Perineal probe

Abstract

The present invention relates to a perineal probe (10), which comprises a probe body having electronic components (110, 111, 112) configured to interact with the perineal muscles of a patient. According to the present invention, the probe body comprises: a cylindrical portion (12) configured to be positioned at the opening of a body cavity of a patient; and a trumpet-shaped portion (13) extending from one end (121) of the cylindrical portion (12), the trumpet-shaped portion (13) extending from the cylindrical portion (12) to an upper free end (130) in a widening manner, the trumpet-shaped portion (13) being elastically deformable between a folded position and an expanded position, and the electronic components (110, 111, 112) being arranged on the trumpet-shaped portion (13) and / or on the cylindrical portion (12).

Description

Technical Field

[0001] The present invention relates to perineal probes and more particularly to probes for perineal diagnosis and rehabilitation. In a wider range, the present invention belongs to the field of paramedical and medical treatment and is particularly intended to analyze the functional state of anatomical structures related to the mechanisms of urinary and / or fecal continence and / or incontinence.

[0002] Continence is a complex mechanism that necessarily involves learned anticipatory and innate stretch reflexes acting on multiple groups of muscles in response to a stimulus. The stimulus usually corresponds to an increase in intra-abdominal pressure. In response to this stimulus, the anticipatory and stretch reflexes drive multiple groups of muscles to contract in order to prevent leakage of urine and / or stool.

[0003] Thus, the first group of muscles includes the urethral sphincter and the anal sphincter, which surround the urethra and the anal canal, respectively. Due to their respective contraction, the urethra and the anal canal are closed. The perineal muscles constitute the second group of muscles involved in the continence mechanism. The perineum is a group of muscles that extends from the pubic bone to the coccyx. The perineum generally performs two functions: on the one hand, it holds the abdominal contents: rectum, bladder, uterus; on the other hand, it participates in damping abdominal hyperpressure and the closure of the bladder and rectum. In fact, it is known that the perineum plays an important role in the continence mechanism.

[0004] With regard to these physiological functions, practitioners and the medical industry are interested in diagnosing and treating incontinence problems in male and female patients with regard to the perineum. Background Art

[0005] From the perspective of the practitioner, the first method of assessing the functional state of the perineum that is still in use today is a manual method involving vaginal or rectal palpation. During this medical procedure, the practitioner evaluates the contractions initiated by the patient. According to this method, the assessment of the functional state of the perineum is performed based on subjective criteria that are closely related to the personal experience of the practitioner. In this case, neither the diagnosis nor the functional rehabilitation can guarantee any regularity in the assessment of dysfunction and the results of rehabilitation.

[0006] There are known perineal probes for performing functional analysis and rehabilitation of anatomical structures involved in continence or incontinence mechanisms.

[0007] Most known prior art perineal probes include a cylindrical probe body with a circular free end. The probe body includes two annular electrodes arranged at a specific distance from each other. This type of perineal probe is designed to be introduced into the vaginal cavity of a patient and / or the anal cavity of a patient. Depending on its size, this probe may cause discomfort during insertion into and withdrawal from the vaginal or anal endocavity. In addition, this type of probe is generally designed to complete rehabilitation by electrotherapy of the connective tissue surrounding the vaginal and / or anal cavity and the muscles surrounding the vaginal or anal cavity. However, the annular nature of the electrodes does not allow the muscles to be isolated from each other for targeted diagnosis or electrotherapy. In addition, the cylindrical shape of the probe body does not allow this type of probe to remain in place during an examination or rehabilitation protocol. In fact, this type of probe tends to withdraw from the inner cavity when the intra-abdominal pressure increases, which makes the examination or rehabilitation time-consuming. In this case, it is difficult to determine the functional state of the muscles surrounding the inner cavity in the case of upright standing or upright movement in the patient's daily life that is prone to cause urine or stool leakage.

[0008] Document FR2941860 describes another example of a perineal probe designed for insertion into the vaginal cavity. This type of probe is capable of measuring the tone of the connective tissue surrounding the vaginal cavity. The perineal probe comprises two hinged and complementary branches. At least one branch has a curved end that covers the free end of the other branch to form a rounded probe head. Each branch carries a force sensor so that the swinging movement of the branch can be determined based on the force difference measured between the front and rear sensors. After inserting the probe into the vaginal cavity, the practitioner separates the branches arranged along the front-back axis. If a small reduction in force is measured on the front sensor, the connective tissue is of good quality and follows the movement of the branch. On the contrary, if a large reduction in force is measured, the connective tissue is of poor quality and follows the movement of the probe branch more slowly. Poor connective tissue quality is a known factor in incontinence. If the practitioner obtains such a diagnosis, they can apply electrical stimulation techniques to increase the trophic level and tone of the connective tissue.

[0009] This type of probe is uncomfortable for the patient and must be held in place by a medical practitioner during the examination. In addition, this type of probe cannot differentiate between malfunctions of the anatomical structures associated with the mechanisms that lock the urethra or anal canal.

[0010] The object of the present invention is to solve the disadvantages of the prior art. Summary of the invention

[0011] The invention aims in particular at providing a perineal probe which limits the discomfort caused during insertion into the vaginal or anal cavity of a patient and during use and during withdrawal of the perineal probe.

[0012] The present invention also aims to provide an intracavitary perineal probe which is held in place in the vaginal or anal cavity during use. Specifically, the present invention aims to provide an intracavitary perineal probe which is held in place while the patient is standing to achieve body movements that are prone to causing urine or stool leakage.

[0013] The invention also aims to provide a diagnostic and / or rehabilitation tool which allows the functional state of the deep and superficial layers of the perineum to be assessed and / or treated in a differentiated and asymmetrical manner.

[0014] An object of embodiments of the present invention is to provide a perineal probe that can be adapted to the anatomical dimensions of a large number of patients.

[0015] In this framework, the present invention relates to a perineal probe comprising a probe body comprising:

[0016] - a cylindrical portion configured to be positioned at the opening of the inner cavity of the vagina or anus of a patient,

[0017] a flared portion extending from one end of the cylindrical portion, the flared portion extending from the cylindrical portion to the upper free end in a flared manner, the flared portion being elastically deformable between a retracted position and an expanded position so as to rest on the wall of the inner cavity, and

[0018] - An electronic component configured to interact with the muscles of the perineum of the patient, the electronic component being arranged on the trumpet-shaped portion and / or on the cylindrical portion.

[0019] The perineal probe according to the invention is characterized in that the trumpet-shaped part comprises, on the one hand, at least one side wall having an inner surface delimiting a conical inner volume of the trumpet-shaped part, and in that the trumpet-shaped part comprises, on the other hand, at least one longitudinal groove extending in the plane of symmetry of the perineal probe.

[0020] The structure of the perineal probe body with a cylindrical bottom portion and a trumpet-shaped top portion enables the perineal probe to remain in place when the patient is engaged in activities or movements that may cause leakage of urine or stool in daily life. In addition, the deformable properties of the trumpet-shaped portion make it possible to reduce the discomfort associated with the insertion of the probe into the inner cavity, and once the perineal probe is in place in the inner cavity, the trumpet-shaped portion can be pressed against the inner cavity wall. The vaginal or anal cavity collapses naturally, and the trumpet-shaped portion is unfolded and supported on the wall of the inner cavity after being inserted into the inner cavity, and the wall therefore collapses against the underlying perineal muscles. In addition, arranging electronic components on the bottom portion and / or top portion of the probe body enables targeting the deep and / or superficial muscles of the perineum. The hollow properties and longitudinal grooves of the trumpet-shaped portion increase the deformation amplitude of the trumpet-shaped portion.

[0021] In an embodiment of the invention, the longitudinal groove extends in the mid-sagittal plane of symmetry of the perineal probe and divides at least one side wall into two half-walls.

[0022] In an embodiment of the invention, the flared portion comprises at least one groove extending transversely relative to the mid-sagittal plane PSM of the perineal probe, the at least one groove extending on the outer surface of the side wall at the level of the base arranged at the junction between the flared portion and the cylindrical portion. The groove reduces the thickness of the side wall at the level of its base so as to increase the convergence of the flared portion.

[0023] In an embodiment of the present invention, the flared portion may include at least one opening arranged in the plane of symmetry of the perineal probe. The opening also increases the deformation amplitude of the probe. More specifically, the flared portion may include:

[0024] - a lateral opening arranged in the plane of symmetry of the perineal probe, and

[0025] - A top opening arranged at the level of the upper free end of the flared portion.

[0026] In an embodiment of the present invention, the perineal probe may include a retaining member that is movable between an extended position and a retracted position, and wherein, in the extended position, the retaining member enables the flared portion to be held in place in the patient's lumen, and in the retracted position, the retaining member enables the perineal probe to be inserted into the lumen. The lateral openings and top openings in the flared portion improve the retraction of the retaining member in the retracted position to be arranged in the internal volume of the flared portion. This makes the head of the perineal probe more compact for insertion into the lumen.

[0027] More precisely, the retaining member may comprise a tongue-shaped portion protruding from the trumpet-shaped portion towards the free end, the tongue-shaped portion protruding in the plane of symmetry of the perineal probe. Thus, the tongue-shaped portion may exert an elastic force on the wall of the inner cavity. The elastic force then participates in retaining the perineal probe in the inner cavity. Specifically, the tongue-shaped portion exerts pressure on the anterior wall of the vagina or rectum in a manner that presses the wall against the deep muscles of the perineum. In a complementary manner, the tongue-shaped portion may have a striated surface at its free end. This striated surface is then able to cooperate with the wall of the inner cavity, which in the case of the vagina also comprises stripes.

[0028] In addition, the retaining member can be attached to the cylindrical portion in a detachable manner. This makes it possible to provide a tongue of multiple sizes to adapt to the patient's anatomical structure. In addition, in the deployed position, the tongue can protrude from the flared portion along an anterior-posterior axis located in a plane. According to this arrangement, the tongue in the deployed position exerts an anteroposterior force on the wall of the vaginal or anal cavity, which helps to keep the perineal probe in place, especially when the patient is performing positional physical activities to evaluate the functional status of the perineal muscles.

[0029] In an embodiment of the invention, the flared portion may extend at an inclination angle α relative to the sidewall of the cylindrical portion, the inclination angle α being between 7° and 40°, inclusive. The inclination of the flared portion corresponds to the natural anterior-posterior inclination of the vagina. This inclination improves the retention of the perineal probe within the lumen and also acts as a polarizer, the perineal probe then being insertable into the lumen in only one anterior-posterior orientation.

[0030] In an embodiment of the invention, the flared portion comprises two electronic components arranged on either side of the symmetry plane of the perineal probe.This enables a differentiated interaction with the deep perineal muscles located on either side of the inner cavity.

[0031] In an embodiment of the invention, the cylindrical portion may include electronic components arranged on both sides of the symmetry plane of the perineal probe. This enables differentiated interaction with the superficial perineal muscles located on both sides of the inner cavity.

[0032] More precisely, the cylindrical part and the flared part may include corresponding electronic components consisting of EMG electrodes, which are arranged on both sides of the mid-sagittal plane PSM of the perineal probe. Thus, the electromyographic activity of the superficial and deep muscles of the perineum can be measured in a differentiated manner on both sides of the inner cavity.

[0033] In an embodiment of the present invention, the electronic components arranged in an anteroposterior manner on both sides of the median cross-section PTM of the perineal probe include two force sensors. Therefore, the anteroposterior force applied to the lower end of the inner cavity can be measured in an isolated manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] By reading the following description, other features and advantages of the present invention will become more clear. The following description is purely illustrative and must be read with reference to the accompanying drawings, in which:

[0035] Figure 1 is a perspective view of a perineal probe according to the present invention.

[0036] Figure 2 is from Figure 1 View from above of the flared portion of the mid-perineal probe.

[0037] Figure 3 is from Figure 1 Peripheral view of the mid-perineal probe as viewed from the front.

[0038] Figure 4 is from Figure 1 A posterior view of a perineal probe schematically positioned within a patient's internal cavity.

[0039] Figure 5 is from Figure 1 A lateral view of the mid-perineal probe showing by way of comparison the two different sized tongues and also schematically illustrating the angle of inclination of the flared portion.

[0040] Figure 6 is a view from the front of an embodiment of a perineal probe according to the invention comprising means for receiving a tongue on the side wall of the cylindrical portion of the perineal probe.

[0041] Figure 7 and Figure 8 is from Figure 1 A side view of the two retaining members of different sizes of a perineal probe.

[0042] Fig. 9 is a schematic diagram showing neuromuscular activity data which can be measured with the aid of the electronic components of the perineal probe according to the present invention. DETAILED DESCRIPTION

[0043] The present invention relates to a perineal probe 10. The perineal probe is designed for diagnosis and rehabilitation of a patient's perineum. The perineal probe 10 according to the present invention is configured to be at least partially inserted into the patient's vaginal cavity. However, the perineal probe 10 can also be inserted into the patient's anal cavity. This makes it possible to treat male patients suffering from fecal incontinence in particular. In this document, the term lumen interchangeably refers to the patient's vaginal cavity and anal cavity.

[0044] refer to Figures 1 to 6, the perineal probe 10 comprises a probe body including electronic components 110 , 111 , 112 configured to interact with the perineal muscles of the patient via the wall of the lumen.

[0045] like Figure 4 As shown, the probe body comprises a cylindrical portion 12, which is configured to be positioned at the level of the lower end 201 of the patient's lumen. In this example, the probe body is made of a medical polymer material such as silicone or polyurethane. In particular, the selected polymer material has elasticity and sealing properties.

[0046] like Figures 1 to 6 As shown, the cylindrical portion 12 has a first end 120 and a second end 121 opposite to each other. Here, the first end 120 of the cylindrical portion 12 is a free end. In this document, the first end 120 defines the lower end of the perineal probe 10. By convention, the terms "bottom" and "lower" and their derivatives when used with specific reference to the perineal probe 10 refer to the longitudinal first end 120 of the cylindrical portion 12.

[0047] The second end 121 of the cylindrical portion 12 has an upper wall 124 defining an upper end of the cylindrical portion 12 .

[0048] In this example, the cylindrical portion 12 includes a first section and a second section. The cylindrical portion 12 can be equipped with an annular flange 123. Here, the annular flange 123 is arranged at the junction between the first section and the second section of the cylindrical portion 12. The annular flange 123 espouses the patient's anatomical structure at the opening of the inner cavity. For example, for a female subject, when the perineal probe 10 is inserted into the vaginal cavity, the annular flange 123 is placed in contact with the labia minora of the patient's vulva. Therefore, the first section extends longitudinally between the annular flange 123 and the second end 121 of the cylindrical port 12 (such as Figure 4 shown).

[0049] like Figure 1 and Figures 3 to 6 As shown, the first section is capable of supporting electronic components 111, 112. At the level of the first section, the cylindrical portion 12 is delimited by a side wall 122. Furthermore, a second section of the cylindrical portion 12 extends from an annular flange 123 to a first end 120 of the cylindrical portion 12. The dimensions of the second section are smaller than those of the first section.

[0050] The body of the perineal probe 10 also includes a flared portion 13 extending from one end 121 of the cylindrical portion 12 to an upper free end 130. In this document, the upper free end 130 of the flared portion 13 defines the longitudinal upper end of the perineal probe 10. By convention, the terms "top" and "upper" and their derivatives when used with specific reference to the perineal probe 10 refer to the free end 130 of the flared portion. The body of the perineal probe 10 can measure between 5 cm and 15 cm between its bottom end and its upper end.

[0051] like Figure 3 , Figure 4 and Figure 6 As shown, the flared portion 13 extends from the cylindrical portion 12 to the upper free end 130 of the flared portion 13 in a flared flared manner. In particular, the flared portion 13 includes a base 131, which is arranged at the junction with the second end 121 of the cylindrical portion 12 of the probe body. In the present example, the flared portion 13 extends from the base 131 to the upper free end 130 of the flared portion 13. More precisely, the base 131 of the inner cavity body 13 is fixed to the upper surface 124 of the cylindrical portion 12. The flared portion 13 constitutes the head of the perineal probe 10.

[0052] In addition, the trumpet-shaped portion 13 can be elastically deformed between a folded position and an deployed position. In the folded position, the head of the perineal probe 10 occupies a small volume, which facilitates the insertion of the perineal probe 10 into the inner cavity. This improves the comfort of the patient. In addition, in the deployed position, the head of the probe can be supported on the inner cavity wall. Therefore, the perineal probe 10 is maintained in the patient's inner cavity by the trumpet-shaped portion 13 in the deployed position. The vaginal or anal inner cavity collapses naturally when at rest, thereby exerting pressure on the inner cavity wall, which enables these walls to contact the anatomical structures (such as perineal muscles) surrounding the inner cavity.

[0053] In particular, if Figures 1 to 6 As shown, the trumpet-shaped portion 13 includes at least one side wall 132. Here, the side wall 132 extends from the base 131 toward the upper free end 130 of the trumpet-shaped portion 13 in a trumpet-shaped manner. The side wall 132 has an inner surface 1320 ( Figure 2 ).

[0054] In the present example, the flared portion 13 includes at least one opening 133, 134 arranged in the plane of symmetry of the perineal probe 10. One or more openings facilitate elastic deformation of the flared portion 13 so as to more comfortably insert the probe into the inner cavity. In particular, the flared portion 13 includes a lateral opening 133 and a top opening 134.

[0055] The lateral opening 133 is arranged in the symmetry plane of the perineal probe 10. Figure 6 As shown, the lateral openings 133 extend longitudinally on both sides of the median sagittal plane PSM of the perineal probe 10 . Figures 1 to 4 and Figure 6 The mid-sagittal plane shown in FIG. 1 defines a longitudinal symmetry plane that coincides with the sagittal orientation of the perineal probe 10. The lateral opening 133 extends from the base 131 of the head to the upper free end 130 of the perineal probe 10. Figure 6 As shown, the lateral opening 133 has a U-shape extending from the base 131 , with a plurality of branches of the U-shape diverging from each other until the upper free end 130 , in such a way that a flared lateral opening 133 is formed.

[0056] like Figure 2 , Figure 3 and Figure 6 As shown in detail in FIG. 1 , the top opening 134 is arranged at the level of the upper free end 130 of the flared portion 13. Figure 2 As shown, the top opening 134 is symmetrical about the mid-sagittal plane PSM of the perineal probe 10. The lateral openings 133 include a top flange 1323 that at least partially defines the top opening 134. The top flange 1323 facilitates patient comfort during insertion of the perineal probe 10 into the lumen.

[0057] like Figure 7 As shown, the top opening 134 extends in a plane intersecting the lateral openings 133, and the two openings 133, 134 are arranged continuously with each other along the median sagittal axis of the perineal probe 10. Here, the median sagittal axis is arranged in the median sagittal plane PSM of the perineal probe 10.

[0058] like Figures 1 to 4 and Figure 6 As shown, the flared portion 13 includes at least one groove 135, 136, 137. Each groove 135, 136, 137 increases the amplitude of elastic deformation of the flared portion 13.

[0059] In particular, the flared portion 13 comprises a longitudinal groove 135 extending along the mid-sagittal plane PSM. Here, the longitudinal groove 135 divides the flared portion 13 into two half-walls 1321, 1322 in the mid-sagittal plane PSM of the perineal probe 10. In fact, the groove 135 extends at least partially between the base 131 and the upper free end 130 of the flared portion 13. Figure 2 In the example shown, the groove 135 extends along the entire height of the flared portion 13 between the base 131 and the upper free end 130 .

[0060] like Figure 2 As shown, the two half walls 1321, 1322 are bent to form a corolla. In particular, the half walls 1321, 1322 are bent in a convex manner relative to the mid-sagittal plane PSM.

[0061] The practitioner can then move the flared portion 13 from its deployed position to the retracted position by pinching the half walls 1321, 1322 to retract the head of the perineal probe 10 in the mid-sagittal plane PSM. The longitudinal grooves 135 advantageously enable the head of the perineal probe 10 to be retracted to increase its extent.

[0062] exist Figure 1 , Figure 4 and Figure 6 In the example of the flared portion 13, the flared portion 13 comprises at least one groove 136, 137 extending on the outer surface of the side wall 132 at the level of the base 131. The groove or grooves 136, 137 extend transversely relative to the median sagittal plane PSM over at least a portion of the periphery of the base 131 of the flared portion 13. These grooves 136, 137 reduce the thickness of the side wall 132 so as to increase the convergence of the flared portion 13. In this example, the flared portion 13 comprises two transverse grooves 136, 137 symmetrical about the median sagittal plane PSM. The two transverse grooves 136, 137 define a plane perpendicular to the median sagittal plane PSM.

[0063] exist Figure 5 In the example of the embodiment, the flared portion 13 extends at an inclination angle α relative to the side wall 122 of the cylindrical portion 12. Here, the inclination angle α can be between 7° and 40°, including extreme values. The inclination angle α can also be between 15° and 30°, including extreme values. The inclination of the flared portion 13 enables the morphology of the perineal probe 10 to adapt to the natural anterior-posterior inclination of the vagina relative to the pelvic floor. The inclination of the flared portion 13 can improve the patient's comfort and the retention of the perineal probe 10 in the appropriate position. In addition, the inclination of the flared portion 13 acts as a polarizer, allowing the practitioner to insert the perineal probe 10 in the correct anterior-posterior orientation.

[0064] like Figures 1 to 3 , Figure 5 and Figures 7 and 8As shown, the perineal probe 10 includes retaining members 14a, 14b. Retaining members 14a, 14b are configured to be supported on the inner cavity wall so as to improve the retention force of the perineal probe 10 in the appropriate position. In this example, retaining members 14a, 14b can move between an extended position and a retracted position. In the extended position, retaining members 14a, 14b protrude from the body of the perineal probe 10 and are supported on the inner cavity wall of the patient so as to keep the perineal probe 10 in the appropriate position. On the contrary, the retracted position of retaining members 14a, 14b enables the perineal probe 10 to be inserted into the inner cavity.

[0065] like Figures 1 to 3 and Figure 5 As shown, the retaining member 14a, 14b comprises a tongue 140 protruding from the flared portion 13 towards the free end 141. Here, the tongue 140 protrudes in the mid-sagittal plane PSM of the perineal probe 10. The tongue 140 can be elastically deformed in the same way as the flared portion 13. To this end, the tongue 140 can be made of the same material as the body of the perineal probe 10.

[0066] The tongue 140 is removably fixed to the cylindrical portion 12 of the perineal probe 10. This enables the use of multiple sizes of tongue 140 depending on the patient's anatomy. In a known manner, the vaginal depth may vary between 7 cm and 15 cm on average from one woman to another. Thus, the practitioner can select the size of the tongue 140 according to the patient's anatomy.

[0067] Figure 7 and Figure 8 Two sizes of tongues 140 are depicted for retaining members 14a, 14b. Figure 5 is a schematic diagram of a perineal probe 10 carrying two retaining members 14a, 14b, so as to be able to assess the different sizes of the tongue 140 of each retaining member 14a, 14b.

[0068] like Figure 7 and Figure 8 As shown, the tongue 140 can be divided into three sections. At a first end, the tongue 140 comprises a fixing section 142. In this example, the fixing section 142 is configured to cooperate with a complementary receiving device 15 on the body of the perineal probe 10. The complementary receiving device 15 is arranged on the body of the perineal probe 10 in a plane PSM.

[0069] exist Figures 1 to 3In the example of , the complementary receiving means 15 comprise a slit 150, the opening of which is on the upper surface 124 of the cylindrical part 12. The slit 150 is in the mid-sagittal plane PSM. The tongue 140 can therefore extend in this same plane and along the same axis of the lateral opening 133 of the inner cavity 13. In this arrangement, the tongue 140 in the deployed position protrudes from the flared part 13 along an anteroposterior axis situated in the plane PSM. This arrangement in the plane PSM also enables the tongue 140 to be retracted into the internal volume of the flared part 13 through the lateral opening 133. The tongue 140 is retracted into the internal volume of the flared part 13 by elastic deformation.

[0070] exist Figure 7 and Figure 8 In the example of the embodiment, the fixing segment 142 is straight and has a rectangular cross-section to cooperate with the slit 150. The size of the fixing segment 142 is complementary to the size of the slit 150. The cross-sections of the slit 150 and the fixing segment 142 can be other shapes, such as circular, hexagonal, triangular, etc.

[0071] As an alternative, Figure 6 In the example of , the complementary receiving means 15 comprises a notch 151 on the side wall 122 of the cylindrical portion 12. The notch 151 is located in the plane PSM. The notch 151 is complementary to the cross section of the fixing section 142 so as to retain the retaining members 14a, 14b during use of the perineal probe 10. To this end, the notch 151 forms a locking groove into which the fixing section 142 is inserted and rests on the bottom of the notch 151. Figure 6 In the embodiment of the present invention, the perineal probe 10 does not include the front and rear electronic components 112.

[0072] The complementary receiving means 15 may also take other forms, such as a clip or any other type of mechanical receiving means capable of removably securing the retaining members 14a, 14b. The removable nature of the retaining members 14a, 14b advantageously enables sterilization of the perineal probe 10 after use or selection of the tongue 140 appropriate to the patient's anatomy.

[0073] Still reference Figure 7 and Figure 8 The tongue-shaped portion 140 includes a spacing segment 143. The spacing segment 143 extends the fixing segment 142 toward the end portion 141. Figures 1 to 3 and Figure 6As shown, a spacer 143 protrudes from the receiving device 15 so as to space the tongue 140 from the body of the perineal probe 10. The spacer 143 is configured to be offset from the body of the perineal probe 10 at a certain angle. In this example, the spacer 143 is curved in a concave manner relative to the central axis of the body of the perineal probe. The central axis extends upward in the plane PSM and is perpendicular to the upper surface 124 of the cylindrical portion 12.

[0074] refer to Figure 7 and Figure 8 , the spacing segment 143 has a radius of curvature ρ, which can be larger or smaller depending on the different sizes of the retaining members 14a, 14b. Figure 8 The curvature radius ρ of the retaining member 14a is greater than Figure 7 The curvature radius ρ of the retaining member 14b in FIG.

[0075] The tongue 140 also includes a support section 144. Here, the support section 144 extends between the spacing section 143 and the free end 141 of the tongue 140. The support section 144 is configured to support on the inner cavity wall when the perineal probe 10 is introduced into the inner cavity. To this end, the support section 144 has a striated surface 145. For example, in a female subject, the striated surface 145 of the tongue 140 can better adhere to the vaginal wall, which itself has striations. In fact, the striated surface 145 improves the retention of the perineal probe 10 in the appropriate position during a diagnostic or rehabilitation program.

[0076] The striped surface 145 is more specifically arranged on the oval portion of the support segment 144. The oval portion has a surface curvature similar to the back of a spoon. This surface curvature improves the contact ability of the striped surface 145 with the vaginal wall when the retaining members 14a, 14b are in the extended position. In addition, when the retaining members 14a, 14b are in the retracted position, the oval portion of the support segment 144 is arranged in the inner volume of the trumpet-shaped portion 13. In this retracted position, the oval portion of the support segment 144 complements the half-walls 1321, 1322 in the retracted position.

[0077] The support section 144 and the half walls 1321, 1322 then form an insertion head, and the circular profile of the insertion head facilitates the insertion of the perineal probe 10 into the inner cavity. Therefore, before the perineal probe 10 is inserted into the patient's inner cavity, the practitioner moves the retaining members 14a, 14b to the retracted position, and then applies pressure to each half wall 1321, 1322 so that the trumpet-shaped portion 13 is moved to the retracted position. Once the perineal probe 10 is inserted into the inner cavity, the elastic properties of the tongue 140 and the curvature of the spacer 143 enable the perineal probe 10 to be locked in place by applying a front-to-back elastic force against the inner cavity wall. When the patient performs positional physical exercise to evaluate the functional state of the deep and superficial layers of the perineum and / or differentiated and asymmetric treatment, the front-to-back force can prevent the perineal probe 10 from being discharged from the inner cavity.

[0078] like Figure 7 and Figure 8 As shown, the size of the retaining members 14a, 14b may differ according to the height H of the tongue 140, and also according to the distance d corresponding to the offset of the free end 141 relative to the fixing section 142. More specifically, the radius of curvature ρ of the spacing section 143 and the length of the support section 144 may have different sizes so as to provide a plurality of retaining members 14a, 14b of different sizes. Figure 7 In the example of Figure 8 The supporting section length of the retaining member 14a in .

[0079] like Figure 1 and Figures 3 to 6 As shown, electronic components 110 , 111 , 112 are arranged on the trumpet-shaped portion 13 and / or on the cylindrical portion 12 .

[0080] The perineal probe 10 includes a power cable 16 for the electronic components 110, 111, 112. In this example, the cylindrical portion 12 includes at least one longitudinal channel so that the power cable 16 can be integrated into the cylindrical portion 12 of the perineal probe 10. Specifically, the at least one longitudinal channel extends from the free end 120 of the cylindrical portion 12 to a point of contact with each electronic component 110, 111, 112. The power cable 16 connects each electronic component 110, 111, 112 to an electronic control unit. Specifically, the electronic control unit can manage each electronic component 110, 111, 112 in a differentiated manner. The electronic control unit may include a computer or any other electronic terminal configured to store and execute a program for managing the electronic components 110, 111, 112 of the perineal probe 10.

[0081] The connector connecting the power supply cable 16 to the electronic components 110 , 111 , 112 is integrated into the body of the perineal probe 10 in order to ensure its insulation. Figure 2 Two pads 160 are shown at the junction between each half-wall 1321, 1322 and the upper surface 124 of the cylindrical portion 12. These pads 160 form respective cavities in which the contacts of the electrical cable 16 are connected to the contacts of the electronic components 110, 111, 112.

[0082] As an alternative to a wired power source, the perineal probe 10 may include a rechargeable battery to power the electronic components 110, 111, 112, a remote transmission device (e.g., etc.), and an electronic control unit for the electronic components 110, 111, 112. The remote transmission device may include a near-field transmitter / receiver of the type of radio, Bluetooth, Wi-Fi, NFC, RFID, etc. In addition, the electronic control unit may include a clock, a processor, and a memory capable of storing and executing data and algorithms, such as diagnostic programs and / or rehabilitation programs previously loaded into the memory.

[0083] According to one embodiment of the invention, the electronic components 110, 111 are arranged two by two on both sides of the mid-sagittal plane PSM. Each electronic component 110, 111 preferably comprises a corresponding EMG electrode. In this context, the abbreviation "EMG" stands for "electromyographic".

[0084] exist Figure 4 and Figure 5 In the embodiment, the electronic components 112 are arranged on the cylindrical portion 12. In particular, the electronic components 112 are arranged two by two in a front-to-back manner on both sides of the median transverse plane PTM of the perineal probe 10. According to this configuration, each electronic component 112 includes a force sensor. Figure 5 The median transverse section PTM presented in FIG. 1 defines a longitudinal symmetry plane according to the transverse orientation of the perineal probe 10 .

[0085] The perineal probe 10 may include only the electronic components 110, 111 equipped with EMG electrodes, or only the electronic components 112 consisting of corresponding force sensors. However, the perineal probe 10 may also combine all the electronic components 110, 111, 112 (see Figure 4 ). In this case, the perineal probe 10 can function in two modes: an EMG mode, in which only the electronic components 110, 111 are active; and a force measurement mode, in which only the electronic component 112 is active.

[0086] like Figure 3 , Figure 4 and Figure 6 As shown, the flared portion 13 comprises two electronic components 110, which are arranged on respective opposite sides of the plane of symmetry of the perineal probe 10. In this example, the two electronic components 110 are arranged on either side of the plane PSM.

[0087] like Figure 4 and Figure 5 As shown, each electronic component 110 of the trumpet-shaped part 13 can extend over a surface greater than 50% of the outer surface of each half-wall 1321, 1322. Each electronic component 110 can preferably extend over a surface greater than 70% of the outer surface of each half-wall 1321, 1322. Also preferably, each electronic component 110 can extend over a surface greater than 90% of the outer surface of each half-wall 1321, 1322. When the electronic component 110 includes an EMG electrode, the electrode extends over the entire surface of the electronic component 110. Now, for example in the context of an electrical stimulation procedure, a large electrode surface enables the current intensity to be more widely distributed over the patient's anatomical structure.

[0088] In fact, when it comes to electrostimulation electrodes, standard 60601-2-10 states that the current density of the electrodes must not exceed a maximum threshold of 2 mA / cm 2 At present, in order to obtain an electrical induction response, a current of at least 30 mA must be applied. Increasing the surface area of ​​the electrode as described above makes it possible to comply with the standard while obtaining a satisfactory electrical induction response.

[0089] like Figure 5 As shown, each electronic component 110 has a trapezoidal shape, and the upper corners of the trapezoidal shape are rounded. This shape makes it possible to follow the morphology of each half wall 1321, 1322, and more generally follow the shape of the flared portion 13. Therefore, the surface of each electronic component 110 is curved. Each electronic component 110 extends upward from the base 131 to the upper free end 130 of the flared portion 13.

[0090] like Figure 3 , Figure 4 and Figure 6 As shown, the cylindrical portion 13 further comprises two electronic components 111 arranged on both sides of the plane PSM of the perineal probe 10. More specifically, the electronic components 111 are arranged in the upper part of the first section of the cylindrical portion 12. The upper part is located near the second end 121 of the cylindrical portion 12.

[0091] Figure 4 The perineal probe 10 is schematically depicted in position in the vaginal cavity, viewed from the rear in cross-section of the vaginal cavity.

[0092] In this figure, half walls 1321, 1322 and electronic component 110 are in contact with the wall 200 of the vaginal cavity. Therefore, electronic component 110 is arranged to face the deep perineal muscles surrounding the vaginal cavity. The deep perineal muscles especially include pubovaginal muscle or pubococcygeus muscle, but also include puborectalis muscle. These are paired muscles surrounding the vagina and rectal cavity. Iliococcygeus muscle and ischiococcygeus muscle form two perineal cupolas, which, from a physiological point of view, show muscle pretension and have potential energy for suppressing intra-abdominal pressure. Here, iliococcygeus muscle and ischiococcygeus muscle 210 are represented as contacting with vaginal wall 200. The deep perineum also includes puborectalis muscle. In fact, when the perineal probe 10 is inserted into the anal cavity, the electronic component 110 is positioned facing the iliococcygeus and ischiococcygeus muscles.

[0093] like Figure 4 As shown, when the perineal probe 10 is in place in the vaginal cavity, the electronic component 111 of the cylindrical portion 13 is also placed to contact the vaginal wall 200 near the vaginal opening. Thus, the electronic component 111 is arranged to face the perineal surface muscles. The perineal surface muscles include the bulbospongiosus muscle and the ischiocavernosus muscle in particular. These are also paired muscles that surround the vagina and the bottom end of the urethra. From a functional point of view, the contraction of the bulbospongiosus muscle and the ischiocavernosus muscle enhances the closure of the urethral sphincter. The perineal surface also includes the external anal sphincter. When the perineal probe 10 is inserted into the anal cavity, the electronic component 111 is positioned to face the external anal sphincter.

[0094] refer to Figure 4 and Figure 5 , an electronic component 112 consisting of a force sensor is arranged on the top part of the cylindrical part 12. When the perineal probe 10 is inserted into the inner cavity, the force sensor is positioned at the level of the surface layer of the perineum. Therefore, the force applied to the bottom end of the inner cavity along the anterior-posterior axis can be measured. For example, the functional state of the pubovaginal muscles, bulbospongiosus muscles and ischiocavernosus muscles surrounding the vagina and urethra can be inferred from these measurement results.

[0095] For reasons of hygiene, when using a force sensor, the perineal probe 10 is inserted in a condom-like envelope before being inserted into the patient's inner cavity. However, it is recommended in all cases to sterilize the perineal probe 10 after each use.

[0096] The perineal probe 10 preferably includes two electronic components 110 arranged on the flared portion 13 and two electronic components 111 arranged on the cylindrical portion 12 of the body of the perineal probe 10 .

[0097] In this configuration, the deep and superficial perineal muscles can be evaluated for their functional status and / or rehabilitated by their EMG activity.Perineal probe 10 is configured to interact with anatomical structures disposed on either side of the mid-sagittal plane of the patient's lumen in a differentiated manner.

[0098] exist Figure 4 In the example of the present invention, the electronic components 110, 111 are arranged on both sides of the mid-sagittal plane PSM of the perineal probe 10 so that the bundled iliococcygeus muscle and ischiococcygeus muscle and / or pubovaginal muscle, ischiocavernosus muscle and bulbospongiosus muscle located on both sides of the vagina can be treated differently. Therefore, the perineal probe 10 makes it possible to diagnose and / or treat asymmetric functional states of these muscles.

[0099] Furthermore, perineal probe 10 is configured to interact in a differentiated manner with anatomical structures surrounding the patient's internal cavity that are arranged in two different anatomical planes. Figure 4 Arranging the electronic components 110, 111 on the cylindrical portion 12 and the trumpet-shaped portion 13 enables independent treatment of the superficial and deep muscles of the perineum.

[0100] By the fact that each electronic component 110, 111 comprises its own electrical cable 16 connecting it independently to a control unit, the possibility of differentially treating the muscles on both sides of the vagina located in two different anatomical planes is also achieved.

[0101] As mentioned in the introduction to this article, the phenomenon of continence is a complex phenomenon involving multiple groups of muscles in terms of muscle tone, reactivity, and the quality of stretch and conditioned reflexes.

[0102] The first group of muscles involved corresponds to the urethral sphincter and the anal sphincter, which surround the urethra and the anal canal, respectively. Due to the respective contraction of these muscles, the urethra and the anal canal are closed.

[0103] The perineal muscles constitute the second group of muscles involved in the continence mechanism. The superficial perineal muscles surround the urethra, vagina, and the lower end of the anal canal. The deep perineal muscles, however, form two perineal vaults that are in a state of muscular pretension and have the potential to suppress intra-abdominal pressure. The deep muscles also surround the vaginal cavity in a deeper anatomical layer.

[0104] As already pointed out, the deep and superficial muscles of the perineum do not have the same role in the continence mechanism. The deep perineal muscles have the function of inhibiting the increase in intra-abdominal pressure, a phenomenon that triggers potential situations of urine or stool leakage. The superficial perineal muscles participate in their part in the closure of the urethra or anal canal.

[0105] During a clinical examination, the perineal probe 10 is inserted into the patient's inner cavity before the patient engages in activities that would normally result in leakage of urine or stool (coughing, bending the knees, leaning forward, weight bearing, etc.).

[0106] During these activities, the perineal probe 10 can measure, through EMG activity, the tone of the superficial and deep perineal muscles, the perineal anticipatory reflex, the muscle tone following the perineal reflex, the stretch reflex, and the fast muscle fiber response triggered by the reflex.

[0107] In addition, by tracking the force applied to the force sensor through the inner cavity wall, it is also possible to evaluate the tension of the deep and superficial layers of the perineum, the perineal anticipatory reflex, the response of the fast fibers, the timing of the stretch reflex (is it present? Or is it delayed?), etc.

[0108] Fig. 9 The graph 500 in FIG. 5 schematically shows four traces A, B, C, D, which are functions of the time T of the neuromuscular activity Ac measured by the electronic components 110 , 111 , 112 of the perineal probe 10 according to the invention.

[0109] Trace A corresponds to the data measured by the rear force sensor of the electronic component 112. The electronic component 112 is placed at the level of the surface of the perineum. First, the basic tension Tb of the perineal cavity and the surface muscles is measured. When the patient is ready to perform a movement that causes an increase in intra-abdominal pressure, an increase in neuromuscular activity can be seen in the graph 500, which corresponds to the perineal expected reflex Ra that activates fiber I. The data measured after the expected reflex Ra corresponds to the tension Tjc of the connective tissue, which increases with the increase in neuromuscular activity (fiber I). In theory, the tension of the functional connective tissue is seen as a trace in the form of a plateau as depicted in trace A.

[0110] In response to the muscle stretching produced by the increase in intra-abdominal pressure, the recruitment (recruitment) of type I muscle fibers or slow fibers gradually increases muscle contraction and closure pressure (urethra and anus). This stage is represented as WFI in trace A. When stretching reaches a specific threshold, the stretch reflex RM triggers the response WFII of type II muscle fibers or fast fibers. Trace A includes solid line and dot-dash curve, and the curvature slope of the solid line increases significantly after the stretch reflex RM, and the slope of the dot-dash curve reduces. Now, the dot-dash portion of the curve of trace A is the feature of the dysfunction of fast fibers or stretch reflex.

[0111] Traces B and C in the graph 500 correspond to data measured by the EMG sensors of the corresponding electronic components 110 of the flared portion 13. These traces therefore correspond to the activity of the perineal muscles on both sides of the plane PSM. Note the hypertonicity of the basic tension Tb on trace C and the contour line with a significantly less curvature than trace B. This trace may indicate a functional asymmetry of the perineal vault. This asymmetry may occur in pregnant women, depending on the position of the baby's head. However, asymmetric hypertonicity may also be caused by obstetric trauma, physical trauma or psychological trauma.

[0112] Trace D in the graph 500 corresponds to data measured by the front force sensor of the electronic component 112. The electronic component 112 is placed at the level of the surface layer of the perineum. In this trace, the dot-dash trace corresponds to the mass reduction of the connective tissue of the perineum.

[0113] The perineal probe 10 can establish a differentiated diagnosis of various muscles constituting the surface and deep layers of the perineum. Specifically, the functional states of two pairs of bundled iliococcygeus and ischiococcygeus muscles and / or pubovaginal muscles and puborectalis muscles (deep layer), bulbospongiosus muscles and ischiocavernosus muscles (surface layer) can be evaluated differently.

[0114] The perineal probe 10 is able to establish precise dysfunctions: hypertonicity or hypotonicity of base tension and / or connective tissue tension, dysfunction of fast and / or slow fibers, absence or delayed presence of expected reflexes, absence or delayed presence of stretch reflexes, etc. The measured data can be interpreted directly or by comparison with a reference database.

[0115] Once a diagnosis is established, the perineal probe 10 can recommend a functional rehabilitation program that can target the anatomical structure with the dysfunctional state. Based on the problem identified, the practitioner can apply an electrical stimulation program through the EMG electrodes that is suitable for treating the diagnosed dysfunction or disorders.

Claims

1. A perineal probe (10), comprising a probe body, the probe body comprising: - a cylindrical portion (12) configured to be positioned at the opening of the inner cavity of the vagina or anus of a patient, - a flared portion (13) extending from one end (121) of the cylindrical portion (12), the flared portion (13) extending in a flared manner from the cylindrical portion (12) to an upper free end (130), the flared portion (13) being elastically deformable between a retracted position and an expanded position so as to rest on the wall of the inner cavity, and - an electronic component (110, 111, 112) configured to interact with the muscles of the perineum of the patient, said electronic component (110, 111, 112) being arranged on said trumpet-shaped portion (13) and / or on said cylindrical portion (12), It is characterized in that the trumpet-shaped part (13) comprises, on the one hand, at least one side wall (132), which has an inner surface (1320) that defines the conical internal volume of the trumpet-shaped part (13), and the trumpet-shaped part (13) comprises, on the other hand, at least one longitudinal groove (135) that extends in the symmetry plane of the perineal probe (10).

2. The perineal probe (10) according to claim 1, wherein: The longitudinal groove (135) extends in the mid-sagittal plane of symmetry (PSM) of the perineal probe (10) and divides the at least one side wall (132) into two half walls (1321, 1322).

3. The perineal probe (10) according to claim 2, wherein: The trumpet-shaped portion (13) comprises at least one groove (136, 137) extending transversely relative to the mid-sagittal plane (PSM) of the perineal probe (10), and the at least one groove (136, 137) extends on the outer surface of the side wall (132) at the level of the base (131) arranged at the junction between the trumpet-shaped portion (13) and the cylindrical portion (12).

4. The perineal probe (10) according to claim 1, wherein: The trumpet-shaped portion (13) comprises at least one opening (133, 134) arranged in a plane of symmetry of the perineal probe (10).

5. The perineal probe (10) according to claim 4, wherein: The trumpet-shaped portion (13) comprises: - a lateral opening (133) arranged in the plane of symmetry of said perineal probe (10), and - a top opening (134) arranged at the level of the upper free end (130) of the flared portion (13).

6. The perineal probe (10) according to claim 2, comprising a retaining member (14a, 14b) movable between an extended position and a retracted position, and wherein: In the deployed position, the retaining members (14a, 14b) enable the flared portion (13) to be retained in place within an inner cavity of a patient, and in the collapsed position, the retaining members (14a, 14b) enable the perineal probe (10) to be inserted into the inner cavity.

7. The perineal probe (10) according to claim 6, wherein: The retaining member (14a, 14b) comprises a tongue (140) protruding from the flared portion (13) towards a free end (141), the tongue (140) protruding in a plane of symmetry of the perineal probe (10).

8. The perineal probe (10) according to claim 7, wherein: The tongue (140) has a striated surface (145) at its free end (141).

9. The perineal probe (10) according to any one of claims 6 to 8, wherein: The retaining member (14a, 14b) is detachably attached to the cylindrical portion (12).

10. The perineal probe (10) according to claim 7 or 8, wherein: In the deployed position, the tongue (140) protrudes from the flared portion (13) along an anterior-posterior axis in the mid-sagittal plane (PSM).

11. The perineal probe (10) according to claim 1, wherein: The flared portion (13) extends at an inclination angle α relative to the side wall (122) of the cylindrical portion (12), the inclination angle α being between 7° and 40°, inclusive.

12. The perineal probe (10) according to claim 1, wherein: The flared portion (13) comprises two electronic components (110) arranged on either side of a symmetry plane of the perineal probe (10).

13. The perineal probe (10) according to claim 1, wherein: The cylindrical portion (12) comprises electronic components (111, 112) arranged on both sides of a symmetry plane of the perineal probe (10).

14. The perineal probe (10) according to claim 13, wherein: The cylindrical portion (12) and the flared portion (13) comprise respective electronic components (110, 111) consisting of EMG electrodes, which are arranged on both sides of the mid-sagittal plane PSM of the perineal probe (10).

15. The perineal probe according to claim 1, wherein: The electronic component (112) arranged in an anteroposterior manner on both sides of the median cross-section PTM of the perineal probe (10) comprises two force sensors.

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