WO2023166116A1

WO2023166116A1 - Portable ultrasound probe and system and method for monitoring

Info

Publication number: WO2023166116A1
Application number: PCT/EP2023/055279
Authority: WO
Inventors: Antonio PELLICER MARTÍNEZ; Pedro ROYO MANERO
Original assignee: Fertoolity, S.L.
Priority date: 2022-03-02
Filing date: 2023-03-02
Publication date: 2023-09-07

Abstract

The present invention belongs to the technical field of ultrasound probes and, particularly, to motorized transducer ultrasound probes for body cavity imaging. More particularly, the present invention provides an ultrasound probe for a body cavity accessible via a body orifice, a portable ultrasound system and a method for monitoring the body cavity of a patient by using said system.

Description

PORTABLE ULTRASOUND PROBE AND SYSTEM AND METHOD FOR MONITORING DESCRIPTION

FIELD OF THE INVENTION

The present invention belongs to the technical field of ultrasound probes and, particularly, to motorized transducer ultrasound probes for body region imaging. More particularly, the present invention provides an ultrasound probe for obtaining ultrasound information of a body region through a body cavity accessible via a body orifice, a portable ultrasound system and a method for monitoring the body cavity of a patient by using said system.

Specifically, the ultrasound probe is portable and includes an ultrasound transducer that is actuated to scan the body cavity of a patient. An improved image acquisition is achieved with the particular configuration of the ultrasound transducer combined with the structural configuration of the probe. In turn, the present probe is configured so that the patient can use it itself in order to monitor its body region. More particular, the portable ultrasound probe is intended to monitor the pelvic region of a patient by inserting it into a body cavity such as for example the vagina without any further patient intervention. However, this portable ultrasound probe can be also applied in other body cavities of a patient.

PRIOR ART

Assisted reproduction requires constant control over the patient to determine her condition, her correct evolution and the suitability of the treatments. Although assisted reproduction clinics are spreading to more places, on many occasions patients or couples who wish to undergo assisted reproduction treatment still have to travel many kilometers to Assisted Reproduction centers.

One of the most used procedures in the assisted reproduction treatments is controlled ovarian stimulation. To carry out the correct monitoring of the patients during stimulation, it is necessary to perform numerous transvaginal ultrasounds to follow the growth of the follicles and to estimate the day of the oocyte retrieval date. That is, in any assisted reproduction treatments is necessary to carry out a controlled ovarian stimulation treatment under ultrasound monitoring.

Throughout the mentioned stimulation treatment, an average of between 3 and 6 ultrasound controls per cycle are carried out by the medical personnel, which implies the visits of the patients to the clinic. These are known transvaginal ultrasound scans, that is, a probe is inserted into the vagina of the patient to capture images of the uterus and ovaries. These ultrasound scans are performed with the aim of evaluating the internal genitalia and the changes that occur throughout the ovulatory cycle. These types of ultrasounds are performed both on women undergoing artificial insemination and on women undergoing ovarian stimulation to retrieve oocytes that will be fertilized in vitro. In the case of artificial insemination, women undergo controlled stimulation and ultrasound monitoring to define the moment in which the woman should be inseminated with semen from her partner or from a donor. On the other hand, ovarian stimulation with ultrasound monitoring is also performed prior to oocyte retrieval by follicular puncture, and this group includes both patients who are going to undergo fertilized in vitro with their own oocytes and all oocyte donors who undergo this procedure.

The way to monitor controlled ovarian stimulation and determine when the follicles are mature for follicular puncture or artificial insemination is under ultrasound examination, which shows whether the response of the ovary and the maturation of the follicles is adequate and is optimal performed by transvaginal ultrasound. Transvaginal ultrasound is performed by inserting a probe into the vagina, this probe sends sound waves that reflect body structures that are received by the ultrasound to create an image.

According to the high number of transvaginal ultrasounds performed during these treatments in assisted reproduction clinics, it is clear that this procedure involves numerous visits from patients to clinics.

Most of the existing medical devices intended to be used by patients themselves consist of simple devices with the ability to measure basic vital signs that can be used by patients themselves (for example, sugar status, oxygen, blood pressure, etc.) or complex devices for which training is necessary as they are designed for use by medical specialists. Specifically for ultrasound imaging devices, in general consist of an ultrasound probe connected to a large equipment that is capable of transforming the received signal into an image that is displayed on a screen built into the same equipment. In other words, due to their dimensions and the complexity of use, these probes have to be used by specialized medical personnel and cannot be transported to carry out tests.

There are known portable ultrasound devices that are designed for use by specialized medical personnel and are not a transvaginal ultrasound machine, but are designed to perform abdominal ultrasound only. In addition, there are also known transvaginal ultrasounds for patient use, but these make 2D images.

On the other hand, there are known devices for in vitro fertilization treatments that can be followed remotely, by inserting a probe connected to a screen which guides the patient during the sonogram. Despite being a self-monitoring device, it does not have a wide angle of capture, so the patient must perform different sonograms in order to obtain information from each of the ovaries, and therefore, it is not capable of obtaining 3D images and it is necessary to follow the image on the screen and for the patient to manually measure the follicles.

This limitation in the technical field of ultrasounds is due to the great complexity involved, on the one hand, in the development of portable medical devices with high performance that are comparable to those existing in clinics and, on the other hand, in the development of devices that do not require specific training for their use, since they should be able to be used by any patient correctly for later interpretation by specialized medical personnel.

Therefore, there is a clear need in the assisted reproduction technical field that is intended to be addressed with the present invention, whose objective is the development and evaluation of a fully automated medical system for transvaginal ultrasound self-monitoring that offers comfortable and ergonomic use for measuring folliculometric throughout cycles of assisted reproduction treatments and that is capable of transferring the information from the patient's home to the clinic. In addition, the present development is not only limited to transvaginal use but also to other cavities of the human body which can also be scanned and monitored by the patient from anywhere.

SUMMARY OF THE INVENTION

The present invention solves the aforementioned problems by means of a portable ultrasound probe according to claim 1 , a portable ultrasound system according to claim 18 and a method for monitoring the body cavity of a patient according to claim 19. In dependent claims, preferred embodiments of the invention are defined.

In a first inventive aspect, the present invention provides a portable ultrasound probe for obtaining ultrasound information of a body region through a body cavity accessible via a body orifice, the probe comprising:

- an insertion portion configured for being inserted into the body cavity via the body orifice, the insertion portion extending along a longitudinal direction X-X’ and comprising at one of its ends a head;

- an ultrasound transducer housed inside the head and provided with a curved configuration, the ultrasound transducer being configured to rotate around a rotation axis for scanning the body region, the rotation axis being arranged inside the head and perpendicular to the longitudinal direction X- X’;

- driving means configured to rotate the ultrasound transducer;

- transmission mechanism configured to transmit the actuation of the driving means to the ultrasound transducer rotation; and

- a support structure housed inside the insertion portion supporting the rotation axis and the ultrasound transducer and comprising a base; wherein: the head is formed by a cylindrical portion and followed at its end, coinciding with an end of the probe, by a hemispherical portion; the head is configured as an acoustic window for enabling transmission of ultrasound energy therethrough; the probe is configured to connect to an image system and transmit to this image system images acquired by the ultrasound transducer; the curved configuration of the ultrasound transducer is a semicircle of 180° and the ultrasound transducer is configured to rotate up to 270°; and the support structure is arranged along the longitudinal direction X-X’ and partially converges from the base towards the inside of the head, where the rotation axis and the ultrasound transducer are supported, so that the rotation of ultrasound transducer is not hindered and allowing the ultrasound transducer to rotate up to 270°.

The present probe is intended for being inserted into a cavity of a patient’s body to obtain information of a body region. The body cavity is located in a body region of a patient and accessible via a body orifice so that at least portion of the probe can be inserted by the patient into the body cavity via said body orifice for obtaining information of said body region. In a particular embodiment, the body region corresponds to the pelvic region of a patient and the probe is inserted into a body cavity (such as for example the vagina) for obtaining information of the pelvic region. That is, by means of the present portable ultrasound probe a patient can monitor its pelvic region by inserting the probe inside the vagina herself.

The probe comprises an insertion portion suitable for being inserted into the body cavity via a body orifice. For example, the probe is configured to be inserted into the vagina of a patient for obtaining ultrasound information of the pelvic region and/or vagina. This insertion portion extends along a longitudinal direction X-X’. The longitudinal direction X-X’ is the main axial direction of the insertion portion and also the main direction that the probe follows when the insertion portion or at least a portion of it is introduce into the body cavity.

The insertion portion corresponds to an elongated insertion section of the probe that is shaped for being easily and smoothly inserted into the body cavity. The insertion portion comprises two ends opposite to each other according to the longitudinal direction X-X’ and a head located at one of the ends of the insertion portion.

The head housed inside an ultrasound transducer for scanning a body region of a patient when the probe is inserted into the body cavity. Specifically, this ultrasound transducer is an acoustic array made of a frequency sensor and has a curved configuration. The curved configuration of the transductor allows the ultrasound transductor achieves 2D ultrasound image.

Moreover, the ultrasound transductor is configured to rotate around a rotation axis that is also arranged inside the head and perpendicular to the longitudinal axis X-X’. The rotation of the ultrasound allows the ultrasound transductor to acquire 3D ultrasound image.

Therefore, the rotation of the transductor with its curved configuration allows the probe scans the body region of the patient from the body cavity when the insertion portion of the probe is inserted into the body cavity.

The probe further comprises driving means, as for example a motor, which is in charge of actuate the rotation of the ultrasound transducer for the probe to perform the scan of the body region.

The probe also includes a transmission mechanism for transmitting the actuation of the driving means to the ultrasound transducer rotation. That is, the transmission mechanism converts the actuation of the driving means into the rotation of the ultrasound transducer around the rotation axis.

The probe further comprises a support structure that is housed inside the insertion portion. This support structured is provided to support the rotation axis and the ultrasound transducer. The support structure comprises a base that is opposite to where the rotation axis and the ultrasound transducer are supported.

Furthermore, the head of the insertion portion comprises a cylindrical portion and a hemispherical portion, the hemispherical portion being arranged after the cylindrical portion so that the insertion portion ends in the hemispherical portion of the head.

Moreover, the fact that the head is configured as an acoustic window for enabling transmission of ultrasound energy there through means that the entire structure of the head itself is a window that it allows the ultrasound transducer scans the body region from inside the head as far as the transducer rotates. The head is understood as an acoustic protection dome designed to be in contact with the human body. In particular, the head is made of shock-resistant and low- attenuation material. In addition, the head allows the ultrasound transductor to run 3D acquisitions without having any mobile part in contact with the patient. This head is also designed to withstand regulatory safety dielectric tests.

By last, the present probe is configured for connecting to an image system in order to transmit to this image system the images that the ultrasound transducer acquires. That is, the information from the body regions of a patient through the scan of this same is transmitted to the image system from the portable ultrasound probe.

The present portable ultrasound probe provides the following advantages:

- easy to use for the patient as it only requires the probe to be inserted into the body cavity via the body orifice, thus allowing the patient to introduce the probe to its body cavity and remove it comfortably, without further manipulation;

- portability, that is, the probe can be used anytime, anywhere, offering exceptional clinical flexibility;

- improved detection ability thanks to the probe configuration that provides sufficient sharpness and an improves viewing angle compared to the prior art solutions, this allows good quality images to be obtained regardless of the angle at which the patient inserts the probe;

- volumetric body region capture in a single step since the 3D ultrasound transductor obtains a sectoral image with a total acquisition angle corresponding to the angle that the transductor rotates in one plane and the angle provides by the curved configuration of the transducer in another other plane, which will ensure the inclusion of the entire body region taking a 3D image;

- reduction of acquisition time so that the probe is able to take an image of the entire body region in 1 minute, unlike existing ultrasound machines in which only one area is evaluated at a time; and

- save time and resources, that is, the patient avoids continually traveling to the clinic, and the clinic avoids the expenses associated with the time spent by performing this type of ultrasound and the time invested by nurses supporting the doctors in the procedure, as well as the occupation of consultation rooms for this purpose is avoided.

In a particular embodiment, the curved configuration of the ultrasound transducer is a semicircle of 180° and the ultrasound transducer is configured to rotate up to 270°. The ultrasound transducer obtains a sectorial image with a total acquisition angle of 270° in one plane and 180° in other plane. This provides an improved volumetric body region capture compared to the prior art solution.

In addition, the support structure is arranged inside the insertion portion of the probe along the longitudinal direction X-X’. This support structure partially converges from the base towards the inside of the head, where the rotation axis and the ultrasound transducer are supported. The partial convergence of the support structure will be understood as there is a part of the support structure that is arranged from the base towards the inside of the head and its hemispherical portion, moving away from the cylindrical portion, and up to where support structure meets the ultrasound transducer and rotation axis to support them. The fact that the support structure converges towards the inside of the head prevents the rotation of the ultrasound transducer to be hindered allowing the ultrasound transducer to rotate up to 270° inside the head. That is, the configuration of the support structure allows space to be freed up inside the head (without anything hindering the rotation of the ultrasound transducer) to allow the transducer to rotate more than 180° and up to 270°.

In a particular embodiment, the support structure further comprises two pillars that protrudes from the base and each pillar comprises a free end on which the ultrasound transducer is configured to rotate relative to the rotation axis, and wherein the cross-section of each pillar gradually decreases from the base until the end of the pillar. These pillars particularly correspond to the part of the support structure that converges from the base towards the inside of the head. The gradually decrease in the thickness (cross-section) of the pillars from the base towards the free end, where the rotation axis and the ultrasound transducer, contributes to a convergence of the support structure towards the inside of the head which avoids hindering the rotation of the ultrasound transducer up to 270°. In a particular embodiment, the portable ultrasound probe further comprises a handle arranged at an end of the insertion portion opposite to the head, wherein the handle is configured to guide and hold the probe in operating mode when the probe is inserted into the body cavity via the body orifice. The handle is arranged opposite to the head according to the longitudinal axis X-X’ and corresponds to the part of the probe that remains outside the body cavity while the insertion portion corresponds to the part that is inserted into the body cavity. The handle helps the patient to direct the probe into its body cavity, thus introducing the insertion portion, and it also helps to hold the probe while in operating mode the insertion portion is inserted into the body cavity via the body orifice.

Terms such as “in operating mode” or “when the probe is inserted into the body cavity” will be used interchangeably throughout the description to refer to the moment in which the probe interacts with the human body, being inserted into the body cavity with the aim of obtaining information on the body region of interest.

Particularly, the handle of the probe is shaped so that it can be easily gripped to assist the patient to insert the insertion portion into the body cavity and to maneuver it.

In a more particular embodiment, the driving means are located inside the handle and the transmission mechanism extends through the insertion portion from the driving means to the ultrasound transducer. The fact that the driving means are housed in the handle and not in the insertion portion ensures that these driving means remain outside the body cavity in operating mode of the probe. As a consequence of the driving means being in the handle, there is a transmission mechanism extending along the insertion portion and being mechanically connected to both the driving means and the ultrasound transducer for transmitting the actuation of the driving means into the rotation of the transducer around the rotation axis.

In another particular embodiment, the driving means are located inside the insertion structure of the insertion portion and the transmission mechanism extends through a part of insertion portion from the driving means to the ultrasound transducer.

In a more particular embodiment, the driving means is a stepper motor.

In a particular embodiment, the ultrasound transducer comprises two ends which in turn comprise a rotation means, the rotation means being connected to the rotation axis allowing the rotation of the ultrasound transducer. The support structure supporting the rotation axis and the ultrasound transducer extends through the insertion portion and the head.

In a particular embodiment, the head is hermetically sealed with respect to the rest of the insertion portion by means of a seal. This seal advantageously ensure hermeticity of the probe head. In a more particular embodiment, the seal is located around the base of the support structure inside the insertion portion. The support structure is a mechanical part used to manage the rotation of the ultrasound transductor and to ensure hermeticity of the probe head. More particularly, the base of the support structure is a gasket and the seal is a rotary seal joint.

In a particular embodiment, the head houses an acoustic coupling liquid inside. The coupling liquid is used as an acoustic coupling between the ultrasound transductor and the head. In particular and advantageously, this coupling liquid has acoustical impedance optimized to reduce reverberations and improve image quality. The volume of the coupling liquid is sufficient to fully immerse the ultrasound transducer along its entire rotation course.

In a particular embodiment, the head is made with a material comprising low attenuation or transparency properties to the ultrasonic waves and also resistant to mechanical shocks and deformations.

In a particular embodiment, the portable ultrasound probe further comprises a focusing lens arranged over the ultrasound transducer and a matching layer arranged between the focusing lens and the ultrasound transducer. The provision of both a focusing lens and a matching layer on the transducer advantageously optimize the image quality. In a particular embodiment, the focusing lens is a silicone component located on the front of the ultrasound with a predetermined radius of curvature in the elevation direction to achieve focusing of the acoustic beam from the ultrasound. On the other hand, the matching layer is a thin layer of material located at the front of the transducer and is configured with tailored acoustic properties to optimize sound propagation from de ultrasound transducer to the focusing leans.

In a particular embodiment, the portable ultrasound probe comprises fixing means configured to fix the probe into the body cavity. This fixing means helps the probe to stay fixed or supported in the patient’s body once it is inserted by the patient into the body cavity. Advantageously, the fixing means improves probe stability at the time of scanning.

In a more particular embodiment, the handle is configured with a contact surface substantially perpendicular to the longitudinal direction X-X’ and facing towards the insertion portion so that this contact surface abuts on the patient's body outside the body cavity and keeps the probe fixed in operating mode when the probe is inserted into the body cavity vi the body orifice. In this embodiment, the contact surface of the handle contacts with the patient’s body outside the body cavity one the insertion portion has been introduces into the body cavity. This contact surface abuts on the patient’s body and maintains the probe fixed and supported on the patient’s body.

In a more particular embodiment, the probe comprises a U-shaped configuration where the handle and insertion portion are facing each other and this U-shaped configuration provides a pincer fixation of the probe in operating mode when the probe is inserted into the body cavity via the body orifice. In this embodiment, the probe is configured with a U-shape in which the handle corresponds to one part of the U-shape and the insertion portion corresponds to the other part of the U- shape so that the handle and the insertion portion are faced each other. This U- shaped configuration allows the probe being fixed and supported on the patient’s body once the insertion portion is introduced into the body cavity.

In a more particular embodiment, the portable ultrasound probe further comprises switching means located on the handle and being configured to automatically start the probe scan by the rotation of the ultrasound transducer. Through this switching means the patient start the scanning of the probe once the probe has been introduced into the body cavity. That is, the patient presses this switching means on the handle and the probe automatically starts scanning the body region thanks to the rotation of the ultrasound transducer. This embodiment provides a fully automated probe without requiring the manipulation of the patient. This is, the patient only needs to introduce the probe with the help of the handle and to press the switching means to start the probe scanning. Thanks to this the probe can be used by anyone.

In a more particular embodiment, the switching means comprises at least one button located on a surface of the handle for providing a patient interface. Advantageously, this button allows the probe turn-on/turn-off and the trigger the actuation of the ultrasound transducer for obtaining information of the body region of interest. The button is preferably a tactile button in order to prevent bacterial contamination and to provide an easy cleaning and disinfection of the probe.

In an alternative embodiment, the switching means are arranged on the image system instead of on the ultrasound probe. In this sense, any user or medical personal may actuate the probe starting to scan from the image system without the need to press a button on the handle of the ultrasound probe.

In another particular embodiment, the probe comprises visual indicators arranged on the handle on the same surface where the switching means are also places. These visual indicators provide information about the probe state, such as if the probe is stating up, ready to operate, or acquiring an image.

In a particular embodiment, the probe comprises control means for starting the probe scan by the rotation of the ultrasound transducer, the control means being configured to be operated remotely. This embodiment is suitable when the actuation of the probe is required in a remote way, for example for a medical professional to order and actuate the actuation of the probe remotely, having been the probe previously introduced into the body cavity by the patient himself.

In a more particular embodiment, the insertion portion comprises, in an area near the end opposite the head, a tubular configuration whose walls are concave towards the inside of the insertion portion. This advantageously provides an ergonomic probe that adapts to its insertion in the body cavity and improve probe fixation.

In a particular embodiment, the probe comprises an external case made of biocompatible material and being sealed to withstand safety and disinfection requirements.

In a particular embodiment, the probe comprises a cable configured to connect the probe with the image system. All the needed signals for the probe, such as the acoustic signal, the driving means signal and the switching control signal, are driven by the cable up to the image system. In a more particular embodiment, the handle of the probe comprises a cable output from which the cable exits towards the image system. Specifically, the cable output comprises a strain relief which ensures the hermeticity of the probe. In another embodiment, the probe is connectable with the image system by wireless connection.

In a particular embodiment, the transmission mechanism comprises a gearbox and a transmission belt. The gearbox is arranged inside the insertion portion but not within the head and is provided with the purpose of reducing the monetarization speed while increasing the holding torque to ensure the transducer position accuracy. Advantageously, the gearbox is designed to have a reduced backlash to optimize 3D image reconstruction. On the other hand, the transmission belt is arranged along the insertion portion and connected the gearbox with the driving means. Specifically, the transmission belt is configured to transmit the rotation movement from the driving means up to the ultrasound transducer. Advantageously, this belt is designed to avoid any backlash in the movement.

In the particular embodiment where the driving means are housed in the handle of the probe, the handle further comprises a holder for holding the driving means. In particular, the holder is configured to adjust the driving means position towards the transmission belt to ensure no additional friction or backlash remains on the mechanical movement over the whole scan plane of the probe. In a particular embodiment, the support structure further comprises: a first hole through which the transmission mechanism passes, connecting at one end to the rotation axis and at the opposite end to the driving means; and a second hole through which communication data is provided from the ultrasound transducer to a control unit.

In a more particular embodiment, the control unit is housed inside the handle. In another embodiment, the control unit is located outside the portable ultrasound probe and the communication data is provided either, by a wireless connection, or along the inside of the probe, from the ultrasound transducer to the inside of the handle and then exits the handle until it reaches the control unit.

More particularly, both first and second holes of the support structure are sealed with an oil seal ring or a glue potting.

In a second inventive aspect, the present invention provides a portable ultrasound system for monitoring the body cavity of a patient, the portable ultrasound system comprising a portable ultrasound probe according to the first inventive aspect and an image system, wherein the probe is connected to the image system so that the images acquired by the probe are monitored on the image system.

In a particular embodiment, the information acquired by the probe can be also stored and/or displayed on the image system. The image system will be understood as a computational device of the computer or mobile type or similar.

The portable ultrasound probe is connectable to the image system so that the images obtained by the probe via the ultrasound transducer are monitored on the image system, and more particular can be stored and/or displayed in the form of images or other type of information on the image system. In this sense, the patient can observe information related to the images acquired by the probe. In addition, the image system can be configured to include a wireless electronic module for transmitting the acquired images by the probe to a clinic.

In another embodiment, the image system includes an internal or external memory and a removable card for transmitting, the information acquired by the probe and stored on the image system, to the clinic. Thanks to this, it will not be necessary for the image system to have a screen, which will facilitate its transport, battery autonomy and use.

The connection between the probe and the image system may be a cable connection or a wireless connection wherein a cable connecting the probe to the image system is not needed.

In a third inventive aspect, the present invention provides a method for monitoring a body region of a patient by using a portable ultrasound system according to the second inventive aspect, wherein the method comprises:

(a) inserting by the patient the probe into the patient’s body cavity via a body orifice,

(b) scanning the body region of the patient by the rotation of the ultrasound transducer inside the head of the probe, and

(c) monitoring on the image system the images acquired by the ultrasound transducer of the probe.

In the first step (a) the patient introduce the probe, in particular the insertion portion, into a body cavity of the patient via a body orifice. Once the probe has been inserted into the body cavity by the patient itself, the probe starts scanning the body region of the patient from the body cavity according to the step (b). This scanning is provided by rotating the ultrasound transducer inside the head of the insertion portion of the probe. By means of the scanning, information of the body region is obtained for then be monitored in step (c) on the image system to which the probe is connected. Specifically, the information acquired by the ultrasound transducer of the probe are monitored on the image system either showing images or showing other types of information.

DESCRIPTION OF THE DRAWINGS

These and other characteristics and advantages of the invention will become clearly understood in view of the detailed description of the invention which becomes apparent from preferred embodiments of the invention, given just as an example and not being limited thereto, with reference to the drawings.

Figure 1 This figure shows a schematic representation of a perspective view of a portable ultrasound probe according to an embodiment of the present invention.

Figure 2 This figure shows a schematic representation of a cross section view of the portable ultrasound probe of Figure 1 .

Figure 3 This figure shows a schematic representation of a perspective view of the inside portion of the probe shown in Figure 2.

Figure 3A This figure shows a schematic detailed of the ultrasound transducer shown in Figure 3.

Figure 3B This figure shows another perspective view of the inside portion of the probe of figure 3.

Figure 3C This figure shows a side view of the inside portion of the probe of figure 3B.

Figure 4 This figure shows a schematic representation of another perspective view of the inside portion of the probe shown in figure 2.

Figure 5 This figure shows a schematic representation of a perspective view of a portable ultrasound probe according to another embodiment of the present invention.

Figure 6 This figure shows a schematic representation of a perspective view of a portable ultrasound system according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 shows a perspective view of a portable ultrasound probe (10) according to an embodiment of the present invention. In this embodiment, the portable ultrasound probe (10) is configured to obtain ultrasound information of a pelvic region from the vagina of a patient. That is, in this embodiment the vagina corresponds to the body cavity and the body orifice corresponds to the vaginal access orifice.

The probe (10) comprises an insertion portion (1 ) configured to being inserted into the vagina of a patient. The insertion portion (1 ) extends along a longitudinal directions X-X’ and comprises at one of tis ends a head (2) and opposite, at the other end of the insertion portion (1 ), the probe (10) further comprises a handle (6) for guiding and holding the probe by the patient in operating mode when the probe (10) is inserted into the vagina via the vaginal access orifice.

Specifically, the head (2) comprises a cylindrical portion (2.1 ) and a hemispherical portion (2.2) so that hemispherical portion (2.2) is arranged at one end of the insertion portion (1 ) opposite to the handle (6). The insertion portion (1 ) not only comprises the head (2) but is mainly formed by an insertion structure (1 .2) with a cylindrical tubular shape which axis is parallel to the longitudinal axis X-X’. In addition, the head (2) is configured as an acoustic window for enabling the transmission of ultrasound energy there through.

Moreover, the head (2) of the probe (10) comprises a seal between the cylindrical portion (2.1 ) of the head (2) and the insertion structure (1.2) of the insertion portion (1 ). This seal hermetically sealed the head (2) with respect to the rest of the insertion portion (1 ).

The head (2) also comprises inside an acoustic coupling liquid for reducing reverberations and improving image quality. Additionally, the head (2) is made with a material comprising low attenuation or transparency properties to the ultrasonic waves and also resistant to mechanical shocks and deformations.

The probe (10) also comprises an ultrasound transducer (3) for scanning the pelvic region of the patent. Specifically, the ultrasound transducer (3) is arranged inside the head (2) and has a curved configuration. The head (2) also includes inside a rotation axis (4) around which the ultrasound transducer (3) rotate for scanning the pelvic region. This rotation axis (4) (shown in detailed on figure 3) is orthogonal to the longitudinal direction X-X’.

This probe (10) also comprises driving means (5) to actuate the rotation of the ultrasound transducer (3) around the rotation axis (4). In particular, the driving means (5) is a stepper motor and is placed inside the handle (6). In another example (not shown), the driving means (5) is placed inside the insertion portion (1 ). In addition, the probe further comprises a transmission mechanism (7) in charge of transmitting the actuation of the driving means (5) to the ultrasound transducer (3). That is, the transmission mechanism (7) converts the driving means (5) actuation into the rotation of the ultrasound transducer (3) around the rotation axis (4).

The probe (10) shown on figure 1 is configured to connect to an image system (14) (shown in detail in figure 5) and to transmit to this image system (14) the images acquired by the ultrasound transducer (3) in the form of ultrasound information.

Furthermore, the probe (10) also comprises fixing means to maintain fix the probe (10) into the vagina of the patient. In particular, the handle (6) comprises a contact surface (6.1 ) that may be substantially perpendicular to the longitudinal direction X-X’ and facing outwards the insertion portion (1 ). In operating mode when the patient inserts the probe (10) into her vagina, the contact surface (6.1 ) of the handle (6) abuts on the patient’s body outside the vagina and keeps the probe (10) then fixed.

In addition, the handle (6) further comprises a control surface (6.2) at which switching means (9) are located for automatically starting the probe (10) scan by the rotation of the ultrasound transducer (3). In particular, the switching means (9) are a plurality of buttons and provides an interface between the probe (10) and the patient. These buttons are tactile. Furthermore, the handle (6) comprises on the control surface (6.2) visual indicators (13) that provides information about the probe state.

The insertion portion (1 ) of the probe (10) shown on figure 1 also comprises between the insertion structure (1.2) and the handle (6) a portion with a tubular configuration whose walls are concave (1.1 ) towards the inside of the insertion portion. The concave walls (1.1 ) make the probe (10) more ergonomic to be inserted into the vagina of the patient.

The probe (10) itself is formed by an external case made of biocompatible material and is sealed to withstand safety and disinfection requirements. Figure 1 also shows the probe (10) comprising a cable (15) (as shown on figure 6) that connects the probe (10) at a cable output (6.3) arranged on the handle (6). In a particular example, this cable output (6.3) is arranged on a surface of the handle (6) opposite to the control surface (6.2). The cable (15) connects the probe (10) with the image system (14) as shown in detailed on figure 5. In another example, the cable (15) may also connect the probe (10) to a charging source. In this particular example, the probe (1 ) is also provided with a rechargeable battery placed inside the handle (6).

In an example, the probe (10) further comprises control means for starting the probe (10) scan by the rotation of the ultrasound transducer (3) wherein this control means can be operated remotely by a doctor.

The probe (10) also comprises a flexible circuit for connecting the cable (15) to the head (2) of the probe (10). In addition, the probe comprises a control circuit for controlling the driving means (5). This control circuit allows actuates the driving means (9) inside the probe (10) and synchronize the information acquired by the ultrasound transducer (3) on the image system (14) with respect to the position of the acoustic plane. Furthermore, this control circuit is also connected to the switching means (9) and the indicator (13).

Figure 2 shows a cross sectional view of the probe (10) of figure 1. The insertion portion (1 ) comprises inside a support structure (8) that extends through the insertion portion (1 ) between the inside of the head (2) and the inside of the insertion structure (1 .2). This support structure (8) fits inside the insertion portion (1 ) and includes a seal around it, which ensures the hermetic closure of the interior of the head (2) with respect to the rest of the insertion portion (1 ). As it can be observed in this figure 2 and also in figure 3, the support structure (8) supports the rotation axis (4) to which the ultrasound transducer (3) is joint at its ends. The support structure (8) comprises two pillars (8.1 ) that protrude from the support structure (8) towards the center of the head until reach the rotation axis (4). These pillars (8.1 ) are moves away from the window itself that conforms the head in order to allow the ultrasound transducer (3) to rotate beyond the rotation axis (4), that is, rotate more than 180° around said rotation axis (4). The support structure (8) also comprises a first hole (8.2) through which the transmission mechanism (7) passes connecting at one end to the rotation axis

(4) inside the head (2) and connecting at an opposite end to the driving means

(5) located inside the handle (6). In this sense, the transmission mechanism (7) are arranged through the insertion portion (1 ) going side the head (2) until connects with the rotation axis (4) and also going inside the handle (6) until connects with the driving means (5).

The transmission mechanism (7) shown on figure 2 comprises a gearbox (7.1 ) and transmission belt (7.2). In particular, the gearbox (7.1 ) is arranged inside the insertion portion (1 ), specifically, inside the insertion structure (1.2) outside the inside of the head (2). In connection with the gearbox (7.1 ) there is a transmission belt (7.2) extending through the insertion portion (1 ) between the gearbox (7.1 ) and the driving means (5) placed inside the handle (6). The transmission belt

(7.2) transmit the rotation movement from the driving means (5) to the gearbox (7.1 ) which reduces the monetarization speed and increases the holding torque to ensure the ultrasound transducer (3) position accuracy. That is, the gearbox (7.1 ) converts the actuation from the driving means (5) into the rotation of the ultrasound transducer (3) around the rotation axis (4). More particularly, the transmission mechanism (7) also comprises another transmission belt (7.2) connecting the gearbox (7.1 ) with the rotation axis (4) for transmitting the actuation from the driving means (5) into the rotation of the ultrasound transducer (3).

Figure 2 also shown that the handle (6) further comprises a holder (6.4) that holds the driving means (5).

Figure 3 shows a detailed perspective view of the ultrasound transducer (3) mounted on the support structure (8) according to figure 2. Specifically, the support structure (8) is a gasket in charge of ensuring hermecity of the head (2). The support structure (8) comprises at the bottom of the head (2) rotary seal joint

(8.3) so that acoustic coupling liquid housed inside the head (2) is thus trapped between the inside of head (2) and the support structure (8). The first hole (8.2) of the supporting structure (8) through which the transmission belt (7.2) passes is also closed so that prevents the acoustic coupling liquid from leaking. In an example, the closure of this first hole (8.2) is provided with an oil seal ring or a glue potting that ensures the tightness of the portable ultrasound probe (10).

Moreover, the ultrasound transducer (3) comprises two ends (3.3) through which the ultrasound transducer (3) is mounted on the rotation axis (4). These ends (3.3) of the ultrasound transducer (3) in turn comprise rotation means connected to the rotation axis for allowing the rotation of the ultrasound transducer (3). In a particular example, each end (3.3) of the ultrasound transducer (3) comprises a bearing (3.4).

The ultrasound transducer (3) shown in detailed on figure 3 has a curved configuration of a semicircle of 180°, and the ultrasound transducer (3) can rotate up to 270°. In this sense, the 180° of the curve configuration of the ultrasound transducer (3) provides a first image acquisition angle and the rotation of the ultrasound transducer (3) up to 270° provides a second image acquisition angle.

In addition, the probe (10) comprises a focusing leans (11 ) places over the ultrasound transducer (3) and a matching layer (12) located between the focusing leans (11 ) and the ultrasound transducer (3). In a particular example, the focusing leans (11 ) is a silicone component with a predetermined radius of curvature substantially parallel to the curved configuration of the ultrasound transducer (3).

Moreover, the ultrasound transducer (3) comprises an ultrasound array (3.1 ) mounted on a stiffener (3.2) or transducer support, preferably metal stiffener as it can be shown in detail on figure 3A.

Figure 3A shows a detailed of the ultrasound transducer (3) comprising the ultrasound array (3.1 ) and the focusing lens (11 ) arranged over the ultrasound array (3.1 ) and a matching layer (12) arranged between the focusing lens (11 ) and the ultrasound array (3.1 ).

Figure 3B shows a perspective view of the support structure (8) supporting the rotation axis (4) and the ultrasound transducer (3). The support structure (8) comprises a base (8.4) arranged in the part of the support structure (8) furthest away from where the rotation axis (4) and the ultrasound transducer (3) are supported. The support structure (8) is arranged along the longitudinal direction X-X’ and partially converges from the base (8.4) towards the inside of the head (not shown), where the rotation axis (4) and the ultrasound transducer (3) are supported.

The support structure (8) further comprises two pillars (8.1 ) that protrudes from the base (8.4) equidistant from each other on the longitudinal axis X-X’. These pillars (8.1 ) converge towards the inside of the head (not shown) or towards the longitudinal axis X-X’ until where the rotation axis (4) and the ultrasound transducer (3) are supported. Each pillar (8.1 ) starts from an upward extension

(8.1.1 ) of the base (8.4), the cross-section of which gradually decreases until it reaches the free end (8.1.2) of the pillar (8.1 ). The free end (8.1.2) of the pillar

(8.1 ) has a curved shape configured to receive the bearing (3.4) that comprises the ultrasound transducer (3) at its ends (3.3) and which is arranged around the rotation axis (4). In the example shown in figure 3B, the rotation axis (4) is only placed through one of the bearings (3.4); however, in another example (not shown), the rotation axis (4) is placed through both bearings (3.4) of the ultrasound transducer (3).

The support structure (8) shown in figure 3B further comprises a seal around the base (8.4) which are configured to fit the support structure (8) inside the insertion portion (1 ) as shown in figure 2. The support structure (8) in an example is a gasket and the seal is a rotary seal joint (8.3).

Figures 2 and 3B also show that the support structure (8) comprises a second hole (8.5) through which communication data (not shown) is provided from the ultrasound transducer (3) to a control unit (not shown). In an example, the control unit is housed in the handle (6). In another example, the control unit is located outside the portable ultrasound probe (10). When the control unit is located outside the portable ultrasound probe (10) the communication data is provided via a wireless connection or arranged along the inside of the probe (10) from the ultrasound transducer (3) to the inside of the handle (6) and then exits through the handle (6) to reach the control unit. In any case, this control unit is in turn configured to be connectable to the image system (14) for transmitting images acquired by the ultrasound transducer (3). The second hole (8.5) is also closed so that prevents the acoustic coupling liquid from leaking. In an example, the closure of the second hole (8.5) is provided with an oil seal ring or a glue potting.

Figure 3C shows a side view of figure 3B. Specifically, this figure shows how a pillar (8.1 ) starts from an extension (8.1 .1 ) that protrudes from the base (8.4) of the support structure (8), which not only converges towards the inside of the head or towards the longitudinal axis X-X’ as seen in figure 3B, but also converges upwards i.e. towards the rotation axis (4); and from there a portion (8.1.3) projects vertically to the curved free end (8.1.2) that receives the bearing (3.4) of the ultrasound transducer (3). Each pillar (8.1 ) comprises said extension (8.1.1 ), portion (8.1 .3) and free end (8.1 .2). The convergence in the support structure (8), in particular at the pillars (8.1 ), allows the ultrasound transducer (2) to rotate more than 180 degrees (up to 270 degrees) around the rotation axis (4).

Figure 4 shows in addition to figure 3 the holder (6.4) supporting the driving means (5). In particular, the holder (6.4) adjusts the position of the driving means (5) towards the transmission belt (7.2) of the transmission mechanism (7) to ensure no additional friction or backlash remains on the mechanical movement over the whole scan plane of the probe (10).

Figure 5 shows another embodiment of a portable ultrasound probe (10) according to the present invention. In this embodiment the probe (10) is also configured to obtain ultrasound information of the pelvic region of a patient through its vagina. Further, in this embodiment the probe (10) comprises a II- shaped configuration where the handle (6) and insertion portion (1 ) are facing each other so that the handle (6) conform at least a half of the U-shape and the insertion portion (1 ) conform the other half of the U-shape. Specifically, this U- shaped configuration corresponds to the external structure of the probe (10) and provides a pincer fixation in operating mode when the probe (10) is inserted into the vagina of the patient. That is, the area where the two halves of the U-shape meet has a flexible configuration that allows the insertion portion (1 ) to flex up to a predetermined value with respect to the handle (6) and vice versa. This flexible properties that the probe (10) has will be understood as that of a clamp or pincer fixation, that is, the both parts of the U-shape allow them to flex up to a predetermined value, this being sufficient for the patient to facilitate the insertion of the insertion portion (1 ) inside the vagina. Once the insertion portion (1 ) is inserted into the vagina, where the patient stops exerting bending force on the probe (10), the probe (10) tends to close like a pincer so that the distance between the insertion portion (1 ) and the handle (6) is reduced until the handle (6) abuts, at its contact surface (6.1 ), with the patient's body outside the vagina.

The area where the two halves of the U-shape meet corresponds to an intermediate portion (17) of the probe (10) that connects the insertion portion (1 ) to the handle (6). The interior of this intermediate portion (17) is hollow in a way that allows interaction between the inside of the handle (6) and the inside of the insertion structure (1.2) of the insertion portion (1 ). In operating mode when the probe (10) is inserted into the vagina of the patient the intermediate portion (17) and the handle (6) both remain outside the vagina. The above description, of the insertion portion (1 ) with the head (2) and the handle (7), for the previously embodiment (shown on figures 1 -4) also applies here for the embodiment of figure 5.

In the embodiment of figure 5, the driving means (5) that actuates the rotation of the ultrasound transducer (3) around the rotation axis (4) may be located inside the intermediate portion (17), inside the handle (6) or inside the insertion portion (1 ). A transmission mechanism is also provided for transmitting the actuation of the driving means (5), i.e. stepper motor, to the rotation of the ultrasound transducer (3).

According to this figure 5, the length of the insertion portion (1 ) is greater than the length of the handle (6), however, the lengths of both insertion portion (1 ) and handle (6) may be also the same or different from each other.

In a particular example (not shown) of the probe (10), the handle (6) and the insertion portion (1 ) are detachable from each other. Advantageously, this allows access to the interior of both the handle (6) and the insertion portion (1 ) for maintenance tasks.

Figure 6 shows an embodiment of a portable ultrasound system (14) that comprises the portable ultrasound probe (10) shown on figures 1 -4 and an image system (14) connected to the probe (10) by a cable (15). The probe (10) is connected to the image system (14) for transmitting to this image system (14) the images acquired by the probe (10). In particular, the image system (14) displays the images acquired by the probe (10) in the form of image or other type of information. The probe (1 ) is further provided with an analog data to digital data converter in order to allow transmitting the ultrasound information obtained by the probe (1 ) to the image system (14).

The above disclosed probe allows monitoring assisted reproduction processes by the patient and under medical supervision of the results obtained if needed. That is, the mentioned probe and the ultrasound system allows the transvaginal ultrasound self-monitoring, fully automated, and offers comfortable and simple use so that the patients themselves can have their ultrasounds done from home and send the results to the clinic so that doctors can obtain the results of ovarian folliculometry and endometrial measuring.

According to an embodiment, the present invention discloses a method for monitoring the pelvic region of a patient by using a portable ultrasound system (16), for example, the ultrasound system (16) shown on figure 6. The method comprises at least the following steps:

(a) inserting by the patient the probe (10) into the patient’s vagina via the vaginal access orifice,

(b) scanning the pelvic region of the patient by the rotation of the ultrasound transducer (3) inside the head (2) of the probe (10), and

(c) monitoring on the image system (14) the images acquired by the ultrasound transducer (3) of the probe (10).

In an example, the method further comprises before step (b) actuating the switching means (9) of the probe (10) by the patient to automatically start the probe (10) scanning the pelvic region of the patient.

In another example, the method further comprises before step (b) remotely operating by a doctor the control means of the probe (10) to start the probe (10) scanning the pelvic region of the patient. In a more particular example, once the patient actuates the switching means (9) or the doctor remotely actuates the control means of the probe, the ultrasound transducer (3) rotates until be positioned to an initial position and then start scanning by its rotation up to 270° where reach its final position.

The examples shown in the figures 1 to 6 and described above are only some embodiments of the present invention and do not limit the scope of the invention. That is, the present probe can be used to monitor body regions of a patient other than the pelvic region and consequently be introduced into another body cavities of the patient.

In particular examples, the present probe is intended to monitor: the endometrium in relation with the field of reproduction; the uterus, cervix and ovaries for pathology in relation with the gynecology field; the embryo and fetus in relation with the obstetrics and fetal medicine; and all the parts that comprise the pelvic floor and the pelvic viscera (rectosigma, urethra and bladder) in relation with physiotherapy, urology and digestive surgery.

Claims

1 Portable ultrasound probe (10) for obtaining ultrasound information of a body region through a body cavity accessible via a body orifice, the probe (10) comprising:

- an insertion portion (1 ) configured for being inserted into the body cavity via the body orifice, the insertion portion (1 ) extending along a longitudinal direction X-X’ and comprising at one of its ends a head (2);

- an ultrasound transducer (3) housed inside the head (2) and provided with a curved configuration, the ultrasound transducer (3) being configured to rotate around a rotation axis (4) for scanning the body region, the rotation axis (4) being arranged inside the head (2) and perpendicular to the longitudinal direction X-X’;

- driving means (5) configured to rotate the ultrasound transducer (3);

- transmission mechanism (7) configured to transmit the actuation of the driving means (5) to the ultrasound transducer (3) rotation; and

- a support structure (8) housed inside the insertion portion (1 ) supporting the rotation axis (4) and the ultrasound transducer (3) and comprising a base (8.4); wherein: the head (2) is formed by a cylindrical portion (2.1 ) and followed at its end, coinciding with an end of the probe (10), by a hemispherical portion (2.2); the head (2) is configured as an acoustic window for enabling transmission of ultrasound energy there through; the probe (10) is configured to connect to an image system (14) and transmit to this image system (14) images acquired by the ultrasound transducer (3); the curved configuration of the ultrasound transducer (3) is a semicircle of 180° and the ultrasound transducer (3) is configured to rotate up to 270°; and the support structure (8) is arranged along the longitudinal direction X-X’ and partially converges from the base (8.4) towards the inside of the head (2), where the rotation axis (4) and the ultrasound transducer (3) are supported, so that the rotation of the ultrasound transducer (3) is not hindered and allowing the ultrasound transducer (3) to rotate up to 270°.

2.- The portable ultrasound probe (10) according to claim 1 , wherein the support structure (8) further comprises two pillars (8.1 ) that protrudes from the base (8.4) and each pillar (8.1 ) comprises a free end (8.1.2) on which the ultrasound transducer (3) is configured to rotate relative to the rotation axis (4), and wherein the cross-section of each pillar (8.1 ) gradually decreases from the base (8.4) until the free end (8.1 .2) of the pillar (8.1 ).

3.- The portable ultrasound probe (10) according to any one of the previous claims further comprising a handle (6) arranged at an end of the insertion portion (1 ) opposite to the head (2), wherein the handle (6) is configured to guide and hold the probe (10) in operating mode when the probe (10) is inserted into the body cavity via the body orifice.

4.- The portable ultrasound probe (10) according to claim 3, wherein the driving means (5) are located inside the handle (6) and the transmission mechanism (7) extends through the insertion portion (1 ) from the driving means (5) to the ultrasound transducer (3).

5.- The portable ultrasound probe (10) according to any one of the previous claims, wherein the ultrasound transducer (3) comprises two ends (3.3) which in turn comprise a rotation means, the rotation means being connected to the rotation axis (4) allowing the rotation of the ultrasound transducer (3).

6.- The portable ultrasound probe (10) according to any one of the previous claims, wherein the head (2) is hermetically sealed with respect to the rest of the insertion portion (1 ) by means of a seal.

7.- The portable ultrasound probe (10) according to the previous claim, wherein the head (2) houses an acoustic coupling liquid inside.

8.- The portable ultrasound probe (10) according to any one of the previous claims further comprising a focusing lens (11 ) arranged over the ultrasound transducer (3), and a matching layer (12) arranged between the focusing lens (11 ) and the ultrasound transducer (3).

9.- The portable ultrasound probe (10) according to any one of the previous claims further comprising fixing means configured to fix the probe (10) into the body cavity.

10.- The portable ultrasound probe (10) according to claims 3 and 9, wherein the handle (6) is configured with a contact surface (6.1 ) substantially perpendicular to the longitudinal direction X-X’ and facing towards the insertion portion (1 ) so that this contact surface (6.1 ) abuts on the patient's body outside the body cavity and keeps the probe (10) fixed in operating mode when the probe (10) is inserted into the body cavity via the body orifice.

11 .- The portable ultrasound probe (10) according to claims 3 and 9, wherein the probe (10) comprises a U-shaped configuration where the handle (6) and insertion portion (1 ) are facing each other and this U-shaped configuration provides a pincer fixation of the probe (10) in operating mode when the probe (10) is inserted into the body cavity via de body orifice.

12.- The portable ultrasound probe (10) according to claim 4 and any one of the previous claims further comprising switching means (9) located on the handle (6) and being configured to automatically start the probe (10) scan by the rotation of the ultrasound transducer (3).

13.- The portable ultrasound probe (10) according to any one of claims 1 to 11 , wherein the probe (10) comprises control means for starting the probe (10) scan by the rotation of the ultrasound transducer (3), the control means being configured to be operated remotely.

14.- The portable ultrasound probe (10) according to any one of the previous claims, wherein the insertion portion (1 ) comprises, in an area near the end opposite the head (2), a tubular configuration whose walls are concave (1.1 ) towards the inside of the insertion portion (1 ).

15.- The portable ultrasound probe (10) according to claim 6, wherein the seal is located around the base (8.4) of the support structure (8), the seal being configured to fit and hermetically seal the support structure (8) inside the insertion portion (1 ).

16.- The portable ultrasound probe (10) according to the previous claim, wherein the base (8.4) of the support structure (8) is a gasket and the seal is a rotary seal joint (8.3).

17.- The portable ultrasound probe (10) according to claim 4 and any one of the previous claims, wherein the support structure (8) further comprises: a first hole (8.2) through which the transmission mechanism (7) passes, connecting at one end to the rotation axis (4) and at the opposite end to the driving means (5); and a second hole (8.5) through which communication data is provided from the ultrasound transducer (3) to a control unit.

18.- Portable ultrasound system (16) for monitoring a body cavity of a patient, the portable ultrasound system comprising a portable ultrasound probe (10) according to any one of the previous claims and an image system (14), wherein the probe (10) is connected to the image system (14) so that the images acquired by the probe (10) are monitored on the image system (14).

19.- Method for monitoring a body region of a patient by using a portable ultrasound system (16) according to claim 18, wherein the method comprises:

(a) inserting by the patient the probe (10) into the patient’s body cavity via a body orifice,

(b) scanning the body region of the patient by the rotation of the ultrasound transducer (3) inside the head (2) of the probe (10), and