Methods, compositions and apparatuses to treat wounds with pressures altered from atmospheric

• US 9,539,373 B2
• Filed: 08/30/2007
• Issued: 01/10/2017
• Est. Priority Date: 08/30/2006
• Status: Active Grant

• Current Assignee: Southeastern Medical Technologies, LLC
• Original Assignee: Southeastern Medical Technologies, LLC
• Inventors: Jones, Curtis E., Kennedy, John P.
• Primary Examiner(s): Nia, Alireza
• Assistant Examiner(s): NELSON, KERI JESSICA
• Application Number:
  US12/439,120
• Publication Number:
  US 20100016767A1
• Time in Patent Office: 3,421 Days
• Field of Search: 602 41- 43, 602/51, 602/53, 602/54, 602/57, 602/58, 604/93.01, 604/128, 604/129, 604/174, 604/176, 604/180, 604/268, 604/304, 604/305, 604315-318, 604/327, 604/543, 601/6, 601/9, 601/11
• US Class Current: 1/1
• CPC Class Codes: A61F 13/00 Bandages or dressings radioactive dressings A61N5/1029; Absorbent pads
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/804 using Laval or Venturi jet pumps
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/985 the dressing itself forming the collection container
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• 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
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

The invention disclosed comprises methods, apparatuses and compositions to treat acute and chronic wounds with pressures altered from atmospheric. The methods, apparatuses and compositions herein improve the performance of Altered Pressure wound therapy. The improvements also make the treatments more comfortable for the patient and the delivery of the treatment more convenient for clinicians. These improvements collectively result in improved efficacy, improved compliance, improved safety and improved clinical efficiency, while limiting clinical errors in treatment.

Claims

1. An altered pressure device for treating a wound, the device comprising:

a cover sized to fit over the wound and including an opening therein, the cover defining an encapsulated space surrounding the wound;

an intermediate material layer positionable in the encapsulated space;

an altered pressure source communicating with the encapsulated space via a length of tubing coupled with the source, the tubing having a proximal end;

a proximal end piece connected to the proximal end of the tubing and including a flange at a lower portion thereof, wherein a bottom of the flange is comprised of a substantially planar surface adapted to be engageable with the periphery of the opening in the cover to create a seal, and wherein the proximal end piece is attachable to the cover adjacent the opening without extending through the cover; and

a hydrophobic semi-solid insertable within the encapsulated space.

2. A device according to claim 1, wherein the hydrophobic semi-solid is comprised of at least one lipid.

3. A device according to claim 2, wherein the at least one lipid is a liquid crystal forming compound.

4. A device according to claim 2, wherein the at least one lipid is a fatty acid ester.

5. A device according to claim 1, wherein the hydrophobic semi-solid provides an anti-infective activity, including biofilm inhibition.

6. An altered pressure device for treating a wound, the device comprising:

a cover sized to fit over the wound and including an opening therein, the cover defining an encapsulated space surrounding the wound;

an intermediate material layer positionable in the encapsulated space;

an altered pressure source communicating with the encapsulated space via a length of tubing coupled with the source, the tubing having a proximal end;

a proximal end piece connected to the proximal end of the tubing and including a flange at a lower portion thereof, wherein a bottom of the flange is comprised of a substantially planar surface adapted to be engageable with the periphery of the opening in the cover to create a seal, and wherein the proximal end piece is attachable to the cover adjacent the opening without extending through the cover; and

a support washer that provides a reinforced base for fixation of the planar surface at the bottom of the flange to the cover.

7. A device according to claim 6, wherein the washer further comprises an adhesive on at least the top or bottom surface.

8. An altered pressure device for treating a wound, the device comprising:

a cover sized to fit over the wound and including an opening therein, the cover defining an encapsulated space surrounding the wound;

an intermediate material layer positionable in the encapsulated space;

an altered pressure source communicating with the encapsulated space via a length of tubing coupled with the source, the tubing having a proximal end; and

a proximal end piece connected to the proximal end of the tubing and including a flange at a lower portion thereof, wherein a bottom of the flange is comprised of a substantially planar surface adapted to be engageable with the periphery of the opening in the cover to create a seal, and wherein the proximal end piece is attachable to the cover adjacent the opening without extending through the cover,

wherein the tubing comprises a partially capsulated union of pressure altering and pressure sensing conduits, located between the altered pressure source and the end piece providing a pressure monitoring site.

9. An altered pressure device for treating a wound, the device comprising:

a cover sized to fit over the wound and including an opening therein, the cover defining an encapsulated space surrounding the wound;

an intermediate material layer positionable in the encapsulated space;

an altered pressure source communicating with the encapsulated space via a length of tubing coupled with the source, the tubing having a proximal end;

a proximal end piece connected to the proximal end of the tubing and including a flange at a lower portion thereof, wherein a bottom of the flange is comprised of a substantially planar surface adapted to be engageable with the periphery of the opening in the cover to create a seal, and wherein the proximal end piece is attachable to the cover adjacent the opening without extending through the cover; and

means for controlling multiple altered pressure cycles in sequence, each pressure cycle composed of a specified target non-atmospheric value for a specified target duration.

10. A device according to claim 9, further comprising at least one negative pressure cycle greater than 0 mm Hg but less than 60 mm Hg relative to atmospheric.

11. An altered pressure device for treating a wound, the device comprising:

a cover sized to fit over the wound and including an opening therein, the cover defining an encapsulated space surrounding the wound;

an intermediate material layer positionable in the encapsulated space;

an altered pressure source communicating with the encapsulated space via a length of tubing coupled with the source, the tubing having a proximal end; and

a proximal end piece connected to the proximal end of the tubing and including a flange at a lower portion thereof, wherein a bottom of the flange is comprised of a substantially planar surface adapted to be engageable with the periphery of the opening in the cover to create a seal, and wherein the proximal end piece is attachable to the cover adjacent the opening without extending through the cover,

wherein the tubing communicating the altered pressure source with the encapsulated space is flush with the flange.

12. A method of treating a wound, wherein a perimeter of the wound delimits a wound bed, the method comprising:

(a) applying an altered pressure apparatus to the wound bed; and

(b) providing an altered pressure to the wound bed in multiple altered pressure cycles in sequence prior to a dressing change, each pressure cycle composed of a specified target non-atmospheric value for a specified duration.

13. A method according to claim 12, wherein the pressure is monitored via a partially capsulated union of pressure altering and pressure sensing conduits, located between an exudate collection device and the wound bed.

14. A method according to claim 12, wherein the multiple altered pressure cycles include at least one negative pressure cycle greater than 0 mm Hg but less than 60 mm Hg, thereby maintaining the encapsulated space at a pressure negative to atmospheric to prevent exudate leakage and contamination.

15. A method according to claim 12, wherein step (a) is practiced by defining an encapsulated space surrounding the wound bed with a cover, and wherein step (b) is practiced by communicating an altered pressure source with the encapsulated space and securing a proximal end piece to the cover without extending through the cover.