Abstract: A sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Abstract: The invention relates to a rotor for a compressible fluid pump, in particular a blood pump that can be introduced through a blood vessel into a patient's body, wherein said rotor comprises one or more conveying elements (15), is compressible and expandable between a first compressed state and a second radially expanded state, is made at least partially from a plastic reinforced with reinforcing elements, in particular fibers (10, 11, 13, 18, 19, 55, 56, 62, 63) and is provided for rotation about an axis of rotation (14). According to the invention, the rotor is tensioned in the first, compressed state and free from external stresses in the second, expanded state. A third state exists, which the rotor (42) occupies in the operating state under load. The reinforcing elements, in particular fibers, extend in the rotor in the third state at least in sections in a stretched manner.

Abstract: A blood pump comprises a pump casing having a blood flow inlet and outlet, and an impeller arranged in said pump casing so as to be rotatable. The impeller has blades sized and shaped for conveying blood from the blood flow inlet to the blood flow outlet. The blood pump comprises an outflow cannula having an upstream end portion, a downstream end portion and an intermediate portion. The upstream end portion is connected to the pump casing such that blood is conveyed from the blood flow outlet through the intermediate portion towards the downstream end portion. The downstream end portion has a blood flow outlet through which blood can exit the outflow cannula. At least a portion of the intermediate portion of the outflow cannula has an outer diameter that is larger than an outer diameter of the pump casing.

Abstract: An introducer sheath for providing access in a patient's body comprises a tubular body with a distal portion and a proximal portion, the proximal portion being configured to be inserted into the patient's body to allow a medical device to be inserted through the introducer sheath into the patient's body. In order for the introducer sheath to be removable from the patient, it can be separated along its length in a longitudinal direction. The introducer sheath further comprises at least a first handle which is pivotable about a fulcrum. The first handle has a first end portion and a free second end portion so as to form a lever, such that pivoting the handle about the fulcrum causes a contacting portion of the handle to act on a respective counter portion that is operatively connected to the distal portion of the tubular body. This creates a breaking force that causes the distal portion of the tubular body to break.

Abstract: A blood pump comprises a pump casing having a blood flow inlet and a blood flow outlet, and an impeller arranged in said pump casing and rotatably supported in the pump casing by a bearing so as to be rotatable about an axis of rotation. The impeller has blades for conveying blood from the blood flow inlet to the blood flow outlet. The bearing comprises at least one stationary bearing portion coupled to the pump casing and having a stationary bearing surface that faces radially outwards. The bearing further comprises a rotating bearing surface interacting with the stationary bearing surface to form the bearing, wherein the rotating bearing surface faces radially inwards and is formed on an exposed radially inner edge of the blades. The blades are designed to draw blood deposit on the stationary bearing surface in a radially outward direction.

Abstract: A blood pump comprises a pump casing, a blood flow inlet and a blood flow outlet connected by a passage, and an impeller. The impeller comprises blades configured to convey blood from the blood flow inlet to the blood flow outlet, the impeller being supported in the pump casing by at least one contact-type bearing comprising a surface of the impeller facing a surface of the pump casing. At least one wash out channel extends through the impeller and is in fluid connection with the passage via a first opening and with the bearing via a second opening. The wash out channel is operatively associated with a secondary pump for pumping blood through the wash out channel towards the bearing. The secondary pump is formed at least partially by said at least one wash out channel extending through the impeller along a direction having at least one tangential directional component.

Abstract: An intravascular blood pump having a drive section (11), a catheter (14) fastened to the drive section proximally and a pump section (12) fastened to the drive section distally possesses an electric motor (21) whose motor shaft (25) is mounted in the drive section (11) with two radial sliding bearings (27, 31) and an axial sliding bearing (40). During operation, purge fluid is conveyed through the bearing gap of the axial sliding bearing (40) and further through the radial sliding bearing (31) at the distal end of the drive section (11). The purge fluid is highly viscous, for example 20% glucose solution.

Abstract: The present disclosure provides medical devices, systems and methods and in particular to devices and methods useful for anchoring graft materials to bodily structures.

Abstract: A sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Abstract: The invention concerns a control device for controlling a blood flow of an intravascular blood pump for percutaneous insertion into a patient's blood vessel, the blood pump comprising a pump unit with a drive unit for driving the pump unit and configured to convey blood from a blood flow inlet towards a blood flow outlet, wherein the control device is configured to operate the blood pump in a selectable zero-flow control mode, wherein a blood flow command signal is selected, and the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow by adjusting a speed command signal for the drive unit, and the second controller is configured to control a drive speed of the drive unit.

Abstract: An apparatus is disclosed including: an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; and a lumen which extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, and to a second end located outside of the pump device. The lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path.

Abstract: The invention relates to an intercardiac pump device comprising a pump (11) whose distal end (13) is connected to a cannula (15) which is provided with a suction head (16) for sucking blood. Said strainer is provided with a non-sucking extension (20) for stabilising the position of said pump device in the heart and mechanically prolonging the cannula (15) without deteriorating hydraulic conditions. Said extension is also used in the form of a spacer in order to avoid that the suction head (16) adheres to a cardiac wall.

Abstract: An introducer sheath (10) comprises a tubular body (11) with a distal portion (12) and a proximal portion (13), the proximal portion (13) being configured to be inserted into the patient's body. Introducer sheath can be separated along its length in a longitudinal direction. The introducer sheath (10) further comprises at least a first handle (15) which is pivotable about a fulcrum (21). The first handle (15) has a first end portion (151) and a free second end portion (152) so as to form a lever, such that pivoting the handle (15) about the fulcrum (21) causes a contacting portion (23) of the handle to act on a respective counter portion (24) that is operatively connected to the distal portion (12) of the tubular body (11). This creates a breaking force that causes the distal portion (12) of the tubular body (11) to break.

Abstract: A method of operating a counterpulsation device (CPD) in a human or animal subject is disclosed, the method including: receiving a heart beat signal indicative of the heart beat of the subject; providing counterpulsation therapy by controlling the pressure supplied to a CPD drive line in pneumatic communication with the CPD to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heart beat signal; while providing counterpulsation therapy, receiving a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjusting the pressure supplied to the drive line based at least in part on the drive line pressure signal.

Abstract: An intravascular blood pump (1) comprises a ring seal (10) that is configured to assume a collapsed configuration and an expanded configuration and configured to contact and seal against an inner wall of the patient's blood vessel when inserted therein in the expanded configuration. A support member (12; 13) is disposed inside the ring seal (10) in order to support the ring seal (10) from the inside, wherein the support member (12; 13) is configured to collapse at least partially when a predetermined pressure difference between a proximal area and a distal area of the blood vessel acting on the ring seal (10) is exceeded.

Abstract: An intravascular blood pump for percutaneous insertion comprises a catheter (10) and a pumping device (1) attached to the catheter (10). The catheter (10) extends along a longitudinal axis and has a distal end (11) and a proximal end (12) opposite the distal end (11). The catheter (10) comprises an elongate stiffening structure (15) extending continuously longitudinally along the length of the catheter (10) between the proximal end (11) and the distal end (12) of the catheter (10). The stiffening structure (15) may comprise a shape-memory material, such as Nitinol. It may be in the form of a wire that extends loosely through the lumen of the catheter and helps to avoid or significantly reduce kinks in the catheter.

Abstract: An apparatus is disclosed including: an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; and a lumen which extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, and to a second end located outside of the pump device. The lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path.

Abstract: An intravascular blood pump having a drive section (11), a catheter (14) fastened to the drive section proximally and a pump section (12) fastened to the drive section distally possesses an electric motor (21) whose motor shaft (25) is mounted in the drive section (11) with two radial sliding bearings (27, 31) and an axial sliding bearing (40). During operation, purge fluid is conveyed through the bearing gap of the axial sliding bearing (40) and further through the radial sliding bearing (31) at the distal end of the drive section (11). The purge fluid is highly viscous, for example 20% glucose solution.

Abstract: An intravascular blood pump comprises a catheter (10) and a pumping device (1) attached to the catheter (10). The catheter (10) extends along a longitudinal axis and has a distal end (11) and a proximal end (12) opposite the distal end (11). The catheter (10) comprises a tubular stiffening structure (15) extending longitudinally between the proximal end (12) and the distal end (11) of the catheter (10). The tubular stiffening structure (15) has a lumen (21) and a proximal end (17) and a closed distal end (16) opposite the proximal end (17), wherein the lumen (21) of the stiffening structure (15) is configured to receive a pressurized fluid having an over-pressure of at least 5 bar.

Abstract: A control device for a ventricular assist device (VAD) with settable speed levels. The control device includes an input configured to receive at least one measuring signal related to a physiological condition of the circulatory system of a patient receiving heart assistance by the VAD, where the control device is configured to derive an actual value of at least one characteristic parameter of the heart from one or more of the at least one measuring signal and to provide a refined actual value of the at least one characteristic parameter in which effects of physiologically caused fluctuations are eliminated or reduced. The control device further includes an output configured to output an updated setting value for the speed level, where the control device is configured to produce the updated setting value based on the refined actual value and a predeterminable set-point value.