Heart assist devices, systems and methods

• US 8,016,739 B2
• Filed: 02/21/2008
• Issued: 09/13/2011
• Est. Priority Date: 06/10/1999
• Status: Active Grant

• Current Assignee: Nuwellis, Inc.
• Original Assignee: Sunshine Heart Company Pty, Ltd. (Nuwellis, Inc.)
• Inventors: Milsom, Frederick Paget, Henrichsen, Hans Hansforth, Unger, Rolf Gunnar, White, Geoffrey Hamilton, Marsh, Peter Crispin Lawrence, Peters, William Suttle, Sullivan, Colin Edward
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US12/035,247
• Publication Number:
  US 20080139873A1
• Time in Patent Office: 1,300 Days
• Field of Search: 600 16- 18
• US Class Current: 600/18
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• 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 60/161 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• 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 60/432 with diastole or systole switching by stopping or reversing the blood pump operating at a much higher cyclical speed than the heart beat
• CPC Class Codes: A61M 60/435 with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
• 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 60/481 generated by a solenoid

Abstract

An apparatus and method for use in assisting a human heart are disclosed. The apparatus comprises an aortic compression means which may be fully implanatable, a fluid reservoir and a pump means adapted to pump a fluid from the reservoir to the aortic compression means so as to actuate the aortic compression means at least partly in counterpulsation with the patient'"'"'s heart. In addition, the device is adapted to be wholly positioned within the right chest cavity of the patient. The aortic compression means of the device may be curved along its length so as to substantially replicate the curve of the ascending aorta.

Claims

1. An aortic compression device for use in a heart assist device, the aortic compression device comprising:

a) a flexible inflatable cuff configured to be positioned adjacent to the ascending aorta of a patient; and

b) a flexible, substantially inelastic sheath configured to extend around the cuff and at least assist in retaining the cuff adjacent to the aorta,

wherein the flexible inflatable cuff is curved along its length so as to substantially replicate the curve of the ascending aorta adjacent to the flexible inflatable cuff.

2. The compression device of claim 1, wherein the sheath is positioned around the cuff in a snug fit.

3. The compression device of claim 1, wherein the cuff comprises a single inlet/outlet port.

4. The compression device of claim 3, wherein the sheath has an opening complimentary to the inlet/outlet port.

5. The compression device of claim 1, wherein the cuff is substantially C-shaped and further comprises two free ends extending from the cuff, wherein the two free ends are configured to overlap when the cuff is positioned adjacent to the aorta.

6. The compression device of claim 1, wherein the sheath comprises two free ends configured to be coupled together in an overlapping relationship.

7. A heart assist system comprising:

a) an aortic compression device configured to be positioned adjacent to the ascending aorta of a patient, wherein the aortic compression device is curved along its length so as to substantially replicate the curve of the ascending aorta adjacent to the aortic compression device; and

b) a pump in fluid communication with the aortic compression device, wherein the pump is configured to pump a fluid to the aortic compression device so as to actuate the aortic compression device.

8. The heart assist system of claim 7, wherein the aortic compression device further comprises:

a) a flexible inflatable cuff; and

b) a flexible, substantially inelastic sheath configured to extend around the cuff and at least assist in retaining the cuff adjacent to the aorta.

9. The heart assist system of claim 7, wherein the cuff is substantially C-shaped and further comprises two free ends extending from the cuff, wherein the two free ends are configured to overlap when the cuff is positioned adjacent to the aorta.

10. The heart assist system of claim 7, further comprising a fluid reservoir in fluid communication with the pump, wherein the pump is configured to pump the fluid from the fluid reservoir to the aortic compression device.

11. The heart assist system of claim 10, further comprising a fluid conduit in fluid communication with the fluid reservoir, the pump, and the aortic compression device.

12. The heart assist system of claim 7, further comprising a fluid pressure adjustment component in fluid communication with the aortic compression device.

13. The heart assist system of claim 12, wherein the fluid pressure adjustment component comprises a reservoir configured for the receiving or removal of fluid therein, thereby allowing for adjustment of fluid pressure in the system.

14. The heart assist system of claim 12, further comprising a pressure sensor operably coupled to the fluid pressure adjustment component, wherein the pressure sensor is configured to measure fluid pressure in the fluid pressure adjustment component.

15. The heart assist system of claim 14, wherein the pressure sensor is further configured to automatically adjust the fluid pressure in the fluid pressure adjustment component based on the fluid pressure in the component.

16. The device of claim 7, further comprising a pressure compliance component.

17. A heart assist system comprising:

a) an aortic compression device configured to be positioned adjacent to the ascending aorta of a patient, wherein the aortic compression device is curved along its length so as to substantially replicate the curve of the ascending aorta adjacent to the aortic compression device, the aortic compression device comprising;

(i) a flexible inflatable cuff; and

(ii) a flexible, substantially inelastic sheath configured to extend around the cuff and at least assist in retaining the cuff adjacent to the aorta;

b) a fluid reservoir; and

c) a pump in fluid communication with the aortic compression device and the fluid reservoir, wherein the pump is configured to pump a fluid from the fluid reservoir to the aortic compression device so as to actuate the aortic compression device.

18. The heart assist system of claim 17, further comprising a fluid pressure adjustment component in fluid communication with the aortic compression device and the fluid reservoir, wherein the fluid pressure adjustment component comprises a reservoir configured for the receiving or removal of fluid therein, thereby allowing for adjustment of fluid pressure in the system.

19. The heart assist system of claim 18, further comprising a pressure sensor operably coupled to the fluid pressure adjustment component, wherein the pressure sensor is configured to measure fluid pressure in the fluid pressure adjustment component.

20. The heart assist system of claim 19, wherein the pressure sensor is further configured to automatically adjust the fluid pressure in the fluid pressure adjustment component based on the fluid pressure in the component.

21. The heart assist system of claim 17, further comprising a pressure compliance component.