Active left-right flow control in a two chamber cardiac prosthesis

• US 6,527,698 B1
• Filed: 10/12/2000
• Issued: 03/04/2003
• Est. Priority Date: 05/30/2000
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Kung, Robert T. V., Fasciano, Robert W.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/687,040
• Time in Patent Office: 873 Days
• Field of Search: 600/16, 600/17, 600/18, 623/3.1
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• 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 60/196 replacing the entire heart, e.g. total artificial hearts [TAH]
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/869 Compliance chambers containing a gas or liquid other than blood to compensate volume variations of a blood chamber

Abstract

A biventricular cardiac prosthesis has a flow balance control system to balance blood flow through the left and right sides of the prosthesis to maintain a patient'"'"'s left atrial pressure within physiologic bounds. The prosthesis can be configured to have flow characteristics so that a signal representative of the difference in hydraulic pumping pressures on the left and right sides of the prosthesis is representative of the difference between left and right atrial pressures of a patient having the prosthesis implanted. This signal can be used as a control signal to drive the prosthesis so that left atrial pressure is approximately equal to right atrial pressure, and within physiologic bounds. A specific prosthesis includes left and right pumping sections, each having a blood pumping chamber and a hydraulic fluid chamber, with a reciprocating hydraulic pump driving systole alternately on the right and left sides. A hydraulic balance chamber is hydraulically coupled to the right hydraulic fluid chamber and an adjustable occluder varies flow resistance through the hydraulic coupling. The occluder can be adjusted based on the control signal to adjustably derate right side blood flow to achieve the desired pressure balance, or the occluder can be adjusted based on fluid communication with sources of pressure in the prosthesis that are representative of right and left atrial pressures.

Claims

1. A method for controlling a biventricular cardiac prosthesis having left and right pumping sections to maintain a patient'"'"'s left atrial pressure within physiologic bounds, comprising the steps of:

measuring the patient'"'"'s left atrial pressure;

determining whether the patient'"'"'s left atrial pressure is outside of a tolerance around a desired left atrial pressure;

adjusting the flow of the right pumping section to bring the patient'"'"'s left atrial pressure within the tolerance wherein when the left atrial pressure is higher than the tolerance, right side flow is decreased, and when the left atrial pressure is lower than the tolerance, right side flow is increased.

2. The method of claim 1, wherein measuring the patient'"'"'s left atrial pressure produces an electric signal representative of the pressure for determining whether the left atrial pressure is within tolerance.

3. The method of claim 2, further comprising the step of calculating a control signal based on the determination of whether the patient'"'"'s left atrial pressure is outside of tolerance.

4. The method of claim 3, wherein the flow of the right pumping section is adjusted by shunting a hydraulic fluid from the right pumping section to a hydraulic balance chamber.

5. The method of claim 4, wherein the shunting is controlled by applying the control signal to adjust the flow resistance of a hydraulic coupling between the right pumping section and the hydraulic balance chamber to thereby effect the amount of shunting.

6. The method of claim 5, wherein the flow resistance of the coupling is adjusted by applying the control signal to vary the effective size of an adjustable orifice positioned in line with the coupling.

7. The method of claim 3, wherein left atrial pressure is measured by placing a pressure sensor in contact with the patient'"'"'s left atrial blood flow to determine the pressure thereof.

8. The method of claim 7, wherein the flow of the right pumping section is adjusted by shunting a hydraulic fluid from the right pumping section to a hydraulic balance chamber, the shunting being controlled by applying the control signal to adjust the flow resistance of a hydraulic coupling between the right pumping section and the hydraulic balance chamber to thereby effect the amount of shunting.

9. The method of claim 8, wherein the flow resistance of the coupling is adjusted by applying the control signal to vary the effective size of an adjustable orifice positioned in line with the coupling.

10. The method of claim 3, wherein left atrial pressure is measured as a difference from a patient'"'"'s right atrial pressure.

11. The method of claim 10, wherein each of the left and right pumping sections includes a hydraulic pumping section and a blood pumping section, the left atrial pressure being measured with respect to the right atrial pressure by measuring a diastolic pressure in the left and right hydraulic pumping sections and taking a difference therebetween.

12. The method of claim 11, wherein the left and right blood pumping sections are configured to provide substantially equal pressure drops for blood flowing through the pumps during pumping.

13. The method of claim 12, wherein the hydraulic pumping sections are driven by a fluid pump and a fluid switch, the left and right diastolic pressure readings being taken by a single pressure transducer coupled to an inlet of the fluid switch.

14. The method of claim 11, wherein the left and right blood pumping sections are configured to provide different pressure drops for blood flowing through the respective pumps during pumping and the left atrial pressure measurement signal comprises a component representing a difference between left and right atrial pressures and an offset component representing the difference in pressure drops.

15. A cardiac prosthesis comprising:

a right pumping section having a blood pumping chamber connectable to a patient'"'"'s right atrium for blood inflow and connectable to a patient'"'"'s pulmonary artery for blood outflow, and a hydraulic pumping section;

a left pumping section having a blood pumping chamber connectable to a patient'"'"'s left atrium for blood inflow and connectable to a patient'"'"'s aorta for blood outflow, and a hydraulic pumping section;

a right pumping section pumping volume derating element;

a control element controlling the derating element to maintain a patient'"'"'s left atrial pressure within physiologic bounds.

16. The cardiac prosthesis of claim 15, wherein the derating element comprises a hydraulic balance chamber hydraulically coupled to the right hydraulic pumping chamber for shunting hydraulic fluid from the right hydraulic pump to the hydraulic balance chamber.

17. The cardiac prosthesis of claim 16, wherein the hydraulic coupling between the right hydraulic pumping chamber and the hydraulic balance chamber includes a variable orifice for adjusting fluid resistance for hydraulic fluid flow through the coupling.

18. The cardiac prosthesis of claim 17, wherein the control element comprises a pressure sensor operatively coupled to a patient'"'"'s left atrial pressure and generating a pressure signal, the control element deriving a control signal from the pressure signal for adjusting the variable orifice to maintain left atrial pressure within physiologic bounds.

19. The cardiac prosthesis of claim 17, wherein the control element comprises at least one pressure sensing element for measuring diastolic hydraulic pressures in each of the left and right pumping sections and generating a pressure signal, the left and right blood pumping chambers being configured to provide substantially similar pressure drops for blood flowing therethrough, the control element deriving a control signal from the pressure signal for adjusting the variable orifice to maintain left atrial pressure within physiologic bounds.

20. The cardiac prosthesis of claim 19, further comprising a reciprocating pump having a hydraulic pump and a fluid switch for alternately driving systole in the left and right hydraulic pumping sections, the control element comprising a pressure sensor disposed in an inlet of the fluid switch for measuring diastolic pressure in the left and right hydraulic pumping sections.

21. In a biventricular cardiac prosthesis having a reciprocating hydraulic pump for alternately pumping left and right hydraulic pumping chambers, a method for controlling flow balance between the left and right hydraulic pumping chambers to maintain left atrial pressure within physiologic bounds, comprising the steps of:

measuring the pressure of each of the left and right hydraulic pumping chambers to generate a first signal representative of left hydraulic pumping chamber pressure and a second signal representative of right hydraulic pumping chamber pressure;

creating a control signal by comparing the first and second signals; and

adjusting the stroke volume of the right hydraulic pumping chamber based on changes in the control signal.

22. The method of claim 21, wherein the stroke volume of the right hydraulic pumping chamber is adjusted by shunting a hydraulic fluid from the right hydraulic pumping chamber to a hydraulic balance chamber.

23. The method of claim 22, wherein the shunting is controlled by applying the control signal to adjust the flow resistance of a hydraulic coupling between the right hydraulic pumping chamber and the hydraulic balance chamber to thereby effect the amount of shunting.

24. The method of claim 22, wherein the flow resistance of the coupling is adjusted by applying the control signal to vary the effective size of an adjustable orifice positioned in line with the coupling.

25. The method of claim 21, wherein the biventricular prosthesis is configured to provide substantially equal pressure drops for blood flowing each of a left and right ventricle prosthesis section, the difference between the first and second signals being representative of the difference between a patient'"'"'s left and right atrial pressures.

26. The method of claim 21, wherein the reciprocating hydraulic pump comprises a fluid pump and a fluid switch, the pressure in each of the left and right hydraulic pumping chambers being measured by a single pressure transducer coupled to an inlet of the fluid switch.

27. A total artificial heart with controlled left and right flow, comprising:

a right pumping section having a blood pumping chamber connectable to a patient'"'"'s right atrium for blood inflow and connectable to a patient'"'"'s pulmonary artery for blood outflow, and a hydraulic pumping section;

a left pumping section having a blood pumping chamber connectable to a patient'"'"'s left atrium for blood inflow and connectable to a patient'"'"'s aorta for blood outflow, and a hydraulic pumping section;

a reciprocating pump causing hydraulic fluid to flow between the right and left hydraulic pumping sections;

a hydraulic balance chamber responsive to a patient'"'"'s left atrial pressure; and

a hydraulic coupling between the hydraulic balance chamber and the right hydraulic pumping section to result in a shunt flow responsive to the difference between right hydraulic pumping pressure and left atrial pressure, the hydraulic coupling having a variable flow resistance that is adjustable to maintain balanced flow between the right and left pumping sections.

28. The total artificial heart of claim 27, further comprising a control element having a pressure sensor operatively coupled to a patient'"'"'s left atrial pressure and generating a pressure signal, the control element deriving a control signal from the pressure signal for adjusting the flow resistance to maintain left atrial pressure within physiologic bounds.

29. The total artificial heart of claim 27, further comprising a control element having at least one pressure sensing element for measuring diastolic hydraulic pressures in each of the left and right pumping sections and generating a pressure signal, the left and right blood pumping chambers being configured to provide substantially similar pressure drops for blood flowing therethrough, the control element deriving a control signal from the pressure signal for adjusting the flow resistance to maintain left atrial pressure within physiologic bounds.

30. The total artificial heart of claim 29, wherein the reciprocating pump comprises a hydraulic pump and a fluid switch, the control element comprising a pressure sensor disposed in an inlet of the fluid switch for measuring diastolic pressure in the left and right hydraulic pumping sections.

31. A total artificial heart with balanced flow for comprising:

a right pumping section having a blood pumping chamber connectable to a patient'"'"'s right atrium for blood inflow and connectable to a patient'"'"'s pulmonary artery for blood outflow, and a hydraulic pumping section;

a left pumping section having a blood pumping chamber connectable to a patient'"'"'s left atrium for blood inflow and connectable to a patient'"'"'s aorta for blood outflow, and a hydraulic pumping section;

a reciprocating pump causing hydraulic fluid to flow between the right and left hydraulic pumping sections;

a sensor connectable to a patient'"'"'s left atrium for measuring left atrial pressure;

hydraulic balance chamber coupled to the right hydraulic pumping section for derating right side pumping volume; and

a controller responsive to the measured left atrial pressure and selectively derating right side pumping volume to maintain a patient'"'"'s left atrial pressure within physiologic bounds.

32. The total artificial heart of claim 31, wherein the hydraulic coupling between the right hydraulic pumping chamber and the hydraulic balance chamber includes a variable orifice for adjusting fluid resistance for hydraulic fluid flow through the coupling in response to the controller.

33. The total artificial heart of claim 31, wherein the hydraulic balance chamber includes a membrane connectable to a patient'"'"'s left atrium whereby the hydraulic balance chamber pressure is an analogue of left atrial pressure.

34. A total artificial heart with balanced flow for comprising:

a right pumping section having a blood pumping chamber connectable to a patient'"'"'s right atrium for blood inflow and connectable to a patient'"'"'s pulmonary artery for blood outflow, and a hydraulic pumping section having a pressure sensor measuring right hydraulic pumping section pressure;

a left pumping section having a blood pumping chamber connectable to a patient'"'"'s left atrium for blood inflow and connectable to a patient'"'"'s aorta for blood outflow, and a hydraulic pumping section having a pressure sensor measuring left hydraulic pumping section pressure;

a hydraulic balance chamber coupled to the right hydraulic pumping section for derating right side pumping volume; and

a controller responsive to the measured left and right hydraulic pressures and selectively derating right side pumping volume to maintain a patient'"'"'s left atrial pressure within physiologic bounds;

wherein the left and right blood pumping chambers are configured to provide substantially equal pressure drops for blood flowing through the left and right sides of the total artificial heart.

35. The total artificial heart of claim 34, wherein the hydraulic balance chamber coupling includes a variable orifice.

36. The total artificial heart of claim 35, wherein the variable orifice comprises an occluder movable in a direction at least partially transverse to fluid flow through the balance chamber coupling and mounted to a translation motor, the controller controlling motion of the translation motor to selectively vary an effective diameter of the balance chamber coupling whereby resistance to flow is varied.

37. The total artificial heart of claim 35, wherein the controller includes control logic to adjust the variable orifice to vary fluid resistance in the coupling and thereby vary the derating of right side pumping volume based on the difference between the measured right and left hydraulic pumping section pressures.

38. The total artificial heart of claim 34, wherein the hydraulic balance chamber includes a membrane connectable to a patient'"'"'s left atrial blood flow.

39. The total artificial heart of claim 34, further comprising a reciprocating pump having a hydraulic pump and a fluid switch for alternately driving systole in the left and right hydraulic pumping sections.

40. The total artificial heart of claim 39, further comprising means for calibrating the left and right hydraulic pumping section pressure sensors.

41. The total artificial heart of claim 40, wherein the means for calibrating includes a controller having control logic to reduce the hydraulic pump speed to zero, measure offset pressures from the left and right hydraulic pumping section pressure sensors, and apply the measured offsets to the difference between left and right hydraulic pumping section measured pressures.

42. The total artificial heart of claim 40, wherein the means for calibrating includes a controller having control logic to vary the hydraulic pump speed to at least two different speeds, measure offset pressures from the left and right hydraulic pumping section pressure sensors at each of the at least two different speeds, extrapolate zero pump speed offsets, and apply the zero pump speed offsets to the difference between left and right hydraulic pumping section measured pressures.

43. The total artificial heart of claim 34, wherein the left and right hydraulic pumping section pressure sensors sample hydraulic pumping section pressures during diastole for the respective left or right section.