Actuator for a heart assist device

• US 8,702,583 B2
• Filed: 05/19/2011
• Issued: 04/22/2014
• Est. Priority Date: 11/11/2003
• Status: Expired due to Fees

• Current Assignee: Nuwellis, Inc.
• Original Assignee: Sunshine Heart Company Pty, Ltd. (Nuwellis, Inc.)
• Inventors: Miller, Scott H
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US13/111,499
• Publication Number:
  US 20110288367A1
• Time in Patent Office: 1,069 Days
• Field of Search: 600 16- 18
• US Class Current: 600/18
• CPC Class Codes: A61M 60/135 inside a blood vessel, e.g. using grafting
• 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 60/289 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 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/839 of devices for mechanical circulatory actuation
• CPC Class Codes: A61M 60/859 Connections therefor

Abstract

An actuator (10) for a heart assist device. The actuator (10) includes an inflatable balloon (12) and a shroud or wrap (14). The inflatable balloon (12) has a first body portion (22), a second body portion (26) and a flexure region joining (24) the first (22) and second (26) body portions. The shroud or wrap (14) is positioned adjacent the first body portion (24) and has a peripheral extent at least equal to the peripheral extent of the balloon flexure region (24). The balloon (12) and the shroud or wrap (14) are shaped such that the shroud or wrap (14) restrains a part of the balloon first body portion (22) at or near the flexure region (24) against displacement towards the shroud or wrap (outward displacement) past a predetermined limit but allows unrestrained displacement away from the shroud or wrap (inward displacement).

Claims

1. An actuator for a heart assist device, the actuator comprising:

(a) a restraint component comprising a hole; and

(b) a flexible balloon comprising;

(i) a tubular neck portion disposed through the hole in the restraint component;

(ii) a first body portion coupled to the neck portion, wherein the first body portion is unattachedly disposed adjacent to the restraint component;

(iii) a second body portion; and

(iv) a flexure portion coupled to the first body portion and the second body portion,

wherein the flexible balloon comprises an inflated configuration in which a length of the first body portion is in contact with the restraint component and an deflated configuration in which at least a portion of the length of the first body portion is displaced inwardly away from the restraint component.

2. The actuator of claim 1, wherein the restraint component comprises a shroud or a wrap.

3. The actuator of claim 1, wherein the restraint component comprises a wrap configured to be disposed around the flexible balloon and an exterior of a patient'"'"'s arterial vessel.

4. The actuator of claim 1, wherein the flexible balloon is formed from silicone, polyurethane, or a polyurethane-polysiloxane block copolymer.

5. The actuator of claim 1, further comprising a bushing disposed within and extending from the tubular neck portion of the flexible balloon, the bushing comprising a bore, wherein the bushing is configured to be coupleable to a fluid line.

6. The actuator of claim 5, wherein the bore comprises at least one internal projection disposed within the bore.

7. The actuator of claim 6, wherein the at least one internal projection comprises at least one flute, at least one rib, or at least one secondary lumen.

8. The actuator of claim 1, wherein the heart assist device is an extra-aortic counterpulsation heart assist device.

9. The actuator of claim 1, wherein the restraint component is disposed against an exterior portion of the tubular neck portion of the flexible balloon, thereby resulting in a snug sealing fit between the restraint component and the tubular neck portion.

10. The actuator of claim 1, wherein the flexure portion has a radius of curvature of at least 0.1 mm in the inflated configuration.

11. The actuator of claim 1, wherein the flexible balloon has a thickness ranging from about 150 microns to about 300 microns.

12. An actuator for a heart assist device, the actuator comprising:

(a) a flexible balloon comprising;

(i) a tubular neck portion;

(ii) a first body portion coupled to the neck portion;

(iii) a second body portion; and

(iv) a flexure portion coupled to the first body portion and the second body portion,

wherein the flexible balloon comprises an inflated configuration in which a length of the first body portion is in contact with the restraint component and an deflated configuration in which at least a portion of the length of the first body portion is displaced inwardly away from the restraint component; and

(b) a bushing disposed within and extending from the tubular neck portion of the flexible balloon, the bushing comprising a bore, wherein the bushing is configured to be coupleable to an external fluid line.

13. The actuator of claim 12, further comprising a restraint component comprising a hole, wherein the restraint component is a shroud or a wrap.

14. The actuator of claim 13, wherein the restraint component is a wrap configured to be disposed around the flexible balloon and an exterior of a patient'"'"'s arterial vessel.

15. The actuator of claim 13, wherein the restraint component is disposed against an exterior portion of the tubular neck portion of the balloon, thereby resulting in a snug sealing fit between the restraint component and the tubular neck portion.

16. The actuator of claim 12, wherein the balloon is formed from silicone, polyurethane, or a polyurethane-polysiloxane block copolymer.

17. The actuator of claim 12, wherein the bore comprises at least one internal projection disposed within the bore.

18. The actuator of claim 17, wherein the at least one internal projection comprises at least one flute, at least one rib, or at least one secondary lumen.

19. The actuator of claim 12, wherein the heart assist device is an extra-aortic counterpulsation heart assist device.