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: A surgical clamp in certain embodiments may be configured to operate with a surgical installation tool. The clamp may have two elongated members with a bight portion that joins the two elongated members at a proximal end of the clamp and that may bias the two elongated members in an open position at a distal end. The bight portion may have one or more engagement features, such as a slotted aperture or other engagement or coupling feature. A clasp mechanism at the distal end of the clamp may have a male or first component disposed on or adjacent one of the two elongated members and a female or second component disposed on or adjacent the other of the two elongated members at the distal end of the clamp. The installation tool may include an elongated member with a proximal end and a distal end that has an engagement feature to engage the clamp, such as at the bight portion.

Abstract: An implantable restriction device is configured to provide a restriction in a patient. A pressure sensor implanted in the patient is configured to sense pressure associated with the restriction device. A remote input device is configured to wirelessly receive pressure measurements from the pressure sensor and transmit the pressure measurements to a display device. The display device is configured to plot the pressure measurements as a function of time. The remote input device also includes buttons that may be used to annotate the pressure measurements, such as to indicate physical events associated with the patient (e.g., coughing, sneezing, etc.). The display device is also configured to display the annotations on or near the plot of pressure measurements. A viewer may thus take the annotations into account when evaluating the pressure measurements, such as by ignoring pressure measurements associated with certain types of annotations.

Abstract: Apparatus and methods are provided comprising an implantable non-hydraulic ring that encircles and provides a controllable degree of constriction to an organ or duct and an external control that powers and controls operation of the ring. The ring includes a rigid dorsal periphery that maintains a constant exterior diameter, and a compliant constriction system that reduces intolerance phenomena. A high precision, energy efficient mechanical actuator is employed that is telemetrically powered and controlled, and maintains the ring at a selected diameter when the device is unpowered, even for extended periods. The actuator provides a reversible degree of constriction of the organ or duct, which is readily ascertainable without the need for radiographic imaging. Methods of use and implantation also are provided.

Abstract: An occlusion device includes a center assembly having a flexible section formed by a spring connector and a safety tether. The flexible spring connector gives the center assembly improved torque and flexure characteristics, which allows the occlusion device to better conform to the contours of the heart. The safety tether serves to further ensure the structural integrity of the center assembly.

Abstract: A method of treating a hollow anatomical structure of a patient comprises implanting a bioabsorbable fibrous body in a hollow anatomical structure. The body is secured in the hollow anatomical structure to limit migration of the body within the hollow anatomical structure.

Abstract: A device and technique for a sutureless wound closure, which limits the risks of rupture and scarring, is described. The device includes a one-piece surgical fastener generally shaped in a curve along the width of the surgical fastener. The fastener includes a tissue insertion tongue with a plurality of tissue attachment points for fixing the fastener to skin tissue. The fastener also includes a clasp for engaging an identical surgical fastener. The surgical fastener can also be a two-piece structure including a male connecting strap and a female connector. Both pieces include a tissue-connecting mechanism for fixing to skin tissue. The female connector includes an engagement clasp for securing the male connecting strap to the female connector.

Abstract: A surgical ligation clip capable of remote deployment through a cannula to engage an anatomical structure.

Abstract: A system includes an adjustable gastric band coupled with an injection port. The port includes sensors, a plate beneath a septum, and a vibration generator in communication with the sensors. A first sensor detects palpation through a patient's skin when the injection port is implanted in the patient. The vibration generator provides a vibratory response to detected palpation, thereby providing haptic feedback to a physician who is attempting to locate the injection port by palpating the patient. A second sensor detects a needle striking the plate, and the vibration generator provides a vibratory response to a detected needle strike. The vibration generator thereby provides haptic feedback to a physician to confirm that the needle has been successfully inserted through the septum. A pressure sensor may be used to provide vibratory feedback to the patient to indicate that an adjustment to the band is needed.

Abstract: In some embodiments, methods to sense parameters associated with restriction procedures and/or devices are disclosed. In some embodiments, the parameters are sensed directly from the region of the procedure and/or device and in other embodiments, associated neural pathways are sensed. Methods for further optimization of the obesity treatment regimens are also disclosed.

Abstract: An implantable device comprising: a stepper motor; a moveable member, moveable by the stepper motor; and an oscillator, wherein the oscillator is influenced by a signal derived from or supplied to the stepper motor to enable information on the moveable member to be fedback to an external controller by passive telemetry.

Abstract: A system and method of occluding a reproductive body lumen (34) to prevent the passage of reproductive cells through body lumen is disclosed. The system can include a catheter delivery system (10) having a handle device (18), a catheter (10) operatively coupled with the handle device (20), and an occluding device adapted for deployment within the body lumen. The handle device can include a damper device adapted to reduce the vibration on the handle device from deployment of the occluding device from the catheter. Further, the handle device can include an indexing member operatively coupled with the catheter to provide indexing of the catheter.

Abstract: An implantable band for placement around an anatomical passageway, such as the stomach or other lumen, includes a first end portion with an opening configured to receive part of a second end portion, with a retaining part included as part of the first or second end portion.

Abstract: A method for creating a plication within a hollow organ. The method uses an elongated member having an end effector attached to its distal end. The end effector has a substantially hollow housing, a fixed jaw extending distally from the housing, and a retractable jaw located within the housing. The method involves the step of inserting the end effector within an organ of a patient such that it is in contact with tissue. The method also involves applying vacuum through the elongated member so as to dispose tissue on the fixed jaw and at least partially within the housing. The method also involves creating a plication by sliding the retractable jaw so that it juxtaposes the fixed jaw.

Abstract: Surgical fasteners are disclosed for terminating flow of fluid through a body lumen, including an outer barrel having an annular side wall having at least a pair of radial slots formed therein, and an inner barrel rotatably and concentrically coupled within the outer barrel. The inner barrel has an annular side wall including a radial slot formed therein corresponding to each radial slot formed in the outer barrel. The surgical fastener has an open position in which the radial slots of the inner of the outer barrel are radially aligned with the corresponding radial slots of the inner barrel and a closed position in which the radial slots of the outer barrel are out of radial alignment with the corresponding radial slots of the inner barrel and constrict the body lumen at two locations along the length thereof. An applier is provided for applying the surgical fasteners.

Abstract: A surgical spring clip is provided for use in minimally invasive surgical procedures. The clip has a flat planar plate shape having pair of arms connected by a base, all generally positioned within a single plane. The arms are elongate linear cantilevered beams extending beyond the base and are biased to a first or closed position generally within the plane. The base and arms define a slot for the positioning of and receiving a vessel and occluding the flow therethrough.

Abstract: A closure device closes an opening in a body cavity. The closure device includes an elongate delivery member and a closure component which is removably connected to the distal end of the delivery member. The closure component has a collapsible backing movable between a non-collapsed position and a collapsed position. The closure component also includes a plurality of fibrous tissue engaging members disposed on the backing and oriented in a non-engaging orientation when traveling in a distal direction and in an engaging orientation when traveling in a proximal direction. The fibrous tissue engaging members become entangled in the backing when the backing is in the collapsed position.

Abstract: The present embodiments provide apparatus and methods for treating tissue by applying a force to the tissue. In one embodiment, the apparatus comprises a deployable segment having proximal and distal regions, a main body extending therebetween, and a loop member formed at the distal region of the deployable segment. A cannula having a bore is dimensioned to circumferentially surround at least a portion of the main body at a location proximal to the loop member, and a spring member is disposed between the cannula and the loop member. The proximal end of the spring member is affixed to the cannula, and the distal end of the spring member is movable to apply a compressive force to adjust the size of the opening of the loop member and compress tissue disposed within the opening of the loop member. In an alternative embodiment, the cannula is omitted, and a diameter of the loop member is configured to be reduced and increased any number of times before final deployment of the deployable segment.

Abstract: A merely exemplary external pressure sensing system comprises a connecting member and a pressure sensor. The connecting member is operable to connect to a syringe barrel and a needle. The connecting member comprises a conduit permitting communication of fluid from the syringe barrel to the needle when the connecting member is connected to the syringe barrel and the needle. The pressure sensor is in communication with the conduit. The pressure sensor is configured to sense pressure of fluid within the connecting member. The connecting member is configured to permit the pressure sensor to sense the pressure of the fluid while the fluid is communicated from the barrel to the needle. The pressure sensor is configured to provide a visual indication of sensed pressure. The visual indication may be provided by a variety of components, including but not limited to a diaphragm, a disc, a needle, or a slider.

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

Abstract: A clip of a self-closing type is used for valve repair. The clip is generally U-shaped with two end points separated from each other when constrained to be in an open configuration, but tends to coil up to assume its natural closed configuration if the constraint is removed. At least one end point is connected through a suture to a tissue-penetrating needle. A needle holder has an outer tube and an inner member which has a slit at the front and is slidable inside the outer tube. A double-arm clip assembly with each of the end points of the clip attached through a suture to a separate needle may be used for valve repair and may contain two of such clips mutually connected by a flexible connector whereby two leaflets are held together by the connector, with the two clips each anchored to a corresponding one of the leaflets.

Abstract: An apparatus for regulating the functioning of a patient's organ or duct includes an elongated member having a first end and a second end. The elongated member has a compressible ventral surface and a substantially rigid dorsal periphery, wherein the elongated member includes a fluid bladder positioned along the ventral surface. A fastener is disposed on the first end of the elongated member. The fastener is configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct. A tension element is disposed for movement within the elongated member. A drive element is associated with and engages the tension element for causing the tension element to control the tension applied by the elongated member against a patient's body organ or duct. Alternate embodiments are also disclosed.

Abstract: An apparatus for regulating the functioning of a patient's organ or duct includes an elongated member having a first end and a second end. A fastener is disposed on the first end of the elongated member. The fastener is configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct. A tension element is disposed for movement within the elongated member. A symmetrical drive system including a drive element associated with and engaging the tension element for causing the tension element to control the tension applied by the elongated member against a patient's body organ or duct is further provided. In accordance with an alternate embodiment an apparatus for regulating the functioning of a patient's organ or duct including an elongated member having a first end and a second end. A fastener is disposed on the first end of the elongated member.

Abstract: An apparatus for regulating the functioning of a patient's organ or duct includes an elongated member having a first end and a second end. A fastener is disposed on the first end of the elongated member. The fastener is configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct. A tension element is disposed for movement within the elongated member. A drive element is associated with and engages the tension element for causing the tension element to control the tension applied by the elongated member against a patient's body organ or duct. A tension release mechanism is associated with the tension element.

Abstract: An inventive method for performing gastric bypass surgery and a gastric bypass band that is used in conjunction with the surgical method is disclosed. The inventive method involves separating a top portion of the stomach along with the esophagus from the remainder of the stomach, and re-connecting the separated portion to the small intestine to form a gastric pouch of about 20-30 cc in size. The inventive gastric band is placed midway along the gastric pouch to act as a restrictor valve to limit the amount of food passing through the valve. The band also retains food within the gastric pouch to give the patient a feeling of satiety. The band is comprised of an expansion-resistant section combined with a one-way latch mechanism. The latch has a curved orientation so that the band is formed into a radial profile when placed around the gastric pouch.

Abstract: Apparatus and methods are provided comprising an implantable non-hydraulic ring that encircles and provides a controllable degree of constriction to an organ or duct and an external control that powers and controls operation of the ring. The ring includes a rigid dorsal periphery that maintains a constant exterior diameter, and a compliant constriction system that reduces intolerance phenomena. A high precision, energy efficient mechanical actuator is employed that is telemetrically powered and controlled, and maintains the ring at a selected diameter when the device is unpowered, even for extended periods. The actuator provides a reversible degree of constriction of the organ or duct, which is readily ascertainable without the need for radiographic imaging. Methods of use and implantation also are provided.

Abstract: A clamp has a handle assembly, a gripping assembly having a pair of jaws that can be opened and closed to grip an element, and a shaft assembly. The shaft assembly has a flexible shaft having a proximal end that is operatively coupled to the handle assembly and a distal end that is operatively coupled to the gripping assembly. The shaft assembly also has a rigid element that can be placed in a first position where the rigid element supports the shaft in a manner where the shaft cannot be bent, and in a second position where the shaft can be bent.

Abstract: The present invention relates to a tissue clamp, a tool for grasping the clamp and a method of using the clamp for surgical procedures. The clamp has a fixture or fixtures positioned on the proximal end of the arms of the clamp so that a tool can be used by the surgeon to securely grasp the clamp during placement thereof on the vasculature or other tissue of the patient. The fixture can have a plurality of channels so that the user can select the angular orientation of the tool relative to the damp.

Abstract: A compression clip assembly for compressing tissue and operable by means of a user-operated applier. The assembly comprises a compression clip and a lock element. The clip includes a pair of normally spaced apart elongate members each having an outward-facing surface, and having respective inward-facing opposing surfaces for compressing tissue; a hinge formed at least partly of a superelastic material and in operative mechanical connection with the elongate members; and a lock region formed on the outer surface of each of the elongate members adjacent to the hinge, each lock region being delimited by a first stop element proximal to the hinge and a second stop element distal from the hinge. The lock element is constructed for lockably engaging the lock regions so as to lock the clip in its closed position. The invention also encompasses a system and method for using the compression clip assembly.

Abstract: A surgical clip is provided for ligating or transecting tissue, such as vessels, other tubular ducts, and the like and a surgical clip applier device for delivering and applying the surgical clip to the tissue. The surgical clip can include a spine and opposed arms extending from the spine where the arms can define a clamping length. In a resting state, the clip can be biased to a closed position such that the ends of each opposed arm are disposed in proximity to each other. With such biasing, when applied to a tissue, such as with a surgical clip applier, the clip can exert a positive clamping pressure to the tissue along the clamping length to seal the tissue and limit passage of fluids, such as blood, from the tissue.

Abstract: Tissue restoration devices, systems, and methods. In at least one embodiment, an implantable restraining device of the present disclosure comprises a first engaging component and a second engaging component, each component configured for laparoscopic insertion into a body cavity, a first swivel arm defining a first bend and a second swivel arm defining a second bend, the first swivel arm coupled to the first engaging component at a first pivot point and coupled to the second engaging component at a second pivot point, and the second swivel arm coupled to the first engaging component at a third pivot point and coupled to the second engaging component at a fourth pivot point, and a first interconnection arm and a second interconnection arm, the first interconnection arm connected to the first swivel arm relative to the first bend, and the second interconnection arm connected to the second swivel arm relative to the second bend.

Abstract: A device includes a clip including first and second arms distal ends of which are biased apart and a core member including first and second portions connected to one another via a frangible link. The first portion includes a first protrusion for engaging a cut-out in the first arm. The frangible link is fractured when subjected to a load of at least a predetermined level deploying the clip. The device also includes a capsule slidably housing the core member and a proximal portion of the clip.

Abstract: Devices, systems and methods are disclosed for providing chronic or temporary tissue support and/or restoration that does not require that the targeted tissue be severed and/or punctured. A device having two components and at least one connector for maintaining a prescribed distance between the two components is described. Such devices, systems and methods may be used on any tissue of a body and may be delivered through laparoscopic and/or endoscopic procedures.

Abstract: A surgical clip assembly which includes a pair of generally linear compression elements for securing tissue between them and for applying to the secured tissue a compression force. The clip assembly has an initial, open position in which the linear compression elements may be positioned about tissue to be secured between them. The assembly also has a final, closed position where the compression elements are substantially parallel to each other, applying a compressive force to the secured tissue. The clip assembly also includes a force means disposed between the pair of compression elements and operative to transmit operational forces between them.

Abstract: Methods and devices for blocking orifices and occluding cavities within a patient are provided. The device in one variation comprises first and second tubular members attached to a collapsible sealing element. The device can be placed through an orifice and the collapsible sealing element can be collapsed to seal the orifice. An embolic may be introduced distal to the sealing element to occlude a cavity. The device may incorporate a locking mechanism which can be engaged to lock the sealing element into the collapsed position. The device may incorporate a valve to prevent flow through the tubular members, for example to prevent egress of the embolic from a cavity. The device can be detached to provide a permanent seal of the orifice, and can retain the embolic within the cavity. The device may be used in conjunction with a stent or other retention device to assist the sealing element in maintaining the seal.

Abstract: An implantable restriction device includes a belt and a balloon secured to the belt for engagement with tissue when the implantable restriction device is positioned about an organ. A protective member is associated with the balloon for positioning between the balloon and a tissue surface defining a band tissue interface.

Abstract: Medical device used to cause hemostasis of blood vessels using a clip arrangement delivered to a target region through an endoscope. Method for using the device to cause hemostasis of a blood vessel through an endoscope. Medical device including a reversibly closeable clip, a locking arrangement, a control wire, a sheath, and a handle with an actuating trigger. Through the endoscope, hemostatic clipping device that is fully reversible and lockable. Hemostatic clip that reversibly targets and clips bleeding ulcers.

Abstract: An apparatus comprises an implantable mechanically adjustable band configured to form a restriction in a patient. The band defines an inner diameter. The mechanical adjustability of the band is configured to permit the inner diameter defined by the band to be selectively varied. The apparatus further comprises an adjustment mechanism in communication with the band. The adjustment mechanism is operable to provide the mechanical adjustability of the band. The apparatus further comprises a sensor in communication with one or both of the mechanically adjustable band or the adjustment mechanism. The sensor is configured to sense a physical parameter associated with operation of the band. The physical parameter sensed by the sensor varies with the inner diameter defined by the band. The band may be used as a gastric band, among other potential uses.

Abstract: A trans-vascular surgical method includes forming an artificial opening in a blood vessel of a patient's vascular system at a substantially predetermined location and moving a distal end portion of a medical instrument through at least a section of the patient's vascular system and through the artificial opening. A surgical port device is disposed inside the blood vessel to inhibit blood from exiting the patient's vascular system through the artificial opening while permitting extension of the distal end portion of the medical instrument through the artificial opening. After moving the distal end portion of the medical instrument through the artificial opening, the medical instrument is operated to perform a medical procedure operation inside the patient.

Abstract: A method for closing a patent foramen ovale in the heart tissue of a patient may include percutaneously advancing a connector applicator to the patent foramen ovale, registering the connector applicator with the patent foramen ovale, deploying connectors into heart tissue to close the patent foramen ovale; and percutaneously removing the connector applicator from the heart. One or more anchors may be used to register the connector applicator with the patent foramen ovale. The connector applicator may include a driver having a longitudinal passage therein, where at least part of at least one connector is positioned within the passage.

Abstract: A method of occluding a defect in the wall of a body vessel is provided. An outlet portion of a microcatheter is delivered to the defect, then at least a body portion of a thin film occlusion device is radially expanded from a collapsed orientation to a deployed orientation for engaging the microcatheter and covering at least a portion of the defect. Thereafter, an embolic media is released into the defect from the microcatheter for facilitating thrombosis. The body portion of the occlusion device is substantially porous in the collapsed orientation, but substantially non-porous in the deployed orientation for preventing prolapse of the embolic media into the body vessel.

Abstract: A medical device for clamping the stomach in morbid obesity surgery consists of a silicone frame that is essentially U-shaped, having opposing legs self-hinged to a bight portion interconnecting the legs. The opposing legs have sufficient stiffness to permit limited bending and have inner surfaces that sealingly carry an inflatable balloon which can be selectively inflated or aspirated after the device has been clamped to the stomach to adjust the gastric restriction stoma. A flexible latch member carried by one of the legs has at least one serration which is inserted into a latch cavity of the opposing leg to lock the opposing legs in fixed spaced relationship. Lumens within the legs communicate with a fluid supply source and respective inflatable balloon for selective inflation or aspiration of the inflatable balloons.

Abstract: A delivery/recovery system to allow an operator to deploy and recover a medical implant, such as an occluder for closing a patent foramen ovale (PFO). In one embodiment, the system includes a delivery mandrel for preventing the occluder from moving in the proximal direction, a delivery wire for securing the occluder to the delivery mandrel and preventing unwanted movement in the distal direction, and a sheath for enveloping the delivery wire, mandrel and occluder. By moving the sheath relative to the occluder in a series of steps, the occluder opens first on a distal side and then on a proximal side, in a manner that holds the occluder in place.

Abstract: Disclosed are methods and apparatus for implantation into the walls of an organ such as the stomach. Deformable or inflatable anchors with a connector between are used to pull the walls of the organ together, or to implant devices in the wall of the organ. Also disclosed are surgical instruments useful in practicing the disclosed methods.

Abstract: An occlusion clip is disclosed that comprises an upper occlusion member having substantially parallel first and second upper occlusion arms each having proximal and distal upper occlusion arm ends. The first and second upper occlusion arms define an upper main body width dimension. An upper arcuate portion connects the first and second upper occlusion arms at their distal ends. The occlusion clip also comprises a lower occlusion member having substantially parallel first and second lower occlusion arms each having proximal and distal lower occlusion arm ends. The first and second lower occlusion arms define a lower main body width dimension. A lower arcuate portion connects the first and second lower occlusion arms at their distal ends. The occlusion clip further comprises a torsion spring connecting the proximal end of the first lower occlusion arm to the proximal end of the second upper occlusion arm.

Abstract: A surgical fastener system includes a plurality of fasteners having a throughbore with an internally threaded portion. The fasteners may engage with a threaded mandrel that passes through the throughbore of the fasteners. A rotator may rotate the fasteners relative to the mandrel to move at least one of the fasteners along the mandrel, e.g., along the mandrel's longitudinal axis. A distal end of the mandrel may be inserted into a material, such as a tissue, prosthetic or other, and a fastener may be deployed from the distal end of the mandrel while the distal end is positioned in the material. The throughbore of the fasteners may include a threaded portion and an unthreaded portion, may include an angled face or other feature to aid in fastener deployment and/or have curved depressions in the head portion.

Abstract: An apparatus and method for non-surgically creating a restriction in a tissue is provided where a binding mechanism (36) is inserted into the issue. This invention also relates to an apparatus for creating a stoma of variable and reproducible size in a hollow organ.

Abstract: A clip apparatus for ligaturing a living tissue includes a clip unit provided removably at a distal end of an insertion part inserted into a forceps channel of an endoscope, and an operating part for the unit, extending in an passage of the insertion part. The unit has a clip holder in an opening of the passage and a passage for elastically opening/closing of a clip, an engaging portion to be opened elastically around the passage when the holder projects from the passage, and longitudinally engaged with the distal end of the insertion part, and a structure preventing excessive opening of the engaging portion when a member connected to the clip and the operating part and moving in the passage is broken at a breakable portion by a pulling force from the operating part.

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: An occluder that has a coil on one or both sides of a medical defect, particularly a septal defect such as a patent foramen ovale (PFO). Each coil can be formed as a tube that is hollow, with or without a closed end. The tube can be delivered over a wire. For occluding a PFO, the coils can be designed to provide a compressive force to one or both of septum primum and septum secundum.