Sterilizable hand-held programmer/interrogator

• US 5,311,449 A
• Filed: 03/25/1991
• Issued: 05/10/1994
• Est. Priority Date: 03/25/1991
• Status: Expired due to Term

• Current Assignee: Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Angeion Corporation (Niterra Co., Ltd.)
• Inventors: Adams, Theodore P.
• Primary Examiner(s): Teska, Kevin J.
• Assistant Examiner(s): CHOI, KYLE JAEHUN
• Application Number:
  US07/674,132
• Time in Patent Office: 1,142 Days
• Field of Search: 364/413.01, 364/413.02, 364/413.27, 364/514, 364/708, 128/419 PT, 128/419 PG
• US Class Current: 340/10.51
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G06F 15/025 adapted to a specific application

Abstract

Sterilizable hand-held programmer/interrogator for communication with an implanted defibrillator, including follow-up. An electromechanical key allows the programmer/interrogator to function fully as a data programmer and as a data interrogator. A removable electromechanical key controlled by a surgeon allows a limited number of programmable functions and only a certain amount of data to be revealed when the device is interrogated by the patient. Interrogated data from the programmer/interrogator can be linked directly to the surgeon via a modem.

Claims

1. A sterilizable hand-held programmer/interrogator for communicating with an implanted medical device in a sterile environment comprising:

a sealed housing having dimensions such that the housing is small enough to be hand-held, the sealed housing including;

processor means for controlling the operation of the programmer/interrogator;

transceiver means connected to the processor means for transmitting and receiving data between the programmer/interrogator and the implanted medical device;

memory means connected to the processor means for storing control algorithms for the processor means and data communicated with the implanted device;

display means connected to the processor means for displaying operating information for the programmer/interrogator and data communicated with the implanted device; and

switch pad means connected to the processor means for manually providing control and data information to the programmer/interrogator,

such that the programmer/interrogator is sterilizable prior to use within the sterile environment to allow the programmer/interrogator to be used during the implantation of the implantable device in order to directly communicate with and program the implantable device without physically connecting the programmer/interrogator to another device.

2. The programmer/interrogator of claim 1 further comprising:

port means connected to the processor means for providing communication with other processors via a cable connected to the port means either before or after the implantable device is implanted in the patient; and

key means insertable into the port means while the programmer/interrogator is being used during the implantation of the implantable device for enabling a full operation mode of the programmer/interrogator, the key means also being sterilized prior to use within the sterile field.

3. The programmer/interrogator of claim 2 wherein removal of the key means from the port means disables the full operation mode of the programmer/interrogator and permits only a limited interrogation mode of operation of the programmer/interrogator.

4. The programmer/interrogator of claim 3 wherein the programming algorithms analyze the data communicated from the implanted device and provide a diagnostic code to be communicated to a physician when the programmer/interrogator is operating in the interrogation mode.

5. The programmer/interrogator of claim 1 further comprising:

automatic modem means for providing telephonic communication between the programmer/interrogator and a remote processor, including;

a body having a means for receiving the programmer/interrogator;

means for connecting the automatic modem means to the port means of the programmer/interrogator;

means for connecting the automatic modem means to a telephone line; and

means for automatically controlling the transfer of data from the memory means of the programmer/interrogator to the remote processor.

6. A method for communicating with an implanted medical device in a sterile environment, the method comprising the steps of:

(a) providing a programmer/interrogator in a sealed housing having dimensions such that the housing is small enough to be hand-held;

(b) sterilizing the programmer/interrogator prior to use within in the sterile environment;

(c) using the programmer/interrogator to directly communicate with and program the implantable device within the sterile environment during an implantation of the implanted device without physically connecting the programmer/interrogator to another device.

7. The method of claim 6 wherein the programmer/interrogator includes within the sealed housing:

a processor that controls the operation of the programmer/interrogator;

a transceiver connected to the processor to transmit and receive data between the programmer/interrogator and the implanted medical device;

a memory connected to the processor to store control algorithms for the processor and data communicated with the implanted device;

a display connected to the processor for displaying operating information for the programmer/interrogator and data communicated with the implanted device;

a communication port connected to the processor that provides for communication with other processors via a cable connected to the port; and

a switch pad connected to the processor for manually providing control and data information to the programmer/interrogator.

8. The method of claim 7 wherein step (c) comprises the steps of:

(c1) sterilizing a key that enables a full operation mode of the programmer/interrogator;

(c2) inserting the key into the communication port prior to using the programmer/interrogator during the implantation of the implantable device; and

(c3) using the programmer/interrogator in the full operation mode to directly communicate with and program the implantable device within the sterile environment during the implantation of the implanted device.

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

(c4) removing the key from the programmer/interrogator after the implantation of the implanted device; and

(c5) providing the programmer/interrogator to the patient such that the programmer/interrogator operates in only a limited interrogation mode operable by the patient.

10. The method of claim 9 wherein the limited interrogation mode of step (c5) comprises the steps of:

(c51) communicating with the implanted device to receive data from the implanted device;

(c52) analyzing the data from the implanted device; and

(c53) providing diagnostic information to be communicated to a physician.

11. The method of claim 10 wherein step (c53) is accomplished by displaying a diagnostic code on the display.

12. The method of claim 9 further comprising the steps of:

(c6) using the programmer/interrogator to communicate with the implanted device to receive data from the implanted device;

(c7) storing the data in the memory of the programmer/interrogator;

(c7) providing a modem separate from the programmer/interrogator for establishing telephonic communication between the programmer/interrogator and a remote processor; and

(c8) automatically controlling the transfer of data from the memory of the programmer/interrogator to the remote processor.

13. A method for allowing two separate users to communicate with an implanted medical device, the method comprising the steps of:

(a) providing a programmer/interrogator that directly communicate with and program the implantable device during an implantation of the implanted device without physically connecting the programmer/interrogator to another device;

(b) inserting a key into the programmer/interrogator prior to using the programmer/interrogator during the implantation of the implantable device to enable a full operation mode;

(c) having a physician use the programmer/interrogator in the full operation mode to directly communicate with and program the implantable device during the implantation of the implanted device;

(d) removing the key from the programmer/interrogator after the implantation of the implanted device to allow only a limited interrogation mode; and

(e) providing the programmer/interrogator to a patient such that the programmer/interrogator operates in only the limited interrogation mode operable by the patient,

such that the same device may be used by the physician to program and interrogate the implantable device during implantation and by the patient to only interrogate the implantable device after implantation.

14. The method of claim 13 wherein the programmer/interrogator includes within the sealed housing:

a processor that controls the operation of the programmer/interrogator;

a transceiver connected to the processor to transmit and receive data between the programmer/interrogator and the implanted medical device;

a memory connected to the processor to store control algorithms for the processor and data communicated with the implanted device;

a display connected to the processor for displaying operating information for the programmer/interrogator and data communicated with the implanted device;

a communication port connected to the processor that provides for communication with other processors via a cable connected to the port; and

a switch pad connected to the processor for manually providing control and data information to the programmer/interrogator.

15. The method of claim 14 wherein the key is inserted in the communication port to enable the full operation mode of the programmer/interrogator.

16. The method of claim 13 wherein the limited interrogation mode of step (e) comprises the steps of:

(e1) communicating with the implanted device to receive data from the implanted device;

(e2) analyzing the data from the implanted device; and

(e3) providing diagnostic information to be communicated to a physician.

17. The method of claim 16 wherein step (e3) is accomplished by displaying a diagnostic code on the display.

18. The method of claim 16 wherein step (e) comprises the steps of:

(e1) using the programmer/interrogator to communicate with the implanted device to receive data from the implanted device;

(e2) storing the data in the memory of the programmer/interrogator;

(e3) providing a modem separate from the programmer/interrogator for establishing telephonic communication between the programmer/interrogator and a remote processor; and

(e4) automatically controlling the transfer of data from the memory of the programmer/interrogator to the remote processor.