Blood pump and method of pumping blood

• US 4,222,127 A
• Filed: 06/02/1978
• Issued: 09/16/1980
• Est. Priority Date: 06/02/1978
• Status: Expired due to Term

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: Donachy and Pierce
• Inventors: Pierce, William S., Donachy, James H.
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/912,033
• Time in Patent Office: 837 Days
• Field of Search: 3/1.7, 128/1 D, 128/DIG. 3, 417/383, 417/384, 417/394, 417/395, 417/474, 417/412, 417/413
• US Class Current: 623/3.21
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• 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 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/196 replacing the entire heart, e.g. total artificial hearts [TAH]
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves

Abstract

A blood pump for implant or paracorporeal use having a rigid case with inlet and outlet valves defining a pumping cavity; an integral thin walled flexible sac freely confined within a pumping cavity; and a flexible diaphragm within the cavity conforming to the shape of the adjacent side of the sac. The case includes a control ring projecting into the cavity between the diaphragm and sac. The diaphragm is moved between diastolic and systolic positions to pump blood through the valves. During pumping, the ring distributes flexing of the diaphragm over an increased area while also preventing the interior walls of the sac from contacting each other. The outlet port and the portion of the sac immediately surrounding the outlet port are less flexible than the remainder of the sac away from the port and the portion of the diaphragm overlying the outlet port is less flexible than the remainder of the diaphragm. The less flexible portions of the sac and diaphragm improve pressure pulse pumping so that the more flexible portion of the sac away from the outlet port is initially collapsed and the sac is progressively collapsed from that portion to the outlet port to minimize stasis in the pumping chamber. The less flexible portion of the sac also prevents collapse at the port due to the decreased Venturi effect pressure during the systolic stroke.

Claims

1. A blood pump comprising a case defining a pumping cavity, inlet and outlet passages leading into the cavity;

a thin walled pumping sac comprising a pumping chamber positioned freely within the cavity and integral inlet and outlet ports positioned within the inlet and outlet passages, the chamber including first and second parts and an equator joining the parts with the outlet port formed in the first part adjacent the equator;

inlet and outlet valves on the case at the ends of the inlet and outlet passages connected in a fluid flow relation to said inlet and outlet ports for controlling the flow of blood through the pump;

means for alternately expanding and collapsing the second part of the chamber to pump blood past the valves, a portion of the pumping sac adjacent to the outlet port having a greater resistance to flexing than the remainder of the chamber, said portion extending across the equator and overlying the outlet port, whereby during pumping of blood from the chamber the portion collapses subsequent to collapse of the remainder of the chamber.

2. A blood pump as in claim 1 wherein the outlet port is positioned freely within the outlet passage and the outlet port has a greater resistance of flexing than the remainder of the chamber to resist Venturi effect collapse during pumping of blood from the chamber.

3. A blood pump as in claim 2 including means for limiting collapse of the pumping chamber to prevent touching of the interior surfaces thereof.

4. A blood pump as in claim 3 wherein the pumping cavity and pumping chamber are both ellipsoidal in shape and have essentially co-planar equators, and said inlet and outlet ports are located adjacent to each other and close to and on one side of the chamber equator.

5. A blood pump as in claim 4 wherein said means includes a generally semiellipsodal diaphragm attached to the case and extending into the pumping cavity adjacent the equator, the diaphragm and the adjacent side of the chamber engaging each other to form a flexible pumping wall, lubricant on the interface of the pumping wall between the diaphragm and the side of the pumping chamber, and means for communicating pressure and vacuum pulses to the chamber between the diaphragm and the side of the pumping cavity away from the pumping chamber.

6. A blood pump as in claim 1 wherein the outlet port and the portion of the sac adjacent the outlet port are thicker than the remainder of the chamber.

7. A blood pump as in claim 6 wherein the sac comprises a number of integrally bonded layers of a flexible material, the inner surface of the sac being defined by a single continuous layer, the outer surface of the sac being defined by a second continuous layer and the less flexible portions of the sac being formed by at least one partial layer lying between the continuous inner and outer layers.

8. A blood pump as in claim 1 wherein the pumping chamber, when expanded, has an equator separating a pair of like chamber sides, said inlet and outlet ports being located on one side of the chamber, and including a control ring extending around the periphery of the pumping cavity on the side of the equator away from the inlet and outlet passages, and a pumping diaphragm attached to the case adjacent the side of the control ring away from the equator and generally conforming to the shape of the adjacent side of the pumping chamber, means for introducing pressure and vacuum pulses into the space between the diaphragm and adjacent wall of the cavity away from the chamber so that the diaphragm and adjacent side of the chamber move together between the expanded and collapsed positions of the chamber with the diaphragm being flexed over the inner edge of the ring when the chamber is collapsed and being flexed about its attachment to the case when the chamber is expanded.

9. A blood pump as in claim 8 wherein the ring extends into the cavity a distance greater than twice the thickness of the sac wall at its equator.

10. A blood pump comprising a case defining a pumping cavity with inlet and outlet passages, a thin walled pumping sac freely positioned within the case with a pumping chamber in the pumping cavity and inlet and outlet ports in the inlet and outlet passages, inlet and outlet valves at the ends of the passages in fluid flow communication with the inlet and outlet ports, the pumping chamber having two like sides separated by an equator, said inlet and outlet ports being located adjacent to each other and close to and on one side of the equator, means for flexing a first side of the pumping chamber away from the inlet and outlet ports between extended and collapsed positions about a smooth generally equatorial flex line to pump blood into and out ot the sac, and means within the cavity for preventing the interior surfaces of the sides from touching each other when the chamber is collapsed.

11. A blood pump as in claim 10 including means operable during collapse of the pumping chamber for moving the portion of said first side away from the outlet port toward the other side faster than the remainder of the first side is moved toward the outlet port.

12. A blood pump as in claim 10 wherein the pumping cavity and pumping chamber are both ellipsoidal in shape and have essentially co-planar equators.

13. A blood pump as in claim 10 wherein the outlet port and the portion of the sac surrounding and overlying the outlet port are less flexible than the remainder of the chamber.

14. A blood pump as in claim 13 wherein the sac comprises a number of integrally bonded layers of a flexible material, the inner surface of the sac being defined by a single continuous layer.

15. A blood pump as in claim 10 including a control ring extending around the pumping cavity on the side of the equator away from the inlet and outlet ports, and a pumping diaphragm attached to the case at the side of the control ring away from the equator and generally conforming to the shape of the adjacent side of the pumping chamber, means for introducing pressure and vacuum pulses into the space between the diaphragm and adjacent wall of the cavity away from the chamber so that the diaphragm and adjacent side of the chamber move together between the expanded and collapsed positions of the chamber with the diaphragm being flexed over the inner edge of the ring when the chamber is collapsed and being flexed about its attachment to the case when the chamber is expanded.

16. A blood pump as in claim 15 wherein the ring extends into the cavity a distance greater than twice the thickness of the adjacent sac wall.

17. A blood pump comprising a case defining a pumping cavity, inlet and outlet passages leading into the cavity, a thin walled pumping sac comprising a pumping chamber positioned freely within the cavity with integral inlet and outlet ports positioned within the inlet and outlet passages, inlet and outlet valves on the case at the ends of the inlet and outlet passages connected in fluid flow relation to said inlet and outlet ports for control flowing of blood through the pump, the pumping chamber having an equator separating first and second like sides with the inlet and outlet ports joining the second side, a diaphragm generally conforming in shape to the first side attached to the case and extending across the cavity, said diaphragm engaging the outer surface of said first side to form a unitary pumping wall, a control ring projecting into the cavity and extending around the cavity between the equator of the chamber and the diaphragm, and means for moving the pumping wall back and forth to expand and collapse the pumping chamber and pump blood past the valves, whereby upon collapse of the pumping wall the control ring prevents the interior surfaces of the chamber sides from touching each other.

18. A blood pump as in claim 17 wherein the control ring extends into the cavity a distance greater than twice the thickness of the adjacent sac wall.

19. A blood pump as in claim 17 wherein a first portion of the pumping chamber surrounding the outlet port is less flexible than the remainder of the pumping chamber away from the outlet port.

20. A blood pump as in claim 19 wherein the inlet and outlet ports are adjacent to each other and are adjacent the pumping chamber equator, and said first portion extends across the chamber equator and overlies the outlet port.

21. A blood pump as in claim 20 wherein the outlet port is less flexible than the remainder of the pumping chamber.

22. A blood pump as in claim 17 wherein the inner edge of said ring is rounded to form a smooth lip and the diaphragm extends from the inner surface of the cavity on the side of the ring away from the equator so that the diaphragm flexes about two radially spaced flex areas as the pumping wall is moved between the systolic and diastolic positions.

23. An improved blood pumping sac adapted to be positioned freely within the case of a blood pump, said sac being formed of a thin, flexible and appendage free material with a hemocompatible inner surface, the sac comprising a pumping chamber with an equator, two like sides separated by the equator, and integral inlet and outlet ports in one side, the outlet port being located adjacent the equator, the sac including a less flexible portion surrounding the outlet port, extending across the equator to the other side and overlying the outlet port to resist premature collapse during pumping of blood from the chamber.

24. An improved blood pumping sac as in claim 23 wherein the less flexible portion of the chamber is thicker than the remainder of the chamber.

25. An improved blood pumping sac as in claim 24 wherein the sac comprises a number of integrally bonded layers of a flexible material, the inner surface of the sac being defined by a single continuous layer and the less flexible portion of the chamber including at least one additional partial layer.

26. An improved blood pumping sac as in claim 25 wherein the outer surface of the sac is defined by a single continuous layer of the flexible material.

27. An improved blood pumping sac as in claim 26 including a tapered transition portion surrounding the thicker portion of the chamber.

28. An improved blood pumping sac as in claim 26 wherein the pumping chamber is generally ellipsoidal and the inlet and outlet ports are located adjacent to each other and adjacent to the equator.

29. A blood pump comprising a case defining a pumping cavity and inlet and outlet passages leading into the cavity;

a thin-walled pumping sac comprising a pumping chamber positioned freely within the cavity with integral inlet and outlet ports positioned within the inlet and outlet passages, the pumping chamber, when expanded, having an equator separating a pair of like chamber sides, said inlet and outlet ports being located on one of the chamber sides;

a control ring unitary with the case extending around the periphery of the pumping cavity on the side of the equator away from the inlet and outlet passages;

a pumping diaphragm attached to the case adjacent to the side of the control ring away from the equator and generally conforming to the shape of and lying on the adjacent chamber side of the pumping chamber to form a flexible pumping wall;

inlet and outlet valves on the case at the ends of inlet and outlet passages connected in fluid flow relation to said inlet and outlet ports for controlling the flow of blood through the pump; and

means for introducing pulses into the space between the diaphragm and adjacent wall of the cavity away from the chamber so that the diaphragm and adjacent side of the chamber move together between expanded and collapsed positions of the chamber with the diaphragm flexed over the inner edge of the ring when the chamber is collapsed and being flexed about its attachment to the case when the chamber is expanded.

30. A blood pump comprising a case defining a pumping cavity having a cavity equator separating a pair of generally like cavity sides, inlet and outlet passages leading into the cavity, said passages being located on one side of the cavity equator;

a thin-walled pumping sac comprising a pumping chamber positioned freely within the cavity with integral inlet and outlet ports positioned within the inlet and outlet passages, said sac having an equator substantially coincident with the cavity equator;

inlet and outlet valves on the case at the ends of the inlet and outlet ports for controlling the flow of blood through the pump;

the case including a control member extending into the pumping cavity on the other side of the cavity equator and extending at least partially along such equator;

a pumping diaphragm attached to the case on the other side of the cavity equator with the control member located between the diaphragm and the cavity equator, the diaphragm generally conforming in shape to the shape of and lying on the adjacent side of the pumping chamber to form a flexible pumping wall; and

means adaptable for moving the pumping wall between expanded and collapsed positions of the chamber with the diaphragm being flexed over the inner edge of the control member when the chamber is collapsed and being flexed about its attachment to the case when the chamber is expanded.

31. A blood pump as in claim 30 wherein said control member includes a control ring extending around the cavity.

32. A blood pump as in claim 30 where the sac includes a relatively less-flexible portion including said inlet and outlet ports and a relatively more flexible portion comprising the remainder of the pumping chamber, said relatively less-flexible portion extending from said inlet and outlet passages across the sac equator and overlying the outlet passage so as to resist flexing into the passage during movement of the sac to the collapsed position.

33. An improved pumping diaphragm for use in blood pump, said diaphragm including a thin domed flexible wall adapted to be moved between extended and retracted positions, and means on the periphery of the wall for attaching the diaphragm to the case of a blood pump, said wall including a peripheral portion having greater resistance to flexing than the remainder of the wall.

34. An improved pumping diaphragm as in claim 33 wherein the peripheral portion is thicker than the remainder of the wall and including a smooth transition portion joining the peripheral portion and remainder of the wall.

35. An improved pumping diaphragm as in claim 33 wherein said peripheral portion is chordal.

36. The method of pumping blood using a collapsible sac having a thin walled flexible pumping side and a nonmoving side with inlet and outlet ports extending from the nonmoving side and with the outlet port located adjacent to the edge of the pumping side, comprising the steps of:

A. Expanding the sac to fill the sac with blood flowing through the inlet port by moving the pumping side away from the nonmoving side; and

then

B. Collapsing the sac to pump blood out the outlet port without obstruction by moving the portion of the pumping side remote from the outlet port toward the nonmoving side faster than the portion of the pumping side overlying the outlet port is moved toward the nonmoving side and completing collapse of the pumping side remote from the outlet port prior to restriction of the outlet port by collapse of the portion of the pumping side overlying the outlet port.

37. The method of claim 36 including the step of forming an initial depression in the pumping side of the sac remote from the outlet port and then radially expanding the depression while collapsing the pumping side to move the pumping side smoothly from the expanded to the collapsed positions.

38. The method of claim 37 including the step of expending the depression in a direction toward the outlet port slower than it is expanded in a direction away from the outlet port.

39. The method of claim 38 including the step of expanding the depression to a smooth crease-free 180°

bend at the junction between the sides when the sac is fully collapsed.

40. The method of claim 39 including the step of preventing touching of the inner surfaces of the two sides while pumping.

41. The method of pumping blood using a pump having a flexible pumping chamber and a flexible diaphragm peripherally secured to the pump overlying one side of the chamber, comprising the steps of:

A. Moving the diaphragm through a diastolic stroke to expand and fill the chamber;

B. Moving the diaphragm through a systolic stroke to collapse and empty the chamber; and

C. During each diastolic and systolic stroke successively flexing the diaphragm at its periphery about each of a pair of spaced peripheral flex areas.

42. The method of claim 41 including steps of:

D. Flexing the diaphragm during each diastolic stroke first about an outer peripheral flex area and then about an inner peripheral flex area; and

E. Flexing the diaphragm during each systolic stroke first about the inner peripheral flex area and then about the outer peripheral flex area.

43. The method of claim 42 including the step during each stroke of flexing the diaphragm approximately 90°

about each of the inner and outer peripheral flex areas.