# US 9,044,579 B2 · Wound treatment apparatus and method

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- Number: US 9,044,579 B2
- Document ID: US9044579B2
- Status: Granted
- Kind: B2
- Application number: 11/919,354
- Filed: 2006-04-27
- Published: 2009-12-10
- Granted: 2015-06-02
- Earliest claimed: 2005-04-27
- Assignees: Smith & Nephew, Inc.
- Applicants: Patrick Lewis Blott; Clare Green; Edward Yerbury Hartwell; Robin Paul Martin; Derek Nicolini; Julian Lee-Webb
- Inventors: Patrick Lewis Blott; Clare Green; Edward Yerbury Hartwell; Robin Paul Martin; Derek Nicolini; Julian Lee-Webb
- Web page: https://patentgrep.com/patent/US9044579B2

## CPC

- 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]
- A61F 13/02: Adhesive bandages or dressings
- A61F 13/0226: {characterised by the support layer}
- A61M 1/77: {Suction-irrigation systems (aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463)}
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- 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 3/02: Enemata; Irrigators
- A61M 3/0208: {before use}
- A61M 3/0212: {after use}
- A61M 3/022: {Volume; Flow rate}
- A61M 35/30: {Gas therapy for therapeutic treatment of the skin}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61F 2013/00536: {for draining or irrigating wounds}
- A61M 1/75: {Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence)}
- A61M 1/94: {with gas supply means}
- A61M 1/96: {Suction control thereof}
- A61M 2205/058: with ultrasound therapy
- A61N 2007/0017: {Wound healing}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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)}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

An apparatus for cleansing wounds in which irrigant fluid from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are moved by a device (which may be a single pump or two pumps) for moving fluid through a flow path which passes through the dressing and a means for providing simultaneous aspiration and irrigation of the wound. The apparatus also comprises means to apply high frequency vibrational energy, e.g. ultrasound, to the wound bed. The former removes materials deleterious to wound healing, while distributing materials that are beneficial in promoting wound healing over the wound bed. The latter promotes healing. The dressing and a method of treatment using the apparatus.

## Claims

### Claim 1

An apparatus for aspirating, irrigating and/or cleansing a wound, comprising:
a conformable wound dressing, having a front surface and a backing layer which is capable of forming a sufficiently fluid-tight seal or closure over a wound;
at least one pipe which passes through and/or under the conformable wound dressing at a point at the conformable wound dressing to allow irrigation and/or aspiration of the wound,
wherein the point at which the at least one pipe passes through and/or under the conformable wound dressing forms a fluid-tight seal or closure over the wound, when in line;
a solid wound filler configured to contact the wound, configured to be disposed in the wound under the backing layer and configured to conform to the wound and allow movement of fluid to and/or from the wound;
a fluid reservoir connectable by a fluid supply tube to the at least one pipe;
at least one device for moving fluid through the wound dressing to the wound and/or moving fluid from the wound;
a wound contact layer configured to be positioned under the wound filler in direct contact with the wound and further configured to conform to a shape of the wound, the wound contact layer comprising a plurality of apertures configured to aspirate fluid from the wound; and
a transducer configured to be positioned between the wound filler and the wound contact layer, the transducer configured to apply a high frequency vibrational energy field to the wound, at a frequency and an intensity selected for a stimulation of a healing of the wound.

### Claim 2 (depends on 1)

The apparatus of claim 1 wherein the at least one pipe comprises at least one inlet pipe for connection to a fluid supply tube to allow irrigation and at least one outlet pipe for connection to a fluid offtake tube to allow aspiration, each of which passes through and/or under the conformable wound.

### Claim 3 (depends on 2)

The apparatus of claim 2 further configured, while applying the high frequency vibrational energy field to the wound, to provide simultaneous aspiration and irrigation of the wound, such that an irrigant fluid may be supplied to the wound from the fluid reservoir via the fluid supply tube while an aspirate fluid is aspirated through the fluid offtake tube.

### Claim 4 (depends on 3)

The apparatus of claim 3 further comprising a first device for moving fluid through the wound applied to fluid downstream of and away from the wound dressing, in combination with at least one of:
a second device for moving fluid through the wound applied to the irrigant in the fluid supply tube upstream of and towards the wound dressing;
an aspirate flow regulator, connected to the fluid offtake tube; and
a supply flow regulator, connected to the fluid supply tube.

### Claim 5 (depends on 4)

The apparatus of claim 4 wherein the first and/or second device for moving fluid through the wound is a variable-throughput device.

### Claim 6 (depends on 4)

The apparatus of claim 4 wherein the first and/or second device is a variable-speed pump.

### Claim 7 (depends on 6)

The apparatus of claim 6 wherein the first and/or second device is a reciprocating pump or a rotary pump.

### Claim 8 (depends on 7)

The apparatus of claim 7 wherein the first device is a diaphragm pump.

### Claim 9 (depends on 7)

The apparatus of claim 7 wherein the second device is a peristaltic pump.

### Claim 10 (depends on 5)

The apparatus of claim 5 wherein the variable-throughput device is capable of pulsed, continuous, variable and/or automated and/or programmable fluid movement.

### Claim 11 (depends on 1)

The apparatus of claim 1 wherein the high frequency vibrational energy is ultrasonic energy.

### Claim 12 (depends on 1)

The apparatus of claim 1 wherein the transducer applies the high frequency vibrational energy field via the irrigant fluid and/or a wound exudate.

### Claim 13 (depends on 1)

The apparatus of claim 1 wherein the transducer comprises a source of the high frequency vibrational energy field and a high frequency vibrational sonode.

### Claim 14 (depends on 13)

The apparatus of claim 13 wherein the source of the high frequency vibrational energy field is integral with the sonode.

### Claim 15 (depends on 13)

The apparatus of claim 13 wherein the transducer comprises a sonode-transducer.

### Claim 16 (depends on 13)

The apparatus of claim 13 wherein the source of the high frequency vibrational energy field is connected to the sonode.

### Claim 17 (depends on 1)

The apparatus of claim 1 wherein the transducer is in the form of a relatively flat member.

### Claim 18 (depends on 1)

The apparatus of claim 1 wherein the transducer is mounted in, on, at, or near the at least one pipe that passes through and/or under the conformable wound dressing.

### Claim 19 (depends on 1)

The apparatus of claim 1 wherein the transducer includes an axis and a focusing element for focusing propagation of ultrasound at a predetermined angle with respect to the axis.

### Claim 20 (depends on 1)

The apparatus of claim 1 wherein the intensity selected for the stimulation of the healing of the wound is ultrasound energy at spatial peak temporal average acoustic intensity between 5-100 mW/cm2.

### Claim 21 (depends on 1)

The apparatus of claim 1 wherein the frequency selected for the stimulation of the healing of the wound is ultrasound energy at a frequency between 20 kHz and 10 MHz.

### Claim 22 (depends on 1)

The apparatus of claim 1 wherein the transducer is capable of applying ultrasound in pulsed manner for the stimulation of the healing of the wound.

### Claim 23 (depends on 22)

The apparatus of claim 22 wherein the high frequency vibrational energy field is pulsed regularly or randomly on an overall vibrational waveform with a relatively low-frequency modulating signal.

### Claim 24 (depends on 22)

The apparatus of claim 22 wherein the high frequency vibrational energy field is pulsed at a frequency of from 5 Hz to 10 kHz.

### Claim 25 (depends on 1)

The apparatus of claim 1 wherein the wound filler comprises a manifold.

### Claim 26 (depends on 1)

The apparatus of claim 1 comprising an adhesive member configured to secure the wound dressing to a site of the wound and maintain a seal.

### Claim 27 (depends on 1)

The apparatus of claim 1, wherein the wound filler comprises reticulated foam.

### Claim 28

A method of treating a wound to promote wound healing comprising:
placing a wound contact layer in direct contact with the wound, the wound contact layer comprising a plurality of apertures configured to aspirate fluid from the wound;
placing a solid wound filler into the wound, the wound filler configured to conform to a wound cavity;
positioning a transducer between the wound filler and the wound contact layer;
positioning a backing layer over the wound, the backing layer forming a sufficiently fluid-tight seal with healthy skin surrounding the wound;
providing a fluid flow path comprising a fluid supply tube and a fluid offtake tube;
causing movement of fluid through the fluid flow path to the wound and/or from the wound; and
causing application of a high frequency vibrational energy field to the wound at a frequency and an intensity selected for a stimulation of a healing of the wound, wherein the high frequency vibration energy field is applied to the wound through the transducer while the fluid is moved through the fluid flow path.

### Claim 29 (depends on 28)

The method of claim 28 wherein application of high frequency vibrational energy to the wound is continuous.

### Claim 30 (depends on 28)

The method of claim 28 wherein application of high frequency vibrational energy to the wound is intermittent.

### Claim 31 (depends on 30)

The method of claim 30 wherein the intermittent application is made for 1-4 times daily.

### Claim 32 (depends on 28)

The method of claim 28 wherein the high frequency vibrational energy field comprises ultrasound energy at spatial peak temporal average acoustic intensity between 5-100 mW/cm2.

### Claim 33 (depends on 28)

The method of claim 28 wherein movement of fluid to the wound has a flow rate in the range of 1 to 1500 ml/hr.

### Claim 34 (depends on 28)

The method of claim 28 wherein movement of fluid out of the wound has a flow rate in the range of 1 to 2000 ml/hr.

### Claim 35 (depends on 28)

The method of claim 28 wherein fluid is moved through the fluid flow path to provide simultaneous aspiration and irrigation to the wound.

### Claim 36 (depends on 28)

The method of claim 28 wherein fluid is moved through the fluid flow path to provide sequential aspiration and irrigation to the wound.

### Claim 37

An apparatus for treating a wound comprising:
a wound dressing configured to be placed over the wound, the wound dressing comprising:
a backing layer configured to form a sufficiently fluid-tight seal over the wound;
a wound filler configured to be disposed in the wound under the backing layer and configured to conform to a shape of the wound and to allow movement of fluid from the wound;
a wound contact layer configured to be positioned under the wound filler in direct contact with the wound and further configured to conform to the shape of the wound, the wound contact layer comprising a plurality of apertures configured to aspirate fluid from the wound; and
a transducer configured to be positioned between the wound filler and the wound contact layer, the transducer configured to apply a high frequency vibrational energy field to the wound at a frequency and an intensity selected for a stimulation of a healing of the wound while fluid is being aspirated from the wound;
a fluid offtake tube fluidically connected to the wound dressing, the fluid offtake tube configured to withdraw fluid from the wound;
a pump configured to move fluid through the fluid offtake tube;
and an ultrasound source configured to power the transducer.

### Claim 38 (depends on 37)

The apparatus of claim 37, wherein the transducer comprises a laminar membrane configured to be placed over the wound contact layer.

### Claim 39 (depends on 38)

The apparatus of claim 38, wherein the membrane is hydrophilic.

### Claim 40 (depends on 37)

The apparatus of claim 37, wherein the wound contact layer comprises a plurality of flow channels radially extending from a center portion of the wound contact layer, wherein the flow channels are interconnected only at the center portion of the wound contact layer, and wherein the plurality of apertures are in fluid communication with the plurality of flow channels.

### Claim 41 (depends on 37)

The apparatus of claim 37, wherein the frequency and intensity of the vibrational energy field is selected to cause fibroblast cells to proliferate.