The disclosed invention provides a transseptal insertion device which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum. The transseptal insertion device includes a sheath that defines at least one lumen therein, one or more positioning balloons that are connected to a distal end of the sheath, a puncture member movably positioned within the at least one lumen, and a puncture member balloon located on the puncture member. The sheath has one or more deflation ports to deflate the one or more positioning balloons. The puncture member balloon, when inflated, is capable of sealing the one or more deflation ports in the sheath, permitting the inflation of the one or more positioning balloons. When the puncture member moves toward fossa ovalis, the inflated puncture member balloon moves away from the deflation ports, allowing the positioning balloons to be deflated.

An apparatus for rolling a bladder includes a support structure, a rolling pin, and a bladder-mounting pin. The apparatus optionally includes a rolling initiator Rolling a bladder includes inserting the bladder while unrolled into an apparatus for rolling a bladder, inserting the bladder between a rolling pin and a bladder-mounting pin of the rolling machine, and rotating the rolling pin to (a) advance a portion of the bladder between the rolling pin and the bladder-mounting pin, (b) roll the portion of the bladder around the bladder-mounting pin, and (c) drive the bladder-mounting pin to rotate in an opposite direction from that of the rolling pin.

A surgical probe and a method for forming and enlarging an access opening through a psoas muscle to provide for minimally invasive lateral approach for surgical access to a lumber intervertebral disc. A distal end portion of the probe is equipped with an electrode useful for confirming proper location of the probe and includes an inflatable dilator body for enlarging an access opening through tissue adjacent to a spinal column. The probe includes a cannula through which a K wire can be extended to anchor the probe to a patient.

Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

An example system for creating a lumen according to the present disclosure includes, among other possible things a balloon wound in a generally helical shape having an inner surface and an outer surface, and a support attached to at least one of the inner surface and the outer surface of the generally helical shape and constraining the tubular balloon in the generally helical shape. The balloon has a first diameter in a low-profile operating mode and the generally helical shape has a second diameter in a high-profile operating mode, and the second diameter is larger than the first diameter. Other example systems for creating a lumen and methods for creating a lumen in an artery are also disclosed.

An access system includes a proximal handle, an overtube coupled to the handle, and an endoscope port extending through handle and overtube sized for receiving an endoscope therethrough. The overtube includes anatomic wall securing system that secures a distal portion of the overtube within a hole in the anatomic wall. The overtube is provided with a shaped distal portion or a controllably shapeable distal portion that aids in directing an endoscope inserted through the port to a particular location within the peritoneal cavity. The access system includes a system for insufflating/deflating the peritoneal space separately from the body cavity accessible via a natural orifice. The access system includes a closure system to cinch closed the hole made in the anatomical wall after the access system has been removed from the hole. Methods are provided for inserting the access system through the anatomical wall to perform intra-abdominal surgery.

Provided is a method of treating orthostatic intolerance in a patient. The method comprises selecting a patient suffering from orthostatic intolerance and creating a flow pathway between a first vascular location and a second vascular location. The first vascular location comprises a source of arterial blood and the second vascular location comprises a source of venous blood. Systems and devices for creating a flow pathway are also provided.

Some embodiments provide a soft tissue device, such as a transverse carpal ligament cutting device having one or more balloons that are deflated when the device is in an inactive position and are inflated when the device is in an active position. Other embodiments provide a soft tissue cutting method, such as a method of cutting a transverse carpal ligament that uses a soft tissue cutting device.

Some embodiments provide a soft tissue device, such as a transverse carpal ligament cutting device having one or more balloons that are deflated when the device is in an inactive position and are inflated when the device is in an active position. Other embodiments provide a soft tissue cutting method, such as a method of cutting a transverse carpal ligament that uses a soft tissue cutting device.

A dilation assembly comprises an expandable and contractible main body having a corrugated outer surface, a guide cannula configured to be disposed through the main body to guide a movement of the main body, and an anchor configured to fix the main body in a target position.