CN116510195A - Transducer, wearable ultrasonic device and ultrasonic monitoring treatment system - Google Patents
Transducer, wearable ultrasonic device and ultrasonic monitoring treatment system Download PDFInfo
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- CN116510195A CN116510195A CN202310416068.7A CN202310416068A CN116510195A CN 116510195 A CN116510195 A CN 116510195A CN 202310416068 A CN202310416068 A CN 202310416068A CN 116510195 A CN116510195 A CN 116510195A
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Classifications
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N7/02—Localised ultrasound hyperthermia
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- A—HUMAN NECESSITIES
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4427—Device being portable or laptop-like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/48—Diagnostic techniques
- A61B8/488—Diagnostic techniques involving Doppler signals
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
- B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
- B06B1/00—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency
- B06B1/02—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency making use of electrical energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0004—Applications of ultrasound therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0039—Ultrasound therapy using microbubbles
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0052—Ultrasound therapy using the same transducer for therapy and imaging
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Abstract
The invention provides a transducer, a wearable ultrasonic device and an ultrasonic monitoring and treating system, wherein the transducer comprises at least one treating piece, at least one monitoring piece and an ultrasonic isolating layer, the treating piece comprises a treating working layer, and the treating working layer is suitable for transmitting ultrasonic waves to an area to be treated so as to assist ablation treatment; the monitoring piece comprises a monitoring working layer, and the monitoring working layer is suitable for transmitting ultrasonic waves to the area to be treated so as to position the treatment area and monitor the treatment state of the area to be treated in real time; the transducer radiation sound field intensity monitoring comprises a thermocouple, a temperature-sensitive resistor and the like, and is used for monitoring the energy of the ultrasonic radiation sound field and the temperature rise state of the area close to the skin; the ultrasonic isolation layer is arranged between the monitoring piece and the treatment piece; the treatment piece and the monitoring piece are suitable for being connected with an external control circuit, the monitoring piece feeds back the information of the treatment state of the monitored area to be treated to the external control circuit in real time, and the direction and the power of ultrasonic waves emitted by the treatment piece are adjusted by the external control circuit by combining AI algorithm software analysis.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a transducer, a wearable ultrasonic device and an ultrasonic monitoring and treating system.
Background
The clinical incidence of tissue lesions such as thrombus, varicose vein, hysteromyoma and prostate diseases is high, wherein the incidence of hysteromyoma is about 30 percent, and the mortality and disability rate caused by tumor and thrombus diseases are high. For example, deep vein thrombosis (deep vein thrombosis, DVT) is one of the most common peripheral vascular diseases with an incidence of about 2%. The acute stage of DVT can be aggravated by progressive venous obstruction caused by thrombus propagation, even the limb necrosis caused by femoral edema needs to be amputation, and the free thrombus can also cause fatal pulmonary arterial embolism once falling off.
At present, common treatment means for tissue lesions in clinic comprise drug treatment, operation treatment, radiation treatment, intervention treatment and the like, wherein the drug treatment is a conservation treatment means and is generally used for early slight tissue lesions and postoperative treatment for inhibiting recurrence, and the side effect of the drug is larger; for serious tissue lesions such as tumors, surgical treatment and radiation treatment are generally adopted, wherein the surgical treatment is a traumatic treatment means, surrounding tissues are easy to damage, and surgical risks and postoperative complications are high; radiation therapy has great ionizing radiation risks for doctors and patients, is difficult to kill all pathological tissues, has skin injury complications, has high nausea and vomiting side effects and the like. The high-intensity focused ultrasound treatment is a safe and effective non-invasive treatment method without ionizing radiation, and can effectively destroy and ablate lesion tissues through the thermal effect and cavitation effect generated by high-intensity energy aggregation at a focus, so as to achieve the aim of treatment, however, due to higher energy, skin and normal blood vessels and tissues around the lesion are easily burned on a propagation path; meanwhile, in order to achieve the purpose of accurate treatment, ablation treatment needs to be conducted in real time under the guidance of image means such as CT/MRI, and in addition, the volume of the in-vitro high-intensity focusing probe is large, and a doctor needs to adjust the position, the irradiation direction and the irradiation intensity of the probe in real time according to an image monitoring result, so that the operation difficulty and the risk of ionizing radiation are greatly increased.
Disclosure of Invention
Therefore, the invention aims to avoid the defects of the prior art and provides a wearable intelligent ultrasonic real-time monitoring treatment device.
To this end, the invention provides a transducer adapted to be connected to an external control circuit, comprising:
at least one treatment member comprising a treatment working layer adapted to emit ultrasound waves towards the area to be treated to assist in ablation treatment;
the monitoring piece comprises a monitoring working layer, wherein the monitoring working layer is suitable for transmitting ultrasonic waves to the area to be treated so as to position the treatment area and monitor the treatment state of the area to be treated in real time;
the ultrasonic isolation layer is arranged between the monitoring piece and the treatment piece;
the treatment piece and the monitoring piece are suitable for being connected with an external control circuit, and the monitoring piece feeds back the information of the treatment state of the monitored area to be treated to the external control circuit in real time, so that the external control circuit can adjust the direction and power of the ultrasonic wave emitted by the treatment piece.
Optionally, the treatment element is juxtaposed with the monitoring element.
Optionally, a placing cavity is formed in the treatment piece, the monitoring piece is arranged in the placing cavity, and the ultrasonic isolation layer is arranged between the wall of the placing cavity and the monitoring piece.
Optionally, the ultrasonic isolation layer is a PVC cavity or an acrylic cavity or an epoxy resin mixed hollow glass microsphere or a high-sound attenuation coefficient insulating material filled between the monitoring piece and the cavity wall of the placing cavity, and the interior of the PVC cavity or the acrylic cavity is filled with gas or vacuum.
Optionally, the thickness of the ultrasonic isolation layer is n+1/2 wavelength of the therapeutic ultrasonic wave, wherein N is a positive integer.
Optionally, the treatment working layer and the monitoring working layer work simultaneously, or the monitoring working layer monitors the treatment state of the region to be treated in the working gap of the treatment working layer and feeds back to an external control circuit.
Optionally, the therapeutic element and the monitoring element are of integrated structural design, and share a backing layer, and the material of the backing layer is matched with the therapeutic element in impedance.
Optionally, the therapeutic element further comprises a therapeutic matching layer, which is arranged on one side of the therapeutic working layer away from the backing layer;
the monitoring piece further comprises a monitoring matching layer which is arranged on one side, away from the backing layer, of the monitoring working layer, and the treatment matching layer and the monitoring matching layer are arranged on the same side.
The wearable ultrasonic device comprises at least one group of treatment units, wherein each treatment unit comprises a flexible PCB (printed circuit board) and at least one transducer, and the transducer is connected with the flexible PCB.
Optionally, the plurality of transducers are arranged on the surface of the flexible PCB in a plurality of groups, and the plurality of transducers in any group are connected with the external control circuit after being connected in series so as to realize single-frequency, multi-frequency or mixed-frequency treatment.
Optionally, the therapeutic unit further comprises a temperature measuring piece connected with the flexible PCB circuit board and arranged on the same side as the transducer.
Optionally, the treatment unit further includes a front packaging protection layer and a back packaging protection layer, where the front packaging protection layer and the back packaging protection layer are disposed on two sides of the flexible PCB.
Optionally, the transducer on the surface of the flexible PCB is disposed towards the front packaging protective layer, and the therapeutic unit further includes a waterproof isolation layer disposed between the back packaging protective layer and the flexible PCB.
Optionally, the front encapsulation protective layer is a cambered surface to attach to the targeted skin of the area to be treated.
The ultrasonic real-time monitoring treatment system comprises the wearable ultrasonic device, and a control display assembly, an intelligent monitoring assembly, an ultrasonic driving assembly and a protection assembly which are electrically connected with the wearable ultrasonic device.
The transducer, the wearable ultrasonic device and the ultrasonic monitoring and treating system provided by the invention have the following advantages:
1. the invention provides a transducer which is suitable for being connected with an external control circuit and comprises at least one treatment piece, at least one monitoring piece and an ultrasonic isolation layer, wherein the treatment piece comprises a treatment working layer, and the treatment working layer is suitable for emitting ultrasonic waves to a region to be treated so as to assist ablation treatment; the monitoring piece comprises a monitoring working layer, wherein the monitoring working layer is suitable for transmitting ultrasonic waves to the area to be treated so as to position the treatment area and monitor the treatment state of the area to be treated in real time; the ultrasonic isolation layer is arranged between the monitoring piece and the treatment piece; the treatment piece and the monitoring piece are suitable for being connected with an external control circuit, and the monitoring piece feeds back the information of the treatment state of the monitored area to be treated to the external control circuit in real time, so that the external control circuit can adjust the direction and power of the ultrasonic wave emitted by the treatment piece.
The transducer with the structure is characterized in that the treatment piece and the monitoring piece are suitable for being connected with an external control circuit, the treatment piece is used for transmitting ultrasonic waves to an area to be treated, and ablation treatment is carried out on the area to be treated by utilizing cavitation effect and mechanical effect of the ultrasonic waves; the monitoring part is used for positioning the treatment area in real time and monitoring the elastomechanical change, doppler blood flow change, vascular recanalization information and the like of the targeted tissue in the treatment area in the treatment process, feeding back the information to the external control circuit in real time, judging whether the target area reaches the required treatment dosage in the treatment process, and judging whether the coagulation necrosis of the target tissue is caused or not, wherein the control circuit controls the treatment part to adjust the optimal ultrasonic treatment parameters according to the preset treatment scheme information; an ultrasonic isolation layer is arranged between the treatment piece and the monitoring piece, so that the ultrasonic wave generated during the working of the treatment piece and the monitoring piece is prevented from affecting each other, and the transducer cannot work normally.
2. According to the transducer provided by the invention, the treatment piece and the monitoring piece are arranged in parallel, the backing layers are arranged at the bottom sides of the treatment piece and the monitoring piece, and the backing layers and the matching layers are arranged at the two opposite sides of the working layer. During treatment, the backing layer is used for absorbing acoustic energy emitted back by the transducer, reducing interference of back radiation signals to an external control circuit and improving the quality of emitted pulses. By arranging the treatment element in parallel with the monitoring element and sharing a backing layer, the overall design size of the transducer can be effectively reduced by sharing the backing layer.
3. According to the wearable ultrasonic device provided by the invention, three transducers are connected in series to form one group, so that the longitudinal ultrasonic treatment length can be increased, and the three groups of transducers are arranged at intervals longitudinally and packaged to form one treatment unit, so that the ultrasonic transverse treatment width is increased.
4. The invention provides a wearable ultrasonic device, a treatment unit further comprises three temperature measuring pieces, the three temperature measuring pieces are uniformly arranged on the sides of the three groups of treatment units so as to monitor the temperature rise state of a transducer in real time, the temperature measuring pieces are thermistors and the like, the temperature measuring pieces are connected with an external control circuit through a signal transmission line, and temperature information of the temperature measuring pieces is transmitted to the external control circuit.
5. According to the wearable ultrasonic device provided by the invention, the wearable ultrasonic device is fixed on a human body limb through a magic tape, three groups of treatment units are distributed on the peripheral side of the human body limb, an ultrasonic irradiation area a formed by ultrasonic waves emitted by transducers in the treatment units can completely cover a target focus, ultrasonic beams are converged on the target focus through an arc-shaped structure of the treatment units, and all-around coverage irradiation and monitoring of focus positions are realized through beams of multiple groups of treatment units. The monitoring piece in the transducer inside the treatment unit monitors the state information of the targeted focus, and feeds back the state information to the external control circuit in real time, the external control circuit makes a decision on the treatment scheme of the treatment unit, single-frequency treatment can be given, multi-frequency or mixed-frequency treatment scheme can also be given, and the optimal sound wave irradiation direction and intensity scheme can be given according to the current treatment state.
6. According to the wearable ultrasonic device provided by the invention, the treatment unit adopts the curved surface structural design, so that the treatment unit can be better attached to the target skin of a wearing part.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic structural view of a transducer provided in an embodiment of the present invention;
FIG. 2 is another schematic structural view of a transducer provided in an embodiment of the present invention;
fig. 3 is a schematic structural view of a therapeutic unit in a wearable ultrasound device according to an embodiment of the present invention;
fig. 4 is a perspective view of a treatment unit in a wearable ultrasound device provided in an embodiment of the present invention;
FIG. 5 is a structural diagram of a wearable ultrasound device provided in an embodiment of the present invention;
FIG. 6 is a block diagram of a wearable ultrasound device in a curved state provided in an embodiment of the present invention;
FIG. 7 is a schematic diagram of the overall structure of a wearable ultrasound device provided in an embodiment of the present invention;
FIG. 8 is an ultrasonic schematic of a wearable ultrasound device provided in an embodiment of the present invention;
fig. 9 is a schematic diagram of an ultrasound monitoring therapy system provided in an embodiment of the present invention.
Reference numerals illustrate:
1-a treatment member; 11-a treatment working layer; 12-a treatment matching layer; 13-backing portion;
2-a monitoring member; 21-monitoring the working layer; 22-monitoring the matching layer;
3-an ultrasonic isolation layer;
4-backing layer;
5-a flexible PCB circuit board;
6, a temperature measuring piece;
7-a front encapsulation protective layer;
8-a back packaging protection layer;
9-a waterproof isolation layer;
101-a wrapper;
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.
Example 1
The present embodiment provides a transducer, as shown in fig. 1 and 2, which includes a therapeutic element 1 and a monitoring element 2, where the therapeutic element 1 and the monitoring element 2 are connected to an external control circuit. The treatment piece 1 is used for emitting ultrasonic waves to a region to be treated, and ablation treatment is carried out on the region to be treated by utilizing cavitation effect and mechanical effect of the ultrasonic waves; the monitoring part 2 is used for transmitting ultrasonic waves to the region to be treated, positioning the treatment region in real time through the ultrasonic waves, monitoring the elastomechanical change of the target tissue in the region to be treated, doppler blood flow change, vascular recanalization information and the like, feeding back to an external control circuit in real time, judging whether the target region reaches the required treatment dosage in the treatment process, and judging whether the target tissue coagulates and necroses or not, wherein the control circuit controls the treatment part 1 to adjust optimal ultrasonic treatment parameters according to preset treatment scheme information.
As shown in fig. 1, the treatment member 1 includes a treatment working layer 11 and a treatment matching layer 12, the treatment working layer 11 is disposed below the treatment matching layer 12, and when thrombolytic treatment is performed by using a transducer, the treatment matching layer 12 is disposed on the outside of the targeted skin of the region to be treated, and the treatment working layer 11 is used for emitting ultrasonic waves to the region to be treated, and performing ablation treatment on the region to be treated by using cavitation effect and mechanical effect of the ultrasonic waves. This is prior art, so the principle thereof will not be described in detail here. The treatment matching layer 12 is disposed between the treatment working layer 11 and the target skin, and the treatment matching layer 12 is used for reducing acoustic impedance difference between the treatment working layer 11 and the propagation medium (water or biological tissue), so that transmission of sound waves into the medium can be better realized, and the working principle of the treatment matching layer 12 is also the prior art, so that the principle thereof is not repeated here.
As shown in fig. 1, the monitoring element 2 includes a monitoring working layer 21 and a monitoring matching layer 22, the monitoring working layer 21 is disposed below the monitoring matching layer 22, when the transducer is used for ablation treatment, the monitoring matching layer 22 is disposed on the outer side of the targeted skin of the region to be treated, the monitoring working layer 21 is used for transmitting ultrasonic waves to the region to be treated, positioning and monitoring the elastomechanical change of the targeted tissue in the region to be treated in real time through the ultrasonic waves, doppler blood flow change, vascular recanalization information and the like, and feeding the information back to an external control circuit in real time to judge whether the target region reaches the required treatment dose or not in the treatment process, and whether the target tissue coagulates and necroses or not, and the external control circuit controls the treatment element 1 to adjust optimal ultrasonic treatment parameters according to preset treatment scheme information. The monitoring working layer 21 is provided with an ultrasonic generating device, which is a prior art, so the principle thereof will not be described herein. The monitoring matching layer 22 is arranged between the monitoring working layer 21 and the target skin, the monitoring matching layer 22 is used for reducing acoustic impedance difference between the monitoring working layer 21 and the propagation medium (water or biological tissue), and transmission of sound waves into the medium can be better realized, and the working principle of the monitoring matching layer 22 is the prior art, so that the principle of the monitoring matching layer 22 is not repeated here.
In this embodiment, as shown in fig. 1, the therapeutic element 1 and the monitoring element 2 are placed in parallel, and the bottom sides of the therapeutic element 1 and the monitoring element 2 are provided with a backing layer 4, and the backing layer 4 and the matching layer are disposed on two opposite sides of the working layer. During treatment, the backing layer 4 is used for absorbing acoustic energy emitted back from the transducer, reducing interference of back radiation signals to an external control circuit and improving the quality of emitted pulses. Through setting up treatment piece 1 and 2 juxtaposing and sharing a backing layer 4, the whole design size of transducer can effectively be reduced to sharing backing layer 4, in order to avoid the ultrasonic wave mutual interference between treatment piece 1 and the 2 of monitoring, sets up ultrasonic isolation layer 3 between treatment piece 1 and 2 of monitoring, can also reduce the interference problem between treatment piece 1 and the 2 of monitoring through timesharing work control.
In other implementations of this embodiment, as shown in fig. 2, the treatment member 1 is configured to be cylindrical, and a cylindrical placement cavity is disposed in the middle of the treatment member 1, the monitoring member 2 is also configured to be cylindrical and placed in the placement cavity in the middle of the treatment member 1, and the treatment member 1 and the monitoring member 2 are coaxially placed. The matching layers of the therapeutic element 1 and the monitoring element 2 are arranged upwards at the same time, and the backing layer 4 is arranged at the bottom of the therapeutic element 1 only to absorb the back scattering acoustic wave signals of the transducer, so that the oscillation of the transducer can be stabilized as soon as possible, and the quality of the emitted acoustic wave pulses is improved. Meanwhile, the ultrasonic isolation layer 3 is arranged between the cavity wall of the placing cavity and the monitoring piece 2, so that the ultrasonic mutual interference between the treatment piece 1 and the monitoring piece 2 is avoided, or the operation can be controlled excessively in time, and the interference problem between the treatment piece 1 and the monitoring piece 2 is reduced. It is understood that the shape of the therapeutic element 1 and the monitoring element 2 is not limited to a cylindrical shape, and may be other shapes. The ultrasonic isolation layer is a PVC cavity or an acrylic cavity or an epoxy resin mixed hollow glass microsphere or a high-sound attenuation coefficient insulating material filled between the monitoring piece and the cavity wall of the placing cavity, gas or vacuum is filled in the PVC cavity or the acrylic cavity, and the thickness of the ultrasonic isolation layer 3 is N+1/2 wavelength of therapeutic ultrasonic waves, wherein N is a positive integer.
In the treatment process, the treatment working layer 11 and the monitoring working layer 21 can work simultaneously, the echo signals reflected by the target treatment area received by the monitoring working layer 21 are detected by a filter circuit in an external control circuit, and real-time treatment state information of the monitoring target treatment area is obtained; alternatively, in order to monitor the treatment area more accurately, the monitoring working layer may monitor the treatment state of the targeted treatment area in the working gap of the treatment working layer 11 and feed back to the external control circuit.
The transducer provided by the embodiment is characterized in that the treatment piece 1 is a broadband treatment transducer (0.5-5 MHz) or a multi-frequency transducer (fundamental frequency 0.5-3.5MHz, intermediate frequency 1.5-11MHz, high frequency (2.5-20 MHz), the monitoring piece 2 is a high-frequency monitoring transducer (8-20 MHz), the high-frequency monitoring transducer is used for transmitting ultrasonic waves to a region to be treated, the treatment region is positioned in real time by the ultrasonic waves, the elasto-mechanical change of targeted tissues in the region to be treated is monitored, doppler blood flow change, vascular recanalization information and the like are fed back to an external control circuit in real time, whether the target region reaches the required treatment dose is judged, whether the coagulation necrosis of the target tissues is caused or not is judged, and the external control circuit is fed back in real time, the broadband treatment transducer is used for giving excitation signals with different frequencies, different phases and intensities in different treatment phases, such as single frequency, frequency mixing, alternation and the like, and accurate treatment of specific frequency and intensity is realized by changing the frequency and energy of the ultrasonic waves radiated by the transducer.
Example 2
This embodiment provides a wearable ultrasound device, as shown in fig. 3-7, comprising at least one set of therapy units comprising a flexible PCB circuit board 5 and nine transducers of embodiment 1 connected in series with each other.
In this embodiment, as shown in fig. 3 and 4, nine transducers are in three rows, each row has three connection elements connected to the surface of the flexible PCB circuit board 5, the therapeutic element 1 in the three transducers in each row is connected to an external control circuit after being connected in series by a wire, and the monitoring element 2 in the three transducers in each row is also connected to the external control circuit in series by a wire, so that the monitoring elements 2 and the therapeutic element 1 of the nine transducers can be connected to the external control circuit, so as to collect data monitored by the monitoring elements 2 and control the therapeutic element 1 to emit ultrasonic waves.
Through setting up three transducer and be a set of and establish ties each other, and three group's transducer all is connected with external control circuit alone through the wire, and then can realize the independent control of three group's transducers, and then realize the timesharing control of different series connection group to and the crossover control, form radiation sound field scope, sound field frequency composition (single frequency, multifrequency, mixing) and radiation intensity is controllable.
Furthermore, three transducers are connected in series to form a group, so that the longitudinal ultrasonic treatment length can be increased, and the three groups of transducers are arranged at intervals longitudinally and packaged to form a treatment unit, so that the ultrasonic transverse treatment width is increased; when the flexible PCB 5 and the transducer are installed, the backing layer 4 of the transducer is fixedly connected with the surface of the flexible PCB 5.
It will be appreciated that in other embodiments, other numbers of transducers may be provided, such as four in one group, five in one group, etc., or four groups of transducers longitudinally spaced apart, five groups of transducers longitudinally spaced apart, etc. The specific number may be set according to the requirements of the transducer in the treatment regimen.
As shown in fig. 5, the treatment unit further includes a front packaging protecting layer 7, a back packaging protecting layer 8 and a waterproof isolating layer 9, wherein the front packaging protecting layer 7 and the back packaging protecting layer 8 are disposed on two sides of the flexible PCB circuit board 5. When packaging, the transducer on the surface of the flexible PCB 5 is arranged towards the front packaging protection layer 7, the waterproof isolation layer 9 is arranged between the back packaging protection layer 8 and the flexible PCB 5, and when the transducer is installed, the backing layer 4 of the transducer is connected with the surface of the flexible PCB 5, so that the matching layer of the therapeutic part 1 and the monitoring part 2 of the transducer is arranged towards the front packaging protection layer 7.
When the medical targeting mask is used, the front packaging protective layer 7 is used for being attached to human body targeting skin, so that the front packaging protective layer 7 must meet medical safety and temperature standards, and medical mature materials such as silica gel patches, non-woven fabric patches, PET+hydrocele gel and the like can be adopted. In addition, in order to improve the effectiveness of ultrasound propagation, an ultrasound couplant bin may be provided as an ultrasound propagation path between the skin and the transducer.
The back packaging protection layer 8 of the transducer adopts a material with high heat conduction coefficient and good heat dissipation, can effectively absorb heat accumulation generated in the high-power working process of the transducer, avoids heat damage to tissues, has higher compliance, and can be a water cooling bin without limitation, and a waterproof isolation layer 9 is arranged between the water cooling bin and the flexible PCB 5 so as to prevent the water cooling bin from leaking to damage the flexible PCB 5.
As shown in fig. 6, the treatment unit adopts a curved surface structure design, so that the treatment unit can better fit the targeted skin of the limb wearing part.
According to the characteristics of clinical different tissue lesion distributions, the structure of the wearable ultrasonic device can be flexibly designed. For example, for the ablation treatment of venous thrombosis of the lower limbs, due to the characteristics of venous thrombosis occlusion of the lower limbs of the human body: the wearable ultrasonic device can cover the treatment and monitoring of the whole section of thrombus in long distance, changeable trend, bending and the like. In this embodiment, as shown in fig. 7, five treatment units are arranged transversely to each other to increase the treatment length; the three groups of treatment units are longitudinally arranged, the treatment width is increased, and each treatment unit is connected with an external control circuit through a communication cable. According to the distribution characteristics of deep vein thrombosis of lower limbs, a plurality of transducers monitor and treat the settlement position that the group is fixed on wearable sheath respectively, form the ultrasonic coverage irradiation and the monitoring of all-round multi-angle to the thrombus blocking section.
As shown in fig. 7, nine treatment units are all fixed on the wrapping member 101, and in order to improve the adaptability of the wearable ultrasonic device to different people, the wrapping member 101 is made of common sports knee-pad materials, including but not limited to chinlon, neoprene, etc., and has strong elasticity, scalability, built-in spring support and strong support. And the upper and lower ends of the wrapping piece 101 are all provided with magic tapes, so that the wrapping piece 101 can be arbitrarily stuck and flexibly adjusted in tightness, and in other embodiments, the wrapping piece 101 can be fixed on a human body in the forms of snap fasteners, binding bands and the like.
As shown in fig. 3, the therapeutic unit further includes three temperature measuring members 6, where the three temperature measuring members 6 are uniformly arranged on the sides of the three groups of therapeutic units to monitor the temperature rising state of the transducer in real time, the temperature measuring members 6 are thermistors, and the like, and the temperature measuring members 6 are connected with an external control circuit through a signal transmission line to transmit temperature information of the temperature measuring members 6 to the external control circuit.
The wearable ultrasonic device provided by the embodiment is fixed on the limb of the human body through the magic tape, as shown in fig. 8, three groups of treatment units are distributed on the peripheral side of the limb of the human body, an ultrasonic irradiation area a formed by ultrasonic waves emitted by an internal transducer of each treatment unit can completely cover a target focus, ultrasonic wave beams are converged on the target focus through an arc-shaped structure of each treatment unit, and all-dimensional coverage irradiation and monitoring of focus positions are realized through wave beams of multiple groups of treatment units. The monitoring piece 2 in the transducer inside the treatment unit monitors the state information of the targeted focus and feeds the information back to the external control circuit in real time, and the external control circuit makes a decision on the treatment scheme of the treatment unit, so that single-frequency treatment with different intensities, different directions and depths can be given, and multi-frequency or mixed-frequency treatment schemes can also be given.
The wearable ultrasonic device provided by the embodiment can be matched with minimally invasive interventional catheters commonly used clinically for accurate positioning and drug delivery, microbubble synergistic auxiliary thrombolysis is performed, and the ultrasonic thrombolysis treatment scheme is optimized through feedback adjustment by monitoring in-vivo thrombus state changes and vascular blood flow recanalization rate changes in real time, so that the problem that patients lying in bed for clinically placing thrombolysis catheters at present is solved, and the comfort level of the patients is greatly improved; the wearable ultrasonic auxiliary can accelerate thrombolysis efficiency of clinical thrombolysis catheter, greatly reduce residence time of thrombolysis catheter in patient, reduce risk brought by catheter, and simultaneously greatly reduce thrombolysis drug dosage under auxiliary action of ultrasonic and microbubble, thereby reducing side effect and complications brought by thrombolysis drug.
It can be appreciated that the wearable ultrasonic device provided in this embodiment is not only suitable for treatment of deep venous thrombosis of lower limbs, but also can be used for relieving and treating other diseases, such as varicose veins, promoting bone tissue regeneration by ultrasound, tumor ablation, and treating prostate diseases.
Example 3
The present embodiment provides an ultrasound monitoring and therapy system, as shown in fig. 9, including the wearable ultrasound device in embodiment 2, and a control display assembly, an intelligent monitoring assembly, an ultrasound driving assembly and a protection assembly electrically connected with the wearable ultrasound device.
In this embodiment, the control display assembly includes a main panel status indicator, a display screen, a knob, buttons, a display and control circuit, and the control display assembly is connected to the ultrasonic drive assembly through a UART interface.
The ultrasonic driving assembly comprises a microcontroller circuit, a signal generating circuit and a power amplifier circuit, and is a central control and regulation module for providing optimal treatment parameter setting for the treatment unit.
The intelligent monitoring component comprises a communication circuit, a filter circuit, a data acquisition or processing circuit, an AI algorithm learning circuit and the like, and is used for positioning and monitoring elastomechanical changes, doppler blood flow changes, vascular recanalization information and the like of a target tissue in a to-be-treated area in real time through a monitoring piece 2 of a transducer in the treatment unit, feeding back the information to an external control circuit in real time, judging whether the target area reaches required treatment dosage in the treatment process, judging whether the target tissue coagulates and necroses or not, feeding back the information to the control circuit in real time, and controlling a signal generating circuit to transmit optimal ultrasonic treatment parameters according to preset treatment scheme information.
The ultrasonic monitoring treatment system further comprises a protection component, and the protection component monitors safety information of the circuit system and temperature rise information of the probe in real time according to a voltage and current sensor in the ultrasonic monitoring treatment system and a temperature measuring piece 6 in the treatment unit and transmits the safety information and the temperature rise information to the controller circuit, so that guarantee is provided for safe and stable operation of the system.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.
Claims (15)
1. A transducer adapted for connection to an external control circuit, comprising:
at least one treatment member comprising a treatment working layer adapted to emit ultrasound waves towards the area to be treated to assist in ablation treatment;
the monitoring piece comprises a monitoring working layer, wherein the monitoring working layer is suitable for transmitting ultrasonic waves to the area to be treated so as to position the area to be treated and monitor the treatment state of the area to be treated in real time;
the ultrasonic isolation layer is arranged between the monitoring piece and the treatment piece;
the treatment piece and the monitoring piece are suitable for being connected with an external control circuit, and the monitoring piece feeds back the information of the treatment state of the monitored area to be treated to the external control circuit in real time, so that the external control circuit can adjust the direction and power of the ultrasonic wave emitted by the treatment piece.
2. The transducer of claim 1, wherein the treatment element is juxtaposed with the monitoring element.
3. The transducer of claim 1, wherein a placement cavity is provided within the treatment element, the monitoring element is disposed within the placement cavity, and the ultrasound isolation layer is disposed between a cavity wall of the placement cavity and the monitoring element.
4. A transducer according to claim 3, wherein the ultrasound isolation layer is a PVC cavity or an acrylic cavity or an epoxy mixed hollow glass microsphere or a high acoustic attenuation coefficient insulating material filled between the monitoring element and the placement cavity wall, the PVC cavity or acrylic cavity being internally filled with a gas or vacuum.
5. The transducer of claim 4, wherein the ultrasound isolation layer thickness is n+1/2 wavelength of therapeutic ultrasound waves, where N is a positive integer.
6. A transducer according to claim 2 or 3, wherein the treatment working layer and the monitoring working layer are operated simultaneously, or the monitoring working layer monitors the treatment state of the region to be treated in the working gap of the treatment working layer and feeds back to an external control circuit.
7. A transducer according to claim 2 or 3, wherein: the therapeutic element and the monitoring element are of integrated structural design and share a backing layer, and the materials of the backing layer are matched with the therapeutic element in impedance.
8. The transducer according to claim 7, wherein:
the treatment piece further comprises a treatment matching layer which is arranged on one side of the treatment working layer away from the backing layer;
the monitoring piece further comprises a monitoring matching layer which is arranged on one side, away from the backing layer, of the monitoring working layer, and the treatment matching layer and the monitoring matching layer are arranged on the same side.
9. A wearable ultrasound device comprising at least one set of therapy units, the therapy units comprising a flexible PCB circuit board and at least one transducer of any of claims 1-8, the transducer being connected to the flexible PCB circuit board.
10. The wearable ultrasonic device according to claim 9, wherein a plurality of the transducers are arranged on the surface of the flexible PCB in a plurality of groups, and the transducers in any group are connected in series with each other and then connected with the external control circuit, so as to realize single-frequency, multi-frequency or mixed-frequency treatment.
11. The wearable ultrasound device of claim 10, wherein the therapy unit further comprises a temperature measurement member connected to the flexible PCB circuit board and disposed on the same side as the transducer.
12. The wearable ultrasound device of claim 11, wherein the therapy unit further comprises a front encapsulation protection layer and a back encapsulation protection layer, the front encapsulation protection layer and the back encapsulation protection layer being disposed on both sides of the flexible PCB.
13. The wearable ultrasound device of claim 12, wherein the flexible PCB circuit board surface transducer is disposed toward the front encapsulation protection layer, and the therapy unit further comprises a waterproof isolation layer disposed between the back encapsulation protection layer and the flexible PCB circuit board.
14. The wearable ultrasound device of claim 13, wherein the front encapsulation protective layer is a cambered surface to conform to the targeted skin of the area to be treated.
15. An ultrasound monitoring therapy system comprising the wearable ultrasound device of any one of claims 9-14, and a control display assembly, an intelligent monitoring assembly, an ultrasound drive assembly, and a protection assembly electrically connected to the wearable ultrasound device.
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US9119533B2 (en) * | 2008-10-07 | 2015-09-01 | Mc10, Inc. | Systems, methods, and devices having stretchable integrated circuitry for sensing and delivering therapy |
CN103028200A (en) * | 2011-10-09 | 2013-04-10 | 北京汇福康医疗技术有限公司 | Ultrasound therapy method and ultrasound therapy device |
CN107107113A (en) * | 2014-03-15 | 2017-08-29 | 赛威医疗公司 | Thin and wearable ultrasound phased array devices |
CN104383646B (en) * | 2014-12-12 | 2020-04-24 | 黄晶 | Ultrasonic interventional therapy system |
US20180161002A1 (en) * | 2015-07-10 | 2018-06-14 | Medtronic, Inc. | Ultrasound delivery for diagnosis and/or therapy |
WO2019204639A1 (en) * | 2018-04-18 | 2019-10-24 | Vibrato Medical, Inc. | Extracorporeal therapeutic ultrasound for promoting angiogenesis |
CN113038987A (en) * | 2018-08-25 | 2021-06-25 | 杰拓奥兹***有限责任公司 | Flexible wearable long-term ultrasound device |
WO2020215075A1 (en) * | 2019-04-18 | 2020-10-22 | The Regents Of The University Of California | System and method for continuous non-invasive ultrasonic monitoring of blood vessels and central organs |
US20220039699A1 (en) * | 2020-06-01 | 2022-02-10 | Rinat O. Esenaliev | Wearable, Noninvasive Monitors Of Glucose, Vital Sign Sensing, And Other Important Variables And Methods For Using Same |
CN214017606U (en) * | 2020-11-11 | 2021-08-24 | 深圳开立生物医疗科技股份有限公司 | Ultrasonic transducer device and ultrasonic imaging system |
CN114101016B (en) * | 2021-11-04 | 2022-08-23 | 之江实验室 | Magnetic control flexible ultrasonic transducer |
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