STERNOTOMY SPLINTING ASSEMBLY, KIT AND METHOD FOR USE

• US 20090163949A1
• Filed: 12/22/2008
• Published: 06/25/2009
• Est. Priority Date: 12/21/2007
• Status: Active Grant

• Current Assignee: Matthew P. Warden, Michael A. Rolnick, Robert A Van Wyk
• Original Assignee: Matthew P. Warden, Michael A. Rolnick, Robert A Van Wyk
• Inventors: Van Wyk, Robert A., Warden, Matthew P., Rolnick, Michael A.
• Granted Patent: US 8,038,634 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61B 17/823 for the sternum
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: Y10S 607/902 Fetal monitoring other than heart rate

Abstract

Herein disclosed is a simple, passive splinting system for sternotomy patients designed to provide a continuous yet readily adjustable, compressive tangential stabilizing force to the ribcage so as to promote healing of a median sternotomy incision while minimizing patient pain.

Claims

1. A method for splinting a median sternotomy incision post-surgery using a splinting assembly comprising (a) two anchor patches having obverse and reverse surfaces, wherein the reverse surface is provided with either application instruction indicia or a pre-formed layer of adhesive covered with a release liner and the obverse surface is provided with a layer of a fastener receiving material, and (b) one or more elongate elastomeric straps having obverse and reverse surfaces and first and second ends, wherein the reverse surface of said one or more straps is provided at the respective first and second ends with a plurality of fasteners that mate with said fastener receiving material to form a releasable bond, said method comprising the steps of:

a. adhesively mounting the two anchor patches more or less vertically at locations on the chest cavity of a median sternotomy patient that are more or less equidistantly displaced from a sternotomy incision;

b. attaching the fasteners disposed at a first end of said elastomeric strap to the layer of fastener receiving material disposed on one of anchor patches;

c. stretching said at least one elastomeric strap so as to produce an initial tension in said at least one elastomeric strap, and

d. coupling the fasteners disposed at the second end of said elastomeric strap to the layer of fastener receiving material disposed on the other of said anchor patches to thereby provide a compressive, stabilizing force tangential to said sternotomy incision.

2. The method of claim 1 wherein said fastener receiving material comprises a plurality of hooks and said fasteners comprise a plurality of corresponding loops or pile portions, wherein said hooks and loops mate for form a fastener pair.

3. The method of claim 1, wherein said anchor patches are provided with a curvilinear perimeter that conforms to the contours of a chest wall.

4. The method of claim 1, wherein said anchor patches have a length of about 4 to 12 inches and a width of about 1 to 5 inches.

5. The method of claim 1, wherein said anchor patches have a length of about 4 to 8 inches and a width of about 1.5 to 4 inches.

6. The method of claim 1, wherein the reverse surfaces of said anchor patches are provided with a pre-formed layer of a high strength, biocompatible ostomy adhesive covered with a release liner.

7. The method of claim 1, wherein said assembly comprises at least two elastomeric straps.

8. The method of claim 1, wherein said assembly comprises at least three elastomeric straps.

9. The method of claim 1, wherein said at least one elastomeric strap is formed from an elastomeric fabric comprising about 88% polyester and about 12% rubber.

10. The method of claim 1, wherein said at least one elastomeric strap has a length of about 4 to 12 inches and a width of about 1 to 4 inches.

11. The method of claim 1, wherein said at least one elastomeric strap has a length of about 5 to 10 inches and a width of about 1.5 to 3 inches.

12. The method of claim 1, further comprising the step of periodically adjusting the tension of said at least one elastomeric strap to maintain sufficient tension to provide patient comfort.

13. The method of claim 1, further comprising the steps of (i) initially positioning a relatively rectangular, semi-rigid locating template over the median sternotomy incision, wherein said locating template comprises a first central opening that permits access to the sternotomy incision, a pair of cut-out openings complementary to the shape of said anchor patches located at either edge of the template, and one or more adhesive strips positioned about the perimeter of said template to permit releasable attachment to the chest wall of the sternotomy patient, and (ii) removing said locating template once said anchor patches are adhesively mounted in the proper position.

14. The method of claim 1 further comprising the steps of (a) providing an elongate locating strip having obverse and reverse surfaces and first and second ends, wherein the reverse surface of said locating strip is provided at the respective first and second ends with a plurality of fasteners that mate with said fastener receiving material on each of said anchor patches to form a releasable bond therewith and the obverse surface is provided with an indicia designating the center line of said locating strip;

(b) positioning said locating strip and anchor patches across said median sternotomy incision such that said center line of said locating strip is positioned over the incision and said anchor patches are positioned at locations equidistant from said incision; and

(c) removing said locating patches once said anchor patches are adhesively mounted in the proper position.

15. The method of claim 1, further comprising the step of placing a pad between said at least one elastomeric strap and the chest wall at the sternotomy site so as to produce a compressive, stabilizing force normal to the chest wall.

16. The method of claim 15 wherein said pad is a heated compress.

17. The method of claim 15 wherein said pad is a cooled compress.

18. A kit for splinting a median sternotomy comprising:

a. two anchor patches having obverse and reverse surfaces, wherein the reverse surface is provided with either application instruction indicia or a pre-formed layer of adhesive covered with a release liner and the obverse surface is provided with a layer of a fastener receiving material;

b. one or more elongate elastomeric straps having obverse and reverse surfaces and first and second ends, wherein the reverse surface of said one or more straps is provided at the respective first and second ends with a plurality of fasteners that mate with said fastener receiving material to form a releasable bond;

c. a positioning means selected from (i) a semi-rigid locating template comprising a first central opening that permits access to the sternotomy incision, a pair of cut-out openings complementary to the shape of said anchor patches located at either edge of the template, and one or more adhesive strips positioned about the perimeter of said template to permit releasable attachment to the chest wall of the sternotomy patient, and (ii) an elongate locating strip having obverse and reverse surfaces and first and second ends, wherein the reverse surface of said locating strip is provided at the respective first and second ends with a plurality of fasteners that mate with said fastener receiving material on each of said anchor patches to form a releasable bond therewith and the obverse surface is provided with an indicia designating the center line of said locating strip;

d. instructions for splinting a median sternotomy incision using elements a-c;

e. an optional compressive pad to be positioned between said at least one elastomeric strap and the chest wall over the site of median sternotomy incision;

f. optional additional ostomy adhesive; and

g. optional removal solvent and gauze pads.

19. The kit of claim 18 wherein said fastener receiving material comprises a plurality of hooks and said fasteners comprise a plurality of corresponding loops or pile portions, wherein said hooks and loops mate for form a fastener pair.

20. The method of claim 18, wherein anchor patches are provided with a curvilinear perimeter that conforms to the contours of a chest wall and have a length of about 4 to 12 inches and a width of about 1 to 5 inches, more preferably a length of about 4 to 8 inches and a width of about 1.5 to 4 inches, while said at least one elastomeric strap is formed from an elastomeric fabric comprising about 88% polyester and about 12% rubber and has a length of about 4 to 12 inches and a width of about 1 to 4 inches, more preferably a length of about 5 to 10 inches and a width of about 1.5 to 3 inches.