Heavy menstrual bleeding, medically termed menorrhagia, is a condition that profoundly affects the lives of women globally, leading to physical discomfort and emotional distress. For those seeking relief, endometrial ablation is a minimally invasive surgical option designed to reduce or eliminate excessive menstrual bleeding by targeting the endometrium, the inner lining of the uterus.
Endometrial ablation involves the deliberate destruction of the endometrial tissue to address abnormal uterine bleeding. It is typically recommended for premenopausal women who are troubled by menorrhagia and are unresponsive to medical treatments. The primary objective is to diminish menstrual flow, with some women experiencing complete cessation of periods post-procedure.
Techniques and instruments for endometrial ablation
Several techniques can be employed to perform endometrial ablation, with each using specialised medical instruments. The most common technique is radiofrequency ablation, which involves the insertion of a specialised device through the cervix into the uterine cavity.
Once in place, the device deploys a flexible mesh that expands to fit the shape of the uterus. Radiofrequency energy is emitted, generating heat that rapidly ablates the endometrial tissue. The process typically only lasts for approximately 90 seconds before the mesh is retracted and the device is removed.
Thermal balloon ablation uses a balloon catheter that is inserted into the uterus and inflated with a sterile fluid heated to approximately 87°C. As the balloon expands, it conforms to the contours of the uterine cavity, ensuring even contact with the endometrial surface, and the heat is maintained for approximately two minutes to destroy the lining.
Hydrothermal ablation circulates heated saline at around 90°C throughout the uterine cavity under direct hysteroscopic visualisation, allowing clinicians to monitor the process in real-time and precisely target areas of abnormal tissue. While this process typically takes up to ten minutes, it has proved effective for patients with irregularly shaped uteri or submucosal fibroids.
Finally, cryoablation uses a cryoprobe that delivers extremely low temperatures to freeze and destroy the endometrial tissue, guided by real-time ultrasound imaging to ensure accurate placement. Multiple freeze-thaw cycles are usually applied to ensure thorough ablation. This method can take longer than heat-based techniques but is associated with less post-procedural discomfort and minimal tissue damage beyond the targeted area.
Key components in ablation devices
Medical-grade thermocouples are key temperature-sensing elements using two dissimilar metal alloys joined together in bifilar and multifilar forms. Thermocouples are built into many ablation devices, which continuously monitor the thermal energy being delivered to the ablation site. By providing accurate, real-time feedback, medical-grade thermocouples help to regulate heat levels so that the endometrial lining is destroyed effectively while preventing damage to nearby areas such as the myometrium or surrounding organs.
Guidewires play a pivotal role in accurately navigating the uterine anatomy, particularly in cases where the cervix may be stenotic or the uterine cavity is distorted due to fibroids or congenital anomalies. These flexible, steerable wires allow clinicians to safely and precisely position ablation devices within the uterine cavity.
Alleima specialises in the development and manufacturing of nitinol-based guidewires, leveraging the unique properties of this nickel-titanium alloy to enhance medical device performance, including superelasticity. This allows guidewires to navigate complex anatomical pathways without permanent deformation, returning to their original shape after bending. The flexibility is crucial in minimally invasive procedures such as endometrial ablation, enabling precise control and reducing the risk of injury.
Once a guidewire has positioned the device correctly, transmitting wires conduct energy from the external power source to the applicator tip within the uterus. Whether the ablation technique involves radiofrequency, microwave, or electrical energy, these wires must be engineered for optimal conductivity and minimal energy loss.
The insulation and structural design of the wires are also essential for efficient energy transfer, which enables the device to reach the temperatures or energy levels needed for complete endometrial destruction. A well-designed transmitting wire ensures that the energy is delivered precisely to the treatment areas, reducing the risk of uneven ablation or thermal spread. Alleima’s ultra-fine transmitting medical wires are often coated with polymers to serve as dielectric barriers, enhance corrosion resistance, and provide a lubricious surface.
Selecting the optimal coating is key to end-performance success and a balancing act between engineering, chemistry, and functionality that tests even the most experienced design teams. Identifying the optimal coating during the initial design phase is essential to prevent unfavourable outcomes in subsequent process steps of the device.
Alleima specialises in the design, development, and manufacturing of multifilar wire configurations, where multiple individually coated wires are twisted or wrapped together to form a single cable. This approach not only provides greater flexibility and versatility compared with single-ended wires but also ensures that the specific needs of customers are effectively addressed.
Ensuring successful patient outcomes
Endometrial ablation has many benefits, including reduced recovery times, minimal invasiveness, and the potential to avoid major surgeries such as hysterectomy. However, it is still essential for patients to undergo thorough pre-procedural evaluations to rule out uterine malignancies or structural abnormalities that would contraindicate the procedure.
Post-ablation, some women may experience changes in menstrual patterns. While many report satisfaction with the outcomes, it is imperative to discuss potential risks and benefits with a healthcare provider.
The efficacy and safety of endometrial ablation relies on well-designed instruments and components. With its material expertise, engineering services and broad range of precision manufacturing capabilities Alleima is dedicated to working with medical device manufacturers to desgin, develop and manufacture life-changing solutions that deliver the best patient outcomes.
To find out more about Alleima, download the whitepaper below or visit their website.
