Heart help device, system, and method

• US 9,005,104 B2
• Filed: 06/21/2013
• Issued: 04/14/2015
• 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): Wieland, Robert N
• Application Number:
  US13/924,146
• Publication Number:
  US 20140135568A1
• Time in Patent Office: 662 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. A surgical method for implanting a pump device for improving the pump function of the heart of a human patient, by applying an external force on the heart muscle to assist in and help the pump function of the heart, the surgical method comprising the steps of:

placing a piston adapted for reciprocating movement,

placing an operating device for operating the piston,

placing a heart contacting organ onto the heart of the patient, wherein the movement of the piston directly or indirectly is transported to said heart contacting organ to assist the pump function of the heart, when implanted, and

wherein the step of placing the operating device comprises;

placing 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

said piston being adapted to use said first chamber for moving said piston in two directions with high pressure fluid, and

said piston being further adapted to use said second chamber for lowering the pressure on one side of said piston, and

the movement of the piston being directly or indirectly transported to said heart contacting organ to assist the pump function of the heart, when implanted.

2. The surgical method according to claim 1, further comprising the steps of:

inserting a needle or a tube like instrument into the thorax of the patient'"'"'s body,

using the needle or a tube like instrument to fill the thorax with gas, thereby expanding the thoracic cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the thorax,

inserting at least one dissecting tool through one of said at least two laparoscopic trocars and dissecting at least one intended placement area in the area of the heart of the patient, and

connecting a source of energy or an energy receiver for powering said pump device for improving the pump function of the heart.

3. The surgical method according to claim 1, further comprising the steps of:

cutting the skin and opening the thorax,

dissecting at least one intended placement area in the area of the heart of the patient, and

connecting a source of energy or an energy receiver for powering said implantable device for improving the pump function of the heart.

4. The surgical method according to claim 1, further comprising the steps of:

inserting a needle or a tube like instrument into the abdomen of the patient'"'"'s body,

using the needle or a tube like instrument to fill the abdomen with gas thereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the abdomen,

inserting at least one dissecting tool through one of said at least two laparoscopic trocars,

dissecting and creating a hole in the diaphragm muscle,

dissecting at least one intended placement area in the area of the heart of the patient through said hole, and

connecting a source of energy or an energy receiver for powering said implantable device for improving the pump function of the heart.

5. The surgical method according to claim 4, further comprising the steps of:

dissecting an area of the abdomen, and

placing at least one of the piston, the operating device and the pressurized fluid system in the dissected area in the abdomen.

6. The surgical method according to claim 4, further comprising the steps of:

dissecting an area of the thorax, and

placing at least one of the piston, the operating device and the pressurized fluid system in the dissected area in the thorax.

7. The surgical method according to claim 1, further comprising the steps of:

cutting the skin and opening the abdomen,

dissecting and creating an opening in the diaphragm muscle,

dissecting at least one intended placement area in the area of the heart of the patient through said opening, and

connecting a source of energy or an energy receiver for powering said implantable device for improving the pump function of the heart.

8. The surgical method according to claim 7, further comprising the steps of:

dissecting an area of the abdomen, and

placing at least one of;

the piston, the operating device and the pressurized fluid system in the dissected area in the abdomen.

9. The surgical method according to claim 7, further comprising the steps of:

dissecting an area of the thorax, and

placing at least one of;

the piston, the operating device and the pressurized fluid system in the dissected area in the thorax.

10. The surgical method according to claim 1, wherein the step of placing an operation device comprises placing an operation device adapted to be controlled from outside of the body non-invasively.

11. The surgical method according to claim 1, wherein the step of placing an operating device comprises placing the operation device, such that it withholds force from at least one of:

the sternum, at least one rib, and at least one vertebra.

12. The surgical method according to claim 1, further comprising placing a valve system comprised in the pressurized fluid system further, the valve system being adapted to direct fluid between:

different sides of said piston, the side to which the fluid is directed 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,

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

said valve system being 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.

13. The surgical method according to claim 12, further comprising the step of

operating the valve system for emptying the high pressurized side of the piston, after the piston away movement has occurred, to allow the reciprocal movement with new high pressure fluid arriving at the opposite side of the piston, and thereby intermittently connecting said second lower pressure chamber to the side of the piston intended to receive the piston in the next piston movement.

14. The surgical method according to claim 1, further comprising the step of:

placing a pump adapted to comprise a non-return valve, and

connecting the non-return valve between the first and second chamber.

15. The surgical method according to claim 1, wherein the step of placing a heart contacting organ comprises placing the heart contacting organ such that the heart contacting organ can exert an external force on the left ventricle of the heart.

16. The surgical method according to claim 1, wherein the step of placing a heart contacting organ comprises placing the heart contacting organ such that the heart contacting organ can exert an external force on two different sides of the left ventricle of the heart.

17. The surgical method according to claim 1, wherein the step of placing a heart contacting organ comprises placing the heart contacting organ such that the heart contacting organ can exert an external force on the right ventricle of the heart.

18. The surgical method according to claim 1, wherein the step of placing a heart contacting organ comprises placing the heart contacting organ such that the heart contacting organ can exert an external force on two different sides of the right ventricle of the heart.

19. The surgical method according to claim 1, wherein the step of placing a heart contacting organ comprises placing a heart contacting organ being operable to change the position of said force exerted on said external part of the heart.

20. The surgical method according to claim 1, further comprising:

placing a first pump device such that the first pump device can exert a force on a first side of the heart, and placing a second pump device such that the second pump device can exert a force on a side of said heart substantially opposite to said first side.

21. The surgical method according to claim 1, further comprising the step of fixating at least a portion if the operating device to at least one of:

the sternum, at least one rib, and at least one vertebra of the patient using a fixation member.

22. The surgical method according to claim 1, wherein the step of placing an operating device for operating the piston comprises:

fixating a fixation plate to the outside or anterior side of the sternum, with a

connecting arm passing along the sternum and in to the abdomen of the patient, and

placing the connecting arm which is bent to extend into the abdomen to a section of the thoracic diaphragm in which the pericardium rests and is fixated to the thoracic diaphragm, such that fixation of the operating device in the abdomen is enabled without entering the thorax outside of the pericardium, such that a difference in pressure between the thorax and the abdomen is avoided.

23. The surgical method according to claim 1, wherein the step of placing the heart contacting organ comprises placing a heart contacting organ comprising changeable hydraulic or pneumatic cushions, such that the hydraulic or pneumatic cushions can change to alter the area of the heart to which force is exerted.

24. The surgical method according to claim 23, further comprising placing a hydraulic system for controlling the changeable hydraulic or pneumatic cushions, the hydraulic system comprising an implantable injection port unit comprising a plurality of chambers comprising wall sections adapted to be penetrated by a needle attached to an injecting member.

25. The surgical method according to claim 1, further comprising placing an electric lead adapted to transfer electric energy from the abdomen of the patient to the thorax of the patient.

26. The surgical method according to claim 1, further comprising placing a fluid conduit adapted to transfer fluid from the abdomen of the patient to the thorax of the patient.

27. The surgical method according to claim 1, further comprising placing a mechanical force transferring member adapted to transfer mechanical force from the abdomen of the patient to the thorax of the patient.

28. The surgical method according to claim 1, further comprising placing at least one sensor in the body of the patient and connecting said sensor to the operating device, and said sensor being adapted to monitor at least one of:

the heart rhythm, the blood pressure, the blood flow, the electric activity of the heart, the temperature, a time, and a variable relating to the content of the blood, such as saturation, sodium, erythrocytes, leukocytes and/or thrombocytes.

29. The surgical method according to claim 1, further comprising placing a pacemaker in connection with the heart for supplying an electric signal for controlling the heart rhythm.

30. The surgical method according to claim 1, further comprising placing an injection port for refilling or calibrating the pressurized fluid system.

31. The surgical method according to claim 1, further comprising placing an implanted energy-transforming device adapted to receive energy transmitted wirelessly from outside the body of the patient to supply energy consuming components of the device with energy via a power supply line.

32. The surgical method according to claim 1, further comprising placing an energy receiver or an energy source in the abdomen of the patient.

33. The surgical method according to claim 1, further comprising placing an energy receiver or an energy source subcutaneously in the patient.

34. The surgical method according to claim 1, further comprising the steps of:

one of the steps of;

laparoscopic procedural steps comprising;

inserting a needle or a tube like instrument into the abdomen of the patient'"'"'s body,

using the needle or a tube like instrument to fill the abdomen with gas, thereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the abdomen,

inserting at least one dissecting tool through one of said at least one laparoscopic trocars and dissecting an area of the abdomen, and

open procedural steps comprising;

cutting the skin and opening the abdomen, and dissecting an area of the abdomen,

one of the steps of;

laparoscopic procedural steps comprising;

inserting a needle or a tube like instrument into the thorax of the patient'"'"'s body,

using the needle or a tube like instrument to fill the thorax with gas, thereby expanding the thoracic cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the thorax,

inserting at least one dissecting tool through one of said at least two laparoscopic trocars, and

dissecting at least one intended placement area in the area of the heart of the patient, and

open procedural steps comprising;

cutting the skin and opening the thorax, and dissecting an area of the thorax,

placing the pressurized fluid system in the dissected area of the abdomen,

placing the heart contacting organ in the dissected area of the thorax, and

hydraulically connecting, directly or indirectly, the pressurized fluid system to the heart contacting organ, such that hydraulic force can be transferred from the pressurized fluid system to the heart contacting organ.

35. The surgical method according to claim 1, further comprising the steps of:

one of the steps of;

laparoscopic procedural steps comprising;

inserting a needle or a tube like instrument into the abdomen of the patient'"'"'s body, using the needle or a tube like instrument to fill the abdomen with gas, thereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the abdomen,

inserting at least one dissecting tool through one of said at least one laparoscopic trocars and dissecting an area of the abdomen, and

open procedural steps comprising;

cutting the skin and opening the abdomen, and dissecting an area of the abdomen,

one of the steps of;

laparoscopic procedural steps comprising;

inserting a needle or a tube like instrument into the thorax of the patient'"'"'s body,

using the needle or a tube like instrument to fill the thorax with gas, thereby expanding the thoracic cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the thorax,

inserting at least one dissecting tool through one of said at least two laparoscopic trocars and dissecting at least one intended placement area in the area of the heart of the patient, and

open procedural steps comprising;

cutting the skin and opening the thorax, and dissecting an area of the thorax,

placing the operating device in the dissected area of the abdomen,

placing the heart contacting organ in the dissected area of the thorax, and

electrically connecting, directly or indirectly, the operating device to at least one of the heart contacting organ, a sensor and a electrode.

36. The surgical method according to claim 1, further comprising the steps of:

one of the steps of;

laparoscopic procedural steps comprising;

inserting a needle or a tube like instrument into the abdomen of the patient'"'"'s body,

using the needle or a tube like instrument to fill the abdomen with gas, thereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the abdomen,

inserting at least one dissecting tool through one of said at least one laparoscopic trocars and dissecting an area of the abdomen, and

open procedural steps comprising;

cutting the skin and opening the abdomen, and

dissecting an area of the abdomen,

one of the steps of;

laparoscopic procedural steps comprising;

inserting a needle or a tube like instrument into the thorax of the patient'"'"'s body,

using the needle or a tube like instrument to fill the thorax with gas thereby expanding the thoracic cavity,

placing at least two laparoscopic trocars in the patient'"'"'s body,

inserting a camera through one of the laparoscopic trocars into the thorax,

inserting at least one dissecting tool through one of said at least two laparoscopic trocars and dissecting at least one intended placement area in the area of the heart of the patient, and

open procedural steps comprising;

cutting the skin and opening the thorax, and

dissecting an area of the thorax,

placing the operating device in the dissected area of the abdomen,

placing the heart contacting organ in the dissected area of the thorax, and

mechanically connecting, directly or indirectly, the operating device to the heart contacting organ such that mechanical force can be transferred from the operating device to the heart contacting organ.

37. The surgical method according to claim 1, further comprising the steps of:

dissecting an area of the abdomen, and

placing at least one of;

the piston, the operating device and the pressurized fluid system in the dissected area in the abdomen.

38. The surgical method according to claim 1, further comprising the steps of:

dissecting an area of the thorax, and

placing at least one of;

the piston, the operating device and the pressurized fluid system in the dissected area in the thorax.