Design Criteria

Device: A novel pocket compression vest 

Classification: Class I under FDA guidelines (1)

Information on Device:

  • It is a non-invasive device that doesn’t require any special control and thus falls under the category of general devices for treatment

Current Device Example: Vacuum Drainage System

  • Limitation: systems do not tend to decrease hematomas, and is more invasive than compressive devices

Goal:

  1. The device must be non-invasive in order to decrease hospital stay, risk of infection, and mortality.
  2. The device should be easy to take off, in other words, user-friendly!
    • Limitation of pressure bandages/pressure tapes: hard to access the area in case of immediate emergency, such as the need to use a defibrillator.

3. Make the device comfortable for patients but achieve the goal of compression.

The three main design criteria are:

–  A non-invasive device, classified Class I under FDA Standards

– An easily removable device, that allows for easy access to the hematoma and body

– A comfortable device that directs compression towards the hematoma and allows for the user to move freely

Overall:

To design a user accessible compression vest for the treatment and prevention of pocket hematomas.

Materials:

              FIRST/OUTSIDE LAYER:

              Use of breathable fabric 

  • 49% cotton 
  • 25% nylon
  • 21% cotton
  • 5% spandex

              SECOND/INSIDE LAYER:

              Mixture of spandex & cotton

  • polyester-spandex blend

Full length compression vest in varying forms: 

  • Zipper in back for child friendly design 
  • One sleeve sweater style for mobility 
  • Velcro for size adjustment
  • Addition of a pressure disk 
  • Double fabric usage 
    • Interior silk film layer 
    • Exterior breathable compression layer

Restrictions/Limitations:

  • The compressive chest device clinical study was performed on a non-randomized and case-controlled study with only 40 patients (2)

 

Images: 

Group Design:

Size Adjustable “Backpack” like Straps:

 

“Weighted Pressure Vest.” National Autism Resources, nationalautismresources.com/weighted-pressure-vest/.

^Device mentioned above^

 

Citations: