Abstract: Annuloplasty rings are employed to treat heart valve defects, such as regurgitation. Synching the heart tissue to the ring restores the valve opening to its approximate original size and operating efficiency. Adjustable annuloplasty rings allow for a proper degree of synching both during open heart surgery and over the patient's lifetime. A subcutaneous port may be coupled to an adjustable annuloplasty ring such that an external activation energy generator can be used to heat the adjustable annuloplasty ring and thereby adjust the size of the annuloplasty ring.

Abstract: A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element is transformable, in response to application of an activation energy, from a first configuration to a second configuration. The at least one adjustable element may engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient's left ventricle, when the at least one adjustable element is in the second configuration.

Abstract: Annuloplasty rings reduce or eliminate tricuspid regurgitation and/or tricuspid annulus dilation. An adjustable annuloplasty device includes a ring body having a first free end and a second free end. The ring body includes a shape memory material to provide a shape change to the adjustable annuloplasty device upon activation. The ring body includes a first segment including the first free end and following a curved path corresponding to an anterior leaflet region of a tricuspid annulus, a second segment following a curved path corresponding to a posterior leaflet region of the tricuspid annulus, and a third segment including the second free end and at least partially following a linear path corresponding to a portion of a septal leaflet region of the tricuspid annulus. Activation of the shape memory material changes a dimension of the adjustable annuloplasty device.

Abstract: A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body from a proximal end to a distal end of the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element.

Abstract: Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves via a trans-apical approach to accessing the heart. A guiding sheath may be introduced into a ventricle of the heart through an access site at an apex of the heart. A distal end of the guiding sheath can be positioned retrograde through the target valve. An annuloplasty ring arranged in a compressed delivery geometry is advanced through the guiding sheath and into a distal portion of the guiding sheath positioned within the atrium of the heart. The distal end of the guiding sheath is retracted, thereby exposing the annuloplasty ring. The annuloplasty ring may be expanded from the delivery geometry to an operable geometry. Anchors on the annuloplasty ring may be deployed to press into and engage tissue of the annulus of the target valve.

Abstract: An adjustable annuloplasty device is described. The device includes a body member comprising a shape memory material, the body member configured to be placed at or near a base of a valve of a heart. The device further includes a hysteretic material configured to undergo magnetic hysteresis in response to a first activation energy, the hysteretic material being in thermal communication with the shape memory material. The body member may have a first size of a body member dimension in a first configuration and a second size of the body member dimension in a second configuration. When the body member is in position in the heart, a change from the first configuration to the second configuration changes a size of a dimension of the annulus of the valve.

Abstract: An adjustable implantable medical device and adjustment device are described. In some embodiments, the adjustment device includes a lead with a distal end modified to permit better engagement and securement to the described implantable devices. In some embodiments, the contact of the lead is bent. Some embodiments include a coil that engages and secures the lead to the implantable device. Some embodiments include a suture line to aid in securing the lead to the implantable device.

Abstract: An adjustable annuloplasty device is described. In some embodiments, the device includes a body member having a surface that conforms at least partially to a cardiac valve annulus. The body member comprises a shape-memory member that transforms from a first configuration to a second configuration in response to an applied energy. In some embodiments, the device further includes a first electrode assembly, coupled to the shape-memory member, that transfers energy to the shape-memory member, and a second electrode assembly, coupled to the shape-memory member, that transfers at least a portion of the energy away from the shape-memory member.

Abstract: Annuloplasty rings are employed to treat heart valve defects, such as regurgitation. Synching the heart tissue to the ring restores the valve opening to its approximate original size and operating efficiency. Adjustable annuloplasty rings allow for a proper degree of synching both during open heart surgery and over the patient's lifetime. A subcutaneous port may be coupled to an adjustable annuloplasty ring such that an external activation energy generator can be used to heat the adjustable annuloplasty ring and thereby adjust the size of the annuloplasty ring.

Abstract: An intraoperative adjustment device is described. In some embodiments, the device includes an elongate body including a proximal end and a distal end, the distal end configured to penetrate an outer surface of an adjustable cardiac implant implanted in a patient's heart, and the proximal end and the distal end connected by at least one energy-transfer member. In some embodiments, the distal end includes at least one electrode coupled to the energy-transfer member and configured to deliver an activation energy to the adjustable cardiac implant. In some embodiments, the proximal end is configured to attach to an energy source that provides the activation energy. In some embodiments, the proximal end is configured to be located outside the patient's body while the distal end is coupled to the adjustable cardiac implant that is implanted in the patient's heart.

Abstract: Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the outer hollow member. The internal anchor member includes a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. The internal anchor member is configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

Abstract: A percutaneous magnetic catheter may be used to position one or more magnetic components near a magnetically driven prosthesis in a patient's heart in order to adjust the magnetically driven prosthesis. In certain embodiments, the one or more magnetic components are rotatable. Rotation of the one or more magnetic components cause variations in a magnetic field. Variations in the magnetic field may be utilized to adjust the size or shape of a magnetically driven prosthesis. In this way, a magnetically driven prosthesis may be adjusted after a patient has recovered from a surgery in which the magnetically driven prosthesis was implanted. Further, a magnetically driven prosthesis may be adjusted based upon progression of a heart condition.

Abstract: Methods and devices are provided for support of a body structure. The devices can be adjusted within the body of a patient in a minimally invasive or non-invasive manner such as by applying energy percutaneously or external to the patient's body. The energy may include, for example, acoustic energy, radio frequency energy, light energy and magnetic energy. Thus, as the body structure changes size and/or shape, the size and/or shape of the annuloplasty rings can be adjusted to provide continued reinforcement. In certain embodiments, the devices include a first body member including a first shape memory material configured to transform the annuloplasty ring from a first configuration having a first size of a dimension to a second configuration having a second size of the dimension. The second size is less than said first size in septal lateral distance.

Abstract: Tissue shaping methods and devices are provided for reinforcing and/or remodeling heart valves. In certain embodiments, magnetic tissue shaping devices are implanted in tissue adjacent heart valve leaflets. The devices are mutually attractive or repulsive so as to remodel the heart tissue and improve heart valve function. In certain other embodiments, one or more tissue shaping devices including shape memory material are implanted in a patient's body within or on tissue adjacent a heart valve leaflet. The shape memory material can be activated within the patient in a less invasive or non-invasive manner, such as by applying energy percutaneously or external to the patient's body. The shape memory tissue shaping devices are implanted in a first configuration and then activated to remember a second configuration that displaces tissue so as to remodel the heart valve geometry and improve heart valve function.

Abstract: A reversibly adjustable heart harness is configured to surround at least a portion of a heart and to provide a compressive force to the heart during at least a portion of a cardiac cycle. The heart harness includes a plurality of wires forming a mesh structure, and one or more tensioning motors connected to the mesh structure. The one or more tensioning motors are configured to selectively increase or reduce tension in the mesh structure to readjust the compressive force provided that the heart harness provides to the heart.

Abstract: Embodiments of a dynamically adjustable artificial chordae tendinae implant are described. In some embodiments the implant includes a body portion, including an adjustable portion. In some embodiments, the implant includes a plurality of adjustable portions. In some embodiments the adjustable element can include a shape memory material. The adjustable portion can be configured to transform from a first conformation to a second conformation in response to an activation energy. In some embodiments, the activation energy can be one of electromagnetic energy, acoustic energy, light energy, thermal energy, electrical energy, mechanical energy, or a combination of energies. The implant couples a heart valve leaflet to a papillary muscle. Activation of the shape memory material regulates tension between the muscle and valve leaflet improving coaptation of heart valve leaflets, and reducing or eliminating regurgitation.

Abstract: A system for treating a cardiac valve includes an adjustable annuloplasty ring configured to attach to or near a cardiac valve annulus. The system also includes a suture comprising a first end coupled to the annuloplasty ring. A second end of the suture is configured to be anchored to a papillary muscle. Selectively adjusting the annuloplasty ring adjusts a tension of the suture to reposition the papillary muscle.

Abstract: Systems and methods to adjust an adjustable medical device that is implanted subcutaneously within the body of a patient. The adjustable medical device is coupled to an adjustment mechanism configured to, when powered, effect a desired adjustment to the adjustable medical device. The adjustment mechanism is electrically coupled to a receiving coil configured to resonate at a desired frequency such that an electric current induced in the receiving coil powers the adjustment mechanism. An induction activation system is configured to utilize magnetic resonance to wirelessly activate the adjustable medical device assembly, from outside the patient's body, through a skin barrier of the patient. The induction activation system comprises a power source and a delivery coil. The power source creates an alternating electrical signal.

Abstract: Systems, methods and devices are provided for improving the hemodynamic efficiency of a patient's heart by implanting one or more reinforcement elements on or with the heart and providing electrical stimulation to the heart. The reinforcement elements may include magnetic and/or shape memory material and are configured to reshape the heart so as to boost the heart's mechanical energy during a response to the electrical stimulation. In some embodiments, at least one reinforcement element includes an electrode configured to sense electrocardiogram signals within the heart. An electrical stimulation device such as an implantable or external pacemaker/defibrillator may be configured to control delivery of electrical pulses to the heart based on the sensed electrocardiogram signals. In addition, or in other embodiments, at least one reinforcement element includes an electrode configured to deliver the electrical pulses to the heart.

Abstract: A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body from a proximal end to a distal end of the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element.