DK178782B1 - Probe for measuring pelvic floor muscle parameters - Google Patents

Probe for measuring pelvic floor muscle parameters Download PDF

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Publication number
DK178782B1
DK178782B1 DKPA201570373A DKPA201570373A DK178782B1 DK 178782 B1 DK178782 B1 DK 178782B1 DK PA201570373 A DKPA201570373 A DK PA201570373A DK PA201570373 A DKPA201570373 A DK PA201570373A DK 178782 B1 DK178782 B1 DK 178782B1
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Prior art keywords
probe
sensor
pelvic
muscle
region
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DKPA201570373A
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Danish (da)
Inventor
Eva Kühne
Kim Lorenzen
Rahimullah Sarban
Benjamin Thomsen
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Fortis Pelvic Aps
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Priority to DKPA201570373A priority Critical patent/DK178782B1/en
Priority to PCT/EP2016/063335 priority patent/WO2016202697A1/en
Publication of DK201570373A1 publication Critical patent/DK201570373A1/en
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Publication of DK178782B1 publication Critical patent/DK178782B1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/22Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224Measuring muscular strength
    • A61B5/227Measuring muscular strength of constricting muscles, i.e. sphincters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1107Measuring contraction of parts of the body, e.g. organ, muscle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6867Arrangements 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
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT 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
    • G16H40/60ICT 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
    • G16H40/63ICT 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 for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0406Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0425Ergonomically shaped housings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0214Capacitive electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04Arrangements of multiple sensors of the same type
    • A61B2562/043Arrangements of multiple sensors of the same type in a linear array
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2225/00Miscellaneous features of sport apparatus, devices or equipment
    • A63B2225/50Wireless data transmission, e.g. by radio transmitters or telemetry
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2230/00Measuring physiological parameters of the user
    • A63B2230/08Measuring physiological parameters of the user other bio-electrical signals
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B2230/00Measuring physiological parameters of the user
    • A63B2230/60Measuring physiological parameters of the user muscle strain, i.e. measured on the user
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B23/00Exercising apparatus specially adapted for particular parts of the body
    • A63B23/20Exercising apparatus specially adapted for particular parts of the body for vaginal muscles or other sphincter-type muscles
    • AHUMAN NECESSITIES
    • A63SPORTS; GAMES; AMUSEMENTS
    • A63BAPPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B71/00Games or sports accessories not covered in groups A63B1/00 - A63B69/00
    • A63B71/06Indicating or scoring devices for games or players, or for other sports activities
    • A63B71/0619Displays, user interfaces and indicating devices, specially adapted for sport equipment, e.g. display mounted on treadmills
    • A63B71/0622Visual, audio or audio-visual systems for entertaining, instructing or motivating the user

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • General Business, Economics & Management (AREA)
  • Business, Economics & Management (AREA)
  • Physiology (AREA)
  • Data Mining & Analysis (AREA)
  • Databases & Information Systems (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (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

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 pelvic floor training, e.g. kegel exercises. In many cases the pelvic floormay regain its original strength prior to e.g. a child birth. Measuring the strength of the pelvic 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. US 2014/058288 A1 discloses a sphincter contraction sensor comprising one or more discrete force sensors. A shell of a biocompatible laminate may be disposed circumferentially about the force sensors. Based on the sensor signals, one or more time derivatives of contact force (speed (rate), acceleration) are computed in a processing unit.
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 pelvic 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 falling out.
Contrary, US20140066813A1 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 6 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 only 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 also comprises a processing unit configured to determine one or more pelvic muscle parameters.
In one or more embodiments the one or more pelvic muscle parameters includes a first pelvic muscle parameter indicative of radial difference in pelvic floor muscle strength.
In one or more embodiments the one or more pelvic muscle parameters includes a second pelvic muscle parameter indicative of pelvic floor muscle strength.
In one or more embodiments , the one or more pelvic muscle parameters includes a third pelvic muscle parameter indicative of contraction rate of the pelvic floor muscle.
The one or more pelvic muscle 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 pelvic 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 second primary pelvic muscle parameter indicative of pelvic floor muscle strength 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 pelvic floor muscle strength in a second direction P2,2.
In one or more embodiments the one or more pelvic muscle parameters includes a third primary pelvic muscle parameter indicative of contraction rate of the pelvic floor muscle in a first direction P3,1.
In one or more embodiments the one or more pelvic muscle parameters includes a third secondary pelvic muscle parameter indicative of contraction rate of the pelvic floor muscle in a second direction P3,2.
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 elements. The initial change allows for a determination of the angular orientation of the probe inside the pelvic cavity prior thereby enabling the user to obtain information on the pelvic floor muscle strength at specific locations inside the pelvic cavity, the radial difference in pelvic floor muscle strength, and/or the contraction rate of the pelvic floor muscle - the latter possibly also depending on the angular orientation.
In one or more embodiments the one or more pelvic muscle parameters includes an initial pelvic muscle parameter indicative of an angular orientation in the pelvic 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 circularly 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 material 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 shell 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 shell 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 overe.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 wirelessly 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 shell comprising at least a first layer of biocompatible material. The biocompatiable material may be a polymer. 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 moistlevel 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 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 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 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 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 will be larger than the largest cross section in the sensor region, e.g. DI/D3 > 1.2 and D2/D3 > 1.2.
The outer shell 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 will 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 mainly 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 wirelessly to an external device.
In order to support a large 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 elements 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 (9)

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, omfattende: - et første sensorelement til tilvejebringelse af et første sensorsignal, - et andet sensorelement til tilvejebringelse af et andet sensorsignal og - et tredje sensorelement til tilvejebringelse af et tredje sensorsignal, • en behandlingsenhed, som er konfigureret til at bestemme en eller flere bækkenmuskelparametre på basis af det første sensorsignal, det andet sensorsignal og/eller det tredje sensorsignal, hvor den ene eller flere bækkenmuskelparametre omfatter en første bæk-kenmuskelparameter, der angiveren radial forskel i bækkenbundsmuskelstyrken, og hvor flerheden af sensorelementer er kapacitive sensorelementer.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 a sensor portion comprising a plurality of sensor elements comprising: - a first sensor element for providing a first sensor signal, - a second sensor element for providing a second sensor signal, and - a third sensor element for providing a third sensor signal, a processing unit configured to determine one or more pelvic muscle parameters on the basis of the first sensor signal, the second sensor signal, and / or the third sensor signal, wherein the one or more pelvic muscle parameters comprise a first pelvic muscle parameter indicating radial difference in pelvic floor muscle strength, where the plurality of sensor elements are capacitive sensor elements . 2. Probe ifølge krav 1, hvor den ene eller flere bækkenmuskelparametre omfatter en anden bækkenmuskelparameter, der angiver bækkenbundsmuskelstyrken.The probe of claim 1, wherein the one or more pelvic muscle parameters comprise another pelvic muscle parameter indicating the pelvic floor muscle strength. 3. Probe ifølge et af de foregående krav, hvor den ene eller flere bækkenmuskelparametre omfatter en tredje bækkenmuskelparameter, der angiver en kontraktionsrate af bækkenbundsmusklen.A probe according to any one of the preceding claims, wherein the one or more pelvic muscle parameters comprise a third pelvic muscle parameter indicating a contraction rate of the pelvic floor muscle. 4. Probe ifølge et af de foregående krav, hvor den ene eller flere bækkenmuskelparametre omfatter en primær bækkenmuskelparameter, der angiver en bækkenmuskelparameter i en første retning, og en sekundær bækkenmuskelparameter, derangiver en bækkenmuskelparameter i en anden retning.A probe according to any one of the preceding claims, wherein the one or more pelvic muscle parameters comprise a primary pelvic muscle parameter indicating a pelvic muscle parameter in a first direction and a secondary pelvic muscle parameter indicating a pelvic muscle parameter in a second direction. 5. Probe ifølge et af de foregående krav, hvor et eller flere af flerheden af sensorelementer omfatter mindst et første elektrodelag, hvor elektrodelaget er mekanisk deformerbart og/eller en ledende polymer.A probe according to any one of the preceding claims, wherein one or more of the plurality of sensor elements comprises at least a first electrode layer, the electrode layer being mechanically deformable and / or a conductive polymer. 6. Probe ifølge et af de foregående krav, hvor proben desuden omfatter en første antenne til trådløs kommunikation med en ekstern indretning, hvor behandlingsenheden er konfigureret til at overføre mindst en bækkenmuskelparameter til den eksterne indretning.The probe according to any one of the preceding claims, wherein the probe further comprises a first wireless communication antenna with an external device, wherein the processing unit is configured to transmit at least one pelvic muscle parameter to the external device. 7. Probe ifølge et af de foregående krav, hvor den udvendige kappe danner et hulrum, som optager sensordelen og behandlingsdelen af proben, hvor hulrummet er fyldt med et hulrumsmateriale, som har en materialestivhed i området fra 0,1 MPa til 1,5 MPa.Probe according to one of the preceding claims, wherein the outer sheath forms a cavity which receives the sensor portion and the processing portion of the probe, wherein the cavity is filled with a cavity material having a material stiffness in the range of 0.1 MPa to 1.5 MPa. . 8. Probe ifølge krav 7, hvor hulrumsmaterialet omfatter en eller flere polymerer.The probe of claim 7, wherein the void material comprises one or more polymers. 9. Probe ifølge et af de foregående krav, hvor det udvendige kappemateriale har en materialestivhed i området fra 0,5 MPa til 2 MPa.Probe according to one of the preceding claims, wherein the outer casing material has a material stiffness in the range of 0.5 MPa to 2 MPa.
DKPA201570373A 2015-06-18 2015-06-18 Probe for measuring pelvic floor muscle parameters DK178782B1 (en)

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