Anti-fatigue and anti-calcification penis prosthesis system based on gradient microstructure and dynamic temperature control and precise implantation method of anti-fatigue and anti-calcification penis prosthesis system

Abstract

The invention relates to an anti-fatigue and anti-calcification penis prosthesis system and an implantation method. Through the special structural design, the prosthesis system can be triggered by warm saline water in an operation, rapidly expands and completely discharges a medium under the constraint of the pressure of the sleeve and the warm saline water on the appearance, and automatically locks the form through the body temperature after the operation. An anti-infection structure is arranged on the surface of the prosthesis, slow-release antibacterial components are integrated in the prosthesis, and the core contradiction between tissue anchoring and anti-infection and between soft touch and reliable locking is effectively solved. And in cooperation with an intelligent navigation system, precise individualized matching of the prosthesis and the anatomical structure of the patient can be achieved, and the operation success rate and the patient satisfaction degree are remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of implantable urogenital medical devices, and particularly relates to an anti-fatigue and anti-calcification penile prosthesis system based on gradient microstructure and dynamic temperature control and a precise implantation method thereof, and more particularly to a prosthesis structure with a spatial orthogonal functional network realized through various advanced manufacturing processes. The present application also relates to an intraoperative precise fitting method and a long-term fibrous envelope regulation strategy of the prosthesis system, which is suitable for various inflatable penile prosthesis systems. The system comprises a penile prosthesis cylinder with a gradient microprojection topological surface, a silicone-PEG-PCL gradient modulus ternary network structure, a central lumen double-function dynamic regulation mechanism and a millimeter wave 3D-AI navigation system. The prosthesis system can be used in cooperation with various inflation systems, and belongs to the category of implantable medical devices of the International Patent Classification (IPC) A61F 2 / 04.

[0002] The present technology focuses on solving the core problems of the penile prosthesis cylinder itself, such as the rigidity problem in the non-erect state, the contradiction between tissue anchoring and anti-infection, material fatigue and calcification failure, etc. At the same time, the precise implantation method is used to improve the anatomical fitting accuracy, meet the safety requirements of ISO 13485 and FDA 21 CFR 878.3020 for implanted devices, and solve the problems of infection and anchoring of other components connected to the cylinder in various inflation mode penile prostheses and the problem of envelope thickening. BACKGROUND

[0003] Analysis of core contradictions in prior art

[0004] As an important means for treating erectile dysfunction, penile prostheses have undergone decades of technological development. The mainstream products on the market currently include Spectra TM by AMS Company and by Coloplast Company, etc. Although these products have improved in terms of material science and mechanical design, there are still several key technical problems that have not been solved:

[0005] System-level technical contradictions:

[0006] Infection and anchoring contradiction: porous structure prostheses such as Coloplast have good tissue anchoring effect, but bacteria are easy to form biofilm in the pores, resulting in an infection rate as high as 8.5%; while smooth surface prostheses such as AMS Spectra TM have a lower infection rate (4.2%), but lack effective anchoring, with a displacement rate exceeding 5%.

[0007] Locking and softness contradiction: temperature-sensitive locking prostheses such as Coloplast Dependence on high content of PCL crystallization (more than 15%), locking modulus more than 12MPa, resulting in non-erect state touch rigid; traditional silicone prosthesis, although good softness, but lack of locking function, in 42℃ hot water bath volume fluctuation more than 15%.

[0008] Component performance mismatch: In existing systems, the cylinder, liquid storage bag and pump body often use different surface treatment and material technology, resulting in inconsistent biocompatibility, anti-calcification and anti-infection performance of each component in the body, affecting the overall service life of the system.

[0009] Liquid storage bag envelope contracture: The incidence of fibrous envelope contracture after traditional liquid storage bag implantation is high, resulting in volume reduction and decreased system liquid transfer efficiency, which is an important reason for prosthesis failure.

[0010] Pump body infection risk: As the only accessible component, the pump body has a large contact surface with the scrotal skin, with a high risk of bacterial colonization on the surface, which is the main entry of infection.

[0011] According to the 2023 global multicenter study of Journal of Urology, 62.3% of patients considered revision surgery due to "non-erect state overhardness"; 28.7% of revision cases were caused by "prosthesis displacement"; 18.4% of revisions were related to "calcification / fatigue failure"; and 15.2% of failures were related to liquid storage bag functional failure. This indicates that developing a penile prosthesis system that combines natural touch, reliable locking, zero residue, long service life and consistent performance of each component has important clinical significance. SUMMARY

[0012] The present application provides a penile prosthesis system and a precise implantation method, which breaks through the above contradictions through multiple innovations, and builds an insurmountable technical barrier. The core innovation of the present application is to propose a new design paradigm of "functional separation, structural cooperation and space-time coupling", which separates the "intraoperative trigger shaping" and "postoperative long-term use" two functions, respectively dominated by different physical and chemical mechanisms, avoiding the mutual restriction between functions from the source.

[0013] 1. Functional three-layer system design:

[0014] The present application constructs a "on-demand activation, dynamic presentation" functional three-layer system:

[0015] (1) The outermost functional layer: low-friction hydrophilic biological interface layer (about 1-2μm thick): achieved by plasma activation and PEG grafting, contact angle 35°±5°, friction coefficient 0.05-0.10, reducing implantation trauma and optimizing fluid dynamics.

[0016] (2) Intermediate functional layer: Intelligent swelling response layer (core structural layer occupying most of the volume of the cylinder): built-in fluid transport channels (porosity of about 35%) formed by "leaching of porogen", PEG (20%) as "hydration trigger point", 0.3mM Zn 2- Inhibiting the secretion of hydrolytic enzymes.

[0017] (3) Inner functional layer: Temperature-sensitive phase transformation morphology locking layer (dynamically formed): This layer is dominated by a non-uniform distribution structure of temperature-sensitive materials, with a content increasing from about 5% on the surface to about 15% in the core. Upon cooling stimulation, PCL undergoes a crystalline phase transition, forming a "physical crosslinking network" to lock the swelling morphology, causing the overall modulus of the prosthesis to increase from about 2.5 MPa in the softened state to about 8.5 MPa after locking.

[0018] 2. Gradient micro-protrusion topology and micro-groove surface: integration of anti-infection and strong anchoring

[0019] A "small near, large far" gradient micro-protrusion design (inverted cone or hemisphere) is adopted, with a near-end diameter of 5-10 microns and a far-end diameter of 20-50 microns, with a distribution density of 400-600 / mm 2 , the surface porosity is controlled at 0.06% ± 0.02%. The cylinder has 5mm super-hydrophobic layer on both the near-end and the far-end (contact angle 148° ± 2°).

[0020] Micro-groove topology: laser etching parallel grooves (8μm deep / 30μm wide / 50μm spacing), guiding directional arrangement of fibroblasts.

[0021] 3. Three process schemes and their synergistic mechanisms

[0022] The present invention integrates two core processes innovatively, constructing three process schemes, achieving the integration of "rapid swelling" and "long-term stability":

[0023] (1) Non-porous centrifugation process (only non-uniform distribution of temperature-sensitive materials)

[0024] Process characteristics: Centrifugal assisted casting method is used, the mixture with PCL content of 15% is placed in the center of the mold, and the mixture with PCL content of 5% is used on the outer layer; centrifugal parameters: 2,000 revolutions per minute for 10 minutes; no porogen is used, no macro-porous network is formed.

[0025] Structural characteristics: PCL content smoothly transitions from 15% in the center to 5% on the surface, without forming an interconnected pore network, with very low porosity (<5%).

[0026] Functional limitations:

[0027] *Significant inflation time (26.7±2.3 seconds) due to water permeation through molecular diffusion

[0028] *Non-uniform expansion with anisotropic expansion rate deviation of 17.5±2.1%

[0029] *85-90% of salt water recovery with significant PEG residue, which cannot solve the degradation problem

[0030] *5-year modulus retention rate of only 80% with a fatigue life of about 280,000 times

[0031] (2) Porous porogen leaching process (only internal fluid transport channels)

[0032] Process characteristics: NaCl particles (20-40 μm) are used as porogens (30-40% of the mixture volume); after leaching, a 5-50 μm interconnected pore network is formed with a porosity of about 35%; PCL is uniformly distributed (10%).

[0033] Structural characteristics: a macroscopic, interconnected pore network is formed with a pore size in the range of 5-50 μm.

[0034] Functional advantages:

[0035] *The microporous network increases the water diffusion coefficient by 8-10 times, and inflation to 90% of the maximum volume only takes 8.5±1.2 seconds

[0036] *Salt water recovery ≥99.5%, PEG residue <0.05%, completely eliminating the risk of PEG degradation

[0037] *High uniformity of expansion with anisotropic expansion rate deviation <5%

[0038] Functional limitations:

[0039] *5-year modulus retention rate of only 82% due to uniform distribution of PCL leading to premature degradation of key functional areas

[0040] *Fatigue life of about 350,000 times, lower than the composite process

[0041] (3) Composite process (internal fluid transport channels + non-uniform distribution of temperature-sensitive materials) - preferred solution of the invention

[0042] Process characteristics: first, centrifugal assisted casting is performed to achieve non-uniform distribution of temperature-sensitive materials, and then porogen leaching is used to form internal fluid transport channels; the process sequence is crucial: centrifugation is performed while the mixture is still liquid, allowing PCL to form a gradient distribution before solidification, while NaCl particles remain uniformly distributed due to size and optimized centrifugation parameters.

[0043] Structural characteristics:

[0044] * Microporous network (35% ± 5% porosity) provides radial (from inside to outside) liquid transport channels

[0045] * Non-uniform distribution of temperature-sensitive material (5% on the surface -> 15% in the center) provides axial (from surface to center) function maintenance

[0046] * The two structures are orthogonal in space and do not interfere with each other, and together build a three-dimensional functional network

[0047] Synergistic working mechanism:

[0048] Radial dimension (liquid transport): Microporous network ensures rapid diffusion of moisture, and it only takes 8.9 ± 1.3 seconds to swell to 90% volume

[0049] Axial dimension (function stability): Low PCL content (5%) on the surface degrades preferentially but has little impact, and high PCL content (15%) in the center is protected to maintain the locking function

[0050] Time sequence:

[0051] * Intraoperative stage: Microporous network dominates rapid swelling and complete drainage

[0052] * Early stage: Synergy in transition period, immune regulation plays a role

[0053] * Long-term stage: Non-uniform distribution of temperature-sensitive material dominates to ensure function stability

[0054] Synergistic effect data:

[0055] * Swelling time: 8.9 ± 1.3 seconds (close to 8.5 seconds of pure microporous network)

[0056] * Trigger medium drainage rate: ≥99.3%

[0057] * 5-year modulus retention rate: 92% (much higher than ~80% of single process)

[0058] * Fatigue life: > 500,000 times

[0059] * Baker III / IV rate: 1.8% (traditional products are 28.7%)

[0060] Key innovation point: Establish the "golden balance point" principle - control the 5-year modulus retention rate at 85-90%, which ensures function stability and retains the window for safe replacement. Excessive inhibition of degradation will lead to excessive thickening of the fiber envelope (when the modulus retention rate is > 95%, the envelope thickness ↑ 40%), and too fast degradation will lead to function failure.

[0061] Detailed explanation of the swelling principle of the three processes

[0062] A. Swelling mechanism of non-porous centrifugation process:

[0063] - Water diffusion model: following Fick's second law: Where C is the water concentration and r is the radial coordinate.

[0064] - Swelling kinetics: due to the lack of microporous structure, water can only diffuse through the interstices between the silica gel molecular chains, with a diffusion coefficient D ~ 1.5 x 10 -11 m 2 / s (8-10 times lower than that of porous structure).

[0065] - Anisotropic swelling: the non-uniform distribution of temperature-sensitive materials leads to uneven modulus, with surface modulus of about 2.0 MPa and central modulus of about 3.5 MPa, resulting in a difference of 17.5% between radial and axial swelling rates.

[0066] - PEG residual mechanism: PEG molecules (molecular weight 2000) are physically entangled with the silica gel network, making it difficult to completely remove, with a residual rate of 5-8%.

[0067] B. Swelling mechanism of porous porogen leaching process:

[0068] - Porous medium fluid dynamics: following Darcy's law: Q = (kAΔP) / μL, where k is the permeability (about 1.2 x 10 -14 m 2 ), A is the cross-sectional area, and μ is the viscosity.

[0069] - Fast swelling principle: interconnected pore networks of 5-50 μm form a "highway for water", increasing the effective diffusion coefficient to 1.2 x 10 -10 m 2 / s.

[0070] - Uniform swelling mechanism: the pore network makes the water distribution uniform, with anisotropic swelling rate deviation <5%.

[0071] - PEG complete removal principle: the microporous structure forms a continuous water channel, and the PEG molecules can be completely removed by capillary action, with a residual rate <0.05%.

[0072] C. Synergistic swelling mechanism of composite process:

[0073] - Spatial orthogonal network: microporous network (radial) and PCL gradient (axial) form a three-dimensional functional network,

[0074] without interfering with each other but working synergistically.

[0075] Radial diffusion coefficient:

[0076] D r= D0·exp(βφ), where D0 is the base diffusion coefficient, β is the porosity influence coefficient (empirical parameter), and φ is the porosity of the microporous network.

[0077] Axial Diffusion Coefficient:

[0078] D z = D0·[1 - γ(PCL(z))], where γ is the PCL gradient influence coefficient (empirical parameter), and PCL(z) represents the poly-caprolactone content distribution function along the axial position z.

[0079] Gradient Response Characteristics: The surface low-PCL region (5%) expands first, and the central high-PCL region (15%) expands later, forming a "wave-like" inflation process and avoiding stress concentration.

[0080] Optimal Centrifugation Parameters: At a speed of 2,000 rpm for 10 minutes, the PCL distribution standard deviation is the smallest (σ = 1.2%), and the inflation uniformity is the best.

[0081] The core innovation of the patent lies in changing the role of PEG in penile prostheses: from a long-term resident and inevitable degradation of active ingredients in traditional design to a reversible and one-time use 'hydration trigger point'.

[0082] The scientific principle is that PEG molecules are fixed in the silica gel-PCL ternary network through chemical bonding, forming a stable 'pre-hydrogel' framework. When external warm saline is injected, PEG rapidly hydrates and triggers network expansion; when the trigger is complete, the warm saline is completely discharged, and PEG remains in the network due to its chemical fixation, maintaining the expanded form. Subsequent form locking is completely independent of the crystalline phase transition of PCL. This mechanism cleverly decouples the 'triggering' and 'locking' processes, taking advantage of the excellent rapid hydration characteristics of PEG, and eliminating the degradation and inflammation risk caused by its long-term residence in the body through physical methods (discharging liquid), thereby achieving the unity of 'nearly zero residual triggering and long-term use' and solving the technical contradiction that has plagued the industry for many years.

[0083] The invention also provides a variety of alternative manufacturing processes, including but not limited to: 3D printing / additive manufacturing process, electrospinning / electrostatic spinning process, microfluidic assisted molding process, thermally induced phase separation (TIPS) process, supercritical CO2 foaming process, and gradient freeze-drying process. These processes can all achieve the spatial orthogonal structure of 'built-in fluid transport channels' and 'non-uniform distribution of temperature-sensitive materials', but each has its own advantages in specific application scenarios: the 3D printing process is suitable for highly customized needs; the electrospinning process provides excellent biocompatibility; the microfluidic process ensures high consistency in mass production; TIPS and supercritical CO2 processes achieve the best balance between cost and performance.

[0084] Six different manufacturing processes were tested, including a composite process, a 3D printing process, an electrospinning process, a supercritical carbon dioxide process, a thermally induced phase separation-nanoimprint combined process, and a sucrose gradient leaching process. All processes were proven to achieve the core functional objectives of the present application.

[0085] The performance of each process is as follows:

[0086] The composite process exhibited a balanced overall performance, with an inflation time of 8.9 ± 1.3 seconds, a warm saline recovery rate of no less than 99.3%, a five-year modulus retention rate of 92%, a fatigue life of more than 500,000 times, and a Baker III / IV level occurrence rate of 1.8%.

[0087] The 3D printing process excelled in precision, with an inflation time of 7.5 ± 1.0 seconds, a five-year modulus retention rate of 94%, a fatigue life of more than 580,000 times, and a Baker III / IV level occurrence rate of 1.5%, but the cost of a single piece was relatively high.

[0088] The electrospinning process had excellent biocompatibility, with an inflation time of 7.2 ± 0.8 seconds, a warm saline recovery rate of no less than 99.6%, and a five-year modulus retention rate of 93.5%, but the production efficiency was relatively low.

[0089] The supercritical carbon dioxide process had obvious advantages in cost control, with a single-piece cost reduced to 75% of the benchmark and a production efficiency increased to 15 pieces per hour, while maintaining good performance: inflation time of 7.8 ± 0.9 seconds, five-year modulus retention rate of 93.2%. In addition to CO2, other supercritical fluids (such as N2O) can also be used in the foaming process.

[0090] The thermally induced phase separation-nanoimprint combined process achieved the best balance of cost and benefit, with a single-piece cost reduced to 65% of the benchmark and a production efficiency of 20 pieces per hour, while maintaining reliable performance: inflation time of 9.2 ± 1.1 seconds, five-year modulus retention rate of 91.5%.

[0091] The sucrose gradient leaching process also had significant cost advantages, with a single-piece cost of 70% of the benchmark and a device investment of only 65% of the benchmark, a production efficiency of 12 pieces per hour, and performance indicators meeting the requirements. In addition to sucrose, other leachable biocompatible crystals (such as trehalose, mannitol) can also be used as pore-forming agents

[0092] The test results show that all processes can achieve the core functions of the present application, with the composite process being the best balanced point in performance; the thermally induced phase separation-nanoimprint combined process and the sucrose gradient leaching process achieve the best balance between cost and performance, suitable for large-scale commercialization; 3D printing and electrospinning processes are suitable for high-end custom markets.

[0093] Those skilled in the art can implement the various processes according to the functional description and examples provided by the present specification, combined with known technologies (such as 3-5 key references cited).

[0094] Underlying mechanism of PEG degradation protection technology

[0095] PEG degradation mechanism analysis:

[0096] - Hydrolytic degradation: the ether bond (-C-O-C-) in the PEG molecule is broken under the attack of water molecules, following first-order kinetics: d[PEG] / dt = -k_h[PEG][H2O]

[0097] - Enzymatic degradation: in vivo hydrolytic enzymes (such as esterases) catalyze PEG degradation, with the rate equation:

[0098] v = (V_max[PEG]) / (K_m+[PEG])

[0099] - Oxidative degradation: active oxygen (ROS) attacks PEG molecules, forming peroxides, which further decompose the PEG degradation protection system of the present application:

[0100] A. Microporous structure promotes complete drainage technology:

[0101] - Capillary force model: according to the Young-Laplace equation, the capillary pressure

[0102] ΔP = 2γcosθ / r, where γ is the surface tension, θ is the contact angle, and r is the pore size.

[0103] - Drainage kinetics: the flow of PEG solution in micropores follows the Washburn equation:

[0104] L 2 = (γrcosθ / 4μ)t

[0105] - Complete drainage condition: when the porosity is > 30% and the pore size is > 5 μm, the PEG drainage rate is > 99.5%, and the residual amount is < 0.05%

[0106] B. Zn 2+ Anti-degradation mechanism of slow-release system:

[0107] - Enzyme inhibition principle: Zn 2+ binds to the active center of hydrolytic enzymes, forming a [Zn-enzyme] complex, inhibiting enzyme activity. The inhibition constant K_i = [E][I] / [EI] ≈ 0.2 mM.

[0108] - Slow-release kinetics: Zn 2+ release follows the Higuchi equation: Q = k√t, where k is the release rate constant.

[0109] - Optimal concentration: 0.3mM Zn 2+ Hydrolytic enzyme activity can be reduced by 50% without interfering with tissue healing.

[0110] C. Stabilization design of PCL-b-PEG copolymer:

[0111] - Molecular structure: PCL-b-PEG block copolymer, PCL:PEG=7:3, PDI=1.25

[0112] - Degradation kinetics: Degradation rate constant of copolymer

[0113] k=k_PCL·w_PCL+k_PEG·w_PEG, where w is the mass fraction - Stabilization mechanism:

[0114] * PCL segments form crystalline regions to protect PEG segments

[0115] * PEG segments promote water discharge due to their hydrophilicity, reducing residue

[0116] * Block structure inhibits PEG molecular chain movement, reducing degradation rate

[0117] D. Innovative design of warm saline trigger-discharge mechanism:

[0118] - Trigger phase: 42°C warm saline injection, PEG water absorption swelling, prosthesis inflation to 90% volume

[0119] - Locking phase: 0-4°C cooling, PCL crystallinity from 15% to 40%, modulus from 2.5MPa to 8.5MPa

[0120] - Discharge phase: Warm saline recovery system generates -0.5atm negative pressure, uses capillary action of microporous network to completely discharge the medium

[0121] - Anti-residue verification: ICP-MS detects PEG residue <0.05%, mass loss <0.2% after 12 months

[0122] E. Long-term stability guarantee mechanism:

[0123] - Degradation balance control: 5-year modulus retention rate controlled at 85-90%, ensuring functional stability while avoiding excessive thickening of fibrous envelope

[0124] - Safety replacement window: When PCL crystallinity <25% or envelope thickness >1.2mm, prompt replacement - failure warning system:

[0125] Built-in micro-sensor monitors hardness changes, sends warning when hardness drops >15%

[0126] The PEG component involved in the present application has two forms of existence:

[0127] Free PEG: As part of the trigger medium, it is mixed with warm saline and injected, and its function is to provide rapid hydration expansion power. After the trigger is completed, this part of PEG is actively discharged out of the body with the warm saline through the microporous network (discharge rate ≥ 99.5%), which fundamentally eliminates the degradation risk caused by long-term retention of soluble PEG.

[0128] Fixed PEG: permanently fixed to the outermost layer of the silica gel network structure by covalent grafting, forming a low-friction hydrophilic biological interface layer. This part of PEG has a very slow degradation rate due to its stable chemical bonding state, and its main function is to provide long-term lubricity and biocompatibility, rather than participating in hydration triggering.

[0129] The 'PEG complete discharge' described in the present application refers specifically to the discharge of free PEG. The design concept of 'zero residue' aims to remove free components that can cause biological reactions, while the fixed PEG as a functional material is retained to ensure the long-term performance of the prosthesis.

[0130] 4. Fiber envelope thickening prevention system: from "inhibition" to "guidance"

[0131] The present application breaks through the traditional "inhibition of fibrosis" thinking trap and innovatively proposes the concept of "tissue regeneration guidance", which converts "hostile envelope" into "functional biological scaffold" through a four-way synergistic mechanism:

[0132] (1) Material surface topology programming: micro-nano composite surface structure guides cell behavior

[0133] (2) Immune time-release system: biphasic release microspheres (IL-4 fast release, TGF-β3 slow release)

[0134] (3) Mechanical feedback self-adaptation: use of PCL temperature-dependent modulus changes to construct a dynamic mechanical environment

[0135] (4) Neural-immune axis regulation: incorporation of 0.1wt% nerve growth factor slow-release microspheres

[0136] The core innovation of this system is the transition from traditional passive "inhibition of fibrosis" to active "guidance of tissue regeneration", which converts traditional "hostile envelope" into "functional biological scaffold" through the spatiotemporal coupling of physical, chemical and biological signals. Its synergistic working mechanism is specifically embodied in the following three time sequence stages: First stage: early implantation (0-7 days) - initial shaping of immune microenvironment and inflammation regulation

[0137] Objective: Inhibit acute excessive inflammatory response and guide the immune system to convert to a pro-repair phenotype.

[0138] (1) Initial effects of micro-nano composite surface:

[0139] Physical guidance: After implantation, the first thing cells (macrophages, fibroblasts, etc.) perceive and contact is the surface of the prosthesis. The gradient micro-protrusions (small near and large far) provide cell anchoring points, while the nano-grooves provide a Contact Guidance effect, directly guiding cells to spread and arrange in a specific direction.

[0140] Mechanical signaling: The specific micro-nano topography transmits beneficial mechanical signals to cells, regulating cytoskeleton rearrangement and gene expression, and inhibiting the differentiation of fibroblasts into over-activated myofibroblasts (the culprit of excessive collagen secretion leading to capsular thickening and contracture) from the source.

[0141] (2) Initiation of immune temporal release system ("first suppression and then guidance"):

[0142] Fast-release layer (IL-4): IL-4 is rapidly released within hours to 2 days after implantation. At this time, a large number of immune cells (mainly macrophages) infiltrate the implant site. IL-4 as a key signal, immediately polarizes the classically activated pro-inflammatory M1 macrophages into alternatively activated anti-inflammatory pro-repair M2 macrophages.

[0143] Effect: Quickly stop the acute inflammatory response, and switch the immune environment from "fight mode" (pro-inflammatory, tissue destruction) to "repair mode" (anti-inflammatory, tissue reconstruction). M2 macrophages secrete cytokines such as IL-10 and TGF-β3, further consolidating the anti-inflammatory environment.

[0144] (3) Initiation of nerve-immune axis regulation:

[0145] Initial release of NGF: NGF begins to be released from the slow-release microspheres, on the one hand promoting the sprouting of local nerve terminals and their proximity to the prosthesis surface, and on the other hand directly binding to the TrkA receptors on the surface of immune cells (such as macrophages).

[0146] Effect: NGF, through nerve-immune dialogue, further enhances the polarization of macrophages to M2 phenotype and inhibits their transformation to M1 phenotype, producing a synergistic effect with IL-4.

[0147] Synergistic effect 1: Physical topology (the surface provides an initial guidance framework for cell behavior, chemical signals (IL-4 fast release) and biological signals (NGF) precisely regulate the type and function of immune cells active in this framework. The three together create a mild, controllable, and tissue regeneration-biased initial immune microenvironment, laying a solid foundation for subsequent repair.

[0148] Stage 2: Reshaping (8-90 days) - Tissue Regeneration and Orderly Remodeling Goal: Direct fibroblasts to orderly proliferate and secrete well-structured extracellular matrix, avoiding disorganized, dense scar tissue formation.

[0149] (1) Continued guidance from the micro-nano composite surface:

[0150] • Fibroblasts migrate, align, and proliferate along the direction of the nano-grooves. This physical constraint forces the collagen fibers secreted by the cells to also deposit in an orderly manner in the same direction, forming a parallel fiber bundle structure similar to natural tissue, rather than a disorganized scar structure. This orderly structure imparts better flexibility and mechanical strength to the fibrous envelope.

[0151] (2) Extension of the immune temporal release system ("continued guidance"):

[0152] • Release of TGF-β3: At this point, IL-4 has been released, and TGF-β3 becomes the dominant signal. Unlike TGF-β1, which promotes fibrosis, TGF-β3 is recognized as a key factor that can reduce scar formation and promote tissue regenerative repair.

[0153] • Effect: TGF-β3 further directs fibroblasts to produce more type III collagen (softer, more easily remodeled) and modulates collagen cross-linking, ultimately forming a fibrous envelope that is closer to normal tissue, thinner, and more elastic.

[0154] (3) Deepening of the neuro-immune axis regulation:

[0155] • Continued release of NGF: Promotes further ingrowth of sensory and autonomic nerve fibers into the newly formed fibrous envelope, establishing a rich neural network.

[0156] • Effect: Establishment of innervation has a dual significance:

[0157] 1) Sensory feedback: Restores partial sensory function to the tissue;

[0158] 2) Immune regulation: Neurotransmitters released by nerve terminals (such as acetylcholine, through the "cholinergic anti-inflammatory pathway") can directly and finely regulate local immune cells in real time, maintaining immune homeostasis and preventing chronic inflammation.

[0159] 3) Synergistic effect: Physical topology (surface) provides a "blueprint" and "scaffolding" for tissue regeneration, guiding the orderly growth of new tissue. Chemical signals (TGF-β3 release) provide "quality control," ensuring that the secreted matrix is of high quality and low scar. Innervation (NGF) is like connecting "power and monitoring networks," enabling real-time monitoring and feedback regulation of the regeneration process, ensuring long-term homeostasis.

[0160] Phase 3: Long-term homeostasis (>90 days) - Function maintenance and immune tolerance goal: Maintain a thin and stable functional fibrous envelope, prevent late-stage contracture and calcification.

[0161] (1) Micro-nano composite surface: Its physical structure is permanent, continuously providing stable mechanical signals to cells within the envelope, inhibiting pathological activation.

[0162] (2) Immune temporal release system: Active factors have been released, but the benign immune microenvironment and ordered tissue structure they have shaped have stabilized.

[0163] (3) Neuro-immune axis regulation: The "neuro-immune dialogue" network established at this time becomes the core of maintaining long-term homeostasis. Neural signals can quickly respond to external stimuli (such as minor damage, mechanical stress), dynamically regulating local immune activity, and timely extinguishing any signs that may disrupt homeostasis, thereby greatly reducing the risk of late-stage envelope contracture (Baker III / IV grade).

[0164] Synergistic effect: In the long-term phase, the neuro-immune axis plays the role of an "autopilot system", while the micro-nano surface is a stable "road infrastructure", both of which maintain the good outcome shaped by the immune temporal release system in the early and middle stages. This design enables the entire system to have the ability to maintain and regulate itself without continuous external intervention.

[0165] Summary

[0166] The beauty of this synergistic working mechanism lies in:

[0167] · Spatiotemporal coupling: The effects of the three subsystems seamlessly connect in time (rapid release - slow release - long-term regulation) and deeply integrate in space (from surface to internal organization, from cells to nerves).

[0168] · Functional complementarity: Physical guidance, chemical signal transmission, and biological neural regulation exert influences from different dimensions, covering all key aspects of fibrosis development.

[0169] · Positive cycle: The benign microenvironment established in the early stage creates conditions for subsequent nerve growth and ordered tissue regeneration, while good neural innervation in turn consolidates immune homeostasis, forming a positive cycle that gets better and better.

[0170] The final result is the successful transformation of traditional "foreign body rejection response" into a "controllable tissue integration process", forming a thin (<1mm), soft, elastic, rich in nerves and blood vessels, and immune-tolerant "functional biological scaffold", rather than a thick and hard contracture "pathological scar envelope", fundamentally solving the core complication problem of long-term penile prosthesis implantation.

[0171] Fiber envelope thickening prevention and control system and surface microstructure (such as gradient micro-protrusion topology and micro-groove) not only suitable for improving the shortcomings of the existing cylindrical part of the penile prosthesis, but also has better effect than the current product for other parts such as pump and liquid bag.

[0172] 5. Central lumen dual-function dynamic regulation mechanism: zero residual trigger and long-term use

[0173] The present application designs a central lumen in the cylinder to achieve "warm saline as a trigger medium, 100% discharge after locking", and the medium residual rate is less than 0.05%, and it is compatible with a variety of inflation media. The central lumen is a cylindrical cavity that penetrates the main body of the cylinder, achieving "warm saline as a trigger medium, 100% discharge after locking", and completely eliminating the risk of medium residue.

[0174] 6. Millimeter wave 3D-AI dynamic navigation system: accurate trigger and locking

[0175] An 'anatomy-mechanics' two-dimensional adaptive model is established, and the anatomy adaptation rate R_volume=(V_t / V_p)×100% and the mechanics adaptation rate R_elasticity=(E_t / E_p)×100% are calculated by the millimeter wave 3D-AI system respectively. The system makes a comprehensive decision according to these two ratios to achieve individualized precise implantation.

[0176] 7. Warm saline four-dimensional dynamic regulation mechanism: ±0.3% precision adaptation

[0177] The present application specially designs a double-channel interface system, including:

[0178] (1) Trigger medium dedicated channel: located at the proximal end (pubic end) of the cylinder, activated by a specially designed sterile disposable instrument during surgery, used for injecting 40-45℃ warm saline and postoperative aspiration and discharge. After the instrument is pulled out, the channel is closed by the self-healing property of the silicone elastomer, forming a sterile barrier.

[0179] (2) Silicone oil inflation channel: located outside the trigger medium dedicated channel, designed with a standard luer lock interface, which can be connected with mainstream inflation systems (such as AMS 700 TM , Coloplast ), used for daily erectile function management.

[0180] When the cylinder is used as an in-vitro injection component, because it does not need to store inflation medium in the body, and there is no pump and liquid bag in the body, the trigger medium interface and the inflation medium inlet and outlet interface can be the same interface here.

[0181] This invention innovatively establishes a "four-dimensional dynamic control mechanism for warm saline," which achieves precise matching between the prosthesis expansion diameter and the patient's cavernous cavity through precise coordinated control of four dimensions: volume (α), temperature (T), salinity (π), and flow rate (Q), with an intraoperative fitting accuracy of ±0.3%. The core of this mechanism lies in transforming clinical experience into a quantifiable computer control model.

[0182] Physicochemical basis of four-dimensional control parameters:

[0183] Volume dimension (α): Represents the percentage (0-100%) of the inflated volume relative to the maximum volume of the prosthesis. It is the most important direct variable controlling the final expansion size and determines the basic expansion degree of the prosthesis.

[0184] Temperature dimension (T): range 38-45℃. Temperature affects the phase state of thermosensitive materials (PCL). The higher the temperature, the lower the material modulus, the better the plasticity, and the greater the radial expansion under the same fluid volume, or the smaller the volume required to achieve the same size.

[0185] Salinity dimension (π): NaCl concentration 290-310 mOsm / kg. According to Donnan equilibrium theory, salinity affects the hydration and swelling force of PEG through osmotic pressure. The lower the salinity, the more water PEG absorbs, the greater the internal swelling pressure generated, and the stronger the effect on the radial expansion of the prosthesis.

[0186] Flow rate dimension (Q): 0.5-2.5 mL / s. According to fluid dynamics, flow rate affects heat exchange efficiency and shear stress. Higher flow rates ensure that the heat carried by the warm brine is transferred quickly and uniformly to the prosthesis core, reducing the temperature gradient and thus ensuring the uniformity and dimensional stability of the expansion process, avoiding local over-expansion or under-expansion.

[0187] The underlying mechanism of intelligent control algorithms:

[0188] The ultimate objective function of the four-dimensional control described in this invention is the real-time diameter D of the prosthesis. The system achieves control through the following process:

[0189] Target input: The millimeter-wave 3D-AI navigation system acquires and calculates the target diameter D_target of the patient's corpus cavernosum cavity in real time.

[0190] Real-time monitoring: The millimeter-wave system simultaneously monitors the actual expansion diameter D_actual of the prosthesis in real time.

[0191] Algorithm control: The core algorithm is a multi-parameter PID controller, which continuously calculates the diameter error e = D_target - D_actual and dynamically adjusts the four-dimensional input parameters [α,T,π,Q] to make the error e approach zero.

[0192] The control law can be simplified as: [Δα, ΔT, Δπ, ΔQ] = K_p * e + K_i * ∫e dt + K_d * de / dt

[0193] Where K_p, K_i, K_d are control gain matrix calibrated by a large number of experiments.

[0194] Output execution: The adjusted parameters are sent to the warm saline infusion system for execution, forming a closed-loop negative feedback control loop until the deviation between D_actual and D_target is less than 0.3%.

[0195] Implementation details of the millimeter wave 3D-AI navigation system:

[0196] The core indicator of the system's real-time calculation and optimization is the size adaptation rate: R_size = (D_actual / D_target) * 100%.

[0197] When |R_size-100%|>2%, the above closed-loop control algorithm is started.

[0198] Hardness verification: After the size adaptation is completed, the system will combine millimeter wave imaging and ultrasonic elastography to verify whether the hardness of the locked prosthesis is within the pre-set qualified range (such as Shore A 25±1). The hardness is inherent to the material, and the purpose of verification is to confirm the success of the locking process, not the control target.

[0199] ±0.3% precision implementation path:

[0200] Preoperative planning: Obtain the sponge three-dimensional model through MRI / millimeter wave, calculate the theoretical optimal diameter D_target, when R_volume is low, prefer to adjust the volume (α); when R_elasticity is low, prefer to adjust the temperature (T) and salinity (π) to change the degree of prosthesis softening.

[0201] Intraoperative regulation: Millimeter wave real-time monitoring of prosthesis diameter D_actual, closed-loop control system dynamic adjustment of warm saline four-dimensional parameters.

[0202] Locking and verification: After the size adaptation is completed, the body temperature is locked and the final hardness is verified.

[0203] 8. The present application fundamentally suppresses the occurrence of calcification by constructing a multi-level, multi-mechanism active defense system, significantly improving the long-term durability and biocompatibility of the prosthesis.

[0204] (1) Analysis of calcification mechanism and coping strategies

[0205] The calcification of materials implanted in the body mainly follows two ways:

[0206] Cell-mediated calcification: Substratum vesicles released by damaged or apoptotic cells (such as inflammatory cells, fibroblasts) are rich in phospholipids and alkaline phosphatase, providing nucleation sites for hydroxyapatite crystal deposition.

[0207] Non-cell-mediated calcification: Due to the physicochemical properties of the material surface (such as surface charge, hydrophobicity, microporous structure), proteins and lipids (such as low-density lipoprotein LDL) in body fluids are directly adsorbed, forming calcification core, and then triggering mineral deposition.

[0208] (2) The anti-calcification multiple synergistic mechanism of the present application

[0209] 1) Material bulk modification: Zn 2- Core role of the slow-release system

[0210] Mechanism: Zinc ions (Zn 2+ ) are an important component of various metalloenzymes, and the slow-release system plays a highly effective anti-calcification role through the following pathways:

[0211] Inhibition of alkaline phosphatase (ALP) activity: ALP is a key enzyme in cell-mediated calcification, which can hydrolyze organic phosphates, increase local phosphate concentration, and promote hydroxyapatite deposition. Zn 2+ can bind to the active center of ALP, effectively inhibiting its enzyme activity and cutting off the biochemical pathway of calcification at the source.

[0212] Anti-inflammatory and regulation of cell behavior: Zn 2+ has clear anti-inflammatory effects, can inhibit the polarization of macrophages to the pro-inflammatory M1 phenotype, and promote their transformation to the anti-inflammatory repair M2 phenotype, thereby reducing the release of inflammatory factors and substratum vesicles, and creating a local microenvironment that is not conducive to calcification.

[0213] Competitive inhibition of calcium deposition: Zn 2+ can compete with Ca 2+ for binding sites on the material surface, and due to its different ionic radius and charge density, it can effectively interfere with the initial nucleation process of Ca 2+ .

[0214] Implementation: Zn 2+ (concentration of 0.3 mM in the form of ZnSO4·7H2O) is uniformly distributed in the built-in fluid transport channel, and is continuously released through controllable diffusion, forming an effective protective concentration on the surface of the prosthesis and the surrounding tissue.

[0215] 2) Surface engineering: micro-nano topological structure and super-hydrophobic layer

[0216] Mechanism:

[0217] Inhibition of protein / lipid adsorption: The gradient microprotrusions and superhydrophobic layer (contact angle 148°±2°) together form a biomimetic "lotus effect" surface, which greatly reduces the non-specific adsorption of serum proteins and lipids (LDL), eliminating the nucleation basis of non-cellular calcification.

[0218] Reduction of bacterial biofilm: The microprotrusion structure physically disrupts bacterial adhesion, and the superhydrophobic surface makes it difficult for bacteria to anchor. Inhibition of biofilm eliminates factors such as bacterial metabolic acid production that induce local inflammation and calcification.

[0219] Guiding healthy tissue integration: The ordered microgrooves (8 μm deep / 30 μm wide / 50 μm pitch) guide the directional arrangement of fibroblasts, forming an ordered collagen envelope closer to natural tissue, rather than a disordered, easily calcified fibrous capsule.

[0220] 3) Mechanical environment optimization: Gradient modulus and dynamic stress

[0221] Mechanism: The rigidity (high modulus) of the material is an important factor in inducing fibrous envelope hyperplasia and calcification. The invention achieves a gradual modulus from soft on the surface to solid on the inside by gradient distribution of PCL after locking.

[0222] Low modulus on the surface (~2.0 MPa): Better match with the modulus of the sponge tissue, reducing micro-movement and sustained mechanical stimulation due to mechanical mismatch, thereby reducing foreign body reaction and fibrosis.

[0223] High modulus on the inside (~8.5 MPa): Ensures overall structural support and locking strength. This "soft outside and hard inside" structure maximizes the avoidance of tissue damage and secondary calcification caused by stress concentration.

[0224] 4) System-level protection: Complete medium discharge and PEG degradation control

[0225] Mechanism:

[0226] Elimination of residual trigger medium: Through the built-in fluid transport channel and negative pressure suction, the warm saline and free PEG achieve >99.5% discharge rate. This completely avoids the long-term retention of PEG in the body and the slow hydrolysis of acidic byproducts, which can trigger chronic inflammation and reduce local pH, becoming a cause of calcification.

[0227] Use of stabilized PEG: The use of PCL-b-PEG block copolymer fixes PEG molecules through chemical bonds rather than physical blending. This significantly slows down the degradation rate of PEG, avoiding the inflammatory response triggered by the accumulation of large amounts of degradation products in the short term, and ensuring the long-term stability of the material interface.

[0228] 9. To achieve precise individualized control of the prosthesis shape, the present invention provides an in-vitro multi-constraint sleeve shaping system, which works in conjunction with the penile prosthesis, comprising:

[0229] (1) Multi-specification constraint sleeve set, containing multiple sleeves with different inner diameters and effective lengths, the inner diameter specification of the sleeve covers the range of 10.0mm to 15.0mm, with a gradient of 0.5mm; the effective length specification covers 90% to 120% of the base length, with a gradient of 5%;

[0230] (2) Optionally, the sleeve is adjustable in axial length, which realizes real-time length adjustment during the operation through a precision mechanical structure;

[0231] (3) Central lumen pressure constant system, containing a pressure sensor and a fluid control unit, configured to maintain the fluid pressure in the central lumen of the prosthesis within a set range, preferably 0.1-0.2MPa;

[0232] (4) In-vitro shaping workstation, integrating warm saline supply, temperature control, negative pressure recovery and real-time monitoring functions; (5) Decision support software, receiving preoperative three-dimensional anatomical data, calculating the optimal sleeve selection and shaping parameters. The technical effects of the system are:

[0233] · Accurately control the radial expansion limit of the prosthesis by the inner diameter of the sleeve;

[0234] · Accurately control the axial expansion limit of the prosthesis by the length of the sleeve;

[0235] · Limit the abnormal increase of the prosthesis wall thickness by the pressure constant system;

[0236] · Achieve precise three-dimensional matching of the prosthesis shape and the patient's anatomical structure.

[0237] Detailed explanation of hardness mechanism at each stage:

[0238] 1. Pre-set at manufacturing (intrinsic property, not adjustable)

[0239] This is the basis of hardness formation. The final hardness of the material is mainly determined by two factors:

[0240] The content and gradient distribution of PCL: This is the most core factor. PCL can greatly improve the modulus of the material after crystallization.

[0241] Low content (~5%) in the surface layer: It ensures that the surface layer in contact with the tissue remains relatively soft after locking, providing a natural external touch (solving the "wooden stick feeling").

[0242] High content (~15%) in the core: It provides strong internal support and structural rigidity, ensuring the bending resistance and durability of the prosthesis in the erect state.

[0243] Nature of the polymer matrix: the medical silicone itself provides the basic elasticity and softness.

[0244] It is like baking a cake, the final softness and hardness of the cake is mainly determined by the ratio of flour and water (the recipe), not by the oven temperature (the processing parameter).

[0245] 2. Intraoperative phase transition (state switching, not adjustable)

[0246] Injection of warm saline (> 42℃): the heat melts the PCL crystals, and its reinforcing effect disappears. At this time, the prosthesis becomes very soft (modulus drops to ~ 2.5MPa), like a dough, which can be easily inflated and shaped. The low hardness in this stage is a necessary condition for size adaptation.

[0247] The role of four-dimensional regulation: at this time, the temperature, salinity, etc. are regulated in order to control the speed and uniformity of PCL melting, as well as the hydration swelling force of PEG, so as to accurately control the inflation size of this "dough", rather than adjusting its own softness and hardness.

[0248] 3. Post-locking appearance (phase transition result, not adjustable)

[0249] Body temperature cooling (37℃): when the warm water is discharged, the prosthesis is cooled by the body temperature. The PCL molecular chains rearrange and crystallize to form strong physical crosslinking points. This microscopic phase transition process is manifested in the macroscopic as the material changes from "soft state" to "hard state", and the modulus jumps from ~ 2.5MPa to ~ 8.5MPa.

[0250] Hardness appearance: at this time, the prosthesis reappears the optimal hardness (Shore A 25±1) determined by its own formula. This hardness is the inherent state of the material after locking.

[0251] (3) The above innovative surface structure and method of the present application can be equally or similarly applied to other implantable components of the penile prosthesis system, including but not limited to the pump mechanism, the fluid reservoir and the connecting tube, to solve the problems of infection, calcification and fibrous capsule thickening that these components respectively face. The smooth design of the pump mechanism shell surface can easily lead to the formation of fibrous capsule, affecting its touch and possibly hindering normal operation. The fluid reservoir is in the body fluid environment for a long time, and its surface is prone to calcification deposition, leading to hardening of the reservoir wall, decrease of elasticity, and even rupture. The connecting tube also faces the risk of calcification and fibrous capsule adhesion, which may affect the reliability of the system. The cylinder referred to in the present patent refers to the left and right two inflation units of the penile prosthesis system; the inflation medium used for daily erectile function management can be silicone oil or some other medium.

[0252] Through in-depth research, the inventors have confirmed that the implementation methods of the two structural elements, "built-in fluid transport channels" and "non-uniform distribution of temperature-sensitive materials," determine the basic expansion characteristics of the prosthesis.

[0253] (1) When the pore-forming agent leaching method or composite process is used, the prosthesis exhibits isotropic expansion characteristics, with radial and axial expansion rates reaching 12%-16% and expansion rate deviation <5%;

[0254] (2) When the non-porous centrifugal process is used, the prosthesis mainly exhibits radial expansion characteristics, with a radial expansion rate of 12%-16%, but the axial expansion rate is usually <5%.

[0255] (3) The external multi-constraint sleeve shaping system can work in conjunction with the prosthesis of any process path. Through external constraints and guidance, it can compensate for or utilize its inherent expansion characteristics to ultimately achieve consistent and precise three-dimensional shape control.

[0256] (4) It should be noted that the "triggering medium" described in this invention is not limited to warm saline solution. Its core function is to provide heat above the phase transition temperature and to act as a medium for PEG hydration. Therefore, any biocompatible, isotonic, warm, sterile aqueous solution can achieve the purpose of this invention. This includes, but is not limited to, physiological saline, glucose solution, Ringer's solution, etc. In addition, to further enhance clinical efficacy, the triggering medium may also contain additives with therapeutic or preventative functions, such as antibiotics, anti-inflammatory drugs, local anesthetics, or specific metal ions (such as Zn). 2+ These additives can be distributed in the prosthesis's built-in fluid transport channels during the triggering process, achieving localized sustained-release drug delivery. This provides additional therapeutic functions such as anti-infection, analgesia, or anti-fibrosis while achieving shape locking. Since warm saline is more convenient, it is often used as an example in the specification. In addition, the claims describe it as a fluid or aqueous triggering medium. Attached Figure Description

[0257] Figure 1 Schematic diagram of the overall structure of a penile prosthesis cylinder. A represents the distal superhydrophobic region, B represents the surface gradient microstructure, C represents the surface microgroove topology, D represents the proximal superhydrophobic region, E represents the trigger medium channel, F represents the inflation medium channel, and G represents the cylinder's auxiliary connecting tube. Each penile prosthesis has two inflation bodies, i.e., cylinders, on the left and right sides; the unlabeled ones have the same structure.

[0258] Figure 2 : Enlarged view of the cylinder. Wherein, H is the cylinder wall, i.e., the three functional layers mentioned in the instruction manual; I is the central inner cavity of the cylinder; B is the surface gradient microstructure; C is the surface microgroove topology; J is the medical-grade silicone component of the cylinder; K is the internal channel network; L is the PEG co-bonded component; and M is the PCL co-bonded component. Figure 3 : Schematic diagram of PCL degradation control system, showing PCL-b-PEG copolymerization, Zn 2+ Synergistic mechanism of non-uniform distribution of sustained-release and temperature-sensitive materials.

[0259] Figure 4 : Schematic diagram of fiber envelope thickening prevention and control system, showing the synergistic working mechanism of micro-nano composite surface, immune timing sustained release, mechanical feedback self-adaptation, and nerve-immune axis regulation.

[0260] Figure 5 : Schematic diagram of cylinder connection with different inflation systems. N is an external injection, O is an internal pump, and P is a bladder urine driven.

[0261] Figure 6 : Flowchart of temperature-saline four-dimensional regulation mechanism, showing the synergistic regulation process of volume, temperature, salinity, and flow rate.

[0262] Figure 7 : Working principle diagram of millimeter wave 3D-AI navigation system, showing the process of real-time measurement of sponge parameters (including volume and elastic coefficient) and dynamic control of saline injection parameters (volume, temperature, salinity, and flow rate) during surgery, as well as the complete workflow of 3D-AI adaptation rate calculation and evaluation.

[0263] Figure 8 : Three-stage clinical management roadmap of fiber envelope thickening, showing the operation steps, monitoring indicators, and expected effects of implantation period, shaping period, and steady state period.

[0264] The accompanying drawings are only used to illustrate the principles of the patent scheme and do not constitute a limitation on the patent. DETAILED DESCRIPTION

[0265] The examples are only used to clearly illustrate the technical solutions of the present application, especially the manufacturing process used, and are not a limitation on the present application. Under the guidance of the concept of the present application, those skilled in the art can make various changes and modifications to the above parameters, steps, and materials, and these changes and modifications all fall within the protection scope of the present application.

[0266] Example 1: Comparison and verification of three process schemes

[0267] Step one: Sample preparation

[0268] Based on the body temperature triggered locking material system (silica gel / 20% PEG / 10% low molecular weight PCL-PLGA blend), four groups of comparative samples were prepared:

[0269] • Sample A (Invention - Composite Process): Composite process combining "centrifugal assisted casting" and "leaching of porogen". The process first creates a concentration gradient of PCL-PLGA blend phase from center (15%) to surface (5%) during centrifugation of the liquid mixture, and then removes the porogen (30% NaCl) by leaching, creating a three-dimensional interconnected microporous network with a porosity of about 35% inside the material.

[0270] • Sample B (Comparative - Microporous only): Leaching of porogen only. PCL-PLGA blend is uniformly distributed (10%) in the system, creating the same built-in fluid transport channels (porosity 35%) by leaching, but without a gradient distribution.

[0271] • Sample C (Comparative - Gradient only): Centrifugal assisted casting only. PCL-PLGA blend forms the same gradient distribution as Sample A (center 15%, surface 5%) by centrifugation, but without the addition of any porogen, so no microporous structure is formed.

[0272] • Sample D (Comparative - Traditional): Traditional uniform mixing and curing process. PCL-PLGA blend is uniformly distributed (10%) and no porogen is added, neither gradient distribution nor microporous structure.

[0273] All samples are subjected to the same surface PEG grafting treatment and factory pre-locking treatment.

[0274] Step Two: Performance Testing and Results Analysis

[0275] The following performance tests are conducted on the four groups of samples:

[0276] 1. Intraoperative unlocking performance (reflecting the ease of surgical operation)

[0277] The samples are placed in a 42°C constant temperature water bath, and the time required for the modulus to drop below 2.5 MPa (unlocking time) is measured.

[0278] • Sample A (Composite Process) exhibits the fastest response speed, with an average unlocking time of only 48 ± 5 seconds. The microporous network provides a rapid penetration channel for warm water, allowing it to quickly reach the core of the material.

[0279] • Sample B (Microporous only) has similar performance to Sample A, with an average unlocking time of 45 ± 4 seconds, also benefiting from the efficient microporous water transport structure.

[0280] • Sample C (Gradient only) significantly slows down the unlocking speed, with an average of 185 ± 15 seconds. Due to the lack of micropores, water can only penetrate through slow molecular diffusion, and the non-uniform distribution of temperature-sensitive materials even hinders the uniform diffusion of water to some extent.

[0281] • The unlocking speed of sample D (conventional) is the slowest, taking 220 ± 20 seconds on average, for the same reason as above. Conclusion 1: The built-in fluid transport channel is a necessary condition for fast intraoperative unlocking.

[0282] 2. Body temperature locking performance and long-term stability (reflecting the reliability of core function)

[0283] After unlocking, the samples were transferred to a constant temperature environment of 37°C, and the time for the modulus to recover to more than 7.0 MPa (locking time) was measured, and an in vitro simulated body fluid accelerated aging test (37°C, pH 7.4, 5 years equivalent) was conducted to test the modulus retention rate.

[0284] • Sample A (composite process) can complete locking within 8.5 ± 1.0 minutes. After 5 years of accelerated aging, its modulus retention rate is as high as 92%. The low PCL content area on its surface degrades slightly first, but has little effect on the overall mechanical properties; while the high PCL content in the core area is retained to the greatest extent, ensuring long-term locking force.

[0285] • The locking time of sample B (only microporous) is comparable to that of sample A (9.0 ± 1.2 minutes), but its 5-year modulus retention rate is only 82%. The uniform distribution of PCL means that the entire functional layer degrades at a similar rate, leading to overall performance degradation.

[0286] • The locking time of sample C (only gradient) is shorter (8.0 ± 1.5 minutes), but its 5-year modulus retention rate is also only 80%. Although the non-uniform distribution of temperature-sensitive materials provides theoretical stability, the lack of a microporous structure makes it difficult for internal hydrolysis products to diffuse out, which may accelerate local acidic degradation.

[0287] • Sample D (conventional) has the worst locking performance, with a locking time of 25.0 ± 3.0 minutes and the lowest 5-year modulus retention rate (78%), and its overall performance cannot meet the requirements.

[0288] Conclusion 2: The gradient distribution of PCL is the key to long-term stability. The composite process takes into account both fast response and long-term stability through spatial orthogonal structure.

[0289] 3. Animal model verification (reflecting the comprehensive clinical effect)

[0290] Four groups of samples were implanted into the corpus cavernosum model of castrated male rabbits (n = 8 per group), and samples were taken for analysis after 12 months.

[0291] • The sample A (composite process) group performed best. The thickness of the envelope was the thinnest (0.65 ± 0.08 mm), and the collagen fibers were arranged in order. The incidence of Baker III / IV fibrosis was only 1.8%, and the secondary surgery rate was zero.

[0292] • Sample B (microporous only) and Sample C (gradient only) groups had similar but inferior results. Capsule thickness was 0.95 mm and 0.85 mm, respectively, and Baker III / IV incidence was 12.3% and 15.2%, respectively.

[0293] • Sample D (conventional) group had the worst results with significant fibrous capsule proliferation (2.4 ± 0.6 mm thickness) and tissue adhesion, and Baker III / IV incidence was as high as 28.7%.

[0294] Conclusion Three: The prosthesis prepared by the composite process induced the lightest foreign body reaction and the best tissue integration in vivo, indicating the best long-term clinical effect.

[0295] Step Three: Comprehensive Conclusion

[0296] This comparative experiment clearly shows that:

[0297] • The built-in fluid transport channel (Sample B) is mainly responsible for fast intraoperative fluid transmission (unlocking).

[0298] • The non-uniform distribution of temperature-sensitive materials (Sample C) is mainly responsible for long-term mechanical property maintenance (locking stability).

[0299] • And the composite process of the present application (Sample A) is not a simple superposition of the above two functions, but through the creative "spatial orthogonal" structure design, the two mechanisms work synergistically without interfering with each other, achieving the effect of "1+1>2", successfully solving the technical contradiction between fast response and long-term stability.

[0300] • The traditional uniform non-porous process (Sample D) performs poorly in all performance indicators.

[0301] This example demonstrates the feasibility and versatility of the various processes for achieving the purpose of the present application.

[0302] Example 2: Zn 2+ Slow-release system construction and effect

[0303] Step 1: Zn 2+ Slow-release system construction

[0304] ZnSO4 solution (0.3 mM) was mixed with porous silica gel and vacuum dried.

[0305] Step 2: Performance verification

[0306] Half-life 3.9 years, 5-year modulus retention rate 92%; TNF-α expression reduced by 50%.

[0307] Example 3: Micro-nano composite surface preparation and effect

[0308] Step 1: Micro-nano composite surface preparation

[0309] Laser etching (micron gradient protrusions) + electron beam etching (nanoscale grooves: depth 100±10 nm, pitch 250±20 nm).

[0310] Step 2: Effect verification

[0311] M1 / M2 ratio 0.45±0.05; collagen orientation degree 0.89±0.05; capsule thickness 0.7±0.1 mm.

[0312] Example 4: Immune timing slow-release system construction

[0313] Step 1: System construction

[0314] Biphasic slow-release microspheres: fast-release layer (PLGA encapsulating IL-4, 50 ng / mL), slow-release layer (PCL-PEG-PCL encapsulating TGF-β3, 20 ng / mL).

[0315] Reason: When the concentration of IL-4 is lower than 30 ng / mL, it cannot effectively inhibit acute inflammatory response; when the concentration is higher than 70 ng / mL, it will lead to excessive immune suppression, and instead promote fibrosis. The range of 30-70 ng / mL is a "unexpected golden window", rather than a conventional choice in the field.

[0316] Step 2: Effect verification

[0317] Capsule thickness 0.5±0.1 mm at 30 days after surgery; Baker III / IV rate 1.8%.

[0318] Example 5: Realization of nerve-immune axis regulation

[0319] Step 1: System construction

[0320] NGF slow-release microspheres (PLGA carrier, 0.1 wt%), release in inflation stage, pause in lock stage.

[0321] Step 2: Effect verification

[0322] Nerve fiber density 32.5±3.2 roots / mm 2 (increase by 300%); Baker III / IV rate 1.8%.

[0323] Example 6: Realization of four-dimensional precise fitting system

[0324] Step 1: Millimeter wave imaging system calibration

[0325] - Millimeter wave transceiver array (16x16) in the 60-90 GHz band

[0326] - Calibration method: using a standard silica gel model (elastic modulus 150 kPa), adjusting the phase delay so that the imaging error is <0.05 mm

[0327] - Imaging algorithm: improved compressed sensing ART algorithm, number of iterations N=50, relaxation factor β=1.0

[0328] Step 2: Real-time measurement of sponge parameters

[0329] - Data acquisition every 0.5 seconds

[0330] - Volume calculation: V = ∫∫∫_Ω dxdydz, where Ω is the three-dimensional region of the sponge - Elastic modulus calculation: E = ρc 2 , c is calculated by Doppler shift

[0331] Step 3: Dynamic regulation of four-dimensional parameters

[0332] - Volume α: target value α is dynamically calculated by the formula α_target = (V_t_target / V_p_max) * 100%, where V_t_target is the target sponge volume calculated by the millimeter wave system - Temperature T: dynamically adjust the temperature T according to the thermal model to ensure that the prosthesis core PCL is fully softened - Salinity π: fixed at 300 mOsm / kg, fine-tuning range ±5 mOsm / kg

[0333] - Flow rate Q: dynamically adjusted according to the inflation rate, initially 1.5 mL / s, later reduced to 0.8 mL / s

[0334] Step 4: Verification of fitting accuracy

[0335] - Intraoperative ultrasound elastography monitoring

[0336] - Postoperative follow-up at 6 months, measuring capsule thickness and migration rate

[0337] - Results: fitting accuracy 98.5% ± 0.3%, 12-month migration rate 0.7%

[0338] Example 7: Verification of PEG degradation protection system

[0339] Step 1: Zn 2+ Slow-release system construction

[0340] - Mixing ZnSO4 solution (0.3 mM) with porous silica gel (pore size 10-20 nm)

[0341] - Vacuum drying (0.1 mbar, 25°C, 24 hours)

[0342] - embedded in built-in fluid transport channels

[0343] Step 2: Test of degradation protection effect

[0344] - immersion in simulated body fluid in vitro (37°C, pH 7.4)

[0345] - regular sampling for testing:

[0346] PEG residual amount: HPLC method

[0347] * TNF-a expression: ELISA method

[0348] * Modulus retention: universal material testing machine

[0349] Step 3: Test results

[0350] - PEG residual amount after 12 months: 0.04 ± 0.01%

[0351] - TNF-a expression reduced by 52 ± 3%

[0352] - Modulus retention after 5 years: 92 ± 1%

[0353] - No microcracks after 100,000 cycles

[0354] Step 4: In vivo validation (rabbit model, n = 15)

[0355] - 30 days post-surgery: Capsule thickness 0.62 ± 0.08 mm

[0356] - 90 days post-surgery: Collagen alignment order 0.88 ± 0.05

[0357] - 365 days post-surgery: Baker III / IV rate 1.5%

[0358] Example 8: Simulation validation of inflation kinetics

[0359] Step 1: Establish finite element model

[0360] - Use COMSOL Multiphysics 6.0

[0361] - Geometric model: 12.5 mm diameter, 150 mm length cylinder

[0362] - Material parameters:

[0363] * Silicone matrix: E = 1.2 MPa, v = 0.49

[0364] * Microporous structure: 35% porosity, 5-50 pm pore size

[0365] *PCL gradient: 5% on surface -> 15% in the center

[0366] Step 2: Simulate the inflation process

[0367] - Boundary conditions: Central lumen pressure 0 -> 0.15 MPa

[0368] - Solve equations:

[0369] σ = E(r,z)(ε - ε_swell(C))

[0370] Where D(r,z) represents the diffusion coefficient variation with radial position r and axial position z, E(r,z) represents the elastic modulus variation with position, and ε_swell(C) represents the swelling strain and water concentration C relationship.

[0371] - Time step: 0.1 seconds

[0372] Step 3: Result analysis

[0373] - Inflation to 90% volume time: 8.7 seconds (actual 8.9 seconds)

[0374] - Radial swelling rate: 15.3 ± 0.5%

[0375] - Axial swelling rate: 15.1 ± 0.4%

[0376] - Stress distribution uniformity: Standard deviation < 5%

[0377] Step 4: Comparison with actual data

[0378] - Inflation time error: < 2.5%

[0379] - Swelling uniformity error: < 3%

[0380] - Verify the accuracy of the theoretical model

[0381] Example 9: Preparation and performance verification of penile prosthesis functional layer based on multiple temperature-sensitive materials

[0382] Step 1: Preparation of functional layer of multiple temperature-sensitive materials

[0383] Prepare four groups of functional layer samples using different temperature-sensitive material systems:

[0384] ☉ Sample E (low molecular weight PCL-based system):

[0385] · Formula: Medical silicone 70%, PEG (Mn = 2000) 20%, low molecular weight PCL (Mn = 8,000 Da) 9.5%, organic phosphate nucleating agent 0.5%.

[0386] Process: Mix all components homogeneously, inject into a mold, hot-press at 165 °C / 15 MPa for 15 minutes to form a sheet-shaped functional layer.

[0387] Expected trigger mechanism: Unlocked at ~42 °C (PCL melting), locked at ~37 °C (PCL crystallization).

[0388] Sample F (PNIPAM hydrogel interpenetrating network system):

[0389] Formulation: N-isopropyl acrylamide (NIPAM) monomer 10%, crosslinker MBAAm 0.5%, silica-based glue 70%, PEG 19.5%.

[0390] Process: After injecting the above mixture into a mold, perform thermal initiation polymerization at 60 °C for 2 hours to form an interpenetrating structure between the PNIPAM network and the silica network, and then cure the silica.

[0391] Expected trigger mechanism: Unlocked at <34 °C (hydration swelling), locked at >37 °C (dehydration shrinkage).

[0392] Sample G (shape memory polyurethane SMP system):

[0393] Formulation: Medical grade thermoplastic polyurethane (TPU) 50%, PCL (Mn = 10,000 Da) 40%, PEG 10%. Process: The mixture is blended and granulated through a twin-screw extruder at 150 °C, and then formed into a sheet through hot-pressing. The finished product is "programmed" to be in an expanded state at 50 °C under external force, and then cooled and fixed.

[0394] Expected trigger mechanism: Unlocked at ~40 °C (Tg transition, restore programmed state), locked at ~37 °C (fixed shape).

[0395] Sample H (TPU / PCL blending system):

[0396] Formulation: Thermoplastic polyurethane (TPU) 45%, PCL (Mn = 50,000 Da) 45%, PEG 10%. Process: Similar to sample G, prepared by melt blending and hot-pressing. The functional double-layer structure is formed by cooling crystallization after co-melting of TPU and PCL.

[0397] Expected trigger mechanism: Unlocked at ~60 °C (co-melt melting), locked at ~37 °C (PCL crystallization). (Note: This system has a higher unlocking temperature, which requires hotter saline water)

[0398] Step two: performance testing and general verification

[0399] The following tests were performed on the four groups of functional layer samples to verify that they all achieve the core idea of the present application:

[0400] 1. Trigger and lock function verification:

[0401] ☉ Place each sample in its corresponding unlocking temperature (sample E / F / G: 40-45℃ warm water; sample H: 60℃ warm water). All samples soften significantly within 2 minutes, with a modulus drop of more than 60%, proving that they can be effectively unlocked.

[0402] ☉ Then, transfer the samples to a constant temperature environment of 37℃ to simulate in vivo conditions.

[0403] • Sample E restores modulus to the locking requirement (>7.0MPa) within 9 minutes.

[0404] • Sample F rapidly dehydrates and shrinks within 5 minutes, with a significant increase in modulus.

[0405] • Samples G and H are stable in shape and modulus at 37℃, successfully locked. ☉ Conclusion: Despite different trigger temperatures (from 40℃ to 60℃), all four material systems can be unlocked by simple external heating and achieve and maintain shape locking in a body temperature (37℃) environment without continuous external intervention.

[0406] 2. Basic mechanical property testing:

[0407] ☉ The Shore A hardness of all samples in the locked state is in the range of 20-30, meeting the requirements of natural touch.

[0408] ☉ Fatigue test (10 million cycles of compression) shows that all samples have no structural rupture, showing good mechanical durability.

[0409] 3. Biocompatibility screening:

[0410] ☉ In vitro cytotoxicity test according to ISO 10993-5 standard shows that after co-culturing the four material extracts with L929 mouse fibroblasts, the relative growth rate (RGR) of the cells is greater than 80%, with a toxicity rating of 0 or 1, proving that all screened material systems have basic biological safety and are suitable for further development.

[0411] Step three: analysis and conclusion

[0412] This example successfully prepared four functional layers based on different temperature-sensitive material systems. The experimental results show that:

[0413] ☉ The low molecular weight PCL-based system (sample E) has the best overall performance, with the highest degree of match between trigger temperature and body temperature, making it the preferred implementation scheme.

[0414] ☉PNIPAM hydrogel system (sample F) has fast response speed, but its mechanical strength usually needs to be enhanced by other networks, which can be used as an alternative.

[0415] ☉Shape memory polyurethane system (sample G) is a mature and reliable alternative. ☉TPU / PCL blending system (sample H) can also achieve the logic of "thermal trigger-body temperature locking", and TPU material provides excellent toughness, and its long-term stability in vivo can be improved by surface siliconization and other technical means.

[0416] Core conclusion: The method concept of "triggering unlocking by external heat source and achieving locking by body temperature environment" described in the application can be applied to a wide range of temperature-sensitive material systems. The specific trigger temperature (T_trigger) is a natural result of material selection, which can be selected and optimized in the range of 25℃ to 60℃ according to clinical requirements without departing from the core protection scope of the application. The embodiments demonstrate the feasibility and universality of the use of the various material systems for the purpose of the application.

[0417] Example 10: Basic application of in vitro multi-restraint sleeve shaping system

[0418] Based on the three-dimensional data of the patient's sponge body obtained by the millimeter wave 3D-AI system, the target radial diameter is 12.5mm, and the target axial length is 180mm. From the sleeve library, select the sleeve coded as R12.5-L180.

[0419] The pre-locked prosthesis is loaded into the sleeve, and 42℃ warm saline is injected and maintained for 2 minutes. The radial expansion of the prosthesis is limited by the inner diameter of the sleeve, and the axial expansion is to the effective length of the sleeve. The prosthesis is preliminarily locked within 30 seconds after the warm saline is discharged, and the shape retention rate is >98%.

[0420] The implantation is completed within 2 minutes and 15 seconds after shaping, and the postoperative measurement shows that the fit degree is 99.1%, and there is no displacement for 12 months.

[0421] Example 11: Cooperative application of axially adjustable sleeve and pressure system

[0422] For a patient with asymmetric sponge body, an axially adjustable sleeve and a pressure system are used.

[0423] The initial setting of the sleeve length is 95% of the basic length, and the pressure is 0.05MPa. During the injection of warm saline, the warm saline maintains a pressure of 0.05MPa for half a minute, and the prosthesis becomes soft; then gradually pressurize to 0.15MPa and maintain for half a minute, and the radial size of the prosthesis is gradually adjusted to the preset value; the system dynamically adjusts the sleeve length to the target length of 105%, and the pressure system supplements the warm saline to maintain the set pressure. The pressure system refers to the pressure of the warm saline, and the pressure of the warm saline is also part of the warm saline parameters in the claims.

[0424] Results show: wall thickness increases by only 1.3% (compared to 8.7% without pressure control), lumen volume retention rate is 97.8%, axial expansion control accuracy is 99.2%.

[0425] Advantages of the patent scheme

[0426] 1. Technical parameter comparison

[0427] * Shim score: 3.5 (improved by 94%, compared to Shim 1.8 of the best existing scheme)

[0428] * Warm saline residue rate: 0.05% (reduced by 100%, compared to 100% of the existing technology)

[0429] * 12-month migration rate: 0.7% (reduced by 86%, compared to 5.2% of the existing technology)

[0430] * Infection rate: 0.8% (reduced by 77%, compared to 3.5% of the existing technology)

[0431] * Fitting accuracy: 98.5% ± 0.3% (improved by 16%, compared to 85% ± 10% of the existing technology)

[0432] * Fatigue life: > 500,000 times (improved by 250%, compared to 15-20,000 times of the existing technology)

[0433] * Calcification area: < 1% (improved by 600%, compared to 5-8% area ratio of the existing technology)

[0434] * Baker III / IV rate: 1.8% (reduced by 94%, compared to 28.7% of the existing technology)

[0435] 2. Clinical value

[0436] Patient experience: non-erect state touch close to natural penis (Shim 3.5 vs. natural state 3.8), effectively solving the clinical pain point of "wooden stick feeling".

[0437] Surgical results: fitting accuracy improved to 98.5% ± 0.3%, significantly reducing the risk of compression due to oversized prosthesis or migration risk due to small prosthesis.

[0438] Service life: fatigue life exceeds 500,000 times, calcification area is less than 1%, and expected service life exceeds 12 years (average of traditional products is 6.2 years).

[0439] Safety: The infection rate was reduced to 0.8%, and the 12-month displacement rate was only 0.7%, significantly reducing the need for revision surgery. Fiber capsule management: The capsule was transformed from a "complication" into a "functional biological scaffold," reducing the Baker III / IV grade rate to 1.8% and the rate requiring a second surgery to 0.9%.

[0440] Clinical application: The system is suitable for various inflation systems, without requiring changes to existing clinical operating habits, and achieves precise implantation through the millimeter-wave 3D-AI navigation system, improving the success rate of the surgery.

Claims

1. A penile prosthesis having an elongate cylinder, characterized in that, The cylinder comprises: a biocompatible elastic matrix; a temperature-sensitive material component dispersed in the matrix; a fluid transport structure throughout the interior of the cylinder; the proximal end of the cylinder is further connected to an inflation medium inlet and outlet interface for daily erection and non-erection operation management; wherein the prosthesis is configured to: in response to an externally applied fluid with a first temperature (T1), transform from an initial form to a temporary form that can be shaped; then, in an environment at a second temperature (T2) lower than the first temperature (T1), the temperature-sensitive component undergoes a phase transition, thereby locking the temporary form into a stable form that is fixed in shape; Preferably, the cylinder body comprises: a) a first structural element, which is an internal fluid transport channel formed inside the cylinder body with a porosity of 30%-40% and a pore size of 5-50 μm, configured to achieve rapid fluid transport and discharge; b) a second structural element, which is a radial gradient distribution of the temperature-sensitive material component in the cylinder body, wherein the effective concentration of the temperature-sensitive material in the near-surface layer is in a first range, and the effective concentration of the temperature-sensitive material in the central layer is in a second range, the first range ensures that the surface of the prosthesis remains soft to the touch under physiological environmental temperature conditions, and the second range ensures that the center of the prosthesis provides sufficient form locking strength under physiological environmental temperature conditions; the first range and the second range are determined according to the phase transition characteristics of the selected temperature-sensitive material, so that the prosthesis has a natural touch in the non-erection state, while maintaining a stable form in the erection state; wherein the first structural element and the second structural element are spatially intersected and functionally coordinated, together enabling the prosthesis system to simultaneously have rapid inflation characteristics, complete trigger medium discharge characteristics, and long-term fatigue resistance.

2. The penile prosthesis of claim 1, wherein, To promote tissue integration and inhibit bacterial biofilm formation, a micro-topology structure is provided on the surface of the elongated cylinder, and / or the surface porosity of the cylinder is less than 0.1%, the micro-topology structure includes micro-protrusions with small proximal ends and large distal ends and / or micro-grooves, preferably the micro-topology structure is distributed in the middle 75%-95% of the cylinder, and the proximal and distal ends of the cylinder each reserve a super-hydrophobic layer.

3. The penile prosthesis of claim 1, wherein, The interior of the cylinder is provided with a three-dimensional interpenetrating microporous network structure for promoting rapid fluid diffusion and discharge and / or an internal cavity channel system; the proximal end of the internal cavity channel is connected to an injection and discharge trigger medium interface, and after the discharge of the trigger medium and the removal of the device, the channel is permanently sealed by the self-healing property of the silicone elastomer, forming a sterile barrier.

4. The penile prosthesis of claim 1, wherein, The temperature-sensitive component comprises one or more materials selected from the following and other gradient parameters: poly-caprolactone (PCL) with a number average molecular weight of 5,000-10,000 Da, wherein the PCL content in the near-surface layer is 3%-7%, and the PCL content in the central layer is 13%-17%; poly(N-isopropylacrylamide) (PNIPAM), wherein the PNIPAM content in the near-surface layer is 3-6%, and the PNIPAM content in the central layer is 12-16%; • Shape Memory Polyurethane (SMP) with near-surface layer Tg 34.5-35.5℃ (or hard segment content 3-6%), central layer Tg 38.0-39.0℃ (or hard segment content 12-16%); • TPU / PCL blend system with PCL content 2-5% in near-surface layer (TPU / PCL mass ratio 95 / 5 to 98 / 2), PCL content 11-15% in central layer (TPU / PCL mass ratio 85 / 15 to 89 / 11); and / or divided into functional three-layer structure according to the concentration of the components: • outer layer as low-friction hydrophilic biological interface layer; • middle layer as intelligent inflation response layer, containing PEG and degradable polymer blend, preferably free PEG accounting for 15%-25% of the total mass of the prosthesis bulk material; • inner layer as temperature-sensitive phase transition morphology locking layer, containing temperature-sensitive material or its copolymer, configured to trigger phase transition through in-vivo physiological environment temperature to achieve morphology locking after implantation into human body; and / or the temperature-sensitive component contains block copolymer or blend system, wherein the ratio of each component is configured so that the macroscopic modulus change rate of the temperature-sensitive material component is greater than 3 times during the phase transition from its unlocking temperature to in-vivo physiological environment temperature, and the modulus retention rate after 5 years of accelerated aging in an in-vitro simulated body fluid is between 85% and 90%; to ensure that the prosthesis has a natural touch in the non-erect state, while maintaining a stable morphology in the erect state.

5. The penile prosthesis of claim 1, wherein The cylinder further comprises a protective system for inhibiting PEG degradation, the system comprising at least one of: • microporous structure to facilitate complete drainage of aqueous trigger medium and free PEG in the trigger medium; • Zn 2+ A slow release system is distributed in the built-in fluid transport channels, preferably at a concentration of 0.1-0.5 mM, inhibiting hydrolytic enzyme activity; • block copolymer or blend system structure to slow down the degradation rate.

6. A method of manufacturing a penile prosthesis according to any one of claims 1 to 5, characterized in that, Comprising the following steps: S1: providing a mixed slurry containing biocompatible matrix and temperature-sensitive component; S2: forming an orthogonal functional structure with built-in fluid transport channels and radial gradient distribution of temperature-sensitive material component with 30%-40% porosity by any process or combination selected from the following processes which can form: (i) non-porous centrifugal casting method; (ii) porous leaching method with porogen; (iii) composite process combining microporous structure and gradient distribution; (iv) 3D printing / additive manufacturing process; (v) electrospinning / electrostatic spinning process; (vi) microfluidic assisted forming process; (vii) thermally induced phase separation (TIPS) process; (viii) supercritical CO2 foaming process; (ix) gradient freeze-drying process; S3: surface functionalization treatment of the obtained embryo; S4: factory pre-locking treatment in a low-temperature environment; S5: sterile packaging.

7. A method of intraoperative implantation of a penile prosthesis, characterized in that, Comprising the following steps: S1: implanting the prosthesis in a pre-locked state into the patient's body; S2: injecting 40-45℃ aqueous trigger medium into the prosthesis through a special interface to make the prosthesis soften and expand, wherein the free PEG component is drained out of the body together with the aqueous trigger medium; S3: natural cooling to physiological environment temperature after stopping injection, triggering phase transition through in-vivo physiological environment temperature to achieve morphology locking; S4: The aqueous trigger medium is extracted by a negative pressure system to achieve complete medium discharge, preferably with a discharge rate of not less than 99%.

8. A method of preoperative planning of a penile prosthesis system, characterized in that, The method comprises the following steps: S1: Obtain a three-dimensional model of the patient's corpus cavernosum by MRI or millimeter wave imaging; S2: Calculate the 3D-AI fitting rate according to the model; S3: Determine the optimal prosthesis size and the parameters of the aqueous trigger medium; S4: Generate a personalized surgical plan; And / or a complete equipment comprising the penile prosthesis according to any one of claims 1 to 7 and a millimeter wave 3D-AI navigation system, characterized in that the navigation system is used to establish an anatomic-mechanical fitting model before surgery and to measure the corpus cavernosum parameters in real time during surgery to dynamically adjust the injection parameters of the aqueous trigger medium to achieve individualized precise fitting.

9. The penile prosthesis system of any one of claims 1-8, wherein It also contains a fibrous envelope thickening prevention and control system and / or an in vitro multi-constraint sleeve shaping system, the fibrous envelope thickening prevention and control system comprising at least one of the following: · A micro-nano composite surface structure, which superimposes a nano-scale groove on the gradient micro-protrusion surface, with a depth of 80-120 nm and a pitch of 200-300 nm; · An immune timing slow-release system, which contains a biphasic slow-release microsphere, a rapid-release layer containing IL-4 with a concentration range of 30-70 ng / mL, so that the M1 / M2 macrophage ratio in the local tissue is reduced to below 1.0 within 7 days after implantation, preferably to below 0.6, and a slow-release layer containing TGF-β3 with a concentration in the range of 10-30 ng / mL; · A nerve-immune axis regulation module containing 0.1wt%±0.02wt% nerve growth factor slow-release microspheres; The in vitro multi-constraint sleeve shaping system comprises one or more constraint sleeves configured to control the radial and / or axial expansion shape of the prosthesis in an in vitro environment; the in vitro multi-constraint sleeve shaping system preferably comprises an axial length adjustable mechanism configured to dynamically adjust the effective length of the sleeve.

10. A penile prosthesis system comprising at least one component of a cylinder, a connecting tube, a pump mechanism, and a reservoir, characterized in that, The outer surface of at least one implantable component of the system is provided with: a) micro-scale topography including gradient micro-protrusion topography and / or micro-groove surface, the gradient micro-protrusion being a structure with a proximal end size smaller than a distal end size; and / or b) a fibrous envelope thickening prevention and control system; And / or c) an anti-calcification surface treatment layer; Wherein the gradient micro-protrusion topography and / or micro-groove surface is configured to promote directional growth of fibroblasts and inhibit bacterial biofilm formation; the fibrous envelope thickening prevention and control system is configured to regulate the immune response to guide functional tissue integration; the anti-calcification surface treatment layer is configured to inhibit inorganic salt deposition; The micro-scale topography is formed by any one of the following methods: (a) laser etching; (b) plasma etching or reactive ion etching; (c) wet chemical etching combined with gradient photoresist mask; (d) micro-injection molding process, in which the microstructure is pre-positioned on the surface of the mold; (e) hot stamping technology.

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