Abstract: The invention relates to the guidance, positioning and placement confirmation of intravascular devices typically inserted percutaneously into the venous or arterial vasculature. An endovenous access and guidance system is described that includes an elongate flexible member adapted and configured to access the venous vasculature of a patient; a sensor disposed at a distal end of the elongate flexible member and configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient; a processor configured to receive and process in vivo non-image based ultrasound information of the venous vasculature of the patient provided by the sensor and to provide position information regarding the position of the distal end of the elongate flexible member within the venous vasculature of the patient; and an output device adapted to output the position information from the processor.

Abstract: A method of navigating and positioning an endovascular device in a vasculature is disclosed. Initially, a system including an endovascular device and at least one transducer is inserted into the lumen of a patient. An acoustic signal is then transmitted within the lumen. A reflected signal is pre-processed to extract one or more acoustic features. The one or more acoustic features are processed using a computer readable set of rules to produce an output related to guidance of the instrument within a blood vessel or a position of the instrument within the blood vessel.

Abstract: An endovascular navigation and positioning system including a transducer on a distal end of an endovascular instrument, a control system connected to the transducer, the control system being configured to generate and receive at least one acoustic signal using the transducer, a pre-processor containing computer-readable instructions for manipulating the acoustic signal input to extract information related to desired parameters, a processor configured to evaluate the parameters to generate an output related to guidance of the instrument, and an output device for displaying an indication of the output generated by the processor. The processor may evaluate the information using artificial intelligence including inference rules related to navigation state, comparisons to information in a database, and probabilities, among others. The system may use an electrical signal as a confirmation input. Further disclosed is a method of navigating and positioning an endovascular device in a vasculature.

Abstract: An endovascular access and guidance system has an elongate body with a proximal end and a distal end; a non-imaging ultrasound transducer on the elongate body configured to provide in vivo non-image based ultrasound information of the vasculature of the patient; an endovascular electrogram lead on the elongate body in a position that, when the elongate body is in the vasculature, the endovascular electrogram lead electrical sensing segment provides an in vivo electrogram signal of the patient; a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and an output device configured to display a result of information processed by the processor.

Abstract: Systems and methods for determining the position of an endovascular device within the body are provided. The system can include a catheter having a tip portion that can generate sound waves which can be detected by auscultation devices which allows the position of the catheter tip to be triangulated. The acoustic triangulation system can be used in conjunction with ECG and/or ultrasound information to further refine the location of the catheter tip.

Abstract: The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. An aspect of the invention includes, for example, an endovenous access and guidance system.

Abstract: An endovascular navigation and positioning system including a transducer on a distal end of an endovascular instrument, a control system connected to the transducer, the control system being configured to generate and receive at least one acoustic signal using the transducer, a pre-processor containing computer-readable instructions for manipulating the acoustic signal input to extract information related to desired parameters, a processor configured to evaluate the parameters to generate an output related to guidance of the instrument, and an output device for displaying an indication of the output generated by the processor. The processor may evaluate the information using artificial intelligence including inference rules related to navigation state, comparisons to information in a database, and probabilities, among others. The system may use an electrical signal as a confirmation input. Further disclosed is a method of navigating and positioning an endovascular device in a vasculature.

Abstract: A method for evaluating flow characteristics in a vessel of a patient includes the steps of positioning a catheter having a balloon at a measuring location within the vessel; transmitting an ultrasound signal into the vessel while the balloon catheter is within the measuring location; evaluating a reflection of the ultrasound signal to determine a flow parameter within the vessel while the catheter is in the measuring position; expanding the balloon within the vessel at the measuring location; and stopping the expanding step when the result of the evaluating step is that the flow through the vessel is substantially stopped. In some embodiments, the method may further comprise the step of detecting an endovascular electrogram signal. The method may be designed for evaluating flow characteristics in a vessel of a patient while enabling the prevention of a balloon from over-expanding and/or over-distending a vessel of a 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 access and guidance system has an elongate body with a proximal end and a distal end; a non-imaging ultrasound transducer on the elongate body configured to provide in vivo non-image based ultrasound information of the vasculature of the patient; an endovascular electrogram lead on the elongate body in a position that, when the elongate body is in the vasculature, the endovascular electrogram lead electrical sensing segment provides an in vivo electrogram signal of the patient; a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and an output device configured to display a result of information processed by the processor.

Abstract: The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. Currently these goals are achieved using x-ray imaging and in some cases ultrasound imaging. This invention provides a method to substantially reduce the need for imaging related to placing an intravascular catheter or other device. Reduced imaging needs also reduce the amount of radiation that patients are subjected to, reduce the time required for the procedure, and decrease the cost of the procedure by reducing the time needed in the radiology department. An aspect of the invention includes, for example, an endovenous access and guidance system.

Abstract: The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. Currently these goals are achieved using x-ray imaging and in some cases ultrasound imaging. This invention provides a method to substantially reduce the need for imaging related to placing an intravascular catheter or other device. Reduced imaging needs also reduce the amount of radiation that patients are subjected to, reduce the time required for the procedure, and decrease the cost of the procedure by reducing the time needed in the radiology department. An aspect of the invention includes, for example, an endovenous access and guidance system.

Abstract: The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. Currently these goals are achieved using x-ray imaging and in some cases ultrasound imaging. This invention provides a method to substantially reduce the need for imaging related to placing an intravascular catheter or other device. Reduced imaging needs also reduce the amount of radiation that patients are subjected to, reduce the time required for the procedure, and decrease the cost of the procedure by reducing the time needed in the radiology department. An aspect of the invention includes, for example, an endovenous access and guidance system.

Abstract: The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. Currently these goals are achieved using x-ray imaging and in some cases ultrasound imaging. This invention provides a method to substantially reduce the need for imaging related to placing an intravascular catheter or other device. Reduced imaging needs also reduce the amount of radiation that patients are subjected to, reduce the time required for the procedure, and decrease the cost of the procedure by reducing the time needed in the radiology department. An aspect of the invention includes, for example, an endovenous access and guidance system.

Abstract: Veins are removed using a pull catheter introduced over a guidewire which extends between first and second percutaneous access points. Optionally, a side branch management tool including an excision device and/or a viewing scope can be advanced over the same guidewire in the direction opposite to that of the pull catheter. In that way, as the pull catheter inverts the vein being removed, side branches can be selectively viewed and/or severed using the side branch management tool. Arteriovenous fistulas are formed by inverting a length of a vein, mobilizing the inverted length relocating the mobilized end of the vein, and connecting the mobilized end to an artery.

Abstract: Veins are removed using a pull catheter introduced over a guidewire which extends between first and second percutaneous access points. Optionally, a side branch management tool including an excision device and/or a viewing scope can be advanced over the same guidewire in the direction opposite to that of the pull catheter. In that way, as the pull catheter inverts the vein being removed, side branches can be selectively viewed and/or severed using the side branch management tool. Arteriovenous fistulas are formed by inverting a length of a vein, mobilizing the inverted length relocating the mobilized end of the vein, and connecting the mobilized end to an artery.

Abstract: Veins are removed using a pull catheter introduced over a guidewire which extends between first and second percutaneous access points. Optionally, a side branch management tool including an excision device and/or a viewing scope can be advanced over the same guidewire in the direction opposite to that of the pull catheter. In that way, as the pull catheter inverts the vein being removed, side branches can be selectively viewed and/or severed using the side branch management tool. Arteriovenous fistulas are formed by inverting a length of a vein, mobilizing the inverted length relocating the mobilized end of the vein, and connecting the mobilized end to an artery.

Abstract: According to the present invention, improved methods and apparatus are provided for regaining hemostasis or otherwise minimizing leakage during endoluminal, surgical or percutaneous intraluminal procedures, and for providing a seal during laparoscopic surgical procedures where there is leakage of the CO2 insufflation, when the primary means of hemostasis or pneumatic CO2 seal is compromised or fails. More particularly the present invention relates to devices having a front hub and a rear hub, one or other of which is adapted to retain a compression seal such that when the front and rear hub are matingly engaged, axial and radial pressure is applied to the compression plug and any devices located therebetween, thereby achieving a seal. The compression device can be applied while a guidewire or additional devices remain within the leaking sheath or trocar, thereby allowing the physician to maintain hemostasis or adequate CO2 insufflation, without exchanging the introducer sheath or laparoscopic port.

Abstract: Veins are removed using a pull catheter introduced over a guidewire which extends between first and second percutaneous access points. Optionally, a side branch management tool including an excision device and/or a viewing scope can be advanced over the same guidewire in the direction opposite to that of the pull catheter. In that way, as the pull catheter inverts the vein being removed, side branches can be selectively viewed and/or severed using the side branch management tool.

Abstract: According to the present invention, improved methods and apparatus are provided for regaining hemostasis or otherwise minimizing leakage during endoluminal, surgical or percutaneous intraluminal procedures, and for providing a seal during laparoscopic surgical procedures where there is leakage of the CO2 insufflation, when the primary means of hemostasis or pneumatic CO2 seal is compromised or fails. More particularly the present invention relates to devices having a front hub and a rear hub, one or other of which is adapted to retain a compression seal such that when the front and rear hub are matingly engaged, axial and radial pressure is applied to the compression plug and any devices located therebetween, thereby achieving a seal. The compression device can be applied while a guidewire or additional devices remain within the leaking sheath or trocar, thereby allowing the physician to maintain hemostasis or adequate CO2 insufflation, without exchanging the introducer sheath or laparoscopic port.