Methods and Devices for Applying Closed Incision Negative Pressure Wound Therapy

• US 20130178897A1
• Filed: 03/01/2013
• Published: 07/11/2013
• Est. Priority Date: 04/10/2009
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Wu, Kenneth, Hu, Dean, Nag, Sumona
• Granted Patent: US 9,044,234 B2
• Time in Patent Office: Days
• US Class Current: 606/216
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61M 1/804 using Laval or Venturi jet pumps
• CPC Class Codes: A61M 1/882 Draining devices provided with means for releasing antimicrobial or gelation agents in the drained fluid
• CPC Class Codes: A61M 1/913 having a bridging element for transferring the reduced pressure from the connector to the dressing
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/962 having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• CPC Class Codes: A61M 1/985 the dressing itself forming the collection container
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

Disclosed herein are devices, systems and methods for using such devices and systems for treating incisions and wounds. In an aspect, disclosed is a device having a generally planar tension relief module and a flexible sealant structure sized to cover the tension relief module, the flexible sealant structure comprising a lower adhesive surface. The tension relief module includes a conduit structure having a plurality of support structures on an upper surface of the conduit structure and at least one opening extending through the conduit structure from a lower surface to the upper surface. At least a portion of the conduit structure is adapted to be aligned with a longitudinal axis of the incision. The tension relief module also includes opposing adhesive structures coupled to the conduit structure. The lower adhesive surface of the flexible sealant structure and the upper surface of the conduit structure form a flow pathway.

Claims

1. A method of treating an incision, the method comprising:

extending a first tab coupled to a first portion of a conduit structure away from a second tab opposite to the first tab and coupled to a second portion of the conduit structure to stretch the first and second tabs from a relaxed configuration towards a first tensile configuration;

positioning the conduit structure over and along a longitudinal axis of an incision, wherein the conduit structure comprises at least one opening extending through the conduit structure from a lower surface to an upper surface of the conduit structure;

adhering the first tab to a first healthy skin surface on a first side of the incision;

adhering the second tab to a second healthy skin surface on a second side of the incision;

applying a flexible sealant structure over the conduit structure forming a flow pathway over the upper surface of the conduit structure; and

relieving tension on the incision.

2. A method as in claim 1, further comprising applying a negative pressure to evacuate the flow pathway.

3. A method as in claim 2, wherein applying a negative pressure comprises applying negative pressure through a vacuum port in the flexible sealant structure, the vacuum port in fluid communication with the flow pathway and a negative pressure source.

4. A method as in claim 1, further comprising removing the flexible sealant structure, wherein tension on the incision continues to be relieved after the flexible sealant structure is removed.

5. A method as in claim 1, further comprising providing fluid communication between the flow pathway and the incision through the at least one opening.

7. A method as in claim 1, further comprising releasing the first and second tabs from the first tensile configuration to return towards the relaxed configuration into a second tensile configuration.

8. A method as in claim 1, wherein relieving tension on the incision comprises shielding the incision from endogenous or exogenous stress by imposing a strain on the first healthy skin surface with the first tab and imposing a strain on the second healthy skin surface with the second tab.

9. A method as in claim 8, wherein further comprising drawing opposed skin edges of the incision toward one another.

10. A method as in claim 1, wherein extending the first tab away from the second tab comprises manually grasping and stretching the first tab and second tab away from one another.

11. A method as in claim 10, further comprising releasing the first tab adhered to the first healthy skin surface and releasing the second tab adhered to the second healthy skin surface

12. A method as in claim 1, further comprising mechanically limiting extension of the first tab away from the second tab.

13. A method as in claim 1, further comprising using an applicator comprising a first portion reversibly coupled to an upper surface of the first tab and a second portion reversibly coupled to an upper surface of the second tab to extend the first tab away from the second tab.

14. A method as in claim 13, wherein extending the first tab away from the second tab comprises manually grasping the first portion and the second portion to stretch the first and second tabs from a relaxed configuration towards the first tensile configuration.

15. A method as in claim 13, wherein the first portion of the applicator comprises a first alignment marker and the second portion of the applicator comprises a second alignment marker.

16. The method as in claim 15, wherein the first and second alignment markers approach alignment with one another when the first tab is extended away from the second tab.

17. The method as in claim 16, further comprising a stretch-limiting element that provides mechanical interference upon alignment between the first alignment marker and the second alignment marker.

18. The method as in claim 17, wherein the stretch-limiting element limits physical over-stretching.

19. The method as in claim 1, wherein applying a flexible sealant structure comprises covering entirely the conduit structure, first tab, second tab and a portion of skin surrounding and not covered by any of the conduit structure, first tab and second tab.

20. The method as in claim 1, wherein relieving tension on the incision comprises imparting a contracting force in a direction that is opposite a direction in which the first tab is extended away from the second tab.