Abstract:
In accordance with this embodiment of the application of a 3D scanning, modeling and printing process to create custom-fitted ostomy devices that minimize leakage and odor and maximize mobility and comfort.

Description:
[0001]    This application claims the benefits of provisional patent applications Ser. No. 61/765,117 filed 2013 Feb 15 by the present inventors. 
     
    
     BACKGROUND 
       [0002]    An ostomy is a surgically-created intestinal (colostomy or ileostomy) or urinary (urostomy) tract diversion that modifies the normal pathway for waste elimination. A colostomy is an abdominal opening from any part of the large intestine (colon), made because part of the colon has been removed or bypassed. An ileostomy is an abdominal opening from the terminal small intestine (ileum), made because the entire colon has been removed or bypassed. A urostomy is an abdominal opening from the urinary tract. 
         [0003]    For all ostomy surgeries, an opening called a stoma is made through the abdominal wall. An ostomy device (wafer and attached pouch) is situated over the stoma to collect waste that flows through and out of the stoma. It is worn at all times and must be periodically emptied and replaced. A person who wears an ostomy device is called an ostomate. This therapeutic approach can be temporary or permanent and creates many quality of life challenges. 
         [0004]    In many cases, wearing current ostomy devices leads to intensified physical and emotional distress, discomfort, and a diminished quality of life. Ostomates report a high percentage of skin irritation (76%), pouch leakage (62%), offensive odor (59%), depression/anxiety (53%) and a reduction in pleasurable activities (54%) using currently available ostomy devices. 
         [0005]    While many types of ostomy devices are available to ostomates, state-of-the-art design technology and materials applications are sorely lacking Current ostomy devices include pouches, wafers, barriers, belts, deodorizers, and seals that are bulky, uncomfortable and prone to leakage of malodorous solids, liquids and gases. The ostomy devices are worn 24 hours a day/seven days a week, making it difficult to travel, empty or change the device. The ostomy industry offers these devices in standard stoma diameters or places the responsibility on an ostomate to cut an opening in an ostomy device to get the best fit around the stoma. 
         [0006]    Current ostomy devices are manufactured using a traditional subtractive process of cutting away material to make molds and prototypes to create a final product. This traditional approach can be costly and time consuming and thus limits production to standardized designs and standardized sizes. 
       SUMMARY 
       [0007]    In accordance with this embodiment a process to create custom-fitted ostomy devices comprises the application of 3D scanning, modeling and printing technologies. 
       ADVANTAGES 
       [0008]    Unlike traditional manufacturing processes, recent advances in 3D scanning, modeling and printing technologies are transforming production capabilities by enhancing product design, offering direct digital manufacturing, and facilitating personal fabrication and quick turn-around times. The 3D scanning, modeling and printing process applies these modern fabrication and materials technologies to create personalized custom-fitted ostomy devices that address important quality of life issues. The custom-fitted ostomy device minimizes leakage and odor and maximizes mobility and comfort. The process can always be re-visited to accommodate future changes in an ostomate&#39;s stoma size and shape. 
     
    
     
       DRAWING 
         [0009]    Drawing shows a flowchart of the 3D scanning, modeling and printing process for the creation of custom-fitted ostomy devices. 
       
    
    
     DRAWINGS—REFERENCE NUMERALS 
       [0000]    
       
           10 —scanned stoma image 
           12 —handheld scanner 
           14 —digital camera 
           16 —smart phone 
           18 —smart pad 
           20 —3D modeling computer &amp; software 
           22 —3D printer 
       
     
       DETAILED DESCRIPTION 
       [0017]    The 3D scanning, modeling and printing process is a computerized state-of-the-art technology and materials application for the design, manufacture and production of custom-fitted ostomy devices. The scanning process includes but is not limited to 3D portable, handheld, and fixed unit scanners  12 , digital cameras  14 , smart phones  16 , smart pads  18  and other imaging technologies to record multiple perspective images of an ostomate&#39;s stoma and surrounding tissue to create a 3D model design of the scanned area. 
         [0018]    The composite image or 3D model design  10  is uploaded to a computer with 3D modeling and design software  20 . The resulting 3D model design of the stoma and surrounding tissue is edited and integrated into the ostomy device design. This integration process includes but is not limited to creating a stoma sleeve where the sleeve&#39;s interior is an exact copy of the exterior structure and surface of the stoma and surrounding tissue. This results in a stoma sleeve that is perfectly fitted for an ostomate&#39;s stoma and surrounding tissue. The personalized custom-fitted design creates a more stable, comfortable, leak-resistant and odor-resistant ostomy device. 
         [0019]    The final integrated 3D model design is uploaded to a 3D printer  22  to manufacture a custom-fitted ostomy device. The 3D printing process includes but is not limited to selective laser sintering and fusion deposition 3D printing technologies. Selective laser sintering and fused deposition are additive processes that use the melting of fine powders or softening of a polymer to produce a 3D shape by adding material in layers. There is an array of materials available to produce the ostomy device including but not limited to various plastics, polymer resins, metals, and glasses. The process can be re-visited to accommodate future changes in stoma size and shape. 
       OPERATION—DRAWING OF FLOWCHART 
       [0020]    Images of the stoma and surrounding tissue are captured using a handheld scanner  12 , or digital camera  14 , or smart phone  16 , or smart pad  18 . The composite image or 3D model design  10  is transmitted wirelessly or by landline to a website, cloud, computer or network  20  containing 3D modeling and design software. 
         [0021]    The resulting 3D model design of the stoma and surrounding tissue is edited and integrated into an ostomy device using 3D design software. The custom-fitted ostomy device 3D model design is transmitted wirelessly or by landline to a website, cloud, computer or network linked for production on a 3D printer  22 . There is an array of materials available to produce the ostomy device including but not limited to various plastics, polymers, resins, metals, and glasses. 
       CONCLUSIONS, RAMIFICATIONS AND SCOPE 
       [0022]    Accordingly, the reader will see that the 3D scanning, modeling and printing process distinguishes itself through the application of modern fabrication and materials technologies with the following advantages: 
         [0023]    it creates a personalized custom-fitted ostomy device based on the unique shape of an ostomate&#39;s stoma and surrounding tissue; 
         [0024]    it addresses important quality of life issues; 
         [0025]    it minimizes leakage and odor and maximizes mobility and comfort; 
         [0026]    it can be re-visited to allow for future changes in stoma size and shape; 
         [0027]    it results in the enhancement of public and personal activities and an increased quality of life for ostomates.