Ventricular assist device having pressure sensor embedded durable displacement blood pump

Abstract

A ventricular assist device is provided, including a blood pump, a driveline and a feedthrough. The blood pump includes a pump housing, an axi-symmetric oval-shaped blood sac and stem assembly received in the pump housing, and a pressure sensing system embedded in the pump housing. The driveline includes a pneumatic lumen, at least one electric wire and a tether included in a wall of the driveline, wherein the electric wires and the tether are disposed on the pneumatic lumen. The feedthrough connects the driveline to the pump housing.

What is claimed is: 
     
         1 . A ventricular assist device, comprising:
 a blood pump, including: 
 an axi-symmetric oval-shaped blood sac and stem assembly, including a flexible membrane sac, a proximal stem, and a distal stem, wherein the flexible membrane sac is attached with the proximal stem and the distal stem as a stress-relief suspension mechanism; 
 a pump housing, including a proximal shell and a distal shell, wherein the stress-relief suspension mechanism is coupled to the pump housing; and 
 a pressure sensing system, embedded in the proximal shell, wherein the pressure sensing system includes a pressure sensor and a pressure sensing chamber which is filled with an incompressible fluid for pressure transmission; 
   a driveline, including a pneumatic lumen, at least one electric wire and a tether which are included in a wall of the driveline, wherein the electric wires and the tether are disposed in the wall of the driveline; and   a feedthrough which connects the driveline to the pump housing.   
     
     
         2 . The ventricular assist device as claimed in  claim 1 , wherein a de-airing port is installed in the proximal shell. 
     
     
         3 . The ventricular assist device as claimed in  claim 2 , wherein a channel is communicated with the de-airing port, and the channel extends alongside a centerline of the axi-symmetric oval-shaped blood sac and stem assembly and located above the septum of the integrated membrane sac and stem. 
     
     
         4 . The ventricular assist device as claimed in  claim 1 , wherein the flexible membrane sac has an inverted membrane located at a distal end of the flexible membrane sac, and the distal stem is wrapped and bonded with the inverted membrane; 
 wherein the proximal stem is located at a proximal end of the flexible membrane sac.   
     
     
         5 . The ventricular assist device as claimed in  claim 1 , further comprising an arterial connector having an interface adapter; 
 wherein the distal shell has a distal shell adapter to facilitate a connection of the blood pump to a human artery;   wherein the distal shell adapter has a first end and a second end, wherein the first end is interfaced with an inlet of the flexible membrane sac, and the second end is interfaced with the interface adapter to connect to the human artery.   
     
     
         6 . The ventricular assist device as claimed in  claim 5 , wherein the distal shell adapter has a beak, and the beak has a flange structure coupled with the interface adapter. 
     
     
         7 . The ventricular assist device as claimed in  claim 1 , further comprising a driver, wherein the driveline connects the blood pump to the driver. 
     
     
         8 . The ventricular assist device as claimed in  claim 1 , wherein the pressure sensor is hermetically housed in a metal canister, and includes a first space for fluid communication. 
     
     
         9 . The ventricular assist device as claimed in  claim 8 , wherein the pressure sensor further includes a second space which is closer to the driveline than the first space, wherein the second space is configured for accommodating a micro electro-mechanical system (MEMS) pressure transducer and electronic circuit. 
     
     
         10 . The ventricular assist device as claimed in  claim 9 , wherein the pressure sensing chamber is situated in the proximal shell and adjacent to the first space, and the pressure sensing chamber is configured to allow a sensing fluid be enclosed in. 
     
     
         11 . The ventricular assist device as claimed in  claim 10 , wherein the pressure sensing chamber has a first arm and a second arm, wherein the first arm is used for installation of pressure sensor, and the second arm is used for filling and sealing a sensing medium. 
     
     
         12 . The ventricular assist device as claimed in  claim 1 , wherein the feedthrough is integrated with the proximal shell;
 wherein the feedthrough has a first portion as an extension of the proximal shell in which the pneumatic lumen, the tether and the electric wires of the driveline are coupled;   wherein the feedthrough further has a second portion interlocked with the first portion working as a bend relief of the driveline.   
     
     
         13 . The ventricular assist device as claimed in  claim 1 , wherein the driveline further includes a middle pneumatic tubing and a coil, wherein the pneumatic lumen is received in the middle pneumatic tubing, and the coil is located between the pneumatic lumen and the middle pneumatic tubing. 
     
     
         14 . The ventricular assist device as claimed in  claim 13 , wherein the driveline further includes an outer layer tubing, wherein the pneumatic lumen and the middle pneumatic tubing are received in the outer layer tubing, and the electric wires are covered by the outer layer tubing. 
     
     
         15 . The ventricular assist device as claimed in  claim 14 , wherein the tether is disposed on the outer layer tubing. 
     
     
         16 . The ventricular assist device as claimed in  claim 15 , wherein the driveline further includes a rigid driver connector located at a proximal end of the driveline; 
 wherein ventricular assist device further comprises a driver, and the driveline is connected to the driver, wherein the rigid driver connector is connected to the driver.   
     
     
         17 . The ventricular assist device as claimed in  claim 16 , wherein the rigid driver connector is flush mounted with a plurality of electrodes soldered with the electric wires. 
     
     
         18 . The ventricular assist device as claimed in  claim 1 , wherein the feedthrough is integrated with the distal shell, and the feedthrough has a first portion as an extension of the distal shell in which the pneumatic lumen, the tether and the electric wires of the driveline are coupled; 
 wherein the feedthrough further has a second portion interlocked with the first portion working as a bend relief of the driveline.   
     
     
         19 . The ventricular assist device as claimed in  claim 18 , wherein the proximal shell and distal shell have an overlapped bonding area, and the pump housing has a superficial trench formed above the overlapped bonding area. 
     
     
         20 . The ventricular assist device as claimed in  claim 19 , wherein the trench is sealed by a potting waterproof material.