Advancing Thermal Management:
Giving Surgeons a Better
Grip on Procedures and Outcomes

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Michael Bucci, Market Development Manager, Thermacore

A governing principle of healthcare is often expressed in the phrase “First, do no harm.” For centuries, this principle has guided decisions between procedural risks versus potential benefits. The continuing drive toward increased surgical instrument functionality, reliability, and miniaturization has helped to mitigate the risk of harm, allowing more procedures to become justifiable. Many of these cutting-edge medical tools are built on the advances in microprocessor computing power, laser precision, ultrasound transducer fidelity, and digital imaging technologies. However, these technological advances can mean more waste heat is produced, while the drive toward miniaturization packs these electronics into smaller spaces. The increase in waste heat combined with miniaturization creates a fundamental challenge for designers: as greater sophistication is sought to make electrosurgical instruments more effective in the operating room, waste heat must be safely dealt with to prevent inaccuracies or complications during and after procedures.

To reduce surgeon fatigue and improve surgical outcomes, forward-thinking designers are seeking to make their surgical tools lighter, easier to manipulate and more reliable, especially for long or complex procedures. One of the key tradeoffs is the concentrated heat loads produced by today’s electronics that can cause performance variability, premature component failure, and even harm the patient.

To address these safety issues, the International Electrotechnical Commission has published and updated the IEC 60601 third edition technical standard, which sets standards for the safety and effectiveness of medical electrical equipment. Included in the updated IEC 60601 standard are allowable temperature limits for medical equipment components that are likely to be in contact with patients or medical personnel.

The International Electrotechnical Commission (IEC) 60601 standard defines both the maximum temperature for different types of materials, and the amount of time that they can be in contact with the skin. This standard protects collateral tissue not involved in procedures and also protects the skin of the hospital staff, should they come into contact with the device. Thermal management solutions enable medical device designers to meet these temperature requirements under the most challenging conditions.



Table 23 from the IEC 60601, 3rd Edition



Thermal Management: Active and Passive

Thermal management, or heat transfer, is the engineering discipline that allows heat to be efficiently controlled to improve system reliability, speed and precision; while minimizing equipment dimensions, energy consumption, and noise levels. This allows medical designers to keep their designs compact, quiet, and address biological contamination concerns. Devices that require large amounts of airflow can contribute to biofouling, exacerbating the risk of infection by collecting pathogens in the device and then distributing them throughout the facility; which can be a source of healthcare-associated infections (HAIs). Advanced thermal management allows designers to maintain consistent temperature control and increase the power level of a device without having to increase airflow through the device. Thermal solutions fall into two primary categories, active and passive, which have their own corresponding advantages.

Active thermal management generally includes pumped liquid cooling, refrigeration, and, most commonly, forced convection or fan-cooled technologies. Active systems provide effective cooling and are relatively easy to control.

Active solutions offer the following design advantages and considerations:
• Forced convection systems allow for adjustable cooling points, but fans can generate noise, can accelerate fouling, require filter servicing, and are a potential failure point that can cause complications or downtime.

Liquid cooling systems, as shown in Figure 1, can handle high heat fluxes, enabling remote heat dissipation, and can be flexible to allow for maneuverability. However, they employ pumps that can generate noise and eventually fail. Precautions must also be made to mitigate the risk of leakage, as this could severely damage the electronics or cause contamination.

• Refrigeration systems primarily use either compressors to circulate a refrigerant or thermoelectric devices to lower temperatures below ambient and usually offer adjustable cooling rates. However, designers must keep in mind that refrigeration systems are also potential failure points, may cause condensation issues, and actually generate more heat than they remove - requiring the resultant heat to be dissipated through other means.



Figure 1: Pumped liquid systems and vacuum brazed cold plates are very effective for cooling specific components or entire enclosures.


Passive thermal management can solve complex cooling problems in small spaces by minimizing the required airflow. This reduces the amount of dust, moisture, and debris that enters medical devices, thereby resolving many “bioburden” and noise concerns. Bioburden, also known as fouling, refers to the potential for bacteria to collect on a given surface, leading to hospital-acquired infections, which is one of the most significant healthcare challenges facing hospitals, rehabilitation facilities, and other treatment locations. Passive cooling technologies generally include heat pipe assemblies, vapor chamber assemblies, phase change materials (PCM), and advanced solid conduction materials, such as encapsulated Annealed Pyrolytic Graphite (APG).

Heat pipes assemblies transfer high heat loads in small spaces, typically reducing the size of heat sinks, providing remote heat transport, and enclosure isolation. They also make natural convection practical by eliminating the need for cooling fans. Sintered powder wick heat pipes offer the advantages of two-phase passive cooling (working fluid evaporation and condensation cycle) with no moving parts, operate better against gravity, and are freeze-thaw tolerant. To enable more flexible design choices, heat pipes can be less than 2 mm in diameter and can be formed to fit in complex spaces.

Vapor chambers are planar or flat versions of heat pipes. Shown in Figure 2, vapor chambers feature an evacuated vessel with a small amount of fluid inside and a capillary wick structure that lines the internal surfaces. Vapor chambers offer excellent heat spreading ability in all directions, allowing them to handle high heat fluxes and rapid thermal cycling. Vapor chambers can be designed to be less than 1 mm thick. For some applications, they can be matched to the coefficient of thermal expansion (CTE) for direct die attachment to the electronics, making this technology especially valuable for medical devices that require compact configurations.

Phase Change Materials begin cooling at specific temperatures, so they can temporarily prevent a component from exceeding its temperature limit. They are also easy to integrate into medical device designs because they absorb heat and do not require access to ambient air or liquid cooling lines. However, they eventually become saturated and begin to act as insulators, which can aggravate thermal issues even further.

A promising new material for medical applications is encapsulated APG. Encapsulated APG offers design versatility because it can be paired with many different biocompatible materials. APG is lightweight and has high thermal conductivity - up to four times the thermal conductivity of copper - with less mass than aluminum. The solid state design provides consistent performance, both with and against gravity, giving designers considerable flexibility in creating medical device solutions.

Passive thermal technology offers the following advantages and design considerations:

• Can handle complex cooling problems in small spaces, offering medical device OEMs greater design freedom. However, attention appropriations must be made since the conductivities that these solutions offer can vary with length and with direction.

• Reduces the risk of bioburden issues associated with fans and other active devices to aid in preventing healthcare-associated infections. However, sufficient surface area on the device must be available to conduct heat away locally or at a remote point.

• Eliminates the need for power sources to reduce a device’s Size, Weight, and Power Consumption (SWAP).

• Yields long-term savings by reducing service costs and extended equipment lifetime, since the thermal management portion of the system has no moving parts.

• Provides exceptional levels of isothermality that enable designers to satisfy the precision requirements of the most cutting edge medical devices.



Figure 2: Vapor chambers can handle high heat fluxes and rapid thermal cycling, making this technology especially valuable for medical devices.


Cooling Compact Instruments: Application Examples

While large-scale diagnostic medical devices such as MRIs, digital X-Ray and PET scanners generate high heat loads that generally use active thermal management solutions. Smaller portable or mobile devices that can be moved to different locations within a facility are in most cases best served with passive thermal management technologies.



Electrosurgical instruments:

In these applications, surgical tools often have electrode tips that are used to create or cauterize incisions within a patient during a procedure. These electrode tips generate heat which must be properly dissipated; in addition, designers of these types of tools seek to minimize size and weight to improve maneuverability and prevent fatigue for the surgeon. Use of heat pipes or encapsulated APG provides an effective solutions.



Lasers:

Advances in laser technologies have made lasers increasingly prevalent in the healthcare industry. While laser based systems often incorporate an active fan cooled heat sink assembly to dissipate heat from the diode, they also require quiet operation and many times need to be portable. By using a heat pipe heat sink assembly, the amount of required airflow can be reduced, which minimizes noise levels, improves laser diode performance, and extends equipment life. For high power lasers, advanced liquid cooling technologies such as micro-channel cold plates and Therma-Cubes™ can manage heat fluxes of up to 12,000 W/cm²!



Diagnostic equipment:

Automated biological analysis tools, such as blood analyzers and the latest DNA sequencing tools, are now broadly used in many healthcare labs. This equipment requires precisely controlled operating temperatures. For example, to properly replicate DNA samples, the temperatures of hundreds of samples are cycled repeatedly across a wide temperature range, yet must be kept within 0.5°C of each other. The use of embedded heat pipes, vapor chambers, and APG cold plate technologies have enabled this type of control.


Figure 3: Heat pipes transfer high heat loads in small spaces, reducing the required size of heat sinks.


Choosing the Optimum Thermal Management Solution

There is no panacea that solves all thermal management issues. Ultimately, the performance requirements, operating conditions, size/weight constraints, noise limitations, and touch temperature limits provide the correct framework for choosing between the available thermal technologies.

In an effort to contain costs and shorten development time, many designers initially search for off-the-shelf products or try to develop a thermal solution on their own. This may work in some cases, but often involves spending a lot of time evaluating a multitude of variables and options. A time consuming trial and error process may or may not lead to a suitable solution. Partnering with experts in their respective fields allows designers to get it right the first time, saving time, reducing development risks, and meeting their project requirements. This process also helps identify any necessary design provisions early enough to accommodate changes.

An expert in designing and manufacturing thermal management solutions can help resolve whether an off-the-shelf or custom solution is the most appropriate option for your medical device -- plus provide insight on the quality management systems and good manufacturing practices that can turn your design into reality.

 

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