DEVICE TO PREVENT URINARY LEAKAGE

• US 20110124955A1
• Filed: 08/07/2008
• Published: 05/26/2011
• Est. Priority Date: 08/24/2007
• Status: Active Grant

• Current Assignee: Uromems
• Original Assignee: Universite Joseph Fourier
• Inventors: Bonvilain, Agnes, Lamraoui, Hamid, Ciquin, Philippe, Robain, Gilberte, Mozer, Pierren
• Granted Patent: US 10,383,714 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

The invention concerns a device to prevent urinary leakage intended to be implanted in a patient, comprising:

• • compression means (1, 3, 4, 5) to compress the patient'"'"'s urethra,
  • electronic control means (2) to actuate the compression means (1, 3, 4, 5),
    characterized in that it further comprises measurement means (7) to measure the patient'"'"'s activity, coupled with the control means (2), the control means (2) functioning according to a predictive model of urinary leakage based on patient activity, so as to anticipate a possible urinary leak in relation to the measured activity of the patient.

Claims

1. A device to prevent urinary leakage intended to be implanted in a patient, comprising:

compression means to compress the urethra of the patient,

electronic control means to actuate the compression means, and further comprising measurement means to measure the activity of the patient and coupled with the control means, the control means operating in accordance with a predictive model of urinary leakage based on the activity of the patient, so as to anticipate any urinary leakage depending on the measured activity of the patient.

2. The device of claim 1, wherein the measurement means comprises means to measure the position and movement of the patient.

3. The device of claim 2, wherein the means to measure the position and movement of the patient comprises an accelerometer comprising at least one measurement axis.

4. The device of claim 1, wherein said measurement means comprises means to measure intra-abdominal pressure of the patient.

5. The device of claim 1, wherein the measurement means comprises means to measure intra-vesical pressure of the patient.

6. The device of claim 1, wherein the measurement means comprises means to measure endo-urethral pressure of the patient.

7. The device of claim 1, wherein the measurement means comprises means to measure activity of a muscle of said patient.

8. The device of claim 7, wherein the means to measure the activity of a muscle comprises a mechanomyograph sensor intended to be placed on said muscle to measure movements generated by contractions of said muscle.

9. The device of claim 7, wherein the means to measure the activity of a muscle comprises an electromyograph sensor intended to be placed through said muscle to measure the electric potential generated by contractions of said muscle.

10. The device of claim 7, wherein the means to measure the activity of a muscle comprises means to measure the activity of at least one portion of a rectus abdominis muscle of said patient.

11. The device of claim 7, wherein the means to measure the activity of a muscle comprises means to measure the activity of at least one pelvic muscle of said patient.

12. The device of claim 7, wherein the means to measure the activity of a muscle comprises means to measure activity of a detrusor of said patient.

13. The device of claim 1, wherein the measurement means comprises means to measure heart rate of the patient.

14. The device of claim 1, wherein the measurement means comprises means to measure respiratory rate of the patient.

15. The device of claim 1, further comprising:

detection means intended to be arranged on the patient to detect urinary leakage,

storage means to store measurement and detection signals respectively derived from the measurement means and the detection means,

processing means to process the measurement and detection signals stored for a determined time corresponding to a significant period of activity of the patient, in order to construct the predictive model of urinary leakage of the patient by correlating a combination of all or part of the measurement signals with the presence or absence of a subsequent urinary leak, so that the predictive model allows anticipation of a possible urinary leak depending on the measured activity of the patient.

16. The device of claim 1, further comprising means to measure filling of the bladder of the patient, the predictive model of urinary leakage being further based on filling of the bladder of the patient.

17. The device of claim 16, wherein the means to measure filling of the bladder comprises an ultrasound sensor intended to be implanted in the patient to visualize the bladder.

18. The device of claim 1, wherein the control means comprises means to actuate the compression means dynamically depending on the measured activity of the patient.

19. The device of claim 1, wherein the compression means comprises means to apply compression of variable intensity to the urethra, ranging from absolutely no compression to full occlusion of the urethra.

20. The device of claim 1, further comprising safety means adapted to actuate the compression means to obtain full absence of compression on the urethra in response to an opening instruction, and in response to a closing instruction to actuate the compression means to obtain compression of the urethra equal to the compression prior to the opening instruction given by the patient.

21. The device of claim 20, wherein the safety means is coupled with a physiological sensor intended to be implanted in the patient, so as to enable the patient to transmit an opening or closing instruction to the safety means.

22. The device of claim 21, wherein the physiological sensor is arranged to measure the contraction of a muscle so that the opening or closing instruction depends on the frequency of contraction of said muscle.

23. The device of claim 20, wherein the safety means is coupled with external control means adapted to allow an assistant to transmit an opening or closing instruction to the safety means.

24. The device of claim 23, wherein the safety means is adapted to be actuated by the external control means via radio waves.

25. The device of claim 23, wherein the safety means is adapted to be actuated by the external control means via magnetic waves.

26. The device of claim 20, wherein the safety means is coupled with an internal clock, the internal clock allowing the recording of the time intervals between patient voidings, the safety means being adapted to actuate the compression means to obtain total absence of compression on the urethra in the event that a maximum time interval between two voidings is exceeded.

27. A method to control a device for the prevention of urinary leakage intended to be implanted in a patient, said device comprising compression means to compress the urethra of the patient, electronic control means to actuate the compression mean, and measurement means to measure the activity of the patient and coupled with the control means, the method comprising

measuring the activity of the patient with the measurement means,

comparing the measured activity of the patient with a predictive model of urinary leakage based on the activity of the patient,

instructing the compression means depending on the measured activity and to the predictive model to anticipate a possible urinary leak.

28. The method of claim 27, further comprising:

for a determined time, corresponding to a significant period of activity of the patient, measuring the activity of the patient with the measurement means, and recording corresponding measurement signals,

simultaneously detecting urinary leaks with the detection means arranged on the patient to detect any leaks, and recording corresponding detection signals,

determining a trend in measurement signals preceding each detected urinary leak,

constructing the predictive model of urinary leakage of the patient, by correlating a given measurement signal with the presence or absence of a subsequent urinary leak, so that the predictive model can be used to anticipate any urinary leak depending on the measured activity of the patient.

29. The method of claim 28, further comprising:

measuring the filling of the bladder of the patient, the urinary leakage predictive model being further determined based on filling of the bladder.

30. The method of claim 27, wherein in response to an opening instruction, the compression means no longer applies any compression on the urethra, and in that in response to a closing instruction, the compression means exerts a compression on the urethra equal to the compression prior to the opening instruction given by the patient, the patient being able to give an opening or closing instruction via a physiological signal.