Antimicrobial and antibiofilm catheter containing adsorbed jelein and process

Description

15 Antimicrobial and antibiofilm catheter containing adsorbed jelein and process

[001] The present invention relates to a urinary catheter with antimicrobial and antibiofilm activity, characterized by impregnation and coating with the synthetic peptide Jelein I.

[002] Urethral catheters are flexible, tubular devices used to assist in bladder emptying. They can be classified as permanent or intermittent, according to the frequency of replacement.

[003] Polyvinyl chloride (PVC) is widely used in the manufacture of urethral catheters due to its biocompatibility, flexibility, durability, transparency, low cost and chemical stability (ZUNIGA-ZAMORANO et al., 2018; BERNARD et al., 2017).

[004] However, the use of urethral catheters is intrinsically linked to the risk of urinary tract infections (UTIs), especially in immunosuppressed patients, who may become contaminated during their handling, as these catheters offer an ideal surface for bacterial adhesion, colonization, and the formation of resistant biofilms (LIM et al., 2015) (ZUNIGA-ZAMORANO et al., 2018). These urinary catheter-associated infections (CAUTIs) are frequently caused by the formation of bacterial biofilms on the catheter surface, making treatment difficult due to the high antimicrobial resistance of these microorganisms (LIMA et al., 2022).

[005] Bacterial adhesion to the catheter surface, followed by biofilm formation, constitutes the main mechanism of development of these infections.

[006] Biofilms give microorganisms a high resistance to antibiotics and the immune system, making treatment difficult and resulting in a significant increase in healthcare-related costs. Petition 870250066146, dated 07 / 30 / 2025, page 3 / 20 / 15

[007] The mechanism by which these infections develop is not yet fully understood (LIM et al., 2015). Several uropathogens, such as Escherichia coli, Proteus, Enterococcus, Pseudomonas, Enterobacter, Serratia, and Candida species, are involved in catheter colonization (RAMADAN et al., 2021). And these CAUTIs arise when pathogens from the periurethral skin migrate to the bladder (LIM et al., 2015).

[008] A biofilm is a community of microorganisms adhered to a surface, surrounded by an extracellular matrix that they themselves produce. Its formation is directly associated with the duration of catheterization: between 10% and 50% of patients with short-term catheterization (< 7 days) develop biofilms, while in catheterizations longer than 28 days, biofilm formation is inevitable (RAMADAN et al., 2021).

[009] Microorganisms in biofilms exhibit high antimicrobial resistance and greater protection against the immune system (RAMADAN et al., 2021). Studies show that eliminating biofilms may require antibiotic concentrations up to 1500 times higher than those needed to combat planktonic bacteria (LIM et al., 2015).

[010] Furthermore, the increase in microorganisms resistant to last-generation antibiotics has brought attention to multidrug-resistant bacteria (MDRs), which represent a significant challenge for public health, also increasing the complexity of treatment and hospital costs. Costs related to UTIs can reach $675 per patient and, in cases of bacteremia, the extra expenses can reach $2800, extending the postoperative hospitalization time by an average of 2 to 4 days (BRAZIL, 2017).

[011] In the face of this challenge, strategies for managing, composing, and using new technologies to functionalize catheters are discussed, with the aim of preventing the occurrence of hospital-acquired infections (BRASIL, 2017). In this context, the development of antimicrobial coatings to prevent CAUTIs stands out (LIM et al., 2015). Petition 870250066146, dated 07 / 30 / 2025, page 4 / 20 / 15

[012] The National Health Surveillance Agency (ANVISA) cites, in its Measures for the Prevention of Healthcare-Associated Infections (2017), the introduction of catheters impregnated with antiseptics or antimicrobials as a promising solution (BRAZIL, 2017).

[013] Wilcox et al. (2000) advanced the development of biomedical devices with antimicrobial coatings, using cationic peptides linked to polymeric surfaces.

[014] These peptides can be attached directly to the polymer or through coupling agents, conferring antimicrobial properties to these devices (WILCOX et al., 2000).

[015] Among antimicrobial peptides (AMPs), Jeleins stand out, a family of oligopeptides isolated from royal jelly of bees (Apis mellifera). Jeleins I, II and III are widely recognized for their antimicrobial activity, demonstrating efficacy against both gram-positive and gram-negative bacteria (FONTANA et al., 2004; ROMANELLI et al., 2011).

[016] In addition, Jelein I also showed efficacy against clinical isolates of multidrug-resistant bacteria (LIMA et al., 2024). Jeleins also showed promise in the treatment of fungal infections, with Jeleins I and II showing high activity against Candida albicans (FONTANA et al., 2004; LIMA et al., 2024).

[017] Additionally, studies show that natural and synthetic jellins exhibit low toxicity (FONTANA et al., 2004; JIA et al., 2018; JIA et al., 2021; ROMANELLI et al., 2011). This potential makes them promising both for use as pharmacological agents and for application in medical devices, conferring antimicrobial properties (FONTANA et al., 2004; JIA et al., 2018; JIA et al., 2021).

[018] There are state-of-the-art documents relating to catheter functionalization with other peptides, as shown below. Petition 870250066146, dated 07 / 30 / 2025, p. 5 / 20 / 15

[019] Patent document US2003 / 0007993M, entitled “Biomedical devices with antimicrobial cationic peptides and protein coatings”, describes a method of functionalizing medical devices, including catheters, with distinct peptides. This process does not resemble the process proposed in the present invention because it uses other peptides, and not Jelein.

[020] Patent document CN110074179B, entitled “Application of antibacterial peptide Jelleine-I in preparation of medicine for preventing and treating postharvest green mold of citrus fruits”, discloses the application of an antibacterial peptide Jelleine-I in the preparation of a medicine to prevent and treat postharvest green mold of citrus fruits. This process is not similar to the process proposed in the present invention.

[021] Patent document BR112022009621-6A2, entitled “Chlorhexidine and nitric oxide releasing catheter for dual antiplatelet and antimicrobial functionality”, The invention discloses a catheter configured to release nitric oxide and chlorhexidine providing antiplatelet and antimicrobial properties.

[022] It is manufactured by impregnating a thermoplastic polyurethane catheter extrusion with a nitric oxide-releasing compound and chlorhexidine. Subsequently, the impregnated catheter extrusion is coated with a polyurethane coating comprising chlorhexidine and / or nitric oxide-releasing compound. This catheter does not resemble that proposed in the present invention.

[023] Although the aforementioned technologies present catheter functionalization processes and / or evaluation of the antimicrobial activity of Jelein I, in none of them was there a catheter functionalized with Jelein.

[024] Therefore, the present invention differs from the technologies cited above mainly by presenting a production process with the adsorption of Jelein I in a simple and efficient manner. It is an efficient process capable of producing stable Jelein I functionalized catheters. It therefore presents itself as a viable and effective alternative for the production of catheters with antimicrobial and antibiofilm activity. Petition 870250066146, dated 07 / 30 / 2025, page 6 / 20 / 15

[025] The product proposed in the present invention uses the impregnation of catheters with peptides in aqueous solution and proposes as an innovation the use of Jelein I and thus provide activity against resistant bacteria and antibiofilm activity. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows the purification chromatogram of Jelein I with a chromatographic peak. Figure 2 Cytotoxicity of Jelein I in HEK293 cells - A) 24h treatment and B) 48h treatment. Figure 3 Cytotoxicity analysis - Control catheter without functionalization with Jelein I and catheter functionalized with Jelein I. Figure 4 Analysis of bacterial antibiofilm activity at dilutions of 1, 10, 100, 1000 and 10,000 - A) Control catheter without functionalization with Jelein I and B) Catheter functionalized with Jelein I. Figure 5 presents Scanning Electron Microscopy photomicrographs showing the formation of bacterial biofilm of E. coli isolates on the catheter without functionalization (Control) and functionalized with Jelein I (J), demonstrating the antimicrobial activity of the treatment. Figure 6 shows the Fourier Transform Infrared Spectroscopy graph of the control catheter (without treatment), the Jelein I catheter, and the catheters with Jelein I (catheter J). Figure 7 shows catheters: (a) control and (b) with Jeleina I. Figure 8 shows the rupture profile of the catheters: (a) control and (b) with Jeleina I. DETAILED DESCRIPTION OF THE TECHNOLOGY

[026] The present invention relates to a catheter containing vacuum-adsorbed and dried Jelein I. This product allows for safer catheterization and reduces the incidence of infections, especially in immunocompromised patients. Petition 870250066146, dated 07 / 30 / 2025, page 7 / 20 / 15

[027] Jelein I was synthesized by Fmoc and purified by high-performance liquid chromatography with a DAD detector (λ= 220 nm) and a C18 preparative column, a gradient containing aqueous solutions of trifluoroacetic acid (0.1%) and acetonitrile with trifluoroacetic acid (0.08%). The collected fractions were lyophilized and evaluated by Maldi-ToF.

[028] The antimicrobial activity and safety of purified Jelein I were determined by the minimum inhibitory concentration assay, minimum bactericidal concentration and cytotoxicity by the method of determining mitochondrial dehydrogenase activity using the method that uses Resazurin in human kidney embryonic cells (HEK-293, ATCC CRL-3216).

[029] The catheters were functionalized by immersion in a solution containing Jelein I at 1 mg / mL and purified water at 25°C for 30 min. After this time, the catheters were rinsed thoroughly with distilled water and vacuum dried for 30 minutes.

[030] The material analysis was performed using Fourier transform infrared (FTIR) spectroscopy in ATR mode. The working range used was 4000 to 650 cm-1, covering the entire range of the equipment (ZUNIGA-ZAMORANO et al., 2018, adapted).

[031] The aim of the assay was to study the chemical structure of the catheter tube material and to observe the presence of modifications in the structure and / or chemical composition of the tubes due to functionalisation.

[032] A surface finish test was also performed, which was carried out according to ISO 20696 - item 5.4. The external surface of the catheters was examined by normal vision, in order to assess the existence of foreign matter and / or surface defects resulting from processing that could pose a risk of causing injury to the patient.

[033] Dimensional analysis was performed using a caliper with a resolution of 0.1 millimeters. The length, internal diameter, and external diameter of the catheters were measured. Petition 870250066146, dated 07 / 30 / 2025, page 8 / 20 / 15, with the objective of evaluating whether the functionalization process would be capable of promoting significant dimensional changes to the polymer.

[034] The peak tensile strength test was performed according to ISO 20696 item 6.8, on the catheters in order to evaluate whether the functionalization process would be able to compromise the mechanical resistance of the polymer. The catheters were subjected to the application of force in the form of axial tension at a speed of 200 mm / min, in an INSTRON brand Universal Testing Machine, model 34TM-5SA, with a 1 kN load cell and Bluehill Universal® control and data acquisition system (INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, 2018).

[035] The analysis of bacterial antibiofilm activity was performed according to the methodology described by LIMA, et al (2022), with adaptations. The Escherichia coli (ATCC 11775) inoculum was prepared in saline solution reaching the 0.5 McFarland scale. 50 µL of this suspension was pipetted into a scintillation tube containing 10 mL of Mueller Hinton Broth (CMH). A catheter fragment was inserted into the tube.

[036] The sample was incubated in a benchtop shaker at 37°C until the following day for conducting the experiments. Samples were removed from the shaker and visually assessed for the presence of bacterial growth.

[037] Next, using sterile forceps, the catheter was carefully removed from the scintillation tube. Each unit was flushed with 3 mL of saline, and the flushed catheters were placed in tubes containing 5 mL of saline, with the forceps being sterilized in the flame between procedures.

[038] The tubes were then incubated in the shaker for 30 minutes. After incubation, the catheters were transferred to new scintillation tubes containing 5 mL of saline.

[039] The tubes were placed in an ultrasonic bath for 5 minutes, and the samples were removed and reserved. 180 pL of saline were pipetted into each well of the microplate, using enough lines to accommodate the desired number of dilutions, with each column of the microplate corresponding to one dilution of the catheter. 20 pL of the solution from the tube containing the catheter were pipetted into line 1 of the microplate and the solution was homogenized 6 times. Petition 870250066146, dated 07 / 30 / 2025, page 9 / 20 / 15

[040] The solution from line 1 was then collected and pipetted into line 2, following the same homogenization procedure. This process was repeated until the last line, with 20 pL being discarded after homogenization of each line. 50 pL of the solution from the tubes containing the catheters and from the microplate lines were plated, starting with the lowest concentration.

[041] The solution was spread using circular motions, touching the sides of the plate and rotating it 360°. The plates were incubated in an oven at 37°C and the results were read 24 hours after incubation.

[042] Scanning electron microscopy (SEM) analysis was performed on samples previously submitted to bacterial antibiofilm activity analysis, using the Jeol 6010 Plus equipment.

[043] After 24 hours of incubation for bacterial biofilm growth, 1 cm long longitudinal sections of catheter tubing were washed 3 times with 0.1 M phosphate buffer (pH 7.4) in order to remove non-adherent bacteria.

[044] Next, they were placed on aluminum stubs and a fixation step was performed using 3% glutaraldehyde in 0.1 M phosphate buffer (pH 7.4) for 2 hours (RAMADAN et al., 2021, with adaptations).

[045] Next, the samples were subjected to dehydration using gradual concentrations of ethanol solutions 30% (15 min), 50% (15 min), 80% (15 min), 100% (30 min) and placed to dry in an oven at 37°C for 24 hours (DJERIBI et al., 2012, with adaptations).

[046] Prior to analysis in the scanning electron microscope, since they were composed of non-conductive material, the samples were subjected to a vacuum coating of a thin layer of gold, performed by the Dentonvaccum Desk V model coating system, with a current of 25 mA for 2 minutes (RAMADAN et al., 2021, with adaptations).

[047] All experiments were conducted in triplicate, with the mean and standard deviation calculated for all measurements. The statistical analysis of the experiments of Petition 870250066146, dated 07 / 30 / 2025, page 10 / 20 / 15 Peak tensile strength and bacterial antibiofilm activity analysis were performed using one-way analysis of variance (ANOVA) followed by Dunnett's multiple analysis (LIMA et al., 2022).

[048] For the analyses of bacterial antibiofilm activity, statistical analysis was used to compare differences in biofilm formation between treated catheters and controls (LIMA et al., 2022).

[049] All statistical analyses were performed using GraphPad Prism 8® software (GraphPad Software Inc., La Jolla, CA), considering a 95% confidence level and p-values<0.05 considered statistically significant (LIMA et al., 2022). EXAMPLE 1 - JELEIN I SYNTHESIS BY FMOC AND HPLC PURIFICATION

[050] The synthesized Jelein I showed a yield above 85% as shown in the chromatogram with few impurities and a major peak of Jelein I around 25 min (Figure 1).

[051] After HPLC purification, Jelein I was obtained with a purity above 95% and was lyophilized and characterized by Maldi-ToF spectroscopy. EXAMPLE 2 - MINIMUM INHIBITORY CONCENTRATION (MIC) AND MINIMUM BACTERICIDAL / FUNGICIDAL CONCENTRATION (MBC) OF JELEIN I

[052] The microbiological strains of Escherichia coli (ATCC 11775), Enterococcus faecalis (clinical isolate) and Candida albicans (ATCC 36802) showed loss of activity in Jelein I solution and culture medium in line A. Table 1 presents the MIC values ​​of Jelein I obtained. Table 1 - MIC of Jelein I Microorganism MIC (µg / mL) Escherichia coli (ATCC 11775) 1 64 1 Enterococcus faecalis (clinical isolate) 1 64 1 Candida albicans (ATCC 36802) 1 64 Petition 870250066146, dated 07 / 30 / 2025, page 11 / 20 / 15 Source: Author's own work.

[053] The concentration of chloramphenicol used inhibited growth (as per visual reading of the MIC microplates), but was not sufficient to promote a bactericidal effect on microorganisms, since, after incubation, the plates from the wells containing the antibiotic showed bacterial growth.

[054] However, for the wells relating to the MIC of Jelein I, there was no growth of microorganisms after incubation of the petri dishes, indicating a bactericidal / fungicidal effect. Thus, the MBC of the peptide was equivalent to the MIC for all isolates tested, as shown in Table 2. Table 2 - CBM of Jeleína I Microorganism CBM Jelein I (ug / mL) ' Escherichia coli (ATCC 11775) 1 64 1 Enterococcus faecalis (clinical isolate) 1 64 1 Candida albicans (ATCC 36802) 1 64 Source: Author's own work.

[055] Thus, it is concluded that at a concentration of 64 ug / mL, the synthesized Jelein I caused irreversible damage to the cellular structure of the microbiological strains tested, culminating in their lethal inactivation, which reinforces its potential as an antimicrobial peptide. EXAMPLE 4 - CYTOTOXICITY

[056] The cytotoxicity of Jelein I and catheters was evaluated in human embryonic kidney cells (HEK-293, ATCC CRL-3216) by determining mitochondrial dehydrogenase activity using the resazurin method.

[057] Figures 2A) and 2B) show the results of the tests performed for Jeleína I, with treatments of 24h and 48h respectively. Petition 870250066146, dated 07 / 30 / 2025, page 12 / 20 / 15

[058] From reading the graphs, it was possible to see that Jelein I did not show a significant reduction in cell viability for HEK293 at the concentrations tested, and the concentration of the peptide necessary to reduce the activity of these cells by 50% (IC50) was not identified.

[059] Furthermore, given the MIC and MBC values ​​of 64 ug / mL, the results demonstrate that Jelein I is capable of promoting bactericidal and fungicidal effects without causing a reduction in cell viability, thus strongly suggesting that the peptide is an excellent product option for use in the production of urethral catheters with antimicrobial action.

[060] Figure 3 presents the results of the tests performed for the catheters with and without Jeleina I.

[061] The results found are in line with other studies, which have shown that natural Jelleins (Fontana et al., 2004; Jia et al., 2018; Jia et al., 2021) and their synthetic analogues (Romanelli et al., 2011) have very low toxicity.

[062] Thus, associating the findings obtained from the MIC, MBC and Cytotoxicity analyses, it is possible to point to Jelein I synthesized in this study as a potential product for the production of medical devices with antimicrobial properties. EXAMPLE 6 - BACTERIAL ANTIBIOFILM ACTIVITY AGAINST ESCHERICHIA COLI ISOLATES

[063] Colony forming units were counted for each replicate, aiming for plates with CFU between 25 and 250. However, even at the lowest dilution, some plates showed CFU values ​​lower than the proposed value (Figures 4A and 4B). In other cases, some replicates showed dilutions with CFU greater than 250, making counting impossible, while the subsequent dilution showed CFU lower than 25. In both scenarios, plates with CFU lower than 25 were considered for analysis. Petition 870250066146, dated 07 / 30 / 2025, page 13 / 20 / 15

[064] There was a large reduction in the average CFU / cm of catheter when compared to the control, again suggesting that treatment in this condition was able to adsorb Jelein I to the surface of the catheters in sufficient quantity to promote an antibacterial effect. EXAMPLE 7 - ANALYSIS OF BIOFILM FORMATION BY SCANNING ELECTRON MICROSCOPY (SEM)

[065] The results obtained through scanning electron microscopy (SEM) images allow for a visual assessment of the effect of Jelein I present in the catheter on biofilm formation, Figure 5A) the catheter without Jelein I showing biofilm with a high presence of bacteria and Figure 5B) showing a reduction in biofilm and bacteria on the surface of the catheter with Jelein I. EXAMPLE 8 - FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR)

[066] In Figure 6, when analyzing the spectrum of the constituent material of the control catheter tube, we observed bands in the range of 3000-2850 cm-1, associated with the symmetrical and asymmetrical stretching vibrations of the CH2 group, and signals at 1426 and 1256 cm-i, related to the bending vibrations of the same group (Zuniga-Zamorano et al., 2018; EDRAKI et al., 2021). In addition, a band was identified at 1722 cm-i, which was reported by Zuniga-Zamorano et al., (2018) as an indication of the presence of plasticizer in the catheters. We also noted the presence of bands around 1100 cm-i referring to stretching vibrations of the CC group (EDRAKI et al., 2021).

[067] After functionalization, it is not possible to observe a reduction in the intensity of these bands, indicating that there was no significant degradation of the PVC.

[068] To verify whether Jelein I was adsorbed on the surface of the functionalized polymer, FTIR analysis of the samples sought to confirm the presence of amide linkages. According to the literature, the representative peaks of these functional groups are: 1533-1549 cm-i (amide II - NH deformation combined with CN stretching), 1645-1658 cm-i (amide I - C=O stretching) (SATTARI-MARAJI et Petition 870250066146, dated 07 / 30 / 2025, page 14 / 20 / 15 al., 2024; ALMARWANI, et al., 2023; LIM, et al., 2015), 1200 cm-1 (amide III) and 3278 cm-1 (amide A - NH bond stretching) (SATTARI-MARAJI et al., 2024).

[069] Analyzing the spectrum of Jelein, bands are noted at 1200 cm-1, 1538 cm-1, 1628 cm-1, and 3272 cm-1, indicating the presence of amide III, amide II, amide I, and amide A groups, respectively. EXAMPLE 9 - SURFACE FINISHING TEST

[070] Control and treated samples were subjected to surface analysis according to ISO 20696 - item 5.4. Thus, initially a visual inspection was performed on the control catheters, in which no foreign matter and / or surface defects resulting from processing were found that could pose a risk of causing injury to the patient. Subsequently, the post-treatment samples were analyzed according to the same methodology, Figure 7A) catheter without Jeleina I and 7B) catheter with Jeleina I.

[071] Through analysis and comparison with the control, it was possible to verify that there were no visible changes under normal vision on the surface of the treated samples, remaining with the transparent color and smooth appearance present in the control catheters.

[072] Thus, we conclude that this treatment can be applied to catheters without causing visible changes under normal vision, thus meeting the requirements established in the normative reference. EXAMPLE 10 - DIMENSIONAL ANALYSIS TEST

[073] The results of the dimensional analysis of the length, external and internal diameter of the control and treated samples are represented in Table 3.

[074] After the measurements, it was found that there were no dimensional changes in the length and external diameter of the samples that could be detected by the resolution of the caliper. However, for the internal diameter of the catheter, variations of approximately 0.1 mm were noted in the measured values ​​in the samples. In Petition 870250066146, dated 07 / 30 / 2025, page 15 / 20 / 15 however, the variations observed in the internal diameter were not considered significant, since the discrepancies in the values ​​correspond to the resolution of the caliper (0.1 mm), which may have resulted from the measurement procedure. Table 3 - Measurements of length, external and internal diameter Condition Length (mm) Outer diameter (mm) Inner diameter (mm) 1 Control 60 3.2 1 2.6 60 3.2 1 2.6 60 3.2 1 2.5 1 Treated 60 3.2 1 2.6 60 3.2 1 2.5 60 3.2 1 2.6 Source: Author's own work

[075] Thus, we can conclude that the results of the dimensional analysis indicate that the treatment can be performed without causing significant dimensional changes in the catheters. EXAMPLE 11 - PEAK TENSILE STRENGTH TEST

[076] The peak tensile strength test was performed on control and post-treatment samples under optimal conditions in order to evaluate whether the process would be able to compromise the mechanical strength of the polymer.

[077] According to ISO 20696 - item 6.8, the test speed should be a ratio of 20 mm / min / mm of length. The specimens prepared for the test had a total length of 60 mm, with 25 mm at each end intended for fixing them in the jaws of the equipment and 10 mm being the effective test length. Thus, the catheters were subjected to force in the form of axial tension at a speed of 200 mm / min, and the rupture profile of the samples is shown in Figure 8. Petition 870250066146, dated 07 / 30 / 2025, page 16 / 20 / 15

[078] The rupture region is located approximately in the center of the test specimens, indicating that the failure was not influenced by the pressure exerted on the ends by the fitting in the test equipment, therefore occurring at the effective test length, as expected, with the rupture force results presented in Table 4. Table 4 - Peak tensile force Condition Average rupture force (N) Standard deviation 1 Control 68.38 3.81 ' 1 Treated 72.02 1.01 ' Source: Author's own work

[079] According to ISO 20696, the minimum value for the peak tensile force of the tubular portion of the urethral catheter should be 10 N for samples with an external diameter of the tubular portion greater than between 2 and 4 mm, a size range in which the samples under test are found.

[080] Through the data obtained in the test, it was found that the average rupture force of the control catheters is 68.38 N, while that of the treated catheters under optimal conditions is 72.02 N. Thus, we can note that there is no significant difference in the values ​​obtained for both conditions, since the divergence of values ​​of 3.64 N is within a plausible margin of sample variability, suggesting that the functionalization process did not significantly impact the resistance of the catheter tubes.

[081] Furthermore, when the breaking forces of the treated samples are analyzed individually (70.98 N, 72.99 N and 72.1 N), it is noted that they are more than 60 N above the minimum value determined by the standard. Thus, we can conclude that the final product meets the normative specifications. Petition 870250066146, dated 07 / 30 / 2025, page 17 / 20

Claims

CLAIMS 1. A polyvinyl chloride (PVC) catheter with antimicrobial and antibiofilm properties, characterized by being impregnated and coated with at least one of the synthetic Jelein peptides, selected from the group comprising Jelein-I whose amino acid sequence is PFKLSLHL-NH2 (SEQ ID No. 1), Jelein-II whose amino acid sequence is TPFKLSLHL-NH2 (SEQ ID No. 2), Jelein-III whose amino acid sequence is EPFKLSLHL-NH2 (SEQ ID No. 3), Jelein-IV whose amino acid sequence is TPFKLSLHL-NH2 (SEQ ID No. 4).

2. A catheter, according to claim 1, characterized in that the coating additionally contains other synthetic antimicrobials.

3. A catheter, according to claim 1, characterized in that the coating additionally contains other antimicrobial peptides.

4. Process for producing the polyvinyl chloride (PVC) catheter defined in claim 1, characterized by comprising the following steps: a) immersion of the catheter in an aqueous solution containing at least one of the peptides defined by SEQ IDs 1, 2, 3 or 4 at a concentration of 1 to 10 (mg / mL); b) vacuum drying. Petition 870250014740, dated 24 / 02 / 2025, pp. 51 / 58

Images