Infusion devices and methods are provided for a drug delivery system and can include an infusion needle (1) having a tip end (2) and a drive unit (D) coupled to the infusion needle and arranged for advancing the tip end of the infusion needle to penetrate any fibrosis when the infusion device is implanted in a patient's body. The infusion needle and drive unit are designed for implantation in a patient's body. Other components of the drug delivery system may be part of the implantable infusion device or, alternatively, be for extracorporal use cooperating with the implanted infusion device. Preferably, the infusion needle can be advanced and retracted with each infusion cycle. Furthermore, upon each advancement and/or retraction, the needle may be moved laterally so as to vary the injection site. Needle (1) and drive unit (D) are preferably disposed within a body (15), with the infusion needle being arranged for penetrating a self-sealing penetration membrane (18).

A catheter is disclosed for locating radiation tagged tissue within a mammalian body and treating tagged tissue or untagged tissue adjacent to the tagged tissue in a single procedure. The catheter includes in or on a distal end thereof one or more detectors for locating labeled tissue. A lumen extending from a proximal end of said tube to the distal end of said tube, includes a retractable and extendable needle positioned adjacent the distal end of said tube for delivering a liquid treatment modality. I the alternative the injector for delivering the treatment modality may be placed adjacent to the catheter for delivery of the treatment.

A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device is connectable to a drug source and includes a dual-lumen catheter, including a treatment device lumen for housing a guidewire and/or a treatment device and a needle lumen for housing a retractable needle. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter.

An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided.

A device for expanding tissue comprises at least one fluid delivery tube and at least one fluid delivery element in fluid communication with the at least one fluid delivery tube. The at least one fluid delivery tube comprises a proximal end, a distal end, and a lumen therebetween. The device is constructed and arranged to perform a near full circumferential expansion of luminal wall tissue. Systems and methods are also provided, including a system for expanding tissue layers and treating tissue proximate to the expanded tissue layers.

Apparatus, systems, and methods for treating PKD by providing access to a patient's renal pelvis of a kidney to treat renal nerves embedded in tissue surrounding the renal pelvis. Access to the renal pelvis may be via the urinary tract or via minimally invasive incisions through the abdomen and kidney tissue. Treatment is effected by exchanging energy, typically delivering heat or extracting heat through a wall of the renal pelvis, or by delivering active substances to ablate a thin layer of tissue lining at least a portion of the renal pelvis to disrupt renal nerves within the tissue lining of the renal pelvis.

Various devices, apparatuses, and methods for transseptal puncture and crossing are disclosed herein. A transseptal puncture and crossing device can include novel puncture member having a crossing coil mated to a body portion to be able to both cross a tissue and allow a wire or guard be inserted through the puncture member. Though not required, the puncture member can have one or more of novel features, including a tapered coil portion, a transition cutter, a gripper coil portion, an atraumatic guard, and a shaped cutting wire. Methods for transseptal punctures and crossing include adding rotation, oscillation and/or ultrasound to a transseptal puncture device.