Heart help device, system, and method

• US 8,509,894 B2
• Filed: 10/12/2009
• Issued: 08/13/2013
• 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): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/123,394
• Publication Number:
  US 20110196485A1
• Time in Patent Office: 1,401 Days
• Field of Search: 607 16- 17, 600 16- 17, 623/3.21
• US Class Current: 607/17
• 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 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular 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 60/196 replacing the entire heart, e.g. total artificial hearts [TAH]
• CPC Class Codes: A61M 60/226 the blood flow through the rotating member having mainly radial components
• CPC Class Codes: A61M 60/258 Piston pumps
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• 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 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/462 Electromagnetic force
• CPC Class Codes: A61M 60/473 generated by an electromotor
• CPC Class Codes: A61M 60/495 Electromagnetic force
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• 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 60/865 : Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/873 : specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/876 : Implantable batteries
• CPC Class Codes: A61M 60/882 : Devices powered by the patient, e.g. skeletal muscle powered devices

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 heart contacting organ. The heart contacting organ is adapted to be movable to change the position of said force exerted on the heart after the implantable device has been implanted in the human patient. The invention further relates to a method of using said device.

Claims

1. An implantable device for improving a pump function of a heart of a human patient by applying an external force on a heart muscle, said device comprising:

at least one heart contacting organ,

wherein the heart contacting organ is configured to periodically exert an external force on the heart muscle following a heart contraction and adding the external force thereto,

wherein said implantable device is adapted to physically change a position of the heart contacting organ in order to change a position of the external force exerted on the heart by said heart contacting organ,

wherein said heart contacting organ is configured to change from exerting the external force to a first area of the heart to exerting the external force to a second area of the heart, after said implantable device has been implanted in the patient;

wherein the first area of the heart and the second area of the heart are different physical locations on the outside of a same chamber of the heart.

2. The implantable device according to claim 1, wherein said at least one heart contacting organ comprises at least one hydraulic or pneumatic cushion.

3. The implantable device according to claim 2, wherein said implantable device further comprises a plate, and wherein said at least one hydraulic or pneumatic cushion is placed in connection to said plate, and wherein said plate is adapted to at least one of:

be movable to change a position of said hydraulic or pneumatic cushion and thereby change the position of said force exerted on the heart of the human patient after said implantable device has been implanted in the human patient, and

enable movement of said cushion in relation to said plate to change the position of said hydraulic or pneumatic cushion and thereby change the position of said force exerted on the heart of the human patient after said implantable device has been implanted in the human patient.

4. The implantable device according to claim 2, wherein said implantable device comprises at least a first and second cushion, wherein said first cushion comprises a first chamber having a volume, and wherein said second cushion comprises a second chamber having a second volume, and wherein said first and second volumes are adapted to be changed individually, to influence said force exerted on the heart of the human patient, after said implantable device has been implanted in said human patient.

5. The implantable device according to claim 2, comprising a plurality of cushions, each cushion having a volume, wherein said plurality of cushions are adapted to be independently changed to influence said force exerted on the heart, wherein said implantable device further comprises a hydraulic system in fluid connection with said plurality of volumes.

6. The implantable device according to claim 5, wherein said hydraulic system comprises at least one of;

a plurality of injection ports for individually changing the volume of said volumes, and an injection port unit which comprises said plurality of injection ports for individually changing the volume of said chambers.

7. The implantable device according to claim 1, wherein said position of said force exerted on the heart is adapted to be changed after at least one of:

a pre-determined number of heart beats,

a pre-determined time, and

receiving a signal from a sensor.

8. The implantable device according to claim 1, wherein said implantable device comprises at least a first and second piston, and wherein said first piston is adapted to move in relation to said second piston to influence said force exerted on the heart of the human patient, after said implantable device has been implanted in the human patient.

9. The implantable medical device according to claim 1, wherein said implantable device comprises at least one of:

at least one operable joint, and wherein said position of said force exerted by said heart contacting organ is adapted to be changed by operation of said at least one operable joint,

a first and a second operable joint, and wherein said position of said force exerted by said heart contacting organ is adapted to be changed by operation of said first and second operable joints, and

a first and a second and a third operable joint, and wherein said position of said force exerted by said heart contacting organ is adapted to be changed by operation of said first, second and third operable joints.

10. The implantable medical device according to claim 9, wherein said operable joints are operable translating joints or operable rotating joints.

11. The implantable device according to claim 1, wherein said implantable device is adapted to compress at least one portion of a tissue wall, by said heart contacting organ exerting force on the heart, and wherein said implantable device is further adapted to stimulate at least a portion of the tissue wall of the heart to further compress the tissue wall, wherein said stimulation of the tissue wall of the heart is performed using electrical stimulation.

12. The implantable device according to claim 1, wherein said at least one heart contacting organ comprises a mechanically operated heart contacting organ.

13. The implantable device according to claim 1, further comprising an operation device for operating the heart contacting organ, and wherein said operation device is at least one of;

electrically, hydraulically, and pneumatically powered.

14. The implantable device according to claim 1, wherein said heart contacting organ is adapted to be moved for every heart beat, and thereby follow the heart muscle contraction.

15. The implantable device according to claim 1, wherein said implantable device further comprises a fixation element adapted to assist in the fixation of said implantable device to an area of the body selected from a group consisting of:

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

16. 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,

two different sides of the left ventricle,

the right ventricle,

two different sides of the right ventricle.

17. The implantable device according to claim 1, wherein said implantable device further comprises a material selected from a group of materials comprising;

Ceramic material,

Titanium,

Stainless steel,

Silicone based material, and

Flourpolymer material.

18. The implantable device according to claim 1, wherein said implantable device is adapted to be part of a system 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 implantable device, being chargeable by the energy transferred from the energy transmission device, and

at least one implantable energy consuming component of the apparatus adapted for at least one of;

directly using the wireless energy in its wireless state, and

using energy supplied from an energy transforming device comprised in the system and adapted for receiving the wireless energy.

19. The implantable device according to claim 1, wherein said implantable device is adapted to be part of a system comprising a wireless remote control for non-invasively controlling or programming the device.

20. The implantable device according to claim 1, wherein said implantable device is adapted to be part of a system comprising an internal control unit adapted to be programmable from outside a patient'"'"'s body, the internal control unit is programmed to regulate the implantable device according to a pre-programmed time-schedule or to input from a sensor sensing a physical parameter of the patient or a functional parameter of the system.