Ventricular assist devices

• US 10,398,819 B2
• Filed: 10/02/2018
• Issued: 09/03/2019
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: TCI, LLC (Allient, Inc.)
• Inventors: Angwin, Denise, Kimball, Brian, Schade, Christian, Kopson, Patrick
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US16/150,150
• Publication Number:
  US 20190030229A1
• Time in Patent Office: 336 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 mechanical circulatory assist system, comprising:

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

an implantable control unit communicatively coupled with the blood pump and storing one or more preprogrammed patient specific settings on which control of the blood pump is based; and

a non-implanted external control unit configured to be operatively coupled with the implantable blood pump and to control the implantable blood pump based on one or more event based rules and at least one of the one or more preprogrammed patient specific settings communicated to the external control unit by the implantable control unit.

2. The mechanical circulatory assist system of claim 1, wherein:

the one or more event based rules comprise one or more event based rules for determining a target speed for the implantable blood pump; and

the non-implanted external control unit controls the implantable blood pump to operate at the target speed.

3. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a target running mode for the implantable blood pump; and

the target speed is set to zero in response to the target running mode for the implantable blood pump being set as stopped.

4. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump and a patient-specific set speed for the implantable blood pump;

when the patient-specific low speed limit is lower than the patient-specific set speed, the target speed is set to the patient-specific low speed limit in response to the implantable blood pump being started up; and

when the patient-specific set speed is lower than the patient-specific low speed limit, the target speed is set to the patient-specific set speed in response to the implantable blood pump being started up.

5. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump; and

the target speed is set to the patient-specific low speed limit in response to the mechanical circulatory assist system detecting that a suction event occurring.

6. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump;

the implantable blood pump comprises a rotor that is rotated to pump blood through the implantable blood pump; and

the target speed is set to the patient-specific low speed limit in response to the mechanical circulatory assist system detecting that instability of the rotor occurring.

7. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump; and

the target speed is set to the patient-specific low speed limit in response to the external control unit determining that a critical power hazard has been active for more than a predetermined period of time.

8. The mechanical circulatory assist system of claim 2, wherein:

the non-implanted external control unit comprises an emergency backup battery for providing backup battery power to power the implantable blood pump;

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump; and

the target speed is set to the patient-specific low speed limit in response to the implantable blood pump being supplied power by the emergency backup battery and a voltage of the emergency backup battery being less than a predetermined voltage.

9. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump and a patient-specific set speed for the implantable blood pump; and

the target speed is maintained at the patient-specific set speed when the patient-specific set speed is lower than the patient-specific low speed limit.

10. The mechanical circulatory assist system of claim 2, wherein:

the one or more preprogrammed patient specific settings comprise a patient-specific low speed limit for the implantable blood pump and a patient-specific set speed for the implantable blood pump; and

the target speed is set to the patient-specific set speed in the absence of any 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; and

the implantable blood pump is running on an emergency backup battery and a voltage of the emergency backup battery is less than a predetermined value.

11. The mechanical circulatory assist system of claim 1, wherein:

the one or more preprogrammed patient specific settings comprise at least one of a patient-specific operating mode for the implantable blood pump and a target running mode for the implantable blood pump;

the one or more event based rules comprise one or more event based rules for determining a target operational mode for the implantable blood pump; and

the non-implanted external control unit controls the implantable blood pump to operate in the target operational mode.

12. The mechanical circulatory assist system of claim 11, wherein the target operational mode is set to continuous in response to the target running mode for the implantable blood pump being set as stopped.

13. The mechanical circulatory assist system of claim 11, wherein the target operational mode is set to continuous in response to the implantable blood pump running on emergency backup battery power.

14. The mechanical circulatory assist system of claim 11, wherein the target operational mode is set to continuous in response to a critical power hazard being active.

15. The mechanical circulatory assist system of claim 11, wherein:

the target operational mode is set to the patient-specific operational mode in the absence of any of the following events;

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

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

a critical power hazard is active.

16. The mechanical circulatory assist system of claim 15, wherein the patient-specific operational mode can be selected to be continuous or pulsatile.

17. The mechanical circulatory assist system of claim 1, wherein the implantable control unit is configured to transmit one or more of the one or more 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.

18. The mechanical circulatory assist system of claim 17, further comprising a system monitor that can be used to change the preprogrammed patient specific settings stored on the implantable control unit.

19. The mechanical circulatory assist system of claim 18, wherein the implantable control unit is configured to transmit one or more of the one or more preprogrammed patient specific settings stored on the implantable control unit to the system monitor in response to a data request transmitted by the system monitor.

20. The mechanical circulatory assist system of claim 1, wherein the implantable control unit is integrally housed with the implantable blood pump.