Gentherm designs ThermAffyx to protect and move patients during robotic surgeries

Many advances in healthcare come from this sector, but innovations from other sectors can also find a role. Gentherm Medical designed its ThermAffyx patient safety system based on thermal management experience from the automotive industry.

The system safely positions the patient and provides patient warming for robot-assisted surgery. Gentherm Inc. said ThermAffyx does both while minimizing the amount of space required and without the need for forced-air equipment.

The Novi, Michigan-based company launched the system at the Association of periOperative Registered Nurses (AORN) global surgical conference this year. Gentherm noted that numerous medical professionals have stated that “nearly all of their robotic patients are hypothermic.”

Adam Hauke, global director of product strategy and innovation at Gentherm, answered the following questions from The robot report.

Gentherm meets the Trendelenburg challenge

What is the challenge faced by ThermAffyx and how are patient positioning and hypothermia conventionally managed?

Hauke: The ThermAffyx Patient Safety System combines active patient warming and safe positioning in one solution, helping to address two critical perioperative challenges: maintaining normothermia and reducing patient motion during surgery.

The current standard of care consists of forced air warming solutions and a fixation pad. Historically, warming and positioning have been approached independently because, in many surgical procedures, they do not significantly interfere with each other. However, this is not the case in most robot-assisted surgeries.

These procedures often require patients to remain in the Trendelenburg position, where the body is tilted upside down to provide surgical access to the pelvis and lower abdomen. Patients can remain in these positions for extended periods while the robotic systems are docked and used.

This positioning introduces several challenges, including increased pressure and shear forces that can contribute to pressure injuries, the risk of nerve-related complications if positioning is not optimized, and the risk of patient movement or displacement during lengthy procedures. Underbody retaining pads are designed to address these positioning challenges.

At the same time, maintaining normothermia becomes more challenging because robotic equipment occupies the physical space where traditional body warming solutions must be implemented. In these situations, doctors often rely on underbody warming approaches, but they are difficult or impossible to use in robotics because they would interfere with the underbody fixation pads used to safely position the patient.

Suddenly, warming up and positioning are no longer separate considerations. They compete for the same property.

How much do patients move during surgery?

Hauke: During routine operating room activities, “patient movement” is not monitored. “Patient movement”, if recorded, is performed as “light anesthesia”. It usually refers to the patient’s anesthetic wearing off prematurely and moving a hand or leg.

No one measures anything on the operating table related to patient movement, since everything is under the sterile drape at that point. The only way the surgical team knows if a patient is moving is if there is typically tension on the robotic instruments.

Any involuntary patient movement during robot-assisted surgeries can vary greatly based on a number of factors. There are multiple individual contributing factors such as patient weight, height and body proportions, as well as procedure-based factors such as patient position, the angle at which the operating table is tilted, and whether or not other positioning solutions such as stirrups are used.

If there is a Trendelenburg-related shift, it is usually noted by anesthesia as difficult breathing or a decline in capnography. Actual, measurable shift in a patient on the operating table does not occur very often and is not currently a recorded statistic.

Is there a weight or size range for the system?

Hauke: The ThermAffyx System is intended for adult patients and has been tested on individuals up to 297 pounds. [134.7 kg]. The pad is designed so that the patient can be positioned anywhere within the warming zone to receive active warming.

The Pad’s safety sensors do not require direct contact with the patient to function. As always, clinicians should follow their facility’s protocols and guidelines for safe patient positioning.

Does the Gentherm system require more power than existing setups?

Hauke: No, ThermAffyx works with standard hospital electrical outlets.

Is there a danger of thermal or electromagnetic interference with some surgical instruments?

Hauke: We have mitigated compatibility risks with other devices as much as possible. The system has been designed and verified to comply with all applicable industry standards and FDA guidelines, including compatibility with electrocautery, diathermy, defibrillation equipment, RFID devices, wireless power transfer devices and 5G cellular networks. Therefore, the risk of thermal or EM interference is low.

However, there is always a residual risk of problems occurring. We do not control the design and use of external devices that may be used in conjunction with ThermAffyx and therefore cannot guarantee that other devices have been designed to meet the same standards or that the devices are used according to the manufacturer’s labeling.

ThermAffyx moves to market

How is the system progressing towards commercialization?

Hauke: Marketing is well underway. Our teams are engaged in active trials across the country with strong adoption in both new accounts and our legacy Gentherm accounts.

How difficult was it to get clearance from the US Food and Drug Administration?

Hauke: While Gentherm is an expert in patient warming devices, obtaining FDA approval for ThermAffyx required careful development planning and execution. This is the first and only all-in-one product to have Class II indications for use in maintaining normothermia and safety.

To ensure that appropriate measures were taken, we began the process with a Q-Sub to the FDA to receive their feedback on our claims and validation plan. We then implemented the appropriate design and testing based on FDA feedback to validate our claims.

An additional FDA requirement is to demonstrate the usability of your device. The operation of the device must fit seamlessly into doctors’ normal workflows to ensure the system can be used safely without introducing complexity. Nurses and anesthesiologists provided critical input to the design through focus groups, then validated the design in extensive hands-on usability studies.

Does this add to the cost of operating equipment or surgical procedures?

Hauke: While ThermAffyx adds incremental costs for the technology – below most capital budget thresholds – the more important consideration is its potential impact on reducing costly downstream complications.

By helping to reduce the risk of inadvertent perioperative hypothermia, patient movement or pressure-related injuries, the system can help avoid adverse events that can increase length of stay, require additional treatments and result in higher overall costs of care.

In robotic surgery, these procedures are already supported by established reimbursement structures and procedural codes, making this technology a natural fit into your existing surgical workflow.

Will you sell it directly or through a third party?

Hauke: ThermAffyx is available for purchase through Gentherm’s U.S. contract sales team.

Are there other potential use cases for ThermAffyx and its component technologies?

Hauke: ThermAffyx was specifically designed to address the challenge of maintaining normothermia in patients undergoing minimally invasive, robot-assisted procedures, particularly in cases of gynecological, urological or general surgery requiring tilted patient positioning.

However, its innovative 3-in-1 design offers benefits that go far beyond these initial applications.

By integrating heating technology into an underbody foam pad that redistributes pressure, ThermAffyx can help support patient temperature management in a wide range of surgical settings where maintaining normothermia can be difficult, including orthopedic, cardiovascular, colorectal and plastic cases.