Heart assist device with expandable impeller pump

• US 7,841,976 B2
• Filed: 03/23/2007
• Issued: 11/30/2010
• Est. Priority Date: 03/23/2006
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated), Penn State Research Foundation, Thoratec LLC
• Original Assignee: Penn State Research Foundation, Thoratec LLC
• Inventors: Hambric, Stephen A., Kunz, Robert F., Mallison, Thomas M., McBride, Mark W., Runt, James P., Boger, David A., Leschinsky, Boris, Campbell, Robert L., Walsh, Justin M., Dillon, Gregory P.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/728,051
• Publication Number:
  US 20080114339A1
• Time in Patent Office: 1,348 Days
• Field of Search: 600 16- 18
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• 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 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/806 Vanes or blades
• CPC Class Codes: A61M 60/808 specially adapted for deformable impellers, e.g. expandable impellers
• CPC Class Codes: A61M 60/824 Hydrodynamic or fluid film bearings
• CPC Class Codes: A61M 60/829 having a purge fluid supply
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: F04D 29/181 Axial flow rotors F04D29/185 take precedence
• CPC Class Codes: F04D 29/247 elastic or self-adjusting
• CPC Class Codes: F04D 29/528 especially adapted for liquid pumps
• CPC Class Codes: F04D 29/542 Bladed diffusers fixing blades to stators F01D9/042
• CPC Class Codes: F04D 3/00 Axial-flow pumps priming or boosting F04D9/00
• CPC Class Codes: F04D 3/02 of screw type
• CPC Class Codes: F05B 2240/311 flexible or elastic
• CPC Class Codes: F05B 2280/5001 Elasticity

Abstract

An impeller includes a hub and at least one blade supported by the hub. The impeller has a stored configuration in which the blade is compressed so that its distal end moves towards the hub, and a deployed configuration in which the blade extends away from the hub. The impeller may be part of a pump for pumping fluids, such as pumping blood within a patient. A blood pump may include a cannula having a proximal portion with a fixed diameter, and a distal portion with an expandable diameter. The impeller may reside in the expandable portion of the cannula. The cannula may have a compressed diameter which allows it to be inserted percutaneously into a patient. Once at a desired location, the expandable portion of the cannula may be expanded and the impeller expanded to the deployed configuration. A flexible drive shaft may extend through the cannula for rotationally driving the impeller within the patient'"'"'s body.

Claims

1. An apparatus for inducing motion of a fluid relative to the apparatus, the apparatus comprising:

an elongated cannula having a proximal portion and a distal portion, the proximal portion including a conduit having a fixed diameter, and the distal portion including an expandable cannula having a diameter expandable to a diameter greater than the fixed diameter; and

an impeller positioned in the elongated cannula and having a deployed configuration and a stored configuration, the impeller including

a hub; and

a plurality of blades supported by the hub, each blade having a proximal end attached to the hub and a distal end, wherein at least one of the proximal and distal ends of a first blade is at least partially offset along the longitudinal length of the hub from at least one of the proximal and distal ends of a second blade, the blades in the deployed configuration of the impeller extending away from the hub, and the blades in the stored configuration of the impeller being compressed so as to move the distal end of the blade towards the hub.

2. The apparatus as claimed in claim 1, wherein the impeller is positioned in the expandable cannula.

3. The apparatus as claimed in claim 1, further comprising a retainer sheath having an inner lumen, the elongated cannula being mounted in the inner lumen for sliding movement relative to the retainer sheath.

4. The apparatus as claimed in claim 3, further comprising an insertion sheath adapted for axial sliding movement over the retainer sheath.

5. The apparatus as claimed in claim 4, wherein the retainer sheath has at least a first stop point, and the insertion sheath is constrained in its sliding movement by at least the first stop point.

6. The apparatus as claimed in claim 4, wherein the retainer sheath has an outermost diameter and the insertion sheath has an outer diameter substantially equal to the outermost diameter of the retainer sheath.

7. The apparatus as claimed in claim 3, wherein axial movement of the elongated cannula relative to the retainer sheath in one direction results in expansion of the expandable cannula and axial movement of the elongated cannula relative to the retainer sheath in a direction opposite the one direction results in compression of the expandable cannula.

8. The apparatus as claimed in claim 3, wherein the elongated cannula is movable relative to the retainer sheath between a first position and a second position, the expandable cannula in the first position being held at the fixed diameter, and the expandable cannula in the second position being expanded to a diameter greater than the fixed diameter.

9. The apparatus as claimed in claim 1, further comprising a drive system operable to rotate the impeller.

10. The apparatus as claimed in claim 9, wherein the drive system includes a drive shaft, and axial movement of the drive shaft relative to the elongated cannula causes axial movement of the impeller relative to the elongated cannula.

11. The apparatus as claimed in claim 10, wherein axial movement of the impeller relative to the elongated cannula in one direction places the impeller in the deployed configuration and axial movement of the impeller relative to the elongated cannula in a direction opposite the one direction places the impeller in the stored configuration.

12. The apparatus as claimed in claim 10, further comprising a bearing system for supporting the drive shaft for both axial and rotational movement of the impeller.

13. The apparatus as claimed in claim 1, wherein the expandable cannula is formed from a tube of flexible material supported by a reinforcing matrix.

14. The apparatus as claimed in claim 13, wherein the reinforcing matrix has an overlapping S design.

15. The apparatus as claimed in claim 13, wherein the flexible material is polyurethane.

16. The apparatus as claimed in claim 13, further comprising a series of deformable struts at a proximal end of the expandable cannula, the series of struts forming an expandable fluid outlet from the expandable cannula.

17. The apparatus as claimed in claim 16, wherein the impeller is located in the expandable fluid outlet.

18. The apparatus as claimed in claim 13, further comprising a series of deformable struts at a distal end of the expandable cannula, the series of struts being deformable to a first configuration to form an insertion tip for the elongated cannula.

19. The apparatus as claimed in claim 18, wherein the series of struts are positioned at an inlet of the expandable cannula for fluid moving across the impeller.

20. The apparatus as claimed in claim 18, wherein the series of struts is deformable to a second configuration to prevent obstructions from entering an open end of the expandable cannula.

21. The apparatus as claimed in claim 13, further comprising a first series of deformable struts adjacent a first open end of the tube of flexible material and a second series of deformable struts adjacent a second open end of the tube of flexible material.

22. The apparatus as claimed in claim 21, wherein in a first position of the reinforcing matrix, the first series of struts and the second series of struts, the expandable cannula has a first diameter, and in a second position of the reinforcing matrix, the first series of struts and the second series of struts, the expandable cannula has a diameter greater than the first diameter.

25. The apparatus as claimed in claim 21, wherein the first and second series of struts are formed of the same material.

26. The apparatus as claimed in claim 21, wherein the first and second series of struts are made of a shape memory material.

27. The apparatus as claimed in claim 21, wherein the first and second series of struts and the reinforcing matrix are formed from the same material.

28. The apparatus as claimed in claim 1, wherein the impeller includes an indentation in the hub proximate the proximal end of the blade.

23. The apparatus as claimed in 21, wherein the first and second series of struts are connected to the reinforcing matrix.

24. The apparatus as claimed in claim 23, wherein the first series of struts and the second series of struts are formed integrally with the reinforcing matrix.

29. A pump for pumping fluid at a desired location, the pump comprising:

a cannula having a compact state for insertion to the desired location and an expanded state;

an impeller positioned in the cannula and having a hub and a plurality of blades supported by the hub, each blade having a proximal end attached to the hub and a distal end, the blades being arranged in blade rows along the hub, the impeller having a stored configuration and a deployed configuration; and

a drive mechanism for rotating the impeller in the deployed configuration,

the blades in the stored configuration of the impeller being compressed so as to move the distal ends of the blades towards the hub, and the blades in the deployed configuration of the impeller extending away from the hub,

the cannula being in the expanded state when the impeller is in the deployed configuration.

30. A method of pumping blood within a subject, the method comprising:

providing a blood pump including an expandable impeller having a plurality of staggered blades and an expandable cannula;

inserting the blood pump into the subject in a stored configuration;

positioning the blood pump so that the expandable impeller and expandable cannula are at a desired location;

expanding the expandable cannula and expanding the expandable impeller within the expandable cannula; and

rotating the expanded impeller so that the impeller pumps blood through the expanded cannula.