Pressure-free insoles for foot ulcers and the manufacturing process.

Abstract

Invention details;

Claims

OCR06WT1. Pressure-free foot insole for foot ulcers and manufacturing process: The manufacturing process is as follows: a. Creating a 3D model of the socket by scanning the inner surface of the splint with a 3D object scanner. The inner surface model of the splint is then used to define the area that will form the socket for assembling or placing the foot insole. Unrelated surface areas are removed. The 3D model of the socket is then saved as a digital file. b. Creating a 3D model of the footprint by using a 3D footprint printer to print the footprint of the patient's affected foot while standing, to obtain the shape of the foot under weight. The footprint is then used to create a 3D model using a 3D object scanner, and unrelated surface areas are removed. The 3D model of the footprint is then saved as a digital file. c. Creating a foot image by using a foot imaging device to capture an image of the patient's affected foot while standing. The image is scaled to the actual size of the foot. The resulting foot image is then saved as a digital file. d. ...Create side and bottom patterns of the insole to fit snugly into the inner socket of the removable splint using data from the 3D socket model as described in point a. The thickness of the insole can be determined from 2.5-5.0 centimeters, depending on the physician's assessment of the patient's foot edema; the normal thickness is 3.5 centimeters. Create a top pattern of the insole with a curved shape that closely matches the patient's foot using the 3D footprint data from point b, following these steps:

1. Adjust the plane and direction of the footprint to be parallel to the insole, aligning the curved rear edge of the heel with the rear line of the insole.

2. Shift the plane of the footprint down into the insole pattern from above, overlapping by at least 20 millimeters, and remove the volume of the insole above the footprint. This ensures the remaining insole surface has the curved contours of the patient's footprint.

3. Import the foot image from point c.

1. Place the insole on top of the foot plate, defining the wound area according to the foot image or the specifications of the treating physician. Subtract the volume of the insole from the portion beneath the wound area, creating a gap in the insole beneath the wound area. Record the completed insole design as a data file.

2. Create the insole by preparing a foam sheet larger than the inner socket area of ​​the removable cast and with the required thickness.

3. Mill the foam sheet using a CNC milling machine according to the completed insole design data file as per clause E.

4. Apply adhesive to the surface of the insole obtained from clause E, and then cover it with a soft material covering 1-4 mm thick, then sand and finish the surface and inspect it for completeness.

2. Pressure-free insole for plantar ulcers and manufacturing process according to claim 1, where the cast is provided as either a removable cast or a shoe for diabetic patients with plantar ulcers, of which the appropriate option according to this invention is the removable cast. 3.Pressure-free foot pads for plantar ulcers and manufacturing procedure under claim 1, where a 3D footprint printing device is available from a portable 3D footprint printer or footprint foam, which is suitable under this invention is a portable 3D footprint printer.

4. Pressure-free foot pads for plantar ulcers and manufacturing procedure under claim 1, where a foot imaging device is available from a portable foot imaging device or a flatbed scanner, which is suitable under this invention is a portable 3D footprint printer.

5. Portable foot imaging device.

6. Pressure-free foot insole for plantar ulcers and manufacturing process under Patent 1, where the foam covering is provided from either EVA (Ethylene-vinyl acetate) or PU (Polyurethane) foam, either individually or in combination, of which PU foam is most suitable under this invention.

7. Pressure-free foot insole for plantar ulcers and manufacturing process under Patent 1, where the skin covering is provided from either leather, foam or cork, either individually or in combination, of which PU foam is most suitable under this invention.The pressure-free foot pad for plantar ulcers and the manufacturing process under any one of the claims 2-6, where the manufacturing process in another manner under this invention is appropriate, provides for the following manufacturing process: a. Create a 3D model of the socket by scanning the inner surface of the removable splint with a 3D object scanner; use the inner surface model of the removable splint to determine the area that is the socket for assembling or placing the foot pad, by cutting out the surface area not related to the socket; save and store the 3D model of the socket as a digital file. b. Create a 3D model of the footprint by starting with using a portable 3D footprint printer to print the footprint of the patient's affected foot while standing to obtain the shape of the foot under weight-bearing conditions; use the footprint to create a 3D model with a 3D object scanner and cut out the surface area not related to the footprint; save and store the 3D model of the footprint as a digital file. c.The process begins by creating a footprint image using a portable foot imaging device. Images of the patient's injured foot are taken while they are standing. The images are scaled to match the actual foot size and saved as digital files. Next, the side and bottom sections of the insole are created to fit snugly into the inner socket of the removable splint, using data from the 3D model of the socket from step a. The thickness of the insole can be determined from 2.5-5.0 centimeters, depending on the physician's assessment of the patient's foot edema; the normal thickness is 3.5 centimeters. Finally, the top section of the insole is created with a curved shape that closely matches the patient's foot, using the 3D footprint data from step b. The steps are as follows:

1. Adjust the plane and direction of the footprint to be parallel to the insole, aligning the curved rear edge of the heel with the rear line of the insole.

2. Shift the plane of the footprint down into the insole model from above, overlapping by at least 20 millimeters, and subtract the volume of the insole above the footprint. This ensures the remaining insole surface has the curves and contours of the patient's footprint.

3. ...Place the foot image from step c on top of the insole, defining the wound area according to the foot image or the treating physician's specifications. Subtract the volume of the insole from the area beneath the wound, creating a gap in the insole beneath the wound area. Save the completed insole design as a data file. Create the insole by preparing a PU foam sheet larger than the inner socket area of ​​the removable splint and with the required thickness. Mold the PU foam sheet using a CNC milling machine according to the completed insole design data file from step e. Apply adhesive to the surface of the insole obtained from step f with a soft foam sheet 1-4 mm thick (the ideal thickness is 2 mm), then sand and finish the surface and inspect for completeness.

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