Abstract: Disclosed are implantable tissue augmentation devices, methods, and associated tools. The devices include an inflatable body, having a self-sealing membrane operably attached to a wall of the implant. The self-sealing membrane provides access for filling the device, and includes a first layer comprising a fabric. The fabric has a first plurality of yarn strands positioned in a first direction, and a second plurality of yarn strands positioned in a second direction. The first and second plurality of yarn strands intersect to form a matrix pattern with cells defined by free spaces between yarn strands. The membrane also includes a first elastomeric material configured to fill the cells as well as form a coating over the first and second plurality of yarn strand, and a second layer comprising a second elastomeric material. The second elastomeric material has a lower durometer than the first elastomeric material. Kits and systems are also disclosed.

Abstract: This is a method and an apparatus for the treatment or introduction of contrast fluids into tissue, particularly cardiac tissue. The apparatus includes a catheter having an elongated flexible body and a tissue infusion apparatus including a hollow infusion needle configured to secure the needle into the tissue when the needle is at least partially inserted into the tissue to help prevent inadvertent removal of the needle from the tissue. This permits the selected treatment or contrast fluid to be confined to a specific site. The catheter may also include a visualization assembly including a transducer at the distal end of the body.

Abstract: This is a method and an apparatus for the introduction of therapeutic compounds into tissue, particularly cardiac tissue. The apparatus includes a catheter having an elongated flexible body and a tissue infusion apparatus including a hollow infusion needle configured to secure the needle into the tissue when the needle is at least partially inserted into the tissue to help prevent inadvertent removal of the needle from the tissue. This permits the selected therapeutic compound to be delivered to a specific site. The catheter may also include a visualization assembly including a transducer at the distal end of the body.

Abstract: Disclosed is a closure catheter, for closing a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a plurality of tissue anchors, which may be deployed into tissue surrounding the opening, and used to draw the opening closed. Methods are also disclosed.

Abstract: The present invention relates to a system adapted to position a medical device, such as an ablation catheter, at a location where a pulmonary vein extends from an atrium. The system optimally includes a deflectable catheter and a sheath. An ablation member is disclosed for use with the positioning system, wherein the deflectable catheter and the sheath cooperate so as to facilitate positioning of the ablation member at the location.

Abstract: A device and method for obliterating or occluding a body cavity or passageway, in particular, the left atrial appendage of a patient's heart. The procedure can be carried out intraoperatively, but is preferably carried out percutaneously by use of a delivery catheter to position an occluding device adjacent a patient's left atrial appendage. The occluding device may prevent the passage of embolic or other material to or from the left atrial appendage by volumetrically filling the appendage, closing the opening of the appendage with an occluding member, or pulling the tissue around the opening of the appendage together and fixing it in a closed state.

Abstract: This invention is a circumferential ablation device assembly which is adapted to forming a circumferential conduction block in a pulmonary vein. The assembly includes a circumferential ablation element which is adapted to ablate a circumferential region of tissue along a pulmonary vein wall which circumscribes the pulmonary vein lumen, thereby transecting the electrical conductivity of the pulmonary vein against conduction along its longitudinal axis and into the left atrium. The circumferential ablation element includes an expandable member with a working length that is adjustable from a radially collapsed position to a radially expanded position. An equatorial band circumscribes the outer surface of the working length and is adapted to ablate tissue adjacent thereto when actuated by an ablation actuator.

Abstract: An implantable prosthesis is provided having a membrane which holds a flowable substance. The membrane is separated into a first chamber and a second chamber with the first and second chambers being fluidly coupled via an orifice. The orifice has a size which may be adjusted by the user after implanting the prosthesis into the patient.

Abstract: An implantable prosthesis is provided having a membrane which holds a flowable substance. The membrane is separated into a first chamber and a second chamber with the first and second chambers being fluidly coupled via an orifice. The orifice has a size which may be adjusted by the user after implanting the prosthesis into the patient.

Abstract: An implantable prosthesis is provided having a membrane which holds a flowable substance. The membrane is separated into a first chamber and a second chamber with the first and second chambers being fluidly coupled via an orifice. The orifice has a size which may be adjusted by the user after implanting the prosthesis into the patient.

Abstract: An implantable prosthesis is provided having a membrane which holds a flowable substance. The membrane is separated into a first chamber and a second chamber with the first and second chambers being fluidly coupled via an orifice. The orifice has a size which may be adjusted by the user after implanting the prosthesis into the patient.

Abstract: Disclosed is a closure catheter, for closing a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a plurality of tissue anchors, which may be deployed into tissue surrounding the opening, and used to draw the opening closed. Methods are also disclosed.

Abstract: A mitral annuloplasty and left ventricle restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

Abstract: A medical device and methods for filling tissue are disclosed. The device has a first configuration for delivery into tissue to be filled and a second configuration in which the device either expands, or is forced to expand within the tissue to be filled. The exterior profile of the expanded device may be customized along its length, to achieve a desired result. The device is adapted to be placed in the skin, and may be used to reduce facial wrinkles or augment facial features such as the lips.

Abstract: Disclosed is a closure catheter, for closing a body cavity such as a vessel, or the left atrial appendage of the heart. The closure catheter includes a plurality of deployable tissue anchors, which may be laterally deployed into surrounding tissue. The anchors may thereafter be used to draw the tissue radially inwardly, to close the body cavity. Methods are also disclosed.

Abstract: This invention is related to a tissue ablation system and method that treats atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium. The system includes a circumferential ablation member with an ablation element and also includes a delivery assembly for delivering the ablation member to the location. The circumferential ablation member is generally adjustable between different configurations to allow both the delivery through a delivery sheath into the atrium and the ablative coupling between the ablation element and the circumferential region of tissue.

Abstract: Medical devices, systems and kits for filling tissue are disclosed. The device has a first configuration wherein the device can pass through a small catheter or needle placed in the tissue to be filled and a second configuration in which the device is expandable to a predetermined or customizable shape. In one application, the device is adapted to be placed into the skin to reduce facial wrinkles or augment facial features such as the lips. Kits and systems include multiple device sizes, filler tubes, and filler media.

Abstract: Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and may also include a stabilizing member. The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue in-growth onto the occlusion member. Methods are also disclosed.

Abstract: Disclosed is a closure catheter, for closing a body cavity such as a vessel, or the left atrial appendage of the heart. The closure catheter includes a plurality of deployable tissue anchors, which may be laterally deployed into surrounding tissue. The anchors may thereafter be used to draw the tissue radially inwardly, to close the body cavity. Methods are also disclosed.

Abstract: A deflectable tip catheter that is used in combination with a guidewire for delivery of an ablation element to target areas of a patient's vasculature. The deflectable tip catheter has a handle portion, an elongated shaft and a deflectable tip portion. A guidewire lumen extends through the elongated shaft and deflectable tip portion. A guidewire passes through the guidewire lumen and exits from a port in the distal end of the deflectable tip portion. The deflectable tip of the catheter is deflected by manipulation of the handle portion to direct the advancement of the guidewire as the guidewire is advanced out of the distal port. By using the deflectable tip portion to direct the advancement of the guidewire, the physician's ability to navigate sharp angles is greatly improved. The deflectable tip catheter is particularly suitable for delivering an ablation element to a pulmonary vein or pulmonary vein branch for performing circumferential ultrasound vein ablation to treat atrial fibrillation.