Patent Publication Number: US-10307147-B2

Title: System for improving cardiac function by sealing a partitioning membrane within a ventricle

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This patent application claims priority as a continuation-in-part of U.S. patent application Ser. No. 13/773,235, titled “SYSTEM FOR IMPROVING CARDIAC FUNCTION BY SEALING A PARTITIONING MEMBRANE WITHIN A VENTRICLE,” filed Feb. 21, 2013, now U.S. Patent Publication No. 2013-0165735-A1, which claims priority as a continuation of U.S. patent application Ser. No. 12/422,144, titled “SYSTEM FOR IMPROVING CARDIAC FUNCTION BY SEALING A PARTITIONING MEMBRANE WITHIN A VENTRICLE,” filed Apr. 10, 2009, now U.S. Patent Publication No. 2009-0254195-A1, which is a continuation-in-part application of U.S. patent application Ser. No. 10/436,959, titled “SYSTEM FOR IMPROVING CARDIAC FUNCTION,” filed May 12, 2003, now U.S. Pat. No. 8,257,428, which claims priority as a continuation-in-part of U.S. patent application Ser. No. 09/635,511, titled “DEVICE AND METHOD FOR TREATMENT OF HOLLOW ORGANS,” filed Aug. 9, 2000, now abandoned, which claims priority to Provisional Patent Application No. 60/147,894, titled “EXPANDABLE, IMPLANTABLE DEVICE AND METHOD,” filed Aug. 9, 1999, each of which are herein incorporated by reference in their entirety. 
     U.S. patent application Ser. No. 12/422,144 also claims priority as a continuation-in-part application of U.S. patent application Ser. No. 11/151,164, titled “PERIPHERAL SEAL FOR A VENTRICULAR PARTITIONING DEVICE,” filed Jun. 10, 2005, now U.S. Pat. No. 7,582,051, which is herein incorporated by reference in its entirety. 
     This application claims priority as a continuation-in-part of U.S. patent application Ser. No. 14/448,778, titled “THERAPEUTIC METHODS AND DEVICES FOLLOWING MYOCARDIAL INFARCTION,” filed Jul. 31, 2014, now U.S. Patent Publication No. 2014-0343356-A1, which is a continuation of U.S. patent application Ser. No. 13/973,868, filed Aug. 22, 2013, titled “THERAPEUTIC METHODS AND DEVICES FOLLOWING MYOCARDIAL INFARCTION,” now U.S. Pat. No. 8,827,892, which is a continuation of U.S. patent application Ser. No. 12/129,443, filed May 29, 2008, titled “THERAPEUTIC METHODS AND DEVICES FOLLOWING MYOCARDIAL INFARCTION,” now U.S. Pat. No. 8,529,430, which is a continuation-in-part of U.S. patent application Ser. No. 11/199,633, filed Aug. 9, 2005, titled “METHOD FOR TREATING MYOCARDIAL RUPTURE,” now U.S. Patent Application Publication No. 2006-0229491-A1, now abandoned, which is a continuation-in-part of U.S. application Ser. No. 10/212,032, filed Aug. 1, 2002, titled “METHOD FOR IMPROVING CARDIAC FUNCTION,” now U.S. Pat. No. 7,279,007, each of which is herein incorporated by reference in its entirety. 
     U.S. patent application Ser. No. 12/129,443 also claims priority to U.S. Provisional Patent Application No. 60/985,171, filed Nov. 2, 2007, titled “ENDOCARDIAL DEVICE FOR IMPROVING CARDIAC FUNCTION,” which is herein incorporated by reference in its entirety. 
    
    
     INCORPORATION BY REFERENCE 
     All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
     FIELD 
     The devices, systems and methods described herein relate generally to the treatment of heart disease, particularly congestive heart failure, and more specifically, to devices, systems and methods for partitioning a patient&#39;s heart chamber and a system for delivering the treatment device. 
     BACKGROUND 
     Congestive heart failure (CHF) is characterized by a progressive enlargement of the heart, particularly the left ventricle and is a major cause of death and disability in the United States. Approximately 550,000 new cases occur annually in the U.S. alone. As the patient&#39;s heart enlarges, it cannot efficiently pump blood forward with each heartbeat. In time, the heart becomes so enlarged the heart becomes ineffective as a pump and cannot adequately supply blood to the body. Even in healthy hearts only a certain percentage of the blood in a patient&#39;s left ventricle is pumped out or ejected from the chamber during each stroke of the heart. The pumped percentage, commonly referred to as the “ejection fraction”, is typically about sixty percent for a healthy heart. A patient with congestive heart failure can have an ejection fraction of less than 40% and sometimes much lower. As a result of the low ejection fraction, a patient with congestive heart failure is fatigued, unable to perform even simple tasks requiring exertion and experiences pain and discomfort. Further, as the heart enlarges, the internal heart valves such as the mitral valve cannot adequately close. An incompetent mitral valve allows regurgitation of blood from the left ventricle back into the left atrium, further reducing the heart&#39;s ability to pump blood forwardly. 
     Congestive heart failure can result from a variety of conditions, including viral infections, incompetent heart valves (e.g., mitral valve), ischemic conditions in the heart wall or a combination of these conditions. Prolonged ischemia and occlusion of coronary arteries can result in myocardial tissue in the ventricular wall dying and becoming scar tissue. Once the myocardial tissue dies, it is less contractile (sometimes non-contractile) and no longer contributes to the pumping action of the heart. It is referred to as hypokinetic or akinetic. As the disease progresses, a local area of compromised myocardium may bulge out during the heart contractions, further decreasing the heart&#39;s ability to pump blood and further reducing the ejection fraction. In this instance, the heart wall is referred to as dyskinetic. The dyskinetic region of the heart wall may stretch and eventually form an aneurysmic bulge. 
     Patients suffering from congestive heart failure are commonly grouped into four classes, Classes I, II, III and IV. In the early stages, Classes I and II, drug therapy is presently the most common treatment. Drug therapy typically treats the symptoms of the disease and may slow the progression of the disease, but it cannot cure the disease. Presently, the only permanent treatment for congestive heart disease is heart transplantation, but heart transplant procedures are very risky, extremely invasive and expensive and are performed on a small percentage of patients. Many patients do not qualify for heart transplant for failure to meet any one of a number of qualifying criteria, and, furthermore, there are not enough hearts available for transplant to meet the needs of CHF patients who do qualify. 
     Substantial effort has been made to find alternative treatments for congestive heart disease. For example, surgical procedures have been developed to dissect and remove weakened portions of the ventricular wall in order to reduce heart volume. This procedure is highly invasive, risky and expensive and is commonly only done in conjunction with other procedures (such as heart valve replacement or coronary artery by-pass graft). Additionally, the surgical treatment is usually only offered to Class III and IV patients and, accordingly, is not an option for most patients facing ineffective drug treatment. Finally, if the procedure fails, emergency heart transplant is the only presently available option. 
     Mechanical assist devices have been developed as intermediate procedures for treating congestive heart disease. Such devices include left ventricular assist devices and total artificial hearts. A left ventricular assist device includes a mechanical pump for increasing blood flow from the left ventricle into the aorta. Total artificial heart devices, such as the Jarvik heart, are usually used only as temporary measures while a patient awaits a donor heart for transplant. 
     Recently, improvements have been made in treating patients with CHF by implanting pacing leads in both sides of the heart in order to coordinate the contraction of both ventricles of the heart. This technique has been shown to improve hemodynamic performance and can result in increased ejection fraction from the right ventricle to the patient&#39;s lungs and the ejection fraction from the left ventricle to the patient&#39;s aorta. While this procedure has been found to be successful in providing some relief from CHF symptoms and slowed the progression of the disease, it has not been able to stop the disease and is only indicated in patients with ventricular dissynchrony. 
     Other efforts to treat CHF include the use of an elastic support, such as an artificial elastic sock, placed around the heart to prevent further deleterious remodeling. 
     Described herein are ventricular partitioning devices that address many of the problems associated with devices that reduce heart volume or modify cardiac contraction. In particular, the devices, systems and methods described herein may reduce volume in a ventricle in a way that avoids leakage or the release of potentially thrombogenic materials. 
     Further, the present invention relates generally to the field of treating heart disease, particularly preventing remodeling following myocardial infarction. 
     When normal blood supply to myocardium is stopped due to occluded coronary artery, affected heart muscle cells get severely damaged and/or die, i.e., the myocardium (heart muscle) becomes infracted. This may result in permanent damage to the heart, reduced effectiveness of the heart pumping ability, and is frequently followed by enlargement of the heart and symptoms of heart failure. 
     An acute myocardial infarction (AMI) may lead to severe myocardial damage resulting in myocardial rupture. Mortality rates for myocardial rupture are extremely high unless early diagnosis and surgical intervention are provided rapidly. Cardiac rupture is a medical emergency. The overall risk of death depends on the speed of the treatment provided, therefore fast and relatively easy treatment option is needed. 
     Myocardial regions affected by infarction may change size and shape, i.e., remodels, and in many cases non-affected myocardium remodels as well. The infracted region expands due to the forces produced by the viable myocardium. Whether these changes become permanent and progress to involve infracted border zones and remote non-infarcted myocardium may depend on multiple factors, including infarct size, promptness of reperfusion, post-infarction therapy, etc. However, even following small infarction, many patients treated with the state-of-the-art therapies show some degree of regional and subsequent global ventricular shape changes and enlargement. Early infarct expansion results from degradation of the extracellular collagen framework that normally provides myocardial cells coupling and serves to optimize and evenly distribute force development within the ventricular walls. In the absence of extracellular matrix, the infracted region becomes elongated, may increase in radius of curvature, and may start thinning which involves the process of myocyte “slippage”. These changes may cause an immediate increase in the radius of curvature of adjacent border zone myocardium also result in the increase in the border zone wall stress. The cumulative chronic effect of these changes is the stress elevation within the ventricular walls, even in the non-infarcted myocardium. Increased stress, in turn, leads to progressive ventricular dilatation, distortion of ventricular shape, mural hypertrophy and more myocardial stress increase, ultimately causing deterioration of the heart pump function.  FIG. 38  shows a summary flowchart illustrating the effects of acute myocardial infarction. Once myocardial infarction has occurred, myocardial cells undergo cell death resulting in expansion of the damaged or infarcted region. Among other effects, myocardial infarction then results in ventricle dilation and remodeling. 
     Therapies for treatment of disorders resulting from cardiac remodeling (or complications of remodeling) are highly invasive, risky and expensive, and are commonly only done in conjunction with other procedures (such as heart valve replacement or coronary artery by-pass graft). These procedures are usually done several months or even years after the myocardial infarction when hear is already dilated and functioning poorly. Thus, it would be beneficial to treat myocardial infarction prior to remodeling. 
     Described herein are methods and devices which may be used for the immediate and early treatment of myocardial infarction. Cardiac rupture post myocardial infarction needs to be treated immediately. The early and rapid appearance of infarct and border zone lengthening and early infarct expansion may be prevented by the early treatments described herein to prevent or attenuate initial myocardial infarct region expansion early after myocardial infarction. These methods and implants may provide an immediate mechanical effect to prevent or attenuate ventricular remodeling, and may also be used in conjunction with therapeutic agents and/or cells to the cardiac endothelium. 
     SUMMARY OF THE DISCLOSURE 
     The present invention is directed to ventricular partitioning devices, systems and methods of employing ventricular partitioning devices in the treatment of a patient with heart disease and particularly congestive heart failure (CHF). Specifically, the devices described herein partition a chamber of the patient&#39;s heart into a main productive portion and a secondary non-productive portion, and form a seal between the two portions. In some variations, the devices include a separate chamber that is configured to fit within the non-productive portion. Partitioning reduces the total volume of the heart chamber, reduces the stress applied to weakened tissue of the patient&#39;s heart wall and, as a result, improves the ejection fraction thereof. Moreover, the expansive nature of the device improves the diastolic function of the patient&#39;s heart. 
     In general, the partitioning devices described herein have a reinforced partitioning component with a concave, pressure receiving surface which defines in part the main productive portion of the partitioned heart chamber when secured within the patient&#39;s heart chamber. The reinforced partitioning component may include a flexible membrane that forms the pressure receiving surface. The partitioning component may be reinforced by a radially expandable frame component formed of a plurality of ribs. The ribs of the expandable frame may have secured distal ends, which are preferably secured to a central hub, and free proximal ends. The distal ends of the ribs may be secured to the central hub to facilitate radial self expansion of the free proximal ends of the ribs away from a centerline axis. The distal ends of the ribs may be pivotally mounted to the hub and biased outwardly or fixed to the hub. The ribs are preferably formed of material such as superelastic NiTi alloy which allows for compressing the free proximal ends of the ribs toward a centerline axis into a contracted configuration for delivery and self-expansion when released for deployment to an expanded configuration when released within the patient&#39;s heart chamber. 
     The free ends of the ribs may be configured to engage and preferably penetrate the tissue lining the heart chamber to be partitioned so as to secure the peripheral edge of the partitioning component to the heart wall and fix the partitioning component within the chamber so as to partition the chamber in a desired manner. The tissue penetrating proximal tips may be configured to penetrate the tissue lining at an angle approximately perpendicular to a center line axis of the partitioning device. The tissue penetrating proximal tips of the ribs may be provided with barbs, hooks and the like which prevent withdrawal from the tips from the heart wall. 
     The portioning devices described herein may also include a sealing element (or sealing elements) configured to seal the device (which may be separately secured to the heart wall) to the heart wall. For example, the device may include an expansive member such as one or more strands, swellable pads, inflatable balloons, or the like, that extend between at least one pair of adjacent ribs at or close to the outer edge or periphery of the membrane to seal the membrane to the heart wall. For example, the sealing element may exert pressure to the flexible membrane periphery when the partitioning device is in an expanded configuration to ensure an adequate seal between the membrane periphery and the lining of the heart wall. In one embodiment, a single strand or strands extend around essentially the entire periphery of the membrane so that the flexible periphery of the membrane between each pair of ribs is effectively sealed against the heart wall. The expansive strand or strands may be formed of material which is stiffer than the flexible, unsupported material of the membrane to provide an outward expansive force or thrust to prevent formation of inwardly directed folds or wrinkles when the ribs of the partitioning device are in at least a partially contracted configuration. Suitable strand or strands are formed of material such as polypropylene suture or superelastic NiTi alloy wires. Such strands may typically be about 0.005 to about 0.03 inch (0.13-0.76 mm) in diameter to provide the requisite outward expansive force when placed in a circular position such as around the periphery of the membrane in less than completely expanded configuration. 
     In another embodiment expandable pads are provided between each adjacent pair of ribs which are configured to swell upon contact with body fluids to provide an outward expansive force or thrust, as above, to prevent formation of inwardly directed folds or wrinkles when the ribs of the partitioning device are in at least a partially contracted configuration. Preferably the pads are formed of expansive hydrophilic foam. Suitable swellable materials includable collagen, gelatin, polylactic acid, polyglycolic acid, copolymers of polylactic acid and polyglycolic acid, polycaprolactone, mixtures and copolymers thereof. Other suitable swellable bioresorbable polymeric materials may be employed. The expandable pads may be formed so as to deliver a variety of therapeutic or diagnostic agents. 
     In some variations, the ribs in their expanded configuration typically angle outwardly from the hub and the free proximal ends curve outwardly so that the membrane secured to the ribs of the expanded frame forms a trumpet-shaped, pressure receiving surface. 
     The partitioning membrane in the expanded configuration may have radial dimensions from about 10 to about 160 mm, preferably about 25 to about 50 mm, as measured from the center line axis. The membrane is preferably formed of flexible material or fabric such as expanded polytetrafluoroethylene (ePTFE). 
     The partitioning device may be designed to be oversized with respect to the chamber in which it is to be deployed so that the ribs of the device apply an outward force against the chamber wall. When the partitioning device is collapsed for delivery, the outwardly biased strand or strands ensures that there are no inwardly directed folds or wrinkles and that none are formed when the partitioning device is expanded for deployment within the heart chamber. 
     In one partitioning device design, the free ends of the expansive strand or strands may be secured together or to the partitioning device. Alternatively, in another device design, the expansive strand or strands may be long enough so that one or both free ends thereof extend out of the patient to facilitate collapse and retrieval of the partitioning device. Pulling on the free ends of the strand extending out of the patient closes the expanded portion i.e., the ribs and membrane, of the partitioning device to collapse of the device and such pulling can pull the collapsed partitioning device into the inner lumen of a guide catheter or other collecting device 
     The reinforced partitioning component may include a supporting component or stem which has a length configured to extend distally to the heart wall surface to support the partitioning device within the heart chamber. For example, the supporting component may have a plurality of pods or feet, preferably at least three, which distribute the force of the partitioning device about a region of the ventricular wall surface to avoid immediate or long term damage to the tissue of the heart wall, particularly compromised or necrotic tissue such as tissue of a myocardial infarct (MI) and the like. Pods of the support component may extend radially and preferably be interconnected by struts or planes which help distribute the force over an expanded area of the ventricular surface. 
     Any of the partitioning devices described herein may be delivered percutaneously or intraoperatively. Thus, methods of delivery and devices for delivering them are also described herein. For example, one delivery catheter which may be used has an elongated shaft, a releasable securing device on the distal end of the shaft for holding the partitioning device on the distal end and an expandable member such as an inflatable balloon on a distal portion of the shaft proximal to the distal end to press the interior of the recess formed by the pressure receiving surface to ensure that the tissue penetrating tips or elements on the periphery of the partitioning device penetrate sufficiently into the heart wall to hold the partitioning device in a desired position to effectively partition the heart chamber. For example, one variation of a suitable delivery device is described in patent application Ser. No. 10/913,608, titled “VENTRICULAR PARTITIONING DEVICE,” filed Aug. 5, 2004, now U.S. Patent Publication No. 2006-0030881-A1, now abandoned and assigned to the present assignee. 
     For example, described herein are devices for partitioning a patient&#39;s ventricle into a productive portion and a non-productive portion, the device comprising: a membrane and a membrane support frame sized to span the patient&#39;s ventricle, wherein the membrane support frame comprises a plurality of support struts configured to have a collapsed and an expanded configuration; at least one securing element extending from the periphery of the membrane; and an inflatable sealing element on a peripheral portion of the membrane configured to seal the peripheral portion of the membrane to a wall of the ventricle. 
     In general, the inflatable sealing element includes swellable sealing elements. A swellable sealing element typically inflates from a smaller profile to a larger (swelled or inflated) profile. Any of the inflatable sealing elements described herein may be considered expansive members that expand in order to secure and/or seal the membrane of the devices against a wall of a heart chamber. In some variations, the inflatable sealing element extends annularly around the perimeter of the membrane. For example, the inflatable sealing element may be a plurality of inflatable sealing elements extending between the support struts. 
     The membrane support frame may be configured to form a recess in the expanded configuration. 
     Any of the devices described herein may also include a valve configured to allow access to the non-productive portion when the device is deployed in the subject&#39;s ventricle. In some variations, the valve comprises a one-way valve. 
     The membrane may be formed at least in part of a flexible material. 
     The devices described herein may also include an inflation valve fluidly connected to the inflatable sealing element. 
     The inflatable sealing element may be formed of any appropriate material, in particular, the inflatable sealing element may be formed of a bioabsorbable material. In some variations, the bioabsorbable material is selected from the group consisting of collagen, gelatin, polylactic acid, polyglycolic acid, copolymers of polylactic acid and polyglycolic acid, polycaprolactone, mixtures and copolymers thereof. 
     Any of the partitioning devices described herein may also include a central hub to which the membrane support frame is secured, and/or a stem with a non-traumatic distal tip configured to engage a region of the chamber defining in part the non-productive portion thereof. The securing elements may be anchors, and may be tissue penetrating. For example, the securing elements may have a tissue penetrating tip. The securing element(s) may be outwardly curved. 
     In some variations, the partitioning device may also include one or more containers secured to the device that may be filled once the device is inserted into the ventricle. For example, the device may include a container secured to the device and configured to be positioned within the non-productive portion of the subject&#39;s ventricle when the device is deployed in the subject&#39;s ventricle. The container may be a bag having flexible walls, or it may have rigid or semi-flexible walls. The container may be collapsed or foldable. In some variations the membrane connected to the support frame forms a wall or portion of the container. Thus, the container may extend from the membrane and/or support frame distally, so that it may be positioned within the non-productive portion of the ventricle when the device is deployed. Portions of the device may be contained within the container. For example, a stem portion, a foot portion, etc. may be positioned within the container. The container may be expandable. For example, the container may be a flexible or stretchable fabric. The container may be configured to hold a fluid or solid. Thus, in some variations the container is configured to be fluid-tight. In some variations the container may be filled with a fluid such as saline, blood, etc. In other variations, the container may be permeable or semi-permeable. 
     Also described herein are methods for treating a patient, including a patient having a heart disorder, or at risk for a heart disorder. The method may include the steps of: percutaneously advancing a contracted partitioning device into a patient&#39;s ventricle; expanding the partitioning device into a deployed configuration within the ventricle; and sealing the expanded partitioning component to the wall of the ventricle to separate the ventricle into a productive portion and a non-productive portion to prevent communication between the productive portion and non-productive portions. 
     The method may also include the step of filling the non-productive portion. For example, the non-productive portion may be filled with a bio-resorbable filler such as polylactic acid, polyglycolic acid, polycaprolactone and copolymers and blends. In some variations, the filler is an occlusive material such as a coil (e.g., vasoocclusive coil) or the like. Fillers may be suitably supplied in a suitable solvent such as dimethylsulfoxide (DMSO). Other materials which accelerate tissue growth or thrombus may be deployed in the non-productive portion, as well as non-reactive fillers. 
     The sealing step may include expanding a sealing element against the ventricle wall from the partitioning device. The sealing step may include the step of biasing a membrane toward the heart wall with the sealing element. For example, the expanding step may include inflating the sealing element. In some variations, the sealing element may be actively expanded (e.g., by applying air or other fluids), or passively expanded (e.g., by allowing swelling). 
     Also described herein are methods of treating a patient comprising the steps of: percutaneously advancing a contracted partitioning device into a patient&#39;s ventricle; expanding the partitioning device into a deployed configuration within the ventricle; securing the expanded partitioning device to the ventricle wall to separate the ventricle into a productive portion and a non-productive portion; and adding a filling material to the non-productive portion. 
     In some variations, the step of adding a filling material includes applying material through a valve on the partitioning device. The valve may be a one-way valve. The material may be applied through a channel in the applicator. For example, the applicator may engage with a valve on or through the device. In some variations, the device is passively filled. For example, one or more valves may allow the entry of blood flow behind the device, but may prevent the blood (or any thrombosis) from exiting the non-productive space behind the valve. Thus the step of adding the filing material may include passively allowing a blood to fill a compartment portion of the partitioning device through a valve on the device. 
     In some variations, the step of adding a filling material includes applying a filling material into a compartment portion of the partitioning device through a valve. As mentioned above the compartment may be filled with any appropriate filling material, including fluids, solids, or some combination thereof. For example, the step of adding a filling material may include applying one or more coils to the non-productive portion. The coils (e.g., vasooccluisve coils) or other filling material may be added to a compartment portion of the partitioning device. The step of adding the filing material may comprise applying saline to a compartment portion of the partitioning device. 
     Also described herein are applicators for applying a partitioning device of a ventricle of a patient&#39;s heart. An applicator may include: an elongated shaft which has proximal and distal ends; an deploying inflation port on the proximal end of the shaft and an inner lumen in fluid communication with the port; a releasable securing element on the distal end of the elongated shaft configured to secure and release the partitioning device; an inflatable member on a distal portion of the elongated shaft having an interior in fluid communication with the deploying inflation port, wherein the inflatable member is configured to expand a membrane of the partitioning device; and a filling interface near the distal end of the elongated shaft, wherein the filling interface is configured to apply a filling material through a valve on the partitioning device. 
     One particular variation of the devices for partitioning a patient&#39;s ventricle into a product and non-productive portion includes an inflatable sealing element that is a balloon element. For example, described herein are devices for partitioning a patient&#39;s ventricle into a productive portion and a non-productive portion. Such devices may include a membrane and a membrane support frame sized to span the patient&#39;s ventricle, wherein the membrane support frame comprises a plurality of support struts configured to have a collapsed and an expanded configuration, at least one securing element extending from the periphery of the membrane, and an inflatable sealing balloon element on a peripheral portion of the membrane configured to seal the peripheral portion of the membrane to a wall of the ventricle. 
     As mentioned above, the inflatable sealing balloon element may extend substantially around the perimeter of the membrane. In some variations, the partitioning devices include a plurality of inflatable sealing balloon elements extending between support struts. 
     A partitioning device may also include an inflation port configured to connect the inflatable sealing balloon element to a channel on a delivery device. The devices may also include an inflation valve fluidly connected to the inflatable sealing element. 
     As mentioned above, the securing element(s) of the partitioning device may have a tissue penetrating tip. 
     These partitioning devices may also include a container secured to the device and configured to be positioned within the non-productive portion of the subject&#39;s ventricle when the device is deployed in the patient&#39;s ventricle. 
     Also described herein are devices for partitioning a ventricle of a patient&#39;s heart into a productive portion and a non-productive portion that include: a membrane and a membrane support frame, the membrane and the membrane support frame sized to span the patient&#39;s ventricle, wherein the membrane and the membrane support frame are configured to have a collapsed configuration and an expanded configuration; at least one securing element on a peripheral portion of the membrane configured to secure the membrane to a wall of the ventricle; and a container secured to the device and configured to be positioned within the non-productive portion of the subject&#39;s ventricle when the device is deployed in the subject&#39;s ventricle. The container may be secured to the membrane. In some variations, the membrane forms a wall or portion of the container. The container may extend from a peripheral portion of the membrane. 
     The container may be configured to substantially conform to the ventricular wall. For example, the container may be fillable so that it contacts all or a portion of the ventricle wall in the non-productive portion of the ventricle. In some variations, the container is configured as a bag. 
     As mentioned above, the container may be expandable, or it may have a fixed volume. The container may be made of a flexible material. In some variations, the container comprises one or more rigid walls. The container may be permeable or impermeable. In general, the container may be fillable. For example, the container may be configured to be filled with a fluid. In some variations, the container is configured to be filled with one or more coils or other occlusive members. The devices described herein may include a valve providing access into the container. For example, the valve may be configured to permit filling, but not emptying of the container. Thus, in one variation the valve is a one-way valve configured to allow the container to passively fill with blood from the ventricle. In some variations, the container may be configured so that the valve can permit emptying. 
     Any of the features of the partitioning devices described herein may be included as part of the portioning devices including a container. For example, the devices may include a central hub, a stem, a foot (e.g., an atraumatic foot), or the like. In some variations the device may be configured so that one or more of these elements is contained within the container. 
     Also described herein are methods of treating a patient comprising: percutaneously advancing a contracted partitioning device into a patient&#39;s ventricle; expanding the partitioning device into a deployed configuration within the ventricle; sealing the expanded partitioning component to the wall of the ventricle to separate the ventricle into a productive portion and a non-productive portion to prevent communication between the productive portion and non-productive portions; and filling a container portion of the implant that is secured within the non-productive portion of the ventricle. 
     The step of filling may comprise filling the container portion with an occlusive device, or with some other solid and/or liquid material, e.g., saline. 
     Also described herein are applicators for applying a partitioning device to a ventricle of a patient&#39;s heart, the applicator comprising: an elongated shaft which has proximal and distal ends; a deploying inflation port and a sealing inflation port on the proximal end of the shaft; an inner lumen in fluid communication with at least one of the ports; a releasable securing element on the distal end of the elongated shaft configured to secure and release the partitioning device; an inflatable member on a distal portion of the elongated shaft having an interior in fluid communication with the deploying inflation port; and a sealing inflation interface near the distal end of the elongated shaft in fluid communication with the sealing inflation port, wherein the sealing inflation interface is configured to couple to an inflatable sealing element of the partitioning device. 
     Other variations of partitioning devices having one or more chambers are also described herein. For example, described herein are ventricular chamber volume reduction systems, comprising: a container body deliverable into a portion of a ventricular chamber, and wherein the container body is expandable from a first shape to a second shape when delivered into the ventricular chamber, the container body having a tissue surface in contact with a wall of the ventricular chamber and an exposed surface facing into the volume of the ventricular chamber not occupied by the container body, and wherein the exposed surface substantially spans across the ventricular chamber, wherein the second shape of the container body occupies substantially all of the space in the ventricular chamber between the wall of the portion of the ventricular chamber and the exposed surface, thereby reducing ventricular volume exposed to a flow of blood. In some variations, these devices also include a partition, wherein the partition is positioned on the side of the container adjacent to the exposed surface. 
     As mentioned above, the second shape of the container body may occupy substantially all of the space in the ventricular chamber between the wall of the portion of the ventricular chamber and the exposed surface. For example, when the device is filled with material, one or more walls of the device may contact the sides of the ventricle in the non-productive portion of the ventricle. 
     The container body may include an attachment device that affixes the tissue surface to the wall of the ventricular chamber. For example, the container body may include one or more anchors, hooks, barbs or the like. In some variations, the container body may include one or more struts or arms that apply pressure to secure the tissue surface to a wall of the ventricular chamber. In some variations the chamber body may be sealed against the wall of the ventricular chamber by expanding or inflating an inflatable member, as described above. The inflatable member may be present with the container. In some variations, the expandable member is present on the outside of the container. The container may also be expandable and/or inflatable. 
     A partitioning device embodying features of the invention may be relatively easy to install and may be a substantially improved treatment of a diseased heart. A more normal diastolic and systolic movement of a patient&#39;s diseased heart may thus be achieved. Concomitantly, an increase in the ejection fraction of the patient&#39;s heart chamber can be obtained. 
     Described herein are methods, devices and systems for treatment the heart following myocardial infarction. In general, these methods typically require the application of a treatment device that supports and/or isolates the infracted region of the heart within about 72 hours of the ischemic event. These methods may be used, for example, to treat a portion of the left ventricle that is affected by myocardial infarction. 
     In general, a treatment device may be a support device that provides mechanical support to the region of the heart affected by the myocardial infarction, and/or a partitioning device (e.g., including a membrane) that at least partially isolates the region of the heart chamber affected by the myocardial infarction and/or cardiac rupture. In some variations the treatment device is both a support device and a partitioning device. 
     For example, described herein is a method of preventing cardiac rupture following myocardial infarction comprising delivering a device to a heart chamber exhibiting myocardial infarction within 72 hours of myocardial infarction (wherein the device comprises a reinforced membrane) and deploying the device in the chamber adjacent the region of the chamber wall exhibiting myocardial infarction. 
     The method may also include the step of identifying the region of the heart chamber exhibiting myocardial infarction. Any appropriate method of identifying the region of the heart chamber exhibiting the myocardial infarction may be used, including visual inspection, electrical inspection, imaging by echocardiography, magnetic resonance or computerized tomography, or the like. For example, electrical inspection may be performed by the use of ECG measurements and analysis, or the use of electrodes on or around the heart tissue. Visual inspection may be done using direct (light) visualization, or by labeling for markers or reactivity. For example, ultrasound may be used to identify region of the heart affected by the myocardial infarction. 
     As mentioned, a treatment device may include a membrane (e.g., a reinforced membrane). The membrane may be non-porous or porous to allow fluid (including blood) exchange across it. The device may include an expandable frame. The membrane may be attached or connected to the expandable frame. The expandable frame may be formed of an elastic or superelastic material, such as a shape memory material (e.g., Nitinol™, or other superelastic materials). The expandable frame may be formed of a plurality of struts that extend from a hub. The device may also include a foot (e.g., a non-traumatic foot) for contacting the wall of the chamber. In some variations the device is configured so that only minimal (if any) space is partitioned. 
     The step of delivering the device may include delivering the device in a collapsed configuration. In general, the delivery step may include the step of delivering the device in a collapsed state through a catheter or other inserter. Thus, the device may be held in a first, collapsed or delivery, configuration and may be deployed by expanding into the deployed configuration. The device may be self-expanding, or it may be expanded using a mechanical expander such as a balloon or other structure. Thus, the step of delivering the device may include using a delivery catheter. 
     When a device is used to treat the heart, the device may be sealed about the periphery of the membrane of the device against the chamber wall of the heart being treated. Any appropriate sealing technique may be used. For example, the device may include a seal region, e.g., an expandable, inflatable, or other region. Examples of devices including a seal are provided herein, and may also be found, for example, in US Patent Publication No. 2006/0281965, herein incorporated by reference in its entirety. 
     The step of deploying the device may therefore also include isolating the region of the chamber wall exhibiting myocardial infarction from the rest of the chamber. 
     The step of deploying the device may also comprise partitioning the heart chamber into a main productive portion and a secondary non-productive portion, with the region of the chamber exhibiting myocardial infarction or cardiac rupture forming a part of the secondary non-productive portion. 
     In some variations the treatment device may include anchors or attachments for securing the device to the wall of the heart chamber. For example, the device may include hooks and/or barbs on the membrane and/or expandable frame. Thus, the methods of preventing remodeling due to myocardial infarction may include the step of securing or anchoring the device to the heart wall. In particular, the device may be anchored or secured to the heart wall over the region of myocardial infarction. 
     One or more therapeutic agents may also be delivered to the heart tissue (e.g., the heart wall) from the device. For example, the device may be coated or impregnated with a therapeutic material. In some variations a therapeutic material is added to the heart chamber after the device is inserted, for example in the space between the device and the heart wall. 
     Also described herein are methods of preventing cardiac remodeling following myocardial infarction comprising the step of: delivering a device to a left ventricle within 72 hours of myocardial infarction (wherein the device comprises a reinforced membrane) and deploying the device in the left ventricle adjacent a region of the left ventricle exhibiting myocardial infarction. 
     Also described herein are methods of preventing cardiac remodeling following myocardial infarction. These methods may include delivering a support device to a heart chamber exhibiting myocardial infarction within 72 hours of myocardial infarction (wherein the support device comprises a an expandable frame) and deploying the support device in the chamber adjacent the region of the chamber wall exhibiting myocardial infarction. As mentioned, the method may also include the step of identifying the region of the heart chamber exhibiting myocardial infarction. 
     The step of delivering the support device may comprise delivering the support device in a collapsed configuration. The support device may be any of the treatment devices described herein; for example, the support devices may be a device having a plurality of struts extending from a central hub. The support device may include a reinforced membrane (which may be impermeable, or permeable, or semi-permeable). The support device may include a foot (e.g., a non-traumatic foot), or a non-traumatic hub. 
     The step of deploying the support device may include securing the support device to the wall of the chamber. In general, the treatment devices described herein may dynamically flex as the wall of the chamber moves. For example, the support device may be made of a material (e.g., a shape memory alloy) that supports the wall, and flexes as the heart beats. 
     These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an elevational view of a partitioning device embodying features of the invention in an expanded configuration. 
         FIG. 2  is a plan view of the partitioning device shown in  FIG. 1  illustrating the upper surface of the device. 
         FIG. 3  is bottom view of the partitioning device shown in  FIG. 1 . 
         FIG. 4  is a perspective view of the non-traumatic tip of the distally extending stem of the device shown in  FIG. 1 . 
         FIG. 5  is a partial cross-sectional view of the hub of the partitioning device shown in  FIG. 2  taken along the lines  5 - 5 . 
         FIG. 6  is a transverse cross sectional view of the hub shown in  FIG. 5  taken along the lines  6 - 6 . 
         FIG. 7  is a longitudinal view, partially in section of a reinforcing rib and membrane at the periphery of the partitioning device shown in  FIG. 1 . 
         FIG. 8  is a schematic elevational view, partially in section, of a delivery system with the partitioning device shown in  FIGS. 1 and 2  mounted thereon. 
         FIG. 9  is a transverse cross-sectional view of the delivery system shown in  FIG. 8  taken along the lines  9 - 9 . 
         FIG. 10  is an elevational view, partially in section, of the hub shown in  FIG. 5  being secured to the helical coil of the delivery system shown in  FIG. 8 . 
         FIGS. 11A, 11B, 11C, 11D and 11E  are schematic views of a patient&#39;s left ventricular chamber illustrating the deployment of the partitioning device shown in  FIGS. 1 and 2  with the delivery system shown in  FIG. 8  to partition a patient&#39;s heart chamber (left ventricle) into a primary productive portion and a secondary, non-productive portion. 
         FIG. 12  is a schematic plan view of the deployed device shown in  FIG. 11E  within a patient&#39;s heart chamber. 
         FIG. 13  is a schematic plan view of the partitioning device shown in  FIG. 1  without the expansive strand after deployment within a patient&#39;s heart chamber. 
         FIG. 14  is a partial schematic view of the partitioning device shown in  FIGS. 1 and 2  in a contracted configuration resulting from pulling the free ends of the expansive strand at the periphery of the reinforced membrane. 
         FIG. 15  is a schematic view of the contracted device shown in  FIG. 14  being pulled into an expanded distal end of a receiving catheter to facilitate withdrawal of the partitioning device into a receiving catheter. 
         FIG. 16  is a schematic view of the contracted device shown in  FIG. 14  pulled further into the inner lumen of the receiving catheter. 
         FIG. 17  is a perspective view of the bottom of an alternative partitioning device which has swellable pads disposed between adjacent ribs to press the membrane between the ribs against the heart wall. 
         FIG. 18  is a cross-sectional view of a swellable pad disposed between two membrane layers secured to the ribs of the partitioning device. 
         FIG. 19A  is a cross-sectional side view of a human heart with the catheter inserted therein. 
         FIGS. 19B, 19C, 19D, 19E, 19F, 19G, 19H, 191, 19J and 19K  are cross-sectional side views of the human heart illustrating installation ( FIGS. 19B-19E ), removal ( FIGS. 19E-19H ), and subsequent final installation ( FIGS. 19I-19K ) of the cardiac device. 
         FIG. 20A  is a perspective view of a cardiac device according to a further embodiment of the invention. 
         FIG. 20B  is a cross-sectional side view of the cardiac device of  FIG. 20A . 
         FIG. 20C  is a cross-sectional side view of the human heart with the cardiac device of  FIG. 20A  installed. 
         FIGS. 21A, 21B and 21C  illustrate a variation of a partitioning device having an inflatable seal.  FIG. 21A  shows the device in the collapsed (delivery) configuration, while  FIG. 21B  shows a partially expanded view.  FIG. 21C  shows a partial cut-away view of the device of  FIGS. 21A and 21B . 
         FIGS. 22A and 22B  show a partitioning device having a container configured to be positioned within the non-productive portion of a ventricle when the device is delivered to a ventricular chamber, as illustrated in  FIG. 22B . 
         FIGS. 23A and 23B , respectively, show a bottom and side perspective view of another variation of a partitioning device including a container portion. 
         FIGS. 24A and 24B  show side perspective and top views, respectively of another variation of a partitioning device having both a container and a valved port for filling the container. 
         FIGS. 25A and 25B  illustrate operation of a partitioning device similar to that shown in  FIGS. 24A and 24B . 
         FIG. 26  shows a delivery catheter for a partitioning device having a valved container. 
         FIG. 27  illustrates operation of a delivery catheter similar to the delivery catheter shown in  FIG. 26 . 
         FIG. 28  illustrates one method of implanting a partitioning device as described herein. 
         FIGS. 29A and 29B  illustrate another variation of a method of using a partitioning implant. 
         FIG. 29C  illustrates an alternative method of operating a portioning device similar to the version shown in  FIG. 29B . 
         FIGS. 30A and 30B  show another variation of a partitioning device including an inflatable sealing element. 
         FIGS. 30C and 30D  illustrate operation of the device shown in  FIGS. 30A and 30B . 
         FIGS. 31A and 31B  show another variation of a partitioning device including an inflatable element that may be used to expand the device. 
         FIG. 32A  is a schematic view of a patient&#39;s heart having a myocardial infarct. 
         FIG. 32B  is a schematic view of the patient&#39;s heart of  FIG. 32A  with a ventricular septal defect resulting from a rupture in the heart wall. 
         FIG. 32C  is a schematic view of the patient&#39;s heart of  FIG. 32B  after treatment following rupture of the heart wall. 
         FIG. 32D  is a schematic view of the patient&#39;s heart after immediate early treatment, as described herein. 
         FIG. 33A  is a schematic view of a patient&#39;s heart exhibiting a myocardial infarct with free wall rupture of the left ventricular chamber. 
         FIG. 33B  is a schematic view of the patient&#39;s heart of  FIG. 33A  with a left ventricular chamber tamponade. 
         FIG. 33C  is a schematic view of the patient&#39;s heart of  FIG. 33B  after treatment following development of tamponade. 
         FIG. 34  is a schematic view of the patient&#39;s heart after treatment according to a method of the present invention. 
         FIG. 35A  illustrate one variation of an implant which may be used with the present invention. 
         FIG. 35B  shows another variation of an implant which may be used with the present invention. 
         FIG. 35C  is a schematic view of a heart in which the implant of  FIG. 35A  has been implanted. 
         FIG. 36A  illustrates another variation of an implant which may be used with the present invention. 
         FIG. 36B  is a schematic view of a heart in which the implant of  FIG. 36A  has been implanted. 
         FIGS. 37A and 37B  show another variation of an implant which may be used following acute myocardial infarction. 
         FIGS. 37C and 37D  illustrate a delivery system for delivering an implant such as the implant of  FIGS. 37A and 37B . 
         FIG. 38  schematically illustrates the effects of myocardial infarction. 
         FIGS. 39A and 39B  are schematic illustrations of a heart in which the implant has been applied. 
     
    
    
     DETAILED DESCRIPTION 
     Partitioning devices, systems including partitioning devices, and methods of using partitioning devices to treat subjects are described herein. In general, the partitioning devices described herein are configured to partition a heart chamber, and in particular a ventricular chamber, into a productive portion and a non-productive portion. These partitioning devices may be delivered in a collapsed configuration (e.g., percutaneously), and expanded within the ventricle and secured in position within the ventricle, thereby partitioning it. The partitioning devices described herein both secure to the heart wall (e.g., by anchors, barbs, spikes, etc.) and also (and possibly separately) seal to the heart wall. Sealing to the wall of a heart chamber may be complicated or made difficult by the presence of trabeculations and wall irregularities. Thus, the devices described herein may include one or more sealing elements that are configured to help seal the device (e.g., the partitioning membrane of the device) to the heart wall. 
     The partitioning devices described herein may also be configured so that the non-productive region formed by the partitioning device may be filled after it is deployed. Filling the non-productive portion may prevent leak, and may also help secure the device in position. As described in detail below, any appropriate filling material may be used, including occlusive material such as coils, fluids (saline, blood, etc.), or the like. 
     Also described below are variations of partitioning devices that include one or more containers. A container may be referred to as a compartment, chamber, bag, or the like. Partitioning devices including containers may be deployed into the heart (e.g., in the ventricle), so that the container portion is within (or at least partially forms) the non-productive region. In some variations, portions of the partitioning device are contained within the container. The container may be filled or fillable, and may include one or more ports for filing. The ports may be valved, and may include one-way valves so that the container does not leak. Thus, the container may be fluid-tight. The container may be located distally to the pressure-receiving membrane of the device (which may form a portion or wall of the chamber), and may fill all or most of the non-productive space. In some variations the chamber includes anchors (e.g., hooks, barbs, adhesive, etc.) to secure the chamber to the wall of the ventricle. These anchors may be in addition to other anchors or securing elements on the device (e.g., around the perimeter of the pressure-receiving membrane). 
     For example,  FIGS. 1-4  illustrate one variations of a partitioning device  10  which includes a partitioning membrane (e.g., pressure-receiving membrane)  11 , a hub  12 , preferably centrally located on the partitioning device, and a radially expandable reinforcing frame  13  is secured to the proximal or pressure side of the frame  13  as shown in  FIG. 1 . The ribs  14  have distal ends  15  which are secured to the hub  12  and free proximal ends  16  which are configured to curve or flare away from a center line axis. Radial expansion of the free proximal ends  16  unfurls the membrane  11  secured to the frame  13  so that the membrane presents a pressure receiving surface  17  which defines in part the productive portion of the patient&#39;s partitioned heart chamber. The peripheral edge  18  of the membrane  11  may be serrated as shown. 
     In this example, the device includes a sealing element that is a continuous expansive strand  19  that extends around the periphery of the membrane  11  on the pressure side thereof to apply pressure to the pressure side of the flexible material of the membrane to effectively seal the periphery of the membrane against the wall of the ventricular chamber. The ends  20  and  21  of the expansive strand  19  are shown extending away from the partitioning device in  FIGS. 2 and 3 . The ends  20  and  21  may be left unattached or may be secured together, e.g., by a suitable adhesive or the membrane  11  itself. While not shown in detail, the membrane  11  has a proximal layer secured to the proximal faces of the ribs  14  and a distal layer secured to the distal faces of the ribs in a manner described in U.S. patent application Ser. No. 10/913,608, titled “VENTRICULAR PARTITIONING DEVICE,” filed Aug. 5, 2004, now U.S. Patent Publication No. 2006-0030881-A1, now abandoned. 
     The hub  12  shown in  FIGS. 4 and 5  may connect to a non-traumatic support component  22 . The support component  22  has a stem  23  a plurality of pods or feet  24  extending radially away from the center line axis and the ends of the feet  24  are secured to struts  25  which extend between adjacent feet. A plane of material (not shown) may extend between adjacent feet  24  in a web-like fashion to provide further support in addition to or in lieu of the struts  25 . The inner diameter of the stem  23  is threaded to secure the partitioning device  10  to a delivery catheter as shown in  FIGS. 8-10 . 
     In the variation shown in  FIG. 5 , the distal ends  15  of the ribs  14  are secured within the hub  12  and, as shown in  FIG. 6 , a transversely disposed connector bar  26  may be secured within the hub which is configured to secure the hub  12  to the atraumatic support component  22 . 
     As illustrated in  FIGS. 5 and 6 , the connector bar  26  of the hub  12  allows the partitioning device  10  to be secured to the non-traumatic support component  22  and to be released from the delivery system within the patient&#39;s heart chamber. The distal ends  15  of the reinforcing ribs  14  are secured within the hub  12  in a suitable manner or they may be secured to the surface defining the inner lumen or they may be disposed within channels or bores in the wall of the hub  12 . The distal end of the ribs  14  are pre-shaped so that when the ribs are not constrained, other than by the membrane  11  secured thereto (as shown in  FIGS. 1 and 2 ), the free proximal ends  16  thereof expand to a desired angular displacement away from the centerline axis which is about 20° to about 90°, preferably about 50° to about 80°. The unconstrained diameter of the partitioning device  10  may be greater than the diameter of the heart chamber at the deployed location of the partitioning device so that an outward force is applied to the wall of the heart chamber by the partially expanded ribs  14  during systole and diastole so that the resilient frame  13  augments the heart wall movement. 
       FIG. 7  illustrates the curved free proximal ends  16  of ribs  14  which are provided with sharp tip elements  27  configured to engage and preferably penetrate into the wall of the heart chamber and hold the partitioning device  10  in a deployed position within the patient&#39;s heart chamber so as to partition the ventricular chamber into a productive portion and a non-productive portion. 
       FIGS. 8-10  illustrate one variations of a delivery system  30  for delivering a partitioning device  10  such as the one shown in  FIGS. 1 and 2  into a patient&#39;s heart chamber and deploying the partitioning device to partition the heart chamber as shown in  FIGS. 11A-11E . This example of a delivery system  30  includes a guide catheter  31  and a delivery catheter  32 . 
     The guide catheter  31  has an inner lumen  33  extending between the proximal end  34  and distal end  35 . A hemostatic valve (not shown) may be provided at the proximal end  34  of the guide catheter  31  to seal about the outer shaft  37  of the delivery catheter  32 . In this example, the guide catheter includes a flush port  36  on the proximal end  34  of guide catheter  31  that is in fluid communication with the inner lumen  33 . 
     The delivery catheter  32  has an outer shaft  37  with an adapter  38  on the proximal end thereof having a proximal injection port  39  which is in fluid communication with the interior of the shaft  37 . As shown in more detail in  FIG. 9 , the outer shaft  37  has an inner shaft  41  which is disposed within the interior thereof and is secured to the inner surface of the outer shaft  37  by webs  43  which extend along a substantial length of the inner shaft. The injection port  39  is in fluid communication with the passageways  42  between the inner and outer shafts  41  and  37  respectively and defined in part by the webs  42 . A torque shaft  44 , which is preferably formed of hypotubing (e.g., formed of stainless steel or superelastic NiTi), is disposed within the inner lumen  45  of the inner shaft  41  and has a proximal end  46  secured within the adapter  38 . Balloon inflation port  47  is in fluid communication with the inner lumen  48  of the torque shaft  44 . In some variations, additional passageways may be present in the delivery catheter. For example, a filling passageway may be included that may be used to fill the non-productive region behind the partitioning device with one or more fillers (e.g., coils, fluids, etc.). In some variations, an additional inflation lumen may be included for inflating a sealing element (e.g., a sealing balloon). 
     Torque shaft  44  may be rotatably disposed within the inner lumen  45  of the inner shaft  41  and secured to rotating knob  49 . A helical coil screw  50  may be secured to the distal end  51  of the torque shaft  44  and rotation of the torque knob  49  on the proximal end  46  of the torque shaft  44  rotates the screw  51  to facilitate deployment of a partitioning device  10 . The proximal end  52  of inflatable balloon  53  may be sealingly secured by adhesive  54  about the torque shaft  44  proximal to the distal end  51  of the torque shaft. The balloon  53  may have an interior  55  in fluid communication with the inner lumen  48  of the torque shaft  44 . Inflation fluid may be delivered to the balloon interior  55  through port  47  which is in fluid communication with the inner lumen  48  of the torque shaft  44 . The distal end  56  of the balloon  53  in this example is sealingly secured by adhesive  57  to the helical screw  50 . The proximal and distal ends  52  and  56  of the balloon  53  are blocked by the adhesive masses  54  and  57  to prevent the loss of inflation fluid delivered to the interior  55  of the balloon  53 . Delivery of inflation fluid through a fluid discharge port  58  in the distal end  51  of the torque shaft  44  inflates the balloon  53  which in turn applies pressure to the proximal surface of the partitioning device  10  to facilitate securing the partitioning component  10  to the wall  59  of heart chamber  60  as shown in  FIGS. 11A-11E  discussed below. 
     In the example shown in  FIG. 11A , the partitioning component  10  is delivered through a delivery system  30  which includes a guide catheter  31  and a delivery catheter  32 . The partitioning component  10  is collapsed in a first, delivery configuration which has small enough transverse dimensions to be slidably advanced through the inner lumen  33  of the guide catheter  31 . Preferably, the guide catheter  31  has been previously percutaneously introduced and advanced through the patient&#39;s vasculature, such as the femoral artery, in a conventional manner to the desired heart chamber  60 . The delivery catheter  32  with the partitioning component  10  attached is advanced through the inner lumen  33  of the guide catheter  31  until the partitioning component  10  is ready for deployment from the distal end of the guide catheter  31  into the patient&#39;s heart chamber  60  to be partitioned. 
     As shown in  FIG. 11B , the partitioning component  10  mounted on the screw  50  is urged further out of the inner lumen  33  of the guide catheter  32  until the support component  22  engages the heart wall  59 . The guide catheter  31  is withdrawn while the delivery catheter  32  is held in place until the proximal ends  16  of the ribs  14  exit the distal end  35  of the guide catheter. As shown in  FIG. 11C , the free proximal ends  16  of ribs  14  expand outwardly to press the sharp proximal tips  27  of the ribs  14  against and preferably into the tissue lining the heart wall  59 . 
     With the partitioning component  10  deployed within the heart chamber  60  and preferably partially secured therein, inflation fluid is introduced through the inflation port  58  in the distal end  51  torque shaft  44  where it is directed into the balloon interior  54  to inflate the balloon  53 . The inflated balloon  53  presses against the pressure receiving surface  17  of the membrane  11  of the partitioning component  10  to ensure that the sharp proximal tips  27  are pressed well into the tissue lining the heart wall  59  as shown in  FIG. 11D . 
     In some variations, the partitioning device may include one or more inflatable elements that may be used to expand the device (or assist with expansion), as describe in greater detail below in reference to  FIGS. 30A-30D . Thus, the applicator (e.g., guide and/or delivery catheters) may not include an inflatable balloon  53 . Instead, the applicator may include a connector to connect to the inflatable elements on (e.g., the periphery of) the partitioning device. 
     With the partitioning device  10  properly positioned within the heart chamber  60 , the knob  49  on the torque shaft  44  (as shown in  FIG. 8 ) is rotated counter-clockwise to disengage the helical coil screw  50  of the delivery catheter  32  from the stem  23  secured within hub  12 . The counter-clockwise rotation of the torque shaft  44  rotates the helical coil screw  50  which rides on the connector bar  26  secured within the hub  12 . Once the helical coil screw  50  disengages the connector bar  26 , the delivery system  30 , including the guide catheter  31  and the delivery catheter  32 , may then be removed from the patient. 
     The proximal end  34  of the guide catheter  31  in this example is provided with a flush port  36  to inject fluids such as therapeutic, diagnostic or other fluids through the inner lumen  33  during the procedure. Similarly, the proximal injection port  39  of adapter  38  is in communication with passageways  43  if the delivery catheter  32  for essentially the same purpose. 
     The deployment of the partitioning component  10  in the patient&#39;s heart chamber  60  as shown in  FIG. 11E  divides the chamber into a main productive or operational portion  61  and a secondary, essentially non-productive portion  62 . The operational portion  61  is smaller than the original heart chamber  60  and provides for an improved ejection fraction and an improvement in blood flow. Over time, the non-productive portion  62  may fill first with thrombus and subsequently with cellular growth. Bio-resorbable fillers such as polylactic acid, polyglycolic acid, polycaprolactone and copolymers and blends may be employed to initially fill the non-productive portion  62 . Fillers may be suitably supplied in a suitable solvent such as dimethylsulfoxide (DMSO). Other materials which accelerate tissue growth or thrombus may be deployed in the non-productive portion  62  as well as non-reactive fillers. Fillers may include solid materials or liquid materials, or both, and may include material that expands after being loaded into the non-productive portion or a chamber within the non-productive portion. For example, the filler may be a coil such as a vasoocclusive coil. 
     As described in greater detail below, the partitioning devices described herein may also be sealed against the wall(s) of the heart, so that the material used to fill does not leak (or does not substantially leak. In some variations a chamber (e.g., bag) may also be part of the partitioning device and may be positioned within the non-productive portion and be filled by the filler. 
       FIG. 12  is a top view of the deployed partitioning device shown in  FIG. 11E  schematically illustrating the sealed periphery of the membrane  11  against the ventricular wall. This is to be compared with the schematic presentation shown in  FIG. 13  which illustrates a partitioning device without a sealing element such as a strand (or other expandable sealing element) having folds along the periphery  18  which do not allow for an effective seal against the wall  59  of the heart chamber  60 . The partitioning device  10  may be conveniently formed by the method described in application Ser. No. 10/913,608, filed Aug. 5, 2004, which is incorporated herein by reference. 
     While porous ePTFE material is preferred, the membrane  11  may be formed of suitable biocompatible polymeric material which includes Nylon, PET (polyethylene terephthalate) and polyesters such as Hytrel. The membrane  11  may be foraminous in nature to facilitate tissue ingrowth after deployment within the patient&#39;s heart. The delivery catheter  32  and the guiding catheter  31  may be formed of suitable high strength polymeric material such as PEEK (polyetheretherketone), polycarbonate, PET, Nylon, and the like. Braided composite shafts may also be employed. 
       FIGS. 14-16  illustrate the collapse and retrieval of a partitioning device  10  by pulling on the ends  20  and  21  of the expansive strand  19  which extends around the periphery of the membrane  11 . Typically, the partitioning device  10  would still be secured to the delivery catheter  32 , but the delivery catheter is not shown to simplify the drawings. In  FIG. 14  the partitioning device  10  is shown in a partially collapsed configuration. In  FIG. 15  the partially collapsed partitioning device  10  is shown being withdrawn into the flared distal end  63  of retrieval catheter  64 .  FIG. 16  illustrates the completely collapsed partitioning device  10  pulled further into the retrieval catheter  64 . The partitioning device  10  may be withdrawn by pulling the device through the inner lumen  65  of the retrieval catheter  64 . Optionally, the partitioning device  10  and retrieval catheter may be withdrawn from the patient together. 
     To assist in properly locating the device during advancement and placement thereof into a patient&#39;s heart chamber, parts, e.g. the distal extremity, of one or more of the ribs  14  and/or the hub  12  may be provided with markers at desirable locations that provide enhanced visualization by eye, by ultrasound, by X-ray, or other imaging or visualization means. Radiopaque markers may be made with, for example, stainless steel, platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals, alloys and oxides of these metals. 
       FIGS. 17 and 18  illustrate an alternative design which illustrates a partitioning device  10  that includes an expandable sealing element. In this example, the expandable sealing elements are a plurality of swellable bodies  70 , preferably hydrophilic foam, around the periphery of the membrane  11  between adjacent ribs  14 . When these bodies contact body fluid, such as blood, upon deployment, they swell, thereby sealing the peripheral portion of the membrane  11  against the patient&#39;s heart wall as previously described. The details of the partitioning device  10  may be essentially the same as in the previous embodiment and elements in this alternative embodiment are given the same reference numbers as similar elements in the previous embodiments. 
     To the extent not otherwise described herein, the various components of the partitioning device and delivery system may be formed of conventional materials and in a conventional manner as will be appreciated by those skilled in the art. 
       FIGS. 19A-19J  illustrate application of another variation of a partitioning device  134  being deployed in a human heart  242 . 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  138  has been inserted through the aorta and aortic valve into the left ventricle  246  to a selected position where the cardiac device  134  can be deployed. The catheter tube  138  is then partially pulled off of the cardiac device  134  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  134  in the selected position at the apex  252  of the akinetic portion  250  of the left ventricle  246 . In some variations the device does not include an active (e.g., distal) anchor, but may include an atraumatic foot, as described above. 
     The catheter  138  is then completely removed from the distal end  54  of the deployment member  46 , exposing the cardiac device  134 . As the cardiac device  134  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  134  has not been properly positioned, or if it is of the wrong size or shape for the particular heart, the device  134  may be repositioned or completely removed from the heart  242 . 
       FIG. 20A  and  FIG. 20B  illustrate another variation of a cardiac (or partitioning) device  288 . This example of a partitioning device  288  includes a sealing element that is configured as a second membrane  300  having fibers (or fringe)  304  that acts to seal against the ventricle wall. The partitioning device  288  in  FIGS. 20A-20B  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  214 , extends downwards from the second hub  294 . Referring specifically to  FIG. 20B , the attachment screw  314  is rotated so that it engages a pin  321  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. 20C  illustrates a human heart with the partitioning device  288  of  FIG. 20A  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. 
     In another variation of the partitioning device described herein, the device includes a plurality of strands extending from the distal side of the device. Thus, the sealing element comprises a plurality of strands or braids that extend from the portion of the device within the non-productive side of the device. These braids may press against an inner surface of the ventricle, and help seal the device within the ventricle. 
     In some variations the sealing element is an inflatable sealing element. For example, the inflatable sealing element may be a swellable element, as described above in  FIGS. 17 and 18 , which inflates with fluid to swell. Alternatively, the device may include an inflatable sealing element configured as a balloon, as shown in  FIGS. 21A-21C . 
       FIG. 21A  illustrates one variation of a partitioning device in a collapsed or delivery configuration. The device includes a plurality of ribs  2101  to which a membrane  2109  is connected. The ribs connect to a central hub  2111  which connects to an atraumatic foot  2113  in this example. The peripheral region of the membrane includes an inflatable balloon sealing element  2103  having a valve  2105 . In  FIG. 21A  the sealing balloon element  2103  is shown collapsed. The device may be inflated after expanding in the ventricle, or it may be inflated to help expand the device. As mentioned, the delivery catheter may be adapted to communicate with the valve and inflate the device. 
     Although the valve  2015  for inflation is shown in this example on the periphery of the partitioning device, in some variations, the valve may be located near the center (e.g., radially) of the partitioning device, so that it may be attached to an inflation port on the applicator. In some variations, the partitioning device may include more than one valve. 
       FIG. 21B  shows the partitioning device of  FIG. 21C  in the (at least partially) expanded configuration, in which the balloon around the periphery of the membrane is inflated. As with the swellable variation of the inflatable sealing element, the balloon may be located at the very periphery of the membrane, or it may be positioned more centrally (e.g., towards the centerline of the device), but still configured to apply pressure to urge the membrane against the wall of the heart and thereby seal the membrane to the wall.  FIG. 21C  shows a partial cut-away version of the inflatable balloon sealing element, including the passive anchors  2111  at the ends of the implant ribs or struts  2101 . 
       FIGS. 30A-30D  illustrate another variation of a partitioning device having an inflatable sealing element. In this example, the inflatable sealing element is a plurality of inflatable elements  3003  that are distributed around the perimeter of the device  3001 . As mentioned, inflation of these elements may both expand the partitioning membrane into the deployed form, and may also help seal the membrane against the wall of the ventricle. Thus, the expandable element may provide both circumferential and radial expansion of the partitioning device. For example,  FIG. 30A  shows a top view of the device indicating the partitioning membrane  3007  (having a peripheral region  3009 ), and the plurality of expandable and inflatable elements  3003 . The inflatable elements may be inflated by one or more inflation channels  3011 , which may be connected to a port and/or valve that can be connected to the applicator or other source of inflation material (gas, fluid, etc.). 
     The inflatable balloon or plurality of balloons at or near the periphery of the membrane of the partitioning device may be formed from the same material as the membrane. For example, the balloon may be integral with the membrane by forming cavities between two layers forming the membrane. For example, the membrane may be formed of two layers of ePTFE sandwiched together. In some variations, the struts or arms are laminated between the two layers. As shown in  FIGS. 30A and 30B , a portion of the membrane may be inflatable by preventing them from sealing (laminating) together. 
     The inflatable element(s) may be connected via an inflation channel  3011  or a plurality of inflation channels  3011 , as shown in  FIG. 30A , to a port or valve. As mentioned, the valve may be located in any appropriate location so that it may couple with an inflation source. For example, a valve may be positioned in the hub (center) region that typically mates with the applicator. One or more inflation channels (or inflation ports) may be used. For example, in  FIG. 30A , the device includes a plurality of inflation channels distributing inflation material to all of the inflatable balloon elements. When a plurality of inflatable balloon elements are used, the device, each inflatable balloon element may be separately inflatable, or all (or a subset) of the inflatable elements may be connected together so as to inflate together. 
     As mentioned above, any appropriate inflation material may be used, including liquids (e.g., saline), gases, solids, gels, etc. In some variations, the inflatable element(s) described herein may be filled with a contrast agent that may help visualize the partitioning device. For example, the inflatable elements may be filled with a radioopaque contrast media that allows visualization of the partitioning device after it has been deployed in the left ventricle. In some variations, such as the partitioning device shown in  FIG. 30B , the periphery of the membrane may be visualized by inflating with a contrast material  3031 . 
     In some variations, the inflation material is a polymerizable or curable. For example, the inflatable elements (e.g., balloon elements) may be inflated with a curable material including a UV curable material or an RF curable material. For example, the filling material may include a UV-curable filling material. Thus, an applicator may also include a light-emitting element such as a fiber optic cable and/or a port for an energy source that can apply the energy (light, heat, etc.) to cure or otherwise modify the material in the inflatable element. 
     In some variations, the partitioning device may include channels or pathways that may be inflated with a curable material to form one or more of the struts. For example, in  FIG. 30A , channels  3011  may be formed within the membrane  3007  either for filing the inflatable elements  3003 , or simply to form inflatable struts. These inflatable struts may be filled with a curable material, as mentioned above, which may provide additional structural support. For example, when the membrane is formed by lamination or otherwise securing two or more layers, the struts or other inflatable members may be formed between them (e.g., in non-adhesive regions). Alternatively, inflatable regions may be attached to the membrane(s). In some variations, the partitioning device may therefore include one or more inflatable struts that are formed in vivo, for example, using an elastomeric (e.g., RTV-like) curable material. In some variations the inflatable struts extend radially (e.g., from a common hub region), towards to the distal end of the membrane. The inflatable struts may communicate with inflatable members including inflatable balloon members  3003 , as shown in  FIG. 30A , or they may not communicate with other inflatable regions, but may terminate or include one or more ports. 
     The inflatable balloon element(s) may be located at or near the peripheral edge of the device. For example, in  FIG. 30A , the inflatable balloon elements are located just proximal to the peripheral edge of the device, so that a portion of the membrane extends distally past the inflatable element. This edge portion may be loose, serrated, (or may form a plurality of flaps), and may help seal the device to the wall of the ventricle. In some variations, the inflatable element is at the periphery of the partitioning device. 
       FIG. 30B  illustrates a side view of the partitioning device of  FIG. 30A , showing the inflatable balloon elements near the proximal edge of the membrane. 
     In use, the inflatable balloon elements may be expanded to open the partitioning device. For example, upon inflation, the inflatable elements may push the expansion of the struts of the device, thereby encouraging radial expansion of the membrane. The inflatable balloon elements may also be configured to accommodate non-circular deployment within the ventricle.  FIGS. 30C and 30D  illustrate different variations of partitioning devices including inflatable balloon elements that may conform to non-circular (or otherwise irregular) walls of the heart. For example, in  FIG. 30C , the plurality of inflatable elements shown  3003  may be inflated so that they provide outward (axially) force to expand the device, and also to seal the device against the ventricle wall, but the plurality of inflatable elements also accommodate irregularities because the size of the sub-regions that include an inflatable balloon element may be displaced without disrupting the rest of the membrane. In  FIG. 30C , one region of the partitioning device  3023  is allowed to follow a contour of the heart wall that is not round. For example, where trabeculations or other projections in the ventricle wall make it irregular. Similarly, when the body region (e.g., ventricle) is not rounded but is oval or otherwise non-circular, the inflatable balloon elements as shown in  FIG. 30D  may allow it to conform to the walls. 
     In some variations, an inflatable balloon may be included in the partitioning device that is not located on or near the periphery of the membrane. For example,  FIGS. 31A and 31B  illustrate one variation in which the central region of the implant (e.g., near the hub) on the membrane is inflatable, and inflation may help rapidly expand the partitioning device. 
     For example, in  FIG. 31A , the partitioning device  3101  includes one or more inflatable regions  3103  that are located on the membrane  3107 . These inflatable region or regions may also be formed between two of the layers forming the membrane, as mentioned above. For example, two layers of ePTFE forming the membrane may be sealed near the outer periphery  3109  of the device, but allowed to be separate closer to the hub, so that this region may be inflated. A port or ports for inflation (including or more valves) may also be included. In addition to the inflatable elements shown in  FIG. 31A , other variations may also include one or more other sealing elements (e.g., a strand, a peripheral inflatable element, etc.) for helping to secure the membrane to the ventricle walls. In some variations the edges of the membrane may also be loose, serrated, etc., so as to help form a seal. 
     The partitioning device of  FIG. 30A  is shown in partially transparent side-view in  FIG. 30B . In this example, the inflatable elements  3103  (which may also be referred to as inflatable expanding elements or inflatable expanding balloon elements) are indicated. Although these elements may drive the membrane open and towards the wall of the ventricle, they are not necessarily sealing elements, since they do not necessarily tension the membrane (e.g., removing wrinkles) to seal, in contrast to the device shown in  FIG. 30A-30D . They may be used in combination with other sealing elements, as mentioned. 
       FIGS. 22A-25B  illustrate variations of the devices including a container surrounding a portion of the partitioning device, and configured to be positioned within the non-productive portion of the heart chamber when the device is deployed in a heart chamber. For example,  FIG. 22A  shows a cross-section through one variation of a partitioning device in which the implant includes a frame of ribs or struts  2203  and a membrane connected to the frame  2205 . One or more passive anchors (e.g., prongs, hooks, etc.)  2213  may be located on the ends of each strut. In this example, the membrane is formed of ePTE, and may be laminated over the frame to form the pressure-receiving surface of the device. The implant also includes a foot  2207  that is relatively soft (e.g., atraumatic) so that it doesn&#39;t penetrate the tissue wall, even when the wall may be weakened or akinetic. In this example, the device also includes a container  2232  formed by the pressure-receiving membrane and a second membrane (e.g., an ePTFE membrane) extending distally around the portion of the device that will be positioned within the non-productive portion of the membrane, as illustrated in  FIG. 22 b   . In  FIGS. 22A and 22B  the container is configured as a bag, the top of which is sealed by the pressure-receiving membrane  2205 . The device may include one or more ports  2209  (which may include valves) for filling the container. In  FIG. 22A , the ports are configured as skives  2209  through which material may be injected to fill the container.  FIG. 22B  illustrates the device of  FIG. 22A  implanted into a ventricle (a left ventricle  2221 ). In this example, saline  2223  has been injected to fill the container, which contacts the wall of the apex region  2225  of the left ventricle  2221 . 
       FIGS. 23A and 23B  show perspective views of a similar variation. 
       FIG. 24A  is another example of a portioning device that includes an occlusive membrane  2403  secured to a plurality of ribs or struts  2405 . The device also includes a container  2432  which, similar to the variation shown in  FIGS. 22A-23B , is an inflatable bag-like structure formed of ePTFE. The example shown in  FIG. 24A  also includes a valve, configured as a flap valve,  2435 , which is a membrane of ePTFE that covers openings (e.g., skives) through which the container may be filled. The membrane may be biased (e.g., by the elastic structure of the valve, and/or by pressure from within the container) so that it opens for filling, but does not permit a significant amount of material to leave the container. Thus the container may be filled through the implant hub  2409 . For example, the container may be filled using the delivery catheter (not shown). The hub portion  2409  and an atraumatic foot region  2401  are shown positioned within the container. In some variations, the container may surround the foot region and/or the hub, but not enclose them. 
       FIG. 24B  shows a top view of the device of  FIG. 24A , illustrating the openings  2409  (skives) into the container that are selectively covered by the flap valve  2435 . These openings may also be configured so that fluid, such as blood from within the ventricle, can be loaded into the chamber once it is positioned. An example of this is shown in  FIGS. 25A  (valve open) and  25 B (valve closed). In this example, the device is shown expanded within a ventricle  2500 . The flap valve allows blood (e.g., blood being pumped through the ventricle) to enter the container  2432 , as indicated by the arrows  2439 . This may inflate the container within the ventricle, so that the walls of the container conform to the wall of the non-productive region of the ventricle, i.e., the region behind the partitioning membrane  2403  and ribs  2405 . For example, during the period of contraction of the ventricle when blood is pushed against the pressure-receiving membrane of the device as the ventricle fills (e.g., diastole), blood may enter and fill the chamber. When the ventricle contracts (e.g., systole), blood is held in the chamber since the flap valve is configured to prevent blood from leaving the chamber. After the chamber is filled, blood may be held within the chamber and prevented from exiting the chamber by the flap valve, as indicated by the arrows  2439 ′ in  FIG. 25B . Thus, this variation may be self-filling. 
       FIG. 26  illustrates one variation of an applicator that may be used with a partitioning device such as the partitioning devices including chambers illustrated above. In  FIG. 26 , the applicator is a delivery catheter  2603  that may be used with a guide catheter  2601 . The guide catheter  2601  in this example has an inner lumen extending between the proximal end  2604  and distal end. A hemostatic valve (not shown) may be provided at the proximal end  2604  of the guide catheter  2601  to seal about the outer shaft of the delivery catheter  2602 . In this example, the guide catheter also includes a flush port  2606  on the proximal end  2604  of guide catheter  2601  that is in fluid communication with the inner lumen. 
     The applicator delivery catheter  2603  (“applicator”) has an elongated outer shaft  2612  with an inflation port (e.g., deployment inflation port  2615 ) near the proximal end. The inflation port may be used to inflate an inflatable member on the distal portion of the elongate shaft configured to help expand the device. This inflatable member may also be referred to as a deployment balloon  2655 . The deployment inflation port is in communication with an inner lumen in the delivery catheter and with a deployment balloon  2655 . 
     The applicator also includes a releasable securing element as previously described, for releasably securing the implant device. For example, the releasable securing element may include a torque shaft and helical coil screw as illustrated and described in  FIG. 8 , above. 
     The applicator may also include a filling interface  2621  near the distal end of the elongate shaft for filling the non-productive portion of the heart formed by the implant. In some variations, the filling interface may be configured as an inflation port for inflating or filling a container portion of the implant. The filling interface may be configured as a filling port, and may be used to fill the non-productive region after the implant has been deployed even if the implant does not include a container portion. 
     The system shown in  FIG. 26  (including a delivery catheter or applicator  2603 , insertion catheter  2601 , and expandable partitioning device  2605 ) may also be configured for use with a UV-curable filling material. In this variation, the applicator also includes a light-emitting element such as a fiber optic cable  2633  near the distal end, and a port  2623  for an energy source near the proximal end, so that energy (e.g., UV-light) can be used to cure the filler in the non-productive region and/or the container  2605 . 
     The applicator may also include a handle  2621  at or near the proximal end. 
       FIG. 27  illustrates another variation of a system including a partitioning device  2705 , and an applicator that is configured to deploy a partitioning device and then deliver occlusive members (e.g., coils) into the non-productive portion formed behind the device. For example, in this variation the applicator  2700  includes a control handle  2701  and a balloon deployment inflation port  2709  at the proximal end, as well as an implant detachment knob  2711 . Turning the implant detachment knob may rotate the torque shaft (not visible) and deploy the implant, as previously described. The system may also include a delivery catheter  2703 . 
     In  FIG. 27 , the partitioning device  2705  is shown deployed within the apical region of a left ventricle  2715  so that the foot  2717  of the device rests against the wall and the pressure-receiving membrane forms a non-productive region  2719  separate from the productive region of the ventricle  2716 . The membrane may be reinforced with ribs or struts, and may be anchored via one or more securing elements (not visible in this example). 
     In this variation, the applicator may also be used to apply occlusive elements into the non-productive region  2719 . As illustrated the occlusive elements are coils, e.g., thrombogenic coils  2733 ). Thus, the applicator may include a port and passageway for the occlusive member. For example, the applicator may include a coil delivery catheter  2755 , and may also include a coil detachment knob  2757 . In operation, the coils may be delivered behind the expanded implant by pushing the coils out of the distal end from behind the deployed partitioning device until this region is filled as desired. The coil may then be detached, although multiple small coils may also be used. Any occlusive material may be used, including any variation of occlusive coil. For example, thrombogenic coils may be used in the non-productive portion. 
       FIG. 28  illustrates another variation of a partitioning device that can be filled with an occlusive material such as a thrombogenic coil. In this variation the non-productive portion is filled after the device has been deployed using a separate coil delivery device  2805 . The coil delivery device (e.g., coil delivery catheter) may be used with the same guide catheter  2703  used to by the applicator to position and deploy the implant. The coil delivery catheter may be used to fill the region behind the device by filling from an edge of the device, by separating the edge of the membrane of the device from the wall of the heart to allow the distal end of the coil delivery device into the non-productive space. 
       FIGS. 29A-29C  illustrate another variation of the method of filling a portion of the non-productive region formed by a partitioning device  2901  with an occlusive material(s) such as occlusive coils.  FIG. 29A  illustrates one variation of a partitioning device  2901  that includes a container  2903  configured as a pouch or bag that is bounded on at least one side by the pressure receiving membrane  2905 . The pressure-receiving membrane  2905  may be supported by struts  2907 . In some variations, the container is not bounded by the pressure-receiving membrane. The implant foot  2912  is within the container (which may also be referred to as a bag or pouch). 
     In operation, the device may be deployed in a heart chamber (e.g., the left ventricle  2950 ) and the container may be filled with occlusive material. For example,  FIG. 29B  illustrates the partitioning device of  FIG. 29A  filled with occlusive coils  2915 . When the device is secured within the heart, as illustrated in  FIG. 29C , the container may be filled so that virtually the entire non-productive portion is filled (by the filled container). 
     Turning to  FIGS. 32A-32D , described herein are methods of treating a patient to prevent or correct cardiac remodeling following myocardial infarction. In general these methods may include inserting or implanting a device in a heart chamber within 72 hours after myocardial infarction, or shortly after a determination of myocardial infarction. The device is preferably placed within the region of the heart chamber exhibiting one or more indication of myocardial infarction. The device may be a support device (e.g., a resilient frame) and/or a partitioning device. 
     For example,  FIG. 32A  is a schematic illustration of a patient&#39;s heart  3210  showing the right ventricle  3211  and the left ventricle  3212  with the mitral valve  3213  and aortic valve  3214 . A pericardium membrane  3215  is shown surrounding the heart  3210 . At least a portion of myocardium layer  3217  of the left ventricle  3212 , as shown in  FIG. 32A , is exhibiting an area of infarct  3218  (“MI”) extending along a portion of ventricular septum wall  3219  which separates the right and left ventricles. This region may exhibit characteristics of an incipient rupture.  FIG. 32B  illustrates the advancing of the infarct leading to the generation of a rupture or opening  3220  in the septum wall  3219 , a condition referred to as VSD. As shown in  FIG. 32B  oxygenated blood  3221  flows directly to the right ventricle  3211  through the septum opening  3220 . As a result of this movement, or shunting, at least two consequences are reached, firstly, the right portion of the heart works harder pumping a greater volume of blood than it normally would, and secondly, the amount of oxygenated blood in the left ventricle is reduced leading to a lower oxygen level to the other tissues of the body. 
     In some variations, the heart may be treated after the development of the rupture, as illustrated in  FIG. 32C .  FIG. 32C  illustrates the left ventricle  3212  of  FIG. 32B  after it has been partitioned, with the use of a partitioning device  3230  according to the present invention and as described further below, into a main productive or operational portion  3223  and a secondary, essentially non-productive portion  3224 . As can be seen from  FIG. 32C , with fluid path to the septum opening blocked or reduced, the normal flow of blood from the left ventricle to the rest of the body through the aortic valve is restored. 
     In some variations, it may be preferable to treat the heart following myocardial infarction prior to remodeling such as the formation of the rupture shown in  FIGS. 32B and 32C . For example,  FIG. 32D  shows the schematic illustration of the heart of  FIG. 32A  shortly after determination of a myocardial infarction. The region of the heart chamber exhibiting myocardial infarction (the area of infarct  3218 ) is indicated, and in this example a device  3230  has been deployed to reinforce this region. As a part of the method, the device is deployed into the heart chamber adjacent to the region of the heart chamber exhibiting myocardial infarction shortly after a determination of the myocardial infarction has been made. Generally, this occurs prior to substantial remodeling of the heart. For example, this may be less than 72 hours after the myocardial infarction, or less than a few days after the determination of a myocardial infarction. 
     The occurrence of a myocardial infarction may be determined by any appropriate method, including diagnostics based on physical examination, electrocardiogram, blood (or other tests) for cardiac markers, angiograms, or the like. For example, enzyme markers (e.g., SGOT, LDH, creatine kinase), or other markers (e.g., troponins, glycogen phoshyorylase isoenzyme, myoglobin, etc.) may help determine myocardial infarction. The region of the heart affected by the myocardial infarction may also be determined. For example, visualization techniques (direct or indirect) may be used. For example, angiograms may be used. Other visualization techniques, including scanning (e.g., echocardiography, CT scanning, etc.), electrical mapping, etc. may also be used to localize an area of infarct. 
       FIG. 33A  is a schematic illustration of a patient&#39;s heart  3210  showing the right ventricle  3211  and the left ventricle  3212  with the mitral valve  3213  and aortic valve  3214 . The pericardium membrane  3215  is shown surrounding the heart. A pericardium (pericardial complex) consists of an outer fibrous layer and an inner serous layer. The pericardial space  3216  normally contains 20-50 mL of fluid. At least a portion of the myocardium layer  3217  of the left ventricle  3212 , as shown in  FIG. 33A , is exhibiting an area of infarct  18  (“MI”) extending along a portion of the left ventricle  3212 , which may result in a wall rupture or opening leading to a movement of blood  3221  from the left ventricle into the pericardial space  3216 , as illustrated in  FIG. 33B . 
       FIG. 33B  shows the remodeling of the heart following MI. In  FIG. 33A  the damage from the infarct has advanced, leading to the rupture or opening  3220  which is increasing in size. As shown in  FIG. 33B , the flow of the blood  3221  into the pericardial space  3216  increases over time leading to a greater accumulation of blood in the pericardial space. This movement and accumulation of blood in the pericardial space, a condition referred to as ventricular tamponade, results in reduced ventricular filling and subsequent hemodynamic compromise. 
     This damage may be prevented or reversed by implanting or inserting a support and/or partitioning device, as shown in  FIG. 33C .  FIG. 33C  illustrates the left ventricle  3212  of  FIG. 33A  after a device  3230  has been inserted. This device  3230  is a partitioning device which both supports the damaged area, and may partition it from other portions of the heart chamber, into the main productive or operational portion  3223  and the secondary, essentially non-productive portion  3224 . As can be seen from  32 D and  33 C, supporting the damaged region of the heart chamber (e.g., the area of infarct  3218 ), and in some variations partitioning it, may prevent or reverse the remodeling of the heart and help restore the normal flow of blood from the left ventricle to the rest of the body through the aortic valve. 
       FIG. 34  illustrates an alternative design which embodies features of a device usable in practicing methods having features of the present invention, in which the device  3230 ′ is provided with an eccentric-shaped membrane  3231  which is well suited for treating VSD lesions that may occur further up (more proximal) the ventricular septum because of the different anatomical features and physiologic action of the ventricular septum versus the anterior free wall. The septal wall primarily moves in and out only, relative to the chamber, versus the free wall that has a rotation component to its excursion. Secondly, the outflow track which comprises the upper half of the ventricular septal wall below the aortic valve has very little or no trabeculation. It is particularly well suited for placement of the device placed to address necrotic failure of the tissue of the ventricular septum. In the embodiment shown in  FIG. 34 , the device is shown with a nubbin foot  3245  (and not the extended stem foot) allowing the device to sit more distally and intimately with the apex. 
     The details of the device  3230 ′ shown in  FIG. 34  are essentially the same as in the previous embodiments and elements in this alternative embodiment are given the same reference numbers but primed as similar elements in the previously discussed embodiments. The device  3230 ′ forms a conical shape as in the previously discussed embodiments but the peripheral base of the conical shape which engages the wall that has a first dimension in a first direction greater than a second dimension in a second direction. Preferably, the second direction is at a right angle with respect to the first direction. The lengths of the ribs  3234  are adjusted to provide the desired shape to the periphery of the device which engages the interior of the heart chamber. 
     Any of the devices described herein (e.g., the devices  3230 ,  3231 ′) may be conveniently formed by the method described in application Ser. No. 10/913,608, which is incorporated herein by reference in its entirety. 
     In variations having a membrane, porous ePTFE materials may be preferred. Alternatively, the membrane  31  may be formed of suitable biocompatible polymeric material which includes Nylon, PET (polyethylene terephthalate) and polyesters such as Hytrel. The membrane  31  is preferably foraminous in nature to facilitate tissue ingrowth after deployment within the patient&#39;s heart. The delivery catheter  52  and the guiding catheter  51  may be formed of suitable high strength polymeric material such as PEEK (polyetheretherketone), polycarbonate, PET, Nylon, and the like. Braided composite shafts may also be employed. 
       FIGS. 35A through 36B  illustrate other variations of devices and methods for using them to prevent remodeling.  FIG. 35A  shows a device that does not include an occlusive membrane. In this variation of a support device, a plurality of struts  1501  extend from a central hub  1503 . The ends of each strut  1501  terminate in an anchor  1505 . The struts are typically flexible, and may be collapsed into a delivery configuration and expanded (e.g., self-expanded) into a deployed configuration. The support device shown in  FIG. 35B  is similar, but has struts of different lengths, similar to the device shown in  FIG. 34 .  FIG. 35C  shows a schematic illustration of a heart in which the support device  1506  of  FIG. 35A  has been implanted adjacent a region of the chamber wall exhibiting myocardial infarction (post-MI infarct  1507 ). In some variations, the devices  1506  may be anchored along the length of the struts rather than, or instead of, just at the ends. In some variations the hub is anchored to the heart chamber wall. 
       FIG. 36A  shows another variation of an implant  1600 , similar to the implant shown in  FIG. 1 , without the plurality of pods or foot  45 . In this example, the hub  1603  may directly contact the wall of the heart chamber. In some embodiments, the implant  1600  further includes one or more struts  1601 , an occlusive membrane  1602 , and one or more passive anchors  1605  (e.g., on the tip of the one or more struts).  FIG. 36B  shows the device of  FIG. 36A  in the heart. For example, the implant  1600  may be positioned in the left ventricle  1610 , proximal to the papillary muscle  1612 , and adjacent to the infarcted region  1614  of the heart. 
     As mentioned, the implant devices used to treat post-acute myocardial infracted hearts may be configured so that the support framework (e.g., struts) and/or any membrane may be positioned adjacent, contacting, or very close to the wall of the heart. For example,  FIGS. 39A and 39B  show cross-sectional views of two hearts that have devices  1901 ,  1901 ′ implanted adjacent to the wall in the region affected by the acute myocardial infarction  1903 ,  1903 ′. 
       FIGS. 37A and 37B  illustrate another variation of a device that may be implanted following acute myocardial infarction in order to prevent cardiac remodeling or damage (configured as an endocardial implant). In this example, the device is configured to be anchored immediately adjacent to the heart wall (e.g., ventricle wall) across from the region of the infarct. The implant  3700  includes a frame  3702  comprising a plurality of expandable struts which extend from a central hub. The base of the hub in this example includes an anchor  3704  (“active anchor”) which may be inserted into the heart wall. For example, the hub anchor may  3704  be screwed into the heart wall by rotating the device to at least partially penetrate the heart wall and secure the device in place. In addition, the device may also include one or more passive anchors  3706  on the struts of the frame  3702 , as illustrated. In this variation the struts are at least partially covered by a membrane  3708 . The implant shown in  FIG. 37A  is shown in side cross-section in  FIG. 37B . 
       FIG. 37C  illustrates one variation of a delivery system including a delivery catheter  3710  and guide catheter  3712  for delivering the implant to the heart so that it can be deployed and inserted. For example, the delivery device shown in  FIG. 37C  includes a delivery catheter  3710  having an implant  3700  (shown in the collapsed state) at the distal end.  FIG. 37D  shows the delivery system inserting the implant  3700  into the left ventricle  3710  of a heart. 
     To the extent not otherwise described herein, the various components of the devices and delivery systems may be formed of conventional materials and in a conventional manner as will be appreciated by those skilled in the art. 
     Cardiac endothelium plays an important role in control of the inflammatory response of the myocardium, growth of the heart muscle cells, contractile performance and rhythmicity of the cardiomyocytes. Cardiac endothelial dysfunction has also important role in the pathogenesis of cardiac failure. Therefore, it may be advantageous to selectively deliver therapeutic agents and/or cells to the endothelium in controlled and predictable fashion. The devices (e.g., support device and partitioning devices) described herein may be used to treat disorders by delivering a therapeutic material, including drugs and cells. For example, a frame of a device and/or the membrane of a device can be coated and/or impregnated with a biodegradable coating containing therapeutic agents and deliver these agents to the endothelium. Similarly, a delivery catheter can provide access to infuse various solutions of the therapeutic agents or cells to the area between the devices (e.g., a membrane of the device) and the endothelium, providing precise control of the delivery process to facilitate healing and local regeneration. Any appropriate therapeutic agents may be used, including cytokines, chemokines, inflammatory mediators, growth factors, inotropic agents, anti-arrhythmic agents, other pharmaceutical agents commonly used for treatment post-infarction condition, and various types of cells (myocytes, myoblasts, stem cells). 
     While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is intended that this invention to be defined by the scope of the appended claims as broadly as the prior art will permit. 
     As used herein, terms such a “element,” “member,” “component,” “device,” “section,” “portion,” “step,” “means” and words of similar import, shall not be construed as invoking the provisions of 35 U.S.C. § 112(6) unless the following claims expressly use the term “means” followed by a particular function without specific structure or the term “step” followed by a particular function without specific action. Accordingly, it is not intended that the invention be limited, except as by the appended claims. All patents and patent applications referred to herein are hereby incorporated by reference in their entirety.