Perineal probe
20240407727 ยท 2024-12-12
Inventors
Cpc classification
A61B90/06
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
A61N1/36007
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/251
HUMAN NECESSITIES
A61B90/00
HUMAN NECESSITIES
Abstract
A perineal probe (10) having a probe body which includes electronic members (110, 111, 112) configured to interact with perineal muscles of the patient. The probe body has a cylindrical portion (12) configured to be positioned at the opening of the body cavity of a patient, and a flared portion (13) which extends from one end (121) of the cylindrical portion (12). The flared portion (13) extends widening from the cylindrical portion (12) as far as a free upper end (130), with the flared portion (13) being elastically deformable between a retracted position and a deployed position. The electronic members (110, 111, 112) are arranged on the flared portion (13) and/or on the cylindrical portion (12).
Claims
1. A perineal probe comprising a probe body which includes: a cylindrical portion configured to be positioned at the opening of the vaginal or anal endocavity of a patient, a flared portion which extends from one end of the cylindrical portion, the flared portion extends in a flared manner from the cylindrical portion to a free upper end, the flared portion being elastically deformable between a folded position and a deployed position so as to rest on the walls of the endocavity, and electronic organs configured to interact with the muscles of the perineum of a patient, the electronic organs being disposed on the flared portion and/or on the cylindrical portion, wherein the flared portion includes, on the one hand, at least one side wall which has an internal face delimiting a conical internal volume of the flared portion, and, on the other hand, at least one longitudinal groove which extends in a plane of symmetry of the perineal probe.
2. The perineal probe as claimed in claim 1 in which the longitudinal groove extends in a median sagittal plane of symmetry of the perineal probe and divides said at least one lateral wall into two half-walls.
3. The perineal probe as claimed in claim 2 in which the flared portion includes at least one groove that extends transversely relative to the median sagittal plane of the perineal probe, the groove extending on the exterior face of the lateral wall at the level of a base disposed at the junction between the flared portion and the cylindrical portion.
4. The perineal probe as claimed in claim 1 in which the flared portion includes at least one opening disposed in a plane of symmetry of the perineal probe.
5. The perineal probe as claimed in claim 4 in which the flared portion includes: a lateral opening disposed in a plane of symmetry of the perineal probe, and a top opening disposed at the level of the free upper end of the flared portion.
6. The perineal probe as claimed in claim 1, including a retaining member that is mobile between a deployed position and a folded position and in which, in the deployed position, the retaining member enables the flared portion to be retained in position in the endocavity of the patient and, in the folded position, the retaining member enables insertion of the perineal probe into the endocavity.
7. The perineal probe as claimed in claim 6 in which the retaining member includes a tongue that projects from the flared portion toward a free end, the tongue projecting in a plane of symmetry of the perineal probe.
8. The perineal probe as claimed in claim 7 in which the tongue has a striated surface at its free end.
9. The perineal probe as claimed in claim 6 in which the retaining member is attached to the cylindrical portion in a detachable manner.
10. The perineal probe as claimed in claim 7 in which in the deployed position the tongue projects from the flared portion along an anterior-posterior axis in the median sagittal plane.
11. The perineal probe as claimed in claim 1 in which the flared portion extends at an angle of inclination relative to a lateral wall of the cylindrical portion, the angle of inclination being between 7 and 40 inclusive.
12. The perineal probe as claimed in claim 1 in which the flared portion includes two electronic members disposed on either side of a plane of symmetry of the perineal probe.
13. The perineal probe as claimed in claim 1 in which the cylindrical portion includes electronic members disposed on either side of a plane of symmetry of the perineal probe.
14. The perineal probe as claimed in claim 10, wherein the cylindrical portion includes electronic members disposed on either side of a plane of symmetry of the perineal probe, and in which the cylindrical portion and the flared portion include respective electronic members including EMG electrodes, the electronic members being disposed on either side of a median sagittal plane PSM of the perineal probe.
15. The perineal probe as claimed in claim 1 in which the electronic members disposed in an anterior-posterior manner on either side of a median transverse plane PTM of the perineal probe include two force sensors.
Description
DESCRIPTION OF THE DRAWINGS
[0034] Other features and advantages of the invention will become more clearly apparent on reading the following description. The latter is purely illustrative and must be read with reference to the appended drawings, in which:
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
DESCRIPTION OF EMBODIMENTS
[0043] The present invention concerns a perineal probe 10. This perineal probe is designed for diagnosis and rehabilitation of the perineum of a patient. The perineal probe 10 in accordance with the invention is configured to be at least partly inserted into the vaginal cavity of a patient. However, the perineal probe 10 may equally be inserted into the anal cavity of a patient. This makes it possible in particular to treat male patients suffering from fecal incontinence. In the present document the term endocavity designates interchangeably the vaginal cavity and the anal cavity of a patient.
[0044] Referring to
[0045] As depicted in
[0046] As depicted in
[0047] The second end 121 of the cylindrical portion 12 has an upper wall 124 that delimits the upper end of the cylindrical portion 12.
[0048] In this example the cylindrical portion 12 comprises a first section and a second section. The cylindrical portion 12 may be equipped with an annular bead 123. Here the annular bead 123 is disposed at the junction between the first section and the second section of the cylindrical portion 12. The annular bead 123 espouses the anatomy of the patient at the opening of the endocavity. For example, for a female subject, when the perineal probe 10 is inserted into the vaginal cavity, the annular bead 123 is placed in contact with the labia minora of the vulva of the patient. Thus the first section extends longitudinally between the annular bead 123 and the second end 121 of the cylindrical port 12 (depicted in
[0049] As depicted in
[0050] The body of the perineal probe 10 also includes a flared portion 13 that extends from one end 121 of the cylindrical portion 12 to the free upper end 130. In the present document the free upper end 130 of the flared portion 13 defines an upper longitudinal end of the perineal probe 10. By convention, the terms top and upper and derivatives thereof, when used specifically with reference to the perineal probe 10, designate 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] As depicted in
[0052] Furthermore, the flared portion 13 is elastically deformable between a folded position and a deployed position. In the folded position the head of the perineal probe 10 occupies a small volume that facilitates the insertion of the perineal probe 10 into the endocavity. This improves the comfort of the patient. Furthermore, in the deployed position the head of the probe is able to bear on the walls of the endocavity. Because of this the perineal probe 10 is retained in the endocavity of a patient by the flared portion 13 in the deployed position. The vaginal or anal endocavity being naturally collapsed at rest, applying pressure to the walls of the endocavity enables those walls to be brought into contact with the anatomical structures surrounding the endocavity such as the muscles of the perineum.
[0053] In particular, as depicted in
[0054] In the present example the flared portion 13 includes at least one opening 133, 134 disposed in a plane of symmetry of the perineal probe 10. The opening or openings facilitate(s) the elastic deformation of the flared portion 13 for more comfortable insertion of the probe into the endocavity. In particular, the flared portion 13 includes a lateral opening 133 and a top opening 134.
[0055] The lateral opening 133 is disposed in a plane of symmetry of the perineal probe 10. As depicted in
[0056] As depicted in
[0057] As depicted in
[0058] As depicted in
[0059] In particular, the flared portion 13 includes a longitudinal groove 135 that extends in the median sagittal plane PSM. Here the longitudinal groove 135 divides the flared portion 13 into two half-walls 1321, 1322 in the median sagittal plane PSM of the perineal probe 10. In practise, the groove 135 extends at least partly between the base 131 and the free upper end 130 of the flared portion 13. In the example depicted in
[0060] As depicted in
[0061] The medical practitioner can then move the flared portion 13 from its deployed position to the folded position by pinching the half-walls 1321, 1322 in order to fold the head of the perineal probe 10 in the median sagittal plane PSM. The longitudinal groove 135 advantageously makes it possible to increase the amplitude of the folding of the head of the perineal probe 10.
[0062] In the example in
[0063] In the
[0064] As depicted in
[0065] As depicted in
[0066] The tongue 140 is detachably fixed to the cylindrical portion 12 of the perineal probe 10. This enables the use of a plurality of sizes of tongues 140 as a function of the anatomy of the patient. In known manner the depth of a vagina may vary from one woman to another between 7 and 15 cm on average. The medical practitioner can then choose the size of the tongue 140 as a function of the anatomy of the patient.
[0067]
[0068] As depicted in
[0069] In the example from
[0070] In the example in
[0071] Alternatively, in the
[0072] The complementary receiving means 15 may also take other forms such as clips or any other type of mechanical receiving means enabling removable fixing of the retaining member 14a, 14b. The detachable character of the retaining member 14a, 14b advantageously enables sterilization of the perineal probe 10 after use or choice of a tongue 140 appropriate for the anatomy of the patient.
[0073] Still with reference to
[0074] Referring to
[0075] The tongue 140 also includes a bearing segment 144. Here the bearing segment 144 extends between the spacing segment 143 and the free end 141 of the tongue 140. The bearing segment 144 is configured to bear on a wall of the endocavity when the perineal probe 10 is introduced into the endocavity. To this end the bearing segment 144 has a striated surface 145. For example, in a female subject the striated surface 145 of the tongue 140 enables better adhesion to the vaginal wall which itself features striations. In fact, the striated surface 145 improves the retention in position of the perineal probe 10 during a diagnostic protocol or a rehabilitation protocol.
[0076] The striated surface 145 is more specifically disposed on an oval portion of the bearing segment 144. The oval portion has a surface curvature like the back of a spoon. When the retaining member 14a, 14b is in the deployed position the surface curvature improves the contact of the striated surface 145 with the vaginal wall. Moreover, when the retaining member 14a, 14b is in the folded position the oval portion of the bearing segment 144 is disposed in the internal volume of the flared portion 13. In this folded position the oval portion of the bearing segment 144 is complementary to the half-walls 1321, 1322 in the folded position.
[0077] The bearing segment 144 and the half-walls 1321, 1322 then form an insertion head the rounded profile of which facilitates the insertion of the perineal probe 10 into the endocavity. Consequently, before insertion of the perineal probe 10 into the endocavity of a patient the medical practitioner causes the retaining member 14a, 14b to move to the folded position before exerting pressure on each half-wall 1321, 1322 in order to move the flared portion 13 into the folded position. Once the perineal probe 10 has been inserted into the endocavity the elastic properties of the tongue 140 and the curvature of the spacing segment 143 enable the perineal probe 10 to be locked in position by exerting an anterior-posterior elastic force against the wall of the endocavity. This anterior-posterior force makes it possible to prevent the perineal probe 10 being expelled from the endocavity when the patient performs a positional physical exercise with a view to evaluation of the functional status and/or differentiated and dissymmetrical treatment of the deep layers and the surface layers of the perineum.
[0078] As depicted in
[0079] As depicted in
[0080] The perineal probe 10 includes power supply cables 16 for the electronic members 110, 111, 112. In this example the cylindrical portion 12 includes at least one longitudinal passage enabling integration of the power supply cables 16 into the cylindrical portion 12 of the perineal probe 10. In particular, said at least one longitudinal passage extends from the free end 120 of the cylindrical portion 12 as far as a point of contact with each electronic member 110, 111, 112. The power supply cables 16 connect each electronic member 110, 111, 112 to an electronic control unit. In particular, the electronic control unit is capable of managing each electric member 110, 111, 112 in a differentiated manner. The electronic control unit may consist of a computer or any other electronic terminal configured to store and to execute a program for management of the electronic members 110, 111, 112 of the perineal probe 10.
[0081] The connectors connecting the power supply cables 16 to the electronic members 110, 111, 112 are integrated into the body of the perineal probe 10 in order to guarantee insulation thereof.
[0082] As an alternative to a wired power supply, the perineal probe 10 may include a rechargeable battery feeding the electronic members 110, 111, 112, remote transmission means (for example, etc.) and an electronic control unit for the electronic members 110, 111, 112. The remote transmission means may consist of a near field transmitter/receiver of radio, Bluetooth, Wi-Fi, NFC, RFID, etc. type. Furthermore the electronic control unit may include a clock, a processor and a memory capable of storing and executing data and algorithms such as a diagnostic program and/or a rehabilitation program previously loaded into the memory.
[0083] In accordance with one embodiment of the invention the electronic members 110, 111 are disposed two by two on either side of the median sagittal plane PSM. Each electronic member 110, 111 preferably includes a respective EMG electrode. In the present document the abbreviation EMG means electromyographic.
[0084] In
[0085] The perineal probe 10 may include only electronic members 110, 111 equipped with EMG electrodes or only electronic members 112 consisting of respective force sensors. Nevertheless, the perineal probe 10 may also combine all the electronic members 110, 111, 112 (see
[0086] As depicted in
[0087] As depicted in
[0088] In fact, where electrostimulation electrodes are concerned, the standard 60601-2-10 specifies that the current density of an electrode must not exceed a maximum threshold of 2 mA/cm.sup.2. Now, to obtain an electro-induced response at least 30 mA must be applied. Increasing the surface area of the electrode as explained above makes it possible to comply with the standard whilst obtaining a satisfactory electro-induced response.
[0089] As depicted in
[0090] As depicted in
[0091]
[0092] In this representation the half-walls 1321, 1322 and the electronic members 110 are in contact with the wall 200 of the vaginal cavity. Because of this the electronic members 110 are disposed facing muscles of the deep layer of the perineum that surround the vaginal cavity. The muscles of the deep layer of the perineum include in particular the pubovaginal or pubococcygeus muscles but also the puborectalis muscles. These are pairs of muscles that surround the vaginal and rectal cavity. The ileococcygeus and ischiococcygeus muscles form two perineal cupolas that in physiological terms are manifested in muscular pretension and dispose of potential energy for damping the intra-abdominal pressure. Here the ileococcygeus and ischiococcygeus muscles 210 are represented in contact with the vaginal wall 200. The deep layer of the perineum also includes the puborectalis muscles. In fact, when the perineal probe 10 is inserted in the anal cavity the electronic members 110 are positioned facing the ileococcygeus and ischiococcygeus muscles.
[0093] As depicted in
[0094] Referring to
[0095] For reasons of hygiene, when the force sensors are used, the perineal probe 10 is inserted into a condom-type envelope before being inserted into the endocavity of a patient. Nevertheless, it is recommended in all cases to decontaminate the perineal probe 10 after each use.
[0096] The perineal probe 10 preferably includes two electronic members 110 disposed on the flared portion 13 and two electronic members 111 disposed on the cylindrical portion 12 of the body of the perineal probe 10.
[0097] In this configuration it is possible to assess via their EMG activity the functional status of and/or to rehabilitate the muscles of the deep and surface layers of the perineum. The perineal probe 10 is configured to interact in a differentiated manner with anatomical structures disposed on either side of the median sagittal plane of the endocavity of the patient.
[0098] In the
[0099] Furthermore, the perineal probe 10 is configured to interact in a differentiated manner with anatomical structures that surround the endocavity of the patient disposed in two distinct anatomical planes. Referring to
[0100] The possibility of differentiated treatment of the muscles situated on either side of the vagina in two different anatomic planes is also made possible by the fact that each electronic member 110, 111 includes its own electrical cable 16 that connects it independently to a control unit.
[0101] As indicated in the introductory part of the present document, the continence phenomenon is a complex phenomenon that involves a plurality of groups of muscles as much in terms of their tone as in terms of their reactivity as in terms of the quality of the myotatic and conditioned reflexes.
[0102] The first group of muscles involved corresponds to the urethra and anal sphincters that respectively surround the urethra and the anal passage. Because of the effect of the respective contraction of these muscles, the urethra and the anal passage are closed.
[0103] The muscles of the perineum constitute a second group of muscles that participate in the continence mechanism. The surface layer of muscles of the perineum surrounds the lower end of the urethra, the vagina and the anal passage. Whereas the deep muscles of the perineum form two perineal cupolas that are in muscular pre-tension and have a potential energy for damping the intra-abdominal pressure. The deep muscles also surround the vaginal cavity in a deeper anatomical layer.
[0104] As has been indicated, the deep and surface muscles of the perineum do not have the same role in the continence mechanism. The deep muscles of the perineum have a function of damping the increased intra-abdominal pressure, which is a phenomenon triggering a potential situation of urinary or fecal leakage. The surface muscles of the perineum for their part participate in closing the urethra or the anal passage.
[0105] During a clinical examination the perineal probe 10 is inserted into the endocavity of a patient before the latter performs exercises that usually lead to urinary or fecal leakage: coughing, bending the knee, leaning forward, carrying loads, etc.
[0106] During these exercises the perineal probe 10 enables measurement via the EMG activity of the tone of the surface and deep muscles of the perineum, the perineal anticipation reflex, the muscle tone after the perineal reflex, the myotatic reflex, and also the response of the rapid muscular fibers initiated by this reflex.
[0107] Furthermore, by tracking the forces that are applied to the force sensors via the wall of the endocavity it is also possible to assess the tone of the deep and surface layers of the perineum, the perineal anticipation reflex, the response of the rapid fibers, the timing of the myotatic reflex (is it present? or delayed?), etc.
[0108] The graph 500 in
[0109] The trace A corresponds to data measured by a posterior force sensor of the electronic member 112. The latter is placed at the level of the surface layer of the perineum. Firstly, there is measured the basic tone Tb of the endocavity and the surface muscles of the perineum. When the patient prepares to perform a movement leading to an increase in the intra-abdominal pressure, there is seen in the graph 500 an increase in the neuromuscular activity that corresponds to the perineal anticipation reflex Ra that activates the fibers I. The data measured after the anticipation reflex Ra corresponds to the tone of the connecting tissue Tjc as increased by the increased neuromuscular activity (fiber I). In theory, the tone of the functional connecting tissue is seen as a trace in the form of a plateau as in the trace A depicted.
[0110] In response to the muscular stretching generated by the increased intra-abdominal pressure, the recruitment of the muscular fibers of type I or slow fibers progressively increases the muscular contraction and the closing pressure (urethra and anal). This phase is denoted WFI in trace A. When the stretching reaches a particular threshold, the myotatic reflex RM triggers the response WFII of the muscular fibers of type II or rapid fibers. The trace A includes a continuous line the slope of the curvature of which increases significantly after the myotatic reflex RM and a curve in chain-dotted line for which the slope of the curve decreases. Now, the chain-dotted section of the curve of trace A is characteristic of a dysfunction of the rapid fibers or of the myotatic reflex.
[0111] The traces B and C in the graph 500 correspond to the data measured by the EMG sensors of the respective electronic members 110 of the flared portion 13. These traces therefore correspond to the activity of the perineal muscles on either side of the plane PSM. Note on trace C a hypertonicity of the basic tone Tb and a profile of less marked curvature than that of trace B. Such traces can reveal a functional dissymmetry of the perineal cupolas. This dissymmetry may be encountered in a pregnant woman, depending on the position of the head of the baby. Nevertheless, dissymmetric hypertonicity can also be caused by an obstetric, physical or psychological trauma.
[0112] The trace D in diagram 500 corresponds to the data measured by the anterior force sensor of the electronic member 112. The latter is placed at the level of the surface layer of the perineum. In this trace the chain-dotted trace corresponds to degraded quality of the connecting tissue of the perineum.
[0113] The perineal probe 10 enables differentiated diagnoses of the various muscles that constitute the surface and deep layers of the perineum to be established. In particular, differentiated evaluation is possible of the functional status of the two pairs of bundles of ileococcygeus and ischiococcygeus and/or pubovaginal and puborectalis muscles (deep layers), bulbospongiosus muscles and ischiocavemosus muscles (surface layers).
[0114] The perineal probe 10 enables precise dysfunctioning to be established: hypertonicity or hypotonicity of the basic tone and/or of the tone of the connecting tissue, dysfunction of the rapid fibers and/or the slow fibers, absence or delayed anticipation reflex, absent or delayed myotatic reflex, etc. The measured data may be interpreted directly or by comparison with a reference database.
[0115] Once the diagnosis has been established, the perineal probe 10 enables recommendation of a functional rehabilitation protocol that can be targeted on the anatomical structures that have a disturbed functional status. Depending on the problem identified, the medical practitioner can apply via the EMG electrodes electrostimulation programs adapted to treat the dysfunction or dysfunctions that have been diagnosed.