Expandable impeller pump

• US 8,992,163 B2
• Filed: 01/11/2013
• Issued: 03/31/2015
• Est. Priority Date: 09/17/2004
• Status: Active Grant

• Current Assignee: Penn State Research Foundation, Thoratec LLC
• Original Assignee: Penn State Research Foundation, Thoratec LLC
• Inventors: McBride, Mark W., Mallison, Thomas M., Dillon, Gregory P., Campbell, Robert L., Boger, David A., Hambric, Stephen A., Kunz, Robert F., Runt, James P., Walsh, Justin M., Leschinsky, Boris
• Primary Examiner(s): Nguyen, Ninh H
• Application Number:
  US13/740,042
• Publication Number:
  US 20130129503A1
• Time in Patent Office: 809 Days
• Field of Search: 415/131, 415/200, 415/211.2, 415/219.1, 415/220, 415/900, 416/189, 416/234, 416/240, 416/241.A
• US Class Current: 415/131
• 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 60/205 Non-positive displacement blood pumps
• 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 60/808 specially adapted for deformable impellers, e.g. expandable impellers
• CPC Class Codes: B63B 2231/42 Elastomeric materials
• CPC Class Codes: B63H 1/26 Blades
• CPC Class Codes: B63H 11/08 of rotary type
• CPC Class Codes: F03G 7/0614 using shape memory elements
• CPC Class Codes: F04D 19/02 Multi-stage pumps
• CPC Class Codes: F04D 29/026 especially adapted for liquid pumps
• 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 29/382 Flexible blades
• CPC Class Codes: F04D 29/526 Details of the casing section radially opposing blade tips ducts F04D29/545
• CPC Class Codes: F04D 29/528 especially adapted for liquid pumps
• 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: F05D 2210/11 liquid, i.e. incompressible
• CPC Class Codes: F05D 2240/305 : related to the pressure side of a rotor blade
• CPC Class Codes: F05D 2240/306 : related to the suction side of a rotor blade
• CPC Class Codes: F05D 2250/51 : Inlet
• CPC Class Codes: F05D 2250/52 : Outlet
• CPC Class Codes: F05D 2300/43 : Synthetic polymers, e.g. plastics; Rubber
• CPC Class Codes: Y10S 415/90 : Rotary blood pump
• CPC Class Codes: Y10T 29/49229 : Prime mover or fluid pump making

Abstract

An impeller includes a hub, and a plurality of blades supported by the hub, the blades being arranged in at least two blade rows. The impeller has a deployed configuration in which the blades extend away from the hub, and a stored configuration in which at least one of the blades is radially compressed, for example by folding the blade towards the hub. The impeller may also have an operational configuration in which at least some of the blades are deformed from the deployed configuration upon rotation of the impeller when in the deployed configuration. The outer edge of one or more blades may have a winglet, and the base of the blades may have an associated indentation to facilitate folding of the blades.

Claims

1. A method for manufacturing a catheter device, the method comprising:

forming an impeller body comprising a hub and a blade to have a continuous material or structure extending from within the hub to within the blade;

forming an expandable sleeve; and

disposing the impeller body within at least a portion of the expandable sleeve.

2. The method of claim 1, wherein forming the expandable sleeve comprises forming a mesh.

3. The method of claim 2, wherein forming the expandable sleeve further comprises:

forming the mesh in a sheet of flexible material; and

applying a coating to the mesh to enclose a space within the mesh.

4. The method of claim 3, further comprising shaping the sheet into a substantially cylindrical body.

5. The method of claim 2, wherein forming the mesh comprises cutting a mesh pattern in a sheet.

6. The method of claim 5, wherein cutting the mesh pattern in the sheet comprises activating a laser to cut the mesh pattern in the sheet.

7. The method of claim 1, wherein forming the impeller body comprises molding the impeller body.

8. The method of claim 7, wherein molding the impeller body comprises molding the impeller body with a one-piece mold.

9. A method for manufacturing a catheter pump, the method comprising:

providing an impeller body;

forming an expandable and collapsible sleeve comprising a mesh and an elastic coating about the mesh, the mesh disposed between an inlet and an outlet of the catheter pump, the mesh arranged such that the sleeve has a collapsed configuration and an expanded configuration, the mesh arranged such that the sleeve remains in the expanded configuration when the impeller body and the sleeve are positioned within a patient during operation of the catheter pump, the sleeve in the expanded configuration defining a flow path through which blood flows, the mesh further arranged such that the sleeve is configured to move to the collapsed configuration from the expanded configuration for storing the catheter pump; and

disposing the impeller body within at least a portion of the expandable and collapsible sleeve such that the mesh substantially surrounds the impeller body,

wherein the outlet is defined at least in part by the mesh, wherein the outlet comprises an open mesh region that is not covered by the elastic coating such that blood can discharge through the outlet.

10. The method of claim 9, further comprising forming the mesh.

11. The method of claim 10, wherein forming the mesh comprises cutting voids in a flexible cylinder or sheet.

12. The method of claim 11, wherein cutting voids comprises activating a laser to cut voids in the cylinder or sheet.

13. The method of claim 10, further comprising applying the elastic coating to the mesh.

14. The method of claim 9, further comprising shaping a sheet of flexible material into a substantially cylindrical body to form the expandable and collapsible sleeve.

15. The method of claim 9, wherein the mesh is arranged such that the expandable and collapsible sleeve has a stored configuration and a deployed configuration, the sleeve movable from the stored configuration to the deployed configuration and from the deployed configuration to the stored configuration.

16. A catheter pump comprising:

an expandable and collapsible sleeve comprising a mesh and an elastic coating about the mesh, the mesh disposed between an inlet and an outlet of the pump, the outlet defined at least in part by the mesh, wherein the outlet comprises an open mesh region that is not covered by the elastic coating such that blood can discharge through the outlet; and

an impeller body positioned within at least a portion of the expandable and collapsible sleeve,

the mesh arranged such that the sleeve has a collapsed configuration and an expanded configuration, the mesh arranged such that the sleeve remains in the expanded configuration when the impeller body and the sleeve are positioned within a patient during operation of the catheter pump, the sleeve in the expanded configuration defining a flow path through which blood flows, the mesh further arranged such that the sleeve is configured to move to the collapsed configuration from the expanded configuration for storing the catheter pump.

17. The catheter pump of claim 16, wherein the mesh substantially surrounds the impeller body.

18. The catheter pump of claim 16, wherein the mesh includes voids disposed in a cylindrical body.

19. The catheter pump of claim 16, wherein the elastic coating is disposed over the mesh.

20. The catheter pump of claim 16, wherein the expandable and collapsible sleeve encloses a fluid flow path, the catheter pump further comprising fluid flow modifying elements disposed in the fluid flow path to influence flow dynamics in the fluid flow path.

21. The catheter pump of claim 20, wherein the fluid flow modifying elements comprise a plurality of vanes.

22. The catheter pump of claim 20, wherein the fluid flow modifying elements have an airfoil shape.

23. The catheter pump of claim 16, further comprising an elongate body having a distal portion and a proximal portion, the impeller body coupled to the distal portion of the elongate body.

24. The catheter pump of claim 16, wherein the impeller body and the expandable and collapsible sleeve are configured such that, when the impeller body and the expandable and collapsible sleeve are being inserted or removed from a patient, the expandable and collapsible sleeve is in a low-profile configuration.

25. The catheter pump of claim 24, wherein the impeller body and the expandable and collapsible sleeve are configured such that, when the impeller body is rotating inside a patient, the expandable and collapsible sleeve is in an expanded configuration.

26. The catheter pump of claim 16, further comprising a storage sleeve, wherein the impeller body and the expandable and collapsible sleeve are configured to expand when urged out of the storage sleeve.

27. The catheter pump of claim 16, wherein the impeller body comprises an expandable blade.

28. The catheter pump of claim 16, wherein the outlet is defined in a transition region between a first portion of the mesh surrounding the impeller and a non-expandable elongate member, the non-expandable elongate member extending proximally from the transition region.

29. The catheter pump of claim 16, wherein at least one of the inlet and outlet is formed through the mesh.

30. A catheter pump comprising:

an expandable sleeve comprising a mesh disposed between inlets and outlets of the pump; and

an impeller body positioned within at least a portion of the expandable sleeve;

wherein the expandable sleeve encloses a fluid flow path, the catheter pump further comprising fluid flow modifying elements disposed in the fluid flow path to influence flow dynamics in the fluid flow path, and

wherein the fluid flow modifying elements comprise linear elements.

31. A catheter pump comprising:

an expandable sleeve comprising a mesh disposed between inlets and outlets of the pump; and

an impeller body positioned within at least a portion of the expandable sleeve, wherein the expandable sleeve encloses a fluid flow path, the catheter pump further comprising fluid flow modifying elements disposed in the fluid flow path to influence flow dynamics in the fluid flow path, and

wherein the fluid flow modifying elements are configured to remove swirl velocity from the impeller discharge flow.

32. A method for manufacturing a catheter pump, the method comprising:

providing an impeller body;

forming an expandable and collapsible sleeve comprising a mesh, the mesh arranged such that the sleeve has a collapsed configuration and an expanded configuration, the mesh arranged such that the sleeve remains in the expanded configuration when the impeller body and the sleeve are positioned within a patient during operation of the catheter pump, the sleeve in the expanded configuration defining a flow path through which blood flows, the mesh further arranged such that the sleeve is configured to move to the collapsed configuration from the expanded configuration for storing the catheter pump;

disposing the impeller body within at least a portion of the expandable and collapsible sleeve such that the mesh substantially surrounds the impeller body; and

coupling the impeller to a distal portion of an elongate body having sufficient length such that, when the impeller body is positioned within a patient, the distal portion of the elongate body is positioned within the patient and a proximal portion of the elongate body is positioned outside the patient.

33. A catheter pump comprising:

an expandable and collapsible sleeve comprising a mesh disposed between inlets and outlets of the pump;

an impeller body positioned within at least a portion of the expandable and collapsible sleeve,

the mesh arranged such that the sleeve has a collapsed configuration and an expanded configuration, the mesh arranged such that the sleeve remains in the expanded configuration when the impeller body and the sleeve are positioned within a patient during operation of the catheter pump, the sleeve in the expanded configuration defining a flow path through which blood flows, the mesh further arranged such that the sleeve is configured to move to the collapsed configuration from the expanded configuration for storing the catheter pump; and

an elongate body having a distal portion and a proximal portion, the impeller body coupled to the distal portion of the elongate body,

wherein the impeller body and the elongate body are arranged such that, when the impeller body is positioned within a patient, the distal portion of the elongate body is positioned within the patient and the proximal portion of the elongate body is positioned outside the patient.

34. The catheter pump of claim 33, the elongate body comprising a flexible shaft, the catheter pump further comprising a drive motor coupled to the proximal portion of the flexible shaft, the drive motor configured to rotate the flexible shaft and the impeller body.

35. A catheter pump comprising:

an expandable and collapsible sleeve comprising a mesh disposed between an inlet and an outlet of the pump; and

an impeller body positioned within at least a portion of the expandable and collapsible sleeve,

the mesh arranged such that the sleeve has a collapsed configuration and an expanded configuration, the mesh arranged such that the sleeve remains in the expanded configuration when the impeller body and the sleeve are positioned within a patient during operation of the catheter pump, the sleeve in the expanded configuration defining a flow path through which blood flows, the mesh further arranged such that the sleeve is configured to move to the collapsed configuration from the expanded configuration for storing the catheter pump,

wherein the outlet is defined in a transition region between a first portion of the mesh surrounding the impeller and a non-expandable elongate member, the non-expandable elongate member extending proximally from the transition region,

wherein the transition regions comprises a second portion of the mesh that is coarser than the first portion of the mesh surrounding the impeller.

36. The catheter pump of claim 35, further comprising an elastic coating over the mesh.

37. The catheter pump of claim 36, wherein the outlet comprises an open mesh region that is not covered by the elastic coating such that blood can discharge through the outlet.