Abstract: An apparatus for distributing a liquid in a patient's body comprises an implantable pump adapted to pump the liquid and an implantable valve device adapted to direct the liquid pumped by the pump. A first ceramic valve member of the valve device includes a first plane surface and a second ceramic valve member of the valve device includes a second plane surface facing and touching the first plane surface. The second valve member is displaceable relative to the first valve member between different positions, wherein the valve members include different liquid channels. The valve device is operable to displace the second valve member to hydraulically connect the pump to at least one of the liquid channels in at least one of the positions.

Abstract: Apparatuses and methods are provided to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery.

Abstract: A cannulation system for cardiac support uses an inner cannula disposed within an outer cannula. The outer cannula includes a fluid inlet for placement within the right atrium of a heart. The inner cannula includes a fluid inlet extending through the fluid inlet of the outer cannula and the atrial septum for placement within at least one of the left atrium and left ventricle of the heart. The cannulation system also employs a pumping assembly coupled to the inner and outer cannulas to withdraw blood from the right atrium for delivery to the pulmonary artery to provide right heart support, or to withdraw blood from at least one of the left atrium and left ventricle for delivery into the aorta to provide left heart support, or both.

Abstract: This is a support device that prevents, reduces, and delays remodeling of diseased cardiac tissue, and also decreases the impact of such remodeling on collateral tissue is disclosed. The invention further reinforces abnormal tissue regions to prevent over-expansion of the tissue due to increased afterload and excessive wall tension. As a result, the support device prevents phenomenon such as systolic stretch from occurring and propagating. The support structure maintains and restores diastolic compliance, wall motion, and ejection fraction to preserve heart functionality. As such, the support device prevents and treats cardiomyopathy and congestive heart failure.

Abstract: A device, potentially implantable in a living organism, intended to utilize at least a part of the hydraulic energy generated by the heart (10)—the primary unit—at the natural phases of work when the cavities of the heart (11, 12 and 16, 17) are filed with blood. The device includes at least one secondary unit (24), which is connectable to the cardiovascular system of the organism and arranged to utilize said hydraulic energy. The secondary unit is represented by at least one hydraulic motor (24a) arranged to transfer the hydraulic energy to a transferal organ (28). The transferal organ (28) is arranged to influence at least one tertiary unit, for example an executive device (29), which is constructed in order to convert the transferred energy to an alternative form of energy, with the purpose to influence certain defined functions within the organism. Preferably is arranged a regulating device (30) in order to control running parameters of the unit.

Abstract: Embodiments of the invention provide for a unidirectional flow valve. For example, embodiments of the invention include a method of providing a unidirectional flow valve to a vein that include folding a first portion of a vein over an adjacent second portion of a vein and engaging at least two opposing areas of the second portion of the vein to adjacent areas of the first portion of the vein. The at least two opposing walls of the second portion of the vein define the unidirectional flow valve. At least one support device may be inserted into the folded valve region of the vein to maintain the folded configuration of the valve.

Abstract: Magnetic force, preferably with one or more permanent magnets, is used to hold together flaps of tissue inside the body, particularly flaps of a PFO. A device or magnets within a device can be retrieved such that no permanent implant is left behind.

Abstract: An actuation system for assisting the operation of a natural heart that includes a dome structure configured for being coupled with a ventricular portion of the heart. The dome structure has at least one opening formed therein. The dome structure, proximate the opening, is configured to interface with at least one of an atrial chamber and a great vessel of the heart. A stabilizing element or an actuating element may be anchored to the dome structure for engaging a portion of the heart.

Abstract: Apparatuses and methods are provided to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery.

Abstract: An intravascular miniature stent pump comprising an intravascular stent for implantation at an implant site within a blood vessel and a miniature pump mounted on the stent, wherein the pump allows an adequate blood flow to prevent clotting within a lumen of the stent, and wherein the blood flow is equal to or greater than a blood flow at the implant site before implantation.

Abstract: A blood pump intended to be carried by a freely moving patient uses perpendicular magnetic and electrical fields to propel blood. A rod mounted coaxially inside a tube has electrodes in blood contact for establishing a radial electric field, and an inductor having windings parallel to the axis of the tube is used to establish a circumferential magnetic field. To avoid the evolution of gas at the electrode surfaces the magnetic and electric fields are periodically reversed, and the electrodes are made to have very high surface areas. The blood pump is powered by batteries or fuel cells (or a combination of both) to provide long service between recharging and to reduce the weight carried by the patient.

Abstract: A ventricular patch to restore the ventricular architecture of the heart includes a sheet of biocompatible material having a generally oval configuration, and a continuous ring fixed to the sheet. The ring has a generally oval configuration similar to the generally oval configuration of the sheet of biocompatible material. The ring defines a central generally oval region of the patch inside the ring and a circumferential region of the patch outside of the ring. The central generally oval region has a major axis and a minor axis. The ratio of the major axis to the minor axis is about 4:1.

Abstract: A pump especially designed for pumping blood comprises a bladder, the interior surface area and volume of which is changeable, i.e., it stretches and expands during the filling phase, and elastically contracts to its normal relaxed size during the ejection phase. The bladder has a fluid inlet and a fluid outlet. A device, such as a vacuum pump, alternately expands and contracts the interior surface area and volume of the bladder. Most of the interior surface area of the bladder expands and contracts in each cycle. One or more check valves or other means for causing substantially one-way fluid flow through the bladder are also provided. The pump of the invention decreases the likelihood of blood clots forming in the pump, decreases the risk of damage to blood cells, improves the pumping characteristics of the device, and decreases or eliminates the chance of foreign fluids passing into the blood stream should a tear or break occur in the bladder.

Abstract: An artificial heart device for minimizing the damage to blood cells having electromagnetically driven pistons which move the blood around and through a toroidal chamber. In first and second preferred embodiments no motor is used to drive the pistons and the pistons are suspended within the toroid by cycling of electromagnets. In a third preferred embodiment the pistons are moved with the use of motor-driven magnets. In each embodiment blood is sucked into the toroidal chamber through one or more intake openings and blood exits the toroidal chamber through one or more outflow openings.

Abstract: Methods for using blood pumps to treat heart failure are disclosed. The pump is mounted on an interior of a stent, and the stent is releasably mounted on a distal end of a catheter. The distal end of the catheter is inserted into a peripheral artery and advanced to position at a region of interest within the descending aorta, the ascending aorta, or the left ventricle. The stent and the pump are released from the catheter, and the pump is activated to increase blood flow downstream of the pump. The pump can also be positioned in the vena cava or used to treat right-sided heart failure following the insertion of an LVAD, or to improve venous return in patients with varicose veins. Non-stent pumps are described for insertion between the pulmonary vein and aorta, and between the vena cava and pulmonary artery designed for use during cardiac surgery.

Abstract: Methods and devices for passively assisting the cardiac function of the heart are disclosed. A method of increasing the cardiac output of a heart includes providing a site of surgical access to the portion of the heart to be restrained, reducing the cardiac expansion of the portion of the heart to be restrained, and maintaining the reduction of cardiac expansion of the portion of the heart to be restrained for a substantial amount of time. Cardiac assist devices for increasing the cardiac output of the heart are disclosed comprising a reinforcing portion configured to contact a portion of the heart tissue wherein the reinforcing portion restricts the expansion of the portion of the heart tissue. The reinforcing portion can be a number of structures, including pads, frames, straps, and other retaining means for limiting cardiac expansion of the portion of the heart tissue to be restrained.

Abstract: A geometric reconfiguration assembly for the natural heart having a collar configured for surrounding the natural heart. The collar can include a plurality of supports configured for positioning on the epicardial surface of the heart. Supports can be joined with connectors that can permit or provide slight deformation of the assembly. An external shell or skin portion can be provided around the supports an/or connectors.

Abstract: A method for treating congestive heart failure (CHF) has been developed that restores kidney renal functions by artificially perfusion of at least one kidney. The kidney is perfused with the patient's blood or other suitable perfusion fluid. A catheter inserted into the aorta of the patient has a distal end that supplies the perfusion fluid into a renal artery of the patient. The catheter may be coupled to an implanted blood pump or to an external supply of perfusion pressure. The restoration of kidney function assists the heart by removing excess fluid, urine and toxin from the patient, and by normalizing the patient's renin-angiotensin system and other neurohormonal substances. The method is applicable to treat chronic and acute CHF.

Abstract: An implant for occluding a passage in a circulatory system is provided. The implant in one form includes a plurality of thin wire-like members each having a proximal and a distal end and a first holder to which the distal ends of the members are attached. The proximal ends of the members are attached to a second holder. The implant includes an expansible occluding body attached to the members at a point intermediate the first and second holders. A carrier rod is releasably attached to the first holder and upon which the second holder is slidably received. A driving implement is located on the carrier rod, the driving implement contacting the second holder and movable toward the first holder along the carrier rod.

Abstract: A synthetic polymeric form of carbon (Tetracarbon™) which exhibits some properties similar to biological tissues. Tetracarbon is highly biocompatible and may have application in medicines and microelectronics. Tetracarbon is a biocompatible substrate coating made by depositing short linear chains of carbon stores upon the surface of the substrate. The carbon chains are non-turbostratic and oriented perpendicular to the substrate surface and are densely packed parallel to one another in hexagonal structures with the distance between the carbon chains being between 4.8-5.03 ANG.. A layer of Tetracarbon is identical to an adjacent layer and randomly shifted laterally relative to each other.

Abstract: Apparatuses and methods are provided to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery.

Abstract: The symptoms of congenital heart failure are addressed in this surgical procedure for mounting a patch in the ventricle of the heart to reduce ventricular volume. Placement of the patch is facilitated by palpating a beating heart to identify akinetic, although normal appearing, tissue. An apical patch having an oval configuration facilitates return of the heart to a normal apical shape which enhances muscle fiber efficiency and a normal writhing pumping action. An inferior patch having a triangular configuration can also be used. The patches include a semi-rigid ring, and a circumferential rim to address bleeding. Patch placement is further enhanced by creating a Fontan-type neck and use of pledged sutures. Intraoperative vascularization and valve replacement is easily accommodated. Increased injection fraction, reduced muscle stress, improved myocardial protection, and ease of accurate patch placement are all achieved with this procedure.

Abstract: The symptoms of congenital heart failure are addressed in this surgical procedure for mounting a patch in the ventricle of the heart to reduce ventricular volume. Placement of the patch is facilitated by palpating a beating heart to identify akinetic, although normal appearing, tissue. The patch has an oval configuration facilitating return of the heart to a normal apical shape which enhances muscle fiber efficiency and a normal writhing pumping action. The patch includes a semi-rigid ring, and a circumferential rim to address bleeding. Patch placement is further enhanced by creating a Fontan neck and use of pledged sutures. Intraoperative vascularization and valve replacement is easily accommodated. Increased injection fraction, reduced muscle stress, improved myocardial protection, and ease of accurate patch placement are all achieved with this procedure.

Abstract: An artificial heart assembly may be provided with a blood inlet conduit adapted to be implanted within a subject, a blood outlet conduit adapted to be implanted within the subject, a pumping mechanism implanted within the subject that pumps blood from the blood inlet conduit to the blood outlet conduit, and a motor coupled to drive the pumping mechanism. The artificial heart apparatus has a power source and a control circuit operatively coupled to cause the motor to drive the pumping mechanism in a regular mode when the power source has a relatively high charge level and in an irregular mode when the power source has a relatively low charge level so that the subject can feel when the pumping mechanism is being driven in the irregular mode and thus know that the power source has the relatively low charge level.

Abstract: A geometric reconfiguration assembly for the natural heart having a collar configured for surrounding the natural heart. The collar can include a plurality of supports configured for positioning on the epicardial surface of the heart. Supports can be joined with connectors that can permit or provide slight deformation of the assembly. An external shell or skin portion can be provided around the supports an/or connectors.

Abstract: A catheter having a first magnet is guided into a pocket of air entrapped in a pumping chamber for an artificial heart using a probe having a second magnet, a Hall-effect sensor an electronic circuit and an indicator disposed thereon. The Hall-effect sensor generates a voltage signal that is related to the distance between the catheter tip and the probe tip and that is measured by the electronic circuit and thereafter used to actuate the indicator. The indicator indicates when the probe is close enough to the catheter such that the catheter tip has been magnetically captured by the probe tip. Once magnetically captured, the probe tip, while remaining outside of the pumping chamber, is used to guide the catheter tip to an elevated portion of the pumping chamber wherein the pocket of entrapped air is located. A vacuum generating device attached to a distal end of the catheter tube is then used to withdraw the air from the pumping chamber.

Abstract: A transmyocardial implant includes a hollow rigid conduit adapted to be inserted into and retained within the heart wall of a heart chamber. The rigid conduit is sufficiently rigid to withstand collapsing in response to contraction forces of the heart wall. A synthetic flexible conduit has a first end secured to the conduit. The flexible conduit is blood compatible. A second end of the flexible conduit is secured to the coronary vessel. The rigid conduit and the flexible conduit define a blood flow path from the heart chamber to the coronary vessel. The flexible conduit is bonded to and wrapped around the rigid conduit for the blood flow path to be defined by an uninterrupted surface of the flexible conduit.

Abstract: A static device for use with the heart that has a plurality of members configured to be positioned adjacent the epicardial surface of the heart. The members are joined by at least one connector wherein the members are fixed in a spatial or spaced relationship relative to each other such that a portion of the heart wall is displaced inwardly. The member(s) can be configured in a rectangular shape, and preferably includes an inner surface having a curved configuration. In one embodiment, the device can have first and second member that are positioned in a spaced relationship relative to each other about 180 degrees apart. The first member is configured to be positioned adjacent the anterolateral surface of the chamber, and the second member configured to be positioned adjacent the posteromedial surface of the chamber.

Abstract: The device and method for reducing heart wall stress. The device can be one which reduces wall stress throughout the cardiac cycle or only a portion of the cardiac cycle. The device can be configured to begin to engage, to reduce wall stress during diastolic filling, or begin to engage to reduce wall stress during systolic contraction. Furthermore, the device can be configured to include at least two elements, one of which engages full cycle and the other which engages only during a portion of the cardiac cycle.

Abstract: An artificial heart assembly may be provided with a blood inlet conduit adapted to be implanted within a subject, a blood outlet conduit adapted to be implanted within the subject, a pumping mechanism implanted within the subject that pumps blood from the blood inlet conduit to the blood outlet conduit, and a motor coupled to drive the pumping mechanism. The artificial heart apparatus has a power source and a control circuit operatively coupled to cause the motor to drive the pumping mechanism in a regular mode when the power source has a relatively high charge level and in an irregular mode when the power source has a relatively low charge level so that the subject can feel when the pumping mechanism is being driven in the irregular mode and thus know that the power source has the relatively low charge level.

Abstract: Pump and cannula systems inserted through the right side and/or left side of the heart provide protection against collapse of the heart chambers and veins and arteries and provide supplemental blood flow through same to enable beating heart bypass surgery on all vessels of the heart, including lateral and posterior vessels. The invention eliminates the use of cardiopulmonary bypass (CPB) machines. The invention further provides stents adapted for protecting from vein, artery, atrium and/or ventricle collapse during beating heart bypass surgery.

Abstract: A ventricular patch to restore the ventricular architecture of the heart includes a sheet of biocompatible material having a generally oval configuration, and a continuous ring fixed to the sheet. The ring has a generally oval configuration similar to the generally oval configuration of the sheet of biocompatible material. The ring defines a central generally oval region of the patch inside the ring and a circumferential region of the patch outside of the ring. The central generally oval region has a major axis and a minor axis. The ratio of the major axis to the minor axis is about 4:1.

Abstract: A geometric reconfiguration assembly for the natural heart having a collar configured for surrounding the natural heart. The collar can include a plurality of bands, such as thin bands of about 0.2 mm in thickness, in a spaced relationship to each other, and a connector bar intersecting the plurality of bands and configured for maintaining the spaced relationship of the bands to each other. The collar may include a plurality of bands, such as from about 2 to about 10 bands, that are positioned parallel to each other. The bands can each be made of a biomedical material, such as polyacetal or a metal, such as titanium or steel.

Abstract: An artificial heart device for minimizing the damage to blood cells having electromagnetically driven pistons which move the blood around and through a toroidal chamber. In first and second preferred embodiments no motor is used to drive the pistons and the pistons are suspended within the toroid by cycling of electromagnets. In a third preferred embodiment the pistons are moved with the use of motor-driven magnets. In each embodiment blood is sucked into the toroidal chamber through one or more intake openings and blood exits the toroidal chamber through one or more outflow openings.

Abstract: Devices and methods for increasing the volume of blood pumped by a heart muscle are disclosed. A therapeutic catheter in accordance with the present invention may comprise an elongate shaft having a proximal end, a distal end, and a lumen extending through at least a portion thereof. The therapeutic catheter may further include a cutter having a cutter lumen fixed to the distal end of the elongate shaft, and a mooring shaft slidingly disposed within the lumen of the elongate shaft. A method in accordance with the present invention may include the steps of engaging a muscle of a donor site with a portion of the mooring shaft, penetrating the muscle of the donor site with the cutter to form a muscle tendril, withdrawing the muscle tendril from the muscle of the donee site, positioning the distal end of the therapeutic catheter proximate a pit defined by the tissue of a donee site, inserting the muscle tendril into the tissue of the donee site, and disengaging the mooring shaft from the muscle tendril.

Abstract: During coronary artery bypass grafting (CABG) surgery in cases when cardio-pulmonary bypass is not used, at times when the heart is manipulated or lifted the inflow to the right ventricle may be kinked and obstructed. Then flow across the lungs will decrease and left ventricular filling may output will be diminished. To avoid this problem a passive shunt, which in the preferred embodiment is a valved shunt, is used to conduct blood from the inferior vena cava (IVC) via the right atrium to the pulmonary artery (PA) bypassing the right ventricle. The shunt uses large diameter cannulae to keep its resistance low. The valve prevents blood from flowing from the PA into the IVC. The shunt may also use a manually actuated shutoff valve or may have a portion which can be clamped. During surgery, the patient may be fluid loaded so that the right atrial pressure is high, such as 25 mmHg.

Abstract: A blood pump intended to be carried by a freely moving patient uses perpendicular magnetic and electrical fields to propel blood. A rod mounted coaxially inside a tube has electrodes in blood contact for establishing a radial electric field, and an inductor having windings parallel to the axis of the tube is used to establish a circumferential magnetic field. To avoid the evolution of gas at the electrode surfaces the magnetic and electric fields are periodically reversed, and the electrodes are made to have very high surface areas. The blood pump is powered by batteries or fuel cells (or a combination of both) to provide long service between recharging and to reduce the weight carried by the patient.

Abstract: An artificial heart has a driving section, a nozzle section, a pump section for insertion into a ventricle of a human heart, and a sealing section forming a seal for a driving shaft extending from the driving section for driving the pump section. A sealing liquid chamber filled with a sealing liquid is formed around the driving shaft between the sealing mechanism and the driving section. The sealing liquid in the sealing liquid chamber maintains the sealing mechanism in a liquid-tight state and lubricates the sealing mechanism, whereby blood is prevented from entering the driving section. Even if blood happens to enter the driving section, the blood is mixed with the sealing liquid and does not coagulate. Thus, the operation of the artificial heart is not suppressed.

Abstract: An apparatus and method of temporarily replacing the function of the left ventricle in a patient whose heart is severely injured and is unable to maintain a systemic arterial pressure adequate to support the inside walls of patient's aorta, the method comprising a removable pressurizable support means having an external profile which is expandable to fit firmly against the inside wall of the aorta of a patient, wherein the external profile of the pressurizable support means presents a central opening that allows blood to flow through the aorta. The pressurizable support means can both support and expand the aorta under low blood pressure to assist the drawing of blood from the left ventricle. The central opening also allows for the placement of a blood flow control means. The blood flow control means can comprise a pumping balloon and a proximal blocking balloon, the two members pressurized and depressurized in opposition within the aorta of a patient to simulate systole and diastole of a healthy heart.

Abstract: The symptoms of congenital heart failure are addressed in this surgical procedure for mounting a patch in the ventricle of the heart to reduce ventricular volume. Placement of the patch is facilitated by palpating a beating heart to identify akinetic, although normal appearing, tissue. An apical patch having an oval configuration facilitates return of the heart to a normal apical shape which enhances muscle fiber efficiency and a normal writhing pumping action. An inferior patch having a triangular configuration can also be used. The patches include a semi-rigid ring, and a circumferential rim to address bleeding. Patch placement is further enhanced by creating a Fontan-type neck and use of pledged sutures. Intraoperative vascularization and valve replacement is easily accommodated. Increased injection fraction, reduced muscle stress, improved myocardial protection, and ease of accurate patch placement are all achieved with this procedure.

Abstract: A geometric reconfiguration assembly for the natural heart having a collar configured for surrounding the natural heart. The collar can include a plurality of bands, such as thin bands of about 0.2 mm in thickness, in a spaced relationship to each other, and a connector bar intersecting the plurality of bands and configured for maintaining the spaced relationship of the bands to each other. The collar may include a plurality of bands, such as from about 2 to about 10 bands, that are positioned parallel to each other. The bands can each be made of a biomedical material, such as polyacetal or a metal, such as titanium or steel. The connector bar of the present invention can be positioned tangential to the plurality of bands, and may have a plurality of grooves configured to receive the thickness of each of the plurality of bands. The grooves also may be beveled to allow for the bands to flex as the heart beats.

Abstract: A single chamber mechanical heart has a movable vane journaled in the apex of the casing, an inlet port and an outlet port in each side wall of the chamber, and means for mechanically reciprocating the vane to pump blood on either side of the vane. The vane can be electromagnetically positioned using electro magnets or a shaft drive through the chest of the patient. The blood pressure and rate can be controlled by appropriate motion of the vane.

Abstract: A static device for use with the heart that has a plurality of members configured to be positioned adjacent the epicardial surface of the heart. The members are joined by at least one connector wherein the members are fixed in a spatial or spaced relationship relative to each other such that a portion of the heart wall is displaced inwardly. The member(s) can be configured in a rectangular shape, and preferably includes an inner surface having a curved configuration. In one embodiment, the device can have first and second member that are positioned in a spaced relationship relative to each other about 180 degrees apart. The first member is configured to be positioned adjacent the anterolateral surface of the chamber, and the second member configured to be positioned adjacent the posteromedial surface of the chamber.