Abstract: Devices and implantation methods utilizing subcutaneous placement into a patient are disclosed for the insertion, advancement and positioning of a subcutaneous implantable medical device (SIMD) such as a medical electrical lead. The device for implanting the SIMD is configured having a pre-biased distal curve for creating a pathway to an implant location within a substernal space.

Abstract: A method and device are provided for non-blood contact mechanically assisting an injured (e.g., infarcted) ventricle by coupling an inflatable bladder or other volume adjustable device to the injured ventricle and selectively inflating the bladder or increasing the size of the volume in systole to apply force against the injured ventricle and deflating the bladder or reducing the size of the volume in diastole to remove force against the injured ventricle. When no mechanical assistance is being provided to the injured ventricle, the inflatable bladder or volume adjustable device is preferably maintained at a predetermined pressure so as to selectively stiffen the injured tissue and alter ventricular geometry a desired amount.

Abstract: A device for administration of substances onto an epicardial surface of a heart includes a frame structure for at least partially encircling a circumference of the heart which is able to assume shaping, positioning, guiding and stabilizing functions. The frame structure may be coupled to a heart-shaped sleeve. A substance carrier for accommodating the substances to be administered may be coupled to the device.

Abstract: The present invention provides methods, systems, kits, and cardiac compression devices that have both passive chambers and active chambers to improve heart function.

Abstract: A resuscitation device is disclosed that includes a pump having a cylinder with a gas inlet and a gas outlet, a piston to travel in the cylinder, and a valve. The valve is configured to allow gas to be displaced into the cylinder through the gas inlet during a first stroke direction and second stroke direction of the piston in the cylinder, and for allowing gas to be displaced through the gas outlet during an opposite of the first stroke direction and second stroke direction of the piston in the cylinder; a motor, selected from one of a stepper motor, a feedback motor, a stepper motor with feedback, and a linear motor, connected to the piston to move the piston in the cylinder; and a patient interface in fluid connection with the pump to receive gas via the gas outlet and to deliver the gas to a patient.

Abstract: Systems, devices and methods for a surgical training tool that drives movement of an organ In order to reproduce a movement of that organ to mimic the conditions of a live surgical procedure.

Abstract: Devices and implantation methods utilizing subcutaneous placement into a patient are disclosed for the insertion, advancement and positioning of a subcutaneous implantable medical device (SIMD) such as a medical electrical lead. The device for implanting the SIMD is configured having a pre-biased distal curve for creating a pathway to an implant location within a substernal space.

Abstract: Substernal implantable cardioverter-defibrillator (ICD) systems and methods for providing substernal electrical stimulation therapy to treat malignant tachyarrhythmia, e.g., ventricular tachycardia (VT) and ventricular fibrillation (VF) are described. In one example, an implantable cardioverter-defibrillator (ICD) system includes an ICD implanted in a patient and an implantable medical electrical lead. The lead includes an elongated lead body having a proximal end and a distal portion, a connector at the proximal end of the lead body configured to couple to the ICD, and one or more electrodes along the distal portion of the elongated lead body. The distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the ICD is configured to deliver electrical stimulation to a heart of the patient using the one or more electrodes.

Abstract: Apparatus and methods are described, including apparatus for treating a cavity in a human body, the apparatus including a delivery tube. A bather device has a collapsed configuration and an expanded configuration, the barrier device moving from the collapsed configuration to the expanded configuration upon being deployed from the delivery tube. A pushing element, slidably disposed within a lumen of the delivery tube, is configured to deploy the barrier device from the delivery tube by pushing the bather device. One or more bather-deployment elements are coupled to the barrier device and to the pushing element, the bather-deployment elements being configured to conformingly contact the barrier device with tissue surrounding the cavity. Other applications are also described.

Abstract: Apparatus and methods are described, including apparatus for treating a cavity in a human body, the apparatus including a delivery tube. A barrier device has a collapsed and an expanded configuration, the barrier device moving from the collapsed to the expanded configuration upon being deployed from the delivery tube. A pushing element, slidably disposed within a lumen of the delivery tube, deploys the barrier device from the delivery tube by pushing the barrier device. One or more barrier-deployment elements are coupled to the barrier device and to the pushing element, the barrier-deployment elements being configured to conformingly contact the barrier device with tissue surrounding the cavity. The barrier device is configured to isolate the cavity from surrounding body fluid that is between the barrier device and the pushing element, following deployment of the barrier device from the delivery tube. Other applications are also described.

Abstract: A barrier of a vacuum pump prevents contamination from entering a vacuum pump air line. The barrier separates parts of the pump and is moveable between an initial state and a distended state. The barrier is assembled within the pump with a pre-load. When the vacuum source is applied to the barrier, the barrier achieves a distended state and when the vacuum source is released, the barrier incrementally self returns to an initial state. The geometry and material construction of the barrier, along with the pre-load, assists in returning the barrier on its own to the initial state from the distended state.

Abstract: A system for treating heart valve malfunction specifically including mitral regurgitation including a positioning structure operative to assume both expanded and contracted orientations and a retaining assembly positioned and structured to operatively dispose the positioning structure in moveably supporting lifting and/or positioning relation to the ventricular wall portion of the heart. The retaining assembly and the positioning structure are cooperatively disposed and structured to accomplish a shape variance of the heart upon a lifting or positioning force being exerted thereon substantially concurrent to the positioning structure being disposed in the expanded orientation. The force exerted on the heart at least partially defines a shape variance thereof to the extent of positioning of the leaflets of the mitral valve into a closed orientation which restricts mitral regurgitation.

Abstract: A sleeve adapter for connecting a ventricular assist device to a ventricle of the heart.

Abstract: Methods for treating a cardiovascular disorder comprising concomitant administration of one or more extracellular matrix (ECM) based compositions directly to damaged or diseased cardiovascular tissue associated with the cardiovascular disorder, and provision of ventricular assistance. In a preferred embodiment, the ECM based compositions include an ECM material derived from a mammalian source.

Abstract: An inflatable garment for applying to parts of the body such as the calf of the leg as a means of enhancing blood circulation in the body. The garment is of universal application in the sense that it comprises two wrap halves (8, 9) provided with inflatable bladders (4, 5, 6). The two wrap halves can be selectively coupled together in such a way as to provide a variable overall length of garment wrap to suit calf's of differing size while at the same time maintaining the integrity of fluid communication between the bladders on the respective wrap halves.

Abstract: An apparatus for treatment of a failing heart by reducing the wall tension therein. In one embodiment, the apparatus includes a tension member for drawing at least two walls of a heart chamber toward each other. Methods for placing the apparatus on the heart are also provided.

Abstract: A device for epicardial support and/or the assuming of cardiac activity having a double membrane (1) having an elastic inner membrane (2) and a non-expandable outer membrane (3) as well as a closed cavity (4) formed therebetween which can be inflated and deflated by means of a fluid. With the objective of further developing a device of the type, so that same can more simply and at substantially lesser risk administer medication to the pericardial sac, a second cavity (7) having a fluid-permeable wall limiting the second cavity (7) relative to the heart is provided at the inward facing side (6) of the inner membrane (2) relative to the heart (5) with this second cavity (7) being able to be filled with a fluid through a separate fluid line (9) from outside the patient's body or drained from within the body.

Abstract: This is a surgical device and a method of using it. In particular, the device is one for reinforcing the pericardial sac surrounding the heart to assist in the treatment of congestive heart failure. The device, generically, is an enclosure having an interior and an exterior. The interior surface is made in such a way that it tends not to or does not form adhesions with or accept ingrowth with the myocardial tissue of the epicardium. The exterior surface of the device, in contrast, is adapted to adhere to or to ingrow with or otherwise attach sufficiently to the pericardium so that it reinforces that membrane or structure. The nature of the device is that it tends not to allow the pericardium to expand further with time. The device, after complete deployment, should envelope some measure of pericardial fluid in its interior separating it from the epicardial surface. This device helps to prevent further declination of the heart during congestive heart failure.

Abstract: Methods and apparatus are disclosed for attaching cardiac devices onto a natural heart by employing arrays of gripping elements, such as hooks or barbs. The gripping elements are designed to penetrate and lodge themselves in the epicardial tissue in order to secure the device to at least a portion of the surface of the heart muscle. The gripping elements, although designed to penetrate the surface of the heart, have limited depth penetration so as to avoid puncture of blood vessels. The attachment mechanisms disclosed herein can also permit both attachment and detachment of device.

Abstract: A resection device and method permits safe and efficient encapsulation, isolation and resection of body tissue. The device includes a sheath of flexible and severable material configured to receive the body tissue to be resectioned as it is drawn therein. The sheath may be expandable and held in an expanded condition as the body tissue to be resectioned is drawn into the sheath. Thereafter, the sheath is permitted to collapse about the body tissue to contain and constrict the body tissue. Once the body tissue to be resectioned is disposed in the sheath, the sheath is severed to resection the body tissue.

Abstract: Devices and methods for treating degenerative, congestive heart disease and related dysfunction are described. Minimally invasive surgical force transfer structures offer devices that mitigate changes in the ventricular structure (i.e. remodeling) and deterioration of global left ventricular performance related to tissue damage precipitating from ischemia, acute myocardial infarction (AMI) or other abnormalities. These force transfer structures resist diastolic filling pressure while simultaneously transmitting a compressive force to the aorta, the pulmonary artery, the atrium and/or other anatomic structure to improve cardiac output thereby reducing the strain on the heart. In addition, the force transfer structures may compensate or provide therapeutic treatment for congestive heart failure and/or reverse the remodeling that produces an enlarged heart.

Abstract: A minimally invasive device for performing direct cardiac massage including an inflatable bladder mounted on a rigid inflation tube. The rigid inflation tube is used to push the bladder into the sternocostal space through an incision in the upper abdomen just below the xiphoid process. A tear-away insertion sleeve is provided over the balloon, so that the device may easily be inserted in to the body. The insertion sleeve includes various features that assist in placement of the device and removal of the sleeve. After insertion into the sternocostal space and removal of the insertion sleeve, the bladder is repeatedly inflated and deflated to massage the heart and provide blood flow.

Abstract: A resection device and method permits safe and efficient encapsulation, isolation and resection of body tissue. The device includes a sheath of flexible and severable material configured to receive the body tissue to be resectioned as it is drawn therein. The sheath may be expandable and held in an expanded condition as the body tissue to be resectioned is drawn into the sheath. Thereafter, the sheath is permitted to collapse about the body tissue to contain and constrict the body tissue. Once the body tissue to be resectioned is disposed in the sheath, the sheath is severed to resection the body tissue.

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: Soft, multi-fingered resilient robotic fingers for selectively assisting the ventricles, and in particular the left ventricle, of a weak heart to produce internal pressure and to pump blood from one or more sides, in synchrony with the natural systolic contraction of the ventricle, as well as providing arrhythmia control of a beating heart. The apparatus is microprocessor and electrically-controlled and completely implantable. The plurality of soft fingers monitor and gently squeeze the heart (systole) to enhance blood circulation and assist a weak heart. The soft fingers work in harmony, by means of a micro-processor controlled solenoid or other linear robotic actuators such as metal-hydride actuators or polymeric artificial muscles, and a resilient body or a spring, to close once the solenoid is powered electrically and quickly retract away from the heart when the solenoid is not powered.

Abstract: A device for performing minimally invasive closed chest heart massage comprises a support having a plurality of curved, deployable struts, optionally carrying a sheet or inflatable bladder for engaging the pericardium. The struts are delivered to the space between the pericardium and the posterior rib cage in a radially collapsed configuration and deployed radially outwardly with minimum advancement in the axial direction.

Abstract: A lung constriction device and method provide lung air leak suppression or lung volume reduction. The lung constriction device includes a jacket of flexible material. The jacket is configured to cover at least a portion of a lung. The jacket is further configured to receive the lung portion as it is drawn therein. The jacket may be expandable and held in an expanded condition as the lung tissue is drawn into the jacket. Thereafter, the jacket is permitted to collapse about the lung portion to constrict the lung portion. The jacket may alternatively be nonexpandable. As the lung tissue is drawn into the jacket, it will collapse. Once disposed in the jacket, the jacket constricts the lung tissue to provide leakage suppression or lung volume reduction. The jacket may further be severable so that after the lung portion is drawn into the jacket, the jacket may be severed to section the lung portion.

Abstract: Apparatus and method for the treatment of congestive heart failure are disclosed that utilize a cuff that surrounds the heart and constrains cardiac dilation, while electrodes embedded in the cuff stimulate the myocardium to contractile function. An EKG signal can be processed to create an optimal pattern of selective stimulation of different areas of the heart at different times. An implantable circuit contains a power source and stimulation circuits. In some embodiments, a telemetry unit and an EKG collection circuit are also included. In accordance with the present disclosure, cuff limits the dilation of the heart and the stimulation electrodes enhance ventricular function by optimizing ventricular contractility.

Abstract: A minimally invasive device for performing direct cardiac massage including an inflatable bladder mounted on a rigid inflation tube. The rigid inflation tube is used to push the bladder into the sternocostal space through an incision in the upper abdomen just below the xiphoid process. After insertion into the sternocostal space, the bladder is repeatedly inflated and deflated to massage the heart and provide blood flow.

Abstract: A surgical method for assisting cardiac function utilizes a pair of inflatable balloons initially in collapsed configurations. The balloons are inserted into an intrapericardial space about a patient's heart. One of the balloons is disposed about one portion of the patient's heart and the other of the balloons about another portion of the patient's heart. The method further includes differentially inflating the balloons in the intrapericardial space to differentially compress the one portion and the another portion of the patient's heart.

Abstract: An activator device for activation of cardiac tissue having a stint for placement within the interior volume of a natural heart adjacent cardiac tissue thereof. The device also includes a yoke for placement around a portion of the exterior surface of the natural heart in general alignment with the stint and connected to the stint by at least one cord. The device provides a simple yet reliable mechanism for assisting in extended activation of a natural heart with minimal impact and intrusion.

Abstract: Cardiac ventricular assist apparatus adapted to be placed by insertion through an incision in the wall of the upper abdomen below the rib cage and an incision in the inferior aspect of the pericardium proximate the heart apex comprises a flexible bladder assembly that adapted to be passed through the incision in the pericardium to a position between the pericardial sac and the epicardium. The bladder assembly is of a size such and shape such as to be engageable with a substantial portion of the outer surface of the left ventricle of a heart. The bladder assembly includes a distensible pumping bladder that is attached to a tube through which a gas can be introduced into it to compress the left ventricle and withdrawn from it to allow the ventricle to fill and a non-distensible retaining bladder, which is substantially coextensive with the pumping bladder and receives a packed body of particulate material.

Abstract: A surgical method for assisting a malfunctioning heart comprises inserting a balloon into an intrapericardial space and inflating the balloon in the intrapericardial space to place a compressive pressure on a heart in the intrapericardial space sufficient to force blood from the heart. A lubricant is fed to the intrapericardial space after insertion of the balloon into the space.

Abstract: A direct mechanical bi-ventricular cardiac assist device comprises a ventricular actuation cup having two independently operated diaphragms for independently actuating the right and left ventricle of the patient's heart. The pressure and timing of each diaphragm can be independently varied to maximize forward cardiac output. The ventricular actuation cup is constructed in two components including a main body section and an end piece. The diaphragm wraps around the ends of the main body section and the edges of the diaphragm are bonded to the outer surface of the main body section. Bonding of the diaphragm to the outer surface of the ventricular actuation cup eliminates lifting and tearing vectors which could result in diaphragm failure.

Abstract: Cardiomyoplasty is a high mortality procedure (fifty percent two year mortality) with limited hemodynamic benefit. Excision of left ventricular myocardium in dilated congestive heart failure is also a high mortality procedure (forty percent one year mortality), but is one which may produce significant hemodynamic improvement in some patients although it can produce fatal hemodynamic deterioration in other patients. Use of cardiomyoplasty following the resection of ventricular myocardial tissue to reduce the diameter of the ventricular chamber provides replacement muscle mass and permits the cardiomyoplasty to function more effectively. The invention provides a new operation to achieve low mortality, which combines the previous two procedures described above in such a way that the strengths of each procedure overcomes the weaknesses of the other.

Abstract: An artificial implantable heart assist system with an artificial myocardium employs a number of flexible, non-distensible tubes with the walls along their long axes connected in series to form a cuff. The tubes are sealed for purposes of inflation and deflation with either hydraulic fluid or pneumatic fluid. The cuff is placed around the natural heart. The inflation of the tubular segments provides that they have a circular cross-section, while in the deflated, or collapsed position without being fluid filled, they are essentially flat sheets. The difference in the perimeter length of the cuff in the plane of the tube short axis, arising from the fact that, inflated, each tube has a length along its perimeter equal to the diameter of the inflated tube, while deflated it has a length equal to the perimeter of the tube divided by two, provides for a contractile force.

Abstract: A ventricular assist device for a heart includes a compression band-stay-pad assembly for encircling substantially the heart perimeter and comprising an elongated band member or chain disposed in a sealed protective structure filled with a lubricating medium. The band member may be fixed at one end and wound upon, or unwound from, a rotatable spool by a drive motor through a speed reducer. Force-transmitting support or stay assemblies are disposed in the protective structure between the band member and a resilient pad assembly for encircling the heart and promoting heart tissue ingrowth therein. The force-transmitting stay assemblies are biased circumferentially, and thus radially outward, by compression return springs disposed therebetween.

Abstract: An intrapericardial assist device and method comprises an electrode carrier in the form of an inflatable cuff-shaped balloon adapted for juxtaposition to a patient's heart in an intrapericardial space. An electrical contact or electrode is disposed on the contact surface of the carrier for conducting electrical energy to the heart upon an insertion of the electrode carrier into the intrapericardial space and upon inflation of the balloon so that the electrode engages cardiac tissues.

Abstract: Methods for employing a heart massager for substernal heart massage are disclosed. The heart massager comprises a heart-contacting member connected to a handle. The disclosed method comprises the following steps: making an incision in the skin in an intercostal space; surgically separating the intercostal space; inserting the heart massager through the intercostal space and guiding heart-contacting member of the massager onto the ventricular region of the heart; and periodically pressing and releasing the handle so that the heart's ventricles are compressed and allowed to return to their non-compressed condition.

Abstract: In a surgical method for resuscitating a stopped heart an inflatable balloon is inserted in a folded, collapsed configuration into an intrapericardial space about the stopped heart. The balloon is inflated in the intrapericardial space to place a compressive pressure on the stopped heart sufficient to force blood from the heart.

Abstract: A ventricular assist device for a heart includes a compression band-stay-pad assembly for encircling substantially the entire heart perimeter and comprising an elongated band member or chain disposed in a sealed protective structure filled with a lubricating medium. The band member may be fixed at one end and wound upon, or unwound from, a rotatable spool by a drive motor through a speed reducer. Force-transmitting support or stay assemblies are disposed in the protective structure between the band member and a resilient pad assembly for encircling the heart and promoting heart tissue ingrowth therein. The force-transmitting stay assemblies are biased circumferentially, and thus radially outward, by compression return springs disposed therebetween.

Abstract: A method is disclosed for the preparation of non-stringy hydrogels that are comprised of a homogeneous uniform mixture of water and at least one water-soluble high molecular weight polymer. Suitable mixtures may be derived from poly(ethylene oxide) and water or poly(vinyl pyrrolidone), a viscosity enhancing hydrophilic polymer and water, and further, may optionally contain an effective amount of a water-soluble electrolyte to provide conductive non-stringy materials. These polymeric mixtures are crosslinked by exposure to radiant energy to provide gel-like solids which are sufficiently tacky and adhesive to adhere to the subjects' skin and yet are substantially non-stringy and non-aggressive such that contact with such hydrogels imparts less discomfort to the user. In addition, the consumer utilizing the products of this invention would not experience the objectionable sticky, stringy sensation associated with existing adhesive gels.