SURGICAL CAVITY DRAINAGE AND CLOSURE SYSTEM

• US 20160317792A9
• Filed: 11/13/2012
• Published: 11/03/2016
• Est. Priority Date: 04/15/2011
• Status: Active Grant

• Current Assignee: University Of Massachusetts
• Original Assignee: University Of Massachusetts
• Inventors: Dunn, Raymond
• Granted Patent: US 10,166,148 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 surgical drain device comprising a plurality of drain tubes positioned with an adhesion matrix, the adhesion matrix having a wound conforming shape and comprising a plurality of apertures for tissue contact through the matrix, the drain tubes being removable from the device and the adhesion matrix comprising a biodegradable polymer.

2. The device of claim 1 wherein the adhesion matrix further comprises an adhesive.

3. The device of claim 1 wherein the adhesion matrix further comprises a tissue anchor.

4. The device of claim 1 wherein the plurality of drain tubes comprises at least three tubes connected to a manifold.

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.

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 device further comprises a wound dressing.

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

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 the apertures have a total of at least 50 percent of a total surface area of the matrix.

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

16. The device of claim 3 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.

20. A method for treating or preventing a seroma, the method comprising the steps of:

positioning an adhesion matrix and a drain device into a surgical wound;

attaching a negative pressure source to a plurality of drain tubes of said device;

draining fluid from the wound for a period of time; and

removing the drain tubes such that the adhesion matrix remains in the wound.

21. The method of claim 20 further comprising attaching tissue to the adhesion matrix with a plurality of tissue anchors.

22. The method of claim 20 further comprising using an adhesive to attach tissue.

23. The method of claim 20 further comprising applying sufficient pressure to provide tissue contact through apertures of the matrix.

24. The method of claim 20 further comprising applying a wound dressing to the wound.

25. The method of claim 24 further comprising applying a negative pressure to the wound dressing.

26. The method of claim 20 further comprising attaching the adhesion matrix with a first plurality of tissue anchors to adipose tissue.

27. The method of claim 20 further comprising attaching the adhesion matrix with a second plurality of tissue anchors to fascia and/or muscle tissue.

28. The method of claim 20 further comprising measuring a fluid flow rate through the drain device.

29. The method of claim 20 further comprising measuring an amount of seroma within the wound with an ultrasound device.

30. The method of claim 20 wherein the adhesion matrix has fluid channels that receive the drain tube.

31. The method of claim 20 wherein the adhesion matrix comprises apertures that enable flow of fluid laterally into the drain tubes.

32. The method of claim 20 further comprising attaching a wound dressing to the wound and applying negative pressure to the wound dressing.

33. The method of claim 20 further comprising attaching the drain tubes to the adhesion matrix.

34. The method of claim 23 wherein the apertures comprise at least 50 percent of a total matrix surface area.

35. A method for draining a surgical wound, the method comprising the steps of:

positioning a drain device with a plurality of drain tubes into a surgical wound in a body of a subject, each drain tubes of the device extending from a single exit site on the body to a distal end, the tubes being connectable to a negative pressure source; and

draining fluid from the wound through the drain tubes.

36. The method of claim 35 further comprising positioning a polymer matrix adjacent the drain device.

37. The method of claim 36 wherein the matrix comprises a mesh with a first plurality of tissue anchors on a first side and a second plurality of tissue anchors on a second site, the second anchors having a more rigid stem than the first anchors.

38. The method of claim 35 further comprising using a matrix with drain channels to receive spaced apart drain tubes.

39. The method of claim 35 further comprising using a matrix with spaced apertures to enable flow to the drain tubes.

40. The method of claim 35 further comprising using a matrix with apertures of varying size.

41. The method of claim 35 further comprising applying a wound dressing to the wound and using a pump to apply negative pressure to the wound.

42. A surgical drain device comprising a matrix having a wound conforming shape, the matrix having a plurality of apertures for tissue contact through the matrix, the matrix further comprising a biodegradable polymer with regions adapted to receive a plurality of drainage tubes.

43. The device of claim 42 wherein the adhesion matrix further comprises an adhesive.

44. The device of claim 42 wherein the adhesion matrix further comprises a tissue anchor.

45. The device of claim 42 further comprising a plurality of drain tubes comprises at least three tubes connected to a manifold.

46. The device of claim 42 wherein the adhesion matrix comprises a sheet having a thickness of less than 2 mm.

47. The device of claim 42 wherein each of the apertures have an area in a range of 1 mm² to 5 cm².

48. The device of claim 42 wherein a total area of the apertures is at least 50% of the surface area of the matrix.

49. The device of claim 42 further comprising a first plurality of tissue anchors on a first side and a second plurality of tissue anchors on the second side, 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.

50. An anchoring matrix comprising a biodegradable mesh, the mesh comprising a first surface with a first plurality of first tissue anchors on the first surface, the mesh further comprising a second surface with a second plurality of tissue anchors on the second surface, the first tissue anchors adapted to attach to a compliant tissue and the second tissue anchors adapted to attach to a less compliant tissue.

51. The anchoring matrix of claim 50 wherein the first plurality of tissue anchors are less rigid than the second plurality of tissue anchors.

52. The anchoring matrix of claim 50 wherein the first plurality of anchors attach to adipose tissue.

53. The anchoring matrix of claim 50 wherein the second tissue anchors attach to fascia or muscle tissue.

54. The anchoring matrix of claim 50 wherein the second tissue anchors comprise barbs.

55. The anchoring matrix of claim 50 wherein the matrix comprises a resorbable polymer mesh.

56. The anchoring matrix of claim 50 wherein the matrix comprises a plurality of spaced apertures.

57. The anchoring matrix of claim 50 wherein the matrix is porous such that fluid can flow along a matrix surface.

58. The anchoring matrix of claim 50 further comprising an adhesive to attach a side of the matrix to tissue.

59. The anchoring matrix of claim 50 wherein each tissue anchor comprises a post and a tip element, each tip element comprising a barb, a hook, or a sphere.

60. The anchoring matrix of claim 50 wherein the matrix comprises a conformable layer having a thickness less than 2 mm.

61. An anchoring matrix comprising a biodegradable mesh, the mesh comprising a first surface with a first plurality of first tissue anchors on the first surface, the mesh further comprising a second surface on an opposite side of the mesh with a second plurality of tissue anchors on the second surface, the first tissue anchors adapted to insert into a first region of tissue and the second tissue anchors adapted to insert into a second region of tissue.

62. The anchoring matrix of claim 61 wherein the first plurality of tissue anchors are less rigid than the second plurality of tissue anchors.

63. The anchoring matrix of claim 61 wherein the first plurality of anchors attach to a first tissue.

64. The anchoring matrix of claim 61 wherein the second tissue anchors attach to organ tissue, nerve tissue or tendon tissue.

65. The anchoring matrix of claim 61 wherein the matrix comprises a resorbable polymer mesh.