# US 6,936,037 B2 · Tissue closure treatment system, patient interface and method

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- Number: US 6,936,037 B2
- Document ID: US6936037B2
- Status: Granted
- Kind: B2
- Application number: 10/409,225
- Filed: 2003-04-08
- Published: 2004-07-01
- Granted: 2005-08-30
- Earliest claimed: 2002-12-31
- Assignees: KCI Licensing, Inc.
- Inventors: Stephen K. Bubb; David S. Zamierowski
- Web page: https://patentgrep.com/patent/US6936037B2

## CPC

- A61M 1/74: {Suction control (underwater drainage A61M1/61)}
- A61M 1/915: {Constructional details of the pressure distribution manifold}
- A61M 1/916: {specially adapted for deep wounds}
- A61M 1/92: {with liquid supply means}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/50: with microprocessors or computers
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A tissue closure treatment system and method are provided with an external patient interface. A first fluid transfer component FTC.1 comprises a strip of porous material, such as rayon, with liquid wicking properties. FTC.1 can be placed directly on a suture line for transferring fluid exuded therethrough. An underdrape is placed over FTC.1 and includes a slot exposing a portion of same. FTC.2 comprises a suitable hydrophobic foam material, such as polyurethane ether, and is placed over the underdrape slot in communication with FTC.1. Negative pressure is applied to FTC.2 through a connecting fluid transfer component FTC.3. A negative pressure source can comprises a manual device or a power-operated suction device. The tissue closure method includes a manual operating mode using a manual suction device with an automatic shut off for discontinuing suction when a predetermined volume of fluid has been drained. An automatic operating mode utilizes a microprocessor, which can be preprogrammed to respond to various patient and operating conditions. The method proceeds through several phases with different components in place and different patient interface functions occurring in each.

## Claims

### Claim 1

A dressing assembly for a closed wound or incision, which comprises:
an external patient interface including a fluid transfer component, said fluid transfer component being adapted for transferring fluid from the closed wound or incision;
said fluid transfer component including a foam core and a wicking material piece fluidically communicating with said foam core, said wicking material piece being adapted for placement on intact skin adjacent to said closed wound or incision;
said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface; and
a pressure source connected to the fluid transfer component.

### Claim 2 (depends on 1)

The dressing assembly according to claim 1, which includes:
said overdrape having an opening located over said fluid transfer component; and
an access panel including said seal strip and mounted on said overdrape with said seal strip selectively providing access to said fluid transfer component through said overdrape opening.

### Claim 3 (depends on 1)

The dressing assembly according to claim 1, which includes:
an internal fluid transfer component located in said wound or incision in fluidic communication with said fluid transfer component.

### Claim 4 (depends on 3)

The dressing assembly according to claim 3 wherein said wound or incision includes an undermined area and said dressing assembly includes an innermost fluid transfer component located in said undermined area.

### Claim 5 (depends on 1)

The dressing assembly according to claim 1 wherein said foam core comprises a hydrophobic material.

### Claim 6 (depends on 1)

The dressing assembly according to claim 1, which includes:
a fluid port mounted on said overdrape and adapted for connection to said pressure source.

### Claim 7 (depends on 6)

The dressing assembly according to claim 6 wherein said pressure source comprises a manually-operated vacuum-type device.

### Claim 8 (depends on 1)

The dressing assembly according to claim 1, which includes:
a sheath including said overdrape and having an interior compartment receiving said foam core; and
said wicking material being located between said foam core and the patient, said wicking material being adapted to wick fluid from the patient and into the foam core.

### Claim 9 (depends on 8)

The dressing assembly according to claim 8 wherein said overdrape comprises a top panel of said sheath and said wicking material comprises a bottom panel thereof.

### Claim 10 (depends on 9)

The dressing assembly according to claim 9, which includes:
said sheath having a perimeter whereat said overdrape is connected to said bottom panel; and
an adhesive band around said perimeter adapted for releasably attaching said dressing assembly to the patient.

### Claim 11 (depends on 8)

The dressing assembly according to claim 8, which includes:
said sheath having a bottom panel and an opening formed in said bottom panel and adapted for exposing said wicking material to the wound or incision.

### Claim 12 (depends on 11)

The dressing assembly according to claim 11, which includes:
adhesive on said bottom panel adapted for releasably attaching said sheath to a patient;
a center backing strip selectively covering said adhesive on a center portion of said bottom panel; and
a pair of side backing strips for selectively covering said adhesive on side portions of said bottom panel.

### Claim 13 (depends on 8)

The dressing assembly according to claim 8 wherein said sheath overdrape, said foam core and said wicking material comprise separate components adapted for independent movement with respect to each other.

### Claim 14 (depends on 8)

The dressing assembly according to claim 8 wherein said wicking material comprises rayon.

### Claim 15 (depends on 1)

The dressing assembly according to claim 1, which includes:
said fluid transfer component having a top, a bottom and sides;
said overdrape having an outer portion covering said fluid transfer component top and sides and having a skirt extending around said outer portion and including adhesive for releasable attachment to the patient; and
said overdrape being tucked under at least a portion of said fluid transfer component bottom.

### Claim 16 (depends on 15)

The dressing assembly according to claim 15, which includes an elbow connector mounted on said overdrape and adapted for connection to said pressure source.

### Claim 17

A method of dressing a closed wound or incision, which method comprises the steps of:
providing a fluid transfer component with a foam material core;
placing the fluid transfer component on the patient in fluidic connection with the closed wound or incision;
providing an overdrape and placing same over the fluid transfer component;
providing a wicking material and placing same substantially exclusively on intact skin adjacent to the closed wound or incision;
providing said overdrape with a seal strip having closed and open positions;
opening said seal strip; and
accessing said fluid transfer component through said open seal strip.

### Claim 18 (depends on 17)

The method of claim 17, which includes the additional steps of:
providing an access panel including said seal strip;
providing an opening in said overdrape communicating with said fluid transfer component; and
placing said access panel on said overdrape with said seal strip located over said overdrape opening.

### Claim 19 (depends on 18)

The method of claim 18, which includes the additional steps of:
providing an internal fluid transfer component within said wound or incision;
fluidically connecting said internal fluid transfer component to said external fluid transfer component;
attaching a fluid pressure source to said fluid transfer component; and
creating a pressure gradient across said external fluid transfer component.

### Claim 20

A dressing assembly for a wound or incision, which comprises:
an external patient interface including an external fluid transfer component, said fluid transfer component being adapted for transferring fluid from the closed wound or incision;
said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface; and
a reclosable seal strip connected to said overdrape and having a closed position sealing same and an open position providing access to said fluid transfer component therethrough;
an internal fluid transfer component located in said wound or incision in fluidic communication with said fluid transfer component; and
a pair of side drapes each located along a respective side of said wound or incision between said external fluid transfer component and the patient's skin.

### Claim 21

A dressing assembly for a wound or incision, which comprises:
an external patient interface including an external fluid transfer component, said fluid transfer component being adapted for transferring fluid from the closed wound or incision;
said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface; and
a reclosable seal strip connected to said overdrape and having a closed position sealing same and an open position providing access to said fluid transfer component therethrough;
said overdrape having an opening located over said fluid transfer component;
an access panel including said seal strip and mounted on said overdrape with said seal strip selectively providing access to said fluid transfer component through said overdrape opening;
said access panel having a perimeter portion with an adhesive coating adapted for attaching same to said overdrape; and
said access panel having an adhesive-free central portion surrounded by said perimeter portion, said central portion including said seal strip.

### Claim 22

A dressing assembly for a wound or incision, which comprises:
an external patient interface including an external fluid transfer component, said fluid transfer component being adapted for transferring fluid from the closed wound or incision;
said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface; and
a reclosable seal strip connected to said overdrape and having a closed position sealing same and an open position providing access to said fluid transfer component therethrough;
said overdrape having an opening located over said fluid transfer component;
an access panel including said seal strip and mounted on said overdrape with said seal strip selectively providing access to said fluid transfer component through said overdrape opening; and
said seal strip includes a longitudinally-extending channel mounted on a first portion of said access panel and a longitudinally-extending rib mounted on a second portion of said access panel and selectively received in said channel with said seal strip in its closed configuration.

### Claim 23

A dressing assembly for a wound or incision, which comprises:
an external patient interface including an external fluid transfer component, said fluid transfer component being adapted for transferring fluid from the closed wound or incision;
said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface;
a reclosable seal strip connected to said overdrape and having a closed position sealing same and an open position providing access to said fluid transfer component therethrough;
a sheath including said overdrape and having an interior compartment receiving said foam core; and
said wicking material being located between said foam core and the patient, said wicking material being adapted to wick fluid from the patient and into the foam core.

### Claim 24 (depends on 23)

The dressing assembly according to claim 23 wherein said wicking material substantially covers said foam core.

### Claim 25 (depends on 23)

The dressing assembly according to claim 23 wherein:
said foam core includes a top, a bottom and sides; and
said wicking material covers said bottom and sides of said foam core and said core top is open.

### Claim 26

A method of dressing a closed wound or incision, which method comprises the steps of:
providing a fluid transfer component with a foam material core;
placing the fluid transfer component on the patient in fluidic connection with the closed wound or incision;
providing an overdrape and placing same over the fluid transfer component;
providing a wicking material and placing same between the foam material core and the closed wound or incision;
providing said overdrape with a seal strip having closed and open positions;
opening said seal strip;
accessing said fluid transfer component through said open seal strip;
providing a sheath including a top panel comprising said overdrape;
providing said sheath with a bottom panel;
providing a fluid transfer component in said bottom panel;
placing said fluid transfer component in said sheath;
communicating fluid from said wound or incision through said fluid transfer to said fluid transfer component;
extracting said fluid transfer component from said sheath;
flipping over or replacing said fluid transfer component and reinserting same in said sheath; and
closing said seal strip.

### Claim 27 (depends on 26)

The method of claim 26, which includes the additional steps of:
providing a fluid port in said sheath;
connecting said fluid port to a fluid pressure source; and
forming a pressure gradient across said fluid transfer component within said sheath.
