Device for perineum reeducation

• US 8,634,920 B2
• Filed: 09/14/2009
• Issued: 01/21/2014
• Est. Priority Date: 09/16/2008
• Status: Active Grant

• Current Assignee: Blue Medical Innovation Ltd.
• Original Assignee: Perinealis Ltd.,
• Inventors: Hagege, Edward
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US13/063,949
• Publication Number:
  US 20110230931A1
• Time in Patent Office: 1,590 Days
• Field of Search: 607 39- 41
• US Class Current: 607/41
• CPC Class Codes: A61B 5/063 using impedance measurements
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4337 of the vagina
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation
• CPC Class Codes: A61B 5/68 Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

The invention provides a perineal rehabilitation device comprising an applicator that is either an endocavity applicator (100) or an annular applicator (100′), locally supporting a charging electrode (104, 105) and at least one stimulation electrode (101, 102) respectively on its periphery or on its inside face, and including at least one energy storage unit that is rechargeable via the charging applicator (104, 105), the applicator (100, 100′) including at least one microprocessor for executing an electrical stimulation program, the device being characterized in that the applicator (100, 100′) is controlled by a control module (200) in the form of a remote control connected to the applicator (100, 100′) by a wireless connection and including a user interface for enabling the user to input operating data for the applicator (100, 100′) and a control unit for controlling the applicator (100, 100′) by sending control signals thereto, the applicator (100, 100′) being suitable for receiving control signals for modifying the intensity of stimulation while it is in operation and for modifying its ongoing operation as a function of such control signals.

Claims

1. A perineal rehabilitation device comprising an applicator that is an endocavity applicator (100), locally supporting a charging electrode (104, 105) and at least one stimulation electrode (101, 102) on its periphery, and including at least one energy storage unit that is rechargeable via the charging applicator (104, 105), the applicator (100) including at least one microprocessor for executing an electrical stimulation program, the device being characterized in that it further comprises an external control module (200) in the form of a remote control connected to the applicator (100) by a wireless connection and including a user interface for enabling the user to input operating data for the applicator (100) and a control unit for controlling the applicator (100) by sending control signals thereto, the said endocavity applicator comprising:

an oblong portion (100a) designed for insertion into a body cavity, said oblong portion being surrounded with annular electrodes (101-105),

an external portion (100b) constituting a handle for removing the applicator after it has been inserted, and the oblong portion (100a) comprising a proximal portion (P) provided with at least two said annular electrodes (101, 102) which are stimulation electrodes to which sequences of electrical stimuli can be applied, and

the oblong portion (100a) comprising a distal portion (D) provided with at least the annular electrodes (104, 105) for charging the applicator and said annular electrode (103) for detecting that the applicator has been inserted into the body cavity,

the control module (200) capable of;

selecting a treatment program among various predetermined programs (P1-P7) to carry out stimulations with different sequences continuously or during different stimulation times, and

selecting the duration of the treatment, and

modifying automatically or on user input an intensity of stimulation, and indicating and storing the intensity of stimulation when increasing intensity and that the stimuli begin to be felt by the user, and

storing in a memory time-stamped data concerning the operating stimulation intensities and durations ordered to the applicator (100), and

stopping the stimulation at any moment.

2. A device according to claim 1, characterized in that all of the programs begin electrical stimulation at zero intensity.

3. A device according to claim 1, characterized in that the control module (200) includes means for indicating stimulation operating ranges of the applicator (100).

4. A device according to claim 1, characterized in that the control module (200) includes at least one connection port (209) for transferring time-stamp data to a computer (600).

5. A device according to claim 1, characterized in that the control module (200) includes means suitable for sending control signals to the applicator (100), causing the applicator to issue automatically stimuli of increasing intensity, and in that the interface includes means enabling the user to indicate the moment when the stimuli begin to be felt.

6. A device according to claim 1, characterized in that the applicator (100) includes means suitable, while the device is in operation, for performing measurements relating to the reaction of the body.

7. A device according to claim 6, characterized in that the applicator (100) includes a pressure sensor for taking measurements relating to muscle contraction.

8. A device according to claim 6, characterized in that the wireless connection is bidirectional and the control module (200) includes a feedback unit for receiving measurements from the applicator, for processing these measurements in real time, for calculating an appropriate operating mode as a function of the measurements, and for sending a control signal corresponding to this mode of operation to the applicator (100).

9. A device according to claim 6, characterized in that the control module (200) includes a memory for storing information relating to the reaction of the body.

10. A device according to claim 1, characterized in that the applicator (100) includes an electrode (103) for detecting that it has been inserted or installed correctly, which electrode is suitable for detecting contact with the body, said electrode (103) being suitable for sending a signal to the microprocessor installed within the applicator and/or the microprocessor installed within the control module, the microprocessor being such as to be suitable for causing stimulation to stop as soon as the applicator is no longer in contact with the body.

11. A device according to claim 1, characterized in that the device enables the rehabilitation treatment of urinary incontinence and said predetermined treatment programs are dedicated to the treatment of various types of incontinency comprising stress incontinence, urge incontinence and mixed incontinence.