Abstract: A transvascularly placed steerable microcatheter, further including internal steerability and the ability to articulate in a direction at right angles to its longitudinal axis at or near its distal end. The steerable microcatheter is generally fabricated from stainless steel, nitinol, or other metal and includes an outer tube, an inner tube, hub structures, and a distal articulating region. The steerable microcatheter can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature. The microcatheter is especially suited to robotic or powered control applications with user intervention or using artificial intelligence (AI).

Abstract: A transvascularly placed steerable microcatheter, further including internal steerability and the ability to articulate in a direction at right angles to its longitudinal axis at or near its distal end. The steerable microcatheter is generally fabricated from stainless steel, nitinol, or other metal and includes an outer tube, an inner tube, hub structures, and a distal articulating region. The steerable microcatheter can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature. The microcatheter is especially suited to robotic or powered control applications with user intervention or using artificial intelligence (AI).

Abstract: An endoluminal punch and introducer sheath are described wherein the endoluminal punch comprises a guidewire lumen through which a user is capable of placing a guidewire. The endoluminal punch system further comprises a mechanism affixed to the hub which is capable of controlling the axial positioning of the guidewire relative to the endoluminal punch distal end. The control mechanism can be released so that the endoluminal punch can be removed from a patient while retaining the guidewire in place within the patient. The endoluminal punch introducer, including a sheath and dilator, can comprise energy emitting electrodes or transducers for cutting larger size holes in stubborn (friable, scarred, or fibrotic) tissue. In other embodiments, the endoluminal punch can comprise a guidewire or stylet, wherein the guidewire or stylet is capable of emitting energy to cut through tissue.

Abstract: A steerable endoluminal access device, such as a guidewire or guide catheter. The steerable endoluminal access device includes an inner tube within an outer tube, with the inner tube fixed to the outer tube near the distal end of the device. The steerable endoluminal access device includes a releasably detachable hub for tensioning or compressing the inner tube relative to the outer tube.

Abstract: An endoluminal punch and introducer sheath are described wherein the endoluminal punch comprises a guidewire lumen through which a user is capable of placing a guidewire. The endoluminal punch system further comprises a mechanism affixed to the hub which is capable of controlling the axial positioning of the guidewire relative to the endoluminal punch distal end. The control mechanism can be released so that the endoluminal punch can be removed from a patient while retaining the guidewire in place within the patient. The endoluminal punch introducer, including a sheath and dilator, can comprise energy emitting electrodes or transducers for cutting larger size holes in stubborn (friable, scarred, or fibrotic) tissue. In other embodiments, the endoluminal punch can comprise a guidewire or stylet, wherein the guidewire or stylet is capable of emitting energy to cut through tissue.

Abstract: An endoluminal traversing system and tissue crossing system are described wherein the access systems are controlled by actuators that allow for robotic control of system functions. The robotic system can be configured for full manual control over the actuators, full computerized control, or a combination of human and computer (AI, neural net, rule set) guidance.

Abstract: An endoluminal punch and introducer sheath. The endoluminal punch includes a secondary blade, or fin blade affixed to the distal end of the endoluminal punch to increase the size of an incision.

Abstract: Devices and methods are disclosed for protecting individuals from the sharp ends of medical objects following use on a patient. Such sharp objects include hypodermic needles, scalpel blades, cannulae, trocars, and the like. The invention utilizes a disposable protective cover for the used sharp. The protective cover is designed to surround and embed the sharp in a permanent cover that is blunt and will not permit further puncture or cutting with the sharp. In an embodiment, the protective cover also absorbs any fluids on or in the used sharp. A refillable or replaceable dispenser dispenses the protective covers at points of use. A disposable receptacle receives the used sharp embedded in the protective cover. When the receptacle is full, the entire receptacle may be discarded in a medical waste container.

Abstract: Disclosure is provided for apparatus and methods to control the temperature of fluids being administered to patients. The apparatus consists of an I.V. reservoir, fluid administration or I.V. tubing, an in-line heater, a heater controller, a temperature sensor located near the patient and feedback circuit connecting the temperature sensor to the heater controller. A method is disclosed which provides for overheating of the fluid so that it cools down to the desired temperature (usually body temperature) by the time it reaches the patient. In another embodiment, apparatus is disclosed for providing distributed heat to fluids being administered to patients. This apparatus includes heating channels or elements running along a length of the fluid administration tubing. These heating elements are controlled by a controller, which is attached to a temperature sensor, preferably located near the patient.

Abstract: A system is disclosed for cannulating the vena cava of a patient during cardiopulmonary bypass procedures. Such cannulation is necessary for drainage of venous blood from the patient so that it may be oxygenated and pumped back to the patient to perfuse tissues during cardiac surgery and, more specifically, during periods of ischemic cardiac arrest or dysfunction. The device of the present invention not only provides venous drainage for cardiopulmonary bypass, but also performs the function of routing cardioplegic solution through the heart in the retrograde direction. Such cardioplegia provides protection to the heart during periods of ischemic cardiac arrest. This invention replaces a plurality of cannulae currently used for open-heart surgery, thus simplifying the surgical field and improving visibility of the heart.

Abstract: A rotationally vibrating imaging catheter and method of utilization has an array of ultrasound transducers and an actuator along with signal processing, display, and power subsystems. The actuator of the preferred embodiment is a solid-state nitinol actuator. The actuator causes the array to oscillate such that the tip of the catheter may be rotated through an angle equal to or less than 360 degrees. The tip is then capable of rotating back the same amount. This action is repeated until the desired imaging information is acquired. The rotationally vibrating catheter produces more imaging points than a non-rotating imaging catheter and eliminates areas of missing information in the reconstructed image. Rotationally vibrating catheters offer higher image resolution than stationary array catheters and greater flexibility and lower costs than mechanically rotating imaging catheters.

Abstract: A system is disclosed for cannulating the vena cava of a patient during cardiopulmonary bypass procedures. Such cannulation is necessary for drainage of venous blood from the patient so that it may be oxygenated and pumped back to the patient to perfuse tissues during cardiac surgery and, more specifically, during periods of ischemic cardiac arrest or dysfunction. The device of the present invention not only provides venous drainage for cardiopulmonary bypass, but also performs the function of routing cardioplegic solution through the heart in the retrograde direction. Such cardioplegia provides protection to the heart during periods of ischemic cardiac arrest. This invention replaces a plurality of cannulae currently used for open-heart surgery, thus simplifying the surgical field and improving visibility of the heart.

Abstract: Disclosure is provided for apparatus and methods to control the temperature of fluids being administered to patients. The apparatus consists of an I.V. reservoir, fluid administration or I.V. tubing, an in-line heater, a heater controller, a temperature sensor located near the patient and feedback circuit connecting the temperature sensor to the heater controller. A method is disclosed which provides for overheating of the fluid so that it cools down to the desired temperature (usually body temperature) by the time it reaches the patient.

Abstract: A rotationally vibrating imaging catheter and method of utilization has an array of ultrasound transducers and an actuator along with signal processing, display, and power subsystems. The actuator of the preferred embodiment is a solid state nitinol actuator. The actuator causes the array to oscillate such that the tip of the catheter may be rotated through an angle equal to or less than 360 degrees. The tip is then capable of rotating back the same amount. This action is repeated until the desired imaging information is acquired. The rotationally vibrating catheter produces more imaging points than a non-rotating imaging catheter and eliminates areas of missing information in the reconstructed image. Rotationally vibrating catheters offer higher image resolution than stationary array catheters and greater flexibility and lower costs than mechanically rotating imaging catheters.

Abstract: Disclosed is an apparatus and method for the treatment of the symptoms of obstructive prostatism. The apparatus comprises an expandable dilation catheter and preferably an axially elongate sheath, adapted for transurethral insertion via the external opening of the urethra. The sheath is ellipsoid in cross-section, and provides an initial path through which the catheter and a standard cystoscope lens is guided. The dilation catheter or the sheath are provided with a non-radiological locating means for positioning the dilation portion of the catheter with respect to an anatomical landmark. Once the catheter has been properly positioned with respect to both the bladder neck and the sphincter, the dilation balloon may be inflated to force open the affected prostatic urethra and eliminate the obstruction.

Abstract: Disclosed is an apparatus and method for the treatment of the symptoms of obstructive prostatism. The apparatus includes an expandable dilation catheter and preferably an axially elongate sheath, adapted for transurethral insertion via the external opening of the urethra. The sheath is ellipsoid in cross-section, and provides an initial path through which the catheter and a standard cystoscope lens is guided. The dilation catheter or the sheath are provided with a non-radiological locating feature for positioning the dilation portion of the catheter with respect to an anatomical landmark. Once the catheter has been properly positioned with respect to both the bladder neck and the sphincter, the dilation balloon may be inflated to force open the affected prostatic urethra and eliminate the obstruction.