CN116115228A - Method for characterizing female pelvic floor by biomechanical integrity score - Google Patents

Abstract

The biomechanical integrity score and five components thereof caused by vaginal tactile probe insertion, lifting, rotation, warburg action, autonomic pelvic muscle contraction, reflex contraction and relaxation with the probe in contact with the vaginal wall are calculated to achieve a comprehensive biomechanical characterization of the pelvic floor. The probe is equipped with a plurality of tactile sensors to record various static and dynamic pressure patterns during vaginal examination.

Description

Method for characterizing female pelvic floor by biomechanical integrity score

Cross-reference to related applications

This U.S. patent application is a partial continuation of U.S. patent application Ser. No. 17/028,636 entitled "method FOR vaginal haptic and ultrasound image fusion (METHDS FOR VAGINAL TACTILE AND ULTRASOUND IMAGE FUSION)" filed by the same inventor at 22, 9, 2020, which in turn is a partial continuation of U.S. patent application Ser. No. 15/249,672 filed by the same inventor at 29, 2016, entitled "method FOR vaginal haptic and ultrasound image and probe (METHODS AND PROBES FOR VAGINAL TACTILE AND ULTRASOUND IMAGING)", which in turn claims the same inventor as priority of U.S. provisional patent application Ser. No. 62/215,227 filed by the same title at 8, 2015. The 17/028,636 patent application is also part of the continuation of the U.S. patent application serial No. 16/055,265 entitled "method for biomechanical mapping of female pelvic FLOOR (METHODS FOR BIOMECHANICAL MAPPING OF THE FEMALE PELVIC FLOOR)" filed by the same inventor at month 8,6 but now abandoned. The 17/028,636 patent application also claims priority from U.S. provisional patent application No. 62/706,663 entitled "method FOR vaginal haptic and ultrasound image fusion (METHODS FOR VAGINAL TACTILE AND ULTRASOUND IMAGE FUSION)" filed by the same inventor at 9/2020. All of the above documents are incorporated by reference herein in their entirety.

Technical Field

The present invention relates generally to female pelvic floor imaging. In particular, methods and devices for providing vaginal tactile imaging to characterize biomechanical and functional conditions of a female pelvic floor are described.

Background

Pelvic organ prolapse (Pelvic organ prolapse, POP) is the abnormal descent or prolapse of a pelvic organ from its normal attachment site or normal location in the pelvic cavity. This condition is often associated with concurrent pelvic floor diseases including fecal incontinence, pelvic pain, sexual dysfunction, urination dysfunction, and social isolation. Recent studies predict that, by 2050, 4,380 ten thousand women in the united states or nearly 33% of the adult female population will suffer from at least one annoying pelvic floor disease. The lifetime risk of receiving surgery due to POP or urinary incontinence is nearly 20%.

Urinary Incontinence (UI) is a symptom of urine storage defined as complaining about any involuntary urination. The most common type of UI Stress Urinary Incontinence (SUI) is defined as involuntary leakage of urine from a complaint, either forceful or sneezing or coughing. Depending on the affected population and the definition of the UI, the estimates of the prevalence of this disease are different. With the broad definition that any leakage of urine occurs at least once in the past year, the popularity of UI ranges from 25% to 51%.

The pelvic floor of women includes pelvic diaphragm (puborectalis, iliorectalis, collectively referred to as levator ani), genitourinary diaphragm (ischial cavernosum, globus cavernosum, and superficial transverse perineum), collectively referred to as perineal muscles; and the urethra and anal sphincter muscle. These muscles are anatomically and functionally interrelated. Normal motion of pelvic floor muscles is described as squeezing and lifting inward around the pelvic opening. Pelvic floor disease is caused by neuro-urinary pathology and muscle dysfunction due to age-related changes in the biomechanical properties of soft tissues. The anatomy of the pelvic floor is very complex and clinical examination alone is often insufficient to diagnose and assess pathology. That is why quantitative characterization and diagnosis of the pelvic floor must involve biomechanical measurements. There is a need to improve the characterization of pelvic conditions.

Current clinical practice in assessing pelvic floor disease is often limited to assessment of surface anatomy and hand palpation. Pelvic organ prolapse quantification system (POP-Q) is widely used to describe and pathologically stage pelvic support systems [ stamp, r.c., mattiasson, a., bo, k., et al; normalization of female pelvic organ prolapse and pelvic floor dysfunction terminology; in 1996, journal of obstetrics and gynecology in the united states; 175:10-17] ([ Bump, R.C., mattiasson, A., bo, K., et al Standardization of Terminology of Female Pelvic Organ Prolapse and Pelvic Floor Dysfunction. American Journal of Obstetrics and Gynecology 1996;175:10-17 ]), pelvic floor disorder Scale (Pelvic Floor Distress Inventory, PFDI) and PFDI-20 were recommended by the International urinary incontinence consultation Commission as systematic evaluations of the class A [ de Arruda GT, dos Santos Henrique T, virtuoso JF., pelvic floor disorder Scale (PFDI) -measuring properties for assessing pelvic floor dysfunction; int Urogynecol J.2021;32 (10): 2657-2669 ] ([ de Arruda GT, dos Santos Henrique T, virtuoso JF. Pelvic Floor Distress Inventory (PFDI) -systematic review of measurement properties. Int Urogynecol J.2021;32 (10): 2657-2669. ]), female sexual function index for diagnosing female sexual dysfunction [ Okobi OE, systematic evaluation of the association between female infertility and sexual dysfunction using female sexual function index as a measuring tool; cureus 2021;13 (6): e16006 ] ([ Okobi oe.a Systemic Review on the Association Between Infertility and Sexual Dysfunction Among Women Utilizing Female Sexual Function Index as a Measuring tool.cureus 2021;13 (6): e16006. ]). In severe or complex cases, additional evaluations may be made using ultrasound, magnetic Resonance Imaging (MRI), and X-ray imaging. Cysts and rectal function tests such as urodynamics, manometry or faecal angiography may also be used. There is currently no biomechanical quantitative indicator to assess female pelvic floor conditions.

The actual etiology of POP is not completely understood, as is the variation observed between individuals. Pelvic cavity disease is thought to share common pathogenesis, changes in tissue elasticity, reduced connective tissue support, and pelvic muscle dysfunction. Logically, biomechanical assessment and characterization of female pelvic floor can bring important information in clinical practice. However, ultrasound and MRI elastography and pelvic floor functional imaging have not been properly accepted in gynaecological urology. The study of biomechanics and functions of female pelvic floor still remains a big gap.

Treatment options for POP and SUI include surgery and pelvic muscle training. Invasive surgery is considered the final treatment for POP and SUI. Surgical treatment of recurrent SUI was found to be associated with a high failure rate. Physical exercise and medication are generally not effective. In order to enhance evidence-based management of gynecological urological surgery, it is necessary to perform objective and quantitative assessment of the pre-and post-operative condition of the pelvic floor.

Vaginal Tactile Imagers (VTIs) have been developed to provide biomechanical images of the pelvic floor with vaginal probes. A new set of clinical markers/parameter sets has been used for biomechanical characterization of pelvic floor conditions [ Egorov, v.; a method for biomechanical mapping of female pelvic floor; U.S. patent application 16055265 filed on 8/6/2018 (Egorov, V.methods for biomechanical mapping of the female pelvic floor. US Patent Application No.16055265 filtered August 6,2018). This set includes 52 parameters that are automatically calculated after the eight inspection procedures (tests) are completed. However, this approach does not have the motivation to be applied in urogynecologists. The reason is that this approach has a long list of parameters that are difficult to interpret to clinicians and patients. In order to make the biomechanical map of urology more readily available and usable, further efforts are needed to develop a short list of easily understood and practical parameters. A single new overall parameter is required to characterize female pelvic floor conditions.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a novel method for objectively and comprehensively characterizing female pelvic floor.

It is another object of the present invention to provide novel methods for objective characterization by biomechanical integration parameters.

It is another object of the present invention to provide novel methods for objective characterization by having a limited number of components that contribute to different biomechanical aspects of the biomechanical integration parameters.

It is another object of the present invention to provide novel methods for objective characterization by biomechanical integration parameters sensitive to POP formation.

It is another object of the present invention to provide novel methods for characterizing pelvic floor tissue and muscle as biomechanical elements based on tissue strain-stress and muscle function data.

According to the present invention, a novel method for characterizing female pelvic floor by vaginal haptic and ultrasound image fusion may comprise the steps of:

a) Recording a tactile response of the vaginal wall in contact with the vaginal tactile imaging probe during deformation of the vaginal wall caused by the vaginal tactile imaging probe;

b) Recording dynamic pressure patterns on the vaginal wall in contact with the vaginal tactile imaging probe during autonomous pelvic muscle contraction and reflex pelvic muscle contraction, involuntary relaxation, and warrior action without further movement of the vaginal tactile imaging probe;

c) Calculating a set of biomechanical components characterizing each of the following using the haptic response recorded in step (b) and the dynamic pressure pattern recorded in step (c):

i. the elasticity of the vaginal tissue,

ii, the supporting force of the pelvic cavity,

pelvic muscle contraction is performed to obtain a product,

iv. the pelvic muscles are not relaxed autonomously,

pelvic muscle activity, and

d) Calculating a biomechanical integrity score using the set of biomechanical components calculated in step (d).

Drawings

The patent or application document contains at least one drawing in color. The present company will provide copies of this patent or patent application publication with color drawings on demand and pay the necessary fees.

The subject matter is particularly pointed out and distinctly claimed in the concluding portion of the specification. The above-described and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are, therefore, not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings in which:

fig. 1 is a perspective view of a vaginal tactile imaging probe.

Fig. 2 is an illustration of the vaginal probe design and probe orientation after vaginal probe insertion during recording of tactile response patterns from two opposing vaginal walls (i.e., anterior and posterior compartments).

FIG. 3 is a schematic diagram showing the anatomical orientation used to collect haptic response data used to calculate biomechanical parameters within a female pelvic floor.

Fig. 4a, 4b, 4c show various box plots of 26 VTI parameters selected, which 26 VTI parameters were identified as demonstrating statistically significant sensitivity to POP conditions and not highly correlated with each other.

Fig. 5 is a diagram illustrating the composition of biomechanical integrity scores from five components and VTI parameters that promote these components with specific weights.

Fig. 6 shows the biomechanical integrity scores calculated for the normal case (hollow circle) and POP case (black circle) for 253 cases (left panel) according to patient age. The box plot was scored for biomechanical integrity for the same normal case and POP case.

Fig. 7 is an example of the results of an examination of a 58 year old patient with grade 2 anterior prolapse, with a biomechanical integrity score and five components thereof.

Fig. 8 shows a flow chart illustrating a method for characterizing female pelvic floor conditions with biomechanical integrity scores.

Detailed Description

The following description sets forth various examples and specific details to provide a thorough understanding of the claimed subject matter. However, it will be understood by those skilled in the art that the claimed subject matter may be practiced without one or more of the specific details disclosed herein. In other instances, well known methods, procedures, systems, components, and/or circuits have not been described in detail so as not to unnecessarily obscure claimed subject matter. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like reference numerals generally identify like components unless context dictates otherwise. The illustrative embodiments described in the specification, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated within and form part of this disclosure.

In the following description, specific terms are used, defined as follows:

a "tactile sensor" is a sensor capable of measuring an average applied force per sensor area or a pressure on per sensor area and converting the force into an electrical signal for use in tactile image formation.

"stress" is the force per unit area (pressure) (kPa) measured at the vaginal wall surface.

"tissue deformation" is used to describe deformation of the vaginal wall and adjacent structures caused by movement of the tactile probe generally in an orthogonal direction away from the vaginal cavity.

"Strain" is the displacement of soft tissue (mm) under tissue deformation.

The ability of "tissue elasticity" soft tissue to (1) resist applied load under relatively small deformations (between 0mm and 15 mm) and (2) return after applied load removal; tissue elasticity is estimated as the ratio of stress to strain (kPa/mm).

"pelvic floor support" is the ability of the overall pelvic structure in the posterior compartment to resist applied loads under significant (above 15mm and up to 45 mm) deformation, calculated as stress to strain ratio (kPa/mm).

"muscle function" is the ability of a muscle to produce actions including muscle contraction, relaxation, and movement.

"muscle strength" is the ability of a muscle to produce a change in force or pressure in kPa or N as a unit of measure on the vaginal wall during muscle contraction.

"tactile imaging" is a medical imaging modality that translates tactile sensation into a digital image. The tactile image is a function of P (x, y, z), where P is the pressure of the soft tissue surface under applied deformation, and x, y and z are the coordinates in which P is measured. The tactile image is a pressure map on which the direction of tissue deformation must be specified.

"functional tactile imaging" translates muscle activity of a region of interest into a dynamic pressure pattern P (x, y, t), where t is time and x and y are coordinates in which pressure is measured. The muscle activity may include: (a) muscle voluntary contraction, (b) involuntary reflex contraction, (c) involuntary relaxation, and (d) specific actions.

"biomechanical imaging" is used herein to describe a combination of "tactile imaging" plus "functional tactile imaging".

A "Vaginal Tactile Imager (VTI)" is a medical device that aids in the diagnosis and assessment of vaginal and pelvic floor conditions. The VTI allows assessment of tissue elasticity, pelvic floor support and function. Target populations include adults with pelvic organ prolapse, urinary incontinence, and tissue atrophy.

Fig. 1 presents a perspective view of a Vaginal Tactile Imaging (VTI) probe 1. The probe may be of known dimensions. The probe 1 may contain a tactile array 2, the tactile array 2 being configured to record tactile signals (pressure patterns), for example, from two opposite sides along the entire length of the vagina. Since the probe size is known and fixed, the haptic response from the haptic array sensor can be translated into useful measurements of biomechanical parameters using the known probe size and recorded probe movement. The probe 1 may have a beveled tip that is covered by a tactile sensor to record pressure patterns on the vaginal wall during probe insertion. The tactile imaging probe 1 may be equipped with an array of pressure sensors mounted on its outer surface that act like a human finger during clinical examination. The probe movement can be used to deform soft tissue during the examination and detect the resulting pressure pattern changes on the probe surface. The sensor head may be moved over the surface of the tissue to be studied and pressure responses at various locations along the tissue are evaluated. The results and haptic response data may be used to generate 2D/3D images to show pressure distribution over the tissue region under study.

Fig. 2 illustrates a vaginal tactile imaging probe 1 positioned in the vagina to record pressure/tactile patterns from two opposing vaginal walls by a tactile sensor array 2 (bold black lines). The anterior vaginal compartment 7 and the opposite posterior vaginal compartment 3 and tactile patterns to the left and right of the vagina can be recorded. The cervix 5 may be used as a reference point for presenting and analyzing the tactile response to vaginal tissue deformation and dynamic pressure patterns during pelvic muscle contraction. The rectum 4 and bladder 6 are shown as anatomical landmarks.

As shown in fig. 2, the vaginal tactile imaging probe 1 may be equipped with a plurality of pressure (tactile) sensors (96 independent sensors in one example) connected at a 2.5mm pitch on both sides of the probe, an orientation sensor, and a temperature controller configured to generate a probe temperature close to the human body prior to examination. Tactile imaging data may be sampled from the probe sensor and displayed on the VTI monitor in real time. The resulting pressure map (tactile image) of the vagina integrates all the pressure and positioning data obtained by each of the pressure sensing elements. In addition, the VTI may record dynamic contractions of pelvic floor muscles with sufficient resolution (e.g., at least 1mm resolution). Gel lubricants can be used to enhance patient comfort and provide reproducible boundary/contact conditions for deformed tissue.

The VTI probe 1 can be sized to cause any tissue displacement and deformation (test 1) between 3-15 mm, for example, caused by initial insertion of the probe. The probe is then moved to cause any tissue deformation between 15-45mm caused by the probe lifting (test 2), and 5-7mm caused by the probe rotation. The probe could also be used to record dynamic tactile responses during pelvic muscle contractions (test 4-8). The probe actions in tests 1-3 allow multiple pressure patterns from the tissue surface to be accumulated to compose an overall tactile image of the investigation region using the probe orientation data. The spatial gradients dP (x, y)/dy of the anterior and posterior compartments within the tactile images obtained in tests 1 and 2 can be calculated; the y-coordinate may be oriented orthogonally to the longitudinal axis of the vaginal cavity and the x-coordinate may be positioned along the vaginal cavity. The VTI probe may be equipped with a microprocessor containing software including data recording and analysis tools and reporting functions. The microprocessor may be configured to present a visual representation of the anatomical tactile pressure map and to (automatically) calculate a plurality of predetermined parameters of at least some or all of the test programs.

A pelvic examination method using a VTI probe may consist of eight tests that may be divided into three groups:

a. The low tissue deformation test by the following working mobile probe, at which time the vaginal tissue is displaced about 3mm to about 15mm to characterize tissue elasticity:

the insertion of the probe head is carried out,

the rotation of the probe head is carried out,

b. significant tissue deformation tests by the following working mobile probe were performed, at which time vaginal tissue displacement was about 15mm to about 45mm to characterize the pelvic floor support structure:

the lifting of the probe head is carried out,

c. testing for tissue-free deformation (beyond initial probe insertion), where the probe remains stationary, requires the patient to perform the following actions to cause autologous and involuntary pelvic muscle contraction and relaxation to characterize dynamic pelvic function:

a Valsalva action,

autonomic muscle contraction (anterior to posterior),

voluntary muscle contraction (left to right),

involuntary relaxation, and

reflex muscle contraction (caused by patient coughing).

Tests 1, 2, 4, 5, 7 and 8 provide pre/post compartment data; test 3 (probe rotation) and test 6, 360 degrees along the entire vagina, provide left/right data (see table 1).

Table 1. Exemplary VTI check including 8 program tests.

Fig. 3 shows an anatomical orientation within a female pelvic floor, in which the tactile/pressure response parameters are measured by VTI. Specifically, the bearing 12 captures the anterior aspect opposite the pubic bone 10; the azimuth 11 provides a response from the urethra (not shown); bearing 19 characterizes the top anterior portion connected to cervix 5; azimuth 14 is related to class III pelvic support; azimuth 17 is associated with class II pelvic support; azimuth 18 is related to grade I pelvic support; orientation 15 is associated with vaginal side 1; and the orientation 16 is related to the vaginal side 2. The rectum 4 and bladder 6 are shown as anatomical landmarks.

Table 2, starting from the next page, provides additional details and explanation of all 52 biomechanical parameters derived from the VTI inspection data.

Table 2.Vti biomechanical parameters

Example 1: data from clinical studies

The dataset analyzed in this study included 253 subjects; of these 125 subjects had normal pelvic floor conditions, 128 had stage ii+ POP. In the multi-site observational case control study (clinical trial identifiers NCT02294383 and NCT 02925585) and the ongoing VTI11 protocol study completed in 2014-2018, these subjects were examined using a VTI probe. It is important that all subjects analyzed did not have any history of pelvic surgery. Table 3 presents the mean and standard deviation of age, birth, weight, and height for normal and POP cohorts. VTI examination data for 8 tests were obtained and recorded at the scheduled urology visit of gynaecology (see table 1).

The whole research workflow comprises the following steps: (1) Women who had not previously received pelvic surgery and were in normal pelvic floor condition (no POP) or POP stage II or higher were recruited; (2) Acquiring clinical diagnostic information related to the cases included in the study by standard clinical means; (3) taking the lithotomy position for VTI examination; and (4) analyzing the VTI data. Prior to VTI examination, standard physical examinations were performed, including two-handed pelvic examination and quantification of pelvic organ prolapse (POP-Q). Pelvic floor conditions are classified by prolapse level based on the maximum level of anterior prolapse, posterior prolapse, and uterine prolapse. Using this method, 68 subjects were found to have a grade II POP,57 subjects had a grade III POP, and three subjects had a grade IV POP.

Statistical method

A total of 52 biomechanical parameters were automatically calculated by the VTI software from each of the 253 analyzed VTI inspection data. A t-test (p < 0.05) of two samples was used to test a null hypothesis (null hypothesis) with equal mean and equal variance for data in the normal and POP groups. An alternative assumption (alternative hypothesis) is that the data in these groups comes from groups with unequal means. The P value for the test hypothesis is calculated. The pearson linear correlation coefficient (r) was calculated among 52 VTI parameters, each of which was against all other 51 parameters. For visual assessment of the analyzed data distribution, box plots with V-cuts were used, showing median (vertical midline), 25% and 75% quartile confidence intervals. The spacing between the different sections of the box helps to compare the variances. The box plot also determines skewness (asymmetry) and outliers (crossover).

Composition of biomechanical integrity scores

It is considered necessary to select VTI parameters that have significant changes in POP versus normal pelvic conditions. Two specific quantitative criteria are imposed on this type of selection: (1) For subset data of 128 POP cases against subset data of 125 normal cases, t-test p <0.05 and (2) for all other parameters, correlation coefficient r < 0.85. The 40 parameters pass the first criterion and only 26 parameters pass both the first criterion and the second criterion. Fig. 4a, 4b, 4c present box plots, table 3 shows the numerical data of these selected 26 VTI parameters in response to POP and not highly correlated with each other. For consistency, the numbering of the VTI parameters in the figures is kept consistent with table 2.

TABLE 3 VTI parameters and sensitivity of biomechanical integrity score to POP conditions, and demographic data for the group studied

The tenth column in table 3 can be used to assess the extent to which each VTI parameter of the POP population changes relative to the population of normal pelvic conditions. In POP, the elastic parameters are reduced by-42.9% … … -55.1%, the pelvic support parameters are reduced by-35.6% … … -46.0%, and in POP, the muscle contraction parameters are reduced by-40.3% … … -55.7%. Muscle relaxation parameters have a negative sign due to involuntary decrease in muscle strength, increasing 65.3% and 90.0% in POP, and accelerating relaxation. Muscle activity parameters may have a negative or positive sign, increasing 79.0% and 167.0% in POP, muscle activity developing along the vagina. The average age and number of children in the normal and POP groups were significantly different: 36 years old versus 65.5 years old and 0.9 versus 2.4, respectively. This is the expected difference for the analyzed groups, since as a reference (zero line in biomechanical integrity score) a younger population without POP is required, which forms with age. The average weight and height of the subjects in both groups were the same (see last part of table 3).

The last column in Table 3 gives the p-value of the t-test of two samples (normal vs POP) found that the p-value range of the VTI parameter is 1.2X10 ^-23 To 4.8X10 ^-2 The method comprises the steps of carrying out a first treatment on the surface of the Most p-values are below 1.0X10 ^-5 . The p-value of the biomechanical integrity score for both groups analyzed was p=4.3×10 ^-31 . This suggests that the data for these groups are from the population with unequal averages and the strongest sensitivity to POP conditions.

The parameters listed in table 3 have different units (see column 5 in table 3). The next step in data analysis is to have all selected parameters in a uniform unit to allow arithmetic combination of the parameters. For this analysis, a preference for standard deviation units is provided, although other methods recognized by those skilled in the art may also be used. All VTI data is transformed according to the following equation 1.

Psd _ni ＝(Po _ni -Pa _n )/SD _n (1)

Here, po _ni Is the original value of the n parameter of i subject; pa (Pa) _n Is the arithmetic mean of n-parameters for subjects aged 18-39 years (92 out of 125 subjects) in the group with normal pelvic conditions; SD (secure digital memory card) _n Is the standard deviation of the n-parameter for 125 subjects in the group with normal pelvic conditions; and Psd _ni Is the transformed value of the n parameter for the i subject in standard deviation units.

Selected biomechanical parameters

A subset of the original 52 biomechanical parameters was chosen as a parametric representation indicating POP versus normal. The remaining portion of the 52 biomechanical parameters were discarded for the purpose of calculating the biomechanical integrity score. The following is a more detailed description of the selected 26 biomechanical parameters and the method of calculating the selected 26 biomechanical parameters in the same order as the order listed in the table above.

Test 1: parameter 2-average vaginal tissue elasticity

The average tissue elasticity is calculated as the work done by the operator during insertion of the probe into the vagina. The vaginal probe has a double-sided oblique tip that moves away from the anterior and posterior walls in the orthogonal direction of the vaginal cavity (probe insertion line). Calculating a force F (x) applied to the probe along the vaginal cavity according to expression (2) (vaginal resistance, x being the coordinate along the vaginal cavity), F (x) being the angle α of the probe and its contact area A with vaginal tissue _tip Pressure profile P on lower probe tip _tip Is a force of (a) to the force of (b). The amount of effort done is the root during insertion of the probe into the vagina until against the cervixExpression (3) is specified by the probe force F (x) multiplied by the probe displacement Δx. The unit of this parameter is joule [ j=n×m ]Or millijoules [ mJ ]]。

F(x)＝cos(α)×Σ _{probe tip} (P _tip ×A _tip ) (2)

Power = Σ _{x＝0...cervix} (F(x)×Δx) (3)

Test 1: parameter 3-maximum front pressure gradient

Calculating the maximum anterior pressure gradient at each probe x-position during probe insertion along the vaginal cavity (pressure change ΔP per anterior wall displacement in the y-direction orthogonal to the vaginal cavity _tip (x) /deltay). This parameter Gmax_a is defined as [ kPa/mm ] according to the following expression (4)]Maximum stress/strain rate in units. This parameter characterizes the maximum anterior tissue elasticity along the vagina.

Gmax_a＝max _{x＝0...cervix} {ΔP _tip (x)/Δy} (4)

Test 1: parameter 5-maximum front pressure

During insertion of the probe into the vagina, the maximum anterior pressure pmax_a is defined according to expression (5). This parameter is in units of [ kPa ] and characterizes the stress at a known tissue displacement (strain) when the probe is inserted.

Pmax_a＝max _{x＝0...cervix} {P _{tip_anterior} (x)} (5)

Test 1: parameter 6 maximum rear pressure

During insertion of the probe into the vagina, the maximum posterior pressure pmax_p is defined according to expression (6). This parameter is in units of [ kPa ] and characterizes the stress at a known tissue displacement (strain) when the probe is inserted.

Pmax_p＝max _{x＝0...cervix} {P _{tip_posterior} (x)} (6)

Test 2: parameter 8 maximum pressure of urethral area

During lifting in the vagina, the maximum anterior pressure at azimuth 11 (urethra area) in fig. 3 is defined according to expression (6). This parameter is in units of [ kPa ] and characterizes the stress at a known tissue displacement (strain) when the probe is lifted. The relatively high tissue deformation imposed in this region characterizes the pelvic support capacity.

P2max_a＝max _{x＝urethral_area} {P _anterior (x)} (7)

Test 2: parameter 10 maximum pressure in perineum area

During probe lifting in the vagina, the maximum posterior pressure p1max_p at the position 14 (perineal region) in fig. 3 is defined according to expression (8). This parameter is in units of [ kPa ] and characterizes the stress at a known tissue displacement (strain) when the probe is lifted. The relatively high tissue deformation (> 10 mm) applied in this region characterizes pelvic support capacity.

P1max_p＝max _{x＝perineal_area} {P _posterior (x)} (8)

Test 2: parameter 11-maximum mid-aft pressure

During probe lifting in the vagina, the maximum posterior pressure p2max_p at position 17 (middle posterior region) in fig. 3 is defined according to expression (9). The unit of this parameter is [ kPa ], which characterizes the stress at a known tissue displacement (strain) when the probe is lifted. The relatively high tissue deformation (> 15 mm) imposed by this region characterizes pelvic support capacity.

P2max_p＝max _{x＝mid_area} {P _posterior (x)} (9)

Test 2: parameter 15-maximum cervical pressure gradient

Calculate the maximum cervical pressure gradient (pressure change Δp per anterior wall displacement in the y-direction orthogonal to the vaginal cavity) of cervical region 19 in fig. 3 during probe lift _anterior (x) /deltay. This parameter G3max_a is defined as [ kPa/mm ] according to the following expression (10)]Maximum stress/strain rate in units. This parameter characterizes pelvic support.

G3max_a＝max _{x＝cervical_area} {ΔP _anterior (x)/Δy} (10)

Test 2: parameter 16-maximum perineal pressure gradient

Calculation of perineum in fig. 3 during probe liftingMaximum perineal pressure gradient of region 14 (pressure change Δp per anterior wall displacement in the y-direction orthogonal to the vaginal cavity _anterior (x) /deltay. This parameter G1max_p is defined as [ kPa/mm ] according to the following expression (11)]Maximum stress/strain rate in units. This parameter characterizes pelvic support.

G1max_p＝max _{x＝perineal_area} {ΔP _posterior (x)/Δy} (11)

Test 3: parameter 19 maximum pressure at vaginal wall

During probe rotation through an angle Ω=0 … … degrees inside the vagina, the maximum pressure Pmax in the vagina can be defined according to expression (12). The unit of this parameter is [ kPa ], which characterizes the stress at a known tissue displacement (strain) as the probe rotates.

Pmax＝max _{x＝0...cervix} {P(x,Ω)} (12)

Test 3: parameter 21-vaginal lateral compression

This Fs force according to expression (15) is calculated as the cumulative force applied to all 96 pressure sensors when the touch sensitive area contacts the left side of the vagina to generate force f_left (see expression 13) and contacts the right side of the vagina to generate force f_right (see expression 14). This parameter is in units of [ N ] and characterizes the stress at a known tissue displacement (strain) as the probe rotates.

F_left＝Σ _{x＝0…cervix} (P _left (x)×A _left (x)) (13)

F_right＝Σ _{x＝0…cervix} (P _right (x)×A _right (x)) (14)

Fs＝Σ _{x＝0...cervix} (F_left+F_right) (15)

Test 3: parameter 22-maximum left side pressure 1

During probe rotation in the vagina, the maximum left side pressure pmax_s1 at position 15 in fig. 3 is defined according to expression (16). This orientation corresponds to the perineal portion of the vagina. This parameter is in units of [ kPa ] and characterizes the stress at a known tissue displacement (strain) as the probe rotates.

Pmax_s1＝max _x＝perineal {P _{left_side} (x)} (16)

Test 3: parameter 23-maximum left side pressure 2

During probe rotation in the vagina, the maximum left side pressure pmax_s2 at the position 16 is defined according to expression (17). This orientation corresponds to the inner portion of the vagina. This parameter is in units of [ kPa ] and characterizes the stress at a known tissue displacement (strain) as the probe rotates.

Pmax_s2＝max _x＝medial {P _{left_lside} (x)} (17)

Test 4: parameter 27-displacement of front pressure peak

The displacement dl_a of the anterior maximum pressure peak along the vaginal cavity during the warrior action is calculated according to expression (18). X coordinate x of front pressure peak at rest _{max(Pa)_rest} Subtracting the x coordinate x of the pressure peak at the warburg action _{max(Pa)_Valsalva} . The x-coordinate points along the vaginal cavity from the hymen to the cervix.

dL_a＝x _{max(Pa)_Valsalva} –x _{max(Pa)_rest} (18)

Test 4: parameter 30-displacement of rear pressure peak

The displacement dl_p of the posterior maximum pressure peak along the vaginal cavity during the warrior action is calculated according to expression (19). X coordinate x of rear pressure peak at rest _{max(Pp)_rest} Subtracting the x coordinate x of the pressure peak at the warburg action _{max(Pp)_Valsalva} . The x-coordinate points along the vaginal cavity from the hymen to the cervix.

dL_p＝x _{max(Pp)_Valsalva} –x _{max(Pp)_rest} (19)

Test 5: parameter 34-rear contractive force

The posterior contractile force df_p is calculated according to expression (20) as the cumulative force increase acting on the pressure sensor in contact with the posterior vaginal wall during spontaneous pelvic floor muscle contractions. The pressure at rest Pr minus the pressure at maximum contraction Pc.

dF_p＝Σ _{x＝0…cervix(Pcposterior} (x)×A _posterior (x))-Σx＝ _0…cervix( Pr _posterior (x)×A _posterior (x)) (20)

Test 5: parameter 36-maximum rear systolic pressure

The maximum posterior contraction pressure pmax_p during autonomous pelvic muscle contraction is calculated according to expression (21).

Pmax_p＝max _{x＝0...cervix} {P _posterior (x)} (21)

Test 6: parameter 38-maximum change in right side pressure

The right pressure maximum variation dpmax_r during the autonomic pelvic muscle contraction is calculated according to expression (22). The pressure at rest Pr minus the pressure at maximum contraction Pc.

dPmax_r＝max _{x＝0...cervix} {Pc _right-side (x)-Pr _right-side (x)} (22)

Test 6: parameter 39-maximum Right side systolic pressure

The maximum right-side contraction pressure pmax_r during the spontaneous pelvic muscle contraction is calculated according to expression (23).

Pmax_r＝max _{x＝0...cervix} {P _right-side (x)} (23)

Test 6: parameter 41-maximum left side pressure variation

The left pressure maximum variation dpmax_l during the autonomic pelvic muscle contraction is calculated according to expression (24). The pressure at rest Pr minus the pressure at maximum contraction Pc.

dPmax_l＝max _{x＝0...cervix} {P _cleft-side (x)–Pr _left-side (x)} (24)

Test 6: parameter 42-maximum left systolic pressure

The maximum left contraction pressure pmax_l during the spontaneous pelvic muscle contraction is calculated according to expression (25).

Pmax_l＝max _{x＝0...cervix} {P _leftt-side (x)} (25)

Test 7: parameter 44-front peak pressure drop

The anterior peak pressure drop dpcdt_a during involuntary pelvic muscle relaxation is calculated according to expression (26). At t from _o After 3 seconds, the slave maximum muscle contraction pressure Pc is obtained _anterior (x,t _o ) Pressure drop P of (2) _anterior (x,t _o +3)。

dpcdt_a＝-100％×{max _{x＝0...cervix} (Pc _anterior (x,t _o ))–P _anterior (x,t _o +3)}/max _{x＝0...cervix} (Pc _anterior (x,t _o )) (26)

Test 7: parameter 46-rear peak pressure drop

The posterior peak pressure drop dpcdt_p during involuntary pelvic muscle relaxation is calculated according to expression (27). In this test, the patient is required to contract the pelvic muscles and remain contracted. At t from _o After 3 seconds, the slave maximum muscle contraction pressure Pc is obtained _posterior (x,t _o ) Is an involuntary pressure drop P _posterior (x,t _o +3)。

dpcdt_p＝-100％×{max _{x＝0...cervix} (Pc _posterior (x,to))–P _posterior (x,to+3)}/max _{x＝0...cervix} (Pc _posterior (x,to)) (27)

Test 8: parameter 48-maximum change in front pressure

The maximum change in anterior pressure dpmax_a during reflex pelvic muscle contraction is calculated according to expression (28). The pressure at rest Pr minus the pressure at maximum contraction Pc.

dPmax_a＝max _{x＝0...cervix} {Pc _anterior (x)–Pr _anterior (x)} (28)

Test 8: parameter 49 displacement of front pressure peak

The displacement dl_a of the anterior maximum pressure peak along the vaginal cavity during reflex muscle contraction (cough) is calculated according to expression (29). X coordinate x of front pressure peak at rest _{max(Pa)_rest} Subtracting the x coordinate x of the pressure peak at reflective contraction _{max(Pa)_reflex} . The x coordinate along the yinThe canal cavity points from the hymen to the cervix.

dL_a＝x _{max(Pa)_reflex} –x _{max(Pa)_rest} (29)

Test 8: parameter 51-maximum change in rear pressure

The maximum change in posterior pressure dpmax_p during reflex pelvic muscle contraction is calculated according to expression (30). The pressure at rest Pr minus the pressure at maximum contraction Pc.

dPmax_p＝max _{x＝0...cervix} {Pc _posterior (x)–Pr _posterior (x)} (30)

Biomechanical integrity scoring

Fig. 5 shows how biomechanical integrity scores may be determined. First, 26 selected parameters were subdivided into five groups in order to characterize the following:

a the elasticity of the tissue 41,

b a pelvic support 42,

c pelvic muscle contraction 43,

d muscle relaxation 44 and muscle activity 45 (see fig. 5).

Component 41 comprises eight parameters with equal weight 0.125 (the total number of all weights per component must be equal to 1.0), component 42 comprises five parameters with equal weight 0.2, component 43 consists of eight parameters with weights 0.1 and 0.2, component 44 comprises two parameters with weights 0.5, and component 45 consists of three parameters with weights 0.2 and 0.4. Finally, as shown in fig. 5, these five components form a biomechanical integrity score 46 with equal weight of 0.2.

Initially, the majority weights may be chosen to be equal in each group such that the respective sum of the weights is equal to 1.0 in each class. In some cases, the relative weight of each component may be reduced or increased accordingly if it is determined that this particular component has a low or high impact on the overall result.

As shown in fig. 5, the biomechanical integrity score is a composite score consisting of five components. The composite score may be determined as a weighted average of these components. The weight of each component and its subcomponents may be predetermined in advance. These five components produce different aspects of the biomechanical characterization of the pelvic floor. Due to the exclusion of the highly correlated original VTI parameter where r is ≡ 0.85, the cross-correlation coefficient has an average value r=0.27, which is regarded as a low correlation or a negligible correlation. It is important to note that the tissue elastic component integrates the tissue/structure elasticity of the layer behind the vaginal wall from 0-8mm corresponding to the depth of deformation of the vaginal wall in tests 1 and 3 (see parameter explanation in fig. 5 and table 2). The pelvic support component will come from a structural support integral of about 10-45mm depth as the vaginal wall deformation in test 2 (see fig. 5 and the parametric explanation in table 2).

All biomechanical integrity score data for 253 subjects analyzed herein can be visualized on a graph according to subject age (see panel 51 in fig. 6). The open circles represent data for women with normal pelvic floor conditions; the black solid dots present data for women with POP conditions. A quadratic polynomial fit of biomechanical integrity scores for control subject ages in all 125 subjects in the group with normal pelvic conditions is presented in fig. 6 by line 53 (baseline). Dashed line 54 shows a standard deviation of 1.0 from baseline. The plot 52 in fig. 6 shows the same biomechanical integrity scoring data in both box plots for normal pelvic conditions and POP pelvic conditions. A significant distance between the two groups can be observed; t-test specifies that for both groups, p=4.3×10 ^-31 . These results can be considered as statistically significant verification of the biomechanical integrity score sensitivity to POP conditions. Since POP is often associated with concomitant pelvic floor disorders (including urinary incontinence, pelvic pain, urination dysfunction and sexual dysfunction), and these disorders are believed to share common pathogenesis, altered tissue elasticity, reduced connective support tissue and pelvic floor muscle dysfunction, the proposed biomechanical integrity scores can be used to characterize the pelvic disorders listed above and/or combinations thereof.

Fig. 7 illustrates biomechanical integrity scores and all 5 components thereof, as they all have the same unit, presented in a graph with the same vertical axis (standard deviation). Three backgrounds represent areas of necessarily normal pelvic conditions with biomechanical integrity scores above zero (white, no background), transition areas with biomechanical integrity scores below zero but above-0.8 (light grey dashed lines), and diseased areas with biomechanical integrity scores below-0.8 (dark grey). The transition from white background to bright gray background at biomechanical integrity score=0 had sensitivity=95.3% and specificity=51.2% for POP condition detection. The transition from a light gray background to a dark gray background at a biomechanical integrity score = -0.80 has almost equal sensitivity = 82.8% and specificity = 84.0% for diagnosing POP conditions. The POP diagnostic accuracy of the biomechanical integrity score was calculated as the area under the Receiver Operating Characteristic (ROC) curve of the sample analyzed, found to be 89.7%. Age-adjusted biomechanical integrity scores may also be calculated relative to the normal curve in fig. 7.

Fig. 8 illustrates a method for characterizing female pelvic floor conditions by biomechanical integrity scoring, according to the present invention, the method comprising the steps of:

a) Inserting a vaginal tactile imaging probe into the vagina, the probe being equipped with a plurality of tactile sensors distributed along its outer surface;

b) Recording a tactile response of the vaginal wall in contact with the vaginal tactile imaging probe during deformation of the vaginal wall caused by the vaginal tactile imaging probe;

c) Recording dynamic pressure patterns on the vaginal wall in contact with the vaginal tactile imaging probe during voluntary pelvic muscle contraction and reflex pelvic muscle contraction, involuntary relaxation, and warburg movements without further movement of the vaginal tactile imaging probe;

d) Calculating a set of biomechanical components characterizing each of the following using the haptic response recorded in step (b) and the dynamic pressure pattern recorded in step (c):

the elasticity of the vaginal tissue,

the supporting force of the pelvic cavity,

the pelvic muscle is contracted and the body is then contracted,

the pelvic muscles do not relax spontaneously and,

pelvic muscle activity, and

e) Calculating a biomechanical integrity score using the set of biomechanical components calculated in step (d).

It is contemplated that any of the embodiments discussed in this specification may be implemented with respect to any of the methods of the present invention, and vice versa. It will also be appreciated that the particular embodiments described herein are shown by way of illustration and not limitation of the invention. The principal features of the invention may be used in various embodiments without departing from the scope of the invention. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific procedures described herein. Such equivalents are considered to be within the scope of the invention and the scope of the claims.

All publications and patent applications mentioned in the specification are indicative of the level of skill of those skilled in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

The terms "a" or "an" when used in connection with the term "comprising" in the claims and/or the specification may mean "one" but are also consistent with the meaning of "one or more", "at least one", and "one or more than one". The term "or" is used in the claims to mean "and/or" unless explicitly indicated to mean only the alternatives or the alternatives are mutually exclusive, but the disclosure herein supports the definition of only the alternatives and "and/or". Throughout this application, the term "about" is used to indicate that a value includes an inherent error change in a device, a method for determining a value, or a change in the presence of an object under investigation.

As used in this specification and the claims, the terms "comprises," "comprising," "has," "having," "contains" (and any form of containing) or "containing" (and any form of containing) are inclusive or open-ended and do not exclude additional unrecited or element or method steps. In an embodiment of any one of the compositions and methods provided herein, "comprising" may be replaced with "consisting essentially of … …" or "consisting of … …". As used herein, the phrase "consisting essentially of … …" requires the specified integers or steps to be made up of those steps which do not materially affect the characteristics or functions of the invention as claimed. As used herein, the term "composition" is used to indicate that only the recited integer (e.g., feature, element, feature, property, method/process step, or limitation) or group of integers (e.g., feature(s), element(s), property(s), method/process step(s), or limitation) is present.

As used herein, the term "or a combination thereof" refers to all permutations and combinations of items listed before the term. For example, "A, B, C or a combination thereof" is intended to include at least one of the following: A. b, C, AB, AC, BC or ABC, and BA, CA, CB, CBA, BCA, ACB, BAC or CAB if order is important in a particular context. Continuing with this example, explicitly included are combinations comprising one or more items or term repetitions, e.g., BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, etc. Those of skill in the art will understand that in any combination, unless otherwise apparent from the context, the number of items or terms is generally not limited.

As used herein, similar words such as, but not limited to, "about," "approximately," or "substantially" refer to the following conditions: such modifications are to be understood as not necessarily absolute or ideal, but are to be construed as sufficient to enable one skilled in the art to ensure that the conditions are present. The extent to which the description may vary will depend on how much variation is possible and still enable those skilled in the art to recognize the desired characteristics and capabilities of the modified features as yet unmodified. In general, but in accordance with the discussion above, a value modified by an approximate term (e.g., "about") herein may differ from that value by at least ±1%, ±2%, ±3%, ±4%, ±5%, ±6%, ±7%, ±10%, ±12%, ±15%, ±20% or ±25%.

All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. Although the apparatus and methods of this invention have been described in terms of preferred embodiments, those of skill in the art will recognize that variations may be applied to the apparatus and/or methods and in the method steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

Claims (13)

1. A method of determining a biomechanical integrity score for use in characterizing a female pelvic floor condition, the method comprising the steps of:

(a) Inserting a vaginal tactile imaging probe into the vagina, the probe being equipped with a plurality of tactile sensors distributed along its outer surface;

(b) Recording haptic responses from the plurality of haptic sensors during deformation of the vaginal wall caused by moving the vaginal haptic imaging probe in contact with the vaginal wall;

(c) Recording a dynamic pressure pattern on a vaginal wall in contact with the vaginal tactile imaging probe during pelvic muscle contraction, involuntary relaxation, and a warrior action caused by voluntary pelvic muscle contraction and reflex, and recording the dynamic pressure pattern as a time-dependent tactile response of the plurality of tactile sensors without further movement of the vaginal tactile imaging probe;

(d) Determining biomechanical parameters characterizing each of the following using the haptic response recorded in step (b) and the dynamic pressure pattern recorded in step (c):

i. the elasticity of the vaginal tissue,

ii, the supporting force of the pelvic cavity,

pelvic muscle contraction is performed to obtain a product,

iv. the pelvic muscles are not relaxed autonomously,

pelvic muscle activity, and

(e) Calculating a biomechanical integrity score using the biomechanical parameters calculated in step (d).

2. The method of claim 1, wherein said step (b) further comprises: moving the vaginal tactile imaging probe along the vagina brings the beveled tip straight against the full length of the vagina to cause deformation of the vaginal wall, whereby the tactile response recorded along the entire vagina is used to calculate biomechanical parameters characterizing the elasticity of vaginal tissue.

3. The method of claim 1, wherein said step (b) further comprises: rotating the vaginal tactile imaging probe about an axis along the vagina to cause deformation of the vaginal wall, whereby the tactile response recorded along the entire vagina is used to calculate biomechanical parameters characterizing the elasticity of vaginal tissue.

4. The method of claim 1, wherein the biomechanical parameter characterizing vaginal tissue elasticity in step (d) comprises:

a) The average vaginal tissue elasticity measured at the point where the probe was inserted into the vagina,

b) An anterior gradient maximum measured at the insertion of the probe into the vagina, the anterior gradient calculated as a pressure change per anterior wall displacement in a direction orthogonal to the vaginal cavity,

c) The maximum pressure along the anterior wall of the vaginal cavity measured at the point where the probe is inserted into the vagina,

d) The maximum pressure along the posterior wall of the vaginal cavity measured at the point where the probe is inserted into the vagina,

e) The maximum pressure along the vaginal wall measured at the rotation of the probe,

f) The vaginal side is tightened up,

g) A maximum pressure along the left vaginal wall in the perineal portion of the vagina measured at the probe rotation, and

h) The maximum pressure along the left side at the vaginal wall in the inner part of the vagina measured at the rotation of the probe.

5. The method of claim 1, wherein step (b) further comprises moving the vaginal tactile imaging probe 15mm to 45mm to cause a high-level vaginal wall deformation, whereby biomechanical parameters characterizing pelvic support force are calculated using the tactile responses recorded during the high-level vaginal wall deformation.

6. A method as in claim 1, wherein the biomechanical parameter indicative of pelvic support force in step (d) comprises:

a) The maximum pressure at the anterior urethral region,

b) The maximum pressure at the posterior perineal region,

c) The maximum pressure at the posterior compartment in the trisected middle portion of the vagina,

d) Maximum pressure gradient at the anterior cervical region, and

e) Maximum pressure gradient at the posterior perineal region

7. A method as set forth in claim 1 wherein step (c) further comprises an autonomous pelvic muscle contraction whereby biomechanical parameters characterizing pelvic muscle contractility are calculated using the dynamic pressure patterns recorded during the contraction.

8. The method of claim 1, wherein the biomechanical parameter indicative of pelvic muscle contraction in step (d) comprises:

a) The overall contractive force in the rear compartment,

b) The maximum systolic pressure in the rear compartment,

c) The maximum pressure change on the right side of the vagina,

d) Maximum systolic pressure on the right side of the vagina,

e) The maximum pressure change on the left side of the vagina,

f) The maximum systolic pressure on the left side of the vagina,

g) Maximum pressure variation in the front compartment, and

h) Maximum pressure variation in the posterior compartment.

9. A method as in claim 1, wherein step (c) further comprises involuntary pelvic muscle relaxation, whereby biomechanical parameters characterizing pelvic muscle relaxation rate are calculated using the dynamic pressure patterns recorded during the relaxation.

10. The method of claim 1, wherein the biomechanical parameter characterizing pelvic muscle relaxation comprises:

a) Front relative pressure change per second at maximum pressure when involuntary relaxation, and

b) The relative pressure at the rear per second at the maximum pressure when involuntary relaxation occurs changes.

11. The method of claim 1, wherein step (c) further comprises performing a warburg action and involuntary (reflex) pelvic muscle contraction upon patient cough, whereby biomechanical parameters characterizing pelvic muscle activity are calculated using the dynamic pressure patterns recorded during the action.

12. The method of claim 1, wherein the biomechanical parameter characterizing pelvic muscle relaxation comprises:

a) Displacement of the maximum pressure peak in the front compartment during the warrior action,

b) Displacement of maximum pressure peak in the rear compartment during the Wash action, and

c) Displacement of the maximum pressure peak in the anterior compartment where the reflex pelvic muscle contracts.

13. The method of claim 1, wherein the biomechanical integrity score is calculated in step (e) in standard deviation units.

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