Abstract: A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.

Abstract: A lead assembly includes an elongate body having a conductor electrically coupled with an electrode coupled to the elongate body. The lead assembly includes a push tube extending along at least a portion of the elongate body. A distal tip is coupled to the elongate body substantially adjacent to the distal end of the elongate body. The distal tip is sized and shaped to couple with a push tube distal end. In one option, the distal tip includes a seat to receive the push tube distal end. In another option, the seat is a side rail seat and a guide wire extends along the elongate body and is slidably coupled with the side rail seat. The lead assembly includes, optionally, an active fixation device slidably coupled with a portion of the elongate body, and the active fixation device is sized and shaped to couple with the push tube.

Abstract: A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.

Abstract: An anchor for an implantable medical device, for example, and implantable physiologic sensor, includes a proximal hub portion, an intermediate portion extending radially and distally from the hub portion, and a distal portion extending distally from the proximal portion and adapted to engage an inner surface of a target vessel for securing the implantable medical device therein. The anchor can assume a collapsed configuration for delivery through a catheter, and an expanded configuration for fixation within the vessel once deployed. The intermediate portion extends from the proximal portion at an oblique angle, allowing the anchor to be retracted and re-collapsed within the delivery catheter after initial deployment, if re-positioning or removal of the implantable medical device is necessary or desired.

Abstract: The present invention provides a cardiac vascular occlusion system which includes inner and outer guide catheters and an occluding member disposed on the inner catheter. The occluding member may be deployed from a compressed to an expanded position to limit retrograde blood flow in a body lumen. The occluding member may be used when injecting a contrast agent into the body lumen.

Abstract: The present invention provides a cardiac vascular occlusion system which includes inner and outer guide catheters and an occluding member disposed on the inner catheter. The occluding member may be deployed from a compressed to an expanded position to limit retrograde blood flow in a body lumen. The occluding member may be used when injecting a contrast agent into the body lumen.

Abstract: A lead assembly includes an elongate body having a conductor electrically coupled with an electrode coupled to the elongate body. The lead assembly includes a push tube extending along at least a portion of the elongate body. A distal tip is coupled to the elongate body substantially adjacent to the distal end of the elongate body. The distal tip is sized and shaped to couple with a push tube distal end. In one option, the distal tip includes a seat to receive the push tube distal end. In another option, the seat is a side rail seat and a guide wire extends along the elongate body and is slidably coupled with the side rail seat. The lead assembly includes, optionally, an active fixation device slidably coupled with a portion of the elongate body, and the active fixation device is sized and shaped to couple with the push tube.

Abstract: A delivery system for an implantable medical device including a tether retaining feature having a bore. The system includes a connector having a top surface, a bottom surface, a rail extending in a proximal direction from the connector, and an aperture sized to receive the tether retaining feature and reduce movement of the connector with respect to the implantable medical device in a plane parallel to the aperture. A tether is sized to fit within the bore of the tether retaining feature. The tether acts against the top surface of the connector to retain the bottom surface of the connector proximal to the implantable medical device when the tether is located within the bore of the tether retaining feature. A method for delivering an implantable medical device including a tether retaining feature.

Abstract: An anchor for an implantable medical device, for example, and implantable physiologic sensor, includes a proximal hub portion, an intermediate portion extending radially and distally from the hub portion, and a distal portion extending distally from the proximal portion and adapted to engage an inner surface of a target vessel for securing the implantable medical device therein. The anchor can assume a collapsed configuration for delivery through a catheter, and an expanded configuration for fixation within the vessel once deployed. The intermediate portion extends from the proximal portion at an oblique angle, allowing the anchor to be retracted and re-collapsed within the delivery catheter after initial deployment, if re-positioning or removal of the implantable medical device is necessary or desired.

Abstract: A lead for implanting into the epicardium includes a pair of tissue anchors coupled to a tissue engaging member, forming an anchor mechanism. The tissue anchors include electrodes coupled to conductors extending from the tissue engaging member. The tissue anchors are movable from a low profile configuration to an implanting configuration in which the tissue anchors are angled away from the tissue engaging member. A device for implanting the lead includes one or more lumens, including a lead lumen and a vacuum lumen terminating at a distal opening in the device. Suction is applied at the distal opening through the vacuum lumen to draw an epicardial bleb. The anchor mechanism of the lead is withdrawn proximally past the bleb, causing the tissue anchors to pierce the epicardium. The device is then withdrawn proximally over the conductors.

Abstract: The present invention is a medical assembly comprising an elongated flexible medical device, such as a cardiac lead, and a torquing member, such as a stylet, slidably receivable inside the medical device. The device and member are coupled at their distal ends by a corresponding set of opposing curves. This coupling allows more precise rotational control of the assembly when it is manipulated at its proximal end. In one embodiment, the assembly has a open curvature at its distal end. In another embodiment, the distal end has a closed curvature.

Abstract: An improved guidewire for assisting in implantation of a cardiac lead includes three sections. The most distal zone is sufficiently floppy to prevent trauma to the vessel walls through which the guidewire and lead are inserted. An intermediate zone is generally stiffer and has a cross-section less than or equal to the cross-section of the distal zone. The third zone is stiffer yet and is joined to the intermediate zone by a shoulder. The shoulder cooperates with protrusions on the lead to transfer forces between the guidewire and lead. A finishing wire having temporary locking means to lock the finishing wire to the lead is employed to remove the guide catheter without moving the lead from its desired location. Lubricious coatings are also provided to reduce friction between the lead and guidewire.

Abstract: An improved guidewire for assisting in implantation of a cardiac lead includes three sections. The most distal zone is sufficiently floppy to prevent trauma to the vessel walls through which the guidewire and lead are inserted. An intermediate zone is generally stiffer and has a cross-section less than or equal to the cross-section of the distal zone. The third zone is stiffer yet and is joined to the intermediate zone by a shoulder. The shoulder cooperates with protrusions on the lead to transfer forces between the guidewire and lead. A removal wire having temporary locking device to lock the removal wire to the lead is employed to remove the guide catheter without moving the lead from its desired location. Lubricious coatings are also provided to reduce friction between the lead and guidewire.

Abstract: An extractable lead and method for lead explantation is provided. The lead includes a distal element having a cavity. The cavity shaped to receive the distal end of a removal stylet. The cavity and the distal end configured to cooperate such that the distal end is secured within the cavity by rotation of the stylet. The method provides for removal of an implanted lead by securing a distal end of a removal stylet with a cavity by rotation and applying an extracting force to the lead through the removal stylet.

Abstract: An improved guidewire for assisting in implantation of a cardiac lead includes three sections. The most distal zone is sufficiently floppy to prevent trauma to the vessel walls through which the guidewire and lead are inserted. An intermediate zone is generally stiffer and has a cross-section less than or equal to the cross-section of the distal zone. The third zone is stiffer yet and is joined to the intermediate zone by a shoulder. The shoulder cooperates with protrusions on the lead to transfer forces between the guidewire and lead. A finishing wire having temporary locking means to lock the finishing wire to the lead is employed to remove the guide catheter without moving the lead from its desired location. Lubricious coatings are also provided to reduce friction between the lead and guidewire.

Abstract: An improved guidewire for assisting in implantation of a cardiac lead includes three sections. The most distal zone is sufficiently floppy to prevent trauma to the vessel walls through which the guidewire and lead are inserted. An intermediate zone is generally stiffer and has a cross-section less than or equal to the cross-section of the distal zone. The third zone is stiffer yet and is joined to the intermediate zone by a shoulder. The shoulder cooperates with protrusions on the lead to transfer forces between the guidewire and lead. A removal wire having temporary locking means to lock the removal wire to the lead is employed to remove the guide catheter without moving the lead from its desired location. Lubricious coatings are also provided to reduce friction between the lead and guidewire.

Abstract: A guidewire which has a tubular member, a flexible distal tip secured to the distal end of the tubular member and an exchangeable elongated core member disposed within the lumen of the tubular member. The elongated core member can be advanced distally to the distal end of the tubular member or withdrawn proximally out of the tubular member proximal end. While the guidewire is inside a patient's vessel, the elongated core member can be removed from the tubular member and exchanged for a different elongated support. By exchanging the elongated core member, the physician is able to change guidewire characteristics, such as flexibility or shape, to facilitate movement of the guidewire within the patient's lumen.

Abstract: A vented drip chamber, threadably engageable with a fluid filled hypodermic syringe, comprises an adapter having dual passageways. A first passageway allows fluid communication between the syringe and the drip chamber while the second passageway provides an air vent from outside the drip chamber to the syringe. The second passageway further comprises a cannula which extends into the fluid upon attachment of the drip chamber with the syringe. A ball valve which is disposed in the second passageway allows air to flow into the syringe to replace the dispensed fluid, but does not allow fluid to flow from the syringe through the second passageway.