Abstract: A disposable absorbent article may comprise a chassis and an ear. The chassis comprises a liquid permeable topsheet, a backsheet, and an absorbent core disposed between the topsheet and backsheet. The ear comprises an elastomeric material and a first substrate joined to the elastomeric material. The ear has a first void region adjacent the proximal edge of the ear. The ear is joined to the chassis by at least one mechanical bond that engages the elastomeric material.

Abstract: A female member for a hook-and-loop fastener is provided. Even when the hook-and-loop fastener part is deformed or an instantaneous impact peel force is applied to the fastener part, the female member does not peel off the male member. When the male member is peeled from the female member, no fluffing caused by shedding of a fibrous material occurs. The female member for a hook-and-loop fastener is constituted of a fibrous material and can engage with a mating male member. The female member is composed of: dense fiber portions arranged in rows and having a high density of the fibrous material; and sparse fiber portions arranged in rows alternately with these dense fiber portions and having a lower density of the fibrous material than the dense fiber portions. The dense fiber portions deform elastically, and this prevents undesirable peeling and diminishes fluffing.

Abstract: A dispensing device comprises a sealed package including a collapsible compartment and an administration assembly. The administration assembly includes a delivery device in fluid communication with a substance within the sealed package. A compression panel collapses the compartment to dispense a substance through the delivery device. Embodiments for a single use dispenser for hypodermic administration of a unit dose of a therapeutic fluid, as well as therapeutic packages and methods for administering therapeutic substances to subjects, are also provided.

Abstract: At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium.

Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein fluid connection means is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Abstract: Described here are devices and methods for treating one or more conditions or symptoms associated with a tonsil procedure. In some variations, a drug-releasing device may be at least partially delivered to one or more tonsillar tissues before, during, or after a tonsil procedure. In some variations, the drug-releasing device may be configured to be biodegradable. In other variations, the drug-releasing device may comprise one or more hemostatic materials or one or more adhesives. The drug-releasing device may be configured to release one or more drugs or agents, such as, for example, one or more analgesics, local anesthetics, vasoconstrictors, antibiotics, combinations thereof and the like.

Abstract: A method for preparing a solution from a solvent and an active substance in and on a disposable injector with a housing, with an at least intermittently fillable cylinder/piston unit which is arranged thereon and has a manually movable piston, and with a detachable container adapter mounted upstream of the cylinder/piston unit, wherein the container adapter supports a container which can be filled at least temporarily with active substance and which is closable by an openable stopper.

Abstract: The present invention provides devices, systems, and methods for delivery of an active agent into the eye of a subject. In one aspect, for example, an ocular active agent delivery device (10) can include an active agent reservoir (14) disposed in an annular housing (12), the annular housing (12) being configured to fit inside of a lens capsule and at least partially encircling a line of sight of an intraocular lens within the lens capsule. The device (10) can further include a semipermeable membrane (16) operatively coupled to the active agent reservoir (14), where the semipermeable membrane (16) is configured to allow diffusion of an active agent from the active agent reservoir (14). Additionally, a valve (18) can be operatively coupled to the active agent reservoir (14), where the valve (18) is configured to allow filling of the active agent reservoir (14) with an active agent.

Abstract: A rotational atherectomy device for abrading a stenotic lesion from a vessel of a patient comprises a flexible drive shaft which extends towards a distal end of the device, a distal fluid inflatable support element located at a distal end of the drive shaft and an abrasive element mounted to the drive shaft proximal to and spaced away from the distal fluid inflatable support element. Both the abrasive element and the distal fluid inflatable support element are rotatable together with the drive shaft.

Abstract: An endovascular sheath apparatus 2 is provided. The endovascular sheath apparatus 2 includes an inner tube 12 that includes a lumen 26 for introducing medical fluids or devices and an outer surface. The apparatus 2 further includes an outer tube 22 with an interior surface. The outer and inner surfaces define a cavity 28 therebetween. The apparatus 2 still further includes a stiffening component 20 which in one embodiment includes a braided material that is at least partially received in at least part of the cavity 28. An actuating mechanism 18 cooperates with the stiffening component 20. A method of providing intravascular delivery of a sheath includes the steps of providing an inner tube 12; positioning a stiffening component 20 around the inner tube 12; and deploying an actuating mechanism 18 that cooperates with the stiffening component 20, a stiffness characteristic of which being adjustable extra-corporeally by movement of the actuating mechanism in combination with the stiffening component.

Abstract: A flexible channel to be incorporated into an endoscopic insertion portion having a flexible portion at least in part of its length, for the purpose of providing a flexible passage internally of the endoscopic insertion portion. The flexible channel is composed of a flexible tube with a helical groove on and around its outer periphery, and a reinforcing coil fitted in the helical groove on the flexible tube. At the root of the helical groove, angular projections are formed at intervals in the longitudinal direction and the reinforcing coil is tightly pressed tightly against the angular projections.

Abstract: A wound therapy device and a kit for same with a housing material, a gasket disposed around at least a portion of the housing material, a non-woven absorption material, and a port. The gasket is sized and configured such that at least a first portion of the gasket will be adhered to a second portion of the gasket upon a folding of the housing material. A method of using a wound therapy device.

Abstract: A wound exudate removal and isolation system includes a porous dressing, a canister in fluid communication with the dressing, and a first valve positioned between the dressing and the canister. The first valve is positionable between an open position and a closed position. A disposal line is fluidly connected to the canister and includes a second valve that is positionable between an open position and a closed position. A pump is fluidly connected to the canister and is configured to draw wound exudate from the dressing into the canister when the first valve is open and the second valve is closed. The pump is configured to force wound exudate from the canister into the disposal line when the first valve is closed and the second valve is open.

Abstract: A negative pressure wound therapy apparatus can include a wound dressing, a fluid collection container, a vacuum pump comprising a pump motor, and tubing. Additionally, the apparatus can include a pressure sensor that measures a pressure in the tubing. One or more tubes can channel a fluid between the wound dressing, the fluid collection canister, and the pump. In addition, first and second control circuits can be provided for controlling the pump motor without using a processor. The first control circuit can generate a difference signal between a desired pressure input and a pressure sensor input, and can further generate a motor control signal responsive to the difference signal. Moreover, a second control circuit can provide an override signal based at least in part on the difference signal and at least one reference signal. The override signal beneficially overrides the motor control signal to prevent the pump motor from stalling.

Abstract: An infusion system that includes a controller device and a communication system to provide for two-way communication between the controller device and an infusion device that controls delivery of fluids to a user's body. Either the controller device or the infusion device may be integrated with a characteristic determining device in a single housing. The housing, in turn, may include a test-strip receptacle and an illuminator disposed so as to illuminate an area covering the receptacle and a test-strip inserted therein. The illuminator may be configured to be activated automatically when a test strip is inserted into the receptacle, selectively by the user via a button, key, or similar mechanism, and/or when the ambient light level, measured, e.g., with a light sensor, falls below a predetermined intensity. The illuminator may be a LED emitting white light, and may provide illumination at various levels of intensity.

Abstract: A therapy system includes a therapy module implantable within a mammalian body that provides a given therapy and a control module implantable within the mammalian body that effects the therapy provided by the therapy module. The control module is physically separate from the therapy module.

Abstract: Disposable loading units (DLUs) configured for mounting to a robotic arm for performing at least one surgical task are presented. Each DLU includes an attachment platform having at least one connector for engaging at least one connector on a distal end of the robotic arm for connecting the DLU to the robotic arm, a head portion connected to the attachment platform at one end and configured for housing an electro-mechanical actuation assembly therein, and at least one surgical tool member extending from the head portion and operatively associated with the electro-mechanical actuation assembly for controlling the operation and movement of the at least one surgical tool member. The at least one surgical tool member may include a cutting assembly, an aortic hole punch assembly, a lasing assembly, a coring assembly, or a vascular suturing assembly.

Abstract: The invention relates to a medical instrument, comprising a signal transmitter and at least one activating device for activating the transmitter which is provided on a transmitter unit which is separate from the instrument, wherein the transmitter unit is a unit which can be fastened to the exterior of the instrument. It also relates to a method for controlling a treatment-assisting medical software by means of a signal transmitter which is arranged on a medical instrument, wherein the instrument is positionally detected by means of a medical tracking system, and wherein the software assigns a different significance to the signal output by the transmitter depending on the position of the instrument.

Abstract: A segmented scleral expansion band adapted for implantation within or fastening to a segment of the sclera of an eye lying outside of and adjacent to the ciliary body of the eye, is formed from a number of arcuate segments, curved to match the curvature of the globe of the eye, and joined together at each end to form a complete scleral expansion band. The band is implanted in the sclera of the eye by forming circumferential tunnels, inserting the band segments through the tunnels, and joining the ends of the segments to form a complete scleral expansion band. The scleral expansion band is useful in treating presbyopia and other ocular disorders.

Abstract: A segmented scleral expansion band adapted for implantation within or fastening to a segment of the sclera of an eye lying outside of and adjacent to the ciliary body of the eye, is formed from a number of arcuate segments, curved to match the curvature of the globe of the eye, and joined together at each end to form a complete scleral expansion band. The band is implanted in the sclera of the eye by forming circumferential tunnels, inserting the band segments through the tunnels, and joining the ends of the segments to form a complete scleral expansion band. The scleral expansion band is useful in treating presbyopia and other ocular disorders.

Abstract: Treatment table verification techniques involve comparing intended refraction information with expected optical refraction information, and validating or qualifying the treatment table based on such comparisons. Systems and methods for verifying treatment tables provide enhanced safety for laser vision correction treatments.

Abstract: System and method of intrastromal refractive correction. The system includes a laser source operable to produce a pulsed beam, a scanner operable to direct the pulsed beam at the eye, and a controller coupled to the laser source and the scanner. The controller determines an intrastromal incision pattern based on a refractive condition of an eye, and directs the scanner to intrastromally incise the pattern in an applanated cornea with the pulsed beam. Following de-applanation, the cornea is reshaped in response to the intrastromal incision pattern to correct the refractive condition.

Abstract: A clearing module is provided that includes a main body configured and dimensioned to be received within a vessel or duct of a patient, adjacent a surgical target area in the patient. The main body includes: an instruction receiving unit configured to receive wireless instructions from an instruction transmitter located outside the patient's body while the module is located inside of the patient's body; a positioning element configured to be monitored by a system external of the patient's body while the positioning element is inside the patient's body; and a destructive energy emitter configured to emit destructive energy from the module toward the surgical target area according to instructions received from the instructions receiving unit.

Abstract: A therapeutic energy system for performing interstitial laser therapy and brachytherapy includes two categories of components. The first category includes components usable to perform both interstitial laser therapy and brachytherapy. The second category of components includes components usable to perform either interstitial laser therapy or brachytherapy, but not both. The components co-act to apply therapeutic energy to tissue. The components of the first system include components inserted percutaneously into the tissue, such that interstitial laser therapy and brachytherapy can be performed sequentially without removing and re-inserting percutaneous components. Components of the second category include components not requiring additional puncturing of the skin of a patient, such that removing and inserting components of the second category from a patient is done easily and painlessly. An energy probe component does not maintain a cavity around the tumor mass.

Abstract: A cryogenic tissue ablation instrument includes an elongate flexible body with a proximal supply port for coupling with a pressurized coolant, a supply lumen in communication with the proximal supply port, and an expandable balloon carried on the elongate body. A dispersion member coupled to the elongate body has an interior lumen in communication with the supply lumen, the dispersion member having one or more coolant dispersion apertures sized and located such that a pressurized flowable coolant will enter the balloon interior in the form of a liquid spray that contacts and provides substantially uniform cooling of the balloon.

Abstract: A tissue treatment device comprises an insertion section sized and shaped for insertion into the body via a trocar and a diagnostic element coupled to the insertion section, the diagnostic element illuminating tissue with light of a wavelength selected to facilitate identification of target tissue in combination with an ultrasound element coupled to the insertion section for delivering to a portion of tissue illuminated by the diagnostic element ultrasound energy.

Abstract: High-strength microwave antenna assemblies and methods of use are described herein. The microwave antenna has a radiating portion connected by a feedline to a power generating source, e.g., a generator. Proximal and distal radiating portions of the antenna assembly are separated by a junction member. A reinforcing member is disposed within the junction member to increase structural rigidity.

Abstract: A system for performing an electrosurgical procedure at a surgical site is disclosed. The system includes a sensor configured to continually sense an electrical and/or a physical property of tissue at a surgical site and to generate a sensor signal as a function thereof. The system also includes a control module configured to process the sensor signal using a processor, an algorithm, and a map having one or more predetermined values. The control module is further configured to compare the sensor signal to a predetermined level to determine reliability of the sensor signal and to signal an electrosurgical generator in response to a reliable sensor signal such that the electrosurgical generator enters energy control mode, wherein the electrosurgical generator matches an output of the control signal with a predetermined value from the map.

Abstract: A high-frequency cauterization power source is an electrosurgical apparatus for joining biological tissues. The electrosurgical apparatus includes a high frequency power supply portion for supplying a high frequency power that is applied to biological tissues; a detection portion for detecting a voltage and a current of a high frequency power that is output from the high frequency power supply portion; a tissue impedance calculating portion that calculates an impedance of biological tissue based on respective values for voltage and current detected at the detection portion; and a control portion that controls so as to substantially stop supply of the high frequency power from the high frequency power supply portion based on whether or not an increase greater than or equal to a predetermined value in the impedance that is calculated at the tissue impedance calculating portion occurs two times.

Abstract: Systems and methods are provided for applying a high frequency voltage in the presence of an electrically conductive fluid to create a relatively low-temperature plasma for ablation of tissue adjacent to, or in contact with, the plasma. In one embodiment, an electrosurgical probe or catheter is positioned adjacent the target site so that one or more active electrode(s) are brought into contact with, or close proximity to, a target tissue in the presence of electrically conductive fluid. High frequency voltage is then applied between the active electrode(s) and one or more return electrode(s) to non-thermally generate a plasma adjacent to the active electrode(s), and to volumetrically remove or ablate at least a portion of the target tissue.

Abstract: Devices, systems, and methods for percutaneous and mini-invasive valve removal are provided. In at least one embodiment of a device for removing a valve, said device comprises a catheter, two mesh umbrellas coupled thereto, a cauterizing mechanism operable to excise a valve from a vessel, and a mechanical drill operable to grind said excised valve to allow for removal of the ground excised valve by way of an enclosure created by the two mesh umbrellas. In another embodiment, a temporary stent valve is positioned near the valve to be excised to avoid aortic insufficiency during valve excision.

Abstract: The present disclosure relates to electrosurgical devices having a plurality of hand-accessible variable controls. An electrosurgical device configured for connection to a source of electrosurgical energy is provided and includes a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy, wherein the electrical circuit is provided with at least one tactile enhancement feature; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on the electrical circuit to affect a change in the electrical circuit and to exert a force on a surface of the housing to engage the tactile enhancement feature and provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing.

Abstract: The present disclosure relates to electrosurgical devices having a plurality of hand-accessible variable controls. An electrosurgical device configured for connection to a source of electrosurgical energy is provided and includes a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on each of the housing and the electrical circuit to affect a change in the electrical circuit and to provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing.

Abstract: In one general aspect, various embodiments are directed to a surgical instrument that can supply mechanical energy and electrical energy to an end effector of the surgical instrument. The surgical instrument may be operated in a first operating mode in which a transducer of the surgical instrument produces mechanical energy, or vibrations, that are transmitted to the end effector and a second operating mode in which electrical energy, or current, can flow through the end effector to perform electrosurgery. In another general aspect, the surgical instrument may comprise a clamp, or jaw, which can be moved into a closed position to hold tissue against a waveguide, or blade, of the end effector. In the second operating mode of the surgical instrument, current can flow from a power source, through the waveguide, and return to the power source through a path comprising the jaw.

Abstract: An endoscopic treatment tool includes a flexible sheath; an operating member inserted to the sheath so as to freely advance and retract; a treatment section disposed at the distal end of the operating member that protrudes and retracts from the sheath; and an operator section connected to the proximal end of the operating member including a sliding member which makes the operating member advance and retract. The endoscopic treatment tool includes the operating member consisting of a member which increases its rigidity by compression, and a member which compresses the operating member. Therefore a sufficient incision or excision is achieved relative to the distance of movement of the treatment tool by preventing a deflection of the flexible tube when in use.

Abstract: An end effector assembly includes opposed jaws moveable from an open to a closed position for grasping tissue therebetween. Each jaw includes an electrically conductive surface adapted to conduct electrosurgical energy through tissue disposed between the jaws. A static bipolar cutting portion including at least one electrically conductive cutting element and at least one insulating element having a first configuration is disposed on at least one of the jaws. The static cutting portion is configured to electrically cut tissue disposed between the jaws upon activation of the cutting element and at least one of an opposing sealing surface and an opposing cutting element. A dynamic cutting portion including at least one electrically conductive cutting element and at least one insulating element having a second configuration is disposed on at least one of the jaws. The dynamic cutting portion electrically transects tissue during movement relative to tissue.

Abstract: A surgical treatment apparatus includes a receptacle which is configured to abut onto a treatment section so that a predetermined clearance is formed between an electrode section and the treatment section when a grip member is closed relative to the treatment section. The surgical treatment apparatus includes a regulating section which is provided in the grip member so that a closing-direction end located on a closing-direction side of the grip member does not protrude from the receptacle toward the closing direction, the regulating section being made of a material harder than the receptacle, and a handle unit configured to operate the grip member so that the regulating section is closed up to a position where the regulating section contacts the treatment section except when the receptacle contacts the treatment section.

Abstract: A surgical nail for treating a fractured bone includes a nail body extending along a longitudinal axis from a trailing end to a leading end and including a trailing end locking aperture extending transversely through a trailing end portion thereof and a leading end locking aperture extending transversely through a leading end portion thereof; a trailing end connecting element located at the trailing end of the nail body adapted and configured to be coupled to a trailing end aiming guide; and a leading end connecting element at the leading end of the nail body adapted and configured to be coupled to a leading end aiming guide.

Abstract: A bone void filler material, including a hydrogel component provided by microparticulates of pre-set hydrogel material dispersed within a carrier component to maintain the microparticulates substantially proximate to one another so that the resulting fill material is rendered as a substantially flowable mass.

Abstract: Methods and devices that displace bone or other hard tissue to create a cavity in the tissue. Where such methods and devices rely on a driving mechanism for providing moving of the device to form a profile that improves displacement of the tissue. These methods and devices also allow for creating a path or cavity in bone for insertion of bone cement or other filler to treat a fracture or other condition in the bone. The features relating to the methods and devices described herein can be applied in any region of bone or hard tissue where the tissue or bone is displaced to define a bore or cavity instead of being extracted from the body such as during a drilling or ablation procedure.

Abstract: Single-unit cutting head systems for safe removal of nucleus pulposis tissue are provided. The cutting heads compose a part of the systems that are provided to address several problems, including clogging of state-of-the-art systems during removal of such tissue, for example. The target tissue can include any tissue that is accessible through a small surgical opening, for example, a joint tissue such as a meniscus or an intervertebral tissue, such as a nucleus pulposus. The devices can be referred to as orthopedic tissue removal devices having cutting heads associated with vacuum systems, making the systems useful in several procedures, including X-LIF (lateral approach to an intervertebral fusions) procedures, T-LIF (transforaminal approach to intervertebral fusions) procedures, P-LIF (posterior approach to intervertebral fusions), and a percutaneous, transforaminal approach (Kambin triangle access).

Abstract: Described herein are elongate devices for modifying tissue having a plurality of flexibly connected rungs or links, and methods of using them, including methods of using them to decompress stenotic spinal tissue. These devices may be included as part of a system for modifying tissue. In general, these devices include a plurality of blades positioned on (or formed from) rungs that are flexibly connected. The rungs are typically rigid, somewhat flat and wider than they are long (e.g., rectangular). The rungs may be arranged, ladder like, and may be connected by a flexible connector substrate or between two or more cables. Different sized rungs may be used. The blades (on the rungs) may be arranged in a staggered arrangement. A tissue-collection or tissue capture element may be used to collect the cut or modified tissue.

Abstract: Instruments and methods for preparing an intervertebral space for receiving an implant. An adjustable trial implant has an adjustable stop mechanism having a stop member connected thereto to vary the distance that a body portion of the trial implant can move into the intervertebral space. Cutting tools for forming cutouts in the adjacent vertebrae use the trial implant and/or a guide to position a cutting tool which may be a burr or a chisel. The chisel cutting tool can be moveable relative to a selected trial implant or the chisel cutting tools can be fixed onto a trial implant shaped body portion.

Abstract: A method according to one embodiment may provide access to an articular surface of a bone. The method includes forming a passage through at least a portion of the bone. The passage provides an opening in the articular surface. The method further includes inserting a tether through the passage. The tether inserted through the passage can be coupled to at least one device from an insertion site remote from the articular surface. The tether can be withdrawn through the passage to convey the device to a location proximate the articular surface.

Abstract: An apparatus and method for introducing portals into bone is described herein. An example apparatus for introducing portals into bone includes a handle, a base, and a driving member. The driving member can be made to project past the base by operating the handle. The base is detachable from the handle. The apparatus also includes a guide coupled at a first end to the handle and at a second end to the base. The base is detachably coupled to the guide. A base coupling detachably coupling the base to the guide includes an actuating member movable between a coupled configuration wherein the base is coupled to the guide and an uncoupled configuration wherein the base is released from the guide. The actuating member is arranged so that motion of the handle toward the base moves the actuating member from the coupled configuration to the uncoupled configuration.

Abstract: An apparatus used in spinal surgery for creating a space of selected shape and dimensions across the disc space between adjacent vertebral bodies of the spine.

Abstract: A boring instrument guiding device which is used to guide a boring instrument that forms a pilot hole for embedding a pedicle screw in a vertebral pedicle includes a reference pin which is used as a reference by being inserted into the vertebral arch from the rear to the front of a spine, and an arm which extends sideward from the proximal end side of the reference pin, and is characterized in that a plurality of guide holes, each of which is opened toward the tip position of the reference pin to guide the boring instrument, are formed in the arm in a radial pattern centered at the tip position of the reference pin. It is possible to provide a boring instrument guiding device which is capable of more easily and precisely guiding the boring instrument.

Abstract: A feeler gauge and alignment device comprises a first outer shim having a first end, a second end, and an alignment aperture disposed between the first end and the second end, a second outer shim having a first end, a second end, and an alignment aperture disposed between the first end and the second end, and one or more inner shims disposed between the first outer shim and the second outer shim, each of the one or more inner shims having a first end, a second end, and an alignment aperture disposed between the first end and the second end. The first outer shim, the second outer shim, and the one or more inner shims are rotatably coupled about the first ends.

Abstract: This invention describes a simple intraocular lens (IOL) design with a removable optic, which can be inserted in and removed from a haptic device. In this haptic the anterior and posterior capsules are sealed in order to have a perfect control over the lens epithelial cell proliferation which is thereby restricted to the peripheral part of the capsular bag. Additionally, a ring caliper is described as new surgical device to allow a precise sizing and centration of the anterior capsulorhexis. The removable optic allows repeatable correction of the eye focusing over time in case the optical parameters of the eye have changed due to a variety of factors. By separating the optic part from the haptic part, the optic part can easily be manufactured in any shape matching the optical errors of the eye, including the ocular aberrations. The optic part can be manufactured out of any biomaterial restoring ocular accommodation.

Abstract: Transgastric abdominal access methods and apparatus are described herein. A shape-lockable elongate body can be advanced endoluminally in a flexible state into the stomach, where an opening is created through the stomach wall. The opening can be created endoluminally or by incising instruments placed through the abdominal wall. The elongate body can be transitioned to a rigid state prior to, during, or after advancement into the patient and is passed through the opening into the peritoneal cavity. A dilation balloon can be positioned simultaneously within the elongate body and within the tissue opening such that the elongate body can be advanced through the tissue opening. A flexible needle catheter can also be delivered through the elongate body or an endoscope to provide for insufflation prior to cutting or piercing through the stomach wall. Also, tissue closure devices and methods to close the opening created through the stomach wall.