Systems, methods, and devices for restoring lymphatic flow associated with a subcutaneous defect in a patients body

• US 9,011,393 B2
• Filed: 10/14/2010
• Issued: 04/21/2015
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: KCI Licensing Incorporated (3M Company)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Kazala, Richard Marvin Jr., Barta, Eric Woodson, Toro, Luis
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Lo, Andrew S
• Application Number:
  US12/904,649
• Publication Number:
  US 20110152796A1
• Time in Patent Office: 1,650 Days
• Field of Search: 604289-290, 604/304, 604/313, 604/315, 604317-327, 604540-543, 294/28, D24/127
• US Class Current: 604/290
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Methods, devices, and systems are disclosed that help to restore lymphatic flow associated with a subcutaneous defect in a patient'"'"'s body by approximating portions of the subcutaneous defect using reduced pressure and a tissue-approximating device. The tissue approximating device may include a curved member that is formed from a semi-rigid material and defines a concave space that goes over the subcutaneous defect. A flange portion is formed on the curved member. A reduced-pressure aperture is formed on the curved member for providing reduced pressure to the concave space. The tissue-approximating device also includes a spacer member disposed on a tissue-facing side of the curved member and aligned substantially with the reduced-pressure aperture. Other systems, devices, and methods are disclosed.

Claims

1. A method for tissue approximation for a subcutaneous tissue defect which is associated with a surface wound, the method comprising the steps of:

deploying a tissue-approximating device over the subcutaneous tissue and the surface wound, wherein the tissue-approximating device comprises;

a curved member formed from a semi-rigid material and having a first side terminating at an outer perimeter, a tissue-facing side terminating at an inner perimeter, and wherein the tissue-facing side of the curved member defines a concave space extending from the inner perimeter to an apex,

a reduced-pressure aperture extending through the curved member in fluid communication with the concave space for receiving reduced pressure from a source of reduced pressure,

a flange portion formed by the thickness of the curved member between the inner perimeter and the outer perimeter, and configured to be disposed adjacent intact epidermis,

an attachment device coupled to the tissue-facing side of the curved member proximate the reduced-pressure aperture, and

a spacer member coupled to the attachment device to form a breathable space between the apex, attachment device, and spacer member, the spacer member having a plurality of flow channels in fluid communication with the reduced-pressure aperture to distribute reduced pressure to the concave space;

fluidly coupling a reduced-pressure source to the concave space; and

causing the reduced-pressure source to deliver reduced pressure to the concave space whereby portions of the subcutaneous tissue are approximated.

2. The method of claim 1, wherein the reduced-pressure aperture is formed at the apex.

3. The method of claim 1, wherein the curved member comprises a dome-shaped member.

4. The method of claim 1, wherein the spacer member comprises a foam.

5. The method of claim 1, wherein the spacer member comprises a non-woven material.

6. The method of claim 1, wherein the semi-rigid material is a medical-grade polymer and a curvature of the curved member provides for a tangential force when under compression.

7. The method of claim 1, wherein the semi-rigid material is a silicone and a curvature of the curved member provides for a tangential force when under compression.

8. The method of claim 1, wherein the step of causing the reduced-pressure source to deliver reduced pressure to the concave space comprises causing reduced pressure in the range of −

90 to −

220 mm Hg to be delivered to the concave space.

9. The method of claim 1, wherein the step of causing the reduced-pressure source to deliver reduced pressure to the concave space comprises causing reduced pressure in the range of −

90 to −

220 mm Hg to be delivered to the concave space with a variable pattern.

10. The method of claim 1, wherein the step of fluidly coupling a reduced-pressure source to the concave space comprises the steps of coupling a reduced-pressure interface to the reduced-pressure aperture and using a reduced-pressure conduit to fluidly couple the reduced-pressure interface to the reduced-pressure source.

11. The method of claim 1, wherein:

the reduced-pressure aperture is formed proximate the apex;

wherein the spacer member comprises a foam;

the step of causing the reduced-pressure source to deliver reduced pressure to the concave space comprises causing reduced pressure in the range of −

90 to −

220 mm Hg to be delivered to the concave space with a variable pattern;

the curved member and flange portion are formed of a semi-rigid, medical-grade polymer and the curvature of the curved member provides for a tangential force when under compression; and

the step of fluidly coupling a reduced-pressure source to the concave space comprises the steps of coupling a reduced-pressure interface to the reduced-pressure aperture and using a reduced-pressure conduit to fluidly couple the reduced-pressure interface to the reduced-pressure source.

12. The method of claim 1, wherein the surface wound is a linear wound and the curved member comprises a member having an aspect ratio of at least 4.

13. The method of claim 1, wherein the curved member has a thickness between one-sixth and one-twelfth of the diameter of the inner perimeter.

14. The method of claim 1, wherein the spacer member is positioned within the concave space above a plane defined by the inner perimeter.

15. A tissue-approximating device for approximating a subcutaneous tissue defect opening to a surface wound, the tissue-approximating device comprising:

a curved member formed from a semi-rigid material and having a first side terminating at an outer perimeter and a tissue-facing side terminating at an inner perimeter, and wherein the tissue-facing side of the curved member defines a concave space extending from the inner perimeter to an apex;

a reduced-pressure aperture extending through the curved member in fluid communication with the concave space for receiving reduced pressure from a source of reduced pressure;

a flange portion formed by the thickness of the curved member between the inner perimeter and the outer perimeter, and configured to be disposed adjacent intact epidermis;

an attachment device coupled to the tissue-facing side of the curved member proximate the reduced-pressure aperture; and

a spacer member coupled to the attachment device to form a breathable space between the apex, attachment device, and spacer member, the spacer member having a plurality of flow channels in fluid communication with the reduced-pressure aperture to distribute reduced pressure to the concave space;

wherein the curved member is shaped to transmit a tangential force of the curved member to the flange portion when reduced pressure is applied to the concave space.

16. The tissue-approximating device of claim 15, wherein the reduced-pressure aperture is formed at the apex.

17. The tissue-approximating device of claim 15, wherein the curved member comprises a dome shaped member.

18. The tissue-approximating device of claim 15, wherein the spacer member comprises a foam.

19. The tissue-approximating device of claim 15, wherein the spacer member comprises a non-woven material.

20. The tissue-approximating device of claim 15, wherein the semi-rigid material is a medical-grade polymer.

21. The tissue-approximating device of claim 15, wherein the semi-rigid material is a silicone.

22. The tissue-approximating device of claim 15, wherein the curved member has a thickness between one-sixth and one-twelfth of the diameter of the inner perimeter.

23. The tissue-approximating device of claim 15, wherein the spacer member is positioned within the concave space above a plane defined by the inner perimeter.

24. A method of manufacturing a tissue-approximating device for a subcutaneous tissue defect opening to a surface wound, wherein the method comprises:

forming a curved member from a semi-rigid material and having a first side terminating at an outer perimeter, a tissue-facing side terminating at an inner perimeter, and wherein the tissue-facing side of the curved member defines a concave space extending from the inner perimeter to an apex, and a flange portion formed by a thickness of the curved member between the inner perimeter and the outer perimeter, and configured to be disposed adjacent intact epidermis;

forming a reduced-pressure aperture extending through the curved member in fluid communication with the concave space for receiving reduced pressure from a source of reduced pressure;

coupling an attachment device coupled to the tissue-facing side of the curved member proximate the reduced-pressure aperture, and

coupling a spacer member to the attachment device to form a breathable space between the apex, attachment device, and spacer member, the spacer member having a plurality of flow channels in fluid communication with the reduced-pressure aperture to distribute reduced pressure to the concave space.

25. The method of claim 24, wherein the step of forming a reduced-pressure aperture comprises forming the reduced-pressure aperture at the apex.

26. The method of claim 24, wherein the step of forming a curved member comprises forming a dome-shaped member.

27. The method of claim 24, wherein the step of providing a spacer member comprises the step of providing a foam member.

28. The method of claim 24, wherein the step of providing a spacer member comprises the step of providing a non-woven member.

29. The method of claim 24, wherein the semi-rigid material is a medical-grade polymer and a curvature of the curved member provides for a tangential force when under compression.

30. The method of claim 24, wherein the semi-rigid material is a silicone and a curvature of the curved member provides for a tangential force when under compression.

31. The method of claim 24, wherein the curved member has a thickness between one-sixth and one-twelfth of the diameter of the inner perimeter.

32. The method of claim 24, wherein the spacer member is positioned within the concave space above a plane defined by the inner perimeter.