Anti-thrombogenic blood pump

• US 4,704,121 A
• Filed: 09/28/1983
• Issued: 11/03/1987
• Est. Priority Date: 09/28/1983
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Nimbus, Inc. (Kentucky)
• Inventors: Moise, John C.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): ISABELLA, DAVID J
• Application Number:
  US06/537,243
• Time in Patent Office: 1,497 Days
• Field of Search: 3/1.7, 415/DIG. 4, 415/111, 415/112, 415/115, 415/116, 128/111, 128/1 R
• US Class Current: 623/3.13
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• 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 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/416 transmitted directly by the motor rotor drive shaft
• 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 60/831 using filtered blood as purge fluid
• CPC Class Codes: F04D 29/108 the sealing fluid being other than the working liquid or being the working liquid treated

Abstract

Thrombus formation in an implantable blood pump is prevented by using a close-tolerance purge seal for the impeller shaft or rotor. A blood-compatible fluid is used for the purge fluid (which is preferably also the bearing fluid), and the purge flow into the blood stream presents to the blood stream a benign interface between the rotating and stationary parts of the pump. The rotating and stationary surfaces adjacent the interface are so configured as to present an essentially continuous smooth surface across the interface which can be swept by the blood stream and presents no cavities in which the blood can stagnate. The close clearances of the purge seal allow a sufficient purge flow rate to be maintained with only a minute amount of purge fluid; and in accordance with one aspect of the invention, the purge fluid can be derived from the blood stream by a protein-filtering membrane system so that no external replenishment of the purge fluid supply is necessary.

Claims

1. An anti-thrombogenic blood pump, comprising:

(a) a rotor means and stator means cooperating to convey a blood stream through said pump, an interface between said rotor means and stator means being exposed to said blood stream; and

(b) purge seal means including;

(i) a source of blood-compatible purge fluid;

(ii) a continuous passageway formed between said rotor means and stator means between said purge fluid source and said interface, said passageway having a close-clearance, substantially uniform cross section over its entire length from said purge fluid source to said interface; and

(iii) means for causing said purge fluid to flow continuously and substantially uniformly through said passsageway and into said blood stream stream at said interface;

(c) whereby said flow substantially pregents the accumulation of blood elements at said interface by preventing entry of blood elements into said interface.

2. The pump of claim 1, in which said rotor means and said stator means are supported for relative rotation by bearing means, and said purge seal means constitute a fluid seal between said blood stream and said bearing means.

3. The pump of claim 2, in which said purge fluid is the bearing fluid used to lubricate said bearing means.

4. The pump of claim 3, in which said bearing means are of the hydrodynamic type, and recirculating means are provided between said bearing means and said purge seal means to prevent the hydrodynamic bearing flow from inducing recirculating effects in said purge seal means.

5. The pump of claim 2, in which the flow of said purge fluid into said blood stream at said interface is just sufficient to prevent blood elements from penetrating said interface.

6. The pump of claim 2, in which said purge seal means is a cylindrical seal.

7. The pump of claim 2, in which said purge seal means is a face seal.

8. The pump of claim 2, in which said purge seal means is a spherical seal.

9. The pump of claim 2, in which said purge fluid consists of protein-free blood filtrate derived from said blood stream.

10. The blood pump of claim 9, in which said filtrate is obtained by providing protein-filtering membrane means having its high-pressure side in operative contact with said blood on the outlet side of said blood pump, and its low-pressure side in operative connectioin with said purge seal means, whereby the protein-free filtrate fluid collected on the low-pressure side of said membrane constitutes the surce of purge fluid for said purge seal means.

26. The pump of claim 1, in which the smallest cross section of said passageway is adjacent said interface.

11. An anti-thrombogenic centrifugal blood pump, comprising:

(a) a housing including an impeller chamber;

(b) driving means disposed in said housing outside said impeller chamber;

(c) impeller means disposed in said impeller chamber, for centrifugally pumping blood through said impeller chamber;

(d) shaft means associated with said motor means and impeller means for driving said impeller means;

(e) said shaft means being rotatably supported in said housing by hydrodynamic journal bearing means operating in a blood-compatible bearing fluid;

(f) said shaft means and housing forming an interface at said impeller chamber; and

(g) purge seal means including;

(i) a source of blood-compatible purge fluid;

(ii) a continuous passageway formed by said shaft means and said housing between said purge fluid source and said interface, said passageway having a close-clearance, substantially uniform cross section over its entire length from said purge fluid source to said interface; and

(iii) means for causing said purge fluid to flow continuously and substantially uniformly through said passageway and into said blood stream at said interface;

(h) whereby said flow substantially prevents the accumulation of blood elements at said interface.

12. The pump of claim 11, in which said impeller means are shroudless.

13. The blood pump of claim 12, in which said impeller means include a hub and a plurality of blades, the surface of said hub and the wall of said impeller chamber forming an essentially continuous smooth surface at the interface between said hub means and said wall.

14. The blood pump of claim 13, in which said blades are arranged to sweep said interface as said impeller means rotate.

15. The blood pump of claim 13, in which said purge fluid flow into said impeller chamber is at a rate just sufficient to overcome the flow of blood or blood elements into said interface at all points along the interface between said shaft means and said housing.

16. The blood pump of claim 11, in which said bearing fluid and said purge fluid are the same fluid.

17. The blood pump of claim 11, further comprising plenum means surrounding said shaft means adjacent said bearing means between said bearing means and said passageway for recirculating said bearing fluid into said bearing means without affecting the flow of said purge fluid into said passageway.

18. The blood pump of claim 17, in which a low-impedance source of bearing fluid is connected to said plenum means.

19. The blood pump of claim 11, in which the clearance of said purge seal means at said interface is on the order of 2.5 μ

m.

20. An anti-thrombogenic axial blood pump, comprising:

(a) stator means defining an elongated housing;

(b) rotor means mounted for axial rotation within said housing to convey a blood stream axially of said housing, said rotor means and stator means defining between them an interface in contact with said blood stream;

(c) bearing means for rotatably supporting said rotor means on said stator means; and

(d) purge seal means interposed between said bearing means and said blood stream at said interface for producing an outflow of purge fluid into said blood stream at said interface sufficient to prevent penetration of blood elements into said interface;

(e) said purge seal means including;

(i) a source of blood-compatible purge fluid;

(ii) a continuous passageway formed between said rotor means and stator means between said purge fluid source and said interface, said passageway having a substantially uniform, close-clearance cross section over its entire length from said purge fluid source to said interface, and forming a hydrodynamic bearing; and

(iii) means for causing said purge fluid to flow continuously through said passageway and into said blood stream at said interface;

(f) whereby by said flow substantially prevents the accumulation of blood elements at said interface while providing the bearing fluid for said hydrodynamic bearing.

21. The pump of claim 20, in which the stator and rotor surfaces adjacent said interface form an essentially continuous smooth surface swept by said blood stream.

22. The method of preventing the accumulation of blood elements in a blood pump having a rotor means and stator means cooperating to convey a blood stream through said pump, an interface between said rotor means and stator means being exposed to said blood stream;

and

purge seal means including;

(i) a source of blood-compatible purge fluid;

(ii) a continuous passageway formed between said rotor means and stator means between said purge fluid source and said interface, said passageway having a close-clearance, substantially uniform cross section over its entire length from said purge fluid source to said interface; and

(iii) means for causing said purge fluid to flow continuously and substantially uniformly through said passageway and into said blood stream at said interface, comprising the steps of

(a) so shaping the rotary and stationary parts of said pump that together they form a continuous surface across the interface between them at which said rotating and stationary parts are in contact with the blood being pumped; and

(b) causing a blood-compatible fluid to continuously flow into the pumped blood at all points of said interface;

(c) whereby said flow substantially prevents the accumulation of blood elements at said interface and prevents entry of blood elements into said interface.

23. The method of claim 22, further comprising the step of continually sweeping all of said points during operation of said pump.

24. The method of claim 22, further comprising the step of adjusting the flow rate of said fluid to just slightly exceed the maximum diffusion rate of elements of said blood into said interface along the perimeter of said interface.

25. The method of claim 24, further comprising the step of deriving said fluid by membrane filtration from said blood at a pressure sufficient to produce at least said adjusted flow rate of said fluid.