Reduced-pressure systems, devices, and methods for treating a tissue site that includes a fistula

• US 9,849,023 B2
• Filed: 05/02/2014
• Issued: 12/26/2017
• Est. Priority Date: 10/20/2010
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Hall, Colin John, Mormino, Richard Paul
• Primary Examiner(s): Anderson, Lynne
• Application Number:
  US14/268,720
• Publication Number:
  US 20140309601A1
• Time in Patent Office: 1,334 Days
• Field of Search: 604319, 604313, 604289, 604337, 604541, 604317, 604290
• CPC Class Codes: A61F 2005/4455 Implantable
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• 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

Abstract

Systems, methods, and devices are disclosed that involve a fistula-isolating device for use when reduced pressure is applied to a wound bed having a fistula. In one instance, the fistula-isolating device includes an adjustable passageway member and a perimeter member that contracts under reduced pressure and that automatically accommodates wound beds of different heights. In another instance, the fistula-isolating device involves a body shaped as a frustro-conical body that is readily sized for different depth wound beds. Other systems, methods, and devices are presented.

Claims

1. A system for providing reduced pressure treatment to a wound bed that includes a fistula, the system comprising:

a fistula-isolating device for isolating the fistula in the wound bed undergoing reduced-pressure treatment, the fistula-isolating device comprising;

a body that is substantially frusto-conical in shape and having a passageway and having a first end and a second end, and

a perimeter member positioned substantially around an exterior of the body and substantially along a length of the body,

wherein at least a portion of the body defining the passageway is fluid impermeable;

a distribution manifold having a fistula aperture for receiving the fistula-isolating device;

a sealing member for covering the fistula-isolating device and the distribution manifold to create a sealed space over at least a portion of the wound bed, wherein the sealing member has an ostomy-interface aperture;

a reduced-pressure source for supplying a reduced pressure to the sealed space; and

an ostomy appliance fluidly coupled to the fistula-isolating device.

2. The system of claim 1 wherein the fistula-isolating device further comprises visual indicia on an exterior of the frusto-conical body showing where sizing cuts may be made.

3. The system of claim 1, wherein the body has a first portion having an external radius R₁, a second portion having a second radius R₂, and a third portion having a third radius R₃, wherein R₁>

R₂>

R₃.

4. The system of claim 1, wherein the distribution manifold has an initial height h_d1 when not subjected to reduced pressure, wherein the fistula-isolating device has an initial height h_F1 when not subjected to reduced pressure, and wherein h_d1 is substantially equal to h_F1.

5. The system of claim 1, wherein

the distribution manifold has an initial height h_d1 when not subjected to reduced pressure;

the fistula-isolating device has an initial height h_F1 when not subjected to reduced pressure and h_d1 is substantially equal to h_F1;

the distribution manifold has a height h_d2 when the sealed space is subjected to reduced pressure in a first therapeutic pressure range; and

the fistula-isolating device has a height h_F2 when the sealed space is subjected to reduced pressure at the first therapeutic pressure, wherein h_d2 is substantially equal to h_F2.

6. The system of claim 1, wherein the body of the fistula-isolating device comprises a first material and the distribution manifold comprises the first material.

7. The system of claim 1, wherein the body of the fistula-isolating device comprises a closed-cell foam.

8. The system of claim 1, wherein the body of the fistula-isolating device comprises an open-cell foam and an impermeable layer along the passageway.

9. A fistula-isolating device for isolating a fistula in a wound bed undergoing reduced-pressure treatment, the fistula-isolating device comprising:

a body that is substantially frusto-conical in shape and having a plurality of segments and a passageway;

wherein at least a portion of the body defining the passageway is fluid impermeable; and

wherein at least one of the plurality of segments is adapted to be removed for adjusting a height of the body of the fistula-isolating device.

10. The fistula-isolating device of claim 9, wherein the body comprises a foam.

11. The fistula-isolating device of claim 10, wherein the foam is an open-cell foam.

12. The fistula-isolating device of claim 9, wherein the device has a length of 4 to 5 inches.

13. The fistula-isolating device of claim 9, further comprising visual indicia on an exterior of the frusto-conical body showing where sizing cuts may be made.

14. The fistula-isolating device of claim 9, wherein the body has a first segment having an external radius R₁, a second segment having a second radius R₂, and a third segment having a third radius R₃, wherein R₁>

R₂>

R₃.