Methods and devices for applying closed incision negative pressure wound therapy
View Patent ↗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.
1. A device for treating an incision, the device comprising:
(a) a generally planar tension relief module, comprising:
(i) a conduit structure comprising 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, wherein at least a portion of the conduit structure is adapted to be aligned with a longitudinal axis of the incision; and
(ii) opposing adhesive structures coupled to the conduit structure; and
(b) a flexible sealant structure sized to cover the tension relief module, the flexible sealant structure comprising a lower adhesive surface,
wherein the lower adhesive surface of the flexible sealant structure and the upper surface of the conduit structure form a flow pathway.
2. The device of claim 1 , wherein the at least one opening is configured to provide fluid communication between the upper surface of the conduit structure and the incision.
3. The device of claim 1 , wherein the plurality of support structures comprise opposed side beams and a plurality of central posts.
4. The device of claim 3 , wherein the plurality of central posts is interspersed with longitudinally arranged openings.
5. The device of claim 1 , wherein the plurality of support structures support the sealant structure and prevent the sealant structure from blocking the flow pathway.
6. The device of claim 1 , wherein the conduit structure further comprises a first mating end and a second mating end and wherein the first mating end is configured to mate with the second mating end.
7. The device of claim 6 , further comprising two or more tension relief modules configured to mate end-to-end.
8. The device of claim 1 , wherein the tension relief module creates a bridge between the incision and a location remote from the incision.
9. The device of claim 8 , wherein the location remote from the incision is a second incision.
10. The device of claim 9 , wherein the location remote from the incision is a non-incision site.
11. The device of claim 1 , wherein the conduit structure comprises a material that is highly elastic and highly recoverable.
12. The device of claim 11 , wherein the material is selected from the group comprising silicone elastomer, polyurethane, polyisoprene, and an elastomer.
13. The device of claim 1 , wherein the opposing adhesive structure are adapted to be manually stretched from a relaxed configuration to a first tensile configuration.
14. The device of claim 13 , wherein the opposing adhesive structures are adapted to return towards the relaxed configuration from the first tensile configuration into a second tensile configuration such that the opposing adhesive structures impart a contracting force towards a center of the incision.
15. The device of claim 14 , further comprising an indicator reversibly coupled to an upper surface of the opposing adhesive structures, the indicator comprising opposing pull tabs each having an alignment marker.
16. The device of claim 15 , wherein application of outward tension to the opposing pull tabs stretches the opposing adhesive structures towards the first tensile configuration.
17. The device of claim 16 , wherein the alignment markers approach alignment with one another when the opposing adhesive structures are stretched towards the first tensile configuration.
18. The device of claim 16 , wherein the indicator further comprises a mechanical interference feature that limits the outward tension that can be applied to the opposing adhesive structures.
19. The device of claim 1 , wherein the opposing adhesive structures shield the incision from endogenous or exogenous stress by imposing a strain on a surface of healthy skin surrounding the incision.
20. The device of claim 1 , wherein the opposing adhesive structures are adapted and configured to provide tensile support to the incision and wherein the tensile support alleviates mechanical tension on the incision.
21. The device of claim 1 , wherein the opposing adhesive structures comprise at least one pair of wings extending outward from the conduit structure.
22. The device of claim 21 , wherein the at least one pair of wings draw healthy tissue surrounding the incision towards the center of the incision.
23. The device of claim 21 , wherein the at least one pair of wings approximates edges of the incision.
24. The device of claim 21 , wherein the at least one pair of wings applies a force transverse to the longitudinal axis of the incision.
25. The device of claim 21 , wherein the opposing adhesive structures comprises a first and second pair of wings extending outward from the conduit structure, wherein the first pair of wings are positioned adjacent to the second pair of wings.
26. The device of claim 25 , wherein the first and second pair of wings are separable to tailor the device to a customized length.
27. The device of claim 25 , further comprising an indicator comprising a first and second pair of opposing pull tabs reversibly coupled to an upper surface of the first and second pair of wings.
28. The device of claim 27 , wherein the first and second pair of opposing pull tabs are coupled together at an adjacent edge.
29. The device of claim 1 , wherein the opposing adhesive structures comprise a material that is highly elastic and has memory.
30. The device of claim 29 , wherein the material is polyurethane coated on a lower surface with an acrylic adhesive.
31. The device of claim 1 , wherein the sealant structure further comprises a vacuum port in fluid communication with the flow pathway and configured to be coupled to a negative pressure source.
32. The device of claim 31 , wherein the negative pressure source comprises a constant force spring, a sliding seal and a fixed external profile independent of its internal volume level.
33. The device of claim 32 , further comprising a one-way flow valve positioned between the negative pressure source and the flow pathway, the valve adapted and configured to prevent the backflow of fluid within the flow pathway.
34. The device of claim 31 , wherein application of negative pressure through the vacuum port evacuates the flow pathway.
35. The device of claim 31 , wherein the vacuum port further comprises a pressure indicator that informs a user when negative pressure is successfully delivered to the flow pathway, wherein the indicator informs the user via at least one of visual and tactile feedback.
36. The device of claim 31 , wherein the vacuum port is positioned near a perimeter of the sealant structure.
37. The device of claim 36 , wherein the sealant structure further comprises a release liner adhered to the lower adhesive surface.
38. The device of claim 37 , wherein the release liner further comprises a break line positioned near the vacuum port.
39. The device of claim 37 , wherein the sealant structure and release liner are in a rolled configuration and gradually separate from each other as they unroll and the sealant structure is adhered to the patient.
40. The device of claim 1 , wherein the sealant structure is sized to cover entirely the tension relief module and a portion of skin surrounding and not covered by the tension relief module.
41. The device of claim 1 , wherein the sealant structure is sized to cover at least two tension relief modules mated end-to-end and a portion of the skin surrounding and not covered by the two tension relief modules.
42. The device of claim 26 , wherein the sealant structure is sized to cover the customized length of the device and cover a portion of the skin surrounding and not covered by the customized length.
43. The device of claim 1 , wherein the sealant structure comprises a polyurethane sheet.
44. The device of claim 1 , wherein the sealant structure comprises a plurality of smaller segments of sealant layers.
45. The device of claim 1 , wherein the lower adhesive surface of the sealant structure comprises a hydrocolloid adhesive, silicone adhesive, rubber adhesive, or acrylic adhesive.
46. The device of claim 1 , wherein the lower adhesive surface does not adhere to the plurality of support structures.
47. The device of claim 1 , further comprising a contact layer adapted to directly contact the incision.
48. The device of claim 47 , wherein the contact layer is a material selected from the group comprising foam, mesh, gauze, sponge, particulate matter, mesh matrix, and porous biocompatible material.
49. The device of claim 47 , wherein the contact layer is adapted and configured to serve as a vehicle for delivery of therapeutic agents.
50. The device of claim 1 , wherein the incision is a closed incision.
51. The device of claim 50 , wherein the incision is closed by sutures, staples, or adhesives.
52. The device of claim 1 , wherein the device has a thickness that is less than 12 mm.
53. The device of claim 1 , wherein the device prevents trapping of fluid under the device.
54. The device of claim 1 , wherein the incision is visible through the device.
55. The device of claim 31 , wherein at least a portion of the tension relief module is configured to provide tensile support to the incision to alleviate mechanical tension on the incision, and wherein the tension relief module provides tensile support independent of an application of negative pressure to the incision.
56. The device of claim 31 , wherein at least a portion of the tension relief module is configured to provide tensile support to the incision to alleviate mechanical tension on the incision, and wherein at least a portion of the tension relief module is configured to continue to provide tensile support after negative pressure is removed from the incision.
57. A system for treating an incision, the system comprising:
a device comprising:
(a) a generally planar tension relief module, comprising:
(i) a conduit structure comprising 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, wherein at least a portion of the conduit structure is adapted to be aligned with a longitudinal axis of the incision; and
(ii) opposing adhesive structures coupled to the conduit structure; and
(b) a flexible sealant structure sized to cover the tension relief module, the flexible sealant structure comprising a lower adhesive surface and a vacuum port,
wherein the lower adhesive surface of the flexible sealant structure and the upper surface of the conduit structure form a flow pathway; and
a negative pressure source configured to couple to the vacuum port, the negative pressure source comprising a constant force spring, a sliding seal and a fixed external profile independent of its internal pressure level.
58. A method of treating an incision, the method comprising:
applying a contact layer in direct contact with the incision;
adhering a generally planar tension relief module over the contact layer and the incision, the tension relief module comprising:
(a) a conduit structure comprising 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; and
(b) opposing adhesive structures coupled to the conduit structure;
wherein adhering comprises manually stretching the opposing adhesive structures from a relaxed configuration towards a tensile configuration and applying the opposing adhesive structures to a healthy skin surface on either side of the incision;
applying a flexible sealant structure over the tension relief module forming a flow pathway on the upper surface of the conduit structure; and
applying a negative pressure to a vacuum port on the sealant structure to evacuate the flow pathway.
59. A method as in claim 58 , further comprising causing the opposing adhesive structures to relieve tension on the incision.
60. A method as in claim 59 , wherein the opposing adhesive structures relieve tension on the incision independent of the negative pressure.
61. A method as in claim 58 , further comprising removing the flexible sealant structure, wherein the opposing adhesive structures continue to relieve tension on the incision after the flexible sealant structure is removed.