Method and apparatus to produce, maintain and report information related to patient treatment using medical devices

• US 7,069,085 B2
• Filed: 09/05/2002
• Issued: 06/27/2006
• Est. Priority Date: 09/05/2002
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lindh, Par, Cao, Wei
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): Mullen, Kristen
• Application Number:
  US10/235,176
• Publication Number:
  US 20040049244A1
• Time in Patent Office: 1,391 Days
• Field of Search: 607 30- 32, 607 59- 60, 128/903
• US Class Current: 607/60
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• 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: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system for automating the process of generating reports, such as warranty and registration reports, for programmable medical devices. The system uses a variety of data collecting and checking techniques to make the generator and transmission of such reports more efficient.

Claims

1. A system for creating records related to the use of medical products with particular patients comprising:

a. a plurality of medical products each having machine readable data, said data comprising at least indicia of the type of medical product and indicia of the specific identity of the medical product;

b. at least one apparatus including data, storage, a user interface, an output device and a data reader all in communication with a processor that controls said apparatus based upon a programmed set of instructions;

wherein said storage contains at least user information, patient information, device information, and treatment information, and a plurality of different treatment record formats, said different treatment record formats being associated with different types of medical product, at least some of said information supplied to the storage using said user interface and at least some of said information supplied to said storage using said data reader to read machine readable data from said medical products,

wherein said processor creates a treatment record for a specific medical product by selecting a treatment record format corresponding to the type of said specific medical product and populated fields of the selected treatment record format using said information associated with the specific medical product, and

wherein said processor outputs the created treatment record.

2. The system of claim 1 wherein said apparatus is a network having multiple nodes.

3. The system of claim 2 where a first portion of said storage is located on a first node of network and a second portion of said storage is on a second node of said network.

4. The system of claim 1 wherein said processor outputs said treatment record to at least one device, said device comprising either a display, printer, facsimile machine or computer.

5. A method by which a user of a programmer can generate a registration card of a correct format for a programmable cardiac rhythm management device implanted in a patient, said cardiac rhythm management device having a memory for storing its type, its identity, and parameters with which it has been programmed, said method comprising:

(a) using said programmer to interrogate the memory of a cardiac rhythm management device to determine its type, its identity, and parameters with which it has been programmed;

(b) storing data derived from interrogating the memory of the cardiac rhythm management device in a database, said database also including patient data and user data;

(c) selecting from a set of report formats a correct format for the registration card for said cardiac rhythm management device based upon its type;

(d) inserting into the selected format data stored within said database required to complete the registration card;

(e) prompting the user of the programmer to supply data required to complete the registration card but not contained within said database;

(f) transmitting the registration card.

6. The method of claim 5 wherein the patient data within said database includes information which can be used to identify and contact a patient in whom said programmable cardiac rhythm management device has been implanted.

7. The method of claim 5 wherein said user data within said database includes information which can be used to identify and contact the user.

8. The method of claim 5 wherein said database includes data related to at least one lead used in conjunction with the cardiac rhythm management device.

9. The method of claim 5 wherein said database includes information related to the patient'"'"'s medical condition.

10. The method of claim 5 wherein said database includes information related to medical devices explanted from the patient.

11. The method of claim 5 wherein said transmitted registration card is re-transmitted to a printer which prints the registration card.

12. The method of claim 5 wherein said programmer includes a network interface card.

13. The method of claim 12 wherein said network interface card is used to connect the programmer to a network of devices and the programmer transmits said registration card to at least one other device on the network.

14. A system for generating warranty and registration records related to medical products used to treat patients, at least some of said medical products having a memory in which an indicia of the type of medical product and an indicia of the specific identity of the medical product is stored, said system including:

a. a first database containing a plurality of warranty and registration record formats and at least some of said formats having a plurality of data fields;

b. a second database for storing data related to patients, medical products used to treat the patients, at least one physician who treats the patients, and at least one facility where the patients are treated; and

c. a device that interrogates the memory of a medical product to retrieve from said memory of said medical product said indicia of the type of medical product and said indicia of the specific identity of the medical product, selects a warranty and registration record format from the plurality of record formats stored in the first database based upon at least some of said indicia retrieved from said memory of said medical product, completes fields in the selected warranty and registration record by selecting and using data from the second database to create a warranty and registration record, and transmits said record.

15. The system of claim 14 further including a printer to which said record is transmitted for printing.

16. The system of claim 14 further including a facsimile machine to which said record is transmitted.

17. The system of claim 14 wherein said device is a first node on a network containing a plurality of nodes.

18. The system of claim 17 wherein said first database is stored on a node of the network other than said first node.

19. The system of claim 17 wherein said second database is stored on a node of the network other than said first node.

20. The system of claim 17 wherein said record is transmitted from said first node to at least one other node on said network.

21. The system of claim 14 wherein said first database contains selectable report formats, in addition to said warranty and registration record formats.

22. The system of claim 21 wherein said device can create a report by selecting one of said selectable report formats from said first database and populates at least one data field of said selected report format using data stored in said second database.

23. A system for creating warranty and registration records related to medical products used with particular patients comprising:

a. a plurality of medical products each having machine readable data, said data comprising at least indicia of the type of medical product and indicia of the specific identity of the medical product;

b. at least one apparatus including data, storage, a user interface, an output device and a data reader all in communication with a processor that controls said apparatus based upon a programmed set of instructions;

wherein said storage contains at least user information, patient information, device information, and treatment information, and a plurality of warranty and registration record formats, each of said warranty and registration record formats being associated with a type of medical product and having a plurality of data fields, at least some of said information supplied to the storage using said user interface and at least some of said information supplied to said storage using said data reader to read machine readable data from said medical products,

wherein said processor creates a warranty and registration record for a specific medical product by selecting the warranty and registration record format corresponding to the type of said specific medical product and populating fields of the selected warranty and registration report format using said information associated with the specific medical product, and

wherein said processor outputs said warranty and registration record.

24. The system of claim 23 wherein said storage contains selectable report formats, in addition to said warranty and registration record formats.

25. The system of claim 24 wherein said apparatus can create a report by selecting one of said selectable report formats and populates at least one of said plurality of data fields of said selected report formation using said information in said storage.

26. The system of claim 23 wherein said apparatus is a network having multiple nodes.

27. The system of claim 26 wherein a first portion of said storage is located in a first node of said network and second portion of said storage is located on a second node of said network.

28. The system of claim 23 wherein said processor outputs said warranty and registration record to at least one device, said device comprising either a display, a printer, a facsimile machine or a computer.

29. The system of claim 23 wherein said indicia of the type of medical product and the indicia of the specific identity of the medical product are both contained within a serial number of the product.

30. The system of claim 23 wherein said indicia of the type of medical product is a model number and said indicia of the specific identity of the medical product is a serial number.

31. The system of claim 23 further including a printer for printing said output warranty and registration record generated by said processor.

32. The system of claim 23 wherein said user interface allows a user to add data to or edit certain data contained in the storage.

33. The system of claim 32 wherein said user interface prompts the user to supply additional data when information not already in the storage is required to complete a field of the selected warranty and registration record.

34. The system of claim 23 wherein said medical products are implantable medical products.

35. The system of claim 34 wherein said implantable medical products are cardiac rhythm management devices.

36. The system of claim 34 wherein said apparatus is an external programmer for said implantable medical products.

37. The system of claim 36 wherein said external programmer is a node on a network containing a plurality of nodes and said external programmer can transfer the warranty and registration records it generates to at least one other node on said network.

38. The system of claim 23 wherein said apparatus is part of a network of devices and is capable of transferring the warranty and registration records it generates to other network devices.

39. The system of claim 23 wherein at least one of said medical products is programmable.

40. The system of claim 23 wherein said apparatus outputs warranty and registration records it generates to a facsimile machine.

41. The system of claim 23 wherein said user information contains data related to at least one facility where patients are treated.

42. The system of claim 23 wherein said storage contains data related to at least one physician who treats said patients.