Abstract: A piercing device includes a tube (10) formed with a needle tip (12). The needle tip (12) includes a bevel having a bevel length (BL) that extends at a bevel angle from a base of a heel (14) to a sharp distal, radially outer edge of the needle tip (12). A reversed edge (17) is formed as a reversed edge angle on the heel (14) of the bevel. The bevel angle is an acute angle, and the reversed edge angle is an obtuse angle.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, particular in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments, a control mechanism coupled to the adjustable flow regulation mechanism may be provided to remotely activate the adjustable flow regulation mechanism.

Abstract: Ultrasound probe systems and methods for using an ultrasound probe to assist during treatment of conditions of the human heart are provided. The method may comprise loading a medical instrument into a guide fastened to the ultrasound probe. The ultrasound probe may be inserted into a patient by way of an incision. The distal end of the ultrasound probe may be navigated to a location adjacent to an exterior surface of the heart. A treatment site may be identified on the exterior surface of the heart based on images obtained from an ultrasound transducer disposed within a distal end of the ultrasound probe. The medical instrument may be advanced within the guide to the treatment site and the medical instrument used for treatment. After treatment, the medical instrument may be withdrawn from the treatment site.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, particular in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments, a control mechanism coupled to the adjustable flow regulation mechanism may be provided to remotely activate the adjustable flow regulation mechanism.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, particular in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments, a control mechanism coupled to the adjustable flow regulation mechanism may be provided to remotely activate the adjustable flow regulation mechanism.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

Abstract: Hypo-tube based support catheter (1) for treating blood vessels, such as below the knee (BTK) blood vessels and other blood vessels (e.g., coronary, pediatric), which are partially or totally occluded. The tip of the support catheter (1) of the invention is shapeable to any desired shape before the insertion of the device into the blood vessel. The disclosed device enables improved angioplasty treatment of blood vessels, especially with a retrograde approach.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: A method of treating a native mitral valve without open-heart surgery is disclosed. An expandable prosthesis includes an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end portion of a delivery catheter and is advanced through a femoral vein and through a pre-made puncture in an atrial septum. The anchoring portion self-expands within the left atrium for anchoring the occluding member in a fixed position. The anchoring portion is preferably a laser cut structure that conforms to the left atrium and uniformly distributes anchoring forces within the left atrium. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole. The occluding member is preferably made from a flexible material, such as pericardial tissue.

Abstract: Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.