Consumable system for supplying and discharging cooling liquid for an ultrasonic energy emission device, consumable assembly and energy emission probe containing same

Abstract

The invention relates to a consumable system for supplying and discharging cooling liquid, intended to be removably assembled to an ultrasonic energy emission device in order to cool it. The invention also relates to the ultrasonic energy emission device configured to be assembled to the consumable system, as well as the resulting ultrasonic energy emission probe. The invention also relates to a method for preparing an ultrasonic energy emission probe according to the invention.

Description

Description Title of the invention: Consumable system for supplying and draining coolant from an ultrasonic energy-emitting device, consumable assembly and energy-emitting probe containing it Technical Field

[0001] The present invention relates to the technical field of apparatus or devices comprising an ultrasonic energy-emitting probe, used in therapeutic treatment and / or for ultrasound imaging of human anatomy. More specifically, the present invention relates to a means for cooling an ultrasonic energy-emitting probe. The invention finds particularly advantageous application in the field of high-intensity focused ultrasound (HIFU). Previous technique

[0002] Generally, an ultrasonic probe contains an acoustic transducer made of a piezoelectric material that converts electrical energy into mechanical energy. Due to imperfect conversion efficiency, the unconverted energy creates a buildup of heat in the transducer material. Excessive heating can lead to damage or even destruction of the transducer.

[0003] The prior art has proposed various technical solutions for dissipating the heat generated in order to lower the transducer temperature. In particular, probes with a casing that, together with the front face of the transducer, forms a cooling chamber through which a coolant circulates are known. The coolant is conveyed via channels integrated within the probe body itself, ensuring good ergonomics and minimal probe size. Such devices are described, for example, in application WO 2006 / 032059. The use of a sleeve in which is inserted the transducer, and an expandable sheath attached to the sleeve and serving as a cooling chamber

[0004] Furthermore, the probe must be decontaminated after each use before it can be reused. This decontamination may include cleaning, disinfection with a disinfectant, or even sterilization at high temperature or with radiation. However, these decontamination steps involve handling products that may pose a risk to the person handling them. Therefore, high-level manual and / or automated disinfection processes have been developed for the high-level disinfection of ultrasound probes, for example, such as the use of wipes and two-component products like Tristel Trio Wipes System from Tristel, Clanisept wipes from THX medical, or WIP'anios excel wipes from Anios, or devices such as ASTRA VR from Civco, GUS® from Civco, Stella from Tristel, or DSD edge® from Medivator.However, this decontamination method is not sufficiently effective when there are long channels for the supply and drainage of the coolant. It is impossible to reach all the internal walls of these channels with a wipe.

[0005] Several sterilization methods can be used. Moist heat sterilization is one of the most widely used decontamination methods in hospitals. It allows for the sterilization of all reusable equipment that is not sensitive to high temperatures. This sterilization method is performed with a sterilizer, also called an autoclave. However, this method is not compatible with an ultrasonic transducer because it would cause the transducer to exceed its Curie temperature.

[0006] Dry heat sterilization is a less common method. This method has the disadvantage of being longer than moist heat sterilization. Furthermore, this method is not compatible with an ultrasonic transducer.

[0007] Ionizing radiation can also be used to sterilize medical devices. Ionizing radiation includes gamma and beta rays. This is a cold sterilization method, thus allowing for sterilization. heat-sensitive materials. However, this type of equipment is not widely used in hospitals, which makes sterilization difficult and prevents rapid reuse of the probe.

[0008] Sterilization using ethylene oxide (EtO) has the disadvantage of requiring a lengthy desorption step. Therefore, the probe cannot be easily and quickly reused.

[0009] Finally, sterilization can be performed using hydrogen peroxide (H2O2). This is a low-temperature sterilization method and therefore compatible with ultrasonic transducers. This equipment is found in large healthcare facilities with surgical suites. Sterilization cycles are relatively short, allowing for rapid reuse of the sterilized probe. However, this technique requires specific technical characteristics for the coolant supply and drain channels, which are long and narrow. For example, the manufacturer of the Sterrad device guarantees the performance of the sterilization process under the conditions of meeting a specific number of mechanical criteria.Furthermore, this process can only be used with medical devices made of specific materials and containing only one channel made of stainless steel, Teflon®, or polyethylene with particular dimensions. The design of the probe, and in particular the presence of these long channels for supplying and draining coolant within the probe, precludes the use of this sterilization method.

[0010] Therefore, there is a need for an ultrasonic energy emission probe equipped with a cooling system that can be easily reused while meeting decontamination requirements. In other words, there is a need for a probe with a cooling system that can be easily and effectively decontaminated after use, thus allowing for its reuse. Advantageously, the cooling system can be quickly operational. Description of the invention

[0011] The Applicant has overcome the problems associated with decontaminating probes, and in particular the coolant supply and drain pipes, by using a consumable coolant supply and drain assembly configured for removable assembly to an ultrasonic energy emitter. After use of the ultrasonic probe, the consumable coolant supply and drain assembly according to the invention can easily be disassembled from the ultrasonic energy emitter, thus allowing decontamination of the ultrasonic energy emitter, and possibly also of the consumable coolant supply and drain assembly, using potentially different techniques.Advantageously, the coolant supply and discharge assembly is made of a material that allows for easy and effective sterilization using conventional techniques, although these techniques are not necessarily compatible with an ultrasonic transducer and / or with a coolant supply and discharge assembly that has channels. Furthermore, the ultrasonic energy-emitting device can be assembled either with a new coolant supply and discharge assembly according to the invention, or with the existing coolant supply and discharge system after it has been decontaminated.

[0012] To this end, the Applicant has developed a consumable system for supplying and draining coolant from an ultrasonic energy-emitting device, said consumable system for supplying and draining coolant being made of a rigid plastic or metallic material, comprising at least one supply channel and at least one drain channel for the coolant, each opening on either side of the consumable system for supplying and draining coolant by an inlet and an outlet, said consumable system for supplying and draining coolant comprising a removable assembly device for attaching to an ultrasonic energy-emitting device.

[0013] The consumable coolant supply and drainage system may also have one or more of the following characteristics: - the consumable system for supplying and draining coolant constitutes a consumable cooling system that must be replaced after each use; - the consumable coolant supply and discharge system is elongated along a longitudinal axis Ll, ​​has a proximal end and a distal end, and comprises at least one supply channel and at least one discharge channel for the coolant, each opening into the proximal end and the distal end by an inlet and an outlet, said consumable coolant supply and discharge system comprising a removable assembly device for an ultrasonic energy emitting device; - the removable assembly device includes at least two elastically deformable tabs arranged between the proximal end and the distal end and positioned symmetrically with respect to the longitudinal axis Ll; - the consumable system for supplying and draining coolant is in the form of a circular or oblong ring, comprising a peripheral rim inside which are at least one supply channel and at least one drain channel for the coolant, said consumable system for supplying and draining coolant comprising a removable assembly device for an ultrasonic energy-emitting device; - the inlet of the supply channel(s) and the outlet of the discharge channel(s) extend upstream along a longitudinal axis of extension L2 belonging to the plane of the consumable system for supplying and discharging coolant; - the removable assembly system includes at least two elastically deformable tabs rising from a lower annular face of the crown; - The consumable system for supplying and draining coolant is in the form of a circular ring having a threaded assembly thread or a snap-fit ​​element intended to cooperate respectively with a additional thread or additional snap-on element present on the consumable system; - at least one of the channels diverges from another channel; - the outlet of the supply channel(s) and the inlet of the discharge channel(s) are located in the same plane; - the outlet of the supply channel(s) and the inlet of the discharge channel(s) are located in offset planes; - the consumable system for supplying and draining coolant also includes a measuring tool, and / or a calibration tool, and / or a spatial location tool, and / or a sterilization indicator, and / or a display of its manufacturing and / or expiry date, and / or an RFID sensor and / or a pump; - The consumable system for supplying and draining coolant is made of metallic material.

[0014] The invention also relates to a consumable coolant supply and discharge assembly comprising the consumable coolant supply and discharge system according to the invention, and a sealing structure configured to continuously surround over a section the supply and discharge channels of the consumable coolant supply and discharge system.

[0015] The consumable assembly for coolant supply and drainage may also have one or more of the following characteristics: - the sealing structure and the consumable system for supplying and draining coolant are made of biocompatible materials; - the sealing structure and the consumable system for supplying and draining coolant are sterilizable; - the sealing structure has a hardness ranging from 15 Shore A to 60 Shore A; - the sealing structure and the consumable system for supplying and draining coolant form a single unit; - the consumable assembly for supplying and draining coolant includes at least one transverse peripheral groove.

[0016] The invention also relates to an ultrasonic energy emission device comprising a support body for a transducer, the transducer having a front face partially delimiting a cooling chamber, the ultrasonic energy emission device comprising a complementary removable assembly device for a consumable assembly for supplying and draining coolant according to the invention.

[0017] The ultrasonic energy-emitting device according to the invention may further have one or more of the following characteristics, or a combination thereof: - a positioning structure is provided in the distal part of the support body; - the additional removable assembly device includes at least two housings provided on the support body to cooperate with elastically deformable tabs arranged on the consumable coolant supply and drainage system; - the additional removable assembly device includes an additional threaded assembly thread or an additional snap-fit ​​element fitted on the support body to cooperate with respectively a threaded assembly thread or a snap-fit ​​element present on the consumable coolant supply and discharge system; - the support body includes a transverse peripheral groove; - the transverse peripheral groove coincides in the mounted position with a groove in the consumable assembly for supplying and draining coolant.

[0018] The invention also relates to an ultrasonic energy emission probe for imaging and / or therapy comprising: - an ultrasonic energy emission device according to the invention, and - a consumable assembly for supplying and draining liquid cooling according to the invention, the consumable assembly for supplying and draining coolant being mounted by elastic deformation or by screwing or by snapping onto the ultrasonic energy emission device to ensure sealing with respect to the cooling chamber, and mounted so that the inlet of each supply channel and the outlet of each drain channel open into the cooling chamber.

[0019] The invention further relates to a kit comprising a consumable system for supplying and draining a coolant according to the invention or a consumable assembly for supplying and draining a coolant according to the invention.

[0020] The kit according to the invention may further include pipes for the circulation of the coolant, assembled or intended to be assembled at the inlet of each supply channel and at the outlet of each discharge channel.

[0021] The invention also relates to a method for preparing an ultrasonic energy emission probe according to the invention, comprising the following steps: a) having a consumable coolant supply and discharge assembly according to the invention, and an ultrasonic energy emission device according to the invention, b) positioning the consumable coolant supply and discharge assembly on the ultrasonic energy emission device so that the consumable coolant supply and discharge assembly is against the positioning structure when the latter is present, and so that the inlet of each supply channel and the outlet of each discharge channel open into the cooling chamber, and c) assembling the consumable coolant supply and discharge assembly and the ultrasonic energy emission device,so as to elastically deform the sealing structure to ensure a seal with respect to the cooling chamber.

[0022] The method for preparing an ultrasonic energy emission probe according to the invention may have one or more of the following characteristics, or a a combination of these: - the process for preparing an ultrasonic energy emission probe further includes a step d) subsequent to step c), of installing pipes on the inlet of each supply channel and the outlet of each coolant discharge channel, and / or of installing a membrane which delimits a cooling chamber with the front face of the transducer; - The process for preparing an ultrasonic energy emission probe includes the following steps after each use of the ultrasonic energy emission imaging probe: 1) Disassemble the entire coolant supply and drain assembly and the ultrasonic energy emission device, 2) Clean the ultrasonic energy emitting device, and disinfect it if necessary. 3) Position a consumable coolant supply and discharge assembly on the ultrasonic energy emitting device that has not been used or that has been disinfected after use, so that the consumable coolant supply and discharge assembly is against the positioning structure when the latter is present, and so that the inlet of the supply channel(s) and the outlet of the discharge channel(s) open into the cooling chamber, 4) Assemble the consumable coolant supply and discharge system and the ultrasonic energy emission device, so as to elastically deform the sealing structure to ensure a seal with respect to the cooling chamber, and 5) possibly install pipes that have preferably not been used on the inlet of each supply channel and the outlet of each coolant drain channel, and / or install a membrane that delimits a cooling chamber with the front face of the transducer.

[0023] Finally, the invention also relates to a method of manufacturing a consumable system according to the invention, a method of manufacturing a consumable assembly according to the invention, and a method of manufacturing an ultrasonic energy emission device according to the invention. Brief description of the drawings

[0024] Figure 1 is a perspective view of an ultrasonic imaging probe according to a first embodiment of the invention.

[0025] Figure 2 is a side view of an ultrasonic imaging probe according to a first embodiment of the invention.

[0026] Figure 3 is an exploded perspective view of an ultrasonic imaging probe according to a first embodiment of the invention.

[0027] Figure 4 is a top view of a consumable coolant supply and discharge assembly according to a first embodiment of the invention.

[0028] Figure 5 is a perspective view of a consumable system for supplying and draining a coolant according to a first embodiment of the invention.

[0029] Figure 6 is a perspective view of an ultrasonic imaging probe according to a second embodiment of the invention.

[0030] Figure 7 is a partially torn-off view of the probe illustrated in Figure 6.

[0031] Figure 8 is an exploded perspective view of an ultrasonic imaging probe according to a second embodiment of the invention.

[0032] Figure 9 is a side view of the consumable assembly for supplying and draining coolant according to a second embodiment of the invention.

[0033] Figure 10 is an exploded perspective view of an ultrasonic imaging probe according to a third embodiment of the invention. Description of the implementation methods

[0034] The invention relates to a new technique for cooling an ultrasonic wave-producing device 1. This ultrasonic energy-emitting device 1 (or ultrasonic wave emitting device 1) can be used for imaging or for therapeutic treatment. As shown in Figures 1, 2, 6 and 7, this ultrasonic energy emitting device 1 is part of an ultrasonic energy emitting probe 2 adapted to perform imaging (whether or not associated with an ultrasound imaging probe of human anatomy) or treatment of tissues of a living being, by means of ultrasonic waves. Advantageously, this ultrasonic energy emitting device 1 produces high-intensity focused ultrasound (HIFU).

[0035] As illustrated in Figures 3 and 8 in particular, the ultrasonic energy-emitting device 1 includes a support body 3 for a transducer 4 comprising one or more ultrasonic emitters, such as piezoelectric elements. The ultrasonic emitters of the transducer 4 are connected, via an amplifier stage, to a control circuit that delivers signals to activate the ultrasonic emitters. The control circuit is not described in more detail because its implementation is part of the technical knowledge of a person skilled in the art. This control circuit typically includes a controlled signal generator that is connected to the ultrasonic emitters via the amplifier stage.

[0036] The transducer 4 has an ultrasonic wave emission face 4a at the front and a rear face (not shown in the figures) at the rear. The front face 4a of the transducer 4 partially defines a cooling chamber (not shown in the figures). In one embodiment, a temperature sensor may optionally be present on this rear face to measure the thermal heating at this surface. The emission face 4a has a smooth surface, being delimited by a peripheral edge 4b ​​and optionally by an internal edge 4c defining a cutout in the central part of the transducer 4.

[0037] The ultrasonic transducer 4 is positioned directly opposite an opening 3e made in the support body 3. Typically, the transducer 4 is located at or slightly behind this opening 3e.

[0038] The support body 3 has a front face 3a and a rear face 3b. The support body 3 has a proximal portion 3c and a distal portion 3d. The opening 3e is typically located in the distal portion 3d of the support body 3. The support body can be made of a biocompatible material. The support body can be made of a rigid plastic material or a metallic material. Preferably, the support body 3 is made of a metallic material such as stainless steel.

[0039] By "rigid plastic material" is meant a plastic material having a hardness of at least 50 Shore D, preferably from 60 Shore D to 100 Shore D, better still from 70 Shore D to 95 Shore D, and better still from 85 Shore D to 95 Shore D. Hardness can be measured using a Shore durometer, according to ISO 48-4:2018, ASTM D2240, or ISO 868:2003.

[0040] By "metallic material" we mean a material comprising a metal or a metallic alloy.

[0041] According to an alternative embodiment of the invention illustrated in figures 1 to 3, the support body 3 of the ultrasonic energy emitting device 1 has at least one transverse peripheral groove 5, which advantageously coincides in the mounted position with a groove 6 of a consumable coolant supply and discharge assembly 7. Advantageously according to this embodiment, the rear face 3b of the support body 3 has at least one transverse peripheral groove 5.

[0042] According to one embodiment, the ultrasonic energy-emitting device 1 includes a positioning structure 8 or shoulder for the coolant supply and discharge consumable assembly 7. Advantageously, this positioning structure 8 is located on the front face 3a of the support body 3, preferably in its distal part 3d. In particular, as illustrated in Figures 1 and 3, the positioning structure is located at the edge of the opening 3e of the support 3. This positioning structure 8 may, for example, be in the form of one or more studs and / or ribs and / or rims extending from the front face 3a of the support body 3 and configured to abut against the supply and discharge consumable assembly. coolant drain 7 in the mounted position of the consumable assembly 7 on the ultrasonic wave emitting device 1.

[0043] To cool the ultrasonic wave generator 1 according to the invention, it is assembled to the consumable coolant supply and drainage assembly 7 (also referred to as the "consumable assembly" 7). This assembly is removable, and the ultrasonic wave generator 1 can be easily assembled and disassembled from the consumable coolant supply and drainage assembly 7, with or without tools. Thus, the consumable assembly 7 can be removed after each use to either be replaced with a new, unused consumable assembly 7, or decontaminated (disinfected and / or sterilized) before being reinstalled on the ultrasonic wave generator 1. Therefore, the ultrasonic wave generator 1 can be quickly reused by the practitioner.

[0044] The coolant supply and outlet consumable assembly 7 comprises a coolant supply and outlet consumable system 9 (also referred to as the "consumable system" 9) and a sealing structure 10. The consumable system 9 has a proximal portion 9a and a distal portion 9b. The assembly between the consumable assembly 7 and the sealing structure is sealed and non-removable.

[0045] The consumable coolant supply and drainage system 9 is advantageously made of biocompatible material. The consumable coolant supply and drainage system 9 is advantageously made of sterilizable material. The consumable system 9 is made of a rigid plastic or metallic material. Advantageously, when the consumable system is made of metallic material, this facilitates cooling due to the thermally conductive nature of the metallic material. As an example of materials that can be used to manufacture the consumable system 9, acrylonitrile butadiene styrene polycarbonate (a mixture of ABS and polycarbonate) can be cited.

[0046] The consumable coolant supply and discharge system 9 comprises at least one coolant supply channel 11, and advantageously only one coolant supply channel 11 (also referred to as the "supply channel" 11). Each coolant supply channel 11 opens on either side of the consumable coolant supply and discharge system 9, on one side through an inlet 1a and on the other through an outlet 11b. In other words, the inlet 1a and the outlet 11b of each supply channel are not contiguous but are positioned at a distance from each other. The relative positioning of the inlet 1a and the outlet 11b of the supply channel can be adjusted by those skilled in the art to ensure good ergonomics and minimal space requirements.The at least one coolant supply channel 11 advantageously has a circular cross-section, but a cross-section of another shape may be considered without departing from the scope of the invention. The at least one coolant supply channel 11 may be partially straight, completely straight, or not. The shape and dimensions of the supply channel 11 may be adjusted by a person skilled in the art.

[0047] The consumable coolant supply and discharge system 9 comprises at least one coolant discharge channel 12, and advantageously only one coolant discharge channel 12 (also referred to as the "discharge channel" 12). The coolant discharge channel 12 opens on either side of the consumable coolant supply and discharge system 9, on one side through an inlet 12a and on the other through an outlet 12b. In other words, the inlet 12a and outlet 12b of each discharge channel are not contiguous but are positioned at a distance from each other. The relative positioning of the inlet 12a and outlet 12b of the discharge channel can be adjusted by a person skilled in the art to ensure good ergonomics and minimal space requirements.At least one coolant discharge channel 12 advantageously has a circular cross-section, but a cross-section of another shape may be envisaged without departing from the scope of the invention. At least one coolant discharge channel 12 may be partly straight or even completely straight, or not. The shape and dimensions of the drainage channel 12 can be adjusted by a person skilled in the art.

[0048] According to an advantageous embodiment of the invention, the supply channel 11 and the discharge channel 12 are arranged in the consumable system 9 symmetrically with respect to a central longitudinal axis L1 or a central longitudinal extension axis L2 of the consumable system for supplying and discharging the coolant 9. Advantageously, when the supply channel 11 and the discharge channel 12 are straight in at least one portion, this portion is parallel to the longitudinal axis L1,L2 of the consumable system for supplying and discharging the coolant 9. According to an advantageous embodiment, the supply channel 11 and the discharge channel 12 are straight at least in the proximal portion 9a of the consumable system 9, and are then preferably parallel to each other, advantageously in a direction parallel to the longitudinal axis L1,L2.

[0049] Advantageously, the supply channel(s) 11 and the discharge channel(s) 12 have a cross-section of the same shape, and preferably circular. Preferably, the diameter of the supply channel(s) 11 and the discharge channel(s) 12 are the same diameter.

[0050] Pipes (not shown in the figures) are intended to be positioned on the inlet lia of each supply channel 11 and on the outlet 12b of each discharge channel 12. For this reason, the inlet lia of each supply channel 11 and the outlet 12b of each discharge channel 12 are preferably tubular or conical in shape. They may have grooves around their circumference to facilitate the installation and retention of the pipes. The inlet lia of the supply channel(s) 11 and the outlet 12b of the discharge channel(s) 12 are advantageously of identical shape and dimensions, although this is not mandatory.

[0051] According to a particular embodiment, the inlet lia of each supply channel 11 and the outlet 12b of each discharge channel 12 can be provided with connecting cones (not shown in the figures) of the shape tubular or conical, which may have grooves around their circumference to facilitate the installation and maintenance of the pipes.

[0052] According to an advantageous embodiment of the invention, the inlet 1a of the supply channel(s) 11 and the outlet 12b of the discharge channel(s) 12 are located in the proximal portion 9a of the consumable coolant supply and discharge system 9. Advantageously, they are not adjacent, but are sufficiently spaced to allow the installation of the pipes on the inlet 1a of the supply channel(s) 11 and on the outlet 12b of the discharge channel(s) 12. In order to maintain good ergonomics of the ultrasonic energy probe 2 and a minimal footprint, the inlet 1a of the supply channel(s) 11 and the outlet 12b of the discharge channel(s) 12 are advantageously adjacent, and preferably superimposed with the ultrasonic energy emitter 1 in the mounted position of the consumable assembly 7 on the emitter. ultrasonic energy 1.

[0053] According to one embodiment of the invention, at least one of the channels 11, 12 diverges from another channel. Advantageously, according to this embodiment, at least one, and preferably one, coolant supply channel 11 diverges from at least one, and preferably one, coolant discharge channel 12. According to a particular embodiment of the invention, the consumable coolant supply and discharge system 9 preferably comprises a diverging supply channel 11 and a diverging discharge channel 12.According to this particular embodiment of the invention, the inlet 11a of the supply channel 11 and the outlet 12b of the discharge channel 12 are preferably adjacent, and the outlet 11b of the supply channel 11 and the inlet 12a of the discharge channel 12 are advantageously positioned at a distance, preferably symmetrically with respect to the longitudinal axis L1 or the longitudinal extension axis L2 of the consumable coolant supply and discharge system 9. In other words, according to this embodiment, the supply channel(s) 11 and the discharge channel(s) 12 diverge in the distal portion 9b of the coolant supply and discharge system 9.

[0054] According to one embodiment of the invention, the outlet 11b of each coolant supply channel 11 and the inlet 12a of each coolant discharge channel 12 are positioned in the same plane. Alternatively, the outlet 11b of each supply channel 11 and the inlet 12a of each discharge channel 12 are positioned in offset planes, preferably two offset planes. In particular, according to this embodiment, the consumable coolant supply and discharge system 9 comprises a coolant supply channel 11 and a coolant discharge channel 12 located in two offset planes.

[0055] According to a first embodiment, at least one supply channel 11 and at least one discharge channel 12 are at least partially straight. Advantageously, according to this embodiment, the straight sections of at least one supply channel 11 and at least one discharge channel 12 are parallel. Advantageously, according to this embodiment, at least one supply channel 11 and at least one discharge channel 12 lie advantageously in the same plane, and their inlets and outlets all lie in the same plane. Advantageously, according to this embodiment, at least one supply channel 11 and at least one discharge channel 12 are superimposed on the ultrasonic energy-emitting device 1 in the mounted position of the consumable assembly 7 on the ultrasonic wave-emitting device 1.

[0056] According to a second embodiment, at least one supply channel 11 and at least one discharge channel 12 are not straight along their entire length, or are even non-straight. According to this embodiment, the inlet of each channel 11, 12 and the outlet of each channel 11, 12 may lie in offset planes. Advantageously, according to this embodiment, at least one supply channel 11 and at least one discharge channel 12 are superimposed on the ultrasonic energy-emitting device 1 in the mounted position of the consumable assembly 7 on the ultrasonic wave-emitting device 1.

[0057] Advantageously, the supply channel 11 and the discharge channel 12 conform to the shape of the ultrasonic energy emitter 1. The relative positions of the inlets 11a, 12a and the outlets 11b, 12b of the supply channel 11 and discharge channel 12 can be adjusted as needed to facilitate the gripping and handling of the consumable coolant supply and drain system 9 and, once mounted, of the ultrasonic energy emission probe 2.

[0058] The consumable coolant supply and discharge system 9 may include, among other things, a measuring tool, and / or a calibration tool, and / or a spatial localization tool, and / or a sterilization indicator, and / or a display of its manufacturing and / or expiry date, and / or an RFID sensor, and / or a pump (primary or secondary). This tool may be positioned in a visible location on the consumable system 9.

[0059] The consumable coolant supply and discharge system 9 further includes a removable assembly device 13 for the ultrasonic energy emitter 1, in order to removably assemble the consumable coolant supply and discharge system 9 to the ultrasonic energy emitter 1. The removable assembly device 13 is intended to cooperate with a complementary removable assembly device 14 present on the ultrasonic energy emitter 1, as detailed below. The removable assembly device 13 may then comprise at least one assembly element, and preferably one, two, three, or four, such as elastically deformable tabs, a threaded ring, or a snap-fit ​​ring, for example.

[0060] According to one embodiment, the removable assembly device 13 comprises at least two assembly elements such as elastically deformable tabs, and typically two, three, or four. These deformable tabs are advantageously located along the consumable system 9, arranged on either side of the longitudinal axis L1, L2, preferably symmetrically with respect to this axis. Each of these deformable tabs has an inner face intended to be in contact with the ultrasonic energy-emitting device 1 in the mounted position of the consumable assembly 7 on the ultrasonic wave-emitting device 1. A rib may project from the inner face of each of these tabs. The inner face and optionally the rib of each of these tabs are intended to cooperate with an additional housing located on the ultrasonic energy emitter 1 as detailed below. These deformable tabs may include grooves on their inner face to improve the assembly of the consumable coolant supply and discharge system 9 and the ultrasonic energy emitter 1.

[0061] According to a second embodiment, the assembly device comprises at least one assembly element such as a threaded ring or a snap-fit ​​ring, and typically one.

[0062] According to one embodiment, the consumable system 9 has a connecting wall 15 intended to cooperate in the mounted position with the positioning structure 8 of the ultrasonic wave emitter 1. According to this embodiment, the connecting wall 15 abuts the positioning structure 8 in the mounted position of the consumable assembly 7 on the ultrasonic wave emitter 1. The connecting wall 15 is then advantageously located in the distal part 3d of the support body 3. According to a particular embodiment of the invention, the connecting wall 15 connects the outlet 11b of the supply channel and the inlet 12a of the discharge channel 12.

[0063] The coolant supply and outlet assembly 7 also includes the sealing structure 10, configured to continuously surround each supply channel 11 and each outlet channel 12 of the coolant supply and outlet system 9 over a cross-section. In other words, the sealing structure 10 completely covers each supply channel 11 and each outlet channel 12 over this cross-section. The sealing structure 10 is configured to conform to the shape of the supply channels 11 and 12 of the system 9 over at least one cross-section. In other words, over at least one cross-section, each supply channel 11 and each outlet channel 12 is in contact with the sealing structure 10 around its entire periphery. The sealing structure 10 is a single unit, with continuous material, without welding or external filler material.In the mounted position of the consumable assembly 7 on the ultrasonic wave emitting device 1, the sealing structure 10 is configured for. be interposed between the consumable system 9 and the ultrasonic energy emitting device 1. In other words, the energy emitting device 1, the sealing structure 10 and the consumable system 9 are superimposed in the mounted position.

[0064] According to a preferred embodiment of the invention, the consumable coolant supply and discharge system 9 and the sealing structure 10 form a single unit, i.e., they form a single piece. However, it is possible, without departing from the scope of the invention, for the consumable system 9 and the sealing structure 10 to be in the form of two separate elements to be assembled.

[0065] According to a first embodiment, the sealing structure 10 is configured to surround each channel 11,12 of the consumable coolant supply and discharge system 9 along their entire length, i.e. from the inlet 11a, 12a to the outlet 11b, 12b of these channels 11,12.

[0066] According to a second embodiment, the sealing structure 10 is configured to surround each channel 11, 12 of the consumable coolant supply and discharge system 9 only partially. In this embodiment, this portion must be sufficiently large to ensure the consumable system 9 is sealed and prevent any coolant leakage from the cooling chamber. The dimensions and position of the sealing structure 10 can then be determined by those skilled in the art.

[0067] The sealing structure is advantageously made of a flexible, i.e., non-rigid, material. In other words, the sealing structure advantageously has a hardness ranging from 15 Shore A to 60 Shore A, preferably from 20 Shore A to 50 Shore A, and preferably from 30 Shore A to 40 Shore A. The hardness can be measured using a Shore durometer, according to ISO 48-4:2018, ASTM D2240. Thus, during the assembly of the probe 2 according to the invention, as will be detailed later, the sealing structure 10 undergoes compression: when the consumable coolant supply and discharge assembly 7 is assembled to the ultrasonic energy emitter 1, the sealing structure 10 is crushed while conforming to the shape of each supply channel 11 and each outlet channel 12 of the coolant continuously over at least one section, which ensures the sealing of the consumable assembly 7. The sealing structure 10 is then elastically deformed.

[0068] The sealing structure 10 is advantageously made of a biocompatible material. The sealing structure 10 is advantageously made of a sterilizable material. The sealing structure 10 can be made of a flexible plastic material. The sealing structure 10 and the consumable system 9 are therefore made of different materials. Thermoplastic elastomers are examples of materials that can be used to make the sealing structure 10.

[0069] The consumable assembly for supplying and draining the coolant 7 may include at least one transverse peripheral groove 6, aligned, when present, with at least one transverse peripheral groove 5 of the ultrasonic energy-emitting device 1 in the mounted position of the consumable assembly 7 on the ultrasonic wave-emitting device 1. When the sealing structure 10 is configured to surround only a portion of the supply 11 and drain 12 channels, the transverse peripheral groove 6 is advantageously located on that portion.

[0070] According to an advantageous feature of the invention, the size of the coolant supply and discharge assembly 7 is minimal in order to allow good gripping and handling of the ultrasonic energy emission probe.

[0071] The invention also relates to an ultrasonic energy-emitting probe 2 for ultrasound imaging and / or for therapeutic treatment of the human body. The ultrasonic energy-emitting probe 2 according to the invention comprises an ultrasonic energy-emitting device 1 according to the invention removably assembled to a consumable coolant supply and discharge assembly 7 according to the invention. More specifically, the consumable assembly 7 and the ultrasonic energy-emitting device 1 are assembled through the cooperation of the removable assembly device 13 of the consumable system 9, and a removable supplementary assembly device 14 of the ultrasonic energy emitting device 1. In the mounted position, the consumable assembly 7 and the ultrasonic wave emitting device 1 are in a superposition or coincidence position.

[0072] The assembly can be achieved by elastic deformation, screwing, or snap-fitting, for example. To this end, the ultrasonic power generation device 1 includes a complementary removable assembly device 14 to the removable assembly device 13 of the coolant supply and discharge consumable system 9. The complementary removable assembly device 14 is preferably located on the support body 3, superimposed on the removable assembly device 13 of the consumable system 9 in the mounted position of the consumable system 9 on the ultrasonic wave emission device 1, so as to be able to cooperate with the latter.The removable assembly support device 14 comprises at least one, and preferably one, two, three, or four, assembly support element, such as a housing configured to cooperate with an elastically deformable tab, a threaded assembly thread configured to cooperate with a threaded ring, or a snap-fit ​​element configured to cooperate with a snap-fit ​​ring. In one embodiment, the removable assembly support device 14 comprises at least two, and preferably two, three, or four assembly support elements, such as housings provided on the support body 3 of the ultrasonic energy emitter 1, each cooperating with an elastically deformable tab arranged on the consumable coolant supply and discharge system 9.According to another embodiment, the supplementary removable assembly device 14 comprises at least one, and preferably one, supplementary removable assembly element 14, such as a threaded assembly thread or a snap-on element, arranged on the support body 3 of the ultrasonic energy-emitting device 1, and intended to cooperate respectively with a threaded ring or a snap-on ring present on the consumable coolant supply and discharge system 9.

[0073] The ultrasonic energy-emitting probe 2 also includes a membrane 30 positioned in front of the emitting face 4a of the transducer 4, and made of a material highly transparent to ultrasonic waves, i.e., having an ultrasonic attenuation of less than 10% for the frequencies used for therapy and imaging (typically between 1 MHz and 15 MHz). The ultrasonic attenuation can be measured using an ultrasonic transmitter and a hydrophone: by generating bursts, the decrease in wave amplitude can be measured, thus allowing the ultrasonic attenuation at a given frequency to be deduced.

[0074] The membrane 30, together with the emission face 4a, defines a cooling chamber through which the cooling fluid circulates. The membrane 30 is flexible and made of suitable materials such as silicone, latex, polyurethane, or any material with low sound absorption to reduce acoustic energy losses due to the membrane 30 heating up. This membrane 30 is advantageously fixed to the support body 3 by suitable, airtight, removable, or detachable means to obtain an airtight cooling chamber.

[0075] According to a first embodiment, the membrane 30 is mounted on the support body 3 using an elastic ring whose spring force is adapted to exert sufficient force to ensure a watertight seal of the membrane 30 on the support body 3, while allowing for easy installation of this ring by hand. This elastic ring is preferably positioned at the transverse peripheral groove 5 and / or the transverse peripheral groove 6, if present. Typically, the membrane 30 can be fixed to the support body 3 using an O-ring or a tie.

[0076] Alternatively, according to a second embodiment, this membrane 30 is interposed between the support body 3 and the consumable assembly 9. According to this embodiment, the support body 3 is provided with a threaded assembly thread intended to cooperate with a complementary thread of the consumable assembly 9. According to this embodiment, the consumable assembly 9 has an opening for the membrane 30, advantageously located opposite the front face 4a of the transducer 4.

[0077] The cooling chamber is also suitable for acoustic coupling with the soundproofed medium. Typically, the cooling fluid is a water-based liquid that has been previously degassed to improve wave propagation, or an oil selected from those exhibiting low acoustic absorption characteristics for ultrasonic waves. The liquid described in patent EP 1 038 551 can also be used.

[0078] According to an important feature of the invention, the outlet 11b of each supply channel 11 and the inlet 12a of each outlet channel 12 of the consumable coolant supply and outlet system 9 open into the cooling chamber. Thus, the coolant enters each supply channel 11 through the inlet 11a, flows through each supply channel 11 and exits through the outlet 11b, then flows into the cooling chamber, and enters each outlet channel 12 through the inlet 12a and exits through the outlet 12b.

[0079] According to a first embodiment illustrated in Figures 1 to 5, the energy-emitting device is elongated along its central longitudinal axis L and comprises a support body 3 consisting of an arm or branch 16, a head 17 defining a housing, and a base. The transducer 4 is located in the housing of the head 17, the front face 4a of the transducer 4 having the same orientation as the front face 3a of the support body 3. The transducer 4 has an oblong ultrasonic wave-emitting face 4a at its front, which partially defines a cooling chamber. The support body 3 has a transverse peripheral groove 5 that coincides with a transverse peripheral groove 6 of the coolant supply and discharge assembly 7 when the assembly 7 is mounted on the ultrasonic wave-emitting device 1.The support body 3 includes a positioning structure 8 in the form of a rim rising from the distal part 3d of the support body 3, and intended to cooperate with. a connecting wall 15 of the consumable system 9 in the mounted position of the consumable system 7 on the ultrasonic wave emitting device 1.

[0080] According to this first embodiment, the consumable coolant supply and discharge system 9 is elongated along the longitudinal axis L1, and has a proximal end 9c and a distal end 9d. In the illustrated example, the consumable coolant supply and discharge system 9 comprises a single supply channel 11 and a single outlet channel 12 for the coolant, each opening into the proximal end 9c and the distal end 9d via an inlet 11a, 12a and an outlet 11b, 12b. The two channels 11, 12 are straight and parallel along part of their length, and lie in the same plane. The supply channel 11 and the discharge channel 12 diverge at the distal portion 9b of the consumable system 9. In contrast, in the proximal portion 9a, the two channels 11,12 are straight and both parallel to the longitudinal axis L1.Thus, the inlet lia of the supply channel 11 and the outlet 12b of the discharge channel 12 are close together, while the outlet 11b of the supply channel 11 and the inlet 12a of the discharge channel 12 are spaced apart and located symmetrically with respect to the longitudinal axis Ll. According to the illustrated example, the outlet 11b of the supply channel 11 and the inlet 12a of the discharge channel 12 are connected by a connecting wall 15, designed to abut and cooperate with the positioning structure 8 of the ultrasonic energy emitter 1 when the consumable assembly 7 is mounted on the ultrasonic wave emitter 1. In the illustrated example, the connecting wall 15 is concave, but another shape suitable for cooperating with a positioning structure 8 could have been considered without departing from the scope of the invention. The illustrated supply and discharge consumable assembly 7 further includes a transverse peripheral groove 6.

[0081] According to this first embodiment, the two coolant supply channels 11 and outlet channels 12 are continuously surrounded over most of their length by the sealing structure 10.

[0082] According to this first embodiment, in the mounted position of the consumable assembly 7 on the ultrasonic wave emitting device 1, the assembly Consumable 7 is superimposed on the arm 16 of the support body 3. As can be seen in particular in Figure 3, the consumable coolant supply and discharge system 9 is assembled on the front face 3a of the support body 3 of the ultrasonic energy emitter 1, by means of a removable assembly device 13 and a complementary removable assembly device 14. More specifically, in the illustrated example, the consumable system 9 comprises two elastically deformable tabs as a removable assembly device 13, arranged symmetrically with respect to the longitudinal axis L1. In the illustrated example, the two tabs are located in the proximal portion 9a of the consumable system 9, but another positioning could be envisaged without departing from the scope of the invention.As illustrated in Figures 1 to 5, each leg of the removable assembly device 13 cooperates with a complementary housing of the complementary removable assembly device 14 located on the ultrasonic energy emitting device 1. The shape and positioning of the legs and complementary housings can be adjusted by a person skilled in the art.

[0083] According to this first embodiment, a membrane 30 can be put in place and fixed to the support body 3 using an elastic ring, for example, advantageously positioned in the transverse peripheral groove 5 and in the transverse peripheral groove 6.

[0084] According to a second embodiment illustrated in Figures 6 to 10, the energy-emitting device 1 comprises a cylindrical support body 3 for a transducer 4 having at the front an ultrasonic wave-emitting face 4a facing an opening 3e in the support body 3, and at the rear a rear face. Typically, the support body 3 is designed to have a tubular wall 18 forming a collar or neck. This tubular wall 18 of the support body 3 is delimited between the front face 3a and the rear face 3b and has at its end an upper annular wall 18a internally delimiting the opening 3e.

[0085] The emitting face 4a of the transducer 4 has a smooth surface, being delimited by a peripheral edge 4b. According to the illustrated example, the emitting face 4a has a concave shape such as a hemispherical shape, although another shape could be envisaged without departing from the scope of the invention, such as a planar or toroidal shape. According to the illustrated example, the emitting face has a circular contour, but it is clear that the emitting face could have a different contour shape, such as rectangular or oblong.

[0086] According to this second embodiment, the ultrasonic energy-emitting device 1 is assembled to a consumable system 9 in the form of an annular body or a ring 19 extended by a portion elongated along a longitudinal axis of extension L2 belonging to the plane of the consumable system for supplying and draining coolant 9. The ring is circular as illustrated, but another shape could have been considered within the scope of the invention, in particular an oblong one. The annular body or ring 19 has an upper annular face 19a and a lower annular face 19b connected by a peripheral wall 19c. In other words, the upper annular face 19a extends at a right angle by a peripheral wall 19c.The peripheral wall 19c has an internal face 19d intended to extend in relation to the tubular wall 18 of the body 3, in the mounted position of the consumable assembly 7 on the support body 3 of the ultrasonic wave emission device 1.

[0087] According to the example illustrated in Figures 6 to 10, the consumable system 9 comprises a single coolant supply channel 11 and a single coolant discharge channel 12. The supply channel 11 and the discharge channel 12 are located within an elongated portion 20 and within the annular ring or body 19. The inlet 1a of the supply channel 11 and the outlet 12b of the discharge channel 12 extend upstream in a straight line parallel to the longitudinal axis of extension L2. More specifically, according to the illustrated example, the supply channel 11 and the discharge channel 12 traverse the elongated portion 20 from its proximal end to its distal end, enter the ring 19 through its inner face 19b, and exit through the upper face 19a of the ring. Thus, the inlet 11 of the supply channel and the outlet 12b of the discharge channel are located in the proximal end of the elongated portion, and the Outlet 11b of the supply channel 11 and inlet 12a of the discharge channel are located on the upper face 19a of the ring 19. In the illustrated example, outlet 11b of the supply channel 11 and inlet 12a of the discharge channel are positioned symmetrically with respect to the longitudinal extension axis L2, with the supply channel 11 and the discharge channel 12 forming an arc of approximately 90° within the ring 19. Within the ring 19, the supply channel 11 and the discharge channel 12 follow the radius of curvature of the ring. In the elongated portion 20, the supply channel 11 and the discharge channel 12 are straight and parallel. According to this embodiment, the inlet 11a of the supply channel and the outlet 12b of the discharge channel 12 are adjacent.According to this embodiment, the plane of the elongated portion 20 (and therefore the inlet lia of the supply channel and the outlet 12b of the discharge channel) is located in a plane parallel to that of the ring 19 (containing therefore the outlet 11b of the supply channel 11 and the inlet 12a of the discharge channel 12).

[0088] According to this second embodiment, the sealing structure 10 surrounds each of the two channels 11, 12 along a portion of their length. More precisely, the sealing structure has a circular shape, like the annular ring or body 19 and the cylindrical support body 3. In the mounted position of the consumable assembly 7 on the ultrasonic wave emitter 1, the sealing structure 10 is interposed between the ring 19 on one side and the cylindrical support body 3 on the other, and continuously surrounds the inlet channel 11 and the outlet channel 12 along their arc-shaped portion.

[0089] According to a first embodiment illustrated in Figures 6 to 9, the consumable system 9 has a removable assembly device 13 in the form of two elastically deformable tabs extending from the lower annular face 19b of the ring 19. Of course, it is clear that the removable assembly device 13 could be in the form of more than two elastically deformable tabs, typically three or four. In the illustrated example, these deformable tabs are arranged symmetrically with respect to the longitudinal extension axis L2. According to this embodiment, the tubular wall 18 of the support body 3 has a complementary device Removable assembly 14 in the form of two housings adapted to cooperate with the two elastically deformable tabs in the mounted position of the consumable assembly 7 on the ultrasonic wave emitter. According to this embodiment, although not illustrated, the support body 3 may have a peripheral groove to facilitate the airtight attachment of the membrane 30. According to this first embodiment, a membrane 30 can be positioned and attached to the support body 3 using, for example, an elastic ring advantageously positioned in the transverse peripheral groove.

[0090] According to a second embodiment illustrated in Figure 10, the support body 3 is provided with an additional thread 21 for threaded assembly intended to cooperate with a thread 22 present on the consumable system 9. More specifically, the tubular wall 18 has an additional thread 21 intended to cooperate with a thread 22 present on the inner face 19d of the annular body or ring 19. In other words, the consumable system 9 and the body 3 are provided with a threaded assembly system 21, 22 to ensure, by screwing the consumable system 9 onto the body 3, that the membrane 30 is held in a tight seal against the body 3.

[0091] According to the example illustrated in Figure 10, the consumable system 9 is in the form of an annular body or ring 19 having an upper annular face 19a defining, in its center, a central passage 19e for a portion of the membrane 30 and, in particular, a central portion 30a of this membrane 30. The membrane 30 and the consumable system 9 are two independent parts. Typically, this central passage 19e has a cross-section corresponding substantially to the cross-section of the opening 3e, so that when the consumable system 9 is mounted on the body 3, the opening 3e and the central passage 19e coincide.

[0092] Typically, the central passage 19e has a circular outline. Naturally, the membrane 30 has a shape adapted or deformable to allow its central portion 30a to pass through the central passage 19e and form the cooling chamber. The central portion 30a of the membrane 30 is bordered by a peripheral portion 30b designed to cooperate with the body 3 to ensure the sealing of the cooling chamber. More specifically, the peripheral part 30b of the membrane 30 is adapted to bear against the upper annular wall 18a of the tubular wall 18.

[0093] The upper annular face 19a extends at a right angle through the peripheral wall 19c having an internal face 19d and intended to extend in relation to the tubular wall 18 of the body 3, in the mounted position of the assembly system 9 on the support body 3.

[0094] The removable assembly system 21, 22 of the consumable system on the support body 3 can be implemented in any suitable manner. Such a threaded assembly system comprises at least one helical rib or thread 21 cooperating with at least one complementary helical rib or complementary thread 22. The thread 21 is provided on the consumable system 9 or on the support body 3, while the complementary thread 22 is provided respectively on the support body 3 or on the consumable system 9. It should be noted that the thread 21 or the complementary thread 22 can be implemented as a continuous element or as discontinuous elements such as lugs or studs. Similarly, the removable threaded assembly system 21, 22 can comprise several helical threads 21 and several complementary helical threads 22.

[0095] In the mounted position of the consumable system 9 on the support body 3, the peripheral part 30b of the membrane 30 is interposed between the consumable system 9 and the support body 3, and more specifically the tubular wall 18. Screwing the consumable system 9 onto the support body 3 ensures that the membrane 30 remains in a watertight bearing against the support body 3. For example, the membrane 30 is dimensioned so that its peripheral part 30b is positioned outside the thread 21.

[0096] According to an advantageous embodiment illustrated in Figure 10, the consumable system 9 is provided with a washer 23 mounted to rotate freely relative to the consumable system 9. This washer 23 has, in its central part, a hole 23a for the passage of the central part 30a of the flexible membrane. The cross-section of this hole 23a corresponds substantially to the cross-section of the central passage 19e of the upper annular face 19a or as in the illustrated example is greater than this section of the central passage 19e of the upper annular face 19a. In the mounted position, the inner edge of the washer 23 thus extends back from the inner edge of the upper annular face 19a of the consumable system 9.

[0097] This washer 23, which has an outer annular face 23b and an inner annular face 23c, is held within the consumable system 9 inside an annular housing defined by the inner face of the upper annular face 19a and by a rib extending projecting from the inner face of the peripheral wall 19c. The housing thus has a C-shaped cross-section. The washer 23 has limited transverse movement on one side by the inner face of the upper annular face 19a, against which the outer annular face 2b can contact, and on the other side by the rib against which the inner annular face 23c can contact. The washer 23 has limited radial movement by the inner face of the peripheral wall 19c. Thus, the washer 23 and the consumable system 9 are connected by a pivot joint along the axis passing through the axis of symmetry of the washer 23.

[0098] According to an advantageous manufacturing characteristic, washer 23 is made of a material with very high non-stick power such as polytetrafluoroethylene (PTFE or TEFLON) for example.

[0099] The assembly between washer 23 and consumable system 9 can be achieved in any suitable manner. One solution is to produce consumable system 9 incorporating washer 23 using a known 3D printing technique. Washer 23 can also be positioned within consumable system 9 by deformation. [0100)11 must be understood that in the unmounted position of the consumable system on the support body 3, there is freedom of rotation between the consumable system 9 and the washer 23. In other words, the consumable system 9 can rotate on itself without causing the washer 23 to rotate, which remains fixed. [0101JII It should be noted that before the consumable system 9 is put in place, the membrane 30 is positioned so that its peripheral part 30b covers the upper annular wall 18a. When the consumable system 9 is mounted on the support body 3, the washer 23 is not yet in contact with the peripheral part 30b of the membrane 30, which itself is only in contact with the upper annular wall 18a of the tubular wall 18. During rotation, the consumable system 9 and the washer 23 rotate simultaneously. When the washer 23 is positioned so as to come into contact with the peripheral part 30b, the membrane 30 is then interposed between this washer 23 and the upper annular wall 18a of the tubular wall 18. The consumable system 9 then continues its rotational movement while the washer 23 remains fixed relative to the upper annular wall 18a of the tubular wall 18 and relative to the membrane 30.

[0102] During the assembly of the consumable system onto the body 3, the consumable system 9 is rotated without rotating the washer 23, which thus holds the membrane 30 in place without creasing it. At the end of the screwing stroke of the consumable system 9, its upper annular face 19a exerts a bearing force on the outer annular face 23e of the washer 23, locking the washer 23 in position, which presses the membrane 30 against the upper annular wall 18a of the tubular wall 18.

[0103] The washer 23 is mounted in the consumable system 9 with limited lateral movement to exert pressure on the diaphragm 30 when the consumable system 9 is screwed onto the body 23. In other words, the washer 23 is brought into its final pressure position when the consumable system is screwed on by the inner face of the upper annular face 19a of the ring bearing against the outer annular face 23b of the washer 23. The screwing stroke of the consumable system 9 depends, of course, in particular on the thread pitch 21 and the clearance between the inner face of the upper annular face 19a and the outer annular face 23e of the washer 23. The lateral movement, combined with the radial movement described above, creates a space into which cleaning and decontamination liquids can penetrate and perform their functions during decontamination and sterilization phases.

[0104] According to this embodiment, the washer 23 can be in direct contact with the membrane 30 or, as in the example illustrated in Figure 10, via a flat or annular sealing gasket 24 bearing against the membrane 30, which is in contact with the upper annular wall 18a of the tubular wall 18. According to a preferred embodiment, the sealing gasket 24 is mounted on the washer 23. The washer 23 may have, on its inner annular face 23c, a mounting groove for the sealing gasket 24.

[0105] According to the example illustrated in figure 10, the consumable assembly 9 then also fulfills the function of a fixing ring for the membrane 30 on the support body 3.

[0106] According to this second embodiment, and although not illustrated, the membrane 30 may not be interposed between the consumable system 9 as illustrated in figure 10, but may be put in place and fixed to the support body 3 using an elastic ring, for example, advantageously positioned in a transverse peripheral groove 5 present on the support body 3.

[0107] The invention also relates to a kit comprising a coolant supply and discharge system 9 according to the invention. Such a kit may also include pipes assembled or intended to be assembled at the inlet 1a of each supply channel 11 and at the outlet 12b of each discharge channel 12.

[0108] The invention also relates to a kit comprising a consumable coolant supply and discharge assembly 7 according to the invention. Such a kit may also include pipes assembled or intended to be assembled at the inlet 1a of each supply channel 11 and at the outlet 12b of each discharge channel 12.

[0109] The invention also relates to a method for manufacturing a consumable system for supplying and draining coolant according to Invention 9. The consumable system 9 can in particular be produced by 3D printing, or by molding in particular.

[0110] The invention also relates to a method for manufacturing a consumable coolant supply and discharge assembly according to the invention. The consumable assembly 7 can be produced by 3D printing or by molding, in particular. When the consumable assembly 7 is produced by molding, the method may include separately producing, by molding, the consumable system 9 on the one hand and the sealing structure 10 on the other, and then assembling them by bonding or heating, for example. According to this embodiment, the adhesive used to bond the consumable system 9 and the sealing structure 10 together may be a hot melt adhesive, a one-component or two-component reactive adhesive, for example. Alternatively, when the consumable assembly is produced by molding, the method may include the simultaneous injection of the material intended to form the consumable system 9 and the material intended to form the sealing structure 10.Alternatively, when the consumable assembly is produced by molding, the process may include the following steps (the so-called overmolding process):

[0111] 1) introduce into a mold Ml a composition intended to form the consumable system 9 after its hardening, the mold Ml having the desired shape and dimensions of the consumable system 9,

[0112] 2) to obtain the hardening of the composition intended to form the consumable system 9,

[0113] 3) Remove the Ml mold to obtain the consumable system 9,

[0114] 4) introduce into a second mold M2 the consumable system 9 obtained in step 3) as well as a composition intended to form the sealing structure, the second mold M2 having the desired shape and dimensions of the consumable assembly 7,

[0115] 5) to obtain the hardening of the composition intended to form the sealing structure 10, and

[0116] 6) unmold the consumable assembly 7 thus obtained.

[0117] According to this last variant of the embodiment, the consumable system 9 and the sealing structure 10 are not glued but are fixed together by means of the adhesion between the constituent materials of the consumable system 9 and the sealing structure 10.

[0118] The invention also relates to a method for manufacturing an ultrasonic energy emission device according to invention 1.

[0119] Finally, the invention relates to a method for preparing the ultrasonic energy emission probe 2 according to the invention. This method comprises the following steps:

[0120] a) to have a consumable coolant supply and drainage assembly 7 according to the invention, and an ultrasonic energy emission device 1 according to the invention,

[0121] b) position the consumable assembly 7 on the ultrasonic energy-emitting device 1 so that the consumable assembly 7 is against the positioning structure 8 when the latter is present, and so that the inlet 11 of each supply channel 11 and the outlet 12b of each discharge channel 12 open into the cooling chamber, and

[0122] c) assemble the consumable assembly 7 and the ultrasonic energy emission device 1, so as to elastically deform the sealing structure 10 to ensure sealing with respect to the cooling chamber.

[0123] At step a), the consumable assembly 7 and the ultrasonic energy emitting device 1 are either decontaminated beforehand or have not been used.

[0124] During step b), the coolant supply and discharge consumable assembly 7 is superimposed on the ultrasonic energy emission device 1. More specifically, the consumable assembly 7 is positioned on the front face 3a of the support body, so that the inlet lia of each supply channel 11 and the outlet 12b of each discharge channel 12 open into the cooling chamber.

[0125] When the ultrasonic energy-emitting device 1 includes a positioning structure 8, the consumable assembly 7 advantageously presents a connecting wall 15. Thus, according to this embodiment, the connecting wall 15 is positioned against the positioning structure 8 in step b).

[0126] The preparation process according to the invention may further include a step d), subsequent to step c). Step d) consists either of placing pipes on the inlet lia of each supply channel 11 and on the outlet 12b of each discharge channel 12 of the coolant, or of placing a membrane 30 which delimits a cooling chamber with the front face 4a of the transducer 4, or of placing pipes on the inlet lia of each supply channel 11 and on the outlet 12b of each discharge channel 12 of the coolant, and of placing a membrane 30 which delimits a cooling chamber with the front face 4a of the transducer 4.

[0127] To facilitate the installation and maintenance of the pipes, the inlet 11 of each supply channel 11 and the outlet 12b of each discharge channel 12 are clear of the ultrasonic energy emitter 1. Furthermore, these inlet(s) 11 and outlet(s) 12b are sufficiently spaced from each other and from the ultrasonic energy emitter 1 to allow for easy installation of each pipe. These inlet(s) 11 and outlet(s) 12b are advantageously positioned opposite the support body 3 to minimize bulk and maintain good ergonomics.

[0128] The installation of the membrane 30 includes positioning it so that it completely or partially surrounds the support body, as described above. The membrane 30 is then held in position by any suitable means to obtain a sealed cooling chamber. By way of example, an O-ring or a ligature may be used, preferably at the transverse peripheral groove and / or transverse peripheral groove where these are present, or a thread or tapped hole.

[0129] In the case where the ultrasonic energy emission probe 1 has already been used, the process for preparing the ultrasonic energy emission probe 1 includes More specifically, the following steps after each use of the ultrasound imaging probe 1:

[0130] 1) Disassemble or remove the consumable assembly 7 and the ultrasonic energy emitting device 1,

[0131] 2) Clean the ultrasonic energy emitting device 1, and possibly disinfect or even sterilize it.

[0132] 3) position a consumable assembly 7 on the ultrasonic energy emission device 1 which has not been used or which has been disinfected or even sterilized, so that the consumable assembly 7 is against the positioning structure 8, and so that the inlet lia of each supply channel 11 and the outlet 12b of each discharge channel 12 open into the cooling chamber,

[0133] 4) assemble the consumable assembly 7 and the ultrasonic energy emission device 1, so as to elastically deform the sealing structure 10 to ensure a seal with respect to the cooling chamber, and

[0134] 5) possibly install pipes which have not, preferably, been used on the inlet lia of each supply channel 11 and on the outlet 12b of each discharge channel 12 of the coolant, and / or install a membrane 30 which delimits with the front face 4a of the transducer 4 a cooling chamber.

[0135] During step 2), cleaning, disinfection or even sterilization can be carried out by any technique known to those skilled in the art and compatible with the presence of transducer 4, such as wipes and two-component products or ionizing radiation for example.

[0136] When the ultrasonic energy emitting device 1 includes a positioning structure 8, the consumable assembly 7 advantageously has a connecting wall 15. Thus, according to this embodiment, the connecting wall 15 is positioned against the positioning structure 8 in step 3).

[0137] The invention is not limited to the examples described and represented, as various modifications can be made to it without departing from its scope.

Claims

AMENDED CLAIMS received by the International Bureau on 07 May 2026 (07.05.26) Demands

1. Consumable coolant supply and discharge system (9) of an ultrasonic energy-emitting device (1), said consumable coolant supply and discharge system (9) comprising at least one supply channel (11) and at least one discharge channel (12) for the coolant each opening on either side of the consumable coolant supply and discharge system (9) by an inlet (11a, 12a) and an outlet (11b, 12b), said consumable coolant supply and discharge system (9) comprising a removable assembly device (13) to an ultrasonic energy-emitting device (1), characterized in that the consumable coolant supply and discharge system (9) is made of a rigid plastic or metallic material.

2. Consumable coolant supply and discharge system (9) according to claim 1, wherein the consumable coolant supply and discharge system (9) constitutes a consumable cooling system that can be replaced after each use.

3. Consumable coolant supply and discharge system (9) according to claim 1 or 2, said consumable coolant supply and discharge system (9) being elongated along a longitudinal axis (L1), having a proximal end (9c) and a distal end (9d), and comprising at least one supply channel (11) and at least one discharge channel (12) for the coolant each opening into the proximal end (9c) and the distal end (9d) by an inlet (11a, 12a) and an outlet (11b, 12b), said consumable coolant supply and discharge system (9) comprising a removable assembly device (13) for an ultrasonic energy emitting device (1).

4. Consumable coolant supply and discharge system according to any one of claims 1 to 3, wherein the removable assembly device (13) comprises at least two elastically deformable tabs arranged between the extremity proximal end (9c) and distal end (9d) and arranged symmetrically with respect to the longitudinal axis (Ll).

5. Consumable coolant supply and discharge system (9) according to claim 1 or 2, said consumable coolant supply and discharge system (9) being in the form of a circular or oblong ring (19) comprising a peripheral rim within which are at least one supply channel (11) and at least one discharge channel (12) for the coolant, said consumable coolant supply and discharge system (9) comprising a removable assembly device (13) for an ultrasonic energy emitting device (1).

6. Consumable coolant supply and discharge system (9) according to the preceding claim, wherein the inlet (l ia) of the supply channel(s) (11) and the outlet (12b) of the discharge channel(s) (12) extend upstream along a longitudinal extension axis (L2) belonging to the plane of the consumable coolant supply and discharge system (9).

7. Consumable coolant supply and discharge system (9) according to any one of claims 5 or 6, wherein the removable assembly system (13) comprises at least two elastically deformable tabs rising from a lower annular face (19b) of the crown (19).

8. Consumable coolant supply and discharge system (9) according to any one of claims 5 or 6, wherein said consumable coolant supply and discharge system (9) is in the form of a circular ring having a threaded assembly thread (22) or a snap-in element intended to cooperate respectively with a complementary thread (21) or a complementary snap-in element present on the consumable system (9).

9. Consumable coolant supply and discharge system (9) according to any one of the preceding claims, wherein at least one of the channels diverges from another channel.

10. Consumable coolant supply and discharge system (9) according to any one of the preceding claims previous, according to which the outlet (11b) of the supply channel(s) (11) and the inlet (12a) of the discharge channel(s) (12) are located in the same plane.

11. Consumable system for supplying and draining coolant (9) according to any one of claims 1 to 9, wherein the outlet (11b) of the supply channel(s) (11) and the inlet (12a) of the drain channel(s) (12) are located in offset planes.

12. Consumable system for supplying and draining coolant (9) according to any one of the preceding claims further comprising a measuring tool, and / or a calibration tool, and / or a spatial localization tool, and / or a sterilization indicator, and / or a display of its date of manufacture and / or expiry, and / or an RFID sensor and / or a pump.

13. Consumable system for supplying and draining coolant (9) according to any one of the preceding claims made of metallic material.

14. Consumable coolant supply and discharge assembly (7) comprising the consumable coolant supply and discharge system (9) according to any one of the preceding claims, and a sealing structure (10) configured to continuously surround over a section the supply and discharge channels (11,12) of the consumable coolant supply and discharge system (9).

15. Consumable coolant supply and discharge assembly (7) according to the preceding claim, wherein the sealing structure (10) and the consumable coolant supply and discharge system (9) are made of biocompatible materials.

16. Consumable coolant supply and discharge assembly (7) according to claim 14 or 15, wherein the sealing structure (10) and the consumable coolant supply and discharge system (9) are sterilizable.

17. Consumable coolant supply and discharge assembly (7) according to any one of claims 14 to 16, wherein the sealing structure (10) has a hardness ranging from 15 Shore A to 60 Shore A.

18. Consumable coolant supply and discharge assembly (7) according to any one of claims 14 to 17, wherein the sealing structure (10) and the consumable coolant supply and discharge system (9) form a unit element.

19. Consumable coolant supply and discharge assembly (7) according to any one of claims 14 to 18 comprising at least one transverse peripheral groove (6).

20. Ultrasonic energy emitting apparatus (1) comprising a support body (3) for a transducer (4), the transducer (4) having a front face (4a) partially delimiting a cooling chamber, characterized in that the ultrasonic energy emitting apparatus (1) comprises a complementary removable assembly device (14) for assembly to a consumable coolant supply and discharge assembly (7) according to any one of claims 14 to 19.

21. Ultrasonic energy emitting device (1) according to the preceding claim, wherein a positioning structure (8) is arranged in the distal part (3d) of the support body (3).

22. Ultrasonic energy emitting apparatus according to claim 20 or 21, wherein the complementary removable assembly device (14) comprises at least two housings arranged on the support body (3) to cooperate with elastically deformable tabs arranged on the consumable coolant supply and discharge system (9).

23. Ultrasonic energy emitting device (1) according to claim 20 or 21, wherein the additional removable assembly device (14) comprises an additional threaded assembly thread or an additional snap-on element provided on the support body (3) to cooperate with respectively a threaded assembly thread or a snap-on element present on the consumable coolant supply and discharge system (9).

24. Ultrasonic energy emitting device (1) according to any one of claims 20 to 23, wherein the support body (3) includes a transverse peripheral groove (5).

25. Ultrasonic energy-emitting apparatus (1) according to the preceding claim, wherein the transverse peripheral groove coincides in mounted position with a groove (6) of the consumable assembly for supplying and draining coolant (7).

26. Ultrasonic energy-emitting probe (2) for imaging and / or therapy comprising: - an ultrasonic energy-emitting device (1) according to any one of claims 20 to 25, and - a consumable coolant supply and discharge assembly (7) according to any one of claims 14 to 19, the consumable coolant supply and discharge assembly (7) being mounted by elastic deformation or by screwing or by snapping onto the ultrasonic energy emission device (1) to ensure sealing with respect to the cooling chamber, and mounted so that the inlet (11a) of each supply channel (11) and the outlet (12b) of each discharge channel (12) open into the cooling chamber.

27. ​​Ultrasonic energy emission probe (2) according to the preceding claim, wherein the consumable assembly (7) and the ultrasonic wave emission device (1) are superimposed in the mounted position.

28. Kit comprising a consumable system for supplying and draining coolant (9) according to any one of claims 1 to 13 or a consumable assembly for supplying and draining coolant (7) according to any one of claims 14 to 19.

29. Kit according to the preceding claim, further comprising pipes for the circulation of the coolant, assembled or intended to be assembled at the inlet (1a) of each supply channel (11) and at the outlet (12b) of each discharge channel (12).

30. A method for preparing an ultrasonic energy emission probe (2) according to claim 26 or 27 comprising the following steps: a) having a consumable coolant supply and discharge assembly (7) according to any one of claims 14 to 19, and an ultrasonic energy emission device (1) according to any one of claims 20 to 25, b) positioning the consumable coolant supply and discharge assembly (7) on the ultrasonic energy emission device (1) so that the consumable supply e and coolant outlet (7) be against the positioning structure (8) when present, and so that the inlet (1a) of each supply channel (11) and the outlet (12b) of each discharge channel open into the cooling chamber, and c) assemble the consumable coolant supply and discharge assembly (7) and the ultrasonic energy emission device (1), so as to elastically deform the sealing structure (10) to ensure sealing with respect to the cooling chamber.

31. Method of preparing an ultrasonic energy emission probe (2) according to the preceding claim, further comprising a step d) subsequent to step c), of placing pipes on the inlet (1a) of each supply channel (11) and the outlet (12b) of each discharge channel (12) of the coolant, and / or of placing a membrane (30) which delimits with the front face (4a) of the transducer (4) a cooling chamber.

32. A method for preparing an ultrasonic energy-emitting probe (2) according to claim 30 or 31, comprising the following steps after each use of the ultrasonic energy-emitting imaging probe: 1) Disassemble the consumable coolant supply and drain assembly (7) and the ultrasonic energy emission device (1), 2) clean the ultrasonic energy emitting device (1), and possibly disinfect it, 3) Position a consumable coolant supply and discharge assembly on the ultrasonic energy emitting device that has not been used or that has been disinfected after use, so that the consumable coolant supply and discharge assembly is against the positioning structure when the latter is present, and so that the inlet of the supply channel(s) and the outlet of the discharge channel(s) open into the cooling chamber, 4) Assemble the consumable coolant supply and drain system and the ultrasonic energy emission device, so as to elastically deform the structure of the sealing to ensure a tight seal against the cooling chamber, and 5) possibly install pipes which have preferably not been used on the inlet of each supply channel and the outlet of each coolant drain channel, and / or install a membrane (30) which delimits with the front face (4a) of the transducer (4) a cooling chamber.

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