Wound treatment device for attachment to skin

Surgery: splint – brace – or bandage – Orthopedic bandage – With light – thermal – or electrical application

Reexamination Certificate

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Details

C602S014000, C602S041000, C607S096000, C607S108000, C607S114000

Reexamination Certificate

active

06293917

ABSTRACT:

TECHNICAL FIELD
The invention relates to a wound treatment device for covering and in some applications heating skin lesions, surgical wounds and the like.
The wound treatment device includes a wound cover and optionally a detachable wound heater which provide a non-contact wound treatment volume over the wound area.
The invention also relates to methods for making and using the wound treatment device.
BACKGROUND OF THE INVENTION
One traditional method of treating a wound involves the placement of a sterile gauze over the wound area and holding the gauze in place with an adhesive tape. This type of wound dressing has numerous shortcomings. The wound is not fully isolated from the air and can exchange bacteria with the environment. The gauze can adhere to the wound itself interfering with the healing process which is undesirable. This traditional form of bandage does not control the thermal environment of the wound which is also undesirable.
Although some forms of wound heaters and non-contact wound coverings are known from Veilhan Fr. 1,527,887 (1969) they are not generally accepted for several reasons. For example, wound coverings which include a rigid enclosure forming a cavity that covers the wound are usually adhesively attached to the skin of the patient with a relatively inelastic material. As a result the wound covering is unable to accommodate patient motion. Consequently patient motion will cause the rigid wound covering to “peel-off” of the patient's skin. The traditional solution to this problem has been to use a more aggressive adhesive tape or the like to more firmly attach the wound covering to the skin. This solution to the problem results in an uncomfortable bandage.
The traditional wound covering does not permit close control over the temperature of the wound area. Prior art heated bandages which rely on a non-contact enclosure may use point source type heaters which result in variations in radiant heat flux depending on the location of the heater within the enclosure. Therefore there is a need for a non-contact bandage which can be used to control the environment of the wound and which may be reliably and comfortably attached to the skin.
SUMMARY OF THE INVENTION
The wound treatment device
10
of the present invention has an upper wound covering surface displaced above the patient's skin surface, and an attachment surface lying generally in the plane of the patient's skin. Together these two surfaces define an enclosed non-contact volume over the wound treatment site.
The wound treatment device
10
may be divided into three separate parts for the purpose of description. These parts are an attachment portion
12
, a wound treatment portion
14
, and a transition portion
16
. Each portion is designed to serve a separate function.
The attachment portion
12
is used to connect the wound treatment device
10
to the skin of a patient. The attachment portion
12
will usually be formed as an annular attachment rim. An adhesive will typically be placed on the attachment rim to couple the wound treatment device
10
to the patient. The attachment portion
12
lies near the patient's skin and defines a so called first plane.
The wound treatment portion
14
of the wound treatment device
10
is illustratively an assembly which includes a standoff
15
which rises above the patient's skin surface, and a wound cover
20
which spans the open portion of the standoff
15
. The standoff
15
helps to define the vertical extent or dimension of the wound treatment device
10
and helps to define the location of a second plane which is used to describe the geometry of the device. Thus the wound treatment portion
14
includes a standoff
15
and a wound cover
20
which together define both a wound treatment volume
24
and a wound treatment area
26
.
The wound treatment volume
24
is located over the surface of the wound. The atmosphere in this wound treatment volume
24
can be controlled by the wound treatment device
10
.
In use the wound treatment area
26
is defined on the patient surface
18
under the wound treatment portion
14
, and will typically be centered over the lesion or wound.
The transition portion
16
connects the attachment portion
12
to the wound treatment portion
14
. This transition portion
16
improves the comfort and utility of the wound treatment device when the patient moves and stretches the wound treatment device
10
. This stretching causes the total projected area of the wound treatment device
10
to increase and the shape of the wound treatment device
10
to change. In practice, the bulk of the patient motion is accommodated by the compliance of the transition portion
16
. As a consequence, the transition portion projected area
17
increases. The standoff of wound treatment portion
14
rests gently on the patient's skin and it may twist to accommodate patient motion thus producing a device which conforms to the contour of the patient's body. However since the standoff can slide along the patient's skin there is no substantial change in the projected wound treatment area
28
due to patient motion. During patient motion the attachment portion
12
remains affixed to the surface of the patient and is easily deformed by body motion because of its relatively small area. Consequently the attachment portion projected area
40
may undergo a slight increase in area as the attachment portion
12
moves with the underlying skin. Throughout this motion the second shaped surface is supported above the patient's skin surface and can be used to support a detachable heater
32
which can heat the wound surface. A switch may also be provided to reduce power supplied to the wound treatment device
10
if the device is crushed in to contact with the wound.


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