Recommendations and Best Practices in the Field of Magnetic Surgery

Magnetic surgery is an innovative and rapidly evolving field that leverages magnetic technology to enhance surgical procedures. This approach utilizes magnetic devices and carriers to perform various surgical techniques, including compression, navigation, levitation, anchoring, and delivery. Over the past decade, the interest in magnetic surgery has grown significantly due to its potential to facilitate minimally invasive procedures, reduce patient trauma, and improve surgical outcomes. As the field continues to advance, it is essential to establish comprehensive guidelines and best practices to ensure the safe and effective use of magnetic technology in surgery.

Classification of Magnetic Devices

Magnetic devices used in surgery can be classified based on their duration of use into three categories: permanently implanted, intra-operative, and temporarily implanted devices.

Permanently Implanted Magnetic Devices

Permanently implanted magnetic devices are designed to remain in the patient’s body for their lifetime. These devices are typically used in conditions where long-term therapeutic intervention is required. Examples include magnetic sphincter augmentation for gastroesophageal reflux disease (GERD) and magnetic hyoid suspension for sleep apnea. These devices provide continuous therapeutic benefits by utilizing magnetic forces to maintain physiological functions.

Intra-operatively Used Magnetic Devices

Intra-operative magnetic devices are used during surgical procedures and are intended to be removed at the end of the operation. These devices are often employed in magnetic anchoring and magnetic navigation techniques. Magnetic anchoring involves using magnets to hold tissues or organs in place during surgery, while magnetic navigation uses magnetic fields to guide surgical instruments or devices within the body. These techniques enhance precision and reduce the invasiveness of surgical procedures.

Temporarily Implanted Magnetic Devices

Temporarily implanted magnetic devices are used for a specific period after the surgical procedure. These devices are commonly utilized in magnetic compression anastomoses of hollow viscera, such as the digestive tract, and in vascular anastomoses. The magnets create a compressive force that promotes tissue healing and anastomosis formation over time. Once the desired therapeutic effect is achieved, the devices are removed.

General Guidelines for Implantable Magnetic Devices

To ensure the safe and effective use of magnetic devices in surgery, several key guidelines must be followed. These guidelines address material selection, surface coatings, sterilization methods, and the management of inadvertent magnetic forces.

Materials

The choice of materials for magnetic devices is critical to ensure adequate magnetic force and biocompatibility. Neodymium iron boron (NdFeB) is commonly used due to its powerful magnetic properties. Various grades of NdFeB, such as N35, N40, N42, N45, and N48, are available to meet different force requirements. In some cases, permanent magnets are paired with magnetizable materials or external electromagnets to generate the necessary magnetic force.

Surface Coatings and Layers

Special coatings are essential for intra-corporeal magnets to ensure biocompatibility and prevent the leakage of toxic components into surrounding tissues. Common coating materials include polycarbonate, gold, and parylene, often applied in multiple layers for redundancy. For short-term implanted magnets, titanium nitride coating is recommended due to its durability and biocompatibility. For permanent implanted magnets, titanium alloy sealing by laser is preferred to ensure long-term stability and safety.

Sterilization Methods

Appropriate sterilization methods are crucial to maintain the integrity and functionality of magnetic devices. Corrosive and high-temperature sterilization methods should be avoided as they can degrade magnetic properties. Effective sterilization techniques include ethylene oxide sterilization, low-temperature cold plasma techniques, and gamma radiation sterilization. These methods ensure that the devices are free from contaminants while preserving their magnetic characteristics.

Awareness of Inadvertent Magnetic Force

Caution must be exercised when placing multiple pairs of magnets, as they may attract each other and exert unexpected magnetic forces. This can lead to unintended tissue compression or displacement. Additionally, the use of electrocautery or ferromagnetic surgical instruments in patients with magnetic devices should be carefully managed to avoid interference with the magnetic fields. Surgeons must be aware of the potential for inadvertent magnetic interactions and take appropriate precautions to mitigate risks.

Patient Safety and Ethical Considerations

As with all medical research and technological advancements, patient safety must be the paramount concern in the development and use of magnetic surgical devices. Rigorous testing and evaluation are necessary to ensure that these devices are safe and effective for clinical use. Ethical considerations, including informed consent and the potential for long-term effects, must be addressed to protect patient welfare.

Applications of Magnetic Surgery

Magnetic surgery has a wide range of applications across various medical fields. The following sections highlight some of the key applications and their clinical significance.

Magnetic Sphincter Augmentation for GERD

Magnetic sphincter augmentation is a minimally invasive procedure used to treat gastroesophageal reflux disease (GERD). The procedure involves implanting a ring of magnetic beads around the lower esophageal sphincter (LES). The magnetic force between the beads helps to strengthen the LES, preventing the backflow of stomach acid into the esophagus. This approach offers an alternative to traditional surgical methods, such as fundoplication, with reduced postoperative complications and faster recovery times.

Magnetic Hyoid Suspension for Sleep Apnea

Magnetic hyoid suspension is a novel technique used to treat obstructive sleep apnea (OSA). The procedure involves the use of magnetic devices to reposition the hyoid bone, thereby opening the airway and reducing episodes of apnea. This minimally invasive approach offers a promising alternative to traditional surgical interventions, such as uvulopalatopharyngoplasty (UPPP), with improved patient outcomes and reduced morbidity.

Magnetic Compression Anastomoses

Magnetic compression anastomoses are used to create connections between hollow viscera, such as the digestive tract, without the need for sutures or staples. The procedure involves placing two magnets on either side of the tissue to be joined. The magnetic force compresses the tissue, promoting healing and the formation of a natural anastomosis. This technique is particularly useful in cases where traditional anastomosis methods are challenging or contraindicated.

Magnetic Navigation in Surgery

Magnetic navigation is a technique that uses magnetic fields to guide surgical instruments or devices within the body. This approach enhances precision and control during minimally invasive procedures, such as laparoscopic surgery. Magnetic navigation systems can be used to guide catheters, endoscopes, and other instruments to target tissues with minimal trauma to surrounding structures.

Future Directions and Challenges

The field of magnetic surgery holds great promise for advancing minimally invasive techniques and improving patient outcomes. However, several challenges must be addressed to fully realize its potential. These include the development of more advanced magnetic materials, the optimization of device designs, and the establishment of standardized protocols for their use. Additionally, further research is needed to evaluate the long-term safety and efficacy of magnetic devices in various clinical applications.

Advanced Magnetic Materials

The development of new magnetic materials with enhanced properties is essential to improve the performance of magnetic surgical devices. Researchers are exploring the use of rare-earth magnets, such as samarium cobalt and alnico, as well as novel composite materials that offer superior magnetic strength and biocompatibility. These advancements will enable the creation of smaller, more powerful devices that can be used in a wider range of surgical applications.

Optimization of Device Designs

The design of magnetic devices must be optimized to ensure ease of use, reliability, and patient safety. This includes the development of devices that can be easily implanted and removed, as well as those that can be adjusted or controlled during the procedure. Innovations in device design, such as the incorporation of smart sensors and wireless communication, will enhance the functionality and versatility of magnetic surgical tools.

Standardized Protocols

The establishment of standardized protocols for the use of magnetic devices in surgery is crucial to ensure consistent and safe practices. These protocols should address device selection, implantation techniques, sterilization methods, and postoperative care. The development of guidelines and training programs for surgeons will help to promote the widespread adoption of magnetic surgery and improve patient outcomes.

Long-term Safety and Efficacy

Further research is needed to evaluate the long-term safety and efficacy of magnetic surgical devices. This includes studies to assess the potential for adverse effects, such as tissue damage, infection, and device migration. Long-term follow-up of patients who have undergone magnetic surgery will provide valuable insights into the durability and effectiveness of these devices.

Conclusion

Magnetic surgery represents a significant advancement in the field of minimally invasive surgery, offering new possibilities for the treatment of various medical conditions. By leveraging magnetic technology, surgeons can perform complex procedures with greater precision, reduced trauma, and improved patient outcomes. However, the safe and effective use of magnetic devices requires adherence to established guidelines and best practices. As the field continues to evolve, ongoing research and innovation will be essential to address the challenges and unlock the full potential of magnetic surgery.

doi.org/10.1097/CM9.0000000000000942

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