Medical Device

• US 20080132747A1
• Filed: 12/01/2006
• Published: 06/05/2008
• Est. Priority Date: 12/01/2006
• Status: Active Grant

• Current Assignee: FBR Medical, Inc.
• Original Assignee: Medical Value Partners, LLC
• Inventors: Shifflette, J. Michael
• Granted Patent: US 9,028,392 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• 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 60/226 the blood flow through the rotating member having mainly radial components
• 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: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/827 Sealings between moving parts

Abstract

A temporary cardiac-assist device is disclosed. The device includes a pump assembly that is deployed in the ascending aorta or the heart. A torque transmission line couples the pump assembly to an external motor for driving impeller blades within the pump assembly. The pump assembly expands in size at its destination site for operation. In operation, neither the torque transmission line nor elements that support the impeller blades are under axial forces.

Claims

1. A temporary cardiac-assist device comprising a casing for enclosing an impeller blade, wherein said casing is reconfigurable between:

(a) an expanded position for accommodating said impeller blade in a deployed configuration; and

(b) a contracted position for moving said device through a patient'"'"'s vascular system;

and further wherein said casing is structured so that in the absence of a restraining force, said casing is in said expanded position.

2. A temporary cardiac-assist device, comprising:

a torque transmission line;

an impeller hub, wherein said impeller hub is operatively coupled to said torque transmission line for axial rotation;

an impeller blade, wherein said impeller blade depends from and rotates with said impeller hub; and

a non-rotating distal support, wherein said non-rotating support and said impeller hub are coupled to one another and axially aligned, and further wherein said distal support extends distal to said impeller hub.

3. The device of claim 2 further comprising a casing, wherein a first end of said casing is proximal to said impeller blade and a second end of said casing is distal to said impeller blade, said casing therefore enclosing said impeller blade.

4. The device of claim 3 wherein:

(a) said non-rotating distal support has a first end and a second end;

(b) said first end of said non-rotating support and said impeller hub are coupled; and

(c) said second end of said non-rotating support and said second end of said casing are coupled.

5. The device of claim 3 wherein said casing comprises a plurality of spaced-apart ribs.

6. The device of claim 3 further comprising a membrane, wherein said membrane overlies a central portion of said casing.

7. The device of claim 3 wherein said casing has at least one physical adaptation that enables said device to change between a first state and a second state, wherein:

(a) in said first state, there is relatively less clearance between said casing and said impeller hub; and

(b) in said second state, there is relatively more clearance between said casing and said impeller hub.

8. The device of claim 7 wherein said physical adaptation comprises a sheath, and wherein said sheath is operatively coupled to said casing, and further wherein placing axial tension on said sheath places and maintains said device in said first state.

9. The device of claim 3 wherein said one of said first and second ends of said casing is movable along an axial direction and the other of said first and second ends is not movable in said axial direction.

10. The device of claim 3 wherein said impeller blade is movable between a collapsed position and a deployed position.

11. The device of claim 2 further comprising a motor, wherein:

(a) said motor is operatively coupled to a first end of said transmission line;

(b) said torque transmission line comprises a portion that is flexible in bending and a portion that is rigid; and

(c) said torque transmission line transmits torque from said motor to said impeller blade.

12. The device of claim 3 wherein said impeller hub, said impeller blade, said distal support, and said casing are a part of a pump assembly of said cardiac-assist device, and wherein said device further comprises an introducing tube, wherein said pump assembly is inserted into said introducing tube to traverse a portion of a vascular system of a patient to a deployment site.

13. A temporary cardiac-assist device, comprising:

an impeller blade, wherein said impeller is rotatable about an axis of rotation;

a casing, wherein said casing defines an enclosed region that includes said impeller blade, and further wherein;

(a) a first end of said casing is movable along said axis;

(b) said casing is reconfigurable between an expanded state and a contracted state by moving said first end between a first position and a second position along said axis; and

(c) in the absence of an applied force, said casing is in said expanded state.

14. The device of claim 13 further comprising a first surface and a second surface that are coaxial with said axis of rotation, wherein:

(a) said first surface is proximal to said impeller blade and fixedly receives said first end of said casing;

(b) said second part of said surface is distal to said impeller blade and slidingly receives said second end of said casing; and

(c) neither said first surface nor said second surface rotates about said axis.

15. The device of claim 14 wherein said first surface is the exterior of a proximal support housing and said second surface is the exterior of a distal support.

16. The device of claim 15 wherein said distal support does not bear an axial load.

17. A temporary cardiac-assist device, comprising:

a torque transmission line that is not subject to an axial load during operation of said cardiac-assist device;

an impeller blade, wherein said impeller blade is operatively coupled to said torque transmission line for axial rotation; and

a casing, wherein said casing defines an enclosed region that includes said impeller blade and wherein at least one end of said casing is movable along a axially-disposed central axis for expansion and contraction.

18. The device of claim 17 and further wherein said torque transmission line is not subject to an axial load during deployment of said cardiac-assist device.

19. The device of claim 17 and further wherein said torque transmission line is not subject to an axial load during withdrawal of said cardiac-assist device.

20. The device of claim 17 further comprising:

an impeller hub, wherein said impeller hub is rigidly coupled to said torque transmission line, and wherein said impeller blade depends from said impeller hub; and

a proximal support housing, wherein;

(a) said proximal support housing and said impeller hub are axially aligned;

(b) said proximal support housing is proximal of said impeller hub;

(c) said proximal support housing does not rotate; and

(d) said torque transmission line passes through said proximal support housing.

21. A temporary cardiac-assist device, comprising:

a torque transmission line that drives an impeller blade about an axis of rotation; and

a casing, wherein;

(a) said casing is reconfigurable between an expanded state and a contracted state by moving an end of said casing along said axis of rotation; and

(b) said casing is not operatively coupled to said drive cable.

22. The device of claim 21 wherein said device is configured so that said torque transmission line experiences substantially no axial load during operation of said cardiac-assist device.

23. The device of claim 21 wherein said device is configured so that said torque transmission line is not subject to an axial load during deployment of said cardiac-assist device into a patient.

24. The device of claim 21 wherein said device is configured so that said torque transmission line is not subject to an axial load during withdrawal of said cardiac-assist device from a patient.

25. A temporary cardiac-assist device, comprising:

a torque transmission line, wherein said torque transmission line comprises a drive shaft;

a bearing, wherein said bearing receives said drive shaft;

a seal, wherein said seal is distal to said bearing;

a non-rotating housing, wherein said housing receives said bearing and said seal;

an impeller hub, wherein said impeller hub is distal to said housing and physically coupled to said drive shaft for axial rotation;

an impeller blade, wherein said impeller blade depends from and rotates with said impeller hub; and

a non-rotating support, wherein said support is distal to said impeller blade, extends in an axial direction, couples to said impeller hub, and is not operatively coupled to said drive shaft.

26. The device of claim 25 further comprising a casing, wherein said casing:

(a) has a first end that extends proximal of said impeller blade;

(b) has a second end that extends to a distal end of said support;

(c) is reconfigurable between an expanded state and a contracted state by movement along said axial direction; and

(d) is not operatively coupled to said drive shaft.