SOLUTIONS FOR BRIDGING AND PRESSURE CONCENTRATION REDUCTION AT WOUND SITES

• US 20130144230A1
• Filed: 06/07/2012
• Published: 06/06/2013
• Est. Priority Date: 06/07/2011
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: Spiracur Inc
• Inventors: WU, Kenneth, HU, Dean, NG, Darren, LEE, Jennifer
• Granted Patent: US 9,681,993 B2
• Time in Patent Office: Days
• US Class Current: 604/319
• 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 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: A61M 1/732 Visual indicating means for vacuum pressure
• 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 1/918 for multiple suction locations
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing

Abstract

Disclosed herein are devices, systems and methods for delivering reduced pressure to a load-bearing wound site. The device can include a distal port configured to connect to a wound dressing positioned over the wound site; a proximal port located a distance from the distal port and configured to connect to a reduced pressure source, and a conduit body having an inner channel extending between the distal port and the proximal port. When the distal port is applied to the wound dressing positioned over the wound site the proximal port is positioned at a non-load bearing location remote from the wound dressing. The inner channel has a non-circular profile having a width larger than a height of the conduit body.

Claims

1. A low-profile device for delivering reduced pressure to a load-bearing wound site, comprising:

a distal port configured to connect to a wound dressing positioned over the wound site;

a proximal port located a distance from the distal port and configured to connect to a reduced pressure source, wherein when the distal port is applied to the wound dressing positioned over the wound site the proximal port is positioned at a non-load bearing location remote from the wound dressing; and

a conduit body comprising an inner channel extending between the distal port and the proximal port, wherein the inner channel has a non-circular profile having a width larger than a height of the conduit body.

2. The device of claim 1, further comprising a sealing layer comprising an adhesive lower surface configured to be adhered to the load-bearing wound site.

3. The device of claim 2, wherein the adhesive lower surface comprises a material that absorbs moisture and maintains skin health.

4. The device of claim 3, wherein the conduit body comprises an adhesive lower surface that prevents movement of the conduit body relative to an underlying skin surface.

5. The device of claim 4, wherein a junction between the adhesive lower surface of the conduit body and the adhesive lower surface of the sealing layer comprises an interruption to prevent peel propagation of the conduit body to the sealing layer.

6. The device of claim 2, wherein a distal region of the conduit body surrounding the distal port is coupled to an upper surface of the sealing layer.

7. The device of claim 6, wherein the distal region of the conduit body is permanently coupled to the upper surface.

8. The device of claim 1, wherein the conduit body comprises one or more support structures protruding into the channel.

9. The device of claim 8, wherein the one or more support structures mitigate collapse of the channel upon application of external pressure to the conduit body.

10. The device of claim 8, wherein the one or more support structures comprise elongate ribs coupled to an inner wall of the conduit body.

11. The device of claim 8, wherein the conduit body has a multi-layer construction comprising the one or more support structures sandwiched between an upper cover and a lower base.

12. The device of claim 11, wherein the one or more support structures have a porosity sufficient to allow the delivery of reduced pressure to the wound site and the flow of fluid from the wound site through the inner channel.

13. The device of claim 11, wherein the support structure is selected from the group consisting of a mesh structure, a synthetic textile, foam, fabric, non-woven fabric, silicone, urethane, cotton and gauze.

14. The device of claim 8, wherein the conduit body has a first durometer and the one or more support structures have a second durometer.

15. The device of claim 14, wherein the first durometer is less than the second durometer.

16. The device of claim 14, wherein the first durometer is more than the second durometer.

17. The device of claim 8, wherein the one or more support structures are arranged adjacent the distal port to evenly distribute loads and maintain patency of the distal port upon application of external pressure to the distal port.

18. The device of claim 1, wherein the distance of the proximal port from the distal port is a range of about 2 inches to about 12 inches.

19. The device of claim 1, further comprising a pressure indicator configured to indicate pressure delivered locally to the wound site.

20. The device of claim 1, further comprising a contact surface positioned under the conduit body.

21. The device of claim 1, further comprising a padding material located on an exterior surface of the conduit body.

22. The device of claim 21, further comprising:

a low-tack adhesive located on at least a portion of the padding material configured to adhere to a patient'"'"'s skin; and

a release liner releasably adhered to the low-tack adhesive, wherein the release liner comprises a porous or padded material configured to contact the patient'"'"'s skin.

23. A reduced pressure therapy device;

comprising;

a conduit structure comprising an upper surface, a lower surface, and a passageway therebetween, a support structure located in the passageway, an inlet opening located in the lower surface, an outlet opening located in the supper surface;

a port coupled to the upper surface and in fluid communication with the outlet opening; and

a first porous tissue protection structure attached to the lower surface of the conduit structure.

24. The reduced pressure therapy device of claim 23, further comprising:

an adhesive structure coupled to at least one of the lower surface of the conduit structure and the first tissue protection structure; and

a release liner adhered to the adhesive structure, the release liner comprising a release surface in contact with the adhesive structure, and a second porous tissue protection structure on a surface opposite of the release surface.

25. The reduced pressure therapy device of claim 24, wherein the release liner comprises an extension located beyond an edge of the adhesive structure.

26. The reduced pressure therapy device of claim 24, wherein the first porous tissue protection structure comprises a different material than the second porous tissue protection structure.

27. The reduced pressure therapy device of claim 24, wherein the first porous tissue protection device comprises a foam.

28. The reduced pressure therapy device of claim 24, wherein the second porous tissue protection device comprises a woven material.

29. The reduced pressure therapy device of claim 24, wherein the support structure comprises a foam.

30. The reduced pressure therapy device of claim 24, wherein the adhesive structure is attached to the first porous tissue protection structure.

31. The reduced pressure therapy device of claim 24, wherein the conduit structure further comprises a proximal region and a distal region.

32. The reduced pressure therapy device of claim 31, wherein the inlet opening is located about the distal region.

33. The reduced pressure therapy device of claim 32, wherein the outlet opening is located about the proximal region.

34. The reduced pressure therapy device of claim 33, wherein the outlet opening is located halfway between the proximal region and the distal region.

35. The reduced pressure therapy device of claim 24, wherein the upper surface and the lower surface are integrally formed.

36. The reduced pressure therapy device of claim 24, wherein the upper surface and the lower surface form a seam along an outer perimeter of the conduit structure.

37. The reduced pressure therapy device of claim 36, wherein the upper surface comprises a non-planar, vacuum formed polymeric structure and the lower surface comprises a planar polymeric structure.

38. The reduced pressure therapy device of claim 24, further comprising a dressing attached to the conduit about the inlet opening.

39. The reduced pressure therapy device of claim 38, wherein an edge of the dressing is aligned with an edge of the first porous tissue protection structure.

40. The reduced pressure therapy device of claim 38, wherein the dressing does not overlap with the first porous tissue protection structure.

41. The reduced pressure therapy device of claim 24, wherein the first tissue protection structure comprises a lateral perimeter portion that extends beyond a lateral perimeter of the conduit structure.

42. A bridging device, comprising:

a flat conduit with a passageway containing a foam structure;

a port adhered to a proximal, upper surface of the flat conduit and in fluid communication with the passageway of the flat conduit;

a dressing attached to a distal, lower surface of the flat conduit and in fluid communication with the passageway of the flat conduit; and

a foam pad attached to a middle and a proximal lower surface of the flat conduit, the foam pad comprising a distal end and an enlarged proximal end, wherein the proximal end comprises a greater width than the distal end.

43. The bridging device of claim 42, further comprising:

an adhesive attached to the enlarged proximal end of the foam pad; and

a release liner releasably adhered to the adhesive, the release liner comprising a tab extending beyond a perimeter of the adhesive;

a fiber material, and a coating on the fiber material that is releasably adhered to the adhesive.

44. The bridging device of claim 42, further comprising a first end of a tubing coupled to the port.

45. The bridging device of claim 44, further comprising a suction source coupling device attached to a second end of the tubing.

46. A method for treating a patient, comprising:

orienting a dressing with a pre-attached bridging conduit about a tissue treatment site;

applying the dressing to a tissue treatment site; and

positioning a first skin protection structure attached to an external surface of the bridging conduit in contact with a patient without adhering the first skin protection structure to the patient, wherein a second porous skin protection structure is releasably preattached to the bridging device.

47. The method of claim 46, further comprising:

pulling a porous second skin protection structure preattached to the bridging device, to expose an adhesive; and

applying the adhesive to the patient to secure the bridging device to the patient.

48. The method of claim 46, further comprising attaching a lower surface opening of a second bridging conduit to an upper surface opening of the pre-attached bridging conduit.

49. A tissue treatment device, comprising:

an elongate body with an enlarged proximal end and a distal end smaller than the proximal end, and a cavity therebetween;

an elongate support structure located in the cavity and configured to facilitate transmission of reduced pressure along the elongate body;

a tubing connector attached to the enlarged proximal end of the elongate body and in communication with a proximal opening of the elongate body; and

a wound cover attached to the distal end of the elongate body and in communication with a distal opening of the elongate body, the wound cover comprising a non-rectangular, non-square, non-circular, non-oval shape.

50. The tissue treatment device of claim 49, wherein the distal opening of the elongate body has a surface are of at least 1 square cm and through which at least 1 square cm surface area of the elongate support structure is exposed.

51. The tissue treatment device of claim 49, wherein the wound cover has a bi-lobed configuration.

52. The tissue treatment device of claim 49, wherein the wound cover comprises an open proximal end and a closed distal end.

53. The tissue treatment device of claim 52, wherein the wound cover further comprises a tab extending proximally from an edge of the open proximal end.

54. The tissue treatment device of claim 52, wherein the wound cover further comprises cavity with a longitudinal axis between the open proximal end and the closed distal end, the cavity comprising a diameter transverse to the longitudinal axis that is less than 4 cm.

55. The tissue treatment device of claim 54, wherein diameter transverse to the longitudinal axis that is less than 3 cm.

56. The tissue treatment device of claim 55, wherein diameter transverse to the longitudinal axis that is less than 2.5 cm.

57. The tissue treatment device of claim 49, wherein the elongate support structure comprises a open-cell foam.

58. The tissue treatment device of claim 49, wherein the elongate support structure protrudes through the distal opening.

59. A method of tissue treatment, comprising:

attaching at least one wound cover to a treatment site, wherein a foam-based conduit with a tubing connector is pre-coupled to the at least one wound cover;

externally compressing the foam-based conduit;

attaching a vacuum source to the foam-based conduit; and

activating the vacuum source after externally compressing the foam-based conduit.

60. The method of tissue treatment as in claim 59, further comprising maintaining at least some external compression of the foam-based conduit while activating the vacuum source.