Managing data for clinical protocols relating to the use of active implantable medical devices

• US 7,027,870 B2
• Filed: 04/23/2002
• Issued: 04/11/2006
• Est. Priority Date: 04/23/2001
• Status: Expired due to Fees

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Limousin, Marcel, Nitzsche, Remi
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/132,057
• Publication Number:
  US 20020169488A1
• Time in Patent Office: 1,449 Days
• Field of Search: 607/59, 607/31
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

A process for managing data collection for clinical protocols and investigations (registry) relating to the use of active implantable medical devices, such as pacemaker, cardiovertor, defibrillator and multisite devices. This process is characterized by the following stages:

• 1) preliminarily initializing a plurality of implants, by writing, in a protocol identification zone provided in a memory of the implant, a protocol identification code common to all the aforementioned implants taking part in the given clinical protocol, and
• 2) at each interrogation of any implant by a practitioner by use of a compatible programmer:
  • a) searching for a protocol identification zone in the memory of the implant and reading the contents thereof,
  • b) determining the presence of a protocol identification code in that zone,
  • c) in the event of presence of a protocol identification code:
    • c1) recognizing the protocol identification code by the programmer,
    • c2) displaying on a screen of the programmer an appropriate questionnaire for the protocol identified by the aforementioned code,
    • c3) capturing answers to that the questionnaire input by a practitioner using the programmer, and
    • c4) memorizing these answers in a memory of the programmer.

Claims

1. A process for managing data collection for clinical protocols having as a subject the use of an implant of an active implantable medical device type, such as a pacemaker, a defibrillator, a cardiovertor and/or a multisite device, comprising:

a) initializing preliminarily a plurality of implants taking part in a clinical protocol and having a protocol identification zone by writing a protocol identification code in said protocol identification zone common to said plurality of implants;

b) providing a programmer having a memory and a display screen, said programmer being able to interrogate at least one of said implants;

c) interrogating an implant using said programmer and, at each interrogation;

i) searching for a protocol identification zone in said memory of the implant and reading the contents thereof,

ii) determining a presence of a protocol identification code in said protocol identification zone contents, and

iii) in the event of a detected protocol identification code;

recognizing the protocol identification code using the programmer,

displaying on said programmer screen a questionnaire associated with the identified protocol identification code,

capturing answers to that questionnaire using the programmer, and

memorizing said answers in said programmer memory.

2. The process of claim 1, further comprising, in the event of a presence of a protocol identification code, the steps of:

reading, using the programmer, one of a parameter setting data and a Holter data contained in the implant memory, and

memorizing said read data in the memory of the programmer jointly with the captured answers to the questionnaire.

3. The process of claim 1, further comprising, in the event of a presence of a protocol identification code, displaying on the programmer screen a text message representative of one of a reminder message of a complementary examination to carry out and an informative message about a next stage of protocol.

4. The process of claim 1, wherein stage a) further comprises reading in the implant memory a date corresponding to one of an implantation date and a date of the last interrogation of the implant, wherein displaying the questionnaire is conditioned by said date.

5. The process of claim 1, further comprising memorizing said questionnaire in the implant memory, and wherein stage c) further comprises reading said questionnaire in said implant memory and displaying said questionnaire.

6. A process for managing a registry data on the use of active implantable medical device implants, such as a pacemaker, a defibrillator, a cardiovertor and/or a multisite device, comprising:

a) providing an implant taking part in a registry and having a memory, said memory having an identification zone containing a content;

b) providing a programmer having a telemetry function for reading said implant memory, a display screen for displaying information, and a memory, said memory containing a questionnaire associated with an implant identification content;

c) successively interrogating an implant using said programmer, and on each interrogation of an implant;

i) reading in the implant memory the contents of the identification zone of the implant model,

ii) recognizing of the implant model in response to the read identification zone contents,

iii) displaying on the programmer screen said questionnaire associated with said recognized implant model,

iv) inputting answers to that said questionnaire using said programmer, and

v) memorizing said answers in the programmer memory.

7. The process of claim 6, wherein said implant memory further comprises one of parameter setting data and Holter data and the process further comprises:

d) reading, using the programmer, said one of the parameter setting data and the Holter data contained in the implant memory, and

e) memorizing in the programmer memory said read data jointly with the answers to the questionnaire.

8. The process of claim 6, further comprising, in response to a recognized implant model code, displaying on the programmer screen one of a reminder message to carry out a complementary examination and an informative message about a next interrogation of the implant.

9. The process of claim 6, wherein stage a) further comprises reading in the implant memory one of an implantation date and a date of the last interrogation of said implant, wherein displaying the questionnaire at stage c) is conditioned by said at least one read date.

10. The process of claim 6, further comprising storing said questionnaire in the implant memory wherein stage c) further comprises reading in said implant memory the questionnaire to be displayed.

11. A process for managing data collection for clinical protocols having as a subject the use of an implant of an active implantable medical device type, such as a pacemaker, a defibrillator, a cardiovertor and/or a multisite device, comprising:

a) initializing preliminary a plurality of implants having a protocol identification zone by writing a protocol identification code in said protocol identification zone common to said plurality of implants taking part in said protocol;

b) providing a programmer having a memory and a display screen, said programmer being able to interrogate at least one of said implants;

c) interrogating an implant using said programmer and, at each interrogation;

i) searching for a protocol identification zone in said memory of the implant and reading the contents thereof,

ii) determining a presence of a protocol identification code in said protocol identification zone contents, and

iii) in the event of a detected protocol identification code;

recognizing the protocol identification code using the programmer,

displaying on said programmer screen a questionnaire associated with the identified protocol identification code,

capturing answers to that questionnaire using the programmer,

memorizing said answers in said programmer memory,

reading, using the programmer, one of a parameter setting data and a Holter data contained in the implant memory,

memorizing said read data in the memory of the programmer jointly with the captured answers to the questionnaire,

periodically aggregating for a secondary processing the answers and said one of the parameter setting data and the Holter data for said plurality of implants taking part in said protocol, and

memorizing said periodically aggregated data in one of a programmer and a plurality of programmers.

12. A process for managing data collection for clinical protocols having as a subject the use of an implant of an active implantable medical device type, such as a pacemaker, a defibrillator, a cardiovertor and/or a multisite device, comprising:

a) initializing preliminary a plurality of implants having a protocol identification zone by writing a protocol identification code in said protocol identification zone common to said plurality of implants taking part in said protocol;

b) providing a programmer having a memory and a display screen, said programmer being able to interrogate at least one of said implants;

c) interrogating an implant using said programmer and, at each interrogation;

i) searching for a protocol identification zone in said memory of the implant and reading the contents thereof,

ii) determining a presence of a protocol identification code in said protocol identification zone contents, and

iii) in the event of a detected protocol identification code;

recognizing the protocol identification code using the programmer,

displaying on said programmer screen a questionnaire associated with the identified protocol identification code,

capturing answers to that questionnaire using the programmer,

memorizing said answers in said programmer memory,

periodically aggregating for a secondary processing the answers for said plurality of implants taking part in said protocol; and

memorizing said periodically aggregated data in one of a programmer and a plurality of programmers.

13. A process for managing a registry data on the use of active implantable medical device implants, such as a pacemaker, a defibrillator, a cardiovertor and/or a multisite device, comprising:

a) providing an implant having a memory, said memory having an identification zone containing a content, and further comprising one of parameter setting data and Holter data;

b) providing a programmer having a telemetry function for reading said implant memory, a display screen for displaying information, and a memory, said memory containing a questionnaire associated with an implant identification content;

c) successively interrogating an implant using said programmer, and on each interrogation of an implant;

i) reading in the implant memory the contents of the identification zone of the implant model,

ii) recognizing of the implant model in response to the read identification zone contents,

iii) displaying on the programmer screen said questionnaire associated with said recognized implant model,

iv) inputting answers to that said questionnaire using said programmer,

v) memorizing said answers in the programmer memory,

vi) reading, using the programmer, said one of the parameter setting data and the Holter data contained in the implant memory,

e) memorizing in the programmer memory said read data jointly with the answers to the questionnaire, and

f) periodically aggregating said questionnaire answers and said read data for a plurality of implants memorized in a programmer or a plurality of programmers for secondary treatment.

14. A process for managing a registry data on the use of active implantable medical device implants, such as a pacemaker, a defibrillator, a cardiovertor and/or a multisite device, comprising:

a) providing an implant having a memory, said memory having an identification zone containing a content;

b) providing a programmer having a telemetry function for reading said implant memory, a display screen for displaying information, and a memory, said memory containing a questionnaire associated with an implant identification content;

c) successively interrogating an implant using said programmer, and on each interrogation of an implant;

i) reading in the implant memory the contents of the identification zone of the implant model,

ii) recognizing of the implant model in response to the read identification zone contents,

iii) displaying on the programmer screen said questionnaire associated with said recognized implant model,

iv) inputting answers to that said questionnaire using said programmer,

v) memorizing said answers in the programmer memory;

vi) periodically aggregating said questionnaire answers relating to a plurality of implants memorized in a programmer or a plurality of programmers for secondary treatment.