Testicular prosthesis after surgical castration of prostate cancer and use thereof

Abstract

The application discloses a testis prosthesis after castration for prostate cancer surgery and application thereof, and relates to the technical field of medical devices, which comprises: a silicon gel support body in an ellipsoidal shape; a silicone rubber adjusting capsule coaxially wrapped outside the silicon gel support body and made of medical-grade silicone rubber doped with fumed silica nanoparticles; and an interface isolation layer containing a polytetrafluoroethylene or cross-linked silicone oil coating and an annular buffer ridge, so that the silicone rubber adjusting capsule and the silicon gel support body are kept in a separated state when the closed chamber is not filled with liquid, mechanical decoupling of the shell and the core is realized, and constant touch is ensured during the process of transcutaneous puncture volume adjustment; meanwhile, a local thinning area is arranged on the outer surface of the silicone rubber adjusting capsule as a puncture positioning mark, and a pure structure design without valves or catheters is adopted, so that safe and convenient valve-free transcutaneous puncture volume adjustment is realized, and the complication risk caused by the traditional valve structure is avoided.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a testicular prosthesis after castration in prostate cancer surgery and its application. Background Technology

[0002] Medical device technology refers to a class of interdisciplinary technologies in engineering and biomedicine applied in the medical field for the prevention, diagnosis, treatment, monitoring, relief or functional compensation of diseases, as well as for the replacement, adjustment or support of anatomical structures. It covers everything from simple medical consumables to complex implants, in vitro diagnostic equipment and high-end imaging systems. Its core objective is to improve patients’ health, enhance the quality of medical care and assist clinical decision-making through safe, effective and reliable physical, mechanical, electronic or material means. All products must comply with strict regulatory and biocompatibility standards.

[0003] Traditional testicular prostheses have a fixed volume after implantation. For pediatric patients, as they enter puberty and adulthood, their physical development can cause the original prosthesis to become too small, severely affecting the appearance symmetry and the patient's mental health. This often necessitates replacement through secondary or even multiple surgeries, causing repeated trauma, infection risks, financial burden, and psychological stress. Furthermore, while existing single-chamber saline prostheses have safe contents, they lack core support, resulting in a rigid texture and unnatural feel. On the other hand, although silicone gel prostheses feel realistic, if they rupture, the silicone gel may leak, leading to biocompatibility risks such as granulomas.

[0004] Furthermore, although adjustable-volume prostheses have been developed in the existing technology, they generally suffer from the following technical defects: Firstly, many prostheses use built-in valves or conduits to achieve volume adjustment. This type of structure not only increases the mechanical complexity and failure rate of the prosthesis, but also makes it prone to adjustment failure or chronic inflammation due to valve wear, conduit blockage or foreign body reaction.

[0005] Secondly, the lack of an effective mechanical isolation mechanism between the outer shell and the contents causes the outer shell and the inner core to deform synchronously and stick together during the filling process, resulting in significant fluctuations in the feel as the volume changes, making it impossible to maintain a constant softness consistent with natural testicles.

[0006] Third, the lack of precise puncture guidance and safety protection design means that percutaneous adjustment relies on the surgeon's experience and blind puncture, which can easily cause unexpected damage to the cyst wall, leakage of contents, or loss of control over puncture depth. The risk is especially increased in pediatric patients with repeated adjustments. Fourth, the lack of integrated imaging function makes it difficult to confirm the internal structural state and filling degree through non-invasive imaging during postoperative follow-up and adjustment operations, which limits the accuracy and safety of clinical application.

[0007] Therefore, there is an urgent need to develop an adjustable testicular prosthesis that does not require a valve catheter, has a constant tactile feel, is safe to insert, and has image guidance capabilities, in order to solve the above-mentioned technical problems. Summary of the Invention

[0008] In view of the aforementioned existing problems, the present invention is proposed.

[0009] Therefore, this invention provides a testicular prosthesis for castration after prostate cancer surgery, which solves the problems of existing single-chamber saline prostheses, which, although safe in contents, lack core support, are rigid in texture, and have an unnatural feel; while silicone gel prostheses, although realistic in feel, may leak silicone gel and cause biocompatibility risks such as granulomas if they rupture.

[0010] To solve the above-mentioned technical problems, the present invention provides the following technical solution: In a first aspect, the present invention provides a testicular prosthesis for castration following prostate cancer surgery, comprising: The prosthesis comprises an ellipsoidal silicone gel support; a silicone rubber adjustment capsule coaxially wrapped around the silicone gel support and made of medical-grade silicone rubber doped with fumed silica nanoparticles; an interface isolation layer disposed between the outer surface of the silicone gel support and the inner surface of the silicone rubber adjustment capsule, the interface isolation layer comprising at least one of a polytetrafluoroethylene coating or a cross-linked silicone oil coating, and an annular buffer ridge extending circumferentially along the inner wall of the silicone rubber adjustment capsule; wherein, the gap between the silicone rubber adjustment capsule and the silicone gel support forms a closed chamber, the outer surface of the silicone rubber adjustment capsule is provided with a locally thinned area as a puncture positioning mark, and the prosthesis does not contain a fluid control valve or catheter.

[0011] As a preferred embodiment of the testicular prosthesis after castration in prostate cancer surgery according to the present invention, wherein: there is a preset gap between the top of the annular buffer ridge and the outer surface of the silicone gel support, and the size of the preset gap is such that the silicone rubber adjustment bladder and the silicone gel support remain separated when the closed chamber is not filled with fluid.

[0012] As a preferred embodiment of the testicular prosthesis after castration in prostate cancer surgery according to the present invention, wherein: the wall thickness of the locally thinned area is less than the wall thickness of other areas of the silicone rubber adjustment capsule, and the mass fraction of fumed silica nanoparticles in the locally thinned area is higher than the mass fraction of fumed silica nanoparticles in other areas of the silicone rubber adjustment capsule.

[0013] As a preferred embodiment of the testicular prosthesis after castration in prostate cancer surgery according to the present invention, wherein: the interior of the silicone gel support is embedded with ultrasound imaging markers, the ultrasound imaging markers are distributed along the central axis and equatorial plane of the silicone gel support, and the surface of the ultrasound imaging markers is coated with a bio-inert polymer layer.

[0014] In a second aspect, the present invention provides the use of the testicular prosthesis after castration for prostate cancer as described in the first aspect in the preparation of an adjustable prosthesis product for castrated prostate cancer patients.

[0015] As a preferred embodiment of the application described in this invention, the application utilizes the independent deformation characteristics of the silicone rubber adjustment capsule and the silicone gel support achieved by the interface isolation layer, so that the prosthesis maintains a constant tactile sensation during percutaneous puncture and volume adjustment.

[0016] In a preferred embodiment of the application described in this invention, the application utilizes the coordination between the local thinning area and the puncture positioning mark to achieve valveless percutaneous puncture volume adjustment.

[0017] As a preferred embodiment of the application described in this invention, the application is suitable for the growth and development adaptation of pediatric patients undergoing prostate cancer surgery, and the volume of the closed cavity is adjusted through multiple percutaneous punctures so that the size of the prosthesis changes synchronously with the patient's development.

[0018] In a preferred embodiment of the application described in this invention, the puncture resistance of the silicone rubber adjustment bladder in the application is provided by the doping of the fumed silica nanoparticles and the structure of the locally thinned region, enabling the prosthesis to withstand repeated percutaneous punctures without structural leakage.

[0019] In a preferred embodiment of the application described in this invention, the ultrasound imaging marker is used to define the boundary of the silicone gel support under ultrasound imaging to confirm the filling state of the closed cavity and the safe puncture depth.

[0020] The beneficial effects of this invention are as follows: By setting an interface isolation layer containing a polytetrafluoroethylene or cross-linked silicone oil coating and an annular buffer ridge, the silicone rubber adjustment bladder and the silicone gel support remain separated when the closed chamber is not filled with fluid, thus achieving mechanical decoupling between the outer shell and the inner core and ensuring a constant tactile sensation during percutaneous puncture volume adjustment. At the same time, by setting a local thinning area on the outer surface of the silicone rubber adjustment bladder as a puncture positioning mark and combining it with a pure structural design without valves or catheters, safe and convenient valveless percutaneous puncture volume adjustment is achieved, avoiding the complication risks of traditional valve structures. Combined with medical-grade silicone rubber material doped with fumed silica nanoparticles and ultrasound imaging markers, the prosthesis's resistance to repeated punctures is improved to prevent structural leakage, and the support boundary is easily defined under ultrasound imaging to confirm the filling state and safe puncture depth. Detailed Implementation

[0021] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below.

[0022] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0023] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in different places in this specification does not necessarily refer to the same embodiment, nor is it a single or selective embodiment that is mutually exclusive with other embodiments.

[0024] Example 1, the first embodiment of the present invention, provides a testicular prosthesis for castration after prostate cancer surgery with a basic interface isolation structure, comprising: The prosthesis comprises an ellipsoidal silicone gel support and a silicone rubber adjustment capsule coaxially wrapped around the silicone gel support, made of medical-grade silicone rubber doped with fumed silica nanoparticles. An interfacial isolation layer is disposed between the outer surface of the silicone gel support and the inner surface of the silicone rubber adjustment capsule. The interfacial isolation layer includes a polytetrafluoroethylene coating and an annular buffer ridge extending circumferentially along the inner wall of the silicone rubber adjustment capsule. The gap between the silicone rubber adjustment capsule and the silicone gel support forms a closed chamber. The outer surface of the silicone rubber adjustment capsule has a locally thinned area as a puncture positioning mark. The prosthesis does not contain fluid control valves or catheters. There is a preset gap between the top of the annular buffer ridge and the outer surface of the silicone gel support. The size of the preset gap ensures that the silicone rubber adjustment capsule and the silicone gel support remain separated when the closed chamber is not filled with fluid.

[0025] This embodiment constructs a basic mechanical decoupling structure by combining a polytetrafluoroethylene coating with an annular buffer ridge, verifying the core role of the interface isolation layer in maintaining constant tactile sensation and providing a benchmark reference for subsequent optimization schemes.

[0026] Example 2, a second embodiment of the present invention, provides a testicular prosthesis for castration after prostate cancer surgery that combines enhanced puncture resistance and precise positioning, comprising: The prosthesis comprises an ellipsoidal silicone gel support and a silicone rubber adjustment capsule coaxially wrapped around the silicone gel support, made of medical-grade silicone rubber doped with fumed silica nanoparticles. An interfacial isolation layer is positioned between the outer surface of the silicone gel support and the inner surface of the silicone rubber adjustment capsule. This layer includes a cross-linked silicone oil coating and an annular buffer ridge extending circumferentially along the inner wall of the silicone rubber adjustment capsule. The gap between the silicone rubber adjustment capsule and the silicone gel support forms a closed chamber. The outer surface of the silicone rubber adjustment capsule has a locally thinned area as a puncture positioning marker. The prosthesis does not contain fluid control valves or catheters. The wall thickness of the locally thinned area is less than that of other areas of the silicone rubber adjustment capsule, and the mass fraction of fumed silica nanoparticles in the locally thinned area is higher than that in other areas of the silicone rubber adjustment capsule. A predetermined gap exists between the top of the annular buffer ridge and the outer surface of the silicone gel support. The size of this predetermined gap ensures that the silicone rubber adjustment capsule and the silicone gel support remain separated when the closed chamber is not filled with fluid.

[0027] Based on Example 1, this embodiment enhances the safety and reliability of valveless puncture by designing differentiated wall thickness and nanoparticle concentration in the local thinning zone. At the same time, a cross-linked silicone oil coating is used instead of a polytetrafluoroethylene coating to verify the equivalence of different isolation materials in terms of mechanical decoupling effect.

[0028] Example 3, the third embodiment of the present invention, provides a testicular prosthesis for castration after prostate cancer surgery that integrates ultrasound imaging and growth and development adaptation functions, comprising: The prosthesis consists of an ellipsoidal silicone gel support and a silicone rubber adjustment capsule coaxially wrapped around the silicone gel support, made of medical-grade silicone rubber doped with fumed silica nanoparticles. An interfacial isolation layer is positioned between the outer surface of the silicone gel support and the inner surface of the silicone rubber adjustment capsule. This layer comprises a composite layer of polytetrafluoroethylene coating and cross-linked silicone oil coating, as well as an annular buffer ridge extending circumferentially along the inner wall of the silicone rubber adjustment capsule. The gap between the silicone rubber adjustment capsule and the silicone gel support forms a closed chamber. The outer surface of the silicone rubber adjustment capsule has a locally thinned area as a puncture positioning marker. The prosthesis does not contain any fluid control valves or guides. The silicone gel support has embedded ultrasonic markers that are distributed along the central axis and equatorial plane of the silicone gel support. The surface of the ultrasonic markers is coated with a bio-inert polymer layer. The wall thickness of the local thinning area is less than that of other areas of the silicone rubber regulating bladder, and the mass fraction of fumed silica nanoparticles in the local thinning area is higher than that in other areas of the silicone rubber regulating bladder. There is a preset gap between the top of the annular buffer ridge and the outer surface of the silicone gel support. The size of the preset gap keeps the silicone rubber regulating bladder and the silicone gel support separated when the closed chamber is not filled with liquid.

[0029] This embodiment integrates all preferred technical features. Through the synergistic effect of composite interface isolation layer, differentiated local thinning area and ultrasound imaging marker, it fully realizes the comprehensive technical effects of constant touch, safe puncture, image guidance and growth and development adaptation, which is especially suitable for long-term follow-up and multiple volume adjustment scenarios for pediatric patients.

[0030] Comparative Example 1 This comparative example provides a testicular prosthesis after castration in prostate cancer surgery. The only difference between this prosthesis and Example 1 is that no interface isolation layer is provided. That is, the inner surface of the silicone rubber adjustment bladder is directly in contact with the outer surface of the silicone gel support. There is no polytetrafluoroethylene coating or cross-linked silicone oil coating, nor is there an annular buffer ridge. The rest of the structure (silicone gel support, silicone rubber adjustment bladder, local thinning area, valve-free design) is the same as that of Example 1.

[0031] This comparative example is used to prove: Without an interface isolation layer, the silicone rubber regulating bladder and the silicone gel support adhere and deform synchronously during the liquid filling process, causing the tactile sensation to change with volume changes. This makes it impossible to achieve the technical effect of mechanical decoupling and constant tactile sensation, thus highlighting the necessity of an interface isolation layer in solving the core technical problem of this invention.

[0032] Comparative Example 2 This comparative example provides a testicular prosthesis after castration in prostate cancer surgery. The only difference between this example and Example 2 is that the outer surface of the silicone rubber adjustment bladder does not have a local thinning area, the entire adjustment bladder wall is of uniform thickness, and there are no puncture positioning marks. The remaining structures (interface isolation layer, annular buffer ridge, fumed silica nanoparticle doping, valve-free design) are the same as in Example 2.

[0033] This comparative example is used to prove: Without a local thinning zone and puncture positioning markers, percutaneous puncture lacks clear guidance and safety weak points, resulting in high puncture resistance, difficulty in positioning, and easy to cause unexpected damage to the adjustment capsule or puncture failure. This makes it impossible to achieve safe and accurate valveless volume adjustment, thus verifying the key contribution of the local thinning zone to the safety and convenience of puncture.

[0034] Comparative Example 3 This comparative example provides a testicular prosthesis after castration in prostate cancer surgery. The only difference between this example and Example 3 is that the silicone gel support does not have an embedded ultrasound imaging marker; the rest of the structure (composite interface isolation layer, differentiated local thinning area, annular buffer ridge, valve-free design) is the same as Example 3.

[0035] This comparative example is used to prove: Without ultrasound-guided markers, the boundaries of the silicone gel support cannot be clearly defined under ultrasound imaging, making it difficult to accurately determine the filling status of the closed cavity and the safe depth of puncture. Especially in pediatric patients, during multiple adjustments, it is easy to cause puncture to be too deep or insufficient filling, affecting the safety and effectiveness of clinical application. This confirms the indispensability of ultrasound-guided markers for image guidance and clinical adaptation.

[0036] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A testicular prosthesis for prostate cancer patients after castration, characterized in that, include: The silica gel support is ellipsoidal in shape. The silicone rubber adjustment capsule, coaxially wrapped around the outside of the silicone gel support, is made of medical-grade silicone rubber doped with fumed silica nanoparticles. An interface isolation layer is disposed between the outer surface of the silicone gel support and the inner surface of the silicone rubber regulating bladder. The interface isolation layer includes at least one of a polytetrafluoroethylene coating or a cross-linked silicone oil coating, and an annular buffer ridge extending circumferentially along the inner wall of the silicone rubber regulating bladder. The gap between the silicone rubber adjustment bladder and the silicone gel support forms a closed chamber. The outer surface of the silicone rubber adjustment bladder is provided with a local thinning area as a puncture positioning mark. The prosthesis does not contain a fluid control valve or catheter.

2. The testicular prosthesis after castration in prostate cancer surgery according to claim 1, characterized in that, There is a preset gap between the top of the annular buffer ridge and the outer surface of the silicone gel support. The size of the preset gap is such that the silicone rubber adjustment bladder and the silicone gel support remain separated when the closed chamber is not filled with liquid.

3. The testicular prosthesis after castration for prostate cancer surgery according to claim 1, characterized in that, The wall thickness of the locally thinned region is less than the wall thickness of other regions of the silicone rubber regulating bladder, and the mass fraction of fumed silica nanoparticles in the locally thinned region is higher than the mass fraction of fumed silica nanoparticles in other regions of the silicone rubber regulating bladder.

4. The testicular prosthesis after castration for prostate cancer surgery according to claim 1, characterized in that, The silicone gel support is embedded with ultrasonic imaging markers, which are distributed along the central axis and equatorial plane of the silicone gel support, and the surface of the ultrasonic imaging markers is covered with a bio-inert polymer layer.

5. The use of the testicular prosthesis after castration for prostate cancer surgery according to any one of claims 1-4 in the preparation of an adjustable prosthesis product for castrated prostate cancer patients.

6. The application according to claim 5, characterized in that, The application utilizes the independent deformation characteristics of the silicone rubber adjustment capsule and the silicone gel support through the interface isolation layer, so that the prosthesis maintains a constant tactile feel during percutaneous puncture and volume adjustment.

7. The application according to claim 5, characterized in that, The application utilizes the combination of the local thinning area and the puncture positioning mark to achieve valveless percutaneous puncture volume adjustment.

8. The application according to claim 5, characterized in that, The application is suitable for the growth and development adaptation of pediatric patients undergoing prostate cancer surgery. By adjusting the volume of the closed cavity through multiple percutaneous punctures, the size of the prosthesis changes synchronously with the patient's development.

9. The application according to claim 5, characterized in that, The puncture resistance of the silicone rubber adjustment capsule in the application is provided by the doping of the fumed silica nanoparticles and the structure of the locally thinned region, enabling the prosthesis to withstand repeated percutaneous punctures without structural leakage.

10. The application according to claim 5, characterized in that, In this application, the ultrasound imaging marker is used to define the boundary of the silicone gel support under ultrasound imaging to confirm the filling state of the closed cavity and the safe depth of puncture.