Thoracoscopic devices and methods for arresting the heart

The invention provides devices and methods for thoracoscopically arresting the heart and establishing cardiopulmonary bypass, thus facilitating a variety of less-invasive surgical procedures on and within the heart and great vessels of the thorax. In one embodiment, the invention provides a thoracoscopic system for arresting a patient's heart including a clamp configured for introduction into the patient's thoracic cavity through a percutaneous intercostal penetration in the patient's chest. The clamp is positionable about the patient's ascending aorta between the coronary arteries and the brachiocephalic artery. The clamp is coupled to the distal end of an elongated handle means for manipulating the clamp from a location outside of the patient's thoracic cavity. A means for actuating the clamp is coupled to the proximal end of the handle means. When actuated, the clamp blocks blood flow through the ascending aorta. A delivery cannula may be used to deliver cardioplegic fluid into the ascending ...

Methods and systems for performing thoracoscopic coronary bypass and other procedures

A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia.

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A system comprisingan implant sized and configured for placement within a heart chamber,a guide wire sized and configured for deployment in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site, anda connector to connect an end of the implant to one end of the guide wire such that pulling on the other end of the guide wire pulls the implant along at least a portion of the intravascular path into the heart chamber.2. A system according towherein the implant comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.3. A system comprisinga bridge element sized and configured to be implanted within the left atrium between the great cardiac vein and the interatrial septum, the bridge element having opposite ends,a guide wire sized and configured to be deployed in an intravascular path that extends from a first ...

DEVICES, SYSTEMS, AND METHODS FOR RETAINING A NATIVE HEART VALVE LEAFLET

Devices, systems and methods retain a native heart valve leaflet to prevent retrograde flow. The devices, systems, and methods employ an implant that, in use, rests adjacent a valve annulus and includes a retaining structure that is sized and shaped to overlay at least a portion of one or more native valve leaflets. The retaining structure retains the leaflet or leaflets it overlays, to resist leaflet eversion and/or prolapse. In this way, the implant prevents or reduces regurgitation. The implant does not interfere significantly with the opening of and blood flow through the leaflets during periods of antegrade flow. 1. An implant that retains a native heart valve leaflet within a heart chamber to resist retrograde flow comprising:a scaffold sized and configured to rest adjacent all or a portion of a native heart valve annulus, at least a portion of the scaffold defining a pseudo-annulus and including a retaining structure near or within the pseudo-annulus that is sized and shaped to overlay at least a portion of one or more native valve leaflets,the scaffold further sized and configured to contact tissue near or within the heart valve annulus to brace the retaining structure to resist leaflet eversion and/or prolapsed, andan auxiliary structure to orient and stabilize the scaffold with the heart chamber.2. An implant according towherein the retaining structure comprises a wire-form structure.3. An implant according towherein at least one of the struts comprises a wire-form structure.4. An implant according towherein the retaining structure and the struts each comprises a wire-form structure.5. An implant claim 1 , according towherein the scaffold is collapsible for placement within a catheter.6. An implant claim 1 , according towherein the scaffold further includes spaced-apart struts for contacting tissue near or within the heart valve annulus to brace the retaining structure to resist leaflet eversion and/or prolapsed.7. An implant claim 6 , according towherein ...

Methods for Preparing a Heat Exchange Catheter System and for Heating and/or Cooling a Subject's Body

Closed loop heat exchange catheter systems and methods for preparing and using such systems wherein a reservoir or fluid bag is connected to the catheter system and used for at least priming of the system with a heat exchange fluid. 1. A method for preparing a heat exchange catheter system that comprises i) a closed loop heat exchange catheter having a heat exchange region and a distal end , ii) a heat exchanger connected to the closed loop heat exchange catheter , iii) apparatus for heating or cooling a heat exchange fluid that circulates through the heat exchanger and iv) a pump for circulating the heat exchange fluid through the heat exchanger and through the closed loop heat exchange catheter thereby heating or cooling the heat exchange region , said method comprising the steps of:connecting, to the system, a reservoir or fluid bag that contains heat exchange fluid; andcausing heat exchange fluid to flow from the reservoir or fluid bag into the heat exchange catheter system to prime the heat exchanger and closed loop heat exchange catheter with heat exchange fluid.2. A method according to wherein the reservoir or fluid bag comprises a bag of saline solution.3. A method according to wherein the heat exchanger is connected to the closed loop heat exchange catheter by way of an inlet line and an outlet line.4. A method according to wherein the reservoir or fluid bag is connected to one of said inlet line and said outlet line.5. A method according to wherein the reservoir or fluid bag is connected to the inlet line.6. A method for heating or cooling at least a potion of the body of a subject using a heat exchange catheter system that comprises i) a closed loop heat exchange catheter having a heat exchange region and a distal end claim 4 , ii) an extracorporeally situated heat exchanger connected to the closed loop heat exchange catheter claim 4 , iii) apparatus for heating or cooling heat exchange fluid that circulates through the heat exchanger and through the heat ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS, INCLUDING THE USE OF MAGNETIC TOOLS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A device for reshaping a mitral valve annulus comprising:a deployment system comprising aguide wire, a cutting tool, a first catheter, a second catheter, the first and second catheters each including a guide lumen having a distal opening, and magnetic or ferromagnetic materials placed adjacent the distal openings of both guide lumens, the magnetic or ferromagnetic materials being sized and configured to magnetically couple the distal opening of the first catheter to the distal opening of the second catheter in an alignment that accommodates passage the guide wire between the guide lumens of the first and second catheters,magnetic tools capable of coupling the distal opening of the first catheter in the left atrium to the distal opening of the second catheter within the great cardiac vein,2. The device according to further comprising a bridging element sized and configured for deployment through an intravascular path on or over the guide wire3. The device according to claim 2 , further comprisingwherein the bridging element further includes tensioning means for selectively lengthening or shortening the span of the intermediate region of the bridging element, thereby shortening a minor axis of the mitral valve.4. The device according to further comprising a second ...

DISPOSABLE CASSETTE FOR INTRAVASCULAR HEAT EXCHANGE CATHETER

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure. 136-. (canceled)37. A disposable fluid circuit for pumping heat exchange fluid to a heat exchange catheter configured to be inserted into a person's vasculature , comprising:a heat exchanger having an input line and an output line, the output line configured to removably connect to a heat exchange catheter;a vent having an output side fluidly connected to the input line of the heat exchanger;a fluid source; anda pump head having an inlet and an outlet, the inlet fluidly connected to the fluid source and to an output line configured to removably connect to the heat exchange catheter and the outlet fluidly connected to an input side of the air vent, the pump head being a portion of tubing, the portion of tubing having an inlet side in fluid communication with the fluid source and the output line and an outlet side in fluid communication with the input side of the vent, the portion of tubing being adapted to insert into a body of a peristaltic pump.38. The disposable fluid circuit of claim 37 , wherein the peristaltic pump has a pump driver configured to compress the portion of tubing to move a fluid through the portion of tubing.39. The disposable fluid circuit of claim 37 , wherein the fluid source is saline.40. The disposable fluid circuit of claim ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS, INCLUDING THE USE OF MAGNETIC TOOLS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. An implant system comprisinga first catheter,a second catheter,the first and second catheters each including a guide lumen having a distal opening, andmagnetic or ferromagnetic materials placed adjacent the distal openings of both guide lumens, the magnetic or ferromagnetic materials being sized and configured to magnetically couple the distal opening of the first catheter to the distal opening of the second catheter in an alignment that accommodates passage of an operative component between the guide lumens of the first and second catheters.2. A system according towherein the first catheter includes an elongated shaft having a distal end, and a head carried at the distal end in which the distal opening is formed, the head including the magnetic or ferromagnetic material.3. A system according towherein the head includes a distal magnetic portion, a center magnetic portion and a proximal magnetic portion.4. A system according towherein the distal magnetic portion has a first end and a second end, the first end having a first magnetic polarity and the second end having a second opposite magnetic polarity;the center magnetic portion has a first end and a second end, the first end having a first magnetic polarity and the second end having a second opposite magnetic ...

In Situ Modification of Therapeutic Agents Using Heat Exchange Catheter System

Closed loop heat exchange catheter systems and methods for preparing and using such systems wherein a reservoir or fluid bag is connected to the catheter system and used for at least priming of the system with a heat exchange fluid. 1. A heat exchange catheter system comprising:A) a closed loop heat exchange catheter having a heat exchange region and a distal end;B) a control unit which comprises, a heat exchanger connected to the closed loop heat exchange catheter, apparatus for heating or cooling a heat exchange fluid that circulates through the heat exchanger and a pump for circulating the heat exchange fluid through the heat exchanger and through the closed loop heat exchange catheter thereby heating or cooling the heat exchange region; andC) a reservoir or fluid bag containing heat exchange fluid, said reservoir or fluid bag being connectable to the heat exchange catheter system to prime the heat exchanger component, inlet lumen, outlet lumen and heat exchange region of the catheter with heat exchange fluid.2. A system according to wherein the reservoir or fluid bag remains connected to the heat exchange catheter system and functions as a reservoir during operation of the system.3. A system according to wherein the reservoir or fluid bag comprises a bag of saline solution.4. A system according to wherein the control unit further comprises a controller that receives data from at least one sensor and controls the amount and direction of heat exchange between the catheter's heat exchange region and a body fluid that flows in heat exchange proximity to the catheter's heat exchange region.5. A system according to wherein said at least one sensor comprises at least one body temperature sensor.6. A system according to wherein said at least one sensor comprises a plurality of body temperature sensors.7. A system according to wherein the controller switches the system back and forth between i) an active state wherein the heat exchange region is exchanging heat with the ...

Method and apparatus for regional and whole body temperature modification

Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette of any one of several disclosed variations is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and 15 ″ cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette so that, for example, a large capacity control unit can be used initially, and a smaller, battery-powered unit can be substituted once the patient reaches the desired target temperature.

METHOD AND SYSTEM FOR CONTROL OF A PATIENT'S BODY TEMPERATURE BY WAY OF A TRANSLUMINALLY INSERTABLE HEAT EXCHANGE CATHETER

Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette of any one of several disclosed variations is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and 15″ cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette so that, for example, a large capacity control unit can be used initially, and a smaller, battery-powered unit can be substituted once the patient reaches the desired target temperature. 136-. (canceled)37. A method of regulating the temperature of at least a portion of a patient , comprising:providing a disposable heat transfer catheter having a heat transfer region and a heat exchange unit having a pump head, the heat transfer catheter and heat exchange unit coupled via conduits that enable circulation of a heat exchange medium therebetween;providing a master control unit housing a heater/cool unit within and having a slot;installing the heat exchange unit through the slot into the master control unit and into thermal communication with the heater/cooler unit;inserting the heat transfer catheter into the patient;sensing the patient's body temperature; ...

METHOD AND APPARATUS FOR MODIFYING THE TEMPERATURE OF A PATIENT

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure. 136-. (canceled)37. A system for maintaining or changing the temperature of at least a portion of the body of a subject , comprising:a heat exchange catheter having at least one recirculating-fluid-type intracorporeal heat exchanger, the heat exchange catheter being insertable into the vasculature of the subject such that the heat exchanger is in contact with blood flowing within the vasculature;an extracorporeal heat exchanger configured to be fluidly coupled to the disposable heat exchange catheter;a pump head in fluid communication with the heat exchange catheter and the extracorporeal heat exchanger, the pump head, extracorporeal heat exchanger and heat exchange catheter providing a disposable fluid circuit through which heat exchange fluid flows;a heater/cooler device in thermal communication with the disposable extracorporeal heat exchanger, the heater/cooler device configured to add heat to the heat exchange fluid or subtract heat from the heat exchange fluid flowing through the primary heat exchanger;at least one sensor for monitoring the temperature of at least a portion of the subject's body, the at least one sensor providing signals representative of the monitored temperature of the at least a portion of the subject's body;a pump driver ...

MULTIPLE LUMEN HEAT EXCHANGE CATHETERS

Catheter devices and methods for intravascular heating and/or cooling of human or veterinary patients. The catheter devices generally comprise catheters having inflow and outflow lumens and at least one curvilinear balloon connected to the inflow and outflow lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated through the balloon(s) to heat or cool blood flowing in heat-exchange proximity to the balloon(s), thereby effecting heating or cooling of all or a portion of the patient's body. 1. A method for controlling the temperature of at least a portion of the body of a human or animal subject , said method comprising the steps of: the heat exchange catheter comprises an elongate, flexible catheter having an inflow lumen and an outflow lumen and at least one heat exchanger having first and second ends, the inflow lumen of the catheter being connected to the first end of the heat exchanger and the outflow lumen being connected to second end of the heat exchanger such that heat exchange fluid may be circulated into the first end of the heat exchanger, through the heat exchanger and out of the second end of the heat exchanger; and', 'the controller receives i) a target temperature input and ii) a sensed subject body temperature input and causes heated or cooled fluid to circulate into the first end of the heat exchanger, through the heat exchanger and out of the second end of the heat exchanger, to warm or cool the sensed subject body temperature as needed to cause the sensed subject body temperature to be approximately the same as the target temperature;, 'A) obtaining a heat exchange catheter system that comprises a heat exchange catheter and a controller, whereinB) inserting the heat exchange catheter into the vasculature of the patent and positioning the heat exchanger within a blood vessel through which blood is flowing such that the heated or cooled fluid ...

INHIBITION OF PLATELET ACTIVATION, AGGREGATION AND/OR ADHESION BY HYPOTHERMIA

A method for treating acute coronary syndromes (i.e., unstable angina or non-Q-wave MI) or transient ischemic attacks in a human or animal patient by placing a heat exchange apparatus in the patient's vasculature and using that heat exchange apparatus to cool the patient to a temperature (e.g. 30-36 degrees C.) at which platelet inhibition (i.e., inhibition of platelet activation and/or aggregation and/or adhesion) occurs. Anti-shivering drugs or anesthesia may be administered to patients whose body temperature is cooled below that patient's shivering threshold (typically approximately 35.5 degrees C.). If it is determined that platelet inhibition is no longer desirable, such as when the patient is about to undergo a surgical or interventional procedure wherein bleeding could be problematic, the hypothermia-induced platelet inhibition may be rapidly reversed by using the intravascular heat exchange apparatus to re-warm the patient's body to normothermia or near normothermia. 1. A method for inhibiting platelet activation , aggregation or adhesion in a human or veterinary patient , said method comprising the steps of:(a) providing a catheter that is insertable into the patient's vasculature and has a heat exchanger for cooling the patient's blood;(b) inserting a distal portion of the catheter, including the heat exchanger, into the patient's vasculature; and,(c) using the heat exchanger to cool the patient's blood sufficiently to inhibit platelet activation, aggregation or adhesion.2. A method according to wherein the patient's blood is cooled to a temperature between approximately 30 degrees C. and approximately 36 degrees C.3. A method according to wherein the heat exchanger is present on less than the full length of the portion of the catheter that is inserted in the patient's vasculature.4. A method according to wherein it is desired to inhibit platelet activation claim 1 , aggregation or adhesion in the coronary vasculature and wherein the heat exchanger is ...

DELIVERY SYSTEM AND METHODS FOR RESHAPING A HEART VALVE ANNULUS, INCLUDING THE USE OF MAGNETIC TOOLS

Delivery systems, methods and associated devices to facilitate delivery and deployment of a heart implant. Such delivery systems and methods of delivery include use of a pair of magnetic catheters, including an anchor delivery catheter carrying an anchor, which can be stacked with or can be axially offset from the magnetic head. Such systems further include use of a puncturing guidewire advanceable through the magnetic head of the anchor delivery catheter to establish access to a chamber of a heart and which is attached to a bridging element such that continued advancement of the guidewire draws a bridging element attached to the first anchor across the chamber of the heart while the bridging element remains covered by the magnetically coupled catheters. Methods and devices herein also allow for cutting and removal of a bridge element of a deployed heart implant. 1. A method of deploying a heart implant in a heart of a patient , the method comprising:inserting, through a first vascular access site in the patient, a first catheter having a distal magnetic head and a posterior anchor and advancing the first catheter to a first location in the heart;inserting a second catheter having a distal magnetic head through a second vascular access site in the patient and advancing the second catheter to a second location in the heart, the first and second locations being separated by a tissue wall;positioning the first and second catheters such that the distal magnetic heads of the first and second catheters magnetically couple across the tissue wall;penetrating the tissue wall with a penetrating member advanced through the first and second catheters while magnetically coupled;advancing a bridging element coupled to the posterior anchor through the penetrated tissue wall and into the second catheter while the distal magnetic heads of the first and second catheter remain magnetically coupled;deploying the posterior anchor from the first catheter at the first location in the ...

DEVICES, SYSTEMS AND METHODS FOR RESHAPING A HEART VALVE ANNULUS

Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors and use of multiple anchors or multiple bridging elements to a single anchor are also provided. 1. A method of treating mitral valve regurgitation in a patient comprising:delivering and deploying an anterior anchor within a desired location along or within a heart of a patient;delivering a posterior anchor within a vasculature of the patient adjacent the heart, the posterior anchor being conformable to an anatomy of the patient upon deployment of the posterior anchor;delivering a first bridging element that extends across a chamber of the heart between the anterior anchor and the posterior anchor to attach the anterior anchor with the posterior anchor with the first bridging element penetrating through a tissue against which the posterior anchor is engaged when the implant is deployed; andconforming the posterior anchor to a desired shape to accommodate the anatomy of the patient by tensioning the first bridging element while interfaced with the posterior anchor and the anterior anchor, wherein tensioning the first bridging element comprises shortening the first bridging element to maintain a desired spacing between the anterior anchor and the posterior anchor so as to reshape the heart by engagement of the conformed ...

DELIVERY SYSTEM AND METHODS FOR RESHAPING A HEART VALVE ANNULUS, INCLUDING THE USE OF MAGNETIC TOOLS

Delivery systems, methods and associated devices to facilitate delivery and deployment of a heart implant. Such delivery systems and methods of delivery include use of a pair of magnetic catheters, including an anchor delivery catheter carrying an anchor, which can be stacked with or can be axially offset from the magnetic head. Such systems further include use of a puncturing guidewire advanceable through the magnetic head of the anchor delivery catheter to establish access to a chamber of a heart and which is attached to a bridging element such that continued advancement of the guidewire draws a bridging element attached to the first anchor across the chamber of the heart while the bridging element remains covered by the magnetically coupled catheters. Methods and devices herein also allow for cutting and removal of a bridge element of a deployed heart implant. 139.-. (canceled)40. A delivery system for a heart implant for treatment of a heart valve in a heart chamber of a patient , the system comprising:a first catheter having a proximal and distal end, wherein the first catheter includes a first lumen extending therethrough for passage of a guidewire, wherein the first catheter further includes:a magnetic head along a distal portion thereof, wherein the magnetic head comprises magnetic poles oriented laterally relative a longitudinal axis of the first catheter and a guide channel defined therein extending to a side hole adjacent a first magnetic pole,a penetrating guidewire advanceable through a second lumen aligned with the guide channel of the distal magnetic head, wherein the penetrating guidewire has a sharpened distal end to facilitate penetration of tissue;a posterior anchor releasably coupled with the first catheter along the distal portion thereof; anda bridging element attached to the posterior anchor at one end and attached to the penetrating guidewire at an opposite end such that advancement of the penetrating guidewire through the side hole and ...

Method for Reducing Myocardial Infarct by Application of Intravascular Hypothermia

Methods and apparatus for preventing myocardial infarction, or lessening the size/severity of an evolving myocardial infarction, by cooling at least the affected area of the myocardium using an intravascular heat exchange catheter. The heat exchange catheter may be inserted into the vasculature (e.g., a vein) and advanced to a position wherein a heat exchanger on the catheter is located in or near the heart (e.g., within the vena cava near the patient's heart). Thereafter, the heat exchange catheter is used to cool the myocardium (or the entire body of the patient) to a temperature that effectively lessens the metabolic rate and/or oxygen consumption of the ischemic myocardial cells or otherwise protects the ischemic myocardium from undergoing irreversible damage or infarction. 1. A method of limiting or preventing infarction of myocardial tissue in a patient who is suffering from cardiac ischemia , said method comprising the steps of:(A) inserting a heat exchange catheter into the vasculature of the patient;(B) using the heat exchange catheter to lower the patient's body temperature to a hypothermic temperature;(C) maintaining the hypothermic temperature for a period of time; and(D) causing or allowing the patient's body temperature to return to normothermia.2. A method according to wherein the organ or tissue is cooled to a temperature below 37° C. but not below 30° C.3. A method according to wherein the organ or tissue is cooled to a temperature below 37° C. but not below 32° C.4. A method as in wherein the organ or tissue is cooled to a temperature below 37° C. but not below 34° C.5. A method according to wherein the hypothermic temperature is maintained until the cardiac ischemia has been alleviated.6. A method according to wherein the hypothermic temperature is maintained until the cardiac ischemia has been alleviated by one or more ischemia-alleviating treatment selected from; a) administration of anti-ischemic medication; b) performance of angioplasty claim ...

MULTIPLE LUMEN HEAT EXCHANGE CATHETERS

Catheter devices and methods for intravascular heating and/or cooling of human or veterinary patients. The catheter devices generally comprise catheters having inflow and outflow lumens and at least one curvilinear balloon connected to the inflow and outflow lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated through the balloon(s) to heat or cool blood flowing in heat-exchange proximity to the balloon(s), thereby effecting heating or cooling of all or a portion of the patient's body. 1. A method for controlling the temperature of at least a portion of the body of a human or animal subject , said method comprising the steps of: the heat exchange catheter comprises an elongate, flexible catheter having an inflow lumen and an outflow lumen and at least one heat exchanger having first and second ends, the inflow lumen of the catheter being connected to the first end of the heat exchanger and the outflow lumen being connected to second end of the heat exchanger such that heat exchange fluid may be circulated into the first end of the heat exchanger, through the heat exchanger and out of the second end of the heat exchanger; and', 'the controller receives i) a target temperature input and ii) a sensed subject body temperature input and causes heated or cooled fluid to circulate into the first end of the heat exchanger, through the heat exchanger and out of the second end of the heat exchanger, to warm or cool the sensed subject body temperature as needed to cause the sensed subject body temperature to be approximately the same as the target temperature;, 'A) obtaining a heat exchange catheter system that comprises a heat exchange catheter and a controller, whereinB) inserting the heat exchange catheter into the vasculature of the patent and positioning the heat exchanger within a blood vessel through which blood is flowing such that the heated or cooled fluid ...

INTRA-AORTIC BALLOON COUNTERPULSATION WITH CONCURRENT HYPOTHERMIA

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger. 112-. (canceled)13. A system for controlling body temperature and providing intra-aortic counterpulsation in a human or animal subject , said system comprising:an endovascular heat exchanger positionable in the vasculature of the subject and useable to exchange heat with blood flowing through the subject's vasculature;an intra-aortic counterpulsation balloon positionable in the aorta of the subject and useable to provide intra-aortic counterpulsation; anddrive and control apparatus operative to control the endovascular heat exchanger and the intra-aortic counterpulsation balloon.14. A system according to wherein the drive and control apparatus comprises at least one controller or computer programmed to i) control inflation/deflation of the counterpulsation balloon in response to received electrocardiogram signals to thereby effect intra-aortic counterpulsation and ii) control the temperature of the endovascular heat exchanger in response to received temperature signals representative of patient body temperature.15. A system according to wherein the drive and ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS, INCLUDING THE USE OF MAGNETIC TOOLS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A method of establishing a pathway to a desired location within a body of a patient , the method comprising:providing a first elongate member extending along a longitudinal axis and having a first magnetically attracting element along a distal portion thereof;providing a second elongate member extending along a longitudinal axis and having a second magnetically attracting element along a distal portion thereof and an interior channel extending to a side hole in the distal portion;positioning the first elongate member at a first location within the body;positioning the second elongate member at a second location within the body adjacent the first location with a layer of tissue therebetween;aligning the distal portions of the first and second elongate member by magnetically coupling the first and second magnetically attracting elements on opposite sides of the layer of tissue; andpassing a piercing element between the first and second elongate elements through the layer of tissue and through the side hole of the second elongate member while magnetically coupled.2. The method of claim 1 , wherein aligning the distal portions comprises aligning the longitudinal axis of the distal portion of the first elongate member transverse to the longitudinal axis of the distal ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS INCLUDING THE USE OF MAGNETIC TOOLS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A method of treatment a human or veterinary patient involving two adjacent bodily structures comprising:providing a first catheter having a first interior channel, the first catheter having a first orifice between said first interior channel and the exterior of the catheter, said first catheter having a first magnetically attracting tip, said first magnetically attracting tip comprising a ferromagnetic material, located in the length of said first catheter that includes said first orifice, said first magnetically attracting tip having a polarity parallel to said interior channel;providing a second catheter having a second interior channel, the second catheter having a second orifice between said second interior channel and the exterior of the second catheter through the side wall of said second catheter, said second catheter having a second magnetically attracting tip, said second magnetically attracting tip comprising a ferromagnetic material, located in the length of said catheter that includes said second orifice, said second magnetically attracting tip comprised of three magnetic sections, a first magnetic section, a middle magnetic section and a third magnetic section, said first and third magnetic sections having opposing polarity, and said middle magnetic ...

SUTURE MANAGEMENT DEVICE AND METHODS

Delivery systems, methods and associated devices for management of an elongate element having sections with differing mechanical properties, in particular, for management of a loop of suture-wire element extending proximally from a delivery catheter for deployment of a heart implant. Such management devices can include an inner feature (e.g. outward facing groove or series of tabs) along an inner circle about which a suture can be coiled and an outer feature (e.g. inward facing groove or tabs) to engage and constrain a wire section having increased stiffness within a coil having a larger diameter than the coiled suture. Such devices can be provided separately or can be integrated within a handle of the delivery catheter. Methods of loading suture-wire management devices and utilizing such devices during deployment of an implantable anchor are also described herein. 1. A catheter handle device with integrated suture-wire management for managing excess suture-wire element , the handle comprising:a catheter handle body having a proximal portion and a distal portion;a catheter shaft and a hemostatic port provided in the distal portion an inner groove facing radially outward to facilitate winding of a suture section of the suture-wire element thereon within a coil, and', 'an outer groove facing radially inward to radially constrain a wire section of the suture-wire element in a coil., 'an enclosure disposed along the proximal portion, the enclosure being configured for storing and managing a loop of excess suture-wire element extending proximally from the hemostatic port, wherein the enclosure includes2. The catheter handle device of claim 1 ,a center portion between the proximal and distal portions, the center portion being configured to facilitate handling of the catheter by an operator.3. The catheter handle device of claim 1 , wherein the enclosure is defined by a proximal portion of the catheter body that interfaces with a releasable cap.4. The catheter handle ...

METHOD AND SYSTEM FOR CONTROL OF A PATIENT'S BODY TEMPERATURE BY WAY OF A TRASLUMINALLY INSERTABLE HEAT EXCHANGE CATHETER

Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette of any one of several disclosed variations is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and 15″ cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette so that, for example, a large capacity control unit can be used initially, and a smaller, battery-powered unit can be substituted once the patient reaches the desired target temperature. 1. (canceled)2. A system for controlling the rate of change of a patient's body temperature , comprising:a heat transfer catheter for insertion into a body cavity, the heat transfer catheter having a heat transfer region disposed thereon and in fluid communication with a heat exchange unit;a pump configured to pump a heat transfer fluid through a fluid circuit defined by the heat transfer catheter and the heat exchange unit;a pump motor configured to engage the pump;a sensor for sensing a pressure of the heat exchange fluid in the fluid circuit, the sensor also configured to provide a signal representative of the sensed pressure;a controller in communication with the- ...

Devices, Systems, and Methods for Reshaping a Heart Valve Annulus, Including the Use of Magnetic Tools

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A method of treatment a human or veterinary patient involving two adjacent bodily structures comprising:providing a first catheter having a first distal end and a first interior channel, the first catheter having a first orifice between said first interior channel and the exterior of the catheter in the vicinity of the first distal end, said first catheter having a first magnetically attractable section located in the vicinity of said first orifice;providing a second catheter having a second distal end and a second interior channel, the second catheter having a second orifice between said second interior channel and the exterior of the second catheter in the vicinity of the second distal end, said second catheter having a magnetically attracting section located in the vicinity of said second orifice;locating said first catheter within a first body structure;locating said second catheter within a second body structure adjacent body structure;placing said first magnetically attractable section within said first body structure adjacent said second magnetically attracting section with a layer of tissue between said first and second magnetically sections such that said first and second magnetically attractable sections align and magnetically couple to each other with ...

Devices and Systems for Reshaping a Heart Valve Annulus, Using a Tensioning Implant

Implants or systems of implants apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants also make use of strong fluoroscopic landmarks. 1. An implant system to treat a mitral heart valve comprisinga posterior anchor structure sized and configured to extend within the great cardiac vein,at least one implant sized and configured to extend across a left atrium, said at least one implant including:a bridging implant member having:a posterior anchoring region sized and configured to extend from the left atrium into the great cardiac vein and couple to the posterior anchor structure within the great cardiac vein,an anterior anchoring region sized and configured to extend from the left atrium through an interatrial septum and into a right atrium, anda bridging region between the posterior and anterior anchoring regions sized and configured to span the left atrium; andan anterior anchor sized and configured to couple to the anterior anchoring region in or near the right atrium to hold in tension the bridging element between the posterior and anterior anchoring regions.2. The implant system according towherein said bridging implant member is a wire form structure.3. The implant structure according towherein the said wire form structure comprises a suture material.4. An implant system according towherein the posterior anchor structure comprises a structure separate from the implant to which the posterior anchoring region is joined.5. An implant system according towherein the posterior anchor structure comprises a structure integrally joined to the posterior anchoring region.6. An implant system according towherein the posterior anchor structure comprises a stent-like structure.7. An implant system according ...

Catheters and Related Devices for Forming Passageways Between Blood Vessels or Other Anatomical Structures

The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheter which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passageway-forming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter. 1. (canceled)2. A catheter device , comprising:an elongate flexible catheter having a distal portion insertable into a blood vessel of a human subject;a tissue penetrating member configured to extend in a first direction from the distal portion of the catheter;a balloon which, when inflated, extends from the distal portion of the catheter in a second direction opposite the first direction; anda lumen extending through the catheter and useable for inflation and deflation of the balloon.3. The catheter device of wherein the tissue penetrating member comprises a hollow needle.4. The catheter device of wherein the tissue penetrating member is configured to penetrate a wall of the blood vessel when the balloon is at least partially inflated.5. The catheter device of claim 2 , further comprising rotational marking indicia at the distal portion of the catheter claim 2 , wherein the rotational marking indicia are useable for rotational adjustment of the distal potion of the ...

Devices, systems, and methods for reshaping a heart valve annulus

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS

Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors, and use of multiple anchors or multiple bridging elements to a single anchor are also provided. 1. An anchor for securing an implant within a body organ for reshaping of a body organ of a patient , the anchor comprising:a substantially cylindrical body that is sized and dimensioned for delivery and deployment in a body lumen or blood vessel of the patient, the cylindrical body being deformable or collapsible in a lateral direction; anda substantially rigid backbone extending longitudinally along at least a portion of the cylindrical body, the substantially rigid backbone being disposed on or within the cylindrical body,wherein the backbone includes an attachment region along an intermediate portion thereof for coupling with a bridging element of the implant,wherein the cylindrical body is configured such that when the bridging element is coupled to the attachment region and tensioned while the anchor is disposed within the body lumen or blood vessel, the backbone deforms or collapses the cylindrical body.2. The anchor of claim 1 , wherein the substantially cylindrical body is configured to engage 180 degrees or less of an inner wall of the body lumen or blood vessel when laterally deformed or collapsed.3. The anchor of ...

Devices, Systems, and Methods for Reshaping a Heart Valve Annulus

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A system comprisingan implant sized and configured for placement within a heart chamber,a guide wire sized and configured for deployment in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site, anda connector to connect an end of the implant to one end of the guide wire such that pulling on the other end of the guide wire pulls the implant along at least a portion of the intravascular path into the heart chamber.2. A system according towherein the implant comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.3. A system comprisinga bridge element sized and configured to be implanted within the left atrium between the great cardiac vein and the interatrial septum, the bridge element having opposite ends,a guide wire sized and configured to be deployed in an intravascular path that extends from a first ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the right atrium, which allow tricuspid valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant. The implants or systems of implants and methods may utilize a bridge stop to secure the implant. 14.-. (canceled)5. A system comprising:an implant sized and configured for placement within a heart chamber,a guide wire sized and configured for deployment in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site, anda connector to connect an end of the implant to one end of the guide wire such that pulling on the other end of the guide wire pulls the implant along at least a portion of the intravascular path into the heart chamber.6. The system of claim 5 ,wherein the implant comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.7. A system comprising:a bridge element sized and configured to be implanted within the right atrium between the superior vena cava and the inferior vena cava, the bridge element having opposite ends,a guide wire sized and configured to be deployed in an intravascular path that extends from a first vascular access site through the right atrium and to a second ...

Devices, Systems, and Methods for Reshaping a Heart Valve Annulus

Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors, and use of multiple anchors or multiple bridging elements to a single anchor are also provided. 1. A method of anchoring an implant and reshaping a body organ of a patient , the method comprising:delivering and deploying an anterior anchor within a desired location along or within an organ of a patient;delivering a posterior anchor within a vasculature of the patient adjacent the body organ, the posterior anchor being conformable to an anatomy of the patient upon deployment of the posterior anchor;delivering a first bridging element that extends across a chamber of the organ between the anterior anchor and the posterior anchor so as to attach the anterior anchor with the posterior anchor with the first bridging element penetrating through a tissue against which the posterior anchor is engaged when the implant is deployed; andconforming the posterior anchor to a desired shape to accommodate the anatomy of the patient by tensioning the first bridging element while interfaced with the posterior anchor and the anterior anchor, wherein tensioning the first bridging element comprises shortening the first bridging element to maintain a desired spacing between the anterior anchor and the posterior anchor so as to reshape the ...

MULTIPLE LUMEN HEAT EXCHANGE CATHETERS

Catheter devices and methods for intravascular heating and/or cooling of human or veterinary patients. The catheter devices generally comprise catheters having inflow and outflow lumens and at least one curvilinear balloon connected to the inflow and outflow lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated through the balloon(s) to heat or cool blood flowing in heat-exchange proximity to the balloon(s), thereby effecting heating or cooling of all or a portion of the patient's body. 1. A method for controlling the temperature of at least a portion of the body of a human or animal subject , said method comprising the steps of: the heat exchange catheter comprises an elongate, flexible catheter having an inflow lumen and an outflow lumen and at least one heat exchanger having first and second ends, the inflow lumen of the catheter being connected to the first end of the heat exchanger and the outflow lumen being connected to second end of the heat exchanger such that heat exchange fluid may be circulated into the first end of the heat exchanger, through the heat exchanger and out of the second end of the heat exchanger; and', 'the controller receives i) a target temperature input and ii) a sensed subject body temperature input and causes heated or cooled fluid to circulate into the first end of the heat exchanger, through the heat exchanger and out of the second end of the heat exchanger, to warm or cool the sensed subject body temperature as needed to cause the sensed subject body temperature to be approximately the same as the target temperature;, 'A) obtaining a heat exchange catheter syste that comprises a heat exchange catheter and a controller, whereinB) inserting the heat exchange catheter into the vasculature of the patent and positioning the heat exchanger within a blood vessel through which blood is flowing such that the heated or cooled fluid ...

Devices, systems, and methods for reshaping a heart valve anulus, including the use of a bridge implant having an adjustable bridge stop

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial adjustability and retrievability years after implant. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilise an adjustable bridge stop to secure the implant, and the methods of implantation employ various tools.

Devices, Systems, and Methods for Reshaping a Heart Valve Annulus

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the right atrium, which allow tricuspid valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant. The implants or systems of implants and methods may utilize a bridge stop to secure the implant. 1. A method of placing an implant within a heart chamber comprisingdeploying a guide wire in an intravascular path that extends from a first vascular access into a heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site,guiding a first catheter along the guide wire from the first vascular access site to a first bridge stop site,deploying a first bridge stop at the first bridge stop site,guiding a second catheter along the guide wire from the second vascular access site to a second bridge stop site,deploying a second bridge stop at the second bridge stop site,coupling one end of the bridging element to the first bridge stop, andcoupling another end of the bridging element to the second bridge stop.2. A method according towherein the heart chamber comprises a right atrium.3. A method according tofurther including placing the implant in tension within the heart chamber.4. A method according towherein the implant comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.5 ...

Devices and Methods for Controlling a Subject's Body Temperature

Devices and methods for controlling the operation of endovascular heat exchange devices and/or body surface heat exchange devices such as blankets. 1. A controller device useable for controlling the operation of a body heat exchanger through which warmed or cooled fluid is circulated to exchange heat with all or a portion of the body of a human or animal subject , said controller device comprising:a processor which is connectable to a) a temperature sensor that senses a subject body temperature, b) a user interface through which a user may input a target subject body temperature and c) at least one heater-cooler for circulating heated or cooled heat exchange fluid through the body heat exchanger to alternately warm or cool the subject's body;the processor being programmed to receive a target subject body temperature that has been entered via the user interface and indicia of the subject body temperature presently being sensed by the temperature sensor;the processor being further programmed to cause said at least one heater-cooler to vary the temperature of heat exchange fluid being circulated through the body heat exchanger thereby controlling its addition of heat to, or removal of heat from, the subject's body as necessary to maintain the sensed temperature between an upper variance set point that is above the target subject body temperature and a lower variance set point that is below the target subject body temperature.2. A controller device according to wherein the processor is programmed to establish the upper variance set point and lower variance set point based on the input target body temperature that is received from the user interface.3. A controller device according to wherein the controller controls said at least one heater-cooler to i) maintain the body heat exchanger in an inactive state when the sensed body temperature is between the upper variance set point and lower variance set point claim 1 , ii) cause the body heat exchanger to be in an active ...

INTRA-AORTIC BALLOON COUNTERPULSATION WITH CONCURRENT HYPOTHERMIA

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

DISPOSABLE CASSETTE FOR INTRAVASCULAR HEAT EXCHANGE CATHETER

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure. 1. A disposable cassette for supplying a heat exchange fluid to a heat exchange catheter , said cassette comprising:an external heat exchanger comprising a flow channel having an inlet and an outlet;a first fluid supply line, said first fluid supply line in fluid communication with said flow channel inlet;a pump head contained in the disposable fluid supply cassette, said pump head having a pump inlet and a pump outlet, said pump inlet in fluid communication with said external heat exchanger flow channel outlet for pumping fluid from said flow channel outlet;a second fluid supply line, said second fluid supply line in fluid communication with said pump outlet for receiving fluid pumped out of said pump outlet; anda pressure regulator, said pressure regulator in fluid communication with said pump outlet for regulating the pressure of fluid pumped from said pump.2. The cassette of wherein said external heat exchanger comprises a structural member and a compliant member claim 1 , said compliant member being sealed to said structural member in a pattern claim 1 , said pattern forming a flow channel between said compliant member and said structural member.3. The cassette of wherein first and second fluid supply lines are connected through a heat exchange ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the right atrium, which allow tricuspid valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant. The implants or systems of implants and methods may utilize a bridge stop to secure the implant. 1. A method of treating regurgitation in a heart of a subject by reshaping a heart chamber using an implant , the method comprising:deploying a guide wire in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site different than the first vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site;guiding a first catheter along the guide wire from the first vascular access site to a first bridge stop site within a wall of the heart chamber or adjacent vasculature;deploying a first bridge stop at the first bridge stop site;guiding a second catheter along the guide wire from the second vascular access site to a second bridge stop site within the wall of the heart chamber or adjacent vasculature;deploying a second bridge stop at the second bridge stop site;coupling one end of a bridging element to the first bridge stop;coupling another end of the bridging element to the second bridge stop; andplacing the implant in tension within the heart chamber, thereby reshaping the heart chamber and treating regurgitation in the heart of the subject.2. The method of claim 1 , wherein the heart chamber comprises a right atrium.3. The method of claim 1 , wherein the ...

Devices, Systems, and Methods for Reshaping a Heart Valve Annulus, Including the Use of a Bridge Implant Having an Adjustable Bridge Stop

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial adjustability and retrievability years after implant. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize an adjustable bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A bridge stop apparatus comprising: an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow at least a portion of a bridging element to extend through at least a portion of the length of the aperture, the bridging element having a length capable of bridging at least a portion of the interior of an atrium of a human heart;', 'a septal member, the septal member having an orifice formed therein, said orifice of sufficient diameter to receive the bridging element slidingly therein; and', 'an adjustment mechanism coupled to the bridge stop housing said adjustment mechanism having a restrained configuration wherein movement of said bridging element is restrained relative to said bridge stop, and an unrestrained configuration wherein movement of said bridging element is unrestrained relative to said bridge stop, said adjustment mechanism movable between said unrestrained and said restrained configuration; and', 'an activation mechanism, said activation mechanism capable of activating said adjustment mechanism to move said adjustment mechanism from said unrestrained configuration to said restrained configuration and from said restrained configuration to said ...

INHIBITION OF PLATELET ACTIVATION, AGGREGATION AND/OR ADHESION BY HYPOTHERMIA

A method for treating acute coronary syndromes (i.e., unstable angina or non-Q-wave MI) or transient ischemic attacks in a human or animal patient by placing a heat exchange apparatus in the patient=s vasculature and using that heat exchange apparatus to cool the patient to a temperature (e.g. 30-36 degrees C.) at which platelet inhibition (i.e., inhibition of platelet activation and/or aggregation and/or adhesion) occurs. Anti-shivering drugs or anesthesia may be administered to patients whose body temperature is cooled below that patient=s shivering threshold (typically approximately 35.5 degrees C.). If it is determined that platelet inhibition is no longer desirable, such as when the patient is about to undergo a surgical or interventional procedure wherein bleeding could be problematic, the hypothermia-induced platelet inhibition may be rapidly reversed by using the intravascular heat exchange apparatus to re-warm the patient=s body to normothermia or near normothermia. 1. A method for causing platelet inhibition in a human or veterinary patient in whom an initial diagnosis or clinical impression has been reached indicating that the patient suffers from an acute coronary syndrome , transient ischemic attack or other disorder that may benefit from therapeutic platelet inhibition , said method comprising the steps of:placing an intravascular heat exchange apparatus within the vasculature of the patient; and,using the intravascular heat exchange apparatus to cool at least a portion of the patient's body to a temperature at which platelet inhibition occurs.2. A method according to wherein Step a comprises:inserting a heat exchange catheter having a heat exchange region into the vasculature of a patient;placing said catheter so that the heat exchange region is in contact with blood flowing to the heart;and wherein Step b comprises:exchanging heat with the blood at the heat exchange region for a period of time sufficient to cause said platelet inhibition.3. A method ...

DEVICES, SYSTEMS, AND METHODS FOR RESHAPING A HEART VALVE ANNULUS, INCLUDING THE USE OF MAGNETIC TOOLS

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools. 1. A method of treatment a human or veterinary patient involving two adjacent bodily structures comprising:providing a first catheter having a first interior channel, the first catheter having a first orifice between said first interior channel and an exterior of the catheter, said first catheter having a first magnetically attracting tip, said first magnetically attracting tip comprising a ferromagnetic material located in a length of said first catheter that includes said first orifice, said first magnetically attracting tip having a polarity parallel to said first interior channel;providing a second catheter having a second interior channel, the second catheter having a second orifice between said second interior channel and an exterior of the second catheter through a side wall of said second catheter, said second catheter having a second magnetically attracting tip, said second magnetically attracting tip comprising a ferromagnetic material, located in a length of said second catheter that includes said second orifice, said second magnetically attracting tip comprised of three magnetic sections, a first magnetic section, a middle magnetic section and a third magnetic section, said first and third magnetic sections having opposing polarity, and said middle ...

System for cardiac procedures

A system for accessing a patient's cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient's arterial system. The endovascular device for partitioning a patient's ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient's aortic arch. An expandable means, e.g. a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient's arterial system. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient's coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

Methods and systems for performing thoracoscopic coronary bypass and other procedures

A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia.

System for cardiac procedures

A system for accessing a patient's cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient's arterial system. The endovascular device for partitioning a patient's ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient's aortic arch. An expandable means, e.g. a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient's arterial system. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient's coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

System for cardiac procedures

A system for accessing a patient's cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient's arterial system. The endovascular device for partitioning a patient's ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient's aortic arch. An expandable means, e.g. a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient's arterial system. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient's coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

Method of delivering cardioplegic fluid to a patient's heart

A system for accessing a patient's cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient's arterial system. The endovascular device for partitioning a patient's ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a fist inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient's aortic arch. An expandable means, e.g. a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient's arterial system. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient's coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

Methods and systems for performing thoracoscopic coronary bypass and other procedures

A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia

Method and system for control of a patient's body temperature by way of a transluminally insertable heat exchange catheter

Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette of any one of several disclosed variations is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette so that, for example, a large capacity control unit can be used initially, and a smaller, battery-powered unit can be substituted once the patient reaches the desired target temperature.

Devices, systems, and methods for supplementing, repairing, or replacing a native heart valve leaflet

Devices, systems and methods supplement, repair, or replace a native heart valve. The devices, systems, and methods employ an implant that, in use, extends adjacent a valve annulus. The implant includes a mobile neoleaflet element that occupies the space of at least a portion of one native valve leaflet. The implant mimics the one-way valve function of a native leaflet, to resist or prevent retrograde flow. The implant restores normal coaptation of the leaflets to resist retrograde flow, thereby resisting eversion and/or prolapse, which, in turn, reduces regurgitation.

Method of reshaping a heart valve annulus using an intravascular device

Devices, systems, and methods employ an implant that is sized and configured to attach in, on, or near the annulus of a dysfunctional heart valve. In use, the implant extends either across the minor axis of the annulus, or across the major axis of the annulus, or both. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation.

Methods and devices for heart valve treatments

The present invention is a group of medical devices designed to improve heart valve function. The medical devices may be used individually, or in combination to supplement damaged valves, replace damaged valves, or improve damaged valves function. The medical devices include leaflet retainers, a neo-annulus, neo-leaflet, and a framework. In addition, the present invention is novel methods for surgically treating heart valves.

Devices and systems for reshaping a heart valve annulus

Devices for retaining native heart valve leaflet

Device, systems, and methods for reshaping a heart valve annulus

Dilatation catheter with thin guide wire

Methods and systems for performing thoracoscopic coronary bypass and other procedures

A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia.

Catheters and related devices for forming passageways between blood vessels or other anatomical structures

The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheter which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passageway-forming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter.

Fluid delivery catheter

A catheter and method of using the catheter for the delivery of therapeutic or diagnostic liquid within a body lumen of a patient. The catheter (10) has an outer inflatable member (19) which has a wall with a plurality of apertures (20) which eject therapeutic or diagnostic liquid in a jet-like form deep within the lumenal tissue adjacent to the outer inflatable member (19). In one embodiment the catheter has an inner inflatable member (16) disposed within the outer inflatable member (19) which upon inflation expands the outer tubular member (19) so as to dilatate a stenotic region of a body lumen such as an artery. The inflatable member may be provided with proximal and distal ends which expand to larger diameters than the central inflatable section so as to seal the larger ends and prevent the loss of fluid.

Heat exchange catheter with discrete heat exchange elements

This invention is a catheter (50) including a main shaft (52), and a heat exchange region (56) having a plurality of heat exchange elements (58) each having a length, opposed ends being attached on at least one of its ends to the shaft,and disposed so that when inserted in a fluid body cavity with fluid, the body fluid may circumferentially surround each heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes a hollow lumen within each of the heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds (70, 72). Alternatively, the heat exchange elements may be connected at only one point and be permitted to float. An insulating member, such as a balloon (204), may be provided along the shaft, and ribs (204) may be provided on each of the heat exchange elements.

Catheters and related devices for forming passageways between blood vessels or other anatomical structures

The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheteer which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway-forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passagewayforming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter.

Intra-aortic balloon counterpulsation with concurrent hypothermia

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon couterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination intra-aortic balloon counterpulsation/heat exchange catheter (10) may be utilized. Such combination catheter (10) comprises a) a catheter (12) sized for insertion into the aorta, b) a counterpulsation balloon (14) and c) a heat exchanger (16). A drive/control system (30) receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Endovascular system for arresting the heart

The invention provides an endovascular device (20) for partitioning the ascending aorta and a system for arresting the heart to facilitate the performance of precedures such as heart valve replacement or coronary artery bypass grafting without the need for a thoracotomy. According to the invention, an endovascular device (20) for partitioning a patient's ascending aorta comprises a flexible shaft (22) having a distal end (24), a proximal end (26), and a first inner lumen (29) therebetween with an opening (31) at the distal end (24). The shaft (22) may have a preshaped distal portion (32) with a curvature generally corresponding to the curvature of the patient's aortic arch Expandable means (28) are disposed near the distal end (24) of the shaft (22) proximal to the opening (31) in the first inner lumen (29) for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles. Means (90) for delivering cardioplegic fluid may be connected to the proximal end (26) of the device to infuse cardioplegic fluid into the coronary arteries for arresting the heart. The endovascular device of the invention is readily positionable in the ascending aorta, resists displacement caused by systolic blood flow, and maintains axial alignment with the center of the ascending aorta and aortic valve.

CATHETERS AND RELATED DEVICES FOR FORMING CHANNELS BETWEEN BLOODS AND OTHER ANATOMICAL WEAVES

Endovascular system for arresting the heart

Intra-aortic balloon counterpulsation with concurrent hypothermia

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon couterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination intra-aortic balloon counterpulsation/heat exchange catheter (10) may be utilized. Such combination catheter (10) comprises a) a catheter (12) sized for insertion into the aorta, b) a counterpulsation balloon (14) and c) a heat exchanger (16). A drive/control system (30) receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Endovascular heat-and gas-exchange catheter device and related methods

An endovascular catheter device capable of heat and gas exchange with a patient's bloodstream comprises a catheter shaft, a heat exchanger, and a gas exchange element. The heat exchanger and the gas exchange element are in fluid communication with one or more internal lumens of the catheter shaft. The catheter shaft may be connected to a control system that permits a heat exchange fluid to be delivered to the heat exchanger, and that permits a gas to be delivered to the gas exchange element. The catheter device may also comprise one or more flow disruption devices to disrupt the laminar flow of blood around the catheter device. The catheter device may be used to cool and oxygenate a patient's blood, and improve organ function.

Intra-Aortic Balloon Counterpulsation with Concurrent Hypothermia

Endovascular system for arresting the heart

Method and apparatus for regional and whole body temperature modification

Methods and apparatus for temperature modification of selected body regions including an induced state of local hypothermia of the brain region for neuroprotection. A heat exchange catheter is provided with heat transfer fins projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or the temperature of a target region. Feed back from temperature sensors located within the patient's body allow for control of the heat transfer from the catheter to automatically control the temperature of the patient or of the target region within the patient. The apparatus may include a blood channeling sleeve that directs body fluid over a heat exchanger where the body fluid's temperature is altered, and then is discharged out the distal end of the sleeve to a desired location, for example, cooled blood to the brain for neuroprotection. The catheter may be used alone or in conjunction with other heat exchangers to cool one region of a patient's body while heating another.

Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Devices, systems, and methods for retaining a native heart valve leaflet

Devices, systems and methods retain a native heart valve leaflet to prevent retrograde flow. The devices, systems, and methods employ an implant that, in use, rests adjacent a valve annulus and includes a retaining structure that is sized and shaped to overlay at least a portion of one or more native valve leaflets. The retaining structure retains the leaflet or leaflets it overlays, to resist leaflet eversion and/or prolapse. In this way, the implant prevents or reduces regurgitation. The implant does not interfere significantly with the opening of and blood flow through the leaflets during periods of antegrade flow.

Disposable cassette for intravascular heat exchange catheter

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Catheters and Related Devices for Forming Passageways Between Blood Vessels or Other Anatomical Structures

The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheter which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passageway-forming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter.

Inhibition of platelet activation, aggregation and/or adhesion by hypothermia

A method for treating acute coronary syndromes (i.e., unstable angina or non-Q-wave MI) or transient ischemic attacks in a human or animal patient by placing a heat exchange apparatus in the patient's vasculature and using that heat exchange apparatus to cool the patient to a temperature (e.g. 30-36° C.) at which platelet inhibition (i.e., inhibition of platelet activation and/or aggregation and/or adhesion) occurs. Anti-shivering drugs or anesthesia may be administered to patients whose body temperature is cooled below that patient's shivering threshold (typically approximately 35.5 C.). If it is determined that platelet inhibition is no longer desirable, such as when the patient is about to undergo a surgical or interventional procedure wherein bleeding could be problematic, the hypothermia-induced platelet inhibition may be rapidly reversed by using the intravascular heat exchange apparatus to re-warm the patient's body to normothermia or near normothermia.

A rapidly exchangeable vascular catheter for maintaining patency of blood vessel

A vascular catheter having an expandable cage mounted on the distal end of a tubular member which is radially expanded and contracted by means of a control wire which is secured to the distal end of the expandable cage. The control wire extends through a first inner lumen within the tubular member which extends along essentially the entire length thereof. A second inner lumen is provided in the distal portion of the tubular member which has a proximal port at least 15 but not more than 60 cm from the distal end of the catheter and a distal port which opens into the interior of the expandable cage. A guidewire or a low-profile steerable catheter is slidably disposed within the second lumen and a tubular member such as a slightly expanded coil through the expandable cage interior to facilitate the rapid exchange of the catheter. The catheter assembly is particularly adapted to hold open a blood vessel after a vascular procedure therein such as an angioplasty.

Methods and devices for heart valve treatments

Heat exchanger catheter for controlling body temperature

H:\tld\Intrwovn\NRPortbl\DCC\TLD31482_I.doc-30/08/2013 Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of local hypothermia of the brain region for 5 neuroprotection. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. Various disposable heat exchange cassettes are attached to the circulatory flow lines of the catheter, the heat exchange cassettes being sized to engage cavities within various re-usable control units. The control units include a heater/cooler device, a 10 user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up and down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages 15 with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette so that a large capacity control unit can be used initially, and a smaller, battery-powered unit can be substituted once the patient reaches the desired target temperature. WO 02/07793 PCT/USOI/23009 co - - - - - - - - - - - - - z U) ri -------------- ---- ------- 5 _j -:L. > CL < 0 0 c co CA ........ LL "2D- 0 m y C) CL lil M 0 ------------------ <-w o 3 p N co Li n- w o IL (Y) - I k -j M U) C) :D 0 -J 0 0 0 0) r l Dq 13-41 t 0 w 0 w o- (.) < f Z F- - () 0 w It, i U) 0 \' -j cr 0 < w MI IL z D > 0 IL C) Ir C) cc cc) a--L Z) (No) ro) w a- V- CL 1 0 0 T 1 0-::) CL C) - ------- --- ----w :z) U) W w m D U) < ------ --------- ------------------ w a. co U) U) z CNO w CY) U) - - - - - - - - - --- - - rl (n cc 0 T - a: 0 K C-) o 0 0 5- U) Y5cn OWZ Cc z m w 0 U2 ZW ...

Disposable cassette for intravascular heat exchange catheter

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Methods and apparatus for connecting openings formed in adjacent blood vessels or other anatomical structures

This invention is methods and apparatus for connecting two anatomical passageways, such as blood vessels, in side-to-side fashion. Openings are formed in the sidewalls of the passageways, and a connector apparatus (10) of the present invention is implanted within such openings, and extends between the passageways or blood vessels (BV1, BV2) so as to connect the passageways or blood vessels (BV1, BV2) such that the openings are held in direct alignment with one another, thereby allowing body fluids to pass from one passageway into the other.

Multiple lumen heat exchange catheters

Catheter devices and methods for intravascular heating and/or cooling of hum an or veterinary patients. The catheter devices generally comprise catheters having inflow (52) and outflow (54) lumens and at least one curvilinear balloon connected to the inflow (52) and outflow (54) lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated throu gh the balloon(s) to heat or cool blood flowing in heat-exchange proximity to t he balloon(s), thereby effecting heating or cooling of all or a portion of the patient's body.

Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures

This invention is methods, devices, and systems for re-vascularization, and/or performing other medical procedures at a vascular or non-vascular intra-corporeal locations within a mammalian body. The methods generally comprise the formation of at least one extravascular passageway from a blood vessel to a vascular or non-vascular target location. In the re-vascularization methods the extravascular passageway is utilized as a conduit for accessing or performing procedures at the vascular or non-vascular target location. Also disclosed are catheter devices (100, 103) and systems (138) which are usable to form the extravascular passageways of the invention, as well as apparatus for modifying, maintaining and/or closing such extravascular passageways.

Cardiopulmonary bypass for closed chest surgery

Disposable cassette for intravascular heat exchange catheter

Methods and apparatus for regional and whole body temperature modification

This invention is methods, and apparatus for temperature modification of selected body regions including an induced state of local hyperthermia of the brain region for neuro-protection. A heat exchange catheter (360) is provided with heat transfer fins (362) projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods, and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter (360) lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or temperature of a target region. The catheter (360) may be used alone or in conjunction with other heat exchangers to cool one region of a patient's body while heating another.

Multiple lumen heat exchange catheters

Methods and devices for heart valve treatments

Published without an

Quickly replaceable vascular catheter to maintain the condition of a blood vessel

Composite vascular catheter

Method of controlling body temperature while reducing shivering

A method and apparatus for lowering the body temperature of a patient while reducing shivering by using a heat exchange device in combination with an α2-adrenoreceptor agonist, a non-opiod analgesic monoamine uptake inhibitor or neuropeptide that temporarily reduces shivering. The devices disclosed include a catheter having a heat exchange balloon thereon with heat exchange fluid circulating through the interior of the balloon. The heat exchange balloon is placed in the vasculature of a patient, and heat exchange fluid at a temperature other than the temperature of the blood in the vasculature is circulated through the interior of the balloon to add or remove heat from the blood of the patient. Various α2-adrenoreceptor agonistα2-adrenoreceptor agonists, non-opiod analgesic monoamine uptake inhibitors and neuropeptides are disclosed including dexmedetomidine, nepofam and neurotensin and pharmaceutically acceptable salts thereof. A control system for the control of the patient's temperature is disclosed for controlling the patient'stemperature in conjunction with administering the α2-adrenoreceptor agonist, non-opiod analgesic monoamine uptake inhibitor or neuropeptide.

Transluminal methods and apparatus for closing, forming attachments to, and/or forming anastomotic junctions in, luminal anatomical structures

A method and apparatus for passing attachment apparatus (20), (e.g., connector devices, staples, etc.) or connector material (88), (e.g., suture thread, wire, cord, filament, monofilament, etc.) into or through the wall of a luminal anatomical structure (e.g., a blood vessel or other anatomical conduit), for the purpose of closing the lumen of the anatomical structure, forming an anastomotic junction between separate anatomical structures (or between approximated segments of the same anatomical structure), and/or attaching an article (e.g., an endoluminal, extraluminal or transluminal graft) or other apparatus to the wall of the anatomical structure.

Heat exchanger catheter for controlling body temperature

Heat exchanger catheter for controlling body temperature

Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia of the brain region for neuroprotection. The temperature modification is accomplished using an in-dwelling heat exchange catheter (52) within which a fluid heat exchange medium circulates. Various disposable heat exchange cassettes are attached to the circulatory flow lines of the catheter, the heat exchange cassettes sized to engage cavities within various control units (50). The control units (50) include a heater/cooler device (66), a user input device (72), and a processor (70) connected to receive input from various sensors (36, 80). The heater/cooler (66) device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up and down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head (98) that engages a pump drive mechanism (68) in the control unit (50).

Composite vascular catheter

An improved vascular catheter having a tubular member of composite structure with a tubular substrate and a resin-impregnated fibrous covering extending over a substantial part of the length thereof. The tubular substrate which is longitudinally flexible but relatively inextendible, is preferably polyimide tubing with a lubricious coating on the inner surface thereof defining an inner lumen. The fibrous covering is preferably epoxy-impregnated aramid or polyester (Dacron) multi-filament fibers. The strands are is snugly wrapped about the tubular substrate and then impregnated with a suitable resin. One or more of the strands in the distal portion are at an angle with respect to the longitudinal axis of the tubular substrate between about 20° and about 45° greater than the angle of one or more strands in the proximal portion. Individual strand wraps in the distal portion are at an angle of about 60° to about 85° and strand wraps in such as the proximal portion are at an angle of about 30° to about 60°. The composite tubular member is preferably utilized in balloon dilatation catheters used in angioplasty procedures.

Heat exchange catheter with discrete heat exchange elements

This invention is a catheter (50) including a main shaft (52), and a heat exchange region (56) having a plurality of heat exchange elements (58) each having a length, opposed ends being attached on at least one of its ends to the shaft,and disposed so that when inserted in a fluid body cavity with fluid, the body fluid may circumferentially surround each heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes a hollow lumen within each of the heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds (70, 72). Alternatively, the heat exchange elements may be connected at only one point and be permitted to float. An insulating member, such as a balloon (204), may be provided along the shaft, and ribs (204) may be provided on each of the heat exchange elements.

Steerable vascular catheter for maintaining the patency of a blood vessel

A STEERABLE VASCULAR CATHETER FOR MAINTAINING THE PATENCY OF A BLOOD VESSEL ABSTRACT OF THE DISCLOSURE A steerable vascular catheter having an expandable cage mounted on the distal end of a tubular member which is radially expanded and contracted by means of a guidewire which is disposed within an inner lumen in the tubular member and secured to the distal end of the expandable cage. A helical coil is disposed about and secured to s distal portion of the guidewire which extends out the distal end of the expandable cage facilitate steering the catheter through the patient's coronary anatomy. The catheter assembly is particularly adapted to hold open a blood vessel after a vascular procedure therein such as an angioplasty.

Systems for coronary bypass procedures

A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia.

Methods and apparatus for treating or deterring injuries to or disorders of the brain or spinal cord of a subject

Methods and apparatus for treating or deterring injuries to or disorders of the brain or spinal cord of a subject. A heat exchange catheter device is inserted into the subject's body and used to cause heating or cooling the subject's cerebrospinal fluid. In some embodiments, the heat exchanger may be positioned within the subject's vasculature so as to heat or cool the flowing blood, thereby resulting in heating or cooling of the cerebrobpinal fluid.

Method for reducing myocardial infarct by application of intravascular hypothermia

Methods and apparatus for preventing myocardial infarction, or lessening the size/severity of an evolving myocardial infarction, by cooling at least the affected area of the myocardium using an intravascular heat exchange catheter. The heat exchange catheter may be inserted into the vasculature (e.g., a vein) and advanced to a position wherein a heat exchanger on the catheter is located in or near the heart (e.g., within the vena cava near the patient's heart). Thereafter, the heat exchange catheter is used to cool the myocardium (or the entire body of the patient) to a temperature that effectively lessens the metabolic rate and/or oxygen consumption of the ischemic myocardial cells or otherwise protects the ischemic myocardium from undergoing irreversible damage or infarction.

Disposable cassette for intravascular heat exchange catheter

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Method of controlling body temperature while inhibiting thermoregulatory responses

A method and apparatus for controlling the body temperature of a patient while reducing shivering by using a heat exchange device in combination with an anti-thermoregulatory response mechanism that temporarily reduces shivering. The devices disclosed include a catheter having a heat exchange balloon thereon with heat exchange fluid circulating through the interior of the balloon. The heat exchange balloon is placed in the vasculature of a patient, and heat exchange fluid at a temperature other than the temperature of the blood in the vasculature is circulated through the interior of the balloon to add or remove heat from the blood of the patient. Various anti-thermoregulatory response agents are disclosed including dopamine receptor blockers, dopamine receptor agonists, κ opioid receptor agonists, μ opioid receptor agonists opioid agonist-antagonist analgesics, serotonin 5 HT1a agonists, α2-adrenorceptor agonists, non-opiod analgesic monoamine uptake inhibitors and neuropeptides. Specific examples of each are give. A control system for the control of the patient's temperature is disclosed for controlling the patient's temperature in conjunction with administering the anti-thermoregulatory response mechanism.

Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures