Wearable flexible ultrasonic urethral scar treatment device

Abstract

The present invention provides a wearable flexible ultrasonic urethral scar therapeutic device, which includes a patch-type flexible ultrasonic probe and a control terminal. The patch-type flexible ultrasonic probe is made of silicone material, in which chips are distributed, and the chips are used to emit ultrasonic waves to the skin surface when receiving the excitation signal of the control terminal. When using the therapeutic device of the present invention, it is only necessary to attach the patch-type flexible ultrasonic probe to the ventral skin surface of the patient's penis, and set the power and frequency of the ultrasound through the control terminal. It is easy to use, has no radiation, no pain, and no side effects. The present invention solves the technical problem of ultrasound attachment to the penis, applies low-frequency ultrasonic technology to the treatment of urethral scars, belongs to the technical expansion of a new field, and is expected to solve the problem of clinical prevention and treatment of urethral scars.

Description

Technical Field

[0001] The invention relates to a wearable flexible ultrasonic urethral scar therapeutic instrument, belonging to the technical field of postoperative scar treatment in urology surgery. Background Art

[0002] The formation of urethral scars is the result of the combined action of multiple factors. The profibrotic protein TGF-β is currently known to be the most closely related and representative growth factor to scar formation. Factors such as inflammation and matrix metalloproteinases (MMPs) also play an important role in the scar formation process. The formation of urethral scars after urethral surgery is a common complication that often affects the postoperative recovery of urethral patients and has always been a very difficult problem faced by urological surgeons.

[0003] At present, the treatment methods for urethral scars and urethral strictures in clinical practice mainly include surgical treatment and drug treatment. Traditional urethral dilation is not only painful but also difficult to cure. Open surgery includes urethral scar segment resection, transurethral scar excision and endoplasty, etc., which have high treatment costs, large surgical trauma, and many complications, such as impotence, penile curvature, etc., and are prone to restenosis after surgery.

[0004] With the development of urethral intracavitary technology, the use of a variety of new methods such as endoscopic cold knife urethral stricture incision, scar vaporization electroresection, bipolar plasma urethral incision and urethral scar electroresection, and holmium laser incision under direct vision of ureteroscope has gradually improved the surgical effect, but each method has its limitations. For example, endoscopic urethral cold knife incision can only be radially incised, and scar tissue cannot be removed and hemostasis is not good. The long-term effect after surgery is poor and the recurrence rate is high. Monopolar high-frequency electrosurgical knife can remove scar tissue and the wound surface is neat, but its temperature is high and produces deep thermal radiation, which will cause different degrees of thermal damage to the tissue around the urethra, and the tissue is prone to necrosis and the formation of new fibrous scar tissue. Holmium laser incision under direct vision of ureteroscope is only suitable for cases with mild stenosis. It is difficult to achieve the purpose of relieving obstruction and unblocking the urethra in cases with long and severe stenosis. At present, the success rate of surgical treatment is still about 75%, and it is easy to fall into the vicious circle of reoperation-restenosis, and multiple urethral dilations are often required after surgery.

[0005] Drugs for treating urethral scars mainly include triamcinolone acetonide, verapamil, hyaluronic acid, etc. Although drug treatment has certain effects, it is often used as an auxiliary treatment after surgery and is difficult to play a good role alone. The method of injecting drugs into scars is difficult to operate, and multiple injections will increase the pain of patients.

[0006] The current common treatment for urethral scars is regular urethral dilation after surgery to prevent urethral stenosis. Severe stenosis requires urethral incision to remove scar tissue.

[0007] Studies in recent years have shown that ultrasound has the effects of promoting vascularization, anti-inflammation, anti-fibrosis, anti-capsular contracture, inhibiting TGF-β expression, and promoting MMP expression. Low-frequency ultrasound has anti-inflammatory effects, and early inflammatory response is an important cause of scar formation. Low-frequency ultrasound can promote the decrease in the expression of pro-fibrotic protein TGF-β1 and the increase in the expression of anti-fibrotic protein MMP2, which can significantly resist fibrosis and thus inhibit scar formation. In addition, low-frequency ultrasound can stimulate the release of angiogenesis factors, thereby accelerating angiogenesis and wound healing. However, there are currently no reports on the preventive and therapeutic effects of ultrasound on urethral scars.

[0008] Chinese patent CN106390278A discloses an ultrasonic therapeutic device, including an ultrasonic therapeutic patch and a therapeutic host, wherein the ultrasonic therapeutic patch includes a patch base, on which at least one drug lumen and at least one ultrasonic transducer are arranged; an attachment unit is distributed around the bottom of the patch base and is used to attach to the skin surface. The invention has a complex structure and is not flexible. It is mainly used to use ultrasound to penetrate drugs into the skin surface. In comparison, the present invention has a simple structure, is easy to use, has good flexibility, has strong adhesion, and is used for the treatment and / or prevention of urethral scars. Chinese patents CN208599011U and CN107789751A disclose a flexible ultrasonic therapeutic probe array and an ultrasonic two-dimensional array therapeutic belt. The ultrasonic therapeutic probe and the ultrasonic two-dimensional array therapeutic belt both include a skin-friendly layer, an ultrasonic crystal element, and a sound-absorbing protective layer. The surface of the skin-friendly layer is provided with a groove for placing the ultrasonic crystal element, and is mainly used in the field of ultrasonic fracture treatment and osteoporosis treatment. The ultrasonic treatment probe and the ultrasonic two-dimensional array treatment belt include a multi-layer structure, the overall thickness is relatively thick, which makes the bendability weak, the adhesion is general, and a fixing bandage is required to be set to fix it to the treated part. In comparison, the patch-type flexible ultrasonic probe of the present invention is an integrated flexible structure, the chip is built into the flexible material, the overall thickness is relatively thin, the flexibility is good, the adhesion is strong, and the application field is the treatment and / or prevention of urethral scars. Chinese patent CN109758180A discloses a flexible ultrasonic probe, which includes a flexible substrate and an ultrasonic transducer unit and is used for ultrasonic diagnosis. In comparison, the probe of the device of the present invention mainly generates low-frequency ultrasound, and uses the mechanical effect and thermal effect of low-frequency ultrasound for the treatment and / or prevention of urethral scars. Summary of the invention

[0009] The purpose of the present invention is to overcome the difficulties in the prior art for the treatment and prevention of urethral scars after urethral surgery, and to invent a wearable flexible ultrasonic urethral scar treatment method; at the same time, it solves the problem that conventional ultrasonic probes are too hard and cannot effectively fit the surface of the penis, and to invent a wearable flexible ultrasonic urethral scar treatment device.

[0010] Studies have shown that low-frequency ultrasound has the effects of promoting vascularization, anti-inflammation, anti-fibrosis and anti-capsular contracture, and can be used to treat and / or prevent urethral scar diseases. Applying low-frequency ultrasound in the clinical treatment of urethral scars and regularly performing low-frequency ultrasound treatment on patients after minimally invasive transurethral surgery can effectively inhibit the occurrence of pathological scars.

[0011] In addition, the current conventional ultrasonic probe is too hard and cannot be effectively attached to the surface of the penis. The present invention also introduces a polymer composite material, that is, ceramic array elements are distributed in a silicone material to form a flexible ultrasonic probe. The ultrasonic probe is suitable for being attached to the surface of the penis and is used in conjunction with the control end through wired transmission, thereby obtaining a wearable flexible ultrasonic urethral scar therapeutic device.

[0012] The wearable flexible ultrasonic urethral scar therapeutic device of the present invention comprises a patch-type flexible ultrasonic probe and a control end. The patch-type flexible ultrasonic probe is attached to the ventral skin surface of the patient's penis for ultrasonic treatment; the control end is connected to the patch-type flexible ultrasonic probe and is used to output an excitation signal to control the patch-type flexible ultrasonic probe. Among them, one or more groups of chips are arranged on the patch-type flexible ultrasonic probe, which are used to emit ultrasonic waves to the patient's skin surface when receiving the excitation signal output by the control end. The probe and the control end can be used in conjunction through wired transmission.

[0013] The patch-type flexible ultrasonic probe is made of silicone material, and the chips are distributed in the silicone material.

[0014] The patch-type flexible ultrasonic probe is in the shape of a circle, an ellipse, a square, a rectangle, a rounded rectangle or an irregular shape, and its shape can be customized according to actual needs. Its thickness is 1-5 mm.

[0015] Preferably, the patch-type flexible ultrasound probe is in the shape of a rectangle.

[0016] The chip is a 4×2 rectangular array and is made of piezoelectric ceramics or single crystal silicon and is flexible. The emitting surface of the chip faces the patient's skin surface. The chip is rectangular in shape and its thickness is less than that of a patch-type flexible ultrasound probe.

[0017] The central frequency of the piezoelectric ceramic or single crystal silicon is 0.4-4 MHz.

[0018] Electrodes are arranged on the upper surface of the chip, and the electrodes are used to collect signal lines of the chip.

[0019] A signal line interface is provided on the side of the patch-type flexible ultrasonic probe, and the control end is connected to the signal line interface through wired transmission to control the patch-type flexible ultrasonic probe.

[0020] The power of the ultrasonic wave generated by the patch-type flexible ultrasonic probe is 30mW / cm 2 -1.5W / cm 2 , the frequency is 1MHz-3MHz.

[0021] When treating and / or preventing urethral scarring, a patch-type flexible ultrasound probe is attached to the ventral skin of the penis for low-frequency ultrasound treatment. Preventive applications are mainly used after various urethral surgeries that may cause urethral scarring (such as urethroplasty, urethral end-to-end anastomosis, etc.). Ultrasound treatment can be started after the dressing on the penis skin is removed after the operation. Treatment can be performed once a day during hospitalization, and outpatient treatment can be performed several times a week after discharge, and the urethral healing level and urination can be regularly reviewed; therapeutic applications are mainly used when urethral scarring has been found. It can be used as a conservative treatment alone or in combination with urethral dilation. For patients with severe scarring that has caused obvious stenosis and requires surgical treatment, it can also be used in combination with surgery to consolidate the postoperative effect.

[0022] During the ultrasound treatment, the parameters of the ultrasound treatment are set through the control terminal. The range of ultrasound power is 30mW / cm 2 -1.5W / cm 2 The ultrasonic frequency range is 1MHz-3MHz, and the time of a single treatment is 5min-30min. During treatment, the ultrasonic probe needs to be moved regularly to avoid excessive local thermal effect and damage to the tissue.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] (1) The wearable low-frequency ultrasound of the present invention has no radiation, no pain, no side effects, and is easy to use;

[0025] (2) The present invention solves the technical problem of attaching ultrasound to the penis and applies low-frequency ultrasound technology to the treatment of urethral scars. It is a technical expansion in a new field and is expected to solve the clinical problem of preventing and treating urethral scars. There are currently no related products in the world.

[0026] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiments of the present invention in conjunction with the accompanying drawings. The specific implementation of the present invention is given in detail by the following embodiments and their accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without creative work.

[0028] Figure 1 Schematic diagram of the wearable flexible ultrasonic urethral scar therapeutic device of the present invention;

[0029] Figure 2 A schematic diagram of a cross section of the flexible ultrasonic patch of the present invention applied to the penis;

[0030] Figure 3 Schematic diagram of the structure of the patch-type flexible ultrasonic probe of the present invention.

[0031] Among them, 1-patch type flexible ultrasound probe, 2-control terminal. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solutions and advantages of the present invention more clear, the following Figure 1-3 The present invention is clearly and completely described in detail with reference to the accompanying drawings and specific embodiments. In the description of the present invention, it should be noted that the terms "upper", "middle", "lower side" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only used to facilitate the description of the present invention and simplify the description, rather than indicating or implying that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as a limitation on the present invention.

[0033] Example 1

[0034] like Figure 1-3 As shown, the wearable flexible ultrasonic urethral scar therapeutic device in this embodiment includes a patch-type flexible ultrasonic probe (1) and a control end (2). The patch-type flexible ultrasonic probe (1) is rectangular in shape and 2 mm thick, and is provided with a rectangular chip made of piezoelectric ceramics, and a signal line interface is provided on the lower side. The patch-type flexible ultrasonic probe (2) is made of silicone material, and the chip is distributed in the silicone material, and both have a certain degree of flexibility. The control end (2) is connected to the signal line interface through a flexible cable to control the patch-type flexible ultrasonic probe (2).

[0035] Example 2

[0036] Example 2 is the preventive application of the device of the present invention in postoperative patients. 50 patients with hypospadias who were admitted to the Urology Department and needed surgical treatment were selected. Preventive ultrasound treatment was started on the day when the penis dressing was removed after urethroplasty (usually about 3-5 days after surgery). The treatment site: the ventral skin of the penis corresponding to the formed urethra segment, and the patch-type flexible ultrasound probe was attached to the surface of the skin at this location; Equipment parameters: Power 0.2W / cm 2 , frequency 650KHz, single treatment time 20min (the ultrasound probe needs to be moved regularly during treatment to avoid excessive local thermal effects and damage to tissues). Treatment is given once a day during hospitalization (generally 7-14 days after surgery), and 1-2 times a week in the outpatient clinic after discharge. The urethral recovery level, urination situation, postoperative complications, etc. are evaluated 4 and 8 weeks after surgery, and the incidence and severity of urethral scars are calculated. Treatment effect: After hypospadias surgery, the use of this preventive ultrasound treatment method can reduce the incidence and severity of postoperative urethral scars, reduce the incidence of postoperative complications, and reduce the pain caused to patients by postoperative urethral dilation or even secondary surgery.

[0037] Example 3

[0038] Example 3 is the application of the device of the present invention in the clinical treatment of patients with urethral scars. 20 patients who have undergone various urethral surgeries and have complications of urethral scars and need further treatment were selected from the Department of Urology. Patients who have developed severe urethral stenosis and seriously affected urination and need surgical treatment within a time limit are not included. Treatment site: The ventral skin of the penis corresponding to the urethral scar segment, the patch-type flexible ultrasound probe is attached to the surface of the skin at this location; Ultrasonic equipment parameters: Power 0.5W / cm 2 , frequency 650KHz, single treatment time 30min (the ultrasound probe needs to be moved regularly during treatment to avoid excessive local thermal effects and damage to tissues). Outpatient treatment is 3 times a week. Scar recovery, urethral patency, urination function and other indicators are regularly evaluated by urethrography, urodynamics and other means 2, 4, 6, and 8 weeks after ultrasound treatment. Treatment effect: After ultrasound treatment with this instrument, it can promote the softening and absorption of existing scars to a certain extent, inhibit the formation of new scars, reduce the probability of reoperation, improve urination symptoms, reduce patient pain and improve their quality of life.

[0039] The above description of the disclosed embodiments enables professionals and technicians in the field to implement or use the present invention. The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, without departing from the principles of the present invention, several improvements and supplements can be made, and these improvements and supplements should also be regarded as the scope of protection of the present invention. Various modifications to these embodiments will be obvious to professionals and technicians in the field, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest range consistent with the principles and novel features disclosed herein.

Claims

1. A wearable flexible ultrasonic urethral scar treatment device, characterized in that: include: A patch-type flexible ultrasound probe is attached to the ventral skin surface of the patient's penis and is used for ultrasound treatment; A control end, connected to the patch-type flexible ultrasonic probe, and used to output an excitation signal to control the patch-type flexible ultrasonic probe; Wherein, one or more groups of chips are arranged on the patch-type flexible ultrasonic probe, which are used to transmit ultrasonic waves to the ventral skin surface of the patient's penis when receiving the excitation signal output by the control end; The chip is a 4×2 rectangular array and is made of piezoelectric ceramics or single crystal silicon and is flexible. The emitting surface of the chip faces the patient's skin surface. The chip is rectangular in shape and its thickness is less than that of a patch-type flexible ultrasound probe.

2. The wearable flexible ultrasonic urethral scar therapeutic device according to claim 1 is characterized in that: The patch-type flexible ultrasonic probe is made of silicone material, and the chips are distributed in the silicone material.

3. The wearable flexible ultrasonic urethral scar therapeutic device according to claim 1 or 2, characterized in that: The patch-type flexible ultrasonic probe has a shape of a circle, an ellipse, a square, a rectangle, a rounded rectangle or an irregular shape, and a thickness of 1 mm to 5 mm.

4. The wearable flexible ultrasonic urethral scar therapeutic device according to claim 1 is characterized in that: The center frequency of the piezoelectric ceramic or single crystal silicon is 0.4 MHz-4 MHz.

5. The wearable flexible ultrasonic urethral scar therapeutic device according to any one of claims 1 or 2, characterized in that: Electrodes are arranged on the surface of the wafer, and the electrodes are used to collect signal lines of the wafer.

6. The wearable flexible ultrasonic urethral scar therapeutic device according to claim 1, characterized in that: A signal line interface is provided on the side of the patch-type flexible ultrasonic probe, and the control end is connected to the signal line interface through wired transmission to control the patch-type flexible ultrasonic probe.

7. The wearable flexible ultrasonic urethral scar therapeutic device according to any one of claims 1, 2, 4 or 6, characterized in that: The power of the ultrasonic wave generated by the patch-type flexible ultrasonic probe is 30mW / cm 2 -1.5W / cm 2 , the frequency is 1MHz-3MHz.

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