Probing device for managing stress urinary incontinence

Abstract

The self-contained endocavitary probe device for managing stress incontinence is capable of being inserted into the vaginal or rectal cavity of a person. The device includes at least one self-contained electrical power supply so as to supply power to at least one device for measuring the variation in a parameter resulting from physical stress and to at least one electrical muscle stimulation device in contact with at least one muscle capable of maintaining urinary continence. The electrical stimulation device is activated in the event of variation in the parameter.

Claims

1. A probe device for inserting into a body cavity, said probe device comprising: a cylindrical tube being comprised of tube body with a periphery, said cylindrical tube having means for manually gripping at one end and a spherical portion at an opposite end; at least one autonomous electric power supplying means; at least one means for measuring a parameter resulting from a physical effort, wherein said parameter is a variation in pressure; and at least one means for producing and delivering an electrical muscle stimulation in communication with said at least one means for measuring, wherein said electrical muscle stimulation has an intensity and a slope of creation of the stimulation, wherein said intensity and said slope of creation of the stimulation are proportional to a rate of creation and a level of said variation in pressure, said variation in pressure being an increase in pressure, wherein the means for measuring is further comprised of a spherical balloon adjacent said spherical portion, wherein said at least one means for an electrical muscle stimulation includes a first stimulation electrode on said periphery of said tube body and a second stimulation electrode positioned at said spherical portion and between said balloon and said first stimulation electrode so as to stimulate in more than one muscular plane.

2. The probe device according to claim 1, wherein the means for measuring is further comprised of a sensor.

3. The probe device according to claim 2, wherein said sensor is comprised of a pressure sensor located inside said balloon.

4. The probe device according to claim 2, wherein the means for measuring is further comprised of a contact lamella on a surface of said balloon, said contact lamella being comprised of deformable material.

5. The probe device according to claim 1, wherein said variation in pressure is a pressure increase amount below a predetermined pressure threshold.

6. The probe device according to claim 1, further comprising: a means for measuring an electrical activity on said probe, said means for measuring being an electrode for bipolar signals.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

(1) The understanding of this description will be facilitated when referring to the attached drawings.

(2) The FIGURE is a schematic view of the probe device of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

(3) As shown in the FIGURE, the present invention relates to a probe device 1, which, after insertion into the vaginal cavity or into the rectal cavity of a patient suffering from urinary incontinence under stress, permits to manage this incontinence.

(4) In a particularly advantageous manner, this probe device 1 according to the invention is autonomous. In other words, said device 1 includes at least one autonomous power supply means, for example a battery or a button cell.

(5) This supply means permits to cause the various components of said probe device 1 of the invention to operate.

(6) Indeed and preferably, said device 1 includes, on the one hand, at least one means for measuring 2 a parameter, which results from a physical effort made by the person carrying said device 1 and, on the other hand, at least one means for an electrical muscle stimulation 3. The latter is into contact with at least one muscle capable of maintaining the urinary continence and permits to stimulate this muscle when a physical effort is detected.

(7) In particular, the stimulation means 3 is into direct contact, or through the vaginal or rectal mucosa, with the at least one muscle.

(8) The probe device 1 according to the invention is particularly interesting because it permits to manage the urinary incontinence in a person, man or woman, when a situation of effort is detected by said device 1.

(9) The stress urinary incontinence results namely from a weakening of the muscles of the perineum (or muscles of the pelvic floor, or pelvic muscles) and/or the muscle ensuring the closing of the bladder, the urethral sphincter.

(10) Indeed, these muscles, when they operate normally, permit to withstand an increase in abdominal pressure, due to a situation of effort, such as coughing, laughing, sneezing, or a physical exercise. More specifically, a contraction of the perineal muscles during an effort reinforces the urethral closing pressure also ensured by the sphincter and results namely into maintaining the urethra in the closed position.

(11) In the event of a decrease in the tone of the perineal muscles, the urinary sphincter alone cannot ensure a closing pressure necessary for the continence. As a result, when the pressure increases in the abdominal cavity as a result of an effort, this pressure affects the bladder and urine leakage can occur.

(12) The people affected by urinary incontinence are mostly women, regardless of their age. In some cases, an obstetric trauma may be the cause of a lack of urinary sphincter tone as well as a relaxation of the muscles of the pelvic floor.

(13) However, men can also experience urinary incontinence, in particular when they have been subjected to a total or partial removal of the prostate, or prostatectomy. Indeed, during the operation, it is possible that the urethral sphincter and/or its innervation is (are) accidentally affected, making said sphincter less effective.

(14) Therefore, the probe device 1 according to the invention is likely to be used by both men and women.

(15) In a first embodiment of the probe device 1 of the invention, the means for measuring 2 a parameter resulting from a physical effort when the parameter is a variation in pressure, is at least one pressure sensor, the latter being capable of measuring a variation, namely an increase in pressure, within a body cavity, such as the vaginal or rectal cavity.

(16) This increase in pressure in the vaginal or rectal cavity results from an increase in pressure in the abdomen, which is in turn caused by a situation of effort.

(17) The detection of an increase in pressure in the cavity by said measuring means 2 permits to trigger the electrical stimulation means 3 of the device 1 positioned into contact with at least one muscle ensuring the urinary continence, preferably a perineal muscle. The electrical stimulation of said muscle causes electro-induced contraction of the latter, resulting into urinary continence.

(18) In particular, the stimulation means is into direct contact, or through the vaginal or rectal mucosa, with said at least one muscle. Thus, the stimulation can be done directly on the muscle ensuring the urinary continence or indirectly via said mucosa.

(19) Preferably, the means for measuring the pressure includes a balloon 4, which is placed into contact with the vaginal mucosa or the anal mucosa, in order to detect the variations in pressure in the abdominal cavity. To this end, the balloon 4 is associated with at least one pressure sensor located inside the balloon 4 and/or at least one contact lamella of deformable material, positioned on the surface of said balloon 4.

(20) Therefore, by applying the probe device 1 according to the invention, urinary leakage is avoided.

(21) In particular, the balloon 4 is placed at one end of the probe. More particularly, said end is intended to be inserted until it is into contact with the cervix or beyond the anal canal.

(22) The embodiment of the device 1 described above permits to avoid the stress urinary incontinence when the muscles, in particular the perineal muscles, no longer show any activity. In this case, as indicated, the parameter resulting from an effort being measured is the variation in pressure, as described above.

(23) However, it is also conceivable that the person suffering from stress urinary incontinence still has a weak contraction of the perineal muscles, but insufficient to avoid a loss of urine fluid.

(24) In this case, corresponding to the second embodiment of the probe device 1 according to the invention, the means for measuring 2 the variation of a parameter resulting from a physical effort consists of a bipolar electrode for measuring an electro-myographic signal from at least one perineal muscle, not shown in the attached FIGURE.

(25) In other words, the parameter being measured here consists of an electric current accompanying the weak but existing muscular activity, namely of the perineum, this activity resulting from a physical effort.

(26) In this particular embodiment, the stimulation means, preferably also a bipolar electrode into contact with the perineal muscles, will permit, through an electro-induced stimulation, to amplify the existing muscular activity and thus to cause a sufficient contraction of the muscle in order to maintain urinary continence.

(27) The probe device 1 according to the invention thus permits, in a particularly advantageous way, to manage the stress urinary incontinence both in patients capable of producing a weak perineal muscle contraction and in patients whose perineum no longer shows any activity.

(28) In an advantageous embodiment, the probe device 1 of the invention includes both a means for measuring the variation in pressure and a bipolar electrode for measuring an electro-myographic signal detecting an electrical activity of the perineal muscles.

(29) In addition, it is also conceivable to calibrate the level of pressure or of intensity of the electro-myographic signal resulting into the triggering of the electrical stimulation means 3, in order to adapt the device 1 to the level of incontinence of the patient.

(30) As regards now said electrical stimulation means 3 of the probe device 1, positioned into contact with at least one muscle capable of maintaining the continence, the latter advantageously includes two stimulation electrodes 31, 32.

(31) During an increase in abdominal pressure, the means for measuring said pressure activates the means 3 for an electrical muscle stimulation of the perineal muscles. Should the case arise, each electrical muscle stimulation as an intensity and the slope or rate of creation of this stimulation, which are proportional to a rate of creation and to a level of pressure, when the parameter is a variation in pressure and when the variation in pressure is an increase in pressure.

(32) Since the electrodes 31 and 32 are placed at the level of the deep muscular planes of the perineum, the so created stimulation causes, via these electrodes 31 and 32, the contraction of said perineum and increases the urethral closing pressure.

(33) In addition, the sensor that activates the electro-induced contraction is adjustable and permits to activate said stimulation at a predetermined pressure threshold below the pressure threshold from which the leak occurs, wherein the variation in pressure is a pressure below the predetermined pressure threshold.

(34) More generally, the device comprises the balloon 4 at one end, and at least one electrode (a second stimulation electrode 32) in front of the balloon 4, then preferably the other electrode (a first stimulation electrode 31) in front of the second stimulation electrode 32. The positions of the electrodes 31 and 32 are adapted to the stimulation of said at least one muscle.

(35) Preferably, as shown in the attached FIG. 1, the probe device 1 according to the invention is comprised of a first portion formed by a cylindrical tube 5 including a tube body 5A having a periphery 5B, and at one of its ends, a means for manually gripping 6 said device 1 and, at the opposite end, a second substantially spherical portion 7.

(36) This spherical portion 7 advantageously comprises the balloon 4 with, on its surface, at least one pressure sensor and/or at least one contact lamella of deformable material. Preferably, the balloon 4 is inflatable by a suitable means that can form the gripping means 6. The inflation means can be a pump. Preferably, the pressure sensor is temperature compensated.

(37) A first stimulation electrode 31 can be positioned on the periphery of the cylindrical tube 5.

(38) As regards the second stimulation electrode 32, it is preferably positioned at the periphery of the spherical portion 7 of the probe device 1 according to the invention.

(39) The probe device 1 according to the invention permits to manage and to avoid the urinary incontinence permanently, while avoiding the drawbacks associated with the currently provided solutions of the state of the art.

(40) Therefore, the user of the present device 1 will be completely autonomous, and will no longer be subject to urinary leakage.

(41) Indeed, in a timely manner the device 1 will cause an electrical stimulation of the perineal muscles, generating an electro-induced contraction of the latter. It is thus understood that by means of the present device untimely stimulation of the perineal muscles is avoided.

(42) In addition, thanks to this probe device 1, as electrical stimulation of the muscles occurs, it is conceivable that the locking reflex and the myotatic reflex of the perineum become functional again.