Torsional ultrasonic transducer and medical equipment thereof

Abstract

A medical device configured to contact a sample through a distal end thereof, the medical device comprising: a) a torsional ultrasonic transducer located at the distal end of the medical device and configured to induce a torsional wave through the sample, b) a force sensor configured to determine a force to contact the medical device with the sample, and c) a processing unit. The torsional ultrasonic transducer is configured to contact the sample with a predetermined range of force, and the processing unit is configured to determine whether the force with which the medical device contacts the sample is within the predetermined range of force. The sample is the cervix uteri, and the torsional ultrasound transducer is configured to contact the cervix uteri in a range between 0 and 200 g / cm2. The invention also relates to a device in which a membrane is arranged in a medical device.

Description

Technical Field

[0001] This invention belongs to the field of medical devices. In particular, this invention relates to a medical device including a torsional ultrasound transducer configured to contact a sample, enabling optimal readings to be obtained from the torsional ultrasound transducer. This invention also relates to a device configured for distributing a membrane within a medical device. Background Technology

[0002] Torsional waves are spatial distributions of transverse waves propagating along an axis, in which particle movement occurs along a circumference centered on that axis, such that the amplitude of movement within the generating plane is proportional to the distance from that axis within the transducer diameter.

[0003] These waves propagate through solid and semi-solid media, but not through perfect liquids; therefore, measuring the speed of sound in this type of medium is very useful for studying the structural characteristics of their input energy being converted into another different type of output energy. These devices include electromechanical transducers, which convert electrical energy into mechanical energy in the form of bidirectional displacement coupled elastically with stress.

[0004] Ultrasonic transducers emit and receive ultrasound waves. Based on solid mechanics, they allow the identification of changes in tissue consistency, which may indicate the presence of a tumor, and quantifying mechanical or physical changes in tissue can predict certain conditions faster than other diagnostic techniques.

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

[0006] Therefore, torsional ultrasonic transducer technology is needed to ensure that the properties of the contact surface are not changed or are changed as little as possible. Summary of the Invention

[0007] A medical device configured to contact a sample via its distal end, the medical device comprising: a) a torsional ultrasound transducer located at the distal end of the medical device and configured to induce a torsional wave through the sample; b) a force sensor configured to determine a force that causes the medical device to contact the sample; and c) a processing unit. The torsional ultrasound transducer is configured to contact the sample within a predetermined force range, and the processing unit is configured to determine whether the force by which the medical device contacts the sample is within the predetermined force range. The sample is a cervix, and the torsional ultrasound transducer is configured to contact the sample with a force from 0 to 200 g / cm². 2 The area between the membranes contacts the cervix. The invention also relates to a device configured for distributing a membrane within a medical device.

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

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

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

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

[0012] In another preferred embodiment, a force sensor is included between a proximal portion and a distal portion of the medical device. In a particular embodiment, the force sensor determines the force required to bring the device into contact with a sample based on the relative position of the distal portion (180) relative to the proximal portion. More preferably, the force sensor determines the force required to bring the device into contact with the sample when the distal portion is longitudinally displaced relative to the proximal portion.

[0013] In another specific embodiment, a force sensor is preloaded and the force that brings the device into contact with the sample is determined based on 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 includes a protection system configured to prevent damage to the force sensor when a force exceeding the operating range is applied to the distal end of the medical device. Preferably, the protection system includes a spring.

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

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

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

[0018] In another preferred embodiment, the torsional ultrasonic transducer includes a transmitter device for emitting torsional ultrasonic waves. The transmitter device includes an electrical signal generator connected to an electromechanical actuator, which in turn is attached to a contact element in contact with a sample, such that when the actuator receives an electrical signal, it causes rotational movement of the contact element, and when the contact element contacts the sample, it generates a torsional wave passing through the sample. The torsional ultrasonic transducer also includes means for receiving the distorted signal after passing through the sample.

[0019] In a preferred embodiment, the means for receiving the distorted signal comprises two or more piezoelectric elements equidistantly positioned between two rings made of a non-conductive material, with the rotation axis of the rings aligned with the rotation axis of the electromechanical actuator. In another preferred embodiment, an attenuation element (preferably an attenuation material with a Shore A hardness below 80) is fixed to the outer surface of the ring furthest from the area in contact with the sample. In yet another preferred embodiment, the contact element has a relatively truncated conical shape, such that its smaller base is attached to the electromechanical actuator, and its larger base is arranged at the distal end of the transducer of the invention, such that it contacts the sample on which a shear wave is to be transmitted.

[0020] In another preferred embodiment, the electromechanical actuator is covered by a Faraday cage to eliminate electronic noise. In yet another preferred embodiment, the outer surface of one of the rings and the sample-contacting surface of the transmitter device element are located on the same plane.

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

[0022] In another preferred embodiment, the medical device further includes: d) a catheter for connecting the outer side to the inner space of the medical device, the catheter being connected to the outer side through an opening; e) a sealing element at the opposite end of the catheter, configured to control airflow between the inner space and the catheter; and f) a vacuum pump connected to the sealing element and configured to draw air from the opening through the catheter. The medical device is configured to receive a membrane covering the opening on its outer side, such that the vacuum pump is configured to draw air between the sealing element and the membrane.

[0023] In a 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 diaphragm and the sealing element as measured by the pressure sensor. More preferably, the minimum pressure is included between 700 and 800 mBar.

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

[0025] In another, more preferred embodiment, the medical device includes at least one recess in its outer surface, the recess being configured to receive the 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 canal and the sample is the cervix.

[0027] Another aspect of the invention relates to an apparatus for arranging a membrane in a probe, the apparatus being substantially elongated, configured to receive the probe longitudinally and including a proximal region and a distal region, wherein the proximal region includes: a) an opening configured for inserting the probe; and b) at least one recess defined by its radially outer surface and configured to receive an edge of the membrane covering the opening. The membrane is substantially longitudinally elongated such that the edge of the membrane comprises a portion of the membrane.

[0028] In a preferred embodiment, the probe includes a distal end through which it is introduced into the device, and wherein the device further includes a distal end in its distal region, which in turn includes an inner surface configured to receive the distal end of the probe. More preferably, the inner surface of the distal end of the device includes a complementary shape to the distal end of the probe and is configured to arrange the membrane in equal contact with the distal end of the probe.

[0029] In another preferred embodiment, the distal end of the device is configured to be decoupled from the rest of the device and is replaced by another distal end of the device depending on the distal end of the probe.

[0030] In another preferred embodiment, the opening is configured to fit the corresponding surface of the probe when the probe is fully inserted into the device.

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

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

[0033] In another preferred embodiment, the opening is substantially circular, and the indentation defines a circumference with a diameter between 5 mm and 50 mm.

[0034] In another preferred embodiment, the device includes at least one side opening configured to allow visualization of the membrane arrangement above the probe.

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

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

[0037] In another preferred embodiment, the membrane (70) is preventative.

[0038] In another preferred embodiment, the device further includes at least one magnet in its proximal region, the magnet being configured to attract at least one ferromagnetic element or magnet included in the proximal component of the probe. Attached Figure Description

[0039] To better understand this disclosure and to show how to implement it, reference will now be made to the accompanying schematic diagrams by way of example only, wherein:

[0040] Figure 1A A perspective view of the distal portion of a medical device according to one or more embodiments of the present invention is shown.

[0041] Figure 1B A side view showing the arrangement of internal components within the distal portion of a medical device according to one or more embodiments of the present invention is shown.

[0042] Figure 2 A perspective view of a medical device according to one or more embodiments of the present invention is shown.

[0043] Figure 3 One or more embodiments of the present invention are shown. Figure 2 A side view of the medical equipment.

[0044] Figure 4 A close-up view of the distal end of a medical device according to one or more embodiments of the present invention is shown.

[0045] Figure 5 The proximal end of a medical device according to one or more embodiments of the present invention is shown.

[0046] Figure 6 The visual feedback device interface according to one or more embodiments of the present invention is shown: before use (A), during use but before a torsional wave is induced to pass through the sample (B), during use while a torsional wave is induced to pass through the sample (C), and after a torsional wave is induced to pass through the sample (D).

[0047] Figure 7 A diagram of a force sensor mechanism of a device according to one or more embodiments of the present invention is shown.

[0048] Figure 8 A transmitter device for a torsional ultrasonic transducer according to one or more embodiments of the present invention is shown.

[0049] Figure 9 The contact element of a torsional ultrasonic transducer according to one or more embodiments of the present invention is shown.

[0050] Figure 10 A portion of a receiver device for a torsional ultrasonic transducer according to one or more embodiments of the present invention is shown, in which a ring and a piezoelectric element can be seen.

[0051] Figure 11 An arrangement of a transmitter and receiver device for a torsional ultrasonic transducer according to one or more embodiments of the present invention is shown, wherein contact elements, rings and piezoelectric elements can be seen.

[0052] Figure 12 The contact between a transducer and a sample is schematically depicted according to one or more embodiments of the present invention.

[0053] Figure 13 A piezoelectric element (5) and its polarization direction (P) according to one or more embodiments of the present invention are depicted.

[0054] Figure 14 A cross-section of a transducer according to one or more embodiments of the present invention is shown, in which the arrangement of the transmitter device relative to the receiver device and its arrangement together with the attenuation element within the housing can be seen.

[0055] Figure 15 A perspective view of a medical device according to one or more embodiments of the present invention is shown.

[0056] Figure 16 Another perspective view of a medical device with a distal and proximal portion in an exploded view, according to one or more embodiments of the present invention, is shown.

[0057] Figure 17A A longitudinal cross-section of a device according to one or more embodiments of the present invention is shown.

[0058] Figure 17B A simplified longitudinal cross-sectional view of the distal portion of a device according to one or more embodiments of the present invention is shown.

[0059] Figure 18A A perspective view of a device according to one or more embodiments of the present invention is shown.

[0060] Figure 18B One or more embodiments of the present invention are shown. Figure 18A A perspective view of the device, which has a membrane.

[0061] Figure 19A One or more embodiments of the present invention are shown. Figure 18A Another perspective view of the device, which has a membrane and a probe, configured to receive the membrane and the probe.

[0062] Figure 19B One or more embodiments of the present invention are shown. Figure 18A The longitudinal section of the device, which has a membrane and a probe, is configured to receive the membrane and the probe.

[0063] Figure 20A One or more embodiments of the present invention are shown. Figure 18A A perspective view of the device, with the probe fully inserted and the membrane fully arranged on the device.

[0064] Figure 20B One or more embodiments of the present invention are shown. Figure 18A The longitudinal section of the device, in which the probe is fully inserted and the membrane is fully arranged on the device.

[0065] Figure 21A One or more embodiments of the present invention are shown. Figure 18A A perspective view of the device and the probe once removed from the device.

[0066] Figure 21B A longitudinal section of a probe with a membrane disposed on its surface once removed from the device is shown according to one or more embodiments of the present invention. Detailed Implementation

[0067] definition

[0068] It should be noted that, as used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. Furthermore, unless otherwise indicated, the term “at least” preceding a series of elements should be understood to refer to each element in the series. Those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments of the invention described herein using only conventional experimentation. This invention is intended to cover such equivalents.

[0069] It is worth noting that, as used herein, the term “about” refers to + / -30% of the indicated reference value, preferably + / -20%, more preferably + / -15%, and even more preferably + / -10%.

[0070] As used herein, the conjunction “and / or” connecting multiple enumerated elements should be understood to encompass both individual and combined options. For example, when two elements are connected by “and / or”, the first option indicates applicability with the first element but without the second. The second option indicates applicability with the second element but without the first. The third option indicates applicability with both the first and second elements. Any of these options should be understood to fall within this meaning and thus satisfy the requirement of the term “and / or” as used herein. The simultaneous applicability of more than one option is also understood to fall within this meaning and thus satisfy the requirement of the term “and / or”.

[0071] Throughout this specification and the appended claims, unless the context otherwise requires, the word “comprising” and its variations such as “containing” and “including” should be understood to imply the inclusion of the entire element or step or group of elements or steps specified herein, but not to exclude any other entire element or step or group of elements or steps. The term “comprising” as used in the text may be replaced by the terms “including” or “containing,” or sometimes by the term “having” as used herein. Any of the foregoing terms (comprising, including, containing, having) may be replaced by the term “consisting of,” albeit less preferred, when used in the context of one aspect or embodiment of the invention herein.

[0072] When used herein, "consisting of" excludes any element, step, or component not specified in the elements of the claim. When used herein, "consisting substantially of" does not exclude materials or steps that do not substantially affect the essential and novel features of the claim.

[0073] In the context of this invention, the term "specimen" preferably refers to a biological sample and, in particular, any type of biological tissue, whether in vivo or in vitro. For example, a sample can be a specimen taken from an animal, or a part taken from an animal, such as a portion of skin, a limb, a cavity, a mucous membrane, or any other part of an animal or human. Therefore, a sample must be understood as a material, preferably a tissue, tissue culture, or cell culture, through which waves emitted by the transducer can pass to understand its structural properties (elastic parameters, viscoelastic parameters, microstructure geometry, porosity, or energy dissipation models, etc.).

[0074] In the context of this invention, the term "medical device" preferably refers to any type of instrument, device, or apparatus used for the diagnosis, prevention, monitoring, prediction, prognosis, treatment, rescue, or research of animals (especially humans).

[0075] In the context of this invention, the term "probe" preferably refers to a substantially tubular device that allows for examination, diagnosis, and / or the delivery of treatment through a catheter or cavity in the body.

[0076] In the context of this invention, the term "membrane" preferably refers to a thin, generally flexible, and preferably elastic film, which may be organic or inorganic and includes materials such as nitrile, latex, or polyurethane.

[0077] In the context of this invention, the term "opening" preferably refers to a hole on the surface of the device that allows access to the interior of the device.

[0078] In the context of this invention, the term "indentation" preferably refers to a narrow, elongated area on a surface that is recessed in front of the rest of the surface, creating a concave region therein.

[0079] In the context of this invention and especially when referring to membranes, the term "edge" preferably refers to the end of the membrane.

[0080] In the context of this invention, the term "substantially circular" preferably refers to a shape whose overall appearance resembles a circle, although it may have irregularities at the edges of the circle, or be partially truncated, or slightly twisted on one or more axes.

[0081] The term "electromechanical actuator" is preferably understood as a device capable of converting electrical energy into motion (particularly rotational motion). In a particular embodiment suitable for the invention, the electromechanical actuator is stimulated by an electrical signal generated by an electrical pulse generator and is capable of converting said signal into a minimal portion of rotation, which will be used to generate a wave to be subsequently analyzed. An example of this type of actuator may consist of an electromagnetic motor. For the purposes of the invention, the electromechanical actuator is preferably stimulated by a device capable of generating an electrical signal or wave (hereinafter referred to as an "electrical signal generator").

[0082] The term "electrical signal" is preferably understood as an electrical amplitude whose value depends on time. For the purposes of this invention, a constant amplitude will be considered a special case of an electrical signal. The electrical signal generated by the electrical signal generator can be a periodic signal (sine wave, square wave, triangle wave, "sawtooth wave," etc.). Thus, by connecting a generator to an actuator that converts the signal into rotational movement, the actuator rotates at least a fraction of a revolution according to the voltage, frequency, and / or time between pulses determined by the signal. Any electronic circuit that digitizes the electrical signal at the desired frequency can be used as an electrical signal generator. Another example of an electrical signal generator used in the experimental design of this invention could be an oscilloscope, as it allows the transmission of an electrical signal with a variable voltage over a specific period of time.

[0083] The term "biocompatible material" is preferably understood as a material whose components do not interfere with or cause degradation of the biological media in which it is used. These materials are commonly used in the manufacture of devices or components that must come into direct, temporary, or prolonged contact with bodily fluids and tissues, such as probes, syringes, prostheses, etc. An example of such a material is polylactic acid (PLA).

[0084] The term "contact element" refers to a part or component located at the far end or front of the transducer and in contact with the sample from which the wave is to be transmitted. The surface of the contact element in contact with the sample must be fairly flat to allow for proper wave transmission.

[0085] describe

[0086] Each embodiment disclosed herein is contemplated to be applicable to each of the other disclosed embodiments. Therefore, all combinations of the various elements described herein are within the scope of this invention. It should also be understood that, unless expressly indicated to the contrary, in any method claimed herein that includes more than one step or action, the order of the steps or actions of the method is not necessarily limited to the order in which the steps or actions of the method are stated.

[0087] against Figure 1A , Figure 1B and Figure 2 As shown, a first aspect of the invention relates to a device (100) configured to contact a sample (200) via its distal end (190). The device (100) includes a torsional ultrasonic transducer (10), a force sensor (20), and a processing unit (30).

[0088] It should be noted that the present invention is not particularly limited to certain types of samples, which may include organic or inorganic samples, such as biological samples or specimens. From the following, reference will be made to the sample (200) by way of example only. Furthermore, in a preferred embodiment of any embodiment of the first aspect of the invention, the sample (200) is a specimen (200).

[0089] A torsional ultrasonic transducer (10) is located at the distal end (190) of the device (100) and is configured to induce a torsional wave through the sample (200). The distal end (190) is preferably understood as the more distant part of the device (100) from which the user controls the device. The torsional ultrasonic transducer can induce torsional waves through various mechanisms, providing flexibility in application. Possible induction methods include mechanical methods (where the transducer physically applies a rotational force to the medium) or electromagnetic methods (where a magnetic field generates the desired torsional motion). These methods will be further described below.

[0090] The force sensor (20) is configured to determine the force that causes the device (100) to contact the sample (200).

[0091] Force sensors (20) can be of various types and can be similar to, the same as, or different from pressure sensors (67), such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical or potentiometric extensometers, etc. Therefore, the force sensor (20) of this invention is not limited to any particular type of force sensor. Depending on the technology, force sensors can determine the applied force using different methods. This includes measuring material deformation, capturing changes in electrical properties, or quantifying pressure changes. Force sensors can be located anywhere within the device (100). Depending on the device architecture, they can be strategically placed at a wide variety of points.

[0092] The processing unit (30) may further include one or more processing units, such as microprocessors, GPUs, CPUs, multi-core processors, etc. Therefore, there are no particular limitations in the implementation of the processing unit (30). In some configurations, the processing unit may be strategically located within the device itself. For example, it may be placed next to a force sensor, facilitating real-time data processing and immediate response to mechanical interactions. This onboard processing enhances the device's autonomy and responsiveness. Alternatively, the processing unit may be part of a broader computing infrastructure. It may be integrated into an external computing device, such as a personal computer (PC) or a remote PC. In this scenario, 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).

[0093] The torsional ultrasonic transducer (10) is configured to contact the sample (200) with a predetermined force or a predetermined range of force. In a preferred embodiment, the torsional ultrasonic transducer (10) is configured to contact the sample (200) with a predetermined range of force.

[0094] In the context of this invention, the term "configured to contact with a predetermined force" is preferably understood to mean that the torsional ultrasonic transducer (10) is configured for use in a particular application, i.e., the device (100) is configured to contact the sample (200). Therefore, the configuration of the torsional ultrasonic transducer is adaptive and specifically tailored to the application and the nature of the sample (200). Depending on the sample (200), the torsional ultrasonic transducer (10) can be arranged and configured to optimally induce torsional waves through the sample within a predetermined force range. Therefore, the range of this force may vary depending on the sample to which the device (100) is configured to contact.

[0095] The preferred force applied by the torsional ultrasonic transducer can be set to a single desired value or a defined range. This feature adapts to a variety of measurement scenarios, providing versatility in force applications.

[0096] For specific examples, when the device (100) is a medical device used as a uterine probe for cervical examination, the force applied by the torsional ultrasound transducer can be set within a specified range, such as 0 to 200 g / cm. 2 Within the range between.

[0097] The processing unit (30) is configured to determine whether the force that brings the device into contact with the sample (200) is within a predetermined force range.

[0098] This determination is achieved through a systematic comparison between the force measured by the force sensor (20) and the range of forces of the torsional ultrasonic transducer (10) configured to contact the sample (200).

[0099] Advantageously, the device (100) is able to monitor the force that brings the device into contact with the sample (200), which means that the user can better understand the use of the device (100) and determine whether he / she needs to change the way the device (100) contacts the sample (200).

[0100] It can be seen that, Figure 1A , Figure 1B and Figure 2 A device (100) is shown that includes many other additional features, which may not be included in other embodiments or may be understood in different ways. For example, in Figure 1A and Figure 1B As can be seen from the figures, the device (100) has a substantially elongated shape, but other devices (100) according to the invention may not be substantially elongated. As can be seen from the two figures, the device (100) includes a specific torsional ultrasonic transducer (10) with a specific distal shape. However, in other embodiments, the device (100) may include any other type of torsional ultrasonic transducer (10).

[0101] from Figure 2 It can also be seen that the device (100) has a specific shape, but other devices (100) according to the present invention may include different shapes. It can also be seen that... Figure 2 The device (100) includes a feedback device (40), a handle (50), and a power input (60). However, in other embodiments, according to a first aspect of the invention, the device (100) may not include any of these.

[0102] It can also be seen that the distal portion (180) is narrower than the proximal portion (120), and the proximal portion (120) includes almost all the electronics of the device (100). However, in other embodiments, the device may include other shapes, and the proximal (110) and distal (190) cross-sections may have similar, identical, or different shapes, depending on the application of the device (100). In this sense, the invention is not limited to any particular form of the device (100).

[0103] It should also be noted that the device (100) may include multiple electronic devices so that the processor (30) can perform all its functions according to one or more embodiments of the invention. It may also include a power source, such as an input power line or a battery cell configured to supply power to the electronic devices. It may also include a data transmission unit, which may be physical or wireless, such as Bluetooth or Wi-Fi.

[0104] In a preferred embodiment of any embodiment of the first aspect of the present invention, the device (100) is a medical device (100). Reference will be made to the medical device (100) from now on, although any embodiment of the first aspect of the present invention is not limited to the medical device (100).

[0105] According to a particularly preferred embodiment, the device (100) is a medical device, the sample (200) is a cervix, and the torsional ultrasound transducer (10) is configured to operate at 0 to 200 g / cm. 2 The area between them contacts the cervix (200).

[0106] According to a preferred embodiment, the torsional ultrasonic transducer (10) is configured to operate at 50 g / cm 2 Up to 200g / cm 2 The range between, more preferably in the range of 100 g / cm 2 Up to 150g / cm 2 The range is approximately 100 g / cm³. 2 Contact with the cervix (200).

[0107] In a specific embodiment of the first aspect of the present invention, such as Figure 6 A to Figure 6 As shown in D, the medical device (100) also includes a feedback device (40), wherein the feedback device (40) is configured to provide feedback to the user of the medical device (100) regarding the force that causes the device to contact the sample (200).

[0108] Please note that the feedback device (40) may include a range of different devices designed to convey force-related information to the user, such as visual devices (e.g., screens, LEDs, light indicators, etc.), tactile devices, or auditory devices.

[0109] It is worth noting that, using feedback devices, the force exerted by the medical device (100) on the sample (200) can be provided to the user in various ways. For example, using a visual device, the applied force can be represented as light, light patterns, or a visual representation in many different ways as can be imagined by those skilled in the art. For example, a light indicator can be used to indicate that the applied force is within a certain range. The force can also be represented as bars, circles, or any other graphical representation of the force, which provides easy readability of the applied force. For example, a bar may fill up as the force increases. A tactile device can provide subtle vibrations based on the applied force, and different frequencies or intensities can be used to indicate the magnitude of the applied force. Using an auditory device, a similar approach can be used, using different sounds to indicate the force exerted by the device (100) on the sample (200).

[0110] Advantageously, the feedback device (40) allows the user to easily determine whether the force applied to the sample is appropriate. The purpose of the feedback device (40) is to provide the user with real-time and preferably constant information about the applied pressure so that they can place the pressure in the optimal range and maintain that force. In this scenario, any system that allows information to be provided to the user is effective.

[0111] Especially Figure 6 A to Figure 6 In D, it can be seen that the feedback element (40) provides the applied force in the form of a bar or gauge to indicate to the user of the medical device (100) the force required to contact the device with the sample (200). In some embodiments, the feedback element (40) may also provide a force value and unit, or any force value, to help the user understand the applied force.

[0112] In a preferred embodiment of the first aspect of the invention, the feedback device (40) is configured to further provide feedback to the user of the medical device (100) regarding whether the force is within a predetermined force range. For this purpose, the feedback element may include, through the feedback device, indicating the relative force applied relative to the predetermined force range. For example, using a visual feedback device (40), a gauge may be used, indicating the minimum and maximum values ​​of the predetermined force range, and representing the applied force as a bar, allowing the user to determine whether a larger or smaller force should be applied. Alternatively or additionally, a color scheme system may be used. For example, blue may indicate insufficient force, green indicates optimal force, and red indicates a large force. Using a tactile feedback device, vibrations may be generated such that when force is applied within the predetermined force range, the vibrations cease, while when force is outside the predetermined force range, the vibrations continue to be generated to indicate to the user a change in the applied force.

[0113] Advantageously, this further allows users to easily determine whether the pressure applied to the sample is appropriate, and how to adjust the applied pressure to be appropriate according to the predetermined range of force.

[0114] exist Figure 6 A to Figure 6 In D, it can be seen that the feedback element (40) provides information on whether the pressure applied to the sample is appropriate and how to correct the applied pressure to make it appropriate according to a predetermined force range, the minimum and maximum values ​​of which are represented by two lines across the bar. If the force is between the two lines, the force is within the predetermined force range.

[0115] It can be seen that, Figure 6 A, Figure 6 B. Figure 6 C and Figure 6 D illustrates the visual feedback device interface (40): before use (A), during use but before a torsional wave is induced to pass through the sample (B), during use while a torsional wave is induced to pass through the sample (C), and after a torsional wave has been induced to pass through the sample (D). These include many other additional features that may not be included in other embodiments or may be interpreted differently. For example, they all further include messages sent to the user, but depending on other feedback devices (40), there may be no message or no message may be provided (e.g., in haptic feedback devices). Figure 6 B and Figure 6 C also shows an image of its use, but this may not be the case in some other embodiments.

[0116] In another preferred embodiment of the first aspect of the invention, such as Figure 5 As shown, the feedback device (40) is located at the proximal end (110) of the medical device (100). The proximal end (110) is the part of the medical device (100) closest to the user. This greatly facilitates the user in determining whether the pressure applied to the sample is appropriate when using the medical device, allowing the user to focus their attention on the medical device (100) and the sample (200).

[0117] In another specific embodiment of the first aspect of the invention, the visual feedback element (41) is configured to provide a measurement result after the medical device (100) has contacted the sample (200) and the torsional ultrasound transducer (10) has completed generating a torsional wave through the sample (200).

[0118] It can be seen that, Figure 5 The proximal end of a medical device according to one or more embodiments of the present invention is shown. It includes many other additional features that may not be included in other embodiments or may be understood in different ways. For example, Figure 5The medical device (100) includes a handle (50), but in other embodiments, the proximal end (110) may not include a handle (50), or may include a handle (50) of a certain shape. The proximal end (110) also includes a set of control buttons (112), but in other embodiments, the proximal end (110) may not include two control buttons (112), and may include more, fewer, or no control buttons (112). The control buttons (112) may also take different shapes, sizes, and positions.

[0119] In another preferred embodiment of the first aspect of the invention, such as Figure 4 , Figure 5 and Figure 6 As shown, the medical device also includes an imaging device (41), wherein the feedback device (40) includes a visual feedback device configured to display images captured by the imaging device (41).

[0120] The imaging device (41) can be any type of device configured to capture images of the medical device (100) when it comes into contact with the sample (200). The imaging device (41) can be, for example, a camera or an ultrasound system such as an ultrasound scanner. However, those skilled in the art can envision other imaging devices (41), such as lidar, also being used to view how the medical device (100) contacts the sample (200). A visual feedback device can be configured to continuously or temporarily display the images captured by the imaging device (41) as needed.

[0121] Figure 4 A close-up view of the distal end (110) of a medical device (100) according to one or more embodiments of the present invention is shown. It can be noted how the distal end (110) includes an imaging device (41) in the same region as a torsional ultrasound transducer (10), represented by a loop surrounding a receiver (14) of a contact element (11), as will be further explained below in more specific embodiments. However, it is worth noting that for other torsional ultrasound transducers (10), the imaging device (41) may be arranged differently to allow the user to understand how they are in contact with the sample (200).

[0122] It is worth noting that the medical device (100) may also include an illumination device associated with the imaging device (41) to facilitate or improve the capture of images from the sample.

[0123] In an alternative embodiment, the imaging device is located outside the medical device (100), such as an external ultrasound scanner. Using a visual feedback device as a feedback device (40) allows for the display of images captured by the imaging device (41), such as... Figure 6 B and Figure 6As shown in C. This, in turn, allows the user to see how the medical device (100) contacts the sample (200). In many applications, such as those involving the cervix, it is necessary to know how the torsional ultrasound transducer (10) located at the distal end (190) of the medical device (100) contacts the cervix (200) because the user cannot directly see the cervix (200).

[0124] In a more preferred embodiment of the first aspect of the invention, such as Figure 3 and Figure 4 As shown, the imaging device (41) is located at the distal end (190) of the medical device (100), and the imaging device (41) and the visual feedback device (40) are coaxially located within the medical device (100). Therefore, the visual feedback device (40) can display the image captured by the imaging device (41), such that movement of the imaging device (41) in a certain direction is also reflected as movement in the same direction in the visual feedback device (40).

[0125] Advantageously, this allows the user to intuitively control the medical device (100), so that movement applied to the medical device (100) is directly translated into precise movement seen through the visual feedback device (40).

[0126] In a more preferred embodiment of the first aspect of the invention, such as Figure 3 As shown, the imaging device (41) and the visual feedback device (40) are coaxially located within the medical device (100) along an axis (130) formed by the distal end (190) and the proximal end (110).

[0127] Advantageously, this further allows the user to intuitively control the medical device (100), so that movement applied to the medical device (100) is directly translated into precise movement seen through the visual feedback device (40). For example, when the sample is the cervix (200), since the user of the medical device cannot see how the distal end (190) of the medical device (100) contacts the cervix (200), it is highly desirable that the imaging device (41) and the visual feedback device be coaxially positioned within the medical device (100) along the axis (130) formed by the distal end (190) and the proximal end (110), because the imaging device (41) is at the distal end, while the user views the visual feedback device (40) in the proximal end (110).

[0128] It can be seen that, Figure 3 The proximal end of a medical device according to one or more embodiments of the present invention is shown. It includes many other additional features that may not be included in other embodiments or may be understood in different ways. For example, Figure 3The medical device (100) includes a handle (50), but in other embodiments, the proximal end (110) may not include the handle (50), or may include a handle (50) having a certain shape. It should also be noted that the shaft (130) is positioned at an angle (α) relative to the handle (50), but in other embodiments, this angle (α) may be different.

[0129] In another specific embodiment of the first aspect of the invention, such as Figure 1B As shown, the force sensor (20) is included in the distal portion (180) of the medical device (100).

[0130] Advantageously, this further reduces the noise introduced into the force sensor (20), thus providing a more accurate reading of the force that brings the device into contact with the sample (200). Since the force sensor captures the force applied to it, it is highly desirable to minimize the noise recorded by the force sensor. By placing the force sensor within the distal portion (180) of the medical device (100), the force applied to the force sensor is not attenuated by the intermediate element between the distal end (190) in contact with the sample (200), thus increasing the signal-to-noise ratio (SNR) of the force sensor (200).

[0131] In another specific embodiment of the first aspect of the invention, such as Figure 1B As shown, the force sensor (20) is positioned perpendicular to the surface of the medical device (100) configured to contact the sample (200).

[0132] Advantageously, this further ensures that the force sensor (20) reads only the axial force applied to the sample, which further reduces noise introduced into the force sensor (20), such as lateral forces, and thus provides an accurate reading of the force that brings the device into contact with the sample (200).

[0133] It is worth noting that the predetermined force range of the torsional ultrasonic transducer is defined by considering only the pressure exerted on the sample by the transmitter-receiver assembly. In this case, lateral forces are not calculated, but only the force perpendicular to the sample applied by the axis of the device tip is calculated, where the force transmitter-receiver system is aligned.

[0134] In another specific embodiment of the first aspect of the invention, such as Figure 7 As shown, a force sensor (20) is included between the proximal portion (120) and the distal portion (180) of the medical device (100). Advantageously, this means that when a sample comes into contact with the distal portion (180) and a user applies force through the proximal portion (120), the transmitted force can be measured because the force sensor (20) is positioned between the two.

[0135] In an even more preferred embodiment, the force sensor (20) determines the force that brings the device (100) into contact with the sample based on the relative position of the distal portion (180) relative to the proximal portion (120). Advantageously, 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 derived from the force applied to the sample. For example, the sensor may have an elastic element that deforms when pressure is applied, and the deformation of the elastic element applies a force to the force sensor (20). Alternatively, the sensor may simply be positioned between the two portions and measure the force applied between them. Several other alternatives can be envisioned by those skilled in the art, by which the force sensor (20) is able to measure the relative position between the proximal portion (120) and the distal portion (180). According to this even more preferred embodiment, the force sensor (20) can measure changes in the relative position between the proximal portion (120) and the distal portion (180) in various directions, including lateral and longitudinal relative positions.

[0136] In such Figure 7 In an even more preferred embodiment of the foregoing embodiments shown, the force sensor (20) determines the force that causes the device (100) to contact the sample when the distal portion (180) moves longitudinally relative to the proximal portion (120). Figure 7 A diagram of a force sensor mechanism (20) of a device (100) according to one or more embodiments of the present invention is shown. Advantageously, this embodiment allows the force applied by the user of the device (100) (transmitted longitudinally along the device (100)) to be directly measured by the force sensor (20) through the longitudinal displacement of the proximal portion (120) relative to the distal portion (180), preferably when the two portions are close to each other.

[0137] like Figure 7 As shown, when a force (F) is applied to the sample via the distal portion (180), the distal portion (180) can move longitudinally relative to the proximal portion (120). 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 that causes the device (100) to contact the sample. For example, it can operate by detecting the force applied to the two portions when they approach each other longitudinally, or by detecting the release of some passively applied force when the force sensor (20) is passively subjected to a given force and longitudinal displacement occurs by bringing the two portions closer together. Those skilled in the art will recognize several ways in which the force sensor (20) can determine the force that causes the device (100) to contact the sample when the distal portion (180) moves longitudinally relative to the proximal portion (120).

[0138] Figure 7A schematic view of the operation of the force sensor mechanism (20) of the device (100) according to this embodiment is shown. However, this figure includes many other additional features that may not be covered in other embodiments or may be understood in a different manner.

[0139] For example, it can be seen that the distal portion (180) and the proximal portion (120) have a certain schematic shape that allows longitudinal displacement between them. Thus, the distal portion moves via a bearing (21), which allows longitudinal sliding between the two portions, thereby minimizing friction and wear while guiding the displacement. However, in other embodiments, the distal portion (180) may use an alternative solution to guide the longitudinal displacement, or it may not have any element guiding the longitudinal displacement. It can also be seen that... Figure 7 The force sensor (20) in the device determines the force that causes the device (100) to contact the sample when the distal portion (180) is longitudinally displaced relative to the proximal portion (120), thereby measuring the passive force released by the displacement. For this purpose, it includes several optional additional elements, which will be described below with reference to preferred embodiments.

[0140] In even more preferred embodiments, such as Figure 7 As depicted in the figure, the force sensor (20) is preloaded and determines the force required to bring the device (100) into contact with the sample based on the release of pressure on the sample as the distal portion (180) is longitudinally displaced relative to the proximal portion (120). Advantageously, by default defining the no-load reference force, this results in higher sensitivity of the force sensor (20).

[0141] The force sensor (20) is preloaded in such a way that when the device (100) is not in use, the sensor receives a constant force from another element (23). Preferably, this force is provided by an elastic element (23), such as a spring, which applies the force directly to the force sensor itself (20) or to another element that transmits the force to the force sensor (20). Therefore, in Figure 7 As can be seen, the device (100) includes an elastic element (23) in the form of a spring, which applies force in such a way that the distal (190) and proximal (110) sections are passively separated. Furthermore, it can be seen that the distal portion (180) itself has a proximal region, a clamp-like portion surrounding the force sensor (20) in such a way that the proximal portion has a support member in contact with the force sensor (20), thereby generating passive pressure on the force sensor (20) due to the preload generated by the elastic element (23). This occurs when the distal portion (180) separates from the proximal portion (120), and the support member of the proximal portion (120) is in the path of the distal portion (180), with the force sensor (20) located between them, thus generating a passive compressive force effect.

[0142] Once the device (100) comes into contact with the sample and applies force to it, the passive force provided by the spring (23) is canceled out, and the passive force applied to the force sensor (20) is released. The force sensor (20) interprets this phenomenon as an externally applied force.

[0143] In another specific embodiment of the first aspect of the invention, such as Figure 1B As shown, the force sensor (20) also includes a protection system configured to prevent damage to the force sensor (20) when a force exceeding the operating range is applied to the distal end (190) of the medical device (100).

[0144] Because the force sensor (20) is very sensitive in order to provide an accurate measurement of the force required to bring the device (100) into contact with the sample (200), the force sensor (20) may be damaged if a strong force is accidentally applied to the distal end (180) of the device (e.g., by placing the device (100) on its distal end (190) or by dropping the device.

[0145] 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).

[0146] To this end, the protection system can, for example, allow longitudinal displacement of the force sensor so that the applied force is not specifically absorbed by the force sensor, thereby preventing damage to the force sensor.

[0147] In a more preferred embodiment, such as Figure 1B As shown, the protection system includes a spring (21). The spring can be adjusted with an appropriate spring constant so that it deforms when a certain force is applied.

[0148] In another specific embodiment of the first aspect of the invention, such as Figure 2 and Figure 3 As shown, the medical device (100) also includes a handle (50) at its proximal end (110), which is configured to be held by hand and has an angle (α) between 85° and 120° relative to an axis (130) formed by the distal end (190) and the proximal end (110). In a preferred embodiment, the handle has an angle between 85° and 115° relative to the axis (130) formed by the distal end (190) and the proximal end (110), more preferably between 90° and 110°.

[0149] Advantageously, it has been found that 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), can significantly increase the dexterity and control of the medical device, and further enable better control of the force applied by the distal end (190) of the medical device (100) to the sample (200). This is because it has been shown that this angle range allows the natural movement of the arm and wrist to be aligned with the movement of the medical device (100) toward the sample (200). Therefore, it allows for a simpler way to ensure that the device contacts the sample (200) within a predetermined force range.

[0150] In another specific embodiment of the first aspect of the invention, the handle (50) has a diameter between 30 mm and 150 mm in any direction across its spindle.

[0151] In another specific embodiment of the first aspect of the invention, the handle (50) includes a surface having a rough material configured to increase grip strength.

[0152] In another specific embodiment of the first aspect of the invention, the handle (50) includes a recess configured to conform to the user's fingers.

[0153] In another specific embodiment of the first aspect of the invention, the processing unit (30) is configured to discard the readings of the torsional ultrasonic transducer (10) if the applied force is not within the range of a predetermined force.

[0154] Advantageously, this allows the medical device (100) to ensure that only readings within a predetermined force range are used, which significantly increases the reliability of the measurement results provided to the user. For example, when a user needs a reading, the torsional ultrasound transducer (10) may take 10 readings each time, but only a portion of these readings are used to determine the value of the torsional wave passing through the sample (200), as some readings are discarded because the force applied to the sample (200) is too large or too small.

[0155] In another specific embodiment of the first aspect of the invention, the processing unit (30) is configured to prevent the torsional ultrasonic transducer (10) from generating torsional waves if the applied force is not within the range of a predetermined force.

[0156] Advantageously, this allows the medical device (100) to ensure that it will not initiate torsional waves through the sample (200) unless a force is provided within a predetermined range of forces, which significantly increases the reliability of the measurement results provided to the user.

[0157] For example, such as Figure 6 A and Figure 6As shown in Figure B, the applied force is below the minimum value within the required range, and the processing unit (30) is configured to prevent the torsional ultrasonic transducer (10) from causing torsional waves.

[0158] Even if the user has indicated a desire to induce a torsional wave through the sample (200), the processing unit can prevent this from happening unless the applied force is within the range of the predetermined force of the torsional ultrasonic transducer (10) for the application of interest.

[0159] In another specific embodiment of the first aspect of the invention, the medical device (100) includes a dummy portion between a distal portion (180) and a proximal portion (120), configured to increase the distance between the distal end (190) and the handle (50). Advantageously, this prevents the user from contacting the sample (200) or any other sensitive element while using the medical device (100). For example, when the medical device is a probe (100) configured to contact the cervix (200), the probe (100) with the dummy portion increases the distance between the distal end (190) and the handle (50), thereby preventing the clinician from being obstructed by the patient's body or the speculum, making the use of the probe (100) simpler and more user-friendly for both the clinician and the patient.

[0160] In another preferred embodiment of the invention, such as for Figure 8 As shown, the torsional ultrasonic transducer (10) includes a transmitter device for emitting torsional ultrasonic waves, wherein the transmitter device includes an electrical signal generator (13) connected to an electromechanical actuator (12), which in turn is attached to a contact element (11) in contact with the sample (200), such that when the actuator receives an electrical signal, it causes a rotational movement of the contact element (11), and when the contact element (11) contacts the sample (200), it causes a torsional wave passing through the sample (200), wherein the torsional ultrasonic transducer (10) also includes means for receiving the distorted signal after passing through (200).

[0161] With this configuration, the transducer of the present invention transmits a torsional wave, rather than a longitudinal wave, which improves the quality of the received signal. Unlike other known transducers with flat wavefronts that propagate along the depth, the wavefront achieved using the transmitter of the present invention is a radially propagating and simultaneously penetrating wavefront (ring wavefront).

[0162] Another aspect of the present invention relates to a method for transmitting torsional waves using the transmitter of the present invention.

[0163] In a particular embodiment, the electrical signal used to stimulate the actuator in the method will be an oscillating signal, more preferably a sinusoidal signal, and even more preferably a sinusoidal signal.

[0164] In this case, the change in voltage over time corresponds to the following function:

[0165] V(t)=A·sin(ωt)

[0166] Where A is the maximum amplitude of the wave, corresponding to the maximum generated voltage.

[0167] In another particular embodiment, the contact element has a fairly truncated conical shape ( Figure 9 The smaller base (b) is attached to the electromechanical actuator, and the larger base (B) is arranged at the far end of the transducer of the present invention so as to contact the sample on which shear waves are to be transmitted.

[0168] In a preferred embodiment, the contact element is made of a biocompatible material.

[0169] In another specific embodiment, the electromechanical actuator is covered by a Faraday cage to eliminate electronic noise. Specifically, the electromechanical actuator is encased in a conductive covering that acts as a Faraday cage.

[0170] In another preferred aspect of the invention, the transducer is capable of generating a torsional ultrasonic pulse that propagates through a sample and is capable of picking up the distorted pulse after it has passed through the sample. The transducer (“the transducer of the invention”) is a transducer comprising the transmitter of the invention and means for receiving the distorted signal after it has passed through the sample, hereinafter referred to as the “receiver”.

[0171] In a specific embodiment ( Figure 10 In this invention, the receiver of the transducer comprises two or more piezoelectric elements (15) positioned equidistantly from each other and placed between two rings (121A and 121B). These rings are preferably made of a non-conductive material, more preferably of a biocompatible material, such that each piezoelectric element is in contact with two electrodes of different charges arranged perpendicular to the polarization of the piezoelectric element.

[0172] In its preferred arrangement ( Figure 11 The rotation axis (e') of the receiver ring (14) and the axis (e) of the contact element (11) must be aligned with each other, and the transmitter is located inside the ring.

[0173] Similarly ( Figure 12 In order for both the transmitter and receiver to come into contact with the sample (S), the outer surface of one of the rings (called the front ring (121A)) and the flat surface of the contact element (11) must be on the same plane (P) (contact plane).

[0174] In another specific embodiment, the surface (inner surface) of the rings in contact with the piezoelectric elements will connect their respective positive and negative electrodes, so that each ring will independently act as an anode and cathode.

[0175] The polarization of a piezoelectric element (which can be understood as the direction between the positive and negative charges of the electrodes) can be implemented in two different ways. In a preferred embodiment, the polarization is parallel to the axis, and the electrodes are arranged on the side of the piezoelectric element; in a more preferred embodiment, the polarization (P) is perpendicular to the axis in the radial direction, and the electrodes are arranged at the attachment between the piezoelectric element and the ring. Figure 13 ).

[0176] In a preferred embodiment, the piezoelectric element (15) is made of piezoelectric ceramic PZT-4 or PZT-5.

[0177] The transducer's transmitting and receiving elements are arranged in the housing (7, Figure 14 Inside, in addition to protecting the transducer from physical impacts (such as drops or scratches), it also ensures the device functions because each component is fixed in the correct position.

[0178] In the specific case where the receiver of the transducer of the present invention is formed by concentric rings, the housing must allow the transmitter to remain within the rings such that its axis of rotation is rotated.

[0179] In a preferred embodiment, the housing is made of polylactic acid (PLA).

[0180] Optionally, in another specific embodiment, the transducer of the present invention further includes an attenuation element (18), preferably an attenuation material with a Shore hardness A of less than 80, fixed to the outer surface of the ring furthest from the area in contact with the sample, to prevent torsional waves from propagating in the opposite direction to the sample, thereby also preventing energy loss. Thus, effective emission of the torsional wave occurs only on one surface of the transducer, i.e., the surface in contact with the sample, and vibrations on the back side are canceled out by the attenuation element. Furthermore, the cancellation of waves emitted in the opposite direction to the sample means that the emitted waves require simpler processing, as a clearer signal is obtained.

[0181] In even more specific embodiments, the transducer of the present invention that allows for the transmission and reception of torsional waves includes the following elements:

[0182] ● The transmitter includes:

[0183] o Electrical signal generator

[0184] o An electromechanical actuator connected to an electrical signal generator and covered by a Faraday cage.

[0185] The contact element attached to the electromechanical actuator causes it to rotate when the actuator receives an electrical signal.

[0186] Transfer; and

[0187] ● Receiver, including:

[0188] The two rings are preferably made of a non-conductive material.

[0189] Two or more piezoelectric elements are arranged between the aforementioned rings and are equidistant.

[0190] The housing allows the transmitter to remain inside the receiver, such that the axes of the contact elements and the rings are aligned with each other, and the outer surfaces of the contact elements and one of the rings remain on the same plane, allowing them to contact the sample.

[0191] Furthermore, in another preferred embodiment, the transducer is equipped with a latex membrane adapted to the shape of the device, thereby utilizing an adapted involute structure between the transmitter and receiver to ensure the dissipation of waves traveling through the latex membrane.

[0192] Second aspect of the invention

[0193] like Figure 15 and Figure 16 As shown, the second aspect of the present invention relates to a medical device (100). It is worth noting that the medical device (100) of the second aspect of the present invention may be the same as or different from the medical device of the first aspect of the present invention. Therefore, it should be understood that any embodiment of the first aspect of the present invention may include features of any second aspect of the present invention in any possible combination, and vice versa.

[0194] The medical device (100) includes a proximal portion (120) and a distal portion (180) and is configured to contact a sample. Figure 15 and Figure 16 A perspective view of a medical device (100) according to one or more embodiments of the present invention is shown. Figure 16 The distal (190) and proximal (110) sections are shown in an exploded view according to one or more embodiments of the present invention. For the sake of brevity, the term "device" will hereafter be used specifically to refer to a medical device.

[0195] It is worth noting that the proximal portion (120) and distal portion (180) of the device (100) refer to different parts of the device (100), which may or may not be defined as having the same length. For example, in some embodiments, the proximal portion (120) may include most of the length of the device (100), while the distal portion (180) includes the remaining small portion of the device (100); and vice versa. Furthermore, as Figure 16As shown, the proximal portion (120) and the distal portion (180) can be physically divided into two separate components. However, in other embodiments, the proximal (110) and distal (190) sections may not be physically separate, but may be confined to different parts of the device (100), even though they belong to the same component of the device. Therefore, in some embodiments, the proximal (110) and distal (190) sections may simply be spatial concepts defined on the same entity. Furthermore, Figure 16 The proximal (110) and distal (190) sections are shown to be mechanically connected by a threaded mechanism, for example. However, as those skilled in the art will recognize, there are several effective alternatives to connecting these two parts. For example, you can use a clamping mechanism, a closure by screws passing through both parts, or a magnetic system. These, and the rest, are obvious to those skilled in the art and are also part of the invention. Furthermore, it can be observed that the device (100) has a substantially elongated shape, but in other embodiments it may take other non-elongated shapes.

[0196] According to a second aspect of the invention, the device (100) is characterized by: a conduit (62), a sealing element (64), and a vacuum pump (65).

[0197] The conduit (62) is configured to connect the outside to the inner space (12) of the device (100), such that the conduit (62) connects to the outside through an opening (63). The conduit (62) can be a tubular object configured to connect the inner space (12) and the outside, terminating at the opening (63) in such a way that the tubular object terminates at the opening (63), or it can be a cavity of the device (100), creating a connection between the outside and the inner space (12) of the device (100) through such an opening (63). Thus, it can be observed that when the conduit (62) is tubular, it can have different shapes and is generally regular, capable of exhibiting different shapes and widths along its length. It can also have different lengths, including the almost symbolic possibility of the conduit (62) entering the inner space (12) of the device (100) through the opening (63). Figure 15 and Figure 16 In this configuration, the conduit (62) connects the outside to the inner space (12) of the device (100) through an opening (63). It can be seen that, in this case, the inner space (12) is defined as the space of the device (100) that does not directly communicate with the outside through the opening (63), and preferably includes a vacuum pump (65). Figure 15 and Figure 16 In this case, it includes the entire proximal portion (120) and a portion of the distal portion (180) because, although the two portions are detachably connected, they define a separate waterproof space in use, which includes all the electronics used to operate the medical device (100).

[0198] Furthermore, it has been observed that the aperture (63) can take different forms. For example, in some embodiments according to the invention, the opening (63) may be a circular hole defined on the surface of the device (100), but in other embodiments, the opening (63) may be a longitudinal hole defined along a larger surface. It should also be noted that in some embodiments, the device (100) may include two or more openings (63) defined on the surface of the device (100). Furthermore, when the device (100) includes more than one opening (63), these openings (63) may be identical to each other or have different shapes and sizes. The openings may also be located at different locations on the surface of the device (100).

[0199] A sealing element (64) is located at the end of the conduit (62) opposite the opening (63). In this way, the sealing element (64) is configured to control airflow between the internal space (12) of the device (100) and the conduit (62), such that all fluid communication is through the sealing element (64). Therefore, the sealing element (64) must cover the entire device body between the conduit (62) and the internal space (12) of the device (100) and effectively conform to its internal shape. The sealing element (64) can be composed of one or more sealing elements, such as a single piece of rubber located between two spaces, or a plastic component forming part of the same device (100). Figure 15 In the diagram, it is shown as a cylindrical sheet covering the entire width of the device body (100) between the conduit (62) and the internal space (12) of the device (100).

[0200] Vacuum pump (65) in Figure 15 and Figure 16 The diagram schematically illustrates the connection to a sealing element (64), in which the vacuum pump is configured to extract air from the opening (63) via a conduit (62). Thus, the sealing element (64) not only controls the airflow between the interior space (12) and the conduit (62), but also ensures that this airflow is controlled by the vacuum pump (65) connected to the sealing element (64). For this connection, the vacuum pump (65) can be integrated into the sealing element (64) or connected via a series of fluid connections (e.g., pipes (54)), as referenced below. Figure 17A The vacuum pump (65) can be of various types, such as rotary vane, diaphragm, or side-channel type. Therefore, the vacuum pump 65 of the present invention is not limited to any particular type of vacuum pump (65).

[0201] The device (100) is configured to receive a membrane (70) covering an opening (63) on its outer side. The device (100) may be configured to receive the membrane (70) in various ways. For example, it may have a series of fasteners for the membrane (70), which allow the membrane (70) to be secured to the device (100). For example, the fasteners may be in the form of hooks or indentations in which the membrane (70) may be secured. Alternatively, the device (100) may have a characteristic shape to allow a membrane (70) having a specified and complementary shape to be mounted thereon.

[0202] Since the device is configured to receive a membrane (70) covering the opening (63) on the outside, this implies 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 airflow between the internal space (12) controlled by the vacuum pump (65) and the conduit (62); and since the conduit (62) communicates with the outside through the opening (63), with the opening (63) covered by the membrane (70), the vacuum pump (65) is configured to extract air between the sealing element (64) and the membrane (70), such as... Figure 17A As shown.

[0203] Figure 17A A sample longitudinal cross-section of a device (100) according to one or more embodiments of the present invention is shown. It can be seen that the device (100) is covered by a membrane (70) covering the opening (63). Furthermore, as indicated by the directional arrows, air between the sealing element (64) and the membrane (70) is evacuated by a vacuum pump (65) generating a vacuum at the level of the sealing element (64), which allows for proper adjustment of the membrane (70) on the device (100).

[0204] In addition, as mentioned above, in some projects, the vacuum pump (65) can be connected to the sealing element (64) via a series of fluid connections (54), such as a vacuum tube, which can also extend through the sealing element (64) itself to the conduit (62).

[0205] Advantageously, the device (100) of the present invention allows the membrane (70) placed thereon to be quickly and effectively adjusted to the surface of the device (100), thereby ensuring that it is properly arranged thereon without altering the function of the medical device (100).

[0206] like Figure 15As shown, in some embodiments, the vacuum pump (65) can be controlled by a user of the medical device (100) via a series of interfaces (652) (e.g., buttons or external controllers) on the device itself (100). This allows the user to control the opening and closing of the vacuum pump (65) and / or the level of negative pressure it applies. Those skilled in the art may appreciate other controls, such as selection from a series of preset programs or used as a safety system, that ensure the pump only operates when a combination of multiple interfaces (652) is pressed simultaneously. In other embodiments, the vacuum pump (65) can be configured to continuously generate a vacuum without user interaction from the device (100), and therefore the interfaces (652) will not be required. In other embodiments, the device (100) may include a sensor that informs the device (100) when a 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 another control device. Therefore, interface (652) is optional.

[0207] To control the vacuum pump (65), the device (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 to be executed by the processor. It should be emphasized that the processor may include one or more processing units, such as a microprocessor, GPU, CPU, multi-core processor, or the like. 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, hard disk drive, floppy disk, magnetic tape, optical disk, etc. The drive may be implemented in software (computer program), hardware (physical device), or any combination thereof to perform the sequences of operations disclosed herein.

[0208] It can be seen that the vacuum pump (65) can be used as follows Figure 15 and Figure 16 The series of power cords (656) shown are supplied from the outside, but in other embodiments, the vacuum pump (65) may also be powered by an internal battery or internal power.

[0209] It can be seen that, Figure 15 , Figure 16 and Figure 17A A medical device (100) is shown that includes many other additional features, which may not be included in other embodiments or may be understood in different ways.

[0210] For example, in Figure 15 and Figure 16As can be seen in the figures, the device (100) has a substantially elongated shape, but other devices (100) according to the invention may not be substantially elongated. It can also be seen that the distal portion (180) is narrower than the proximal portion (120), and the proximal portion (120) contains almost all the electronics of the device (100). However, in other embodiments, the device may include other shapes, and the proximal portion (110) and the distal portion (190) may have similar, identical, or different shapes, depending on the application of the device (100). In this sense, the invention is not limited to any particular form of the device (100). As can be seen in both figures, the device (100) includes a power cord (56); however, in other embodiments, there may be no cord, and the device may be powered by an internal power source (e.g., a battery), or may include two or more cables (656) as information lines, allowing the device to be electronically connected to another device. Figure 15 It can also be seen that the device (100) includes three interfaces (652) configured to control it. However, in other embodiments, the device (100) may include more or fewer interfaces (652), or may not include any interfaces (652), as described above. Figure 16 As can be seen, the opening (63) is located at the far end of the far end portion (180) of the device (100) and has a circular shape. However, in other embodiments, the opening (63) may exist in another location and have other shapes and sizes, or have multiple openings (63) as described above.

[0211] for Figure 17A As described above, it can be seen that the vacuum pump (65) is located in the proximal portion (120) and connected to the sealing element (64) via a tube (54). However, in other embodiments, the vacuum pump (65) may be located next to the sealing element (64) or included in the sealing element itself (64). It can also be seen that the membrane (70) is arranged in a specific shape on the distal portion (180) of the device (100) having a specific distal end. However, in other embodiments, the device (100) may take other forms. In addition, several optional additional elements are also appreciated, which will be described below with reference to preferred embodiments.

[0212] In a preferred embodiment, such as Figure 17A As shown, a vacuum pump (65) is connected to a pressure sensor (67), which is configured to measure the pressure in the pipe (62). The pressure sensor (67) can be of various types, such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical, or potentiometer. Therefore, the pressure sensor (67) of the present invention is not limited to any particular type of pressure sensor.

[0213] exist Figure 17AIn this configuration, a pressure sensor (67) is connected to a vacuum pump (65) via a fluid connection (57), which fluidly connects the pressure sensor (67) to a tube (54), which in turn connects to the vacuum pump (65) and the conduit (62). However, in other versions, the pressure sensor (67) may be incorporated into the vacuum pump (65) or connected to the conduit (62), the vacuum pump (65), the tube (54), or a sealing element (64). Those skilled in the art will foresee that the pressure sensor (67) may be positioned in various ways to measure the pressure applied in the conduit (62).

[0214] Furthermore, in this implementation, the vacuum pump (65) is configured to regulate its operation based on the pressure measured by the pressure sensor (7). The vacuum pump (65) may be regulated or not regulated based on 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 achieved in various ways; for example, the vacuum pump (65) may be configured to maintain a negative pressure relative to a given ambient pressure so that the vacuum pump starts until that value is reached. Once the pressure rises above that value or a value indicating a vacuum loss, the pump can be restarted until that pressure is reached again. Alternatively, the pump can be started continuously, and its vacuum power can be modified in such a way that when the minimum pressure is reached, its suction level decreases, and when the pressure rises above that value or a value indicating a vacuum loss, the suction pressure increases again until the minimum reference pressure value is reached. Therefore, in those devices that include the algorithm, the memory of the device (100) can store instructions corresponding to the algorithm, and the processor of the device (100) can execute these instructions stored in the memory. Alternatively, the memory and / or processor can be externally located, and the vacuum pump (65) can be directly controlled from the outside.

[0215] Advantageously, this preferred embodiment allows the device (100) to ensure that the vacuum pump (65) maintains pressure over time, thereby always adjusting the membrane (70). This is particularly useful when the device (100) is used with samples that may cause the membrane (70) to shift or partially lose vacuum, increasing the pressure in the space between the membrane (70) and the sealing element (64).

[0216] In some embodiments, when the device (100) includes one or more interfaces (52), the interfaces (652) can set a target pressure for the vacuum pump (65) so that the minimum pressure to be maintained can be adjusted. Furthermore, the device (100) may include a visual interface, such as a display or a series of LEDs, allowing the user (100) to understand the minimum set pressure that the vacuum pump (65) is configured to maintain. Advantageously, this allows the user of the device (100) to adjust the minimum pressure in the space between the diaphragm (70) and the sealing element (64) during use of the device (100), for example, if conditions change.

[0217] In another preferred embodiment, the device (100) is substantially elongated and configured to contact the sample via a distal portion (180), wherein the device (100) is configured such that the membrane (70) at least covers the distal portion (180). (See Figure 1.) Figure 2 and Figure 20A As shown, the device (100) is essentially elongated, especially in its distal portion (180). Furthermore, as... Figure 17A As shown, the device (100) is configured such that the membrane (70) at least covers the distal portion (180), and since the device (100) is configured to contact the sample through the distal portion (180), this implies that the device (100) is configured to contact the sample through the membrane (70) closely arranged by the vacuum pump (65). When the device (100) is configured such that the membrane (70) covers a portion of the proximal portion (120), the opening (63) may be located in either the distal portion (180) or the proximal portion (120) where the membrane (70) is disposed.

[0218] In a more preferred embodiment, the opening (63) is included in the distal portion (180) of the device (100). Advantageously, since the membrane (70) is arranged on the distal portion (180) and the device (100) is inherently elongated, this allows a vacuum to be generated from a point that allows for uniform adjustment of the arrangement of the membrane (70), thus avoiding wrinkles. Most preferably, the opening (63) is located at the distal end of the distal portion (180). Advantageously, this allows for a more uniform and compact arrangement of the membrane (70). In embodiments where the device (100) includes more than one opening (63), according to this preferred embodiment, the device (100) includes at least one opening (63) in the distal portion (180) of the device (100), preferably at the distal end of the distal portion (180).

[0219] In another preferred embodiment, such as Figure 17B As shown, the device (100) includes a force sensor (20) configured to determine the force that causes the device (100) to contact the sample. Figure 17BA simplified longitudinal cross-section of the distal portion (180) of a device (100) according to one or more embodiments of the present invention is shown.

[0220] like Figure 17B As shown, the device (100) includes a force sensor (20) capable of recording the force applied by a user when bringing the device (100) into contact with a sample. Advantageously, this allows the device (100) to measure the force in embodiments where the pressure applied to the sample affects the measurement results of the device (100). The force sensor (20) can be of various types and can be similar to, the same as, or different from the pressure sensor (67), such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical or potentiometric extensometer, etc. Therefore, the force sensor (20) of the present invention is not limited to any particular type of force sensor.

[0221] Preferably, the device includes an interface (652) that allows a user to receive information about the pressure applied to the sample by the device (100) so that adjustments can be made accordingly. The interface may include a display or a set of LEDs by defining default code labels. For this purpose, in the device (100) including the algorithm, the device's memory may store instructions corresponding to the algorithm, and the device's processor may execute these instructions stored in the memory. Alternatively, the memory and / or processor may be externally included, and the information to be displayed to the user may be processed externally.

[0222] and Figure 17A Same, Figure 17B A device (100) is shown that includes many other additional features, which may not be included in other embodiments or may be understood in different ways. Those commonalities, such as the shape of the device (100) and the sealing element (64), can be applied in the same manner. It should also be noted that the device (100) includes a force sensor (20) located proximal to the distal portion (180) of the device (100). However, in other embodiments, the force sensor (20) may be included at other locations on the device (100) and may have a different type of mechanism of action.

[0223] In a more preferred embodiment, the distal portion (180) is configured to contact the sample, and a force sensor (20) is arranged between the distal portion (180) and the proximal portion (120). Advantageously, this means that when the sample contacts the distal portion (180) and the user applies force through the proximal portion (120), the transmitted force can be measured because the force sensor (20) is arranged between the two.

[0224] In an even more preferred embodiment, the force sensor (20) determines the force that brings the device (100) into contact with the sample based on the relative position of the distal portion (180) relative to the proximal portion (120). Advantageously, 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 derived from the force applied to the sample. For example, the sensor may have an elastic element that deforms when pressure is applied, and this deformation applies a force to the force sensor (20). Alternatively, the sensor may simply be positioned between the two portions and measure the force applied between them. Several other alternatives can be envisioned by those skilled in the art, by which the force sensor (20) is able to measure the relative position between the proximal portion (120) and the distal portion (180). According to this even more preferred embodiment, the force sensor (20) can measure changes in the relative position between the proximal portion (120) and the distal portion (180) in various directions, including lateral and longitudinal relative positions.

[0225] In such Figure 7 In an even more preferred embodiment of the foregoing embodiments shown, the force sensor (20) determines the force that causes the device (100) to contact the sample when the distal portion (180) moves longitudinally relative to the proximal portion (120). Figure 7 A diagram of a force sensor mechanism (20) of a device (100) according to one or more embodiments of the present invention is shown. Advantageously, this embodiment allows the force applied by the user of the device (100) (transmitted longitudinally along the device (100)) to be directly measured by the force sensor (20) through the longitudinal displacement of the proximal portion (120) relative to the distal portion (180), preferably when the two portions are close to each other.

[0226] like Figure 7 As shown, when a force (F) is applied to the sample via the distal portion (180), the distal portion (180) can move longitudinally relative to the proximal portion (120). 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 that causes the device (100) to contact the sample. For example, it can operate by detecting the force applied to the two portions when they approach each other longitudinally, or by detecting the release of some passively applied force when the force sensor (20) is passively subjected to a given force and longitudinal displacement occurs by bringing the two portions closer together. Those skilled in the art will recognize several ways in which the force sensor (20) can determine the force that causes the device (100) to contact the sample when the distal portion (180) moves longitudinally relative to the proximal portion (120).

[0227] Figure 7A schematic view of the operation of the force sensor mechanism (20) of the device (100) according to this embodiment is shown. However, this figure includes many other additional features that may not be covered in other embodiments or may be understood in a different manner.

[0228] For example, it can be seen that the distal portion (180) and the proximal portion (120) have a certain schematic shape to allow longitudinal displacement between them. Thus, the distal portion moves via a bearing (21), which allows longitudinal sliding between the two portions, thereby minimizing friction and wear while guiding the displacement. However, in other embodiments, the distal portion (180) may use an alternative solution to guide the longitudinal displacement, or it may not have any element guiding the longitudinal displacement. It can also be seen that... Figure 7 The force sensor (20) in the device determines the force that causes the device (100) to contact the sample when the distal portion (180) is longitudinally displaced relative to the proximal portion (120), thereby measuring the passive force released by the displacement. For this purpose, it includes several optional additional elements, which will be described below with reference to preferred embodiments.

[0229] In even more preferred embodiments, such as Figure 7 As depicted in the figure, the force sensor (20) is preloaded and determines the force required to bring the device (100) into contact with the sample based on the release of pressure on the sample as the distal portion (180) is longitudinally displaced relative to the proximal portion (120). Advantageously, by default defining the no-load reference force, this results in higher sensitivity of the force sensor (20).

[0230] The force sensor (20) is preloaded in such a way that when the device (100) is not in use, the sensor receives a constant force from another element (23). Preferably, this force is provided by an elastic element (23), such as a spring, which applies the force directly to the force sensor itself (20) or to another element that transmits the force to the force sensor (20). Therefore, in Figure 7 As can be seen, the device (100) includes an elastic element (23) in the form of a spring, which applies force in such a way that the distal (190) and proximal (110) sections are passively separated. Furthermore, it can be seen that the distal portion (180) itself has a proximal region, a clamp-like portion surrounding the force sensor (20) in such a way that the proximal portion has a support member in contact with the force sensor (20), thereby generating passive pressure on the force sensor (20) due to the preload generated by the elastic element (23). This occurs when the distal portion (180) separates from the proximal portion (120), and the support member of the proximal portion (120) is in the path of the distal portion (180), with the force sensor (20) located between them, thus generating a passive compressive force effect.

[0231] Once the device (100) comes into contact with the sample and applies force to it, the passive force provided by the spring (23) is canceled out, and the passive force applied to the force sensor (20) is released. The force sensor (20) interprets this phenomenon as an externally applied force.

[0232] In another preferred embodiment of the invention, such as Figure 17A As shown, the membrane (70) is preventative. Advantageously, this allows the device (100) to be covered by the membrane (70) at low cost and is readily available. Preferably, the outer surface of the preventative element (70) additionally includes a lubricant to facilitate introduction into the device (100) through a conduit or cavity for the sample.

[0233] In another preferred embodiment of the invention, the device (100) includes at least one recess (69) on its outer surface, which is configured as an edge of the receiving membrane (70).

[0234] Those skilled in the art will understand that the indentation (69) can be formed in various ways. For example, the indentation (69) can be formed as a groove on the outer surface of the device (100), or it can be formed by arranging one or more radial extensions of the surface such that the indentation is radially formed on the proximal surface of the device (100). Very preferably, the indentation (69) will define a plane perpendicular to the longitudinal axis of the device (100). The indentation (69) can be defined at different heights of the device (100), in the proximal portion (120) and the distal portion (180). In a preferred embodiment, the indentation (69) will be defined at the proximal end of the distal portion (180).

[0235] In addition, Figure 20A and Figure 20B As can be seen, the indentation (69) is configured to receive the edge (69) of the membrane (70) of the covering device (100). The membrane (70) is substantially elongated, preferably substantially cylindrical, in shape such that the edge (69) of the membrane (70) may include a portion of the membrane (70).

[0236] Advantageously, this design of the indentation (69) allows the device (100) to be configured such that once the membrane (70) is arranged such that the edge (69) of the membrane (70) is received by the indentation (69), the membrane (70) is secured in the device (100).

[0237] In even more preferred embodiments, the indentation (69) is configured to receive the edge of the membrane (70) in a sealed manner. For example, the indentation (69) may comprise a series of seals with a high coefficient of friction to create greater tightness between the surfaces of the device (100), or it may be optimally designed to receive the edge (69) of the membrane (70). Advantageously, once the vacuum pump (65) generates minimum pressure, the surface of the membrane (70) is sealed, thereby preventing air leakage into the defined space between the sealing element (64) and the membrane (70), resulting in a more efficient vacuum system.

[0238] In another preferred embodiment, the device (100) is a probe. In this embodiment, the device (100) is essentially elongated and advantageously benefits from the solution proposed in this invention because it contacts the sample via a distal portion (180) on which the membrane (70) is arranged, and can easily accommodate an opening (63) at the distal end of the distal portion (180), since in many cases, the probe includes various solutions, such as sensors or other surgical instruments, at the distal end of its distal portion (180). Advantageously, this more preferred method allows the use of the same probe (100) in multiple scans by having a mechanism that tightly arranges the membrane (70) on the probe (100) in multiple scans, simply by changing the membrane (70) placed on the probe (100) in each scan.

[0239] In a more preferred embodiment, the device (100) is a uterine probe and the sample is the cervix. Preferably, the distal end (190) of the distal portion (180) is configured to receive the cervix from the patient's uterus, using a design including a notch (192) to allow access to the cervix once the probe is inserted into the vagina. It should be noted that Figure 1... Figure 2 , Figure 20A and Figure 20B The probe (100) in this example is merely representative, and the uterine probe (100) can be of different shapes, enabling it to interact in different ways, for different applications, and / or in different orientations. Advantageously, this more preferred method allows the use of the same uterine probe (100) in different examinations of the same or different patients, simply by changing the membrane (70) placed on the probe (100) for each examination.

[0240] In an even more preferred embodiment, the device (100) is a uterine torsion wave probe (100) comprising a torsion wave transmitter and receiver at its 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 several examinations of the same or different patients, simply by changing the membrane (70) placed on the probe (100) for each examination. Even more preferably, the uterine torsion wave probe (100) is a torsion ultrasound (100) probe.

[0241] Even more preferably, the device (100) is a uterine torsion wave probe (100) such that it includes a torsion wave emitting device, which in turn includes an electrical signal generator connected to an electromechanical actuator attached to the distal end of the probe, such that when the actuator receives an electrical signal, it causes a rotational movement of a contact element, and when the contact element contacts the sample, this rotational movement causes a torsion wave passing through the sample. Preferably, the probe (100) also includes means for receiving the distorted signal after passing through the sample. For example, the medium may include two or more piezoelectric elements positioned equidistantly from each other and placed between two rings made of a non-conductive material.

[0242] Third aspect of the invention

[0243] The third aspect of the invention can be Figure 18A and Figure 18B The image shows a perspective view of a device (300) for distributing a membrane (70) in a probe (not shown) according to one or more embodiments of the invention. Note that the probe of the third aspect of the invention may be the same medical device (100) as that of the first aspect of the invention or a different medical device. Therefore, it can be understood that any embodiment of the first aspect of the invention may include features of any second aspect of the invention in any possible combination, and vice versa.

[0244] The device (300) is inherently elongated, which allows it to be configured as a longitudinal receiving probe (not shown). It should be noted that, although... Figure 18A and Figure 18B A device (300) with a certain length and aspect ratio has been described, but the device (300) of the present invention is not limited to any particular length. Similarly, it can be seen that... Figure 18A and Figure 18B The device (300) in the invention has an irregular shape on the outside; however, the invention is not limited thereto, and in other embodiments, it may have a different shape on the outside or may be completely smooth.

[0245] The device (300) includes a proximal region and a distal region. The proximal region includes an opening (302) and a recess (304). The opening (302) is configured for inserting a probe (not shown), and a membrane (70) is arranged to the probe in such a way that the probe (not shown) is inserted into the device (300). Although Figure 18A A circular opening is shown, but the form of the opening (302) of the present invention is not limited. Therefore, in other embodiments, the aperture can have different sizes and shapes, which can vary depending on the shape of the probe (not shown) and the membrane (70), as will be understood by those skilled in the art. Thus, for example, the opening can be elliptical, quadrilateral, or any other shape.

[0246] The indentation (304) is radially defined by the outer surface of the proximal region of the device (300). As will be understood by those skilled in the art, the indentation (304) can be formed in various ways. For example, the indentation can be formed as a groove on the outer surface of the device (300), or it can be formed by arranging one or more radial extensions of the surface in such a way that a radial indentation is formed on the proximal surface of the device (300). Very preferably, the indentation (304) will define a plane parallel to the opening (302). The indentation can be defined at different distances from the opening (302). Preferably, the indentation (304) will be defined at the end of the proximal area, immediately adjacent to the opening (302).

[0247] In addition, such as Figure 18B As seen, the recess (304) is configured to receive the edge (74) of the membrane (70) covering the opening (302). The membrane (70) is substantially elongated, preferably substantially cylindrical, such that the edge (74) of the membrane (70) includes a portion of the membrane (70). The membrane (70) to be received is substantially elongated so that it can accommodate the length and width of the probe (not shown) to be covered. Since the edge (74) includes a portion of the membrane (70), the membrane has a substantially flat configuration when its edge (74) is placed in the recess (304). Preferably, the edge (74) includes a portion of the membrane (70) formed in a wound manner, such that the membrane (70) is wound internally and included between the unfolded membrane (70) and the recess (304), as... Figure 18B As shown. The indentation (304) is preferably defined as a substantially concave shape, such that it can receive an edge (74) having a preferably annular shape.

[0248] Advantageously, this design of the indentation (304) allows the device (300) to be configured such that once the membrane (70) is arranged such that the edge (74) of the membrane (70) is received by the indentation (304), the membrane completely covers the opening (302), thus allowing the entire process to be performed without contact with the membrane at any time, ensuring its sterility. Since the opening (302) is configured for insertion of the probe (100), insertion of the probe (100) involves forcefully applying the membrane (70) onto the surface of the probe (100), as will be discussed below. Figure 20A , Figure 20B , Figure 21A and Figure 21B To explain.

[0249] It can be seen that, Figure 18A and Figure 18B A device (300) is shown that includes many other additional features that may not be found or are found differently in other embodiments. For example, in its distal region, the device (300) includes a circular handle-like surface (364) that allows the device to be gripped (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 lateral openings (12) that allow observation of the correct arrangement of the membrane (70) on the probe (100), which is not shown. However, in other embodiments, the lateral openings (12) may be non-contacting, have a different shape, or the number of openings may be different. The device (300) also includes a series of extensions in the proximal and distal regions to allow for better manipulation of the device (300) during use. However, in other embodiments, the device may not include these extensions or may have other shapes.

[0250] It can also be seen that, Figure 18B The membrane (70) shown has a substantially circular shape. However, in other embodiments, the device (300) may be configured to receive the edges of membranes with different or irregular shapes. In this way, the device (300) according to the invention may be configured to arrange membranes (70) of different shapes to fit on probes of different 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 the protrusion (72), or it may include the protrusion at another non-central location, or it may have more than one protrusion (72) or have one or more protrusions (72) of different shapes. Preferably, the membrane (70) includes a lubricant on its outer surface to facilitate the introduction of the probe (100) through a conduit or body cavity.

[0251] Figure 19A and Figure 19BOne or more embodiments of the present invention are shown. Figure 18A A perspective view and longitudinal section of a device (300) having a membrane (70) and a probe (100), the device being configured to receive the membrane and the probe.

[0252] The probe (100) is essentially tubular and allows for probe, diagnosis, and / or the delivery of treatment through catheters or cavities within the body. It should be noted that... Figure 19A and Figure 19B The probe (100) has an inner surface such that its interior is hollow, allowing access from the proximal portion opposite the distal end (190). However, in other embodiments, the probe (100) may be solid rather than hollow, or may have a different design, for example, housing different elements within it depending on the function the probe is to perform. Similarly, the probe (100) is also widened in its proximal portion. However, in other embodiments, the probe (100) may not include this widening 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) once the membrane (70) is placed on the probe (100), as will be discussed later. Figure 20A , 20B The explanation is based on 21A and 21B.

[0253] It should be noted that, such as Figure 18A and Figure 18B As shown, the device (300) and membrane (70) include additional features that may not be present or may be present in different ways in other embodiments. Therefore, the same considerations regarding alternative forms also apply. Figure 19A and Figure 19B .

[0254] In such Figure 19A and Figure 19B In the preferred embodiment shown, the probe (100) includes a distal end (190) through which the probe is introduced into the device (300). The distal end (190) of the probe (100) can have various shapes and sizes depending on the catheter application. The probe (100) has a distal end with a specific shape, such as... Figure 19B As shown, but in other embodiments, the shape of the distal end (190) may be different.

[0255] In this preferred embodiment, the device (300) also includes a distal end (360) in its distal region, which in turn includes an inner surface of the distal end (190) configured to receive the probe (100). Advantageously, this allows the membrane (70) to be inserted into the device (300) to be closely arranged at the distal end (190) of the probe (100).

[0256] In even more preferred embodiments, such as Figure 19A and Figure 19B As shown, the inner surface of the distal end (360) of the device (300) includes a complementary shape to the distal end (190) of the probe (100), and is configured to arrange a membrane (70) in uniform contact with the distal end (190) of the probe (100) along the entire surface of the distal end (190) of the probe (100).

[0257] Figure 20A and Figure 20B One or more embodiments of the present invention are shown. Figure 18A The image shows a perspective view and longitudinal section of the device, with the probe fully inserted and the membrane fully positioned on it. It should be noted that... Figure 18A , Figure 18B , Figure 19A and Figure 19B As shown, the device (300), membrane (70), and probe (100) include additional features that may not be present or may be present in different ways in other embodiments. Therefore, the same considerations regarding alternative forms also apply. Figure 20A and Figure 20B .

[0258] like Figure 20A and Figure 20B As shown, 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) includes the complementary shape of the distal end (190) of the probe (100), the membrane is evenly arranged between the device (300) and the probe (100) along the entire surface of the distal end (190) of the probe (100).

[0259] exist Figure 19A , Figure 19B , Figure 20A and Figure 20B In the case of the device (300), the membrane is arranged in a characteristic pattern, in Figure 20B The indentation (192) is considered in the longitudinal section. This is the surface shape of the distal end (190) of the probe (100) according to the example in the reference figure. However, it can be seen that in other embodiments, the probe (100) may include a distal end (190) with a different shaped surface, with or without the indentation (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 evenly distributed on the surface of the probe (100), especially on the surface of the distal end (190) of the probe (100).

[0260] Therefore, advantageously, even if the distal end (190) of the probe (100) is irregularly shaped, this preferred embodiment allows the membrane (70) to be evenly distributed on the probe (100) during insertion.

[0261] like Figure 20A and Figure 20B As shown, when the membrane (70) unfolds from its planar shape, it obtains an elongated shape, preferably a substantially cylindrical shape. The edge (74) of the membrane (70), which includes a portion of the membrane (70), hardly constitutes a portion of the membrane (70) because it has already unfolded when the probe (100) is introduced into the device (300). Thus, the indentation (304) of the device (300) contains only a portion of the membrane because almost the entire edge has been unfolded. In a preferred embodiment, the edge (74) includes the portion of the membrane (70) in the form of a coil, which is unfolded by unwinding.

[0262] According to another preferred embodiment of the invention, the distal end (360) of the device (300) is configured to be decoupled from the rest of the device (300) and replaced by another distal end (not shown) of the device (300) depending on the distal end (190) of the probe (100). Advantageously, this allows the same device (300) to be compatible with different probes (100) and to be able to place membranes (70) on them regardless of their shape or size.

[0263] In this preferred embodiment, the device (300) is designed to accommodate the membrane (70) on different probes (100), regardless of their length or the shape of their distal ends (190). When the device (300) has a distal end (360) configured for probes other than the probe (100) to which we want to attach the membrane (70), we can decouple the distal end (360) from the device (300) and replace it with another distal end (not shown) suitable for the probe (100).

[0264] It should be noted that those skilled in the art will understand that the distal end (360) can be adapted to have different lengths, widths, and shapes depending on the probe (100). Therefore, for example, if the probe (100) is longer than the probe with the distal end (360), it can be replaced with a new distal end that is longer than the current distal end (360). Similarly, if the width or shape of the probe (100) differs from that of the probe with the distal end (360), it can be replaced with a new distal end that has a different width or shape than the current distal end (360).

[0265] It should also be noted that the remote end (360) of the device (300) can be decoupled and attached in various ways. Although Figure 19B and Figure 20BThe device (300) shown is attached to the rest of the device (300) by means of screws (62), but those skilled in the art will observe that in other embodiments, there are several alternatives in which the distal end (360) of the device (300) can be used. For example, the distal end (360) may have a threaded surface, such that mating is achieved by screwing the distal end (360) into the distal region of the device (300). Alternatively, the distal end (360) snaps into the distal region of the device (300). All these alternatives are also part of the present invention.

[0266] According to another preferred embodiment of the invention, when the probe (100) is fully inserted into the device (300), the opening (302) is configured to conform to the corresponding surface of the probe (100). Figure 20A and Figure 20B As shown, the device (300) has an opening (302) wherein, when the probe (100) is fully inserted into the device (300), the aperture has a specific shape that conforms to the corresponding surface of the probe (100).

[0267] Advantageously, this means that when the membrane (70) is fully positioned on the surface of the probe (100) (which occurs when the probe (100) is fully inserted into the device (300), the membrane (70) adheres tightly to the surface of the probe (100), which helps it adhere to the designated location.

[0268] More preferably, when the probe (100) has a circular cross-section to define the diameter (35), such as Figure 18A , Figure 19B and Figure 20B As shown, the opening (302) is set to conform to the diameter (35) of the probe (100) surface at the corresponding position when the probe (100) is fully inserted into the device (300). It can be seen from these figures that when the probe (100) is fully inserted into the device (300), the diameter of the opening (302) of the device (300) is equal to the diameter (35) of the probe (100) at the height of the opening (302).

[0269] It should be noted that, although Figure 19A , Figure 19B , Figure 20A and Figure 20B The device (300) and probe (100) are configured such that when the probe (100) is fully inserted into the device (300), the position of the probe (100) at the opening (302) is wider than the rest of the probe (100), but in other embodiments, the width of the probe (100) at this height may be equal to the rest of the probe.

[0270] In another preferred embodiment of the invention, the notch (304) is configured to allow the release of the membrane (70) once the probe (100) has been inserted into the distal end (360) of the device (300). Once the probe (100) has been inserted into the distal end (360) of the device (300), the edge (74) of the membrane (70) hardly constitutes part of the membrane because it has already unfolded when the probe (100) has been inserted into the device (300). According to the figures discussed, the notch (304) of the device (300) includes a sloping surface that exerts almost no resistance to the release of the edge (74) of the notch (304) once the edge has unfolded. Therefore, by removing the probe (100) from the device (300), the edge (74) of the membrane (70) can be released from the notch (304) of the device (300). It should be noted that in other embodiments, the slit may be configured to allow release of the membrane (70) once the probe (100) is introduced to the distal end (360) of the device (300), as will be understood by those skilled in the art. For example, in other embodiments, the device (300) may have a flexible or retractable notch (304) configured such that it no longer receives the edge (74) of the membrane when the probe (100) is inserted to the distal end (360) of the device (300).

[0271] Advantageously, this allows the probe (100) to be inserted into the device (300) in the same orientation, which, as explained, arranges the membrane (70) similarly on the surface of the probe (100) and also frees the membrane (70) from the recess (304), thus making the system simple and efficient.

[0272] Figure 21A and Figure 21B One or more embodiments of the present invention are shown. Figure 18A Perspective and longitudinal sectional views of the device and the probe once removed from it. It should be noted that, as Figure 18A , Figure 18B , Figure 19A , Figure 19B , Figure 20A and Figure 20B As shown, the device (300), membrane (70), and probe (100) include additional features that may not be present or may be present in different ways in other embodiments. Therefore, the same considerations regarding alternative forms also apply. Figure 21A and Figure 21B .

[0273] In another preferred embodiment of the invention, the device (300) is configured to place the membrane (70) in the probe (100), and the probe (100) in turn includes a slit or recess (69) in its proximal part, which is configured to receive the edge (74) of the membrane (70) once the membrane (70) is placed on the probe (100).

[0274] Those skilled in the art will understand that the indentation (69), similar to the indentation (304), can be formed in various ways. For example, the indentation can be formed as a groove on the outer surface of the device (300), or it can be formed by arranging one or more radial extensions of the surface in such a way that a radial indentation is formed on the proximal surface of the device (300). Very preferably, the indentation (69) will define a plane parallel to the longitudinal axis of the probe (100). When the probe (100) is fully inserted into the device (300), the slit can be defined at a distance from the position of the probe (100) at the opening (302). Preferably, the slit (34) will be defined at a position close to the probe (100) that is at the level of the opening (302) when the probe (100) is fully inserted into the device (300).

[0275] like Figure 21A and Figure 21B As shown, this advantageously allows the edge (74) of the membrane (70) to be secured in the indentation (69) of the probe (100) when the probe (100) is removed from the device.

[0276] In even more preferred embodiments of the invention, such as Figure 19A , Figure 19B , Figure 20A , Figure 20B , Figure 21A and Figure 21B As shown, the notch (304) is configured to allow the release of the membrane (70) once the probe (100) is introduced into the distal end (360) of the device (300), and the probe (100) in turn includes a slit or notch (69) in its proximal part, which is configured to receive the edge of the membrane (70) once it is placed on the probe (100). Advantageously, this allows the membrane (70) to be placed equally, uniformly and rapidly by inserting the probe (100) into and removing it from the device (300), wherein the membrane (70) has been placed over the probe (100) through its opening (302).

[0277] In a preferred embodiment of the present invention, such as Figure 18A , Figure 18B , Figure 19A , Figure 19B , Figure 20A , Figure 20B , Figure 21A and Figure 21B As shown, the opening (302) is substantially circular. While the opening (302) is circular as shown, in other embodiments of the invention, the opening (302) may have other shapes, as will be understood by those skilled in the art. For example, the opening (302) may have a substantially circular shape and be slightly elliptical in some portions, or if circular, the opening (302) may lack segments thereof. Additionally, for example, to orient the probe insertion correctly and prevent rotation during insertion, the substantially circular opening (302) may have a groove on its surface configured to guide another groove included in the probe (100), such that the probe (100) can only be inserted through the opening (302) at a specific location. Therefore, those skilled in the art can contemplate various ways to make the opening (302) substantially circular, all of which are covered by this invention.

[0278] Furthermore, according to this preferred embodiment, the indentation (304) defines a circumference with a diameter between 5 mm and 50 mm on the surface of the proximal region, more preferably between 10 mm and 40 mm.

[0279] Advantageously, this preferred embodiment allows the membrane (70) to be substantially elongated and substantially cylindrical, thereby allowing the use of a variety of common medical-grade membranes, such as prophylactic membranes. As mentioned above, the opening (302) is indeed substantially circular, allowing commercial membranes to be arranged in a regular and smooth manner when the probe (100) is inserted into the opening (302), since these membranes typically have a substantially circular cross-section. With a diameter between 5 mm and 50 mm, the device (300) can be configured to receive common medical-grade membranes in the recess (304) covering the opening (302) according to various commonly used sizes (e.g., commercial and prophylactic sizes).

[0280] In another preferred embodiment of the invention, such as Figure 18A , Figure 18B , Figure 19A , Figure 19B , Figure 20A , Figure 20B , Figure 21A and Figure 21B As shown, the membrane (70) is preventative. Advantageously, this allows the device (300) to be configured to deliver the membrane (70) quickly and efficiently into the probe (100), and is inexpensive and readily available. Preferably, the membrane (70) additionally includes a lubricant on its outer surface to facilitate insertion of the probe (100) through a conduit or cavity of the body.

[0281] In another preferred embodiment of the invention, such as Figure 18A , Figure 18B , Figure 19A , Figure 19B , Figure 20A and Figure 21A As shown, the device includes at least one side opening (12) configured to allow the arrangement of the membrane (70) above the visualization probe (100). It should be noted that although the device (300) in the figures is illustrated to include three (12) side openings, in other embodiments according to the invention, the device (300) may include one, two, or more side openings (12) to allow the arrangement of the visualization membrane (70) above the probe (100). Similarly, it can be observed from the figures that the side openings (12) have an elongated shape, parallel to the longitudinal axis of the device (300), and are substantially rectangular with rounded corners. Furthermore, the three side openings (12) are arranged at equal intervals on the surface of the device (300) and parallel to each other. However, those skilled in the art will understand that various methods exist for designing and arranging at least one side opening (312) on the surface of the device (300). In this sense, at least one side opening (312) can have any other shape, length, and arrangement, and when the device (300) includes more than one opening, they can be arranged irregularly or regularly thereon, and can have the same or different shapes. Therefore, all these possible alternatives to at least one side opening (312) designed to allow for the arrangement of the visualization membrane (70) on the probe (100) are included in this preferred embodiment of the invention.

[0282] Advantageously, the arrangement of the membrane (70) on the probe (100) can be visualized, allowing verification that it is being correctly inserted into the device (100) so that no wrinkles or irregularities are formed in the membrane (70), preventing uneven arrangement of the membrane (70) on the probe (30), and thus enabling correction of the insertion of the probe (100) into the device (300) when the probe (100) is introduced to ensure uniform arrangement of the membrane (70).

[0283] In another preferred embodiment, such as Figure 19A , Figure 19B , Figure 20A , Figure 20B , Figure 21A and Figure 21B As shown, the device (300) is configured to place a membrane (70) within a probe (100), more preferably within a uterine probe. As shown, the probe (100) is a uterine probe, the distal end (190) of which is configured to receive the cervix from the patient's uterus, and is designed including a notch (192) to allow contact with the cervix once the probe is inserted into the vagina. It should be noted that... Figure 19A , Figure 19B , Figure 20A , Figure 20B , Figure 21A and Figure 21B The probe (100) in this example is merely representative, and the uterine probe (100) can take on different shapes, enabling it to interact in different ways, for different applications, and / or in different orientations. Advantageously, this preferred method allows the same uterine probe (100) to be used for multiple examinations of the same patient or different patients, simply by changing the membrane (70) placed on the probe (100) during each examination.

[0284] In an even more preferred embodiment of this example, the device (300) is configured to arrange a membrane (70) within a uterine torsion wave probe (100) such that it includes a torsion wave transmitter and receiver at its 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 of the same or different patients, simply by changing the membrane (70) placed on the probe (100) for each examination. Even more preferably, the uterine torsion wave probe (100) is a torsion ultrasound uterine probe (100).

[0285] In another preferred embodiment of the invention, such as Figure 18A , Figure 18B , Figure 19A , Figure 19B , Figure 20A , Figure 20B and Figure 21A As shown, the device (300) includes a handle (364) at its distal end (360). Advantageously, this allows the probe (100) to be disengaged from the device (300) once the probe (100) is fully inserted into the device (300), thereby separating the device (300) in the distal direction.

[0286] In another preferred embodiment of the invention, the device (300) further includes at least one magnet in its proximal region, which is configured to attract at least one ferromagnetic element or magnet in the proximal component of the probe (100). Advantageously, this allows the device (300) and the probe (100) to be connected by magnetic interaction between at least one magnet of the device (300) and at least one ferromagnetic element or magnet of the probe (100) once the probe (100) is inserted into the device (300), facilitating easier manipulation of the connection. Preferably, the magnetic interaction is strong enough to allow opposing elements to disengage without applying force by gripping the device (300) or the probe (100). In practice, this means that the device-probe assembly (100) can be operated with one hand, freeing up the other hand for other purposes, such as ensuring that the membrane (70) is correctly positioned on the probe (100).

[0287] Furthermore, when the probe (100) is inserted into the device (300), the correct orientation of the probe (100) can be defined by means of a specific arrangement of the magnets (10). For example, the device (300) may include at least one magnet arranged at a specific location, which will attract at least one ferromagnetic element or magnet located at a specific location on the probe (100) to its specific location, thereby effectively aligning the two locations.

[0288] At least one magnet can be made of a variety of materials, as understood by experts in the field. For example, the magnet may include one or more neodymium or magnetite. Furthermore, at least one magnet may include a variety of shapes: circular, rectangular, cubic, and not limited to any particular shape.

[0289] All of the above is entirely within the scope of this disclosure and is considered to form the basis of alternative embodiments applying one or more combinations of the above features, and is not limited to the specific combinations disclosed above.

[0290] In view of this, many alternative solutions will be available to implement the teachings of this disclosure. It is anticipated that those skilled in the art will be able to modify and adapt the above disclosure within the scope of this disclosure to suit their own circumstances and requirements, while retaining some or all of the above disclosure or the technical effects derived therefrom, in accordance with general common sense in the art. All such equivalents, modifications, or adaptations fall within the scope of this disclosure.

Claims

1. A medical device (100) configured to contact a sample (200) by its distal end (190), the medical device (100) comprising: a. a torsional ultrasound transducer (10) located at the distal end (190) of the medical device (100) and configured to induce torsional waves through the sample (200), b. a force sensor (20) configured to determine a force with which the medical device (100) contacts the sample (200), and c. a processing unit (30); wherein the torsional ultrasound transducer (10) is configured to contact the sample (200) with a predetermined range of forces, wherein the processing unit (30) is configured to determine whether the force with which the medical device (100) contacts the sample (200) is within the predetermined range of forces; and wherein the sample (200) is a cervix, and the torsional ultrasonic transducer (10) is configured to contact the cervix (200) in a range of 0 to 200 g / cm 2 between 0 and 200 g / cm.

2. The medical device (100) according to claim 1, further comprising a feedback means (40), wherein, the feedback means (40) is configured to provide feedback to a user of the medical device (100) regarding the force with which the device contacts the sample (200).

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

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 any one of claims 2 to 4, further comprising an imaging apparatus (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 wherein 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 coaxially located 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 of the preceding claims, wherein the force sensor (20) is comprised within a distal portion (180) of the medical device (100).

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

10. The medical device (100) according to any of the preceding claims, wherein the force sensor (20) is comprised between a proximal portion (120) of the medical device (100) and a 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 with which the device contacts the sample (200) based on a 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 with which the device contacts the sample (200) when the distal portion is longitudinally displaced with respect to the proximal portion.

13. The medical device (100) according to claim 11 or 12, wherein the force sensor (20) is pre-loaded and determines the force with which the device contacts the sample (200) upon release of pressure on the sample (200) when the distal portion is longitudinally displaced with respect to the proximal portion.

14. The medical device (100) according to any one of the preceding claims, wherein, The force sensor (20) further comprises a protection system configured to prevent the force sensor (20) from being damaged when a force exceeding the working range is applied to the distal end (190) of the medical device (100), preferably wherein the protection system comprises a spring (21).

15. The medical device (100) according to any one of the preceding claims, further comprising a handle (50) on its proximal end (110), the handle being configured to be held by a hand and having an angle (a) comprised between 85° and 120° with respect to the shaft (130) formed by the distal end (190) and the proximal end (110).

16. The medical device (100) according to any one of the preceding claims, wherein, The processing unit (30) is configured to discard the readings of the torsional ultrasound transducer (10) if the applied force is not within the predetermined range of forces.

17. The medical device (100) according to any of the preceding claims, wherein, The processing unit (30) is configured to prevent the torsional ultrasound transducer (10) from inducing torsional waves if the applied force is not within the predetermined range of forces.

18. The medical device (100) according to any one of the preceding claims, wherein, The torsional ultrasound transducer (10) comprises a transmitter device for transmitting torsional ultrasound waves, wherein the transmitter device comprises an electrical signal generator (13) connected to an electromechanical actuator (12) which in turn is attached to a contact element (11) in contact with the sample (200) so that when the actuator receives an electrical signal, it induces a rotational movement of the contact element (11) and when the contact element (11) is in contact with the sample (200), it induces a torsional wave through the sample (200), wherein the torsional ultrasound transducer (10) further comprises means for receiving the distorted signal after it has passed through the sample (200).

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

20. The medical device (100) according to claim 18 or 19, wherein a damping element (18), preferably a damping material with a Shore A hardness lower than 80, is fixed to the outer surface of the ring farthest from the area in contact with the sample (200).

21. The medical device (100) according to any one of claims 18 to 20, wherein, The contact element (11) has a rather truncated conical shape so that its smaller base (b) is attached to the electromechanical actuator (12) and its larger base (B) is arranged at the distal end of the transducer (10) of the present invention so that it is in contact with the sample (200) on which the shear wave is to be transmitted.

22. The medical device (100) according to any one of claims 18 to 21, wherein, The electromechanical actuator (12) is covered by a Faraday cage that eliminates electronic noise.

23. The medical device (100) according to any one of claims 18 to 22, wherein, The outer surface of one of the rings (14a) and the surface of the elements of the transmitter device that are in contact with the sample (200) lie on the same plane.

24. The medical device (100) according to any one of claims 18 to 23, wherein, The polarization of the piezoelectric elements (15) is perpendicular to the axis of rotation of the rings in the radial direction.

25. The medical device (100) according to any of the preceding claims, wherein, The medical device (100) further comprises: d. a conduit (62) for connecting an outside to an inside space (120) of the medical device (100), the conduit (62) being connected to the outside via an opening (63), e. a sealing element (64) at an opposite end of the conduit (62) configured to control an air flow between the inside space (120) and the conduit (62), and f. a vacuum pump (65) connected to the sealing element (64) and configured to extract air from the opening (63) through the conduit (62); wherein the medical device (100) is configured to receive a membrane (70) covering the opening (63) at its outside, such that 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 a pressure in the conduit (62), and wherein the vacuum pump (65) is configured to maintain a minimum pressure in a 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 comprised between 700 mBar and 800 mBar.

28. The medical device (100) according to claims 25 to 27, wherein The medical device (100) is substantially elongated and configured to contact the sample (200) via the distal end portion (20), and wherein the medical device is configured such that the membrane (70) covers at least the distal end portion (20).

29. The medical device (100) according to any one of claims 25 to 28, wherein, The opening (63) is comprised in a distal end (190) of the medical device (100).

30. The medical device (100) according to any one of claims 25 to 28, wherein, The medical device (100) is configured to receive a prophylactic as a membrane (70).

31. The medical device of any of claims 25 to 30, wherein, The medical device (100) comprises at least one indentation (69) in its outer surface, the at least one indentation being configured to receive an edge of the membrane (70).

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

33. The medical device (100) according to any of the preceding claims, wherein, The medical device (100) is a probe.

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

35. A device (300) configured for arranging a membrane (70) in a probe (100), the device (300) being substantially elongated, configured to receive the probe (100) longitudinally and comprising a proximal region and a distal region, in its proximal region comprising: a. an opening (302) configured for inserting a probe (100); and b. at least one indentation (304) defined by a radially outer surface thereof and configured to receive an edge (74) of a membrane (70) covering the opening (302); and wherein the membrane (70) is substantially longitudinally elongated such that the edge (74) of the membrane (70) comprises a portion of the membrane (70). ​ 36. The apparatus (300) according to claim 35, wherein The probe (100) comprises a distal end (190) through which the probe is introduced into the device (300), and wherein the device (300) further comprises at its distal end region a distal end (360) which in turn comprises an inner surface configured to receive the distal end (190) of the probe (100).

37. The apparatus (300) according to claim 36, wherein The inner surface of the distal end (360) of the device (300) comprises a complementary shape of the distal end (190) of the probe (100) configured to arrange the membrane (70) in equal contact with the distal end (190) of the probe (100).

38. The apparatus (300) according to claim 36 or 37, wherein The distal end (360) of the device (300) is configured to be decoupled from the rest of the device (300) and replaced by another distal end of the device (300) according to the distal end (190) of the probe (100).

39. The apparatus (300) according to any one of claims 35 to 38, wherein The opening (302) is configured to fit a corresponding surface of the probe (100) when the probe is fully inserted into the device (300).

40. The device (300) according to any one of claims 35 to 39, wherein The indentation (304) is configured to allow the release of the membrane (70) once the probe (100) is inserted into the distal end (360) of the device (300).

41. The device (300) according to any one of claims 34 to 39, wherein The device (300) is configured to arrange the membrane (70) in the probe (100) which in turn comprises in its proximal part an indentation (69) configured to receive the edge (74) of the membrane (70) once the membrane is placed on the probe (100).

42. The apparatus (300) according to any one of claims 34 to 40, wherein The opening (302) is substantially circular, and wherein the indentation (304) defines a circumference with a diameter between 5 mm and 50 mm.

43. The apparatus (300) according to any one of claims 35 to 43, wherein The device comprises at least one side opening (312) configured to allow the visualization of the membrane (70) arrangement above the probe (100).

44. The apparatus (300) according to any one of claims 35 to 43, wherein The device (300) is configured to arrange the membrane (70) in a uterine probe (100).

45. The apparatus (300) according to claim 44, wherein The device (300) is configured to arrange the membrane (70) in a torsional wave uterine probe (100), preferably in a torsional ultrasound wave probe (100).

46. The apparatus (300) according to any one of claims 35 to 45, wherein The device (300) comprises a handle (364) at its distal end (360).

47. The apparatus (300) according to any of claims 35 to 46, wherein The membrane (70) is preventive.

48. The apparatus (300) according to any one of claims 35 to 47, wherein The device (300) further comprises in its proximal region at least one magnet configured to attract at least one ferromagnetic element or magnet comprised in the proximal part of the probe (100).

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