Abstract: An arrangement for introducing and implanting the electrode(s) of an endocardial implantable cardiac lead at a cardiac implantation site within a heart chamber or vessel. An elongated guide body formed of flexible material and extending between a guide body proximal end and a guide body distal end is advanced transvenously to position the guide body distal end in relation to the cardiac implantation site. Guide body tracking means is coupled with the lead distal end for receiving and slidingly engaging the guide body to allow the cardiac lead to be advanced along the guide body until the electrode is positioned at the cardiac implantation site. Pusher means formed of an elongated pusher body of flexible material extends between a pusher body proximal end and a pusher body distal end and has a cardiac lead engaging means for engaging the cardiac lead at or adjacent the distal lead end.

Abstract: A tubular suction tool for accessing an anatomic surface or anatomic space and particularly the pericardium to access pericardial space and the epicardial surface of the heart to implant cardiac leads in a minimally invasive manner are disclosed. The suction tool incorporates a suction pad concave wall defining a suction cavity, a plurality of suction ports arrayed about the concave wall, and a suction lumen, to form a bleb of tissue into the suction cavity when suction is applied. The suction cavity extends along one side of the suction pad, so that the suction pad and suction cavity can be applied tangentially against a tissue site. The suction tool can incorporate light emission and video imaging of tissue adjacent the suction pad. A working lumen terminating in a working lumen port into the suction cavity enables introduction of tools, cardiac leads, and other instruments, cells, drugs or materials into or through the tissue bleb drawn into the suction cavity.

Abstract: An instrument including an elongated shaft and a non-conductive handle is disclosed. The shaft defines a proximal section and a distal section. The distal section forms an electrically conductive tip. Further, the shaft is adapted to be transitionable from a straight state to a first bent state. The shaft is capable of independently maintaining the distinct shapes associated with the straight state and the first bent state. The handle is rigidly coupled to the proximal section of the shaft. The instrument is useful for epicardial pacing and/or mapping of the heart for temporary pacing on a beating heart, for optimizing the placement of ventricular leads for the treatment of patients with congestive heart failure and ventricular dysynchrony and/or for use in surgical ablation procedures.

Abstract: An implantable electrical medical system comprises a low voltage cathode electrode assembly, including a cathode surface adapted for intimate contact with electrically active tissue, and a low voltage anode electrode assembly, including an anode surface and a porous layer extending over the anode surface. The cathode surface and the anode surface function as a bipolar pair for pacing and the porous layer extending over the anode surface allows conduction therethrough and prevents the anode surface from contacting the electrically active tissue in order to prevent anodal stimulation.

Abstract: A medical electrical lead includes a first low voltage electrode adapted for intimate contact with tissue at an implant site, in order to provide pacing stimulation, and a second low voltage electrode positioned in proximity to the first electrode, isolated from the first electrode and adapted to function in conjunction with the first electrode to provide bipolar sensing of near-field signals. A porous layer is formed over the second electrode; the porous layer allows conduction therethrough while preventing contact between the second electrode and tissue in proximity to the implant site.

Abstract: A method of performing a medical procedure is provided. The medical procedure includes stimulation of a patient's heart while stimulating a nerve of the patient in order to modulate the patient's inflammatory process. More particularly, the medical procedure includes pacing the ventricles of the patient's heart while stimulating the vagal nerve of the patient. Systems and devices for performing the medical procedure are also provided.

Abstract: A tubular suction tool for accessing an anatomic surface or anatomic space and particularly the pericardium to access pericardial space and the epicardial surface of the heart to implant cardiac leads in a minimally invasive manner are disclosed. The suction tool incorporates a suction pad concave wall defining a suction cavity, a plurality of suction ports arrayed about the concave wall, and a suction lumen, to form a bleb of tissue into the suction cavity when suction is applied. The suction cavity extends along one side of the suction pad, so that the suction pad and suction cavity can be applied tangentially against a tissue site. The suction tool can incorporate light emission and video imaging of tissue adjacent the suction pad. A working lumen terminating in a working lumen port into the suction cavity enables introduction of tools, cardiac leads, and other instruments, cells, drugs or materials into or through the tissue bleb drawn into the suction cavity.

Abstract: Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Abstract: A tubular suction tool for accessing an anatomic surface or anatomic space and particularly the pericardium to access pericardial space and the epicardial surface of the heart to implant cardiac leads in a minimally invasive manner are disclosed. The suction tool incorporates a suction pad concave wall defining a suction cavity, a plurality of suction ports arrayed about the concave wall, and a suction lumen, to form a bleb of tissue into the suction cavity when suction is applied. The suction cavity extends along one side of the suction pad, so that the suction pad and suction cavity can be applied tangentially against a tissue site. The suction tool can incorporate light emission and video imaging of tissue adjacent the suction pad. A working lumen terminating in a working lumen port into the suction cavity enables introduction of tools, cardiac leads, and other instruments, cells, drugs or materials into or through the tissue bleb drawn into the suction cavity.

Abstract: A lead for delivering electrical signals to and/or receive electrical signals from a human heart that includes a solid inner conductor, and a fixation device having a titanium nitride coated surface and electrically coupled to the inner conductor. A steroid is applied to the titanium nitride surface of the fixation device, and at least one layer of insulation is positioned around the inner conductor. A conductive coil is positioned around and is insulated from the inner conductor, an electrode ring electrically coupled to the conductive coil is positioned around and is electrically isolated from the inner conductor, and an insulating spacer is positioned between and electrically isolates the ring electrode and the fixation device.

Abstract: A catheter for introducing a lead into a heart that includes a hub and a shaft. The shaft forms a lumen that is adapted for positioning a lead therein, and extends from a proximal section coupled to the hub to a distal section including a distal end having a distal opening formed thereon. The shaft also includes an intermediate section positioned between the proximal section and the distal section. A proximal bend is formed along the shaft in a first plane, the proximal bend positioned between the proximal section and the intermediate section.

Abstract: Medical devices and methods for accessing an anatomical space of the body and particularly for penetrating the epicardium to access pericardial space and the epicardial surface of the heart in a minimally invasive manner employing suction are disclosed. The distal end of a tubular access sleeve having a sleeve wall surrounding a sleeve access lumen and extending between a sleeve proximal end and a sleeve distal end having a plurality of suction ports arrayed around the sleeve access lumen distal end opening is applied against an outer tissue layer. Suction is applied through the plurality of suction ports to a plurality of portions of the outer tissue layer. A perforation instrument is introduced through the sleeve access lumen to perforate the outer tissue layer to form an access perforation into the anatomic space while the applied suction stabilizes the outer tissue layer, whereby further treatment drugs and devices can be introduced into the anatomic space.

Abstract: Methods and apparatus employed to locate body vessels and occlusions in body vessels finding particular utility in cardiac surgery, particularly minimally invasive cardiac surgery to locate cardiac arteries and occlusions in cardiac arteries are disclosed. An elongated vessel lumen probe incorporating a lumen probe element at or near the elongated vessel lumen probe distal end is advanced into the vessel lumen. A vessel surface probe manipulated by the surgeon and having a surface probe element sensor is employed to detect the lumen probe element and to follow the progress of the vessel lumen probe element as it approaches and is advanced through or is blocked by an occlusion. In the location of a coronary artery, the surface probe element sensor is moved about against the epicardium over the suspected location of the artery of interest until a surface probe element sensor of the present invention at the surface probe distal end interacts with the lumen probe element of the vessel lumen probe.

Abstract: A method for cardioverting or defibrillating a human heart, performed by placing a transvenous lead having a cardioversion or defibrillation electrode such that the electrode is located at least partially within the middle cardiac vein of a patient's heart and placing an additional cardioversion or defibrillation electrode in the superior vena cava of the patient's heart and thereafter delivering a cardioversion or defibrillation pulse between the first and second electrodes. The method may be practiced by placing the transvenous such that the defibrillation electrode it carries extends around the apex of the patient's heart, and the transvenous lead may be advanced through one cardiac vein toward the apex of the patient's heart and thereafter advanced upward through a different cardiac vein.

Abstract: The present invention provides methods and systems for regulating delivery of therapeutic proteins and nucleic acids.

Abstract: In general, an apparatus including a lead body and at least two electrodes. The lead body is so shaped that the lead body brings the first electrode against cardiac tissue yet keeps the second electrode away from contact with the cardiac tissue. These electrodes may be separated by a very small distance. When the lead is implanted in the superior vena cava, each electrode generates a distinct voltage signal as a function of sensed electrical activity. Although each electrode may sense a far-field R-wave in addition to a P-wave, the difference between the signals from the electrodes preserves the P-wave but includes a reduced far-field R-wave.

Abstract: A method and apparatus for accessing the pericardial space is provided for stable short term or long term placement of a delivery catheter or cannula having its distal-most end fixed on the endocardial surface such that a pericardial access device including a dilator and a puncturing device may be advanced through the myocardium into the pericardial space. The catheter is provided with a distal fixation member that maintains the catheter position over the myocardial pericardial access created by the access device allowing various medical instruments to be passed through the pericardial access into the pericardial space. Alternatively, the catheter may be positioned against the septal wall to access a left heart chamber via a right heart chamber.

Abstract: An introducer is structured with an elongated tube having first and second lumens. A molded handle is coupled to the proximal end of the tube with an opening aligned with the first lumen. Further, a wall adjacent the opening of the handle defines a slot and is located diametrically opposite the second lumen. A tubular reinforcement member is located within the second lumen and the handle is provided with a second opening, thereby having a communication with the second lumen. In another embodiment a lead/catheter introducer includes an implantable lead or catheter having an elongated first lumen through which the lead or catheter passes and a second lumen extends parallel to the first lumen along at least a distal portion thereof. A tubular reinforcement member is disposed within the second lumen. The tubular reinforcement member further includes an internal lumen and a curvable stylet disposed in the lumen.

Abstract: A cardiac pacing lead for pacing the atria and a method of its use. The lead is provided with a mechanism for maintaining an atrial pacing electrode adjacent stimulable tissue in a patient's superior vena cava and an additional electrode locatable in the right ventricle or elsewhere when the atrial electrode is so located One such mechanism for maintaing the atrial electrode's position may be a lead body displaying pre-formed laterally extending curves sized to span a patient's superior vena cava, with the atrial electrode located thereon.

Abstract: An arrangement for introducing and implanting the electrode(s) of an endocardial implantable cardiac lead at a cardiac implantation site within a heart chamber or vessel. An elongated guide body formed of flexible material and extending between a guide body proximal end and a guide body distal end is advanced transvenously to position the guide body distal end in relation to the cardiac implantation site. A guide body tracking mechanism is coupled with the lead distal end for receiving and slidingly engaging the guide body to allow the cardiac lead to be advanced along the guide body until the electrode is positioned at the cardiac implantation site. A pusher mechanism formed of an elongated pusher body of flexible material extends between a pusher body proximal end and a pusher body distal end and has a cardiac lead engaging mechanism for engaging the cardiac lead at or adjacent the distal lead end.