Positive displacement piston driven blood pump

• US 5,066,282 A
• Filed: 05/04/1989
• Issued: 11/19/1991
• Est. Priority Date: 09/23/1987
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Leocor, Inc.
• Inventors: Wijay, Bandula, Angelini, Paolo
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/347,406
• Time in Patent Office: 929 Days
• Field of Search: 604/151, 604/152, 604/153, 604/154, 604/155, 604/141, 604/142, 604/246, 604/247, 417/437, 417/540, 128/DIG. 12
• US Class Current: 604/152
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/438 the force acting on the blood contacting member being mechanical
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/849 Disposable parts
• CPC Class Codes: A61M 60/851 Valves
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

The invention is a disposable, positive-displacement piston pump, having a polycarbonate body, a piston, an inlet valve, and an outlet valve. The outlet valve is connected to an exit chamber, which is separated from the exit valve by an elastomeric membrane. The elastomeric membrane encloses an accumulation chamber which is filled with a fluid such as air under atmospheric pressure. Pulsations in outlet pressure caused by stroking of the piston are dampened by the flexing action of the elastomeric membrane, compressing the fluid within the accumulator chamber. The throw out of the pump is pressure-dampened and is of sufficient pressure to flow through very low-profile angioplasty catheters having perfusion lumens extending therethrough. The combination of the pump with a very low-profile balloon angioplasty catheter allows access of the catheter to a constricted passage with the ability to pump a sufficient volume of blood through such a low-profile catheter during balloon inflations.

Claims

1. A pumping source for pumping blood comprising:

a pump body;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity.

2. The pump of claim 1 wherein said pulsation-dampening means is integral with said pump body and wherein said membrane is disposed in said pulsation dampening means in a manner as to avoid the creation of dead spots where blood can accumulate in the flowpath through said body.

3. The pump of claim 1 wherein said pressure-elevating means further comprises:

at least one inlet valve;

at least one outlet valve;

at least one pressurization chamber defining a volume in fluid communication with both said inlet and outlet valves; and

means for varying the volume of said pressurization chamber.

4. The pumping system of claim 3 wherein:

said pressurization chamber is cylindrical; and

said volume-varying means is a piston.

5. The pumping system of claim 1, further comprising:

a balloon angioplasty catheter having a perfusion lumen having an internal diameter adjacent its distal end of approximately 0.020 inches extending therethrough; and

said body in flow communication with said perfusion lumen in said catheter, thereby allowing pulsation-dampened, pressurized blood to be pumped through the catheter during balloon angioplasty procedures.

6. The apparatus of claim 1 wherein said pump further comprises:

drive means connected to said pressure-elevating means for selective operation thereof;

said pump, including said driver, is portable.

7. The apparatus of claim 6 wherein:

said body, pressure-elevating means and pulsation-dampening means are disposable and said drive means is reusable with replacement units comprising a body, pressure-elevating means and pulsation-dampening means.

8. An apparatus for perfusing blood during angioplasty comprising:

a blood pump capable of developing pressure of at least 120 psig;

means in flow communication with said pump for dampening pulsation of the blood as it emerges from said pump, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity;

an angioplasty catheter having a perfusion lumen, having an internal diameter adjacent its distal end of approximately 0.020 inches, running through it;

said pump in flow communication with said perfusion lumen to allow blood to be pumped through said lumen and distally of the catheter when said catheter is used on a patient.

9. The apparatus of claim 8 wherein said pump further comprises an inlet port adapted to be mounted to a patient'"'"'s renal vein or an artery, thereby allowing continuous blood flow from the patient through said pump and said catheter during angioplasty.

10. The apparatus of claim 8 wherein said pump further comprises:

drive means connected to said pump for selective operation thereof;

said pump, including said driver, is portable.

11. The apparatus of claim 10 where said pump is disposable and said drive means can be used with replacement pumps.

12. The pump of claim 8 wherein said pulsation-dampening means is integral with said body and wherein said membrane is disposed in said pulsating dampening means in a manner as to avoid the creation of dead spots where blood can accumulate in the flowpath through said body.

13. A pumping source for pumping blood comprising:

a pump body;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening potation of the blood as it emerges from said pump body, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity;

at least one inlet valve;

at least one outlet valve;

a least one pressurization chamber defining a volume in fluid communication with both said inlet and outlet valves; and

means for varying the volume of said pressurization chamber;

said outlet valve is in flow communication with an exit port in said body;

said membrane covering said exit port when said outlet valve is in the closed position, said accumulator cavity disposed on the opposite side of said membrane from said exit port;

said body further comprising an exit chamber cavity defined therein, said exit chamber cavity spaced apart from said exit port;

said exit chamber cavity is in flow communication with said exit port when said outlet valve is open and said membrane flexes, thereby reducing the volume of said accumulator cavity.

14. The pumping system of claim 13 wherein said body further comprises an outlet opening in flow communication with said exit chamber cavity.

15. The pumping system of claim 14, further comprising:

a balloon angioplasty catheter having a perfusion lumen having an internal diameter adjacent its distal end of approximately 0.020 inches extending therethrough; and

said outlet opening in said body in flow communication with said perfusion lumen in said catheter, thereby allowing pulsation-dampened, pressurized blood to be pumped through the catheter during balloon angioplasty procedures.

16. The pumping system of claim 15 wherein said pulsation-dampening means is integral with said body and wherein said membrane is disposed in said pulsating dampening means in a manner as to avoid the creation of dead spots where blood can accumulate in the flowpath through said body.

17. A blood pump comprising:

a body defining a cavity therein;

at least one double-acting piston dividing said cavity into at least one first and second chambers;

inlet and outlet valves in flow communication with said first and second chambers;

said valves selectively operable in response to movement of said piston to allow sequential operation of said valves to facilitate pressurization of blood in said first chamber as said piston moves in one direction, then in said second chamber as said piston moves in an opposite direction;

means in said body for dampening pulsation of the pressure of the blood as it emerges from pump, said pulsation-dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity.

18. The pump of claim 17 wherein said pulsation-dampening means is integral with said body and wherein said membrane is disposed in said pulsation dampening means in a manner as to avoid the creation of dead spots where blood can accumulate in the flowpath through said body.

19. A pumping source for pumping blood comprising:

a pump body;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity;

a balloon angioplasty catheter having a perfusion lumen having an internal diameter adjacent its distal end of approximately 0.020 inches extending therethrough; and

said body in flow communication with said perfusion lumen in said catheter, thereby allowing pulsation-dampened, pressurized blood to be pumped through the catheter during balloon angioplasty procedures;

said pressure-elevating means further comprises an inlet port adapted to be mounted to a patient'"'"'s renal vein or an artery, thereby allowing continuous blood flow from the patient through said pump and said catheter during angioplasty.

20. A pumping source for pumping blood comprising:

a pump body;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity;

said pressure-elevating means is capable of developing pressures at least as large as 120 psig.

21. A pumping source for pumping blood comprising:

a pump body;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges form said pump body, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity;

a balloon angioplasty catheter having a perfusion lumen having an internal diameter adjacent its distal end of approximately 0.020 inches extending therethrough; and

said body in flow communication with said perfusion lumen in said catheter, thereby allowing pulsation-dampened, pressurized blood to be pumped through the catheter during balloon angioplasty procedures;

said pressure-elevating means is capable of developing pressures at least as large as 120 psig.

22. A blood pump comprising:

a body defining a cavity therein;

at least one double-acting piston dividing said cavity into at least one first and second chambers;

inlet and outlet valves in flow communication with said first and second chambers;

said valves selectively operable in response to movement of said piston to allow sequential operation of said valves to facilitate pressurization of blood in said first chamber as said piston moves in one direction, then in said second chamber as said piston moves in an opposite direction;

said pump is capable of developing pressure at least as large as 120 psig.

23. A pumping source for pumping blood comprising:

a pump body;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby isolating blood passing through said body from said cavity;

a balloon angioplasty catheter having a perfusion lumen having an internal diameter adjacent its distal end of approximately 0.020 inches extending therethrough; and

said body in flow communication with said perfusion lumen in said catheter, thereby allowing pulsation-dampened, pressurized blood to be pumped through the catheter during balloon angioplasty procedures;

said pump further comprises;

drive means connected to said pressure-elevating means for selective operation thereof;

said pump, including said driver, is portable.

24. The apparatus of claim 23 wherein:

said body, pressure-elevating means and pulsation-dampening means are disposable and said drive means is reusable with replacement units comprising a body, pressure-elevating means and pulsation-dampening means.

25. A blood pump comprising:

a body defining a cavity therein;

at least one double-acting piston dividing said cavity into at least one first and second chambers;

inlet and outlet valves in flow communication with said first and second chambers;

said valves selectively operable in response to movement of said piston to allow sequential operation of said valves to facilitate pressurization of blood in said first chamber as said piston moves in one direction, then in said second chamber as said piston moves in an opposite direction;

means in said body for dampening pulsation of the pressure of the blood as it emerges from pump, said pulsation-dampening means further comprising;

a housing defining an accumulator cavity therein; and

a membrane covering said accumulator cavity, thereby enclosing said cavity;

said pulsation-dampening means is integral with said body and wherein said membrane is disposed in said pulsation dampening means in a manner as to avoid the creation of dead spots where blood can accumulate in the flowpath through said body.