A conformable wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer

Abstract

The present application relates to the technical field of medical equipment, and discloses a conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer, which comprises a pulsed light source emitter and a photoacoustic conversion composite material, and a use method of the treatment device, which comprises the following steps: uniformly applying the photoacoustic conversion composite material to a penis part of a patient, and allowing the photoacoustic conversion composite material to solidify to form a flexible conformal film layer; turning on the pulsed light source emitter, and irradiating the conformal film layer with far-infrared pulsed light emitted by the pulsed light source emitter; after the conformal film layer absorbs light energy of the far-infrared pulsed light, the light energy is converted into heat energy, then thermal expansion of the conformal film layer is caused, so that LIPUS is generated, and rehabilitation treatment is performed on the penis part of the patient. The present application provides a more portable, more comfortable and lower-cost LIPUS ED treatment device and method, and helps the clinical promotion and market application of LIPUS in the ED treatment field.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer. Background Technology

[0002] Low-intensity pulsed ultrasound (LIPUS) is a non-invasive physical therapy method. It promotes tissue repair and improves local blood circulation, and is currently being used clinically in the treatment of erectile dysfunction (ED). The core technology of existing LIPUS treatment devices revolves around the "piezoelectric effect." These devices typically consist of a main unit, a piezoelectric ultrasound probe, a coupling agent, and a power module. Their working principle involves converting electrical energy into ultrasonic waves through the piezoelectric probe, which are then applied to the corpora cavernosa of the penis to ultimately improve erectile function. While traditional LIPUS devices have shown some effectiveness in ED treatment, their technical design has several intractable flaws.

[0003] First, the equipment lacks portability. The piezoelectric ultrasound probe needs to be connected to the main unit via a cable, and the main unit is relatively large and usually needs to be fixed on a treatment table. This forces patients to travel to a medical institution for treatment, making it impossible to complete the treatment at home, significantly limiting the flexibility of the treatment scenario.

[0004] Second, the probe's fit is insufficient. The penis has a curved surface structure, but existing piezoelectric probes are rigid and fixed. This type of probe easily creates gaps between itself and the penile skin, leading to uneven distribution of ultrasound energy. The energy at some treatment sites will be significantly attenuated, directly affecting the stability of the treatment effect.

[0005] Third, the treatment is inefficient and patient compliance is poor. The rigid probe has a limited area of ​​application and cannot simultaneously cover multiple key treatment sites such as both sides of the penile shaft and penile crura, requiring treatment point by point, which prolongs the treatment time per session. Furthermore, the rigid probe can cause discomfort to patients when in contact with the skin, and the need for multiple trips to the hospital ultimately makes it difficult for many patients to complete the entire treatment process.

[0006] Fourth, high manufacturing costs. The precision piezoelectric ceramic components in the piezoelectric probe, as well as the complex drive circuitry accompanying the equipment, all contribute to the overall manufacturing cost. This not only increases procurement costs for medical institutions but also indirectly raises treatment expenses for patients, hindering the widespread adoption of this technology.

[0007] Currently, ED patients have an increasing demand for convenient, comfortable, and low-cost treatments. The aforementioned shortcomings of traditional LIPUS devices have become key issues limiting their clinical promotion and market application. Summary of the Invention

[0008] In view of this, the purpose of the present invention is to provide a conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer, in order to solve the problems of low convenience, poor comfort and high cost of traditional LIPUS devices as pointed out in the background art.

[0009] The present invention solves the above-mentioned technical problems through the following technical means:

[0010] A conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer, the device comprising a pulsed light source transmitter and a photoacoustic conversion composite material, and the method of using the device comprising:

[0011] S110. Apply the photoacoustic conversion composite material evenly to the patient's penis and allow the photoacoustic conversion composite material to solidify to form a flexible conformal film layer;

[0012] S120. Turn on the pulse light source emitter and irradiate the conformal film layer with far-infrared pulse light emitted by the pulse light source emitter.

[0013] S130. After the conformal membrane absorbs the light energy of the far-infrared pulsed light, it converts the light energy into heat energy, which then causes the conformal membrane to expand thermally, thereby generating LIPUS and performing rehabilitation treatment on the patient's penis.

[0014] In one possible implementation, the photoacoustic conversion composite material is a carbon black-polydimethylsiloxane composite material.

[0015] In one possible implementation, in S130, the carbon black first absorbs the light energy of the far-infrared pulsed light and converts the light energy into heat energy, which then causes the polydimethylsiloxane to thermally expand, thereby generating LIPUS for rehabilitation treatment of the patient's penis.

[0016] In one possible implementation, the method for preparing the photoacoustic conversion composite material includes:

[0017] S210. Mix carbon black with dispersant as an initial mixture;

[0018] S220. Add polydimethylsiloxane and a curing agent to the initial mixture to form an intermediate mixture;

[0019] S230. The intermediate mixture is added to toluene solvent, and then magnetically stirred and ultrasonically dispersed to form a uniform mixture.

[0020] S240. After the mixture is allowed to stand, the air bubbles are extracted to obtain a photoacoustic conversion composite material.

[0021] In one possible implementation, the particle size of the carbon black is selected to be 13-30 nm.

[0022] In one possible implementation, the thickness of the conformal membrane layer is 15-25 μm.

[0023] In one possible implementation, the pulsed light source emitter includes:

[0024] shell;

[0025] A pulsed light source, mounted on the housing, is used to emit far-infrared pulsed light;

[0026] A beam control structure, mounted on the housing, is used to adjust the spot size and irradiation range of the far-infrared pulse light; and

[0027] A control module, installed inside the housing, is used to adjust the power, pulse frequency, and operating time of the pulse light source.

[0028] In one possible implementation, the pulsed light source comprises a plurality of LEDs arranged in an array.

[0029] In one possible implementation, the beam control structure includes a mask and a lens, which are mounted on the housing near the pulsed light source.

[0030] In one possible implementation, the housing is provided with a handheld portion.

[0031] The beneficial effects of this application are:

[0032] 1. Traditional LIPUS devices require connection to a main unit and a wired probe, necessitating hospital visits for treatment, making home use impossible and limiting portability. This application, however, only requires a pulsed light source transmitter and a photoacoustic conversion composite material. The pulsed light source transmitter is a small, portable device, enabling both wireless and home-based treatment, thus offering greater portability.

[0033] 2. Traditional LIPUS devices require rigid probes, causing significant discomfort to patients during treatment. Furthermore, the single-size rigid probes cannot accommodate diverse patient needs, resulting in poor adaptability. In contrast, the flexible conformal membrane layer formed by the curing of the photoacoustic conversion composite material in this application not only improves patient comfort but also adapts to different patient needs.

[0034] 3. Traditional rigid probes do not fit well with the patient's genitals, which can lead to uneven distribution of ultrasound energy and affect the treatment effect. However, the flexible conformal membrane layer formed by the curing of the photoacoustic conversion composite material in this application can not only adapt to the curvature of the human body and reduce energy loss, but also simultaneously excite multiple sites, with a large and controllable range of action, shortening the treatment time, and the treatment process is painless and non-invasive.

[0035] 4. The piezoelectric probes and complex circuit systems of traditional LIPUS devices increase equipment costs, leading to higher treatment expenses for patients. In contrast, the pulsed light source emitter and photoacoustic conversion composite material in this application are inexpensive, effectively reducing treatment costs for patients. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0037] Figure 1 This is a schematic diagram of the pulse light source emitter in an embodiment of this application;

[0038] The following are the symbols in the attached diagram: 1. Outer shell; 2. Pulsed light source; 3. Lens; 4. Mask; 5. Handheld part. Detailed Implementation

[0039] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0040] It should be noted that all directional indicators (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indicator will also change accordingly.

[0041] Furthermore, the use of terms such as "first," "second," etc., in this application is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0042] Furthermore, the technical solutions of the various embodiments of this application can be combined with each other, but only if they are based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by this application.

[0043] like Figure 1 As shown in the illustration, this application provides a conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer. The device includes a pulsed light source emitter and a photoacoustic conversion composite material. The pulsed light source emitter emits far-infrared pulsed light with a wavelength of 800-1100 nm and a pulse width of 4-10 ns. The photoacoustic conversion composite material converts the far-infrared pulsed light into low-intensity pulsed ultrasound (LIPUS). LIPUS, as a non-invasive physical therapy method, has been clinically applied in the treatment of erectile dysfunction (ED).

[0044] The method of using this treatment device includes the following steps:

[0045] S110. Apply the photoacoustic conversion composite material evenly to the patient's penis and allow the photoacoustic conversion composite material to solidify to form a flexible conformal film layer;

[0046] S120. Turn on the pulse light source emitter and irradiate the conformal film layer with far-infrared pulse light emitted by the pulse light source emitter.

[0047] S130. After the conformal membrane absorbs the light energy of the far-infrared pulsed light, it converts the light energy into heat energy, which then causes the conformal membrane to expand thermally, thereby generating LIPUS and performing rehabilitation treatment on the patient's penis.

[0048] The above technical solutions provide a more portable, comfortable, and cost-effective LIPUSED treatment device and method, facilitating the clinical promotion and market application of LIPUS in the treatment of erectile dysfunction. Specific advantages are as follows:

[0049] 1. Traditional LIPUS devices require connection to a main unit and a wired probe, necessitating hospital visits for treatment, making home use impossible and limiting portability. This application, however, only requires a pulsed light source transmitter and a photoacoustic conversion composite material. The pulsed light source transmitter is a small, portable device, enabling both wireless and home-based treatment, thus offering greater portability.

[0050] 2. Traditional LIPUS devices require rigid probes, causing significant discomfort to patients during treatment. Furthermore, the single-size rigid probes cannot accommodate diverse patient needs, resulting in poor adaptability. In contrast, the flexible conformal membrane layer formed by the curing of the photoacoustic conversion composite material in this application not only improves patient comfort but also adapts to different patient needs.

[0051] 3. Traditional rigid probes do not fit well with the patient's genitals, which can lead to uneven distribution of ultrasound energy and affect the treatment effect. However, the flexible conformal membrane layer formed by the curing of the photoacoustic conversion composite material in this application can not only adapt to the curvature of the human body and reduce energy loss, but also simultaneously excite multiple sites, with a large and controllable range of action, shortening the treatment time, and the treatment process is painless and non-invasive.

[0052] 4. The piezoelectric probes and complex circuit systems of traditional LIPUS devices increase equipment costs, leading to higher treatment expenses for patients. In contrast, the pulsed light source emitter and photoacoustic conversion composite material in this application are inexpensive, effectively reducing treatment costs for patients.

[0053] The following is a detailed explanation of each step in the above usage method:

[0054] In step S110, the patient or medical staff first applies the prepared photoacoustic conversion composite material evenly to the patient's penis. Then, the photoacoustic conversion composite material can be transformed into a flexible conformal membrane layer that fits the shape of the patient's penis by natural curing or heat curing. The thickness of the conformal membrane layer is 15-25 μm, preferably 20 μm.

[0055] In this embodiment, the photoacoustic conversion composite material mainly comprises two materials: carbon black (CB) and polydimethylsiloxane (PDMS), i.e., the photoacoustic conversion composite material is a carbon black-PDMS composite material. Carbon black is used as a light absorber, while PDMS is used as a thermal expansion agent. Small-particle-size carbon black is selected, preferably with a particle size of 13-30 nm.

[0056] In another embodiment, the photoacoustic conversion composite material can also be a carbon nanotube (CNT)-polydimethylsiloxane composite material, a self-healing polydimethylsiloxane-V2C (vanadium carbide) composite material, etc., but these materials are not as effective as the carbon black-polydimethylsiloxane composite material.

[0057] In step S120, the user can use a handheld pulse light source emitter to irradiate the conformal film layer according to the actual situation. The pulse light source emitter can emit far-infrared pulse light with a wavelength of 800-1100nm and a pulse width of 4-10ns.

[0058] In step S130, when the far-infrared pulse light emitted by the pulse light source emitter irradiates the conformal film layer, the carbon black in the conformal film layer can quickly absorb the light energy. Due to the small particle size (13-30nm) and uniform dispersion of the carbon black, the absorbed light energy will be quickly converted into local heat energy, causing the temperature of the polydimethylsiloxane material in the film layer to rise in a short time.

[0059] Polydimethylsiloxane (PDMS) itself has excellent thermal response characteristics. When the heat energy transferred by carbon black acts on PDMS, the PDMS molecules will vibrate rapidly and increase in spacing due to the increase in temperature, resulting in volume expansion. Furthermore, since the light source is "pulsed," the heat energy supply is not continuous but brief and intermittent. This causes the thermal expansion of PDMS to also exhibit a "pulsed" pattern: that is, it expands rapidly when heated and contracts slightly when cooled, forming a high-frequency "expansion-contraction" reciprocating motion.

[0060] The pulsed expansion-contraction reciprocating motion of polydimethylsiloxane continuously compresses and pushes the surrounding medium (such as air on the skin surface or subcutaneous tissue), causing the medium to produce periodic compression-sparse vibrations. When the frequency of this vibration reaches 1-3MHz, LIPUS is formed, and ultimately these ultrasound waves act on the patient's penile cavernous tissue to achieve the effect of treating ED.

[0061] In one possible embodiment, the method for preparing the photoacoustic conversion composite material includes the following steps:

[0062] S210. Mix carbon black with dispersant as an initial mixture;

[0063] S220. Add polydimethylsiloxane and a curing agent to the initial mixture to form an intermediate mixture;

[0064] S230. The intermediate mixture is added to toluene solvent, and then magnetically stirred and ultrasonically dispersed to form a uniform mixture.

[0065] S240. After the mixture is allowed to stand, the air bubbles are extracted to obtain a photoacoustic conversion composite material.

[0066] It should be noted that the photoacoustic conversion composite material used in this embodiment is existing technology, and the preparation method given above is the main method for preparing the photoacoustic conversion composite material. For details such as the specific selection of materials and proportions in this method, please refer to the photoacoustic conversion composite material and its preparation method disclosed in application number 201810084565.0. This embodiment will not elaborate further.

[0067] Furthermore, experimental verification showed that the photoacoustic conversion composite material (carbon black-polydimethylsiloxane composite material) selected in this embodiment produced a peak sound pressure of 16.8 MPa at a laser energy density of 10.285 mJ / cm², and a photoacoustic conversion efficiency of 3.44 × 10⁻³, which is higher than that of previously reported materials (such as CNT's 2.99 × 10⁻³ and Gold NPs' 1.89 × 10⁻³). 4 Therefore, by using carbon black-polydimethylsiloxane composite material as the photoacoustic conversion composite material, this application can achieve better therapeutic effects.

[0068] In one possible embodiment, the pulsed light source 2 emitter includes a housing 1, a pulsed light source 2, a beam control structure, and a control module. The housing 1, serving as the carrier integrating all structures, can be designed to be handheld or wearable. This embodiment preferably features a handheld design, with a handheld part 5 provided on the housing 1 for easy user handling.

[0069] The pulse light source 2 is installed at the end of the housing 1 and is used to emit far-infrared pulse light. Specifically, the pulse light source 2 includes several LEDs arranged in an array, which can be arranged in a circular array or a square array structure.

[0070] A beam control structure is mounted on the housing 1 to adjust the spot size and irradiation range of the far-infrared pulsed light. Specifically, the beam control structure includes a mask 4 and a lens 3, which are mounted on the housing 1 near the pulsed light source 2. The lens 3 can focus or diverge the far-infrared light emitted by the pulsed light source 2, controlling the convergence of the beam. The mask 4, through a specific patterned shielding structure—which can be a long strip or arc-shaped opening adapted to the penile area—limits the irradiation area of ​​the beam, ultimately achieving precise control of the spot size and irradiation range to suit the needs of the treatment site.

[0071] To verify the effectiveness of this treatment device, this embodiment uses a rat ED model for animal experiment verification.

[0072] 1. Establish a rat ED model

[0073] In this embodiment, adult male SD rats were used, and a diabetic ED model or a bilateral cavernous nerve injury ED model was induced by streptozotocin (STZ) to establish a reliable rat ED model.

[0074] 2. Experimental Grouping

[0075] Rats that successfully established the model were randomly divided into an experimental group, a sham treatment group, and a model control group, with an additional normal control group. The number of rats in each group was the same. The following describes the situation of each group:

[0076] (1) Experimental group: received conformal wireless LIPUS treatment (treatment parameters: 1.5 MHz, 30 mW / cm², 20% duty cycle).

[0077] (2) Sham treatment group: only the composite material was applied and the patient received sham light (no ultrasound was generated);

[0078] (3) Model control group: No treatment was given after modeling;

[0079] (4) Normal control group: Healthy rats were not treated in any way.

[0080] 3. Effectiveness Evaluation

[0081] (1) Evaluation indicators: After treatment, the intracavernosal pressure (ICP) and mean arterial pressure (MAP) of rats were measured by electrical stimulation of the cavernous nerve (CNC) to objectively evaluate erectile function by the ICP / MAP ratio; the expression levels of key proteins or genes related to endothelial function (eNOS), nerve regeneration (NGF) and fibrosis (TGF-β1) in penile tissue were detected by RT-PCR technology.

[0082] (2) Evaluation data:

[0083] detection indicators normal control group Model control group sham treatment group experimental group ICP / MAP 0.61±0.05 0.25±0.04 0.24±0.02 0.46±0.02 eNOS (pg / mL) 66.54±0.81 29.46±0.61 30.16±0.92 52.73±0.43 NGF 87.6±21.8 36.3±7.6 38.4±9.4 66.2±14.5 TGF-β1 1.0±0.1 1.6±0.2 1.5±0.2 1.1±0.1

[0084] 4. Conclusion

[0085] Experimental data verified that the ICP / MAP ratio of the experimental group rats was significantly higher than that of the sham treatment group and the model control group, the pathological damage of penile tissue was significantly improved, the expression of beneficial factors such as eNOS was upregulated, and the fibrosis index such as TGF-β1 was downregulated, proving that this treatment device can effectively improve the erectile function of ED model rats.

[0086] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications and substitutions should be covered within the scope of the claims of the present invention. Technical aspects, shapes, and structures not described in detail in this invention are all well-known technologies.

Claims

1. A conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer, characterized in that, The treatment device includes a pulsed light source emitter and a photoacoustic conversion composite material, and the method of using the treatment device includes: S110. Apply the photoacoustic conversion composite material evenly to the patient's penis and allow the photoacoustic conversion composite material to solidify to form a flexible conformal film layer; S120. Turn on the pulse light source emitter and irradiate the conformal film layer with far-infrared pulse light emitted by the pulse light source emitter. S130. After the conformal membrane absorbs the light energy of the far-infrared pulsed light, it converts the light energy into heat energy, which then causes the conformal membrane to expand thermally, thereby generating LIPUS and performing rehabilitation treatment on the patient's penis.

2. The conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to claim 1, characterized in that, The photoacoustic conversion composite material is a carbon black-polydimethylsiloxane composite material.

3. The conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to claim 2, characterized in that, In S130, the carbon black first absorbs the light energy of the far-infrared pulsed light and converts the light energy into heat energy, which then causes the polydimethylsiloxane to expand thermally, thereby generating LIPUS for rehabilitation treatment of the patient's penis.

4. A conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to any one of claims 1-3, characterized in that, The preparation method of the photoacoustic conversion composite material includes: S210. Mix carbon black with dispersant as an initial mixture; S220. Add polydimethylsiloxane and a curing agent to the initial mixture to form an intermediate mixture; S230. The intermediate mixture is added to toluene solvent, and then magnetically stirred and ultrasonically dispersed to form a uniform mixture. S240. After the mixture is allowed to stand, the air bubbles are extracted to obtain a photoacoustic conversion composite material.

5. The conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to claim 4, characterized in that, The particle size of the carbon black is selected to be 13-30 nm.

6. A conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to any one of claims 1-3, characterized in that, The thickness of the conformal membrane layer is 15-25 μm.

7. A conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to any one of claims 1-3, characterized in that, The pulsed light source emitter includes: Outer shell (1); A pulse light source (2) is mounted on the housing (1) and is used to emit far-infrared pulse light; A beam control structure, mounted on the housing (1), is used to adjust the spot size and irradiation range of the far-infrared pulse light; and A control module is installed inside the housing (1) and is used to adjust the power, pulse frequency and working time of the pulse light source (2).

8. The conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to claim 7, characterized in that, The pulsed light source (2) includes several LEDs arranged in an array.

9. The conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to claim 7, characterized in that, The beam control structure includes a mask (4) and a lens (3), which are mounted on the housing (1) near the pulse light source (2).

10. The conformal wireless LIPUS erectile dysfunction treatment device based on a photoacoustic transducer according to claim 7, characterized in that, The outer casing (1) is provided with a hand-held part (5).

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