Remote delivery of software-based training for implantable medical device systems

• US 6,386,882 B1
• Filed: 11/10/1999
• Issued: 05/14/2002
• Est. Priority Date: 11/10/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Linberg, Kurt R.
• Primary Examiner(s): Martin-Wallace, Valencia
• Assistant Examiner(s): ADAMS, CHANDA L
• Application Number:
  US09/437,615
• Time in Patent Office: 916 Days
• Field of Search: 434/262, 434/267, 434/272, 607/32
• US Class Current: 434/262
• CPC Class Codes: G09B 23/30 Anatomical models G09B23/281 - G09B23/288 take precedence
• CPC Class Codes: G09B 5/00 Electrically-operated educational appliances working with questions and answers G09B7/00; simulators G09B9/00; advertising or displaying in general G09F
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04M 11/022 Paging systems personal calling arrangements or devices G08B3/1008; selective calling networks H04W84/022

Abstract

A system and method for remote delivery of software-based simulated training and certification for technicians/operators involved in the management of programmers, programmer-IMD interface and related procedures is disclosed. Preferably a web-based expert data center directs the software-based simulated training and certification which is remotely imported to a programmer. The programmer or equivalent device is coupled to the web-based expert data center via preferably one of many data communication systems. A set of skill-based training activities corresponding to a plurality of software applications on the programmer is accessible from the programmer. The operator issues a training request from the programmer to the expert data center for a specific software application. The expert data center builds a simulated training module based on the operator'"'"'s request, and returns the training module to the programmer. The training module executes a simulated skill-based training corresponding to the operator'"'"'s desired software application. Upon completion of the training module, the training results are analyzed. Thereafter, certification may be issued if the operator scores a passing grade on a test at the end of the training. The training results and certification information are archived on the computer, and the certification is electronically transmitted to a certification authority. Upon certification, the operator is granted access to use the specific software application through an authorization key.

Claims

1. An interactive medical device operations training system comprising:

a remote expert data center, said expert data center including training management software and databases for remotely administering skill-based training of an operator for an implanted medical device programmer;

a programmer for use at a patient location and adapted to be in data communication with a medical device implanted in a patient, said programmer serving to manage the operation of the implanted medical device including acquisition of patient data through a plurality of software applications resident on the programmer and having training software operable with a skill-based simulation module for supervising training of an operator in the use of the resident software applications; and

a bi-directional communications link establishing operable data communications between the programmer and the remote expert data center including a request for training issued by the programmer and the servicing of the request by the expert data center.

2. The system of claim 1, wherein the skill-based simulation module resides in the remote expert data center and is downloaded therefrom to the programmer over the bi-directional communications link in servicing a training request.

3. The system of claim 1, wherein the IMD is in data communications with to the programmer such that the programmer acquires the patient data from the IMD.

4. The system of claim 1, wherein the bi-directional link is a telephone line.

5. The system of claim 1, wherein the bi-directional communications link is an intranet.

6. The system of claim 1, wherein the bi-directional communications link is an internet.

7. The system of claim 1, wherein bi-directional communications link is a satellite.

8. The system of claim 1, wherein the bi-directional communications link is a global positioning system.

9. The system of claim 1, wherein the bi-directional communications link includes at least two communication links selected from the group of communication links consisting of a telephone line, an intranet, an internet link, a satellite, a laser waveform, and a global positioning system.

10. The system of claim 1, wherein the skill-based simulation module resides in the programmer.

11. The system of claim 1, wherein the remote expert data center further comprises:

a database of authorized operator accounts and certification information;

an authenticator module for authenticating an operator training request;

a training module processor for processing the authenticated operator training request and generating an interactive training module corresponding to at least one skill-based simulation module, the interactive training module including a list of the software applications residing on the programmer; and

a certification processor for processing, distributing, and archiving operator certification information generated by the programmer.

12. The system of claim 11, wherein the remote data center further comprises:

an application enabler for enabling operator access to the software application, residing within the interactive training module processor of the remote data center, when the operator has achieved certification on the software application.

13. The system of claim 11, wherein the programmer further comprises:

a training request generator for generating an operator training request, and for transmitting the operator training request to the remote data center;

a trainer module for receiving and executing the training module generated by the remote data center;

a certificate generator for evaluating a performance of an operator on the training module and generating operator certification data if the performance of the operator on the training module exceeds a pre-defined performance criteria; and

a certificate distributor for distributing the operator certification data to a certification authority.

14. The system of claim 13, wherein the certification authority is the remote data center.

15. The system of claim 13, wherein the location of the certification authority is independent and separately located from the remote data center.

16. The system of claim 13, wherein the location of the certification authority is an electronic mail address.

17. A method for remote delivery of an interactive training software package for operations of a programmer used in conjunction with IMDs, wherein a remote data center for managing the interactive training software package is linked to the programmer via a data communication network link, and wherein at least one skill-based simulated training software program for training a technician in at least one programmer software application is accessible to the programmer, the method comprising:

connecting the programmer to the remote data center via the data communications network link;

authenticating the technician of the programmer as an authorized training candidate for the simulated training software program;

selecting a training module on the remote data center corresponding to the software program upon which the technician desires training;

transferring the training module from the remote data center to the programmer via the data communications network;

executing the set of at least one skill-based simulated training software corresponding to the training module selected on the remote data center;

generating a set of training results for the technician upon completion of the training module;

analyzing the training results for the technician;

certifying the technician as an authorized operator of the software application if the technician'"'"'s training test scores exceed a pre-defined performance threshold;

transmitting the training results from the programmer to the remote data center;

forwarding the technician'"'"'s certification to an appropriate certification authority;

archiving the technician'"'"'s certification in a database on the remote data center; and

issuing an authorization key from the remote data center to the programmer to allow the technician to perform procedures on the programmer for the software application.

18. The method of claim 17, wherein the at least one skill-based simulated training software program is located on the programmer.

19. The method of claim 17, wherein the at least one skill-based simulated training software program is located on the remote data center.

20. The method of claim 17, wherein the at least one skill-based simulated training software program is located on the programmer and the remote data center.

21. The method of claim 17, wherein the programmer'"'"'s in operable data communications with a certification authority.

22. The method of claim 17, wherein the data communications network is a telephone line.

23. The method of claim 17, wherein the data communications network is an intranet.

24. The method of claim 17, wherein the data communications network is an internet.

25. The method of claim 17, wherein the data communications network is a satellite.

26. The method of claim 17, wherein the data communications network is a global positioning system.

27. The method of claim 17, wherein the data communications network includes at least two communication links selected from the group of communication links consisting of a telephone line, an intranet, an internet, a satellite, a laser wave form, and a global positioning system.

28. The method of claim 17, wherein the step of forwarding the operator certification to an appropriate certification authority is performed by the programmer.

29. The method of claim 17, wherein the step of forwarding the operator certification to an appropriate certification authority is performed by the remote data center.

30. The method of claim 17, and further comprising:

enabling operator access to the software application upon presentation of the authorization key by the operator.

31. The method of claim 17, and further comprising:

disabling operator access to the medical device software application if the operator has not successfully achieved certification on a corresponding training module.

32. A bi-directional communications link integrated with a remote web-based expert data center, wherein a programmer for an IMD is uplinked to the web-based expert data center via the bi-directional communications system, wherein remote delivery of an interactive simulated software-based training for managing the programmer is effected by importing the software-based training from the expert data center to the programmer via the bi-directional communications link, and wherein at least one skill-based training software program for training a technician to acquire proficiency in at least one software application residing on the programmer, is accessible via the programmers, the system comprising:

means for connecting the programmer to the expert data center via the bi-directional communications link;

means for authenticating the technician of the programmer as an authorized training candidate for the software application;

means for selecting a training module on the remote data center corresponding to the software application upon which the technician desires training;

means for transferring the training module from the remote data center to the programmer via the bi-directional communications link;

means for executing the at least one skill-based activity on the programmer corresponding to the training module selected on the expert data center;

means for generating a set of training results for the technician upon completion of the training module;

means for analyzing the training results for the technician;

means for certifying the technician as an authorized technician of the programmer software application if the technician'"'"'s training results exceed a pre-defined performance threshold;

means for transmitting the training results for the technician from the programmer to the remote data center;

means for forwarding the technician'"'"'s certification to an appropriate certification authority;

means for archiving the technician certification in a database on the computer; and

means for issuing an authorization key from the remote data center to the programmer for the technician who has successfully achieved certification for the software application.

33. The system of claim 32, wherein the programmer operates a multiplicity of implantable devices.

34. The system of claim 32, wherein the system further comprises:

means for enabling technician access to the software application on the programmer upon presentation of the authorization key by the operator.

35. The system of claim 32, and further comprising:

means for disabling the technician'"'"'s access to the programmer software application if the technician has not successfully achieved certification on a corresponding training module.

36. A computer implemented interactive training software system for remote delivery of software-based certification for operating/managing a programmer used in conjunction with an implantable medical device, the system comprising:

a remote data center for managing the software-based training;

a bi-directional communications link;

a programmer coupled to the remote data center via the information bi-directional communications link network link, wherein the programmer directs and monitors the acquisition of patient data through a plurality of software applications; and

at least one skill-based certification software program for certifying a technician of the programmer in the operation of the plurality of software applications.

37. The system of claim 36, wherein the at least one skill-based certification program resides on the remote data center.

38. The system of claim 36, wherein the IMD is in data communications with the programmer such that the programmer acquires the patient data from the IMD.

39. The system of claim 36, wherein the bi-directional communications link is a telephone line.

40. The system of claim 36, wherein the bi-directional communications link is an intranet.

41. The system of claim 36, wherein the bi-directional communications link is an internet.

42. The system of claim 36, wherein the bi-directional communications link is a satellite.

43. The system of claim 36, wherein the bi-directional communications link is a global positioning system.

44. The system of claim 36, wherein the information network link includes at least one communication link selected from the group of communication links consisting of a telephone line, an intranet, an internet, a satellite, a laser waveform, and a global positioning system.

45. The system of claim 36, wherein the set of at least one skill-based certification program resides on the programmer.

46. The system of claim 45, wherein the remote data center further comprises:

a database of authorized operator accounts and certification information;

an authenticator module for authenticating an operator training request;

a certification processor for processing the authenticated operator training request and generating a certification module corresponding to at least one software applications, the certification module including a selected list of the at least one skill-based activities residing on the programmer; and

a certification distributor for distributing and archiving operator certification information generated by the programmer.

47. The system of claim 46, wherein the remote data center further comprises:

an application enabler for enabling the technician to access the software application residing within a certification processor in the remote data center when the technician has achieved certification on the software application.

48. The system of claim 36, wherein the programmer further comprises:

a training request generator for generating a technician training request, and for transmitting the request to the remote data center;

a trainer module for receiving and executing the training module generated by the remote data center;

a certificate generator for evaluating a performance of the technician on the training module and generating technician certification data if the performance of the technician on the training module or exceeds a pre-defined performance criteria; and

a certificate distributor for transmitting the technician'"'"'s certification data to a certification authority.

49. The system of claim 48, wherein the certification authority is the remote data center.

50. The system of claim 48, wherein the location of the certification authority is independent of the remote data center and globally located elsewhere.

51. The system of claim 48, wherein the location of the certification authority is an electronic mail address.

52. A method for remote delivery of an interactive software-based certification document to certify trained manager'"'"'s in the operations of a programmer used in conjunction with IMDs wherein a remote data center for managing the software-based certification is linked to the programmer via a bi-directional communications link, and wherein at least one skill-based certification software program for certifying a technician for a specific software application for controlling and monitoring the programmer is downloaded to the programmer, the method comprising:

connecting the programmer to the remote medical device via the bi-directional communications link;

authenticating the technician of the programmer as an authorized certification candidate for the software application;

selecting a certification module on the remote data center corresponding to the software application upon which the technician desires certification;

transferring the certification module from the remote data center to the programmer via the bi-directional communications link;

executing the set of at least one skill-based activities corresponding to the certification module selected on the remote data center;

generating a set of training results for the technician upon completion of the certification module;

analyzing the certification results for the technician;

certifying the operator as an authorized technician of the software application if the technician'"'"'s certification results exceed a pre-defined performance threshold;

transmitting the certification results for the technician from the programmer to the remote data center;

forwarding the technician certification to an appropriate certification authority;

archiving the technician certification in a database on the remote data center; and

issuing an authorization key from the remote data center to the programmer for the technician.

53. The method of claim 52, wherein the at least one skill-based certification software-based program is located on the programmer.

54. The method of claim 52, wherein the set of at least one skill-based certification software-based program is located on the remote data center.

55. The method of claim 52, wherein the set of at least one skill-based certification software-based program is located on the programmer and the remote data center.

56. The method of claim 52, wherein the programmer is in direct data communications with the certification authority.

57. The method of claim 52, wherein the information network link is a telephone line.

58. The method of claim 52, wherein the information network link is an intranet.

59. The method of claim 52, wherein the information network link is an internet.

60. The method of claim 52, wherein the information network link is a satellite.

61. The method of claim 52, wherein the information network link is a global positioning system.

62. The system of claim 52, wherein the bi-directional communications link includes at least two communication links selected from the group of communication links consisting of a telephone line, an intranet, an internet, a satellite, a laser waveform, and a global positioning system link.

63. The method of claim 52, wherein the step of forwarding the technician'"'"'s certification to an appropriate certification authority is performed by the programmer.

64. The method of claim 52, wherein the step of forwarding the technician'"'"'s certification to an appropriate certification authority is performed by the remote data center.

65. The method of claim 52, and further comprising:

enabling the technician'"'"'s access to the software application upon presentation of the authorization key by the operator.

66. The method of claim 52, and further comprising:

disabling access to the programmer software application if the technician has not successfully achieved certification on a corresponding training module.

67. A system for remote delivery of a software-based certification for operating/managing a programmer, wherein a remote data center monitors the software-based certification and is in operable data communications with the programmer via a bi-directional communications link, and wherein at least one skill-based interactive software program is implemented for certifying an operator after training and testing on at least one software application residing on the programmer, the system comprising;

means for authenticating the operator of the programmer as an authorized certification candidate for the software application;

means for selecting a certification module on the remote data center corresponding to the software application upon which the operator desires certification;

means for transferring the training module from the remote data center to the programmer via the bi-directional communications link;

means for executing the at least one skill-based activity on the programmer corresponding to the certification module selected on the remote data center;

means for generating a set of certification results for the operator upon completion of the certification module;

means for analyzing the certification results for the operator;

means for certifying the operator as an authorized operator of the software application if the operator'"'"'s test results exceed a pre-defined performance threshold;

means for transmitting the certification results for the operator from the medical device to the remote data center;

means for forwarding the operator certification to an appropriate certification authority;

means for archiving the operator certification in a database on the remote data center; and

means for issuing an authorization key from the remote data center to the programmer to permit the operator, who has successfully achieved certification, access to the software application.

68. The system of claim 67, wherein the programmer is in direct data communications with the certification authority.

69. The system of claim 67, wherein the system further comprises:

means for enabling operator access to the software application on the programmer upon presentation of the authorization key by the operator.

70. The system of claim 67 further comprising:

disabling the operator'"'"'s access to the programmer software application if the operator has not successfully achieved certification on a corresponding training module.