Transparent self-adhesive film made of polyurethane and hypoallergenic non-woven adhesive.

Description

5 Transparent self-adhesive film made of polyurethane and hypoallergenic non-woven adhesive. Clarifications

[001] It is clarified, for all due purposes, that the original title: Sterile transparent film in self-adhesive polyurethane, and hypoallergenic adhesive nonwoven fabric called Abracefix.

[002] Furthermore, the required amendments, consisting of five files, are attached to this filing request: clarifications, summary, claims, descriptive report and drawings. Utility model field

[003] This is a utility model for a product for hospital use, consisting of a protective, waterproof film to adhere to the skin after insertion of the catheter into the vein in hospitalized patients who use an intravenous catheter (IVC) to receive intravenous medication.

[004] Fixing the VSD is extremely important to keep it within the blood vessel. This is due to the high possibility of adverse events, such as infection, premature displacement due to micromovement of the VSD during bathing, and other medical-hospital procedures that may occur during hospitalization, which must not happen under any circumstances.

[005] To that end, the utility model described ensures patient safety during the administration of antibiotics or any other medical-hospital procedure that is performed safely, guaranteeing the intravenous infusion of the medication and other procedures necessary for the recovery of health and the benefits inherent to the act in question, without incurring the loss of the CIV before the end of the medication infusion and any possible infection. Petition 870250105784, dated 11 / 19 / 2025, page 9 / 17 / 5

[006] ABRACFIX is a sterile, self-adhesive, single-use product for intravenous catheters, low cost and easy to attach to central and peripheral VICs, as it can be used in hospital settings as well as long-term care facilities and residences, being specifically for use in the health field. Fundamentals of the utility model

[007] Hospitalized patients require intravenous medication, necessitating the use of an intravenous catheter (insertion of a VSD into a superficial or deep vein) for continuous drug treatment, such as antibiotics, intravenous fluids, corticosteroids, sedatives, electrolyte solutions, parenteral nutrition, and blood products. However, its use requires secure fixation to improve safety in prescribing, using, and administering medications.

[008] Furthermore, it requires strict control of the fixation of the CIV to the skin and hygiene, on the part of the nursing staff (or health team) given the high possibility of infection of the ostium and displacement by micromovement, resulting in extravasation of the medications outside the blood vessel causing mild, moderate or severe skin injury (depending on the drug).

[009] Due to the facts described above, it is necessary to adapt a film that adheres properly to the skin and embraces the CIV connector, immobilizing it within the blood vessel so that the infusion is not interrupted, resulting in a repeat puncture in another location.

[010] Such difficulty interrupts drug therapy, greatly impairing the patient's treatment and effective improvement.

[011] To solve this problem, this utility model was designed, a disposable, transparent adhesive film for catheter fixation, allowing visualization of the ostium, with two arms for secure stabilization of the catheter on the skin. Petition 870250105784, dated 11 / 19 / 2025, page 10 / 17 / 5

[012] There are other self-adhesive film options on the market, but none with a differentiated design that embraces the catheter against the skin, making it stable against traction and micromovement.

[013] Aiming to solve these inconveniences, the Abracefix self-adhesive film has an exclusive and standardized model for practical use. However, there is no film that embraces the connector to keep it stable in the intima layer of the vein, making it more efficient by providing comfort and safety to the patient.

[014] We sought to improve the method of securing intravenous catheters with a differentiated design to stabilize the device for a longer time and / or until the end of intravenous therapy. It was cut and assembled from the prototype, designed by the authors.

[015] The objective of the present utility model: to reinforce the stabilization of the CIV within the blood vessel. And, another objective is that the differentiated design stabilizes the catheter for a longer time and / or until the end of intravenous therapy.

[016] It should be noted that the Abracefix waterproof film should not be used in water immersion, such as in bathtubs.

[017] The following schematic figures from the film are presented, the measurements of which are real. Brief description of the drawings

[018] Abracefix: Transparent self-adhesive film made of hypoallergenic polyurethane and non-woven adhesive, fenestrated, sterile. It has two strips fixed to the body of this film to embrace the intravenous catheter connector, offering greater stability and security, preventing micromovement and displacement outside the blood vessel.

[019] The piece is composed of three parts that are overlapped and pressed together. Petition 870250105784, dated 11 / 19 / 2025, page 11 / 17 / 5 Figure 1. Neonatal Size. After overlapping Part B onto Part A: total measurement: 5.60 x 4.00. Shows frontal view. Figure 2. Pediatric Size. After overlapping Part B onto Part A: Total measurement: 7.0 x 5.00. Shows a front view. Figure 3. Adult size. After overlapping Part B onto Part A: Total measurement: 8.50 x 6.00. Shows a front view. Figure 4. CIV connector. Description of the utility model

[020] As shown in the attached figures. The piece is composed of three parts (A + B + C). Part B is glued onto part A by the upper arc.

[021] In the center of part A, an orifice with a radius of 0.5 cm was designed for passage of the catheter connector, followed by a 0.2 cm fenestration for passage of the catheter connector, fixed to the patient's skin. It has a transparent adhesive film for visualization of the ostium.

[022] Part C is overlapped and pressed 0.6 cm onto the base of part B.

[023] Part B consists of two arms with a 0.5 cm hole, followed by a slit; after puncture these arms are passed over the catheter connector to immobilize it.

[024] Abracefix Transparent self-adhesive film made of polyurethane and hypoallergenic adhesive nonwoven fabric, fenestrated, sterile.

[025] As shown in figures 1, 2, and 3, the film has dimensions consistent with the following sizes: neonatal, pediatric, and adult. Petition 870250105784, dated 11 / 19 / 2025, page 12 / 17 / 5

[026] We include two extra strips: one to stabilize the CIV connector and one for date recording. Length according to size.

[027] To attach the Abracefix to the CIV, follow these steps:

[028] Open the packaging using aseptic technique. Remove the protective paper from an extra strip and stabilize the CIV connector to the skin. Remove the protective paper from part A, fixing it to the skin, and keep the ostium centered. Approximate the fenestration, keeping the CIV connector aligned and anchored over part A of the Abracefix. Remove the protective paper from the strips of part C and embrace the CIV connector. Write the date of the procedure on the extra strip.

[029] Catheter parts. Part C of the Abracefix should embrace the VCD connector (figure 4). Petition 870250105784, dated 11 / 19 / 2025, page 13 / 17

Claims

CLAIMS 1. Self-adhesive film for securing the connector of an intravenous catheter for hospital and home use, characterized by having two adhesive strips, overlapping the adhesive film, that embrace the CIV (Central Venous Catheter) constructed to keep the catheter within the bed of the stabilized blood vessel, i.e., without micromovement. Petition 870250105784, dated 11 / 19 / 2025, page 8 / 17

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