Abstract: Provided herein are anisotropic muscle implants that have a biodegradable scaffold comprising a plurality of fibers oriented along a longitudinal axis. The implants may include mammalian muscle cells seeded and/or fused into myotubes on the scaffold. Methods of forming the muscle implants are provided, as are methods of treating a subject in need of skeletal muscle reconstruction.

Abstract: The proposed device includes two segments adapted to enclose a body part in a form-fitting manner. Each segment contains an electroactive-material-based actuator, which is adapted to receive an electrical control signal and in response thereto adjust the actuator's morphology, so as to cause the segment to apply a basic pressure profile to the body part. A pressure transition is adapted to redistribute the basic pressure profiles between the first and second segments. A control signal in respect of the first segment causes the pressure transition system to apply a first adjusted pressure profile to at least part of the second portion of the body part, and vice versa, a control signal in respect of the second segment causes the pressure transition system to apply a second adjusted pressure profile to at least a part of the first portion of the body part.

Abstract: An implantable device and method for adjustably restricting a selected body lumen such as the urethra of a patient to treat urinary incontinence. The device includes an expandable element or membrane such as a balloon attached pressure-tightly to a flexible conduit at its forward end and includes a rear port portion containing an elastic septum and flow connected to the expandable element by a first passageway. The conduit contains a second passageway which allows it to be slid along an elongated guide probe initially inserted surgically into a patient's body adjacent the body lumen which is to be adjustably restricted. A suitable flowable material is injected from a syringe source into the device rear port sufficient to expand the membrane element and restrict the body lumen to the desired degree. The syringe and guide probe are removed and the skin incision is closed over the rear port end of the implanted device.

Abstract: A medical treatment device (200), for treating reflux from a stomach (201) to an oesophagus (202) and for delivering a therapeutic agent to an inner surface of the oesophagus (202), comprises a valve member (203), a lining member (204), and a support member (205). The valve member (203) is movable between a closed configuration and an open configuration, in which the valve member (203) facilitates passage of material between the oesophagus (202) and the stomach (201). The valve member (203) is biased towards the closed configuration and gradually moves over a period of 4 to 10 secs from the open configuration to the closed configuration. The support member (205) supports the device (200) relative to the oesophagus (202) and the stomach (201). The lining member (204) lines part of the inner surface of the oesophagus (202) for delivery of a therapeutic agent to the oesophagus (202).

Abstract: An actuable truss with ordered or disordered planar or strut elements or pore walls may be seeded with tissue cells, wherein application of a magnetic field may result in mechanical strain on the cells and increased fluid flow in and out of the truss structure. Modified polymers, such as ?-Fe2O3/PLGA, may be used to form actuable scaffolds suitable for tissue engineering. It is also disclosed a device with a trap-door that may be remotely actuated by applying a magnetic field. Such a device may be employed to deliver and control the release of other micro-devices or materials such as drugs to a specific location inside the body of a human or an animal.

Abstract: Artificial sphincter, the present invention refers to an artificial sphincter for treating urinary incontinence, and more specifically, an artificial sphincter to be implanted in a live being, particularly a male human being for treating urinary incontinence. According to one aspect of the present invention, the artificial sphincter (10) comprises a cuff (M) intended to surround at least part of the urethra of an individual, said cuff being in fluid communication with an unidirectional displacement pump (B1), said artificial sphincter (1) comprising additionally a second pump (B2) in fluid communication with said first pump and said cuff, and a third pump (B3) in fluid communication with said cuff.

Abstract: A method for treatment of obesity involves implantation of bulking devices within the upper esophageal sphincter (UES) to inhibit swallowing, thereby limiting food intake and treating obesity. One or more bulking devices are implanted within or near the UES to create a partial obstruction, partially impair UES muscle function, or both. The bulking devices make swallowing difficult, limiting the rate of food intake by a patient, and discouraging the patient from quickly consuming an excessive amount of food at one time.

Abstract: A surgical implant includes an inflatable element that is inflatable in response to fluid pressure; a tank for fluid under pressure in communication with the inflatable element to regulate the pressure of the element; a manually controlled pump in communication firstly with the inflatable element via a one-way check valve, and secondly with the tank via a one-way check valve; and a control unit incorporating the tank and the manual pump. The control unit presents a through opening for the fluid, the opening being in communication firstly on the inside of the control unit with the tank and the manual pump, and secondly on the outside of the control unit solely with the inflatable elements via a catheter mounted between the inflatable element and the control unit. According to the invention, the tank is formed by a leaktight chamber of fluid under pressure defined by a movable piston elastically biased by a spring.

Abstract: An inguinal hernia repair device in the form of an implantable plug that is affixed at one end to the center region of a sheet of implantable material. The plug takes the form of a plurality of hollow members, arranged so as to be in substantially parallel relationship when implanted into a defect. The hollow members are preferably tubular members and are preferably bundled together by various means, such as bonding or wrapping a band or strand about the plurality of hollow members to maintain them in adjacent and contacting relationship during insertion into a defect. The device is provided with a base member for anchorage made of a composite material having a non-bioabsorable component and a bioabsorbable component.

Abstract: A surgical procedure is described for the restoration of eyelid function in individuals suffering from ptosis or upper eyelid droop syndrome that makes a patient unable to voluntarily fully raise an eyelid. The surgical procedure includes implantation and suturing of eye drop (pH) activated and actuated fibrous contractile and expansive artificial muscles such as pH active hydrogels of polyacrylonitrile (PAN) artificial muscles that are surgically implanted and sutured under the superior palpebral conjunctiva in a serpentine parallel configuration with respect to the tarsal (meibomian) glands of the upper eyelid and anchored to the tissues of superior fornix.

Abstract: A surgical procedure is described for the restoration of eyelid function in individuals suffering from ptosis or upper eyelid droop syndrome that makes a patient unable to voluntarily fully raise an eyelid. The surgical procedure includes implantation and suturing of eye drop (pH) activated and actuated fibrous contractile and expansive artificial muscles such as pH active hydrogels of polyacrylonitrile (PAN) artificial muscles that are surgically implanted and sutured under the superior palpebral conjunctiva in a serpentine parallel configuration with respect to the tarsal (meibomian) glands of the upper eyelid and anchored to the tissues of superior fornix.

Abstract: The invention relates to a device for producing a three-dimensional circular muscle body from a carrier substance and from cell cultures incorporated therein comprising a cell culture dish (1) and at least one element (2) placed inside said cell culture dish (1). The invention also relates to a multi-well plate constructed of a number of devices, which are arranged side by side and/or one behind the other, for producing a three-dimensional circular muscle body. The invention additionally relates to a solution for cultivating mammal cardiomyocytes, to a method for cultivating a cell culture, to a device for measuring isometric force parameters of cell cultures, and to a method for following, in a measurable manner, contractions of a cell tissue incorporated in a carrier substance. Finally, the invention relates to an artificially produced three-dimensional muscle tissue, in particular, a heart muscle tissue.

Abstract: A method of producing organized skeletal muscle tissue from precursor muscle cells in vitro comprises: (a) providing precursor muscle cells on a support in a tissue media; then (b) cyclically stretching and relaxing the support at least twice along a first axis during a first time period; and then (c) optionally but preferably maintaining the support in a substantially static position during a second time period; and then (d) repeating steps (b) and (c) for a number of times sufficient to enhance the functionality of the tissue formed on the support and/or produce organized skeletal muscle tissue on the solid support from the precursor muscle cells.

Abstract: Provided are artificial muscle patches, which are adapted to be implanted adjacent a patient's heart, and artificial sphincter cuffs, which are adapted to be implanted around a body lumen, such as the urethra, the anal canal, or the lower esophagus. The devices of the present invention comprise: (a) one or more electroactive polymer actuators; and (b) a control unit for electrically controlling the one or more electroactive polymer actuators to expand or contract the devices.

Abstract: The invention is directed toward a cartilage repair assembly comprising a shaped allograft construct comprising a cylindrical mineralized cancellous bone base member and a demineralized cancellous bone cap member having a cylindrical top portion and a stem extending from the top portion mounted to the bone base member. The base member has a central bore and a transverse bore which intersect the central bore and the cap member stem has a through going bore which is aligned with the base member transverse bore when the stem is mounted in the central bore to receive a pin member. Milled cartilage particles having a size ranging from 10 to 212 microns are mixed with a biocompatible carrier and a cartilage growth factor, with the mixture being infused in the cap member to generate cartilage growth.

Abstract: The present invention provides a method of modifying the lower esophagus by injecting biocompatible particles in a biocompatible carrier into a submucosal tissue site of the lower esophagus of a patient. The method may be used to treat gastroesophageal reflux disease by optimizing the closing function of the lower esophageal sphincter.

Abstract: A gastrointestinal device including a casing including fixation elements adapted for intraluminal fixation of the device in a gastrointestinal tract (e.g., the anorectal wall), a valve disposed in the casing and controllable to move from a closed position, which significantly restricts passage of gastrointestinal (e.g., fecal) matter therepast, and an open position, which permits passage of gastrointestinal matter therepast, and a controller operatively connected to the valve for externally controlling the position of the valve between the closed and open positions.

Abstract: The present invention relates to an occlusive device for medical or surgical use, having a hollow, axial twist deformable cylindrical element (1) designed to create a striction zone, and obturation elements (2a, 2b) integral to the inner wall of the cylindrical element, allowing a passage and arranged in such a manner as to be pressed against each other to block the passage when the cylindrical element (1) is twisted.

Abstract: An implantable prosthesis and a method of repairing an anatomical defect, such as a tissue or muscle wall defect, by promoting tissue growth thereto, while limiting the incidence of postoperative adhesions between a portion of the prosthesis and tissue or organs. The prosthesis is formed of a biologically compatible, flexible layer of repair fabric suitable for reinforcing tissue or muscle and closing anatomical defects, and a barrier layer for physically isolating at least a portion of one side of the fabric from areas likely to form adhesions. A peripheral barrier extends about at least a portion of the outer peripheral edge of the repair fabric to inhibit adhesions between the outer peripheral edge and adjacent tissue and organs. The repair fabric may include an outer margin that has been melted and resolidified to render the outer peripheral edge substantially impervious to tissue ingrowth.

Abstract: The invention relates to surface modifying macromolecules (SMMs) having high degradation temperatures and their use in the manufacture of articles made from base polymers which require high temperature processing. The surface modifier is admixed with the base polymer to impart alcohol and water repellency properties.

Abstract: A pump apparatus, which comprises: (a) a tubular portion comprising an electroactive polymer actuator that expands and contracts an inner volume of the tubular portion based upon received control signals; and (b) a control unit electrically coupled to the electroactive polymer actuator and sending control signals to the actuator. The pump apparatus can further include at least one valve that is in fluid communication with the inner volume of the tubular portion. The pump apparatus can be used, for example, as a heart-lung bypass pump apparatus. Also disclosed herein is a method of providing circulatory support for patient.

Abstract: An implantable device and method for adjustably restricting a selected body lumen such as the urethra of a patient to treat urinary incontinence. The device includes an expandable element or membrane such as a balloon attached pressure-tightly to a flexible conduit at its forward end and includes a rear port portion containing an elastic septum and flow connected to the expandable element by a first passageway. The conduit contains a second passageway which allows it to be slid along an elongated guide probe initially inserted surgically into a patient's body adjacent the body lumen which is to be adjustably restricted. A suitable flowable material is injected from a syringe source into the device rear port sufficient to expand the membrane element and restrict the body lumen to the desired degree. The syringe and guide probe are removed and the skin incision is closed over the rear port end of the implanted device.

Abstract: Acellular matrix grafts are provided with are isolated from natural sources and consist essentially of a collagen and elastin matrix which is devoid of cellular components. The grafts are useful scaffolds which promote the regeneration of muscle tissue and aid in restoring muscle function. Due to their acellular nature, the grafts lack antigenicity. As a result, the acellular matrix grafts can be isolated from autographic, allographic or xenographic tissues.

Abstract: A shape memory shutter device for controlling the rectum of a disabled person, comprises a section of conduit to be connected to the rectum of the disabled person, and a shutter which controls the passage through the conduit section and actuated by a shape memory actuator. The shutter comprises a plurality of petals positioned circumferentially around the conduit section and able to move between a closed and an open position. The actuator comprises shape memory wires associated to the petals which are supplied with electrical current to cause opening of the petals.

Abstract: An ostomy plug is described comprising first and second chambers having adjacent ends coupled to, and in fluid communication with, each other. The first chamber may be for insertion into a stoma. The second chamber may contain fluid for inflating the first chamber when the second chamber is squeezed or otherwise compressed. The plug may have a figure-of-eight configuration. The plug may be configured to permit venting of flatus while obstructing escape of other body waste from the stoma. The plug may incorporate an insertion aid for aiding insertion into a stoma. The plug may also incorporate a device for regulating the inflation pressure of the fluid to avoid undesirably high inflation pressures in the stoma.

Abstract: The present invention is directed to a composition comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. Also disclosed is a tissue graft or implant comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. The composition and/or tissue graft or implant of the invention is usable in combination with seeded cells, a tissue growth factor, and/or a chemotactic agent to attract a desired cell.

Abstract: This invention relates to a spinal facet joint ligament.

Abstract: Surgical correction of presbyopia and hyperopia by a circularly distributed assembly of mini-bridges implanted between the interior surfaces of the ciliary muscle and the exterior surface of the lens capsule, for augmenting the transmission of the contraction force of the ciliary muscle/zonule assembly to the lens capsule. The lens is symmetrically squeezed by mini-bridges acting in concert with the ciliary muscle thus changing the curvature of the lens. The mini-bridges are composite synthetic muscles comprising either passive biocompatible mini-bridges made with polymeric gels, silicone polymers or a composite, electromagnetically or mechanically deployable mini-bridges, inflatable balloons or synthetic muscles. The surgical procedure comprises using a ciliary muscle relaxant to stretch the lens/zonules/ciliary muscle assembly.

Abstract: The present invention is directed to an intermediate composition for producing a muscle tissue matrix suitable for implantation in humans, comprising shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier, preferably a biocompatible acid solution, to form a muscle tissue slurry having a viscosity within the range of 1 centistoke to 20,000 centistokes measured at 25° C. In another aspect, the present invention is directed to a tissue implant comprising a human muscle tissue matrix.

Abstract: With an object of providing an artificial sphincter for which repeated shape changes are possible, and for which the quantity of shape change is sufficient so as to be used as a substitute for a large natural sphincter, an artificial sphincter 11 that opens and closes, as required, either the anus of a living body or part of the intestine 19 led outside the body is provided, wherein this artificial sphincter 11 comprises a pair of shape memory alloy elements 13 that change reversibly between two opposite shapes upon changes in temperature and hinges 15 that link the shape memory alloy elements 1 together in a cylindrical shape.

Abstract: With an object of providing an artificial sphincter for which repeated shape changes are possible, and for which the quantity of shape change is sufficient so as to be used as a substitute for a large natural sphincter, an artificial sphincter 11 that opens and closes, as required, either the anus of a living body or part of the intestine 19 led outside the body is provided, wherein this artificial sphincter 11 comprises a pair of shape memory alloy elements 13 that change reversibly between two opposite shapes upon changes in temperature and hinges 15 that link the shape memory alloy elements 1 together in a cylindrical shape.

Abstract: With an object of providing an artificial sphincter for which repeated shape changes are possible, and for which the quantity of shape change is sufficient so as to be used as a substitute for a large natural sphincter, an artificial sphincter 11 that opens and closes, as required, either the anus of a living body or part of the intestine 19 led outside the body is provided, wherein this artificial sphincter 11 comprises a pair of shape memory alloy elements 13 that change reversibly between two opposite shapes upon changes in temperature and hinges 15 that link the shape memory alloy elements 1 together in a cylindrical shape.

Abstract: An implantable digestive organ is provided for the transport of materials through the digestive tract and in one particular application to an artificial large bowel for replacing all or part of a colon or large bowel. The prosthetic organ of one embodiment includes an outer support structure, an expandable member or members located within the outer support structure, and a flexible inner member forming a conduit for the passage of material. The flexible inner member is located within the outer member and the expandable member or members are located between the inner member and the outer support structure. The expandable members are expanded and contracted, or inflated and deflated to provide a pumping action that pumps the material through the organ. The prosthesis may also include valves or sphincters at the entrance and/or exit points of the organ where material moves into and out of the prosthesis.

Abstract: An implantable device for selectively controlling defecation has an outer body defining on one end a flange that is surgically attachable to the patient's anus and/or tissue adjacent to the anus. A connector is mounted on the other end of the outer body and is secured to the distal end of the patient's large intestine for connecting the large intestine in fluid communication with the artificial rectum. An inner body is slidably received within the outer body. A macerator-type pump is mounted within the inner body and an inlet valve is mounted between the pump and the connector. An actuator in the form of an RF receiver is electrically coupled to the inlet valve and the pump and a remote transmitter is operatively coupled to the receiver. The receiver is responsive to control signals received from the transmitter to open the inlet valve and operate the pump in order to move fecal matter through the artificial rectum.

Abstract: An implantable prosthesis for repairing an anatomical defect, such as a soft tissue and muscle wall defect. The prosthesis is configured to reduce the likelihood that an applied force at the repair site, such as due to intraabdominal pressure or tissue shrinkage, can lead to detrimental effects associated with tension at the anchoring locations between the prosthesis and host tissue and/or contraction of the prosthesis. In this regard, the prosthesis may be configured to limit the amount of tension at the anchoring locations caused by the application of a force or pressure to the prosthesis and/or contraction of the prosthesis. Alternatively, the prosthesis may be configured to compensate for contraction of the prosthesis due to tissue shrinkage at the repair site. The prosthesis may be configured to both limit tension at the anchoring locations and compensate for tissue shrinkage.

Abstract: A method for treating morbid obesity in a body of a mammal having a gastrointestinal tract extending through a stomach and a pyloric sphincter and a wall forming the stomach and pyloric sphincter. At least one implant is formed in the wall in the vicinity of the pyloric sphincter to inhibit emptying of the stomach.

Abstract: Correction of eye refractive errors such as presbyopia, hyperopia, myopia, and astigmatism by using either pre-tensioned or transcutaneously energized artificial muscle implants to change the axial length and the anterior curvatures of the eye globe by bringing the retina/macula region to coincide with the focal point. The implants are scleral constrictor bands, segments or ribs for inducing accommodation of a few diopters, to correct the refractive errors on demand or automatically. The implant comprises an active sphinctering band encircling the sclera, implanted under the conjunctiva and under the extraocular muscles to uniformly constrict the eye globe, to induce active temporary myopia (hyperopia) by increasing(decreasing) the length and curvature of the globe. Multiple and specially designed constrictor bands enable surgeons to correct astigmatism.

Abstract: A muscle implant includes an extracellular matrix, tendon and muscle cells. The extracellular matrix is made of a matrix of electrospun polymer fibers. The tendon is made of extruded collagen fibers and the muscle cells are disposed on the extracellular matrix in such a manner that the combination of components will functionally and structurally act as normal muscle tissue. Cardiac and smooth muscles may be similarly formed without tendons but including the extracellular matrix and muscle cells.

Abstract: An implantable prosthesis for an anatomical defect, such as a tissue or muscle defect, that promotes tissue or muscle growth into the prosthesis and subsequently strengthens the area of the defect. At least one pocket and preferably two concentric pockets may be provided to aid with manipulating the prosthesis. Where two pockets are used, a barrier or partition exists between the pockets and the outer pocket allows manipulation of the outer periphery. The incidence of postoperative adhesions between a portion of the prosthesis and tissue, muscle or organs may be minimized with the use of a barrier layer. Reinforcing members may be attached to portions of the prosthesis to aid in positioning and deployment in the area of desired coverage without rendering the prosthesis unduly difficult to implant or uncomfortable for the patient. Typically, two concentric members are employed.

Abstract: Hydrophilic polymer actuators for an implantable device and methods of forming such actuators are provided, wherein the hydrophilic polymer actuators are actuated by the hydration and dehydration of a hydrophilic polymer material.

Abstract: The present invention relates to connective tissue substitute implant and method of preparation thereof. The implant is essentially composed of two bone anchors joined at the proximal ends by matrix layers and/or filaments coated by supplementary biocompatible matrix coating layer which can contain living stem cells isolated from injured connective tissue.

Abstract: Surgical correction of presbyopia and hyperopia by a circularly distributed assembly of mini-bridges implanted between the interior surfaces of the ciliary muscle and the exterior surface of the lens capsule, for augmenting the transmission of the contraction force of the ciliary muscle/zonule assembly to the lens capsule. The lens is symmetrically squeezed by mini-bridges acting in concert with the ciliary muscle thus changing the curvature of the lens. The mini-bridges are composite synthetic muscles comprising either passive biocompatible mini-bridges made with polymeric gels, silicone polymers or a composite, electromagnetically or mechanically deployable mini-bridges, inflatable balloons or synthetic muscles. The surgical procedure comprises using a ciliary muscle relaxant to stretch the lens/zonules/ciliary muscle assembly.

Abstract: Artificial muscle analog 1000 is located within hollow exoskeletal bone 10. Muscle 1000 comprises inflatable bladder 120, cable 130, roller 140, anchor point 150, and connection means 160 whereby said bladder may be inflated and deflated. Bladder 120 is affixed to the interior surface of said bone. Cable 130, attached to bone 10 at point 150, passes over bladder 120 and through roller 140. Cable 130, if unobstructed and taut, takes a shortest path from point 150 to roller 140. When inflated, bladder 120 forces cable 130 to deviate from this shortest path, pulling cable 130 in through said roller, under tension. In their paired opposing muscle form 2000, the artificial muscles synergistically assist each other when used in opposition. Paired muscles 2000 may actuate a robotic arm 3000, and are easily controlled by the associated simple low-cost control systems 100a,b,c of the present invention.

Abstract: An intestine dysfunction treatment apparatus comprises an electric stimulation device (56) implanted in a patient, who suffers from intestine dysfunction. The stimulation device comprises electric conductors adapted to directly engage with a muscle that directly or indirectly affects the transportation of the content of the patient's intestines, for example the anal sphincter (58) or a portion of the muscle that contracts the bowels, to electrically stimulate the muscle to increase the tonus thereof. A control device (62) is provided for controlling a source of energy (64), which may or may not be implanted, to release electric energy for use in connection with the power of the stimulation device. The apparatus can be used for treating patients suffering from anal incontinence or constipation.

Abstract: The present invention relates to the field of prostheses for plastic reconstruction, especially to mammary and muscular prostheses.

Abstract: Ion exchange membrane-based sensors, actuators and sensor/actuators and methods of making same for applications requiring sensing, actuating and controlling displacement. Sensors, actuators, and sensor/actuators are useful in biological as well as other applications. Encapsulation of the sensors, actuators, or sensor/actuators further increases the utility of the present invention. Devices according to the present invention made using lithium are preferred over those made using only sodium.

Abstract: Acellular matrix grafts are provided with are isolated from natural sources and consist essentially of a collagen and elastin matrix which is devoid of cellular components. The grafts are useful scaffolds which promote the regeneration of muscle tissue and aid in restoring muscle function. Due to their acellular nature, the grafts lack antigenicity. As a result, the acellular matrix grafts can be isolated from autographic, allographic or xenographic tissues.

Abstract: An integral fabric made of at least one thread and having a thickness making apparent two opposite porous surfaces, the fabric having a honeycomb-like structure comprising transverse channels along the thickness of the fabric which are close and parallel to one another and emerging into an opening on either porous surface.

Abstract: An artificial urinary sphincter operable as a single, uncomplicated component, not prone to failure, and easily repaired. Being preassembled, installation is easy through a single incision in one site. It incorporates an outer cuff having an inner cuff of interconnecting flexible fluid-containing portions. The outer cuff overlaps itself where a spring loaded push button device is installed. The device acts like a retractable ball point pen, pushing on the overlapped portion to compress the fluid-containing portions, to compress and shut the urethra when the push button is first pushed, and then alternately relaxing pressure on the overlapped portion so as to release pressure on the urethra upon additional pushing. Circumferential wires on pulleys mounted on an inner portion of the button alternately contract and relax radially inward pressure on the inner cuff, coordinated with inward pressure and relaxation of overlapped outer cuff portion.

Abstract: An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable, self-sealing element having a continuous wall, including an inner surface defining a chamber. The adjustable element expands or contracts due to fluid volume introduced into the chamber for restricting a body lumen. After being implanted into a patient, the size of the adjustable element is altered by first locating the adjustable element implanted adjacent the body lumen, and then establishing fluid communication with the adjustable element. The volume of the adjustable element is then adjusted by either introducing or removing volume from the chamber of the adjustable element.