Method for treating chronic wounds with an extracellular polymeric substance solvating system

• US 9,700,344 B2
• Filed: 06/25/2014
• Issued: 07/11/2017
• Est. Priority Date: 06/12/2008
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Oliver, Dana A., Myntti, Matthew F., Hissong, James B., Medina, Jennifer G.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): EBRAHIM, NABILA G
• Application Number:
  US14/314,974
• Publication Number:
  US 20140309581A1
• Time in Patent Office: 1,112 Days
• Field of Search: 424 7806, 514 94, 514828
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/09 having two or more such linkages
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/7036 having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
• CPC Class Codes: A61K 33/22 Boron compounds
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Chronic wounds may be treated by debriding necrotic and other devitalized tissue from the wound, and applying to the wound an extracellular polymeric substance solvating system comprising a metal ion sequestering agent, surfactant and buffering agent. The solvating system disrupts biofilms which may be present in the wound and aids or enables the resumption of normal healing.

Claims

1. An apparatus for treating a chronic wound, comprising:

a) a debriding device comprising a reservoir containing an extracellular polymeric substance solvating system comprising an aqueous solution of a metal ion sequestering agent, surfactant and buffering agent wherein the solvating system has an osmolarity of about 1,000-4,000 milliosmoles of solute per liter, and wherein the reservoir is in fluid communication with an applicator for applying the solvating system to a wound at a sufficient flow rate or under sufficient pressure to debride at least some devitalized tissue from the wound; and

b) an aspirating device which removes at least some debrided necrotic or other devitalized tissue and excess solvating system from the wound.

2. An apparatus according to claim 1 wherein the applicator applies the solvating system at a flow rate more than 7 and less than 20 cm³/sec.

3. An apparatus according to claim 1 wherein the applicator applies the solvating system at a delivery pressure of about 30 to about 500 KPa.

4. An apparatus according to claim 1 wherein the applicator applies the solvating system at a delivery pressure of about 60 to about 350 KPa.

5. An apparatus according to claim 1 wherein the metal ion sequestering agent comprises a mild acid whose acidity is sufficient to sequester one or more metal ions in a bacterial biofilm but which is not so acidic so as to harm healthy or healable tissue in the wound.

6. An apparatus according to claim 1 wherein the metal ion sequestering agent comprises a sequestering agent for sodium, calcium or iron.

7. An apparatus according to claim 1 wherein the metal ion sequestering agent comprises a carboxylic acid, diacid, triacid or mixture thereof.

8. An apparatus according to claim 1 wherein the metal ion sequestering agent comprises formic acid, acetic acid, chloroacetic acid, dichloroacetic acid, oxalic acid, oxamic acid, glycolic acid, lactic acid, pyruvic acid, aspartic acid, fumaric acid, maleic acid, succinic acid, iminodiacetic acid, glutaric acid, 2-ketoglutaric acid, glutamic acid, adipic acid, glucuronic acid, mucic acid, nitrilotriacetic acid, salicylic acid, ketopimelic acid, benzoic acid, mandelic acid, chloromandelic acid, phenylacetic acid, phthalic acid, boric acid or mixture thereof.

9. An apparatus according to claim 1 wherein the metal ion sequestering agent comprises citric acid.

10. An apparatus according to claim 1 wherein the surfactant comprises an alkyl sulfate, alkyl sulfonate or aryl sulfonate or mixture thereof.

11. An apparatus according to claim 1 wherein the solvating system comprises at least about 0.01 M of metal ion sequestering agent and at least about 0.002 M of surfactant.

12. An apparatus according to claim 1 wherein the buffering agent maintains the solvating system at an appropriate pH for contacting chronic skin wounds.

13. An apparatus according to claim 1 wherein the solvating system has an osmolarity of about 1,500 to about 2,600 milliosmoles of solute per liter.

14. An apparatus according to claim 1 wherein the solvating system breaks down bacterial biofilms in chronic wounds.

15. An apparatus according to claim 1 wherein the solvating system aids in chronic wound biofilm detachment, removal or disruption.

16. An apparatus according to claim 1 wherein the solvating system further comprises an antimicrobial agent.

17. An apparatus according to claim 16 wherein the antimicrobial agent comprises a topical antibiotic.

18. An apparatus according to claim 16 wherein the antimicrobial agent comprises a peptide.

19. An apparatus according to claim 16 wherein the antimicrobial agent comprises a bacterially selective peptide.

20. An apparatus according to claim 16 wherein the antimicrobial agent comprises gallium acetoacetonate, gallium bromide, gallium chloride, gallium fluoride, gallium iodide, gallium maltolate, gallium nitrate, gallium nitride, gallium percolate, gallium phosphite, gallium sulfate or mixture thereof.

21. A patient care kit for treating a chronic wound, the kit comprising a tray;

syringe;

vessel containing an extracellular polymeric substance solvating system comprising an aqueous solution of a metal ion sequestering agent, surfactant and buffering agent wherein the solvating system has an osmolarity of about 1,000-4,000 milliosmoles of solute per liter; and

printed instructions describing the proper use of the kit for treating chronic wounds.

22. A product comprising an extracellular polymeric substance solvating system for use in treatment of chronic skin wounds, the solvating system comprising an aqueous solution of at least about 0.01 M of metal ion sequestering agent, at least about 0.002 M of surfactant, and buffering agent that maintains the solvating system at an appropriate pH for contacting chronic skin wounds, wherein the solvating system has an osmolarity of about 1,000-4,000 milliosmoles of solute per liter, a sufficiently low viscosity to enable delivery to the wound using spray application, and aids in chronic wound biofilm detachment, removal or disruption.