Abstract: Devices and methods for fistula-free vascular access for hemodialysis are disclosed. In exemplary embodiments, devices are provided comprising a transcutaneous access port (200) for needlelessly connecting a patient to a dialyzer, the port having different inner lumen profiles for arterial or venous blood flow and further comprising an intracorporeal conduit providing a fluid path between the transcutaneous port and a blood vessel, wherein the intracorporeal conduit is attached to a device anchor (400) having distal and proximal self-expandable segments for anastomosing the intracorporeal conduit to a blood vessel. An exemplary fistula-free hemodialysis method (100) provided herein consists of percutaneously deploying a first device in an artery and a second device in a vein and independently connecting each of the devices to the arterial and venous lines of a dialyzer.

Abstract: Devices and methods for fistula-free vascular access for hemodialysis are disclosed. In exemplary embodiments, devices are provided comprising a transcutaneous access port (200) for needlelessly connecting a patient to a dialyzer, said port having different inner lumen profiles for arterial or venous blood flow and further comprising an intracorporeal conduit providing a fluid path between said transcutaneous port and a blood vessel, wherein said conduit has a distal more rigid segment attached to a device anchor (400), said device anchor having distal and proximal self-expandable segments for anastomosing said conduit to a blood vessel. An exemplary fistula-free hemodialysis method (100) provided herein consists of percutaneously deploying a first intracorporeal conduit in an artery and a second intracorporeal conduit in a vein and independently connecting each of said conduits to the arterial and venous lines of a dialyzer using said transcutaneous access ports.

Abstract: Devices and methods obtain and use endovascular electrograms (or electrocardiograms/ECGs) in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying a P-wave segment in an endovascular ECG signal associated with the indwelling medical device, then calculating a positive energy value relating to an amount of energy of the P-wave segment above a baseline of the endovascular ECG signal and a negative energy value relating to an amount of energy of the P-wave segment below a baseline of the endovascular ECG signal. A position of the medical device within the vasculature can be determined using at least one of the positive energy value and the negative energy value in a graphical user interface.

Abstract: A new apparatus, algorithm, and method are introduced herein to support navigation and placement of an intravascular catheter using the electrical conduction system of the heart (ECSH) and control electrodes placed on the patient's skin.

Abstract: A system for facilitating vascular access is disclosed. The system includes an imaging device including a transducer configured for ultrasound image data acquisition, an ECG signal acquisition device configured to acquire ECG signal data via one or more leads, wherein a first lead is directly connected to skin of a patient, and a mobile application configured to render a graphical user interface to be displayed on a display screen of a mobile device, wherein the graphical user interface illustrates a representation of at least one of the ultrasound image data or the ECG signal data that is wireless transmitted to the mobile device.

Abstract: Devices and methods obtain and use endovascular electrograms in a number of clinical applications and settings. In one embodiment, methods for triggering analysis of an endovascular ECG waveform are based on the detection of a peak in a skin-based ECG waveform in order to determine a location of an indwelling medical device, such as a catheter. In another embodiment, the position of a catheter or other medical device within the vasculature can be determined by analysis of the energy profile of a detected P-wave. In yet other embodiments, magnetic connecting devices are used for establishing an operable connection through a sterile field.

Abstract: Graphical layouts, algorithms, and methods are introduced herein to implement user interfaces for mobile and/or wearable medical devices. In one aspect of the present invention, new graphical layouts are introduced for simplified presentation of time-dependent patient data. In another aspect of the invention, methods and algorithms are introduced to acquire, extract and present relevant features of patient data in real-time in order to simplify the graphical presentation and interpretation. In another aspect of the invention, elements of a multi-modal user interface are introduced in order to simplify and minimize the user's interaction with the medical wearable device. In yet another aspect of the invention, further methods are introduced for real-time interaction between a user or several users and a wearable or several wearable medical devices.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member configured to access the venous vasculature of a patient, a processor, and a display. The elongate flexible member includes an endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal of the venous vasculature of the patient, and a first wireless interface configured to wirelessly transmit the endovascular electrogram signal to the processor. The processor includes a second wireless interface configured to wirelessly receive the endovascular electrogram signal from the elongate flexible member. The processor is configured to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient.

Abstract: In an aspect, embodiments of the invention relate to the effective and accurate placement of intravascular devices such as central venous catheters, in particular such as peripherally inserted central catheters or PICC. One aspect of the present invention relates to vascular access. It describes devices and methods for imaging guided vascular access and more effective sterile packaging and handling of such devices. A second aspect of the present invention relates to the guidance, positioning and placement confirmation of intravascular devices without the help of X-ray imaging. A third aspect of the present invention relates to devices and methods for the skin securement of intravascular devices and post-placement verification of location of such devices. A forth aspect of the present invention relates to improvement of the workflow required for the placement of intravascular devices.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a processor, and a display. The elongate flexible member includes an endovascular electrogram lead disposed at its distal end for sensing an endovascular electrogram signal of the venous vasculature of the patient, and a first wireless interface configured to wirelessly transmit the endovascular electrogram signal to the processor. The processor includes a second wireless interface configured to wirelessly receive the endovascular electrogram signal from the elongate flexible member. The processor is configured to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The display is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member configured to access the venous vasculature of a patient, a sensor disposed at a distal end of the elongate flexible member and configured to sense a physiological characteristic of the venous vasculature of the patient, a processor and an output device. The processor is configured to receive and process the physiological characteristic of the venous vasculature of the patient, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, where the visual indication is different from the physiological characteristic of the venous vasculature of the patient.

Abstract: A new apparatus, algorithm, and method are introduced herein to support navigation and placement of an intravascular catheter using the electrical conduction system of the heart (ECSH) and control electrodes placed on the patient's skin.

Abstract: Devices and methods obtain and use endovascular electrograms (or electrocardiograms/ECGs) in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying a P-wave segment in an endovascular ECG signal associated with the indwelling medical device, then calculating a positive energy value relating to an amount of energy of the P-wave segment above a baseline of the endovascular ECG signal and a negative energy value relating to an amount of energy of the P-wave segment below a baseline of the endovascular ECG signal. A position of the medical device within the vasculature can be determined using at least one of the positive energy value and the negative energy value in a graphical user interface.

Abstract: In an aspect, embodiments of the invention relate to the effective and accurate placement of intravascular devices such as central venous catheters, in particular such as peripherally inserted central catheters or PICC. One aspect of the present invention relates to vascular access. It describes devices and methods for imaging guided vascular access and more effective sterile packaging and handling of such devices. A second aspect of the present invention relates to the guidance, positioning and placement confirmation of intravascular devices without the help of X-ray imaging. A third aspect of the present invention relates to devices and methods for the skin securement of intravascular devices and post-placement verification of location of such devices. A forth aspect of the present invention relates to improvement of the workflow required for the placement of intravascular devices.

Abstract: A method for positioning an endovascular device in or near the heart using electrocardiogram (ECG) signals. The method includes receiving an endovascular ECG signal including a plurality of waveforms, processing the endovascular ECG signal to calculate a P-wave amplitude and a spectral power for each predetermined time period, determining a maximum P-wave amplitude and an associated maximum spectral power, associating the maximum P-wave amplitude and the maximum spectral power with a predetermined location in or near the heart, calculating a location based on a ratio of the P-wave amplitude to the maximum P-wave amplitude and a ratio of the spectral power to the maximum spectral power, and displaying the location to a user.

Abstract: The endovascular navigation system includes an elongate flexible member configured to access the venous vasculature of a patient, a sensor disposed at a distal end of the elongate flexible member and configured to sense a physiological characteristic of the venous vasculature, a processor and an output device. The processor is configured to receive and process the physiological characteristic of the venous vasculature, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature, where the visual indication is different from the physiological characteristic of the venous vasculature of the patient.

Abstract: A new apparatus, algorithm, and method are introduced herein to support navigation and placement of an intravascular catheter using the electrical conduction system of the heart (ECSH) and control electrodes placed on the patient's skin.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal, a processor and an output device. The processor is configured to receive the endovascular electrogram signal, to determine a peak amplitude of a P-wave in the endovascular electrogram signal, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, where the visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.

Abstract: Devices and methods obtain and use endovascular electrograms (or electrocardiograms/ECGs) in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying an endovascular ECG waveform complex from an endovascular ECG signal associated with the indwelling medical device, then calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof. A position of the medical device within the vasculature is then determined by observation of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex.

Abstract: An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal, a processor and an output device. The processor is configured to receive the endovascular electrogram signal, to determine a peak amplitude of a P-wave in the endovascular electrogram signal, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, where the visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.