Medical device, method of making and using the same

• US 10,070,987 B2
• Filed: 03/12/2014
• Issued: 09/11/2018
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: James Gordon Scott
• Original Assignee: James Gordon Scott
• Inventors: Scott, James Gordon
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US14/205,868
• Publication Number:
  US 20140276500A1
• Time in Patent Office: 1,644 Days
• CPC Class Codes: A61F 5/4404 Details or parts
• CPC Class Codes: A61F 5/449 Body securing means, e.g. belts, garments
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An ostomy armor includes a rigid base plate that covers a stoma of a patient and at least a portion of a waste collection bag attached to the stoma. The ostomy armor further includes a plate pad attached to the back surface of the rigid base plate. The ostomy armor also includes a belt that to hold the ostomy armor on the patient.

Claims

1. A medical apparatus, comprising:

a base plate comprising a convex curved outer surface, a concave curved inner surface wherein each of the entire convex curved outer surface and the entire concave curved inner surface form a substantially planar curved structure that is configured to be substantially similar to a curvature of an abdominal area of a user where the base plate is configured to reside, a top side, a bottom side, a right side, a left side, the right side is substantially perpendicular to the bottom side and the top side, the left side comprises a first angle extending from the bottom side to the top side, the first angle is in a range from about thirty degrees to about seventy five degrees, a first cutout extending through the base plate and a second cutout extending through the base plate, each of the first cutout and the second cutout are arranged within an interior dimension of the base plate, the base plate is dimensioned to substantially cover at least a stoma, an adjacent abdomen region of a user, and at least an upper portion of a waste collection bag when in use;

a plate pad comprising a soft flexible foam material, the plate pad is non-releasably attached to a back surface of the base plate, the plate pad having an external dimension substantially identical to the base plate, the plate pad comprising a cutout region, the cutout region includes a channel region sized to be narrower at an upper portion of the channel region and wider at a lower portion of the channel region, the upper portion of the channel region is closed and the lower portion of the channel region is open, wherein the base plate and plate pad are configured to prevent or minimize herniation of a stoma or ostomy site and accommodate existing hernias by contact of the plate pad across a surface of the abdominal area; and

a belt comprising a first piece and a second piece, the first piece of the belt comprising a first end fixedly attached to the first cutout and a second end coupled to a first attachment mechanism, the second piece of the belt comprising a first end fixedly attached to the second cutout and a second end coupled to a second attachment mechanism, wherein the first attachment mechanism and the second attachment mechanism are configured to releasably couple to each other.

2. The medical apparatus of claim 1, wherein the plate pad further comprises a plate pad cover.

3. The medical apparatus of claim 2, wherein the plate pad cover comprises one or more of a chamois material, microfiber material, terry cloth material, and cotton jersey knit material.

4. The medical apparatus of claim 1, wherein the belt further comprises a waist pad extending from a portion of the belt, the waist pad comprising a foam material, a rigid backing on a portion of the foam material, and a soft cover.

5. The medical apparatus of claim 1, wherein the first attachment mechanism comprises a female connector and the second attachment mechanism comprises a male connector.

6. The medical apparatus of claim 1, wherein the base plate comprises an aluminum material.

7. The medical apparatus of claim 3, wherein the base plate comprises a titanium material.

8. The medical apparatus of claim 1, wherein the base plate comprises a logo arranged on a surface of the base plate.

9. The medical apparatus of claim 1, wherein the base plate comprises one or more layers of composite materials.

10. The medical apparatus of claim 1, wherein a face of the base plate comprises one or more of a color finish and a marking.

11. The medical apparatus of claim 1, wherein the base plate in operation is configured to prevent or minimize herniation of a stoma or ostomy site and accommodate existing hernias.

12. The medical apparatus of claim 1, wherein the cutout region has a keyhole type geometry.

24. The medical apparatus of claim 1, further comprising a waste wick comprising an absorbent material.

25. The medical apparatus of claim 1, further comprising a waste collection bag comprising a three-dimensional flange.

26. The medical apparatus of claim 25, wherein the three-dimensional flange comprises a gel material and is reusable.

27. The medical apparatus of claim 24, wherein the absorbent material comprises a cellulose material.

13. A method of making an ostomy apparatus, comprising the steps of:

forming a substrate material into a base plate having a dimension to cover a stoma of a user and at least a portion of a waste collection bag, the base plate comprising a convex curved outer surface, a concave curved inner surface, wherein each of the entire convex curved outer surface and the entire concave curved inner surface have a curvature configured to be substantially similar to a curvature of an abdominal area of a user where the base plate is configured to cover, a top side, a bottom side, a right side, a left side, the right side is substantially perpendicular to the bottom side and the top side, the left side comprises a first angle extending from a bottom most portion of the bottom side to a top most portion of the top side, the first angle is in a range from about thirty degrees to about seventy five degrees, a first cutout extending through the base plate and a second cutout extending through the base plate, each of the first cutout and the second cutout are arranged within an interior dimension of the base plate;

forming a soft compressible flexible foam plate pad including an external dimension substantially identical to the base plate, the plate pad comprising a cutout region, the cutout region includes a channel region sized to be narrower at an upper portion of the channel region and wider at a lower portion of the channel region, the upper portion of the channel region is closed and the lower portion of the channel region is open, wherein the base plate and plate pad are configured to prevent or minimize herniation of a stoma or ostomy site and accommodate existing hernias by contact of the plate pad on the abdominal area;

non-releasably attaching the plate pad to a back side of the base plate;

attaching a first end of a first belt piece to the first cutout of the base plate;

attaching a second end of the first belt piece to a first attachment mechanism;

attaching a first end of a second belt piece to the second cutout of the base plate; and

attaching a second end of the second belt piece to the second attachment mechanism.

14. The method of claim 13, wherein the forming the substrate into a base plate comprises the steps of laser cutting the substrate material.

15. The method of claim 14, further comprising the step of marking a surface of the base plate with information indicative of one or more of make, model, serial number, trademark, informational notice, and warning notice.

16. The method of claim 15, wherein the marking step comprises the step of laser etching.

17. The method of claim 14, wherein the substrate material comprises a material selected from the group consisting of aluminum, titanium, and combinations of the same.

18. A medical apparatus, comprising:

a first base plate comprising a convex curved outer surface, a concave curved inner surface, a top side, a bottom side, a right side, a left side, the right side is substantially perpendicular to the bottom side and the top side, the left side comprises a first angle extending from the bottom side to the top side, the first angle is in a range from about thirty degrees to about seventy five degrees, a first cutout extending through the base plate and a second cutout extending through the base plate, each of the first cutout and the second cutout are arranged within an interior dimension of the base plate, the base plate is dimensioned to substantially cover at least a first stoma, an adjacent abdomen region of a user, and at least an upper portion of a first waste collection bag when in use;

a first plate pad comprising a flexible material, the plate pad adhered to a back surface of the base plate, the plate pad having an external dimension substantially identical to the base plate, the plate pad comprising a cutout region, the cutout region includes a channel region sized to be narrower at an upper portion of the channel region and wider at a lower portion of the channel region, the upper portion of the channel region is closed and the lower portion of the channel region is open;

a second base plate comprising a second convex curved outer surface, a second concave curved inner surface, a second top side, a second bottom side, a second left side and a second right side, the base plate is dimensioned to substantially cover at least a portion of a second stoma, an adjacent abdomen region of a user, and at least an upper portion of a second waste collection bag when in use; and

a connection unit having a first end and a second end, the first end is attached to the right side of the first base plate and the second end is attached to a second right side of the second base plate, wherein the connection unit is adjustable to permit adjustment of a separation between the first base plate and the second base plate in an x-axis direction and also adjustment of a separation in a y-axis direction such that the first base plate can be arranged substantially over the first stoma and the second base plate can be arranged over the second stoma, the first stoma is positioned at a different x-y location from the second stoma.

19. The medical apparatus of claim 18, wherein the first plate pad comprises an open celled foam material.

20. The medical apparatus of claim 18, wherein the second plate pad comprises an open celled foam material.

21. The medical apparatus of claim 18, wherein the first base plate and the second base plate is made using a three-dimensional mold and at least partially vacuum formed from the mold.

22. The medical apparatus of claim 18, wherein the first base plate and second base plate in operation are configured to prevent or minimize herniation of a stoma or ostomy site.

23. The medical apparatus of claim 18, wherein the first base plate and the second base plate comprise a composite material.