Ventricular assist devices

• US 10,111,996 B2
• Filed: 11/21/2017
• Issued: 10/30/2018
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Inventors: Angwin, Denise, Kimball, Brian, Schade, Christian, Kopson, Patrick
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US15/819,725
• Publication Number:
  US 20180093026A1
• Time in Patent Office: 343 Days
• 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. A method of controlling an implantable blood pump, the method comprising:

storing preprogrammed patient specific settings within an implantable control unit;

communicating at least one of the preprogrammed patient specific settings from the implantable control unit to a non-implanted external control unit; and

controlling, by the non-implanted external control unit, operation of the implantable blood pump in accordance with the at least one of the preprogrammed patient specific settings communicated to the external control unit from the implantable control unit.

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

3. The method of claim 1, wherein:

the preprogrammed patient specific settings include at least one of a patient specific set speed and a patient specific low speed limit; and

the non-implanted 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.

4. The method of claim 3, 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.

5. The method of claim 1, wherein:

the preprogrammed patient specific settings include at a patient specific operating mode of the implantable blood pump; and

the 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 implantable blood pump and a set of event based rules for the target operating mode.

6. The method of claim 5, 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 non-implanted external control unit is running on an emergency backup battery; and

a critical power hazard is active.

7. The method of claim 1, further comprising changing at least one of the preprogrammed patient specific settings stored within the implantable control unit while the implantable control unit remains implanted.

8. The method of claim 1, further comprising:

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

communicating at least one of the preprogrammed patient specific settings from the implantable control unit to the second non-implanted external controller for use in processing performed by the second non-implanted external controller.

9. The method of claim 1, wherein the preprogrammed patient specific settings include a patient specific operating mode of the implantable blood pump.

10. The method of claim 9, wherein the preprogrammed patient specific operating mode for the implantable blood pump can be selected to be continuous or pulsatile.

11. The method of claim 10, wherein the non-implanted external control unit controls the implantable blood pump to run in a target operating mode selected as either the patient specific operating mode or continuous.

12. The method of claim 1, wherein the preprogrammed patient specific settings include a patient specific set speed of the implantable blood pump.

13. The method of claim 1, wherein the preprogrammed patient specific settings include a patient specific low speed limit for the implantable blood pump.

14. The method of claim 1, wherein the preprogrammed patient specific settings include at least one of:

a patient specific hemacrit;

a patient specific hematocrit and a patient specific hematocrit date; and

a patient specific blood density.

15. The method of claim 1, wherein the preprogrammed patient specific settings include a patient specific periodic log rate for event and periodic data.

16. The method of claim 1, wherein the preprogrammed patient specific settings include a patient specific spoken language.

17. The method of claim 1, further comprising selectively changing one or more of the preprogrammed patient specific settings stored within the implantable control unit while the implantable control unit remains implanted.

18. The method of claim 17, wherein the one or more preprogrammed patient specific settings stored within the implantable control unit are changed via wireless communication.

19. The method of claim 18, wherein the non-implanted external control unit controls the implantable blood pump to run at a target speed based at least in part on at least one of a patient specific low speed limit of the implantable blood pump and a patient specific set speed limit of the implantable blood pump.

20. The method of claim 1, wherein the implantable control unit is configured to transmit one or more of the preprogrammed patient specific settings stored on the implantable control unit to the non-implanted external control unit in response to a data request transmitted by the non-implanted external control unit to the implantable control unit.