Reduced-pressure systems and methods employing a leak-detection member

• US 9,622,914 B2
• Filed: 08/10/2012
• Issued: 04/18/2017
• Est. Priority Date: 09/14/2011
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Locke, Christopher Brian, Robinson, Timothy Mark, Tout, Aidan Marcus, Long, Justin Alexander
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US13/571,860
• Publication Number:
  US 20130066285A1
• Time in Patent Office: 1,712 Days
• Field of Search: 604318
• CPC Class Codes: A61F 13/0206 with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
• 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 2013/00795 special helping devices
• CPC Class Codes: A61F 2013/00846 with transparent or translucent part
• CPC Class Codes: A61F 2013/00885 impervious, i.e. occlusive bandage
• CPC Class Codes: A61F 2013/0094 for sensing physical parameters plasters for conducting test A61F2013/00429
• CPC Class Codes: A61F 2013/00948 Ph, e.g. acid
• CPC Class Codes: A61F 2013/0097 oxygen content
• CPC Class Codes: A61H 7/001 without substantial movement between the skin and the device
• 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 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production

Abstract

Systems, methods, and apparatus are provided for detecting leaks in systems for treating a patient with reduced pressure. In one instance, a system includes a distribution manifold for disposing proximate to the tissue site and a sealing member for disposing over the distribution manifold and at least a portion of intact epidermis of the patient. The sealing member has at least a portion that is substantially transparent. The system further includes a reduced-pressure source associated with the distribution manifold for providing reduced pressure to the distribution manifold and a leak-detection member sized and configured to substantially surround the distribution manifold. The leak-detection member includes a detection material that develops a color contrast when a portion is exposed to air and a portion is not exposed to air. The leak detection member works with even low flow systems. Other systems, methods, and apparatus are presented.

Claims

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

a distribution manifold for disposing proximate to the tissue site;

a sealing member for disposing over the distribution manifold, wherein the sealing member comprises at least a portion that is substantially transparent, the sealing member configured to form a sealed space having the distribution manifold therein;

a reduced-pressure source associated with the distribution manifold for providing reduced pressure to the distribution manifold; and

a leak detection ring having an inner and outer circumference, the inner circumference configured to be disposed outboard of the distribution manifold, the leak detection ring being formed from a detection material configured to develop a color contrast in response to a leak of the sealing member, the detection material being reactive to air and becoming fluorescent when exposed to a diction tool in an activated state and changing fluorescence when exposed to oxygen.

2. The system of claim 1, wherein the leak detection ring comprises one or more members concentric with the distribution manifold.

3. The system of claim 1, wherein the detection material further comprises a hydrophilic adhesive disposed in the leak detection ring on a tissue facing side of the sealing member.

5. The system of claim 1, wherein the detection material is selected from at least one of the following:

methylene blue,

N-phenylanthranilic acid, titanium dioxide, and glycerol.

16. The system of claim 1, wherein the leak detection ring is configured to be disposed between the sealing member and the tissue site.

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

a distribution manifold for disposing proximate to the tissue site;

a sealing member for disposing over the distribution manifold, wherein the sealing member comprises at least a portion that is substantially transparent, the sealing member configured to form a sealed space having the distribution manifold therein;

a reduced-pressure source associated with the distribution manifold for providing reduced pressure to the distribution manifold;

a leak detection ring having an inner and outer circumference, the inner circumference configured to be disposed outboard of the distribution manifold, the leak detection ring being formed from a detection material configured to develop a color contrast in response to a leak of the sealing member; and

wherein the detection material comprises a first agent covering at least a portion of a tissue-facing side of the sealing member, and a skin-preparation fluid forming the leak detection ring and having a second agent, the first agent of the sealing member and the second agent of the skin-preparation fluid forming a contact color when combined that is indicative of contact between the first agent and the second agent, the contact color providing the color contrast with portions of the first agent not in contact with the second agent.

6. A method for providing reduced-pressure treatment to a tissue site on a patient, the method comprising:

disposing a distribution manifold proximate to the tissue site;

disposing at least one ring having an inner and outer circumference formed from a detection material around the distribution manifold and the tissue site onto at least one of an epidermis of the patient outboard of the tissue site and onto a tissue-facing side of a sealing member, so that the inner circumference is outboard of the distribution manifold, the at least one ring comprising one or more curved members;

covering the distribution manifold and at least partially covering the at least one ring with the sealing member to seal the distribution manifold in a sealed space, wherein the sealing member has at least a portion that is substantially transparent;

providing reduced pressure to the distribution manifold; and

identifying a color contrast in the detection material indicative of a leak in the sealed space.

8. The method of claim 6, wherein the detection material reacts to air.

12. The method of claim 6, wherein disposing the at least one ring comprises applying a hydrophilic adhesive to a tissue-facing side of the sealing member.

7. A method for providing reduced-pressure treatment to a tissue site on a patient, the method comprising:

disposing a distribution manifold proximate to the tissue site;

disposing at least one ring having an inner and outer circumference formed from a detection material around the distribution manifold and the tissue, so that the inner circumference is outboard of the distribution manifold by applying a liquid onto an intact epidermis of the patient outboard of the tissue site;

covering the distribution manifold and at least partially covering the at least one ring with a sealing member to seal the distribution manifold in a sealed space, wherein the sealing member has at least a portion that is substantially transparent;

providing reduced pressure to the distribution manifold; and

identifying a color contrast in the detection material indicative of a leak in the sealed space.

9. A method for providing reduced-pressure treatment to a tissue site on a patient, the method comprising:

disposing a distribution manifold proximate to the tissue site;

disposing at least one ring having an inner and outer circumference formed from a detection material around the distribution manifold and the tissue site, so that the inner circumference is outboard of the distribution manifold;

covering the distribution manifold and at least partially covering the at least one ring with a sealing member to seal the distribution manifold in a sealed space, wherein the sealing member has at least a portion that is substantially transparent;

providing reduced pressure to the distribution manifold;

identifying a color contrast in the detection material indicative of a leak in the sealed space by;

exposing the detection material to a detection tool so that the detection material fluoresces; and

identifying areas of the detection material having differing fluorescence.

10. A method for providing reduced-pressure treatment to a tissue site on a patient, the method comprising:

disposing a distribution manifold proximate to the tissue site;

disposing at least one ring having an inner and outer circumference formed from a detection material around the distribution manifold and the tissue site, so that the inner circumference is outboard of the distribution manifold wherein the detection material reacts to a challenge gas;

covering the distribution manifold and at least partially covering the at least one ring with a sealing member to seal the distribution manifold in a sealed space, wherein the sealing member has at least a portion that is substantially transparent;

providing reduced pressure to the distribution manifold;

identifying a color contrast in the detection material indicative of a leak in the sealed space by

spraying the challenge gas onto the sealing member.

11. A method for providing reduced-pressure treatment to a tissue site on a patient, the method comprising:

disposing a distribution manifold proximate to the tissue site;

disposing at least one ring having an inner and outer circumference formed from a detection material around the distribution manifold and the tissue site, so that the inner circumference is outboard of the distribution manifold by disposing a first agent on a tissue-facing side of a sealing member, and disposing a skin-preparation fluid having a second agent on an intact epidermis of the patient, wherein the first agent of the sealing member and the second agent of the skin-preparation fluid form a contact color when combined that is indicative of contact between the first agent and the second agent and sealing of the sealed space;

covering the distribution manifold and at least partially covering the at least one ring with the sealing member to seal the distribution manifold in a sealed space, wherein the sealing member has at least a portion that is substantially transparent;

providing reduced pressure to the distribution manifold;

identifying a color contrast in the detection material indicative of a leak in the sealed space.

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

a distribution manifold for disposing proximate to the tissue site;

a sealing member for disposing over the distribution manifold, wherein the sealing member comprises at least a portion that is substantially transparent, the sealing member configured to form a sealed space having the distribution manifold therein;

a reduced-pressure source associated with the distribution manifold for providing reduced pressure to the distribution manifold; and

a leak detection ring having an inner and outer circumference, the inner circumference configured to be disposed outboard of the distribution manifold, the leak detection ring being formed from a detection material configured to develop a color contrast in response to a leak of the sealing member and the detection material reacts to a challenge gas sprayed onto the sealing member by a challenge gas distributor.

14. The system of claim 13, wherein the challenge gas is carbon dioxide.

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

a distribution manifold for disposing proximate to the tissue site;

a sealing member for disposing over the distribution manifold, wherein the sealing member comprises at least a portion that is substantially transparent, the sealing member configured to form a sealed space having the distribution manifold therein;

a reduced-pressure source associated with the distribution manifold for providing reduced pressure to the distribution manifold; and

a leak detection ring having an inner and outer circumference, the inner circumference configured to be disposed outboard of the distribution manifold, the leak detection ring being formed from a detection material configured to develop a color contrast in response to a leak of the sealing member and wherein the detection material comprises a skin-preparation fluid reactive to air.