Enclosure-based reduced pressure treatment system

• US 8,708,998 B2
• Filed: 04/07/2009
• Issued: 04/29/2014
• Est. Priority Date: 03/09/2004
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Bluesky Medical Group Inc. (Smith & Nephew PLC)
• Inventors: Weston, Richard Scott, Johnson, Timothy Robert, Miller, Michael Seth
• Primary Examiner(s): Hand, Melanie
• Assistant Examiner(s): CRAIG, PAULA L
• Application Number:
  US12/419,542
• Publication Number:
  US 20090192499A1
• Time in Patent Office: 1,848 Days
• Field of Search: 604292-293, 604/313, 604315-316, 604/319, 604/541, 604/543, 604/317, 604/320
• US Class Current: 604/543
• 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 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/00574 shaped as a body part A61F2013/00187 take precedence; use of plasters A61F2013/00365; containing means for different purposes A61F2013/00902
• CPC Class Codes: A61H 2205/065 Hands
• CPC Class Codes: A61H 2205/106 for the lower legs
• CPC Class Codes: A61H 2205/12 Feet
• CPC Class Codes: A61H 9/0057 Suction suction kneading A61H7/008
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/917 specially adapted for covering whole body parts
• CPC Class Codes: A61M 1/962 having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate

Abstract

A reduced pressure treatment appliance is provided for enclosing and providing reduced pressure treatment to a portion of a body of a patient. The reduced pressure treatment appliance may be used to treat wounds and other conditions, such as lymphedema, varicose veins, venous insufficiency and stasis, and other infirmities. In some embodiments, the appliance comprises an enclosure that encloses the portion of the body to be treated for purposes of applying a reduced pressure to the enclosed portion of the body. In other embodiments, the wound treatment appliance also includes a vacuum system to supply reduced pressure to the portion of the body to be treated in the volume under the enclosure. In yet other embodiments, the treatment appliance also includes wound packing means to prevent overgrowth of the wound or to encourage growth of wound tissue into an absorbable matrix comprising the wound packing means. In still other embodiments, a suction bulb may be used to provide a source of reduced pressure to an enclosure that encloses the portion of the body to be treated. Finally, methods are provided for using various embodiments of the treatment appliance.

Claims

1. A method of treating an extremital portion of a human body, such method comprising the steps of:

positioning a flexible enclosure having an opening over the extremital portion of the body to be treated, wherein the enclosure is sized to be placed over and completely enclose the extremital portion of the body to be treated and adapted to maintain reduced pressure at the extremital portion of the body to be treated, and wherein the extremital portion of the body to be treated is selected from the group consisting of an arm, a leg, and any extremital regions thereof;

sealing the area of the enclosure adjacent to the opening to the body, so that reduced pressure may be maintained in the volume under the enclosure at the portion of the body to be treated;

operably connecting the enclosure with a vacuum system for producing reduced pressure in the volume under the enclosure at the portion of the body to be treated, such that application of reduced pressure causes substantially all of the enclosure to deform to substantially conform to a majority of the contours of the extremital portion of the body to be treated;

removing fluid from the volume under the enclosure at the portion of the body to be treated via the application of reduced pressure;

storing fluid removed from the volume under the enclosure in a collection system; and

maintaining the reduced pressure under the enclosure at the portion of the body being treated.

2. The method of claim 1, wherein the vacuum system is comprised of a suction bulb and the step of operably connecting the enclosure with the vacuum system further comprises the step of squeezing the suction bulb to reduce its volume and then releasing the suction bulb, so that reduced pressure is produced in the volume under the enclosure at the portion of the body to be treated.

3. The method of claim 1, wherein the reduced pressure under the enclosure at the portion of the body to be treated is in the range from approximately 20 mm of Hg below atmospheric pressure to approximately 125 mm of Hg below atmospheric pressure.

4. The method of claim 1, wherein the reduced pressure is applied cyclically.

5. The method of claim 1, further comprising the step of placing a wound packing mechanism between the portion of the body to be treated and the enclosure, such step being performed prior to positioning the enclosure over the portion of the body to be treated.

6. The method of claim 1, further comprising the step of placing a liner over the portion of the body to be treated, wherein the liner is disposed between the portion of the body to be treated and the enclosure, such step being performed prior to positioning the enclosure over the portion of the body to be treated.

7. The method of claim 1, wherein positioning the enclosure over the portion of the body to be treated occurs before coupling the enclosure with a vacuum system for producing reduced pressure in the volume under the enclosure at the portion of the body to be treated.

8. The method of claim 1, wherein positioning the enclosure over the portion of the body to be treated occurs after operably connecting the enclosure with a vacuum system for producing reduced pressure in the volume under the enclosure at the portion of the body to be treated.

9. The method of claim 1, wherein the collection system comprises a canister.

10. The method of claim 9, wherein the canister is positioned between the flexible enclosure and the vacuum system, the canister disposed outside the flexible enclosure.

11. The method of claim 1, wherein the fluid is a liquid.

12. A method of treating an extremital portion of a human body, such method comprising the steps of:

positioning a flexible enclosure having an opening over the portion of the body to be treated, wherein the enclosure is sized to be placed over and completely enclose the portion of the body to be treated, wherein the enclosure is adapted to maintain reduced pressure at the portion of the body to be treated and configured to substantially completely deform to substantially conform to a majority of the contours of the portion of the body to be treated, and wherein the portion of the body to be treated is selected from the group consisting of an arm, a leg, and any extremital regions thereof;

operably connecting the enclosure with a vacuum system for producing reduced pressure in the volume under the enclosure;

sealing the area of the enclosure adjacent the opening to the body, so that reduced pressure may be maintained in the volume under the enclosure at the portion of the body to be treated;

applying reduced pressure to the volume under the enclosure at the portion of the body to be treated such that fluid may be removed therefrom; and

storing fluid removed from the volume under the enclosure in a collection system.

13. The method of claim 12, wherein positioning the enclosure having an opening over the portion of the body to be treated occurs after operably connecting the enclosure with a vacuum system for producing reduced pressure in the volume under the enclosure at the portion of the body to be treated.

14. The method of claim 12, wherein positioning the enclosure having an opening over the portion of the body to be treated occurs before coupling the enclosure with a vacuum system for producing reduced pressure in the volume under the enclosure at the portion of the body to be treated.

15. The method of claim 12, wherein the collection system comprises a canister.

16. The method of claim 15, wherein the canister is positioned between the flexible enclosure and the vacuum system, the canister disposed outside the flexible enclosure.

17. The method of claim 12, wherein the fluid is a liquid.

18. A method of treating an extremital portion of a human body, such method comprising the steps of:

operably connecting an enclosure having an opening with a vacuum system, wherein the enclosure is sized to be placed over and completely enclose the portion of the body to be treated, the enclosure is configured to substantially completely deform to substantially conform to a majority of the contours of the portion of the body to be treated and adapted to maintain reduced pressure at the portion of the body to be treated, and the vacuum system produces reduced pressure for the volume under the enclosure at the portion of the body to be treated;

positioning the enclosure over the portion of the body to be treated, wherein the portion of the body to be treated is selected from the group consisting of an arm, a leg, and any extremital regions thereof;

sealing the area of the enclosure adjacent to the opening to the body, so that reduced pressure may be maintained in the volume under the enclosure at the portion of the body to be treated;

removing fluid from the volume under the enclosure at the portion of the body to be treated with the vacuum system;

storing fluid removed from the volume under the enclosure in a collection system; and

applying the reduced pressure under the enclosure at the portion of the body being treated.

19. The method of claim 18, wherein operably connecting the enclosure having an opening with a vacuum system occurs before positioning the enclosure over the portion of the body to be treated.

20. The method of claim 18, wherein coupling the enclosure having an opening with a vacuum system occurs after positioning the enclosure over the portion of the body to be treated.

21. The method of claim 18, wherein the collection system comprises a canister.

22. The method of claim 21, wherein the canister is positioned between the enclosure and the vacuum system, the canister disposed outside the enclosure.

23. The method of claim 18, wherein the fluid is a liquid.