Torsional Ultrasound Transducer Medical Device

Abstract

1. A medical device configured to contact a specimen via its distal end, the medical device comprising: a) a torsional ultrasound transducer disposed at the distal end of the medical device and configured to induce shear waves that pass through the specimen; b) a force sensor configured to determine the force of contact of the medical device with the specimen; and c) a processing unit. The torsional ultrasound transducer is configured to contact the specimen with a predetermined range of forces, and the processing unit is configured to determine whether the force of contact of the medical device with the specimen is within the predetermined range of forces. The specimen is a cervix, and the torsional ultrasound transducer is configured to measure a force of 0 to 200 g / cm. 2 The present invention further relates to a device configured to place a membrane on a medical device.

Description

[Technical Field]

[0001] The present invention relates to the field of medical devices. In particular, the present invention relates to a medical device that includes a torsional ultrasound transducer configured to contact a sample and provide the best readings from the torsional ultrasound transducer. Furthermore, the present invention relates to such a device configured to place a membrane on the medical device. [Background technology]

[0002] A torsional wave is a spatial distribution of transverse waves propagating along an axis, and particle motion occurs circumferentially about this axis such that the amplitude of motion in the generating plane is proportional to the distance from the axis within the diameter of the transducer.

[0003] Since these waves propagate through solid and semi-solid media but not through complete liquids, measurements of the speed of sound in such media can be extremely useful for studying their structural properties, which translate input energy into different types of output energy. These devices include, among other things, electromechanical transducers, which convert electrical energy into mechanical energy in the form of bidirectional displacements that elastically couple to stress.

[0004] Ultrasound transducers transmit and receive ultrasound waves, which, based on solid mechanics, can identify changes in tissue consistency that may indicate the presence of a tumor and quantify mechanical or physical changes in the tissue, thereby predicting certain pathologies earlier than other diagnostic techniques.

[0005] Because torsional wave (TW) is a contact technique and quantifies mechanical parameters of the surface being measured, the values ​​obtained can change rapidly when the surface properties change. This can lead to erroneous measurements and a lack of consistency between measurements, preventing the reliable use of torsional wave technology in medical environments.

[0006] Therefore, there is a need for a torsional ultrasonic transducer technology that can ensure that the properties of the surface of the contacting device are not changed, or that the change is as small as possible. Summary of the Invention

[0007] 1. A medical device configured to contact a specimen via its distal end, the medical device comprising: a) a torsional ultrasound transducer disposed at the distal end of the medical device and configured to induce shear waves that pass through the specimen; b) a force sensor configured to determine the force of contact of the medical device with the specimen; and c) a processing unit. The torsional ultrasound transducer is configured to contact the specimen with a predetermined range of forces, and the processing unit is configured to determine whether the force of contact of the medical device with the specimen is within the predetermined range of forces. The specimen is a cervix, and the torsional ultrasound transducer is configured to measure a force of 0 to 200 g / cm. 2 The present invention further relates to a device configured to place a membrane on a medical device.

[0008] In a preferred embodiment, the medical device further comprises a feedback means configured to provide a user of the medical device with feedback regarding the force of contact of the device with the sample. More preferably, the feedback means is configured to further provide a user of the medical device with feedback regarding whether the force is within a predetermined range of forces. In another more preferred embodiment, the feedback means is located at the proximal end of the medical device.

[0009] In another more preferred embodiment, the medical device further comprises imaging means, and the feedback means comprises a visual feedback device configured to display an image captured by the imaging means. More preferably, the imaging means is located at a distal end of the medical device, and the imaging means and visual feedback device are located coaxially within the medical device. Even more preferably, the imaging means and visual feedback device are coaxial within the medical device along an axis formed by the distal end and the proximal end.

[0010] In another preferred embodiment, the force sensor is included in a distal portion of the medical device.

[0011] In another preferred embodiment, the force sensor is positioned perpendicular to a surface of the medical device configured to contact the sample.

[0012] In another preferred embodiment, a force sensor is provided between the proximal portion of the medical device and the distal portion of the medical device. In certain embodiments, the force sensor determines the force of contact of the device with the sample based on the relative position of the distal portion (180) with respect to the proximal portion. More preferably, the force sensor determines the force of contact of the device with the sample as the distal portion is longitudinally displaced relative to the proximal portion.

[0013] In another specific embodiment, a force sensor is preloaded and determines the force of contact of the device with the sample in response to the release of pressure on the sample as the distal portion is longitudinally displaced relative to the proximal portion.

[0014] In another preferred embodiment, the force sensor further comprises a protection system configured to prevent damage to the force sensor when a force exceeding the working range is applied to the distal end of the medical device, preferably the protection system comprises a spring.

[0015] In another preferred embodiment, the medical device further comprises a handle at its proximal end configured to be held by hand and having an angle comprised between 85° and 120° relative to an axis formed by the distal end and the proximal end.

[0016] In another preferred embodiment, the processing unit is configured to discard the torsional ultrasound transducer readings if the applied force is not within a predetermined range of forces.

[0017] In another preferred embodiment, the processing unit is configured to prevent the torsional ultrasonic transducer from inducing torsional waves if the applied force is not within a predetermined range of forces.

[0018] In another preferred embodiment, the torsional ultrasonic transducer comprises an emitter device for emitting torsional ultrasonic waves, the emitter device comprising an electric signal generator connected to an electromechanical actuator, the electromechanical actuator being attached to a contact element in contact with a sample, the actuator inducing a rotational movement of the contact element upon receiving an electric signal, the contact element inducing a torsional wave that passes through the sample upon contact with the sample, the torsional ultrasonic transducer further comprising means for receiving the distorted signal after passing through the sample.

[0019] In a more preferred embodiment, the means for receiving the strain signal comprises two or more piezoelectric elements positioned equidistant from one another and disposed between two rings made of a non-conductive material, the rotational axes of the rings coinciding with the rotational axis of the electromechanical actuator. In another more preferred embodiment, a damping element, preferably a damping material having a hardness of less than 80 Shore A, is attached to the outer surface of the ring furthest from the area of ​​contact with the sample. In another more preferred embodiment, the contact element has a substantially frusto-conical shape, the smaller base of which is attached to the electromechanical actuator and the larger base of which is located at the distal end of the transducer of the present invention to contact the sample and transmit shear waves.

[0020] In another more preferred embodiment, the electromechanical actuator is covered by a Faraday cage that filters out electronic noise. In another more preferred embodiment, the outer surface of one of the rings and the surface of the emitter device element that contacts the sample are coplanar.

[0021] In another more preferred embodiment, the polarization of the piezoelectric element is radially perpendicular to the axis of rotation of the ring.

[0022] In another preferred embodiment, the medical device further comprises: d) a conduit connecting an exterior to an interior space of the medical device, the conduit leading to the exterior through an opening; e) a sealing element located at the other end of the conduit and configured to control the passage of air between the interior space and the conduit; and f) a vacuum pump connected to the sealing element and configured to draw air through the opening through the conduit. The medical device is configured to receive a membrane on its exterior that covers the opening, and the vacuum pump is configured to extract air between the sealing element and the membrane.

[0023] In a more preferred embodiment, the vacuum pump is connected to a pressure sensor configured to measure the pressure in the conduit, and the vacuum pump is configured to maintain a minimum pressure in the space between the membrane and the sealing element measured by the pressure sensor. More preferably, the minimum pressure is comprised between 700 and 800 mBar.

[0024] In another more preferred embodiment, the medical device is elongated in nature and configured to contact the sample through a distal portion, and the device is configured such that a membrane covers at least the distal portion. In another more preferred embodiment, the opening is included in the distal end of the medical device. In another more preferred embodiment, the medical device is configured to receive a prophylactic membrane as the membrane.

[0025] In another more preferred embodiment, the medical device comprises at least one recess in an outer surface thereof configured to receive an edge of the membrane. More preferably, the recess is configured to receive the edge of the membrane in a sealing manner.

[0026] In another preferred embodiment, the medical device is a probe. More preferably, the medical device is a uterine tube and the sample is a cervix.

[0027] Another aspect of the invention relates to a device configured to place a membrane on a probe, the device being essentially elongated and configured to longitudinally receive the probe, the device comprising a proximal zone and a distal zone, the proximal zone comprising: a) an opening configured to receive the probe inserted therethrough; and b) at least one recess defined by a radially outer surface thereof and configured to receive an edge of the membrane covering the opening, the membrane being essentially elongated in the longitudinal direction such that the edge of the membrane constitutes a part of the membrane.

[0028] In a preferred embodiment, the probe comprises a distal end by which it is introduced into the device, and the device further comprises a distal end at its distal region, the distal end comprising an inner surface configured to receive the distal end of the probe. More preferably, the inner surface of the distal end of the device comprises a complementary shape to the distal end of the probe configured to position the membrane in uniform contact with the distal end of the probe.

[0029] In another preferred embodiment, the distal end of the device is configured to be separated from the remainder of the device and replaced with another distal end of the device corresponding to the distal end of the probe.

[0030] In another preferred embodiment, the openings are configured to fit over respective surfaces of the probe when the probe is fully inserted into the device.

[0031] In another preferred embodiment, the recess is configured to allow release of the membrane when the probe is inserted to the distal end of the device.

[0032] In another preferred embodiment, the device is configured to place the membrane on a probe that includes a recess in its proximal portion configured to receive the edge of the membrane when the membrane is already placed on the probe.

[0033] In another preferred embodiment, the opening is essentially circular and the recess defines a circumference having a diameter of between 5 and 50 mm.

[0034] In another preferred embodiment, the device comprises at least one side opening configured to allow visualization of the placement of the membrane on the probe.

[0035] In another preferred embodiment, the device is configured to place the membrane on a uterine probe. More preferably, the device is configured to place the membrane on a shear wave uterine probe, preferably a torsional ultrasound probe.

[0036] In another preferred embodiment, the device includes a handle at its distal end.

[0037] In yet another preferred embodiment, membrane (70) is a prophylactic membrane.

[0038] In another preferred embodiment, the device further comprises at least one magnet in its proximal region configured to attract at least one ferromagnetic element or magnet provided in the proximal portion of the probe.

[0039] To enable a better understanding of the present disclosure and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying schematic drawings. [Brief explanation of the drawings]

[0040] [Figure 1A] 1 shows a perspective view of a distal portion of a medical device in accordance with one or more embodiments of the present invention. [Figure 1B] 1 illustrates a side view of the arrangement of internal components in a distal portion of a medical device in accordance with one or more embodiments of the present invention. [Figure 2] 1 illustrates a perspective view of a medical device in accordance with one or more embodiments of the present invention. [Figure 3] 3 shows a side view of the medical device of FIG. 2 in accordance with one or more embodiments of the present invention. [Figure 4] 1 shows an enlarged view of a distal end of a medical device in accordance with one or more embodiments of the present invention. [Figure 5]1 illustrates a proximal end of a medical device in accordance with one or more embodiments of the present invention. [Figure 6] 1A-1D show a visual feedback device interface according to one or more embodiments of the present invention before use (A), in use but before generating shear waves in the sample (B), in use while generating shear waves in the sample (C), and after generating shear waves in the sample (D). [Figure 7] 1 shows a diagram of a force sensor mechanism of a device in accordance with one or more embodiments of the present invention. [Figure 8] 1 illustrates an emitter arrangement for a torsional ultrasound transducer in accordance with one or more embodiments of the present invention. [Figure 9] 1 illustrates a contact element of a torsional ultrasonic transducer in accordance with one or more embodiments of the present invention. [Figure 10] 1 illustrates a cross section of a receiver device of a torsional ultrasound transducer in accordance with one or more embodiments of the present invention, where the ring and piezoelectric element are visible. [Figure 11] 1 illustrates the arrangement of an emitter device and a receiver device of a torsional ultrasound transducer according to one or more embodiments of the present invention, where the contact element, ring, and piezoelectric element are visible. [Figure 12] 10A and 10B illustrate schematic diagrams of contact between a transducer and a sample in accordance with one or more embodiments of the present invention. [Figure 13] 1 shows a piezoelectric element (5) and its polarization direction (P) according to one or more embodiments of the present invention. [Figure 14] 1 shows a cross-sectional view of a transducer according to one or more embodiments of the present invention, in which the placement of an emitter device relative to a receiver device can be seen, and the placement of the transducer and damping element inside the casing. [Figure 15] 1 illustrates a perspective view of a medical device in accordance with one or more embodiments of the present invention. [Figure 16] 1 is another perspective view of a medical device in accordance with one or more embodiments of the present invention, showing an exploded view of the distal and proximal portions. [Figure 17A] 1 shows a longitudinal cross-sectional view of an apparatus according to one or more embodiments of the present invention. [Figure 17B] 1 shows a schematic diagram of a longitudinal cross section of a distal portion of a device according to one or more embodiments of the present invention. [Figure 18A] 1 shows a perspective view of an apparatus according to one or more embodiments of the present invention. [Figure 18B] FIG. 18B shows a perspective view of the device of FIG. 18A having a membrane in accordance with one or more embodiments of the present invention. [Figure 19A] 18B shows another perspective view of the device of FIG. 18A having a membrane and a probe configured to be received therein in accordance with one or more embodiments of the present invention. [Figure 19B] 18B shows a longitudinal cross-sectional view of the device of FIG. 18A having a membrane and a probe configured to be received therein in accordance with one or more embodiments of the present invention. [Figure 20A] FIG. 18B shows a perspective view of the device of FIG. 18A with the probe fully inserted and the membrane fully positioned over the probe in accordance with one or more embodiments of the present invention. [Figure 20B] 18B shows a longitudinal cross-section of the device of FIG. 18A with the probe fully inserted and the membrane fully positioned over the probe in accordance with one or more embodiments of the present invention. [Figure 21A] 18B shows a perspective view of the device of FIG. 18A and a probe removed from the device in accordance with one or more embodiments of the present invention. [Figure 21B] 1 illustrates a longitudinal cross-sectional view of a probe after removal from a device in accordance with one or more embodiments of the present invention, with a membrane disposed on the surface of the probe. DETAILED DESCRIPTION OF THE INVENTION

[0041] Description of the Invention definition It should be noted that, as used herein, the singular forms "a," "an," and "the" include plural referents unless this is clearly not the case from the context. Further, unless otherwise indicated, the term "at least" preceding a series of elements is to be understood to refer to every element of the series. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the present invention.

[0042] It should be noted that the term "about" as used herein refers to + / -30%, preferably + / -20%, preferably + / -15%, and more preferably + / -10% of the indicated reference value.

[0043] As used herein, the term "and / or" connecting multiple listed elements is understood to encompass both individual options and combinations of options. For example, when two elements are connected by "and / or," the first option refers to the applicability of the first element without the second element. The second option refers to the applicability of the second element without the first element. The third option refers to the applicability of the first and second elements together. Any of these options is understood to fall within the meaning and thus meet the requirements of the term "and / or" as used herein. The simultaneous application of two or more of the options is also understood to fall within the meaning and therefore meet the requirements of the term "and / or."

[0044] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise," and variations such as "comprises" and "comprising," will be understood to mean the inclusion of the stated integer or step or group of integers or steps, but not the exclusion of any other integer or step or group of integers or steps. As used herein, the term "comprising" is interchangeable with the terms "containing" or "including," and, in some cases, when used herein, with the term "having." Any of the foregoing terms (comprising, containing, including, having), whenever used herein in the context of an aspect or embodiment of the invention, may be replaced, but is less preferred, with the term "consisting of."

[0045] As used herein, "consisting of" excludes elements, steps, or ingredients not specified in the claim element. As used herein, "consisting essentially of" does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claim.

[0046] The term "sample" in the context of the present invention preferably refers to a biological sample, in particular any type of biological tissue, whether in vivo or in vitro. For example, the sample may be a sample obtained from an animal or from a part of an animal, such as a skin fragment, a limb, a cavity, a mucous membrane, or any other part of an animal or human. A sample should therefore be understood as a material, preferably a tissue, tissue culture, or cell culture, through which waves emitted by a transducer are passed in order to know its structural characteristics (especially elastic parameters, viscoelastic parameters, shape related to the microstructure, porosity, or energy dissipation model).

[0047] The term "medical device" in the context of the present invention preferably refers to any kind of instrument, apparatus or equipment for the diagnosis, prevention, monitoring, prediction, prognosis, treatment, mitigation or research of animals, especially humans.

[0048] The term "probe" in the context of the present invention preferably refers to an essentially tubular device that allows for examination, diagnosis, and / or delivery of therapy through a body duct or cavity.

[0049] The term "membrane" in the context of the present invention preferably refers to a thin, generally flexible, and preferably elastic film which may be organic or inorganic and may comprise materials such as nitrile, latex, or polyurethane.

[0050] The term "opening" in the context of the present invention preferably refers to a hole in the surface of the device that allows access to the interior of the device.

[0051] The term "depression" in the context of the present invention preferably refers to a narrow, elongated area on a surface that sinks in front of the rest of the surface, creating a concave zone in the surface.

[0052] In the context of the present invention, the term "edge" particularly with respect to a membrane preferably refers to the edge of the membrane.

[0053] The term "essentially circular" in the context of the present invention preferably refers to a shape whose overall appearance resembles a circle, but which may have irregularities at the edges of the circle, or may be partially truncated, or may be slightly distorted in one or more axes.

[0054] The term "electromechanical actuator" is preferably understood as a device capable of converting electrical energy into motion, in particular rotational motion. In a particular embodiment suitable for the present invention, the electromechanical actuator is stimulated with an electrical signal generated by an electrical pulse generator and is capable of converting this signal into a minimally small rotation, which is used to generate the waves that will be analyzed later. An example of this type of actuator may consist of an electromagnetic motor. For the purposes of the present invention, the electromechanical actuator is preferably stimulated by a means capable of generating an electrical signal or wave, hereinafter referred to as an "electrical signal generator".

[0055] The term "electrical signal" is preferably understood as an electrical magnitude whose value depends on time. For the purposes of the present invention, a constant magnitude is considered a specific case of an electrical signal. The electrical signal generated by an electrical signal generator may be a periodic signal (sine, square, triangular, "sawtooth", etc.). Thus, by connecting the generator to an actuator that converts the signal into rotational motion, the actuator performs a minimum rotation of a fraction of a revolution, depending on the voltage, frequency, and / or time between pulses determined by the signal. Any electronic circuit that digitizes an electrical signal at a desired frequency can be used as an electrical signal generator. Another example of an electrical signal generator used in the experimental design of the present invention may be an oscilloscope, as it can emit an electrical signal with a variable voltage over a specific time period.

[0056] The term "biocompatible material" is understood to mean a material having a composition that preferably does not interfere with or cause degradation of the biological media with which it is used. These materials are typically used to fabricate devices or components thereof, such as probes, syringes, prosthetic devices, etc., that must be in direct, temporary or long-term contact with body fluids and tissues. An example of this material is polylactic acid (PLA).

[0057] The term "contact element" refers to the portion or element located at the distal or front of the transducer that contacts the sample and transmits waves. The surface of the contact element that contacts the sample must be fairly flat to allow for proper wave transmission. explanation

[0058] Each embodiment disclosed herein is considered applicable to each of the other disclosed embodiments. Accordingly, all combinations of the various elements described herein are within the scope of the present invention. Also, unless expressly indicated otherwise, it should be understood that in any method described herein including two or more steps or acts, the order of the steps or acts of the method is not necessarily limited to the order of the recited steps or acts of the method.

[0059] A first aspect of the present invention, illustrated with reference to Figures 1A, 1B, and 2, relates to an apparatus (100) configured to contact a sample (200) via its distal end (190). The apparatus (100) comprises a torsional ultrasonic transducer (10), a force sensor (20), and a processing unit (30).

[0060] It should be noted that the present invention is not particularly limited to a particular type of sample, which may include either organic or inorganic samples, such as biological samples or specimens. Reference will be made below to sample (200) by way of example only. Furthermore, according to a preferred embodiment of any of the embodiments of the first aspect of the present invention, sample (200) is specimen (200).

[0061] The torsional ultrasonic transducer (10) is located at the distal end (190) of the device (100) and is configured to induce shear waves that pass through the sample (200). The distal end (190) is preferably understood to be the portion of the device (100) that is farthest from where the user controls the device. The torsional ultrasonic transducer can induce shear waves via a variety of mechanisms, providing flexibility in application. Possible induction methods include mechanical means, in which the transducer physically imparts a rotational force to the medium, or electromagnetic means, in which a magnetic field generates the required torsional motion. These methods are described in further detail below.

[0062] The force sensor (20) is configured to determine the force of contact of the device (100) with the sample (200).

[0063] The force sensor (20) can be any of a number of types of force sensors, which may or may not be similar or identical to the pressure sensor (67), such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical, or potentiometric extensometer, among others. Thus, the force sensor (20) of the present invention is not limited to any particular type of force sensor. Depending on the technology, the force sensor can determine the applied force in a variety of ways, including measuring the deformation of a material, capturing changes in electrical properties, or quantifying pressure fluctuations. The force sensor can be located anywhere within the device (100). It may be strategically placed at various points depending on the device's configuration.

[0064] The processing unit 30, in turn, can include one or more processing units, such as a microprocessor, GPU, CPU, or multi-core processor. Therefore, the implementation of the processing unit 30 is not particularly limited. In certain configurations, the processing unit may be strategically located within the device itself. For example, it can be placed alongside the force sensor, contributing to real-time data processing and immediate response to mechanical interactions. This on-board processing enhances the device's autonomy and responsiveness. Alternatively, the processing unit may be part of a broader computing infrastructure. It can be integrated into an external computing device, such as a personal computer (PC) or a remote PC. In this situation, the device benefits from the processing power of the external computing unit, enabling more complex calculations and data analysis, such as aggregating data from other devices 100.

[0065] The torsional ultrasonic transducer (10) is configured to contact the sample (200) with a predetermined force or a predetermined range of forces. In a preferred embodiment, the torsional ultrasonic transducer (10) is configured to contact the sample (200) with a predetermined range of forces.

[0066] The term "configured to contact at a predetermined force" in the context of the present invention is preferably understood to mean that the torsional ultrasonic transducer (10) is configured to be used in a specific application, i.e., to contact the sample (200) that the device (100) is configured to contact. The configuration of the torsional ultrasonic transducer can therefore be tailored specifically to the application and the properties of the sample (200). Depending on the sample (200), the torsional ultrasonic transducer (10) may be positioned and configured to optimally induce torsional waves in the sample at a predetermined range of forces. Therefore, this range of forces may vary depending on the sample that the device (100) is configured to contact.

[0067] The preferred force applied by the torsional ultrasonic transducer can be set as either a single desired value or a desired defined range, a feature that accommodates a variety of measurement situations and provides versatility in force application.

[0068] For example, if the device 100 is a medical device used as a uterine probe for examining the cervix, the force applied by the torsional ultrasound transducer may be controlled within a specified range, e.g., 0-200 g / cm. 2 can be set within the range.

[0069] The processing unit (30) is configured to determine whether the force of contact of the device with the sample (200) is within a predetermined range of forces.

[0070] This determination is accomplished by a systematic comparison between the force measured by the force sensor (20) and the range of forces for which the torsional ultrasonic transducer (10) is configured to contact the sample (200).

[0071] Advantageously, the device (100) can monitor the force of contact of the device with the sample (200), which means that the user can better understand the use of the device (100) and determine whether to change the way the device (100) contacts the sample (200).

[0072] As can be seen, Figures 1A, 1B, and 2 depict device 100 that includes numerous additional features that may not be included in other embodiments or may be understood differently. For example, while device 100 can be seen in Figures 1A and 1B to have an essentially elongated shape, other devices 100 according to the present invention may not have an essentially elongated shape. In both figures, device 100 can be seen to include a particular torsional ultrasound transducer 10 having a particular distal end shape. However, in other embodiments, device 100 may include any other type of torsional ultrasound transducer 10.

[0073] Furthermore, in Figure 2, it can be seen that the device (100) comprises a particular shape, however, other devices (100) according to the present invention may comprise other shapes. It can also be seen that the device (100) of Figure 2 comprises a feedback means (40), a handle (50), and a power input (60). However, in other embodiments, according to the first aspect of the present invention, the device (100) may not comprise any of these.

[0074] It can also be seen that distal portion 180 is thinner than proximal portion 120, and that proximal portion 120 contains substantially all of the electronics of device 100. However, in other embodiments, the device may have other shapes, and proximal portion 110 and distal portion 190 may have similar, identical, or different shapes depending on the intended use of device 100. In this sense, the present invention is not limited to any particular form of device 100.

[0075] It should also be noted that the device 100 may comprise multiple electronic means to enable the processor 30 to perform all of its functions according to one or more embodiments of the present invention, an energy source such as an input power cable or a battery unit configured to power the electronics, and a data transfer unit, either physical or wireless, such as Bluetooth or Wi-Fi.

[0076] According to a preferred embodiment of any of the embodiments of the first aspect of the present invention, the device 100 is a medical device 100. Although reference will be made below to a medical device 100, none of the embodiments of the first aspect of the present invention are limited to a medical device 100.

[0077] According to a particularly preferred embodiment, the device (100) is a medical device, the sample (200) is a uterine cervix, and the torsional ultrasound transducer (10) has a torsional load of 0-200 g / cm 2 The probe is configured to contact the cervix (200) in the range of .about..times ...

[0078] According to a preferred embodiment, the torsional ultrasonic transducer (10) has a resistance of 50 to 200 g / cm 2 , more preferably 100 to 150 g / cm 2 range, or about 100 g / cm 2 The device is configured to contact the cervix (200) with the

[0079] In certain embodiments of the first aspect of the present invention, as shown in Figures 6A to 6D, the medical device (100) further comprises a feedback means (40), which is configured to provide feedback to a user of the medical device (100) regarding the force of contact of the device with the sample (200).

[0080] It should be noted that the feedback means (40) may include a variety of devices designed to convey force-related information to the user, such as visual means (e.g., a screen, LED, light indicator, etc.), tactile means, or auditory means, among others.

[0081] It should be noted that feedback means can be used to provide the user with a variety of ways to indicate the force of contact of the medical device 100 with the sample 200. For example, visual means can be used to indicate the applied force as a light, light pattern, or visual representation in a number of different ways that would be apparent to one skilled in the art. For example, a specific light indicator can be used to indicate that the applied force is within a specific range. Force can also be represented as a bar, circle, or any other graphical representation of force that provides an easy readout of the applied force. For example, a bar can fill up as the force increases. Tactile means can provide a slight vibration in response to the applied force, and different frequencies or intensities can be used to indicate the amount of force applied. Audible means can be used to employ a similar approach using different sounds to indicate the force applied by the device 100 to the sample 200.

[0082] Advantageously, the feedback means 40 allows the user to easily determine whether the pressure applied to the sample is appropriate. The purpose of the feedback means 40 is to provide the user with real-time, preferably continuous, information on the applied pressure so as to position the pressure in the optimum zone and maintain the force. In this context, any system that allows for providing information to the user may be useful.

[0083] 6A-6D, it can be seen that the feedback element 40 presents the applied force in the form of a bar or gauge to inform the user of the medical device 100 about the force of contact of the device with the specimen 200. In some embodiments, the feedback element 40 can further provide a force value and units, or an arbitrary force value, to aid the user in understanding the applied force.

[0084] In a preferred embodiment of the first aspect of the present invention, the feedback means (40) is further configured to provide feedback to the user of the medical device (100) regarding whether the force is within the predetermined range of forces. To do so, the feedback element may include a specific manner in which the feedback means indicates the relative force applied with respect to the predetermined range of forces. For example, visual feedback means (40) may be used, such as a gauge showing the minimum and maximum values ​​of the predetermined range of forces and representing the applied force as a bar, to allow the user to determine whether to apply more or less force. Alternatively or additionally, a color scheme may be used, such as blue indicating insufficient force, green indicating optimal force, and red indicating high force. Tactile feedback means may be used to generate vibrations such that the vibrations stop when a force within the predetermined range of forces is applied and begin when the force is outside the range, informing the user that a change in force should be applied.

[0085] Advantageously, this also allows the user to easily determine whether the pressure applied to the sample is appropriate and how to modify the applied pressure to be appropriate for a given range of forces.

[0086] 6A-6D, it can be seen that the feedback element (40) provides feedback on whether the pressure applied to the sample is appropriate and how to modify the applied pressure to be appropriate for a predetermined range of forces, with the minimum and maximum values ​​of the range shown as two lines across the bar. If the force is between the two lines, the force is within the predetermined range of forces.

[0087] As can be seen, Figures 6A, 6B, 6C, and 6D show the visual feedback device interface (40) before use (A), during use but before generating torsion waves in the sample (B), during use and generating torsion waves in the sample (C), and after generating torsion waves in the sample (D). They include numerous other additional features that may not be included or may be understood differently in other embodiments. For example, they all further include a message to the user, whereas with other feedback means (40), a message may not be present or it may not be possible to provide a message, such as a tactile feedback means. Also, while Figures 6B and 6C show images during use, this may not be the case in some other embodiments.

[0088] In another preferred embodiment of the first aspect of the present invention, as shown in Figure 5, the feedback means (40) is located at the proximal end (110) of the medical device (100). The proximal end (110) is the portion of the medical device (100) closest to the user. This makes it very easy for the user to determine whether the pressure being applied to the sample during use of the medical device is appropriate, so that the user can remain focused on the medical device (100) and the sample (200).

[0089] In another particular embodiment of the first aspect of the present invention, the visual feedback element (41) is configured to provide a measurement result after the medical device (100) contacts the sample (200) and the torsional ultrasound transducer (10) has finished inducing torsional waves through the sample (200).

[0090] As can be seen, Figure 5 illustrates the proximal end of a medical device according to one or more embodiments of the present invention. It includes numerous other additional features that may not be included in other embodiments or may be understood differently. For example, while the medical device (100) of Figure 5 includes a handle (50), in other embodiments, the proximal end (110) may not include a handle (50) or may include a shaped handle (50). The proximal end (110) further includes a set of control buttons (112), but in other embodiments, the proximal end (110) may include fewer, more, or no control buttons (112). Furthermore, the control buttons (112) may be of different shapes, sizes, and locations.

[0091] In another preferred embodiment of the first aspect of the present invention, as shown in Figures 4, 5 and 6, the medical device further comprises an imaging means (41), and the feedback means (40) comprises a visual feedback device configured to display an image captured by the imaging means (41).

[0092] The imaging means 41 may be any type of means configured to capture images of the medical device 100 as it contacts the specimen 200. The imaging means 41 may be, for example, a camera or an ultrasound system such as an echographer. However, those skilled in the art can envision other imaging means 41, such as a lidar, that may also be used to observe how the medical device 100 looks when it contacts the specimen 200. The visual feedback device may be configured to display the images captured by the imaging means 41 continuously or ad hoc as needed.

[0093] 4 shows a close-up view of the distal end (110) of a medical device (100) according to one or more embodiments of the present invention. It can be noted how the distal end (110) includes an imaging means (41) within the same region that includes the torsional ultrasound transducer (10), indicated by the ring of receivers (14) around the contact element (11), as described further below in more specific embodiments. Nevertheless, for other torsional ultrasound transducers (10), the imaging means (41) may be positioned differently to allow for a user-defined manner of contact with the sample (200).

[0094] It should be noted that the medical device (100) may further comprise illumination means associated with the imaging means (41) to facilitate or improve the capture of images from the sample.

[0095] In an alternative embodiment, the imaging means is external to the medical device (100), such as an external echographer. Having a visual feedback device as the feedback means (40) allows for the display of images captured by the imaging means (41), as seen in Figures 6B and 6C. This allows the user to observe how the medical device (100) is contacting the specimen (200). In many applications, such as cervical applications, the user does not have a direct view of the cervix (200), and therefore it is desirable to know how the torsional ultrasound transducer (10) located at the distal end (190) of the medical device (100) is contacting the cervix (200).

[0096] In a further preferred embodiment of the first aspect of the present invention, as shown in Figures 3 and 4, the imaging means (41) is disposed at the distal end (190) of the medical device (100), and the imaging means (41) and the visual feedback device (40) are disposed coaxially within the medical device (100), thereby enabling the visual feedback device (40) to display images captured by the imaging means (41) such that movement of the imaging means (41) in a particular direction is also reflected as movement of the visual feedback device (40) in the same direction.

[0097] Advantageously, this allows intuitive control of the medical device (100) by the user, such that movements applied to the medical device (100) are directly translated into precise movements observed via the visual feedback device (40).

[0098] In a further preferred embodiment of the first aspect of the present invention, as shown in FIG. 3, the imaging means (41) and the visual feedback device (40) are coaxially arranged within the medical device (100) along an axis (130) formed by the distal end (190) and the proximal end (110).

[0099] Advantageously, this further allows intuitive control of the medical device (100) by the user, such that movements applied to the medical device (100) are directly translated into precise movements observed via the visual feedback device (40). For example, if the specimen is a cervix (200), the user of the medical device will not be able to observe how the distal end (190) of the medical device (100) contacts the cervix (200), and therefore it is highly desirable that the imaging means (41) and visual feedback device be coaxially positioned within the medical device (100) along an axis (130) formed by the distal end (190) and the proximal end (110), with the imaging means (41) at the distal end and the user viewing the visual feedback device (40) at the proximal end (110).

[0100] As can be seen, Figure 3 illustrates the proximal end of a medical device according to one or more embodiments of the present invention. It includes numerous other additional features that may not be included in other embodiments or may be understood differently. For example, while medical device (100) in Figure 3 includes a handle (50), in other embodiments, proximal end (110) may not include a handle (50) or may include a shaped handle (50). Also, note that while axis (130) is disposed at a particular angle (α) relative to handle (50), in other embodiments, this angle (α) may be different.

[0101] In another particular embodiment of the first aspect of the present invention, as shown in FIG. 1B, the force sensor (20) is included within the distal portion (180) of the medical device (100).

[0102] Advantageously, this further reduces noise introduced into the force sensor 20, thus providing a more accurate reading of the force of contact of the device with the sample 200. Because the force sensor reads the force applied to it, it is highly desirable to reduce the noise recorded by the force sensor as much as possible. By locating the force sensor at the distal portion 180 of the medical device 100, the signal-to-noise ratio (SNR) of the force sensor 20 is improved because the force applied to the force sensor is not attenuated by intermediate elements between it and the distal end 190 where the sample 200 contacts it.

[0103] In another particular embodiment of the first aspect of the present invention, as shown in FIG. 1B, the force sensor (20) is positioned perpendicular to a surface of the medical device (100) configured to contact the sample (200).

[0104] Advantageously, this further ensures that the force sensor (20) only reads the axial force applied to the sample, which further reduces noise introduced into the force sensor (20), such as lateral forces, and therefore provides a more accurate reading of the force of contact of the device with the sample (200).

[0105] It is important to note that the given force range of a torsional ultrasonic transducer is defined by considering only the pressure of the emitter-receiver assembly against the sample. In this case, lateral forces are not counted, only forces perpendicular to the sample exerted by the axis of the tip of the device to which the force emitter-receiver system is aligned.

[0106] In another particular embodiment of the first aspect of the present invention, as shown in Figure 7, force sensor (20) is included between proximal portion (120) of medical device (100) and distal portion (180) of medical device (100). Advantageously, this means that when a sample contacts distal portion (180) and a user applies force via proximal portion (120), force sensor (20) is positioned between the two and is therefore able to measure the force transmitted.

[0107] In an even more preferred embodiment, the force sensor 20 determines the force of contact of the device 100 with the sample based on the relative position of the distal portion 180 with respect to the proximal portion 120. Conveniently, this allows the sensor to be positioned between the proximal portion 120 and the distal portion 180, allowing the force sensor 20 to measure the relative position between the two portions resulting from the force applied to the sample. For example, the sensor can have an elastic element that deforms when pressure is applied, and that deformation exerts a force on the force sensor 20. Alternatively, the sensor can simply be positioned between the two portions and measure the force applied between them. Those skilled in the art can envision several other alternatives by which the relative position between the proximal portion 120 and the distal portion 180 can be measured by the force sensor 20. According to this even more preferred embodiment, the force sensor (20) is capable of measuring changes in relative position between the proximal portion (120) and the distal portion (180) in various directions, including both lateral and longitudinal relative positions.

[0108] In an even more preferred embodiment of the preceding embodiment shown in Figure 7, the force sensor (20) determines the force of contact of the device (100) with the sample as the distal portion (180) moves longitudinally relative to the proximal portion (120). Figure 7 shows a diagram of the force sensor mechanism (20) of the device (100) in accordance with one or more embodiments of the present invention. Advantageously, this embodiment allows a force exerted by a user of the device (100) that is transmitted longitudinally along the device (100) to be directly measured by the force sensor (20), preferably through the longitudinal displacement of the proximal portion (120) relative to the distal portion (180) as the proximal and distal portions (120) approach each other.

[0109] As shown in FIG. 7 , the distal portion (180) can move longitudinally relative to the proximal portion (120) when a force (F) is applied to the sample through the distal portion (180). As the distal portion (180) moves, a force sensor (20) located between the proximal portion (120) and the distal portion (180) can determine the force of contact of the device (100) with the sample. For example, the force sensor (20) can function by detecting the force applied to the force sensor (20) as the two portions approach each other longitudinally, or by detecting the release of the force when the force sensor (20) passively experiences a given force and a portion of that passively applied force is released by the longitudinal displacement of the two portions as they approach each other. Those skilled in the art will recognize several ways in which the force sensor (20) can determine the force of contact of the device (100) with the sample as the distal portion (180) moves longitudinally relative to the proximal portion (120).

[0110] Figure 7 shows a schematic diagram of the operation of the force sensor mechanism 20 of the device 100 according to this embodiment, however the diagram includes numerous other additional features that may not be included or may be understood differently in other embodiments.

[0111] For example, it can be seen that the distal portion (180) and the proximal portion (120) have a particular general shape that allows longitudinal displacement between them. Accordingly, the distal portion travels through a bearing (21) that allows longitudinal sliding between the two portions and minimizes friction and wear while guiding the displacement. However, in other embodiments, the distal portion (180) can use a different solution for guiding longitudinal displacement, or it can have no elements that guide longitudinal displacement. It can also be seen that the force sensor (20) in FIG. 7 measures the passive force release due to longitudinal displacement of the distal portion (180) relative to the proximal portion (120) to determine the force of contact of the device (100) with the sample. To this end, it includes several optional additional elements, which are described below with respect to preferred embodiments.

[0112] In an even more preferred embodiment, as illustrated in the diagram of Figure 7, the force sensor (20) is preloaded and the force sensor (20) determines the force of contact of the device (100) with the sample according to the release of pressure on the sample as the distal portion (180) is longitudinally displaced relative to the proximal portion (120). Advantageously, this allows for greater sensitivity in the force sensor (20) by defining a default no-load reference force.

[0113] Force sensor 20 is preloaded so that it is subjected to a constant force from another element 23 when device 100 is not in use. Preferably, this force is provided by a resilient element 23, such as a spring, that applies a force directly to force sensor 20 itself or to another element that transmits the force to force sensor 20. Thus, in FIG. 7, device 100 can be seen to include a resilient element 23 in the form of a spring that exerts a force such that both distal portion 190 and proximal portion 110 are passively pulled apart. Additionally, distal portion 180 can be seen to have a proximal region that is itself a clamp-like portion that surrounds force sensor 20, and the proximal portion has a support that contacts force sensor 20 such that the preload generated by resilient element 23 creates a passive pressure on force sensor 20. This occurs when the distal portion (180) is pulled away from the proximal portion (120) and the support of the proximal portion (120) is in the path of the distal portion (180) with the force sensor (20) between them, resulting in the action of a passive compressive force.

[0114] When the device (100) comes into contact with a sample and a force is applied, the passive force provided by the spring (23) is overcome and the passive force applied to the force sensor (20) is released, which the force sensor (20) interprets as an externally applied force.

[0115] In another specific embodiment of the first aspect of the present invention, as shown in FIG. 1B, the force sensor (20) further comprises a protection system configured to prevent damage to the force sensor (20) when a force beyond its operating range is applied to the distal end (190) of the medical device (100).

[0116] Because the force sensor (20) is highly sensitive in order to provide accurate measurements of the contact force of the device (100) against the sample (200), it may be damaged if a large force is accidentally applied to the distal end (180) of the device, for example, by placing the device (100) on its distal end (190) or if the device is dropped.

[0117] Advantageously, this ensures that the force sensor (20) will not be damaged if the medical device is dropped or if excessive force is applied to the distal end (190) of the medical device (100).

[0118] To do so, the protection system may, for example, allow longitudinal displacement of the force sensor so that the applied forces are not absorbed solely by the force sensor, thus preventing damage to the force sensor.

[0119] In a more preferred embodiment, as seen in Figure 1B, the protection system comprises a spring (21), which can be adjusted with an appropriate spring constant to deform when a specific force is applied.

[0120] In another particular embodiment of the first aspect of the present invention, as shown in Figures 2 and 3, the medical device (100) comprises:

[0121] At its proximal end (110), it further comprises a handle (50) configured to be held by hand and having an angle (α) comprised between 85° and 120° relative to the axis (130) formed by the distal end (190) and the proximal end (110). In a preferred embodiment, the handle is configured at an angle between 85° and 115°, more preferably between 90° and 110°, relative to the axis (130) formed by the distal end (190) and the proximal end (110).

[0122] Advantageously, an angle (α) between 80° and 150°, preferably between 85° and 120°, relative to the axis (130) formed by the distal end (190) and the proximal end (110) has been shown to allow for significant improvements in dexterity and manipulation of the medical device, as well as better control of the force exerted by the distal end (190) of the medical device (100) on the specimen (200). This is because this range of angles has been shown to allow for alignment of the natural movement of the arm and wrist with the movement of the medical device (100) towards the specimen (200). This therefore allows for a simpler method of ensuring that the device contacts the specimen (200) within a predetermined range of forces.

[0123] In another particular embodiment of the first aspect of the present invention, the handle (50) has a diameter in any direction transverse to its major axis of between 30 mm and 150 mm.

[0124] In another particular embodiment of the first aspect of the present invention, the handle (50) comprises a surface having a textured material configured to enhance grip.

[0125] In another particular embodiment of the first aspect of the present invention, the handle (50) comprises indentations configured to fit over the fingers of a user.

[0126] In another particular embodiment of the first aspect of the present invention, the processing unit (30) is configured to discard the readings of the torsional ultrasonic transducer (10) if the applied force is not within a predetermined range of forces.

[0127] Advantageously, this allows the medical device 100 to ensure that only readings within a predetermined range of forces are used, thereby greatly increasing the reliability of the measurements provided to the user. For example, a torsional ultrasound transducer 10 may take 10 readings each time a user requires a reading, but only a portion of them are used to determine the value of the shear waves passing through the sample 200, as some will be discarded because the force applied to the sample 200 was too strong or too weak.

[0128] In another particular embodiment of the first aspect of the present invention, the processing unit (30) is configured to prevent the torsional ultrasonic transducer (10) from inducing torsional waves when the applied force is not within a predetermined range of forces.

[0129] Advantageously, this allows the medical device (100) to ensure that it does not begin to induce shear waves through the sample (200) unless the applied force is within a predetermined range of forces, thereby greatly improving the reliability of the measurements provided to the user.

[0130] For example, the processing unit (30) is configured to prevent the torsional ultrasonic transducer (10) from inducing torsional waves, as shown in Figures 6A and 6B, which show that the applied force is below a minimum value within the desired range.

[0131] Even if the user indicates that they wish to induce shear waves through the sample (200), the processing unit can prevent this from happening unless the applied force is within a predetermined range of forces of the torsional ultrasonic transducer (10) for the intended application.

[0132] In another specific embodiment of the first aspect of the present invention, the medical device (100) includes a dummy section between the distal portion (180) and the proximal portion (120) configured to increase the distance between the distal end (190) and the handle (50). Advantageously, this prevents a user from contacting the sample (200) or any other delicate element when using the medical device (100). For example, if the medical device is a probe (100) configured to contact the cervix (200), having the probe (100) with a dummy section that increases the distance between the distal end (190) and the handle (50) prevents the clinician from being obstructed by the patient's body or the speculum, making use of the probe (100) easier and more user-friendly for both the clinician and the patient.

[0133] In another preferred embodiment of the present invention, as shown with reference to FIG. 8, a torsional ultrasonic transducer (10) comprises an emitter device for emitting torsional ultrasonic waves, the emitter device comprising an electric signal generator (13) connected to an electromechanical actuator (12), the electromechanical actuator (12) being attached to a contact element (11) that contacts the sample (200), the actuator, upon receiving an electric signal, causing a rotational movement of the contact element (11), which, when in contact with the sample (200), generates a torsional wave that passes through the sample (200), and the torsional ultrasonic transducer (10) further comprises means for receiving the distorted signal after passing through the sample (200).

[0134] Due to this configuration, the waves transmitted by the transducer of the present invention are torsional waves rather than longitudinal waves, which improves the quality of the received signal. Unlike other known transducers which have a flat wavefront that travels in depth, the wavefront achieved by the emitter of the present invention is a radially propagating and penetrating wavefront (toroidal surface).

[0135] Another aspect of the present invention relates to a method for emitting shear waves using the emitter of the present invention.

[0136] In certain embodiments, the electrical signal used to stimulate the actuator in this manner is an oscillatory signal, more preferably a sinusoidal signal, and even more preferably a sinusoidal signal.

[0137] In this case, the change in voltage over time corresponds to the following function:

number

[0138] In another particular embodiment, the contact element has a substantially frusto-conical shape (FIG. 9), the smaller base (b) of which is attached to the electromechanical actuator and the larger base (B) of which is positioned at the distal end of the transducer of the present invention to contact the sample and transmit shear waves.

[0139] In a preferred embodiment, the contact elements are made from a biocompatible material.

[0140] In another particular embodiment, the electromechanical actuator is covered by a Faraday cage that filters out electronic noise. Specifically, the electromechanical actuator is encased in a conductive cover that acts as a Faraday cage.

[0141] In another preferred embodiment of the present invention, a transducer is capable of generating a torsional ultrasonic pulse that propagates through a sample and capturing the distorted pulse after passing through the sample, said transducer ("transducer of the present invention") comprising an emitter of the present invention and means for receiving the distorted signal after passing through the sample, hereinafter referred to as "receiver".

[0142] In a particular embodiment (FIG. 10), the receiver of the transducer of the invention comprises two or more piezoelectric elements (15) equidistant from each other and located between two rings (121A and 121B), preferably made of a non-conductive material, more preferably a biocompatible material, each piezoelectric element being in contact with two electrodes of different charge arranged perpendicular to the polarization of the piezoelectric elements.

[0143] In their preferred arrangement (FIG. 11), the axis of rotation (e') of the receiver ring (14) and the axis (e) of the contact element (11) must coincide with each other, and the emitter is placed inside the ring.

[0144] Similarly (Figure 12), in order for both the emitter and receiver to contact the sample (S), the outer surface of one ring, called the front ring (121A), and the flat surface of the contact element (11) must lie in the same plane (P) (contact plane).

[0145] In another specific embodiment, the surfaces of the rings that contact the piezoelectric element (inner surfaces) are connected to respective positive and negative poles such that each ring acts independently as an anode and a cathode.

[0146] The polarization of the piezoelectric element, understood to be the direction between the positive and negative charges of the electrodes, can be carried out in two different ways: in a preferred embodiment, the polarization is parallel to the axis and the electrodes are placed on the sides of the piezoelectric element, and in a more preferred embodiment, the polarization (P) is perpendicular to the axis in the radial direction and the electrodes are placed at the attachment between the piezoelectric element and the ring (Figure 13).

[0147] In a preferred embodiment, the piezoelectric element (15) is made from piezoelectric ceramic PZT-4 or PZT-5.

[0148] The transmitting and receiving elements of the transducer are placed inside a casing (7, Figure 14) which, in addition to protecting the transducer from physical shocks (such as drops or scratches), also ensures the functionality of the device since each element is fixed in its correct position.

[0149] In the particular case where the receiver of the transducer of the invention is formed by concentric rings, the casing must enable the emitter to remain located inside said rings so that their axes of rotation coincide.

[0150] In a preferred embodiment, the casing is made from polylactic acid (PLA).

[0151] Optionally, in another specific embodiment, the transducer of the present invention further comprises a damping element (18), preferably made of a damping material with a Shore A hardness of less than 80, fixed to the outer surface of the ring furthest from the contact area with the sample, to prevent the propagation of shear waves in the direction opposite to the direction of the sample, and therefore energy loss. This ensures that effective emission of shear waves occurs only on one face of the transducer, i.e., the face in contact with the sample, while vibrations on the rear face are canceled by the damping element. Furthermore, cancellation of the emitted waves in the direction opposite to the direction of the sample means that simpler processing of the emitted waves is required, as a cleaner signal is achieved.

[0152] In an even more specific embodiment, a transducer of the present invention capable of emitting and receiving shear waves comprises the following elements: an emitter, an electrical signal generator; an electromechanical actuator connected to an electrical signal generator and covered by a Faraday cage; an emitter comprising a contact element attached to an electromechanical actuator, wherein a rotational movement of the contact element is induced when the actuator receives an electrical signal; and A receiver, two rings, preferably made of a non-conductive material; two or more piezoelectric elements spaced equidistantly apart and positioned between said rings. A casing that allows the emitter to remain located inside the receiver such that the axes of the contact element and the rings coincide with each other and the outer portion of said contact element and the outer surface of one of the rings remain in the same plane so that they can contact the sample.

[0153] Furthermore, in another more preferred embodiment, the transducer is completed with a latex membrane adapted to the shape of the device, ensuring dissipation of the waves traveling therethrough by adapted involution between the emitter and receiver.

[0154] Second Aspect of the Invention

[0155] The second aspect of the present invention, shown in Figures 15 and 16, relates to a medical device (100). It should be noted that the medical device (100) of the second aspect of the present invention may be the same medical device of the first aspect of the present invention or a different medical device. It is therefore understood that any of the embodiments of the first aspect of the present invention may include features according to any of the second aspect of the present invention in any possible combination, and vice versa.

[0156] The medical device (100) comprises a proximal portion (120) and a distal portion (180) and is configured to contact a sample. Figures 15 and 16 show perspective views of the medical device (100) in accordance with one or more embodiments of the present invention, and Figure 16 shows the distal portion (190) and the proximal portion (110) in an exploded view in accordance with one or more embodiments of the present invention. For economy of language, the term "device" will be used hereafter in reference to the medical device.

[0157] It should be noted that the proximal portion (120) and distal portion (180) of the device (100) refer to distinct portions of the device (100) that may or may not be defined by the same length. For example, in some embodiments, the proximal portion (120) may comprise the majority of the length of the device (100), while the distal portion (180) comprises the remaining smaller portion of the device (100), or vice versa. Furthermore, as shown in FIG. 16 , the proximal portion (120) and distal portion (180) may be physically separated into two distinct portions, while in other embodiments, the proximal portion (110) and distal portion (190) may not be physically separated and may belong to the same piece of device but be confined to different portions of the device (100). Thus, in some embodiments, the proximal portion (110) and distal portion (190) may simply be spatial concepts defined on the same solid body. Additionally, while Figure 16 illustrates the proximal and distal portions (110, 190) being mechanically joined by, for example, a screw mechanism, those skilled in the art will appreciate that several viable alternatives exist for joining the two pieces. For example, a clip mechanism, a threaded closure that passes through both pieces, or a magnetic system could be used. These and other alternatives apparent to those skilled in the art are also part of the present invention. Additionally, while device (100) can be seen to have an essentially elongated shape, other, non-elongated shapes are possible in other embodiments.

[0158] According to a second aspect of the invention, the device (100) features a conduit (62), a sealing element (64), and a vacuum pump (65).

[0159] The conduit (62) is configured to connect the outside to the interior space (12) of the device (100), and the conduit (62) is connected to the outside through an opening (63). The conduit (62) may be a tube configured to form a connection between the interior space (12) and the outside in such a manner that it terminates at the opening (63), or it may be a cavity of the device (100) in such a manner that a connection between the outside and the interior space (12) of the device (100) is created through such opening (63). Thus, it can be observed that the conduit (62), when a tube, can have a variety of shapes, be more or less regular, and can take on various shapes and widths along its length. It can also have a variety of lengths, such that the conduit (62) may be almost symbolic when the interior space (12) of the device (100) is accessed through the opening (63). In Figures 15 and 16, the conduit (62) connects the outside to the interior space (12) of the device (100) through the opening (63). It can be seen that the interior space (12) is in this case defined as the space of the device (100) that is not in direct communication with the outside through this opening (63), and preferably comprises a vacuum pump (65). In the case of Figures 15 and 16, it includes the entire proximal portion (120) and part of the distal portion (180), since both portions, although detachably connected, define a single watertight space that, in use, contains all the electronics for the operation of the medical device (100).

[0160] It is further observed that the openings (63) can take a variety of forms. For example, in some embodiments according to the present invention, the openings (63) can be circular holes defined in the surface of the device (100), while in other embodiments, the openings (63) can be longitudinal holes defined along a larger surface. It is further noted that in some embodiments, the device (100) can include two or more openings (63) defined in the surface of the device (100). Furthermore, when the device (100) includes two or more openings (63), the openings (63) can be identical to one another or can have different shapes and sizes. It is also possible for the openings to be located at different locations on the surface of the device (100).

[0161] The sealing element 64 is positioned at the end of the conduit 62 opposite the opening 63. In this manner, the sealing element 64 is configured to control the passage of air between the interior space 12 of the device 100 and the conduit 62, so that all fluid communication occurs through the sealing element 64. Therefore, the sealing element 64 must cover the entire body of the device between the conduit 62 and the interior space 12 of the device 100 and effectively conform to its internal shape. The sealing element 64 may consist of one or more sealing elements positioned between the two spaces, such as a single piece of rubber, or it may be a plastic part forming part of the same device 100. In FIG. 15, it is shown as a cylindrical piece that covers the entire width of the device body 100 between the conduit 62 and the interior space 12 of the device 100.

[0162] The vacuum pump (65), shown schematically in FIGS. 15 and 16 , is connected to the sealing element (64) in such a manner that it is configured to extract air from the opening (63) via the conduit (62). Thus, the sealing element (64) not only controls the passage of air between the interior space (12) and the conduit (62), but also ensures that this passage of air is controlled by the vacuum pump (65) connected to the sealing element (64). For such connection, the vacuum pump (65) may be integrated into the sealing element (64) or may be connected via a series of fluid connections, such as tubes (54), as described below with reference to FIG. 17A. The vacuum pump (65) may be of various types, such as a rotary vane, diaphragm, or diaphragm or side channel, among others. Therefore, the vacuum pump (65) of the present invention is not limited to any particular type of vacuum pump (65).

[0163] The device (100) is configured to receive a membrane (70) on its exterior, which covers the opening (63). The device (100) can be configured to receive the membrane (70) in a variety of ways. For example, it can have a series of fasteners for the membrane (70) that allow it to be secured to the device (100). For example, the fasteners can be in the form of hooks or recesses that can secure the membrane (70). Alternatively, the device (100) can have a characteristic shape that allows it to be fitted over a membrane (70) with a specific, complementary shape.

[0164] Since the device is configured to receive a membrane (70) covering the opening (63) on the outside, this means that the vacuum pump (65) is configured to extract air between the sealing element (64) and the membrane (70). This is because the sealing element (64) controls the air passage between the interior space (12) and the conduit (62) governed by the vacuum pump (65), and since the conduit (62) communicates with the outside through the opening (63) and is covered at the opening (63) by the membrane (70), as shown in Figure 17A, the vacuum pump (65) is configured to extract air between the sealing element (64) and the membrane (70).

[0165] 17A shows a sample longitudinal section of a device (100) according to one or more embodiments of the present invention. As can be seen, the device (100) is covered by a membrane (70) covering the opening (63). Furthermore, as indicated by the directional arrow, air between the sealing element (64) and the membrane (70) is extracted by a vacuum generated by a vacuum pump (65) at the level of the sealing element (64), allowing for precise adjustment of the membrane (70) on the device (100).

[0166] Additionally, as mentioned above, in some projects, a vacuum pump (65) may be connected to the sealing element (64) via a series of fluid connections (54), such as vacuum tubing, which may also extend through the sealing element (64) itself to the conduit (62).

[0167] Advantageously, the device (100) of the present invention allows the membrane (70) placed thereon to be quickly and efficiently adjusted to the surface of the device (100) in a manner that ensures correct placement in a manner that does not alter the function of the medical device (100).

[0168] As shown in FIG. 15 , in some embodiments, the vacuum pump (65) can be controlled by a user of the medical device (100) through a series of interfaces (652) on the device (100), such as buttons or external controls. In this manner, the user can control whether the vacuum pump (65) is turned on or off and / or the level of negative pressure exerted. Those skilled in the art will recognize other controls that should be included, such as selecting from a series of pre-set programs or functioning as a safety system, such that the pump only activates when a combination of interfaces (652) are pressed simultaneously. In other embodiments, the vacuum pump (65) can be configured to continuously generate vacuum without requiring interaction from the user of the device (100), and thus the interface (652) would not be present. In other embodiments, the device (100) can include a sensor that indicates when the membrane (70) is placed on the device (100) and activates the vacuum pump (65) only when the membrane (70) is placed on the device (100). In other versions, the vacuum pump (65) can be remotely controlled by a separate controller. To this end, interface (652) is optional.

[0169] To control the vacuum pump 65, the apparatus 100 may optionally include a processor configured to control the operation of the vacuum pump 65 and / or a memory unit configured to store instructions executed by the processor. It is emphasized that the processor may comprise one or more processing units, such as a microprocessor, a GPU, a CPU, a multi-core processor, etc. Similarly, the memory may include one or more volatile or non-volatile memory devices, such as DRAM, SRAM, flash memory, read-only memory, ferroelectric RAM, a hard disk drive, a floppy disk, a magnetic tape, an optical disk, etc. The driver may be implemented in software (a computer program), hardware (a physical device), or any combination, to perform the sequence of operations disclosed herein.

[0170] It can be seen that the vacuum pump (65) may be externally powered by a series of power cables (656) as shown in Figures 15 and 16, although in other embodiments the vacuum pump (65) may be powered by an internal battery or internal power source.

[0171] As can be seen, Figures 15, 16, and 17A show a medical device (100) that includes numerous other additional features that may not be included in other embodiments or may be understood differently.

[0172] For example, in Figures 15 and 16, it can be seen that device 100 has an essentially elongated shape, while other devices 100 according to the present invention may not have an essentially elongated shape. It can also be seen that distal portion 180 is thinner than proximal portion 120, which contains substantially all of the device's electronics. However, in other embodiments, the device may have other shapes, and proximal portion 110 and distal portion 190 may have similar, identical, or different shapes depending on the intended use of the device 100 itself. In this sense, the present invention is not limited to any particular form of device 100. In both figures, it can be seen that device 100 includes power cable 56, but in other embodiments, the cable may be absent, the device may operate from an internal power source, such as a battery, or may include two or more cables 656 as information cables enabling electronic connection to another device. In Figure 15, it can be seen that device 100 includes three interfaces 652 configured to control device 100. However, in other embodiments, device 100 may include more, fewer, or no interfaces 652 as described above. In Figure 16, opening 63 can be seen to be located at the distal end of distal portion 180 of device 100 and to have a circular shape, although in other embodiments opening 63 may be found in other locations, may have other shapes and sizes, or may have several openings 63 as described above.

[0173] With respect to Figure 17A, it can be seen that the vacuum pump (65) is located in the proximal portion (120) and connected to the sealing element (64) via the tube (54), as described above; however, in other embodiments, the vacuum pump (65) may be located adjacent to the sealing element (64) or may be included in the sealing element (64) itself. It can also be seen that the membrane (70) is arranged in a particular shape over the distal portion (180) of the device (100) having a particular distal end. However, in other embodiments, the device (100) may take other forms. Additionally, several optional additional elements are contemplated, which are described below with respect to preferred embodiments.

[0174] In a preferred embodiment, as shown in Figure 17A, the vacuum pump (65) is connected to a pressure sensor (67) configured to measure the pressure within the conduit (62). The pressure sensor (67) may be of various types, such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical, or potentiometric gauge, among others. Thus, the pressure sensor (67) of the present invention is not limited to any particular type of pressure sensor.

[0175] 17A, pressure sensor (67) is connected to vacuum pump (65) via fluid connection (57) that fluidly connects pressure sensor (67) to tube (54), which in turn is connected to vacuum pump (65) and conduit (62). However, in other versions, pressure sensor (67) may be included in vacuum pump (65) or may be connected to conduit (62), vacuum pump (65), tube (54), or sealing element (64). Those skilled in the art can envision various ways in which pressure sensor (67) may be positioned in such a manner that the pressure exerted within conduit (62) can be measured.

[0176] Furthermore, in this embodiment, the vacuum pump 65 is configured to adjust its operation in response to the pressure measured by the pressure sensor 7. The vacuum pump 65 may or may not adjust in response to the pressure sensor 7. Preferably, the vacuum pump 65 is configured to maintain a minimum pressure in the space between the membrane 70 and the sealing element 64. This can be done in various ways. For example, the vacuum pump 65 can be configured to operate to maintain a negative pressure relative to a given ambient pressure until this value is reached. When the pressure rises above this value or another value indicative of a loss of vacuum, the pump can be turned on again until the pressure is reached again. Alternatively, the pump can be operated continuously, and its vacuum power can be varied in such a way that its drain level is reduced when the minimum pressure is reached and, when the pressure rises above this value or another value indicative of a loss of vacuum, the drain pressure is increased again until the minimum reference pressure value is reached. To this end, in an apparatus equipped therewith, the memory of the apparatus (100) can store instructions corresponding to this algorithm, and the processor of the apparatus (100) can execute these instructions stored in the memory. Alternatively, the memory and / or processor can be provided externally, and control of the vacuum pump (65) can be directed externally.

[0177] Advantageously, this preferred embodiment allows the device 100 to ensure that the vacuum pump 65 maintains pressure over time so that the membrane 70 is constantly regulated. This is particularly useful when the device 100 is used with samples that may cause displacement of the membrane 70 or loss of some of the vacuum, which increases the pressure in the space between the membrane 70 and the sealing element 64.

[0178] In some embodiments in which device (100) includes one or more interfaces (52), interface (652) can set a target pressure for vacuum pump (65) in a manner that allows the minimum pressure to be maintained to be adjusted. Additionally, device (100) can include a visual interface, such as a display or a series of LED lights, that can inform user (100) of the minimum set pressure that vacuum pump (65) is configured to maintain. Advantageously, this allows a user of device (100) to adjust the minimum pressure in the space between membrane (70) and sealing element (64) while device (100) is in use, for example, as conditions change.

[0179] In another preferred embodiment, the device (100) is essentially elongated and configured to contact the sample through the distal portion (180), and the device (100) is configured such that the membrane (70) covers at least the distal portion (180). As shown in Figures 1, 2, and 20A, the device (100) is essentially elongated, particularly at its distal portion (180). Furthermore, as shown in Figure 17A, the device (100) is configured such that the membrane (70) covers at least the distal portion (180), and the device (100) is configured to contact the sample through the distal portion (180), which means that the device (100) is configured to contact the sample through the membrane (70) that is tightly positioned by the vacuum pump (65). The opening (63) can be located either in the distal portion (180) where the membrane (70) is located or in the proximal portion (120) when the device (100) is configured so that the membrane (70) covers a portion of the proximal portion (120).

[0180] In a more preferred embodiment, the opening (63) is included in the distal portion (180) of the device (100). Advantageously, this allows the membrane (70) to be positioned in the distal portion (180), and since the device (100) is essentially elongated, a vacuum is generated from the point where it is possible to uniformly adjust the placement of the membrane (70), thus avoiding seating. Most preferably, the opening (63) is located at the distal end of the distal portion (180). Advantageously, this allows for greater uniformity in the snug placement of the membrane (70). According to this preferred embodiment, in embodiments in which the device (100) comprises multiple openings (63), the device (100) comprises at least one of the openings (63) in the distal portion (180) of the device (100), preferably at the distal end of the distal portion (180).

[0181] In another preferred embodiment, as shown in Figure 17B, the device (100) includes a force sensor (20) configured to determine the force of contact of the device (100) with the sample. Figure 17B shows a schematic diagram of a longitudinal cross section of a distal portion (180) of the device (100) in accordance with one or more embodiments of the present invention.

[0182] As shown in FIG. 17B, device 100 includes a force sensor 20 that can record the force with which a user contacts device 100 with a sample. This advantageously allows device 100 to measure pressure applied to a sample in embodiments where that pressure affects measurements by device 100. Force sensor 20 can be any of a number of types of force sensors, which may or may not be similar or identical to pressure sensor 67, such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical, or potentiometric extensometers, among others. Thus, force sensor 20 of the present invention is not limited to any particular type of force sensor.

[0183] Preferably, the device includes an interface (652) that allows the user to receive information about the pressure exerted on the sample by the device (100) and adjust the pressure accordingly. The interface can include a display or a group of LED lights by defining a default code. For this purpose, in the device (100) equipped with such an interface, the memory of the device (100) can store instructions corresponding to this algorithm, and the processor of the device (100) can execute these instructions stored in the memory. Alternatively, the memory and / or processor can be provided externally, and the information displayed to the user can be processed externally.

[0184] Like Figure 17A, Figure 17B shows device 100 with numerous other additional features that may not be included in other embodiments or may be understood differently. The common features, such as the shape of device 100 and sealing element 64, can be applied in the same manner. Note also that device 100 includes force sensor 20 at the proximal end of distal portion 180 of device 100. However, in other embodiments, force sensor 20 may be included in other locations on device 100 or have a different type of mechanism of action.

[0185] In a more preferred embodiment, distal portion 180 is configured to contact the sample, and force sensor 20 is positioned between distal portion 180 and proximal portion 120. Advantageously, this means that when a sample contacts distal portion 180 and a user applies a force via proximal portion 120, force sensor 20 is positioned between the two and can measure the transmitted force.

[0186] In an even more preferred embodiment, the force sensor 20 determines the force of contact of the device 100 with the sample based on the relative position of the distal portion 180 with respect to the proximal portion 120. Conveniently, this allows the sensor to be positioned between the proximal portion 120 and the distal portion 180, allowing the force sensor 20 to measure the relative position between the two portions resulting from the force applied to the sample. For example, the sensor can have an elastic element that deforms when pressure is applied, and that deformation exerts a force on the force sensor 20. Alternatively, the sensor can simply be positioned between the two portions and measure the force applied between them. Those skilled in the art can envision several other alternatives by which the relative position between the proximal portion 120 and the distal portion 180 can be measured by the force sensor 20. According to this even more preferred embodiment, the force sensor (20) is capable of measuring changes in relative position between the proximal portion (120) and the distal portion (180) in various directions, including both lateral and longitudinal relative positions.

[0187] In an even more preferred embodiment of the preceding embodiment shown in Figure 7, the force sensor (20) determines the force of contact of the device (100) with the sample as the distal portion (180) moves longitudinally relative to the proximal portion (120). Figure 7 shows a diagram of the force sensor mechanism (20) of the device (100) in accordance with one or more embodiments of the present invention. Advantageously, this embodiment allows a force exerted by a user of the device (100) that is transmitted longitudinally along the device (100) to be directly measured by the force sensor (20), preferably through the longitudinal displacement of the proximal portion (120) relative to the distal portion (180) as the proximal and distal portions (120) approach each other.

[0188] As shown in FIG. 7 , the distal portion (180) can move longitudinally relative to the proximal portion (120) when a force (F) is applied to the sample through the distal portion (180). As the distal portion (180) moves, a force sensor (20) located between the proximal portion (120) and the distal portion (180) can determine the force of contact of the device (100) with the sample. For example, the force sensor (20) can function by detecting the force applied to the force sensor (20) as the two portions approach each other longitudinally, or by detecting the release of the force when the force sensor (20) passively experiences a given force and a portion of that passively applied force is released by the longitudinal displacement of the two portions as they approach each other. Those skilled in the art will recognize several ways in which the force sensor (20) can determine the force of contact of the device (100) with the sample as the distal portion (180) moves longitudinally relative to the proximal portion (120).

[0189] Figure 7 shows a schematic diagram of the operation of the force sensor mechanism 20 of the device 100 according to this embodiment, however the diagram includes numerous other additional features that may not be included or may be understood differently in other embodiments.

[0190] For example, it can be seen that the distal portion (180) and the proximal portion (120) have a particular general shape that allows longitudinal displacement between them. Accordingly, the distal portion travels through a bearing (21) that allows longitudinal sliding between the two portions and minimizes friction and wear while guiding the displacement. However, in other embodiments, the distal portion (180) can use a different solution for guiding longitudinal displacement, or it can have no elements that guide longitudinal displacement. It can also be seen that the force sensor (20) in FIG. 7 measures the passive force release due to longitudinal displacement of the distal portion (180) relative to the proximal portion (120) to determine the force of contact of the device (100) with the sample. To this end, it includes several optional additional elements, which are described below with respect to preferred embodiments.

[0191] In an even more preferred embodiment, as illustrated in the diagram of Figure 7, the force sensor (20) is preloaded and the force sensor (20) determines the force of contact of the device (100) with the sample according to the release of pressure on the sample as the distal portion (180) is longitudinally displaced relative to the proximal portion (120). Advantageously, this allows for greater sensitivity in the force sensor (20) by defining a default no-load reference force.

[0192] Force sensor 20 is preloaded so that it is subjected to a constant force from another element 23 when device 100 is not in use. Preferably, this force is provided by a resilient element 23, such as a spring, that applies a force directly to force sensor 20 itself or to another element that transmits the force to force sensor 20. Thus, in FIG. 7, device 100 can be seen to include a resilient element 23 in the form of a spring that exerts a force such that both distal portion 190 and proximal portion 110 are passively pulled apart. Additionally, distal portion 180 can be seen to have a proximal region that is itself a clamp-like portion that surrounds force sensor 20, and the proximal portion has a support that contacts force sensor 20 such that the preload generated by resilient element 23 creates a passive pressure on force sensor 20. This occurs when the distal portion (180) is pulled away from the proximal portion (120) and the support of the proximal portion (120) is in the path of the distal portion (180) with the force sensor (20) between them, resulting in the action of a passive compressive force.

[0193] When the device (100) comes into contact with a sample and a force is applied, the passive force provided by the spring (23) is overcome and the passive force applied to the force sensor (20) is released, which the force sensor (20) interprets as an externally applied force.

[0194] In another preferred embodiment of the present invention, as shown in Figure 17A, the membrane (70) is a prophylactic membrane. Advantageously, this allows the device (100) to be covered by a membrane (70) that is low cost and easily obtainable. Preferably, the prophylactic membrane (70) further comprises a lubricant on its outer surface to facilitate the introduction of the device (100) through a sample conduit or cavity.

[0195] In another preferred embodiment of the present invention, the device (100) comprises at least one recess (69) on its outer surface configured to receive the edge of the membrane (70).

[0196] The depression (69) can be formed in a variety of ways, as will be understood by those skilled in the art. For example, the depression (69) can be formed as a groove in the outer surface of the device (100), or by arranging one or more radial extensions of the surface in such a way that the depression is formed radially on the proximal surface of the device (100). Most preferably, the depression (69) defines a plane perpendicular to the longitudinal axis of the device (100). The depression (69) can be defined at different heights of the device (100) in both the proximal portion (120) and the distal portion (180). In a preferred embodiment, the depression (69) is defined at the proximal end of the distal portion (180).

[0197] 20A and 20B, the recess (69) is configured to receive the edge (69) of the membrane (70) covering the device (100). The membrane (70) is essentially elongated, preferably essentially cylindrical in shape, such that the edge (69) of the membrane (70) can include a portion of the membrane (70).

[0198] Advantageously, this design of the recess (69) makes it possible to configure the device (100) such that when the membrane (70) is positioned in such a way that the edge (69) of the membrane (70) is received in the recess (69), the membrane (70) is secured to the device (100).

[0199] In an even more preferred embodiment, the recess (69) is configured to sealingly receive the edge of the membrane (70). For example, the recess (69) may include a series of seals with a high coefficient of friction that creates a greater seal with the surface of the device (100), or may be optimally designed to receive the edge (69) of the membrane (70). Advantageously, when the vacuum pump (65) generates a minimum pressure, the surface of the membrane (70) is sealed in such a way that air leakage cannot enter the defined space between the sealing element (64) and the membrane (70), resulting in a more efficient vacuum system.

[0200] In another preferred embodiment, the device 100 is a probe. In this embodiment, the device 100 is essentially elongated and contacts the sample at its distal portion 180, where the membrane 70 is located. Since probes often include various solutions, such as sensors or other surgical instruments, at the distal end of the distal portion 180, the opening 63 can be easily accommodated at the distal end of the distal portion 180, and thus advantageously benefit from the solution proposed in this invention. Advantageously, this more preferred method has a mechanism for tightly positioning the membrane 70 over the probe 100 for several scans, thereby making it possible to use the same probe 100 for several scans by simply replacing the membrane 70 placed on the probe 100 for each scan performed.

[0201] In a more preferred embodiment, the device (100) is a uterine probe and the sample is a cervix. Preferably, the distal end (190) of the distal portion (180) is configured to receive the cervix from a patient's uterus using a design that includes a recess (192) that allows the probe to contact the cervix when inserted into the vagina. The probe (100) in Figures 1, 2, 20A, and 20B is merely representative; the uterine probe (100) can take on a variety of shapes to enable interaction by different means, for different uses, and / or in various orientations. Advantageously, this more preferred method allows the same uterine probe (100) to be used in different tests on the same or different patients by simply changing the membrane (70) placed on the probe (100) for each test performed.

[0202] In an even more preferred embodiment, the device (100) is a uterine shear wave probe (100) comprising a shear wave emitter and receiver at its distal end (190). Preferably, the uterine shear wave probe (100) is configured to characterize the structure of the cervix. Advantageously, this allows the same uterine shear wave probe (100) to be used in several examinations on the same or different patients by simply replacing the membrane (70) placed on the probe (100) for each examination performed. Even more preferably, the uterine shear wave probe (100) is a torsional ultrasound (100) probe.

[0203] Even more preferably, the device (100) is a uterine torsion wave probe (100) and comprises a torsion wave emitting device, the torsion wave emitting device comprising an electrical signal generator connected to an electromechanical actuator attached to the distal end of the probe, the electromechanical actuator receiving an electrical signal inducing a rotational movement of a contact element which, upon contact with the sample, induces a torsion wave that passes through the sample. Preferably, the probe (100) further comprises means for receiving the strain signal after passing through the sample. For example, the medium can comprise two or more piezoelectric elements positioned equidistant from each other and located between two rings made of a non-conductive material.

[0204] Third aspect of the present invention

[0205] A third aspect of the present invention can be seen in Figures 18A and 18B, which show perspective views of an apparatus (300) configured to place a membrane (70) on a probe (not shown) according to one or more embodiments of the present invention. It should be noted that the probe of the third aspect of the present invention may be the same medical device (100) of the first aspect of the present invention or a different medical device. It is therefore understood that any of the embodiments of the first aspect of the present invention may include features according to any of the second aspect of the present invention in any possible combination, and vice versa.

[0206] The device 300 is essentially elongated so as to be configured to longitudinally receive a probe (not shown). It should be noted that while Figures 18A and 18B illustrate the device 300 having a particular length and a particular length-to-width ratio, the device 300 of the present invention is not limited to any particular length. Similarly, while the device 300 in Figures 18A and 18B can be seen to have an irregular exterior shape, the present invention is not limited in this sense; in other embodiments, the exterior can have a variety of shapes, or can be completely smooth.

[0207] The device (300) comprises a proximal zone and a distal zone. The proximal zone comprises an opening (302) and a recess (304). The opening (302) is configured for insertion of a probe (not shown) into which the membrane (70) is disposed in a manner that allows the probe (not shown) to be inserted into the device (300). While FIG. 18A shows a circular opening, the shape of the opening (302) of the present invention is not limited. Thus, in other embodiments, the opening can have various sizes and shapes that can vary depending on the shape of the probe (not shown) and the shape of the membrane (70) that are available, as will be understood by those skilled in the art. Thus, for example, the opening can be oval, square, or any other shape.

[0208] The depression (304) is radially defined by the outer surface of the proximal region of the device (300). The depression (304) can be formed in a variety of ways, as will be understood by one skilled in the art. For example, the depression may be formed as a groove in the outer surface of the device (300), or by arranging one or more radial extensions of the surface in such a way that a radial depression is formed in the proximal surface of the device (300). Most preferably, the depression (304) defines a plane parallel to the opening (302). The depression can be defined at various distances from the opening (302). Preferably, the depression (304) is defined at the end of the proximal region adjacent the opening (302).

[0209] Furthermore, as can be seen in FIG. 18B, the recess (304) is configured to receive the edge (74) of the membrane (70) covering the opening (302). The membrane (70) is essentially elongated and preferably essentially cylindrical, such that the edge (74) of the membrane (70) includes a portion of the membrane (70). The received membrane (70) is essentially elongated so that it can conform to the length and width of the probe (not shown) to be covered. Because the edge (74) includes a portion of the membrane (70), the membrane has an essentially flat configuration when its edge (74) is placed in the recess (304). Preferably, the edge (74) includes a portion of the membrane (70) in a coiled manner so that the membrane (70) is wound inward, and is included between the unfolded membrane (70) and the recess (304), as shown in FIG. 18B. The recess (304) is preferably defined with an essentially concave shape so as to be able to receive the edge (74), which preferably has a toroidal shape.

[0210] Advantageously, this design of recess (304) allows the device (300) to be configured such that when the membrane (70) is positioned in such a way that its edge (74) is received in recess (304), the membrane completely covers the opening (302), and the entire process is carried out without ever touching the membrane, ensuring its sterility. Since opening (302) is configured for the insertion of probe (100), the insertion of probe (100) involves pressing the position of membrane (70) against the surface of probe (100), as described below with respect to Figures 20A, 20B, 21A, and 21B.

[0211] As can be seen, Figures 18A and 18B show device 300 including a number of other additional features that may not be present or may appear differently in other embodiments. For example, in its distal region, device 300 includes a circular handle-like surface 364 that allows for holding of device 10. However, this feature is optional, and other embodiments may not include it or may have a handle 364 of a different shape. Another feature is the presence of a series of side openings 12 that allow for observation of correct placement of membrane 70 on probe 100, not shown. However, in other embodiments, side openings 12 may not be present, may have a different shape, or may have a different number of openings. Additionally, device 300 includes a series of extensions in the proximal and distal regions that allow for better handling of device 300 during use. However, in other embodiments, the device may not include these extensions or may have other shapes.

[0212] It can be seen that the membrane (70) shown in FIG. 18B has an essentially circular shape. However, in other embodiments, the device (300) may be configured to accept membrane edges having different or irregular shapes. In this manner, the device (300) according to the present invention can be configured to accommodate membranes (70) of various shapes suitable for placement on probes of various shapes. It can also be seen that the membrane (70) includes a protrusion (72) at its center, which may be designed to optimally fit the probe (not shown). However, in later embodiments, the membrane (70) may not include this protrusion (72), may include it in another non-central location, may have multiple protrusions (72), or may have one or more protrusions (72) of different shapes. Preferably, the membrane (70) includes a lubricant on its outer surface to facilitate easier introduction of the probe (100) through a duct or body cavity.

[0213] 19A and 19B show perspective and longitudinal cross-sectional views of the device (300) of FIG. 18A and the membrane (70) and probe (100) configured to be received therein in accordance with one or more embodiments of the present invention.

[0214] The probe (100) is tubular in nature, allowing for examination, diagnosis, and / or delivery of therapy through a duct or body cavity. It should be noted that the probe (100) of FIGS. 19A and 19B has an interior surface such that the interior is hollow and accessible from a proximal portion opposite the distal end (190). However, in other embodiments, the probe (100) may be solid and not hollow, or may have a different design, such as housing various elements therein depending on the function to be performed by the probe. Similarly, the probe (100) has an enlarged portion at its proximal portion. However, in other embodiments, the probe (100) may not include this enlarged portion or may have other shapes. Preferably, the probe (100) has a slit or recess (69) in its proximal portion configured to receive the edge of the membrane (70) when the membrane (70) is placed on the probe (100), as described below with respect to Figures 20A, 20B, 21A, and 21B.

[0215] As with Figures 18A and 18B, device (300) and membrane (70) include other additional features that may not be present or may appear differently in other embodiments, and therefore the same considerations regarding alternatives apply with respect to Figures 19A and 19B.

[0216] In a preferred embodiment as shown in Figures 19A and 19B, the probe (100) includes a distal end (190) by which it is introduced into the device (300). The distal end (190) of the probe (100) may be of various shapes and sizes depending on the intended use of the catheter. While the probe (100) has a distal end with a particular shape as shown in Figure 19B, in other embodiments the shape of the distal end (190) may be different.

[0217] In this preferred embodiment, device (300) further comprises a distal tip (360) at its distal region, the distal tip comprising an inner surface configured to receive distal end (190) of probe (100). Advantageously, this allows membrane (70) to be inserted into device (300) so as to be positioned snugly against distal end (190) of probe (100).

[0218] In an even more preferred embodiment, as shown in Figures 19A and 19B, the inner surface of the distal end (360) of the device (300) comprises a complementary shape to the distal end (190) of the probe (100) configured to position the membrane (70) in contact with the distal end (190) of the probe (100) uniformly along the entire surface of the distal end (190) of the probe (100).

[0219] Figures 20A and 20B show perspective and longitudinal cross-sectional views of the device of Figure 18A with the probe fully inserted and the membrane fully positioned over the probe in accordance with one or more embodiments of the present invention. Note that, as with Figures 18A, 18B, 19A, and 19B, the device (300), membrane (70), and probe (100) include additional features that may not be present or may appear differently in other embodiments. Thus, the same considerations regarding alternative forms apply with respect to Figures 20A and 20B.

[0220] As can be seen in Figures 20A and 20B, when the probe (100) is inserted through the opening (302), the membrane (70) slides along the probe (100), and because the inner surface of the distal end (360) of the device (300) has a complementary shape to the distal end (190) of the probe (100), the membrane is evenly positioned between the device (300) and the probe (100) along the entire surface of the distal end (190) of the probe (100).

[0221] In the case of the device (300) of Figures 19A, 19B, 20A, and 20B, the membrane is arranged in a characteristic pattern, which can be seen as depressions (192) in the longitudinal cross section of Figure 20B. This is the shape of the surface of the distal end (190) of the example probe (100) in the referenced figures. However, it can be understood that in other embodiments, the probe (100) may be provided with a distal end (190) having a differently shaped surface, with or without depressions (192), such that the device (300) according to this preferred embodiment will have another shape corresponding to the complementary shape of the distal end (190) of the probe (100). Therefore, the membrane should also be arranged in such a way that it is uniformly distributed over the surface of the probe (100), and particularly over the surface of the distal end (190) of the probe (100).

[0222] Advantageously, therefore, this preferred embodiment allows the membrane (70) to be evenly distributed over the probe (100) when the probe (100) is inserted, even if the distal end (190) of the probe (100) is irregularly shaped.

[0223] As can be seen in Figures 20A and 20B, when membrane (70) is unfolded from its flat shape, it acquires an elongated shape, preferably an essentially cylindrical shape. The edge (74) of membrane (70), which includes a portion of membrane (70), is largely free of the membrane (70) since it was unfolded when probe (100) was introduced into device (300). In this manner, recess (304) of device (300) includes only a portion of the membrane since nearly the entire edge is unfolded. In a preferred embodiment in which edge (74) includes a portion of membrane (70) in a coiled configuration, edge (74) unfolds by unwinding.

[0224] According to another preferred embodiment of the present invention, the distal end (360) of the device (300) is configured to be separated from the remainder of the device (300) and replaced by another distal end (not shown) of the device (300) corresponding to the distal end (190) of the probe (100). Advantageously, this allows the same device (300) to be adapted to different probes (100) and to place the membrane (70) on them regardless of their shape or size.

[0225] In this preferred embodiment, device 300 is designed to allow membrane 70 to be placed on a variety of probes 100, regardless of their length and the shape of their distal ends 190. If device 300 has a distal end 360 configured for a probe other than probe 100 to which it is desired to attach membrane 70, distal end 360 can be detached from device 300 and replaced with another distal end (not shown) that fits probe 100.

[0226] It should be noted that, as will be appreciated by those skilled in the art, distal end (360) can be adapted to have various lengths, widths, and shapes depending on the probe (100). Thus, for example, if probe (100) has distal end (360) configured for a shorter probe, it can be replaced with a new distal end that is longer than the current distal end (360). Similarly, if probe (100) has distal end (360) configured for a probe of a different width or shape, it can be replaced with a new distal end having a different width or shape than the current distal end (360).

[0227] It should also be noted that the distal end (360) of the device (300) can be detached and attached in a variety of ways. While the device (300) in Figures 19B and 20B is shown attached to the remainder of the device (300) by screws (62), one skilled in the art can observe that there are multiple alternatives for using the distal end (360) of the device (300) in other embodiments. For example, the distal end (360) can have a threaded surface such that the distal end (360) is mated by screwing it onto the distal region of the device (300). Alternatively, the distal end (360) snaps onto the distal region of the device (300). All of these alternatives are also part of the present invention.

[0228] According to another preferred embodiment of the present invention, the openings (302) are configured to conform to the respective surfaces of the probe (100) when the probe (100) is fully inserted into the device (300). As shown in Figures 20A and 20B, the device (300) has openings (302), which have a specific shape that conforms to the respective surfaces of the probe (100) when the probe (100) is fully inserted into the device (300).

[0229] Advantageously, this means that upon full placement of the membrane (70) on the surface of the probe (100), which occurs when the probe (100) is fully inserted into the device (300), the membrane (70) is closely attached to the surface of the probe (100), which is advantageous for attachment to a designated location.

[0230] More preferably, when probe (100) has a circular cross-section defining diameter (35), as shown in Figures 18A, 19B, and 20B, opening (302) is set to match diameter (35) of the surface of probe (100) at the respective positions when probe (100) is fully inserted into device (300). In these figures, it can be seen that the diameter of opening (302) in device (300) is equal to diameter (35) of probe (100) at the position where probe (100) is at the level of opening (302) when probe (100) is fully inserted into device (300).

[0231] Although the device (300) and probe (100) in Figures 19A, 19B, 20A, and 20B are configured so that the position of the probe (100) at the opening (302) when the probe (100) is fully inserted into the device (300) is wider than the remainder of the probe (100), in other embodiments, the width of the probe (100) at this height may be equal to the remainder of the probe.

[0232] In another preferred embodiment of the present invention, the recess 304 is configured to allow release of the membrane 70 when the probe 100 is inserted to the distal end 360 of the device 300. When the probe 100 is inserted to the distal end 360 of the device 300, the edge 74 of the membrane 70 is only part of the membrane because it was deployed when the probe 100 was inserted into the device 300. According to the relevant figure, the recess 304 of the device 300 has a sloped surface that, when the edge is deployed, provides little resistance to the release of the edge 74. Thus, the edge 74 of the membrane 70 can be released from the recess 304 of the device 300 by removing the probe 100 from the device 300. It should be noted that, as will be appreciated by those skilled in the art, in other embodiments, the slit may be configured to allow release of membrane (70) once probe (100) is introduced to the distal end (360) of device (300). For example, in other embodiments, device (300) may have a flexible or retractable recess (304) configured to no longer receive membrane edge (74) when probe (100) is inserted to the distal end (360) of device (300).

[0233] Advantageously, this means that the same gesture that places membrane (70) evenly on the surface of probe (100) as described above by inserting probe (100) into device (300) also releases membrane (70) from recess (304), making the system simple and efficient.

[0234] Figures 21A and 21B show perspective and longitudinal cross-sectional views of the device of Figure 18A and a probe removed from the device in accordance with one or more embodiments of the present invention. As with Figures 18A, 18B, 19A, 19B, 20A, and 20B, the device (300), membrane (70), and probe (100) include additional features that may not be present or may appear differently in other embodiments. Accordingly, the same considerations regarding alternatives apply with respect to Figures 21A and 21B.

[0235] In another preferred embodiment of the present invention, the device (300) is configured to place the membrane (70) on the probe (100), the probe (100) comprising, in its proximal portion, a slit or recess (69) configured to receive the edge (74) of the membrane (70) once the membrane (70) is already placed on the probe (100).

[0236] The depression 69, like the depression 304, can be formed in a variety of ways, as will be understood by those skilled in the art. For example, the depression may be formed as a groove in the outer surface of the device 300, or by arranging one or more radial extensions of the surface in such a way that a radial depression is formed in the proximal surface of the device 300. Highly preferably, the depression 69 defines a plane parallel to the longitudinal axis of the probe 100. The slit can be defined at various distances from the position of the probe 100 at the opening 302 when the probe 100 is fully inserted into the device 300. Preferably, the slit 34 is defined near the position of the probe 100 at the level of the opening 302 when the probe 100 is fully inserted into the device 300.

[0237] As shown in Figures 21A and 21B, this advantageously allows the edge (74) of the membrane (70) to be secured in the recess (69) of the probe (100) when the probe (100) is removed from the device.

[0238] In an even more preferred embodiment of the present invention, as shown in Figures 19A, 19B, 20A, 20B, 21A, and 21B, the recess (304) is configured to allow release of the membrane (70) when the probe (100) is introduced to the distal end (360) of the device (300), and the probe (100) includes a slit or recess (69) at its proximal portion configured to receive the edge of the membrane (70) disposed on the probe (100). Advantageously, this allows for uniform, consistent, and rapid deployment of the membrane (70) by the gesture of inserting and then removing the probe (100) into the device (300) with the membrane (70) disposed on the probe (100) over its opening (302).

[0239] In a preferred embodiment of the present invention, as shown in Figures 18A, 18B, 19A, 19B, 20A, 20B, 21A, and 21B, the opening 302 is essentially circular. While the opening 302 is circular as shown in the figures, in other embodiments according to the present invention, the opening 302 may have other shapes, as would be understood by one skilled in the art. For example, the opening 302 may have an essentially circular shape with some portions thereof being slightly oval, or the circular opening 302 may lack a portion. Also, for example, to orient the probe for insertion and prevent rotation during insertion, the essentially circular opening 302 may have a notch on its surface, which is configured to guide another notch included in the probe 100 so that the probe 100 can be inserted through the opening 302 only in a specific position. Therefore, one skilled in the art can envision various ways of making the opening 302 essentially circular, all of which are encompassed by the present invention.

[0240] Further, according to this preferred embodiment, the depression (304) defines a circumference on the surface of the proximal zone having a diameter between 5 and 50 mm, more preferably between 10 and 40 mm.

[0241] Advantageously, this preferred embodiment allows for the membrane (70) to be essentially elongated and essentially cylindrical, allowing for the use of a variety of common medical-grade membranes, such as prophylactic membranes. The fact that the opening (302) is essentially circular as described above allows for regular and fluid positioning of commercially available membranes when the probe (100) is inserted through the opening (302), as commercially available membranes typically have an essentially circular cross-section. With a diameter between 5 and 50 mm, the device (300) can be configured to accommodate common medical-grade membranes over the opening (302) and into the recess (304) in a variety of commonly used sizes, such as commercially available and prophylactic membrane sizes.

[0242] In another preferred embodiment of the present invention, as shown in Figures 18A, 18B, 19A, 19B, 20A, 20B, 21A, and 21B, membrane (70) is a prophylactic membrane. Advantageously, this allows device (300) to be configured to quickly and efficiently apply a low-cost, readily available membrane (70) to probe (100). Preferably, membrane (70) further includes a lubricant on its outer surface to facilitate insertion of probe (100) through a body canal or cavity.

[0243] In another preferred embodiment of the present invention, as shown in Figures 18A, 18B, 19A, 19B, 20A, and 21A, the device comprises at least one side opening (12) configured to allow visualization of the placement of the membrane (70) on the probe (100). It should be noted that while the device (300) in the above figures comprises three side openings (12), in other embodiments according to the present invention, the device (300) may comprise one, two, or more side openings (12) to allow visualization of the placement of the membrane (70) on the probe (100). Similarly, in the figures, it can be seen that the side openings (12) have an elongated shape parallel to the longitudinal axis of the device (300), are essentially rectangular, and have rounded corners. Furthermore, the three side openings (12) are arranged parallel to one another and equidistantly spaced on the surface of the device (300). However, those skilled in the art will appreciate that there are numerous ways to design and position the at least one side opening (312) on the surface of the device (300). In this sense, the at least one side opening (312) can have any other shape, length, and arrangement, and if the device (300) includes multiple openings, they can be irregularly or regularly positioned on the device, and can have the same or different shapes. Thus, all of these possible alternatives for designing the at least one side opening (312) configured to allow visualization of the placement of the membrane (70) on the probe (100) are included in this preferred embodiment of the present invention.

[0244] Advantageously, being able to visualize the placement of the membrane (70) on the probe (100) makes it possible to confirm that the membrane is correctly inserted into the device (100) so that no creases or irregularities are formed in the membrane (70) and uneven placement of the membrane (70) on the probe (30) is prevented, and therefore makes it possible to correct the insertion of the probe (100) into the device (300) upon introduction to ensure uniform placement of the membrane (70).

[0245] In another preferred embodiment, as shown in Figures 19A, 19B, 20A, 20B, 21A, and 21B, device (300) is configured to place membrane (70) on probe (100), more preferably a uterine probe. As can be seen, probe (100) is a uterine probe, the distal end (190) of which is configured to receive the cervix from a patient's uterus by a design that includes a recess (192) that allows the probe to contact the cervix when introduced into the vagina. The probe (100) in Figures 19A, 19B, 20A, 20B, 21A, and 21B is merely representative, and uterine probe (100) can take on a variety of shapes to enable interaction by different means, for different uses, and / or in various orientations. Advantageously, this preferred method allows the same uterine probe (100) to be used for several examinations on either the same patient or different patients by simply replacing the membrane (70) placed on the probe (100) for each examination performed.

[0246] In an even more preferred embodiment of this embodiment, the device (300) is configured to position the membrane (70) on the uterine torsion wave probe (100) in a manner that provides a shear wave emitter and receiver at the distal end (190). Preferably, the uterine torsion wave probe (100) is configured to characterize the structure of the cervix. Advantageously, this allows the same uterine torsion wave probe (100) to be used in different examinations on the same or different patients by simply replacing the membrane (70) positioned on the probe (100) for each examination performed. Even more preferably, the uterine torsion wave probe (100) is a torsional ultrasound uterine probe (100).

[0247] In another preferred embodiment of the present invention, as shown in Figures 18A, 18B, 19A, 19B, 20A, 20B, and 21A, device (300) includes a handle (364) at its distal end (360), which advantageously allows probe (100) to be separated from device (300) and device (300) to be moved distally once probe (100) is fully inserted into device (300).

[0248] In another preferred embodiment of the present invention, the device 300 further comprises at least one magnet in its proximal region configured to attract at least one ferromagnetic element or magnet in the proximal portion of the probe 100. Advantageously, this allows the device 300 and the probe 100 to be coupled together by magnetic interaction between the at least one magnet in the device 300 and the at least one ferromagnetic element or magnet in the probe 100 when the probe 100 is inserted into the device 300, making it easier to manipulate the two together. Preferably, the magnetic interaction is strong enough so that the opposing elements can be separated without applying force by holding either the device 300 or the probe 100. In practice, this means that the device-probe assembly 100 can be operated with one hand, leaving the other hand free for other purposes, such as ensuring that the membrane 70 is correctly positioned on the probe 100.

[0249] Furthermore, this also allows for the specific placement of magnets 10 to determine how to properly orient probe 100 when inserted into device 300. For example, device 300 may include at least one magnet located at a specific position, which may attract at least one ferromagnetic element or magnet located at a specific position on probe 100 to the specific position where it is located, effectively aligning both positions.

[0250] As will be appreciated by those skilled in the art, the at least one magnet can be made of a variety of materials. For example, the magnet can include one or more of neodymium or magnetite. Furthermore, the at least one magnet is not limited to any particular shape, but can have a variety of shapes, such as circular, rectangular, cubic, etc.

[0251] All of the above are fully within the scope of the present disclosure and are not limited to the specific combinations disclosed above, but are considered to form the basis of alternative embodiments in which one or more combinations of the above features are applied.

[0252] In light of this, there are many alternatives for implementing the teachings of the present disclosure. It is expected that a person skilled in the art can modify and adjust the above disclosure to suit his or her own situation and requirements within the scope of the present disclosure, in light of his or her common general knowledge in this technical field, while retaining some or all of the technical effects of the present disclosure disclosed above or derivable from the above. All such equivalents, modifications, or adjustments are included within the scope of the present disclosure.

Claims

1. A medical device (100) configured to contact a sample (200) via its distal end (190), a. A torsional ultrasonic transducer (10) is positioned at the distal end (190) of the medical device (100) and configured to induce a torsional wave passing through the sample (200), b. A force sensor (20) configured to determine the force of contact between the medical device (100) and the sample (200), c. Processing unit (30) and Equipped with, The torsional ultrasonic transducer (10) is configured to contact the sample (200) with a force within a predetermined range. The processing unit (30) is configured to determine whether the force of contact between the medical device (100) and the sample (200) is within the predetermined range. The sample (200) is the cervix, and the torsional ultrasonic transducer (10) is 0-200 g / cm². ２ A medical device (100) configured to contact the cervix (200) within a certain range.

2. A feedback means (40) configured to provide the user of the medical device (100) with feedback regarding the force of contact between the device and the sample (200). The medical device (100) according to claim 1, further comprising the above.

3. The medical device (100) according to claim 2, wherein the feedback means (40) is configured to further provide feedback to the user of the medical device (100) regarding whether the force is within the predetermined range.

4. The medical device (100) according to claim 2 or 3, wherein the feedback means (40) is located at the proximal end (110) of the medical device (100).

5. The medical device (100) according to claim 2 or 3, further comprising an imaging means (41), wherein the feedback means (40) comprises a visual feedback device configured to display an image captured by the imaging means (41).

6. The medical device (100) according to claim 5, wherein the imaging means (41) is located at the distal end (190) of the medical device (100), and the imaging means (41) and the visual feedback device are coaxially located within the medical device (100).

7. The medical device (100) according to claim 6, wherein the imaging means (41) and the visual feedback device are coaxial within the medical device (100) along an axis (130) formed by the distal end (190) and the proximal end (110).

8. The medical device (100) according to any one of claims 1 to 3, wherein the force sensor (20) is included in the distal portion (180) of the medical device (100).

9. The medical device (100) according to any one of claims 1 to 3, wherein the force sensor (20) is positioned perpendicular to the surface of the medical device (100) configured to contact the sample (200).

10. The medical device (100) according to any one of claims 1 to 3, wherein the force sensor (20) is located between the proximal portion (120) and the distal portion (180) of the medical device (100).

11. The medical device (100) according to claim 10, wherein the force sensor (20) determines the force of contact between the device and the sample (200) based on the relative position of the distal portion (180) with respect to the proximal portion (120).

12. The medical device (100) according to claim 11, wherein the force sensor (20) determines the force of contact between the device and the sample (200) when the distal portion is displaced longitudinally relative to the proximal portion.

13. A load is applied to the force sensor (20) in advance, and the force sensor (20) determines the force of contact between the device and the sample (200) in response to the release of pressure on the sample (200) when the distal portion is displaced longitudinally relative to the proximal portion, according to claim 11, the medical device (100).

14. The medical device (100) according to any one of claims 1 to 3, wherein the force sensor (20) further comprises a protective system configured to prevent damage to the force sensor (20) when a force exceeding its operating range is applied to the distal end (190) of the medical device (100), the protective system comprising a spring (21).

15. A medical device (100) according to any one of claims 1 to 3, further comprising a handle (50) at a proximal end (110), wherein the handle (50) is configured to be held by hand and has an angle (α) between 85° and 120° with respect to an axis (130) formed by the distal end (190) and the proximal end (110).

16. The medical device (100) according to any one of claims 1 to 3, wherein the processing unit (30) is configured to discard the reading of the torsional ultrasonic transducer (10) when the applied force is not within the predetermined range.

17. The medical device (100) according to any one of claims 1 to 3, wherein the processing unit (30) is configured to prevent the induction of torsional waves by the torsional ultrasonic transducer (10) when the applied force is not within the predetermined range.

18. The torsional ultrasonic transducer (10) comprises an emitter device for emitting torsional ultrasonic waves, the emitter device comprises an electrical signal generator (13) connected to an electromechanical actuator (12), the electromechanical actuator (12) is attached to a contact element (11) that contacts a sample (200), the actuator, upon receiving an electrical signal, induces rotational motion of the contact element (11), the contact element (11), upon contact with the sample (200), induces a torsional wave passing through the sample (200), and the torsional ultrasonic transducer (10) further comprises means for receiving the distorted signal after it has passed through the sample (200), according to any one of claims 1 to 3.

19. The medical device (100) according to claim 18, wherein the means for receiving the distorted signal comprises two or more piezoelectric elements (15) positioned between two rings (14a and 14b) made of a non-conductive material and equidistant from each other, the axis of rotation of the rings coincides with the axis of rotation of the electromechanical actuator (12).

20. The medical device (100) according to claim 18, wherein a damping material (18) having a Shore A hardness of less than 80 is attached to the outer surface of the ring furthest from the area in contact with the sample (200).

21. The medical device (100) according to claim 18, wherein the contact element (11) has a considerably frustoconical shape, its smaller base (b) being attached to the electromechanical actuator (12), and its larger base (B) being positioned at the distal end of the transducer (10) of the present invention, in contact with the sample (200) to transmit shear waves.

22. The medical device (100) according to claim 18, wherein the electromechanical actuator (12) is covered by a Faraday cage that eliminates electronic noise.

23. The medical device (100) according to claim 18, wherein the outer surface of one of the rings (14a) and the surface of the element of the emitter device that contacts the sample (200) are located on the same plane.

24. The medical device (100) according to claim 18, wherein the polarization of the piezoelectric element (15) is perpendicular to the rotation axis of the ring in the radial direction.

25. d. A conduit (62) that connects the outside to the internal space (120) of the medical device (100), and a conduit (62) that connects to the outside through an opening (63), e. A sealing element (64) located at the other end of the conduit (62) and configured to control the passage of air between the internal space (120) and the conduit (62), f. A vacuum pump (65) connected to the sealing element (64) and configured to draw air from the opening (63) through the conduit (62) and Furthermore, The medical device (100) according to any one of claims 1 to 3, wherein the medical device (100) is configured to receive a membrane (70) on the outside thereof that covers the opening (63), and the vacuum pump (65) is configured to extract air between the sealing element (64) and the membrane (70).

26. The medical device (100) according to claim 25, wherein the vacuum pump (65) is connected to a pressure sensor (67) configured to measure the pressure in the conduit (62), and the vacuum pump (65) is configured to maintain a minimum pressure in the space between the membrane (70) and the sealing element (64) as measured by the pressure sensor (67).

27. The medical device (100) according to claim 26, wherein the minimum pressure is between 700 and 800 mBar.

28. The medical device (100) according to claim 25, wherein the medical device (100) is essentially elongated and configured to contact the sample (200) via the distal portion (20), and the device is configured such that the membrane (70) covers at least the distal portion (20).

29. The medical device (100) according to claim 25, wherein the opening (63) is included in the distal end (190) of the medical device (100).

30. The medical device (100) according to claim 25, wherein the medical device (100) is configured to receive a preventive membrane as a membrane (70).

31. The medical device (100) according to claim 25, wherein the medical device (100) comprises on its outer surface at least one recess (69) configured to receive the edge of the membrane (70).

32. The medical device (100) according to claim 31, wherein the recess (69) is configured to receive the edge of the membrane (70) in a sealed manner.

33. The medical device (100) is a probe, according to any one of claims 1 to 3.

34. The medical device (100) according to claim 33, wherein the medical device (100) is a uterine tube and the sample (200) is the cervix.

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