Heart help device, system, and method

1. A medical device for assisting in the maintaining of an opening created in the thoracic diaphragm, said medical device comprises a diaphragm contacting part adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm, wherein the diaphragm contacting part is a grommet.

2. The medical device according to claim 1 , wherein the diaphragm contacting part further comprises a fixation portion adapted to assist in the fixation of said medical device to the thoracic diaphragm, wherein said fixation portion is adapted to enable fixation of said medical device to the thoracic diaphragm by sutures running through said fixation portion.

3. The medical device according to claim 1 , wherein the diaphragm contacting part further comprises a fixation portion adapted to assist in the fixation of said medical device to the thoracic diaphragm, wherein said fixation portion is adapted to enable fixation of said medical device to the thoracic diaphragm by staples running through said fixation portion.

4. The medical device according to claim 1 , wherein the diaphragm contacting part further comprises a fixation portion adapted to assist in the fixation of said medical device to the thoracic diaphragm, wherein said fixation portion is adapted to enable fixation of said medical device to the thoracic diaphragm by staples or sutures running in connection with said fixation portion.

5. The medical device according to claim 1 , wherein the diaphragm contacting part further comprises a fixation portion adapted to assist in the fixation of said medical device to the thoracic diaphragm, wherein said medical device further comprises a fixation member adapted to run through said fixation portion for enabling fixation of said medical device to the thoracic diaphragm, said fixation member comprises a first portion adapted to be inserted from a first side of the thoracic diaphragm, through a part of the thoracic diaphragm, and to a second side of the thoracic diaphragm, and wherein said fixation member further comprises a second portion adapted to engage the thoracic diaphragm on the second side and thereby lock said fixation member to the thoracic diaphragm.

6. The medical device according to claim 5 , wherein said second portion is hinged to said first portion.

7. The medical device according to claim 1 , further comprising a force transferrin 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, wherein said diaphragm contacting part is adapted to at least partly encircle said force transferring part, when in use.

8. The medical device according to claim 7 , 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.

9. The medical device according to claim 1 , wherein the diaphragm contacting part is further adapted to be in contact with the pericardium and thereby also assisting in the maintaining of an opening in the pericardium.

10. A medical device system, including the medical device according to claim 1 , comprising;

a heart help device or heart assistant device, and

an operation device or a drive unit,

wherein said heart help device comprises at least one of:

an artificial heart valve device or a device for operating an artificial heart valve,

a heart help device, adapted to compress the heart of the patient, periodically by exerting force onto the heart following the heart contractions and adding force thereto,

an artificial heart, and

an LVAD device.

11. The medical device system according to claim 10 , comprising a force transferring part or force transferring member adapted to transfer force between the abdominal side of the thoracic diaphragm and the thoracic side of the thoracic diaphragm or the pericardium,

wherein the force transferring part comprises a first and second portion, wherein said first portion is adapted to be in connection with the operation device, said second portion is adapted to be in connection with the heart help device, and said force transferring part is adapted to transfer force from said operation device to said heart help device, and wherein the diaphragm contacting part in contact with the thoracic diaphragm assist in the maintaining of the opening created in the thoracic diaphragm for allowing the force transferring part to pass through the thoracic diaphragm.

12. The medical device system according to claim 10 , wherein said force transferring part further comprises an electric lead adapted to transfer electric energy, the medical 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 the 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 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.

13. The medical device system according to claim 12 , 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 receive input from any sensor sensing at least one of; at least one physical parameter of the patient and functional parameter of the system.

14. The medical device system according to claim 10 , 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 the 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 of said patient for moving a fluid from the pericardium of said patient to the abdomen of said patient.

15. The medical device system according to claim 10 , comprising a fixation device or fixation member, adapted to fixate at least a section of said device to at least of:

g. a rib of the patient,

h. the sternum of the patient, and

i. a vertebra of the patient.

16. The medical device system according to claim 15 , comprising a fibrotic tissue movement structure adapted to allow the respiratory movement of the heart in relation to the stable bone position caused by the a fixation device or fixation member, without interference from surrounding fibrotic tissue, when implanted in the body.

17. The medical device system according to claim 10 , 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.

18. The medical device system according to claim 10 , comprising 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 comprised in the system, being chargeable by the energy transferred from the energy transmission device, and

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

19. The medical device system according to claim 10 , wherein the heart help device comprises at least one heart contacting organ, adapted to periodically exert force onto the heart following the heart contractions and adding force thereto, and wherein said medical device being adapted to receive kinetic movement created by the operation device or the drive unit to be used by the heart contacting organ.

20. The medical device system according to claim 19 , further comprising the drive unit and a respiration movement compensator for compensating for the respiratory movement of the heart in relation to the stable bone position, wherein said drive unit is adapted to allow a movement to compensate for the respiratory movement in relation between said heart contacting organ and said bone, when the medical device system 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 hydraulic construction,

a mechanical construction,

a pneumatic construction

a combination of at least two of the hydraulic, mechanical and pneumatic construction,

a suspension involving a compressible cuff of air,

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

a spring suspension, and

a guided movement using only frictional resistance, for to compensate for the respiratory movement.

21. The medical device system according to claim 19 , 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 force from said mechanical element.

22. The medical device system according to claim 10 , further comprises 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, wherein said force transferring part comprises a mechanical element adapted to transfer mechanical force.

23. The medical device system according to claim 22 , wherein said mechanical element is adapted to transfer at least one of a rotating force and a translating force.

24. The medical device system according to claim 22 , wherein said rotating force is an eccentrically rotating force.

25. The medical device system according to claim 10 , further comprising 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, wherein said force transferring part comprises a conduit adapted to transfer hydraulic or pneumatic force.

26. The medical device system according to claim 11 , wherein at least one of said diaphragm contacting part and said force transferring part comprises ceramic material.

27. The medical device system according to claim 26 , wherein said diaphragm contacting part and said force transferring part are adapted to contact each other in at least one contacting point, and wherein said at least one contacting point comprises said ceramic material.

28. The medical device system according to claim 26 , 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.

29. The medical device system according to claim 10 , wherein the diaphragm contacting part is further adapted to be in contact with the pericardium and thereby also assisting in the maintaining of an opening in the pericardium.

30. The medical device system according to claim 22 , wherein at least one of said diaphragm contacting part and said force transferring part comprises ceramic material.

31. The medical device system according to claim 10 , further comprising a force transferring part, and wherein said force transferring part comprises an electric lead adapted to transfer electric energy.

32. A medical device for assisting in the maintaining of an opening created in the thoracic diaphragm, said medical device comprises a diaphragm contacting part adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm, wherein said medical device further comprises a force transferring part, and wherein said force transferrin 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, wherein said force transferring part comprises a mechanical element adapted to transfer mechanical force.

33. The medical device according to claim 32 , wherein said mechanical element is adapted to transfer at least one of a rotating force and a translating force.

34. The medical device according to claim 32 , wherein said rotating force is an eccentrically rotating force.

35. A medical device system, including the medical device according to claim 32 , wherein the force transferring part, is adapted to transfer force between the abdominal side of the thoracic diaphragm and the thoracic side of the thoracic diaphragm or the pericardium, the medical device system further comprising;

a heart help device or heart assistant device, and

an operation device or a drive unit,

wherein the force transferring part comprises a first and second portion, wherein said first portion is adapted to be in connection with the operation device, said second portion is adapted to be in connection with the heart help device, and said force transferring part is adapted to transfer force from said operation device to said heart help device, and wherein the diaphragm contacting part in contact with the thoracic diaphragm assist in the maintaining of the opening created in the thoracic diaphragm for allowing the force transferring part to pass through the thoracic diaphragm,

wherein said heart help device comprises at least one of:

an artificial heart valve device or a device for operating an artificial heart valve,

a heart help device, adapted to compress the heart of the patient, periodically exerting force onto the outside of the heart following the heart contractions and adding force thereto,

an artificial heart, and

an LVAD device.

36. The medical device system according to claim 35 , wherein said force transferring part further comprises an electric lead adapted to transfer electric energy, the medical 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.

37. The medical device according to claim 36 , 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.

38. The medical device system according to claim 35 , 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 of said patient for moving a fluid from the pericardium of said patient to the abdomen of said patient.

39. The medical device system according to claim 35 , 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.

40. The medical device system according to claim 39 , comprising a fibrotic tissue movement structure adapted to allow the respiratory movement of the heart in relation to the stable bone position caused by the a fixation device or fixation member, without interference from surrounding fibrotic tissue, when implanted in the body.

41. The medical device system according to claim 35 , 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.

42. The medical device system according to claim 35 , comprising 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 comprised in the system, being chargeable by the energy transferred from the energy transmission device, and

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

43. The medical device system according to claim 35 , wherein the heart help device, comprises at least one heart contacting organ adapted to periodically exert force onto the heart following the heart contractions and adding force thereto, said medical device being adapted to receive kinetic movement from the operation device or the drive unit to be used by the heart contacting organ.

44. The medical device system according to claim 43 , comprising the drive unit and a respiration movement compensator for compensating for the respiratory movement of the heart in relation to a stable bone position, wherein said drive unit is adapted to allow movement to compensate for the respiratory movement between said heart contacting organ and said bone, when the medical device system 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 hydraulic construction,

a mechanical construction,

a pneumatic construction

a combination of at least two of the hydraulic, mechanical and pneumatic construction,

a suspension involving a compressible cuff of air,

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

a spring suspension, and

a guided movement using only frictional resistance,

for to compensate for the respiratory movement.

45. The medical device system according to claim 43 , 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.

46. A medical device for assisting in the maintaining of an opening created in the thoracic diaphragm, said medical device comprises a diaphragm contacting part adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm, wherein said medical device further con rises 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, wherein said force transferring part comprises a conduit adapted to transfer hydraulic or pneumatic force.

47. A medical device system, including the medical device according to claim 46 , wherein the force transferring part, is adapted to transfer force between the abdominal side of the thoracic diaphragm and the thoracic side of the thoracic diaphragm or the pericardium, the medical device system further comprising;

a heart help device or heart assistant device, and

an operation device or a drive unit,

wherein the force transferring part comprises a first and second portion, wherein said first portion is adapted to be in connection with the operation device, said second portion is adapted to be in connection with the heart help device, and said force transferring part is adapted to transfer force from said operation device to said heart help device, and wherein the diaphragm contacting part in contact with the thoracic diaphragm assist in the maintaining of the opening created in the thoracic diaphragm for allowing the force transferring part to pass through the thoracic diaphragm,

wherein said heart help device comprises at least one of:

an artificial heart valve device or a device for operating an artificial heart valve,

a heart help device, adapted to compress the heart of the patient, periodically by exerting force onto the heart following the heart contractions and adding force thereto,

an artificial heart, and

an LVAD device.

48. The medical device system according to claim 47 wherein said force transferring part further comprises an electric lead adapted to transfer electric energy, the medical 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 the 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 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.

49. The medical device system according to claim 48 , 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 receive input from any sensor sensing at least one of; at least one physical parameter of the patient and functional parameter of the system.

50. The medical device system according to claim 47 , 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 the 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 of said patient for moving a fluid from the pericardium of said patient to the abdomen of said patient.

51. The medical device system according to claim 47 , comprising a fixation device or fixation member, adapted to fixate at least a section of said device to at least of:

d. a rib of the patient,

e. the sternum of the patient, and

f. a vertebra of the patient.

52. The medical device system according to claim 51 , comprising a fibrotic tissue movement structure adapted to allow the respiratory movement of the heart in relation to the stable bone position caused by the a fixation device or fixation member, without interference from surrounding fibrotic tissue, when implanted in the body.

53. The medical device system according to claim 47 , 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.

54. The medical device system according to claim 47 , comprising 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 comprised in the system, being chargeable by the energy transferred from the energy transmission device, and

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

55. The medical device system according to claim 47 , wherein the heart help device comprises at least one heart contacting organ, adapted to periodically exert force onto the heart following the heart contractions and adding force thereto, and wherein said medical device being adapted to receive kinetic movement created by the operation device or the drive unit to be used by the heart contacting organ.

56. The medical device system according to claim 55 , further comprising the drive unit and a respiration movement compensator for compensating for the respiratory movement of the heart in relation to the stable bone position, wherein said drive unit is adapted to allow a movement to compensate for the respiratory movement in relation between said heart contacting organ and said bone, when the medical device system 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 hydraulic construction,

a mechanical construction,

a pneumatic construction

a combination of at least two of the hydraulic, mechanical and pneumatic construction,

a suspension involving a compressible cuff of air,

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

a spring suspension, and

a guided movement using only frictional resistance,

for to compensate for the respiratory movement.

57. The medical device system according to claim 55 , 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 force from said mechanical element.

58. A medical device for assisting in the maintaining of an opening created in the thoracic diaphragm, said medical device comprises a diaphragm contacting part adapted to be placed in contact with the thoracic diaphragm and thereby assist in the maintaining of the opening created in the thoracic diaphragm, wherein said medical device further comprises 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, wherein at least one of said diaphragm contacting part and said force transferring part comprises ceramic material.

59. The medical device according to claim 58 , wherein said diaphragm contacting part and said force transferring part are adapted to contact each other in at least one contacting point, and wherein said at least one contacting point comprises said ceramic material.