Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall.

A catheter-based/intravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic or/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel. The preferred embodiment of the catheter delivered through the vascular system of a patient includes a multiplicity of expandable guide tubes that engage the wall of a blood vessel. Injection needles having injection egress at or near their sharpened distal end are then advanced through the guide tubes to penetrate the wall of the blood vessel to a prescribed depth. The ability to provide PeriVascular injection so as to only affect the outer layer(s) of a blood vessel without affecting the media has particular application for PeriVascular Renal Denervation (PVRD) of the sympathetic nerves which lie in the adventitia or outside the adventitia of the renal artery.

A catheter-based/intravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic and/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel. The preferred embodiment of the catheter delivered through the vascular system of a patient includes a multiplicity of expandable guide tubes that engage the wall of a blood vessel. Injection needles having injection egress at or near their sharpened distal end are then advanced through the guide tubes to penetrate the wall of the blood vessel to a prescribed depth. The ability to provide PeriVascular injection so as to only affect the outer layer(s) of a blood vessel without affecting the media has particular application for PeriVascular Renal Denervation (PVRD) of the sympathetic nerves which lie in the adventitia or outside the adventitia of the renal artery.

Disclosed herein are medical instrument and medical method for localized drug delivery. The medical instrument can comprise a catheter shaft assembly, a hub coupled to the proximal end of the catheter shaft assembly, an inflatable component at the distal end of the catheter shaft assembly, a tissue penetrating member coupled to the inflatable component in an orientation transverse to the longitudinal axis of the catheter shaft assembly, and at least one protective element coupled to the inflatable component in proximity to the tissue penetrating member. The protective element can be configured to prevent any damage of the inflatable body during a placement of the medical instrument and an actuation of the inflatable component.

Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may optionally include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall. The methods may include delivering a first fluid out of one or more needles, and delivering a secondary fluid (which may be the same type of fluid as the first fluid, or a different type of fluid) from the device without delivering the secondary fluid through a needle.

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. Applications include renal denervation for the treatment of hypertension, atrial fibrillation, congestive heart failure, tissue ablation for COPD, BPH and prostate cancer and prevention of restenosis after balloon angioplasty or stent implantation and other disorders.

Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may optionally include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall. The methods may include delivering a first fluid out of one or more needles, and delivering a secondary fluid (which may be the same type of fluid as the first fluid, or a different type of fluid) from the device without delivering the secondary fluid through a needle.

A microneedle device for delivering a therapeutic fluid to a fistula comprises a carrier element (5) formed by a pair of shells (9). The shells (9) are of semi-circular cross-section and are urged together by resilient bands (10) to define a main bore (14) extending therethrough. A plurality of microneedles (17) extend from the respective shells (9). An operating member (30) of circular transverse cross-section of external diameter greater than the diameter of the main bore (14) is urgeable into the main bore (14) for urging the shells (9) and in turn the microneedles (17) radially outwardly from a rest state to an engagement state, and into the tissue within the fistula (3). A tubular shield (23) of circular transverse cross-section having a carrier element accommodating bore (25) extending therethrough is provided for accommodating the carrier element (3) with the microneedles (17) in the rest state for facilitating insertion of the carrier element (3) located within the tubular shield (24) into the fistula (3) in order to avoid engagement of the microneedles (17) with the tissue of the fistula (3) during insertion of the carrier element (5). On the carrier element (5) being correctly located in the fistula (3), the tubular shield (24) is withdrawn and the operating member (30) is urged into the main bore (14) of the carrier element (5) for urging the microneedles (17) into engagement with the tissue. Main chambers (40) communicate with the microneedles (17) through communicating ports (45) and corresponding inlet ports (21) when the operating member (30) is aligned in the carrier element (5). A delivery needle is urgeable sequentially into the main chambers (40) for delivering the therapeutic fluid into the main chambers (40) for in turn delivery through the microneedles (17).

Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall.

An injection device is used for “tattooing” markers inside the heart of a patient at specific locations. Placement within the heart of markers, such as points marked with a radiopaque dye, may reduce the use of x-ray dye and echocardiography, may allow a quicker cardiac procedure, and thus may improve the procedure outcome for the patient. Alternatively or additionally to cardiac marking with a radiopaque dye, cardiac tissue fibrosis, cardiac tissue contraction, and/or cardiac tissue stiffening (or hardening) can be promoted at specific locations by delivering a suitable substance.