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: 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: Disclosed is a device and method for accessing the lower esophageal sphincter through the esophagus. In one embodiment, a catheter is inserted through the mouth or nose of a patient and advanced to the region of the diaphragm. Under fluoroscopy or endoscopy, a hollow needle at the distal end of the catheter punctures the wall of the esophagus from the inside so that the distal end of the needle is positioned outside the esophagus. An implant is next advanced out through the hollow needle to the region outside the sphincter where it is deflected and coerced to bluntly dissect around the circumference of the esophagus, where the implant is left in place to heal. The hollow needle is removed and the esophageal wall is allowed to heal. Subsequent diametric adjustment of the implant allows for tightening or loosening of the sphincter to minimize gastric reflux. The device and method can also be used to treat the pyloric or other body sphincters, hollow organs, or ducts.

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 comprise a shape memory material, and further include a body member and an insert member. The body member has a circumference and a slot that extends at least partially along the circumference of the body. The insert member extends at least partially along the circumference of the body.

Abstract: The present invention relates generally to systems and methods for aligning and implanting orthopedic fixation or stabilization implants within the body. In one embodiment, the system includes at least two bone anchors, at least one of which is provided with a transverse portal and a locking member. In one aspect, the system also includes at least one linkage rod, for linking two or more bone anchors through their respective locking members. The linking rod may include at least one angularly adjustable joint, which may be fixed by actuating the locking member. The bone anchors and the linkage rod may be locked into place to form a spinal fusion or fixation prosthesis.

Abstract: An inflatable corpectomy device comprises a balloon, which defines a cavity for receiving a hardenable media. The device can be inserted in an un-inflated form into a space formerly occupied by a diseased or damaged vertebrae bone. When inflated with a hardenable material, the device expands and fills the space. Various bone anchors or plates can be used in combination with the inflatable device to bridge the space and stabilize the spine while the device hardens.

Abstract: Disclosed is a tubular endoluminal vascular prosthesis, useful in treating, for example, an abdominal aortic aneurysm. The prosthesis comprises a self-expandable wire support structure having a tubular main body support and first and second branch supports. The support structure may include sliding links to permit flexibility while maintaining patency of the central lumen. The branch supports may articulate with the main body to permit the branches to pivot laterally from the axis of the main body throughout a substantial range of motion. Exoskeleton components or barbs may be provided to resist migration and endoleaks.

Abstract: Implants for treatment of obesity may be placed within the stomach and/or esophagus or around the outside surface of the stomach and/or esophagus. The implants comprise at least a portion constructed of a shape memory material. The implants are thus adapted to be implanted in a deformed shape, and then to be transformed through the application of activation energy into a memorized shape. The shape and/or size transformation induces a change in shape of the stomach and/or esophagus, thus altering the normal digestive path of food entering the patient's gastrointestinal tract.

Abstract: Tissue shaping methods and devices are provided. The devices can be adjusted within the body of a patient in a less invasive or non-invasive manner, such as by applying energy percutaneously or external to the patient's body. In one example, the device is positioned within the coronary sinus of the patient so as to effect changes in at least one dimension of the mitral valve annulus. The device may also advantageously include a shape memory material that is responsive to changes in temperature and/or exposure to a magnetic field. In one example, the shape memory material is responsive to energy, such as electromagnetic or acoustic energy, applied from an energy source located outside the coronary sinus. A material having enhanced absorption characteristics with respect to the desired heating energy may also be used to facilitate heating and adjustment of the tissue shaping device.

Abstract: A device, method, and system for treating abdominal aortic aneurysms is described, where the device is an endovascular graft implant that one or more adjustable elements. The adjustable elements provide improved performance, for example, reduced leaking. The adjustable elements are adjustable 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. Examples of suitable types of energy include, for example, acoustic energy, radio frequency energy, light energy, and magnetic energy.

Abstract: Methods and devices are provided for treatment of an aneurysm within a patient. 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, the size and/or shape of the embolic coils can be adjusted to provide optimal filling of the aneurysm. In certain embodiments, the devices include a shape memory material that is responsive to changes in temperature and/or exposure to a magnetic field. A material having enhanced absorption characteristics with regard to a desired heating energy may be used in order to facilitate heating and adjustment of the embolic coil.

Abstract: Methods and devices for treating diseases and conditions that change the spacial relationship between the vertebral bodies and the intervertebral disks, or that cause instability of the vertebral column, or both, and a method and devices that allow the surgeon to access the intervertebral space to restore a more normal three-dimensional configuration of the space, with or without additionally fusing two adjacent vertebrae.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a removable tubular restraint. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures.

Abstract: The present invention provides a stent assembly for expanding a bodily passage in a patient and draining a fluid therefrom. The assembly comprises at least one expandable stent and an elongated carrier for delivery or retrieval of the stent. The stent is circumferentially attached to a distal end of the carrier. The carrier defines at least two concentric lumens therethrough, a drainage lumen in fluid communication with the bodily passage for drainage of the fluid and an inflation lumen in fluid communication with the expandable stent. The invention also provides a method of expanding a bodily passage in a patient and draining a fluid therefrom. The method comprises providing a stent assembly of the present invention; inserting a guidewire into the bodily passage through the drainage lumen of the carrier; advancing the assembly along the guidewire until the assembly reaches a desired location; expanding the stent; and draining the fluid through drainage lumen of the carrier.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross sectional configuration by a removable tubular restraint. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures.

Abstract: Disclosed is a deployment catheter for deploying a tubular endoluminal vascular prosthesis, useful in treating, for example, an abdominal aortic aneurysm. The deployment catheter includes a proximal tubular section and a distal tubular section which are axially movable in opposite directions to deploy a prosthesis. A central core extends throughout the proximal tubular section and into the distal tubular section. A reinforcing structure is carried by the central core, spanning the junction between the proximal tubular section and distal tubular section, to improve flexibility characteristics of the catheter. In one embodiment, the proximal tubular section and/or distal tubular section are rotationally linked to the central core.

Abstract: Systems, methods and devices are provided for treating heart failure patients suffering from various levels of heart dilation. Such heart dilation is treated by reshaping the heart anatomy with the use of shape memory elements. Such reshaping changes the geometry of portions of the heart, particularly the right or left ventricles, to increase contractibility of the ventricles thereby increasing the stroke volume which in turn increases the cardiac output of the heart. The shape memory elements have an original shape and at least one memory shape. The elements are implanted within the heart tissue or attached externally and/or internally to a surface of the heart when in the original shape. The elements are then activated to transition from the original shape to one of the at least one memory shapes. Transitioning of the elements cause the associated heart tissue areas to readjust position, such as to decrease the width of the ventricles.

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: Systems, methods and devices are provided for treating heart failure patients suffering from various levels of heart dilation. Heart dilation treated by reshaping the heart anatomy with the use of magnetic forces. Such reshaping changes the geometry of portions of the heart, particularly the right or left ventricles, to increase contractibility of the ventricles thereby increasing the stroke volume which in turn increases the cardiac output of the heart. The magnetic forces are applied with the use of one or more magnetic elements which are implanted within the heart tissue or attached externally and/or internally to a surface of the heart. The various charges of the magnetic forces interact causing the associated heart tissue areas to readjust position, such as to decrease the width of the ventricles. Such repositioning is maintained over time by the force of the magnetic elements, allowing the damaging effects of heart dilation to slow in progression or reverse.

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 body member including a ferromagnetic shape memory material. The body member has a first size of a dimension in a first configuration and a second size of the dimension in a second configuration. The body member is configured to be implanted into a heart so as to reinforce a cardiac valve annulus in the first configuration.