Acoustic monitoring system

• US 6,685,638 B1
• Filed: 12/23/2002
• Issued: 02/03/2004
• Est. Priority Date: 12/23/2002
• Status: Expired due to Term

• Current Assignee: Integra LifeSciences Switzerland Sàrl
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Rosenberg, Meir, Taylor, Terri K., Dextradeur, Alan J., Gupta, Rainuka, Ostiguy, Pierre S., Wilson, Stephen F., Romner, Bertil
• Primary Examiner(s): Imam, Ali M.
• Application Number:
  US10/328,748
• Time in Patent Office: 407 Days
• Field of Search: 600/407-471, 600/300, 600/309, 600/500, 604/9-10, 128/900, 128/903, 128/904, 128/898, 128/899, 128/916, 736/25, 736/26, 737/00, 737/08, 731/71, 737/16, 623/2.11, 623/1.26, 607/30-33, 607/60, 607/61, 607/9, 367/7, 367/11, 367/130, 367/138
• US Class Current: 600/437
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 7/005 Detecting noise caused by implants, e.g. cardiac valves

Abstract

An acoustic monitoring system that is able to verify the success or failure of the positional adjustment of a valve without the need for additional energy during non-invasive reprogramming is provided. The acoustic monitoring system includes a programmer for generating a sequence of commands to adjust the valve mechanism, and for receiving acoustic signals for analysis, a transmitter to implement the command and adjust the valve, and a sensor for detecting an acoustic signal generated from the valve during execution of the commands. A method for using the acoustic monitoring system is also provided.

Claims

1. A method for verifying the position of a valve mechanism in an adjustable programmable valve implanted in a patient, comprising the steps of:

providing an acoustic monitoring system comprising a programmer for generating a sequence of commands to adjust an opening pressure of the valve mechanism, and a transmitter electronically coupled to the programmer for receiving the commands, the transmitter being electronically coupled to a sensor for detecting an acoustic signal generated from the valve mechanism during an adjustment cycle, the sensor being held by a tubular coupling rod within the transmitter;

manually determining the location of the valve mechanism of the implanted valve;

positioning the transmitter over the valve mechanism;

initiating the sequence of commands from the programmer;

detecting the acoustic signal generated from the valve mechanism during the adjustment cycle with the sensor;

analyzing the acoustic signal with the programmer; and

generating a signal to confirm the success or failure of the adjustment.

2. The method of claim 1, further including the step of contacting the tubular coupling rod to the patient'"'"'s skin.

3. The method of claim 2, further including the step of applying an ultrasound gel to the patient'"'"'s skin to optimize coupling between the tubular coupling rod and the valve mechanism.

4. The method of claim 1, wherein the sequence of commands directs the transmitter to generate a magnetic field during the adjustment cycle.

5. The method of claim 1, wherein the step of adjusting the opening pressure of the valve mechanism includes the step of applying a magnetic field to the valve mechanism using the transmitter.

6. The method of claim 5, wherein the valve mechanism includes a stepped motor, and the step of adjusting the opening pressure of the valve mechanism includes causing the stepped motor to rotate.

7. The method of claim 1, further including the step of inserting the sensor into the transmitter after positioning the transmitter over the patient.

8. The method of claim 1, wherein the step of analyzing includes translating the acoustic signal generated from the valve mechanism to an electronic signal for determining the success or failure of the adjustment cycle.

9. The method of claim 8, further including the step of classifying the acoustic signals into clicks or bangs.

10. The method of claim 9, wherein the actual streams of clicks and bangs are compared to an expected stream of clicks and bangs to determine the success or failure of the adjustment cycle.

11. The method of claim 1, wherein the step of generating a signal to confirm the success or failure of the adjustment includes generating an audible or visual signal.

12. An acoustic monitoring device for verifying the position of a valve mechanism in an adjustable programmable valve in a patient, comprising:

a housing having a top surface, a bottom surface, and a central opening extending therethrough;

a transmitter contained within the housing, the transmitter having a plurality of electromagnetic coils for generating an electromagnetic field sufficient to rotate the valve mechanism of the adjustable programmable valve;

a tubular coupling member extending through the central opening of the housing; and

an acoustic sensor being selectively disposed inside the tubular coupling member, the acoustic sensor detecting an acoustic signal generated by the valve mechanism during an adjustment cycle after the housing is placed over the valve mechanism.

13. The device of claim 12, wherein the tubular coupling member extends beyond the bottom surface of the housing.

14. The device of claim 13, wherein the tubular coupling member is configured to contact a patient'"'"'s skin.

15. The device of claim 12, wherein the acoustic sensor is electromagnetically isolated from the transmitter.

16. The device of claim 12, further including mechanical isolating pads surrounding the inner surface of the tubular coupling member.

17. The device of claim 16, wherein the sensor is seated on top of the tubular coupling member.

18. The device of claim 12, further including a plurality of feet extending from the bottom surface of the housing to focus the generated magnetic field on the valve mechanism.

19. The device of claim 12, wherein the acoustic signal is selected from the group consisting of clicks and bangs.

20. The device of claim 12, further including a power source for driving the electromagnetic coils.

21. The device of claim 12, further including a signal amplifier, a digitizing filter, and a data storage unit for downloading the acoustic signal to a programmer for analysis.

22. The device of claim 12, further comprising means for wireless communication between the acoustic monitoring device and the programmer.

23. The device of claim 22, wherein the means for wireless communication comprises a wireless communication transmitter connected to the transmitter of the acoustic monitoring device.

24. The device of claim 12, wherein the acoustic sensor is inserted into the housing after the housing is placed over the valve mechanism.

25. The device of claim 12, wherein the tubular coupling member is held in springing engagement with respect to the housing and self-adjusts to conform to the patient'"'"'s anatomy.

26. An acoustic monitoring system for verifying the position of a valve mechanism in an adjustable programmable valve in a patient, comprising:

a programmer for generating a set of commands to adjust an opening pressure of the valve; and

a transmitter for actuating the set of commands, the transmitter comprising a housing having a top surface, a bottom surface, and a central opening extending therethrough, the housing enclosing therein a plurality of electromagnetic coils for generating an electromagnetic field sufficient to rotate the valve mechanism of the adjustable programmable valve, a tubular coupling member extending through the central opening of the housing, and an acoustic sensor seated inside the tubular coupling member, the acoustic sensor detecting an acoustic signal generated by the valve mechanism during an adjustment cycle;

wherein the transmitter communicates the detected acoustic signal to the programmer for analysis.

27. The system of claim 26, wherein the programmer includes a microprocessor that translates the acoustic signal into information for determining the success or failure of an adjustment cycle.

28. The system of claim 27, wherein the microprocessor classifies the acoustic signal into clicks or bangs.

29. The system of claim 28, wherein the microprocessor compares the actual streams of clicks and bangs to an expected stream of clicks and bangs to determine the success or failure of the adjustment cycle.