Abstract: A method of treating a tricuspid valve that defines an annulus between a right atrium and a right ventricle of the heart is described. A first anchor and a second anchor are transluminally advanced to the heart. The first anchor is anchored inside a coronary sinus of the heart. The second anchor is anchored, from the right atrium, at a site that is across the annulus from the coronary sinus by driving a distal portion of the second anchor into the annulus at the site. Subsequently, a distance between the first and second anchors is reduced by applying tension to a tensioning member coupled to the first and second anchors. The tension is maintained by locking a lock member to the tensioning member. Other embodiments are also described.

Abstract: Apparatus, for use at a valve of a heart of a subject, includes a first catheter, a second catheter, and a translation element. The translation element is connected to, and operatively joins, the distal ends of the first catheter and the second catheter. The translation element is operable to translate the distal ends laterally with respect to each other to transition the apparatus between (i) a first state in which the distal ends are held next to each other for transluminal advancement to the heart, and (ii) a second state in which the distal ends are spaced apart from each other for positioning at a first location on the annulus and a second location on the annulus, respectively. The apparatus is configured to, while in the second state, from the distal ends, anchor a first tissue anchor at the first location, and a second tissue anchor at the second location.

Abstract: A first anchor is anchored inside a coronary sinus of a heart of a subject. A second anchor can be driven into a tricuspid annulus of the heart. A distal portion of the second anchor can be disposed adjacent and parallel to a center portion of the second anchor. The second anchor can be seated against a surface of the annulus, for example, such that (i) the distal portion is disposed perpendicular to the center portion, (ii) the center portion extends through the annulus, and (iii) a proximal portion of the second anchor is disposed in the atrium. A distance between the first and second anchors can be reduced by applying tension to a tensioning member coupled to the first anchor and the proximal portion of the second anchor. Other embodiments are also described.

Abstract: A catheter system including a wire, a translatable catheter, and first and second tethers is introduced into a body of a subject. The translatable catheter has a curved portion proximate a distal end of the translatable catheter. The first tether is coupled to the wire, and passes proximally through the translatable catheter. The second tether is attached to the curved portion. The catheter system is positioned such that the wire is disposed at a first location in the body. While the wire remains at the first location, the translatable catheter is translated away from the wire by manipulating the first tether and the second tether. Other embodiments are also described.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: The present teachings provide systems, devices, and methods for treating the heart and reducing valve regurgitation. A delivery catheter is used to advance a balloon to a treatment site outside the heart. The balloon includes a flexible outer layer encasing a primary cavity and a secondary cavity outside of the primary cavity. The secondary cavity contains a tissue-binding adhesive. While the balloon is at the treatment site, an injection medium is introduced into the primary cavity in a manner that inflates the balloon from a collapsed delivery profile into an inflated deployment profile, and squeezes the tissue-binding adhesive out of the secondary cavity. Other embodiments are also described.

Abstract: The present teachings provide systems, devices, and methods for reshaping the heart and reducing valve regurgitation. A device can be positioned proximate the heart and have a delivery profile and an inflated profile. The device can have a primary cavity and a secondary cavity, and an adhesive inside the secondary cavity. An injectable medium can be injected to the primary cavity of the device. As the primary cavity is filled, the adhesive is forced out of the secondary cavity to adhere the device. The inflated device can exert pressure on the heart, change the shape of a valve annulus, and allow a better coaptation of the valve leaflets.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: A first anchor is anchored inside a coronary sinus of a heart of a subject. A second anchor can be driven into a tricuspid annulus of the heart. A distal portion of the second anchor can be disposed adjacent and parallel to a center portion of the second anchor. The second anchor can be seated against a surface of the annulus, for example, such that (i) the distal portion is disposed perpendicular to the center portion, (ii) the center portion extends through the annulus, and (iii) a proximal portion of the second anchor is disposed in the atrium. A distance between the first and second anchors can be reduced by applying tension to a tensioning member coupled to the first anchor and the proximal portion of the second anchor. Other embodiments are also described.

Abstract: The present teachings provide systems, devices, and methods for reshaping the heart and reducing valve regurgitation. A device can be positioned proximate the heart and have a delivery profile and an inflated profile. The device can have a primary cavity and a secondary cavity, and an adhesive inside the secondary cavity. An injectable medium can be injected to the primary cavity of the device. As the primary cavity is filled, the adhesive is forced out of the secondary cavity to adhere the device. The inflated device can exert pressure on the heart, change the shape of a valve annulus, and allow a better coaptation of the valve leaflets.

Abstract: A catheter system including a wire, a translatable catheter, and first and second tethers is introduced into a body of a subject. The translatable catheter has a curved portion proximate a distal end of the translatable catheter. The first tether is coupled to the wire, and passes proximally through the translatable catheter. The second tether is attached to the curved portion. The catheter system is positioned such that the wire is disposed at a first location in the body. While the wire remains at the first location, the translatable catheter is translated away from the wire by manipulating the first tether and the second tether. Other embodiments are also described.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter and/or a removable and/or replaceable shunt portion. Devices may include absorbable materials, the absorption of which directly or indirectly causes alterations of the fluid flow capacities the devices.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upon exit from the patient's tissue, and returning the needle to a position such that the process of delivering additional sutures to the patient can be repeated. A safety shield mechanism ensures the user is protected from the needle at all times. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter shunt portion which can be manually adjusted in vivo. Methods are provided for adjusting the flow rate of the devices in vivo.

Abstract: A tissue anchoring system includes a tissue anchor member that is suitable for anchoring against tissue. The system also includes a tensioning member operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member, the tensioning member capable of being pulled to cause the anchor member to move relative to the tensioning member into a position seated against the tissue. A hand operated deployment catheter is operable to extend and deploy the anchor member therefrom. The deployment catheter includes a rotatable member about which the tensioning member is routed and a clutch assembly for limiting tension within the tensioning member to prevent the deployed anchor from being pulled through the tissue.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart's pumping cycle.

Abstract: A device according to one exemplary embodiment is a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle and suture assembly (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle assembly upon exit from the patient's tissue, and returning the needle to position such that the process of delivering additional sutures to the patient can be repeated. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique that is familiar to a user based on experience with other surgical techniques.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart's pumping cycle.