Mechanical stapler 4.5x7.0 mm

The 4.5x7.0 mm Mechanical Stapler is a surgical instrument designed to offer quick, efficient and reliable solutions in tissue closure during operating procedures. Thanks to its advanced mechanical technology, this stapler allows the surgeon to perform precise sutures, significantly reducing operating times compared to traditional manual stapling techniques. The ergonomic handle and compact design facilitate use even in difficult-to-access operating areas, promoting easy and safe application for a wide range of operations. The use of the mechanical stapler guarantees optimal tissue fixation, minimizing the risk of post-operative bleeding and promoting uniform healing, with smaller scars compared to conventional methods.

The precision forceps are made of biocompatible and resistant materials, reducing the likelihood of contamination and ensuring maximum safety for the patient. The automatic staple loading system allows for a rapid sequence of application without the need for frequent replacement during the procedure, making it particularly useful for operations requiring multiple stitches. The size of 4.5x7.0 mm makes this stapler ideal for applications on medium thickness tissues, particularly in abdominal, thoracic, gastrointestinal surgery, as well as in tissue resection or anastomosis procedures.

The 4.5x7.0 mm Mechanical Stapler is packaged in individual sterile units to guarantee the maximum level of intraoperative safety and hygiene, essential to prevent surgical site infections. The use of this device also contributes to reducing stress and operative fatigue, thanks to superior handling and a staple release mechanism designed to limit the force required during compression. All these features make the 4.5x7.0 mm Mechanical Stapler an excellent and fundamental choice in the set of devices for modern surgical stapling.

Therapeutic Indications

The 4.5x7.0 mm Mechanical Stapler is indicated for the application of automatic sutures in soft tissues during surgical operations that require rapid, homogeneous and safe closure of incisions, resections or anastomoses, both in the abdominal and thoracic areas. It is frequently used in general and specialist surgery, including oncology, digestive, bariatric procedures and in some emergency surgery applications. The device is designed to ensure hemostasis and tissue stability, helping to prevent complications such as wound dehiscence, post-operative bleeding and fistula formation at suture sites.

Its dimensions make it particularly suitable for use on organs and tissues of medium thickness, such as the small intestine, colon, stomach, lung and other body areas that require a regular fixed stitch to maintain anatomical and physiological integrity. It is also indicated for the approach to linear surgical wounds and for the creation of lateral-lateral or end-to-end anastomoses, offering a high safety margin thanks to the low risk of tissue laceration.

The Mechanical Stapler can be included in the program for the prevention of post-surgical complications and in the advanced management of complex wounds, especially when speed of execution and precision are critical factors. Furthermore, the device can also be used in outpatient practice for the rapid closure of incisions or surgical wounds in minimally invasive or traditional procedures, always guaranteeing optimal clinical results. If necessary, it is also used in emergency room and emergency surgery settings, where saving time is vital.

Composition

Construction materials: The 4.5x7.0 mm Mechanical Stapler is mainly manufactured with high quality and biocompatible medical materials. The supporting structure of the instrument is made of surgical grade stainless steel, capable of withstanding sterilization processes and providing rigidity and durability over time. The parts in contact with the fabrics are made of sterile, non-toxic and latex-free plastic polymers, to reduce the risk of allergic reactions or local inflammation.

Suture system: The closing clips are made of titanium alloy, a material chosen for its excellent resistance to corrosion, bioinertia and ability to maintain ideal traction on the tissue edges without causing necrosis or excessive compression. The automatic loading system of the device provides a safe and sterile housing for the staples, ensuring an orderly distribution throughout the surgical procedure.

Accessory components: The ergonomic handle is covered in non-slip material to ensure precision of movement and avoid the risk of slipping even with gloved hands. The device features an integrated safety lever to prevent accidental operation of the staple release mechanism. All components are free of phthalates and other substances potentially harmful to the patient.

Packaging: Each stapler is individually packaged in sterile blisters, made of transparent and rigid materials to maintain integrity until use, while facilitating rapid identification and manipulation in the operating room.

Contraindications

The use of the 4.5x7.0 mm Mechanical Stapler is contraindicated in patients with known allergies or documented sensitivity to the construction materials of the stapler itself, such as titanium, specific stainless steels or medical plastic polymers. Do not use if there are active infections at the site to be sutured, as the risk of contamination and subsequent secondary infection may increase. The stapler is not suitable for use on extremely friable, irradiated or severely compromised tissues, where the pressure of the staples could cause further damage or mechanical complications, such as laceration of the tissue margins.

The stapler must not be used to close small caliber vascular structures or on tissues that require a continuous and uninterrupted suture, where there is a need for greater elasticity than that which a metal staple can guarantee. Use on anatomical sites close to important nerves or vascular bundles is not recommended, to avoid the risk of compression or damage to the nervous structures or blood vessels.

The Mechanical Stapler should not be used on children, newborns or pediatric patients without a prior specific and in-depth evaluation, as the size of the staples may not be suitable for the characteristics of the thinner or more fragile tissues typical of the pediatric age. It is advisable to also exclude its use in patients with rare connective tissue diseases or conditions that alter the normal composition and resistance of the soft tissues.

Repeated use or multiple sterilization of the disposable device is strictly contraindicated, as it could compromise the mechanical effectiveness, asepsis and safety of the surgical procedure itself.

Safety of the drug for the species

The 4.5x7.0 mm Mechanical Stapler, being a high precision disposable medical device, is designed to guarantee maximum safety for both the patient and the healthcare personnel involved in the operating procedure. The internal controlled release mechanism of the staples ensures that the pressure exerted is always optimal and uniform, avoiding possible complications such as excessive compression, tissue necrosis or the formation of additional lesions. Each unit is subjected to rigorous quality controls to ensure that there are no manufacturing defects or malfunctions that could compromise the safety of the intervention.

The construction materials are tested to guarantee complete biocompatibility, minimizing the risk of allergic reactions, local rejection or post-operative inflammatory phenomena. The sterile packaging system prevents bacterial contamination and the transmission of cross infections, protecting patients and operators from any intraoperative infectious risk. The safety lever on the stapler prevents accidental activation, adding an important level of protection during all preparation and manipulation phases.

The ergonomics and movement control offered by the 4.5x7.0 mm Mechanical Stapler reduce the possibility of human error, improving performance in terms of precision and uniformity of the suture itself. This translates into a greater probability of optimal healing of surgical wounds, a reduced incidence of complications and a reduction in post-operative hospital stays. The "hand-proof" design makes it safe even for the less experienced operator, reducing the learning curve and increasing the safety of surgical procedures in different operating contexts.

Precautions

The use of the 4.5x7.0 mm Mechanical Stapler requires compliance with specific precautions, both to guarantee the safety of the patient and to preserve the health of the operator. It is recommended to always check the integrity of the sterile package before use: any signs of opening, damage or humidity of the package must lead to the immediate discarding of the device. Use the stapler exclusively according to the indications and after adequate training in the use of the instrument, to ensure correct execution of the suture and prevent technical errors or the application of inadequate force.

Before proceeding with the application, make sure that the margins of the tissues to be sutured are vital, non-necrotic and free of active infection. Do not place mechanical staples in areas in close contact with metal endoprostheses or permanent implantable devices, to avoid mechanical interference phenomena or post-surgical complications. During the procedure, handle the instrument carefully, always wearing personal protective equipment such as suitable surgical gloves and, if necessary, masks and protective glasses.

It is crucial to dispose of the device immediately after use in appropriate containers for sharps and contaminated material, to reduce the risk of accidental cutting or environmental contamination. Avoid exposure to excessive heat, corrosive agents and humid or dusty environments that could compromise the functionality and sterility of the stapler before use. Keep the device out of reach of children and unauthorized persons or those without the necessary technical expertise. At the end of the operation, carefully monitor the suture site for any signs of bleeding, infection or tissue dehiscence, intervening promptly if complications arise.

Method of administration

The correct use of the 4.5x7.0 mm Mechanical Stapler involves some fundamental steps to ensure effective and safe suturing. After removing the instrument from the sterile package, the surgeon identifies the tissue edges to be joined and brings them into close contact. The stapler is then introduced on the area to be treated, ensuring that the tissues are well aligned and included within the jaws of the instrument. Once the correct positioning has been carried out, the release mechanism is activated, generally through controlled pressure on the main lever of the device.

The pressure must be exerted uniformly and calibrated according to the thickness and resistance of the tissues. When the staple is released, it passes through the edges of the tissues causing a smooth and secure closure. If necessary, the procedure can be repeated several times along the suture line, maintaining constant visual control to ensure that each stitch is correctly applied and that the staples are equidistant from each other.

At the end of the procedure, the stability of the suture is checked and, if necessary, any manual reinforcements or the addition of local dressings are carried out. The device, being disposable, must be disposed of according to the provisions in force for sharp and contaminated medical materials. The entire process must take place in a sterile environment, with the use of auxiliary instruments such as apposition forceps and operating microscopes, if required by the type of intervention or the anatomical site treated.

Treatment program

The use of the 4.5x7.0 mm Mechanical Stapler must be integrated into the patient's specific surgical protocol, depending on the type and complexity of the operation. To close laparotomy or thoracotomy incisions, we recommend applying staples at regular intervals, taking into account the characteristics of the tissues and the degree of tension required for optimal healing. In intestinal or gastrointestinal resection operations, the number of stitches and the distance between the staples must be decided based on the length of the suture line and the tissue thickness, constantly checking the integrity and perfusion of the flaps.

In emergency surgery or emergency conditions, the Mechanical Stapler represents an essential tool for the rapid control of bleeding and the prevention of intra-abdominal or intrathoracic contamination, accelerating wound closure and reducing the overall time of the operation. In cases where wound revision is necessary, the staple removal protocol should follow standard post-operative care recommendations, including timing of wound monitoring and assessment of clinical signs of healing.

After applying the staples, it is advisable to keep the wound clean and protected, with periodic checks to prevent local infections or dehiscence. The interval between the application and possible removal of the staples, if the procedure requires it, must be determined based on the patient's condition, the type of suture performed and the tissue repair observed during post-surgical follow-ups. In the case of patients with impaired healing, close and personalized monitoring is recommended.

Target species

The 4.5x7.0 mm Mechanical Stapler is intended for use in adult humans for the surgical closure of soft tissues in various operating areas, such as abdominal, thoracic, gastrointestinal surgery and specialized sectors that require rapid and safe suturing of incisions or surgical wounds. The device is not indicated for veterinary, pediatric or neonatal use without specific clinical evaluation, considering the size of the clips and the anatomical peculiarities of the tissues involved.

The choice of this mechanical stapler in human surgical procedures is supported by long clinical experience and the consolidated reliability of the materials used, which ensure maximum compatibility and safety of use in the healthcare sector. However, the selection of the device must always be carried out by the doctor or qualified healthcare personnel, based on the clinical needs and individual characteristics of the patient, thus ensuring optimal performance and tissue healing without complications.