WO2024263784A1 - Systems, methods, and devices to measure and analyze vaginal skin biomechanics - Google Patents

Abstract

Systems, methods, and devices include a tissue measuring device for analyzing tissue laxity. The tissue measuring device includes a probe with a probe housing removably coupled to a first end of a manifold body. A sensor assembly extending from the first end of the manifold body includes a proximity sensor at a distal end, which aligns with a measurement opening in the probe housing when the probe housing is attached to the manifold body. A camera and/or light capture additional tissue data via video. The proximity sensor, the camera, and/or the light are controllable to perform the tissue laxity data collection and analysis procedures using a control console which uses one or more ramp profiles to generate the tissue laxity data. The one or more ramp profiles can include a first hold plateau, a peak, a second hold plateau, and/or a tissue release period.

Description

TITLE

SYSTEMS, METHODS, AND DEVICES TO MEASURE AND ANALYZE VAGINAL SKIN BIOMECHANICS

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Patent Serial No. 63/509,708, filed June 22, 2023, and titled “SYSTEMS, METHODS, AND DEVICES TO MEASURE AND ANALYZE VAGINAL BIOMECHANICS,” which is incorporated by reference herein in its entirety.

BACKGROUND

1. Field

[0002] The present disclosure relates generally to the field of biomechanical tissue analysis and, more particularly, to measuring vaginal skin biomechanics.

2. Discussion of Related Art

[0003] Vaginal wall tissue deterioration can cause pelvic organ prolapse (POP), a hernia of the pelvic organs through the interior vaginal walls and the vaginal opening. POP affects a significant number of aging women, often necessitates surgical repair, and tends to recur over time. Approximately 200,000 operations are performed annually in the United States for POP. POP is life altering and results in significant quality of life changes in women.

[0004] Currently, evaluation of the vaginal wall is limited to physical examination and imaging modalities. Quantitative and practical devices for measuring the unique viscoelastic properties of the vagina to objectively determine tissue deterioration during an in-office visit are limited. Such devices perform poorly as a result of various operational/engineering challenges. Consistent, low-noise data is difficult to generate due to the physical challenge of positioning and maintaining the device in a consistent data collection location for every measurement in an in-office setting. Variations in the measurement location and/or angle can cause the quality of the data to suffer. Additionally, keeping the sensor sufficiently clean to collect high-resolution data is difficult when the sensor is placed inside a patient and exposed to patient fluids. Further problems arise for devices relying on vacuum pressure because such systems have difficulty achieving an airtight seal and are prone to air leaks. It is also difficult to collect meaningful data and to convert the data into actionable information. Patient acceptance of such devices remains an obstacle as well.

[0005] It is with these observations in mind, among others, that various aspects of the present disclosure were conceived and developed. BRIEF SUMMARY

[0006] The presently disclosed technology addresses the foregoing problems by providing systems, methods and devices to measure tissue laxity. A device for measuring tissue laxity can include a probe. The probe can have a probe housing with an attachment end removably couplable to a manifold body manifold body at a first end; and/or a sensor assembly (e.g., a printed circuit board (PCB) or other mounting board) extending from the first end with a proximity sensor at a distal end of the sensor assembly. The proximity sensor can be aligned with a measurement opening in the probe housing when the probe housing is coupled to the manifold body. Additionally, the device can include an airway opening at a second end operable to couple to a vacuum source; and/or a control console communicatively coupled to the sensor assembly. The control console can include one or more processors; and one or more memories storing computer-readable instructions that, when executed by the one or more processors, cause the device to activate a vacuum source to create suction or other vacuum draw at the measurement opening; measure, using the proximity sensor a tissue deformation caused by the vacuum draw at the measurement opening; and/or cause, at a display communicatively coupled to the control console, one or more measured values corresponding to the tissue deformation to be presented.

[0007] In some examples, the probe further includes a guide channel formed into an interior surface of the probe housing to mate with an edge of the sensor assembly and maintain a front plane of the proximity sensor parallel to the measurement opening. Additionally, the device can include a raised opening lip around the measurement opening extending from a curved portion of an exterior surface of the probe housing, wherein, the raised opening lip can include a flat opening surface around the measurement opening to form a seal with patient tissue during a tissue laxity measurement procedure. Furthermore, the device can include an O-ring positioned around an attachment opening of the probe housing forming a sealed air pathway for the vacuum draw.

[0008] The device can also have a camera (e.g., a micro camera) inside the probe housing and/or directed along a lateral axis of the probe (e.g., the lateral direction 214 in FIG. 2) and/or directed towards the distal end 1 12 to generate a video of the tissue deformation inside the probe. The computer-readable instructions, when executed by the one or more processors, can further cause the video of the tissue deformation to be presented at the display with the one or more measured values. In some instances, the tissue deformation includes a tissue uplift and a tissue release (e.g., recoil, recovery, or rebound); and/or measuring the tissue deformation includes generating tissue location data points at a rate of between 20 and 100 data points per second during the tissue uplift and the tissue release. Additionally or alternatively, the computer-readable instructions, when executed by the one or more processors, can cause the device to calculate a first slope value associated with the tissue uplift and a second slope value of the tissue release; and/or present, at the display and during the tissue deformation, one or more indications of the first slope value and the second slope value. Furthermore, the computer-readable instructions, when executed by the one or more processors, can further cause the device to release the vacuum draw by closing the one or more vacuum valves or turning off power to the vacuum source; and/or cause a visual aid of tissue rebound to be presented at the display while releasing the vacuum draw. The probe can be formed of stainless steel or titanium and, in some instances, the device further can include one or more data connectors at the second end to communicatively couple to a control console.

[0009] In some examples, a method for measuring tissue laxity includes positioning a measurement opening of a probe over a target tissue area, the measurement opening being fluidly coupled to a vacuum source via an air pathway in the probe and a manifold body to which the probe is removably coupled. The method can also include aligning one or more proximity sensors of a sensor assembly with the measurement opening and the target tissue area, the sensor assembly being disposed inside the probe and fixed to the manifold body; and/or causing a tissue deformation by generating a vacuum draw at the measurement opening using the vacuum source. Furthermore, the method can include measuring the tissue deformation using the one or more proximity sensors; and/or causing one or more measured values corresponding to the tissue deformation to be presented at a display.

[0010] In some examples, the sensor assembly is a printed circuit board (PCB) with the one or more proximity sensors, a camera, and a light mounted to the PCB, and an edge that mates with a guide feature on an interior surface of the probe. Additionally, the method can include positioning the one or more proximity sensors a predetermined distance from the target tissue area, the one or more measured values are calculated based on the predetermined distance; and/or generating a video using a camera of the sensor assembly directed towards a distal end of the probe and the measurement opening such that a camera front alignment is perpendicular to a proximity sensor front alignment. Moreover, the method can include presenting the video of the tissue deformation at the display simultaneously with the one or more measured values; calculating a first slope value corresponding to a tissue uplift of the tissue deformation and a second slope value corresponding to a tissue release of the tissue deformation; and/or presenting the first slope value and the second slope value simultaneously with the video. In some scenarios, the method includes positioning the probe with a tripod assembly including at least one of a lateral slide rail or a visual level. Additionally or alternatively, causing the tissue deformation or measuring the tissue deformation can be responsive to one or more user inputs at a control console using a designated start button and/or a designated stop button.

[0011] In some examples, a method for measuring tissue laxity includes positioning a measurement opening of a probe, surrounded by raised opening lip, over a target tissue area, the measurement opening being fluidly coupled to a vacuum source via an interior portion of the probe. The method can further include causing a tissue deformation by generating a vacuum pressure at the measurement opening using the vacuum source, the tissue deformation including a tissue uplift and a tissue release; and/or measuring the tissue uplift and the tissue release using one or more sensors attached to a sensor assembly inside the probe and fixed to a manifold body such that the one or more sensors are aligned with the measurement opening and the target tissue area. Moreover, the method can include causing one or more measured values corresponding to the tissue uplift and the tissue release to be presented at a display via a live stream from the one or more sensors.

[0012] The foregoing is intended to be illustrative and is not meant in a limiting sense. Many features of the embodiments may be employed with or without reference to other features of any of the embodiments. Additional aspects, advantages, and/or utilities of the presently disclosed technology will be set forth in part in the description that follows and, in part, will be apparent from the description, or may be learned by practice of the presently disclosed technology.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. For the purpose of illustration, there is shown in the drawings certain embodiments of the disclosed subject matter. It should be understood, however, that the disclosed subject matter is not limited to the precise embodiments and features shown. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate an implementation of systems and methods consistent with the disclosed subject matter and, together with the description, serves to explain advantages and principles consistent with the disclosed subject matter, in which:

[0014] FIG. 1 illustrates an example system for measuring and/or analyzing tissue laxity with a tissue measuring device;

[0015] FIG. 2 illustrates an example system for measuring and/or analyzing tissue laxity with a tissue measuring device in an operating environment, which can form at least a portion of the system depicted in FIG. 1 ; [0016] FIG. 3 illustrates an example system for measuring and/or analyzing tissue laxity with a tissue measuring device for a target tissue area, which can form at least a portion of the system depicted in FIG. 1 ;

[0017] FIG. 4 illustrates an example system for measuring and/or analyzing tissue laxity with a tissue measuring device using one or more computing systems, which can form at least a portion of the system depicted in FIG. 1 ;

[0018] FIG. 5 illustrates an example system for measuring and/or analyzing tissue laxity with a control console, which can form at least a portion of the system depicted in FIG. 1 ;

[0019] FIG. 6 illustrates an example system for measuring and/or analyzing tissue laxity with a tissue measuring device and presenting measurement outputs, which can form at least a portion of the system depicted in FIG. 1 ;

[0020] FIG. 7 illustrates an example method for measuring and/or analyzing tissue laxity, which can be performed by the system depicted in FIG. 1 ; and

[0021] FIGS. 8A-8D illustrate an example system for measuring and/or analyzing tissue laxity using one or more ramped profiles, which can be performed by the system depicted in FIG. 1.

DETAILED DESCRIPTION

[0022] It will be appreciated that for simplicity and clarity of illustration, where appropriate, reference numerals have been repeated among the different figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein can be practiced without these specific details. In other instances, methods, procedures and components have not been described in detail so as not to obscure the related relevant feature being described. Also, the description is not to be considered as limiting the scope of the embodiments described herein. The drawings are not necessarily to scale and the proportions of certain parts may be exaggerated to better illustrate details and features of the present disclosure.

I. TERMINOLOGY

[0023] The phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. For example, the use of a singular term, such as, “a” is not intended as limiting of the number of items. Also, the use of relational terms such as, but not limited to, “top,” “bottom,” “left,” “right,” “upper,” “lower,” “down,” “up,” and “side,” are used in the description for clarity in specific reference to the figures and are not intended to limit the scope of the presently disclosed technology or the appended claims. Further, it should be understood that any one of the features of the presently disclosed technology may be used separately or in combination with other features. Other systems, methods, features, and advantages of the presently disclosed technology will be, or become, apparent to one with skill in the art upon examination of the figures and the detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the presently disclosed technology, and be protected by the accompanying claims.

[0024] Further, as the presently disclosed technology is susceptible to embodiments of many different forms, it is intended that the present disclosure be considered as an example of the principles of the presently disclosed technology and not intended to limit the presently disclosed technology to the specific embodiments shown and described. Any one of the features of the presently disclosed technology may be used separately or in combination with any other feature. References to the terms “embodiment,” “embodiments,” and/or the like in the description mean that the feature and/or features being referred to are included in, at least, one aspect of the description. Separate references to the terms “embodiment,” “embodiments,” and/or the like in the description do not necessarily refer to the same embodiment and are also not mutually exclusive unless so stated and/or except as will be readily apparent to those skilled in the art from the description. For example, a feature, structure, process, step, action, or the like described in one embodiment may also be included in other embodiments, but is not necessarily included. Thus, the presently disclosed technology may include a variety of combinations and/or integrations of the embodiments described herein. Additionally, all aspects of the present disclosure, as described herein, are not essential for its practice. Likewise, other systems, methods, features, and advantages of the presently disclosed technology will be, or become, apparent to one with skill in the art upon examination of the figures and the description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the presently disclosed technology, and be encompassed by the claims.

[0025] Any term of degree such as, but not limited to, “substantially,” as used in the description and the appended claims, should be understood to include an exact, or a similar, but not exact configuration. For example, “a substantially planar surface” means having an exact planar surface or a similar, but not exact planar surface. Similarly, the terms “about” or “approximately,” as used in the description and the appended claims, should be understood to include the recited values or a value that is three times greater or one third of the recited values. For example, about 3 mm includes all values from 1 mm to 9 mm, and approximately 50 degrees includes all values from 16.6 degrees to 150 degrees. [0026] The term "coupled" is defined as connected, whether directly or indirectly through intervening components, and is not necessarily limited to physical connections. The connection can be such that the objects are permanently connected or releasably connected. The terms "comprising," "including" and "having" are used interchangeably in this disclosure. The terms "comprising," "including" and "having" mean to include, but not necessarily be limited to the things so described. The term “real-time” or “real time” means substantially instantaneously.

[0027] Lastly, the terms “or” and “and/or,” as used herein, are to be interpreted as inclusive or meaning any one or any combination. Therefore, “A, B, or C” or “A, B, and/or C” mean any of the following: “A,” “B,” or “C”; “A and B”; “A and C”; “B and C”; “A, B and C.” An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.

II. GENERAL ARCHITECTURE

[0028] The systems, methods, and devices disclosed herein provide a clinical based examination of vaginal tissue properties by measuring drawn or released tissue during a metered load applied displacement. In some instances, the system may include a tissue measuring device with a probe, sensor assembly, and/or control console for collecting tissue data to determine tissue characteristics (e.g., tissue laxity, tissue elasticity, tissue health, and the like). The tissue measuring device can generate and measure a tissue deformation at a target tissue area using a proximity sensor on the probe and vacuum system. The probe can include a probe housing removably coupled to a manifold body. A sensor assembly extending from the manifold body can slide into an interior space of the probe housing by mating with a guide rail inside the probe housing. The sensor assembly can include a proximity sensor at a distal end for aligning with a measurement opening in the probe housing when the probe housing is secured to the manifold body. A camera and light can also be disposed on the sensor assembly for generating a video of the tissue deformation from inside the probe housing, which can be presented at a display simultaneously with the measurement data of the tissue deformation.

[0029] The probe housing can be removed from the manifold body after use (e.g., for cleaning) and can be reattached. Multiple components of the tissue measuring device can create a sealed air flow pathway for the vacuum system, which can be deconstructed for cleaning and then reconstructed and resealed when the probe is reattached to the manifold body (e.g., using an O-ring, one or more vacuum connectors, etc.). A raised inner lip around the measurement opening can further improve the seal created by the probe against the targe tissue area. The tissue measuring device can include a tripod attachment and/or one or more levels for positioning the tissue measuring device in a consistent measurement location for the data collection procedure. Additionally, the control console can provide an easy-to-use interface for performing the data collection procedure and presenting the results to the patient. As such, the tissue measuring device can generate highly consistent measurement data points, with a higher signal-to-noise ratio and less error sources than previous techniques. The accuracy of POP diagnosis is, thus, greatly improved with the tissue measuring device. Furthermore, the tissue measuring device discussed herein can have a higher overall patient acceptance than previous devices.

[0030] Additional advantages of the systems, methods, and devices discussed herein will become apparent from the detailed description below.

[0031] FIG. 1 illustrates an example system 100 for measuring and/oranalyzing tissue laxity using a tissue measuring device 102 with a probe 104 communicatively coupled to a control console 106 via an attachment cable 108. The probe 104 can include a detachable portion such as a probe housing 1 10 with a first housing end (e.g., an attachment end) couplable to a manifold body 1 14 at a first side 1 16 of the manifold body 1 14. The probe housing 1 10 can include a measurement opening 1 18 formed at or proximate to a second end (e.g., a distal end 1 12) of the probe 104. The probe 104 can include a sensor assembly 120 extending from the first side 1 16 of the manifold body 114.

[0032] In some examples, the sensor assembly 120 can be securely or fixedly coupled to the first side 1 16 of the manifold body 1 14 (e.g., via glue, a screw, a weld, a friction fitting, etc.) and the probe housing 1 10 can be removably or detachably coupled to the first side 1 16 of the manifold body 1 14 (e.g., via a screw threading, a clamp ring, a friction fit, a snap-fit, a latch, or the like). As such, the probe housing 110 can be removed, and can be reattached to the manifold body 114 after being separated and/or cleaned. Various components of the tissue measuring device 102 can facilitate these transitions between a separated state and an attached state. For instance, the sensor assembly 120 can include one or more edges or alignment protrusions for mating with a corresponding channel 122, hole, and/or groove on an interior surface 126 of the probe housing 110. In some scenarios, the channel 122 can run along a length dimension of the probe housing 110 and can mate with the side edge of the sensor assembly 120 to restrict the rotational movement of the probe housing 110 with respect to the sensor assembly 120 as the probe housing 110 is slid over or off the sensor assembly 120. In other words, the edge/channel mating configuration can provide a guide channel or rail for guiding the sensor assembly 120 into the probe housing 1 10. Moreover, the edge/channel mating configuration can secure or hold one or more proximity sensor(s) 124 of the sensor assembly 120 (e.g., mounted to the PCB) positioned in alignment with a measurement opening 1 18 formed into the probe housing 1 10. Additional sensors and/or components (e.g., a camera, a light, etc.) can be secured to the PCB forming the sensor assembly 120 can be secured or maintained in position by the edge/channel mating configuration with alignments towards the measurement opening 1 18, as discussed in greater detail below.

[0033] The probe housing 1 10 can define/cover an interior space 128 at least partially occupied by the sensor assembly 120 when the tissue measuring device 102 is in the attached or operational state. The probe housing 1 10 can be formed of metal, plastic, glass, composites, and the like. For example, the probe housing 1 10 may be formed of stainless steel or titanium, which can provide rigidity for the probe 104 and/or be easy to clean when the probe housing 110 is detached from the probe 104. Furthermore, in some scenarios, patient acceptance may rely on various aspects of the probe 104, such as an appearance, shape, perceived cleanliness, and/or material of the probe housing 1 10. As such, the stainless steel and/or titanium material may increase patient acceptance of the tissue measuring device 102.

[0034] In some instances, the interior space 128 defined by the probe housing 110 can also form at least part of an air pathway 130 for providing vacuum pressure to create a vacuum draw at the measurement opening 1 18. The air pathway 130 can extend from the measurement opening 118 (e.g., at a distal end of the probe housing 1 10) through the interior space 128 of the probe housing 1 10, into another, interior portion or air channel in the manifold body 1 14, and through an air pathway connector 132 extending from a second side 134 of the manifold body. The air pathway connector 132 can be couplable to a vacuum hose 136 which, in turn couples, to a vacuum source (e.g., vacuum system 414 discussed below regarding FIG. 4). The vacuum hose 136 can form at least a part of the attachment cable 108, which can be a multi-axial cable having multiple hoses and/or cables for different functions controllable by the control console 106. One or more valves can be disposed in the air pathway 130 that are actuated via one or more commands from the control console 106, as discussed in greater detail below. Additionally, an O-ring 138 can be disposed between the first housing end and the first side 1 16 to further seal the air pathway 130 and prevent air leaks. The O-ring 138 can be secured or compressed by a circular threaded ring/clamp that screws onto the first side 1 16 of the manifold body 114 to secure the probe housing 110 to the manifold body 1 14.

[0035] In some examples, a data connector 140 can be formed into and/or extend from the second side 134 of the manifold body 1 14. The data connector 140 can communicatively couple to the sensor assembly 120 and/or the components of the sensor assembly 120 (e.g., the proximity sensor(s) 124, a light, a camera, etc.) and/or to one or more processors of the control console 106 to perform various data collection, control, and analysis operations. Additionally or alternatively, the sensor assembly 120 can connect to a control system via a wireless transceiver (e.g., Bluetooth, cellular, Wi-Fi, data, etc.). The control console 106 can include a display 142 for viewing data being generated by the tissue measuring device 102. Additionally, the manifold body 114 can include a mounting system 144, for instance, to attach the tissue measuring device 102 to a tripod (e.g., as discussed regarding FIG. 2).

[0036] FIG. 2 illustrates an example system 200 for measuring and/or analyzing tissue laxity with the tissue measuring device 102 in an operating environment 202. The system 200 can include a tripod 204 to which the tissue measuring device 102 can be mounted/attached for insertion into a patient. The system 200 can form at least a portion of the system 100.

[0037] In some examples, the mounting system 144 of the tissue measuring device 102 is adjustable to attach and/or detach the manifold body 1 14 of the tissue measuring device 102 to the tripod 204. The mounting system 144 can include a screw-clamp 206 for releasably attaching a top half 208 of the mounting system 144 to a bottom half 210 of the mounting system 144 (e.g., to partially enclose and hold the tissue measuring device 102). An adjustable attachment can provide movement in a lateral direction 212 (e.g., along a length dimension of the probe 104), for instance, using one more sliding rails or sliding grooves. A protrusion or groove on the bottom of the manifold body 1 14 can mate with a corresponding groove or protrusion on the top surface of the tripod 204 so that the tissue measuring device 102 can move relative to the tripod 204 while staying attached to the tripod 204. Moreover, the tripod 204 can include one or more levels 214, mounted along edges or sides of the tripod 204, for instance, along the lateral direction 212 and/or along a transverse direction 216 across a width dimension of the tissue measuring device 102, perpendicular to the lateral direction 212 direction. The tripod 204 can further include one or more legs 218, mounting attachments, handles, straps, and/or gripping portions for further stabilizing the tissue measuring device 102 with the tripod 204 via additionally support. In some examples, the mounting system 144 can include an open center for wrapping around and/or attaching to the manifold body 114. For instance, the mounting system 144 can have a circular profile corresponding to a circular profile of the manifold body 1 14. Alternatively, the mounting system 144 (e.g., and any components of the mounting system 144 discussed herein) can be integrated or formed integral with the manifold body 114, such that the manifold body 114 and the mounting system 144 form a single component. The components of the mounting system 144 and the manifold body 1 14, and the various connectors can be reduced or miniaturized in size, and/or can be combined together in various other embodiments.

[0038] The tissue measuring device 102 can be used to measure laxity of vaginal skin on an anterior vaginal wall of a patient 220, for instance, to determine whether a measured tissue laxity value is an indicator of pelvic organ prolapse (POP). In the operating environment 202, the distal end of the probe 104 is inserted into the vaginal opening 222 of the patient 220 until the measurement opening 118 is aligned with and pressed against the anterior vaginal wall. One or more visual indicators along the probe 104 can indicate a depth (e.g., a predetermined distance from the tip of the probe 104) such that a consistent insertion depth can be reached (e.g., multiple times)for the data collection procedure. Once the tissue measuring device 102 a predetermined distance in the lateral direction 212, and leveled with respect to the lateral direction 212 and the transverse direction 216, a seal can be formed with the measurement opening 118 against the vaginal skin, and a data collection procedure using the tissue measuring device 102 can commence, as discussed in greater detail below. As such, the tissue measuring device 102 can generate high quality data (e.g., with low error rates) by creating a consistent data collection environment for the data collection procedure.

[0039] FIG. 3 illustrates an example system 300 for measuring and/or analyzing tissue laxity with the tissue measuring device 102 for a target tissue area 302. The system 300 can include the measurement opening 118 spaced a predetermined distance 304 from the proximity sensor 124 to measure a tissue deformation 306. The system 300 can form at least a portion of the system 100.

[0040] Once the measurement opening 118 is placed against the target tissue area 302, such as a portion of the vaginal skin, the tissue measuring device 102 can begin collecting measurement data. The vacuum system can be activated and the vacuum draw can be formed at the measurement opening 118 to pull the tissue into the measurement opening 118, between the walls of the measurement opening 118, forming the skin deformation 306. The proximity sensor 124 can be positioned aligned with the measurement opening 118 across from the measurement opening 118 at an opposite side of the probe 104 (e.g., in a direction perpendicular to the lateral direction 212). As such, the proximity sensor 124 can detect a measurement distance 308 between the proximity sensor 124 and the surface of the target tissue area 302. Data points collected indicating the measurement distance 308 can represent a distance of the tissue from the proximity sensor 124 (e.g., location data points for the skin) and/or can be associated with a timestamp. In some instances, a protective layer or membrane 125 may be disposed over the proximity sensor 124 (e.g., a transparent or at least partially transparent cover), to protect the proximity sensor 124 from fluids and/or being obscured. Furthermore, the protective layer 125 can be a calibration membrane which can have a specific color filter to increase or maintain a sensitivity of the proximity sensor(s) 124 (e.g., for detecting a color associated with human tissue or vaginal skin). The data collection procedure can include a calibration process for taking the protective cover 125 into account when calculating the data measurements. Furthermore, the interior surface 126 of the probe housing 1 10 can include a non-reflective coating or material to prevent or reduce light reflections (e.g., noise) inside the probe 104, further increasing quality of the collected data. A data collection rate for measuring the measurement distance 308 can be set and/or stored by one or more computing devices, for instance, of the control console 106 (e.g., discussed below regarding FIGS. 4-7).

[0041] In some instances, the light can illuminate the inside of the probe housing 110 and the skin deformation 306, and the camera can generate a video of the skin deformation 306 during the data collection procedure. The light and the camera can be positioned inside the probe housing 1 10 mounted to the PCB or other mounting platform of the sensor assembly 120, and directed with one or more alignment direction(s) from their positions on the PCB toward the measurement opening 118 and the skin deformation 306. First data points indicating the measurement distance 308, as well as second data points indicating an amount of pressure created by the vacuum draw, can be generated, stored, and/or presented at the display 142, for instance, simultaneously with the video (e.g., a live video stream) of the skin deformation 306 being generated by the vacuum draw. Presenting the live video stream of the skin deformation 306 with the measurement data during the in-office visit of the patient 220 can make the patient 220 more comfortable with the procedure, further improving patient acceptance of the tissue measuring device 102.

[0042] In some examples, the tissue measuring device 102 includes a raised lip 310 around the measurement opening 1 18. The raised lip 310 can extend from an exterior surface 312 of the probe housing 1 10 to create a flat surface 314 around the measurement opening 1 18. In some instances, the probe housing 1 10 has a circular profile 316, for instance, with round/curved portions. The raised lip 310 can extend from the round/curved surface of the probe housing 1 10 to create a flat surface over the curved surface surrounding the measurement opening 1 18. As such, the raised lip 310 can improve the seal created by converting the measurement opening 118 into a flat opening rather than a curved opening, which establishes better contact with the skin around the target tissue area 302 and reduces air leaks from the air pathway 130.

[0043] FIG. 4 illustrates an example system 400 for measuring and/or analyzing tissue laxity with the tissue measuring device 102 using one or more computing system(s) 402, which can form a part of the control console 106. The system 400 depicted in FIG. 4 can form at least a portion of the system 100.

[0044] In some instances, the computer system 402 includes one or more processor(s) 404, data storage device(s) 406, input/output (I/O) port(s) 408, and/or communication port(s) 410. The I/O port(s) 408 can receive one or more user inputs 412, and the processor 404 can execute one or more operations discussed herein (e.g., in response to the user input(s) 412). For instance, the system(s) 402 can perform various operations to control a vacuum system 414, activate one or more sensors 416 (e.g., the proximity sensor(s) 124, the camera, etc.), calculate analysis outputs (e.g., laxity values), and/or cause the measured values and/or analysis outputs to be presented at the display 142. Furthermore, the computer system(s) 402 can store various data types and instructions in one or more database(s) of the data storage device(s) 406 which, upon being executed, implement the tissue measuring device 102 as a special purpose computing device, as discussed in greater detail below.

[0045] In some instances, the computer system(s) 402 may be integral or formed into the control console 106, which can be a clamshell-style console, as discussed below regarding FIG. 5. Additionally or alternatively, the computer system 402 can be at least one of a computer, a desktop computer, a laptop computer, a cellular or mobile device, a smart mobile device, a wearable device (e.g., a smart watch, smart glasses, a smart epidermal device, etc.) an Internet-of-Things (loT) device, a virtual reality (VR) or augmented reality (AR) device, combinations thereof, and the like. The computer system 402, either as a single computer or as multiple computers, can provide operational control over the tissue measuring device 102 to implement the steps for measuring and analyzing tissue laxity.

[0046] For instance, the computer system 402 may be capable of executing a computer program product to execute a computer process. Data and program files may be input to the computer system 402, which reads the files and executes the programs therein. Some of the elements of the computer system 402 are shown in FIG. 4 including the one or more hardware processors 404, the data storage devices 406, the I/O ports 408, and/or the communication ports 410. Additionally, other elements that will be recognized by those skilled in the art may be included in the computer system 402 but are not explicitly depicted in FIG. 4 or discussed further herein. Various elements of the computer system 402 may communicate with one another by way of one or more communication buses, point-to-point communication paths, or other communication means.

[0047] The processor 404 may include, for example, a central processing unit (CPU), a microprocessor, a microcontroller, a digital signal processor (DSP), and/or one or more internal levels of cache. There may be one or more processors 404, such that the processor 404 comprises a single central-processing unit, or a plurality of processing units capable of executing instructions and performing operations in parallel with each other, commonly referred to as a parallel processing environment.

[0048] The computer system 402 may be a conventional computer, a distributed computer, or any other type of computer, such as one or more external computers made available via a cloud computing architecture. The presently described technology is optionally implemented in software stored on the data storage device(s) 406 and/or communicated via the one or more of the I/O port(s) 408 and/or communication port(s) 410, thereby transforming the computer system 402 in FIG. 4 to a special purpose machine for implementing the improved tissue laxity data collection and analysis procedures. The computer system 402 forming the tissue measuring device 102 can include a unique arrangement of unconventional and non-generic (e.g., special purpose) components such as the proximity sensor(s) 124 and/or other sensors 416, the light, the measurement opening 118, and/or one or more panel buttons 418 to receive the user input(s) 412. As such, the computer system 402 can form a non-conventional and non-generic arrangement that integrates the various algorithmic components of the tissue measuring device 102 into a practical application (e.g., by improving the data collection procedure for tissue laxity measurements).

[0049] The one or more data storage device(s) 406 may include any non-volatile data storage device capable of storing data generated or employed within the computer system 402, such as computer-executable instructions for performing a computer process, which may include instructions of both application programs and an operating system (OS) that manages the various components of the computer system 402. The data storage device(s) 406 may include, without limitation, magnetic disk drives, optical disk drives, solid state drives (SSDs), flash drives, and the like. The data storage devices 406 may include removable data storage media, non-removable data storage media, and/or external storage devices made available via a wired or wireless network architecture with such computer program products, including one or more database management products, web server products, application server products, and/or other additional software components. Examples of removable data storage media include Compact Disc Read-Only Memory (CD-ROM), Digital Versatile Disc Read-Only Memory (DVD-ROM), magneto-optical disks, flash drives, and the like. Examples of nonremovable data storage media include internal magnetic hard disks, SSDs, and the like. The data storage device(s) 406 may include volatile memory (e.g., dynamic random-access memory (DRAM), static random access memory (SRAM), etc.) and/or non-volatile memory (e.g., read-only memory (ROM), flash memory, etc.). The data storage device may include a non-transitory machine-readable medium having stored thereon instructions, which may be used to program a computer system (or other electronic devices) to perform a process according to the present disclosure. A machine-readable medium includes any mechanism for storing information in a form (e.g., software, processing application) readable by a machine (e.g., a computer). The machine-readable medium may include, but is not limited to, magnetic storage medium, optical storage medium; magneto-optical storage medium, read only memory (ROM); random access memory (RAM); erasable programmable memory (e.g., EPROM and EEPROM); flash memory; or other types of medium suitable for storing electronic instructions.

[0050] Computer program products containing mechanisms to effectuate the systems and methods in accordance with the presently described technology may reside in the data storage device(s) 406, which may be referred to as machine-readable media. It will be appreciated that machine-readable media may include any tangible non-transitory medium that is capable of storing or encoding instructions to perform any one or more of the operations of the present disclosure for execution by a machine or that is capable of storing or encoding data structures and/or modules utilized by or associated with such instructions. Machine-readable media may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more executable instructions or data structures. The machine-readable media may store instructions that, when executed by the processor, cause the systems to perform the operations disclosed herein.

[0051] In some examples, one or more data collection rate(s) 420 can be stored and/or retrieved by the processor 404 to control the number of data points collected by the proximity sensor 124 or other sensors 416. The data collection rate(s) 420 can be between 20 and 100 data points per second (e.g., 20, 30, 40, 50, 60, 70, 80, 90, or the like). In some instances, a data collection rate 420 can be increased to a first, greater value between 20 and 100 from a lower, second value (e.g., below 100 data points per second) in response to activating the vacuum system 414 and/or initiating the skin deformation 306. Furthermore, the databases of the device(s) 406 can store one or more vacuum pressure profile(s) 422, which indicate an amount of vacuum pressure to be provided to the measurement opening 118 over e predetermined time period. The vacuum pressure profile(s) 422 can be retrieved by the processor 404 and/or used to control how power is provided to the vacuum system 414 and/or how the vacuum valves are opened and closed during the data collection procedure. Additionally or alternatively, the data storage device(s) 406 can store one or more user interface control(s) 424. For instance, the control(s) 424 can convert the one or more user inputs 412, for instance, at the button(s) 418 or the display 142, into commands to the other components of the computer system 402.

[0052] In some implementations, the computer system 402 includes one or more ports, such as the one or more input/output (I/O) port(s) 408 and the one or more communication port(s) 410, for communicating with other computing devices, network devices, the vacuum system 414, the other sensors 416, and/or the display 142. It will be appreciated that the I/O port(s) 408 and the communication port(s) 410 may be combined or separate and that more or fewer ports may be included in the computer system 402. [0053] The I/O port(s) 408 may be connected to an I/O device, or other device, by which information is input to or output from the computer system 402. Such I/O devices may include, without limitation, one or more input devices, output devices, and/or environment transducer devices.

[0054] In one implementation, the input devices can convert a human-generated signal, such as, human voice, physical movement, physical touch or pressure, and/or the like, into electrical signals as input data into the computer system 402 via the I/O port 408. Similarly, the output devices may convert electrical signals received from computer system 402 via the I/O port 408 into signals that may be sensed as output by a human, such as sound, light, and/or touch. The input device may be an alphanumeric input device, including alphanumeric and other keys for communicating information and/or command selections to the processor 404 via the I/O port 408. The input device may be another type of user input device including, but not limited to: direction and selection control devices, such as a mouse, a trackball, cursor direction keys, a joystick, and/or a wheel; one or more sensors, such as a camera, a microphone, a positional sensor, an orientation sensor, a gravitational sensor, an inertial sensor, and/or an accelerometer; and/or a touch-sensitive display screen (“touchscreen”) with a graphical user interface (GUI). In some instances, the input device(s) are the panel button(s) 418 and/or a touchscreen component of the display 142. The output devices may include, without limitation, a display, a touchscreen, a projector, a speaker, a tactile and/or haptic output device, and/or the like. In some implementations, the input device and the output device may be the same device, for example, in the case of a touchscreen.

[0055] In one implementation, the communication port(s) 410 can connect various components of the tissue measuring device 102. The communication port(s) 410 can connect through hardwiring and/or over a local area network (LAN), a wide area network (WAN) (e.g., the Internet), one or more scientific equipment application programming interface (API) connections, or other communication protocols. The communication port(s) 410 can provide various other types of connections, such as for a Universal Serial Bus (USB), Ethernet, Wi-Fi, Bluetooth®, Near Field Communication (NFC), a cellular network (e.g., a Third Generation Partnership Program (3GPP) network), and the like. Further, the communication port 410 may communicate with an antenna or other link for electromagnetic signal transmission and/or reception.

[0056] In an example implementation, operations performed by the systems discussed herein may be embodied by instructions stored on the data storage devices 406 and executed by the processor 404 to measure and analyze tissue laxity data. The computer system 402 set forth in FIG. 4 is but one possible example of a computer system that may be employed or configured in accordance with aspects of the present disclosure. It will be appreciated that other non-transitory tangible computer-readable storage media storing computer-executable instructions for implementing the presently disclosed technology on a computing system may be utilized. The methods disclosed herein, such as method 700 regarding FIG. 7, may be implemented as sets of instructions or software readable by the computer system 402.

[0057] FIG. 5 illustrates an example system 500 for measuring and/or analyzing tissue laxity with the tissue measuring device 102. The system 500 can include the control console 106 for receiving the user inputs 412, controlling operation of the tissue measuring device 102, and presenting information at the display 142. The system 500 can form at least a portion of the system 100.

[0058] The control console 106 can have a clam-shell housing 502 with one or more hinges for transitioning the control console 106 between an open, operational position and a closed, storage ortransport position. The control console 106 can further include a front panel 504 with the panel button(s) 418 positioned (e.g., mounted) at the front panel 504. The panel button(s) 418 can include a start button 506 for initiating the data collection procedure. The start button 506 can activate the vacuum system 414, initiating the data collection rate for the proximity sensor 124, and/or cause the data at the display 142, and/or cause the video to be presented at the display 142. The panel button(s) 418 can include a stop button 508 for stopping or pausing the data collection procedure.

[0059] In some instances, the control console 106 further includes one or more connectors for attaching to various cables or hoses of the attachment cable 108. The connectors can include a data connector 510 for connecting to a data cable to send control commands and/or receive data from the proximity sensor 124 or other sensors 416. One or more power connectors can provide power to the camera and/or light. Furthermore, a vacuum connector 512 can connect to a vacuum hose of the attachment cable 108 to form the vacuum draw in the air pathway 130 between the vacuum system 414 and the measurement opening 118. As noted above, the various connectors can be separate connectors and/or combined or formed into one or more integrated connectors. The control console 106 can include a data storage system to automatically store the measurement data as it is collected (e.g., at the data storage device(s) 406 such as an internal hard drive, a USB drive, etc.).

[0060] The control console 106 can also include the display 142 for viewing the measured laxity values during the data collection process, the video, and/or data analysis outputs of the data collection process. The display 142 can include one or more displays 142. For instance, the display 142 be formed into a screen mount 514. The screen mount 514 can be rotatable between a viewing position with the screen mount 514 and the display 142 rotated out of the control console 106, and a stored position with the screen mount 514 and the display 142 rotated into a screen storage area 516 of the control console 106 (e.g., a gap formed behind and/or adjacent to the front panel 504). In some instances, the display 142 is integrally formed into the screen mount 514, whereas in other instances the display 142 can be a removable screen (e.g., a mobile device), and the screen mount 514 can include a screen connector for attaching and/or detaching the display 142 from the screen mount 514. Additionally or alternatively, the control console 106 can include a second display 518, for instance, mounted to the front panel 504. The second display 518 can be an instructional display that presents programmed instructions or messages as operator instructions for conducting the data collection process (e.g., “ready to start,” “press the start button,” “data collection complete,” and the like).The control console 106 can include a third display 520, which can be mounted to an inside of a top half 522 of the control console 106. The third display 520 can be a higher resolution display than the second display 518. In some instances, the measurement data can be presented at the third display 520 (e.g., along with the vacuum pressure profile(s) 422 being used), during the data collection procedure. The control console 106 can include any combination of the first display 142, the second display 518, or the third display 520, and any of the functions of these displays discussed herein can be combined.

[0061] In some examples, the vacuum system 414 (e.g., one or more vacuum pumps and/or vacuum controllers) can be contained and/or formed into the control console 106. The vacuum connector 512 can extend from the front panel 504 for connecting the vacuum system 414 to a first end of the vacuum hose of the attachment cable 108. A second end of the vacuum hose can attach to the second side 134 of the manifold body 1 14. As such, the air pathway 130 can be entirely formed between the control console 106 containing the vacuum system 414 and the measurement opening 1 18 at which the vacuum draw is generated. Additionally or alternatively, the vacuum system 414 can be separate from the control console 106, for instance, as a standalone vacuum source. In some scenarios, the vacuum system 414 includes one or more filters (e.g., in-line with the air pathway 130 at the manifold body 114 and/or at one of the connectors on the manifold body 1 14). The filter can maintain clean air in the air pathway 130, in accordance with regulatory standards, such as an FDA standard. The tissue measuring device 102 can further determine (e.g., at the control console 106) whether an air leak occurs and, in response, cause the data collection procedure to stop or pause. For instance, the tissue measuring device 102 can detect whether the vacuum pressure of the vacuum system 414 increases or decreases at a certain rate outside a predetermined threshold rate — indicative of a drop or spike in vacuum pressure.

[0062] FIG. 6 illustrates an example system 600 for measuring and/or analyzing tissue laxity with the tissue measuring device 102. The system 600 can include one or more measurement outputs 602 generated by the tissue measuring device 102 and/or presented at the display 142. The system 600 can form at least a portion of the system 100.

[0063] In some instances, the display 142 can present a graph of the one or more measurement outputs 602 with time on the x-axis, and a tissue distension value on the y-axis. The tissue distension value can indicate the change in the measurement distance 308 as the skin deformation 306 is created by the vacuum draw. Additionally or alternatively, the y-axis can indicate a vacuum pressure created by the vacuum system 414, for instance, in millimeters of mercury (mmHg). For instance, a first Ul presentation 604 can present one or more measurement outputs 602 including tissue deformation data 606, and vacuum pressure data 608 (e.g., corresponding to the vacuum pressure profile 422) layered over the tissue deformation data 606. In some instances, numerical values representing a current or realtime amount of tissue deformation (e.g., the measurement distance 308) can be presented in addition to the graphs of the measurement outputs 602.

[0064] The tissue measuring device 102 can calculate and/or present additional data analysis outputs. For instance, the skin deformation 306 can have a tissue uplift 610 corresponding to an increase in vacuum pressure pulling the tissue, and the tissue measuring device 102 can calculate and/or present a first numerical value or other symbol representing a first slope of the skin deformation 306 representing the tissue uplift 610. Moreover, the skin deformation 306 can have a tissue release 612 (e.g., recoil, recovery, or rebound) corresponding to a decrease in vacuum pressure releasing the tissue. The tissue measuring device 102 can calculate and/or present a second numerical value or other symbol representing a second slope of the tissue release 612. The values can be presented simultaneously with the graphs in real-time during the data collection process along with the video of the skin deformation 306.

[0065] The data collection process can include generating a plurality of sequential vacuum pressure profiles 422 by increasing and decreasing the vacuum draw multiple times, which generates the plurality of skin deformations 306. For instance, three skin deformation 306 can be generated sequentially and a second Ul presentation 614 can present the data collected during the three skin deformation 306. The multiple skin deformations 306 can be presented sequentially along the x-axis, as shown in the second Ul presentation 614, or presented overlayed with each other, as shown in the first Ul presentation 604 (which includes actual, high quality, low error data collected with the tissue measuring device 102). Tissue uplift and tissue release values for the three skin deformations can be calculated, presented, and/or averaged together. Other amounts of tissue deformations 306 can be generated in other embodiments (e.g., two, four, five, and the like). The vacuum pressure profile(s) 422 can include modulations of the vacuum draw and skin deformation 306 and/or the vacuum draw can be held constant for one second, two seconds, three seconds, or the like. Moreover, the tissue measuring device 102 can generate other types of skin deformations 306 using other vacuum pressure profiles 422. For instance, the vacuum pressure profiles 422 can have a plateau shape in which the vacuum drawn tissue is held in a pulled position for a predetermined amount of time — forming the top of the plateau — which can be used to measure other types of tissue characteristics with the proximity sensor 124 and/or other sensors 416 (e.g., tissue elasticity, tissue health, and the like).

[0066] FIG. 7 illustrates an example method 700 for measuring and/or analyzing tissue laxity with the tissue measuring device 102. The method 700 can be performed by any of the systems 100-600 or 800 discussed herein.

[0067] In some examples, at operation 702, the method 700 positions a measurement opening of a probe over a target tissue area, the measurement opening being surrounded by a raised lip and fluidly coupled to a vacuum source via an air pathway in the probe and a manifold body to which the probe is removably coupled. At operation 704, the method 700 aligns one or more proximity sensors of a sensor assembly with the measurement opening and the target tissue area, the sensor assembly being disposed inside the probe and fixed to the manifold body. At operation 706, the method 700 causes a tissue deformation by generating a vacuum draw at the measurement opening using the vacuum source, the tissue deformation corresponding to a vacuum ramp profile that includes a peak followed by a hold plateau. At operation 708, the method 700 measures the tissue deformation using the one or more proximity sensors. At operation 710, the method 700 causes one or more measured values corresponding to the tissue deformation to be presented at a display simultaneously with a video of the tissue deformation.

[0068] FIGS. 8A-8D illustrates an example system 800 for measuring and/or analyzing tissue laxity with the tissue measuring device 102 using one or more ramped profiles 802. The system 800 can form at least a portion of any of the system(s) 100-600.

[0069] In some examples, the system 800 can use an advanced software protocol to apply an energy value which generates a ramped event staying within a tissue deflection range to avoid causing damage to vaginal tissue. Tissue displacement can be within a deflection range which provides very accurate and repeatable measurements. In addition, some procedures or methods performed by the system 800 can include observations of tissue response for recoil and recovery measurements, which can provide data for calculating tissue mechanical values, stress, and/or strain. Moreover, the relationship of single fiber elasticity can be compared to tissue visco-elasticity. [0070] In some examples, a series of ramped profiles 802 can use an energy induced dynamic-to-static load technique. For instance, a number of measurements can be performed within a controlled loaded sequence. During the sequence, the tissue’s resistance to stretch (physical property of elastomers) can be measured while the tissue is stopped, held, and released, which can cause the stretched tissue to naturally recoil from the applied load (e.g., during a tissue recovery period). This can be termed a Load-Hold-Release protocol, which can be useful because the natural vaginal tissue anterior wall has pleats and rolled folds for tissue expansion during childbirth, making it difficult to measure mechanical properties of the tissue. An Infrared (IR) emitted signal can be used to measure the vaginal tissue and record data during the recoil portion as tissue is moving. The IR signal(s) can emit at a higher rate than the tissue is able to recover. Once measure, the charted data can show the natural tissue response and physical properties.

[0071] In some examples, the tissue measuring device 102 can be programmed with a selection of a plurality of different profiles, such as three different profiles, that have different specific ramp protocols and patterns. The first selected program, or first ramp profile 804, can plot a single vacuum draw to 150mmHg which is immediately released, forming a vacuum peak 806 (e.g., an initial vacuum peak), as discussed above regarding the tissue uplift 610 and tissue release 612 in FIG. 6. This protocol can confirm vaginal tissue being responsive and can show that the tissue is measurable on a consistent basis for clinical use. A second ramp profile 808 can also be used to confirm the responsiveness of deflected vaginal anterior tissue, and the ability to recoil while being held at a loaded condition. The second ramp profile 808 can include a hold plateau 810, which can be selected at 75mmHg for approximately 3 seconds. After the hold position plateau 810, then the vacuum can be increased to create the vacuum peak 806 (e.g., a subsequent vacuum peak following the hold plateau 808). The vacuum peak 806 of the second ramp profile 808 can be at 150mmHg and can be released to form the tissue release 612, similar to the first ramp profile 804.

[0072] In some examples, a tissue deflection protocol of the system 800 includes a third ramp profile 812. The third ramp profile 812 can use a full applied Load-Hold-Release sequence confirming vaginal tissue responsiveness for both drawn/held tissue and a programmed release/hold position. For instance, the third ramp profile 812 can include a first hold plateau 814 followed by the vacuum peak 806, which is in turn followed by a second hold plateau 816, and, finally, a release period 818. By using the third ramp profile 812, the system 800 can confirm tissue properties during both a force loaded condition to a natural recovery condition and a dynamic type of testing live in vivo tissue. This type of dynamic testing can be effective for analyzing tissue having a folded overlapping structure. [0073] In some examples, the system 800 can set a standard unit of measure from infrared (IR) wave pulses to Millimeters. For instance, infrared emitted light waves can be transmitted by a micro-controlled chip in a programmed mode to be reflected when the emitted waves contact objects in a line-of-sight transmission. Accordingly, the reflective light wave signals can be received by a biased micro-controlled collector portion of the same micro-controlled chip producing the pulsed electrical signal. The infrared light waves can be frequency generated. They can have a signal strength range programmed for transmission and configured for wave signal sensing of a measured timed response. Additionally or alternatively, the time based signals can be processed as a timed differential measurement for distance.

[0074] In some instances, the micro-controller can compare the time-based signals to a known mathematical value to convert the time-based signal to a physically measured distance in millimeters. This measurement can be used to determine distance changes of the deflected vaginal tissue. Once the distance measurement and the applied vacuum force are determined, the micro-controller can calculate vaginal tissue stress in mmHg per millimeter units. For instance, a linear equation of D = CiR_c + K can be used to convert an IR sensor reflection count to a distance to the measurement opening 118 value. D can be the distance to the measurement opening 118 in millimeters, R_c can be the IR sensor reflection count value, Ci can be an IR sensor Coeffient, K can be a measurement scaling constant. In some scenarios, Ci can be a first real number value between 0.001 and 0.002, such as 0.00142. K can be a second real number value between 0.01 and 0.1 , such as 0.061 . Moreover, in some scenarios, a clinician may use the following data for calculating 1)

[0075] This data can be generated using a micrometer positioned at the top of the aperture (e.g., the measurement opening 118), with a starting value indicated on the spindle (e.g., the probe 104) of 0.825 inches. A series of IR sensor readings in 0.025 increments can be taken using the sensor assembly 120. By subtracting the current /) from the starting location of 7.811mm, one can find the distance from the end of the spindle to the top of the aperture. This value, D2A, in mm, can be used to correlate to the IR sensor readings. An average reading from the sensor at a D2A of 0mm can be 5206.4. This value can be used as a baseline offset number. The output value(s) of the sensor can increase as an object gets closer, thus one can subtract this baseline value from subsequent readings to get a delta value (e.g., a change in reflection count from one position to the next) and an AVG delta. There can be, however a threshold at which an object can get too close to the sensor and cause readings become smaller rather than larger, although this can be a rare scenario unlikely to occur for normal functionality as skin would not be getting this close to the sensor. Once the distance range is narrowed down to the usable spectrum, the data points can become fairly linear. From this, one can create a linear model, such as the linear formula discussed above, to give a distance value in mm to any reflection count data point gathered.

[0076] In other words, the system 800 can use a comparative tissue distance measured for vaginal tissue mechanical properties. For example, the tissue measuring device 102 can measure tissue properties for relative tissue tension strength per a predetermined area for evaluation of both mechanical stress and strain properties.

[0077] As depicted in FIG. 8D, a series of pulsed infrared signal measurements can be charted, producing a relative value graph 820 of the measurements. This relative value graph 820 can be a value based timed chart of force (in some instances, measured in joules) per displaced tissue measurement in a relative sequence of pulsed signals, which can be used for comparative analysis and evaluation. For example, FIG. 8D depicts a relative value graph 820 which can be used, applying the third ramp profile 812, for comparative analysis of an up sloped hold position and a down slope hold position, to show the tissue’s response in a dynamic stressed condition. Also, the charted values can show a trend-shaped curve of applied or released loads. These curves can vary from patient-to-patient. These curves can indicate visco-laxity stress having a stronger vaginal tissue strength during the hold portion or a weakened tissue stress as the force is held then released. For instance, a tissue release slope 822 can be detected and/or determined to occur during the first hold plateau 814 and/or the second hold plateau 816. As discussed herein, this comparative value analysis can aid in the possible detection of vaginal prolapse. Furthermore, these method(s) to collect a dynamic sequence of waveform measurements in an in vivo protocol can aid in optimal tissue analysis.

[0078] In some examples, the tissue measuring device 102 uses software, written in C, and geared towards micro-controllers as the main processing power for the device. However, the framework and processes discussed herein can be written in a number of other languages to be implemented on any number of modern micro-controllers, micro-processors, PCs, or other devices. Touch screen operation or wireless operation via a cell phone/tablet/computer are also available for implementation. Furthermore, the tissue measuring device can include a number of independent and/or interoperating systems for both data collection and device operation including an interchangeable probe and probe calibration, a vacuum application system, an infrared distance detection system, visual inspection via a video camera, an operator friendly probe release system, and a tripod mounted telescopic probe positioner.

[0079] For instance, the Vacuum Application System (VAS) can include at least a vacuum pump, reserve reservoir, a pair of control solenoids, a coarse monitoring pressure sensor, and/or a fine monitoring pressure sensor. When combined and coordinated by the device software, a finite and accurate closed vacuum system can be created which can apply a pressure differential to a desired test area of skin via a 10mm aperture at the end of the probe. Changes in the pressure differential can be constantly monitored and reported via the fine pressure sensor. A peak vacuum applied can range from 0 to 258mmHG. The default value for a peak vacuum can be set to 150mmHg via control values in the software.

[0080] Furthermore, the Infrared Distance Detection (IDD) system can contain an infrared (IR) distance sensor and an optical lens filter to measure the distance a target area of skin moves from a baseline, located at the aperture opening, towards the sensor itself. To compensate and normalize the effects of differing skin tones, an optical filtering lens can be located directly on top of the IR sensor.

[0081] In some examples, the system 800 can use a visual inspection via video camera. The video camera can be a small, scope style camera added to the inside of the end of the probe, as discussed above. In conjunction with a recording device/ LCD screen, the camera can provide visual inspection of the applied test area. An operator can physically see the device functioning during a test, thus gaining instant feedback on how the device is functioning as well as potential visual inspection of hard or even previously impossible to view areas. The camera system can begin collecting data at the beginning of patient testing and can continue throughout the entire testing process. In some instances, the camera is activated and timed in coordination with an individual test and/or the collection of tissue deformation data 606, such that the camera can start and stop recording automatically when tests are performed. [0082] In some examples, the tissue measuring device 102 includes an operator friendly probe release system to aid in removing and/or replacing the probe housing 1 10 for cleaning, sterilization, and/or reassembly. This system can include a thumb actuated slide release which involves pressing down on a gate plate to release the probe, such that it can be removed from the probe housing 110. Once the probe housing 110 has been removed, cleaning both the housing, PC board and infrared sensor lens can be easily done. Thereafter reassembly is done by reversing the removal process.

[0083] In some scenarios, the system 800 can include a tripod mounted telescopic probe positioner. This positioner can be used to securely position and hold the probe in place for consistent measurements without the need for clinical support staff to stabilize the probe during the procedure. The probe can be inserted into the patient using the tripod by a gentle slide action to provide patient comfort and probe stability.

[0084] Additionally, the system 800 can include probe calibration and interchangeability features. For instance, the tissue measuring device 102 can be precisely manufactured to defined specifications of size, overall configuration with an interchangeable mount one device to another device without the need for calibration. The infrared sensor can be positioned and shielded with an optical filter lens to provide accurate signal emission and collection.

[0085] The systems and devices disclosed herein can provide improvements in previous techniques. For instance, the system 800 can have increased reading rate across the board for the sensors, with faster and more frequent readings providing more data points and an increased clarity in overall trends/results. Increased reading rates can provide for implementation of a rolling average algorithm when taking IR sensor readings to increase sensor accuracy and to help eliminate sensor drift that occurs in many IR sensors. This rolling average can be calculated by reading the current IR sensor value, adding it to the previous 4 readings and averaging their values to generate a rolling average value. This end result can also account for errant readings or outlier values by reducing their impact while maintaining the overall integrity of the other readings. Additionally, to address issues related to unit-less measurements, a test rig can be created to use micrometer measurements and a controlled sample to formulate an equation which converts the IR sensors’ exponential, reflection count output values to usable millimeter value.

[0086] Furthermore, the system(s) (e.g., systems 100-600 and/or 800) and/or method(s) (e.g., method 700) disclosed herein can include one or more operations of a test preparation procedure, a test performance procedure, using the camera, and/or cleaning the probe, as discussed in greater detail below. [0087] For example, the system(s) and/or method(s) can include a test preparation procedure. The test preparation procedure can include placing a box (e.g., a clamshell container) containing the control system of the tissue measuring device 102 on a flat, level surface, making sure it is stable, and opening the lid. Then the test preparation procedure can include connecting all the parts before the device is turned on. At a Step 1 , the tissue measuring device 102 can be plugging into two vacuum lines (e.g., red and blue vacuum lines) with one or more color-coded designated connections (e.g., red and blue), and/or attaching the probe data line to the control unit. Step 2 can include checking that, after cleaning the probe, the inside of the probe is dry; and placing the circular rubber gasket on the probe and attaching the probe to the handle. Step 2 can also include checking that the sensor on the sensor board inside the probe is aligned with the aperture; attaching the probe assembly to the handle; and/or tightening the probe assembly to a mark/indicator on the handle. Step 3 can include plugging the USB storage device into USB port on the control unit. The USB drive can be 1 Gb drive. Step 4 can include plugging in a power jack. Step 5 can include turning on and setting up the camera recording unit.

[0088] In some examples, upon power up, the current software version number can be displayed and the control unit can perform a hardware self-check for probe sensor communication and can automatically synchronize with the USB storage device. An IR Sensor Failure Error message can occur if sensor communication is not established. The data cable can be firmly connected to the control unit manually, and an operator can restart the device by unplugging the power jack from the unit and re-inserting it. If the USB drive is not found, an error message can prompt the user to re-insert a storage device and synchronize by pressing one of the control buttons (e.g., a blue button). If the sync process gets caught up in a loop, the operator can unplug the control unit, make sure the USB drive is securely inserted, count to 10, and power up the control unit to start over. Once the self-check is complete, a menu can display a choice to continue testing under the previous patient number, by pressing one of the control buttons (e.g., an orange button), or to create a new patient number by pressing another control button (e.g., a red button).

[0089] In some examples, the control unit can then display the current patient number on top of the following main menu selection choices. A first button (e.g., the blue button) can be pressed to show a Demo I Calibration menu, which performs a quick ramp profile to 150mmHG. This can be used to check for vacuum leaks or demonstrate unit functionality. A second button (e.g., the orange button) can be pressed to show a perform test menu. A third button (e.g., the red button) can be pressed to show a settings menu. The settings menu can show the ramp profiles such that the user can select one of the available vacuum ramp profiles with the one or more control buttons (e.g, by selecting the blue button). The settings menu can also provide an option to change patient, for instance, by increasing the patient number count and/or resetting the current test number to 001 . The settings menu can also present an option to return to the main menu.

[0090] In some examples, a Demo and/or Calibration menu can prompt the user to hold the probe against the skin of the patient (e.g., inside of an arm, a cheek, etc.) and to press one of the control buttons (e.g., the blue button) to perform demonstration test. The unit can perform a quick ramp, pause, ramp, and release profile, peaking at a predetermined value (e.g., 150mmHG), and can plot vacuum values taken during the test. A failure to reach the predetermined value during this test can indicate a leak. When the test completes, a user can press the blue button to repeat the test, or the red button to return to the main menu.

[0091] In some examples, to perform the test procedure, some patient information may be determined, such as patient discomfort. Patients should not feel any discomfort during the measurements. If they do, the user may recheck the probe placement. Furthermore, the patient can be tested with a fairly empty bladder. Urine or any liquid in the vagina can interfere with the vacuum sealing effect.

[0092] Furthermore, to perform the test procedure, the user can place the probe on the tripod. Then, the user can carefully insert the probe in the vagina and test the probe alignment for instance, by using the artificial horizon for levelling and/or a groove or marking on the probe for vaginal positioning. The groove or marking can be disposed on the probe at a 5 cm distance from the end, which can correspond to the area of the vagina located under the bladder base.

[0093] In some examples, the test procedure can also include aligning the top of the probe’s aperture surface against the skin to ensure a vacuum without distorting the skin. The user can press the blue button to set an initial offset value for the patient. This offset value can act as a baseline for calculations during the test. A flashing light (e.g., blue light) and/or beep sound can indicate that the probe is in position and can act as a short countdown prior to the test starting automatically. Furthermore, a flashing orange light can indicate that the probe is in a different range than expected based on the offset value. A user can readjust the probe until another light (e.g., a yellow light) flashes and beeps are heard. Additionally or alternatively, the user can force the test to begin manually by holding the blue button for 3 seconds. Moreover, the user can press the orange button to reset the offset value, or press the red button to change the ramp profile being used, change the patient number, or to return main menu I cancel test.

[0094] As noted above, in some examples, the unit can perform one of the following three vacuum ramp profiles. The first ramp profile 804 can include the vacuum starting at 0 and increasing to 150 mmHg in 1 second, then dropping to 0 and holding at 0 for an additional 5 seconds. The second ramp profile 808 can include the vacuum starting at 0 and increasing to 50 mmHg (e.g., the hold plateau 810). The vacuum can be held at this level for 3 seconds before increasing again to 150 mmHg. The vacuum can then drop to 0 and be held there for the remainder of the test. The third ramp profile 812 can include the vacuum starting at 0 and increasing to 50 mmHg. The vacuum can be held at this level (e.g., the first hold plateau 814) for 3 seconds before increasing again to 150 mm Hg. The vacuum can then be dropped to 60mmHg (e.g., the second hold plateau 816) and held there for 3 seconds. In other words, the second hold plateau 816 may be a different pressure value than the first hold plateau 814 (e.g., a higher value or a lower value). The vacuum can then be released to 0 mm Hg and held there for the remainder of the test. The graphic representation of the deforming skin can be displayed on the screen. Peak sensor reading values (e.g., reflection counts) and peak laxity (mm) can be calculated and displayed on the screen as well.

[0095] In some examples, upon test completion, test data can automatically be saved to the USB storage device, a successful save can be displayed, and a beep tone can sound before returning to the perform test sub menu. If a curve does not seem as expected, an additional repeat can be done. In some instances, the test procedure can include generating at least three recordings that are fairly consistent from which an average laxity parameter can be calculated.

[0096] As noted above, in some examples, the system includes a camera inside the probe. For instance, the camera can be attached and connected to a small fiber light inside the probe. Accordingly, one can view the deflection of the vaginal wall in real time during the measurement, such as during a clinical test in which the disclosed system is utilized.

[0097] Furthermore, the systems and methods can include a probe cleaning procedure. For instance, the probe housing can be disconnected from the infra-red sensor board and placed in a cleaning solution for a predetermined amount of time, such as CIDEX for 45 minutes. Then the probe housing can be rinsed and completely dried inside and out before being connected back to the handle and sensor board. The sensor board can avoid touching the patient and can be cleaned with an alcohol pad before being re-inserted inside the probe housing. A rubber gasket can be positioned into a corresponding groove in the probe handle to avoid any leaks. Once the sensor board is replaced, proper alignment of the aperture with the sensor IR head can be verified, as discussed above.

[0098] It is to be understood that the specific order or hierarchy of steps in the method(s) depicted throughout this disclosure are instances of example approaches and can be rearranged while remaining within the disclosed subject matter. For instance, any of the operations depicted throughout this disclosure may be omitted, repeated, performed in parallel, performed in a different order, and/or combined with any other of the operations depicted throughout this disclosure. For instance, operations 702 and 704 of method 700 can be combined and/or performed as a single action, and the like.

[0099] While the present disclosure has been described with reference to various implementations, it will be understood that these implementations are illustrative and that the scope of the present disclosure is not limited to them. Many variations, modifications, additions, and improvements are possible. More generally, implementations in accordance with the present disclosure have been described in the context of particular implementations. Functionality may be separated or combined differently in various implementations of the disclosure or described with different terminology. These and other variations, modifications, additions, and improvements may fall within the scope of the disclosure as defined in the claims that follow.

Claims

CLAIMS What is claimed is:

1 . A device for measuring tissue laxity comprising: a probe including: a probe housing with an attachment end removably couplable to a manifold body at a first end; and a sensor assembly extending from the first end with a proximity sensor at a distal end of the sensor assembly, the proximity sensor aligned with a measurement opening in the probe housing when the probe housing is coupled to the manifold body; an air pathway opening at a second end operable to couple to a vacuum source; and a control console communicatively coupled to the sensor assembly, the control console including: one or more processors; and one or more memories storing computer-readable instructions that, when executed by the one or more processors, cause the device to: activate the vacuum source to create a vacuum draw at the measurement opening using one or more ramp profiles, the one or more ramp profiles including at least one hold plateau; measure, using the proximity sensor a tissue deformation caused by the vacuum draw at the measurement opening; and cause, at a display communicatively coupled to the control console, one or more measured values corresponding to the tissue deformation to be presented.

2. The device of claim 1 , wherein, the probe includes a guide channel formed into an interior surface of the probe housing to mate with an edge of the sensor assembly and maintain a front plane of the proximity sensor parallel to the measurement opening.

3. The device of claim 1 , further comprising: a raised opening lip around the measurement opening extending from a curved portion of an exterior surface of the probe housing.

4. The device of claim 3, wherein, the raised opening lip includes a flat opening surface around the measurement opening to form a seal with patient tissue during a tissue laxity measurement procedure.

5. The device of claim 1 , further comprising: an O-ring positioned around an attachment opening of the probe housing forming a sealed air pathway for the vacuum draw.

6. The device of claim 1 , further comprising: a camera directed along a lateral axis of the probe to generate a video of the tissue deformation inside the probe, and the computer-readable instructions, when executed by the one or more processors, further cause the video of the tissue deformation to be presented at the display with the one or more measured values.

7. The device of claim 1 , wherein, the tissue deformation includes a tissue uplift and a tissue release corresponding to a first vacuum hold plateau, a vacuum peak, and a second vacuum hold plateau.

8. The device of claim 7, wherein, the computer-readable instructions, when executed by the one or more processors, cause the device to: calculate a first slope value associated with the tissue uplift and a second slope value of the tissue release; and present, at the display and during the tissue deformation, one or more indications of the first slope value and the second slope value.

9. The device of claim 8, wherein, the computer-readable instructions, when executed by the one or more processors, further cause the device to: release the vacuum draw by closing one or more vacuum valves or turning off power to the vacuum source; and cause a visual aid of tissue release to be presented at the display while releasing the vacuum draw.

10. The device of claim 1 , wherein, the probe is formed of stainless steel or titanium.

1 1 . The device of claim 1 , further comprising: one or more data connectors at the second end to communicatively couple to a control console.

12. A method for measuring tissue laxity, the method comprising: positioning a measurement opening of a probe over a target tissue area, the measurement opening being fluidly coupled to a vacuum source via an air pathway in the probe and a manifold body to which the probe is removably coupled; aligning one or more proximity sensors of a sensor assembly with the measurement opening and the target tissue area, the sensor assembly being disposed inside the probe and fixed to the manifold body; causing a tissue deformation by generating a vacuum draw at the measurement opening using the vacuum source, the tissue deformation corresponding to a vacuum ramp profile that includes a peak followed by a hold plateau; measuring the tissue deformation using the one or more proximity sensors; and causing one or more measured values corresponding to the tissue deformation to be presented at a display.

13. The method of claim 12, wherein, the sensor assembly is a printed circuit board (PCB) with the one or more proximity sensors, a camera, and a light mounted to the PCB, and an edge that mates with a guide feature on an interior surface of the probe.

14. The method of claim 12 further comprising: positioning the one or more proximity sensors a predetermined distance from the target tissue area, the one or more measured values are calculated based on the predetermined distance.

15. The method of claim 12 further comprising: generating a video using a camera of the sensor assembly directed towards a distal end of the probe and the measurement opening such that a camera front alignment is perpendicular to a proximity sensor front alignment.

16. The method of claim 15 further comprising: presenting the video of the tissue deformation at the display simultaneously with the one or more measured values.

17. The method of claim 15 further comprising: calculating a first slope value corresponding to a tissue uplift of the tissue deformation and a second slope value corresponding to a tissue release of the tissue deformation; and presenting the first slope value and the second slope value simultaneously with the video.

18. The method of claim 12 further comprising: positioning the probe with a tripod assembly including at least one of a lateral slide rail or a visual level.

19. The method of claim 12, wherein, causing the tissue deformation or measuring the tissue deformation are responsive to one or more user inputs at a control console using a designated start button or a designated stop button.

20. A method for measuring tissue laxity, the method comprising: positioning a measurement opening of a probe, surrounded by raised opening lip, over a target tissue area, the measurement opening being fluidly coupled to a vacuum source via an interior portion of the probe; causing a tissue deformation by generating a vacuum pressure at the measurement opening using the vacuum source, the tissue deformation including a tissue uplift to a first hold plateau, a peak, and a tissue release to second hold plateau; measuring the tissue uplift and the tissue release using one or more sensors attached to a sensor assembly inside the probe and fixed to a manifold body such that the one or more sensors are aligned with the measurement opening and the target tissue area; and causing one or more measured values corresponding to the tissue uplift and the tissue release to be presented at a display via a live stream from the one or more sensors.