US20030093041A1 - Waste container for negative pressure therapy - Google Patents

Abstract

A system for treating a patient with a wound comprises a bandage, a receptacle, and a vacuum source. The bandage comprises a cover to seal about the wound and to define a space above the wound in which a vacuum is to be formed. The bandage further comprises a port providing communication with the space. The receptacle is connected to the port to receive exudate from the wound and is provided to be placed below the wound. The vacuum source is spaced apart from the receptacle, is connected to the receptacle, and is effective to provide a vacuum in the receptacle and in the space.

Description

• This application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Application Serial No. 60/328,542, filed Oct. 11, 2002, which is expressly incorporated by reference herein.[0001]
FIELD OF THE INVENTION
• The present invention relates to a wound treatment system and specifically to a vacuum therapy wound treatment system for surface wounds. More specifically, the present invention relates to the drainage and collection of exudate from the wound surface through vacuum therapy.[0002]
BACKGROUND FO THE DISCLOSURE
• Medical professionals, such as nurses and doctors, routinely treat patients having surface wounds of varying size, shape, and severity. It is known that controlling the topical atmosphere adjacent a wound can enhance the healing process. For example, by applying medicinal agents or even water over a wound, dirt and bacteria are either killed or washed away, thereby promoting healing. In addition, applying a negative pressure or vacuum to a wound draws out exudate, which might contain dirt and bacteria, from the wound to further promote healing.[0003]
• 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. This vacuum applied to the wound surface accelerates healing of chronic wounds. Typically, suction tubes are provided for drawing exudate away from the wound. 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 provide the space in which the vacuum is formed. 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.[0004]
• 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. FIG. 1 of the '081 patent discloses an open cell polyester foam section covering the wound, a flexible hollow tube inserted into the foam section at one end and attached to a vacuum pump at another end, an adhesive sheet overlying the foam section, and tubing to adhere to the skin surrounding the wound in order to form a seal that allows the creation of a vacuum when the suction pump is operating. The '081 patent further teaches use of negative pressure between about 0.1 and 0.99 atmospheres, and that the pressure can be substantially continuous, wherein the pressure is relieved only to change the dressing on the wound. Alternatively, the '081 patent teaches use of a cyclic application of pressure in alternating periods of application and non-application. In a preferred embodiment, pressure is applied in 5 minute periods of application and non-application.[0005]
• 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 that establish the efficacy of vacuum therapy. 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 wound”, 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).[0006]
• The Russian articles distinguish wound drainage from the 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 article describes the vacuum therapy techniques as a reduction of 0.8-1.0 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.[0007]
• The Russian articles teach using this vacuum method to decrease the number of microbes in the wound. The June 1990 article teaches that vacuum therapy provides a significant antibacterial effect. The June 1990 article describes the stepped up inflow of blood to the zone around the wound, which leads 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 prior art, therefore, teaches the benefit and value of a vacuum bandage.[0008]
SUMMARY OF THE DISCLOSURE
• Accordingly, a vacuum therapy system for treating a patient with a wound is provided. The system includes a vacuum bandage comprising a cover to seal about the wound. The cover also defines a space above the wound in which a vacuum is to be formed. The bandage further comprises a port which provides communication with the space. The system further includes a receptacle to be placed below the wound. The receptacle is connected to the port to receive exudate from the wound. Finally, the system includes a vacuum source spaced apart from the receptacle and connected to the receptacle. The vacuum source is effective to provide a vacuum in the receptacle and in the space above the wound.[0009]
• Illustratively, the system may comprise one or more of the following features alone or in combination with each other: a first tube coupled to the port of the bandage and the receptacle, a second tube coupled to the vacuum source and the receptacle, a means for attaching the receptacle to a support below the wound, a means for supporting the vacuum source away from the receptacle, and/or a control dominating the vacuum source to establish the amount of vacuum applied to the space and the time when the vacuum is applied to the space.[0010]
• Further illustratively, the receptacle of the system may comprise one or more of the following features alone or in combination with each other: an antimicrobial filter, an air vent to allow an inner area of the receptacle to communicate with the surrounding atmosphere, a mounting portion, and an upper portion and a lower portion coupled to the upper portion. The anti-microbial filter may be hydrophobic, and the upper portion of the receptacle may be made of a rigid material while the lower portion pf the receptacle may be made of a flexible material.[0011]
• The vacuum source of the system may comprise a vacuum pump and associated controls and/or a flow sensor to be connected to a vacuum line. Illustratively, the flow sensor may be configured to determine the level of vacuum present in the receptacle.[0012]
• A method for treating a wound on a patient is also provided including the steps of sealing a bandage having a port about the wound to define a space above the wound in which a vacuum can be formed, placing a receptacle below the wound, and placing a vacuum source spaced away from the receptacle. The method further includes the steps of connecting the receptacle to the port of the bandage, connecting the vacuum source to the receptacle, and operating the vacuum source to evacuate the receptacle and provide a vacuum in the space above the wound. The method further includes the step of controlling the level of vacuum applied to the space and the time of application of the vacuum.[0013]
• Additional features and advantages of the apparatus will become apparent to those skilled in the art upon consideration of the following detailed descriptions exemplifying the best mode of carrying out the apparatus as presently perceived.[0014]
BRIEF DESCRIPTION OF THE DRAWINGS
• The detailed description particularly refers to the accompanying figures in which:[0015]
• FIGS.[0016]1-4 are perspective views of a vacuum therapy system and a patient undergoing vacuum therapy treatment showing a vacuum bandage of the system coupled to the patient, a waste drainage container or receptacle coupled to the vacuum bandage by a first tube and a housing including a vacuum source coupled to the receptacle by a second tube, and also showing the receptacle positioned below the wound and spaced apart from housing;
• FIG. 1 is a perspective view showing the housing mounted on a mobile IV pole;[0017]
• FIG. 2 is a perspective view similar to FIG. 1 showing the housing positioned on a bedside cabinet;[0018]
• FIG. 3 is a perspective view similar to FIGS. 1 and 2 showing the housing mounted to an on-bed IV pole;[0019]
• FIG. 4 is a perspective view similar to FIGS.[0020]1-3 showing the housing mounted on a footboard of the patient's hospital bed;
• FIG. 5 is a sectional view of an illustrative receptacle showing the first tube coupled to an inlet port of the receptacle and showing the second tube coupled to an outlet port of the receptacle and also showing a hydrophobic filter positioned at the outlet port of the receptacle;[0021]
• FIG. 6 is a perspective view of another illustrative waste receptacle of the present invention showing a mounting portion of the receptacle for mounting the receptacle to a bed frame of the hospital bed, as shown in FIGS.[0022]1-4; and
• FIG. 7 is a perspective view of yet another illustrative waste receptacle of the present invention showing an alternative mounting portion of the receptacle for mounting the receptacle to the bed frame of the hospital bed.[0023]
DETAILED DESCRIPTION OF THE DRAWINGS
• A[0024]vacuum therapy system10 is provided for use with a wound on apatient14, as shown in FIGS.1-4.System10 comprises avacuum bandage16, a waste container orreceptacle18 coupled to thebandage16, and ahousing20 coupled to thereceptacle18.Housing20 includes a vacuum source21 (shown in FIG. 5) for applying negative pressure to the wound to draw exudate from the wound in order to facilitate healing.Receptacle18 is provided to collect the exudate drawn from the wound and is placed below the wound to facilitate the drainage of exudate from the wound by gravity as well as suction.Housing20, which includes thevacuum source21, is spaced apart fromreceptacle18 in order to allow a caregiver to place thehousing20 in any convenient location while still benefiting from the gravitational effects gained by maintaining thereceptacle18 at a level below the wound.
• Illustrative vacuum bandages and vacuum and irrigation systems are disclosed in U.S. patent application Ser. No. 09/725,352 to Lockwood, et al. titled “VACUUM THERAPY AND CLEANSING DRESSING FOR WOUNDS”, U.S. patent application Ser. No. 09/725,666 to Risk et al. titled “WOUND TREATMENT APPARATUS”, and U.S. patent application Ser. No. 09/369,113 to Henley et al. titled “WOUND TREATMENT APPARATUS”. Each of these applications are assigned to the same assignee as the present application and are specifically incorporated herein by reference.[0025]
• [0026]Vacuum bandage16 includes acover22 to seal about the wound. Thebandage16 operates to define a space above the wound to which negative pressure can be applied to form a vacuum. Thebandage16 further includes aport23 in communication with the space above the wound. Theport23 is coupled toreceptacle18 by afirst tube24 of thesystem10.First tube24 includes afirst end26 coupled to theport23 and asecond end28 coupled to thereceptacle18.System10 further includes asecond tube30 coupled at afirst end32 to thereceptacle18 and coupled at asecond end34 to thevacuum source21 which may be contained withinhousing20.
• [0027]Illustrative receptacle18 of thevacuum therapy system10 includes abody40 which forms aninterior cavity42 for collecting exudate62 (shown in FIG. 5) and fluid drawn from the wound therein. Althoughreceptacle18 is illustratively shown in FIG. 5, the height, width, and shape ofreceptacle18 may take various forms.Body40 includes anupper portion44 and alower portion46 coupled to theupper portion44.Upper portion44 defines aninlet port48 coupled to thefirst tube24, and anoutlet port50 coupled to thesecond tube26. In illustrative embodiments,upper portion44 of thereceptacle18 is formed from a rigid material and thelower portion46 of thereceptacle18 is also formed from a rigid material and is integral with theupper portion44, as shown, for example, in FIGS.5-7. However, it is within the scope of this disclosure to include a receptacle having alower portion46 made from a flexible material as well. For example,lower portion46 may be a flexible bag removably coupled to theupper portion44 ofreceptacle18.
• As shown in FIG. 5,[0028]receptacle18 further includes ahydrophobic filter60 in communication withsecond tube30 and thus thevacuum source21. Illustratively, filter60 is a 0.2-micron hydrophobic anti-microbial filter.Upper portion44 ofreceptacle18 further defines anair vent64 to provide communication betweeninterior cavity42 ofreceptacle18 and the outside atmosphere. Preferably, as shown in FIG. 5,hydrophobic filter60 is positioned overair vent64 to prevent bacteria, etc. in the surrounding atmosphere from enteringreceptacle18.
• As mentioned above,[0029]first end32 ofsecond tube30 is coupled tooutlet port50 ofreceptacle18 andsecond end34 ofsecond tube30 is coupled to vacuumsource21. Vacuumsource21 may be contained withinhousing20 or may be external to thehousing20. For example, most medical facilities have vacuum ports near where patients are treated, such as in-wall vacuum ports, for example. Each port is served by a system vacuum pump to provide negative pressure. Vacuumsource21 is also defined to include any type of mechanism for providing negative pressure such as an electrically operated or manual pump, for example.Housing20 is configured to be a portable unit allowing a caregiver to movehousing20 to wherever the patient is located within close proximity to the wound or wounds. For example, as shown in FIGS.1-4, thehousing20 is shown to be coupled to amobile IV pole70, positioned on abedside cabinet72, coupled to an on-bed IV pole74, and coupled to afootboard76 of thehospital bed78. Each of themobile IV pole70,cabinet72, in-bed IV pole74, andfootboard76 illustrate an example of a means for supporting thehousing20 andvacuum source21 away fromreceptacle18. Thehousing20 and itsvacuum source21 may be placed above, at generally the same level, or below thereceptacle18. Preferably, thereceptacle18 will be placed below the wound.
• In addition to the[0030]vacuum source21, it is also within the scope of the disclosure forhousing20 to include a controller (not shown) for controlling the amount and rate of negative pressure to be applied to the wound, for example.Housing20 may also include an irrigation system and such other devices and components as disclosed in U.S. patent application Ser. No. 09/725,666, referenced above and incorporated herein.
• As described above, the components of system[0031]10 (vacuum bandage16,first tube24,receptacle18,second tube30, and vacuum source21) are coupled to each other in series. The port ofvacuum bandage16 is coupled to thereceptacle18 byfirst tube24.First tube24 is coupled toinlet port48 ofreceptacle18 andreceptacle18 is coupled to thehousing20, or more specifically, to thevacuum source21, bysecond tube30. First end32 ofsecond tube30 is coupled tooutlet port50 ofreceptacle18 andsecond end34 ofsecond tube30 is coupled to vacuumsource21. By this series configuration, thevacuum source21 is thus in fluid communication with thereceptacle18 through the second tube3, and the space above the wound created byvacuum bandage16 is in fluid communication withreceptacle18 throughfirst tube24. Therefore, thevacuum source21 operates to create negative pressure, or a vacuum, in the space above the wound, in thefirst tube24, inreceptacle18, and insecond tube30.
• Illustratively, a flow sensor (not shown) may be coupled to[0032]second tube30 betweenreceptacle18 andvacuum source21 for monitoring the fluid flow fromreceptacle18 to vacuumsource21. The flow sensor may then provide feedback to the controller, for example, located withinhousing20. If, for example, the flow sensor detects no fluid flow, the feedback sent to the controller would signal thevacuum source21 to turn off or cease running.
• In operation, it is possible that at a period of time after negative pressure is created above the wound,[0033]system10 may become relatively static due to a lack of fluid flow throughsystem10. As mentioned above, this lack of fluid flow could cause thevacuum source21 to be turned off. However, it may still be beneficial to provide a vacuum above the wound in order to draw blood up to the surface of the wound.Air vent64 is provided inreceptacle18 in order to maintain a small amount of fluid flow to prevent the flow sensor from detecting a static system. Oncesystem10 has become relatively static and there is little to no fluid flow frombandage16 throughfirst tube24 and to receptacle18,vacuum source21 is still able to pull air throughair vent64 thus allowing the flow sensor to detect a fluid flow in order to keep thevacuum source21 running. Once the level ofexudate62 collected withinreceptacle18 reachesair vent64 and/oroutlet port50,hydrophobic filter60 will prevent liquid to pass therethrough and the flow sensor will sense that the flow has become static. The flow sensor will send a signal to the controller which will, in turn, tell thevacuum source21 to turn off.
• In use,[0034]receptacle18 is positioned below thevacuum bandage16 and the patient's wound to which thevacuum bandage16 is attached. As shown in FIGS.1-4, placingreceptacle18 below the wound facilitates the drainage of exudate from the wound through gravity. Therefore, exudate is drawn from the wound through the use of a negative pressure supplied byvacuum source21 and through the use of gravity.Receptacle18 is also spaced apart fromvacuum source21 and/or thehousing20, as shown in FIGS.1-4. As stated above,vacuum source21 is often provided withinhousing20. Therefore, spacingreceptacle18 apart from thevacuum source21 allows thehousing20 to be placed at any desired location or level while still maintaining use of gravity for the collection of exudate withinreceptacle18.
• In illustrative embodiments,[0035]receptacle18 includes a mountingportion80 coupled to thebody40, as shown in FIGS. 6 and 7. Mountingportion80 is provided to allow a caregiver to mount thereceptacle18 tohospital bed78 below thepatient14 and thus below the wound in order to facilitate the drainage of the exudate from the wound by gravity.Hospital beds78 often to include a hook (not shown) or a type of mount or support coupled to abed frame82 of thebed78. Urine bags, for example, are often hung by the caregiver from these hooks to facilitate drainage through the use of gravity alone.
• Mounting[0036]portion80 ofreceptacle18, as shown in FIG. 6, is in the shape of a handle to define anaperture84 for receiving the hook or mount coupled tobed frame82. Mountingportion80 is coupled to atop wall86 ofbody40 to cooperate withbody40 andform aperture84. Mountingportion80 includes a first generallyvertical member88 coupled totop wall86, a second generallyvertical member90 coupled totop wall86, and a generallyhorizontal member92 spaced-apart fromtop wall86 and coupled to and positioned to extend between each of the first and second generallyvertical members88,90.
• Another illustrative mounting[0037]portion180 is shown in FIG. 7. Alternate mountingportion180 is hook-shaped and includes a single curved member coupled to thetop wall86 of thereceptacle18 to define a hook-receivingspace182 for receiving a hook or mount of thebed frame82. Although mountingportion80 and alternate mountingportion180 are disclosed and described herein, it is within the scope of this disclosure to include a receptacle having a mounting portion adapted to cooperate with the bed frame of the hospital bed in order to support the receptacle below the wound of the patient being treated.
• Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the scope and spirit of the invention.[0038]

Claims (24)

1. A system for treating a patient with a wound, the system comprising:

(a) a bandage comprising a cover to seal about the wound and define a space above the wound in which a vacuum is to be formed, and a port providing communication with the space,

(b) a receptacle to be placed below the wound and connected to the port to receive exudate from the wound, and

(c) a vacuum source spaced apart from the receptacle and connected to the receptacle, the vacuum source being effective to provide a vacuum in the receptacle and in the space.

2. The system ofclaim 1, further including a first tube coupled to the port of the bandage and the receptacle and a second tube coupled to the vacuum source and the receptacle.

3. The system ofclaim 2, wherein the receptacle further includes an inlet port coupled to the first tube and an outlet port coupled to the second tube.

4. The system ofclaim 3, wherein the receptacle further includes an anti-microbial filter adjacent the outlet port.

5. The system ofclaim 4, wherein the filter is hydrophobic.

6. The system ofclaim 1, wherein the receptacle includes an air vent to allow an inner area of the receptacle to communicate with the surrounding atmosphere.

7. The system ofclaim 1, wherein the receptacle includes an upper portion and a lower portion coupled to the upper portion, and wherein the upper portion of the receptacle is formed from a rigid material.

8. The system ofclaim 7, wherein the upper portion of the receptacle includes an inlet port coupled to the bandage and an outlet port coupled to the vacuum source.

9. The system ofclaim 7, wherein the lower portion of the receptacle is formed from a flexible material.

10. The system ofclaim 1, wherein the vacuum bandage, receptacle, and vacuum source are configured to operate in series with each other.

11. The system ofclaim 1, further including a mounting portion coupled to the receptacle.

12. The system ofclaim 1, comprising a control dominating the vacuum source, the control being configured to establish the amount of vacuum applied to the space.

13. The system ofclaim 12, wherein the control is configured to establish the time when vacuum is applied to the space.

14. The system ofclaim 1, comprising means for attaching the receptacle to a support below the wound.

15. The system ofclaim 1, comprising means for supporting the vacuum source away from the receptacle.

16. A system for creating a vacuum above a wound and drawing exudate away from the wound, the system comprising:

(a) a vacuum bandage to place over and seal about the wound on a patient to provide a vacuum space above the wound and a port communicating with the space,

(b) a receptacle configured to be placed below the wound, the receptacle being in communication through the port with the vacuum space, and

(c) a vacuum source positioned away from the receptacle and connected to the receptacle to provide a vacuum in the receptacle and in the vacuum space, thereby subjecting a surface of the wound to vacuum therapy.

17. The system ofclaim 16, wherein the vacuum source comprises a vacuum pump and associated controls, the pump being connected to the receptacle.

18. The system ofclaim 17, wherein the vacuum source is positioned above the receptacle.

19. The system ofclaim 16, wherein the vacuum source is positioned above the receptacle.

20. The system ofclaim 16, wherein the vacuum source comprises a flow sensor to be connected to a vacuum line, the flow sensor being configured to determine the level of vacuum present in the receptacle.

21. The system ofclaim 16, comprising means for supporting the receptacle below the wound.

22. The system ofclaim 16, comprising means for supporting the vacuum source above the receptacle.

23. A method for treating a wound on a patient, the method comprising the steps of:

(a) sealing a bandage having a port about the wound to define a space above the wound and in communication with the port in which a vacuum can be formed,

(b) placing a receptacle below the wound,

(c) placing a vacuum source spaced away from the receptacle,

(d) connecting the receptacle to the port of the bandage,

(e) connecting the vacuum source to the receptacle, and

(f) operating the vacuum source to evacuate the receptacle and provide a vacuum in the space above the wound.

24. The method ofclaim 23, comprising the step of controlling the level of vacuum applied to the space and the time of application of the vacuum.

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