Abstract: A self-regulating gastric band apparatus for adjusting stoma size is disclosed. The apparatus includes an adjustable gastric band that has an expandable portion containing a volume of fluid. A band adjustment assembly is provided for implanting with the gastric band that includes a sensor for sensing fluid pressure in the expandable portion. The band adjustment assembly further includes a pump assembly connected to the expandable portion and to a controller that operates the pump assembly to adjust the volume of the fluid in the band based on the sensed fluid pressure. The band adjustment assembly includes memory storing an operating range relative to a target fluid pressure, and the pump assembly is operated to maintain the sensed band pressure within the operating range. The target pressure is set to maintain pressure variations below a predefined variation limit generally corresponding with satiated fill volumes for a particular patient and implanted band.

Abstract: 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.

Abstract: An intraluminal sleeve system is provided, which generally includes an intraluminal sleeve capable of dispensing an active agent to a patient, for example, a metabolic agent or satiety inducing agent. The intraluminal sleeve may be structured to contain the active agent and permit controlled release of the active agent to the patient while the intraluminal sleeve is positioned within the patient's intestine. Methods for treating obesity are also provided which include positioning an intraluminal sleeve in a patient's intestine, the intraluminal sleeve being capable of dispensing an active agent to the patient. In one embodiment, the active agent may be contained in a reservoir and dispensed to a portion of the patient's body.

Abstract: A releasably-securable gastric band (12) having a tail end (10a) and a head end (10b) for receiving the tail end (10a) is disclosed. The gastric band (12) also includes a releasable locking means (20) that releasably secures the head (10b) and tail ends (10a) together. The tail end (10a) may include a tooth (14) and the head end (10b) may include a notch (22) for engaging the tooth (14). Upon insertion of the tail end (10a) into the head end (10b), the tooth (14) mates with the notch (22) and releasably locks the tail end (10a) in the head end (10b). The releasably-securable gastric band (12) includes a release tab (24). When force is applied to the release tab (24) in a direction perpendicular to a central axis of the gastric band (12), the tooth (14) is disengaged from the notch (22) to allow the gastric band (12) to be released.

Abstract: An implantable device controls the movement of fluid to an inflatable portion of a gastric band. The implantable device includes a body. The body has an inlet, an outlet and a valve seat positioned between the inlet and the outlet. The body defines a fluid passage from the inlet to the outlet. The implantable device also includes a diaphragm. The diaphragm has one or more edges coupled to the body. The diaphragm is made of an elastomeric material and capable of being moved between a closed position that blocks the valve seat and does not allow the fluid to move from the inlet to the outlet and an open position that does not block the valve seat and allows the fluid to move from the inlet to the outlet.

Abstract: A mechanism for removing a fluid-filled object from a patient. The apparatus includes a deflation tube with a puncture member at one end of the tube for piercing a hole in the object wall. The apparatus includes a retrieval mechanism slidable within the deflation tube lumen. The retrieval mechanism includes an expansion element that is expandable when positioned within the object from a first configuration with a dimension less than that of the deflation tube lumen to a second or deployed configuration with a dimension that is greater than an outer dimension of the puncture member. The expansion element contacts an inner surface of the inflatable object as the deflation tube and retrieval mechanism are withdrawn from the body cavity. The expansion element may be a T-bar, a foldable anchor, an inflatable member, or another expandable form.

Abstract: An intraluminal sleeve system is provided, which generally includes an intraluminal sleeve capable of dispensing an active agent to a patient, for example, a metabolic agent or satiety inducing agent. The intraluminal sleeve may be structured to contain the active agent and permit controlled release of the active agent to the patient while the intraluminal sleeve is positioned within the patient's intestine. Methods for treating obesity are also provided which include positioning an intraluminal sleeve in a patient's intestine, the intraluminal sleeve being capable of dispensing an active agent to the patient. In one embodiment, the active agent may be contained in a reservoir and dispensed to a portion of the patient's body.

Abstract: An implantable injection port comprises a base. A first gear is coupled to the base, and a first anchor is coupled to the first gear. A second gear is coupled to the base, and a second anchor is coupled to the second gear. A top portion of the injection port is spaced apart from the base of the port and has a first plurality of top teeth that engage with a first plurality of gear teeth on the first gear. This engagement occurs prior to rotation of the second gear. The top portion rotates, which causes rotation of the first gear, which in turn causes movement of the first anchor through the anchor opening of the base and into the tissue of the patient. The first gear and the second gear rotate non-simultaneously.

Abstract: A mechanism for removing a fluid-filled object such as an intragastric balloon from a patient. The apparatus includes a delivery tube having a lumen and a retrieval tool able to slide within the lumen that can both puncture and grasp the intragastric balloon. The retrieval tool may have sharpened graspers with either a sharp tip and/or knife-like edges. Alternatively, the delivery tube itself may have sharpened cutting blades that deploy outward to puncture the intragastric balloon. One embodiment utilizes a suction cup tip on the delivery sheath and a sharpened puncture rod that extends past the distal tip of the lumen, for rapid deflation of a balloon. Various embodiments hasten the deflation process and simplify the manipulation required by the surgeon.

Abstract: An implantable injection port facilitates filling and/or draining an inflatable portion of a gastric band. In an embodiment, the port comprises a movable cap that causes anchor wires to extend from anchor devices in order to implant the injection port in the tissue of a patient. In another embodiment, the port comprises a handle that rotates to implant curved anchors into the tissue of a patient. In yet another embodiment, a cap is configured to move towards a base of the port in order to cause the curved anchors to rotate into the tissue of a patient. The cap may also rotate with respect to the base in order to lock the cap and the anchors in position. Further, surfaces of the injection port may be textured to increase adhesiveness to the patient's tissue during installation and to facilitate simpler installation.

Abstract: Generally described herein are apparatus, systems and methods related to utilizing a guiding tip to connect two open ends of respective tubes of a gastric banding system. More particularly, one of these tubes may include a barbed element at or near the point of connection which makes it difficult to connect the two tubes as the barbed element may be larger than an opening to receive the barbed element. The guiding tip provides a solution to this problem by acting as an interface between the barbed element and the receiving tube. In this manner, the sealing functionality of the barbed element may be retained while improving the ease of inserting the barbed element into the receiving tube.

Abstract: A transorally implanted intragastric balloon or treating obesity and for weight control including a variable size balloon with one or interconnected regions acting to exert a pressure on the stomach, to provide a stomach volume occupying effect, and/or to anchor the balloon within the stomach.

Abstract: Transoral obesity treatment devices and related methods for operation thereof are described which occupy space within a stomach and/or stimulate the stomach wall. The transoral obesity treatment devices and related methods are intended to assist a patient in maintaining a healthy body weight. Features of the devices include insertion transorally and without invasive surgery, without associated patient risks of invasive surgery, and without substantial patient discomfort. The life span of these devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer. The devices have the capacity to vary in size and are desirably self-actuating in that they change shape and/or volume using internal motors or actuators. The changing character of the devices helps prevent the person's stomach from compensating for the implant, such as sometimes happens with static intragastric devices.

Abstract: Generally described herein are apparatus, systems and methods related to a stem insertable into the access port tubing for the prevention of fluid leaks. More particularly, the stem or stems may be larger than the interior diameter of the access port tubing thereby providing a fluid seal to keep the fluid within the access port tubing. However, these fluid seals might not be absolute and may still allow a certain degree of leakage. In one embodiment, by including barbs which further presses against the interior diameter of the access port tubing, the sealing of the fluid may be substantially improved. The stem itself, while impenetrable by a needle, may still allow for bend flexibility of the access port tubing by employing a ball and socket joint for connecting to a next stem. In this manner, fluid leak prevention is improved while retaining the mobility of the access port tubing.

Abstract: A remotely controllable gastric banding device (10) for placement around the stomach of a patient for the treatment of obesity. The device (10) comprises a gastric band (10) having an inflatable chamber (16) for adjusting the inner circumference of the band (10), a pressurized reservoir (20) with a valve (31) for providing fluid to inflate the inflation chamber (16), a valve (32) for releasing fluid from the inflatable chamber (16), and a controller (41) for controlling the valves (31, 32). The controller (41) is remotely controllable from outside the patient.

Abstract: An implantable device comprises a reservoir that contains a fluid for filling an inflatable portion of a gastric band. A device is coupled to the reservoir and includes stored potential energy having a first state and a second state. The first state represents a higher level of potential energy and the second state represents a lower level of potential energy. The implantable device further comprises a filling valve coupled between the reservoir and the gastric band, and the filling valve is configured to be opened in response to a first telemetric signal. The stored potential energy decreases from the first state to the second state when the filling valve is open, and a filling amount of the fluid moves from the reservoir to the gastric band when the stored potential energy decreases from the first state to the second state.

Abstract: An implantable intragastric volume occupying device system is provided which generally includes a volume occupying device and an active agent, for example, a metabolic agent or satiety inducing agent. The volume occupying device may be structured to contain the agent and permit controlled release of the agent to the patient while the volume occupying device is positioned within the patient's stomach. Methods for treating obesity are also provided which include positioning a volume occupying device in the stomach of a patient and administering a satiety inducing agent to the patient while the volume occupying device is positioned in the stomach. In one embodiment, the active agent may be contained in a reservoir and dispensed to a portion of the patient's body.

Abstract: An implantable device monitors a pressure of fluid within an inflatable portion of a gastric band. The implantable device comprises a tube defining a lumen, and a pressure sensor positioned within at least one of the lumen or the tube. The pressure sensor is configured to sense the pressure of the fluid within the inflatable portion of the gastric band. The pressure sensor is also configured to transmit a pressure signal based on the pressure to a microcontroller, which transmits the pressure signal to a remote control device. The pressure sensor confers strain relief upon at least a portion of the tube, and the pressure sensor shields at least a portion of the tube from puncture by a needle.

Abstract: A suture cinch, cinch applicator, and cinch loader for loading the cinch into the cinch applicator are provided and permit re-use of the applicator with multiple cinches during an endoscopic procedure. The applicator can be loaded with a first cinch, apply the first cinch onto a portion of suture to fix the portion of suture relative to anatomical tissue, reloaded with a second cinch optionally using the loader, and subsequently used to apply the second cinch to fix another portion of suture to fix the other portion of suture relative to anatomical tissue. The cinch is a tubular member through which the suture can be advanced when the cinch is loaded within the applicator. The cinch defines multiple ribs and cutter defined in a wall thereof. Operation of the applicator deforms the ribs inward to retain the cinch on the suture, and displaces the cutter to sever the suture.

Abstract: Generally described herein are certain embodiments directed to an orientation-independent injection port fluidly coupled to a gastric banding system. The injection port may be configured to simplify the port-targeting process when a medical professional attempts to penetrate the injection port with a needle during a gastric band-adjusting procedure. For example, the injection port may be orientation-independent with the entire outer shell acting as the needle access point. Alternatively, and/or in addition, the inner core of the injection port may be hard or firm, thereby allowing for easier locating (e.g., when the medical professional performs palpation). Furthermore, the hard inner core may prevent needle over-throws, and help stabilize pressure.