DK178783B1 - Symmetrical probe for measuring pelvic floor muscle parameters - Google Patents

Symmetrical probe for measuring pelvic floor muscle parameters Download PDF

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Publication number
DK178783B1
DK178783B1 DKPA201570372A DKPA201570372A DK178783B1 DK 178783 B1 DK178783 B1 DK 178783B1 DK PA201570372 A DKPA201570372 A DK PA201570372A DK PA201570372 A DKPA201570372 A DK PA201570372A DK 178783 B1 DK178783 B1 DK 178783B1
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probe
sensor
region
cross
section
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DKPA201570372A
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Danish (da)
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Rahimullah Sarban
Benjamin Thomsen
Kim Lorenzen
Eva Kühne
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Fortis Pelvic Aps
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Priority to DKPA201570372A priority Critical patent/DK178783B1/en
Priority to PCT/EP2016/063334 priority patent/WO2016202696A1/en
Publication of DK201570372A1 publication Critical patent/DK201570372A1/en
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Publication of DK178783B1 publication Critical patent/DK178783B1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1107—Measuring contraction of parts of the body, e.g. organ, muscle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224—Measuring muscular strength
    • A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0425—Ergonomically shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0214—Capacitive electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2225/00—Miscellaneous features of sport apparatus, devices or equipment
    • A63B2225/50—Wireless data transmission, e.g. by radio transmitters or telemetry
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2230/00—Measuring physiological parameters of the user
    • A63B2230/08—Measuring physiological parameters of the user other bio-electrical signals
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2230/00—Measuring physiological parameters of the user
    • A63B2230/60—Measuring physiological parameters of the user muscle strain, i.e. measured on the user
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B23/00—Exercising apparatus specially adapted for particular parts of the body
    • A63B23/20—Exercising apparatus specially adapted for particular parts of the body for vaginal muscles or other sphincter-type muscles
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B71/00—Games or sports accessories not covered in groups A63B1/00 - A63B69/00
    • A63B71/06—Indicating or scoring devices for games or players, or for other sports activities
    • A63B71/0619—Displays, user interfaces and indicating devices, specially adapted for sport equipment, e.g. display mounted on treadmills
    • A63B71/0622—Visual, audio or audio-visual systems for entertaining, instructing or motivating the user

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physiology (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

Disclosed herein is a probe for measuring the strength of the pelvic floor muscle when inserted inside the pelvic cavity of a user, the probe extending from a first end to a second end, wherein the probe comprises an outer shell comprising at least a first layer of biocompatible material, a sensor part comprising a plurality of sensors elements, and a processing unit configured to determined one or more pelvic muscle parameters.

Description

Symmetrical probe for measuring pelvic floor muscles parameters
The invention relates to a probe for measuring the strength of the pelvic floor muscle when inserted inside the pelvic cavity of a user.
Background
The pelvic muscles might be our most important muscle. We train all other muscle groups, but often does not train the pelvic floor muscles.
The pelvic muscles are a large group of muscles supporting the abdomen organs including the uterus in the female body, the bladder and the bowel. The pelvic muscles also control channels in the abdomen.
As we age, the pelvic muscles weakens. Also giving birth and being obese may weaken the pelvic floor muscles. As a result of a weakening in the pelvic floor muscle incontinence, a dropping uterus, dropping bladder or hanging rectum may occur. These issues can reduce the life quality significantly and lead to social isolation and a poor sex life. Operation may be needed in order to help the user.
The pelvic floor can be strengthen with peivic floor training, e.g. kegei exercises. In many cases the pelvic floormay regain its original strength prior to e.g. a child birth. Measuring the strength of the peivic floor muscles is the first step of using biofeedback to guide and motivate the user during pelvic floor training, and determining how strong or weak the pelvic floor muscles of the user is.
Description of the invention
Disclosed herein is a probe for measuring the strength of the pelvic floor muscle when inserted inside the pelvic cavity of a user, the probe extending from a first end to a second end. The first end is extending furthest inside the user when the probe is inserted inside the peivic cavity of the user.
The probe comprises an outer shell comprising at least a first layer of biocompatible material and a sensor part comprising a plurality of sensors elements. The biocompatiable material may be a polymer.
The plurality of sensors elements may include a first sensor element for provision of a first sensor signal, a second sensor element for provision of a second sensor signal, and a third sensor element for provision of a third sensor signal. The plurality of sensor elements may be capacitive sensor elements.
By using capaticy sensor elements a very high high flexibility in the sensor is obtained along with a high signal precision thereby providing a high information level. This is a vast advantage compared to other solutions as shown in e.g. US20100174218A1 and US20140066813A1 using pressure sensors.
The probe further comprises a processing unit configured to determine one or more pelvic muscle parameters.
The determination of the one or more pelvic muscle parameters may be based on the first sensor signal, the second sensor signal and/or the third sensor signal.
By the above is obtained a probe which has a high flexibility and gives a high signal precision and thereby a high information level. The probe enables reliable and precise measurements of the strength of the pelvic floor muscle, the contraction rate of the pelvic floor muscle, and/or the radial difference in pelvic floor muscle strength.
The probe may comprise a first region at the first end of the probe, a second region at the second end of the probe, and a sensor region between the first region and the second region. The sensor region is extending on both sides of the pelvic floor muscle of the user when the probe is inserted inside the user, and the sensor region comprising the plurality of sensors elements positioned inside the outer shell of the probe.
The sensor region may have a plurality of circular cross sections each along an axis extending from the first to the second end of the probe, the plurality of cross sections including at least a first sensor region cross section having a first region sensor diameter D3,1, a second sensor region cross section having a second sensor region diameter D3,2, and a third sensor region cross section having a third sensor region diameter D3,3. The second sensor region cross section is positioned between the first sensor region cross section and the third sensor region cross section, and wherein D3,1 > D3,2 < D3,3.
By the above is obtained a probe with an hourglass sensor region. The hourglass shape makes it very easy for the user in insert the probe correctly, as the hourglass shape ensures that the probe will be positioned with the smallest diameter in the sensor region positioned in the middle of the pelvic floor muscles cavity. The hourglass shape also ensures that the probe stays in the correct position with the sensor elements extending on both sides of the pelvic floor muscles. The hourglass shape also minimize the risk of probe failing out.
Contrary, US2014Q066813A1 disclsoes an intra vaginal device to determine the muscle strength where the device cannot be randomly oriented upon insertion as the three sensors used in the device are directed at measuring different parameters.
Further, the symmetric circular cross section in the sensor region allows the user to insert the probe in any radial orientation, in other words, there are no front and back of the probe, which the user will need to take into account when inserting it.
The probe is completely encapsulated in the biocompatiable material. This gives high hygiene, minimize the possibility for bacteriea sits. It also minimize risk for cuts inside the vagina, during insertion and removal of probe.
Brief description of the drawings
Figure 1 shows a probe according to the invention inserted in the pelvic floor cavity.
Figure 2 shows the radial distribution around the opening in the pelvic floor muscle cavity.
Figure 3 shows a probe according to the invention in a transparent front view.
Figure 4 shows a probe according to the invention in a transparent tilted front view. Figure 5 shows a plurality of sensor elements in the probe.
Figure 8 shows a sensor element.
Description of preferred embodiments
Disclosed herein is a probe for measuring the strength of the pelvic floor muscle when inserted inside the pelvic cavity of a user, the probe extending from a first end to a second end, wherein the probe comprises an outer shell comprising at least a first layer of biocompatible material. Additional layers of material may also be part of the outer shell. However, at least the outermost layer will always be of biocompatible material. The outer shell has a smooth surface with no opening to the inside of the probe. This ensures that the inside of the probe is protected from being exposed to dirt, fluids or similar.
The biocompatible material may be a polymer.
The biocompatible material further allows for the probe to be washed at high temperatures ensuring that the user can clean the probe easily.
In one or more embodiments, the outer shell material is a temperature resistant and washable. By temperature resistant is meant a material which can withstand temperatures up to 100-105 degrees. This allows the user to clean the probe 100 in boiling water. Also cleaning and sterilization in autoclave is possible.
The probe also has a sensor part comprising a plurality of sensors elements.
The sensor part may comprise a first sensor element for provision of a first sensor signal, a second sensor element for provision of a second sensor signal, and a third sensor element for provision of a third sensor signal. The sensor part may alternatively include oniy a first sensor element and a second sensor element for provision of a first sensor signal and a second sensor signal, respectively.
Yet alternatively, the sensor par may include a total of four, five, six or more sensor elements each for provision of a sensor signal.
The probe aiso comprises a processing unit configured to determine one or more pelvic muscie parameters. in one or more embodiments the one or more peivic muscie parameters includes a first peivic muscle parameter indicative of pelvic floor muscie strength.
In one or more embodiments , the one or more pelvic muscie parameters includes a second peivic muscie parameter indicative of contraction rate of the peivic floor muscie.
In one or more embodiments the one or more pelvic muscie parameters includes a third pelvic muscle parameter indicative of radial difference in pelvic floor muscle strength.
The one or more pelvic muscie parameters may be determined based on the first sensor signal, the second sensor signal and/or the third sensor signal.
Figure 1 shows a probe 100 according to the invention inserted in the pelvic cavity of a user. The probe 100 extends on both sides of the pelvic floor muscles 200. The bladder 202, the uterus 204 and the rectum 206 is also shown in figure 1.
Figure 2 illustrates the pelvic floor muscle 200 seen in a very schematic bottom up view where the arrows marks the direction towards the bladder 202 and the rectum 206. The direction towards the bladder 202 also marks a 0° radial direction and the direction towards the rectum 206 corresponds to a 180° radial direction. The radial difference in peivic floor muscles strength may be found by comparing the pelvic floor muscles strength at different directions, e.g. by comparing the pelvic floor muscle strength at a first direction P1 and with that at a second direction P2 and so forth. in one or more embodiments the one or more pelvic muscle parameters includes a primary pelvic muscle parameter indicative of pelvic muscle parameter in a first direction and a secondary pelvic muscle parameter indicative of pelvic muscle parameter in a second direction. in one or more embodiments the one or more pelvic muscle parameters includes a first primary pelvic muscle parameter indicative of pelvic floor muscle strength in a first direction P1,1. in one or more embodiments the one or more pelvic muscle parameters includes a first secondary pelvic muscle parameter indicative of pelvic floor muscle strength in a second direction P1,2. in one or more embodiments the one or more pelvic muscle parameters includes a second primary pelvic muscle parameter indicative of contraction rate of the pelvic floor muscle in a first direction P2,1, in one or more embodiments the one or more pelvic muscle parameters includes a second secondary pelvic muscle parameter indicative of contraction rate of the pelvic floor muscle in a second direction P2,2.
In one or more embodiments the first sensor element has a plate area in the range from 20 mm2 to 2000 mm2. Alternatively the plate area is in the range from 20 mm2 to 1885 mm2, or from 50 mm2 to 1000 mm2, or from 50 mm2 to 600 mm2.
The plurality of sensor elements are capacitive sensor elements.
In one or more embodiments the one or more of the plurality of sensor elements comprises at least a first electrode layer, wherein the electrode layer is a conducting polymer.
The conducting polymer may in one or more examples be silicone based.
In one or more embodiments, the one or more of the electrode layer can undergo mechanical deformation while remaining electrically conductive.
The conductive and deformable layers, e.g. being a conducting polymer material, insures that the plurality of sensor elements are stretchable. This in turns facilitates that the entire probe is bendable in all angular directions.
When inserted into the pelvic cavity of the user, the natural curvature of the pelvic cavity will bend the probe in one angular direction. Thereby the plurality of sensor elements inside the probe is stretched and/or bended. The bending of the probe upon insertion into the pelvic cavity introduces an initial change experienced by the sensor eiements. The initial change allows for a determination of the angular orientation of the probe inside the peivic cavity prior thereby enabling the user to obtain information on the peivic floor muscle strength at specific locations inside the pelvic cavity, the radial difference in peivic floor muscle strength, and/or the contraction rate of the peivic floor muscle - the latter possibly also depending on the angular orientation. in one or more embodiments the one or more peivic muscle parameters Includes an initial peivic muscle parameter indicative of an angular orientation in the peivic cavity. Obtaining the initial pelvic muscle parameter may be based on the first sensor signal, the second sensor signal, and/or the third sensor signal.
Alternatively, Obtaining the initial pelvic muscle parameter may be based on the relative changes of the plurality of sensor signals from their initial values.
The probe comprises different regions including a first region at the first end of the probe, a second region at the second end of the probe, and a sensor region between the first region and the second region. The sensor region is extending on both sides of the pelvic floor muscle of the user when the probe is inserted inside the user. The sensor region comprising the sensors elements positioned inside the outer shell of the probe.
The sensor region has a plurality of circular cross sections each along the longitudinal direction of the probe. The plurality of cross sections includes at least a first sensor cross section having a first sensor diameter D3,1, a second sensor cross section having a second sensor diameter D3,2, and a third sensor cross section having a third sensor diameter D3,3. The second sensor cross section is positioned between the first sensor cross section and the third sensor cross section, where the diameter of the second sensor cross section being smaller than the cross sections of the first and third cross section, i.e. D3,1 > D3,2 < D3,3.
In one or more examples of the probe, each cross section extending along the axis from the first end of the probe to the second end of the probe has a circuiarly shaped outer shell. in one or more examples of the probe, the first region comprising the processing unit enclosed by the outer shell.
In one or more examples of the probe, the second region comprising a first antenna enclosed by the outer shell.
The probe has in one or more embodiments a plurality of cross sections each along the longitudinal direction of the probe each having a diameter D. The plurality of cross sections includes at least a first region cross section having a diameter D1, a second region cross section having a diameter D2, and a sensor region cross section having a diameter D3, wherein D1/D3 > 1.2 and D2/D3 > 1.2, D1 may be the largest diameter in the first region, D2 may be the largest diameter in the second region and D3 may be the largest diameter in the sensor region. The size of the largest cross sections in the first and second regions will always be larger than the largest cross section in the sensor region.
In one or more embodiments, the outer shell of the probe forms a cavity accommodating the sensor part and the processing part of the probe. The cavity is normally filled with a cavity material having a material stiffness in the range from 0.1 MPa to 1.5 MPa. Alternatively, the cavity material has a material stiffness in the range from 0.1 MPa to 1.0 MPa or in the range from 0.1 MPa to 0.5 MPa.
The cavity material may be relatively soft.
In one or more embodiments the cavity material comprises one or more polymers.
In one or more embodiments the cavity materia! comprises silicon, acryl or the like.
In one or more embodiments the outer shell material of the probe has a material stiffness in the range from 0.5 MPa to 2 MPa.
Alternatively, the outer shell material of the probe has a material stiffness in the range from 0.8 MPa to 1.2 MPa. Compared to the cavity material, the outer shell material may be harder than the cavity material.
Alternatively, the cavity is filled with a cavity material having a material stiffness which is higher than that of the outer sheil material.
In one or more embodiments, the sensor region is softer than the first region. This is mainly due to the electronics, which is normally found in the processing part in the first region being of a harder material than the soft sensors in the sensor region.
The overall softness of the probe ensures that it is bending when the user contracts/relaxes the pelvic floor muscle. The softness also makes it comfortable for the user to wear the probe and measure the pelvic muscle parameters.
Normally, the probe is solid. Substantially no air pockets are thereby present inside the probe.
In one or more embodiments the first layer of the outer sheil has a thickness in the range from 1 mm to 3 mm. Alternatively, the thickness may be in the rage from 0.1-3 mm, or 0.3-3 mm, or 0.5-3 mm.
The sensor elements may be positioned next to each other forming a circle with the sensor elements extending in parallel with the axis from the first end of the probe to the second end of the probe.
Normally, two successive sensor elements are positioned at a distance from each other being substantially the same for any two successive sensor elements.
The probe may in one or more embodiments further comprise a first antenna for wireless communication with an external device, wherein the processing unit is configured to transmit at least one pelvic muscle parameter to the external device, in this manner, the information relating to the pelvic floor muscle parameter can be transmitted to an external device such as a smart phone or a computer. A wireless interaction with an app on a smart phone allows the user to get information on how to train the pelvic floor muscles correctly. Also measurements of the strength by which a user is able to contract the pelvic floor muscles, the during of time over which the user can contract the pelvic floor muscles and the speed by which the user contracts the pelvic floor muscles can be displayed directly to the user.
Further, the app may allow the user to document the training over time and follow the development towards a stronger pelvic floor muscle group. Included in the app may also be function allowing the user or a health care personal to make an individual training program which gives the user advice, guidance and motivates the user. The information obtained during the training may be shared online over e.g. social medias. Additional functionalities may be acquired for the app introducing additional traning possibilities.
The probe may also measure the differences in strength in the pelvic floor muscles at different angular values. Differences in the pelvic floor muscles may arise as a result of vaginal child birth where the child birth canal introduces a fracture in one side of the pelvic floor muscles.
The training programs may also follow the progress in the training towards strengthening the pelvic floor muscles in the weakened side.
In one or more embodiments, the probe further comprising a battery unit connected to the processing part, wherein the probe comprises a second antenna connected to the battery unit for wireless charging of the battery unit. This allows for a wirelessiy recharging of the probe without inserting any type of wire into an opening in the probe.
The probe may be recharged through the battery unit and its connection to the second antenna by positioning the probe inside a recharging case. This case could also have the function of protecting the probe when the probe is not in use.
Alternatively, the battery is non-chargeable.
In one or more embodiments the processing unit comprises: • a first input connected to the first sensor element for receiving the first sensor signal, • a second input connected to the second sensor element for receiving the second sensor signal, and • a third input connected to the third sensor element for receiving the third sensor signal,
The processing unit may further in one or more embodiments be configured to: • determine a first pressure signal based on the first sensor signal, ® determine a second pressure signal based on the second sensor signal, • determine a third pressure signal based on the third sensor signal, and • transmitting the first, second and third pressure signals via the first antenna.
The processing unit may further in one or more embodiments have an update rate of a digital input of between 50-500 updates per second, or 50-200 updates per second, or 75-125 updates per second. in one or more embodiments, an individual update will be a running average of the last n measured values, with n being an integer from 1 to 100.
Figures 3 and 4 show a probe 100 according to the invention. The probe 100 is displayed in a transparent side view in figure 3 and in a transparent tilted view in figure 4. The probe 100 extends from the first end 102 to a second end 106. The probe 100 is inserted inside the pelvic cavity of the user with the first end 102 entering the pelvic cavity first as shown in figure 1.
The probe 100 is covered by an outer sheli comprising at least a first layer of biocompatible material. The biocompatiable material may be a poiymer. The outer shell has a smooth surface with no opening to the inside of the probe 100. This ensures that the inside of the probe is protected from being exposed to dirt, fluids or similar. The biocompatible material further allows for the probe 100 to be washed at high temperatures ensuring that the user can clean the probe 100 easily. in one or more embodiments, the outer shell material is a temperature resistant, washable and biocompatible material. By temperature resistant is meant a material which can withstand temperatures up to 100-105 degrees. This allows the user to clean the probe 100 in boiling water, autoclave or similar.
The probe 100 comprises a sensor part 103 comprising a plurality of sensors elements 104. In figure 4 and the separate view of the sensor part in figure 5, the sensors elements includes a first sensor element 104a, a second sensor element 104b and a third sensor element 104c. The first, second and third sensor elements 104a, 104b, 104c provides a first sensor signal, a second sensor signal, and a third sensor signal, respectively. Additional sensor elements such as four, five, six, seven, eight, or more may also be used. Alternatively, only two sensor elements may also be used.
The sensor part 103 may alternatively include only a first sensor element and a second sensor element (not shown in the figures) or yet alternatively include a total of four, five, six or more sensor elements each providing a sensor signal (not shown in the figures).
The probe 100 also comprises a processing unit 108 configured to determined one or more pelvic muscle parameters. The determination of the one or more pelvic muscle parameters may be based on the first sensor signal and/or the second sensor signal and/or third sensor signal. Additional sensor signals may also be found and may potentially include information on the temperature and the moistievel in the pelvic cavity.
As is illustrated in figure 3, the probe comprises different regions including a first region 112 at the first end 102 of the probe, a second region 116 at the second end 106 of the probe 100. and a sensor region 114 between the first region 112 and the second region 116. The sensor region 114 is extending on both sides of the pelvic floor muscle of the user when the probe is inserted inside the user as illustrated by the area 208. The sensor region 114 comprising the plurality of sensors elements 104 positioned inside the outer shell of the probe 100.
The sensor region has a plurality of circular cross sections each along the longitudinal direction of the probe. The plurality of cross sections inciudes at ieast a first sensor cross section having a first sensor diameter D3,1, a second sensor cross section having a second sensor diameter D3,2, and a third sensor cross section having a third sensor diameter D3,3. The second sensor cross section is positioned between the first sensor cross section and the third sensor cross section, where the diameter D3,2 of the second sensor cross section is smaller than the diameters D3,1, D3,3 of the first and third cross section, i.e. D3,1 > D3,2 < D3,3.
The probe has a plurality of cross sections each aiong the longitudinal direction of the probe each having a diameter D. The plurality of cross sections inciudes at least a first region cross section having a diameter D1 being the largest diameter in the first region, a second region cross section having a diameter D2 being the largest diameter in the first region, and a sensor region cross section having a diameter D3 being the largest diameter in the sensor region.
The size of the largest cross sections in the first and second regions wili be larger than the largest cross section in the sensor region, e.g. DI/D3 > 1.2 and D2/D3 > 1.2.
The outer she!! of the probe forms a cavity accommodating the sensor part 103 and the processing part 108 of the probe. Normally, the sensor elements 104 are attached to the inside of the outer shell. The cavity is after attaching the sensor elements 104 and positioning the processing unit 108 inside the outer shell filled with a cavity material to form a solid probe. Prior to or in combination with filling the cavity with the cavity material, an antenna 110 for wireless communication with an external device can be added in the second region 116 of the probe 100. Afterwards the second end 106 is sealed by the same material making up the outer shell thereby completing the outer shell. An additional layer of biocompatible material may be applied over the outer shell for an even better sealing of the probe items inside the probe.
By filling the probe with the cavity material, it is ensured that the probe is solid and that substantially no air pockets are present inside the probe 100.
The cavity material may have a material stiffness in the range from 0.1 MPa to 1.5 MPa. The cavity material is thus a relatively soft material. The cavity material may comprise one or more polymers, e.g. silicon, acryl or the like.
The outer shell material of the probe wiil normally have a material stiffness in the range from 0.5 MPa to 2 MPa. Thus, compared to the cavity material, the outer shell material is a harder material.
The sensor region 114 will normally be softer than the first region 112. This is mainiy due to the electronics, which is normally found in the processing part 108 in the first region 112 being of a harder material than the soft sensor elements 104 in the sensor region 114.
The plurality of sensor elements 104, e.g. the first, second and third sensor elements 104a, 104b and 104c as shown in figures 3-6, are capacitive sensor elements. The individual sensor elements 104a, 104b, 104c connects directly to the electronics in the processing unit 108 and measure the capacitance of the sensor element. The electronics in the processing unit converts the measured capacitance into an analogue 0-5 V signal, which will be a linear representation of the measured parameter, e.g. a 0-50 Newton force measurement.
The main functionality of the electronics in the processing unit 108 is to measure the capacitance of the sensor elements 104 and then convert the measured signal into the needed pelvic muscle parameter(s) and output the result on the analogue output and/or to transmit it wireiessiy to an externa! device. in order to support a iarge range of sensor elements a multiple of capacitive ranges may be necessary. The installed ranges shall be selectable via the serial communication interface.
The update rate of the digital input will normally around be 100 updates/sec.
The update rate of samples transmitted via the serial communication interface may be selectable with a maximum of up to 100 updates/sec. The rate may be settable via the serial communication interface.
The individual update will be a running average of the last n measured values, with n being an integer from 1 to 100. in figures 4 and 5 it is shown that when the sensor eiernents 104 are arranged inside the probe, they each bend slightly around a longitudinal axis thereby together forming a configuration with circular cross sections along the longitudinal axis. The first sensor element 104a is positioned between the second sensor element 104b and the third sensor element 104c and the second sensor element 104b is also positioned next to the third sensor element 104c.
The sensor elements 104 further flex outwards in the sense that the diameter of the circular cross sections formed be the sensor elements combined first decrease from the first end of the sensor elements towards a middle sections of the sensor elements, where after the cross sections increases again towards the second end of the sensor elements.
The distance between A) the first sensor element 104a and the second sensor element 104b, B) the second sensor element 104b and the third sensor element 104c, and C) the third sensor element 104c and the first sensor element 104a may in one or more embodiemnts of the sensor be the same at any given cross sectional position.
As shown in figure 6, the sensor elements 104 each has a width (w), which changes along the direction of the height (h) of the sensor element. This ensures that the distance between the different sensor elements can be kept the same at every position along the height of the sensor element as the sensor elements bends inwards and outwards as shown in figure 5.
Alternatively the sensor elements may have a constant width (w) whereby the distance between two sucsessive sensor elements will change along the axis from the first end of the probe to the second end of the probe.
The sensor elements 104a, 104b, 104c may each occupy a radial distribution of 100 degrees with a distance between them of 20 degrees along the height of the sensor elements when positioned inside the probe 100.
The probe 100 may come in different sizes with a total length extending from the first end 102 to the second end 106 between 30-150 mm. The width of the probe 100 may also vary with the largest cross sectional diameter varying from 20-50 mm and the smallest correspondingly varying between 5-30 mm. In this way, different sizes of the probe may be obtained fitting the requirements set out by the difference in physiology of the user.
References 100 Probe 102 First end of the probe 103 Sensor part 104 Sensor elements 104a First sensor element 104b Second sensor element 104c Third sensor element 106 Second end of the probe 108 Processing unit 110 Antenna area 112 First region 114 Sensor region 116 Second region 200 Pelvic floor muscles 202 Bladder 204 Uterus 206 Rectum 208 Area on the sensor elements positioned in the pelvic floor muscle D1 Largest diameter in the first region D2 Largest diameter in the second region D3 Largest diameter in the sensor region D3,1 First sensor region diameter D3,2 Second sensor region diameter D3,3 Third sensor region diameter

Claims (10)

1. Probe til måling af styrken af bækkenbundsmusklen, når den indføres indvendigt i bækkenhulen af en bruger, hvor proben strækker sig fra en første ende til en anden ende, hvor proben omfatter: • en udvendig kappe, som omfatter mindst ét første lag af biokompatibelt materiale, • en sensordel, som omfatter en flerhed af sensorelementer, og • en behandlingsenhed, der er konfigureret til en bestemt eller flere bestemte bækkenmuskelparametre, hvor proben yderligere omfatter: - et første område ved den første ende af proben, - et andet område ved den anden ende af proben, og - et sensorområde mellem det første område og det andet område, hvor sensorområdet strækker sig på begge sider af bækkenbundsmusklen af brugeren, når proben er indført indvendigt i brugeren, og sensorområdet omfatter flerheden af sensorelementer, der er anbragt indvendigt i den udvendige kappe af proben, hvor sensorområdet har en flerhed af cirkulære tværsnit, som hver især befinder sig langs en akse, der strækker sig fra den første til den anden ende af proben, hvor flerheden af tværsnit omfatter mindst: - ét første sensorområdetværsnit, som har en første sensorom-rådediameter D3,1, - ét andet sensorområdetværsnit, som har en anden sensor-områdediameter D3,2, og - ét tredje sensorområdetværsnit, som har en tredje sensorom-rådediameter D3,3, hvor det andet sensorområdetværsnit er anbragt mellem det første sensorområdetværsnit og det tredje sensorområdetværsnit, og hvor D3,1 > D3,2 < D3,3.A probe for measuring the strength of the pelvic floor muscle when inserted internally into the pelvic cavity by a user, the probe extending from a first end to a second end, the probe comprising: • an outer sheath comprising at least one first layer of biocompatible material, • a sensor portion comprising a plurality of sensor elements, and • a processing unit configured for a particular or more specific pelvic muscle parameters, the probe further comprising: - a first region at the first end of the probe, - a second region at the other end of the probe, and in the outer casing of the probe, wherein the sensor region has a plurality of circular cross sections, each of which is s along an axis extending from the first to the second end of the probe, the plurality of cross sections comprising at least: - one first sensor region cross-section having a first sensor region diameter D3.1, - one second sensor region cross-section having a second sensor region diameter D3,2, and - a third sensor region cross-section having a third sensor region diameter D3,3, wherein the second sensor region cross-section is disposed between the first sensor region cross-section and the third sensor region cross-section, and where D3,1> D3,2 <D3 , third 2. Probe ifølge krav 1, hvor hvert tværsnit, der strækker sig langs aksen fra den første ende af proben til den anden ende af proben, har en cirkulært formet udvendig kappe.The probe of claim 1, wherein each cross section extending along the axis from the first end of the probe to the second end of the probe has a circularly shaped outer sheath. 3. Probe ifølge et af de foregående krav, hvor det første område omfatter behandlingsenheden, som omsluttes af den udvendige kappe.Probe according to one of the preceding claims, wherein the first region comprises the treatment unit which is enclosed by the outer sheath. 4. Probe ifølge et af de foregående krav, hvor det andet område omfatter en første antenne, som omsluttes af den udvendige kappe.Probe according to one of the preceding claims, wherein the second region comprises a first antenna enclosed by the outer sheath. 5. Probe ifølge et af de foregående krav, hvor en flerhed af tværsnit hver især strækker sig langs en akse fra den første ende af proben til den anden ende af proben, hvor flerheden af tværsnit omfatter mindst: - ét første områdetværsnit med en diameter D1, - ét andet områdetværsnit med en diameter D2, og - et sensorområdetværsnit med en diameter D3, hvor D1/D3 > 1,2 og D2/D3 > 1,2.The probe according to any one of the preceding claims, wherein a plurality of cross sections each extend along an axis from the first end of the probe to the second end of the probe, wherein the plurality of cross sections comprises at least: - one first region cross-section having a diameter D1 , - one other region cross-section with a diameter D2, and - a sensor region cross-section with a diameter D3, where D1 / D3> 1,2 and D2 / D3> 1,2. 6. Probe ifølge et af de foregående krav, hvor sensorelementerne er anbragt ved siden af hinanden og danner en cirkel med sensorelementerne, der strækker sig parallelt med aksen fra den første ende af proben til den anden ende af proben.Probe according to one of the preceding claims, wherein the sensor elements are arranged side by side and form a circle with the sensor elements extending parallel to the axis from the first end of the probe to the second end of the probe. 7. Probe ifølge et af de foregående krav, hvor to på hinanden følgende sensorelementer er anbragt med en indbyrdes afstand, som i det væsentlige er den samme for hvilke som helst af to på hinanden følgende sensorelementer.Probe according to one of the preceding claims, wherein two successive sensor elements are spaced apart substantially the same for any of two successive sensor elements. 8. Probe ifølge et af de foregående krav, hvor proben er massiv.Probe according to one of the preceding claims, wherein the probe is solid. 9. Probe ifølge et af de foregående krav, hvor behandlingsenheden har en opdateringsandel af en digital indlæsning på mellem 50-500 opdateringer per sekund, eller mellem 50-200 opdateringer per sekund, eller 75-125 opdateringer per sekund.The probe according to any one of the preceding claims, wherein the processing unit has an update rate of a digital input of between 50-500 updates per second, or between 50-200 updates per second, or 75-125 updates per second. 10. Probe ifølge et af de foregående krav, hvor en individuel opdatering vil være et løbende gennemsnit af de sidste n målte værdier, hvor n er et heltal fra 1 til 100.Probe according to one of the preceding claims, wherein an individual update will be a continuous average of the last n measured values, where n is an integer from 1 to 100.
DKPA201570372A 2015-06-18 2015-06-18 Symmetrical probe for measuring pelvic floor muscle parameters DK178783B1 (en)

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FR3072272A1 (en) * 2017-10-16 2019-04-19 Fizimed DEVICE FOR MEASURING CONTRACTIONS AND / OR MUSCLE RELEASE OF A BODY CAVITY AND RELATED METHODS.

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US20100174218A1 (en) * 2009-01-06 2010-07-08 Youngtack Shim Pelvic exercise systems and methods
US20120215135A1 (en) * 2011-02-17 2012-08-23 Galliano Domingo E Pelvic Region Analyzer and Associated Therapeutic and Diagnostic Methods
WO2013147992A1 (en) * 2012-03-29 2013-10-03 Vladimir Egorov Method and device for measuring tactile profile of vagina

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US3417743A (en) * 1965-06-23 1968-12-24 Carrera Rafael Training and diagnostic apparatus
AT402366B (en) * 1992-03-09 1997-04-25 Michl Ilse Dr DEVICE FOR MONITORING THE CONTRACABILITY OF THE PELVIC MUSCULAR
ES2407459B1 (en) * 2011-11-11 2013-12-26 E-Process Consulting And Management 2013, S.L. DEVICE FOR FEMALE SEXUAL STIMULATION.

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US20100174218A1 (en) * 2009-01-06 2010-07-08 Youngtack Shim Pelvic exercise systems and methods
US20120215135A1 (en) * 2011-02-17 2012-08-23 Galliano Domingo E Pelvic Region Analyzer and Associated Therapeutic and Diagnostic Methods
WO2013147992A1 (en) * 2012-03-29 2013-10-03 Vladimir Egorov Method and device for measuring tactile profile of vagina

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