• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    coverage, treatment device and method of use of such device. The present invention relates to a covering element, especially for a hifu head, comprising a peripheral outer wall, a first open side configured to partially cover an ultrasound head and a second closed side, comprising a flexible membrane adapted for the contract with the patient's skin, characterized by the fact that the covering element is detachably attachable to the tip of said ultrasound probe.
    公开号:BR112012012769B1
    申请号:R112012012769-1
    申请日:2010-11-23
    公开日:2021-07-13
    发明作者:Thierry Pechoux
    申请人:Theraclion Sas；
    IPC主号:
    专利说明:

    [0001] The present invention relates to a removable cover element for ultrasound probe heads, especially HIFU (High Intensity Focused Ultrasound) probe heads, for a treatment device and a method of using a device according to with the preamble of the independent claims.
    [0002] Treatment of patients with ultrasound waves, particularly high-intensity focused ultrasound (HIFU) is well known in the art. It is especially used for the treatment of thyroid, breast, uterus and prostate tumors. Tumors are thus destroyed by means of thermal energy. The necessary heat is generated by focusing high intensity ultrasound waves on a single focal point. As an acoustic wave propagates through tissue, some of it is absorbed and converted into heat. At the focal point, due to significant energy deposition, the temperature within the tissue rises to 65° to 85°C, destroying diseased tissue by coagulation necrosis. A major advantage of HIFU treatment is that it is a non-invasive treatment method, thus considerably reducing the risks for the patient.
    [0003] HIFU treatment devices generally comprise a treatment head with a HIFU transducer. The treatment head is placed over the tissue to be treated or in tissues adjacent to the organ to be treated. Such devices are sold, for example, by TMS EDAP under the Ablatherm® trademark or by Theraclion under the name TH-One. In most cases, the treatment head comprises a cover membrane defining a space between said membrane and the ultrasound transducer that is filled with coupling liquid. The use of liquid coupling allows ultrasound waves to travel through liquid or similar media without encountering reflective air interfaces between the transducer and a patient's skin.
    [0004] The Sonolith® Praktis lithotripter sold by EDAP TMS comprises a removable cover over the ultrasound head to allow mounting an electrode on the ellipsoidal reflector. The roof is made of a circumferential metal wall and a flexible membrane on one side. The cover is held over the ultrasound head using three metal clips. The ellipsoidal reflector, covered by the covering element can later be filled with a coupling liquid.
    [0005] This cover has the disadvantages that it is not easily attachable to the ultrasound head, as all clamps have to be locked in place separately. Also, care must be taken to check for cover leakage, as different parts of different materials are assembled together.
    [0006] WO 2009/082874 describes a probe head with a membrane filled with a coupling liquid such as gel. The probe transducer is cooled by the air flow.
    [0007] WO 2008/081147 refers to a HIFU probe head with a cover membrane defining a chamber filled with acoustic coupling liquid. The chamber is coupled to a closed liquid circuit. By means of pumps the liquid is pumped through the chamber and cooled in a cooling chamber. Therefore the liquid additionally functions as a coolant to reduce the temperature of the transducer as well as the patient's skin.
    [0008] In both cases, the membrane must be cleaned and/or sanitized together with the probe head.
    [0009] It is, therefore, an object of the present invention to provide a probe head cover that overcomes the disadvantages of the prior art and in particular to provide a probe head cover, an ultrasound device and a method of using the device. ultrasound with an increased level of hygiene.
    [00010] The present invention relates to a covering element for a HIFU head, comprising a dimensionally stable outer peripheral wall, a first open side configured to partially cover an ultrasound head and a second closed side, comprising an adapted flexible membrane to come into contact with the patient's skin. The cover element is provided with connecting means for releasably coupling to the tip of said ultrasound probe. The membrane is configured to minimize the absorption of HIFU ultrasound waves.
    [00011] The outer peripheral wall is dimensionally stable, which consequently maintains its shape regardless of whether the covering element is mounted on a probe head or not. This dimensional stability is possible, for example, by selecting a suitable thickness and/or material for the wall. Preferably the outer peripheral wall is shaped that is configured to match the shape of a specific ultrasound head. This makes it easier to mount the cover element onto the ultrasound head, as in most cases the cover can just be easily slid over the probe head. In a specific modality, the outer peripheral wall has a frustoconical shape. Alternatively, the outer peripheral wall can be cylindrical, cubic or frustopyramidal in shape.
    [00012] The attachment means are configured to be easily attached and decoupled with the probe head.
    [00013] The flexible membrane is configured to minimize the absorption or reflection of HIFU waves. When the covering element is mounted on an ultrasound probe head, the flexible membrane will be positioned between the ultrasound transducer and the organ and/or tissue to be treated, thus reflecting or absorbing the energy of HIFU ultrasound waves. Having a membrane adapted to minimize this absorption or reflection leads to greater treatment efficiency. Energy reflection off the membrane depends on the thickness and acoustic impedance of the material used. Minimizing in this sense means that the thickness of the flexible membrane and the acoustic impedance of the material are selected in a way that allows the ultrasound energy to reach the maximum amount of the organ and/or tissue to be treated. The flexible membrane absorbs or reflects less than 5% of the ultrasound energy is, more preferably less than 3% and more preferably less than 1%.
    [00014] In addition, the flexible membrane is configured to provide a high thermal conductivity. This has the beneficial effect that heat from the skin can be easily transferred to a liquid cooling within a confined space between the cover element and the probe head. The thermal conductivity of the membrane can be influenced by the thickness of the membrane as well as the proper choice of material. Preferably, the membrane material has a thermal conductivity of more than 0.1 Wm-1K-1, more preferably more than 0.2 Wm-1K-1, and a thickness of less than 100µm.
    [00015] The fastening means have to be configured to resist the certain pressure of disassembly of coupling liquid and/or cooling that is pumped in a confined space between the covering element and the probe head. Generally, the operating pressure will be limited to a few mbar, usually 1 to 5 mbar. Preferably, the securing means will dismount if the pressure of the coupling and/or cooling liquid exceeds a certain limit, for example 300mbar. In this way, excess liquid will be able to escape from the covering element. This feature has the advantage of protecting the probe head and especially the transducer from more pressure inside the chamber.
    [00016] The cover element also comprises sealing means such as to process any connection between the cover and a waterproof probe head. This prevents any leakage of coupling and/or cooling liquid.
    [00017] Each treatment with the ultrasound device can be performed with a new, clean probe head cover and used cover elements can be discarded. Alternatively, the probe head cover can be cleaned and/or sterilized separately from the probe head, for example, in a standard steam or ethylene oxide sterilizer. Compared to known systems where the membrane can only be cleaned and/or sterilized together with the probe head, for example with a sterilizing solution, the overall cleanliness and sterility are vastly improved.
    [00018] It is also possible to use cover elements made of different materials so that patients suffering from an allergy to one material can be treated using a cover element made of a different material.
    [00019] In addition, different coverage elements with different shapes allowing different distances between the patient's skin and the transducer can be used, depending on the minimum depth required for the ultrasound focal point. For example, depending on the treatment to be administered to the patient or the position of the tissue and/or organ to be treated, a covering element that allows a good distance between the ultrasound head and the organ and/or tissue can be selected.
    [00020] In a preferred embodiment, the covering element is formed as a single piece. Therefore, the flexible membranes, the outer peripheral wall as well as the fastening means are all in one integral piece.
    [00021] A covering element made as a single piece has the advantage that the area of contact of the covering element with the skin corresponds to the intersection with the skin of the ultrasound beam emitted by the treatment transducer. It is therefore possible to reduce the area of contact between a patient's tissues, eg the skin and the covering element to a minimum. Furthermore, configuring the cover element as a single piece eliminates any assembly steps during production. In this way, it is possible to mold the covering element, thus allowing a quick and economical manufacture.
    [00022] The covering element is preferably made of at least one elastomeric material. This material preferably comprises a silicone compound. As an alternative, the covering element can also be made of latex. As an alternative, the covering element can also be made of two or more different elastomeric materials. For example, the second closed side, which is adapted to contact the patient's skin and comprises a flexible membrane, may be composed of material more elastic than the outer peripheral wall. Both materials can be molded in one step.
    [00023] An elastic peripheral wall offers the advantage that the cover element can be attached to the probe head without the use of a tool or additional fastening means such as screws or spring locks. For example, coupling of the cover element is possible by providing a cover element with a circumference slightly smaller than the probe head. When a cover element is slid over a probe head, the cover element material must be deformed to fit the probe head. When in place, the material tries to relax its original shape, generating a contraction force on the probe head.
    [00024] The use of elastomers also provides easy fabrication of the covering element, as it can be molded in one piece of a single material. Alternatively, different elastomers can be used to mold the covering element. Elastomeric materials also have the advantage that the material itself will provide for the sealing the connection between the covering element and the probe head through the generated contraction force. Also, elastomers, such as silicone, are generally biocompatible. Furthermore, they offer a favorable combination of low acoustic impedance, high extensibility or elongation, mechanical strength and high thermal conductivity.
    [00025] One embodiment provides for a covering element where the thickness of the elastomeric material varies between the open side towards the closed side to allow regions with different elasticity and/or stiffness. Preferably the outer peripheral wall is thicker in the open side area than in the closed side area. Preferably the outer peripheral wall is thicker in the area of the fastening means. In a preferred embodiment, the fastening means is located close to the open side of the covering element and the peripheral outer wall has a decreasing thickness from the open side to the closed side.
    [00026] In another embodiment, the thickness of the elastomeric material of the flexible membrane is about or less than 1/4 of the wavelength of the waves emitted by the ultrasound transducer. Preferably, the thickness of the flexible membrane is in the range of between 50μm and 150μm, more preferably 75μm for 3 MHz operation.
    [00027] When the thickness of the flexible membrane is about % of the used ultrasound wavelength, any one of the multiple reflections of the ultrasound waves will be in phase. Furthermore, this will increase the overall efficiency of the treatment.
    [00028] Presenting a thin membrane will also facilitate the transport of heat from the skin to a coolant contained within the covering element.
    [00029] The material used for the flexible membrane must have an acoustic impedance that is similar to the acoustic impedance of the coupling and/or cooling liquid to be used and/or the tissue and/or skin. Preferably the acoustic impedance of the material is between 1.4^106 and 1.7^106 [Pa-s-m-1], preferably about 1.56-106 [Pa-s-m-1] at room temperature. Using similar acoustic impedances reduces the amount of total HIFU wave reflections on surfaces.
    [00030] Furthermore, the covering element can be configured in such a way that the flexible membrane can be elastically deformed by at least 25% with respect to its diameter in a direction perpendicular to its surface. Deformation is measured at the center of the flexible membrane. The deformation of the flexible membrane is preferably carried out by the pressure of the coupling liquid and/or cooling.
    [00031] Deformation of the membrane allows to move the focal point of the ultrasound transducer along an axis that is perpendicular to the membrane surface within the patient's body. When the membrane is not expanded, the focal point will be at its deepest position. Gradually deforming the membrane in the direction opposite the probe head, therefore moving the probe head away from the organ and/or tissue to be treated, will also move the focal point. Preferably, the membrane is expandable to at least 15 mm, more preferably 25 mm in a direction that is perpendicular to its surface to a diameter of 60 mm.
    [00032] Alternatively, the membrane is elastically deformable at least 25% of the diameter of the second closed side in a direction perpendicular to its surface compared to the initial configuration of the covering element. For example, if the diameter of the closed side is 60 mm, the membrane will be deformable by at least 15 mm.
    [00033] A deformation of the membrane will lead to an increase in the volume of confined space formed between the outer peripheral wall, the membrane and the probe head. Due to the initial configuration of the covering element, the confined space has a certain initial volume. When coupling and/or cooling liquid is pumped into said confined space, this initial volume will be deposited by the liquid. The deposit of that initial volume does not require the use of any type of pressure. Once said initial volume has been filled, the membrane will expand if the liquid pressure is increased. Preferably, the membrane is configured in such a way that a pressure increase of 40 mbar leads to an increase in the volume of the confined space of about 10 ml.
    [00034] The membrane is preferably configured in such a way that its maximum deformation moves the focal point to a minimum depth of treatment.
    [00035] The covering element may include at least one inlet opening and at least one outlet opening for a coupling and/or cooling liquid. A coupling and/or cooling liquid can therefore flow in a defined space between the covering element and the probe head through at least one opening inlet. Likewise, such a liquid can flow out of said space through at least one outlet opening. Preferably, at least one inlet opening and at least one outlet opening are coupled or coupleable to the closed liquid circuit. This circuit can include at least one pump. By increasing the pressure and/or amount of coupling and/or cooling liquid, the distance between the transducer and the patient's skin can be increased. Likewise, by reducing the amount of liquid, this distance can be decreased. Changing the distance can be used to move the ultrasound focus point along an axis perpendicular to the flexible membrane of the cover element. Alternatively, the liquid circuit may additionally comprise a cooling and/or heating chamber in order to change the temperature of the coupling and/or cooling liquid
    [00036] The inlet opening and the outlet opening can be configured as simple openings in the outer peripheral wall. Alternatively, they can be in the form of protruding tubes. Furthermore, the inlet and outlet openings may include securing means for external tubes, for example, of a closed liquid circuit.
    [00037] The coupling and/or cooling liquid is preferably pumped by a pump, which can be a peristaltic pump, through a tube to the inlet opening of the covering element. In a first embodiment, the liquid will then flow between the covering element and the probe head to the confined space. Second, as an alternative modality, liquid will flow through the openings in the probe head inside the probe head, that is, into the space between the transducer(s) and the inner wall of the probe head before reaching the confined space. The flexible membrane can be expanded, increasing the pressure and/or the amount of liquid. Liquid may flow outside the probe head cover element assembly through the outlet opening. The outlet opening can be connected directly to a reservoir or a piped cooling chamber. Alternatively, a second pump and/or valve can be provided between the outlet opening and the reservoir and/or cooling chamber. The use of a cooling chamber allows you to regulate the temperature of the liquid, such as applying cooling to the transducer and/or the patient's skin.
    [00038] The fixing means can be arranged inside said peripheral outer wall by coupling or being coupleable to the fixing means on the outside of said ultrasound head.
    [00039] This configuration allows for easy and reversible attachment of the cover element to the ultrasound probe head. This can easily be done by partially sliding the cover element on the tip of the probe head and engaging the fastening means with each other, thereby securely locking the cover element on the probe head.
    [00040] An embodiment of the present invention provides fastening means within said peripheral wall which is at least one circumferential groove. The fixation means on the ultrasound head is at least a circumferential ridge. The ridge is configured in such a way as to be attachable to said groove.
    [00041] This modality of the fastening means has the advantage that the cover element can be easily attached and removed from the probe head, while still providing a firm connection. Furthermore, it provides a tight coupling between the cover element and the probe head, consequently preventing leakage of coupling liquid and/or cooling. Furthermore, this configuration is able to absorb the force generated by expansion of the flexible membrane. When coupling and/or cooling liquid is pumped into the confined space, the peripheral wall of the covering element will slightly expand the radial direction in the area around that confined space. This expansion leads to a light compression force of the capping element around the probe head. In this way, the ridge is pressed more strongly into the furrow.
    [00042] In addition, in the case that too much coupling and/or cooling liquid is pumped into the space between the covering element and the probe head, the covering element will be pressed away from the probe head due to the increase in pressure . This will force the ridge out of the groove, thus causing disassembly of the probe head cover element. This reduces the risk of damage to the transducer. Preferably, the cover element is configured in such a way that the securing means will dismount at liquid pressures of more than 100 or 300mbar.
    [00043] Alternatively, the ridge and groove can be discontinuous rather than fully circumferential. In another alternative embodiment, the fastening means within the outer peripheral wall of the covering element may include a plurality of ridges alternating with a plurality of grooves, either one above the other or one behind the other, arranged in a circumferential circle.
    [00044] Yet another embodiment of the present invention provides for the covering element further to include at least one ridge inside said outer peripheral wall.
    [00045] At least one additional ridge provides for a liquid-tight seal when the cover element is mounted on an ultrasound probe head, thus preventing any coupling and/or cooling liquid from flowing out of the confined space. At least one ridge is configured such that its inner surface is lightly pressed against the probe head when mounted. For better waterproofing, the roof head can include more than one of these ridges, preferably 2, 3 or 5.
    [00046] Ridges can also be arranged to form a channel between two ridges. These ridges can be configured to guide liquid from the inlet to an opening in the surface of the probe head, as well as from a second opening of the probe head to the outlet. This allows for optimized liquid flow independent of the radial alignment of the cover element in the probe head.
    [00047] In an alternative embodiment, the covering element further comprises at least one pulling means on the outside of said peripheral outer wall.
    [00048] A pulling means helps to mount and dismount the probe head cover element. By pulling, a portion of the capping element will be pushed out and the ridge will lose its connection with the groove. The cover element can then be removed by pulling it down.
    [00049] In a preferred embodiment, the pulling means is in the form of at least one pulling guide.
    [00050] In an alternative embodiment, the capping element comprises markings on its outer sides to help a user correctly align the capping element on the probe head. This facilitates subsequent connection to the pipes carrying the coupling and/or cooling liquid.
    [00051] Generally, the covering element can be any suitable shape. For practical reasons it is preferred that the covering element is cup-shaped. The flexible membrane thus defines the base of the cup. The flexible membrane is preferably circular in shape, but it can also be configured to any suitable shape, such as rectangular or polygonal. The outer peripheral wall can also be adapted into different shapes suitable to fit the probe head, but preferably it will also define a circular shape, such as frustoconical.
    [00052] The ultrasound treatment device comprises at least: - an ultrasound probe head; - an ultrasound transducer, preferably a HIFU transducer located in said ultrasound probe head; - a removable cover element being attachable to the ultrasound probe head; and - The fastening means to secure the cover element to the probe head.
    [00053] The covering element is removably coupled or attachable to said ultrasound probe head, thereby creating a confined space between said peripheral outer wall of said covering element and the ultrasound probe head.
    [00054] Having a system with a removable cover element increases the hygiene of the treatment and reduces the time between two treatments, since instead of having to clean and/or disinfect the membrane attached to the probe head, a new or recent disinfected and/or cleaned cover element can be mounted.
    [00055] Fastening means are provided to reversibly attach the cover element to the probe head. These fastening means can be, for example, threads, clamps, pins and the like. Preferably, the securing means includes at least one ridge and at least one groove that are configured to engage with one another. The groove, for example, can be arranged on the inside of the outer peripheral wall of the covering element while the ridge can be arranged on the outside of the probe head.
    [00056] Furthermore, if the patient to be treated suffers from an allergy to the covering element material, it can quickly be replaced by a covering element made of a different material.
    [00057] It is also possible to mount a covering element adapted for a specific treatment depth and/or adapted for a specific coupling and/or cooling liquid.
    [00058] In an alternative embodiment, the ultrasound treatment device further comprises a coupling liquid and/or cooling circuit comprising at least one cooling chamber and at least one coupling pump. The pump is preferably a peristaltic pump. Coupling and/or cooling liquid is pumped through said confined space.
    [00059] In an embodiment of the present invention the liquid flows between the outer peripheral wall of the covering element and the probe head to the confined space. In another embodiment, openings have been designed in the probehead, which allow liquid to flow between the interior of the probehead wall and the ultrasound transducer.
    [00060] This mode allows adjustment of the temperature of the coupling and/or cooling liquid. The ultrasound transducer as well as the patient's skin will be heated by pulses of ultrasound. To allow the transducer to function properly and avoid burning the patient's skin, it is advantageous to cool the coupling liquid or use a coolant. The temperature can be adjusted only by the temperature of the at least one cooling chamber, as well as the liquid flow rate, which can be influenced by the pumping rate.
    [00061] The liquid circuit preferably further comprises a coupling and/or cooling liquid containing a replaceable pouch. In this way, the liquid can be replaced quickly and easily using a new bag of fresh liquid. The cooling chamber can be in the form of a simple ice water bath. Alternatively, the cooling chamber may comprise cooling plates such as Peltier elements. Additional sensor means are preferably present in the liquid circuit, such as pressure or temperature measurement sensors. In a special embodiment, the liquid circuit comprises two pumps, one connected to the inlet opening and one connected to the outlet opening of the covering element. This setting allows adjustment of the liquid inlet and outlet flow rate and therefore also allows control of the liquid pressure. A liquid circuit, for example, is described in WO 2008/081147, which is incorporated herein by reference.
    [00062] Preferably the control means additionally consist of a closed liquid circuit mode. Control means, for example, make it possible to control the pump speed, liquid pressure, flow rate and/or liquid temperature. Appropriate means of control, for example, might be a computer.
    [00063] Another objective of the present invention is to provide a method of using an ultrasound device.
    [00064] The method comprises the steps of: (a) assembling a covering element comprising a peripheral outer wall, a first open side and a second closed side, comprising a flexible membrane configured in such a way as to minimize the absorption of HIFU ultrasound waves on the tip of an ultrasound probe head; (b) coupling fastening means of said cover element with fastening means of said ultrasound probe head; and (c) filling a confined space between the flexible membrane of the cover element and the ultrasound transducer with a coupling and/or cooling liquid.
    [00065] This method allows the use of an ultrasound treatment device with a removable and preferably disposable cover element, thus increasing the overall hygiene of the treatment and also reducing the time between two treatments.
    [00066] Another embodiment of the method provides an additional step of connecting tubes for an inlet opening and an outlet opening of the covering element before step (c).
    [00067] In this way, the confined space can be connected to a liquid circuit, providing, for example, liquid cooling. Alternatively, the flexible membrane of the covering element can be elastically deformed, increasing the pressure of the liquid.
    [00068] More details and benefits of the present invention will be apparent from the following figures and examples: Figure 1 is an exemplary embodiment of the cover element mounted on an ultrasound probe head; Figure 2a is an alternative embodiment of the covering element with inlet and outlet for the coupling and/or cooling liquid mounted on an ultrasound probe with an expanded membrane; Figure 2b is the covering element of Figure 2a in an unexpanded state; Figure 3 is a top view of another alternative embodiment of the cover element with pull guides; Figure 4 is the covering element as shown in Figure 2 disassembled from the probe head;
    [00069] Figure 1 shows an exemplary embodiment of a covering element 1 according to the invention. The cover element comprises an outer peripheral wall 14, a flexible membrane 5 and an open side configured to be slid over the probe head 2. The probe head 2 comprises an ultrasound transducer 6. The area between the probe head 2 and the flexible membrane 5 defines a confined space 7, which can be filled with a coolant and/or coupling. The covering element 1 is attachable to the probe head 2 by means of fastening the covering element 1 and the fastening means of the probe head 2. This figure shows an exemplary embodiment of the fastening means. A circumferential groove 3 is provided as a fastening means within the covering element 1. The groove 3 is configured to fit a ridge 4 formed in the probe head 2. In the present embodiment, the groove 3 is arranged close to the side. open 15 of the covering element 1 and extends circumferentially around the entire outer peripheral wall 14. Alternatively, the groove 3 and the ridge 4 can be intermittent.
    [00070] The covering element 1 is made of a single piece of elastomeric material and therefore is flexible enough to be slightly spread out so that the part of the peripheral outer wall 14 that is above the groove can be slid over the summit. Once the ridge and groove are aligned, the outer extension wall 14 will relax and the ridge will engage. In this way, a stable connection can be established between the covering element 1 and the probe head 2. Again by spreading beyond the outer wall 14 and pulling the covering element 1 away from the probe head 2 it is possible to disassemble the probe element. cover 1 of probe head 2.
    [00071] In a preferred embodiment the cover element 1 is made of an elastomeric material comprising a silicone compound, more preferably MED-4050 obtained from NuSil Silicone Technology of Carpentera, Florida.
    [00072] In another embodiment, the open side 15 of the covering element 1 has a circular shape with a diameter between 10mm and 200mm, preferably 66mm. The closed side 16 comprising the flexible membrane 5 also preferably has a circular shape with a diameter between 10mm and 200mm, preferably 60mm. The flexible membrane 5 can comprise the entire area of the closed side. Alternatively, the flexible membrane 5 may have a diameter slightly smaller than the closed side, preferably between about 70% and 99% of the diameter of the closed side, more preferably about 90%.
    [00073] In yet another embodiment, the outer peripheral wall 14 has a height between 30mm and 100mm, preferably between 45mm and 50mm between the open side 15 and the closed side 16. The thickness of the outer peripheral wall 14 is constant throughout from full height. Alternatively, the outer peripheral wall 14 can have a variable thickness. In an exemplary embodiment, the thickness of the outer peripheral wall 14 decreases from the open side 15 to the closed side 16. For example, the outer peripheral wall 14 may have a thickness of 4.6 mm in the area of the open side 15 and decrease the thickness 1.5 mm in the closed side area 16.
    [00074] In one embodiment, the covering element 1 is configured so that when it is mounted to the probe head 2, the membrane 5 is at a distance of 15 mm in its initial state from the probe head 2. Alternatively , depending on the method of treatment, the tissue and/or organ to be treated, the covering element 1 can be configured to provide for other distances between the membrane 5 and the probe head 2, for example, 5 mm, 8 mm, 13 mm and others.
    [00075] Figure 2a shows another embodiment of the present invention. In this mode the probe head 1 additionally comprises inlet opening 9 and outlet opening 10. A coupling and/or cooling liquid can be pumped into the confined space 7 through the inlet opening 9. The outlet opening is used to evacuate air while filling the confined space 7 and can also serve to remove or pump coupling and/or cooling fluid. In a preferred embodiment, the inlet opening 9 and the outlet opening 10 are connected via tubes to a closed liquid circle comprising at least one pump and at least one heating and/or cooling chamber. When such a closed liquid circle is used, it is possible to control the amount and/or pressure of the coupling and/or cooling liquid in the confined space 7 (and therefore also the expansion of the flexible membrane 5), as well as the temperature of the said liquid.
    [00076] The covering element 2 additionally comprises three circumferential ridges 8 on the side of the peripheral wall 14. The ridges 8 are configured so that their inner surfaces protrude from the inner surface of the outer peripheral wall 14 such that these surfaces are pressed lightly against probe head 2 when covering element 1 is mounted to it. In one embodiment, these ridges 8 serve as liquid impermeable seals to prevent coupling and/or cooling liquid from leaking out of the cover element 1 assembly with probe head 2. However, in the embodiment as shown, the ridges 8 serve to form channels 18 on the inner side of the peripheral wall 14. These channels 18 can be configured to direct the liquid flow to the openings 11 on the outside of the probe head 2. The liquid will then fill the space between the interior of the peripheral wall of the probe head 2 and the ultrasound transducer 6, as well as the confined space 7. The openings 11 can be arranged so as to optimize the flow of liquid. Flexible membrane 5 is placed on the skin 12 of a patient to be treated.
    [00077] In a preferred embodiment, the inlet opening 9 and the outlet opening 10 are externally extended through the bulge of the pipe 17. This allows easy connection of the inlet opening 9 and the outlet opening 10 with external tubes, for example, of a liquid circuit.
    [00078] The at least one inlet opening 9 and the at least one outlet opening 10 have a diameter between 3 mm and 5 mm. In a preferred embodiment, the inlet opening 9 and the outlet opening 10 have a diameter of 3.2 mm. In an alternative embodiment, the at least one inlet opening 9 and the at least one outlet opening 10 have connecting means to allow a liquid circuit to be connected. This connecting means is preferably in the form of an enlarged diameter to allow the introduction of tubes.
    [00079] Figure 2b shows the same modality of covering element 1 as shown in figure 2a, with the difference that the pressure of the coupling and/or cooling liquid is such that the flexible membrane 5 is in its initial state. In this way, confined space 7 is at its minimum volume. This setting can be used when the focal point of the ultrasound transducer 6 has to be moved to a maximum depth of treatment.
    [00080] In figure 3 a top view of an alternative modality is represented. In the present embodiment, two pull guides 13 are arranged on the outer side of the peripheral wall 14. The covering element 1 is circular in shape to be fitted to a circular probe head. The position of both pull guides 13 is about 120° from the center of the piping bulge 17.
    [00081] Figure 4 shows a cross section of the cover element 1 modality as shown in figure 2 disassembled from the probe head. As can be seen in this figure, both the grooves serving as fastening means within the covering element 3 as well as the ridges 8 are circumferential and fully elastic around the interior of the outer peripheral wall 14. The embodiment as shown has a circular configuration. and its top view corresponds to one as seen in figure 3.
    权利要求:
    Claims (19)
    [0001]
    1. Covering element (1) for a HIFU head, comprising an outer peripheral wall (14) being dimensionally stable, a first open side (15) configured to partially cover an ultrasound head (2) and a second closed side (16), comprising a flexible membrane (5) for contact with the patient's skin, said covering element (1) provided with a connection means for removable attachment with the tip of said ultrasound probe (2) , in which said membrane (5) is configured so as to minimize the absorption of HIFU ultrasound waves, characterized by the fact that the membrane absorbs or reflects less than 5% of the ultrasound waves, comprises at least one inlet opening ( 9) and at least one outlet opening (10) for the coupling and/or cooling liquid, and wherein said inlet opening (9) and said outlet opening (10) further comprise attachment means for external tubes .
    [0002]
    2. Covering element according to claim 1, characterized in that said covering element (1) comprises said connecting means and said flexible membrane (5) is formed as a single piece.
    [0003]
    3. Covering element according to claim 1 or 2, characterized in that the membrane (5) is further configured to provide a high thermal conductivity.
    [0004]
    4. Covering element according to any one of claims 1 to 3, characterized in that it is made of at least one elastomeric material, preferably an elastomeric material comprising a silicone compound.
    [0005]
    5. Covering element according to any one of claims 1 to 4, characterized in that the thickness of the outer peripheral wall (14) varies from said first open side (15) to said second closed side (16) to enable regions with different elasticity and/or stiffness.
    [0006]
    6. Covering element according to any one of claims 1 to 5, characterized in that the thickness of the flexible membrane (5) is approximately 1/4 of the wavelength of the HIFU waves, preferably in the range between 50μm and 150μm.
    [0007]
    7. Covering element according to any one of the preceding claims, characterized in that the flexible membrane (5) has an acoustic impedance of between 1.4^106 and 1.7^106 [Pa-sm-1], of preferably about 1.56-106 [Pa-sm-1] at room temperature.
    [0008]
    8. Covering element according to any one of claims 1 to 7, characterized in that said covering element (1) is configured so that the flexible membrane (5) is elastically deformable by at least 25% of the diameter of the second closed side (16) in a direction perpendicular to its surface with respect to its initial configuration.
    [0009]
    9. Covering element according to any one of claims 1 to 7, characterized in that said covering element (1) is elastically deformable by at least 15 mm in a direction perpendicular to its surface in relation to its initial configuration .
    [0010]
    10. Covering element according to any one of claims 1 to 9, characterized in that said fastening means are arranged inside said peripheral outer wall (14) by coupling or being coupleable to the fastening means on the outside of said ultrasound head (2).
    [0011]
    11. Covering element according to claim 10, characterized in that said fastening means is at least one circumferential groove (3) being engageable with at least one circumferential ridge (4) arranged on the outside of said head of the probe (2).
    [0012]
    12. Covering element according to any one of claims 1 to 11, characterized in that the covering element (1) additionally comprises at least one ridge (8) inside said peripheral outer wall (14).
    [0013]
    13. Covering element according to any one of the preceding claims, characterized in that the covering element (1) additionally comprises at least one pulling means (13) on the outside of said peripheral outer wall (14) , said pulling means (13) preferably being at least one pull tab.
    [0014]
    14. Ultrasound treatment device, at least comprising: - an ultrasound probe head (2) - a HIFU transducer located in said ultrasound probe head (2) - a covering element (1) as defined in any of the preceding claims, characterized in that said covering element (1) is removably coupled or attachable to said ultrasound probe head (2), thereby creating a confined space (7) between said wall outer peripheral (14) and said flexible membrane (5) of said covering element (1) and the ultrasound probe head (2).
    [0015]
    15. Treatment device according to claim 14, characterized in that said treatment device further comprises a liquid coupling and/or cooling circuit comprising at least one cooling chamber and at least one pump, preferably a peristaltic pump, through which said coupling and/or cooling liquid is pumped through said confined space (7).
    [0016]
    16. Treatment device according to claim 15, characterized in that said liquid circuit additionally comprises a replaceable bag with coupling liquid and/or sterile cooling.
    [0017]
    17. Method of operating an ultrasound treatment device characterized by the fact that it comprises the steps of: (a) first assembling a covering element (1) as defined in any one of claims 1 to 13, on the tip of a head probe (2); (b) then coupling the covering element attachment means (1) with the probe head attachment means (2), thereby creating a confined space (7) between said peripheral outer wall (14) and said flexible membrane (5) of said covering element (1) and the ultrasound probe head (2); and (c) then filling the confined space (7) with a coupling and/or cooling liquid.
    [0018]
    18. Method according to claim 17, characterized in that it further comprises the step of connecting tubes to said inlet (9) and said outlet (10) before step (c).
    [0019]
    19. Set with at least two covering elements (1) with different shapes of a HIFU head, as defined in any one of claims 1 to 13, characterized in that said different shapes are configured in order to provide different minimum distances between the treatment transducer (3) and a patient's skin (27) when the membrane (5) is in its initial state.
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    同族专利:
    公开号 | 公开日
    KR20170120214A|2017-10-30|
    US9028471B2|2015-05-12|
    BR112012012769A2|2018-04-17|
    JP2013512016A|2013-04-11|
    CN102753236A|2012-10-24|
    EP2327450A1|2011-06-01|
    WO2011064209A1|2011-06-03|
    EP2504063A1|2012-10-03|
    US20130131704A1|2013-05-23|
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    KR20120101661A|2012-09-14|
    CN102753236B|2016-01-27|
    EP2504063B1|2018-07-18|
    KR101884584B1|2018-08-01|
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-30| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-05-18| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-07-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/11/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
    优先权:
    申请号 | 申请日 | 专利标题
    EP09177407A|EP2327450A1|2009-11-27|2009-11-27|A cover, a treatment device and a method of use of such a device|
    EP09177407.5|2009-11-27|
    PCT/EP2010/068034|WO2011064209A1|2009-11-27|2010-11-23|A cover, a treatment device and a method of use of such a device|
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