SYSTEMS AND METHODS FOR TREATING A TISSUE SITE WITH REDUCED PRESSURE INVOLVING A REDUCED-PRESSURE INTERFACE HAVING A CUTTING ELEMENT

• US 20130030394A1
• Filed: 07/20/2012
• Published: 01/31/2013
• Est. Priority Date: 07/26/2011
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Locke, Christopher Brian, Robinson, Timothy, Tout, Aidan Marcus
• Granted Patent: US 8,758,328 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 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61M 1/00 Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems catheters A61M25/00; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; devices for taking samples of blood A61B5/15; filters implantable into blood vessels A61F2/01
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/912 Connectors between dressing and drainage tube
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

Systems and methods for a reduced-pressure interface for providing reduced pressure through a sealing member to a distribution manifold includes a housing having a flange portion and a cavity wall portion such that the cavity wall portion forms a cavity having a tissue-facing cavity opening. A conduit port is coupled to the cavity wall and has a conduit aperture, such that the conduit port is adapted to receive a reduced-pressure delivery conduit. An attachment device is coupled to a tissue-facing side of the flange portion of the housing such that the attachment device couples the housing to the sealing member. Additionally, a cutting element is at least temporarily coupled to the housing proximate to the tissue-facing cavity opening such that the cutting element is adapted to form an aperture in the sealing member when the cutting element is driven into the sealing member with a driving force.

Claims

1. A reduced-pressure interface for providing reduced pressure through a sealing member to a distribution manifold, the reduced-pressure interface comprising:

a housing having a flange portion and a cavity wall portion;

wherein the cavity wall portion forms a cavity having a tissue-facing cavity opening;

a conduit port coupled to the cavity wall and having a conduit aperture, wherein the conduit port is adapted to receive a reduced-pressure delivery conduit;

an attachment device coupled to a tissue-facing side of the flange portion of the housing, the attachment device for coupling the housing to the sealing member; and

a cutting element coupled to the housing proximate to the tissue-facing cavity opening, the cutting element configured to form an aperture in the sealing member when the cutting element is driven into the sealing member with a driving force.

2. The reduced-pressure interface of claim 1, wherein the cutting element comprises:

a base member;

a stylus member coupled to the base member, wherein the stylus member has a leading edge and is configured to perforate the sealing member to form an access aperture in the sealing member and to apply a tensile force on the access aperture.

3. The reduced-pressure interface of claim 1, wherein a piercing length (L_p) of the cutting element is less than 3 centimeters.

5. The reduced-pressure interface of claim 2, wherein the base member is sized and configured to form an interference fit with the tissue-facing cavity opening, whereby the cutting element is releasably coupled to the housing.

6. The reduced-pressure interface of claim 2, wherein the stylus member has a first blade and a second blade configured to make orthogonal cuts in the sealing member.

7. The reduced-pressure interface of claim 1, wherein the attachment device is an adhesive.

8. The reduced-pressure interface of claim 1, wherein the cutting element is formed from a water soluble material.

9. The reduced-pressure interface of claim 8, wherein the water soluble material comprises at least one of the following:

Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, sugars (sucrose, glucose, fructose), weak acids (tartaric, citric, malic), salts (sodium chloride, sodium carbonate, sodium bicarbonate), polyethylene oxide (PEO), and polyethylene glycol (PEG).

10. The reduced-pressure interface of claim 1, wherein the housing is made of a semi-rigid material that collapses when exposed to a pressure in the cavity that is less than a threshold pressure.

4. (canceled)

11. A reduced-pressure interface comprising:

a housing having a collapsible cavity wall portion and a conduit aperture;

a conduit adapter having a protrusion for engaging a primary lumen of a reduced-pressure conduit;

an adapter flange coupled to the conduit adapter and positioned on an exterior of the cavity wall;

a tube extension coupled to the adapter flange and configured to extend through the conduit aperture; and

,

a cutting element comprising a base member and a stylus member coupled to the base member;

wherein the base member is coupled to the tube extension and the stylus member comprises a first blade and a second blade configured to make an orthogonal cut.

12. A system for treating a tissue site with reduced pressure, the system comprising:

a distribution manifold for placing proximate to the tissue site;

a sealing member for covering the distribution manifold to form a sealed space;

a reduced-pressure interface for providing reduced pressure through the sealing member to the distribution manifold;

a reduced-pressure source;

a reduced-pressure delivery conduit for fluidly coupling the reduced-pressure source to the reduced-pressure interface;

wherein the reduced-pressure interface comprises;

a housing having a flange portion and a cavity wall portion;

wherein the cavity wall portion forms a cavity having a tissue-facing cavity opening;

a conduit port coupled to the cavity wall and having a conduit aperture, wherein the conduit port is adapted to receive the reduced-pressure delivery conduit;

an attachment device coupled to a tissue-facing side of the flange portion of the housing, the attachment device for coupling the housing to the sealing member; and

a cutting element coupled to the housing proximate to the tissue-facing cavity opening, the cutting element comprises a base member and a stylus member coupled to the base member, wherein the stylus member has a leading edge and is configured to perforate the sealing member to form an access aperture in the sealing member and to apply a tensile force on the access aperture.

14. The system of claim 12, wherein the distribution manifold has a thickness greater than T when subject to reduced pressure, wherein the cutting element has a piercing length (L_p), and wherein L_p<

T.

15. The system of claim 12, wherein the base member is sized and configured to form an interference fit with the tissue-facing cavity opening, whereby the cutting element is releasably coupled to the housing.

16. The system of claim 12, wherein the stylus member has a first blade and a second blade configured to make orthogonal cuts in the sealing member.

17. The system of claim 12, wherein the cutting element is formed from a water soluble material.

18. The system of claim 17, wherein the water soluble material comprises at least one of the following:

Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, sugars (sucrose, glucose, fructose), weak acids (tartaric, citric, malic), salts (sodium chloride, sodium carbonate, sodium bicarbonate), polyethylene oxide (PEO), and polyethylene glycol (PEG).

19. The system of claim 12, wherein the housing is made a semi-rigid material that collapses when exposed to a pressure in the cavity that is less than a threshold pressure.

20. The system of claim 12, wherein the cutting element further comprises a conduit adapter for receiving a reduced-pressure conduit and having an adapter flange on an exterior of the cavity wall and having a tube extension sized and configured to mate with the conduit aperture, and wherein the base member is coupled to the tube extension.

21. The system of claim 12, wherein the reduced-pressure delivery conduit comprises a multi-lumen conduit having a primary lumen and at least one sensing lumen, and further comprising a instrumentation unit fluidly coupled to the at least one sensing lumen, wherein the instrumentation unit includes a microprocessor and is adapted to:

process a pressure signal representative of a pressure at distal end of the at least one sensing lumen;

monitor the pressure signal;

issue an alert if the pressure signal does not follow a pattern of sustained decrease, increase, and stability within an application time period.

13. (canceled)

22. A method for treating a tissue site on a patient with reduced pressure, the method comprising:

disposing a distribution manifold proximate to the tissue site;

covering the distribution manifold with a sealing member to form a sealed space in which the distribution manifold is disposed, wherein the sealing member has a first side and a second, tissue-facing side;

providing a reduced-pressure source;

coupling a reduced-pressure interface proximate to the first side of the sealing member;

fluidly coupling a reduced-pressure delivery conduit between the reduced-pressure source and the reduced-pressure interface;

wherein the reduced-pressure interface comprises;

a housing having a wall portion,

wherein the wall portion forms a cavity having a tissue-facing cavity opening,

a conduit port coupled to the wall portion for receiving the reduced-pressure delivery conduit,

an attachment device for coupling the reduced-pressure interface to the sealing member, and

a cutting element coupled to the housing proximate to the tissue-facing cavity opening, the cutting element configured to perforate the sealing member when the cutting element is driven into the sealing member with a driving force; and

applying the driving force to the reduced-pressure interface of sufficient strength to cause the cutting element to perforate the sealing member.

26. The method of claim 22, further comprising applying reduced pressure through the reduced-pressure interface to create sufficient reduced pressure in the cavity to pull a portion of the distribution manifold into the cavity such that the distribution manifold abuts a distal aperture of the at least one sensing lumen in the reduced-pressure delivery conduit.

28. The method of claim 22, wherein applying the driving force to the reduced-pressure interface comprises reducing pressure in the cavity to collapse the wall portion and impact the cutting element driving a portion of the cutting element through the sealing member.

29. The method of claim 22, further comprising providing reduced pressure to the reduced-pressure interface after perforating the sealing member to remove liquids from the tissue site and dissolve the cutting element.

37. The method of claim 22, further comprising:

coupling an instrumentation unit to a sensing lumen in the reduced-pressure delivery conduit;

processing a pressure signal representative of a pressure at distal end of the sensing lumena;

monitoring the pressure signal; and

issuing an alert if the pressure signal does not follow a pressure set-up pattern within a application time period.

23. (canceled)

24. (canceled)

25. (canceled)

27. (canceled)

30. (canceled)

31. (canceled)

32. (canceled)

33. (canceled)

34. (canceled)

35. (canceled)

36. (canceled)

38. (canceled)

39. An interface for providing reduced pressure through a drape to a manifold, the interface comprising:

a housing having a flange portion and a cavity wall portion, wherein the cavity wall portion forms a cavity, and wherein a cavity wall aperture is formed within the cavity wall portion for receiving a tube;

a coupler positioned on a tissue-facing side of the flange portion of the housing, the coupler for attaching the housing to the drape; and

a protrusion coupled to the housing, the protrusion extending beyond the tissue-facing side of the flange portion of the housing, the protrusion configured to form an aperture in the drape when the protrusion is driven into the drape by the reduced pressure.

40. A system for treating a wound with reduced pressure, the system comprising:

a manifold for positioning adjacent the wound;

a drape for covering the manifold and a portion of epidermis of the patient to form a sealed space;

a reduced-pressure interface for providing reduced pressure through the drape to the manifold;

a reduced-pressure source;

a conduit for fluidly coupling the reduced-pressure source to the reduced-pressure interface;

wherein the reduced-pressure interface comprises;

a housing having a flange portion and a cavity wall portion, wherein the cavity wall portion forms a cavity, and wherein a cavity wall aperture is formed within the cavity wall portion for receiving a tube;

a coupler positioned on a tissue-facing side of the flange portion of the housing, the coupler for attaching the housing to the drape; and

a protrusion coupled to the housing, the protrusion extending beyond the tissue-facing side of the flange portion of the housing, the protrusion configured to form an aperture in the drape when the protrusion is driven into the drape by the reduced pressure.

41. A method for treating a wound on a patient with reduced pressure, the method comprising:

disposing a manifold proximate to the wound;

covering the manifold and a portion of epidermis of the patient with a drape to form a sealed space in which the manifold is disposed, wherein the drape has a first side and a second, tissue-facing side;

providing a reduced-pressure source;

coupling a reduced-pressure interface proximate to the first side of the drape;

fluidly coupling a tube between the reduced-pressure source and the reduced-pressure interface;

wherein the reduced-pressure interface comprises;

a housing having a flange portion and a cavity wall portion, wherein the cavity wall portion forms a cavity, and wherein a cavity wall aperture is formed within the cavity wall portion for receiving a tube;

a coupler positioned on a tissue-facing side of the flange portion of the housing, the coupler for attaching the housing to the drape; and

a protrusion coupled to the housing, the protrusion extending beyond the tissue-facing side of the flange portion of the housing, the protrusion configured to form an aperture in the drape when the protrusion is driven into the drape with a driving force; and

applying the driving force to the reduced-pressure interface of sufficient strength to cause the protrusion to perforate the drape.

42. (canceled)