Pelvic floor stiffness measuring device employing physical method

Abstract

One embodiment of the present invention provides a pelvic floor stiffness measuring device comprising a pair of pressing members (10) each having, in the longitudinal direction: an insertion portion (100) formed at one end; a gripping portion (200) formed at the other end; and a hinge portion (300) configured to be non-intersecting between the insertion portion (100) and the gripping portion (200), such that the pair of insertion portions (100) are opened and closed by opening and closing the pair of gripping portions (200) about the hinge portion (300). Each of the pair of insertion portions (100), with respect to the longitudinal direction, has one end forming a pelvic floor pressing region (110) and the other end connected to the hinge portion (300), and is connected to an intermediate region (130), that is formed as a downwardly convex curved surface with respect to a widthwise symmetry axis of the pair of pressing members, the intermediate region (130) including, at least in part, a point (131) at which the pair of insertion portions intersect.

Description

A device for measuring pelvic floor stiffness using physical methods

[0001] The present invention relates to a portable pelvic floor stiffness measuring device that is designed to be inserted into the pelvic cavity and uses a physical method.

[0002] "Pelvic floor" refers to the pelvic floor muscles of the pelvic floor, and is composed of muscle fibers of the pubococcygeus, levator ani, coccygeus, and related connective tissues that span the lower part of the pelvis as pelvic floor muscles or pelvic floor. The pelvic floor is a muscle that separates the upper pelvic cavity from the perineum (including the genitals and anus) below, and surrounds the genitals like a hammock while supporting organs such as the uterus, bladder, and rectum (see Figure 5 (b)).

[0003] As mentioned above, one of the main roles of the pelvic floor muscles is support. The pelvic floor muscles work in conjunction with the abdominal muscles to prevent the organs from sagging. They also attach to the tailbone, helping to keep the back straight. In other words, by providing support and support, they stabilize the core of the body. Furthermore, the pelvic floor muscles surround the urethra, vagina, and anal openings. They tighten and relax the anus and urethra to control or expel urine and feces, and their contraction also influences orgasm during sexual intercourse.

[0004] These pelvic floor muscles naturally age with age, and lifestyle habits such as sitting at a desk for long periods of time or riding in a car can cause them to weaken due to lack of strength. In particular, during pregnancy, the weight of the baby and amniotic fluid puts stress on the pelvic floor muscles that support it, and during childbirth, they can be damaged due to incisions and other reasons. In addition, pelvic floor muscles weakened by pregnancy and childbirth are not properly restored and menopause occurs, and during menopause, pelvic floor muscles are also affected by hormones, and their function significantly declines, leading to serious problems.

[0005] Pelvic floor muscle tone refers to the resting muscle state. Clinically, it is defined as the "distance a tissue moves in response to a passive external force," and is commonly used as a term to refer to the degree of tissue stiffness. Biomechanically, muscle tone is defined as the tissue's resistance to the application of external force, and can be measured by stiffness.

[0006] Tone includes contractile factors such as muscles and non-contractile factors such as fascia, tendons, and connective tissue. Although the method and criteria for measuring pelvic floor tone are not standardized (Rachel Worman, 2023), electromyography is mainly used to measure contractile factors, and pressure-based measurement methods such as perineal pressure meters (perineometer, dynamometer, manometry, etc.) are used to measure the tissue itself, including non-contractile factors.

[0007] These physical measurement methods, such as 2D, 3D Ultrasound (Shearwave elastography), MRI, and finger palpation, are combined with the expert's opinion on tissue stiffness in response to pressure to diagnose Tone. However, pressure-based measurement mainly measures the contraction strength of the sphincter muscles in the pelvic floor tissue, which is a physically different characteristic from the stiffness of the tissue. In addition, no physical measurement device has been developed to measure the levator ani muscle, which acts as the main muscle supporting the pelvic floor tissue, not just the sphincter muscle in the round, bowl-shaped pelvic floor muscles, at a vertical angle.

[0008] Prior art 1 (EP 2689724 A1) is a pelvic floor muscle strength measuring device, which comprises a speculum comprising a grip area (31, 32); a pivotally coupled portion (11, 12); and a front area (41, 42) introduced into the vagina; wherein the grip area (31, 32) of the speculum is provided with a movement sensor (2) coupled with a spring (21) having a rigidity constant K, and is connected to a module (50) for reading movement. However, prior art 1 has limitations in that the structure of the speculum is specific to the pelvic floor sphincter, the sphincter is a part of the structure corresponding to the second layer of the three layers of the pelvic floor muscles, and measuring the generation of a tightening force (muscle force) is a completely different characteristic from the non-contractile stiffness of the tissue.

[0009] Prior art 2 (KR 0904751 B1) is a pressure measuring device composed of a balloon sensor for vaginal insertion and a pressure sensor that can quantify and display pressure, which extracts parameters such as maximum contraction pressure and maximum pressure duration from the contraction pressure of the pelvic floor muscles. However, prior art 2 measures the contraction pressure of the pelvic floor muscles, and like prior art 1, it measures the generation of a tightening force (muscle force) throughout the vagina, so it is practically impossible to measure the non-contractile stiffness of the pelvic floor tissue with the device.

[0010] Prior art 3 (KR 2024-0035222A) discloses a pressure detection sensor inserted into the vagina to measure the pressure within the body cavity, and relates to a device for treating urinary and fecal incontinence, including an electrode unit that directly contacts the pelvic floor muscles to measure muscle strength and apply electrical stimulation signals. However, prior art 3 is problematic in that it is an electromyography technology used to measure contractile elements (muscles), and is not suitable for measuring the pelvic floor tissue itself, including non-contractile elements.

[0011] Accordingly, there is a need for the development of a portable measuring device capable of screening by measuring the pressure that can be applied to tissue within the pelvic cavity and the distance that the tissue moves from the point of contact to the end point of pressure when a certain pressure is applied to the tissue according to the definition of stiffness.

[0012] The purpose of the present invention is to provide a pelvic floor rigidity measuring device that can provide objective data and improve portability and accessibility by applying a simple scissor-shaped diagnostic and measuring tool equipped with a pressurizable pressure sensor and a movement sensor capable of measuring non-contractile displacement of tissue after reaching the levator ani, which is a major muscle layer in the pelvic cavity.

[0013] Specifically, the present invention aims to calculate tissue stiffness by measuring the distance moved by non-contractile tissue and the pressure at this time when a pair of insertions spaced apart in the width direction presses both walls of pelvic floor tissue as a user opens and closes (progresses) the grip portion of a scissors-shaped measuring device in the width direction so that a pair of insertions inserted into the vagina or anus with a hinge portion as the center is opened and closed while in contact with body tissue within the pelvic cavity.

[0014] In addition, the purpose of the present invention is to improve the problem of pressure dispersion during operation of a measuring device by having a scissor-shaped pressure member efficiently contact and pressurize only the (horizontal) walls of the target pelvic floor tissue and not contact other internal body tissues except the pelvic floor.

[0015] In addition, the present invention aims to improve the problem of pressure dispersion during operation of the measuring device by preventing contact with and pressure on other internal body tissues in the thickness (vertical) direction of the front of the body, as the position of the levator ani muscle, a deep structure of the pelvic floor whose stiffness is to be measured, is located in the lower part at the 4-5 o'clock and 7-8 o'clock directions when the front of the vaginal or anal entrance is approximated as a uniform circle.

[0016] One embodiment of the present invention includes a pair of pressure members (10), each end of which forms an insertion portion (100) in the longitudinal direction, each other end forms a grip portion (200), and a hinge portion (300) that is non-intersecting between the insertion portion (100) and the grip portion (200), such that the pair of insertion portions (100) are opened and closed by opening and closing the pair of grip portions (200) around the hinge portion (300), and the pair of insertion portions (100) are provided with a convex curved surface downward based on the widthwise symmetry axis of the pair of pressure members, wherein a point (131) where the pair of insertion portions intersect is formed at least in a portion thereof. A pelvic floor rigidity measuring device characterized by being connected to an intermediate region (130) is provided.

[0017] The above pair of inserts (100) may satisfy the following relationship 1.

[0018] [Relationship 1]

[0019] 0 ≤ D2 / D1 < 1

[0020] In relational expression 1, the D1 and D2 are the distance (D1) between the pair of pelvic floor pressurization areas (110) and the distance (D2) between the pair of intermediate areas (130) based on the width-wise symmetry axis of the pair of pressurization members (10) when the pair of insertion parts (100) are opened and closed by the opening and closing of the pair of gripping parts (200), respectively.

[0021] The pair of insertion parts (100) may further include a safety area (150) in which each end is connected to the hinge part (300), and when the pair of insertion parts (100) is changed from a closed state to an open state by opening and closing the pair of grip parts (200), the pair of pelvic floor pressure areas (110) may exhibit a gradient in which the separation distance (D1) increases, the pair of intermediate areas (130) may exhibit a gradient in which the separation distance (D2) decreases and then increases, and the pair of safety areas (150) may not exhibit any of the gradients in which the separation distance (D3) increases and decreases.

[0022] The above pair of inserts (100) may be provided with a convex shape so that each pelvic floor pressurization area (110) is positioned lower than the hinge portion (300) based on the central axis in the thickness direction of the above pair of pressurization members (10).

[0023] The above pair of pressure members (10) may further include a sensor unit (400) including a movement sensor (410) that measures the movement distance of the pair of pelvic floor pressure areas (110) and a pressure sensor (420) that measures the pressure applied to the pelvic floor when the pair of insertion parts (100) are opened and closed by opening and closing the pair of grip parts (200).

[0024] The above pressure sensor (420) may be installed in the pelvic floor pressure region (110) of the pair of insertion parts (100) and / or at least a portion of the pair of grip parts (200).

[0025] When the insertion part (100) is expanded in the width direction starting from the point where the pelvic floor pressure area (110) contacts the pelvic floor deep structure, the pressure applied to the pelvic floor is measured through the pressure sensor (420) to output pressure information, the movement distance of the pelvic floor pressure area (110) is measured through the movement sensor (410) to output tissue movement distance information, and the stiffness of the pelvic floor deep structure can be calculated through the pressure information and movement distance information.

[0026] According to the present invention, there is an advantage in that it can evaluate pelvic floor tension by accurately measuring the pressure element without the need for finger palpation and has a small volume, and it can provide a useful pelvic floor rigidity measurement tool that can obtain information on pelvic floor tension even in an environment without expensive equipment such as ultrasound or MRI.

[0027] In the present invention, i) a pair of pressure members are curved so as to contact but not intersect each other at the hinge portion connecting the scissors-shaped insertion portion and the grip portion in the middle, and ii) a pair of insertions contact and intersect at the middle region located between the hinge portion and the insertion portion (based on the axis of symmetry in the width direction), so that when the measuring device is in a non-open state, the width of each of the end portion and the middle portion is very narrow. Therefore, it is possible to insert into a narrow vagina or anus without any particular physical damage. In addition, when the inserted pressure member (pressure area of ​​the insertion portion) is advanced (opened) in the width direction, the separation distance (in the width direction) of the pressure area of ​​the insertion portion increases, and the separation distance in the middle portion decreases and then increases, so that contact of the measuring device with internal body tissues other than the pelvic floor with which the end portion is in contact can be prevented, thereby improving the pressure distribution problem.

[0028] In addition, since each pelvic floor pressure region of the vaginal insertion part is i) located lower than the hinge part, and ii) has an upward convex shape, the pelvic floor pressure region of the insertion part is easily inserted downward when inserted into the vagina or anus, and even in an environment where the distance between the two walls of the pelvic floor narrows as it goes down to the pelvic floor in the thickness direction in the vaginal or anal passage, contact and pressure distribution to other internal body tissues other than the pelvic floor can be prevented.

[0029] FIG. 1 is a schematic diagram of a pelvic floor stiffness measuring device having a pair of pressurizing members according to one embodiment of the present invention.

[0030] FIG. 2a is a front schematic diagram of a pelvic floor stiffness measuring device in a closed state, with the longitudinal direction of a pair of pressure members as the standard according to one embodiment of the present invention.

[0031] Figure 2b is a front schematic diagram showing the insertion portions of the pair of pressurizing members in an open and closed state.

[0032] FIG. 3 is a side schematic diagram of a pelvic floor stiffness measuring device in a closed state, with the thickness direction of a pair of pressurizing members as the standard according to one embodiment of the present invention.

[0033] Fig. 4 is a photograph showing a pelvic floor stiffness measuring device according to one embodiment of the present invention.

[0034] Figures 5 and 6 are reference drawings explaining the operating state of the pelvic floor stiffness measuring device according to the present invention.

[0035] The advantages and features of the present invention, and the methods for achieving them, will become clearer with reference to the embodiments described in detail below together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be implemented in various different forms. These embodiments are provided solely to ensure that the disclosure of the present invention is complete and to fully inform those skilled in the art of the scope of the invention, and the present invention is defined solely by the scope of the claims.

[0036] Unless otherwise defined, all terms (including technical and scientific terms) used in this specification may be used in a meaning that can be commonly understood by a person of ordinary skill in the art to which the present invention belongs.

[0037] When a part of a specification is said to "include" a component, this does not mean that it excludes other components, but rather that it may include other components, unless otherwise specifically stated. Furthermore, the singular includes the plural unless specifically stated otherwise.

[0038] When a part such as a layer, film, region, plate, structure, frame, member, or portion is said to be “on top” or “over” another part in this specification, this includes not only cases where it is “directly above” the other part, but also cases where there is another part in between.

[0039] One embodiment of the present invention provides a pelvic floor stiffness measuring device. Fig. 1 is a schematic diagram of a pelvic floor stiffness measuring device having a pair of pressurizing members according to one embodiment of the present invention, Fig. 2a is a front schematic diagram of the pelvic floor stiffness measuring device in a closed state, shown with respect to the longitudinal direction of the pair of pressurizing members according to one embodiment of the present invention, and Fig. 2b is a front schematic diagram showing an open state and a closed state of the insertion portion of the pair of pressurizing members.

[0040] Referring to FIGS. 1, 2a and 2b, the pelvic floor rigidity measuring device is characterized in that, based on the longitudinal direction of a pair of pressure members, each end of a pair of pressure members (10) forms an insertion portion (100); each other end forms a grip portion (200); and a hinge portion (300); which is non-intersecting between the insertion portion (100) and the grip portion (200) is formed. The pair of pressure members may have a scissors shape in which the pair of insertion portions (100) are opened and closed by opening and closing the pair of grip portions (200) about the hinge portion (300). According to the present invention, when a user opens and closes the grip portion, the pair of insertion portions inserted into the vagina or anus about the hinge portion are opened and closed in a state in which they are in contact with the pelvic region. Accordingly, the principle is that a pair of inserts are spaced apart to pressurize both walls of the pelvic floor tissue, and the distance the tissue moves and the pressure at this time are measured to calculate the tissue stiffness. According to the present invention, there is an advantage in that it is small in volume and can accurately measure the pressure element without finger palpation, thereby evaluating the pelvic floor tension.

[0041] The above pair of insertion parts (100) are inserted into the vagina or anus to directly contact and apply pressure to the pelvic floor, which is the target of stiffness measurement, and each end of the pair of pressure members forms a pelvic floor pressure region (110) based on the longitudinal direction of the pair of pressure members, and each other end is formed by being connected to the hinge part (300).

[0042] The above insertion portion (100) is provided with a downward convex curved surface between the pelvic floor pressing area (110) and the hinge portion (300) based on the width-wise symmetry axis through which the pair of pressing members are opened and closed, and is connected to an intermediate area (130) in which a point (131) where the pair of insertions intersect is formed at least in part.

[0043] Meanwhile, the axis of symmetry in the width direction along which a pair of pressurized members are opened and closed means a straight axis connecting the center point (A) of the pair of gripping parts (200) and the center point (A') of the pair of inserting parts (100), as shown in FIGS. 1, 2a and 2b, and is a central axis along which a pair of inserting parts are opened and closed with the hinge part as the center by opening and closing of the pair of gripping parts.

[0044] In the present invention, i) a pair of pressure members are curved so as to contact but not intersect each other at a hinge portion (300) connecting the insertion portion (100) and the grip portion (200) in the middle, and ii) a pair of insertions contact and intersect (131) at an intermediate region located between the hinge portion and the insertion portion (based on the axis of symmetry in the width direction), which is different from the configuration of general scissors in which the grip portion and the blade portion (corresponding to the insertion portion) contact and intersect at the hinge portion (corresponding to the hinge portion) and contact and not intersect at the intermediate region of the blade portion. Accordingly, as shown in FIG. 2A, when a pair of insertions is closed (in a compressed state), the distance between the pair of pelvic floor pressure areas (110) is short, so that the pair can be inserted into a narrow vagina or anus without any particular physical damage. Next, when the insertion part is opened (in a spread state) according to the opening of the grip part as shown in Fig. 2b, the distance between the intermediate region (130) located in the opposite direction to the pelvic floor pressure region (110) based on the intersection point (131) tends to decrease and then increase, which can improve the problem of pressure dispersion by preventing the measuring device from contacting internal body tissues other than the pelvic floor. Accordingly, the pelvic floor pressure region (110) formed at each end of a pair of pressure members (10) can efficiently contact and pressurize only both walls of the pelvic floor tissue.

[0045] In addition, iii) since the intermediate region is provided with a downward convex curved surface (based on the axis of symmetry in the width direction), in addition to the effect of preventing damage to the body simply by forming the insertion part surface into a curved surface, the above-described effect can be further improved. On the other hand, if it is provided with an upward convex curved surface or a flat surface, the range of variation in the distance between the intermediate region when the insertion part is opened and closed may be large, so the effect of preventing contact with and pressure from being distributed to other internal body tissues except for the pelvic floor may be relatively reduced.

[0046] In addition, the above pair of inserts (100) may be characterized by satisfying the following relational expression 1.

[0047] [Relationship 1] 0 ≤ D2 / D1 < 1

[0048] In relational expression 1, the D1 and D2 are the distance (D1) between the pair of pelvic floor pressurization areas (110) and the distance (D2) between the pair of intermediate areas (130), respectively, based on the width-wise symmetrical axis of the pair of pressurization members (10) when the pair of insertion parts (100) are opened and closed by the opening and closing of the pair of gripping parts (200).

[0049] In the above relational expression 1, 0 < D2 / D1 < 1, 0.1 < D2 / D1 < 0.9, 0.1 < D2 / D1 < 0.8 or 0.1 < D2 / D1 < 0.7 may be satisfied. In the present invention, the relational expression 1 may be satisfied when the grip portion and the insertion portion are closed (maximally compressed). In this case, 0.5 < D2' / D1' < 0.75 or 0.6 < D2' / D1' < 0.7 (relational expression 1-1). Accordingly, when inserting the measuring device into the vagina or anus, it is possible to insert it into a narrow vagina or anus without any special physical damage (see <insertion portion closed state> of FIG. 2b). In addition, in the present invention, after the insertion part is inserted into the vagina or anus, the grip part and the insertion part may be opened (slowly unfolded from a completely closed state) and the above relationship 1 may be satisfied. In this case, 0 < D2" / D1" < 0.5, 0 < D2" / D1" < 0.3, or 0.1 < D2" / D1" < 0.2 (Relationship 1-2). By reducing the variation range of the separation distance (D2) of the middle region when opening the insertion part after insertion and relatively increasing the variation range of the separation distance (D1) of the pressurized region, when opening the insertion part in a narrow and winding vaginal or anal passage, the problem of contact and pressure being distributed to other internal body tissues except for the pelvic floor can be improved (see <Insertion part opening state> of FIG. 2b).

[0050] Here, the separation distance (D2) of the pair of intermediate regions (130) may be the average separation distance of at least a portion of the pair of intermediate regions, and may be the average separation distance of all regions except each pelvic floor pressure region (110) and the lower safety region (150) in the pair of insertions based on the longitudinal direction of the pair of pressure members (10), and preferably, may be the separation distance of the region with the longest or shortest separation distance among the pair of intermediate regions when the pair of insertions is closed.

[0051] In addition, the pair of insertion parts (100) may further include a safety area (150) in which each end is connected to the hinge part (300). Reflecting this, when the pair of insertion parts (100) is changed from a closed state to an open state by opening and closing the pair of grip parts (200), the pair of pelvic floor pressure areas (110) may exhibit a gradient in which the separation distance (D1) increases, the pair of intermediate areas (130) may exhibit a gradient in which the separation distance (D2) decreases and then increases, and the pair of safety areas (150) may not exhibit any gradient in which the separation distance (D3) increases or decreases. In addition, conversely, when the pair of insertion parts (100) are changed from an open state to a closed state by opening and closing the pair of grip parts (200), the pair of pelvic floor pressure areas (110) may exhibit a gradient in which the separation distance (D1) decreases, the pair of intermediate areas (130) may exhibit a gradient in which the separation distance (D2) increases and then decreases, and the pair of safety areas (150) may not exhibit any of the gradients in which the separation distance (D3) increases and decreases. Accordingly, the effects described above in the present invention can be further improved.

[0052] FIG. 3 is a schematic diagram of a pelvic floor stiffness measuring device in a closed state, based on the thickness direction of a pair of pressure members according to one embodiment of the present invention.

[0053] Referring to FIG. 3, the pair of inserts may be provided such that each pelvic floor pressurization area (110) is i) positioned lower than the hinge portion (300), and ii) has a convex shape, based on the central axis in the thickness direction of the pair of pressurization members (10).

[0054] Accordingly, since each pelvic floor pressure region (110) is i) located below the hinge portion (300), the pelvic floor pressure region (110) of a pair of insertions can be easily inserted downward when inserted into the vagina or anus, as shown in FIG. 5, when the front of the vaginal or anal entrance is approximated as a uniform circle, the pressure region (110) of the insertion portion can effectively reach the levator ani muscle, which is a deep structure of the lower pelvic floor, located at the 4 to 5 o'clock and 7 to 8 o'clock directions. In addition, since the pelvic floor pressure region (110) is provided in a convex shape upward, when generally approximated as a lying cylinder shape, there is a tendency for the distance between the two walls of the pelvic floor to narrow as one goes down to the lower pelvic floor in the thickness direction in the vaginal or anal passage, the present invention can prevent contact with and pressure from being distributed to other internal body tissues except for the pelvic floor. Conversely, if the pelvic floor pressure area is provided in a convex shape downward, it may not be easy to open and close the insertion part within the pelvic cavity, and other insertion part (100) areas such as the intermediate area (130) and the safety area (150) may come into contact with the deep structures of the lower pelvic floor, which is not desirable.

[0055] Meanwhile, the central axis in the thickness direction of a pair of pressure members (10) means a straight axis connecting the central point (B) of the pair of gripping parts (200) and the central point (B') of the hinge part (300) based on the thickness direction, as shown in FIG. 3.

[0056] The pair of gripping parts (200) may have a loop shape with each end positioned opposite the insertion part, and may be formed with a first finger hole into which a thumb is inserted and a second finger hole into which a finger other than the thumb is inserted. The first and second finger holes may be circular, oval, or egg-shaped. In addition, each other end of the gripping parts (200) may be formed to extend from each end and be connected to the pair of hinge parts.

[0057] The above pair of hinge parts (300) is positioned between the insertion part (100) and the grip part (200), and the pair of pressure members (10) are formed to contact but not intersect at the hinge part, and further, first and second protrusions (not shown) protruding from the surface in the thickness direction of the pair of pressure members (10) can be formed. When a through hole is formed in an overlapping state, the first and second protrusions can be configured to allow an axis to pass through them and fix both ends so that the first and second protrusions can rotate. Accordingly, the pair of insertion parts (100) is configured to be opened and closed by opening and closing the pair of grip parts (200) centered on the hinge part (300) in the pair of pressure members (10).

[0058] The above pair of pressurizing members (10) may further include a sensor unit (400) having a movement sensor (410) and a pressure sensor (420) for calculating the rigidity of the pelvic floor. According to the present invention, when the pair of insertion parts (100) are opened and closed by opening and closing the pair of gripping parts (200), the movement sensor (410) can measure the movement distance of the pair of pelvic floor pressurizing areas (110), and the pressure sensor (420) can measure the pressurizing force on the pelvic floor.

[0059] The pressure sensor (420) may be installed in the pelvic floor pressure region (110) of the pair of insertions (100) and / or at least a portion of the pair of gripping parts (200), and preferably may be installed in the pelvic floor pressure region (110) of the pair of insertions (100) or at least a portion of the pair of gripping parts (200).

[0060] For example, when the pressure sensor (420) installed in the pelvic floor pressure area (110) starts from the point where it comes into contact with the pelvic floor deep structure (real-time graph or detects significant pressure change) and the insertion part is expanded in the width direction, the pressure applied to the pelvic floor is measured through the pressure sensor (420) to output pressure information, and at this time, the movement distance of the pelvic floor pressure area (110) is measured through the movement sensor (410) to output information on the movement distance of the tissue, thereby calculating the stiffness of the pelvic floor deep structure.

[0061] The above motion sensor (410) can output movement distance information by calculating the change in length of each (insertion part) pelvic floor pressure area (110) when the central angle between a pair of insert parts (100) based on the hinge part (300) changes as a pair of pressure members (10) are opened and closed in the width direction. At this time, the change in length may mean a change in the length of an arc or chord according to the change in the central angle, but the present invention is not limited thereto.

[0062] A pelvic floor stiffness measuring device according to one embodiment may further include a control unit (500). Accordingly, a pressure sensor (420) is disposed in the pelvic floor pressurization area (110) of the insertion unit (100), and a movement distance measuring module (not shown) and a pressure measuring module (not shown) are built into the control unit (500), so that after the insertion unit (100) is inserted into the vagina or anus, the grip unit (200) is opened and closed to apply pressure to the pelvic floor, and the applied pressure and movement distance are measured to output pressure information and movement distance information. Subsequently, a stiffness calculation module (not shown) is built into the control unit (500), so that pelvic floor tissue stiffness can be calculated using the pressure information and movement distance information.

[0063] Hereinafter, the operating state of the pelvic floor stiffness measuring device according to the present invention will be described in detail with reference to the drawings.

[0064] Figures 5 and 6 are reference drawings explaining the operating state of the pelvic floor stiffness measuring device according to the present invention.

[0065] As shown in Fig. 5, in order to reach the pressure area (110) of the insertion part to the levator ani muscle, which is a deep structure of the lower pelvic floor located at the 4-5 o'clock and 7-8 o'clock directions when the front of the vaginal or anal inlet is approximated as a uniform circle, a pair of pressure members (10) of the pelvic floor rigidity measuring device is closed so that one end (pelvic floor pressure area) of the insertion part (100) is folded in the width direction to touch the vaginal introitus, and the hinge part (300) is adjusted to be positioned at the center of the front of the vaginal or anal inlet. At this time, the device is slowly inserted into the vaginal introitus while keeping the grip part (200) closed, but is carefully inserted while minimizing the distance between the two ends of the pair of insertions touching the introitus (see ① of Fig. 6).

[0066] A pair of pressure members (10) are slowly opened (unfolded) in a widthwise opening (deployment) range of about 6 to 8 cm to find the point where a valid pressure change (the point where the external force begins to act by contacting the tissue) appears in the pressure sensor (420), and the distance between the two pelvic floor pressure areas (110) is output (marked) (see ② of Fig. 6).

[0067] To fix the insertion site, a certain downward pressure is applied and the pressure area (110) of the insertion site is opened (unfolded), and the external force applied to the extent that the pelvic floor tissue no longer moves is measured (see ③ of Fig. 6).

[0068] Next, the tissue stiffness is calculated by dividing the output external force by the movement distance (see ④ in Fig. 6).

[0069] The pelvic floor tissue stiffness measuring device of the present invention can be easily used by pelvic floor health experts (doctors, physical therapists, nurses, etc.) in clinical practice. For example, it can be used to screen objective information on pelvic floor tissue tension in private clinics that are not equipped with imaging equipment. The clinical significance of pelvic floor tissue tension is related to the function of the pelvic floor muscles, and pelvic floor muscle dysfunction can be associated with various symptoms such as urinary incontinence, sexual dysfunction, pelvic floor pain, nonbacterial prostatitis, urinary frequency, residual urine, chronic constipation, and fecal incontinence. In particular, symptoms such as urinary frequency, residual urine, dyspareunia, and pelvic floor pain are thought to be related to high pelvic floor tissue tension. Conversely, urinary incontinence and pelvic organ prolapse (urethrocele, cystocele, uterine prolapse, rectocele, etc.) are associated with low pelvic floor tissue tension. Accordingly, according to the present invention, the measurement values ​​and standard deviations of normal individuals are obtained, and based on these, information on the tension of pelvic floor tissue for each disease is obtained, and then it can be usefully utilized to determine therapeutic methods for normalizing the same.

[0070] (Explanation of symbols)

[0071] 1: Pelvic floor stiffness measuring device 10: Pressure member

[0072] 100: Insertion area 110: (Insertion area) Pelvic floor pressure area

[0073] 130: (Inset) Middle area 131: (Inset) Intersecting point

[0074] 150: (Insertion) Safety area 200: Grab area

[0075] 300: Hinge part 400: Sensor part

[0076] 410: Motion sensor 420: Pressure sensor

[0077] 500: Control Unit

Claims

1. A pair of pressure members (10) each having one end forming an insertion portion (100) in the longitudinal direction, each other end forming a grip portion (200); and a hinge portion (300); which is non-intersecting between the insertion portion (100) and the grip portion (200), and including a pair of pressure members (10) in which the pair of insertion portions (100) are opened and closed by opening and closing the pair of grip portions (200) with the hinge portion (300) as the center. A pelvic floor stiffness measuring device characterized in that the pair of inserts (100) each form a pelvic floor pressurization area (110) in the longitudinal direction, each other end is connected to the hinge portion (300), and is provided with a convex curved surface downward based on the widthwise symmetrical axis through which the pair of pressurizing members (10) open and close, and is connected to an intermediate area (130) in which at least a portion of the pair of inserts intersects (131).

2. In paragraph 1, The above pair of inserts (100) is a pelvic floor stiffness measuring device that satisfies the following relational expression 1: [Relationship 1] 0 ≤ D2 / D1 < 1 In relational expression 1, the D1 and D2 are the distance (D1) between the pair of pelvic floor pressurization areas (110) and the distance (D2) between the pair of intermediate areas (130) based on the width-wise symmetry axis of the pair of pressurization members (10) when the pair of insertion parts (100) are opened and closed by the opening and closing of the pair of gripping parts (200), respectively.

3. In paragraph 1, The above pair of inserts (100) further includes a safety area (150) in which each end is connected to the hinge portion (300), A pelvic floor rigidity measuring device, wherein when the pair of insertion parts (100) are changed from a closed state to an open state by opening and closing the pair of gripping parts (200), the pair of pelvic floor pressure areas (110) exhibit a gradient in which the separation distance (D1) increases, the pair of intermediate areas (130) exhibit a gradient in which the separation distance (D2) decreases and then increases, and the pair of safety areas (150) exhibit neither a gradient in which the separation distance (D3) increases nor decreases.

4. In paragraph 1, A pelvic floor rigidity measuring device, wherein the pair of inserts are provided with a convex shape so that each pelvic floor pressurization area (110) is positioned lower than the hinge portion (300) based on the central axis in the thickness direction of the pair of pressurization members.

5. In paragraph 1, The above pair of pressure members (10) are: A pelvic floor rigidity measuring device further comprising a sensor unit (400) including a movement sensor (410) that measures the movement distance of the pair of pelvic floor pressure areas (110) when the pair of insertion parts (100) are opened and closed by opening and closing the pair of gripping parts (200) and a pressure sensor (420) that measures the pressure applied to the pelvic floor.

6. In paragraph 5, A pelvic floor rigidity measuring device, wherein the pressure sensor (420) is installed in the pelvic floor pressure region (110) of the pair of insertion parts (100) and / or at least a portion of the pair of grip parts (200).

7. In paragraph 5, When the above pelvic floor pressure area (110) starts from the point where it contacts the pelvic floor deep structure and the insertion part (100) is expanded in the width direction, The pressure applied to the pelvic floor is measured through the pressure sensor (420) to output pressure information, and the movement distance of the pelvic floor pressure area (110) is measured through the movement sensor (410) to output tissue movement distance information. A pelvic floor stiffness measuring device characterized in that it calculates the stiffness of the pelvic floor deep structure using the above pressure information and movement distance information.

Images