The present disclosure relates to bandages for wounds, and more particularly to bandages for use with a vacuum and/or irrigation source.
The prior art contemplates that chronic wounds may be treated by providing a vacuum in the space above the wound to promote healing. A number of prior art references teach the value of the vacuum bandage or the provision of vacuum in the space above the surface of a chronic wound.
A vacuum bandage is a bandage having a cover for sealing about the outer perimeter of the wound and under which a vacuum is established to act on the wound surface. Applying vacuum to the wound surface promotes healing of chronic wounds. Typically, suction tubes are provided for drawing exudate away from the wound and for creating vacuum under the cover. If the cover is a flexible cover, which is typically more comfortable for the patient, a porous packing may be provided under the cover to fill the space in which the vacuum is formed. It will be appreciated, however, that the packing will be omitted by many caregivers, and it may be preferable not to have packing. The following U.S. patents establish the nature of vacuum treatment bandages and devices: U.S. Pat. Nos. 6,095,992, 6,080,189, 6,071,304, 5,645,081, 5,636,643, 5,358,494, 5,298,015, 4,969,880, 4,655,754, 4,569,674, 4,382,441, and 4,112,947. All of such references are incorporated herein by reference for purposes of disclosing the nature of such vacuum treatment of wounds.
As shown, for example, in U.S. Pat No. 5,645,081 (hereinafter the '081 patent), a method of treating tissue damage is provided by applying negative pressure to a wound. The negative pressure is provided in sufficient duration and magnitude to promote tissue migration in order to facilitate the closure of the wound.
Various other prior art references teach the value of the vacuum bandage or the provision of vacuum to the surface of a chronic wound. Several Russian language articles exist which establish the efficacy of vacuum therapy in the 1980's. Examples of such prior art articles, each of which discusses the use of application of vacuum to a wound to promote healing, are as follows: “Vacuum therapy in the treatment of acute suppurative diseases of soft tissues and suppurative wounds”, Davydov, et al., Vestn, Khir., September 1988 (The September 1988 article); “Pathenogenic mechanism of the effect of vacuum therapy on the course of the wound process”, Davydov, et al. Khirurigiia, June 1990 (the June 1990 article); and “Vacuum therapy in the treatment of suppurative lactation mastitis”, Davydov, et al. Vestn. Khir., November 1986 (the November 1986 article).
The Russian articles distinguish wound drainage from use of vacuum therapy for healing. The Russian authors report that vacuum therapy resulted in faster cleansing of the wound and more rapid detoxification than with the traditional incision-drainage method. The November 1986 Russian article describes the vacuum therapy techniques as a reduction of 0.8-1 atmosphere for 20 minutes at the time of surgery, and subsequent 1.5 to 3 hour treatments at a reduced pressure of 0.1 to 0.15 from atmosphere, twice daily. These Russian articles teach the use of negative pressure to effect healing. The articles describe using several sessions per day, each lasting up to one hour, with a vacuum of 76-114 mmHg. The Russian articles teach using this vacuum method to decrease the number of microbes in the wound. The June 1990 Russian article teaches that this vacuum therapy provides a significant antibacterial effect. The article describes the stepped up inflow of blood to the zone around the wound to lead to an increase in the number of leukocytes reaching the focus of inflammation. Subsequent articles and patents further develop the benefits obtained with vacuum therapy.
The present invention comprises one or more of the following features, discussed below, or combinations thereof:
A member for use with a wound having a wound surface is provided. The member is also provided for use in a vacuum bandage connected to a vacuum source. The member may include a top surface and a bottom surface adapted to be in contact with and generally conform to the wound surface. The member may further include a plurality of discrete holes formed in the bottom surface and at least one discrete opening formed in the top surface. The member may include a port communicating with the vacuum source, each discrete hole, and at least one discrete opening.
The member may include a wound contacting layer, or wound contactable layer, having channels formed therein and a cover coupled to the wound contacting layer to cooperate with the channels of the wound contacting layer to define a set of passageways.
The cover may have a first surface area and the wound contacting layer may have a second surface area that is larger than the first surface area. The channels of the wound contacting layer may extend beyond an outer edge of the cover to define the plurality of discrete openings in an outer peripheral portion of the member.
The cover may include a plurality of discrete holes in communication with the channels of the wound contacting layer to define the plurality of discrete openings of the member.
Features of the invention will become apparent to those skilled in the art upon consideration of the following detailed description of the preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.
The detailed description particularly refers to the accompanying figures in which:
A vacuum bandage 10 is provided for use with a wound 12 having a wound surface 13, shown in
Vacuum bandage 10 is provided for use with a vacuum source 14 and an irrigation source 16 through the use of a switch valve 55, as shown in
As stated above, access openings 62, 64 are provided to allow vacuum suction and irrigation to be dispensed on the top as well as the bottom of member 19, as is described in more detail below. As shown in
Referring now to
Member 19, including layer 20, cover 22, and connector 23, is also made of a generally non-adhesive material. Therefore, wound contacting layer 20, which lies adjacent to the wound surface 13, does not adhere to the wound surface 13. Further, member 19 is solid in nature and generally non-compressible. Member 19 is also transparent, as shown in
Layer 20 includes or wound contacting surface 24 and an upper or opposite surface 26. Wound contacting surface 24, or portions thereof, contact and generally conform to the wound surface 13. Opposite surface 26 includes a central area 28 and a plurality of channels 30 spaced-apart from and extending radially away from central area 28. Central area 28 is recessed relative to the portions of upper surface 26 between channels 30. As shown in
A plurality of radially extending protrusions or bosses 32 are positioned around central area 28. Bosses 32 are positioned between central area 28 and channels 30, 31, as shown in
As mentioned above, port 40 is in communication with central area 28 of layer 20. Illustratively, four bosses 32 are shown in
Connector 23, as shown in
In some embodiments, member 19 is formed by heat sealing opposite surface 26 of layer 20 and bottom surface 34 of cover 22 together and by heat sealing connector 23 to top surface 36 of cover 22. For example, each of connector 23, cover 22 (or the combination of cover 22 and connector 23), and layer 20 may be pre-shaped and formed from semi-cured silicone. Once the connector 23, cover 22, and layer 20 are placed together appropriately, the entire member 19 may be heated to heat seal and cure each of the three components to one another. Alternatively, for example, the cover 22 only may be made from semi-cured silicone while the connector 23 and layer 20 may be made from fully cured silicone. Once placed together and heated, connector 23 and layer 20 will heat seal to cover 22. Semi-cured silicone may be bought and pre-molded from a manufacturer such as NuSil Technology, for example.
Although the method of heat sealing the cover 22, connector 23, and layer 20 to each other is disclosed, it is within the scope of this disclosure to form member 19 by coupling layer 20, cover 22, and connector 23 together by any other suitable means such as through the use of adhesives, for example. Further, it is within the scope of this disclosure to provide a member 19 where cover 22 lies adjacent to, but is not coupled to, layer 20.
As mentioned above, cover 22 is coupled to layer 20 and connector 23 is coupled to cover 22 to form member 19. Cover 22 and layer 20 cooperate to form discrete passageways 42 of member 19 defined by channels 30, 31 of layer 20 and bottom surface 34 of cover 22, as shown in
Layer 20 includes through holes 46 which extend from channels 30, 31 to wound contacting surface 24, as shown best in
As mentioned above, member 19 further includes peripheral access holes 64. Specifically, holes 64 are formed through cover 22 and are positioned near outer edge 66, as shown in
It is within the scope of this disclosure to include an adhering, but removable, piece of disposable paper on the top surface of member 19 so that a caregiver may trace the shape of the wound 12 onto the paper and cut the member 19 to fit wound 12. Further, member 19 may be trimmed to leave a space of ¼ inch (6.35 mm) to ½ inch (12.7 mm) or greater between the cut outer edge of member 19 and an inner boundary edge of wound 12. It is not necessary for member 19 to be in contact with the entire wound surface 13. As shown in
Member 19, including layer 20, cover 22, and connector 23, includes a top surface and a bottom surface. The bottom surface of member 19 is wound contacting surface 24 of layer 20. The top surface of member 19, however, includes top surface 36 of cover 22 and the portion of upper or opposite surface 26 of layer 20 positioned between outer edge 66 of cover 22 and outer edge 68 of layer 20. Therefore, the access openings (including access channels 62 of layer 20 and access holes 64 of cover 22) are formed in the top surface of member 19.
As mentioned above, bandage 10 further includes a sealing layer or film 50 that is placed over cover 22 and around tube 41, as shown in
As shown in
As shown in
The vacuum or negative pressure, which draws blood from the body to the wound surface 13 and draws exudate from the wound 12 up through member 19, promotes the healing of wound 12. The negative pressure is distributed to a bottom portion of wound 12 through holes 46 and is distributed to undermined areas 15 and overhanging tissue 17 of the wound 12 through openings 62, 64 to draw exudate from these areas of the wound 12 through passageways 42 and out port 40 of member 19. As wound 12 heals, granulations form along the wound surface 13. Granulations, therefore, are the replacement within the wound bed of tissue lost. As the granulations fill in the wound bed causing the wound 16 to heal, member 19 rides up on the wound surface 13 on top of the granulations which are formed.
As mentioned above, port 40 of cover 22 communicates with vacuum source 14 and/or irrigation source 16 via connector 23 and tube 41. As shown in
Although this invention has been described in detail with reference to certain embodiments, variations and modifications exist within the scope and spirit of the invention as described and defined in the following claims.
This application is a U.S. national counterpart application of international application serial no. PCT/US02/41210 filed Dec. 20, 2002, which claims the benefit of U.S. provisional application Ser. No. 60/371,618 filed Apr. 10, 2002.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/US02/41210 | 12/20/2002 | WO | 00 | 9/27/2004 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO03/086232 | 10/23/2003 | WO | A |
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