Invention for Biocompatible encapsulation for negative pressure wound therapy dressings with sensor

Electronics / By

Invented by Allan Kenneth Frazer Grugeon Hunt, Lee Partington, Felix Clarence Quintanar, Daniel Lee Steward, Charlotte Urwin, Smith and Nephew PLC

The market for biocompatible encapsulation for negative pressure wound therapy (NPWT) dressings with sensors is rapidly growing as healthcare professionals and patients seek advanced wound care solutions. NPWT is a widely used technique for the management of complex wounds, such as diabetic foot ulcers, pressure ulcers, and surgical wounds. It involves the application of negative pressure to the wound bed, promoting healing by removing excess fluid, reducing edema, and enhancing blood flow. Traditionally, NPWT dressings consist of a foam or gauze dressing covered by an adhesive film or drape. While these dressings have proven effective in wound healing, the addition of sensors and biocompatible encapsulation further enhances their functionality and patient outcomes. Biocompatible encapsulation refers to the use of materials that are compatible with the human body, minimizing the risk of adverse reactions or complications. These encapsulations are typically made of medical-grade silicone or hydrocolloid materials, which provide a barrier between the wound and the external environment, preventing infection and promoting healing. The integration of sensors into NPWT dressings allows for real-time monitoring of wound conditions, such as temperature, moisture levels, and pH. This data can be transmitted wirelessly to healthcare professionals, enabling them to make informed decisions regarding wound management. For example, if the sensor detects an increase in temperature or moisture, it may indicate the presence of infection or excessive wound exudate, prompting healthcare providers to adjust the treatment plan accordingly. The market for biocompatible encapsulation for NPWT dressings with sensors is driven by several factors. Firstly, the rising prevalence of chronic wounds, such as diabetic foot ulcers, due to an aging population and increasing rates of diabetes, necessitates advanced wound care solutions. NPWT dressings with sensors offer a more personalized approach to wound management, allowing for timely interventions and improved outcomes. Secondly, the growing demand for remote patient monitoring and telehealth services has further fueled the adoption of NPWT dressings with sensors. These dressings enable healthcare professionals to remotely monitor wound progress and intervene when necessary, reducing the need for frequent clinic visits and improving patient convenience. Additionally, advancements in sensor technology and biocompatible encapsulation materials have made these dressings more reliable, comfortable, and cost-effective. Manufacturers are investing in research and development to enhance the accuracy and durability of sensors, as well as improve the breathability and flexibility of encapsulation materials. However, there are challenges that need to be addressed for wider adoption of biocompatible encapsulation for NPWT dressings with sensors. Cost is a significant factor, as these dressings tend to be more expensive than traditional NPWT dressings. Reimbursement policies and healthcare budgets need to accommodate the added cost of sensor integration and biocompatible encapsulation. Furthermore, the integration of sensors and wireless connectivity raises concerns regarding data privacy and security. Healthcare providers and manufacturers must ensure that patient data is protected and comply with relevant regulations, such as the Health Insurance Portability and Accountability Act (HIPAA). In conclusion, the market for biocompatible encapsulation for NPWT dressings with sensors is expanding rapidly, driven by the need for advanced wound care solutions and remote patient monitoring. These dressings offer real-time monitoring of wound conditions, enabling timely interventions and improved patient outcomes. However, challenges related to cost and data privacy need to be addressed for wider adoption. With ongoing advancements in technology and increased awareness among healthcare professionals, the market for these innovative dressings is expected to continue growing in the coming years.

The Smith and Nephew PLC invention works as follows

Devices and methods are disclosed for encapsulating part of a wound dressing in a biocompatible coating. In certain embodiments, the method comprises coating a first surface of a flexible layer that forms the wound contact with a hydrophobic material. The first side can be used to support multiple electronic components. The method may also include coating the second side of wound contact layer, opposite to the first side, with the hydrophobic material. The wound contact material can be made up of hydrophilic materials.

Background for Biocompatible encapsulation for negative pressure wound therapy dressings with sensor

Field

The present disclosure includes “Embodiments” that relate to systems and methods of treating tissues using sensor-enabled monitors in conjunction with different therapy regimes.

Description of Related Art

Many types of treatment are still performed routinely without sensor data collection. These treatments are based on visual inspections by caregivers or other limited methods, rather than sensor data. In the case of wound treatments via dressings or negative pressure wound therapy the data collection is usually limited to visual inspections by caregivers. Often the wounded tissue beneath the bandages and other visual obstructions may be hidden. Even unwounded, intact skin can have damage beneath the surface that is not visible. This could be a compromised vascular system or deeper tissue damage which may lead to ulcers. Similar to wound treatments, orthopedic treatments that require the immobilization or encasement of a limb using a cast, or similar encasement only gather limited information on the underlying tissues. When internal tissue is repaired, as with a boneplate, continuous sensor-driven data gathering is not done. Braces or sleeves that support musculoskeletal functions do not monitor the function of muscles under the brace, nor the movement of limbs. “Beds and blankets in hospital rooms, which are used for direct treatment, could be enhanced by adding the capability to monitor patient parameters.

Therefore there is a requirement for improved sensor monitoring. This can be achieved by using sensor-enabled materials that are easily incorporated into treatment regimes.

According to certain embodiments, a method is provided for coating a dressing wound, the method consists of:

The method of coating a wound dressing as described in the paragraphs above may include one or more features. The method may include coating the wound-contact layer. The coating can be hydrophobic and/or biocompatible. At least one electronic connector may be included in the plurality of electronic elements. The method can also include coating multiple layers on at least some electrical components. Spraying coating on the first and second side of the wound contact layer is one way to coat them. Spraying can be done with compressed air, inert gases or a combination of both. The coating can be made from materials that comply with IEC 60601 standards.

According to certain embodiments, a method is provided for coating a dressing wound, the method consists of:

In some embodiments described in the paragraphs above, one or more features can be included. The first coating can be non-stretchable. At least one of Dymax 23051, Dymax 20555, Dymax 9000-E or Loctite 32111 may be used in the first coating. The contact layer for the wound may be made up of hydrophilic material. The first and/or second coatings can be hydrophobic or made from materials that comply with IEC 60601 standards. The first coating cannot have a viscosity greater than 50,000 centipoise.

According to certain embodiments, a method is provided for coating a dressing wound, the method consists of:

The method described in any of the paragraphs above can have one or more features. The non-biocompatible layer may be non-stretchable. In some embodiments coating the first wound contact layer with a biocompatible coating includes coating the nonbiocompatible coating over the plurality electronic components. The biocompatible layer may be hydrophobic or made from materials that comply with IEC 60601 standards.

According to certain embodiments, a method is provided for coating a dressing wound, the method consists of:

The method described in any of the paragraphs above can have one or more features. The method may also include supporting the first face of the wound-contact layer in a substantially horizontal position using a mold that includes a plurality recesses for holding the plurality electronic components, and applying the coating substantially evenly to the second face of the wound-contact layer. The method can further include supporting the second side in a substantially horizontal position between the first frame and the second frame; and applying the coating substantially evenly to the first surface of the contact layer. In certain embodiments, the coating can be applied by spraying or encapsulating wound contact layers with biocompatible coating. Spraying can be done with compressed air, or an inert gas. The biocompatible coating comprises material that conforms to IEC 60601 standards. In certain embodiments, coating the first surface of the substantially elastic wound contact layer that supports the plurality electronic components may also include making at least one hole in the layer. The at least perforation may be made under at least a single electronic component. When coating the first surface, the method can also include applying more pressure to the first than the second side.

Accordingly to certain embodiments, a wound dressing is provided by a method that comprises:

The wound dressing described in any of the paragraphs above can have one or more features. The wound-contact layer can be flexible. The coating can be biocompatible and/or substantially stretchable, or made from materials that comply with IEC 60601 standards. Before coating the first surface of the wound-contact layer with the hydrophobic coat, the process can include coating the electronic components with a coating that is substantially non-stretchable. The process can also include making at least one hole in the wound-contact layer before coating the first side supporting the plurality electronic components. The at least perforation can be made under one or more electronic components. The process can also include applying more pressure to the first than the second side of wound contact layer while coating the first.

According to certain embodiments, a wound dressing is provided that has been manufactured or coated using any of the methods described in this document.

Accordingly to certain embodiments, a device is provided for coating a dressing wound, the device comprising

The device described in any of the previous paragraphs may include one or more features. The device can further include a base, a mold with a plurality recesses that are configured to hold the plurality electronic components. The mold and first frame may be configured to be placed on the base. The mold can be configured to hold a plurality wound contact sheets in a substantially flat position. At least one of the wound contact surfaces may have a different arrangement of components than a second wound surface. The wound contact layer can be made of thermoplastic polyurethane. The coating can be made of urethane-acrylate or may be used to encapsulate wound contact layer. At least one of the plate or the mold may comprise nylon or polytetrafluoroethylene (PTFE). In some embodiments the coating can be applied by spray. The device can further include a spraying apparatus that includes a reservoir of compressed air or an inert gas, and is configured to dispense the uncured coating on the wound contact layer. This removes oxygen from the wound and allows the coating to cure. The wound contact layer can be used to provide negative pressure wound therapy.

Accordingly to certain embodiments, a device is provided for coating a dressing wound, the device comprising

The device described in any of the paragraphs above can have one or more features. The shape, position and shaping of the recesses can be similar to that of the electronic components.

According to certain embodiments, a method is provided for coating an electrical device, and the method comprises:

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