Device to be used in a glove for vaginal touch measure for pelvic measurement and respective glove

Abstract

The present disclosures relates to a glove and device to be used with the glove for vaginal touch measure for pelvic measurement, the glove having a palm portion and a plurality of finger portions extending from the palm portion, the device comprising: a first magnet for placing on a first finger of a user's hand; a first magnetic sensor for sensing magnetic field, for placing on a second finger of a user's hand; a second magnetic sensor for sensing magnetic field for placing on a third finger of a user's hand; and a data processing device; wherein the data processing device is arranged to: acquire, from the first magnetic sensor, a signal corresponding to the sensed magnetic field by the first magnetic sensor; acquire, from the second magnetic sensor, a signal corresponding to the sensed magnetic field by the second magnetic sensor; obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor.

Description

D E S C R I P T I O NDEVICE TO BE USED IN A GLOVE FOR VAGINAL TOUCH MEASURE FOR PELVIC MEASUREMENT AND RESPECTIVE GLOVETECHNICAL FIELD

[0001] The present disclosure relates to a medical device and system for obstetrics, specifically to a glove and a device which can be integrated into the glove for measuring cervical dilation and fetal presentation.BACKGROUND

[0002] During child birth is important to keep track of the anatomical measurements which are usually extracted by positioning the health professional's fingers in specific positions of the mother and child's anatomy. Currently, such measurements are measured through vaginal examination, carried out by physicians or nurses, in an imprecise way and without any instrument that calibrates and / or validates such measurement.

[0003] Assessment of cervical dilation by vaginal examination is commonly used during childbirth as one of the main indicators of labour progress. It refers to the evaluation of the opening of the cervix, which is the lower part of the uterus, during labour and childbirth. Typically, cervical dilation is measured in centimeters and progresses from 0 to 10, corresponding to closed cervix to a fully dilated cervix respectively, indicating that the cervix is fully open to allow the passage of the baby through the birth canal.

[0004] Despite consistent inaccuracies, this practice remains widely chosen among midwives and obstetricians. Various methods, including electromechanical and electromagnetic devices, have been tested over the decades without being able to provide an objective means of obtaining accurate measurements of cervical dilation during labour.

[0005] Intrapartum ultrasound in the form of assessments with transperineal or transabdominal probes has demonstrated promising results in the assessment and monitoring of labour progress, but they still depend on who performs the examination, that is, they are operator dependent, in addition to being highly specific, operated only by subspecialists and needing an ultrasound device present during labour.

[0006] Cervical assessment is considered the "cornerstone of labour management" and remains the best accepted method of measuring labour progress to date. The values obtained by vaginal examination are recorded prospectively in a partogram, which produces a printed graph recording maternal and fetal observations that allow monitoring and whose format is substantially similar throughout the world. However, the primary source of all this data is based on a human examination, carried out subjectively, subject to measurement errors, distortions of touch or even pure and simple human error, with its limitations, fatigue and exposed to bias factors and with margin increased error rate.

[0007] Therefore, an accurate assessment of cervical dilation is a central component for managing labour; however, there is long-standing scientific evidence of inaccuracy, inconsistency, and insensitivity in obtaining vaginal examination assessments.

[0008] There are a multitude of cervical measurement devices, whether mechanical, electromechanical or electromagnetic, that have been suggested as useful tools for providing an objective measurement of dilation that would not be influenced by human error. However, such devices have been reported to be bulky, with some devices introducing measurement errors due to imperfections in their design, such as interference or distortion. Furthermore, mechanical cervimeters using clips as a fixation method have been reported to be difficult to apply and cause patient discomfort and even occasional neck trauma. In conclusion, no single instrument was able to meet the requirements, with each group characterized by problems and drawbacks that limited their broad application.

[0009] Measurement tools for cervical dilatation have been proposed in the existing literature.

[0010] The documents US 2020 / 0022674 Al presents a device that uses ultrasound strain data to measure cervical elasticity. Other patent documents include pressure sensors in order to evaluate the distance between elements (US 2008 / 0188774 Al and US 2007 / 0255185 Al) or mechanical instruments as reported in document US 2008 / 0177204 Al. Document WO 2023 / 113764 A2 discloses a glove for vaginal touch that helps to assess the cervical dilatation during childbirth. However, the effectiveness of this device is overshadowed by practical challenges in real applications. The fact that they use the vaginal touching gloves suggest difficulties in cleaning and sterilization of these elements, raising significant concerns regarding hygiene and infection transmission during repeated use. Furthermore, the limited reusability of these gloves may result in increased operational costs. Additionally, these gloves do not enableto measure the height of cephalic presentation, limiting the overall measurement and disabling the professional from taking correct actions.

[0011] Therefore, there is no reusable sensor device on the general market that makes such measurements and has real applicability on childbirth. Although there are ultrasound devices that can measure such values, which are used in research, they are very expensive and require sub-specialists to be operated, and albeit imprecisely.

[0012] These facts are disclosed in order to illustrate the technical problem addressed by the present disclosure.GENERAL DESCRIPTION

[0013] The present disclosure relates to a device for digitally measure pelvic measurements of a patient. The device of the present disclosure seeks to address the aforementioned problems by providing a device equipped with sensors for measuring cervical dilation. This device allows healthcare providers to assess dilation accurately and consistently, minimizing subjective errors and increasing comfort for both the patient and the practitioner.

[0014] The device can be used for follow-up labour such as measure of bicuspid diameter (distance between the sciatic spines), conjugata vera obstetrica (distance from the promontory to the inner surface of the pubic symphysis), conjugata exitus (distance from the lower edge of the pubic bone to the coccyx), cervical dilation during labour and childbirth.; vaginal assessment for the use of pessaries in pregnancies with a short cervix.; benign and malignant gynecological tumors of the cervix and vagina, vaginal abscesses, vaginal hematomas; vaginal assessment before using pessaries for uterine prolapse and urinary incontinence.

[0015] The present description allows the anatomical measurements important for labour progression to be quantified, reducing subjectivity and making it possible for physicians to assist a birth remotely, in case of need. Furthermore, the device offers a more convenient and hygienic alternative to existing cervical dilatation measurement devices, addressing challenges related to cleaning, sterilization, and patient discomfort.

[0016] This device consists of a system with embedded technology, for use in contact with the hands, that does not cause discomfort to the user or the patient during use. The device can send measurement data wirelessly to a device using different technologies, such as Bluetooth, NFC,infrared or similar or with wires to be used with a glove, in a non-evasive and discreet way to use. Data transmission depends on the usage rules of each region and medical unit.

[0017] One of the advantages of the present disclosure is to present a new practical and hygienic design concept of a device for measuring cervical dilatation, by introducing finger-mounted devices with advanced sensor measurement system, aiming to overcome the challenges associated with existent devices. Another advantage is that the present device is accurate and can be reused several times.

[0018] By combining sensor-based measurement with the ergonomics of manual examination, the solution bridges the gap between traditional tactile assessment and digital precision, resulting in improved measurement accuracy, reproducibility, and clinical outcomes.

[0019] The present disclosure relates to a device to be used with a glove for vaginal touch measure for pelvic measurement, the glove having a palm portion and a plurality of finger portions extending from the palm portion, the device comprising:a first magnet for placing on a first finger of a user's hand;a first magnetic sensor for sensing magnetic field, for placing on a second finger of a user's hand;a second magnetic sensor for sensing magnetic field for placing on a third finger of a user's hand; anda data processing device;wherein the data processing device is arranged to:acquire, from the first magnetic sensor, a signal corresponding to the sensed magnetic field by the first magnetic sensor;acquire, from the second magnetic sensor, a signal corresponding to the sensed magnetic field by the second magnetic sensor;obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor.

[0020] In an embodiment, the device further comprises a second magnet for placing on a fourth finger of a user's handwherein the data processing device is arranged to:obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor; wherein the fourth finger and a finger of the first, second, or third fingers are the same finger.

[0021] In an embodiment, the device further comprises a first strut and a second strut, wherein the first strut is pivotably attached to the second strut with one degree of rotational freedom;wherein the first magnet is arranged on the first strut;wherein the first magnetic sensor is arranged on the second strut for sensing a magnetic field created by the first magnet.

[0022] Traditional methods for measuring cervical dilation are subjective and vary between examiners, leading to potential inconsistencies in labor management.

[0023] And embodiment of the proposed disclosure integrates struts with sensors, to be used with a glove. These sensors are designed to measure the distance between two points on the cervical opening as the device is inserted and positioned by the examiner.

[0024] In an embodiment, the device further comprises a third strut and a fourth strut, wherein the third strut is pivotably attached to the fourth strut with one degree of rotational freedom;wherein the second magnet arranged on the third strut; andwherein the second magnetic sensor arranged on the fourth strut for sensing a magnetic field created by the second magnet;wherein the data processing device is further arranged to:acquire, from the second magnetic sensor, a signal corresponding to the magnetic field created by the second magnet;obtain from the acquired signal in the previous step, a distance between the second magnet and the second magnetic sensor.

[0025] In an embodiment, the data processing device is further arranged to:acquire, from the second magnetic sensor, a signal corresponding to the magnetic field created by the first magnet, or acquire, from the first magnetic sensor, a signal corresponding to the magnetic field created by the second magnet;obtain from the acquired signal in the previous step, a distance between magnet and magnetic sensor.

[0026] In an embodiment, the first strut and the second strut are pivotably attached by a first hinge.

[0027] In an embodiment, the third strut and the fourth strut are pivotably attached by a second hinge.

[0028] In an embodiment, the magnetic sensor or sensors are magnetic tunnel junction sensors.

[0029] In an embodiment, the magnet is magnetic stripe.

[0030] In an embodiment, the device further comprises a glove, in particular a disposable glove.

[0031] It is also disclosed a glove comprising the device, where:the first magnet is arranged on a tip region of the thumb portion of the glove and the first magnetic sensor is arranged on a tip region of the index finger portion of the glove, and the second magnet is arranged on a tip region of the index finger portion of the glove and the second magnetic sensor is arranged on a tip region of the middle finger portion of the glove, orthe first magnetic sensor is arranged on a tip region of the thumb portion of the glove and the first magnet is arranged on a tip region of the index finger portion of the glove, and the second magnetic sensor is arranged on a tip region of the index finger portion of the glove and the second magnet is arranged on a tip region of the middle finger portion of the glove.

[0032] In an embodiment, the first strut is arranged on a thumb portion of the glove and the second strut is arranged on an index finger portion of the glove. Preferably the first strut is pivotably attached to the second strut with one degree of rotational freedom; wherein the first magnet is arranged on the first strut; wherein the first magnetic sensor is arranged on the second strut for sensing a magnetic field created by the first magnet.

[0033] In an embodiment, the first magnet is arranged on a tip region of the thumb portion of the glove and the first magnetic sensor is arranged on a tip region of the index finger portion of the glove, or vice-versa.

[0034] In an embodiment, the third strut is arranged on a middle finger portion of the glove and the fourth strut is arranged on an index finger portion of the glove. Preferably wherein the third strut is pivotably attached to the fourth strut with one degree of rotational freedom; wherein the second magnet is arranged on the third strut; and wherein the second magnetic sensor arranged on the fourth strut for sensing a magnetic field created by the second magnet.

[0035] In an embodiment, the second magnet is arranged on a tip region of the middle finger portion of the glove and the second magnetic sensor is arranged on a tip region of the index finger portion of the glove, or vice-versa.

[0036] In an embodiment, the second strut and fourth strut arranged on opposite sides of the index finger portion.

[0037] In an embodiment, the first strut and the second strut comprised in the glove are pivotably attached by a first hinge and the third strut and the fourth strut are pivotably attached by a second hinge.BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The following figures provide preferred embodiments for illustrating the disclosure and should not be seen as limiting the scope of invention.

[0039] Figure 1: Representation of the magnetic tunnel junction layer stack (left panel) and of the transfer curve of the sensor, characterizing the dependency between its resistance and magnetic field (right panel).

[0040] Figure 2: Representation of the (a) schematics and micro-image of multiple magnetic tunnel junctions sensors (MTJs sensors) connected in a series (b) Microimages of the 2 mm x 2 mm devices, patterned by lithography; (c) Layout on a printed circuit board (PCB), where the arrows show the directions of the pinned layers in the devices; (d) Transfer curve recorded from the bridge.

[0041] Figure 3: Graphic representation of the dependence of the magnetic field on the distance between the sensor and the magnet.

[0042] Figure 4: Representation of an embodiment a) the middle finger section of an embodiment of the measurement medical device; (b) the index finger section of an embodiment of the measurement medical device; (c) the sensor signal (V) vs the distance between both fingertips; (d) the same data (4c), plotted in semi-log scale: log (V) vs distance.

[0043] Figure 5: Representation of (a) the alternative two MTJ sensors embodiment; (b) the signal of the first sensor VI vs the distance dl between the index finger and the middle finger; (c) the signal of the second sensor V2 vs the distance d2 between the index finger and the thumb.

[0044] Figure 6: Representation of the alternative embodiment with a continuous magnet stripe, in different perspectives (a, b, c, d); (e) of the signal of the first sensor VI vs the distance to the middle finger; (f) of the signal of the second sensor V2 vs the distance to the thumb.

[0045] Figure 7: Representation of an embodiment of the glove comprising the magnets and sensors.

[0046] Figure 8: Representation of an embodiment of the glove comprising the magnets and sensors.

[0047] Figure 9: Representation of an embodiment of the device to be used with a glove, the device comprising the magnets and magnetic sensors to be placed on the fingers of the user's hand.DETAILED DESCRIPTION

[0048] The present disclosure relates to a device to be used with a glove for vaginal touch measure for pelvic measurement, the glove having a palm portion and a plurality of finger portions extending from the palm portion, the device comprising:a first magnet for placing on a first finger of a user's hand;a first magnetic sensor for sensing magnetic field, for placing on a second finger of a user's hand;a second magnetic sensor for sensing magnetic field for placing on a third finger of a user's hand; anda data processing device;wherein the data processing device is arranged to:acquire, from the first magnetic sensor, a signal corresponding to the sensed magnetic field by the first magnetic sensor;acquire, from the second magnetic sensor, a signal corresponding to the sensed magnetic field by the second magnetic sensor;obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor.

[0049] Furthermore, the device comprises a second magnet for placing on a fourth finger of a user's hand,wherein the data processing device is arranged to:obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor; wherein the fourth finger and a finger of the first, second, or third fingers are the same finger.

[0050] In an embodiment, the device comprises:a first strut and a second strut, wherein the first strut is pivotably attached to the second strut with one degree of rotational freedom;the first magnet arranged on the first strut;the first magnetic sensor arranged on the second strut for sensing a magnetic field created by the first magnet; anda data processing device;wherein the data processing device is arranged to:acquire, from the first magnetic sensor, a signal corresponding to the magnetic field created by the first magnet;obtain from the acquired signal in the previous step, a distance between the first magnet and the first magnetic sensor.

[0051] Furthermore, the device may further comprise:a third strut and a fourth strut, wherein the third strut is pivotably attached to the fourth strut with one degree of rotational freedom;the second magnet arranged on the third strut; andthe second magnetic sensor arranged on the fourth strut for sensing a magnetic field created by the second magnet;wherein the data processing device is further arranged to:acquire, from the second magnetic sensor, a signal corresponding to the magnetic field created by the second magnet;obtain from the acquired signal in the previous step, a distance between the second magnet and the second magnetic sensor.

[0052] The present disclosure concerns a medical device for measuring the essential distances used in obstetric practice during childbirth, related to the dilation of the uterus and height of fetal presentation, in order to help health professionals make more informed decisions.

[0053] In an embodiment, the glove is made from a hypoallergenic, medical-grade, flexible material that conforms comfortably to different hand sizes. Preferably is made of latex-free nitrile.

[0054] In an embodiment, the sensors are located in the gloves.

[0055] In an embodiment, the sensors are located in the struts, preferably at the fingertips of the user.

[0056] In an embodiment, the strutswill the arranged in the thumb, the index and middle fingers.

[0057] In an embodiment, the sensors are capable of detecting distances and pressure applied, providing real-time data to a connected digital readout.

[0058] In an embodiment, the data processing device will show the dilation measurement. This device can store data for multiple patients and can be synced with hospital management systems. Preferably the wireless connectivity is via Bluetooth or Wi-Fi.

[0059] The present disclosure allows to accurately monitor the progress of labour and whose purpose is to measure: (1) Dilation of the cervix (diameter of the external and internal orifice of the cervix) and (2) Insinuation of the fetal head by measuring the height of the fetal presentation (distance from the cephalic pole to the perineum) in centimetres, using a precise, digital (electronic) and objective instrument.

[0060] The disclosed medical device is based on magnetic tunnel junction (MTJ) sensors. The working principle of the MTJ sensor is based on dependence between tunnelling conductivity through the magnesium oxide (MgO) barrier and mutual orientations of the magnetizations in the free and pinned layers. Parallel orientation of magnetizations in these two layers facilitates higher probability of electron tunnelling through the MgO barrier, whereas the antiparallel magnetizations in the free and pinned layers lead to lower conductivity. In general, the dependence between the conductivity and the angle 0M between the free and pinned layer magnetizations isoMTJ = oO + oTMR cos GM (1),leading to the correspondent equation for resistance:

[0061] The tunnel magnetoresistance rate (TMR) is defined as the ratio between the highest and the lowest resistances on the RMTJ vs field H transfer curve:

[0062] The higher the TMR is, the higher is the ratio.

[0063] In an embodiment, Figure 1 relates to MTJ layer stack comprising two structures: a free layer made of CoFeB (Cobalt Iron Boran), Ta (Tantalum), NiFe (Nickel Iron), Ru (Ruthenium) and IrMn (Iridium Manganese) and a pinned layer made of Ta (Tantalum), Ru (Ruthenium), IrMn (Iridium Manganese), CoFe (Cobalt Iron), Ru (Ruthenium) and CoFeB (Cobalt Iron Boran), separated by an insulating MgO layer. All the layers of the stack are grown subsequently by magnetron sputtering deposition.

[0064] To amplify the signal from the sensor and compensate thermal drifts in resistance, an array of multiple MTJs is connected in a series and a set of four arrays are connected in a Wheatstone bridge, as represented in Figure 2c.

[0065] The bridge configuration of the sensor also improves linearity of the output: when the resistance of a single MTJ is inversely proportional to cos 0M (which is linear with magnetic field H), the output signal of the bridge is directly proportional to cos 0M. When the bridge is powered by a constant voltage of the electronics, the output of the bridge doesn't depend on the thermal drift of the resistance:

[0066] In this configuration, the sensor is compatible with standard input voltages of electronic boards (1 V - 10 V), the noise level is considerably reduced compared to a single MTJ, whereas the sensor footprint size is still sufficiently small to implement into devices "on a fingertip". The parameters of the sensor are summarized in a Table 1.Table 1 - Parameters of the MTJ sensors

[0067] When the magnetic sensor is placed into inhomogeneous magnetic fields, the sensor detects changes in this field, associated to displacements of the sensor along the magnetic field gradient.

[0068] A single permanent magnet can be considered as a source of inhomogeneous magnetic field with high gradients. A Neodymium Iron Boron (NdFeB) permanent magnet with a size of 10 mm * 2 mm * 3 mm was selected as a source of magnetic field with high gradient. The dependence of the magnetic field on the distance between the sensor and the magnet is given in Figure 3.

[0069] Since there is a one-to-one correspondence between the magnetic field and the distance and there is a linear dependence of the MTJ bridge on magnetic field, there could be also a one-to-one correspondence between the MTJ bridge signal and the distance between the MTJ sensor and the magnet. With this principle, the magnet MTJ sensor platform provides a possibility for contactless detection of the displacements of the sensor in respect to the magnet. This principle was applied to the design of a medical device to determine the size of surgical objects when operating inside a human body, without other type of access. The distance can be determined with ultrasound or optically.

[0070] In an embodiment, the disclosed measurement medical device contains two small frames or struts 3, adjustable to the size of human index and middle fingers (Figure 4a).

[0071] In an embodiment, the device comprises small devices to be applied on the index and middle fingers of the user, adjustable to the size of human fingers, ensuring ease of use and minimal interference with medical procedures. This non-invasive nature of the device allows for easy and quick application, contributing to a more comfortable experience for patients.

[0072] In an embodiment, Figure 4a included two frames or struts connected with a hinge, allowing only one degree of rotational freedom in the system. The ensemble of the frames with the hinge are attached to a standard medical glove: one of the frames parallel and in contact with the index finger and the other parallel and in contact with the middle finger (Figure 4b).

[0073] In Figure 4a and Figure 4b, 1 represents the magnet, 2 the sensor, 3 the struts and 4 the hinge.

[0074] In an embodiment, the MTJ sensor is installed on the first frame or first strut, near to the fingertip of the index finger. The magnet is installed on the second frame or second strut, near to the fingertip of the middle finger. The orientation of the magnet is adjusted to have the sensor signal within linear range of the sensor. Both magnet and sensor are installed on the interior side of the frames. The range of distances between both fingertips is from 10 mm to 90 mm.

[0075] The distance between the sensor and the magnet can be controlled by movement of the index finger and the middle finger. As the frames or struts are rigid and the hinge allows only one rotational degree of freedom, there is one-to-one correspondence between the angle between these two frames (controlled by fingers) and the distance between the fingertips. Thus, one can also expect one-to-one correspondence between the distance (or the angle between the index and middle fingers) and the sensor signal, since there is no additional rotations in the system that could correlate with the distance. Figures 4c and 4d show the dependence of the sensor signal on the distance between both fingertips, recorded at increasing and decreasing distances, at normal and logarithm scale, respectively. Coincidence between graphs from Figures 4c and 4d shows good bidirectional reproducibility. Within the error of 0.5 cm, the data are bi-directionally reproducible, and there is one-to-one correspondence between the sensor output and the distance between the fingertips.

[0076] In an embodiment, the device that comprises four components - glove; a support for supporting a sensor and a magnet; data acquisition system; and software - is meant to be used as a stand-alone equipment or it can be interfaced with other digital equipment (for instance to allow measurements to be transmitted over the web in real time, if needed).

[0077] In an alternative embodiment, the disclosed measurement medical device can include more than one sensor, allocated on the fingertips of the other fingers. A potential application of this device could be a real-time control of mechanical parts of surgical equipment during the patient's medical diagnostics. An example of the first prototype of this system is shown in Figure 5a. In this embodiment, the magnet is allocated on the index finger, whereas the 2 MTJ sensors are on the thumb (s2) and the middle fingers (si), on different rigid frames ensembles. The sensor signals are recorded independently and, as such, it can monitor two distances simultaneously: the distance between the fingertips of the index and the middle fingers (dl) and between the index finger and thumb 5 (d2). For both the sensors, there is a one-to-one correspondence between the signal and its distance from the fingertip of the index finger, on which the magnet is allocated (Figure 5b).

[0078] In an alternative embodiment, there could also be a modification of the system, when, instead of the "point" magnet, the sensor is magnetized by a continuous magnet stripe. In this case, the magnetic field still changes with the distance from the stripe, but more homogeneously along the direction of the stripe. A potential application of this embodiment could be to control of distance between two "continuous" metallic objects during surgical manipulations. The first prototype and the output characteristics are shown in Figure 6. In this configuration, the magnetic stripe provides a magnetic field with "less inhomogeneity" - the field higher at the distance 7 mm from the stripe, and lower at the close proximity to the stripe. This facilitates better linearity of signal with the variations in distance.

[0079] In an embodiment, the device is attachable to the hand of a doctor or nurse, comprising three small, ergonomically designed devices or struts to be affixed onto the index, middle fingers and thumb, equipped with a sensor measurement system.

[0080] In an embodiment, Figure 7 and Figure 8 represents a glove with the magnets and sensors. In Figure 7, 1 represents the magnet and 2 the sensor. In Figure 8, 5 represents the thumb.

[0081] In an embodiment, Figure 9, (a), (b), (c), and (d) is a representation of the device to be used with a glove for vaginal touch measure for pelvic measurement, the glove having a palm portion and a plurality of finger portions extending from the palm portion, the device comprising the magnets and magnetic sensors to be placed on the fingers of the user's hand.

[0082] In an embodiment, the device can be produced using additive manufacturing technologies providing a customizable solution while maintaining a high degree of precision and quality.

[0083] It is also disclosed a data acquisition system that digitizes the analog signal of the sensors and feeds the result into a data analysis software and a software component which analyses the data streaming out the sensors to provide quantified and meaningful information concerning the relative position of specific fingers during labour related obstetrician procedures.

[0084] In an embodiment, the device comprises advanced sensor technology that detects changes in cervical dilatation in real-time, providing accurate and reliable measurements during childbirth.

[0085] The term "comprising" whenever used in this document is intended to indicate the presence of stated features, integers, steps, components, but not to preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0086] The disclosure should not be seen in any way restricted to the embodiments described and a person with ordinary skill in the art will foresee many possibilities to modifications thereof. The above-described embodiments are combinable.

[0087] The following dependent claims further set out particular embodiments of the disclosure.

Claims

C L A I M S1. Device to be used with a glove for vaginal touch measure for pelvic measurement, the glove having a palm portion and a plurality of finger portions extending from the palm portion, the device comprising:a first magnet for placing on a first finger of a user's hand;a first magnetic sensor for sensing magnetic field, for placing on a second finger of a user's hand;a second magnetic sensor for sensing magnetic field for placing on a third finger of a user's hand; anda data processing device;wherein the data processing device is arranged to:acquire, from the first magnetic sensor, a signal corresponding to the sensed magnetic field by the first magnetic sensor;acquire, from the second magnetic sensor, a signal corresponding to the sensed magnetic field by the second magnetic sensor;obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor.

2. Device according to the previous claim further comprising a second magnet for placing on a fourth finger of a user's handwherein the data processing device is arranged to:obtain, from the acquired signals, a distance between the first magnet and the first magnetic sensor, and a distance between the first magnet and the second magnetic sensor; wherein the fourth finger and a finger of the first, second, or third fingers are the same finger.

3. Device according to any of the previous claims comprising a first strut and a second strut, wherein the first strut is pivotably attached to the second strut with one degree of rotational freedom;wherein the first magnet is arranged on the first strut;wherein the first magnetic sensor is arranged on the second strut for sensing a magnetic field created by the first magnet.

4. Device according to any of the previous claims further comprising a third strut and a fourth strut,wherein the third strut is pivotably attached to the fourth strut with one degree of rotational freedom;wherein the second magnet arranged on the third strut; andwherein the second magnetic sensor arranged on the fourth strut for sensing a magnetic field created by the second magnet;wherein the data processing device is further arranged to:acquire, from the second magnetic sensor, a signal corresponding to the magnetic field created by the second magnet;obtain from the acquired signal in the previous step, a distance between the second magnet and the second magnetic sensor.

5. Device according to the previous claim wherein the data processing device is further arranged to:acquire, from the second magnetic sensor, a signal corresponding to the magnetic field created by the first magnet, or acquire, from the first magnetic sensor, a signal corresponding to the magnetic field created by the second magnet;obtain from the acquired signal in the previous step, a distance between magnet and magnetic sensor.

6. Device according to any of the previous claims wherein the first strut and the second strut are pivotably attached by a first hinge.

7. Device according to any of the previous claims 4 to 6 wherein the third strut and the fourth strut are pivotably attached by a second hinge.

8. Device according to any of the previous claims wherein the magnetic sensor or sensors are magnetic tunnel junction sensors.

9. Device according to any of the previous claims wherein the magnet is magnetic stripe.

10. Device according to any of the previous claims further comprising a glove, in particular a disposable glove.

11. Glove comprising the device according to any of the claims whereinthe first magnet is arranged on a tip region of the thumb portion of the glove and the first magnetic sensor is arranged on a tip region of the index finger portion of the glove, and the second magnet is arranged on a tip region of the index finger portion of the glove and the second magnetic sensor is arranged on a tip region of the middle finger portion of the glove, orthe first magnetic sensor is arranged on a tip region of the thumb portion of the glove and the first magnet is arranged on a tip region of the index finger portion of the glove, and the second magnetic sensor is arranged on a tip region of the index finger portion of the glove and the second magnet is arranged on a tip region of the middle finger portion of the glove.

12. Glove according to previous claim wherein the first magnet is arranged on a tip region of the thumb portion of the glove and the first magnetic sensor is arranged on a tip region of the index finger portion of the glove, or vice-versa.

13. Glove according to any of the previous claims 11 or 12 wherein the second magnet is arranged on a tip region of the middle finger portion of the glove and the second magnetic sensor is arranged on a tip region of the index finger portion of the glove, or vice-versa.

14. Glove according to any of the previous claims 11 o 13 comprising the first strut arranged on a thumb portion of the glove and the second strut arranged on an index finger portion of the glove,wherein the first strut is pivotably attached to the second strut with one degree of rotational freedom;wherein the first magnet is arranged on the first strut;wherein the first magnetic sensor is arranged on the second strut for sensing a magnetic field created by the first magnet.

15. Glove according to any of the previous claims 11 to 14 comprising the third strut arranged on a middle finger portion of the glove and the fourth strut arranged on an index finger portion of the glove,wherein the third strut is pivotably attached to the fourth strut with one degree of rotational freedom;wherein the second magnet is arranged on the third strut; andwherein the second magnetic sensor arranged on the fourth strut for sensing a magnetic field created by the second magnet.

16. Glove according to any of the claims 14 and 15 wherein the second strut and fourth strut are arranged on opposite sides of the index finger portion.

17. Glove according to any of the claims 14 to 16 wherein the first strut and the second strut are pivotably attached by a first hinge and the third strut and the fourth strut are pivotably attached by a second hinge.

Images