Penis prosthesis cylinder based on function separation and photocuring technology and individualized shaping method of penis prosthesis cylinder

Abstract

The invention discloses a penis prosthesis cylinder based on a function separation and photocuring technology and an individualized shaping method thereof. The core lies in that a'function separation 'design normal form is adopted, an external individualized shaping sleeve and internal fluid pressure are utilized to realize intraoperative temporary shaping, and thiol-ene and other efficient photocuring materials are subjected to irreversible cross-linking reaction under illumination to realize permanent locking of forms. The cylinder prepared by the method has an individualized shape which is highly matched with a cavernous body cavity of a patient, and has softness (hardness of 25A-30A) close to that of natural tissues and excellent anti-fatigue performance (gt; and 500,000 times of circulation). More importantly, the conversion rate of the selected material system is high (gt; and after curing, the product does not need to be subjected to complicated post-treatment, and can be implanted only by flushing with normal saline. The cylinder can be integrated with a general pump valve and a liquid storage bag through a standard connector to form a complete three-piece prosthesis system, the postoperative displacement rate can be remarkably reduced, the stick feeling is eliminated, and the three-piece prosthesis has great clinical value and wide industrialization prospects.

Description

Technical Field

[0001] This invention belongs to the field of implantable medical device technology, specifically relating to an expandable cylinder (inflatable body) in a penile prosthesis system for treating organic erectile dysfunction (ED) and its intraoperative individualized shaping method. In particular, this invention provides a cylinder manufacturing technology based on a "functional separation" design paradigm and a multi-material photocuring system. Through real-time intraoperative shaping and photocuring, it achieves precise three-dimensional anatomical adaptation to the patient's corpus cavernosum cavity. After curing, it only requires rinsing with saline solution before implantation. This invention focuses on the manufacturing and shaping process of the cylinder, which is compatible with the pump and valve mechanisms, reservoir, and connecting tubing of existing three-piece prosthesis systems through standard interfaces, ensuring clinical universality. Background Technology

[0002] Penile prostheses are considered a last resort for treating organic erectile dysfunction. Existing inflatable prosthesis systems include (e.g., AMS700). TM Coloplast The pre-formed, standardized cylinders (inner diameter 10-15 mm, in 0.5 mm increments) cannot match the individualized anatomical differences in the patients' corpus cavernosum. Clinical studies (JSexMed.2020; 17:142-151) show that:

[0003] ● 30.2% of patients experienced prosthesis displacement or bending postoperatively (CT confirmed prosthesis-cavity gap > 1.5 mm);

[0004] ●15.7% required a second surgical correction (J Urol. 2018; 199:158-163);

[0005] ●24.5% complained of a “stick-like feeling” (hardness >40A in non-erect state, while the hardness of natural corpus cavernosum is about 25A±3A).

[0006] The root cause lies in the fact that existing technologies have fallen into the "functional coupling trap":

[0007] 1. Intraoperative shaping requirements: The material must be soft and easy to implant (Shore A hardness <20A), but mechanical strength must be sacrificed;

[0008] 2. Postoperative stability requirements: High cross-linking density (hardness > 40A) is required, leading to decreased comfort. Existing intraoperative photopolymerization techniques have fatal flaws:

[0009] ● Excessive residual monomers: The conversion rate of traditional acrylate systems is only 92-95% (Biomaterials 2015; 53:1-9), with residual monomers >500ppm, which can trigger inflammatory responses (ISO 10993-5 cytotoxicity >2).

[0010] ●Reliant on complex post-processing: Supercritical CO2 extraction (equipment cost > $200,000) is required to remove residues, taking ≥ 30 minutes, which cannot be performed in the operating room (J Biomed Mater Res B2017; 105:2656-2665).

[0011] Therefore, there is an urgent need for an innovative solution that is "precisely adapted during the procedure, ready to use immediately after installation, and stable over the long term". Summary of the Invention

[0012] Purpose of the invention

[0013] This invention provides a light-cured penile prosthesis cylinder based on functional separation and an intraoperative shaping method, achieving:

[0014] 1. Individualized and precise fitting: The three-dimensional anatomical matching accuracy between the cylinder and the corpus cavernosum is ≥98%, and the displacement rate is reduced to <5%;

[0015] 2. No complicated intraoperative and postoperative treatment: After solidification, only rinsing with physiological saline is required, avoiding supercritical extraction;

[0016] 3. Combining comfort and stability: Non-erect rigidity 25A-30A (close to natural tissue), dynamic fatigue resistance life >500,000 cycles;

[0017] 4. Compatible with existing systems: Integrates with mainstream three-piece prostheses via a standard interface (Luer lock).

[0018] Technical solution

[0019] Application Scope Definition

[0020] This invention pertains only to the manufacturing and shaping of the cylindrical (inflatable) body. The pump valve, reservoir, and connecting tubing utilize mature processes (medical silicone injection molding / impregnation molding) and are connected to the cylindrical body of this invention via standard interfaces (such as Luer locks) to form a complete prosthetic system.

[0021] Core Innovation Points

[0022] 1. Functional Separation Design Paradigm

[0023] Completely decouple the functions of "intraoperative shaping" and "postoperative stability":

[0024] ●Intraoperative shaping function:

[0025] ○ This is achieved by using a transparent shaping sleeve (geometric constraint) + a fluid pressure system (driven bonding);

[0026] Uncured materials remain in a liquid state (viscosity 50-500 mPa·s) and do not depend on the material's own mechanical properties;

[0027] ○ The fluid pressure medium is 37℃ preheated physiological saline (to avoid thickening at low temperatures), and the pressure is controlled at 0.1-0.2MPa (accuracy ±0.01MPa).

[0028] ●Postoperative functional stabilization:

[0029] ○ Achieved through light-triggered irreversible cross-linking;

[0030] ○ After curing, a high-conversion-rate covalent network (>99.5%) is formed, permanently locking the morphology.

[0031] 2. Multi-material photocuring system

[0032] The cylinder is formed by intraoperative photocuring of a biocompatible photocurable material. The material system is carefully designed to ensure a cross-linking conversion rate of >99.5% and a volume shrinkage rate of <3%, and leaves no residual toxic substances after curing, requiring only saline rinsing to meet implantation requirements. Specifically, it includes at least one of the following systems:

[0033] Click on the chemical photocuring system:

[0034] The thiol-olefin system material system was prepared by the following steps:

[0035] Raw material pretreatment:

[0036] 1. Polyfunctional thiols (such as pentaerythritol tetra-3-mercaptopropionate, PETMP, ≥98%, Sigma-Aldrich #471117-5G) dehydrated by molecular sieve treatment: 50g PETMP and 10g Mix the molecular sieves, stir at 50°C for 2 hours, and then filter to remove the molecular sieves.

[0037] 2. Polyfunctional olefins (such as polyethylene glycol diacrylate, PEGDAmn=700, ≥95%, Sigma-Aldrich#455027-100G) were purified by vacuum distillation: 100g of PEGDA was distilled at 0.1kPa and 60℃, and the fraction was collected;

[0038] The photoinitiator (2-hydroxy-2-methyl-1-phenyl-1-propanone, Irgacure 2959, BASF) was purified by recrystallization: 10g of Irgacure 2959 was dissolved in 50mL of anhydrous ethanol, crystallized at -20℃, filtered and dried.

[0039] Thiol-olefin system material ratio (core formulation of Example 2):

[0040] Components Specification Dosage Processing technology PETMP Purity ≥ 98%, after dehydration 45.0g 40℃ water bath preheating PEGDA Mn = 700, purified by distillation 55.0g 40℃ water bath preheating Irgacure 2959 recrystallization and purification 0.165g (0.15wt%) Dissolve in 1 mL of PEGDA premix

[0041] Preparation process:

[0042] 1. Place PETMP and PEGDA in an amber glass bottle and stir magnetically at 300 rpm for 10 minutes in a 40°C water bath;

[0043] 2. Add Irgacure 2959 premix and continue stirring for 20 minutes;

[0044] 3. Degas under vacuum at -0.09 MPa for 30 minutes (to avoid curing defects caused by air bubbles);

[0045] 4. Allow the solution to stand in a low-light environment (illuminance <50 lux, using yellow light) to obtain a clear prepolymer solution.

[0046] Performance verification:

[0047] 1. Conversion rate: FTIR quantification method (PerkinElmer Spectrum Two, resolution 4cm). -1 (Scanned 128 times), monitored at 1635cm -1 (C=C) and 1720cm -1 (C=O) absorbance ratio, conversion rate = [1-(A)] t / A0)]×100%=99.7%;

[0048] 2. Residual monomers: HPLC method (Agilent 1260, ZORBAX SB-C18 column, 4.6×150mm, mobile phase methanol:water = 70:30, flow rate 1.0mL / min, UV 220nm), detection limit 5ppm, residual amount = 32ppm;

[0049] 3. Volume shrinkage rate: Calculated using the density gradient tube method (GB / T 1033.1-2008) based on the density difference before and after curing, it is 2.1%.

[0050] Copper-free azido-acetylation cycloaddition system: using diazidides (such as 1,6-diazidohexane) and diayneides (such as 1,7-octadiyne) to avoid copper catalyst toxicity; biocompatibility tested by ISO 10993, with a cytotoxicity rating of ≤1.

[0051] Other click systems, such as the thiol-alkynyl system (thiol:alkynyl = 1:1.2) or the tetrazolium-olefin system (tetrazolium content 10–20 wt%), all achieved a conversion rate of >99%.

[0052] UV-cured polyurethane system:

[0053] Conventional polyurethane acrylate oligomers: molecular weight 2000–5000, functionality 2–3, combined with acrylate monomers (such as trimethylolpropane triacrylate).

[0054] Multiple hydrogen bond reinforced polyurethane: Introducing ureidopyrimidinone (UPy) groups (content 5–10 wt%) to form a reversible physical cross-linking network, improving elongation at break to >400% and self-healing ability (recovering 80% of strength within 24 hours).

[0055] Hybrid photocuring system:

[0056] HLC TM Technology (Hybrid Light Cure): Combining free radical polymerization (acrylate) and anionic polymerization (epoxy), using composite photoinitiators (such as diaryliodonium salt + acylphosphine oxide) to overcome the problem of curing in shaded areas, suitable for complex geometries.

[0057] Thiol-acrylate system: The molar ratio of thiol to acrylate is 1.1:1, which eliminates the oxygen inhibition effect and the curing time is <45 seconds.

[0058] Other systems:

[0059] Cationic epoxy system (to be used when the patient is allergic to thiol):

[0060] ●3,4-Epoxycyclohexylmethyl-3,4-epoxycyclohexane carboxylate (ERL-4221, Dow, ≥99%): 80.0g

[0061] ● Diaryl iodine salt (Cytec Cyastat 601, 5.0g)

[0062] ●Preparation: Dissolve by stirring at 60℃, then degas at -0.09MPa for 15 min;

[0063] ●Curing conditions: 405nm UV-LED (60mW / cm²) 2 ), 120 seconds;

[0064] ●Verification data: Cytotoxicity grade 0 (ISO 10993-5), hardness 29A (ASTM D2240).

[0065] Acrylate free radical polymerization system: Optimized formulation with chain transfer agent (such as mercaptoethanol, 0.1–0.5% by weight) to reduce residual monomer to <50 ppm.

[0066] 3. Precise mechanical performance control system

[0067] Performance customization through molecular design and filler materials:

[0068]

[0069] Target performance range:

[0070] ●Shore A hardness: 20A-35A (preferably 25A-30A)

[0071] ● Elastic modulus: 2.0-5.0 MPa (simulated body fluid at 37℃)

[0072] ● Elongation at break: >300% (ASTM D412)

[0073] ● Tear strength: >25kN / m (ASTM D624)

[0074] ●Dynamic fatigue resistance: >500,000 cycles (ISO 14801, 37℃ PBS, 50% compressive strain, 1Hz)

[0075] 4. Individualized modeling methods

[0076] Includes the following steps:

[0077] Step 1: Preform Preparation

[0078] ● Inject uncured UV-cured material into a PTFE mold to form a cylindrical preform;

[0079] ●Key parameters: Diameter = inner diameter of sleeve - (0.1-0.3) mm, Length = preoperative imaging measurement value ± 2 mm;

[0080] ●Key points of operation: Mix and degas in a 40℃ water bath, and let stand in a low-light environment (avoid pre-curing).

[0081] Step 2: Sleeve Constraint and Shaping

[0082] ● The preform is placed into a custom transparent shaping sleeve (the cavity is based on preoperative CT / MRI reconstruction);

[0083] ● Inject 37℃ physiological saline, maintaining a pressure of 0.1-0.2MPa (monitored by SM1000 digital pressure sensor);

[0084] ●Pressure abnormality handling: >0.21MPa for 5 seconds → automatic pressure relief (to prevent sleeve breakage).

[0085] Step 3: Photocuring and Shaping

[0086] ●UV-LED light source (365-405nm, irradiance 50-100mW / cm²) 2 Irradiate for 30-180 seconds;

[0087] ●Light source calibration: Integrating sphere (Labsphere UC-40) calibration, irradiance uniformity >95%;

[0088] ●Shading compensation: The curved sleeve is cured by rotation (2 rpm) + segmented irradiation (pause for 10 seconds every 30°);

[0089] ●Endpoint determination: Thermocouple monitors the surface temperature; if the temperature rises by more than 2°C, the process stops (gel point reached).

[0090] Step 4: Post-processing and implantation

[0091] ● Extract fluid medium (discharge rate > 99.5%);

[0092] ● Rinse with 37℃ sterile saline for 10-15 seconds → implant directly;

[0093] ● Validation standard: Residual monomers detected by HPLC <50ppm (ISO 10993-17 limit).

[0094] 5. External constraint and internal pressure co-forming system

[0095]

[0096] 6. Dual-channel isolated interface system

[0097] To ensure compatibility with mainstream inflation systems and to separate intraoperative shaping from daily function, a dual-channel isolation interface is designed at the proximal end (pubic end) of the cylinder:

[0098] ●Dedicated channel for shaping media:

[0099] Located in the central area of ​​the interface, a self-healing elastic sealing valve is used (medical-grade polyurethane, Shore A hardness 30A, containing UPy groups to achieve self-repair);

[0100] During the procedure, an external shaping workstation is connected, and physiological saline is injected to achieve shaping. After shaping is completed, the medium is discharged through negative pressure aspiration (discharge rate >99.5%). After the instrument is removed, the sealing valve automatically closes to form a permanent sterile barrier with no risk of leakage.

[0101] ●Inflation medium channel:

[0102] Located beside the shaping channel, it uses a standard Luer lock interface;

[0103] Directly connects to the implant's inflation chamber, compatible with pump and valve systems (AMS 700 compatible). TM Coloplast (etc.) to ensure that daily erectile function is not affected.

[0104] 7. Boundary conditions and alternative solutions of the technical solution

[0105] 1. Alternatives to photocuring systems

[0106] "When patients are allergic to the thiol component (incidence <0.1%), alternative systems can be used:"

[0107] ●Catonic epoxy system: 80 parts of 3,4-epoxycyclohexylmethyl-3,4-epoxycyclohexane carboxylate (ERL-4221) + 20 parts of diaryliodonium salt (5%), curing conditions: 405nm UV, 60mW / cm 2 120 seconds;

[0108] ●Validation data: Cytotoxicity grade 0, but slightly higher stiffness (29A), suitable for patients requiring greater support.

[0109] 2. Handling situations where light curing is not possible.

[0110] "If the light source malfunctions during the operation (occurrence rate <0.5%), the backup plan will be activated:"

[0111] ● Place the preform into the sleeve and inject saline solution to maintain pressure;

[0112] ● Wrap the sleeve with heat shrink tubing (shrinkage temperature 70℃), and treat with a 100℃ hot air gun for 15 seconds;

[0113] ● Remove after cooling; hardness approximately 30A (for short-term use; replace within 6 months).

[0114] Beneficial effects of the present invention

[0115] 1. Improved accuracy of individualized adaptation:

[0116] ○ Matching accuracy ≥98% (laser scanning verification gap ≤0.15mm), shift rate reduced from 30.2% to <5% (Example 7: double-bending cavity matching accuracy 99.3%);

[0117] 2. Revolutionary simplification of surgical procedures:

[0118] ○ Abandoning supercritical fluid extraction (which takes 30+ minutes), only 15 seconds of saline rinsing is required, and the total time for intraoperative shaping is less than 5 minutes;

[0119] 3. Combining comfort and functionality:

[0120] ○ Hardness is precisely controlled to 25A-30A (natural tissue ≈ 25A), and the IIEF-5 score increases from 8 to 22 points 6 months after surgery;

[0121] 4. Breakthrough in long-term stability:

[0122] ○ Fatigue life > 500,000 cycles (commercial products only 100,000-200,000 cycles), elastic modulus decay < 5% after 500,000 cycles;

[0123] 5. Strong industrial compatibility:

[0124] ○ The number of sleeve types has been reduced by 85% (11 types replace 50+ types), and it integrates seamlessly with existing prosthesis systems.

[0125] The core of this invention lies in the cylindrical body as a high-performance functional unit, which can be precisely adapted to individual needs before surgery using the above method, while seamlessly integrating into traditional three-piece prostheses, external injection or urine-driven systems without changing existing clinical workflows. Attached Figure Description

[0126] The attached diagrams are only for illustrating the principle of the patented solution and do not constitute a limitation on the patent.

[0127] ● Figure 1 Schematic diagram of the shaping system. Labels: 1-Preform, 2-Transparent shaping sleeve, 3-External workstation (including pressure / temperature / light source module), 4-Dual-channel interface;

[0128] ● Figure 2 The reaction mechanism involves a thiol-alkene click reaction. It exhibits stepwise growth and low shrinkage characteristics (the byproduct is small molecule water). Detailed Implementation

[0129] The embodiments are merely examples to clearly illustrate the technical solutions of the present invention, particularly the manufacturing processes used, and are not intended to limit the invention. Guided by the inventive concept, those skilled in the art can make various changes and modifications to the above parameters, steps, and materials, all of which fall within the protection scope of the present invention. The embodiments are prepared based on the ISO 13485 quality management system, and all materials comply with USP Class VI and ISO 10993 biocompatibility standards.

[0130] Example 1: Detailed Implementation of the Sleeve Length Vector Adjustable Mechanism

[0131] Sleeve structure:

[0132] ●Material: Medical-grade polycarbonate (ISO 10993-10 certified, light transmittance ≥90%);

[0133] ●Modular design:

[0134] ○ Cylindrical body: fixed outer diameter 12.5mm, inner diameter 12.0mm, length standard 100mm;

[0135] ○ Movable end cap: Connected by precision thread (0.5mm pitch), rotating 1 turn → length change of 0.5mm;

[0136] ○ Sealing structure: The end cap has a built-in silicone O-ring (hardness 40A, cross-sectional diameter 1.0mm).

[0137] Operating procedures:

[0138] 1. Input the patient's cavernous body length (118.3 mm) into the decision-making software before surgery;

[0139] 2. Software output target length: 118.5mm (base length 110mm × 1.08);

[0140] 3. The operator rotates the adjustment knob to the mark 118.5mm (requires 23.7 turns), and the latch locks in place;

[0141] 4. After shaping, autoclave (121℃, 20min) and reuse.

[0142] Key validation data:

[0143] parameter Test methods result Length adjustment accuracy Laser rangefinder (accuracy ±0.01mm) ±0.05mm Sealing Hold pressure at 0.25 MPa for 5 minutes No leakage Clinical coverage Statistics of 200 patients 11 types of sleeves cover 95%

[0144] Example 2: Thiol-Al Click System Cylinder (Core Example)

[0145] Material preparation:

[0146]

[0147]

[0148] Process steps:

[0149] 1. Preparation of prepolymer solution:

[0150] Stirring in a 40℃ water bath for 30 min (viscosity monitoring: Brookfield DV3T, target viscosity 300 mPa·s);

[0151] -0.09MPa vacuum degassing (vacuum fluctuation < ±0.005MPa);

[0152] Allow to stand in low-light environment (illuminance meter confirms <50 lux) → for later use.

[0153] 2. Preform manufacturing:

[0154] PTFE mold inner diameter: 10.3mm (sleeve inner diameter 10.5mm-0.2mm);

[0155] After injecting the prepolymer solution, centrifuge to remove bubbles (800 rpm, 2 min);

[0156] Let stand in a low-light environment for ≤10 minutes (avoid pre-curing).

[0157] 3. Intraoperative shaping:

[0158] Sleeve parameters: Inner diameter 10.5mm, length 135.0mm (L) CT=125mm×1.08);

[0159] Preheating of physiological saline: 37.0±0.2℃ (constant temperature water bath);

[0160] UV irradiation: 365nm, irradiance 60.0±0.5mW / cm 2 (Integrating sphere calibration);

[0161] Endpoint determination: Surface temperature rises sharply by 2.1℃ (thermocouple record) → Stop irradiation.

[0162] ●Performance Verification (Supplementary Test Conditions):

[0163] Test Project Standard Method condition result Crosslinking conversion rate FTIR (C=C attenuation) <![CDATA[Scan 128 times, resolution 4cm -1 > 99.7％ Shore A hardness ASTM D2240 Soak in PBS at 37°C for 24 hours 26.3A Residual monomers HPLC (ISO 10993-17) C18 column, methanol:water = 70:30, UV 220nm 32ppm Dynamic fatigue resistance ISO14801 50% compressive strain, 1 Hz, 37°C PBS >500,000 times

[0164] Example 3: Nano-reinforced cylinder (optimized mechanical properties)

[0165] Material preparation:

[0166] ●Example 2 formulation + silanized Aerosil 200 (BET specific surface area 300m²) 2 / g): 8g nano-dispersion process:

[0167] 1. Aerosil 200 was dispersed in anhydrous ethanol (10% solids content) and sonicated at 500W for 30 minutes;

[0168] 2. Add KH560 (filler:silane = 100:5wt%), reflux at 80℃ for 6 hours;

[0169] 3. Centrifuge (10,000 rpm, 15 min) 3 times, then vacuum dry at 60℃;

[0170] 4. The filler is dispersed in PEGDA and processed by a three-roll mill (gap 0.05mm, 300rpm, 3 passes).

[0171] Performance improvements:

[0172] performance Unenhanced Enhanced Improvement rate Tear strength (kN / m) 21 35 +67％ Strength retention rate after 500,000 cycles 78％ 95％ +17％ SEM morphology Aggregates >1μm Uniformly dispersed <200nm —

[0173] Example 4: Verification of the Adjustability of Mechanical Properties

[0174] Comparison of three formulas:

[0175]

[0176] Conclusion: Hardness can be precisely controlled between 20A and 35A by adjusting monomer functionality, chain segment flexibility, and filler content.

[0177] Example 5: Optimized application of multi-hydrogen-bonded polyurethane system

[0178] Material preparation

[0179] A slurry is prepared by mixing polyurethane acrylate oligomer (functionality 2.5, 40 parts by weight), trimethylolpropane triacrylate (30 parts by weight), UPy functionalized monomer (6-[(3,5-dimethyl-1H-pyrazol-1-yl)methyl]uracil, 10 parts by weight), and photoinitiator TPO-L (2 parts by weight).

[0180] Preform dimensions: diameter 10.3mm (target sleeve inner diameter 10.5mm), length 130mm.

[0181] Intraoperative shaping

[0182] Select a sleeve with an inner diameter of 10.5mm and adjust the length to 135mm (108% of the base length of 125mm);

[0183] The internal pressure is 0.12 MPa, and the curing time is 45 seconds (405 nm light source).

[0184] After aspiration, rinse with saline solution and it is ready for use.

[0185] performance advantages

[0186] The UPy group imparts self-healing properties, restoring 85% of the strength of micro-damage within 24 hours;

[0187] With a hardness of 25A, the tear strength remains >26kN / m after 500,000 cycles of dynamic compression.

[0188] Example 6: HLC TM Application of hybrid systems in complex anatomical structures

[0189] Scenario: The patient's corpus cavernosum is S-shaped (bending radius 2.5cm).

[0190] process:

[0191] Recommended sleeve by the decision-making software: Recommended sleeve by the decision-making software (inner diameter 11.5mm, length 15.2cm, preset bending angle 15°).

[0192] HLC TM System design finalized: internal pressure 0.12 MPa. Irradiation for 180 seconds (cationic solidification continues after free radical reaction).

[0193] result:

[0194] No uncured areas at bends: No uncured areas at bends (conversion rate > 99.2%);

[0195] Matching accuracy: 99.1%, with no postoperative displacement.

[0196] Example 7: Verification of Adaptation to Extreme Anatomical Structures

[0197] ●Patient data:

[0198] 1. CT reconstruction: First segment R = 3.2cm (60mm long), second segment R = 5.1cm (70mm long);

[0199] 2. Preoperative MRI segmentation: The elliptical axis length of the cavernous cavity is a = 11.2 mm, b = 9.8 mm.

[0200] ●Customization process:

[0201] 1. Mimics 21.0 generates a 3D model → the decision software outputs sleeve parameters:

[0202] ■ Inner diameter: D=√(11.2×9.8)×1.02=10.6mm→Select a 10.5mm sleeve (closest to the standard size);

[0203] ■Length: L target =130mm × 1.06 = 137.8mm;

[0204] ■ Curvature: Segmented design R1 = 3.2cm, R2 = 5.1cm.

[0205] 2. Select HLC TM Mixed system (free radical: cation = 6:4).

[0206] ● Finalization process:

[0207] 1. Stage 1: 365nm UV, 80mW / cm 2 90 seconds (free radical polymerization, conversion rate >95%);

[0208] 2. Stage 2: 405nm UV, 40mW / cm

[0209] Example 8: Biocompatibility and Sterilization Validation

[0210] Full set of ISO 10993 tests:

[0211] Test Project standard result Cytotoxicity ISO 10993-5 Level 0 (RGR = 98.5%) Allergenicity ISO 10993-10 No allergic reaction Intradermal reaction ISO 10993-10 Rating ≤ 1 (No stimulation) Acute systemic toxicity ISO 10993-11 No toxic reaction Implantation trial (rabbit) ISO 10993-6 6 months: Thickening without fiber wrapping sterilization method Verification Standards result Ethylene oxide (EO) ISO 11135 Residual amount <0.1ppm Irradiation (25 kGy) ISO 11137 Hardness change < ±1A

[0212] Example 9: Preclinical animal experiment (rabbit corpus cavernosum implantation)

[0213] Experimental Design:

[0214] ●Grouping: The cylindrical prosthesis of this invention (n=10) vs. commercial silicone prostheses (n=10);

[0215] ●Implantation site: Bilateral corpora cavernosa;

[0216] ●Observation period: 6 months.

[0217] Key results:

[0218] index This invention Commercial prostheses Fiber wrapping thickness (μm) 120±15 285±30* Inflammatory cell infiltration Mild (Rating 1) Moderate (rating 2–3) Prosthesis displacement rate 0％ 30％* Organizational compatibility score Excellent (9.2 / 10) Good(6.5 / 10)

[0219] *p<0.01 vs. this invention group

[0220] Conclusion: This invention significantly reduces foreign body reaction and improves long-term stability.

[0221] Key Parameter Control Points

[0222] in conclusion

[0223] This invention completely decouples intraoperative shaping and postoperative stabilization functions through a "functional separation" design paradigm:

[0224] 1. Individualized anatomical adaptation is achieved intraoperatively using an external sleeve and internal pressure system;

[0225] 2. A permanent cross-linked network is formed postoperatively through high-conversion-rate photocuring;

[0226] 3. Multi-material system (thiol-olefin / HLC) TM (Nano-reinforced) ensures a hardness of 25A-30A and fatigue resistance of >500,000 cycles;

[0227] 4. Implantation can be completed simply by rinsing with saline solution, overcoming the problem of residual monomers.

[0228] This solution is fully compatible with existing prosthetic systems, significantly reduces displacement rate (<5%), eliminates the "stick feeling," and provides a revolutionary solution for ED patients.

Claims

1. A method for individualized shaping of a cylindrical penile prosthesis, characterized in that, Includes the following steps: a) Provide cylindrical preforms made of biocompatible photocurable materials; b) The preform is placed within a restraint device whose interior is matched to the target size to provide geometric constraints during the operation; c) Apply fluid pressure to the preform to cause it to expand and conform to the inner wall of the restraint device; d) Irradiate the preform with ultraviolet light to trigger a photochemical cross-linking reaction, thereby permanently locking its morphology.

2. The method according to claim 1, characterized in that, The constraint device is a transparent, shaped sleeve with a light transmittance of ≥90%, and the inner cavity surface is hydrophobically treated to reduce material adhesion and / or the geometry and / or size of the inner cavity are adjustable.

3. The method according to claim 1, characterized in that, The biocompatible photocurable material is selected from at least one of click chemistry photocurable systems, photocurable polyurethane systems, hybrid photocurable systems, or cationic epoxy systems.

4. The method according to claim 3, characterized in that, The click chemistry photocuring system is a thiol-olefin click chemistry system, composed of multifunctional thiols and multifunctional olefins.

5. The method according to claim 4, characterized in that, In the thiol-olefin click chemistry system, the molar ratio of thiol to olefin is 1:1 to 1.2:

1.

6. The method according to claim 1, characterized in that, The photocurable material contains nanoscale reinforcing fillers, which are silanized and have aggregate sizes of less than 300 nm, and / or the crosslinking conversion rate of the photocurable material is greater than 99.5%, and the residual monomer content is less than 50 ppm.

7. The method according to claim 1, characterized in that, After the cylinder is locked in its shape, it does not require complex chemical or physical post-treatment before implantation to remove residual monomers or initiators, and / or the Shore A hardness of the cured cylinder material is 25A to 30A, and / or the fluid for shaping by the auxiliary restraint device is discharged after the preform is permanently locked in its shape.

8. A penile prosthesis system, characterized in that, include: a) The cylinder according to claims 1-7 b) Pump valves and / or reservoirs; c) An in vitro shaping workstation, the in vitro shaping workstation being used to provide shaping fluid and / or fluid pressure and / or recover shaping fluid and / or photocuring shaping during the procedure.

9. The system according to claim 8, characterized in that, The cylinder includes left and right cylinders, which are connected to a dual-channel isolation interface. The dual-channel isolation interface includes a dedicated channel for the shaping medium and a channel for the filling medium. The filling medium channel of the dual-channel isolation interface is connected to the pump valve and the liquid storage bladder through a standard interface.

10. The system according to claim 9, characterized in that... The dedicated channel interface for the shaping medium adopts a self-healing elastic sealing valve. Preferably, the self-healing elastic sealing valve is made of medical-grade polyurethane with a Shore A hardness of 30A and contains UPy groups to achieve self-repair.

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