VENTRICULAR ASSIST DEVICES

• US 20150290375A1
• Filed: 04/15/2015
• Published: 10/15/2015
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: Thoratec LLC
• Inventors: Kimball, Brian, Schade, Christian, Kopson, Patrick, Angwin, Denise
• Granted Patent: US 9,849,224 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2230/207 hematocrit
• 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 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/585 User interfaces
• CPC Class Codes: A61M 60/814 Volutes
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/863 Apex rings
• CPC Class Codes: A61M 60/88 Percutaneous cables

Abstract

An implantable blood pump includes a control unit storing patient specific settings. The control unit is configured to store patient specific settings. The patient specific settings can be used to determine a target operating speed for the blood pump and/or a target operating mode for the blood pump. The patient specific settings can include at least one of an operating mode for the pump, a set speed for the pump, a lower speed limit for the pump, a patient hematocrit value, a patient hematocrit date, a patient blood density, and a periodic log rate for event and periodic data.

Claims

1. An implantable blood pump assembly, comprising:

an implantable blood pump configured to supplement or replace the pumping function of a heart; and

an implantable control unit communicatively coupled with the blood pump and storing patient specific settings stored within the control unit.

2. The pump assembly of claim 1, wherein the patient specific settings include a patient specific operating mode of the blood pump.

3. The pump assembly of claim 2, wherein the patient specific operating mode for the blood pump can be selected to be continuous or pulsatile.

4. The pump assembly of claim 3, wherein a non-implanted external control unit controls the blood pump to run in a target operating mode selected as either the patient specific operating mode or continuous.

5. The pump assembly of claim 1, wherein the patient specific settings include a patient specific set speed of the blood pump.

6. The pump assembly of claim 1, wherein the patient specific settings include a patient specific low speed limit for the blood pump.

7. The pump assembly of claim 1, wherein the patient specific settings include at least one of a patient specific hematocrit and a patient specific hematocrit date.

8. The pump assembly of claim 1, wherein the patient specific settings include a patient specific blood density.

9. The pump assembly of claim 1, wherein the patient specific settings include a patient specific periodic log rate for event and periodic data.

10. The pump assembly of claim 1, wherein the patient specific settings include a patient specific spoken language.

11. The pump assembly of claim 1, wherein one or more of the patient specific settings stored within the control unit can be selectively changed or updated while the control unit remains implanted.

12. The pump assembly of claim 11, wherein the patient specific settings are changed via wireless communication.

13. The pump assembly of claim 1, wherein the patient specific settings stored within the control unit are communicated to an external non-implanted controller for use in processing performed by the external controller.

14. The pump assembly of claim 1, further comprising a hard wire driveline to provide operating power to the pump assembly.

15. The pump assembly of claim 1, further comprising a transcutaneous energy transfer system configured to wirelessly provide operating power to the pump assembly.

16. The pump assembly of claim 1, wherein the implantable control unit is configured to control the blood pump to run at a target speed.

17. The pump assembly of claim 16, wherein the target speed is based at least in part on at least one of a patient specific low speed limit of the blood pump and a patient specific set speed limit of the blood pump.

18. The pump assembly of claim 1, wherein the control unit is integrally housed with the blood pump or in a separate implantable housing.

19. A method of controlling an implantable blood pump assembly, the method comprising:

storing patient specific settings within an implantable control unit, the patient specific settings including at least one of (a) a patient specific operating mode of the blood pump, (b) a patient specific set speed of the blood pump, (c) a patient specific low speed limit of the blood pump, (d) a patient specific hematocrit, (e) a patient specific hematocrit date, (f) a patient specific blood density, and (g) a patient specific periodic log rate for event and periodic data; and

operating the blood pump in accordance with the patient specific settings stored within the implantable control unit.

20. The method of claim 19, wherein the implantable control unit is integrally housed with the blood pump or in a separate implantable housing.

21. The method of claim 19, wherein an external control unit controls the implantable pump to operate at a target speed that is based on at least one of the patient specific set speed, the patient specific low speed limit, and a set of event based rules for the target speed.

22. The method of claim 21, wherein the set of event based rules for the target speed is based on at least one of the following events:

a target running mode for the implantable blood pump is set as stopped;

the implantable blood pump has just started up;

a suction event is occurring;

instability of a rotor of the implantable blood pump is occurring;

a critical power hazard has been active for more than a predetermined period of time;

the implantable blood pump is running on an emergency backup battery; and

voltage of a backup battery is less than a predetermined value.

23. The method of claim 19, wherein a non-implanted external control unit controls the implantable pump to operate in a target operating mode that is based on at least one of the patient specific operating mode of the blood pump and a set of event based rules for the target operating mode.

24. The method of claim 23, wherein the set of event based rules for the target operating mode is based on at least one of the following events:

a target running mode for the implantable blood pump is set as stopped;

a current set speed for the implantable blood pump is set to be an auto-start threshold speed;

the controller is running on an emergency backup battery; and

a critical power hazard is active.

25. The method of claim 19, further comprising changing at least one of the patient specific settings stored within the implantable control unit while the implantable control unit remains implanted.

26. The method of claim 19, further comprising transmitting the patient specific settings stored within the implantable control unit to a non-implanted control unit.

27. The method of claim 19, further comprising:

transmitting at least one of the patient specific settings from the blood pump assembly to a first external non-implanted controller for use in processing performed by the first external controller;

replacing the first external controller with a second non-implanted controller, the second external controller being different from the first external controller; and

transmitting at least one of the patient specific settings from the blood pump assembly to the second external non-implanted controller for use in processing performed by the second external controller.