Wearable penile cancer individualized tissue compensation device

Abstract

The invention discloses a wearable penile cancer individualized tissue compensation device which comprises a wearable frame, a tissue compensation assembly, a testis protective cover and an intelligent monitoring assembly. The wearing frame is connected with a fixing belt with a holding hole through a magic tape waistband; a liquid injection cavity is formed in a tubular flexible bag body of the tissue compensation assembly and is used for simulating a human tissue electron density elimination dose build-up effect; the testis protective cover is detachably installed on the inner side of the fixing band. An epoxy resin capsule of the intelligent monitoring assembly is integrated with a sensor and a wireless module. According to the device, the penis surface dose reaches nearly 100%, the displacement error of a target region is smaller than 3 mm, the dose uniformity is remarkably improved, and the testis stress is reduced to 4.8 goals; when the pressure and the temperature exceed the limit, the pressure is automatically relieved and an alarm is given, the flexible bag body adapts to the size of an individual, radiotherapy accuracy, radiation protection efficiency and wearing convenience are achieved, and the clinical problems of organ displacement, non-uniform dose and testis protection are solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical supplies, in particular to a wearable penile cancer individualized tissue compensation device. BACKGROUND

[0002] In the radiotherapy of penile cancer, it is necessary to accurately fix the target area while protecting the surrounding sensitive tissues such as testicles and urethra. The existing fixing method mainly fixes the penis through a self-made foam module, but this fixing method has the following defects: first, the positioning accuracy is insufficient, because the penis has a large activity, during erection or breathing movement, the penis will produce a target area displacement error of 5-10mm relative to the self-made fixing device; second, the dose distribution is uneven, the dose build-up effect of high-energy X-rays (such as 6MV) makes the skin surface dose only 10%-40% of the prescribed dose, and the target area dose homogeneity index (HI) is as low as 0.565 due to the poor adhesion of the traditional plane compensation film (the dose attenuates to 90% when the air gap is >5mm); third, the testicle protection is weak, the existing technology cannot effectively isolate the testicles from the high-dose area, and the dose received by the testicles often reaches 35Gy, which seriously affects the preservation of reproductive function (the preservation rate is <50%).

[0003] At present, there is no integrated wearable device that integrates fixing, dose compensation and intelligent monitoring. Especially lacking dynamic compensation design for irregular surface of penis, and real-time pressure feedback mechanism, resulting in low patient comfort, poor repeat treatment adaptability, and inconvenient to use. SUMMARY

[0004] The technical problem to be solved by the present application is to provide a wearable penile cancer individualized tissue compensation device, which can be individually adjusted, accurately shield sensitive tissues and optimize dose distribution, and can solve the problem of inconvenient use in the past.

[0005] In order to solve the above technical problems, the present application discloses a wearable penile cancer individualized tissue compensation device, which comprises a wearable frame, a fixed belt and an adjustable annular waistband, the outer surface of the annular waistband is provided with a rough surface layer, the two ends of the fixed belt are fixedly installed with a hook surface magic tape, and a holding hole is formed in the middle of the fixed belt; a tissue compensation assembly, which comprises a flexible capsule arranged in a tubular shape, an internal cavity is formed in the flexible capsule, and a liquid injection port and a pressure relief port in communication with the internal cavity are further arranged on the outer side of the flexible capsule; a testicle protection cover, which is detachably installed on the inner side of the fixed belt, and the testicle protection cover is located below the holding hole; an intelligent monitoring assembly, which comprises an epoxy resin capsule, and the epoxy resin capsule is integrated with a pressure sensor, a magnetic control switch, a temperature sensor, a Bluetooth module, a micro button cell and a wireless charging module.

[0006] The annular waistband comprises a cloth belt, a male buckle and a female buckle, one end of the cloth belt is wound and fixed on the male buckle, and the other end is wound and fixed on the female buckle; in use, the male buckle and the female buckle are inserted and fixed.

[0007] The hole wall of the holding hole extends outward to form a holding portion, and the holding portion is an annular thin-walled structure with elasticity.

[0008] The hole diameter of the holding portion gradually decreases from the inside to the outside.

[0009] The flexible capsule is made of latex material.

[0010] The liquid injection port and the pressure relief port are both fixedly installed with a one-way valve.

[0011] The inner side wall of the flexible capsule is formed with anti-skid lines.

[0012] The testicular protective cover is made of lead-boron polyethylene composite material, and is lined with a layer of medical silica gel.

[0013] The plastic sheath is provided with an accommodating hole arranged in the axial direction, and the outer circumferential side of the plastic sheath is provided with a lateral opening communicated with the accommodating hole, and the flexible capsule is placed into the accommodating hole through the lateral opening.

[0014] The intelligent monitoring assembly further comprises a circuit board located in the epoxy resin capsule, the circuit board is welded with a controller, and the pressure sensor, the magnetic control switch, the temperature sensor, the Bluetooth module, the micro button cell and the wireless charging module are all welded on the circuit board, and the pressure sensor, the magnetic control switch, the temperature sensor, the Bluetooth module, the micro button cell and the wireless charging module are all electrically connected with the controller.

[0015] Compared with the prior art, the embodiments of the present application have the following beneficial effects: (1) By arranging the flexible capsule, the tissue compensation assembly simulates the human tissue electron density (1.00-1.01) through the cavity, eliminates the high-energy X-ray dose build-up effect, increases the surface dose of the penis from 10%-40% of the traditional method to nearly 100%, and ensures accurate coverage of the target area (≥60Gy).

[0016] (2) In combination with the upright fixation of the holding hole to the penis, the organ displacement error is reduced to <3mm, and the dose uniformity is significantly improved.

[0017] (3) The annular waistband and the fixing belt are quickly connected through the magic tape to form a stable fixing structure of "waist-penis", avoiding the displacement risk of the traditional split device.

[0018] (4) The testicular protective cover is detachably installed in the inner side of the fixing belt, directly covers the testicular projection area, the shielding efficiency of the lead-boron polyethylene composite material (lead equivalent is greater than or equal to 0.5mmPb) is 99%, the testicular dose is reduced from 35Gy to less than 5Gy, and the fertility function retention rate is increased to 78%.

[0019] (5) The epoxy resin capsule integrates an intelligent monitoring component, the pressure sensor is used for real-time feedback of the pressure in the capsule, the pressure relief port is automatically triggered to prevent overpressure damage, the temperature sensor is used for monitoring the contact surface temperature to avoid tissue scalding caused by long-time compression (alarm when the temperature is greater than 40 DEG C), the Bluetooth module is used for wireless data transmission to realize closed-loop monitoring during the whole treatment, reduce the restriction of cable winding on the activity of the patient, and realize individualized adaptation and convenient operation; the magnetic control switch realizes contactless start and stop of the system, the wireless charging module prolongs the endurance to more than 200 hours to meet the repeated treatment requirements.

[0020] (6) The elastic characteristics of the flexible capsule (latex material) are adapted to different penis sizes, the cavity volume is adjustable, and 10%-15% expansion space is reserved to be compatible with edema changes in radiotherapy. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0022] Figure 1 is a structure schematic diagram of the wearing frame in the embodiment; Figure 2 is a structure schematic diagram of the flexible capsule in the embodiment. DETAILED DESCRIPTION

[0023] In order to make the person skilled in the art better understand the present application, the following will combine the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the present application.

[0024] The terms "first", "second", and the like in the description and in the claims of the present application and above-described drawings are used to distinguish different objects, rather than to describe a particular sequential order. Moreover, the terms "comprises", "comprising", and the like are intended to encompass not only the listed steps or units, but also additional steps or units not listed, or optional steps or units, that are inherent in the processes, methods, devices, products, or servers.

[0025] Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive of one another. As will be apparent to one of skill in the art, embodiments described herein can be combinable with other embodiments.

[0026] The present application discloses a specific embodiment of a wearable penile cancer individualized tissue compensation device, please see Figure 1 and Figure 2 The wearable penile cancer individualized tissue compensation device comprises a wearable frame, a tissue compensation assembly, a testis protection cover, and an intelligent monitoring assembly.

[0027] In the present embodiment, the wearable frame comprises a ring-shaped waistband 1 and a fixing belt 2. The length of the ring-shaped waistband 1 can be adjusted. Specifically, the ring-shaped waistband 1 comprises a cloth belt, a male buckle, and a female buckle. One end of the cloth belt is wound and fixed to the male buckle, and the other end is wound and fixed to the female buckle. The stepless adjustment of the waist circumference is realized by the male-female buckle pair. The device is suitable for different body types with a waist circumference of 80 to 130 cm. This design avoids the fabric fatigue caused by repeated tearing of the magic tape, and the service life is improved by 3 times.

[0028] In order to facilitate the connection and fixation of the fixing belt 2 and the ring-shaped waistband 1, a rough surface layer 11 is sewn on the outer surface of the ring-shaped waistband 1, and a hook surface magic tape 21 is sewn at both ends of the fixing belt 2, which is bonded and positioned with the rough surface layer 11 on the outer surface of the waistband, realizing quick disassembly. A holding hole 3 is formed in the middle of the fixing belt 2. The hole wall of the holding hole 3 extends outwardly to form a holding portion 31. The holding portion 31 is a ring-shaped thin-walled structure with elasticity. The thin-walled structure deforms radially by ±15% with the penile edema, providing dynamic cushioning to prevent pressure necrosis. The hole diameter of the holding portion 31 gradually changes from 32 mm on the inner side to 38 mm on the outer side, forming a self-locking effect so that the displacement of the penis during treatment is less than 1 mm. The ring-shaped waistband 1 and the fixing belt 2 are quickly connected by the magic tape, forming a "waist-penis" stable fixation structure, avoiding the displacement risk of traditional split devices.

[0029] As an improvement, in combination with Figure 2The tissue compensation assembly comprises a plastic sheath 5 (not shown) and a flexible capsule 4. The plastic sheath 5 is provided with an axial accommodating hole and a lateral opening. The plastic sheath 5 can be made of polycarbonate material, which can provide a bending stiffness of 8.5 N / mm, effectively play a supporting role, better fix the penis, and reduce the organ displacement error to <3 mm in combination with the upright fixation of the holding hole 3 of the penis, thereby significantly improving the dose uniformity.

[0030] In the embodiment, the flexible capsule 4 is made of latex material and has a tubular structure. The flexible capsule 4 is placed into the accommodating hole through the lateral opening. In addition, the inner side wall of the flexible capsule 4 is pressed to form an anti-skid pattern with a depth of 0.3 mm, and the friction coefficient reaches 0.8 to prevent slipping. The compensation material in the flexible capsule 4 has good fluidity and adhesion to the irregular surface of the penis, which can well drive the inner side of the flexible capsule 4 to adhere to the complex curved surface of the outer surface of the penis, accurately match the body surface curvature, eliminate air gaps, and avoid dose attenuation caused by air gaps (when the air gap is >5 mm, the surface dose decreases to 90%). The flexible capsule 4 can adjust the adhesion with the body position, dynamically adjust the space, and reserve the swelling space (such as penis irradiation), thereby reducing the secondary adjustment demand caused by swelling or tumor shrinkage.

[0031] The supplementary device of the embodiment eliminates the high-energy X-ray dose build-up effect by simulating the electron density of human tissue (1.00-1.01) through the flexible capsule 4, and the tissue compensation assembly, so that the surface dose of the penis is increased from 10%-40% in the traditional method to nearly 100%, and the target area (≥60 Gy) is accurately covered. The elastic property of the flexible capsule 4 (latex material) is suitable for different penis sizes, the cavity volume is adjustable, and 10%-15% swelling space is reserved to adapt to the edema changes in radiotherapy.

[0032] It should be noted that the plastic sheath 5 can pass through the holding hole 3 of the fixing belt 2, and the holding part 31 holds and fixes the plastic sheath 5, which can play a supporting and stabilizing role.

[0033] In the embodiment, a cavity is formed in the inside of the flexible capsule 4, and the cavity can be filled with air or liquid. Therefore, the cavity can also be called a liquid injection cavity. The outside of the flexible capsule 4 is provided with a liquid injection port 41 and a pressure relief port 42 which are in communication with the cavity. The cavity is connected with an external pipeline through the liquid injection port 41 and the pressure relief port 42. Unidirectional valves 43 are installed at both ports to ensure that the pressure fluctuation is less than ±0.5 kPa. After physiological saline is injected into the liquid injection cavity, the flexible capsule 4 expands, simulates the electron density of human tissue 1.00, and completely eliminates the high-energy X-ray dose build-up effect.

[0034] In this embodiment, the testicular shield (not shown) is detachably mounted on the inner side of the fixing belt 2 by buckling and is located directly below the holding hole 3. The shield body is made of lead-boron polyethylene composite material with a shielding efficiency of 99.2%. The inner lining (inner side of the testicular shield) is provided with a 2mm-thick medical silica gel layer to reduce the skin contact pressure to below 5kPa, and the testicular dose is reduced from the traditional 35Gy to 4.8Gy, thereby improving the wearing comfort of the patient. In addition, the testicular shield can reduce the pressure on the groin skin through an arc-shaped design. The testicular shield is detachably mounted on the inner side of the fixing belt 2 to directly cover the testicular projection area. The lead-boron polyethylene composite material (lead equivalent ≥0.5mmPb) has a shielding efficiency of 99%, and the testicular dose is reduced from 35Gy to <5Gy, and the fertility preservation rate is increased to 78%.

[0035] The epoxy resin capsule of the intelligent monitoring assembly is embedded in the wall of the flexible capsule 4. The internal circuit board is vacuum filled with a nano waterproof coating. The controller, pressure sensor, temperature sensor, magnetic control switch, Bluetooth module, micro button cell and wireless charging coil are all welded on the circuit board, and the controller is in electrical communication connection with each module. The magnetic control switch activates the system after being activated by an external magnet. When the pressure exceeds 15kPa or the temperature exceeds 40℃, the controller triggers the pressure relief valve to drain and sends a Bluetooth alarm, realizing closed-loop safety control. The waterproof level of the capsule is IP68, and it can be soaked in a 500ppm sodium hypochlorite solution for disinfection.

[0036] The working process of the compensation device of the present embodiment is as follows: the patient wears the device in a supine position, and the waist belt male-female buckle is locked at the waist. The plastic sheath 5 and the flexible capsule 4 are sleeved on the outside of the penis and pass through the holding hole 3. The holding part 31 of the holding hole 3 holds and fixes the plastic sheath 5. The cavity is filled with physiological saline to a pressure of 12kPa, and the capsule is inflated tightly against the curved surface of the penis. The shield covers the testicular area, and the magnetic control switch starts the monitoring system. During intensity modulated radiotherapy (60Gy), CT scanning shows that the target displacement error is only 2.3mm, and the dose uniformity index HI is 0.812; the real-time monitoring pressure fluctuation range is 11.8-12.3kPa, and the temperature is stable at 36.5℃, without triggering the pressure relief. After treatment, the shield is disassembled, the capsule liquid preparation is emptied, and ethanol is wiped. The epoxy resin capsule is reused after wireless charging for 2 hours.

[0037] The compensation device of the embodiment reduces organ displacement, improves target area coverage precision, and dose compensation is more accurate, and has the characteristics of accurate positioning, through the adjustable structure and the filling design. The elastic material fits the body shape, can be fixed for a long time, effectively improves the comfort, the device can be disassembled and reused, is suitable for multiple treatments. Multifunctionality, suitable for patients at different stages, especially for the treatment plan of preserving the function of the penis in the early stage of penile cancer. Individualized adaptation, without the need to customize the filling parameters according to the size of the patient's penis and the location of the tumor. The penile cancer fixation technology solves the problems of organ movement and inaccurate positioning in traditional radiotherapy by adjusting the combination with biocompatible materials, and provides an important guarantee for precise treatment. In the future, it may further integrate image-guided technology (such as CT / MRI) and intelligent materials to improve real-time adaptability.

[0038] Finally, it should be noted that: the separation guide mechanism with the slotless glue roller 11 disclosed by the embodiment of the application is only the preferred embodiment of the application, and is used to illustrate the technical solutions of the application, but not to limit it; although the application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that; it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement for part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the application.

Claims

1. A wearable penile cancer individualized tissue compensation device, characterized by, The utility model relates to a wearable framework, tissue compensation component, testicular protective cover and intelligent monitoring component, which are used for preventing the testicular injury of the user. The wearable framework comprises a fixing belt and an adjustable annular waistband, the outer surface of the annular waistband is provided with a rough surface layer, the two ends of the fixing belt are fixedly provided with hook-faced magic tapes, and a holding hole is formed in the middle part of the fixing belt. The tissue compensation component comprises a flexible capsule arranged in a tubular shape, a cavity is formed in the inside of the flexible capsule, and a liquid injection port and a pressure relief port are provided on the outside of the flexible capsule and communicated with the cavity. The testicular protective cover is detachably mounted on the inside of the fixing belt and located below the holding hole. The intelligent monitoring component comprises an epoxy resin capsule integrated with a pressure sensor, a magnetic control switch, a temperature sensor, a Bluetooth module, a micro button cell and a wireless charging module.

2. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The annular waistband comprises a cloth belt, a male buckle and a female buckle, one end of the cloth belt is wound and fixed on the male buckle, and the other end is wound and fixed on the female buckle. During use, the male buckle and the female buckle are fixed by insertion.

3. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The hole wall of the holding hole extends outwardly to form a holding part in the form of an annular thin-walled structure with elasticity.

4. The wearable penile cancer individualized tissue compensation device according to claim 3, wherein, The hole diameter of the holding part gradually decreases from the inside to the outside.

5. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The flexible capsule is made of latex material.

6. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The liquid injection port and the pressure relief port are fixedly provided with one-way valves.

7. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The inside wall of the flexible capsule is provided with anti-skid lines.

8. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The testicular protective cover is made of lead-boron polyethylene composite material and lined with a layer of medical silica gel.

9. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The plastic sheath is provided with an accommodating hole arranged in the axial direction, the outer circumferential side of the plastic sheath is provided with a lateral opening communicated with the accommodating hole, and the flexible capsule is placed into the accommodating hole through the lateral opening.

10. The wearable penile cancer individualized tissue compensation device according to claim 1, wherein, The intelligent monitoring component further comprises a circuit board located in the epoxy resin capsule, the circuit board is welded with a controller, the pressure sensor, the magnetic control switch, the temperature sensor, the Bluetooth module, the micro button cell and the wireless charging module are welded on the circuit board, and the pressure sensor, the magnetic control switch, the temperature sensor, the Bluetooth module, the micro button cell and the wireless charging module are electrically connected with the controller.

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