Heart help device, system, and method

• US 8,469,874 B2
• Filed: 10/12/2009
• Issued: 06/25/2013
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Milux Holding SA
• Inventors: Forsell, Peter
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US13/123,587
• Publication Number:
  US 20110201871A1
• Time in Patent Office: 1,352 Days
• Field of Search: 600/16
• US Class Current: 600/16
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61M 1/04 Artificial pneumothorax apparatus
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/476 with means converting the rotation into a translational movement of the displacement member
• CPC Class Codes: A61M 60/478 the axis of both movements being parallel, e.g. roller screw actuators or cylindrical cam transmissions
• CPC Class Codes: A61M 60/495 Electromagnetic force
• CPC Class Codes: A61M 60/50 Details relating to control
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/867 : using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
• CPC Class Codes: A61M 60/873 : specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/894 : Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3962 : in combination with another heart therapy

Abstract

An implantable device for improving the pump function of the heart of a human patient by applying an external force on the heart muscle is provided. The device comprises at least one pump device having a pump. The pump comprising: a piston adapted for reciprocating movement, an operating device for operating the piston, a heart contacting organ. The movement of the piston assists the pump function of the heart through said heart contacting organ.

Claims

1. An implantable device for improving the pump function of the heart of a human patient by applying an external force on the heart muscle, said device comprising at least one pump device adapted to assist in the pump function of the heart comprising:

a piston adapted for reciprocating movement,

an operating device for operating the piston,

a heart contacting organ,

a pressurized fluid system comprising;

a first chamber adapted to hold a pressurized fluid, wherein said first chamber is adapted to hold a fluid having a high pressure and

a second chamber adapted to hold a pressurized fluid, wherein said second chamber is adapted to hold a fluid having a lower pressure, and

wherein said piston is adapted to use said first chamber for moving said piston in two directions with high pressure fluid, and wherein said piston is further adapted to use said second chamber for lowering the pressure on one side of said piston, and

wherein the movement of the piston directly or indirectly is transported to said heart contacting organ to assist the pump function of the heart.

2. The implantable device according to claim 1, wherein said pressurized fluid system further comprises a valve

system and wherein said valve system is adapted to direct fluid between;

different sides of said piston, which side depending on the piston position or piston direction, and

said first chamber and/or said second chamber to allow reciprocal and iterative movement of said piston, wherein

said second lower pressure chamber is adapted to empty the high pressurized side of the piston, after a piston away movement has occurred, adapted to allow the reciprocal movement with new high pressure fluid arriving at the opposite side of the piston, and

wherein said valve system is adapted to intermittently connect said second lower pressure chamber to the side of the piston intended to receive the piston in the next piston movement.

3. The valve according to claim 2, adapted to intermittently connect said second lower pressure chamber to the side of the piston intended to receive the piston in the next piston movement step.

4. The implantable device according to claim 3, wherein said first higher pressure chamber is adapted to fill one side of the piston with high pressurized fluid, and after a piston away movement has occurred, being adapted to allow the reciprocal movement with a new high pressurized fluid arriving at the opposite side of the piston, and wherein said valve system is adapted to intermittently connect said first higher pressure chamber to the side of the piston intended to transmit the piston away in the next piston movement step.

5. The implantable device according to claim 2, comprising a pump adapted to comprise a non return valve and be connected between the first and second chamber, wherein said second lower pressure chamber is adapted to be periodically be emptied into the first high pressure chamber, adapted to allow continuous movement of said piston.

6. The implantable device according to claim 2, comprising a volume refilling device to refill fluid leaking from the system.

7. The implantable device according to claim 1, wherein said implantable device comprises a second pump device.

8. The implantable device according to claim 1, wherein said operating device comprises an eccentrically rotating member adapted to affect said piston.

9. The implantable device according to claim 1, wherein said piston is arranged in a sleeve, and wherein said sleeve and said piston confines a sealed chamber.

10. The implantable device according to claim 9, wherein said operating device, at least partly placed inside of said sealed chamber.

11. The implantable device according to claim 1, wherein at least one of:

the implantable device, the piston, the sleeve, a contacting surface between the piston and the sleeve, and the heart contacting organ, comprises at least one of;

a ceramic material and a carbon material ceramic material.

12. The implantable device according to claim 1, comprising a fixation device or fixation member, adapted to fixate at least a section of said device to at least of:

a. a rib of the patient,

b. the sternum of the patient, and

c. a vertebra of the patient.

13. The implantable device according to claim 1, wherein the operating device further comprises at least one of

an eccentrically rotating member adapted to affect said piston,

a magnetic motor adapted to be operated by successive energizing of coils in connection with magnets,

a solenoid,

a hydraulic motor,

a pneumatic motor, and

a servo motor.

14. The implantable device according to claim 1, wherein said heart contacting organ is adapted to exert an external force on at least one of:

the left ventricle of the heart,

two different sides of the left ventricle of the heart,

the right ventricle of the heart,

two different sides of the right ventricle of the heart.

15. The implantable device according to claim 1, wherein said heart contacting organ is operable to change the position of said force exerted on said external part of the heart.

16. The implantable device according to claim 1, wherein said heart contacting organ is operable using at least one of:

a motor, and a hydraulic operating system.

17. The implantable device according to claim 1, wherein said at least one pump device is a adapted to compress at least one portion of a tissue wall of the heart and wherein said pump device is further adapted to stimulate at least a portion of said tissue wall of said heart using electrical stimulation to further compress said tissue wall.

18. The implantable device according to claim 15 wherein said heart contacting organ is able to change from exerting force to a first area of the heart to exerting force to a second area of the heart, after said implantable device has been implanted in said human patient, wherein said heart contacting organ is adapted to receive said hydraulically or pneumatic force.

19. The implantable device according to claim 1, wherein said implantable device comprises a diaphragm contacting part for assisting in the maintaining of an opening created in the thoracic diaphragm, adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm or pericardium, wherein the diaphragm contacting part is a grommet.

20. The implantable device according to claim 1, comprising at least one of;

a diaphragm contacting part for assisting in the maintaining of an opening created in the thoracic diaphragm, adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm or pericardium, wherein said implantable device, and

a force transferring part, and wherein said force transferring part is adapted to travel through the opening and transfer force between the abdominal side of the thoracic diaphragm and the thoracic side of the thoracic diaphragm or the pericardium.

21. A implantable device according to claim 20, wherein at least one of said diaphragm contacting part and said force transferring part comprises ceramic material.

22. The implantable device according to claim 20, wherein said diaphragm contacting part and said force transferring part are adapted to seal against each other, such that the thorax is sealed from the abdomen in the area of the diaphragm contacting part.

23. The implantable device according to claim 1, comprising at least one of;

heart help device or heart assistant device, wherein the at least one heart contacting organ is adapted to compress the heart of the patient, wherein the heart contacting organ exerts force on the heart muscle through the movement of the piston, periodically exerting force onto the outside of the heart following the heart contractions and adding force thereto,

an artificial heart, and

an LVAD device.

24. The implantable device according to claim 23, the implantable device further comprising an electric system, wherein the heart help device or the heart assistant device comprising at least one of;

at least one electrode supplying an electric signal for controlling the heart rhythm, such as a pacemaker signal, and

an internal control unit and a sensor sensing physiological electrical pulses or muscle contractions of the heart, wherein said control unit controls said heart help device according to the sensed information, for at least one of;

achieving heart muscle contractions and controlling heart contractions, adapted to coordinate the heart help device or heart assistant device with the heart contractions,

wherein the electric system is at least partially adapted to be placed in at least one of;

the abdomen, the thorax, and subcutaneously or close thereto of the patient, and the electric lead is adapted to transfer at least one of;

electric energy, an electric control signal and sensor input to or from the part of the implantable heart help device or heart assistant device placed in the thorax of the patient.

25. The implantable device according to claim 24, wherein the internal control unit is programmable from outside the patient'"'"'s body, to regulate the device according to a pre-programmed time-schedule or to input from any sensor sensing at least one of at least one physical parameter of the patient and functional parameter of the system.

26. The implantable device according to claim 1, further comprising a pericardial drainage device for draining a fluid from the pericardium of a patient, said pericardial drainage device comprising a conduit, said conduit comprising a first and second section, wherein at least a portion of said first section is adapted to receive a fluid inside of said pericardium, and wherein said second section of said conduit is adapted to be positioned outside of the pericardium of a patient and enable the exhaust of said fluid received from said pericardium through at least a portion of said second section, and wherein said second section is adapted to be placed in the abdomen or thorax of said patient for moving a fluid from the pericardium of said patient to the abdomen or thorax of said patient.

27. The implantable device according to claim 20, further comprising a force transferring part, and wherein said force transferring part comprises at least one of;

a conduit adapted to transfer hydraulic or pneumatic force, and

an electric lead adapted to transfer electric energy,

from the abdomen.

28. The implantable device according to claim 1, comprising a feedback device, comprising a sensor or measuring device implantable in the patient for sensing at least one of;

a physical parameter of the patient, wherein the physical parameter is at least one selected from the group consisting of pressure, volume, diameter, stretching, elongation, extension, movement, bending, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heartbeats and breathing, and

a functional parameter, wherein the functional parameter is at least one of a parameter correlated to the transfer of energy for charging an implanted energy source and at least one selected from the group of parameters consisting of;

electricity, any electrical parameter, pressure, volume, diameter, stretch, elongation, extension, movement, bending, elasticity, temperature and flow,

wherein the feedback is sent to at least one of an internal control unit and an external control unit outside the body directly or via the internal control unit.

29. The implantable device according to claim 1, comprising a fibrotic tissue movement structure adapted to allow the respiratory movement of the heart in relation to the stable bone position caused by a fixation device or fixation member, without interference from surrounding fibrotic tissue, when implanted in the body.

30. The implantable device according to claim 23, comprising an internal energy receiver, adapted to be energized non-invasively and wirelessly by an external energy source from outside the patient'"'"'s body, adapted for sending wireless energy to and comprising at least one of:

an implantable internal energy source or energy storage device connected to the heart assistant device or heart help device, being chargeable by the energy transferred from an external energy source,

an internal energy receiver or internal energy source, adapted to be implanted in the abdomen, and

at least one implantable energy consuming component of the device energized by the wireless energy to be directly consumed.

31. The implantable device according to claim 23, comprising a respiration movement compensator for compensating for movements in the body created by the respiration of the patient, the respiratory movement of the heart in relation to a stable position, wherein said drive unit or operation device is adapted to allow movement to compensate for the respiratory movement between said heart contacting organ and said stable position, when the implantable device is implanted wherein said respiration movement compensator is adapted to be placed between the operation device and the heart help device for compensating for the movements created by the respiration, and wherein said respiration movement compensator comprises at least one of;

a telescopic functionality thereby extend or being compressible through the respiration movement, and

a guided movement,

for to compensate for the respiratory movement.

32. A system, including the implantable device according to claim 1, comprising a sensor and/or a measuring device sensing or measuring at least one of;

at least one physical parameter of the patient, and at least one functional parameter related to the apparatus, comprising at least one of;

a functional parameter correlated to the transfer of energy for charging the internal energy source, according to claim 14, and any other functional parameter related to the apparatus, wherein

the apparatus further comprising a feedback device for sending feedback information from inside the patient'"'"'s body to at least one of;

an implantable internal control unit comprised and

the outside of the patients body,

wherein the feedback information being related to at least one of;

the at least one physical parameter of the patient and the at least one functional parameter related to the apparatus.