Dual communication interface for artificial heart system

• US 7,794,384 B2
• Filed: 12/07/2007
• Issued: 09/14/2010
• Est. Priority Date: 12/07/2007
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: Terumo Heart, Inc. (Terumo Corporation)
• Inventors: Medvedev, Alexander, Sugiura, Naoya
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US11/999,858
• Publication Number:
  US 20090149951A1
• Time in Patent Office: 1,012 Days
• Field of Search: 600 16- 17, 607 30- 32, 607/60, 340/539.12, 623/3.1, 623/3.13
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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 60/515 Regulation using real-time patient data
• 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 60/876 Implantable batteries

Abstract

An artificial heart pump system has a heart pump implanted in a patient. A pump control unit worn by a patient includes a programmable device for adapting a secure aspect of heart pump operation in response to pump operating commands. The pump control unit has a wired interface and a wireless interface. A clinical external unit is adapted to be connected to the wired interface for delivering a pump operating command to the pump control unit. An auxiliary external unit is adapted to be connected to the wireless interface for collecting patient and/or pump system performance-related data from the pump control unit. The wireless interface is unable to consummate a pump operating command.

Claims

1. An artificial heart pump system in which a heart pump is implanted in a patient, comprising:

a pump control unit to be worn by a patient including a programmable device for adapting a secure aspect of heart pump operation in response to pump operating commands, wherein the pump control unit has a wired interface and a wireless interface;

a clinical external unit adapted to be connected to the wired interface for delivering a pump operating command to the pump control unit; and

an auxiliary external unit adapted to be connected to the wireless interface for collecting performance-related data from the pump control unit, wherein the wireless interface is unable to consummate a pump operating command;

wherein the wireless interface is two-way, wherein the pump control unit further includes a first transceiver, wherein at least one of the external units includes a second transceiver, wherein the programmable device determines presence of the at least one external unit by operating the wireless interface in a polling mode, wherein the programmable device operates the wireless interface in a data transfer mode in response to detecting presence of the at least one external unit, wherein the programmable device disables the receiving functionality of the first transceiver during the data transfer mode, and wherein the programmable device automatically sends the performance-related data over the wireless interface when in the data transfer mode; and

wherein the at least one external unit detects an incomplete transmission of performance-related data, wherein the at least one external unit includes an alerting indicator for indicating the occurrence of the incomplete transmission, wherein the pump control unit includes a reset element for being manually activated in response to the indication by the alerting indicator, and wherein the programmable device returns the wireless interface to the polling mode in response to the manual activation.

2. The system of claim 1 further comprising:

a centralized data management system in communication with at least one of the external units for receiving performance-related data for analysis by a health care professional.

3. The system of claim 2 wherein the clinical external unit is connected to the wireless interface for collecting the performance-related data, and wherein the centralized data management system is further in communication with a plurality of other wireless interfaces for other pump control units in a health care facility.

4. The system of claim 2 wherein the auxiliary external unit is remotely located from the centralized data management system, and wherein the auxiliary unit is in communication with the centralized data management system via a data network connection for transmitting the performance-related data.

5. The system of claim 2 wherein the auxiliary external unit is remotely located from the centralized data management system, and wherein the auxiliary unit is in communication with the centralized data management system via a telephone network connection for transmitting the performance-related data.

6. The system of claim 2 wherein the auxiliary external unit is remotely located from the centralized data management system, and wherein the auxiliary unit is comprised of a smart phone device in communication with the centralized data management system via a wireless cellular network connection for transmitting the performance-related data.

7. An artificial heart pump system in which a heart pump is implanted in a patient, comprising:

a pump control unit to be worn by a patient including a programmable device for adapting a secure aspect of heart pump operation in response to pump operating commands, wherein the pump control unit has a wired interface and a wireless interface;

a clinical external unit adapted to be connected to the wired interface for delivering a pump operating command to the pump control unit; and

an auxiliary external unit adapted to be connected to the wireless interface for collecting performance-related data from the pump control unit, wherein the wireless interface is unable to consummate a pump operating command;

wherein the pump control unit further includes a one-way transmitter for the wireless interface operable in a polling mode or a data transfer mode, wherein at least one of the external units includes a receiver and an acknowledgement indicator to indicate detection by the receiver of the polling mode, wherein the programmable device initiates operation of the wireless interface in the polling mode, wherein the pump control unit includes a start element coupled to the programmable device for being manually activated in response to the indication by the acknowledgement indicator, and wherein the programmable device operates the wireless interface in the data transfer mode in response to the manual activation of the start element; and

wherein the at least one external unit detects an incomplete transmission of performance-related data, wherein the at least one external unit includes an alerting indicator for indicating the occurrence of the incomplete transmission, wherein the pump control unit includes a reset element for being manually activated in response to the indication by the alerting indicator, and wherein the programmable device returns the wireless interface to the polling mode in response to the manual activation.

8. A method of operating an artificial heart pump system in which a heart pump is implanted in a patient, comprising the steps of:

providing pump operating commands to a pump control unit to be worn by a patient, wherein the pump control unit includes a programmable device for adapting a secure aspect of heart pump operation in response to the pump operating commands, wherein the pump control unit has a wired interface for receiving the pump operating commands from a clinical external unit, and wherein the pump control unit has a two-way wireless interface including a first transceiver;

the programmable device collecting performance-related data in response to the heart pump operation;

operating the wireless interface of the pump control unit in a polling mode to determine presence of either the clinical external unit or an auxiliary external unit having a second transceiver that responds to the polling mode;

operating the wireless interface of the pump control unit in a data transfer mode in response to detection of one of the external units to automatically send the performance related data, wherein the data transfer mode includes disabling the receiving functionality of the first transceiver;

detecting an incomplete transmission of performance-related data;

indicating the occurrence of the incomplete transmission by activating an alerting element of the one external unit;

manually activating a reset element of the pump control unit in response to the indication by the alerting element; and

returning the wireless interface to the polling mode in response to the manual activation.

9. The method of claim 8 further comprising the step of:

transmitting performance-related data from the detected external unit to a centralized data management system for analysis by a health care professional to determine the pump operating commands.