Abstract: Devices, systems and methods are provided for treating conditions of the heart, particularly the occurrence of arrhythmias, more particularly atrial fibrillation, atrial flutter, ventricular tachycardia, to name a few. The devices, systems and methods deliver therapeutic pulsed electric field energy to portions the heart to provide tissue modification, such as to the entrances to the pulmonary veins in the treatment of atrial fibrillation. Such tissue modification creates a conduction block within the tissue to prevent the transmission of aberrant electrical signals. Generally, the tissue modification systems include a specialized catheter, a high voltage waveform generator and at least one distinct energy delivery algorithm. Example embodiments of specialized catheter designs are provided and include a variety of delivery types including focal delivery, “one-shot” delivery and various possible combinations.

Abstract: Devices, systems and methods are provided for delivering molecules, particularly small molecules and/or macromolecules, to cells within the body, particularly to target cells which directly therapeutically benefit from the functionality of the molecules. Example molecules include DNA plasmids, RNAs (e.g. messenger RNA (mRNA), small interfering RNA (siRNA), micro RNA), oligonucleotides, antisense oligonucleotides (ASO), proteins and/or materials which invoke genetic or epigenetic changes in the cellular behavior, to name a few. In such instances, the molecules are driven into the target cells with the use of pulsed electric fields (PEFs) which deliver the molecules through the cell wall of the target cells so that the desired genes are able to carry out the desired effect within the cells. Thus, the molecules are to be delivered to the desired location within the body at a desired time and in a desired concentration relative to the delivery of the pulsed electric fields for optimal outcomes.

Abstract: Devices, systems and methods are provided for treating conditions of the heart, particularly the occurrence of arrhythmias. The devices, systems and methods deliver therapeutic energy to portions the heart to provide tissue modification, such as to the entrances to the pulmonary veins in the treatment of atrial fibrillation. Generally, the tissue modification systems include a specialized catheter, a high voltage waveform generator and at least one distinct energy delivery algorithm. Other embodiments include conventional ablation catheters and system components to enable use with a high voltage waveform generator. Example catheter designs include a variety of delivery types including focal delivery, “one-shot” delivery and various possible combinations. In some embodiments, energy is delivered in a monopolar fashion. However, it may be appreciated that a variety of other embodiments are also provided.

Abstract: A tissue connector assembly having a flexible member and a surgical clip releasably coupled to the flexible member. A needle may be secured to one end portion of the flexible member with the surgical clip coupled to the other end portion of the flexible member. A locking device may be used to couple the flexible member to the surgical clip. A method for connecting tissues is also disclosed. The method includes drawing tissue portions together with a clip assembly and securing the tissue portions together with the clip assembly.

Abstract: A torque mechanism for interventional catheters provides direct control over rotary positioning of the distal end of a catheter by rotating a proximal handle of the catheter. The torque mechanism comprises a stiff tube within and running the length of a flexible catheter body tube. The stiff tube is bonded at its distal end to the catheter body tubing and at its proximal end to a rotary handle. Catheter body tubing is bonded at its proximal end to a catheter hub. The catheter hub and rotary handle rotate independently, thus torque and position are transmitted by the torque tube while the catheter tube acts as a torsional spring.

Abstract: Tissue connector assemblies having at least two piercing members, each releaseably coupled to a surgical fastener such as a surgical clip. A flexible member such as a suture may be used to couple one or both piercing members to respective ends of the fastener.

Abstract: Methods and apparatus are provided for improved administration of brachytherapy in the treatment of prostate disease. More particularly, a prostate visualization device is provided comprising a catheter coupled to at least one deployable member at the distal end of the catheter. The deployable member is preferably manufactured from a shape memory alloy having a petal-shaped configuration suitable for engaging and defining the proximal region of a patient's bladder. The deployable member may comprise tubing filled with air or other radiopaque agents to facilitate ultrasonic imaging of the deployable members near the bladder/prostate junction.

Abstract: Methods and apparatus are provided for converting standard catheters or balloon catheters into drug infusion devices on an as-needed basis in a sterile environment, and which permit re-use of catheter devices previously used in a preceding non-invasive procedure. Apparatus is provided having a cavity for receiving a catheter device and a plurality of perforation pins or teeth for creating apertures in the catheter. Apparatus capable of converting a wide range of catheter devices into drug infusion devices is provided, which apparatus may be single-use disposable or re-sterilizable and re-usable.

Abstract: Methods and apparatus are provided for converting standard catheters or balloon catheters into drug infusion devices on an as-needed basis in a sterile environment, and which permit re-use of catheter devices previously used in a preceding non-invasive procedure. Apparatus is provided having a cavity for receiving a catheter device and a plurality of perforation pins or teeth for creating apertures in the catheter. Apparatus capable of converting a wide range of catheter devices into drug infusion devices is provided, which apparatus may be single-use disposable or re-sterilizable and re-usable.

Abstract: A torque transmitting assembly for guidewires, steerable fixed wire catheters and the like with a drive mechanism wherein the rotational output is greater than the rotational input. The assembly has a supporting structure with proximal and distal end pieces and a connecting arm or strut extending between and secured to the end pieces. An outer cylindrical shaped housing is rotatably mounted about the connecting arm and between the ends. A ring gear or other torque transmitting element is secured to the interior of the housing. A pinion gear or other torque transmitting element having a smaller diameter than the ring gear is rotatably mounted within support structure and the housing and is adapted to engage the ring gear in a torque transmitting relationship. The proximal end of a guidewire or the guiding element of a steerable catheter is secured to the pinion gear so that rotation thereof by the rotation of the housing causes a much greater the rotation of the attached guidewire or guiding element.

Abstract: A device to facilitate the joining of a male proximal end of a guidewire to the female end of an extension wire. The device has a relatively flat body with a guiding groove in the upper surface with two aligned sections, the goove sections tapering inwardly toward the intersection thereof. One of the groove sections is adapted to receive the male end of the guidewire and one groove is adapted to receive the female end of the extension. One, preferably two, flexible tabs are secured to the upper surface of the body to maintain one of the ends within its respective groove section. The device and/or the connecting wires can be disengaged by the rotation thereof with respect to each other.