WO2013147992A1 - Procédé et dispositif de mesure du profil tactile du vagin - Google Patents

Procédé et dispositif de mesure du profil tactile du vagin Download PDF

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Publication number
WO2013147992A1
WO2013147992A1 PCT/US2013/024380 US2013024380W WO2013147992A1 WO 2013147992 A1 WO2013147992 A1 WO 2013147992A1 US 2013024380 W US2013024380 W US 2013024380W WO 2013147992 A1 WO2013147992 A1 WO 2013147992A1
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WO
WIPO (PCT)
Prior art keywords
tactile
vagina
probe
vaginal
deformation
Prior art date
Application number
PCT/US2013/024380
Other languages
English (en)
Inventor
Vladimir Egorov
Armen P. Sarvazyan
Original Assignee
Vladimir Egorov
Sarvazyan Armen P
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/439,165 external-priority patent/US8419659B2/en
Application filed by Vladimir Egorov, Sarvazyan Armen P filed Critical Vladimir Egorov
Publication of WO2013147992A1 publication Critical patent/WO2013147992A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4824—Touch or pain perception evaluation
    • A61B5/4827—Touch or pain perception evaluation assessing touch sensitivity, e.g. for evaluation of pain threshold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4318—Evaluation of the lower reproductive system
    • A61B5/4337—Evaluation of the lower reproductive system of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224—Measuring muscular strength
    • A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H19/00—Massage for the genitals; Devices for improving sexual intercourse
    • A61H19/40—Devices insertable in the genitals
    • A61H19/44—Having substantially cylindrical shape, e.g. dildos
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0207—Characteristics of apparatus not provided for in the preceding codes heated or cooled heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5061—Force sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5082—Temperature sensors

Definitions

  • the present invention generally relates to characterization methods for female pelvic tissues. Specifically, the invention describes methods and devices for characterizing pelvic floor support structures including vaginal tissue elasticity and muscle strength.
  • POP pelvic organ prolapse
  • Conservative treatment of pelvic floor abnormalities includes lifestyle interventions, physical therapies, pelvic floor muscle training, scheduled voiding regimens, electrical and magnetic stimulations, complementary and alternative medicines (i.e. those not considered part of the traditional biomedical model), anti- incontinence devices, supportive rings and pessaries, pads and catheters.
  • Conservative therapies are usually low cost, and managed principally by the patient with instruction/supervision from a health professional. They differ from other forms of incontinence and prolapse management, in that they have a low risk of adverse effects and do not prejudice other subsequent treatments [Smith JH, Berghmans B, Burgio K, et al. Adult Conservative Managements. Committee 12. Incontinence. Eds: Abrams P, Cardozo L, Khoury S, Wein A. Health Publication Ltd. ; 2009:1026-1 120]. There is a need in quantitative characterization of outcome of the conservative treatment of pelvic floor abnormalities.
  • the object of the present invention is to overcome the drawbacks of the prior art and to provide novel method and device for objective characterizing of pelvic floor support structures including vaginal tissue elasticity, in particular by measuring tactile profile of vagina using tactile sensors mounted on a novel transvaginal probe.
  • Another object of the invention is to provide methods and devices for objective detection of pelvic organ disease or abnormality.
  • Another object of the invention is to provide methods and devices for objective quantitative characterization of outcome of a conservative treatment of a pelvic floor disease.
  • a further object of the invention is to provide methods and devices for quantitative characterization of outcome of pelvic floor reconstructive surgery.
  • a further object of the invention is to provide methods and devices for detecting pelvic organ disease by comparing a calculated tactile profile of a particular patient against a pool of profiles for a population with a known clinical status.
  • a further object of the invention is to provide methods and devices for measuring static and transitional tactile patterns of vaginal walls.
  • a further object of the invention is to provide methods and devices for determining vaginal muscle strength by measuring tactile response on a rigid surface of the probe during pelvic floor muscle contraction.
  • a further yet object of the invention is to provide methods and devices for objective diagnosis of a pelvic organ disease by comparing a calculated elasticity profile, static tactile pattern and pelvic floor muscle strength of a particular patient against respective normal values obtained from clinical data collected from a number of patients with known clinical status.
  • the method for measuring tactile profile of vagina comprises the steps of:
  • vaginal tactile profile from the static and/or transitional tactile patterns and distribution of vaginal tissue elasticity based on the static and transitional tactile responses recorded for the same location in vagina.
  • the method for measuring tactile profile of vagina may also include a step of determining of pelvic floor muscle strength using a tactile pattern recorded during vaginal muscle contraction.
  • a transvaginal probe for measuring tactile profile of vagina includes a hand-held housing equipped with a tactile sensor array configured to simultaneously obtain tactile signals from a plurality of locations in vagina including at least a portion of one or two opposing vaginal walls such as an anterior and a posterior wall and/or a uterus.
  • the probe is also configured to detect and communicate to the user with an indicator the position of the probe of reaching the uterus, which may be used as a reference point in composing a vaginal tactile profile.
  • the transvaginal probe also includes a controller with a data processor for composing the vaginal tactile profile using tactile patterns and responses obtained during probe insertion into vagina.
  • the probe is adapted to record both dynamic and static tactile patterns when it is respectively being moved or left in place.
  • the probe has a distal portion shaped for atraumatic insertion into vagina. This portion of the probe has a tapered front portion and optionally an adjacent extrusive portion or predetermined shape and size so as to provide the vaginal walls with a known geometrical tissue deformation upon insertion.
  • the transvaginal probe is further equipped with a display and optionally with an accelerometer for detecting its angle relative to the Earth horizon, which is used in measuring of vaginal transitional tactile pattern for anterior and posterior compartments, when the probe is elevated up and down relative to hymen or allowed to deform pelvic floor tissues based on its own weight.
  • the transvaginal probe for measuring tactile profile of vagina may be configured to obtain tactile patterns at at least two levels of tissue deformation from a portion or the entire length of the anterior and posterior walls and/or the uterus, these levels are defined by the geometry of the front portion and the remainder of the distal portion of the probe.
  • the probe is shaped and the data processor is configured for obtaining tactile patterns from vagina for at least three levels of tissue deformation - the initial deformation from the front portion of the probe, followed by the maximum deformation from the extrusive portion of the probe, followed by the intermediate deformation by the remaining part of the distal portion of the probe.
  • FIG. 1 illustrates a process of insertion of the transvaginal probe into vagina and acquisition of tactile signals for three levels of tissue deformation
  • FIG. 2 shows acquired tactile signals at three levels of tissue deformation along vagina
  • FIG. 3 illustrates insertion of the transvaginal probe with an adjacent extrusive portion into vagina and acquisition of tactile signals for three levels of tissue deformation
  • FIG. 4 shows acquired tactile signals at three levels of tissue deformation along vagina
  • FIG. 5 illustrates transvaginal probe location after its insertion during recording of a static tactile pattern from two opposing vaginal walls and uterus
  • FIG. 6 is a flow chart illustrating one method for measuring tactile profile of vagina
  • FIG. 7 is a flow chart illustrating another method for measuring tactile profile of vagina including recording of a transitional tactile pattern
  • FIG. 8 is a flow chart illustrating another method for measuring tactile profile of vagina including recording of tactile patterns in response to intentional vaginal muscle contraction;
  • FIG. 9 illustrates an exemplary calculated distribution of Young's modulus of vaginal tissue along vagina
  • FIG. 10 illustrates an exemplary recorded static tactile pattern from vaginal walls along vagina
  • FIG. 1 1 illustrates an exemplary calculated muscle strength along vagina
  • FIG. 12 presents a schematic diagram of one embodiment of the transvaginal probe with an external data processor
  • FIG. 13 presents a schematic diagram of another embodiment of the transvaginal probe
  • FIG. 14 presents a schematic diagram of yet another embodiment of the transvaginal probe
  • FIG. 15 presents a perspective view of the transvaginal probe as depicted in FIG. 12.
  • FIG. 1 6 presents a perspective view of the transvaginal probe as shown in FIG 14.
  • FIG. 1 illustrates a transvaginal probe insertion into vagina and acquisition of one or more tactile patterns from vaginal walls.
  • the transvaginal probe 10 may be covered by a lubricant and equipped with a plurality of tactile sensors 1 1 forming together a tactile array.
  • the transvaginal probe is shown inserted along the vaginal canal 13 under applied force 15 shown by the arrow to the left end of the probe 10.
  • the anterior vaginal wall 12 and opposing posterior vaginal wall 14 are deformed by a front tapered portion of the probe 10, which is shaped to cause progressively increasing deformation levels as the probe 10 is inserted deeper into vagina.
  • Probe location in vagina is calculated during its insertion by analyzing tactile patterns on the tactile sensors 1 1 on one or both sides of the probe; the deeper the probe is inserted into vagina, the more tactile sensors acquire signals from being in contact with the deformed vaginal wall.
  • Tissue deformation may be described as initial Level 1 tissue deformation D1 for at least one of the opposing vaginal walls such as the anterior vaginal wall, followed by tissue deformation D2 to Level 2, and further increasing tissue deformation D3 to Level 3 at the flat surface of the distal portion of the probe 10 behind the tapered front portion.
  • the tactile sensors 1 1 may be placed on one or both opposite sides of the transvaginal probe 10 including locations on the front portion of the probe 10 to provide Level 1 tactile signal S1 and Level 2 tactile signal S2.
  • Level 3 tactile signal S3 may be provided by the flat sides of the probe 1 0.
  • insertion of the probe 10 provides one, two, three or more levels of vaginal wall deformation and respective tactile signals (or tactile patterns) may be recorded for these tissue deformations.
  • a tactile response all tactile patterns recorded by the tactile sensors 1 1 of the transvaginal probe 10 during the probe insertion into vagina are referred to as a tactile response. These patterns may be recorded during soft tissue deformation and therefore may not be linear.
  • the tissue deformation by the probe 10 may be applied to the opposing walls of the vagina, e.g. anterior versus posterior walls or left wall vs right wall.
  • the probe 10 may have a rectangular, ellipsoidal or circular cross-section.
  • the probe 10 is shaped for atraumatic insertion into vagina and may have a generally rectangular cross-section with rounded edges and angles, so that smaller sides of the probe 10 may be equipped with at least some of the tactile sensors 1 1 .
  • the vaginal tissue deformation during insertion of the transvaginal probe 10 may be used in place of spreading vaginal walls by other probes including those suggested in our previous patent applications.
  • the transvaginal probe of the present invention is generally designed and shaped for easy application of a tissue deformation load directed orthogonally and away from vaginal canal by a simple insertion of the probe into the vaginal canal and towards the uterus assisted with using a lubricated gel.
  • a disposable elastic cover for entire probe can be used for hygiene protection.
  • FIG. 2 illustrates exemplary tactile patterns S1 -S3 at three levels of tissue deformation D1 -D3 along vagina for the probe design shown in FIG. 1 .
  • Elasticity or the capability of substance to be deformed under applied force is generally defined as a ratio of applied stress to resulting strain.
  • the tactile signals S1 -S3 may be used as a stress while deformations D1 -D3 may be used as a strain for calculating vaginal tissue elasticity.
  • the probe 10 may be shaped and tactile sensors 1 1 may be appropriately placed along the probe 10 in order to provide a constant level of strain during probe insertion.
  • Young's modulus may in that case be calculated as a ratio of (S3-S1 )/(D3-D1 ), (S2-S1 )/(D2-D1 ) and (S3-S2)/(D3-D2), all multiplied by a correction factor F, which can be derived from theoretical and experimental data with tissue models.
  • the vaginal tissue deformation may be described by a nonlinear mathematical model accounting for hysteresis.
  • Other methods of mathematical processing of tactile signals are also envisioned to be within the scope of this invention. For example, tactile patterns obtained along a plurality of probe locations along its trajectory of insertion into vagina may be used for determining of one or more 2-D tactile images of vagina as location of each tactile sensor 1 1 on the probe and the probe geometry and size are all known in advance.
  • FIG. 3 illustrates insertion of the transvaginal probe 10 into vagina and acquisition of three levels of tactile signals from the vaginal walls according to another embodiment of the invention.
  • the transvaginal probe 10 may be covered by a suitable lubricant and is also equipped with a plurality of tactile sensors 1 1 positioned along the path aligned with the center of vaginal canal 13. Insertion force 15 is shown by the arrow to the left end of the transvaginal probe 10.
  • the anterior vaginal wall 12 and the opposing posterior vaginal wall 14 are deformed and separated apart by a front portion of the probe 10.
  • Probe insertion causes a progressively increasing deformation from initial Level 1 tissue deformation D1 to the maximum Level 3 tissue deformation D3 by the largest extrusive portion of the probe 10 following the most distal front portion, and then back down to intermediate Level 2 tissue deformation D2 along the flat surface of the probe having a smaller dimension than the extrusive portion behind the front portion.
  • the tactile sensors 1 1 may be placed on one or both of the opposite sides of the probe along the flat back portion of the probe 10. Tactile sensors 1 1 may be located at the tapered front portion, extrusive portion or the distal portion of the probe, and provide respective recordings of the initial, maximum and intermediate tactile patterns.
  • vaginal wall deformation may be obtained along with tactile patterns corresponding to these deformations.
  • All tactile signals recorded by the tactile sensors 1 1 during the probe 10 insertions into vagina are referred together as a dynamic tactile response because these signals are recorded during examination when soft tissue deformation may not be linear and may have a certain hysteresis.
  • the described deformation is generally applied to the opposing sides of the vagina, e.g. anterior versus posterior walls or left side versus right side. Probe insertion may cause even or uneven tissue deformation in the opposing vaginal walls.
  • FIG. 4 illustrates exemplary tactile patterns S1 -S3 at three levels of tissue deformation D1 -D3 along vagina for the probe shown in FIG. 3.
  • Elasticity is again defined as a ratio of applied stress to resulting strain, in the most basic case S1 -S3 over D1 -D3.
  • Young's modulus can be calculated as a ratio of (S3-S1 )/(D3-D1 ), (S2- S1 )/(D2-D1 ) and (S3-S2)/(D3-D2) multiplied by the factor F.
  • the tactile signals S1 -S3 may be corrected or adjusted by a speed of probe insertion into vagina in order to remove a tangential component from tactile signals; the tissue deformation may also be described by nonlinear model accounting for hysteresis.
  • the tactile signals obtained for multiple probe locations during its insertion into vagina may be treated as a 2-D cloud of data and each location on the vaginal wall may be characterized by tactile signals recorded from different tactile sensors at deformation level D2.
  • This approach may be limited as it does not allow elasticity measurement in the vicinity of uterus since only Level 1 tactile signal may be obtained at this location (see FIG. 2).
  • FIG. 5 illustrates the transvaginal probe 10 positioned for recording of a static tactile pattern by tactile sensors 1 1 from two opposing vaginal walls and uterus 32.
  • the static tactile pattern may be recorded for the anterior 12 and the opposing posterior 14 vaginal walls as well as for left and right sides of vagina.
  • Uterus may be used as a reference point in presenting and analyzing static and/or dynamic tactile responses and patterns. Detection of probe position as reaching uterus may be done using the tactile sensors on the front portion of the probe. Reaching uterus may be confirmed when the tactile signals from sensors on the probe tip exceed a certain predetermined threshold. Location of hymen 31 may be used as an additional reference point for tactile profile.
  • Capture of the static tactile pattern may occur after 3-5 seconds following completion of probe insertion to allow vaginal tissue to get equilibrium in internal stress and strain distribution.
  • probe 10 To accurately record the static tactile pattern, probe 10 must be held in place without any displacements and keeping the probe orientated in parallel to vagina canal.
  • the patient may be placed in a horizontal position during the probe insertion and capturing the static tactile pattern.
  • the patient may be asked to contract vaginal muscles to enable recording of tactile signals on the flat rigid back surface of the probe 10. The patient may be asked to follow the instruction from a medical professional as to the appropriate time for vaginal muscles contraction.
  • the probe 10 might be let go and allowed to be freely displaced gravitationally under its own weight as shown by arrows 30 and 33.
  • the transitional tactile response may then be recorded by tactile sensors 1 1 .
  • vaginal walls have more support around hymen 31 than in the apical anterior part of vagina 12.
  • the probe 10 under its own weight may mostly deform generally the apical anterior part of vagina.
  • a tilt sensor mounted into the probe 10 provides data of its angle changes during transitional probe displacement.
  • the probe can be tilted up and down ( ⁇ 20 degrees) by applying elevating, tilting or rotating force relative to the hymen to record deeper transitional tactile response from median and apical anterior and posterior compartments.
  • the recorded transitional tactile response provides vital information about biomechanical conditions of pelvic floor support structures.
  • FIG. 6 illustrates one method for measuring tactile profile of vagina comprising the steps of:
  • vaginal tactile profile from the distribution of vaginal tissue elasticity, static tactile pattern, and pelvic floor muscle strength
  • FIG. 7 illustrates another method for measuring a tactile profile of vagina comprising the additional step of recording a transitional tactile response by allowing the probe gravitationally or by applying elevating, tilting or rotating force to deform the median and apical anterior vaginal wall so as to provide additional information about biomechanical conditions of pelvic floor support structures.
  • additional steps for composing a vaginal tactile profile may include obtaining a recording of tactile patterns when the vaginal muscles are contracted so as to determine pelvic floor muscle strength. Visualizing tactile profile of vagina may be done as shown for example in FIGS. 9 and 10.
  • FIG. 8 illustrates another method for measuring a tactile profile of vagina which includes the additional steps of: - recording a tactile response for three levels of deformation at one or two opposing vaginal walls during probe insertion into vagina,
  • vaginal tactile profile from said distribution of vaginal wall elasticity, static tactile pattern and pelvic floor muscle strength
  • the step of composing tactile profile of vagina includes data presentation according to FIGS. 9 -1 1 .
  • FIG. 9 illustrates an exemplary calculated distribution of Young's modulus of vaginal tissue along vagina for anterior and posterior vaginal compartments.
  • the Young's modulus is calculated as a ratio of (S3-S1 )/(D3-D1 ), (S2-S1 )/(D2-D1 ) and (S3-S2)/(D3-D2) multiplied by the factor F, where S1 -S3 are tactile signals and D1 - D3 are respective tissue deformations (see FIGS. 2 and 4).
  • FIG. 10 illustrates an exemplary recorded static tactile pattern from vaginal walls along vagina for anterior and posterior vaginal compartments (see FIG. 5 description for details).
  • FIG. 1 1 illustrates an exemplary calculated vaginal muscle strength profile along vagina for anterior and posterior vaginal compartments (see FIG. 5 description for details).
  • FIGS. 12 and 15 present a schematic diagram and a perspective view of the transvaginal probe 10 with its internal components and a controller including a data processor 100.
  • the data processor 100 may be incorporated with the probe 10 or be external to its housing.
  • the probe 10 for measuring tactile profile of vagina generally includes a tactile sensor array 1 1 configured to obtain simultaneously tactile signals at one or more levels of tissue deformation from a portion or the entire length of anterior and posterior vaginal walls and optionally the uterus, a light indicator 91 configured to provide a confirmation signal indicating that the probe reached uterus.
  • the indicator may be turned on when the tactile pattern on the front portion of the probe is detected as exceeding a predetermined threshold as may be the case when the probe cannot be advanced any further. Reaching the uterus may be used as a reference point in composing a vaginal tactile profile.
  • the probe 10 may further include at least one temperature sensor 98 and a micro heater with a heater controller 95 configured to increase the surface temperature of tactile sensors to within 5 degrees or better from body temperature of 37 degree Celsius. Heating up the surface of the probe may not only improve the comfort of the vagina examination but also avoid heat expansion of the tactile sensors while inside the vagina which may cause data distortion.
  • the probe may further include data acquisition electronics 93, a rechargeable battery 92, and a port 90 for communicating with external data processor 100.
  • the data processor 100 may include a display 102 to present examination results with vaginal tactile profiles.
  • the probe 10 may be shaped for atraumatic insertion into vagina with two flat parts 94 and 101 shaped for contact with two opposing vaginal walls and providing intermediate level 2 deformation (see FIG. 1 ).
  • the probe 10 may also have two extrusive parts 96 and 99 to contact with two opposing vaginal walls providing maximal level 3 deformation (see FIG. 1 ).
  • the probe 10 may further have a front tapered portion to contact with two opposing vaginal walls and uterus providing initial level 1 deformation (see FIG. 1 ).
  • Tactile sensors 1 1 may cover some or all of these listed parts (94, 96, 97, 99 and 101 ) of the probe 10.
  • the data acquisition electronics 93 may include a memory element for storing acquired tactile signals before transmission to the data processor 100. Also, the data acquisition electronics 93 may include a tilt sensor (such as an accelerometer) to provide angle orientation data relative to the Earth horizon.
  • Communication and data transfer between the probe 10 and data processor 100 may be wireless as shown by the dotted line 103.
  • data transfer between the probe 10 and data processor 100 may be provided by a wire connection; in this case there is no need for a rechargeable battery 92 to be located inside the probe 10.
  • a computer may be used as a data processor 100.
  • Appropriate software may be developed to support at least three operational modes: a. data acquisition mode, b. data management mode, and c. device management mode.
  • the software may allow for storing the data in a digital format, visualization of the tactile profile of vagina, comparison of multiple vaginal tactile profiles, software updates and examination data transmission over the Internet.
  • the processor 100 and the display 102 may be configured for a comparative analysis of acquired vaginal tactile profile with a variety of vaginal tactile profiles recorded for a defined population with known clinical status so as to assist in detecting a disease.
  • FIG. 13 presents a schematic diagram of an alternative transvaginal probe
  • the probe 200 is shaped to have two flat parts 94 and 101 suitable to contact with two opposing vaginal walls providing level 2 deformation (see FIG. 3) and two extrusive parts 96 and 99 to contact with two opposing vaginal walls providing level 3 deformation (see FIG. 3).
  • Tactile sensors 201 may cover some or all of the probe parts 94, 96, 99 and 101 .
  • the data acquisition electronics 93 includes a memory 203 for storing acquired tactile signals before transmission to the data processor.
  • the data acquisition electronics 93 further includes an accelerometer 204 which is used as a tilt sensor and as a shock sensor to detect high probe impact, for example if the probe 200 is accidently dropped on a floor.
  • FIGS. 14 and 1 6 present a schematic diagram and a perspective view of a transvaginal probe 10 with its internal components according to that previously described.
  • the probe 10 comprises a tactile sensor array 1 1 configured to record tactile signals at least at three levels of tissue deformation from part of entire length of vagina and uterus, a temperature sensor 98, a micro heater with heater controller 95 to support temperature of tactile sensors about 37 ⁇ 5 degree Celsius with the purpose of improving tactile sensor accuracy, and a data acquisition electronics 93 communicating with the external data processor 100.
  • a number of temperature sensors may be increased from 1 up to 10 sensors (for different zones) and a number of heaters also may be increased accordingly to provide for an even temperature distribution along the probe surface.
  • the data processor 100 may include a display 102 to present examination data with vaginal tactile profiles.
  • the probe 10 may have two flat parts 94 and 101 to contact with two opposing vaginal walls providing level 3 deformation (see FIG.
  • Tactile sensors 1 1 may cover some or all listed parts (94, 97, and 101 ) of the probe 10.
  • Data acquisition electronics 93 may further include a tilt sensor to provide probe angle orientation data relative to the Earth horizon. Data transfer between the probe 10 and data processor 100 may be provided by a wired or wireless connection.

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  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

L'invention concerne des sondes transvaginales (10) munies de capteurs tactiles (11) configurées pour le placement dans le vagin en vue d'enregistrer une réponse tactile lors de l'insertion, d'acquérir un modèle tactile statique de la paroi vaginale après l'achèvement de l'insertion et d'acquérir des modèles tactiles dynamiques lors du mouvement de la sonde ainsi que pour l'enregistrement d'une réponse tactile dynamique lors de la contraction du muscle vaginal. Les données tactiles acquises et enregistrées sont transmises à un processeur de données (100) destiné à composer un profil tactile du vagin et à le présenter visuellement sur un affichage. Le profil d'élasticité du tissu vaginal est calculé à partir de la réponse tactile enregistrée depuis les différentes parties de la sonde lors de son insertion, à partir du modèle de pression statique et à partir du modèle tactile dynamique. La force musculaire du plancher pelvien est définie comme une augmentation de la pression de contact détectée sur une surface fixe de la sonde lors de la contraction musculaire. Le profil tactile du vagin est déterminé à l'aide du modèle tactile statique, du profil d'élasticité et de la force musculaire du plancher pelvien. Le processeur de données permet une analyse comparative du profil tactile avec divers profils tactiles vaginaux enregistrés pour une population donnée présentant des états cliniques connus de manière à aider à diagnostiquer une maladie.
PCT/US2013/024380 2012-03-29 2013-02-01 Procédé et dispositif de mesure du profil tactile du vagin WO2013147992A1 (fr)

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US201261617555P 2012-03-29 2012-03-29
US61/617,555 2012-03-29
US13/439,165 US8419659B2 (en) 2009-09-02 2012-04-04 Methods for assessment of improvements in pelvic organ conditions after an interventional procedure
US13/439,165 2012-04-04

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DK201570372A1 (en) * 2015-06-18 2017-01-09 Fortis Pelvic Aps Symmetric probe for measuring pelvic floor muscle parameters
WO2017070787A1 (fr) * 2015-10-30 2017-05-04 Standard Innovation Corporation Dispositif capteur de pression
US10022293B2 (en) 2014-09-13 2018-07-17 Standard Innovation Corporation Devices and methods for sexual wellness
US11234894B2 (en) 2011-04-05 2022-02-01 Pelvital Usa, Inc. Apparatus, system, and method for testing and exercising the pelvic floor musculature
US11406279B2 (en) 2014-10-28 2022-08-09 Chiaro Technology Limited Method and apparatus for monitoring the pelvic floor muscles

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11234894B2 (en) 2011-04-05 2022-02-01 Pelvital Usa, Inc. Apparatus, system, and method for testing and exercising the pelvic floor musculature
US11938077B2 (en) 2011-04-05 2024-03-26 Pelvital Usa, Inc. Apparatus, system, and method for testing and exercising the pelvic floor musculature
US10022293B2 (en) 2014-09-13 2018-07-17 Standard Innovation Corporation Devices and methods for sexual wellness
US11406279B2 (en) 2014-10-28 2022-08-09 Chiaro Technology Limited Method and apparatus for monitoring the pelvic floor muscles
DK201570372A1 (en) * 2015-06-18 2017-01-09 Fortis Pelvic Aps Symmetric probe for measuring pelvic floor muscle parameters
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WO2017070787A1 (fr) * 2015-10-30 2017-05-04 Standard Innovation Corporation Dispositif capteur de pression

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