Surgical cavity drainage and closure system

• US 10,166,148 B2
• Filed: 11/13/2012
• Issued: 01/01/2019
• Est. Priority Date: 04/15/2011
• Status: Active Grant

• Current Assignee: University Of Massachusetts
• Original Assignee: University Of Massachusetts
• Inventors: Dunn, Raymond
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US13/675,736
• Publication Number:
  US 20130274717A1
• Time in Patent Office: 2,240 Days
• Field of Search: 604541
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61F 13/00072 Packaging of dressings
• CPC Class Codes: A61F 13/0203 with fluid retention members
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 13/148 Abdomen bandages or bandaging garments
• CPC Class Codes: A61F 2013/00174 possibility of applying pressure
• CPC Class Codes: A61F 2013/00412 for use with needles, tubes or catheters
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61M 1/70 Gravity drainage systems drainage containers not being adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 1/71 Suction drainage systems containers therefor A61M1/60, A61M1/64; negative pressure wound therapy systems A61M1/90
• CPC Class Codes: A61M 1/76 Handpieces specially for suction-irrigation A61M1/774, aspiration tips A61M1/84
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• 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 2027/004 with at least a part of the circuit outside the body
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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

A surgical drain device includes a matrix of biodegradable polymer material and a plurality of drain tubes attached to the matrix. The device is implanted within a surgical wound to treat the presence of seromas, for example, and is used to promote drainage, tissue adhesion, and wound closure. The drain tubes converge into a common collection tube that leads wound fluid outside the body under gravity feed or negative pressure applied to the collection tube. The matrix contains an array of apertures that allow tissue contact across the device. A preferred embodiment comprises a tissue anchoring system including anchor elements such as hooks or barbs. The device can be used with a negative pressure system to further improve the drainage band can also be used with a wound dressing. The device and systems containing the device are particularly useful to promote the healing of surgical wounds from abdominal surgery.

Claims

1. A negative pressure surgical drain device comprising a plurality of drain tubes positioned in contact with a surface of an adhesion matrix, the adhesion matrix comprising a layer of porous biodegradable material having a wound conforming shape and comprising a plurality of spaced apertures formed through the layer of the adhesion matrix, the apertures being configured to allow tissue contact through the layer of the adhesion matrix upon implantation into an open wound such that a first tissue surface on a first side of the layer of the adhesion matrix can contact a second tissue surface on a second side of the layer of the adhesion matrix through the plurality of apertures during application of negative pressure to the wound, the drain tubes being positionable at tube receiving regions of the layer of the adhesion matrix between the spaced apertures and wherein the drain tubes are configured to be removed from contact with the surface of the layer of the adhesion matrix after application of negative pressure to the adhesion matrix, the adhesion matrix being configured to remain in the wound upon removal of the drain tubes from the wound.

2. The device of claim 1 wherein the adhesion matrix further comprises an adhesive that bonds the adhesion matrix to a tissue surface of the wound.

3. The device of claim 1 wherein the adhesion matrix further comprises a tissue anchor that attaches the adhesion matrix to a tissue surface of the wound.

4. The device of claim 1 wherein the plurality of drain tubes comprises at least three tubes connected to a manifold wherein each tube has a lumen to transport fluid.

5. The device of claim 1 wherein the adhesion matrix comprises a flexible planar mesh having a thickness of less than 2 mm.

6. A system for surgical wound drainage, the system comprising the drain device of claim 1, a vacuum source, and a tube connecting the vacuum source to the drain tubes of said drain device such that a negative pressure is applied to the wound.

7. The device of claim 1 wherein the adhesion matrix comprises a polymer mesh having a first plurality of tissue anchors on a first side surface and a second plurality of tissue anchors on a second side surface.

8. The device of claim 1 wherein each drain tube extends from a wound entry site at a proximal portion to a distal end positionable within a wound.

9. The system of claim 6 wherein the drain device further comprises a wound dressing.

10. The system of claim 9 wherein the wound dressing is coupled to a pump.

11. The system of claim 9 wherein the wound dressing overlies a drain tube exit site.

12. The system of claim 6 further comprising a flow regulation system that regulates flow from the drain tubes.

13. The device of claim 1 wherein the apertures have varying sizes.

14. The device of claim 1 wherein a total area of the apertures is at least 50 percent of a surface area of the matrix.

15. The device of claim 7 wherein the first plurality of tissue anchors are more rigid than the second plurality of tissue anchors.

16. The device of claim 4 wherein the manifold is connectable to a negative pressure source.

17. The device of claim 1 wherein the drain tubes are positioned in a spaced array emanating along different radial directions from an edge of the matrix.

18. The device of claim 1 wherein the drain tubes are positioned in drain channels of the matrix.

19. The device of claim 1 wherein the apertures are positioned to promote flow to the drain tubes.

28. The device of claim 7, wherein each of the first side surface and the second side surface comprise from 1 to 10 tissue anchors per square millimeter.

29. The device of claim 7, wherein the first plurality of tissue anchors and the second plurality of tissue anchors comprise anchors of different lengths.

30. The device of claim 7, wherein the first plurality of tissue anchors and the second plurality of tissue anchors comprises single fiber strands having one of curved ends, sharpened ends, mushroom ends, or ball-shaped ends.

31. The device of claim 7, wherein the first plurality of tissue anchors and the second plurality of tissue anchors comprises tips or ends that are shaped to promote adhesion.

32. The device of claim 7, wherein the first plurality of tissue anchors comprise a first end of a plurality of posts and the second plurality of tissue anchors comprise a second end of the plurality of posts, the first end and the second end of the plurality of posts having anchor tips that can penetrate tissue.

33. The device of claim 32, wherein the plurality of posts can rotate relative to the polymer mesh.

34. The device of claim 7, wherein a first portion of the first plurality of tissue anchors can penetrate into a tissue more deeply than a second portion of the first plurality of tissue anchors.

35. The device of claim 7, wherein the first plurality of tissue anchors or the second plurality of tissue anchors are elastic such that they bend and release from a tissue under sufficient force.

20. A negative pressure surgical drain device comprising a matrix having a wound conforming shape for abdominal flap surgery, the matrix comprising a layer of porous biodegradable material having a plurality of spaced apart apertures formed through the layer and configured to allow tissue contact through the matrix upon placement into an abdominal wound such that a first tissue surface within the abdominal wound on a first side of the matrix can contact a second tissue surface on a tissue flap of the abdominal wound on a second side of the matrix through the plurality of apertures during application of negative pressure to the wound, the matrix further comprising tube receiving regions on a surface of the matrix layer adapted to receive a plurality of drain tubes connectable to a negative pressure source, the tube receiving regions extending across the surface of the matrix and wherein one or more of the plurality of apertures are located between the tube receiving regions and are configured such that the drain tubes can be removed from the wound after the application of negative pressure to the wound such that the matrix remains in the wound after wound closure.

21. The device of claim 20 wherein the matrix further comprises an adhesive.

22. The device of claim 20 wherein the matrix further comprises a tissue anchor.

23. The device of claim 20 wherein the plurality of drain tubes comprises at least three tubes connected to a manifold.

24. The device of claim 20 wherein the matrix layer comprises a sheet having a thickness of less than 2 mm.

25. The device of claim 20 wherein each of the plurality of apertures have an area in a range of 1 mm² to 5 cm².

26. The device of claim 20 wherein a total area of the apertures is at least 50 % of the surface area of the matrix.

27. The device of claim 20 further comprising a first plurality of tissue anchors on the first side of the matrix and a second plurality of tissue anchors on the second side of the matrix, the first plurality of tissue anchors adapted to attach to adipose tissue and the second plurality of tissue anchors adapted to attach to fascia and/or muscle tissue.

36. A negative pressure surgical drain device comprising:

a matrix having a wound conforming shape and a drain channel; and

a drainage element positioned within the drain channel wherein the matrix comprises a layer of porous biodegradable polymer and a plurality of spaced apertures formed through the layer and configured to allow tissue contact through the matrix, the plurality of spaced apertures having a total area of at least 50 percent of an area of a first side of the matrix such that a first tissue surface on the first side of the matrix can contact a second tissue surface on a second side of the matrix through the plurality of spaced apertures during application of negative pressure to the matrix, the drainage element being connectable to a negative pressure source and configured to be removed from the drain channel that is positioned between apertures of the matrix, the matrix being configured to remain in the wound upon removal of the drainage element from the drain channel.

37. The device of claim 36, wherein the drainage element comprises one or more drain tubes.

38. The device of claim 37, further comprising a sealing layer to seal a wound and provide a port to connect the plurality of drain tubes.

39. The device of claim 36, wherein a first side of the matrix comprises a plurality of tissue anchors.

40. The device of claim 36, wherein each of the plurality of apertures have an area in a range of 1 mm² to 5 cm².

41. The device of claim 36, wherein each of the plurality of apertures have an area less than 1 mm².

42. The device of claim 36, further comprising an adhesive.