Mechanical assist device

Abstract

Methods and apparatuses relate to an implantable device for providing contractile assistance to an organ. The device may include an actuator and anchors located on either side of the actuator. The anchors engage with oppositely positioned tissue walls of an organ chamber, and provide contractile assistance to the organ, repeatedly, at appropriate times. For example, the device may be implanted within the right ventricle, anchored to the right ventricular free wall and the ventricular septum. The device may function to bring the opposing walls of the ventricle toward one another, synchronized with the pacing of the heart, resulting in an improved ejection fraction of blood from the chamber. In some embodiments, the actuator includes a bladder that is configured to contract upon receiving an inflow of pressurized fluid therein. When the fluid exits therefrom, the bladder relaxes back to an initial, extended state.

What is claimed is: 
     
         1 . A device for providing mechanical assistance to an organ, the device comprising:
 a first anchor adapted to engage with a first wall region of the organ;   a second anchor adapted to engage with a second wall region of the organ; and   an actuator coupled with the first anchor and the second anchor, and configured to move the first and second anchors relative to one another repeatedly between a contracted position where the anchors are moved toward each other to draw the first and second wall regions of the organ toward each other and an extended position where the anchors are moved away from each other relative to the contracted position to move the first and second wall regions away from each other.   
     
     
         2 . The device of  claim 1 , wherein the actuator is located between the first and second anchors. 
     
     
         3 . The device of  claim 1 , wherein at least one of the first anchor and the second anchor is configured to be retracted from engagement with the respective wall region of the organ. 
     
     
         4 . The device of  claim 1 , wherein at least one of the first anchor and the second anchor is configured to form a seal with the respective wall region of the organ. 
     
     
         5 . The device of  claim 1 , wherein at least one of the first anchor and the second anchor includes a flange for securing the anchor to the respective wall region of the organ. 
     
     
         6 . The device of  claim 5 , wherein at least one of the first anchor and the second anchor includes an anchoring member constructed and arranged to couple with the flange for securing the anchor to the respective wall region of the organ. 
     
     
         7 . The device of  claim 6 , wherein the anchoring member and the flange are constructed and arranged to provide compressive force on opposing sides of the respective wall region of the organ. 
     
     
         8 . The device of  claim 5 , wherein at least one of the first anchor and the second anchor includes at least one suture for securing the flange to the respective wall region of the organ. 
     
     
         9 . The device of  claim 5 , wherein the flange is adapted to be placed in an undeployed position for installation of the anchor to the respective wall region of the organ and a deployed position for securing the anchor to the respective wall region of the organ. 
     
     
         10 . The device of  claim 1 , wherein at least one of the first anchor and the second anchor includes a compartment for receiving fluid, and the compartment is adapted to expand so as to engage with the respective wall region of the organ. 
     
     
         11 . The device of  claim 1 , wherein the first anchor is constructed and arranged to be secured at an inner wall surface of a left ventricle. 
     
     
         12 . The device of  claim 1 , wherein the second anchor is constructed and arranged to be secured at a wall surface of a right ventricle. 
     
     
         13 . The device of  claim 1 , wherein the second anchor includes a fastener having a first fastening component and a second fastening component, each of the fastening components having surfaces complementary to one another. 
     
     
         14 . The device of  claim 13 , wherein the first fastening component includes threaded bolt having a lumen therethrough and the second fastening component includes a threaded nut, wherein the threads of each of the bolt and the nut are complementary to one another. 
     
     
         15 . The device of  claim 1 , wherein the actuator includes a compartment for receiving an inflow of fluid, and the compartment is adapted to contract along a longitudinal direction and expand in a radial direction to the contracted position upon receiving the inflow of fluid. 
     
     
         16 . The device of  claim 15 , wherein the compartment is adapted to extend along the longitudinal direction and contract in the radial direction to the extended position upon outflow of the fluid from the compartment. 
     
     
         17 . The device of  claim 15 , wherein the compartment includes a bladder and a mesh surrounding the bladder. 
     
     
         18 . The device of  claim 17 , wherein the mesh is constructed and arranged to guide contraction of the bladder along the longitudinal direction and expansion of the bladder along the radial direction, upon the bladder receiving the fluid. 
     
     
         19 . The device of  claim 15 , further comprising a pumping apparatus for forcing the fluid into and out of the compartment. 
     
     
         20 . The device of  claim 15 , further comprising a reservoir for supplying the fluid to the compartment. 
     
     
         21 . The device of  claim 20 , wherein the reservoir is constructed and arranged to be located inside the body during use. 
     
     
         22 . The device of  claim 15 , further comprising a valve for regulating flow of fluid into and out of the compartment. 
     
     
         23 . The device of  claim 1 , further comprising a sensor for sensing information from the organ or information from the actuator during use. 
     
     
         24 . The device of  claim 23 , wherein the sensor is configured to sense electrocardiogram information from the organ. 
     
     
         25 . The device of  claim 23 , further comprising a controller configured to cause the actuator to move the first and second anchors according to a pattern based on the sensed information. 
     
     
         26 . The device of  claim 1 , further comprising a biocompatible coating disposed over at least one of the first anchor, the second anchor and the actuator. 
     
     
         27 . The device of  claim 1 , wherein the first anchor is adapted to be inserted through the second wall region and then into the first wall region. 
     
     
         28 . A method of using a device for providing mechanical assistance to an organ, the method comprising:
 engaging a first anchor with a first wall region of the organ;   engaging a second anchor with a second wall region of the organ; and   operating an actuator coupled with the first anchor and the second anchor to move the first and second anchors relative to one another repeatedly between a contracted position where the anchors are moved toward each other to draw the first and second wall regions of the organ toward each other and an extended position where the anchors are moved away from each other relative to the contracted position to move the first and second wall regions away from each other.   
     
     
         29 . The method of  claim 28 , wherein engaging the first and second anchors with respective first and second wall regions of the organ includes using a catheter to deploy the first and second anchors to respective first and second wall regions of the organ. 
     
     
         30 . The method of  claim 28 , wherein engaging the first anchor with the first wall region of the organ includes piercing a ventricular septum and securing the first anchor at a wall surface of a left ventricle. 
     
     
         31 . The method of  claim 30 , wherein engaging the first anchor with the first wall region of the organ includes moving a flange through an opening of the pierced ventricular septum and into a volume defined by the left ventricle. 
     
     
         32 . The method of  claim 31 , wherein moving a flange through an opening of the pierced ventricular septum includes placing the flange in an undeployed position. 
     
     
         33 . The method of  claim 32 , further comprising coupling an anchoring member with the flange to secure the anchor to the respective wall region of the organ. 
     
     
         34 . The method of  claim 33 , further comprising moving the anchoring member and the flange toward one another to compress together opposing sides of the respective wall region of the organ. 
     
     
         35 . The method of  claim 34 , wherein moving the anchoring member and the flange toward one another includes pulling a suture coupled with the flange toward the anchoring member. 
     
     
         36 . The method of  claim 28 , wherein engaging the second anchor with the second wall region of the organ includes piercing a right ventricular wall and securing the second anchor at a wall surface of a right ventricle. 
     
     
         37 . The method of  claim 36 , wherein securing the second anchor at the wall surface of the right ventricle includes coupling a first fastening component and a second fastening component together. 
     
     
         38 . The method of  claim 37 , wherein coupling the first and second fastening components together includes screwing a threaded nut on to a threaded bolt. 
     
     
         39 . The method of  claim 28 , wherein operating the actuator includes moving the first and second anchors toward one another to result in the contracted position, and moving the first and second anchors away from one another to result in the extended position. 
     
     
         40 . The method of  claim 28 , wherein operating the actuator to move the first and second anchors relative to one another to the contracted position includes flowing a fluid into a lumen defined by the actuator. 
     
     
         41 . The method of  claim 40 , wherein operating the actuator to move the first and second anchors relative to one another to the extended position includes flowing a fluid out of the lumen defined by the actuator. 
     
     
         42 . The method of  claim 28 , further comprising sensing information from the organ or information from the actuator during use, and providing the information to a controller. 
     
     
         43 . The method of  claim 42 , wherein sensing information from the organ includes recording electrocardiogram information from a heart. 
     
     
         44 . The method of  claim 43 , wherein operating the actuator includes moving the first and second anchors relative to one another according to the electrocardiogram information of the heart.