Abstract: Devices for treating or managing fecal or bowel incontinence and methods employing them. Such a device can form a seal with at least a portion of the bowel to prevent unwanted discharge of fecal matter from the rectum. Such a device can include an elastomeric skin having a bulbous portion. Such a device can include a grip configured to remain exterior to the subject.

Abstract: Embodiments of a Urological implant include an implant with an elongated body having a longitudinal axis. Optionally longitudinal ribs symmetrically oppose each other and are connected to elongated body. The longitudinal ribs are optionally elastically shiftable between a collapsed state and an expanded state relative to the spinal longitudinal axis, in order to retract or/and support periurethral tissue. Optionally the system includes an implant extraction handle. The extraction handle is optionally positioned proximally to the elongated body and connected to the longitudinal rib and subject to a pulling force to facilitate and/or force approximation of the longitudinal supports to the longitudinal axis. In some embodiments, an implant body includes longitudinally spaced arched members, interconnected via arch ends sequentially along a length of a first and second longitudinal rib.

Abstract: An endoscope includes an insertion portion including a distal end portion in which an image pickup unit is disposed, the insertion portion being configured to be inserted into an organ of a subject, an operation portion disposed at a proximal end of the insertion portion, and a sensor disposed in the operation portion, the sensor being configured to detect a pressure of a fluid in a flow passage passing through from the operation portion to a first opening of the distal end portion, the flow passage being configured to allow the fluid flowed into the operation portion to be flowed out from the first opening.

Abstract: A rectocele device having a rectocele handle with a first static paddle removably affixed to a rectocele paddle connector at a paddle connector end. A second static paddle is configured to replace the first static paddle after the first static paddle is removed from the rectocele paddle connector. The first static paddle is configured and sized to fit within a human vagina wherein the first static paddle is only removable from the handle distal end when the first static paddle is not deployed in the human vagina. The first static paddle is shaped differently from the second static paddle. The first or second static paddle is inserted in a human vagina (by a woman using the rectocele device) wherein the first or second static paddle can be leveraged against a rectocele via the rectocele handle thereby pushing the rectocele bulge back into the colon so that the woman can evacuate a bowel more efficiently.

Abstract: A brain interaction apparatus is provided. The apparatus comprises a plurality of filaments; and a brain invasive launcher having a plurality of launching channels extending in a longitudinal direction between a proximal end and a distal end thereof. Each launching channel is configured for holding one of the plurality of filaments moveably arranged therein. At least one of the plurality of filaments is provided with a steering tip affixed to a distal end thereof. The steering tip comprises a portion tapering in a longitudinal direction of the at least one of the plurality of filaments thereby narrowing toward a distal end of the steering tip. The tapered portion is rotationally asymmetrical about a longitudinal axis of the at least one of the plurality of filaments.

Abstract: A mesh assembly for cosmetic surgery that can be used for tissue lifting is proposed. The mesh assembly includes: a mesh sleeve that includes a multiple number of helical string members, which are entwined in intersecting directions to form a passage having a particular diameter within the mesh sleeve; a core that extends along a first direction and is positioned within the passage; and a protrusion that protrudes from the outer perimeter of the core in a direction inclined towards one side and extends through a gap between the string members to the outside of the mesh sleeve. The mesh assembly can have a drastically greater strength compared to a regular surgical thread and can also be joined to the surgical site with high strength, thus providing greater utility in procedures such as tissue lifting.

Abstract: Artificial contractile structure (1) for a medical device, said artificial contractile structure (3) comprising: —an elongated member (3) adapted to contact a hollow body organ; —a closure (9) adapted to form the artificial contractile structure (1) into a closed loop around said hollow body organ; —a tension system (11) arranged to be connected to a control unit (28), said tension system (1) being adapted to modify an internal diameter of said closed loop in response to a force applied by said control unit (28). According to the invention, said elongated member (3) comprises a resilient core (5) and a biocompatible outer sheath (7). Said tension system (11) furthermore comprises a first tensile element (13) attached to a first point (3c) of said elongated member, and a second tensile element (15) attached to a second point (3d) of said elongated member, each of said tensile elements (15, 17) passing through an adaptor (17) situated between said first point (3c) and said second point (3d).

Abstract: A vaginal device and method of preventing urinary incontinence is disclosed. The device includes a longitudinal portion having a geometrical centre line, a first end and a second end, the first end being the innermost of the vaginal device during use, at least one supporting portion protruding from the longitudinal portion at the first end, the at least one supporting portion being configured to support against the urethra, through the vaginal wall, at a site located adjacent the maximal urethral pressure point, and a reference member protruding from the longitudinal portion at the second end, wherein the reference member during use is fixated against the vaginal introitus, holding the vaginal device securely fixated inside of the vagina and ensuring the at least one supporting portion is arranged at the intended site.

Abstract: An intravaginal device that has a hollow open-ended cylindrical body and a removal strip, wherein the body has features that keep the removal strip in a track. During removal when the removal strip is pulled, the cross-sectional area of the device is decreased. A kit includes the device, removal strip and an assistive wand to aid with insertion and removal.

Abstract: An apparatus for treating urinary incontinence in a patient includes at least one adjustable lifting device for supporting a patient's urethra to restore urinary control. The adjustable lifting device can post-operatively and non-invasively adjust the level of lift of a patient's urethra, to thereby affect the patient's incontinence. The adjustable lifting device is placed above the pubis bone of the patient. The device includes first and second fixation devices that are adjustable to thereby adjust the length of a sling that cradles and lift's the patient's urethra. The apparatus could also be used to treat anal incontinence.

Abstract: A method performed by a computer correlates vesicoelastic pressure data (10, 12, 14) with volume data and calculates vesicoelastic work performed by the bladder (20), wherein the amount of vesicoelastic work performed by the bladder (20) is determined by calculating an area under said vesicoelastic pressure data (10, 12, 14) when said vesicoelastic pressure data (10, 12, 14) is correlated against the volume data.

Abstract: Disclosed are an apparatus and method for forming a passage extending along a plane crossing an organ's volumetric region from an entry point to an opposing exit point at a surface of the organ, and for passing a tension member around the volumetric region by pulling the tension member from the exit point to the entry point through the passage. The apparatus can include a rigid outer tube with a tip for penetrating the organ and reach a penetration depth; an inner needle with an elastic body configured to pass straightened through the outer tube lumen and to partially protrude and voluntarily flex to a curved form greater than the diameter of the volumetric region; and a tension member passer with a pulling portion for engaging with a portion of the tension member and for pulling the tension member when withdrawn.

Abstract: A medical implant system for implantation in a patient to treat erectile dysfunction includes a first fluid path, an inflatable penile prosthesis cylinder, an electric pump, and implant controller, and an implantable power supply. The inflatable penile prosthesis cylinder is in fluid communication with the first fluid path and is configured for implantation in a corpus cavernosum of a patient. The electric pump is in fluid communication with the first fluid path. The implant controller is electrically coupled to the pump and is configured to activate the pump to drive a flow of fluid through the first fluid path and into the cylinder. The implantable power supply provides electrical power to the pump.

Abstract: A medical device has an artificial contractile structure including at least one contractile element adapted to contract a hollow body organ in such a way that said contractile element is adapted to be in a resting position or in an activated position, the activated position being defined with the contractile element constricting the hollow body organ and the resting position being defined with the contractile element not constricting the hollow body organ. The medical device further includes a tensioning device adapted to apply a force so as to tighten the contractile element around the hollow body organ. The medical device further includes a means for eliminating a dead zone of the contractile element when the contractile element is attached around hollow organ with a circumference of the contractile element less than a maximum possible circumference.

Abstract: Urinary incontinence devices generally include a body configured to be inserted into a vagina. The body may have a proximal insertion portion, a plurality of legs coupled to and extending distally from the insertion portion, and a distal retrieval portion. The plurality of legs may each have a length, a width, and a distal end, and the distal ends of the plurality of legs may be coupled together. The body may have a compressed configuration, an expanded configuration, and a lateral cross-sectional diameter, and the lateral cross-sectional diameter of the body may be largest at the widest point of each of the plurality of legs. Methods of treating urinary incontinence may include loading a urinary incontinence device into an applicator, inserting the applicator into the vagina, advancing the incontinence device out of the applicator to position a distal end of the device past the pelvic floor, and removing the incontinence device from the vagina using the distal retrieval portion.

Abstract: An artificial valve for implantation in a mammal body, in or adjacent to a mammal blood vessel, the artificial valve comprising a casing and a closing mechanism, with at least part of said closing mechanism being a first moving part adapted to make movements relative to said casing. The movements are movements to assume a fully open and a fully closed position for opening and closing, respectively, the blood flow through said blood vessel, as well as at least one position in between said fully open and fully closed positions. The first moving part is adapted to receive energy for at least one of its movements at least in part from an energy device which is also comprised in the artificial valve and arranged to be placed external to said blood vessel.

Abstract: A cuff for use an as artificial sphincter includes an inflatable chamber and a backing. The inflatable chamber includes opposing inside and outside surfaces and inflated and deflated states. The backing is adjacent the outside surface of the chamber. The inside surface of the chamber includes two or more grooves that define the location of fold lines of the inflatable chamber when the inflatable chamber is in the inflated state. The inflatable chamber and backing are configured to surround a duct of a patient with the inside surface of the chamber facing the duct and the grooves extending substantially parallel to the duct.

Abstract: A method for occluding a blood vessel has steps for encasing a semi-rigid, circular plastic ring, open at one point, in silicon material, forming a bladder along an inside diameter of the silicon material, placing a mixture of sodium and potassium salts and polyacrylamide granules in the bladder, closing and sealing the bladder, forming a pair of opposed stirrups on an outside diameter of the silicon material, spreading the encased plastic ring by the stirrups accomplishing an opening through the ring of an extent enabling the ring to be placed over a blood vessel, placing the encased plastic ring over the blood vessel, releasing the stirrup, allowing the ring and bladder to close around the blood vessel, such that the bladder, constrained by the ring from expanding outward, absorbing moisture by osmosis over time, expands inward, and over a time t fully occludes the blood vessel.

Abstract: A medical device for shutting off an anatomical channel is provided, including: a band section that can be placed around the body tissue surrounding the body channel and can be closed to form a ring enclosing a passage opening for the body tissue, and that includes a cavity which makes up one part of a receiving chamber of the arrangement, for receiving working fluid; and a pump unit for conveying the working fluid. The passage opening can be made smaller by introducing the working fluid into the cavity. An expansion body is provided having an expansion chamber, and the expansion body is arranged on the band section, on a side of the band section that faces the passage opening, and the expansion chamber can be made bigger by introducing an auxiliary fluid, which is separate from the working fluid, into the expansion chamber.

Abstract: A novel intraluminal therapy system for providing a quick and effective way to treat gastrointestinal infections. The invention includes a brand new system of treating Helicobacter pylori infections and an agent dispenser for an endoscope apparatus, comprising a pump, a catheter connected to the pump and a nozzle connected to the catheter. The devices are used along with a complex of antibiotic and/or antimicrobial agents to eradicate Helicobacter pylori while performing an endoscopic procedure.

Abstract: A vaginal device and method of preventing urinary incontinence is disclosed. The device includes a longitudinal portion having a geometrical centre line, a first end and a second end, the first end being the innermost of the vaginal device during use, at least one supporting portion protruding from the longitudinal portion at the first end, the at least one supporting portion being configured to support against the urethra, through the vaginal wall, at a site located adjacent the maximal urethral pressure point, and a reference member protruding from the longitudinal portion at the second end, wherein the reference member during use is fixated against the vaginal introitus, holding the vaginal device securely fixated inside of the vagina and ensuring the at least one supporting portion is arranged at the intended site.

Abstract: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools. A tool may include a hand-held implant delivery device that holds, moves, orients, inserts, or shapes an implant. An implant may be a biodegradable, longitudinal implant that may be oriented for implantation by an implant delivery device.

Abstract: A surgical instrument includes a power pack, an outer shell housing configured to selectively encase the power pack, and an adapter assembly configured to selectively couple the outer shell housing to a loading unit. The outer shell housing includes a motor and a drive shaft coupled to and rotatable by the motor. The outer shell housing includes a drive member supported in a distal portion thereof. The drive member is configured to selectively couple to the drive shaft. The adapter assembly has a drive member supported in its proximal end. The drive member of the adapter assembly is configured to selectively couple to the drive member of the outer shell housing such that rotation of the drive shaft actuates movement of the drive member of the adapter assembly via the drive member of the outer shell housing.

Abstract: An intravaginal pessary device in an applicator is provided. The device has a top and a bottom, and a sidewall that extends between the top and the bottom. The sidewall, top and bottom form an outer periphery defining a total area of the device. The pessary device has a maximum diameter that is less than about 25 mm. The pessary device and applicator exhibit a maximum expulsion force that is below 1500 grams.

Abstract: A gastrointestinal-tract constricting method comprises: while observing the gastrointestinal tract with an endoscope inserted into the gastrointestinal tract, placing a protection substance, which does not damage tissue, in at least one of a region between the mucosal layer and muscular layer of the gastrointestinal tract and a region in a mucosal surface of the mucosal layer so as to form a protection region that protects the mucosa basal layer from a medical substance that damages the tissue; and, after forming the protection region, supplying the medical substance to a mucosal surface in a target region, which is at a position different from the protection region in a circumferential direction of the gastrointestinal tract, or to a position between the mucosal layer and the muscular layer.

Abstract: Surgical instruments for pelvic repair can include straight portions and helical portions. Surgical methods for treating prolapse and other pelvic disorders can include passing a distal end region of the surgical instruments through pelvic tissue, associating an implant with the surgical instruments, and securing the implant in place to stabilize the vagina.

Abstract: One aspect of the invention provides a vaginal stent system including: an inflatable vaginal stent and a removable handle. The inflatable vaginal stent include includes: an elastomeric exterior wall and a first fitting located at a base of the inflatable vaginal stent. The removable handle is adapted and configured for insertion, inflation, and removal of the inflatable vaginal stent from a subject's vagina. The removable handle includes a second fitting complementary to the first fitting and adapted and configure to form substantially fluid tight coupling when the handle is coupled to the inflatable vaginal stent. Another aspect of the invention provides a method of fabricating a customized vaginal stent or dilator. The method includes: generating a 3D model of a vaginal stent or dilator; and controlling a 3D printer to fabricate a vaginal stent or dilator according to the 3D model.

Abstract: An implantable interbody negative pressure device that permits reduced or negative pressure therapies to be applied to a portion of a patient's body. More specifically, the implantable interbody negative pressure device comprises a body portion having a plurality of openings in fluid communication with both an internal passageway and a vacuum source, and that serves as a manifold and permits reduced or negative pressure therapy to be applied to a surgical site, such as a wound or damaged bone. The application of the reduced or negative pressure to the body improves circulation and the disposal of cellular waste, and promotes bone growth and healing.

Abstract: An apparatus for controlling pressure of a medical gas during treatment of a patient includes is a balloon (1) that through a catheter (2) is introducable into an arterial system of the patient, and a damping bag (20), of greater volume than that of the balloon (1), adapted to be loaded with medical gas at a compliance pressure (Pc) and placed in direct fluid communication with the balloon (1). The damping bag (20) is kept in direct fluid communication with the balloon (1) for the entire duration of the treatment of the patient. The apparatus further includes fine adjusting means (30) for acting on the damping container in such a way that the compliance pressure (Pc) is maintained between the systolic pressure and the diastolic pressure of the patient when the balloon is introduced into the arterial system of the patient and during the treatment of the patient.

Abstract: An ostomy management device (100) including an ostomy port (102) insertable inside a stoma (202) on a patient's abdomen. The ostomy port (102) includes an outer flange (204) placed at periphery of the stoma (202). The outer flange (204) includes a collapsible chamber (210) to collect instilling fluid in a non-operating state of the outer flange (204). A fixation element (208) to anchor the ostomy management device (100) inside an intestine (214). The fixation element (208) is to expand after displacement of the instilling fluid contained in the outer flange (204) to the fixation element (208). An intermediate channel (206) to transport body waste to the stoma (202). A stoma plug (106), attached to the outer flange (204), to cover an opening in the outer flange (204) to stop the body waste from flowing out from the stoma (202) during an operating state of the outer flange (204).

Abstract: A colpotomy system includes a surgical instrument having a cutting element and a receiver at a distal end thereof and a uterine instrument. The uterine instrument has a handle operably coupled to a shaft having a balloon at a distal end thereof, the shaft extending through a retaining member to access a surgical site, the retaining member including a plurality of transmitters for transmitting at least one signal. A distance between the cutting element of the surgical instrument and one end of the retaining member of the uterine instrument is calculated to determine whether the cutting element is within a predetermined operating zone.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: A powered or automatic air management system for measuring pressure from an air pressure catheter located within a patient. Powered pumps are included in a remote pump assembly to automatically adjust the air volume to a desired level. A pressure transducer assembly is located at the bed of the patient and is connected to an air catheter, and a separate pump assembly is fixed to an IV pole away from the patient and connected to a pressure monitor to display the pressure readings. By locating the pressure transducer to a location relatively close to the connection point of the catheter, more accurate pressure readings can be achieved.

Abstract: Described embodiments include a method that includes inserting an ablation catheter into a Eustachian tube of a subject, and, using the ablation catheter, while the subject is awake, passing an ablating signal, which is audible to the subject, through epithelial cells that line the Eustachian tube, while controlling an amplitude of the ablating signal responsively to a loudness of the ablating signal as perceived by the subject. Other embodiments are also described.

Abstract: A technology is described for an electronic peripheral nerve stimulation system. The electronic nerve stimulation system can include a stimulation device and an electrode array. The stimulation device can be operable to generate a high-frequency alternating current. The electrode array can be operable to apply the high-frequency alternating current received from the stimulation device to selected subpopulations of peripheral nerve fibers within a peripheral nerve to block transmission of neural signals along the selected subpopulations of peripheral nerve fibers within the peripheral nerve.

Abstract: The invention, in various embodiments, is directed to systems, devices, and methods relating to pre-pubic approaches to delivering a supportive sling to periurethral tissue of a patient. In some embodiments, a system includes a sling assembly having a sling and a sleeve, a guide tube coupled to an end portion of the sleeve, and a delivery device having a shaft, where the shaft can slidably interfit into a lumen of the guide tube such that the distal-most tip of the shaft extends out of the lumen of the guide tube.

Abstract: A urethral plug inserter for insertion a urethral plug into a urethra of a male subject. The device including: a proximal insertion end; a distal gripping end; a central portion disposed between the proximal insertion end and the distal gripping end; and a central channel comprising a floor and axially extending from the proximal insertion end to the distal gripping end and configured to accept a lanyard section of the urethral plug.

Abstract: Systems for providing support to body tissue to alleviate incontinence are disclosed that comprise an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus and first and second sling end portions extending from the central support portion through body tissue and a tension adjustment mechanism acting on or within one or both of the sling end portions. The sling tension adjustment mechanism comprises one or more of a sling tensioning suture or band, a tensioning device coupled to a suture or band free end, a tissue anchor coupled to one or more of a suture free end and a sling end, a mesh fold, a suture tube, and a sling sheath in various combinations.

Abstract: An orthotopic artificial bladder endoprosthesis includes a casing made of a PGA fiber fabric; the casing having two first connectors for the connection with the ureters of a patient and a further connector for the connection with the urethra of a patient; an inflatable element inserted in the casing; the inflatable element being switchable between an inflated configuration, in which it supports and maintains in position the casing, and a deflated configuration.

Abstract: A puncture apparatus is disclosed, which can include an insertion portion that is insertable into a living body, the insertion portion including an urethral insertion portion and a vaginal insertion portion, the urethral insertion portion and the vaginal insertion portion each having at least two sensors; a puncture needle that punctures living body tissues near the insertion portion in a state in which the insertion portion is inserted into the living body, the puncture needle having at least one sensor on a distal portion of the puncture needle; and a monitor configured to receive information relating to a positional relationship between a distal portion of the puncture needle and the insertion portion.

Abstract: An apparatus for treating urinary incontinence, comprising a node; a support section adapted for providing urethral support attached to the node; and, an anchoring section adapted for resisting movement of the apparatus attached to the node; wherein the node is no longer than 30% of the entire length of the apparatus comprising the node, support section and the anchoring section together.

Abstract: An implantable device to treat obesity and a method of using the same, the device (31) is able to create a repetitive mechanical constraint on a gastrointestinal organ wall and includes: an energy source (36), and a mechanical stimulation element (35).

Abstract: Methods and apparatus are provided for treating tissue with apparatus that includes an priming portion for initiating a healing response in the tissue to be treated, and which delivers a bioactive agent during or after preparing tissue adjacent the apparatus, as by generating or aiding a healing, regeneration or repair response in the tissue. The priming portion may comprise an abrasive surface, fluid ejection ports, and/or stimulation by electrical, thermal, or light energy.

Abstract: There is provided a method for controlling a flow of urine in the urinary passageway of a patient's urethra, ureter, renal pelvis or bladder. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the urinary tissue wall) at least one portion of the urinary tissue wall to influence the flow in the urinary passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the urinary passageway. The method can be used for restricting or stopping the flow in the urinary passageway of a urinary incontinent patient, or for actively moving the urine in the urinary passageway, with a low risk of injuring the urethra, ureter, renal pelvis or bladder.

Abstract: Described are pelvic implants (e.g., urinary incontinence sling, hammock, etc.) and method of implanting a pelvic implant that provide treatment for pelvic floor disorders such as incontinence, stress urinary incontinence, prolapse (e.g., cystocele, enterocele, rectocele, vault prolapse), fecal incontinence, and the like, wherein the implant and methods involve various features, such as the ability to adjust dimensions of an implant before, during, or after implantation.

Abstract: A fabricated component for providing desired structural support has plural strands of material extending between opposing gathering points, and free ends extending from the gathering points. The component is preferably fabricated from a single strand of material using an appropriate folding procedure which includes the formation of plural loops of the strand, one upon the other, and development of the gathering points in opposing regions of the looped strand by passing opposing ends of the strand around the loops of the strand, and then through the resulting throws, or using a separate knotting arrangement. The fabricated component can be used in medical procedures, such as the support of subcutaneous tissue, muscle and organs, and other non-medical applications.

Abstract: A urinary incontinence device includes a working portion having an insertion equivalent diameter ranging from about 10 to about 25 mm and a use equivalent diameter ranging from about 25 to about 35 mm under an expansion pressure of about 20 to about 150 cm H2O.

Abstract: An anvil assembly delivery system includes an anvil assembly having a center rod and an anvil head assembly pivotally secured to the center rod a flexible tube having a first end configured for oral insertion into a patient and a second end engaged with the anvil assembly, and a retrieval suture connected to the head assembly positioned to extend from the anvil assembly in a direction opposite to the flexible tube. The anvil assembly delivery system also includes a spacer suture tube positioned adjacent the anvil head assembly and defining a suture channel, which is supported on the retrieval suture and is dimensioned to prevent the retrieval suture from becoming trapped in the staple line of a stapling device. In an embodiment, the spacer is a suture tube defining a suture channel which receives the retrieval suture.

Abstract: A tissue anchor system includes a support, a suture inserted through the support, an anchor having a fin forming an eyelet, where the suture is engaged with the eyelet of the fin. An introducer is provided having a cannula defining a bore sized to receive the anchor and a slot formed in a wall of the cannula, with the slot sized to receive the fin of the anchor.