Abstract: A torsional ligation clip applier and method of use for endoscopic or laparoscopic vessel occlusion procedures is provided. The ligation clip includes a hub portion and ligation arms for occluding a vessel. Ligation arms are independently rotatable about a common axis that is parallel to the longitudinal axis of the ligation arms. The ligation arms are biased in a first position by a biasing mechanism. The ligation arms of the clip are rotatable through at least one of a plurality of positions wherein it has a larger diameter than an access device. An applier receives at least one ligating clip in a first position and delivers the ligating clip to a vessel in a second position. Occlusion of the vessel occurs when one of the ligation arms is rotated into a third position.

Abstract: A plurality of structures that resiliently attract one another are provided for implanting in a patient around a body tissue structure of the patient. For example, the body tissue structure may be the esophagus, and the plurality of structures may be implanted in an annulus around the outside of the esophagus, the annulus being substantially coaxial with the esophagus. The attraction may be between annularly adjacent ones of the structures in the annulus, and it may be provided, for example, by magnets or springs. The array of structures is preferably self-limiting with respect to the smallest area that it can encompass, and this smallest area is preferably large enough to prevent the apparatus from applying excessive pressure to tissue passing through that area.

Abstract: A system for regulating the functioning of an organ or duct generally includes an implantable band structured to at least partially circumscribe an organ or duct and an actuating mechanism operable to effect constriction of the band. The system further includes a plurality of incompressible cushion segments defining a substantially star-shaped inner circumference of the band, the star-shape effective to prevent pinching and necrosis of tissue during adjustment.

Abstract: An occlusion device includes a center assembly having a flexible section formed by a fabric connector. The flexible fabric connector gives the center assembly improved flexure characteristics, which allows the occlusion device to better conform to the contours of the heart.

Abstract: A gastric restrictor assembly is provided which includes a first longitudinal member, a second longitudinal member, a first connector and a second connector. The first and second connectors support the first and second longitudinal members in spaced relation. The second longitudinal member is rotatably supported between the first and second connectors and includes a bend or offset. The second longitudinal member is rotatable to rotate the offset in relation to the first longitudinal member to selectively vary the width of a channel defined between the first and second longitudinal members. In one embodiment, the second longitudinal member includes engagement structure for engaging a positioning tool and indexing structure for releasably securing the second longitudinal member at fixed positions of rotation in relation to the first longitudinal member.

Abstract: Implantable devices for providing tissue and/or organ restriction. Embodiments of an implantable magnetic device are described with respect to restricting gastric capacity while avoiding nutritional deficiencies and other complications. In at least one embodiment, the device comprises first and second bars that are biased to magnetically attract each other and engage a portion of tissue therebetween. In at least one embodiment, the device may comprise at least one strap and one or more pins, the pins configured to provide an amount of space between the first and second bars so that the tissue disposed therebetween is not overly compressed.

Abstract: A plurality of structures that resiliently attract one another are provided for implanting in a patient around a body tissue structure of the patient. For example, the body tissue structure may be the esophagus, and the plurality of structures may be implanted in an annulus around the outside of the esophagus, the annulus being substantially coaxial with the esophagus. The attraction may be between annularly adjacent ones of the structures in the annulus, and it may be provided, for example, by magnets or springs. The array of structures is preferably self-limiting with respect to the smallest area that it can encompass, and this smallest area is preferably large enough to prevent the apparatus from applying excessive pressure to tissue passing through that area.

Abstract: A closing assembly for a clamping device having first and second jaw members includes a closing mechanism connected between the first and second jaw members, the jaws extending distally from the closing mechanism; and a member for applying a separating force to the first and second jaw members proximally of the closing mechanism, whereby the first and second jaw members can be maintained substantially parallel during closing. The clamp has a very strong clamping force.

Abstract: The present invention relates to medicine, in particular, to clamps used in vascular surgery for occlusion of blood vessels during a surgical operation, such as vascular clamps used in aortic aneurysm repair. The claimed supplementary vascular clamp comprises a pair of pivoting arms, each of them having a proximal end and a distal handle end. Each pivoting arm contains clamping jaws rigidly attached to a respective proximal end of this arm and shaped as a concave semi-cylindrical or semi-oval cavity. The clamping jaws are movable between the open position and closed position and define a through cylindrical or oval cavity in their closed position. The clamping jaws of the vascular clamp are also provided with a tightening means to provide intra-aortal bending of the ends of staples of an open approach stapler. The tightening means is shaped as plates or a strip of resilient material. The strip may be provided with a tensioning device.

Abstract: A surgical ligation clip for double ligating a vessel, duct or other fluid carrying structure and a method for double ligating such structure.

Abstract: This gastric ring (1) comprises: a band (3) which is able to surround the wall of the stomach, and connection means (4, 40, 51, 54) with which this band can be maintained in the form of a ring. According to the invention, the band (3) is made of a bioabsorbable material.

Abstract: A device for occluding septal defects or other bodily passage-ways includes two anchors connected to an occluding body. The occluding body may be formed as a plug or tube of biocompatible material configured to occlude a bodily passageway. At least one of the anchors includes a grasping member in the form of a loop or suitably shaped structure, which is configured for releasable attachment to an anchor engaging member, such as a biopsy forceps. In a further aspect a closure device assembly includes a closure device linked to the biopsy forceps and collapsibly disposed in a catheter. By positioning the catheter near a bodily passageway, such as a PFO, and disengaging the forceps from the grasping member, the closure device may be released so as to facilitate stable closure of a septal opening, such as a PFO.

Abstract: Devices and methods are disclosed for providing static and dynamic tissue and organ restriction. A magnetic component is used to stabilize an apparatus to provide tissue and organ restriction. Such a device is described with respect to occluding a hernia via a mesh attachment, and, alternatively, with respect to closing or reinforcing the crural closure via a parallel magnetic arrangement.

Abstract: This tissue fastening apparatus is a tissue fastener for clamping first biological tissue and second biological tissue so as to be in close contact with each other, including: a first tissue fixation portion, made of an elastic wire wound in a coil, that is locked on the first biological tissue; and a second tissue fixation portion, made of an elastic wire wound in a coil, that is locked on the second biological tissue, the second tissue fixation portion continuing into the first tissue fixation portion, in which when falling off first and second biological tissue necrotized by being clamped between the first tissue fixation portion and the second tissue fixation portion, the tissue fastener moves only from the second tissue fixation portion to the first tissue fixation portion side and falls off.

Abstract: A closing assembly for a clamping device having first and second jaw members includes a closing mechanism connected between the first and second jaw members, the jaws extending distally from the closing mechanism; and a member for applying a separating force to the first and second jaw members proximally of the closing mechanism, whereby the first and second jaw members can be maintained substantially parallel during closing. The clamp has a very strong clamping force.

Abstract: Devices and methods are provided for tissue approximation and repair. Fixation devices comprise a pair of elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being moveable between an open position wherein the free ends are spaced apart and a closed position wherein the free ends are closer together with the engagement surfaces generally facing each other. The fixation devices also include a locking mechanism coupled to the elements for locking the elements in place. The devices and methods find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions. The invention is particularly useful in procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site.

Abstract: A surgical fastening system for implantable devices is disclosed. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

Abstract: A surgical instrument includes a hollow member having a sidewall provided with a window and a closure member movably connected to the hollow member for alternately covering and uncovering the window. The hollow member has a first clamping surface along an edge of the window, while the closure member has a second clamping surface opposing the first clamping surface and disposable substantially adjacent thereto in a clamping or closure configuration of the instrument. The instrument additionally comprises a tissue occlusion component mounted to at least one of the hollow member and the closure member for acting on tissues gripped between the first clamping surface and the second clamping surface, to couple the tissues to each other.

Abstract: A system including surgical compression clips is described and used for endoscopic full thickness resection. Similarly, methods for endoscopic full thickness resection using the described system are also discussed. Surgical compression clips using shape-memory elements are discussed. These clips are advanceable to the site of suspect tissue to be resected through a lumen of a multi-lumen sleeve encasing an endoscope. At the site of the tissue, the compression clip is opened and operated to circumscribe the suspect tissue. Grasper assemblies, advanceable through an endoscope, are also described. These latter grasp and bring the suspect tissue to the open clip. The clip is then closed and the tissue resected. The clip effects necrosis and healing at the resected site.

Abstract: Disclosed are methods and devices for limiting expansion in at least one portion of gastric tissue.

Abstract: Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together include a first member, a second member, and a connecting member extending between the first and second members. One of the first and second members has an elongated slot permitting fastener deployment while avoiding excessive tissue compression.

Abstract: A gastric band of a belt type is presented for attaching around a circumference of a patient's stomach, so as to define the diameter of the stomach opening. The band comprises outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof. A through-going opening is made in the elongated member and is located so as to define an end portion of the band having a predetermined length. An opposite end portion of the band is shaped so as to be insertable into the through-going opening for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.

Abstract: The gastric ring has two ends (11, 12) and, between these ends, an intermediate portion (13) of solid section for coming to bear simply against a stomach portion that is to be surrounded. The first end (11) forms an opening (115) in which the second end (12) can be inserted. The second end (12) is suitable for being prevented from moving in said opening (115) in at least two distinct positions, thereby enabling the inside diameter (d?1) of the ring to be adjusted to its implantation conditions.

Abstract: The invention relates to system for controlling a controllable gastric band (1), comprising a control unit (11), wherein the gastric band (1) includes a nonextensible back (4) and a chamber (2) arranged on the stoma side of the back and capable of being filled with a fluid, which chamber is in connection with a second chamber (5) and has at least one sensor (7) for the detection of the pressure on the gastric wall, and wherein the sensor (7) is connected with a device (8) for the wireless transmission of the detected pressure values to the control unit (11), and wherein the control unit (11) includes a device (13) for receiving transmitted pressure data from the at least one sensor (7) of the gastric band (1), as well as a housing (12). In order to ensure the optimum adjustment of the gastric band (1) and a self-control by the patient (P), at least one memory (9, 14) for storing the pressure values detected and a device (16) for processing the time courses of the pressure values detected are provided.

Abstract: The present invention relates to an aneurysm stent having a base and connector. The base has a vessel facing side and an aneurysm facing side, and is shaped to cover an aneurysm sufficiently. The connector is coupled to the aneurysm facing side of the base such that when deployed the connector is adapted to extend partially into the aneurysm to anchor the base about the aneurysm and alter flow into the aneurysm. Further, the stent can be used as a delivery mechanism to deliver growth factor.

Abstract: A flexible extension for a shape memory polymer occlusion removal device. A shape memory polymer instrument is transported through a vessel via a catheter. A flexible elongated unit is operatively connected to the distal end of the shape memory polymer instrument to enhance maneuverability through tortuous paths en route to the occlusion.

Abstract: There is provided a method for controlling a flow of sperms in a uterine tube formed by a uterine tube wall of a patient. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the uterine tube wall) at least one portion of the uterine tube wall to influence the flow of sperms in the uterine tube, and stimulating the constricted wall portion to cause contraction of the uterine tube wall portion to further influence the flow of sperms in the uterine tube. The method can be used for restricting or stopping the flow of sperms in the uterine tube, or for actively moving the fluid in the uterine tube, with a low risk of injuring the uterine tube.

Abstract: A device, system and method for providing tissue and organ restriction. A magnetic device is described with respect to restricting gastric capacity while avoiding nutritional deficiencies and other complications.

Abstract: The invention relates to an inflatable gastric belt comprising an elongate tubular body (2), connecting means (10, 11) arranged in relation with the two ends (12, 19), and an inflation catheter. According to the invention, the tubular body (2) is preformed in such a way that, at rest and before closure of the belt, it has a longitudinal cross section with the general shape of a “C”.

Abstract: A shape memory material with integrated actuation using embedded particles. One embodiment provides a shape memory material apparatus comprising a shape memory material body and magnetic pieces in the shape memory material body. Another embodiment provides a method of actuating a device to perform an activity on a subject comprising the steps of positioning a shape memory material body in a desired position with regard to the subject, the shape memory material body capable of being formed in a specific primary shape, reformed into a secondary stable shape, and controllably actuated to recover the specific primary shape; including pieces in the shape memory material body; and actuating the shape memory material body using the pieces causing the shape memory material body to be controllably actuated to recover the specific primary shape and perform the activity on the subject.

Abstract: A device, system and method provides mitral valve therapy. The device is implantable in the coronary sinus of the heart to partially encircle the mitral valve annulus. The device is elongated, is resilient, and has a preformed arched configuration. When the device is implanted in the coronary sinus, the device exerts a substantially radially inward force to the mitral valve to restore mitral valve annulus geometry.

Abstract: Various methods and devices are provided for reorienting an implantable port. In one embodiment, an implantable port is provided and includes a base adapted to be anchored to tissue, and a housing pivotally mounted on the base and having a septum formed therein and adapted to receive fluid and to provide access to a fluid reservoir formed within the housing. In an exemplary embodiment, the housing can be pivotally mounted to the base using a ball and socket joint. For example, at least one of a distal surface of the housing and a proximal surface of the base is convex, and the other one of the distal surface of the housing and the proximal surface of the base is concave.

Abstract: An inflatable, adjustable implantable band for encircling an anatomical passageway to create an artificial stoma. The band is made of a flexible silicone tube having a first lumen enclosing at least one band or wire of a material such as nitinol having a thermal shape memory. The flexible tube is a double lumen tube in which the nitinol band or wire is enclosed in the first lumen and the second lumen is fluid inflatable from outside the patient to final adjustment of the internal diameter of the ring. The implantable band is easier to implant and more comfortable to the patient than known devices. Controlling and adjusting the internal diameter is very easy to perform by adding cold saline or water to the lumens to straighten out the ring so that it can be removed or by adding a warm or hot fluid to adapt it to a ring-shape.

Abstract: A device for controlling the weight of a body can be a passive or expandable food restriction device. The presence of the device decreases abdominal wall compliance and increases intra-abdominal pressure thereby producing satiety. One embodiment of the expandable device includes a hollow member with an expandable and a non-expandable portion to its exterior surface. The hollow member is selectively expanded and/or contracted following implantation in order to maintain pressure in the abdominal cavity. Additionally, a surgical method applying two or more versions of the food restriction device is described, such that multiple passive and/or expandable devices may be inserted into the body for additional weight control measures. The device is preferably positioned superficial to the abdominal cavity according to the present disclosure to minimize the risks associated with traditional food intake restriction surgeries.

Abstract: Methods and devices are provided for regulating a hydraulic restriction system. In general, the methods and devices can allow for non-invasive pressure control using a flow control mechanism. The flow control mechanism can be disposed between an implantable restriction device and a fluid source and include an adjustable, variably-sized fluid communication member in fluid communication with the restriction device and the fluid source. The geometry of the fluid communication member can control a rate of fluid flow between the restriction device and the fluid source, thereby also regulating a rate at which a pressure of fluid within the restriction device changes. Alternatively, the fluid flow control mechanism can include a biasing mechanism that can control the rate of fluid flow between the restriction device and the fluid source.

Abstract: A gastric restrictive device positionable around a human stomach to limit the flow of food therethrough is provided with structure for facilitating suturing of the gastric restrictive device to the stomach and thereby preventing movement of the gastric restrictive device relative to the stomach.

Abstract: A suture clip with stop ribs and method for making same is provided. The clip includes a housing having an outer surface, and a pair of jaws extending longitudinally from the housing in an opposing relationship to each other. A resilient pad is carried by one of the jaws and defines with the outer surface of the housing a shutoff cavity. At least one rib extends longitudinally of the housing and across the cavity to inhibit any undesirable passage of the suture into the cavity.

Abstract: A device for controlling food intake including a band, is configured to be placed around the stomach of a patient, dividing the stomach into lower and upper pouches. At least one sensor, located on the band detects pressure against the band caused by food ingestion collected in the upper pouch. A controller is coupled to the senor for receiving signals from the sensor for comparison against a predefined threshold. At least one electrode is coupled to the controller and the stomach, where the controller, upon the detection of pressure in the sensor above the pre-defined threshold, generates an electronic interference signal to the stomach of the patient.

Abstract: Devices, tools and methods for occluding fluid flow between two walls of tissue in a patient. Two walls of tissue are compressed together with sufficient compressive force to prevent fluid flow between the two walls, while ensuring that the compressive force is not so great as to cause tissue necrosis. The devices, tools and methods may be carried out using minimally invasive surgical techniques, such as in reduced-access surgical sites. Devices, tools and methods are provided for occluding an atrial appendix.

Abstract: An implantable system having internal circuitry configured to withstand a pre-determined amount of sterilization radiation is provided. In general, the system includes an internal control module in electrical communication with an implantable medical device. The internal control module can include a circuit board configured to withstand radiation and/or any number of integrated circuits (e.g., application specific integrated circuits) wherein the circuits or at least some portion thereof are fabricated so as to withstand some amount of radiation. For example, some portion of the circuitry can be fabricated utilizing radiation compliant material(s), silicon-on-insulator technology, and/or gallium arsenide technology. Additionally, the circuitry can include various components which are inherently resistant to such radiation (e.g., components fabricated utilizing magnetic field based technology, surface acoustical wave devices, etc.).

Abstract: Devices and methods for forming a restriction in a patient are disclosed. In one exemplary embodiment, a restriction system is provided including an implantable restriction device, an implantable port in fluid communication with the implantable restriction device, and an implantable pump in fluid communication with the restriction device. In general, the implantable restriction device is adjustable and configured to form a restriction in a patient, and the implantable port is configured to receive fluid from a fluid source external to the patient. The implantable pump has a plurality of actuators configured to change shape upon the application of energy thereto such that sequential activation of the plurality of actuators is effective to create pumping action to move fluid through the pump.

Abstract: Devices and methods for forming a restriction in a patient are disclosed. In one exemplary embodiment, a restriction system is provided including an implantable restriction device, an implantable port in fluid communication with the implantable restriction device, and an implantable pump in fluid communication with the restriction device. In general, the implantable restriction device is adjustable and configured to form a restriction in a patient, and the implantable port is configured to receive fluid from a fluid source external to the patient. The implantable pump is a micro-electro-mechanical systems (MEMS) device effective to create pumping action to move fluid through the pump.

Abstract: An implant having a base body comprising entirely or in part a biocorrodible iron alloy wherein the base body of the implant comprises at least one of the following: (i) a biocorrodible iron alloy of formula (1): Fe—P where the amount of P in the alloy is from 0.

Abstract: An inflatable gastric band incorporates a fluid channel within an outer surface of the band and an inflatable bladder on a stomach-facing side of the band. The gastric band attaches to a double lumen catheter, which communicates with a dual infusion port. One lumen communicates with the fluid channel and one port, while the other lumen communicates with the inflatable bladder and a second port. Injection of fluid into one chamber of the infusion port expands inflatable bladder, allowing adjustment to the diameter of the stoma. Injection of drugs or therapeutic agents into the second chamber allows the infusion of drugs or agents directly into the abdominal cavity of a gastric band recipient. The inflatable bladder can be continuous or segmented. A segmented bladder reduces pinching and/or folding of the inner surface of the gastric band during expansion/contraction, thereby lessening stomach pinching and/or irritation.

Abstract: Disclosed is a swallowable self-expanding gastric space occupying device and related methods of making and using the device to control obesity. The device has a membrane through which gastric liquid can pass, wherein the membrane provides an enclosure volume separated from the gastric environment by the membrane. A plurality of self-expanding components is contained in the enclosure volume, so that the components expand in volume upon contact with the gastric fluid, thereby expanding the device from an unexpanded volume to an expanded volume. Composite membranes provide the ability to precisely control how and when the membrane degrades in the stomach, to release the self-expanding components from the enclosure and to ensure that the released pieces are sufficiently small to not obstruct any portion of the gastrointestinal system.

Abstract: Methods and devices for effecting a gastric restriction system are disclosed. In one exemplary embodiment, a restriction system for forming a restriction in a patient is provided and can include an implantable restriction device and at least one implantable sensor that is in communication with the restriction device. In general, the implantable restriction device can be adjustable and can be configured to form a restriction in a patient. The implantable sensor(s) can be defaulted to a dormant power usage mode and can have a triggering mechanism that is configured to place the sensor(s) in a use configuration upon the occurrence of a triggering event.

Abstract: Methods and devices are provided for diagnosing performance of a gastric restriction system. In general, the methods and devices can enable patients, health care providers, and others to use pressure data as a feedback mechanism to monitor efficacy of an implantable restriction device and to identify, train, and/or prescribe treatment plan options. Pressure data monitoring can be used locally and/or remotely to monitor a restriction in a patient and compare gathered pressure data with a typical pressure of the restriction. Based on the results of the comparison, possible problems related to the patient and the restriction can be identified and diagnosed with possible cause(s) and solution(s). Notice of any detected possible problems, causes, and/or solutions can be provided to a user.

Abstract: Methods and devices for optimizing the operation of a restriction system for forming a restriction in a patient are disclosed. In one exemplary embodiment, a method for optimizing the operation of a gastric restriction system includes providing an implantable restriction system for forming a restriction in a patient, determining an optimum value of a control parameter of the restriction system, and maintaining the control parameter at the optimum value such that a result parameter of the restriction system is substantially convergent as a function of time. Determining an optimum value of a control parameter can generally include adjusting the restriction device, determining the value of the control parameter to be optimized, and repeating the steps of adjusting the restriction device and determining the value of the control parameter until the control parameter is substantially convergent as a function of time.

Abstract: The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member includes an apron member surrounding a first occluding member, which is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device of the present invention is arranged transluminally, with the distal member disposed in the duodenum and the proximal member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying the flow of gastric contents through the pyloric valve. In certain embodiments, a reservoir may be included for releasing a substance of interest, for example for releasing insulin from a reservoir disposed in the distal member. Sensors, actuators, and data transmission devices may also be included.

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.