Abstract: Embodiments of the invention provide optimized sputtered metallic surfaces adapted for use with implantable medical devices as well as methods for making and using such polymeric surfaces. These sputtered metallic surfaces have features that function to inhibit or avoid an inflammatory immune response generated by implantable medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes having a sputtered metallic surface adapted to contact an in vivo environment.

Abstract: Disclosed is the design, fabrication, and characterization of a novel system comprising a parallel set of nanopore microneedles (NPMs) for cell transfection through controlled nanoelectroporation (NEP) and electrophoretic insertion of genetic materials.

Abstract: A connector and lead (or other elongated body) can produce a tactile sensation that indicates alignment between connector contacts of the connector and the terminals on the lead (or other elongated body). For example, a terminal or retention sleeve of the lead (or other elongated body) may include an indented circumferential groove that interacts with a connector contact or retention contact of the connector to produce the tactile sensation. As another example, one or more terminals or spacers may have a larger diameter than adjacent spacers or terminals to interact with a connector contact to produce the tactile sensation.

Abstract: A medical electrode array system comprising a thin-film substrate, a plurality of electrode contacts disposed on the thin-film substrate, and a plurality of traces. The plurality of electrode contacts is configured to provide electrical contact points. The plurality of traces is electrically connected to the plurality of electrode contacts. A electrode contact of the plurality of electrode contacts has a dedicated trace of the plurality of traces that provides electrical connectivity to the electrode contact. The thin-film substrate is configured to flex to maintain continuous contact with contours of patient anatomy. The plurality of traces includes flexible spring-like portions to add flexibility to the thin-film substrate.

Abstract: A device for insertion into soft tissue including a micro electrode, a micro light source; a stiffening element having a material dissolvable or degradable in aqueous body fluid or a material swellable in such fluid to form a transparent gel; a coat of a flexible non-conducting polymer material on the stiffening element; a base disposed at the rear end of the device. The flexible coat has a distal opening allowing light emitted from the light source to leave the device upon said collapse or dissolution or swelling. Also disclosed is a therapeutic or diagnostic device formed in the tissue from the insertable device, uses thereof, and a method of disposing the insertable device in soft tissue.

Abstract: A method includes providing electrical energy to a transducer for sealing a vessel, where a frequency of the electrical energy is in an ultrasound range, controlling the electrical energy to achieve a predetermined velocity of an end effector coupled to the transducer, when the end effector is grasping the vessel, sensing parameters of the electrical energy when the end effector achieves the predetermined velocity, calculating power of the electrical energy based on the sensed parameters and estimating a size range of the vessel based on the power, and controlling the electrical energy to achieve a target velocity, which is determined based on the estimated size range of the vessel, to seal the vessel.

Abstract: An antenna assembly includes a metal layer configured to emit linearly polarized electromagnetic energy to a receiving antenna implanted underneath a subject's skin; and a feed port configured to connect the antenna assembly to a signal generator such that the antenna assembly receives an input signal from the signal generator and then transmits the input signal to the receiving dipole antenna, wherein the antenna assembly is less than 200 um in thickness, and wherein the metal layer is operable as a dipole antenna with a reflection ratio of at least 6 dB, the reflection ratio corresponding to a ratio of a transmission power of the antenna assembly in transmitting the input signal and a reflection power seen by the antenna assembly resulting from electromagnetic emission of the input signal.

Abstract: A method for producing a catheter includes inserting a temporary mandrel into a catheter tube, followed by preshaping a FPCB in a round hollow cylindrical shape and position it on the catheter tube. Then a shrink tube is positioned around the FPCB on the outside of the catheter tube. The assembly is preheated to the point that the shrink tube has fully contracted and directly contacts and closes the FPCB around the catheter tube. Then the assembly is heated above the melting temperature of the catheter tube to reflow the catheter tube material around the FPCB inside the shrinking tube. After a resting period to allow solidification of the assembly material the mandrel is removed from the inner lumen of the re-solidified catheter tube, and finally the shrink tube is removed.

Abstract: In one embodiment, the present invention provides a device, wherein the device comprises a skin patch, configured to attach to the skin surface of the perineum of a subject suffering from premature ejaculation, wherein the skin patch contains electrodes configured to deliver electrical impulses transcutaneously to the bulbcavernosus muscle of the subject, wherein the transcutaneously delivered electrical impulses are configured to treat premature ejaculation.

Abstract: A surgical system comprising a steering tool and a powered tool. The steering tool includes a shaft defining a bore with a bendable section, an inelastic cable, and an elastic cable. The elastic cable may be arcuately spaced from the inelastic cable. The powered tool comprising a tube assembly with a tube flexible section, a working head, and a motor. The tube assembly is configured to be removably disposed through the shaft such that the tube flexible section is seated within the bore of the bendable section of the steering tool. The elastic cable is configured to be placed in tension, and the inelastic cable causes the shaft bendable section and the tube flexible section to bend towards the inelastic cable while the inelastic cable and the elastic cable remaining in tension to resist radial loading on the working head. Methods for using the surgical system are also disclosed.

Abstract: Implantable medical systems include implantable percutaneous medical leads and/or implantable medical lead extensions that have fewer conductors than distal electrodes, or distal connectors for extensions, by having one or more conductors be electrically coupled to multiple distal electrodes. The multiple distal electrodes may span a general area of a body of a patient that includes a specific point that requires therapy, such as multiple vertebral segments. Because all distal electrodes spanning the general area that are coupled to an active conductor will output the stimulation therapy, the specific point within the general area will receive the therapy even without identifying which electrode is most effective. Bipolar and unipolar stimulation modes may be used. Multiple leads may be used where each lead has more distal electrodes than conductors. Additionally, a single lead may have more distal electrodes than conductors while also carrying multiple stimulation waveforms.

Abstract: An exemplary tissue detection and location identification apparatus can include, for example, a first electrically conductive layer at least partially (e.g., circumferentially) surrounding a lumen, an insulating layer at least partially (e.g., circumferentially) surrounding the first electrically conductive layer, and a second electrically conductive layer circumferentially surrounding the insulating layer, where the insulating layer can electrically isolate the first electrically conductive layer from the second electrically conductive layer. A further insulating layer can be included which can at least partially surrounding the second electrically conductive layer.

Abstract: An integrated functional electrical stimulation therapeutic apparatus for foot drop based on a sequence of electrodes is provided, including an upper casing, a waterproof ring, a control circuit, a lower casing, a support molded integrally with the lower casing, a sequence of small electrodes, and a large electrode; wherein the sequence of small electrodes and the large electrode are embedded in surfaces of the lower casing and the support by using an in-mold injection process, and the sequence of small electrodes and the large electrode are stainless steel metal electrodes. An integrated waterproof design is used in the above therapeutic apparatus.

Abstract: Systems and methods are disclosed in which changes in the position and/or orientation of an anatomical structure or of a surgical tool can be measured quantitatively during surgery. In some embodiments, a surgical electronic module can be configured to attach to a surgical device, to continually detect changes in a position and/or orientation of the surgical device during surgery, and to communicate the changes to a user. In this way, where the surgical device is attached to a portion of a patient's anatomy and/or is used to manipulate the patient's anatomy, the surgical electronic module can detect changes in the position and/or orientation of said anatomy. In embodiments where more than one module is used during surgery, the modules can continually detect changes in their positions and/or orientations relative to one another, which correspond to changes in relative positions and/or orientations of the surgical devices to which the modules are attached.

Abstract: A method includes receiving monitoring data from at least one sensing device coupled to a subject and analyzing the monitoring data to identify one or more physiologic parameters of the subject. The method also includes providing signaling to at least one stimulating device in response to the identified physiologic parameters, the signaling comprising instructions to apply a stimulus to the subject. The method further includes receiving additional monitoring data from the at least one sensing device, analyzing the additional monitoring data to identify one or more changes in the one or more physiologic parameters of the subject after application of the stimulus to the subject, and providing additional signaling to the at least one stimulating device, the additional signaling comprising instructions to modify the stimulus applied to the subject based on the identified changes in the one or more physiologic parameters.

Abstract: A method for treating a heart failure patient by ablating a nerve of the splanchnic sympathetic nervous system to increase venous capacitance and reduce pulmonary blood pressure. A method including: inserting a catheter into a vein adjacent the nerve, applying stimulation energy and observing hemodynamic effects, applying ablation energy and observing hemodynamic effects, applying simulation energy after the ablation and observing hemodynamic effects.

Abstract: Systems and methods for designing and implementing patient-specific surgical procedures and/or medical devices are disclosed. In some embodiments, a method includes receiving a patient data set of a patient. The patient data set is compared to a plurality of reference patient data sets, wherein each of the plurality of reference patient data sets is associated with a corresponding reference patient. A subset of the plurality of reference patient data sets is selected based, at least partly, on similarity to the patient data set and treatment outcome of the corresponding reference patient. Based on the selected subset, at least one surgical procedure or medical device design for treating the patient is generated.

Abstract: A method includes obtaining monitoring data recorded by first and second devices, the first and second devices being attached to the subject at different first and second sties, respectively. The monitoring data comprises signals associated with at least one physiological parameter of the subject. The method also includes extracting one or more features of the signals recorded by the first and second devices during a transitionary period when the first and second devices simultaneously monitor the at least one physiological parameter of the subject. The method further includes generating at least one correlation parameter by analyzing the extracted features of the signals recorded by the first and second devices for at least a portion of the transitionary period, the at least one correlation parameter when applied to signals recorded by the second device at least partially compensating for relative changes in signals recorded by the first and second devices.

Abstract: A connector and lead (or other elongated body) can produce a tactile sensation that indicates alignment between connector contacts of the connector and the terminals on the lead (or other elongated body). For example, a terminal or retention sleeve of the lead (or other elongated body) may include an indented circumferential groove that interacts with a connector contact or retention contact of the connector to produce the tactile sensation. As another example, one or more terminals or spacers may have a larger diameter than adjacent spacers or terminals to interact with a connector contact to produce the tactile sensation.

Abstract: A lead body for implantation includes at least one segmented electrode with a first electrode segment and a second electrode segment radially positioned about a lumen and electrically isolated from each other. A sectioned hypotube includes a distal end and a proximal end and a first conducting section and a second conducting section each extending between the distal and proximal ends. The first conducting section of the sectioned hypotube is coupled to the first electrode segment adjacent the distal end and the second conducting section of the sectioned hypotube is coupled to the second electrode segment adjacent the distal end.

Abstract: A method is presented for forming a nanowire electrode. The method includes forming a plurality of nanowires over a first substrate, depositing a conducting layer over the plurality of nanowires, forming solder bumps and electrical interconnections over a second flexible substrate, and integrating nanowire electrode arrays to the second flexible substrate. The plurality of nanowires are silicon (Si) nanowires, the Si nanowires used as probes to penetrate skin of a subject to achieve electrical biopotential signals. The plurality of nanowires are formed over the first substrate by metal-assisted chemical etching.

Abstract: A device comprising monolithic substrates forming a chip including a wireless, battery-less monolithically-integrated neural interface (MINI) device. The chip comprises an integrated circuit (IC) being embedded in a first monolithic substrate and comprising a plurality of amplifiers configured to amplify received neural signals from a monitored subject, and a radio data signal generator configured to process the amplified neural signals and generate a multiplexed digital signal. The chip includes radio-frequency (RF) planar coils embedded in a second monolithic substrate, being electrically connected to the IC through the first monolithic substrate, being configured for wireless transmission of the multiplexed digital signal to a remote wireless device and being configured to receive wireless power signals to power the IC. A plurality of on-chip electrodes is included to directly sense the neural signals of the subject and provide the neural signals to the plurality of amplifiers.

Abstract: Devices and methods to measure gastric residual volume (GRV) are described where at least one additive component (a GRV indicator) may be dispersed in a body lumen such as a stomach. The GRV indicator may changes a physical (chemical, electrical, thermal, mechanical, optical, etc.) characteristic within the stomach by a measureable degree. This degree of change and/or the rate of return to the previous state, may be used to determine the GRV of a patient. The determined GRV can also be used to automatically or semi-automatically control the patient's feeding rate and/or volume and/or frequency to adequately nourish the patient but avoid complications. The physical characteristic(s) may also be used to detect that the feeding catheter or tube is in the correct location (ie stomach vs lung or esophagus.

Abstract: Systems, methods and devices for controlled sympathectomy procedures for neuromodulation in the treatment of subjects having neoplastic conditions are disclosed. Systems, methods, and devices for interventionally treating a cancerous tumor and cancer related pain are disclosed.

Abstract: According to an embodiment of the present invention, a structure for a strain gauge device is provided. The structure comprises a layer of strain gauge material and one or more contact pads positioned directly on the layer of strain gauge material. The structure further comprises a multiplexer, measuring device, amplifier, analog to digital converter, microcontroller, and wireless adapter. According to the structure, the multiplexer selects a given contact pad pair of the one or more contact pad pairs, the measuring device measures signal generated by the layer of strain gauge material between the given contact pad pair, the amplifier amplifies the measured signal, the analog to digital converter converts the amplified analog signal to a digital signal, the microcontroller processes the digital signal, and the wireless adapter transmits the processed digital signal. In addition, the structure may further comprise a battery to provide energy to the structure.

Abstract: A surgical system may include a conductive stylet with a distal end advanceable into bone material and a proximal end coupled to a stylet hub. A handle is non-removably attached to the stylet hub, and removably attachable to an insulative cannula hub. The cannula hub is non-removably attached to a conductive cannula that surrounds the stylet when the handle is attached to the proximal end of the insulative cannula hub. An outer insulative sheath is slideably engaged to insulative cannula hub, and has a radiopaque distal tip. An electrical signal source may be applied to the stylet hub to conduct a pedicle integrity assessment. The handle and stylet may be removed from the cannula assembly, leaving the cannula assembly in place at the surgical site.

Abstract: Various examples are described for needle alignment for wearable biosensors. One example device includes a housing comprising an upper portion and a lower portion, the housing defining a cavity between the upper portion and the lower portion and configured to be worn on a wearer's skin, wherein: the upper portion defines a first opening extending through the upper portion to the cavity, and the lower portion defines a second opening extending through the lower portion to the cavity, the cavity establishing a substantially unobstructed pathway including the first opening and the second opening to enable an insertion needle to be inserted through the housing; and a needle guide extending into and along a portion of the pathway and aligned with a sensor wire to enable alignment between the insertion needle and the sensor wire.

Abstract: A system comprising a surgical instrument is disclosed. The surgical instrument includes a handle, a shaft, a plurality of magnets, a plurality of sensors configured to determine a distance away from one or more of the plurality of magnets, and a processor communicatively coupled to the plurality of sensors. The processor is configured to determine a three dimensional change in position of the shaft by computing a three dimensional change in position of the one or more magnets, using the change in the distances determined by the one or more plurality of sensors.

Abstract: Various systems and methods for controlling an ultrasonic surgical instrument according to the location of tissue grasped within an end effector are disclosed. A control circuit can be configured to apply varying power levels, via a generator, to an ultrasonic transducer driving an ultrasonic electromechanical system to oscillate an ultrasonic blade. Further, the control circuit can measure impedances of the ultrasonic transducer corresponding to the varying power levels and determine a location of tissue positioned within the end effector according to a difference between the impedances of the ultrasonic transducer relative to a threshold.

Abstract: A system and method for detecting and verifying bradycardia/asystole episodes includes sensing an electrogram (EGM) signal. The EGM signal is compared to a primary threshold to sense events in the EGM signal, and at least one of a bradycardia or an asystole is detected based on the comparison. In response to detecting at least one of a bradycardia or an asystole, the EGM signal is compared to a secondary threshold to sense events under-sensed by the primary threshold. The validity of the bradycardia or the asystole is determined based on the detected under-sensed events.

Abstract: Catheter curve shape struts for steerable medical devices such as catheters are disclosed. These struts may not only help shape a steerable portion of a medical device (e.g., a distal portion of a catheter), but also may help to return a steered or deflected portion of the medical device to an uncurved configuration when it is no longer desirable or necessary to steer or deflect the medical device. These struts may include first and second pluralities of complementary, staggered cutout regions. When used in a catheter that is deployed via an introducer, at least some configurations of the catheter curve shape strut can enable the catheter to be rotated about its longitudinal axis, even when the distal deflectable section is in a curved configuration and inside of the introducer.

Abstract: Surgical instruments for use in a surgical robot are provided herein. The instruments are preferably part of a translational instrument interface and are removably coupled to the surgical robot. In one aspect, the translational instrument interface has a slave hub mounted on a distal end of the slave unit, a sterile shield insertable within the slave hub, and an instrument having an end-effector for contacting tissue insertable within the sterile shield. The instrument may be disposable after a single use. The handle of the surgical robot is preferably coupled to the translational instrument interface such that actuation at the handle causes movement of the end-effector for performing surgery.

Abstract: The present invention relates to an assembly for replacing a heart valve or coronary angioplasty assembly, including an insertion sheath (13) of an introducer (1) or a delivery catheter (1?), which is smaller in size than an introducer, intended for being inserted into an artery of a human body. The invention essentially involves integrating the metal substrate of an electrode of the cardiac stimulator directly into the sheath for insertion into the artery of a patient.

Abstract: A new class of peripheral nerve interfaces that combines microfluidics with microelectronics. A peripheral nerve interface that allows intraneural targeting through the combined use and sequential application of lysing agents and neurotrophic factors.

Abstract: There is disclosed an apparatus for treating a sexual dysfunctional female patient, comprising a stimulation device adapted to stimulate an erectile blood passageway to increase the amount of blood in the female erectile tissue and thereby obtaining engorgement with blood of the female erectile tissue by affecting said erectile blood flow passageway. Moreover there is disclosed a system and an operation method for treating a sexual dysfunctional female patient.

Abstract: A sensing system comprises an elastic sensing element for sensing a movement, an inertial measurement system for sensing a movement, and a controller programmed for obtaining movement sensing data from the elastic sensing element and from the inertial measurement system and for calibrating the elastic sensing element using the combined movement sensing data from the elastic sensing element and the inertial measurement system.

Abstract: Disclosed systems include a self-contained electroencephalogram (EEG) recording patch comprising a first electrode, a second electrode and wherein the first and second electrodes cooperate to measure a skin-electrode impedance, a substrate containing circuitry for generating an EEG signal from the measured skin-electrode impedance, amplifying the EEG signal, digitizing the EEG signal, and retrievably storing the EGG signal. The patch also comprises a power source and an enclosure that houses the substrate, the power source, and the first and second electrodes in a unitary package.

Abstract: An implantable medical device that can include a main body having a tissue-contacting surface comprising a first edge and a second edge, an elongated shaft coupled at or near a first edge of the main body, and an anchoring feature extending from a second end of the elongated shaft. The elongated shaft can have a long axis that extends from a first end of the elongated shaft to a second end of the elongated shaft. The elongated shaft can be oriented such that the second end is positioned above the tissue-contacting surface and an angle between the long axis of the elongated shaft and the tissue-contacting surface is an acute angle. The device can further include an opposing elongated shaft coupled at or near a second edge of the main body.

Abstract: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter. Tip electrodes can be constructed from an electrically insulative substrate comprising an inner lumen, an external tip surface, and a plurality of channels extending from the inner lumen to the external tip surface, a plurality of segmented electrodes, and a plurality of spot electrodes. Each of the plurality of segmented electrodes and each of the plurality of spot electrodes can be laterally separated from each other by an electrically non-conductive substrate portion and each of the spot electrodes and each of the segmented electrodes can be electrically coupled to at least one wire or conductor trace.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis with a distal end and a proximal end. First and second pull wires can extend along the elongated body and can have a proximal end and a distal end. First and second pull wire liners can be disposed over a portion of one of the first and second pull wires, respectively. Each of the first and second pull wires can have a proximal end and a distal end. A first gap can exist between the proximal end of the first pull wire liner and the proximal end of the elongated body and a second gap can exist between the proximal end of the second pull wire liner and the proximal end of the elongated body.

Abstract: Mechanical thrombectomy apparatuses, and particularly knitted rolling tube mechanical thrombectomy apparatuses configured to have improved tracking for delivery through tortious vessels are described herein. Also described herein are methods of removing clots using a mechanical thrombectomy apparatuses in which the clot is larger than the tractor portion of the mechanical thrombectomy apparatus.

Abstract: A system for controlled sympathectomy procedures is disclosed. A system for controlled micro ablation procedures is disclosed. Methods for performing a controlled surgical procedure are disclosed. A system for performing controlled surgical procedures in a minimally invasive manner is disclosed. Systems and methods for accessing target tissues as part of a neuromodulation procedure from within a lumen are disclosed.

Abstract: Systems and methods for a spinal surgical procedure are described. Specifically systems and methods for calculating global spinal alignment are described.

Abstract: A catheter with three distinct compression resistance coils, including a body coil and two pull wire coils, is disclosed. The triple coil system can provide maximal resistance to compression of the catheter's proximal shaft, as well as maximization of the curve angle that the catheter tip can achieve. Additionally, the tri-coil catheter can allow for a lower initial compression load and a more flexible proximal shaft. A gap between the outer diameter of the pull wire and the inner diameter of the pull wire compression coil that is equal to about 10-30% of inner diameter of the pull wire compression coil can provide optimal catheter performance.

Abstract: Ablation systems of the present disclosure facilitate the safe formation of wide and deep lesions. For example, ablation systems of the present disclosure can allow for the flow of irrigation fluid and blood through an expandable ablation electrode, resulting in efficient and effective cooling of the ablation electrode as the ablation electrode delivers energy at a treatment site of the patient. Additionally, or alternatively, ablation systems of the present disclosure can include a deformable ablation electrode and a plurality of sensors that, in cooperation, sense the deformation of the ablation electrode, to provide a robust indication of the extent and direction of contact between the ablation electrode and tissue at a treatment site.

Abstract: Detachment of an implant from a delivery assembly can be electrolytic and provide an electrical current pathway through a fluid within a portion of a delivery system containing the delivery assembly. After the implant is located at a target location within a patient, a voltage potential is applied between (i) a delivery electrode electrically connected to an electrolytic detachment zone and (ii) an infusion electrode disposed outside of the patient and electrically connected to the electrolytic detachment zone via a fluid from a fluid source disposed outside of the patient. While applying the voltage potential, the fluid can be flushed from the fluid source past the detachment zone.

Abstract: An apparatus and method for detecting and reducing bruxism is described. The method includes the placement of a pressure resistive (or piezoelectric) sensor on the skin above the temporalis muscle in order to detect grinding of the teeth based on movement of the temporalis muscle. Alternatively, a pressure resistor could be used in the ear. The pressure resistive sensor could be made of carbon-impregnated polyolefin. Once bruxism is detected, a patient is notified and uses bio-feedback to curtain the grinding of the teeth.

Abstract: The presence of the pull wire ring in the distal end portion leads to limited functionality of the distal end of a steerable medical device. A steerable medical device (1) includes a pull wire ring (100a-e) for imparting a bending movement on the steerable medical device. By providing the pull wire ring (100a-e) with an eccentric recess (105a-f) which defines a passage between a first end face (101) and a second end face (105) of the ring, it becomes possible to guide ancillary elements such as electrical lines, data cables and fiber optics past the pull wire ring (100a-e) further towards the distal end of the steerable medical device. By this measure, functionality of the distal end of the medical device is enhanced without obstructing a main lumen of the device.

Abstract: Disclosed are various examples and embodiments of a cardiac mapping catheter configured for electrophysiological (EP) mapping and suitable for intravascular insertion in a patient's heart, and methods of making same. The cardiac mapping catheter comprises a plurality support arms having electrodes disposed thereon. Various configurations of the cardiac mapping catheter are described and disclosed which provide improved spatial resolution and sensing of EP signals acquired from inside a patient's heart.

Abstract: A medical access tool includes a needle member extending along a longitudinal axis, and a coiled wire extending around the axis. An inner surface of the coiled wire, along a proximal segment thereof, is spaced radially apart from an outer surface of the needle member, and a distal segment of the coiled wire extends distally to a tissue-engaging tip of the coiled wire, a piercing distal tip of the needle member being recessed proximally from the tissue-engaging tip at a fixed distance. An operator may rotate the coiled wire to engage tissue, for example, that of a pericardial sac or a diaphragmatic attachment, which then travels proximally along the coiled wire and into contact with the needle member's distal tip, to be pierced through thereby. At least one lumen of the needle member provides a passageway through which the operator may advance a guide wire and/or inject a fluid.