Invented by William A. Blair, Covidien LP

The market for sterilizable wirelessly detectable objects for use in medical procedures is rapidly expanding, driven by the increasing demand for advanced medical devices and the need for improved patient safety. These objects, which can be easily tracked and located within the human body during surgical procedures, are revolutionizing the field of medicine. In recent years, there has been a significant shift towards minimally invasive procedures, which require smaller incisions and result in faster recovery times for patients. This has created a need for smaller, more precise medical devices that can be easily manipulated within the body. Sterilizable wirelessly detectable objects, such as surgical instruments, implants, and catheters, have emerged as a solution to this demand. One of the key advantages of these objects is their ability to be sterilized without compromising their wireless detectability. Traditional medical devices often lose their tracking capabilities after undergoing sterilization processes, making them less reliable during surgical procedures. However, sterilizable wirelessly detectable objects are designed to withstand sterilization methods such as autoclaving or ethylene oxide gas sterilization, ensuring their functionality remains intact. The wireless detectability of these objects is achieved through the incorporation of radiofrequency identification (RFID) or other similar technologies. RFID tags, embedded within the objects, emit a unique signal that can be detected by specialized tracking systems. This enables surgeons and medical staff to precisely locate and track the objects in real-time, reducing the risk of leaving foreign objects inside patients or damaging surrounding tissues. The market for sterilizable wirelessly detectable objects is witnessing significant growth due to the numerous benefits they offer. Firstly, these objects enhance patient safety by reducing the occurrence of retained surgical items (RSIs). RSIs, such as surgical sponges or instruments, left inside a patient’s body can lead to serious complications, infections, and even death. By providing real-time tracking, these objects minimize the chances of such incidents occurring, improving patient outcomes. Secondly, the use of sterilizable wirelessly detectable objects improves operational efficiency in healthcare facilities. The ability to quickly locate and retrieve these objects reduces the time spent searching for misplaced or lost instruments, ultimately saving valuable time during surgical procedures. This efficiency also translates into cost savings for hospitals and clinics, as it reduces the need for unnecessary additional procedures or treatments. Furthermore, the market for these objects is driven by the increasing adoption of digital healthcare systems and the integration of Internet of Things (IoT) technologies in the medical field. The ability to wirelessly detect and track medical devices aligns with the broader trend of digitizing healthcare processes, allowing for seamless data collection and analysis. This integration enables healthcare providers to make informed decisions, optimize workflows, and improve patient care. In terms of manufacturing, the production of sterilizable wirelessly detectable objects requires specialized expertise and adherence to strict quality standards. Manufacturers must ensure that the objects are not only sterilizable but also durable, reliable, and safe for use in medical procedures. This involves rigorous testing, validation, and compliance with regulatory requirements. In conclusion, the market for sterilizable wirelessly detectable objects for use in medical procedures is experiencing rapid growth, driven by the increasing demand for advanced medical devices and improved patient safety. These objects offer numerous benefits, including enhanced patient safety, improved operational efficiency, and integration with digital healthcare systems. As the medical field continues to evolve, the demand for these innovative objects is expected to rise, making them an integral part of modern medical practices.

The Covidien LP invention works as follows

The invention provides “Various embodiments” of wirelessly detectable medical objects. These may include ionizing radio frequency identification (RFID), other wireless transponders or integrated circuits and attachment structures. All of these retain structural and function integrity when exposed standard doses of ionizing rays. Alternatively, or in addition, wireless radio frequency (RFID), other wireless transponders, integrated circuits and attachment structures may retain structural and functionality when exposed to standard sterilization pressures and/or temperatures.

Background for Sterilizable Wirelessly Detectable Objects for Use in Medical Procedures and Methods of Making Same

Technical Field

The present disclosure relates generally to medical procedure-related objects (e.g. sponges, tools, instruments, etc.). Tags with wirelessly-readable transponders.

Description of Related Art.

It is vital to ensure that any objects related to surgery or medical procedures (e.g. labor and delivery) are removed from the patient’s body prior to surgery or medical procedure. This will prevent unwanted retention of objects which are considered foreign to the body. These medical procedure objects can take on a variety forms. The medical procedure objects can take many forms, such as instruments or tools like scalpels, hemostats and endoscopes. Medical procedure objects can also be disposable or consumable, such as surgical sponges and gauzes. If a medical object is not located before the procedure is completed (e.g. closing an incision or a wound), it may be necessary to perform additional procedures (e.g. additional surgeries) to retrieve it. This can expose the patient to additional trauma, complications, and inconvenience. In some cases, failure to find a medical object can have severe medical consequences. For example, an infection that leads to sepsis or death. In addition, failing to locate a medical object can result in additional medical costs.

Most hospitals have implemented procedures that use checklists or require multiple manual counts in order to determine the number of medical objects at both the beginning and end of a procedure. These processes are sometimes called manual count-in/count out or check-in/checkout processes because they usually involve a manual counting or checking in/checking out at the beginning and end of a procedure. These manual approaches are time-consuming, require highly trained personnel and are prone for error.

Another method marks different objects with optically-readable machine-readable symbol, each of which encodes a unique identifier. These machine-readable symbol can take many forms. For example, they may be linear or one-dimensional, also known as barcode symbols. Or, two-dimensional, usually called area or matrix codes. The symbols can be encoded using a wide variety of symbologies, such as mappings between machine-readable and human-readable character sets. The optically-readable symbols can be printed on labels or tags that are attached, via adhesive, to medical procedure objects. Symbols can also be etched on medical procedure objects. A machine-readable symbols reader (e.g. barcode scanners) can illuminate the machine-readable symbols and read a unique identification encoded in them. This process is similar to the manual check-in/checkout or count-in/count out processes. Each item is scanned before or at the beginning of a procedure and again at the end or after the procedure. The processor-based device can perform an automated comparison and provide an alert if the list at the beginning of a medical procedure is different from the list at the end.

Yet another method marks different objects with transponders that can be read wirelessly, and each transponder encodes a unique identifier. The wirelessly readable tags and transponders that are used for radio frequency identification can operate at high radio frequencies or microwaves. The RFID transponders usually include a memory, such as an integrated circuit. For example, a read/writeable memory that can be read and written many times. RFID transponders, in general, are passive devices without batteries. The RFID transponders are passive devices that derive their electrical power from the interrogation signals transmitted by RFID readers or interrogators. RFID transponders can be attached to the respective medical procedure objects. An RFID reader or interrogator emits radio or microwave frequencies when in use. An RFID transponder, upon receiving the interrogation, charges a capacitance. This provides enough power to send back (e.g. by backscattering) a response that encodes the unique ID stored in the RFID Transponder. Interrogator receives return signal identifying RFID transponder. This process is similar to the manual check-in/checkout or count-in/count out processes. Each item is scanned before or at start of medical procedure and again after or at end of medical procedure. The processor-based device can perform an automated comparison and provide an alert when the list at the beginning of a medical procedure is different from the list at the end.

Another method uses wirelessly detectable transmitters and a wireless detector system. This approach uses simple LC resonant transponders that do not encode unique identifying data or return it. They are therefore referred to as dumb? Wireless transponders. These dumb wireless transmitters are attached to medical objects with a variety structures (e.g. adhesives, epoxy resin, potting materials, housings). Wireless detection systems include one or more radios with a transmitter emitting pulsed wideband wireless signals (e.g. radio or microwave frequency), and a detector or receiver that detects wireless response or return signals sent by dumb wireless transponders as a response to these pulsed wideband signals. The wireless detection system is used to scan a portion or the entire body of the patient in order to detect the presence of a dumb transponder. This automated detection system can operate in relatively low frequency ranges. This increases accuracy, especially when the dumb transponder is located in vivo, i.e. in body tissue, as opposed to RFID-based approaches. This automated detection system can also reduce the time that highly-trained and highly-compensated personnel are required to spend compared to other approaches. U.S. Pat. discusses some examples of the dumb transmitter and wireless detector approaches. No. Patent Publication No. U.S. 2004/0250819 published on December 16, 2004. The dumb transponder approach and wireless detector contrasts with previously described approaches. This approach does not rely on previously described check-in/checkout or count-in/count out techniques.

The medical procedure object should be sterilized before use. The sterilization procedure can take many forms. These include heating, pressurization and/or exposure of ionizing radiation.

In any of the approaches described above, everything attached to the medical device (e.g. machine-readable symbol or RFID wireless transponder or dumb wireless transponder), must be able to undergo sterilization procedures. Sterilization procedures can damage integrated circuits, semiconductor devices, and/or the attachment structures they are attached to (e.g. adhesives). Gamma radiation can cause data and information to become unreliable in many semiconductor-based devices or integrated circuits (e.g. memory). “Various adhesives and polymers, such as plastics, are negatively affected by heat or pressure.

Therefore, new approaches, techniques and structures are desired to facilitate the marking and automated detection and inventorying of medical devices objects in body tissue, and prevent unintentional foreign object retention.

The use of materials resistant to sterilization is advantageous when a medical device will be sterilized prior to its use or subjected to repeated sterilization procedures. For example, in preparation for reuse, or for repeated use with multiple medical procedures.

A radiation-hard (e.g. X-ray or Gamma-ray radiation-hard) RFID transponder (or other wireless transponder) and/or integrated chip, in particular a radiation-hard read-only memory (i.e. write-once) that encodes a unique identification, can be useful for marking and identifying the medical procedure items to be used during an operation. These can be used to identify medical procedure items that are durable or reusable, such as medical instruments and tools, or disposable medical procedure items, like gauzes or spongs. The RFID transponder or other wireless transponder or integrated circuit can also be made of materials that are resistant to high temperatures or pressures or combinations of these.

The radiation-hard integrated circuit can be in the form of a wireless RFID transponder that has a memory made from radiation-hard material to store a unique identification. The radiation-hard wireless RFID transponder can transmit and/or received signals at a radio frequency below that of traditional RFID transponders.

It may be beneficial if the attachment structures used to attach RFID transponder or other wireless transponder or integrated circuits are also radiation-resistant and/or made of materials that can withstand high temperatures or pressures or combinations of these.

The RFID transponder can be used on medical procedure sponges. The pouch can be sealed or closed using a heat weld or RF weld and/or one or more stitched threads (e.g. sewn thread) or one or two staples. This will retain the RFID transponder or other wireless transponder in the interior of the bag. The pouch can be attached to a gauze or sponge using a heat weld or RF weld and/or one or more stitch. The pouch is made from a material which can withstand elevated temperatures, high pressures and/or combinations thereof, commonly used in sterilizing objects for medical procedures. For example, sterilization gauze or sponges. The pouch is made from a radiation-resistant material that can withstand (essentially unaffected by) exposure to ionizing radio waves (e.g. X-rays, Gamma Rays), especially doses and durations used in sterilization procedures for medical objects, such as gauzes or sponges.

The material used to close or seal the pouch, or attach the pouch to the sponge or gauze, is made from a radiation-resistant material which can withstand elevated temperatures, high pressures and combinations thereof, as are commonly used in the sterilization process of medical objects, such as gauzes and sponges. The material used to close or seal the pouch, and/or to attach the pouch to gauze or a sponge is made from a radiation-resistant material. This material can withstand (almost unaffected by) exposure to ionizing rays (e.g. X-rays, Gamma Rays), especially doses and durations.

Gauze can be folded in order to place or space the pouches, RFID transponders, other wireless transmitters and/or integrated-circuits on one or several interior folds of a number of folds of portions or folds. This may occur within a pair of outermost folds of portions or layers.

Sponges can optionally include one piece of radio-opaque materials to aid detection by medical imaging (e.g. ray-tech or X-ray). One or more radio-opaque threads may be woven or knitted into the gauze or attached at different locations. “For example, a set of radioopaque filaments can be woven, knitted or attached to the gauze at one, two or more distinct locations.

The gauze can be folded in such a way that the radio-opaque materials are positioned or spaced on one or several interior folds of a multitude of folds of portions, or on a pair of outermost folds of portions or layers. This can help detect closely spaced sponges. For example, when checking the total number of sponges within a package or packet of sponges.

When used on medical instruments, RFID transponders, other wireless transmitters or integrated circuits can be attached using a variety attachment structures. Attachment structures can include, for instance, adhesive, epoxy, or potting materials. Attachment structures can include, for example one or more clamps with a bias member or spring, or a fastener such as a threaded screw, with or without nuts or similar members. The attachment structure can be a housing that clamps or attaches to the RFID transponder. The attachment structure can position the RFID transponder (or other wireless transponder) or integrated circuit more than 2 centimeters away from the metal of the medical procedure tool.

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