NipKap™

 

 

According to the American Board of Plastic Surgeons, there are over 140,000 mastectomies and 90,000 breast reduction surgeries performed each year in the United States. These procedures are sometimes necessary to remove cancerous tumors or for functional reasons, such as in the case of breast reductions, to remove excessive, painful and heavy breast tissue (e.g., macromastia/gigantomastia).

Regardless of the reason for the surgery, the goal is to provide the best outcome for each patient to help them feel comfortable and confident as they adjust to their changed body. A critical part of these breast reconstruction procedures involves the nipple and areola, which is what the NipKap™ seeks to help construct and protect.

The NipKap™ is a medical device that both assists in the construction of a new Nipple Areola Complex (NAC) during surgery along with protecting the construct postoperatively until tissue maturation has occurred. This medical-grade device is designed specifically for this purpose to provide the best results each time it is used on patients. This device can be easily attached and removed from the body. Once the device is removed, it can continue to be used throughout the recovery process to provide protection for the nipple and areola.

 

 

DEVICE FEATURES & BENEFITS

Special Features

  • Provides the best protection for the nipple and areola after breast surgery with sturdy design
  • Assists with the process of creating a nipple areola construct during breast surgery
  • Prevents distortion or separation of the nipple or areola by relieving any potential pressure in the area
  • Protects fabricated flap from being crushed during recovery
  • Prevents fluid such as blood from accumulating underneath the skin graft
  • Easily adhered in the operation room with either sutures or medical tape
  • Device can be removed easily post-operation in an outpatient setting
  • Can use the device by placing it in a bra or surgical support after it is removed from the body to continue protecting the nipple and areola post-operation
  • Compressible and flexible material helps promote comfort during use
  • Designed to increase the likelihood of quality long-term surgery outcomes
  • Made of high-quality, durable medical grade thermoplastic elastomer
  • Affordable solution to produce and purchase
  • Simple manufacturing process

 

 

DEVICE DETAILS

The NipKap™ is a medical device that covers the nipple and areola allowing it to assist with the reconstruction of the area during breast surgery along with protecting the area post-operation. Using this device, a nipple areola construct is made from the residual skin of the breast after a skin sparing mastectomy or from the skin of a flap brought in to replace the breast mound that has been totally surgically removed. While numerous types of nipple areola reconstruction techniques have been described over the years, the best technique for autologous tissue reconstruction still appears to be the modified skate or star flap for the nipple construct combined with a full thickness skin graft for the areola. The NipKap™ assists in the process of constructing the nipple and areola by stabilizing and containing the area during surgery.

Standard surgical technique for obtaining uniform skin graft take, also known as revascularization, most commonly involves the application of some type of pressure dressing to the graft so that fluid such as blood does not accumulate under the skin graft preventing the ingrowth of blood vessels from the underlying raw bed to the underside, or dermis, of the skin graft. While this type of pressure dressing is necessary for the skin graft take, direct pressure on the flap construct for the nipple is absolutely contraindicated and would lead to crushing of the flap, distortion, component separation or at worst, flap necrosis and tissue death. This is where the NipKap™ seeks to help the patient by properly protecting the nipple and areola post-operation while also ensuring it prevents fluids such as blood from accumulating underneath the skin graft.

The NipKap™ accomplishes this by applying pressure to the surface of the skin graft used for the areola and at the same time protecting the flap fabrication at the center of the nipple areola construct from being crushed by the same pressure dressing. This pressure relief prevents any distortion or separation of the nipple or areola when the person moves or encounters foreign objects such as clothing when recovering. With its sturdy design and channel, the device also protects the fabricated flap from being crushed during recovery. This allows for a better healed nipple and areola and hence provides a more pleasing result for the patient once they are fully healed.

The NipKap™ is designed to be easily applied in the operation room and can be fixed by a few sutures placed in the suture guides or alternatively taped in place to the surrounding skin of the reconstructed breast. The device is subsequently removed in a quick procedure from its attachment to the breast 7 to 10 days after the surgery is completed. Once the device is removed, it is utilized as a protective device in a bra or surgical support to prevent injury to the newly constructed nipple areola complex, especially the nipple, in the ensuing weeks, until the nipple areola construct is deemed sufficiently healed to withstand normal wear and tear trauma from clothing or physical activity.

The NipKap™ is made from medical grade thermoplastic elastomer material that is high quality and durable, ensuring it does not easily get damaged or worn out when it is being used by the patient. On top of the material being durable, it is compressible and pliable, making it comfortable for patients to use and not constantly be bothered by when in use. This device is incredibly cost-effective to produce for manufacturers along with being inexpensive for patients to use with the possibility of insurance covering part of the cost. As made clear in the granted patent, the material used to produce       this device can be changed, such as in the case another material is preferred by a manufacturer or found to be superior for the final design. The NipKap™ seeks to provide the best quality long-term surgery outcomes for breast surgery patients ensuring they are comfortable and confident in their newly adjusted bodies.

 

 

 

Materials needed to produce the NipKap™:

  • StarMed 9025-0000 thermoplastic elastomer (TPE) material
  • Wepco plastics device mold

 

A working prototype of the NipKap™ can be made available to demonstrate the design and functionality of the device. The NipKap™ is still in the proof-of-concept stage of development with no current FDA approval. A video of how this device is used during a medical procedure, including a demonstration, can be shared upon request.

 

 

 

 

 

The NipKap™ is covered by United States Utility Patent: 10,925,719

 

 

For additional information, licensing opportunities, and a full prospectus on the NipKap™ contact:

 

 

BankOnIP

VP of Business Development

Email: info@BankOnIP.com