Heart help device, system, and method

• US 8,696,745 B2
• Filed: 10/12/2009
• Issued: 04/15/2014
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/123,586
• Publication Number:
  US 20110224787A1
• Time in Patent Office: 1,646 Days
• Field of Search: 623/3.1
• US Class Current: 623/3.1
• 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

The present invention relates to 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 comprising: a first part having a first surface, and a second part having a second surface. The first part is displaceable in relation to the second part and said first and second surfaces abut each other, at least partially. The second part exerts, directly or indirectly, force on an external part of said heart muscle.

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 comprising:

first part having a first surface adapted to be placed outside the heart, and

a second part having a second surface adapted to be paced outside the heart, wherein

said first part is adapted to be displaceable in relation to the second part,

said first and second surfaces are adapted to abut each other, at least partially,

said first surface is substantially parallel to said second surface,

said first and/or second part comprises coils and said first and/or second part comprises magnets,

said displacement of said first part is created through successive energizing of said coils, and wherein

said first part is adapted to exert, directly or indirectly, force on an external part of said heart muscle, when implanted.

2. The implantable device according to claim 1, wherein said first and/or said second part comprises a plate.

3. The implantable device according to claim 2, wherein said plate is substantially circular.

4. The implantable device according to claim 1, wherein said first part is rotationally displaceable in relation to said second part.

5. The implantable device according to claim 1, wherein said pump device comprises an operating device and a force transferring member, and wherein said operating device comprises said first part, and wherein said first part is connected to said force transferring member for transferring force from said operating device to said force transferring member adapted to exert, directly or indirectly, force on an external part of the heart muscle.

6. The implantable device according to claim 5, wherein said force transferring member is adapted to transfer force from the abdominal side of the thoracic diaphragm to the thoracic side of the thoracic diaphragm.

7. The implantable device according to claim 6, wherein said implantable device further comprises a diaphragm contacting part, adapted to maintain an opening in the thoracic diaphragm, and wherein said force transferring member is adapted to transfer force from the abdominal side of the thoracic diaphragm to the thoracic side of the thoracic diaphragm through said diaphragm contacting part.

8. The implantable device according to claim 5, wherein said force transferring member is adapted to transfer a force, being a force selected from a group consisting of:

mechanical force, hydraulic force and pneumatic force.

9. The implantable device according to claim 1, wherein said device further comprises a third part adapted to abut said second part.

10. The implantable device according to claim 9, wherein said first and third part comprises magnets, and wherein said second part comprises coils, and wherein said first and third part is adapted to be displaceable in relation to said second part through energising of said coils of said second part.

11. The implantable device according to claim 1, wherein said pump device further comprises a center shaft adapted to guide the displacement of said first part in relation to said second part.

12. The implantable device according to claim 11, wherein said first part is adapted to be rotationally displaceable in relation to said second part, and wherein said center shaft is adapted to form a center point of said rotational displacement.

13. The implantable device according to claim 12, wherein said implantable device further comprises a third part adapted to abut said second part, and wherein said third part is adapted to be rotationally displaceable in relation to said second part, and wherein said center shaft is adapted to form a center point of said rotational displacement.

14. The implantable device according to claim 12, wherein said implantable device further comprises a third part adapted to abut said second part, or being integrated in said second part, and wherein said third part is adapted to be eccentrically rotationally displaceable in relation to said first part, and wherein said center shaft is adapted to form a center point of said non-eccentric rotational displacement.

15. The implantable device according to claim 1, wherein said device comprises a second pump device, wherein said first and second pump device is adapted to operate on substantially opposite sides of the heart, wherein said first pump device is adapted to operate on the anterior side of said heart and said second pump device is adapted to operate on the posterior side of said heart.

16. The implantable device according to claim 1, wherein said successive energizing is performed from a control unit or from outside of the patient'"'"'s body.

17. The implantable device according to claim 1, wherein said pump device is adapted to be fixated to at least one of:

the sternum, at least one rib, at least one vertebra, and another part of the human body comprising bone.

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

said device, said first part, and said second part comprises at least one of;

a carbon material, and a metallic material.

19. The implantable device according to claim 1, wherein said medical device further comprises a heart contacting organ adapted to be in direct contact with said heart and in direct or indirect contact with at least one of:

said first part and said second part.

20. The implantable device according to claim 19, wherein said heart contacting organ is adapted to be operable, by at least one of:

an arm,

a replaceable arm,

an implantable motor,

a motor from outside the human body in two axes, and

an eccentric rotational movement of said first or second part, and

wherein the heart contacting organ is adapted to change the position of said force exerted on said external part of said heart muscle.

21. The implantable device according to claim 19, wherein said heart contacting organ is adapted to exert an external force on at least one of:

the left ventricle of said heart, two different sides of the left ventricle of said heart, the right ventricle of said heart, and two different sides of the right ventricle of said heart.

22. The implantable device according to claim 1, wherein the implantable device is adapted to be part of a system including an internal energy receiver, adapted to be energized non-invasively and wirelessly by an energy transmission device from outside the patient'"'"'s body, adapted for sending wireless energy to at least one of:

an implantable internal energy source according to any one of the preceding claims, being chargeable by the energy transferred from the energy transmission device, and

at least one implantable energy consuming component of the apparatus energized with the wireless energy.

23. The implantable device according to claim 1, wherein the implantable device is adapted to be part of a system including a sensor, a measuring device or a sensor and a measuring device, adapted to sense or measure 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 an internal energy source, 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, 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.

24. The implantable device according to claim 1, wherein said first part is adapted to be reciprocally displaceable in relation to said second part.

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

said device, said first part and said second part comprises a ceramic material.

26. The implantable device according to claim 17, wherein the pump device is adapted to be placed on an adjustment system comprising a first fixation member, wherein said pump device is adapted to be fixated to said bone by said first fixation member, wherein said first fixation member is adapted to be involved in adjusting the position of the pump device.

27. The implantable device according to claim 26, further comprising a second fixation member adapted to be adjustable in relation to the first fixation member to adjust the position of the pump device.

28. The implantable device according to claim 27, comprising a third fixation member adapted to further adjust the position of the pump device, the pump device being adapted to be adjustable three dimensionally, thereby adapted to change the position of the force exerted on the heart.

29. The implantable device according to claim 27, wherein the adjustment system is adapted to be operable by at least one implantable motor, at least one of:

at least one electric, hydraulic or pneumatic motor, wherein the at least one motor is adapted to be remotely controlled from outside of the human body using a remote control, wherein the pump device could hence be post-operatively adjusted to change the position of the force exerted on the heart from outside the patients body.

30. The implantable device according to claim 26, wherein the first fixation member, is adapted to be fixated to the sternum using at least one of:

at least one plate, at least one screw, and at least one washer, adapted to be placed on at least one of;

one side of the sternum, two sides of the sternum and inside the sternum, to fixate the pump device.

31. The implantable device according to claim 19, comprising an operation device including the surfaces of the first and the second part being plates abutting each other, adapted to be in substantially constant movement, the operating device being adapted to cause rotational movement or reciprocating movement to operate directly or indirectly said heart contacting organ.

32. The implantable device according to claim 31, wherein said first and second plate comprises a ceramic material, being at least one of:

zirconium ceramics, alumina ceramics, partially stabilised zirconia (PSZ), zirconium dioxide, titanium carbide, silicon carbide, sialons, silicon aluminium oxynitrides, boron nitride, a hydroxy-apatite coating and other ceramic type of material.

33. The implantable device according to claim 1, comprising an operation device and a control unit, wherein the operating device and other elements of the implantable device that require control are controlled by the control unit, adapted to communicate with the pump device and the other elements of the implantable device through a connecting member or wirelessly.

34. The implantable device according to claim 1, further comprising

a sensor, adapted to sense physiological electrical pulses or muscle contractions of the heart, and

an internal control unit adapted to be placed in a subcutaneous area, close to a subcutaneous area, in a thorax, or in an abdomen of the human patient, adapted to receive the sensor input relating to the electrical pulses or muscle contractions of the heart, for controlling heart contractions to coordinate with the pump device.

35. The implantable device according to claim 1, further comprising at least one electrode supplying an electric signal for controlling the heart rhythm, such as a pace maker signal, further comprising an internal control unit is adapted to transmit energy pulses to said electrode for achieving heart muscle contractions and controlling heart contractions, being adapted to coordinate the pump device with the heart contractions.

36. 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.

37. 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 applying an external force on the heart muscle by periodically exerting force onto the outside of the heart muscle following the heart contractions and adding force thereto,

an artificial heart, and

an LVAD device.