be dyskinetic, or akinetic. The dyskinetic portion of the myocardium may stretch and eventually form an aneurysmic bulge. Certain diseases may cause a global dilated myopathy, i.e., a general enlargement of the heart when this situation continues for an extended period of time. 
     As the heart begins to fail, distilling pressures increase, which stretches the ventricular chamber prior to contraction and greatly increases the pressure in the heart. In response, the heart tissue reforms to accommodate the chronically increased filling pressures, further increasing the work that the now comprised myocardium must perform. 
     This vicious cycle of cardiac failure results in the symptoms of congestive heart failure, such as shortness of breath on exertion, edema in the periphery, nocturnal dypsnia (a characteristic shortness of breath that occurs at night after going to bed), waking, and fatigue, to name a few. The enlargements increase stress on the myocardium. The stress increase requires a larger amount of oxygen supply, which can result in exhaustion of the myocardium leading to reduced cardiac output of the heart. 
     SUMMARY OF THE INVENTION 
     The invention provides an apparatus for improving cardiac function comprising at least one external actuator, an elongate manipulator connected to the external actuator, a manipulator-side engagement component on a distal end of the elongate manipulator, a collapsible and expandable frame, a frame-side engagement component releasably engageable with the manipulator side-engagement component so that the external actuator can steer the frame when collapsed into a ventricle of a heart where after the frame is expanded, and at least one anchor connected to the frame, movement of the external actuator allowing for (i) insertion of the anchor and (ii) a myocardium ventricle, (iii) subsequent withdrawal of the anchor of the myocardium, (iv) subsequent reinsertion of the anchor into the myocardium, said insertion securing the frame to the myocardium in a selected position, and (v) subsequent disengagement of the manipulator-side engagement component from the frame-side engagement component, said disengagement for releasing the frame from the elongate manipulator. 
     The frame may have a small cross-dimension when collapsed suitable for being inserted into the ventricle of the heart through a tubular passage in a large cross-dimension when expanded in the ventricle. 
     The frame may comprise plurality of segments extending from a central portion of the frame. 
     The frame may be made of nickel titanium or stainless steel. 
     The apparatus may further comprise a membrane stretched between the segments, the membrane dividing the ventricle into at least two volumes. The membrane may be made of ePTFE. The membrane may be a mesh. 
     The segments may further comprise first and second portions connected at ends thereof such that the second portions are at an angle to the first portions. 
     The frame may have proximal and distal sections. The frame may have a diameter of between 10 mm and 100 mm when expanded. 
     The apparatus may further comprise at least one active anchor and at least one passive anchor. Said insertion of the passive anchor may be in a first direction and said withdrawal of the passive anchor may be in a second direction, the second direction being substantially 180 degrees from the first direction. 
     The apparatus may further comprise a first passive anchor extending in the first direction and a second passive anchor extending in a third direction. The active and passive anchors may have sharp ends that penetrate the myocardium. 
     The apparatus may further comprise a tubular passage with a distal end suitable to be inserted into the ventricle. 
     The elongate manipulator may further comprise a frame member with proximal and distal ends and an anchor member with proximal and distal ends, the frame and anchor members being moveable through the tubular passage. 
     The manipulator side-engagement component may further comprise a frame formation on the distal end of the frame member and an anchoring formation on the distal end of the anchor member 
     The apparatus may further comprise an external frame actuator connected to the proximal end of the frame member and an external anchor actuator connected to the proximal end of the anchor member. 
     When the distal end of the elongate manipulator is in the selected position, a first movement of the external anchor actuator may cause the active anchor to be inserted into the myocardium to secure the frame to the myocardium and a second movement of the external anchor actuator may cause the active anchor to withdraw from the myocardium, said withdrawal releasing the frame from the myocardium. 
     A first movement of the external frame actuator may cause the frame formation to engage the frame-side engagement component, said engagement securing the frame to the distal end of the elongate manipulator and a second movement of the external frame actuator may cause the frame formation to disengage the frame-side engagement component, said disengagement releasing the frame from the elongate manipulator. 
     The frame may be shaped such that entry of the proximal section of the frame into the tubular passage causes the frame to partially collapse such that the passive anchor withdraws from the myocardium in the second direction and entry of the distal section of the frame into the tubular passage causes the frame to collapse to the small cross-section so that the distal end of the elongate manipulator and the frame can be removed from the heart. 
     The elongate manipulator and the frame may be insertable into the heart simultaneously and the frame may be shaped such that exposure of the distal section of the frame from the distal end of the tubular passage allows the frame to partially expand and exposure of the proximal section of the frame from the distal end of the tubular passage allows the frame to expand to a large cross-section, said expansion causing the passive anchors to penetrate the myocardium to secure the frame to the myocardium. 
     The invention also provides an apparatus for improving cardiac function comprising a frame which includes a plurality of central segments surrounding a central axis, the central segments having first and second ends, the first ends being pivotally connected to one another, and a plurality of outer segments having first and second ends, the first ends being pivotally secured to the second ends of the central segments, a membrane secured to the frame such that movement of the second ends of the central segments away from the central axis causes the membrane to unfold, the unfolding of the membrane causing the outer segments to pivot relative to the respective central segments away from the central axis and movement of the second ends of the central segments toward the central axis causes the membrane to fold, the folding of the membrane causing the outer segments to pivot relative to their respective central segments toward the central axis, and an anchor connected to the frame, the anchor being insertable into a myocardium of a heart to secure the cardiac device to the myocardium in a ventricle of the heart. 
     The frame may include at least three central segments and at least three outer segments. 
     The membrane may be stretched between the central and the outer segments 
     The anchor may be secured directly to the frame. 
     The invention further provides an apparatus for improving cardiac function comprising a frame, a membrane, having an inner surface, secured to the frame, the membrane and the frame jointly forming a cardiac device being moveable between a collapsed and an expanded state, in a collapsed state at least a portion of the inner surface of the membrane facing a vertical axis of the cardiac device and the cardiac device being insertable into a ventricle of a heart, in the expanded state the portion of the inner surface of the membrane facing away from the vertical axis and being in contact with a myocardium and the cardiac device being in a selected position in the ventricle, and an anchor connected to the cardiac device, the anchor being insertable into the myocardium of the heart to secure the cardiac device to the myocardium in the selected position in the ventricle. 
     The cardiac device may collapse toward the vertical axis and expand away from the vertical axis. 
     The membrane may fold towards the vertical axis when the cardiac device collapses and may unfold away from the vertical axis when the cardiac device expands. 
     The frame may be at least one of nickel titanium and stainless steel. 
     The membrane may be made of ePTFE. 
     The anchor may have a sharp end. 
     The invention further provides an apparatus for improving cardiac function comprising a frame being expandable in a selected position to a pre-set shape in a ventricle of a heart, a formation on the frame, and an anchoring device having an anchor, the anchoring device being engaged with and rotatable relative the formation to rotate the anchor relative to the frame, said rotation causing the anchor to be inserted into a myocardium of the heart, said insertion securing the frame in the selected position in the ventricle. 
     The anchoring device may engage the formation such that a first rotation of the anchoring device causes the anchor to move away from the frame and a second rotation of the anchoring device causes the anchor to move toward the frame. 
     The formation may be a pin, and the anchor may be a screw. 
     The invention further provides an apparatus for improving cardiac function comprising at least a primary expandable frame being in a selected position in a ventricle of a heart when expanded, an anchor connected to the frame, the anchor being insertable into a myocardium of the heart to secure the primary frame within the ventricle, a frame-side engagement component connected to the primary frame, a membrane, and a membrane-side engagement component being engageable with the frame-side engagement component, said engagement securing the membrane to the frame. 
     The apparatus may further comprise a secondary expandable frame being in a selected position in the ventricle of the heart when expanded, the secondary frame being secured to the membrane and connected to the membrane-side engagement component thereby interconnecting the membrane to the membrane-side engagement component. 
     The anchor may be connected to the at least one frame. 
     The frame-side engagement component may be connected to the primary frame at a central portion of the primary frame. 
     The membrane-side engagement component may be connected to the secondary frame at a central portion of the secondary frame. 
     The apparatus may further comprise an active anchor being connected to the frame-side engagement component such that a first m. movement of the frame-side engagement component causes the active anchor to enter the myocardium and a second movement of the frame-side engagement component causes the active anchor to withdraw from the myocardium. 
     The apparatus may further comprise a passive anchor being connected to at least one of the frames such that the passive anchor enters the myocardium when the frame expands. 
     The invention further provides an apparatus for improving cardiac function comprising a flexible liner, a membrane secured to the liner, the membrane and the liner jointly forming a cardiac device being moveable between a collapsed and an expanded state, in the collapsed state the cardiac device being insertable into a ventricle of a heart. In the expanded state the cardiac device being in a selected position in the ventricle, the liner covering a wall in the ventricle and the membrane separating the ventricle into two volumes, and an anchor connected to the cardiac device, the anchor being insertable into a myocardium of the heart to secure the cardiac device to the myocardium in the selected position in the ventricle. 
     The flexible liner may comprise a plurality of lengths of strands being connected at endpoints thereof. 
     The apparatus may further comprise a frame secured to the cardiac device and connected to the anchor thereby interconnecting the cardiac device and the anchor. 
     The apparatus may further comprise a frame-side engagement component being connected to the cardiac device and an active anchor being connected to the frame-side engagement component such that a first movement of the frame-side engagement component causes the active anchor to enter the myocardium and a second movement of the frame-side engagement component causes the active anchor to withdraw from the myocardium. 
     The apparatus may further comprise a passive anchor being connected to the cardiac device such that the passive anchor enters the myocardium when the cardiac device expands. 
     The invention further provides an apparatus for improving cardiac function comprising an expandable frame being in a selected position in a ventricle of the heart and having an outer edge when expanded, the outer edge defining a non-planar cross-section of an inner wall of a ventricle and an anchor connected to the frame, the anchor being insertable into the myocardium of the heart to secure the frame to the myocardium in the selected position in the ventricle. 
     The apparatus may further comprise a membrane being secured to a frame, the membrane separating the ventricle into two volumes. 
     The frame may have a vertical axis and the outer edge may have a diameter, the diameter intersecting the vertical axis at an angle other than 90 degrees. 
     The invention further provides an apparatus for improving cardiac function comprising an anchor being insertable into a myocardium of a heart to secure the anchor to the myocardium within a ventricle of the heart, an anchor-side engagement component being secured to the anchor, an expandable frame being in a selected position in the ventricle when expanded, and a frame-side engagement component being secured to the frame, the frame-side engagement component being engageable with the anchor-side engagement component, said engagement securing the frame to the anchor in the selected position in the ventricle. 
     The apparatus may further comprise a membrane being secured to the frame. 
     A first movement of the anchor-side engagement component may cause the anchor to enter a myocardium and a second movement of the anchor-side engagement component may cause the anchor to withdraw from the myocardium. 
     A first movement of the frame-side engagement component may cause the frame-side engagement component to engage the anchor-side engagement component and a second movement of the frame-side engagement component may cause the frame-side engagement component to disengage the anchor-side engagement component. 
     Said engagement may release the frame from the anchor. 
     The invention further provides an apparatus for improving cardiac function comprising a flexible body, a membrane connected to the flexible body, the membrane and flexible body jointly forming a cardiac device being movable between a collapsed and an expanded state, in the collapsed state the cardiac device being insertable into a ventricle of the heart, in the expanded state the cardiac device being in a selected position in the ventricle, and an anchor connected to the cardiac device, the anchor being insertable into the myocardium of the heart to secure the cardiac device to the myocardium in the selected position of the ventricle. 
     The apparatus may further comprise a frame having a distal end, the membrane may be secured to the frame, and the body may have proximal and distal ends, the proximal end of the body being secured to the distal end of the frame, and the distal end of the body being connected to the anchor. 
     The body may be cylindrical with a diameter of between 0.5 mm and 6 mm and a height of between 1 mm and 100 mm. 
     The cardiac device may have a vertical axis.
         The body may have a proximal opening at the proximal end, a distal opening at the distal end, and a passageway there through connecting the proximal and distal openings.       

     The body may be able to bend between 0 and 120 degrees from the vertical axis. 
     The invention further provides a device for improving cardiac function comprising a collapsible and expandable frame having first and second portions, the frame being insertable into a ventricle of a heart when collapsed, when expanded the frame being in a selected position in the ventricle and the second portion of the frame covering a wall in the ventricle, a membrane secured to the frame such that the membrane divides the ventricle into at least two volumes when the frame is expanded, the frame and the membrane jointly forming a cardiac device, and an anchor connected to the cardiac device, the anchor being insertable into a myocardium of the heart to secure the cardiac device in the selected position in the ventricle. 
     The frame may further comprise a plurality of segments, each segment having an inner and outer portion being connected at ends thereof, the outer portions being at an angle to the inner portions. 
     The membrane may be secured to the inner and outer portions of the segments. 
     The device may further comprise a plurality of anchors being connected to at least one segment such that when the frame expands the anchors enter the myocardium in a first direction, and when the frame collapses the anchors withdraw from the myocardium in a second direction approximately 180 degrees from the first direction. 
     Some of the anchors may extend in a third direction. 
     The invention further provides a system for improving cardiac function comprising a collapsible and expandable frame, when collapsed the frame being insertable into a selected position in a ventricle of the heart through an opening in the heart having a small cross-dimension, when expanded in the selected position, the frame having a large cross-dimension, and an anchor connected to the frame, being insertable into a myocardium of the heart to secure the frame to the myocardium in the selected position. 
     The opening may be an incision in the myocardium. 
     The anchor may further comprise a plurality of strands woven through the myocardium such that the opening is closed. 
     The invention further provides a system for improving cardiac function comprising an external actuator, an elongate manipulator having a tube suitable to be inserted into a ventricle of a heart to a selected position and a deployment member positioned therein slidable between a first and second position, the deployment member having proximal and distal ends, the distal end being within the tube when the deployment member is in the first position and out of the tube when the deployment member is in the second position, the deployment member being connected to the external actuator at the proximal end thereof, a deployment-side engagement component on the distal end of the deployment member, a frame-side engagement component being engageable with the deployment-side engagement component, said engagement securing the deployment-side engagement component to the frame-side engagement component such that a movement of the external actuator causes the engagement components to disengage, said disengagement releasing the deployment-side engagement component from the frame-side engagement component, a frame being connected to the frame-side engagement component, the frame being moveable between a collapsed and an expanded state, the frame being connected to the deployment member in the collapsed state with a small cross-dimension when the deployment member is in the first position and the frame is within the tube, the frame being shaped such that when the deployment member is moved to the second position and the frame exits the tube, the frame expands to the expanded state with a large cross-dimension and when the deployment member is moved back to the first position, the frame collapses to the collapsed state as the frame enters the tube, and an anchor connected to the frame being insertable into a myocardium of the heart to secure the frame to the myocardium of the heart, such that the deployment mechanism can be removed from the heart, the anchor entering the myocardium in a first direction when the frame expands and withdrawing from the myocardium in a second direction when the frame collapses, said withdrawal releasing the frame from the myocardium 
     The external manipulator may further comprise an anchor deployment knob and a detachment knob. 
     The deployment member may further comprise an anchor shaft having proximal and distal ends and a detachment shaft having proximal and distal ends, the proximal end of the anchor shaft being connected to the anchor deployment knob, the proximal end of the detachment shaft being connected to the detachment knob. 
     The deployment-side engagement component may further comprise a deployment-side anchor formation connected to the distal end of the anchor shaft and a deployment-side detachment formation connected to the distal end of the detachment shaft. 
     The frame-side engagement component may further comprise a frame-side anchor formation being connected to the anchor and a frame-side detachment formation on the frame, the frame-side anchor formation being engageable with the deployment-side anchor formation, the frame-side detachment formation being engageable with the deployment-side detachment formation, a first movement of the detachment knob causing the deployment-side detachment formation to engage the frame-side detachment formation, said engagement securing the frame to the deployment member, a first movement of the anchor deployment knob causing the anchor to enter the myocardium and a second movement of the anchor deployment knob causing the anchor to withdraw from the myocardium, a second movement of the detachment knob causing the deployment-side detachment formation to disengage the frame-side detachment formation, said disengagement releasing the frame from the deployment member. 
     The anchor shaft and the detachment shaft may be coaxial. 
     The anchor shaft may be an inner torque shaft and the detachment shaft may be an outer torque shaft. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is further described by way of examples with reference to the accompanying drawings, wherein: 
         FIG. 1  is an exploded side view of a system for improving cardiac function, according to one embodiment of the invention, including a cardiac device and a deployment system, the deployment system including a deployment mechanism and a catheter tube; 
         FIG. 2  is a cross-sectional side view of a handle of the deployment mechanism and a proximal end of a deployment member of the deployment mechanism; 
         FIG. 3A  is cross-sectional side view of a distal end of the deployment member including a key and a detachment screw; 
         FIG. 3B  is a cross-sectional end view on  3 B- 3 B in  FIG. 3A  of the deployment member; 
         FIG. 3C  is a cross-sectional end view on  3 C- 3 C in  FIG. 3A  of the key; 
         FIG. 4  is a perspective view of the cardiac device including a hub, a frame, and a stem thereof; 
         FIG. 5A  is a side view of the cardiac device; 
         FIG. 5B  is a perspective view of the hub; 
         FIG. 5C  is a top plan view of the hub; 
         FIG. 6  is a cross-sectional side view of the stem; 
         FIG. 7A  is a side view of the distal end of the deployment member connected to the cardiac device; 
         FIG. 7B  is a cross-sectional view on  7 B- 7 B in  FIG. 7A  of the cardiac device; 
         FIG. 8  is a cross-sectional side view of the cardiac device with the key connected thereto; 
         FIG. 9  is a side view of the system of  FIG. 1  with the components integrated with and connected to one another; 
         FIG. 10A  is a view similar to  FIG. 9  with the cardiac device partially retracted into the catheter; 
         FIG. 10B  is a cross-sectional side view of a portion of  FIG. 10A ; 
         FIG. 11A  is a side view of the system with the cardiac device further retracted; 
         FIG. 11B  is a cross-sectional side view of a portion of  FIG. 11A ; 
         FIG. 12A  is a side view of the system with the cardiac device fully retracted; 
         FIG. 12B  is a cross-sectional side view of a portion of  FIG. 12A ; 
         FIG. 13A  is a cross-sectional side view of a human heart with the catheter inserted therein; 
         FIGS. 13B-13K  are cross-sectional side views of the human heart illustrating installation ( FIGS. 13B-13E ), removal ( FIGS. 13E-13H ), and subsequent final installation ( FIGS. 13I-13K ) of the cardiac device; 
         FIG. 14A  is a perspective view of a cardiac device according to another embodiment of the invention; 
         FIG. 14B  is a cross-sectional side view of the human heart with the cardiac device of  FIG. 14A  installed; 
         FIG. 15A  is a perspective view of a cardiac device according to a further embodiment on the invention; 
         FIG. 15B  is a cross-sectional top plan view of the cardiac device on  15 B- 15 B in  FIG. 15A ; 
         FIG. 15C  is a cross-sectional side view of the human heart with the cardiac device of  FIG. 15A  installed; 
         FIG. 16A  is a perspective view of a cardiac device according to a further embodiment of the invention; 
         FIG. 16B  is a cross-sectional side view of the cardiac device of  FIG. 16A ; 
         FIG. 16C  is a cross-sectional side view of the human heart with the cardiac device of  FIG. 16A  installed; 
         FIG. 17A  is a perspective view of a cardiac device according to a further embodiment of the invention; 
         FIG. 17B  is a cross-sectional side view of the human heart with the cardiac device of  FIG. 17A  installed; 
         FIG. 18A  is a perspective view of a cardiac device according to a further embodiment of the invention; 
         FIG. 18B  is a cross-sectional side view of the human heart with the cardiac device of  FIG. 18A  installed; 
         FIG. 19A  is a perspective view of a cardiac device according to a further embodiment of the invention; 
         FIG. 19B  is a cross-sectional side view of the human heart while the cardiac device of  FIG. 19A  is being installed; 
         FIG. 19C  is a cross-sectional side view of the human heart while the cardiac device of  FIG. 19A  is being installed; 
         FIG. 19D  is a cross-sectional side view of a human heart with the cardiac device of  FIG. 19A  installed; 
         FIG. 20A  is a perspective view of a frame of a cardiac device according to another embodiment of the invention; 
         FIG. 20B  is a perspective view of a stem of the cardiac device of  FIG. 20A ; 
         FIG. 20C  is a cross-sectional side view of the cardiac device of  FIG. 20A  and  FIG. 20B  with the stem attached to the frame; 
         FIG. 20D  is a cross-sectional side view of a distal end of a deployment member of a deployment mechanism according to another embodiment of the invention; 
         FIG. 20E  is a cross-sectional side view of the distal end of the deployment member of a deployment mechanism of  FIG. 20D ; and 
         FIGS. 20F-20I  are cross sectional side views of a human heart illustrating installation of the cardiac device of  FIG. 20A  and  FIG. 20B . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  illustrates a system  30  for improving cardiac function according to one embodiment of the invention. The system  30  includes a deployment system  32  and a cardiac device  34 . The deployment system  32  includes a deployment mechanism  36  and a catheter tube  38 . 
     The catheter tube  38  is cylindrical with a length  40  of 110 cm and a diameter  42  of 5 mm. The catheter tube  38  has a circular cross-section and is made of a soft, flexible material. 
     The deployment mechanism  36  includes a handle  44  and a deployment member  46 . The handle  44  has a proximal end  48  and a distal end  50 . The deployment member  46  has a proximal end  52  and a distal end  54 . The proximal end  52  of the deployment member  46  is secured to the distal end  50  of the handle  44 . 
       FIGS. 2 ,  3 A,  3 B, and  3 C illustrate the deployment mechanism  36  in more detail.  FIG. 2  illustrates the handle  44  while  FIGS. 3A ,  3 B, and  3 C illustrate components at the distal end  54  of the deployment member  46 . The components of the deployment mechanism  36  are primarily circular with center lines on a common axis. 
     The handle  44  is made of molded plastic and includes a main body  56 , an anchor knob  58 , an end piece  60 , a proximal rotating hemostatic valve  62 , a fluid line  64 , a distal rotating hemostatic valve  66 , and a detachment knob  68 . The main body  56  is cylindrical with a length  70  of 80 mm and a diameter  72  of 25 mm. The main body  56  has a proximal  74  and a distal  76  opening at the respective ends thereof and a passageway  78  there through connecting the openings with an inner diameter  80  of 4 mm. 
     The proximal rotating hemostatic valve  62  is a cylindrical body with a passageway  82  there through having an inner diameter  84  of 4 mm, a locking hypo tube  86  within the passageway, a tapered outer end  88 , and a raised formation  90  at a central portion thereof. The proximal rotating hemostatic valve  62  is rotationally secured to the proximal opening  74  of the handle  44 . The locking hypo tube  86  is a cylindrical body secured within the passageway  82  of the proximal rotating hemostatic valve  62 . 
     The end piece  60  is a cylindrical body with a passageway  92  there through connecting a proximal  94  and distal  96  opening at respective ends and having an inner diameter  98  of 5 mm. Raised formations  100  stand proud from respective central and outer portions of the end piece. A cylindrical end piece pin  102  is connected to an inner surface and extends across the inner diameter  98  of the passageway  92 . The end piece pin  102  is made of stainless steel and has a length of 5 mm and a diameter of 2 mm. The distal opening  96  of the end piece  60  mates with the tapered outer end  88  of the proximal rotating hemostatic valve  62 . 
     The anchor knob  58  is a cap-shaped body with a length  104  of 20 mm and an outer diameter  106  of 10 mm. The anchor knob  58  has a small opening  108  at a proximal end  110  with a diameter  112  of 4 mm and a large opening  114  at a distal end  116  with a diameter  118  of 6 mm. The anchor knob  58  fits over and is secured to both the end piece  60  and the proximal rotating hemostatic valve  62 . 
     The fluid line  64  enters the handle  44  through the small opening  108  of the anchor knob  58  and is secured to the proximal opening  94  of the end piece  60 . The fluid line  64  has an outer diameter  120  of 5 mm. 
     The distal rotating hemostatic valve  66  is a cylindrical body with a passageway  122  there through having a proximal inner diameter  124  of 4 mm at a proximal end  126  thereof and a distal inner diameter  128  of 5 mm at a distal end  130  thereof. The distal end  130  is tapered, and a raised formation  132  lies at a central portion thereof. The distal rotating hemostatic valve  66  is rotationally secured to the distal opening  76  of the main body  56 . 
     The detachment knob  68  is a cap-shaped body with a length  134  of 20 mm and an outer diameter  136  of 20 mm. The detachment knob  68  has a large opening  138  at a proximal end  140  with a diameter  142  of 8 mm and a small opening  144  at a distal end  146  with a diameter  148  of 5 mm. The detachment knob  68  fits over and is secured to the distal rotating hemostatic valve  66 . 
     Referring to  FIGS. 3A-3C , the deployment member  46  includes an inner torque shaft  150  and an outer torque shaft  152 . The inner torque shaft has a diameter  154  of 2 mm and is made of surgical stainless steel. The outer torque shaft is a hollow, cylindrical body with an inner diameter  156  of 3 mm and an outer diameter  158  of 5 mm. The outer torque shaft  152  is a polymer. 
     Referring again to  FIG. 2 , the inner torque shaft  150  passes through the detachment knob  68 , through the distal rotating hemostatic valve  66 , into and out of the passageway  78  of the main body  56 , through the proximal rotating hemostatic valve  62 , and into the end piece  60 . The proximal end of the inner torque shaft  150  is wrapped around the end piece pin  102 , reenters the proximal rotating hemostatic valve  62 , and is attached to the locking hypo tube  86  within the proximal rotating hemostatic valve  62 . 
     The outer torque shaft  152  is coaxial with and surrounds the inner torque shaft  150 . A proximal end  160  of the outer torque shaft  152  passes into the distal hemostatic valve  66  and is secured thereto. 
     The distal end  54  of the deployment member  46  includes a key  162 , a detachment screw  164 , and a securing mechanism  166 . A distal end  168  of the inner torque shaft  150  extends out of a distal end  170  of the outer torque shaft  152 , and the key  162  is attached thereto. The key  162  is rectangular with a length  171  of 7 mm and a height  172  of 3 mm. The key  162  has a semi-circular cross section with a radius  174  of 1.5 mm. The detachment screw  164  is attached to the distal end  170  of the outer torque shaft  152 , extends to a length  176  of 7 mm, and has a diameter  178  of 5 mm. 
     The securing mechanism  166  includes an inner component  180  and an outer component  182 . The inner component  180  is a raised cylindrical portion coaxial with and on the inner torque shaft  150 . The inner component  180  stands proud of the inner toque shaft  150  by 0.5 mm. The outer component  182  is a hollow, cylindrical body secured to an inner surface of the outer torque shaft  152  and has proximal and distal openings with diameters of 2.25 mm so that the inner toque shaft  150  cannot move axially relative to the outer torque shaft  152 . 
       FIGS. 4 ,  5 A- 5 C, and  6  illustrate the cardiac device  34  in more detail. The cardiac device  34  includes a frame  184  and a stem  186 , or flexible body, and has a vertical axis  188 . 
     The frame  184  includes a frame hub  190 , a plurality of main segments  192 , and a membrane  194 . The hub  190  is a ring-shaped body with an outer surface  196  with a diameter  198  of 5 mm, an inner surface  200  with a diameter  202  of 4 mm, a thickness  204  of 3 mm, and a pin  206  extending off-center across the inner surface  200  creating a smaller and a larger gap. The pin  206  has a length of 3.5 mm and a diameter of 1 mm and is located in a plane  208 . The frame  184  has a diameter  209  of approximately 25 mm; however, other embodiments may have diameters of between 10 mm and 100 mm. The entire hub  190  is made of nickel titanium. 
     The main segments  192  include first portions, or central segments,  210 , second portions, or outer segments,  212 , and passive anchors  214 . The first portions  210  are connected to the hub  190  at a central portion of the outer surface  196  and extend radially from the hub  190  at an angle away from the plane  208  of the pin  206  to a length  216  of 8 mm. The second portions  212  of the segments  192  are connected to ends of the first portions  210  and further extend radially from the hub  190  but at an angle towards the plane  208 . The second portions  212  each have a length  218  of 5 mm. The passive anchors  214  are formed at an end of each of the second portions  212 . The passive anchors  214  have sharp ends that point slightly radially from the hub  190 . The segments  192  are made from nickel titanium, which after a prescribed thermal process, allows for the segments  192  to hold their shape as illustrated, for example, in  FIG. 4 . The entire frame  184 , or just portions of the frame  184 , may also be made of stainless steel. 
     The membrane  194  is stretched over the first  210  and second  212  portions of the segments  192  to give the frame  184  a disk like shape. The membrane  194  is made of expanded Poly Tetra Fuoro Ethylene (ePTFE) and has a thickness of 0.08 mm. Other embodiments may use a mesh membrane. 
       FIG. 6  illustrates the stem  186  unattached to the frame  184 . The stem  186  is a hollow, cylindrical body with a passageway  220  there though connecting a proximal  222  and a distal  224  opening. The stem  186  has a height  226  of 9 mm, an outer diameter  228  of 5 mm, and an inner diameter  230  of 4 mm. The stem  186  includes a first hub  232  and a second hub  234 , both similar to the hub  190  on the frame  184 . The second hub  234  is secured within the passageway  220  near the distal opening  224  of the stem  186 . The first hub  232  is loose within the stem  186  so that it may move, and has an active anchor  236 , in the shape of a screw, attached. The active anchor  236  spirals from the first hub  232  to engage with the pin on the second hub  234 . The active anchor  236  has a diameter  238  of 3.5 mm and a length  240  of 7 mm. 
     The stem  186  is made of Poly Tetra Fuoro Ethylene (PTFE) and is thus expandable and flexible. Referring again to  FIG. 4 , the stem  186  can be compressed or stretched by 30% of its length and can be bent from the vertical axis  188  of the device  34  by 120 degrees in any direction. The first hub  232 , second hub  234 , and active anchor  236  are made of nickel titanium. In other embodiments, the hubs may be made of stainless steel. 
       FIGS. 7A ,  7 B,  8 , and  9  illustrate the system  30  with the stem  186  connected to the cardiac device  34  and the cardiac device  34  connected to the deployment mechanism  36 . The stem  186  is fused to the frame hub  190  thus securing the stem  186  to the device  34 . 
     In use, the deployment member  46  is inserted through the catheter tube  38  so that the distal end  54  of the deployment member  46  exits the distal end of the tube  38 . As shown is  FIGS. 7A and 7B , the deployment member  46  connects to the cardiac device  34  such that the key  162  engages the hub  190  of the frame  184  by passing through the larger gap in the hub  190 . As shown in  FIG. 8 , the key  162  passes through the hub  190  of the frame  184  to engage with the first hub  232  of the stem  186 , but does not reach the second hub  234 . Once the key  162  is fully inserted into the stem  186 , the detachment knob  68  is turned which rotates the outer torque shaft  152  and thus the detachment screw  164  because the detachment screw  164  is attached to the outer torque shaft  152 . The rotation thereof causes the detachment screw  164  to engage with the pin  206  of the frame hub  190 , securing the cardiac device  34  to the deployment mechanism  36 . 
     Rotation of the anchor knob  58  in a first direction causes the active anchor  236  to be deployed from the distal opening  224  of the stem  186  because the anchor knob  58  is connected to the inner torque shaft  150  which, in turn, is connected to the key  162 . Rotation of the key  162  causes the first hub  232  to rotate and because the active anchor  236  is connected to the first hub  232  and engaged with the pin of the second hub  234 , the active anchor  236  “twists” out of the distal opening  224  of the stem while the first hub  232  is pulled toward the distal opening  224 . Rotation of the anchor knob  58  in a second direction causes the active anchor  236  to reenter the distal opening  224  of the stem  186 . 
     As illustrated in  FIGS. 10A and 10B , the distal end  54  of the deployment member  46  is then pulled into the distal end of the catheter tube  38 . As a proximal section of the frame  184  enters the catheter tube  38 , the first portions  210  of the segments  192  begin to collapse towards the stem  186 . The segments  192  collapse, or fold, against a spring force that is created by the resilient nature of the nickel titanium material from which they are made. At the same time, the second portions  212  fan out radially away from the hub  190 . 
     As illustrated in  FIGS. 11A and 11B , by the time a distal section of the frame  184  and the second portions  212  of the segments  192  begin to enter the tube  38 , the second portions  212  have been bent back to collapse towards the stem  186  similarly to the first portions  210 . 
       FIGS. 12A and 12B  illustrate the system  30  with the cardiac device  34  completely contained within the catheter tube  38 . 
       FIGS. 13A-13J  illustrates a human heart  242  while the cardiac device  34  is being deployed. The heart  242  contains a right ventricle  244  and a left ventricle  246  with papillary muscles  248  and an akinetic portion  250  with an apex  252 . The distal end of the catheter  38  has been inserted through the aorta and aortic valve into the left ventricle  246  to a selected position where the cardiac device  34  can be deployed. The catheter tube  38  is then partially pulled off of the cardiac device  34  exposing the stem  186 . 
     The active anchor  236  is then deployed by rotating the anchor knob  58  in a first direction. The active anchor  236  penetrates the myocardium of the heart  242  to secure the cardiac device  34  in the selected position at the apex  252  of the akinetic portion  250  of the left ventricle  246 . 
     The catheter  38  is then completely removed from the distal end  54  of the deployment member  46 , exposing the cardiac device  34 . As the cardiac device  34  expands, due to the resilient nature of the segments  192  and the pre-set shape of the frame  184 , the passive anchors  214  on the segments  192  penetrate the myocardium in a first direction. The membrane  194  seals a portion of the ventricle  246  and separates the ventricle  246  into two volumes. 
     If the cardiac device  34  has not been properly positioned, or if it is of the wrong size or shape for the particular heart, the device  34  may be repositioned or completely removed from the heart  242 . 
     Rotation of the anchor knob  58  in a second direction will cause the active anchor  236  to be removed from the apex  252  of the akinetic portion  250  of the left ventricle  246  thus releasing the cardiac device  34  from the heart  242 . The distal end  54  of the deployment member  46  may be retracted into the catheter  38  to once again fold the cardiac device  34  into the position shown in  FIG. 12B , from where it can again be deployed. The passive anchors  214  are removed from the myocardium in a second direction which is approximately 180 degrees from the first direction so that minimal damage is done to the myocardium. 
     However, if the cardiac device  34  has been properly positioned and is of the proper size and shape, rotation of the detachment knob  68  in a second direction will cause the detachment screw  164  at the distal end  170  of the outer torque shaft  152  to disengage the pin  206  in the frame hub  190 , thus releasing the deployment member  46  from the cardiac device  34  to allow removal of the deployment member  46  from the heart  242 .  FIG. 13K  illustrates the heart  242  with the cardiac device  34  installed and the deployment mechanism  36  removed from the heart  242 . 
     One advantage of this system is that the shape of the frame  184  allows the device  34  to be retrieved as long as the deployment member  46  is still connected to the device  34 . When the device  34  is retrieved, the passive anchors  214  withdraw from the myocardium in a direction that is approximately 180 degrees from, or opposite, the first direction to minimize the amount of damage done to the myocardium. The device  34  also provides support for the akinetic region  250 , minimizes the bulging of the akinetic region  250 , and reduces stress on the working parts of the myocardium. A further advantage is that the ePTFE membrane  194  is biocompatible, has a non-thrombogenic surface, promotes healing, and accelerates endothelization. 
       FIG. 14A  illustrates a cardiac device  254  according to another embodiment of the invention. The cardiac device includes a hub  256 , a frame  258 , and a membrane  260 . The hub  256  lies at a central portion of the frame  258  and an active anchor  262  is connected to the hub  256  and extends downwards there from. The frame  258  includes a plurality of segments  264  which extend radially and upwardly from the hub  256 . A sharp passive anchor  266  lies at the end of each of the segments  264 . The membrane  260  is stretched between the segments  264  to form a cone-shaped body. 
       FIG. 14B  illustrates a human heart with the cardiac device  254  of  FIG. 14A  having been secured to an akinetic portion thereof. 
       FIG. 15A  and  FIG. 15B  illustrate a cardiac device  268  according to a further embodiment of the invention. The cardiac device includes a hub  270 , a frame  272 , and membrane  274 . The hub  270  lies at a central portion of the frame  272  and an active anchor  276  extends downwardly from the hub  270 . The frame  272  includes a plurality of segments  278  which extend radially and upwardly from the hub  270 . The segments  278  are of different lengths such that an outer edge  280  of the cardiac device  268  is not planar. The device  268  has a vertical axis  282  which intersects a diameter  284  across the outer edge  280  of the device  268  at an angle other than 90 degrees. A sharp passive anchor  286  lies at the end of each of the segments  278 . The membrane  274  is stretched between the segments  278  to form a cone-shaped body. Referring specifically to  FIG. 15B , a cross-section perpendicular to the vertical axis  282  of the device  268  is circular. 
       FIG. 15C  illustrates a human heart with the cardiac device  268  of  FIG. 15A  having been secured to an akinetic portion thereof. The outer edge  280  of the cardiac device  268  defines a non-planar cross-section of an inner surface of the left ventricle. 
     A further advantage of this embodiment is that the device  268  can be sized and shaped for use on a wider variety of akinetic portions in left ventricles. 
       FIG. 16A  and  FIG. 16B  illustrate a cardiac device  288  according to a further embodiment of the invention. The cardiac device  288  includes a first hub  290 , a first frame  292 , a second hub  294 , a second frame  296 , a first membrane  298 , and a second membrane  300 . The first hub  290  is attached to a central portion of the first frame  292 . A plurality of segments  302  extend radially from and upwards from the first hub  290 . The first membrane  298  is occlusive and made of a thrombogenic material and stretched between the segments  302  to form a first cone-shaped body. A plurality of fibers  304  extend radially from an outer edge  306  of the first cone-shaped body. An active anchor  308  extends down from the first hub  290 . 
     The second frame  296  includes a plurality of segments  310  extending radially and upwardly from the second hub  294  and end in sharp passive anchors  312 . An attachment screw  314 , similar to the detachment screw  164 , extends downwards from the second hub  294 . Referring specifically to  FIG. 16B , the attachment screw  314  is rotated so that it engages a pin  316  within the first hub  290 , similarly to the frame hub  190  already described, to secure the second frame  296  to the first frame  292 . The second membrane  300  is made of ePTFE and stretched between the segments  310  to form a second cone-shaped body. 
       FIG. 16C  illustrates a human heart with the cardiac device  288  of  FIG. 16A  secured to an akinetic portion thereof. The fibers  304  on the outer edge  306  of the first frame  292  are interacting with an inner surface of the left ventricle to seal off the volume below the outer edge  306  of the first frame  292 . The passive anchors  312  on the ends of the segments  310  of the second frame  296  have penetrated the myocardium to hold the device  288  in place. 
     A further advantage of this embodiment is that the fibers  304  of the first membrane  298  interface with trabeculae and further block the flow of blood into the apex of the akinetic portion. 
       FIG. 17A  illustrates a cardiac device  318  according to a further embodiment of the invention. The cardiac device  318  includes proximal  320  and distal  322  hubs, a frame  324 , a stem  326 , a braided structure  328 , and a membrane  330 . The frame  324  includes a plurality of segments  332  extending radially and upwards from the distal hub  322 , and the membrane  330  is stretched between the segments  332  to form a cone-like body having an outer edge  334 . Two extra segments  336  extend across the outer edge  334  of the cone-like body and are connected to and support the proximal hub  320  above the distal hub  322 . The stem  326 , including an active anchor  338 , extends downwards from the distal hub  322 . The braided structure  328  is made of nickel titanium and is connected to a distal end of the stem  326  into the ends of the segments  332 . The segments  332  end in sharp passive anchors  340 . The braided structure  328  may also be made of a biodegradable material or a polymer. 
       FIG. 17B  illustrates a human heart with the cardiac device  318  of  FIG. 17A  having been secured to an akinetic portion thereof. The braided structure  328  presses against an inner surface of the left ventricle. 
     A further advantage of this embodiment is that the braided structure  328  allows the device to “nestle” into position before the active anchor  338  is deployed to secure the device  318  in place. Further advantages are that the braided structure  328  adds structural stability to the device  318  and the nickel titanium of the braided structure  328  provides a mechanism for containing thrombi in the static chamber. 
       FIG. 18A  illustrates a cardiac device  342  according to a further embodiment of the invention. The cardiac device  342  includes proximal  344  and distal  346  hubs, a frame  348 , and a membrane  350 . A plurality segments  352 , having first  354  and second  356  portions, extend upwardly and radially from the distal hub  346  in a curved fashion and are bent and extend inwards to meet at the proximal hub  344 . The membrane  350  is stretched across the segments  352  to form a semi-circular or basket-shaped body. Sharp passive anchors  358  extend from the segments  352  between the first  354  and second  356  portions. 
     Some of the passive anchors  358  extend in a primarily axial direction with a small radial component, and some of the passive anchors  358  extend in a primarily radial direction with a small axial component. Other embodiments may have both types of passive anchors on a single segment. 
       FIG. 18B  illustrates a human heart with the cardiac device  342  of  FIG. 18A  having been installed into an akinetic portion thereof. The segments  352  are pressed against the myocardium because the device is slightly oversized. 
     A further advantage of this embodiment is that because of the size of the device  342  and shape of the segments  352 , the passive anchors  358  are assisted in penetrating the myocardium. A further advantage is that because of the shape of the frame  348 , the device  342  can be retrieved from the left ventricle as long as the device  34  is still attached to the deployment member  46 . A further advantage is that because the entire frame  348  is covered with the membrane  350 , the flow of blood to the apex of the akinetic portion is even further blocked. 
       FIG. 19A  illustrates a cardiac device  360  according to a further embodiment of the invention. The cardiac device  360  includes a frame  362  and a stem  364 . The frame  362  includes a plurality of segments  366  which extend upwardly and radially from the stem  364  and end in a plurality of sharp passive anchors  368 . The stem  364  extends downwards from the frame  362  and includes two suture strands  370  at a distal end thereof. 
       FIGS. 19B ,  19 C, and  19 D illustrate the installation of the cardiac device  360  of  FIG. 16 . While a high pressure is maintained in the left ventricle the catheter tube  38  is inserted through the outer wall into the left ventricle with the cardiac device  360  inserted in the distal end thereof. The catheter  38  is removed from the cardiac device  360 , and the cardiac device  360  expands such that the passive anchors  368  are inserted into the inner surface of the left ventricle. The catheter  38  is then completely removed and the sutures  370  are used to close the insertion made by the catheter  38  and to secure the cardiac device  360  to the akinetic portion. 
       FIGS. 20A ,  20 B, and  20 C illustrate a cardiac device  372  according to a further embodiment of the invention. The cardiac device  372  includes a frame hub  374 , a frame  376 , a membrane  378 , and a stem  380 . The frame hub  374  lies at a central portion of the frame  376 . The frame  376  includes a plurality of segments  382  which extend radially and upwardly from the frame hub  374 . A sharp passive anchor  384  lies at the end of each of the segments  382 . The membrane  378  is stretched between the segments  382  to form a cone-shaped body. Before installation, the stem  380  is unattached to the frame hub  374  and includes a proximal hub  386 , an anchor hub  388 , and a distal hub  390 , each having a pin  392  extending across an inner surface thereof, similar to that of the frame hub  190 . The proximal  386  and distal  390  hubs are frictionally held near their respective ends in the stem  380 , and the anchor hub  388  is loose within the stem  380  so that it may move. An active anchor  394  extends downwards from the anchor hub  388 . 
       FIGS. 20D and 20E  illustrate another embodiment of a distal end  396  of a deployment member  398 . The distal end  396  includes a detachment piece  400  and an attachment hub  402 . The detachment piece  400  has been added to the distal end of the outer torque shaft  152 . The detachment piece  400  is a ring shaped body made of stainless steel with a length of 3 mm and an inner diameter suitable to frictionally hold the attachment hub  402 , which is similar to the frame hub  190 . An attachment screw  404 , similar to the detachment screw  164 , extends downwards from the attachment hub  402 . Referring specifically to  FIG. 20E , forces along the length of the deployment member  398  will, by design, cause the attachment hub  402  to become dislodged from the detachment piece  400 . 
       FIGS. 20F-20H  illustrate installation of the cardiac device  372  of  FIGS. 20A and 20B  into a human heart. In this embodiment, the deployment member used does not include the securing mechanism  166  so that the inner and outer torque shafts may move axially relative to one another. 
     Before the device  372  and stem  380  are inserted into a heart, the inner torque shaft is passed through the frame hub  374 , the proximal hub  386 , and the anchor hub  388 , and the outer torque shaft is positioned and rotated so that the attachment screw  404  engages both the pins  392  of the frame  374  and proximal  386  hubs, securing the cardiac device  372  to the stem  380 . The device  372  and the stem  380  are then retracted into the catheter  38  and steered into a left ventricle. The stem  380  is secured to an apex of an akinetic portion of a left ventricle of the heart by rotating the inner torque shaft, causing the active anchor  394  to penetrate the myocardium. Rotation of the outer torque shaft then causes the attachment screw  404  to disengage the pin  392  of the proximal hub  386 , and the device  372  is released from the stem  380 . However, the inner torque shaft remains engaged with the hubs in the stem  380 . 
     If it is determined that the stem  380  has been properly positioned, the cardiac device  372 , secured to the outer torque shaft, is pushed over the inner torque shaft to meet the stem  380 . The outer torque shaft is again rotated so that the attachment screw  404  reengages the pin  392  on the proximal hub  386  of the stem, thus re-securing the stem  380  to the frame  376 . The deployment member  398  is then forcibly pulled away from the device  372  and the detachment piece  400  releases the attachment screw  404 .  FIG. 201  illustrates the human heart with the cardiac device  372  of  FIGS. 20A and 20B  installed. 
     While certain exemplary embodiments have been described and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative and not restrictive of the current invention, and that this invention is not restricted to the specific constructions and arrangements shown and described since modifications may occur to those ordinarily skilled in the art.