Device to prevent urinary leakage

• US 10,383,714 B2
• Filed: 08/07/2008
• Issued: 08/20/2019
• Est. Priority Date: 08/24/2007
• Status: Active Grant

• Current Assignee: Uromems
• Original Assignee: Uromems
• Inventors: Cinquin, Philippe, Mozer, Pierren, Lamraoui, Hamid, Bonvilain, Agnes, Robain, Gilberte
• Primary Examiner(s): Kuhlman, Catherine B
• Application Number:
  US12/674,501
• Publication Number:
  US 20110124955A1
• Time in Patent Office: 4,030 Days
• Field of Search: 600 29- 31, 600 37, 128897-899
• 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:

an occlusive cuff to compress the urethra of the patient,

an electronic controller to actuate the occlusive cuff,

at least one sensor to measure at least one activity of the patient that precedes the occurrence of a urinary leakage and coupled with the electronic controller, wherein the at least one sensor comprises an accelerometer having at least one measurement axis adapted to measure an acceleration of the patient,

the electronic controller being configured to;

determine a position and a movement of the patient based on the acceleration of the patient and a period of the acceleration,

operate in accordance with a predictive model of urinary leakage to anticipate a possible urinary leak based on the position and movement of the patient, wherein the predictive model correlates data from the accelerometer with a type of activity of the patient and determines a pressure to be exerted by the occlusive cuff depending on the type of activity, so as to vary the pressure exerted by the occlusive cuff in relation to the measured position and movement of the patient to prevent any urinary leakage, and

vary the pressure to at least two non-zero predetermined pressures, each predetermined pressure being specific to a type of activity of the patient.

2. The device of claim 1, wherein the at least one sensor further comprises a sensor adapted to measure intra-abdominal pressure of the patient.

3. The device of claim 1, wherein the at least one sensor further comprises a sensor adapted to measure intra-vesical pressure of the patient.

4. The device of claim 1, wherein the at least one sensor further comprises a sensor adapted to measure endo-urethral pressure of the patient.

5. The device of claim 1, wherein the at least one sensor further comprises a sensor adapted to measure activity of a muscle of the patient.

6. The device of claim 5, wherein the at least one sensor adapted to measure the activity of the muscle comprises a mechanomyograph sensor intended to be placed on the muscle to measure movements generated by contractions of the muscle.

7. The device of claim 5, wherein the at least one sensor adapted to measure the activity of the muscle comprises an electromyograph sensor intended to be placed through the muscle to measure the electric potential generated by contractions of the muscle.

8. The device of claim 5, wherein the at least one sensor adapted to measure the activity of the muscle comprises a sensor adapted to measure the activity of at least one portion of a rectus abdominis muscle of the patient.

9. The device of claim 5, wherein the at least one sensor adapted to measure the activity of the muscle comprises a sensor adapted to measure the activity of at least one pelvic muscle of the patient.

10. The device of claim 5, wherein the at least one sensor adapted to measure the activity of the muscle comprises a sensor adapted to measure activity of a detrusor of the patient.

11. The device of claim 1, wherein the at least one sensor further comprises a sensor adapted to measure heart rate of the patient.

12. The device of claim 1, wherein the at least one sensor further comprises a sensor adapted to measure respiratory rate of the patient.

13. The device of claim 1, wherein the electronic controller configured to actuate is the occlusive cuff dynamically depending on the measured activity of the patient.

14. The device of claim 1, wherein the occlusive cuff is configured to apply compression of variable intensity to the urethra, ranging from absolutely no compression to full occlusion of the urethra.

15. The device of claim 1, wherein the electronic controller is adapted to actuate the occlusive cuff 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 occlusive cuff to obtain compression of the urethra equal to the compression prior to the opening instruction given by the patient.

16. The device of claim 15, wherein the electronic controller 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 in the form of a physiological signal generated by the patient to the electronic controller.

17. The device of claim 15, wherein the electronic controller is coupled with an external controller adapted to allow an assistant to transmit an opening or closing instruction to the electronic controller.

18. The device of claim 17, wherein the controller is adapted to communicate with the external controller via radio waves.

19. The device of claim 17, wherein the controller is adapted to communicate with the external controller via magnetic waves.

20. The device of claim 15, wherein the electronic controller is coupled with an internal clock, the internal clock allowing the recording of the time intervals between patient voidings, the electronic controller being adapted to actuate the occlusive cuff to obtain total absence of compression on the urethra in the event that a maximum time interval between two voidings is exceeded.

21. The device of claim 1, wherein the electronic controller is capable of varying the pressure to each of:

a minimal non-zero pressure, a lying pressure, a normal activity pressure, and an effort pressure.

22. The device of claim 1, wherein the electronic controller is configured to vary the pressure to at least three predetermined pressures, each predetermined pressure being specific to a type of activity of the patient.

23. The device of claim 1, wherein the predictive model correlates the data from the accelerometer with the type of activity of the patient so as to break down the patient'"'"'s activity between at least:

a sleep phase, a normal activity phase and a phase of activity involving an effort, and

wherein the electronic controller is configured to vary the pressure to at least three predetermined pressures, each predetermined pressure being specific to a type of activity of the patient.

24. The device of claim 1, further comprising a reservoir for a fluid, wherein the electronic controller is configured to actuate the occlusive cuff by causing the fluid to circulate between the reservoir and the occlusive cuff.

25. The device of claim 1, wherein the electronic controller is configured to:

determine that the patient is lying down when the acceleration of the patient is less than a predetermined acceleration for a predetermined period; and

vary the pressure exerted by the occlusive cuff based on whether the patient is lying down.

26. The device of claim 1, wherein the accelerometer is adapted to measure a static acceleration of the patient and a dynamic acceleration of the patient, and the electronic controller is configured to determine the position and the movement of the patient based on the static and dynamic acceleration of the patient.

27. The device of claim 1 wherein determining the position of the patient includes determining whether the patient is standing or lying down.

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

an occlusive cuff to compress the urethra of the patient,

a reservoir for a fluid,

an electronic controller to actuate the occlusive cuff by causing a fluid to circulate between the reservoir and the occlusive cuff,

at least one activity sensor to measure at least one activity of the patient that precedes the occurrence of a urinary leakage and coupled with the electronic controller, wherein the at least one activity sensor comprises an accelerometer having at least one measurement axis adapted to measure a position and a movement of the patient,

a pressure sensor intended to be arranged on the patient to measure an abdominal pressure of the patient in order to detect urinary leakage,

storage medium to store activity and pressure signals respectively derived from the at least one activity sensor and the pressure sensor, and

processor to process the activity and pressure signals stored for a determined time corresponding to a period of activity of the patient, in order to construct a predictive model of urinary leakage of the patient by correlating a combination of all or part of the activity signal 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,

the electronic controller operating in accordance with the predictive model of urinary leakage to anticipate the possible urinary leak based on the position and movement of the patient, wherein the predictive model correlates data from the accelerometer with a type of activity of the patient and determines a fluid pressure to be applied within the occlusive cuff depending on the type of activity, so as to vary the fluid pressure within the occlusive cuff in relation to the measured position and movement of the patient to prevent any urinary leakage,

wherein the electronic controller is capable of varying the pressure to at least two non-zero predetermined pressures, each predetermined pressure being specific to a type of activity of the patient.

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

an occlusive cuff to compress the urethra of the patient,

a reservoir for a fluid,

an electronic controller to actuate the occlusive cuff by causing a fluid to circulate between the reservoir and the occlusive cuff,

at least one first sensor to measure at least one activity of the patient that precedes the occurrence of a urinary leakage and coupled with the electronic controller, wherein the at least one first sensor comprises an accelerometer having at least one measurement axis adapted to measure a position and a movement of the patient,

wherein the electronic controller is configured to estimate a mean fill time of the bladder of the patient based on a number of voidings by the patient and a plurality of periods that are each between two consecutive ones of the voidings,

the electronic controller operating in accordance with a predictive model of urinary leakage to anticipate a possible urinary leak based on the position and movement of the patient and the mean fill time of the bladder of the patient, wherein the predictive model correlates data from the accelerometer with a type of activity of the patient and determines a fluid pressure to be applied within the occlusive cuff depending on the type of activity, so as to vary the fluid pressure within the occlusive cuff in relation to the measured position and movement of the patient to prevent any urinary leakage,

wherein the electronic controller is capable of varying the pressure to at least two non-zero predetermined pressures, each predetermined pressure being specific to a type of activity of the patient.

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

an occlusive cuff to compress the urethra of the patient,

a reservoir for a fluid,

an electronic controller to actuate the occlusive cuff by causing a fluid to circulate between the reservoir and the occlusive cuff,

at least one sensor to measure at least one activity of the patient that precedes the occurrence of a urinary leakage and coupled with the electronic controller, wherein the at least one sensor comprises an accelerometer having at least one measurement axis adapted to measure a position and a movement of the patient,

the electronic controller operating in accordance with a predictive model of urinary leakage to anticipate a possible urinary leak based on the position and movement of the patient, wherein the predictive model correlates data from the accelerometer with a type of activity of the patient and determines a fluid pressure to be applied within the occlusive cuff depending on the type of activity, so as to vary the fluid pressure within the occlusive cuff in relation to the measured position and movement of the patient to prevent any urinary leakage,

wherein the electronic controller is capable of varying the pressure to at least two non-zero predetermined pressures, each predetermined pressure being specific to a type of activity of the patient,

the electronic controller being adapted to actuate the occlusive cuff 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 occlusive cuff to obtain compression of the urethra equal to the compression prior to the opening instruction given by the patient,

wherein the electronic controller 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 in the form of a physiological signal generated by the patient to the electronic controller,

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 the muscle.

31. A method to control a device for the prevention of urinary leakage intended to be implanted in a patient, the device comprising an occlusive cuff to compress the urethra of the patient, an electronic controller to actuate the occlusive cuff, and at least one sensor to measure at least one activity of the patient that precedes an occurrence of the urinary leakage and coupled with the electronic controller, which is capable of varying a pressure exerted by the occlusive cuff on the urethra to at least two non-zero predetermined pressures, each of the pressures being specific to a type of activity of the patient, wherein the at least one sensor comprises an accelerometer having at least one measurement axis adapted to measure an acceleration of the patient, the method comprising:

measuring the acceleration of the patient with the at least one sensor,

estimating an activity of the patient based on the acceleration of the patient and a period of the acceleration;

comparing the estimated activity of the patient with a predictive model of the urinary leakage to anticipate a possible urinary leak, where in the predictive model correlates data from the accelerometer with a type of activity of the patient and determines a pressure to be applied within the occlusive cuff depending on the type of the activity, and

instructing the occlusive cuff to vary the pressure exerted by the occlusive cuff on the urethra in relation to the measured activity and to the predictive model to prevent the possible urinary leak,

wherein the pressure exerted can be varied to at least two non-zero predetermined pressures, each predetermined pressure being specific to a phase of activity of the patient.

32. The method of claim 31, further comprising:

for a determined time, corresponding to a period of activity of the patient, measuring the activity of the patient with the at least one sensor, and recording corresponding measurement signals,

simultaneously detecting the urinary leaks with detectors 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 the 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.

33. The method of claim 32, further comprising:

measuring the volume of fluid in a bladder of the patient, the urinary leakage predictive model being further determined based directly on the volume of fluid in the bladder.

34. The method of claim 33 further comprising:

measuring an abdominal pressure of the patient;

increasing the pressure exerted by the occlusive cuff when the abdominal pressure of the patient is greater than a threshold; and

selecting the threshold based on the volume of fluid in the bladder of the patient.

35. The method of claim 31, wherein in response to an opening instruction, the occlusive cuff no longer applies any compression on the urethra, and in response to a closing instruction, the occlusive cuff 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 in the form of a physiological signal generated by the patient that can be sensed by a physiological sensor coupled with the electronic controller.