Abstract: An implantable medical device (IMD) including a housing defining a propellant chamber, a drug reservoir located within the propellant chamber of the housing configured to receive a therapeutic fluid, a propellant gas within the propellant chamber; and a volume measurement system that includes a temperature sensor configured to measure a temperature of the propellant gas within in the propellant chamber and a pressure sensor configured to measure a pressure of the propellant gas within the propellant chamber. The volume measurement system is configured to measure the pressure and the temperature of the propellant gas to provide current volume information of the therapeutic fluid in the drug reservoir.

Abstract: A surgical staple cartridge is disclosed comprising a plurality of staples removably stored within the surgical staple cartridge. The staples comprise staple legs which extend from a staple base portion. The staple legs comprise staple tips configured to pierce tissue and contact a corresponding forming pocket of an anvil of surgical stapling instrument. The staples further comprise zones having different hardnesses.

Abstract: A medical device that may include an elongate member having a proximal end and a distal end, and a lumen disposed through the elongate member is disclosed. The medical device may also include an opening disposed at the distal end of the elongate member in communication with the lumen, and a pushing element disposed with the lumen. The medical device may also include at least one fiducial disposed within the lumen and distal to the pushing element, and a separating mechanism disposed at the distal end of the elongate member. The separating mechanism may be configured to apply a separating force to deploy the at least one fiducial.

Abstract: An anvil buttress loading system includes an anvil assembly, an anvil buttress loading tool, and an anvil buttress. The anvil buttress is retainable on each of the anvil buttress loading tool and the anvil buttress, and is transferrable from the anvil buttress loading tool to the anvil assembly.

Abstract: A tissue thickness compensator may generally comprise a compressible core comprising a plurality of movable particles, and a wrap surrounding the compressible core. The plurality of movable particles may comprise at least one medicament. A tissue thickness compensator may generally comprise a compressible core comprising a plurality of crushable particles, and a wrap surrounding the compressible core. The plurality of crushable particles may comprise at least one medicament. The compressible core may comprise a material selected from a group consisting of a biocompatible material. The wrap may comprise a material selected from a group consisting of a biocompatible material. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Abstract: Suturing apparatuses can be configured to suture biological tissue, such as an anatomical valve. The suturing apparatuses can include a suturing device having an elongate shaft having a proximal end and a distal end, one or more tissue grasping arms, and a handle with actuators. The suturing device can further include at least two needles. One of the tissue grasping arms can have at least two suture mounts each loaded with a suture portion. The suture portions on the suture mounts can form a single suture strand. Methods for suturing bodily tissue may be performed with the suturing apparatuses. The tissue grasping arms can grasp tissue therebetween and at least two needles can be deployed toward the suture mounts, engage the suture portions, and be retracted through the tissue. A knot can be tied on the ends of the suture strand retrieved by the needles.

Abstract: A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include electrodes coupled to an implantable pulse generator (IPG), a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Abstract: An ultrasonic surgical instrument that can be used in a robotic surgical system includes an end effector having an ultrasonic blade and a clamp arm pivotally secured relative to the ultrasonic blade. A shaft assembly extends proximally from the end effector and includes a tube, an acoustic waveguide received within the tube, and a sheath positioned between the acoustic waveguide and the tube to damp acoustic vibrations from the acoustic waveguide toward the tube. At least one sensor is positioned on at least one of the end effector or the sheath to measure a force applied at the end effector or the sheath as a measured force, respectively, and thereby provide real-time feedback of a non-clamping force applied against one of the ultrasonic blade or the clamp arm.

Abstract: A surgical clamp is disclosed. The surgical clamp comprises a two-piece body comprising atop jaw housing that inter-fits with a bottom jaw housing; the top jaw housing comprising a top jaw; the bottom jaw housing comprising a bottom jaw; the inter-fitting top jaw housing and bottom jaw housing disposed for movement relative to one another; a bias to the top jaw housing and bottom jaw housing apart; and a lever moveable between a lock position and an open position and the lever disposed to prevent opening movement of the top jaw housing relative to the bottom jaw housing and to allow graduated relative closing movement of the top jaw housing relative to the bottom jaw housing in the lock position and to allow opening and closing movement of the top jaw housing relative to the bottom jaw housing in the open position.

Abstract: The present invention relates to an automatic tension measurer, comprising: a band lengthily formed in a longitudinal direction; a main body formed to allow the band to be guided thereinto such that one-side end portion of the band is fixed and the other-side end portion thereof is drawn to the outside; a marking part implemented in the main body, and formed so as to enable marking in the band at a specific position in response to the tension applied to the band; and a stopper formed in the main body, and stopping the band at a specific position.

Abstract: Systems, devices and methods described herein relate to endovascular devices for delivering sutures for securing grafts or other objects to patient vessels. In some embodiments, a suture includes a set of two legs having proximal ends joined to each other and elongate bodies that extend parallel to one another such that the set of two legs form a U-shaped structure. A suture delivery system can include a housing configured to contain a suture in a flattened configuration, and a deployment element having a ribbon-shaped distal portion disposed in the housing and including a set of formations, where the housing and the set of formations of the deployment element are configured to collectively constrain the suture in the flattened configuration until the suture is released through the opening of the housing.

Abstract: A fastener cartridge can comprise a support portion, a tissue thickness compensator positioned relative to the support portion, and a plurality of fasteners positioned within the support portion and/or the tissue thickness compensator which can be utilized to fasten tissue. In use, the fastener cartridge can be positioned in a first jaw of a surgical fastening device, wherein a second jaw, or anvil, can be positioned opposite the first jaw. To deploy the fasteners, a staple-deploying member is advanced through the fastener cartridge to move the fasteners toward the anvil. As the fasteners are deployed, the fasteners can capture at least a portion of the tissue thickness compensator therein along with at least a portion of the tissue being fastened.

Abstract: In general, scapular tethers and methods of using scapular tethers are provided. A tether is configured to be implanted in a body of a patient and to control movement of the patient's scapula. In an exemplary embodiment, the tether is configured to be attached to at least one body structure in a patient. The tether includes a flexible member configured to, when implanted in the patient, flex in response to movement of the patient's scapula accompanying arm movement of the patient.

Abstract: A surgical stapler, or fastening instrument, may generally comprise a layer, such as a tissue thickness compensator, for example, releasably attached to a fastener cartridge and/or anvil by a flowable attachment portion. The flowable attachment portion may be indefinitely flowable. The flowable attachment portion may be flowable from the time that layer is installed to the fastener cartridge to the time in which the layer is implanted to patient tissue. The flowable attachment portion may comprise a pressure sensitive adhesive. The flowable attachment portion may comprise an adhesive laminate comprising a base layer comprising the tissue thickness compensator and an adhesive layer on at least a portion of a surface of the base layer comprising the pressure sensitive adhesive. Articles of manufacture comprising flowable attachment portion and methods of making and using the flowable attachment portion are also described.

Abstract: A method of generating a computer-based observable model of an implantable repair material secured to a patient is provided. The method includes processing data corresponding to a patient using a computing device including a processor and a memory storing a software application executable by the processor. The method also includes indicating an implantable repair material and a fixation for securing the implantable repair material to the patient and indicating a distribution of the fixation about the implantable repair material. The method also includes generating an observable model of the implantable repair material secured to the patient on a display operably associated with the computing device. The observable model depicts the indicated distribution of the fixation about the implantable repair material.

Abstract: A method for making a braided medical device may involve positioning an insert inside a braided material, processing the braided material to form the braided medical device, dissolving and/or crushing the insert into multiple pieces, and removing the multiple pieces from the braided medical device. In some embodiments, the insert is made of gypsum. A braided medical device for occluding a defect in a heart may include a right disc for residing in a right side of the heart, a left disc having a partially circular shape for residing in a left side of the heart, and a waist extending between the right disc and the left disc and having a smaller diameter than that of either the right disc or the left disc.

Abstract: The present disclosure is directed to Myointegration, the improvement of breast implant apparatus, system and methods for a design that extends the breast implant centrifugally, or in which a separate device is utilized in combination with a breast implant, that has one or more straps originating from the breast implant extension or from the separate device. The one or more straps are looped through the pectoralis major muscle then back into the implant extension or the separate device repeatedly. The straps are eventually attached in some manner to themselves, to the implant extension, or to the separate device. Since the pectoralis major muscle contains neuromuscular spindles that sense length, velocity and acceleration, when the user changes position from supine to vertical, the gravitational force generated by the mass of the breast implant pulls on the strap or straps, which pulls the muscle and stimulates the neuromuscular spindles, thereby generating lift of the implanted breast insert.

Abstract: A device includes a clip including a capsule and a pair of clip arms, proximal ends of which are slidably received within a channel of the capsule to move the clip arms between an open configuration and a closed configuration. The clip arms are aligned relative to one another via a pin received within openings extending through proximal ends of the clip arms. A proximal portion includes a flexible shaft extending from a proximal end to a distal end including a bushing releasably coupled to the capsule. A control member extends longitudinally through the flexible shaft from a proximal end to a distal end releasably coupled to the proximal ends of the clip arms, the distal end of the control member including a pair of holding jaws, each of which include a pair of fingers extending about the pin along opposing sides thereof to grip the pin therebetween.

Abstract: A pin lock may be used to prevent a compressor-distractor from pushing off of a surgical pin as the compressor-distractor is actuated to move one bone relative to another bone. In some examples, the compressor-distractor is attached to a metatarsal with a first pin and to a cuneiform with a second pin. The pin lock can be inserted onto the first pin or the second pin, optionally with a second pin lock inserted onto the other pin. The compressor-distractor can then be actuated while the compressor-distractor is locked by the pin lock from moving up along the axial length of the first pin or the second pin.

Abstract: A buttress applier cartridge configured to interface with an end effector of a surgical stapling instrument is disclosed. The buttress applier cartridge includes a first loading region configured to interface with an anvil of the end effector and a second loading region configured to interface with an elongate channel of the end effector. The first loading region includes a first absorbable layer and a loading assembly for securing the first absorbable layer to the anvil as the anvil approaches the first absorbable layer. The second loading region includes a staple cartridge removably coupled to the buttress applier cartridge. The staple cartridge includes a deck and a second absorbable layer positioned on the deck.

Abstract: Disclosed embodiments include apparatuses, systems, and methods for guiding a rotatable actuator along a helical path with a varied pitch to motivate an attached implement. In an illustrative embodiment, an apparatus includes an elongated implement movable along an axis and a rotatable actuator operably coupled with a proximal end of the implement to motivate the implement to move along the axis in response to rotation of the rotatable actuator. A guide is operably coupled with rotatable actuator, where the guide defines a generally helical channel around the axis to direct movement of a rotatable actuator, and wherein a pitch of the helical channel is varied to reduce a distance of travel of the actuator along the axis per unit of rotation of the actuator.

Abstract: Ligation bands are provided having improved compression and anti-slip properties. For example, a ligation band can be provide with a substantially ring-shaped elastic body that has a first tissue-contacting surface, a second tissue-contacting surface opposite the first tissue-contacting surface, and an aperture that extends therethrough. At least one of the tissue-contacting surfaces can have a plurality of protrusions that define an interlinking web-pattern with a plurality of recesses.

Abstract: Compressible adjuncts for use with a surgical cartridge are provided. In one exemplary embodiment, a compressible adjunct includes a biocompatible adjunct material that is configured to be releasably retained on a staple cartridge and that is configured to be delivered to tissue by deployment of staples in the cartridge. The adjunct material includes a lattice main structure having at least one absorbable sub-structure formed in the lattice main structure, the at least one absorbable sub-structure configured to control fluid movement through the adjunct material such that the fluid movement impacts healing of tissue adjacent the adjunct material when the adjunct material is in a tissue deployed state. Stapling assemblies for use with a surgical stapler are also provided.

Abstract: A method may include displaying to a user an interface at which the user inputs a fear of hypoglycemia index (FHI), the FHI corresponding to an acceptable probability of a blood glucose level being below a threshold blood glucose level. The method may also include receiving blood glucose data for a person with diabetes (PWD). The method may additionally include calculating a probability of the PWD having a blood glucose level below the threshold blood glucose level based on the variability of the received blood glucose data. The method may also include setting one or more target blood glucose levels to align the probability of the PWD having a blood glucose level below the threshold blood glucose level with the acceptable probability associated with the user input FHI. The method may additionally include delivering insulin, using the insulin delivery device, based on the target blood glucose level.

Abstract: A first catheter has a first lumen therealong, a first-catheter proximal portion, and a steerable first-catheter distal portion that is transluminally advanceable to the heart. A second catheter has second lumen therealong, a second-catheter proximal portion, and a steerable second-catheter distal portion. The second catheter extends through the first lumen, such that the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, the second-catheter distal portion extends distally out from the first-catheter distal portion, and within at least the first-catheter proximal portion, the first lumen and the second lumen are coaxial on a longitudinal axis. A first handle is coupled to the first-catheter proximal portion, and extends obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis. A second handle is coupled to the second-catheter proximal portion, and is disposed proximally from the first handle.

Abstract: A protective assembly for use during laparoscopic surgery, the assembly comprising: a thin membrane formed from non-toxic material, the membrane being sufficiently thin and maneuverable to be passed through a cannula of a trocar; a flexible connector extending from the thin membrane; and an insertable shaft dimensioned to be passed through the cannula wherein a distal portion of the shaft is anchored to the flexible connector.

Abstract: An assembly includes an applicator, which includes a housing defining a gap configured to receive an end effector jaw of a surgical stapler. The applicator also includes a platform positioned within the gap. The assembly also includes a buttress assembly having a first length and positioned on the platform. The assembly further includes a trimming feature presented by the applicator or the buttress assembly, and configured to facilitate trimming of the buttress assembly from the first length to a predetermined second length.

Abstract: Packaging for a medical implant such as a hernia repair prosthetic material includes a carrier and a stiffener. The hernia repair prosthetic material is placed adjacent to the stiffener within the carrier. The carrier assembly is sealed within an outer pouch, such as a foil pouch, and sterilized. When the carrier is being removed from the pouch in preparation for surgery, the stiffener helps prevent the carrier assembly from contacting non-sterile portions of the pouch.

Abstract: An implant removal device includes a body, a first arm, a second arm, an actuation interface, and an extraction member. The first arm is supported at the body and configured to move relative to the body between a retracted position and a skin gripping position. The second arm is supported at the body and configured to move relative to the body between the retracted position and the skin gripping position. The actuation interface is supported at the body. The actuation interface is configured to receive a first actuation input thereat to cause at least one of the first arm and the second arm to move from the skin gripping position to the retracted position. The extraction member is supported at the body and located between the first arm and the second arm.

Abstract: An implant delivery device may include an implant holding portion proximate the distal end, the implant holding portion being configured to retain a sheet-like implant during implantation of the implant. In addition, the implant holding portion may be configured to receive the implant with a fixed implant supporting flange member configured to support the implant on one side, and a movable implant supporting flange member. The movable implant supporting flange member may be configured to be slidable between a distal position and a proximal position, wherein, in the distal position, the movable implant supporting flange member and secures the implant against the fixed implant supporting flange member, and in the proximal position, the movable implant supporting flange member is withdrawn from the distal end of the implant delivery device, thus enabling release of the implant.

Abstract: Drug delivery articles, resident articles, and retrieval systems e.g., for gram-level dosing, are generally provided. In some embodiments, the residence articles are configured for transesophageal administration, transesophageal retrieval, and/or gastric retention to/in a subject. In certain embodiments, the residence article includes dimensions configured for transesophageal administration with a gastric resident system. In some cases, the residence article may be configured to control drug release e.g., with zero-order drug kinetics with no potential for burst release for weeks to months. In some embodiments, the residence articles described herein comprise biocompatible materials and/or are safe for gastric retention. In certain embodiments, the residence article includes dimensions configured for transesophageal retrieval. In some cases, the residence articles described herein may comprise relatively large doses of drug (e.g., greater than or equal to 1 gram).

Abstract: Fixation system for engaging tissue of a patient including an implantable fixation device having a first arm and a second arm, a first proximal element, a second proximal element, and a coupling member. The system includes a delivery device having a catheter, a shaft extending through the at least one lumen of the catheter, a first proximal element actuator and a second proximal element actuator. The second end portions of the first proximal element actuator and second proximal element actuator can be coupled to at least one of the shaft and the coupling member.

Abstract: Compressible adjuncts for use with a staple cartridge are provided. In one exemplary embodiment, the compressible adjunct includes a non-fibrous adjunct material formed of at least one fused bioabsorbable polymer and configured to be releasably retained on a cartridge and delivered to tissue by deployment of staples in the cartridge. The adjunct material includes a lattice macrostructure having primary and secondary microreservoirs formed in the lattice macrostructure. The primary microreservoirs and secondary microreservoirs are different in size relative to each other and contain drug.

Abstract: The present disclosure describes kits for surgical repair of soft tissue defects, including hernias. The kits include any combination of components selected from an implantable sheet, at least one loop tie, a delivery tool, a positioner, a rolling device, and a insertion member. Packaging for the kits and/or components and methods of using the kits and/or components are also provided.

Abstract: An endovascular medical assembly and method for restoring chordal support to a leaflet of a heart valve by implanting artificial chordae tendinea in the heart. A chord is inserted into the heart endovascularly with a leaflet grasper which pierces the leaflet and implants the chord through the leaflet. An anchor assembly is implanted into an intracardiac wall and has anchor lines extending therefrom. The chord and an anchor line are assembled by a line gathering member and the tension of the chord is adjusted and secured. The chord is, thus, secured to the anchor assembly to support the leaflet.

Abstract: Detachment of a medical device from a delivery assembly can utilize features of electrolytic detachment and features of mechanical detachment. Detachment zones can facilitate mechanical retention of the medical device as well as electrolytic corrosion of portions of the delivery assembly to allow mechanical release of the medical device. Such a delivery system, can include an implant comprising a hub, the hub defining an aperture having an aperture cross-sectional dimension; and a delivery wire comprising (i) a core member extending through the aperture and (ii) a stopper positioned distal to the aperture, the stopper having a first cross-sectional dimension larger than the aperture cross-sectional dimension, and the stopper being electrolytically corrodible to reduce the first cross-sectional dimension to a second cross-sectional dimension smaller than the aperture cross-sectional dimension.

Abstract: Braided occluding devices having an access passage and methods including the same are described herein. The occluding device includes a braided frame which includes. The braided frame includes an annular distal disc portion, a waist member, and an annular proximal disc portion defining a passageway through the braided frame. The braided frame is formed with a closed end braid.

Abstract: The disclosure describes and illustrates improvements to an incontinence clamping device, to include an adjustable hinge. An embodiment of the incontinence clamping device more specifically includes two arms coupled together with a hinge pin in a way that permits two configurations of the arms. The improvements and inventions discussed herein provide a better user experience and increase the usability of the incontinence clamp device.

Abstract: The present invention relates to a synthetic prosthesis for tissue reinforcement comprising: a porous knit made from a monofilament of a synthetic biocompatible material, said knit defining two opposite faces, a first face and a second face, a synthetic non porous biodegradable film comprising at least a copolymer of at least ?-caprolactone, said film covering at least part of said first face, a synthetic biodegradable binder bonding said film to said first face, said binder comprising at least a polymer of ?-caprolactone, wherein said second face of said porous knit is left open to cell colonization. The invention also relates to a method for forming such a prosthesis.

Abstract: A self-closing device for implantation within a patient's body includes base material including an inner surface area for securing the base material to a tissue structure, and a plurality of support elements surrounding or embedded in the base material. The support elements are separable laterally within a plane of the base material to accommodate creating an opening through the base material for receiving one or more instruments through the base material, and biased to return laterally towards a relaxed state for self-closing the opening after removing the one or more instruments. The device may be provided as a patch or integrally attached to a tubular graft or in various shapes.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: Anchors and systems for docking a prosthetic heart valve at a native heart valve are disclosed. An anchor can include at least three coils and a seal positioned between at least two adjacent coils of the at least three coils. The seal circumscribes at least a portion of the at least two adjacent coils and has opposite ends that are spaced away from corresponding opposite ends of the at least three coils.

Abstract: A buttress assembly is configured to temporarily adhere to a wet surgical stapler end effector. The buttress assembly includes a buttress body and a humidity tolerant adhesive material. The humidity tolerant adhesive material is applied to at least one side of the buttress body. The humidity tolerant adhesive material is configured to hold the buttress body to an underside of an anvil or a deck of a staple cartridge for at least five minutes in an environment of 100% relative humidity at approximately 37° C.

Abstract: An enclosure provides a prophylactic barrier that may be permeable to gases, hormones, proteins, and peritoneal fluid, but restrains tumor cells within the enclosure so as to inhibit ovarian cancer invasion of adjacent tissue, and increase the speed of diagnosis of ovarian dysplasia, including cancer. The enclosure includes one or more of fiducial markers, heat sensors, and blood flow reflectors, which may be imaged non-invasively in order to detect conditions or pathology affecting the ovary. The enclosure may also include an access port that permits sampling of the enclosure's contents to further aid in detecting or treating conditions or pathology affecting the ovary.

Abstract: Resorbable implants comprising poly(butylene succinate) and copolymers thereof have been developed. The implants implants are preferably sterilized, and contain less than 20 endotoxin units per device as determined by the limulus amebocyte lysate (LAL) assay, and are particularly suitable for use in procedures where prolonged strength retention is necessary, and can include one or more bioactive agents. The implants may be made from fibers and meshes of poly(butylene succinate) and copolymers thereof, or by 3d printing, and the fibers may be oriented. Coverings and receptacles made from forms of poly(butylene succinate) and copolymers thereof have also been developed for use with cardiac rhythm management devices and other implantable devices. These coverings and receptacles may be used to hold, or partially/fully cover, devices such as pacemakers and neurostimulators.

Abstract: A knotless suture anchor construct for securing a tissue in a desired position relative to a bone hole. The construct includes a substrate having a first end and a second end, and a filament woven through a plurality of passing locations along the substrate. The filament forms a first loop extending to a passing limb and reducing limb. There is a passing portion in the reducing limb between two adjacent passing locations of the plurality of passing locations. In a pre-deployment configuration, the first loop of the filament extends from a first end of the substrate and the passing limb and the reducing limb extend from the second end of the substrate. Also, in the pre-deployment configuration, the passing portion extends through the first loop, forming a second loop in the reducing limb.

Abstract: In general, systems and methods described herein include active or passive sensing mechanisms, such as sensors, that can monitor at least one exposure condition of an adjunct and any medicant(s) retained therein. In some instances, the active or passive sensing mechanisms can also track the extent of the adjunct's and medicant(s)'s exposure, e.g., frequency, intensity, and/or duration).

Abstract: Surgical delivery devices of the invention have a delivery shaft extending from a handle, with a deformable member such as a plate or a leaf at a distal portion of the shaft with a surface carrying an implant for orthopedic surgery. A trigger or lever on the device positions the deformable member between a first cylindrical configuration that can pass through a cannula used in arthroscopic surgery and a second, substantially flat configuration useful to place the implant on tissue during the arthroscopic surgery. Preferably the trigger may be operated to hold the deformable plate or leaf in any of a continuum of positions between the first cylindrical configuration and the second, substantially flat configuration.

Abstract: This disclosure relates to surgical tools and methods. The surgical tools can include a handle, which includes an outer surface. A first rod extends from the handle and includes a first lumen. A second rod extends from the handle and includes a second lumen. A first set of suture cleating channels are formed in the outer surface. A second set of suture cleating channels are formed in the outer surface and spaced apart from the first set of suture cleating channels.

Abstract: A microelectrode array comprises three or more flexible oblong, electrically co-operating microelectrodes in wire and/or ribbon form disposed substantially in parallel. The microelectrodes are electrically insulated except for at a distal section thereof. The array further comprises electrically non-conducting microfibres connecting central portions of the microelectrodes in oblique directions in respect of the array axis. In a preferred array variety the microelectrodes are joined by a glue that is dissolvable or degradable in aqueous body fluid. Also disclosed is a combination of two or more arrays of the invention.