Abstract: A rules engine acquires sensor data from sensors applied to the heart and detects an intrinsic beat of the heart. The rules engine determines whether an electrical waveform should be applied to the heart and, if so, the type of electrical waveform.

Abstract: Sensors are applied to the heart and sensor data is supplied to a rules engine. The rules engine applies rules that reflect a CRM pharmaceutical regime of the patient to the sensor data to determine whether an electrical waveform should be applied to the heart. When electrical stimulation is warranted, the drug “awareness” rules are used by the rules engine to instruct a multi-phase cardiac stimulus generator to generate an electrical waveform that improves the performance of the drugs administered to the patient, allow the patient to be administered a lower dose of a particular drug, and/or reduce or eliminate side effects from the drugs.

Abstract: Diastolic function is monitored within a patient based on dynamic cardiogenic impedance as measured by a pacemaker or other implantable medical device. In one example, the device uses ventricular cardiogenic impedance values to detect E-wave parameters representative of passive filling of the ventricles. Atrial cardiogenic impedance values are used to detect A-wave parameters representative of active filling of the ventricles. Diastolic function is then assessed or evaluated based on the E-wave and A-wave parameters. Various functions of the implantable device are then controlled based on the assessment of diastolic function, such as by adjusting atrioventricular delay parameters to improve diastolic function. In some examples, the detection of E- and A-wave parameters is achieved by aligning impedance signals to atrial activation, and separately to ventricular activation, during asynchronous VOO pacing or while artificially inducing a 2:1 block.

Abstract: Methods, implantable medical devices and systems configured to perform analysis of captured signals from implanted electrodes to identify cardiac arrhythmias. In an illustrative embodiment, signals captured from two or more sensing vectors are analyzed, where the signals are captured with a patient in at least first and second body positions. Analysis is performed to identify primary or default sensing vectors and/or templates for event detection.

Abstract: A system for designing a therapy or for treating a gastrointestinal disorder or a condition associated with excess weight in a subject comprising at least one electrode configured to be implanted within a body of the patient and placed at a vagus nerve, the electrode also configured to apply therapy to the vagus nerve upon application of a therapy cycle to the electrode; an implantable neuroregulator for placement in the body of the patient beneath the skin layer, the implantable neuroregulator being configured to generate a therapy cycle, wherein the therapy cycle comprises an on time during which an electrical signal is delivered, the electrical signal comprising: a) a set of pulses applied at a first selected frequency of about 150-10,000 Hz, wherein each pulse of the set of pulses has a pulse width of at least 0.01 milliseconds and less than the period of the first selected frequency.

Abstract: One aspect of the present disclosure relates to a system for electrical stimulation. A waveform generator can be configured to generate an electrical waveform. An electrode can be electrically coupled to the waveform generator and configured to deliver the electrical waveform to a nerve to reduce at least one reflex that affects a bodily function.

Abstract: Devices, systems and methods for increasing the efficacy and/or efficiency of deep brain stimulation (DBS) using parameters of stimulation that are custom tailored to a unique set of one or more symptoms and/or to a specific patient is shown and described herein. Also disclosed are devices, systems and methods for recording pertinent neural activity during non-regular patterns of stimulation and processing techniques for these recorded signals and stimulation parameter optimization based on these neural recordings may be used to tune computational models of the stimulation patterns to reproduce the observed neural activity.

Abstract: A neurostimulation system is shown and described. The neurostimulation system may include a stimulation device implantable into a patient, a lead operatively coupled with the stimulation device, a first power cell providing power to the stimulation device where the first power cell is charged by an externally applied AC (High HF) magnetic field.

Abstract: Peripheral nerve field stimulation (PNFS) may be controlled based on detected physiological effects of the PNFS, which may be an efferent response to the PNFS. In some examples, a closed-loop therapy system may include a sensing module that senses a physiological parameter of the patient, which may be indicative of the patient's response to the PNFS. Based on a signal generated by the sensing module, the PNFS may be activated, deactivated or modified. Example physiological parameters of the patient include heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflex, or thermal activity of the patient's body. In some examples, a patient pain state may be detected based on a signal generated by the sensing module, and therapy may be controlled based on the detection of the pain state.

Abstract: Bioelectronics for controlling a skeletal muscle by means of a neuro-electrical coded signal. An actual neuro-coded signal that is naturally generated in a body and operative in control of a skeletal muscle can be collected from a nervous network and stored in a database associated with an electronic device. An implantable muscle control device having one or more electrodes can be directly attached to an appropriate nerve leading to one or more target skeletal muscles associated with a subject. The actual neuro-coded signal can be then selected from the database and broadcasted to the implantable device associated with the subject via a neuro-code transmission approach in order to activate and regulate the affected skeletal muscles.

Abstract: An apparatus for the cardio-synchronised stimulation of skeletal or smooth muscle, but excluding the heart muscles, in a counterpulsation mode of a patient.

Abstract: Here we present the first model that quantitatively predicts the apparent spatial position and shape of percepts elicited by retinal electrical stimulation in humans based on the known anatomy of the retina. This model successfully predicts both the shape of percepts elicited by single electrode stimulation and the shape and relative positions of percepts elicited by multiple electrode stimulation. Model fits to behavioral data show that sensitivity to electrical stimulation is not confined to the axon initial segment, but does fall off rapidly with the distance between stimulation and the initial segment. Using the model, it is possible to compensate, preferably with a look up table, to match percepts to a desired image.

Abstract: Implantable medical devices and instruments (tools) including one or more implantable sensors. In certain embodiments, a hearing prosthesis comprises an implantable stimulating assembly configured to be implanted in a recipient's cochlea. At least one implantable sensor is disposed in the implantable stimulating assembly and is configured to monitor an insertion attribute.

Abstract: Information can be stored in a cochlear stimulation system by determining an item of patient specific information, transferring the item of patient specific information to an implantable portion of the cochlear stimulation system, and permanently storing the item of patient specific information in the implantable portion of the cochlear stimulation system. The item of patient specific information can comprise a parameter for use in generating a stimulation current. The implantable portion of the cochlear stimulation system also can be configured to permanently store one or more items of patient specific information in an alterable fashion. Further, an item of patient specific information can be retrieved from the implantable portion of the cochlear stimulation system. Additionally, an item of non-patient specific information for use in processing a received acoustic signal can be determined and permanently stored in an external portion of the cochlear stimulation system.

Abstract: The present invention relates inter alia to a new class of metal complexes comprising 1,2,3-triazoles having improved solubility and enhanced electro-optical properties. The present invention further relates to the preparation and use of these compounds.

Abstract: A wearable hands-free apparatus for providing phototherapy treatment to a number of hair, scalp and skin related conditions includes a supporting member for pivotally supporting a light emitting plate in spaced, opposing relation to the user's head. The light emitting plate is fitted with an array of light generating sources, such as light emitting diodes (LEDs), laser diodes, or infrared lights, that emit light within a particular wavelength range correlating with the treatment of one or more specific hair, scalp and/or skin-related conditions. The light emitting plate is specifically designed to conform to the shape of the human face or scalp for providing complete, uniform and consistent light coverage to the respective areas.

Abstract: An oscillating photo light therapy device includes a base and a light emitting unit pivotally mounted to the base. The light emitting unit is provided with at least one light emitting source. A movement imparting mechanism is provided for displacing the light emitting unit relative to the base along an oscillating motion, wherein the light source emits at different angles towards the user's body.

Abstract: The present application relates to systems and methods for altering temperature in a mammalian body. Optionally, the systems and methods can be used to lower or raise core body temperature of a mammalian subject. Optionally, the systems and methods can be used to lower or raise the temperature of glabrous skin of a mammalian subject.

Abstract: A resonant radio frequency diathermy heat applicator, including a flexible pad, an inductive coil with moderate defined resistance, fixed tuning capacitors, connecting cable and shielding that is broadly tuned to the signal source in a manner that eliminates the requirement for variable tuning elements.

Abstract: An electromagnetic hyperthermia assembly includes: a substrate; a plurality of hyperthermia needles each having a needle portion that extends through and downwardly from the substrate and that has a needle tip distal from the substrate; and a guiding plate having a plurality of through holes. The needle portions of the hyperthermia needles respectively and removably extend through the through holes such that the guiding plate is movable along the needle portions and between the substrate and the needle tips of the needle portions. The through holes keep the needle tips spaced apart from each other at predetermined positions.

Abstract: Systems and methods for lowering the core body temperature of subject are generally described. In certain embodiments, the core body temperature of a subject can be lowered by using a heat exchanger configured to cool an intubation gas that is transported to the subject via an intubation tube. The intubation tube used to deliver cooled intubation gas to the subject can include one or more features facilitating cooling of the subject. For example, in certain embodiments, the intubation tube may include multiple lumens. In some embodiments, one of the lumens can be used to deliver the relatively cool intubation gas and a second lumen can be used to transport relatively warm gas away from the patient's lungs. In certain embodiments, the system can be configured such that water (e.g., in the form of ice particles and/or liquid mist) can be delivered to the subject via the intubation tube, which can provide an enhanced cooling effect.

Abstract: Compositions and methods are provided for modulating the growth, development and repair of bone, cartilage or other connective tissue. Devices and stimulus waveforms are provided to differentially modulate the behavior of osteoblasts, chondrocytes and other connective tissue cells to promote proliferation, differentiation, matrix formation or mineralization for in vitro or in vivo applications. Continuous-mode and pulse-burst-mode stimulation of cells with charge-balanced signals may be used. Bone, cartilage and other connective tissue growth is stimulated in part by nitric oxide release through electrical stimulation and may be modulated through co-administration of NO donors and NO synthase inhibitors. Bone, cartilage and other connective tissue growth is stimulated in part by release of BMP-2 and BMP-7 in response to electrical stimulation to promote differentiation of cells.

Abstract: A neurostimulator lead including an elongated lead body having stimulating and proximal end portions and a center axis extending therebetween. The lead body includes an inner tubing that extends along the center axis. The inner tubing includes wire conductors that extend between the stimulating and proximal end portions. The lead also includes multiple electrode-inductor assemblies that are positioned along the stimulating end portion and spaced apart from one another along the center axis. Each of the electrode-inductor assemblies includes an inductor coil that is electrically coupled to one of the wire conductors and an electrode that is located proximate to the inductor coil. The electrode and the inductor coil are electrically joined, and the inductor coil is configured to prevent a flow of induced current that occurs when the lead is exposed to external magnetic fields.

Abstract: Methods of making an implantable pulse generator are disclosed herein. The implantable pulse generator can include a body defining an internal volume and a plurality of wires extending from out of the internal volume of the body. Some of these wires can be connected, either directly or indirectly to a lead via a welded joint. The welded joint can be created by first resistance welding and then laser welding some of the wires to a connector.

Abstract: A modular biomedical implant includes a processor, an electrode array, and a cable. The first end of the cable is attached to the electrode array and a second end of the cable terminates in a first array of contacts. A second array of contacts is electrically connected to the processor. A separate anisotropic conductor is disposed between the first array of contacts and the second array of contacts and forms electrical connections between the first array of contacts and the second array of contacts. A method for replacing a processor of a modular biomedical implant is also provided.

Abstract: An apparatus for neuromuscular electrical stimulation is provided. The apparatus may be a stimulation lead having an elongated member made up of at least one conductor and an insulative sheath surrounding at least a portion of the conductor. A distal portion of the elongated member may include one or more electrodes and at least one fixation element to secure the one or more electrodes in or adjacent to a desired anatomical site for providing stimulation thereto. The stimulation lead has a strain relief portion on the proximal side of the one or more electrodes, configured to reduce axial forces on the distal region of the elongated member, and the effects thereof, to reduce the risk of, or even prevent, displacement of the one or more electrodes and to accommodate localized flexural motion. The apparatus also may include at least one fixation element sized and configured to be deployed between muscle layers to maintain the electrode position at the stimulation site.

Abstract: Implantable medical leads include a shield that is guarded at a termination by having a first portion and a second portion of the shield, where the first portion is between a termination of the shield at the second portion and an inner insulation layer that surrounds the filars. The first portion may reduce the coupling of RF energy from the termination of the shield at the second portion to the filars. The first and second portions may be part of a continuous shield, where the first and second portions are separated by an inversion of the shield. The first and second portions may instead be separate pieces. The first portion may be noninverted and reside between the termination at the second portion and the inner layers, or the first portion may be inverted to create first and second sub-portions. The shield termination at the second portion is between the first and second sub-portions.

Abstract: In some examples, a lead identification system includes a first set of first lead indicators and a second set of second lead indicators. Each of the first lead indicators is configured to removably attach to at least one of a first therapy delivery element, a first epidural needle, or a first connector to uniquely identify at least one of the first therapy delivery element, the first epidural needle, or the first connector during implantation of the first therapy delivery element in the patient. Each of the second lead indicators is configured to removably attach to at least one of a second therapy delivery element, a second epidural needle, or a second connector to uniquely identify at least one of the second therapy delivery element, the second epidural needle, or the second connector during implantation of the second therapy delivery element in the patient.

Abstract: The invention provides a stent-graft system comprising a graft member and a stent having a connection end interconnected with the graft member and a free end opposed thereto. A belt retaining structure is provided at the stent free end. A belt is releasably retained in the belt retaining structure and is configured to constrain the stent free end independent of the stent connection end. A method of securing at least one end of a stent-graft within a vessel is also provided.

Abstract: An expandable intraluminal medical device is provided. The medical device is provided with end structures that have transitional surfaces defined by two angled planes. The transitional surfaces may be useful in reducing scraping between the expandable device and a restraining sheath used for delivering the medical device.

Abstract: An endovascular stent-graft (10) includes a generally tubular hourglass-shaped body (22), which is configured to assume a radially-compressed delivery configuration and a radially-expanded deployment configuration. The hourglass-shaped body (22) includes a flexible stent member (26), which includes a plurality of structural stent elements (28); and a tubular fluid flow guide (24), which includes a fabric (29), and is attached to the structural stent elements (28). The hourglass-shaped body (22) is shaped so as to define a narrow waist portion (32) longitudinally surrounded by and adjacent to wider first and second longitudinal portions (30, 34). The fabric (29) along the waist portion (32) is shaped so as to define at least first and second lateral apertures (36, 38). Other embodiments are also described.

Abstract: Biodegradable endoprostheses are formed from amorphous polymers having desirable biodegradation characteristics. The strength of such amorphous polymers is enhanced by annealing to increase crystallinity without substantially increasing the biodegradation time.

Abstract: An endoluminal prosthesis for deployment in a body which has a first tubular structure for stabilising the prosthesis, the first tubular structure being substantially concentric about a first axis and movable between a compact and an expanded state. The prosthesis also has a second tubular structure for supporting an artificial heart valve, the second tubular structure being substantially concentric about a second axis and moveable between a compact and an expanded state. The first axis and the second axis extend at different angles when the first and second structures are in the compact and/or expanded state. A third structure which is shape and/or length adjustable is positioned between the first and second structures.

Abstract: Described, in certain aspects of the invention, are apparatuses and methods for deploying artificial devices within the vascular system. One apparatus includes a delivery device having a lumen and a deployment member slidably received within the lumen. This apparatus further includes an artificial device having an anchoring element releasably engaged with the deployment member. Such an apparatus can be percutaneously delivered to a site within a vascular vessel, and thereafter manipulated so that the anchoring element attaches to the vessel wall. The delivery device and deployment member can then be withdrawn from the vessel, whereby the deployment member disengages from the anchoring element, leaving the artificial device implanted in the vessel.

Abstract: A device (200) for implantation in or near an annulus of a tricuspid valve comprising at least one blood flow control element (202) adapted to capture a volume of blood therein. Optionally or alternatively, the blood flow control element is adapted to allow at least some volume of blood (406) to regurgitate through the annulus during at least some part of systole. Optionally or alternatively, the device comprises a relatively rigid annulus with an arc length of less than 300 degrees. Optionally or alternatively, the relatively rigid annulus comprises a plurality of tissue fixation elements positioned along no more than 300 degrees of a circumference of the annulus, for example to avoid damaging conduction pathways between an atria and a chamber.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: The present invention concerns an actuating device for actuating a mechanical adjustment element of surgical implant, said mechanical adjustment element allowing to modify the functional shape and/or the functional size of the surgical implant when actuated, said actuating device comprising transmission means linked with one end to the mechanical adjustment element and able to move the mechanical adjustment element when said transmission means are actuated, connecting means (7) mounted on the other end of the transmission means and able to actuate the transmission means, said connecting means (7) comprising coupling means and driving means (24) comprising complementary shaped coupling means, said driving means (24) being designed to be removable and fitted into the coupling means for moving the mechanical adjustment element by driving into movement a movable part of the connecting means (7).

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: A heart valve prosthesis includes an expandable prosthetic valve including three valve leaflets coupled to an anchoring structure. The anchoring structure includes an annular member and a plurality of arms movably coupled to the annular member at one end. The free ends of the arms extend radially away from the prosthesis toward a valve annulus. The arms are configured to fit in a space defined between an open native valve leaflet and a wall of a valve sinus. The arms are sufficiently resilient such that they resist downward movement in response to pressure exerted on the prosthesis, facilitating anchorage and stabilization of the prosthesis at the implantation site.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient's body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation.

Abstract: A self-expanding valved stent is constructed from a polytetrafluoroethylene (PTFE) covered nitinol or stainless steel wire frame. Anchoring is facilitated by arms emanating from the ventricular end of the device that are designed to atraumatically insinuate themselves around chordae and leaflets and trap them against the expanded stent body. The valve prosthesis includes a partially self-expanding stent having a wire framework defining outer and interior surfaces and anchoring arms. The stent has an unexpaneled and an expanded state and anchoring arms having an elbow region and a hook that clamps around mitral tissue of the patient when seated. An elastic fabric/cloth made of for example, PTFE material, is wrapped circumferentially around the wire framework. A valve having at least one leaflet is fixedly attached to the interior surface of the stent.

Abstract: A medical device is disclosed that reinforces weakened or degenerated areas of at least a portion of a leaflet (24) of the heart valve. Function of a heart valve is thus improved. The medical device comprises at least a first partly flexible leaflet reinforcement patch (30) having an extension between an inner section (34) and an outer section (32), wherein said outer section (32) is configured to be oriented towards said annulus, and said inner section (34) is configured to be oriented towards said inner section of said valve tissue, and at least a portion of said inner section (34) of said flexible leaflet reinforcement patch (32) having at least one of said plurality of leaflets (24) in juxtaposition to said portion of said inner section (34), and said portion of said inner section (34) being positioned to provide reinforcement to said plurality of leaflets (24).

Abstract: The present invention relates to a biomedical implant for use in a fluid shear stress environment of a subject. The biomedical implant of the present invention includes a patterned surface having a plurality of cellular niches. The cellular niches of the patterned surface are effective to maintain at least one localized layer of living cells within the plurality of cellular niches by decreasing fluid shear stress within the cellular niches as compared to fluid shear stress measured outside of the cellular niches, with the fluid shear stress measured outside of the cellular niches having a peak fluid shear stress of at least about 50 dynes per square centimeter (dynes/cm2). The present invention also relates to methods of making and using the biomedical implant. The present invention further relates to a biomedical implant system.

Abstract: An ophthalmic lens is disclosed, one embodiment comprising an optic having an anterior surface and a posterior surface disposed about an optical axis, wherein at least one of the surfaces has a profile characterized by superposition of a base profile and an auxiliary profile, the auxiliary profile comprising a continuous pattern of surface deviations from the base profile. The auxiliary profile is a sinusoidal profile and can be amplitude modulated, frequency modulated or both amplitude and frequency modulated. The ophthalmic lens can be an IOL.

Abstract: Methods for breast reconstruction and augmentation are provided which may reduce the incidence of capsular contracture. Methods for treating an encapsulated breast and reducing potential for capsular contracture in the breast are also provided.

Abstract: A system for an anatomical joint includes a first fastener, a second fastener, a prosthetic ligament member, and a biasing member associated with at least one of the first and second fasteners. The first fastener is operable to be connected to a first bone portion. The second fastener is operable to be connected to a second bone portion. The prosthetic ligament member is flexible and is directly coupled to both the first and second fasteners to support the first bone portion and the second bone portion for relative movement. A portion of the prosthetic ligament member extends from the first fastener to the second fastener and has an adjustable length. The biasing member is operable to bias the prosthetic ligament member to thereby maintain tension in the prosthetic ligament member.

Abstract: The invention relates to an implantable prosthetic device for the repair of connective tissue in an animal or a human. In one embodiment, an implantable prosthetic device (100) for the repair of connective tissue (500) in an animal or human is disclosed which comprises a biocompatible pad (101) having an open structure to provide a scaffold for the in-growth of tissue into the pad; and a reinforcement region (206) attached to or formed integrally with the pad. The device is arranged so that it can be attached to tissue by forming a puncture (301) either a) within the reinforcement region, or b) in an area of the pad which is inboard of the reinforcement region, so that a suture (300) can be located through the puncture, the reinforcement region serving to support tensile loading in the device during use by resisting pull-through of the suture.

Abstract: A prosthetic anchor to be attached to a natural or prosthetic structure of a human or animal. The anchor includes a central layer with first and second surface. A plurality of fiber bundles, each with a medial portion, are concentrically embedded within the central layer to substantially define a horseshoe-shaped pattern. A substrate element is configured to be secured to the natural or prosthetic structure and to receive the second surface of the central layer. A securing element operably coupled to the second surface of the central layer is configured to secure the central layer to the substrate element in at least two positions.

Abstract: One aspect of the present invention is a method of producing a decellularized composite tissue bioscaffold for musculoskeletal tissue interface reconstruction by physicochemically treating a musculoskeletal tissue interface isolated from allogeneic sources. In certain embodiments, such musculoskeletal tissue interfaces can also be isolated from xenogeneic sources. The method comprises treatment of the interface with detergents, chemical oxidants and ultrasonic energy, and wash steps in between to remove residual detergents as well as oxidants. The resulting bioscaffold may be freeze-dried or lyophilized, sterilized and aseptically packaged for subsequent use.