Patent Grant
7615036
The disclosure relates in general to a device and method for wound therapy that is capable of treating a variety of chronic and acute wound types, including, but not limited to, infection wounds, venous ulcers, arterial ulcers, diabetic ulcers, burn wounds, post amputation wounds, surgical wounds, and the like. Specifically, the present disclosure is related to wound treatment devices and methods that utilize negative pressure therapy.
Negative pressure therapy has been one tool used for the treatment of a variety of wounds by practitioners in the art. Conventional devices are generally large in size and often require the use of complicated equipment such as suction pumps, vacuum pumps and complex electronic controllers. Other associated equipment may include wound liquid/exudate collection canisters, liquid transporting conduits, and pressure regulators/transducers/sensors. As a result, such devices may be bulky, power intensive, relatively costly and substantially non-disposable. Furthermore, the complexity of conventional devices requires steady patient supervision and that initial placement and any changing of the devices be conducted by a physician or nurse. At present, a typical cost for the use of these devices is on the order of about $100 per day per patient.
The rising costs of healthcare and of medical devices place pressure on patients and care providers alike to seek out solutions that allow use by a patient in-home, with less supervision. Furthermore, patients continue to demand devices that are more easily portable to allow travel and mobility.
The present disclosure provides a self-integrated wound therapy device for providing negative pressure therapy to a wound. In one embodiment, the device may include a housing to cover at least a portion of a wound. The device may also include a liquid-retention chamber and a vacuum connection for coupling to a vacuum source. The vacuum connection may be in gaseous communication with the liquid-retention chamber. The vacuum connection may be separated from the liquid-retention chamber by a liquid barrier. The wound therapy device may also include a seal to seal the housing to a body surface of a patient.
The vacuum connection in some embodiments may be coupled to a micro-vacuum pump that may be optionally located within or adjacent to the housing. In other embodiments, the vacuum connection may comprise a vacuum port that may be coupled to a vacuum source located at some distance from the housing.
In other embodiments, the wound therapy device may be modular in nature, optionally including a wound interface module, a liquid-retention module and a vacuum pump module. Each module of the wound therapy device may be optionally separately replaceable.
The present embodiments will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that the accompanying drawings depict only typical embodiments, and are, therefore, not to be considered to be limiting of the scope of the present disclosure, the embodiments will be described and explained with specificity and detail in reference to the accompanying drawings as provided below.
It will be readily understood that the components of the embodiments as generally described and illustrated in the Figures herein could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the Figures, is not intended to limit the scope of the present disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
Referring now to the enclosed figures and in particular to
In one embodiment, the housing 20 is semi-permeable. The exemplary semi-permeable housing may be substantially impermeable to liquids but somewhat permeable to water vapor and other gases while capable of maintaining a negative pressure underneath the housing 20 upon application of a vacuum. By way of example, the housing material may be constructed of polyurethane or other semi-permeable material such as those sold under the Tegaderm® brand. In one embodiment the housing 20 may have a water vapor transmission rate (“WVTR”) of about 836 grams/m2/day or more. However, in other embodiments the WVTR may be less than about 836 grams/m2/day. In yet other embodiments, the housing material may be substantially impermeable to both liquids and gases (including water vapor).
When the device 10 is placed on a patient and activated, or attached to an external pump via a vacuum connection 30, through adapter 32, the device 10 delivers negative pressure to the wound. The device 10 is generally attached to the body surface of a patient using one of a variety seals known in the art, such as, in one embodiment, a housing seal 24. In some adaptations, however, the device 10 may optionally include a flexible barrier 12 used to secure the device 10 to the patient. Furthermore, in some embodiments a micro-vacuum pump may be used internal to or adjacent the housing 20.
In one embodiment, the vacuum connection 30 may be coupled to an osmotic or electro-osmotic pump adjacent or internal to the housing. An osmotic pump involves imbibing water or another driving fluid. The pump may consist of a salt chamber and a liquid chamber. The salt and water chambers are separated by a semi-permeable membrane that is substantially permeable to water but substantially impermeable to salt. Water imbibes osmotically into the salt chamber creating a vacuum or partial vacuum. Materials other than salt and water can be used to cause a liquid to vacate a space in order to create a vacuum or partial vacuum. The semi-permeable or osmotic membrane may be any cation or anion membrane in communication with the liquid retention chamber. Many osmotic membranes are available commercially, any of which could be included in the present invention.
In one embodiment, electro-osmotic pump may be used to create a vacuum or partial vacuum. A selectively permeable membrane may be positioned at or near the vacuum chamber which enables a fluid to osmotically diffuse thereby creating a vacuum, partial vacuum, or negative pressure in the vacuum chamber. In operation, the electro-osmotic pump is actuated, whereupon an electrical circuit is complete and a voltage is applied from power source across a pair of electrodes, which causes an electrode reaction to take place and water or other fluid to be extracted to create the vacuum or partial vacuum.
In these alternative embodiment, the method of treating the wound may include the steps of providing housing having a cavity, positioning at least a portion of the wound within a cavity of the housing, and the steps of first filling the cavity with fluid such as water removing the fluid (water) from the cavity and then using osmotic or electro-osmotic cell and thereby generating a controlled vacuum or partial vacuum within the cavity or housing.
The liquid barrier 36 serves to prevent travel of liquid from the liquid-retention chamber 40 to the vacuum connection 30. As such, it may comprise any of a large family of suitable technologies that prevent travel of liquid from the liquid-retention chamber 40 into the vacuum chamber 24 while allowing gas flow, and thus transmission of negative pressure provided through the vacuum connection 30. As such, the liquid barrier 36 may include a porous hydrophobic film, a porous hydrophobic structure, a droplet gap, or a labyrinth. Examples of porous hydrophobic films include, but are not limited to, porous and microporous polytetrafluoroethylene, polypropylene, polyethylene, or fibrous layers of each and combinations thereof. For example, porous hydrophobic films sold under the Gore-Tex® brand may be suitable. Other technologies that allow gas flow but prevent liquid flow may also be used as suitable liquid barriers 36 as would be apparent to those having skill in the art with the aid of the present disclosure.
In the device 10 of
Thus, in operation, the device 10 may be applied to a wound site of a patient like a patch, wherein a vacuum source coupled to the vacuum connection 30, provides negative pressure to the wound. Prior to use, the device 10 may be packaged to prevent contamination. Such packaging could be a bag or envelope, or could include the use of an optional protective seal 16, with an optional pull tab 18 that is removed from the device prior to placement on the patient. During application of negative pressure to the wound site, liquid is drawn into the liquid-retention chamber 40 and held within the liquid-retention chamber 40, being prevented from further travel by the liquid barrier 36.
The housing 20 of the devices 10 disclosed may be produced out of any suitable material known to one of ordinary skill in the art, including, without limitation, rubbers, including polyurethane, and dense plastics such as, but not limited to, polypropylene, polyvinyl chlorides, polyethylene, acrylonitrile-based copolymer, such as those sold under the Barex® brand, polyester, nylon, polychlorotrifluoroethylene, fluoropolymer, polytetrafluoroethylene, such as those sold under the Teflon® brand, or combinations thereof and similar materials. The housing 20 may be a rigid or semi-rigid structure generally surrounding the liquid-retention chamber 40 and the vacuum chamber 24, and substantially retains its size and structure during the application of negative pressure, thus allowing a vacuum to be held within the housing 20.
Alternatively, the housing 20 may be made of a flexible barrier supported by customizable rigid or semi-rigid structural supports that provide support to the housing 20 allowing the maintenance of vacuum within the housing 20. The housing 20 may also be made of a flexible barrier or a surface wrap, such as a thin polyurethane film with a dermal compatible adhesive, supported by structural foam that also serves as a liquid-retention chamber. These structural supports may be constructed from rigid or semi-rigid plastics and foams (e.g., polystyrene, polyester, polyether, polyethylene, silicone or neoprene).
The housing 20 of the devices 10 disclosed may additionally contain a wound interface layer 41 in direct contact with the wound and may comprise single or multiple layers. The wound interface 41 may be either placed directly inside the wound or over the wound. The wound interface 41 may serve many functions such as being a layer that allows supply of vacuum to the wound while allowing easy and unpainful removal from the wound site during dressing change, e.g., degradable copolymer foil, such as those sold under the Topkin® brand, or a layer that provides beneficial bioagents in the form of specialized dressings such as dermal regeneration templates (e.g., those sold under the Integra® brand), bioabsorbable gels, foams and barriers that prevent tissue adhesion (e.g., those sold under the Incert® brand), a skin substitute (e.g., those sold under the BioFill® brand), a layer for selectively maintaining moisture at the wound site (e.g., those sold under the Alevyn® brand), a layer that is angiogenic (e.g., those sold under the Theramers® brand), and/or a layer that is antimicrobial. The wound interface 41 may take a variety of forms including but not limited to a sheet, foam, gel, gauze or a porous matrix.
In some specific embodiments, the housing 20 may further include a pressure relief valve (not shown). Such a valve may additionally include an inflow filter to prevent entry of contaminants into the device 10, and thus to further protect the wound site. In still other embodiments, the device 10 may include a fill indicator. The device 10 may additionally include an overflow valve such as a float valve for the vacuum connection to prevent transmission of liquid into the vacuum source. The wound healing device 10 may also alternatively include a sensor to detect the pressure or oxygen level over the wound and within the cavity.
The housing 20 of the device 10 may be adapted to be sealed to a body surface of a patient. In some embodiments, this sealing may occur simply as a result of placing the housing 20 against the body surface and drawing a vacuum within the device 10. Adhesives, gaskets, and other sealing technologies known to one of ordinary skill in the art may also be used as a seal 28 including the use of adhesive backed thin polyurethane films. Other suitable seals are known to those of ordinary skill in the art and may be used with the embodiments disclosed. As illustrated in
Referring next to
As with the device 10 of
The wound therapy device of
Referring again to
The exemplary structure, shape, and construction of the vacuum chamber 124 of the device 110 is further illustrated in
Referring next to
In some embodiments, negative pressure may be applied to the liquid-retention chamber 240 via a tube or other coupling 232 attached to the vacuum pump 234. When the vacuum source 230 is an internally-placed vacuum pump 234, the coupling 232 may travel from the pump 234 to the vacuum chamber 224 in gaseous communication with the liquid-retention chamber 240. When the vacuum source 230 is an internally-placed vacuum pump 234, an outlet 235 is provided for the vacuum pump to vent. The outlet may include a filter 237 to prevent germs from outside from entering inside or vice-versa. The opening of the coupling 232 in the vacuum chamber 224 may include a filter 261 (such as, in some embodiments, as antimicrobial filter) to prevent wound liquids from reaching the vacuum source 230 and to prevent any outside germs from entering the wound site. Moreover, in some embodiments the device 210 may include both inlet and outlet filters to prevent venting of microorganisms outside the housing 220.
In operation, the wound therapy device 210 may first be placed on a body surface of a patient so as to at least partially enclose a wound area. As discussed above, the device 210 may be sealed to the body surface using either just the suction generated by the device 210 alone, or using a seal 228 chosen from those known to those skilled in the art. The seal 228 illustrated in
Following attachment of the device 210 to a patient, the vacuum source 234 is activated, reducing the internal pressure of the device 210. As negative pressure is generated, liquids are drawn from the wound into the liquid-retention chamber 240 of the device 210, and are blocked from further progress into the vacuum chamber 224 or the negative pressure source 230 by the liquid barrier 236. As in the previous embodiments, the liquid barrier 236 may be any of those known to those of ordinary skill in the art, including, without limitation, porous hydrophobic films, and porous hydrophobic structures such as sponges and/or foams.
The exemplary device 210 of
The pressure relief valve 260 may additionally include an inflow filter (not shown) to prevent entry of contaminants into the device 210, and thus to further protect the wound site. The pressure relief valve 260 could operate in a variety of ways, including opening at a pre-set pressure point to allow ambient air to enter the device 210, opening the device 210 and deactivating the vacuum source 234, or simply deactivating the vacuum source 234.
The fill indicator 270 may operate in a variety of ways known to one of ordinary skill in the art. Some fill indicators 270 operate by detecting presence of free moisture in the liquid-retention chamber 240, which denotes that the porous pad has reached its absorptive capacity. Alternatively, fill indicator 270 may use electrical conductivity through a path in a portion of the liquid-retention chamber 240 to sense when moisture has reached the zone and provide a signal to shut off the vacuum source 230. Other fill indicators are known in the art and are suitable for use with the devices disclosed, including color-change technology based upon moisture content of the material or a change in a physical feature or characteristic. In some configurations, the fill indicator 270 may be coupled to an overflow valve to prevent wound liquids from reaching the vacuum pump 234.
In this embodiment, the negative pressure source 430 extends through the housing 420 into the vacuum chamber 424 at an outlet 432. The outlet 432 may include a filter 461 (such as, in some embodiments, as antimicrobial filter) to prevent entry of wound exudate into the vacuum source 434. As with the other embodiments, this device 410 may include a liquid barrier 436, such as a hydrophobic membrane, that prevents flow of liquid into the vacuum chamber 424, but allows the negative pressure to extend into the liquid-retention chamber 440, causing liquid to be drawn into the liquid-retention chamber 440 from the wound. In some embodiments, the vacuum chamber 424 may include a porous hydrophobic foam. In other embodiments, the vacuum chamber 424 may be empty.
As described herein, the device 410 may be sealed to the body surface of a patient using either just the suction generated by the device 410 alone, or using a seal 428 chosen from those known to individuals skilled in the art. The seal 428 illustrated in
To accomplish this, the device 510 shown in
In one embodiment the liquid-retention chamber 540 is shaped such that the majority of wound fluid or exudate is collected at a location adjacent to the negative pressure source 530 and away from the wound site. In this instance, the liquid-retention chamber 540 may have a low aspect ratio at the wound site to minimize pressure loading as the patient sits, stands, or lies on the wound site.
Alternatively, the device 510 may have two separate housings: one housing 520a having a sealing surface 512 around the wound site and the other housing 520b being located at some distance away from the wound site. The latter housing 520b may or may not seal to the skin. Both housings 520a, 520b shown in
The negative pressure source 530 may include a micro-vacuum pump 534 operably coupled to a power source 538, such as a battery. The negative pressure source 530 may be external to the housing 520, as illustrated. However, it should be understood that alternative embodiments of the wound therapy device 510 may include the micro-vacuum pump 534 and/or power source 538 internal to the housing 520. The negative pressure source 530 may be an osmotic or electroosmotic pump adjacent or internal to or adjacent the housing as discussed above.
For example, if the liquid-retention module 640, 640′ is filled to capacity with exudate, it may be replaced with a new liquid-retention module 640, 640′, while keeping the functional vacuum pump module 630, 630′. Alternatively, the liquid-retention module 640, 640′ may be replaced at regular intervals to prevent overflow and assure appropriate capacity. Likewise, the wound interface module 641, 641′ may be replaced independent of the other modules.
In the embodiment of
The wound interface module 641, 641′ of both embodiments may serve many functions as described above, such as being a layer that allows supply of vacuum to the wound while allowing easy and unpainful removal from the wound site during dressing changes. Alternatively, the wound interface may be a layer that provides beneficial bioagents in the form of specialized dressings such as dermal regeneration templates, bioabsorbable gels, foams and barriers that prevent tissue adhesion. The wound interface may also be a skin substitute, a layer for selectively maintaining moisture at the wound site, a layer that is angiogenic, and a layer that is antimicrobial. The wound interface may take a variety of forms, including, but not limited to a sheet, foam, gel, gauze or a porous matrix.
Without limitation, it is believed that the disclosed devices and their methods of use may be useful for the therapy of surface wounds on a patient. These wounds may include, but are not limited to, infectious wounds, burn wounds, venous and arterial ulcers, diabetic ulcers and wounds, post-surgical wounds, bed sore wounds, and the like. Additionally, such devices are contemplated for use in a variety of fields, as would be contemplated by one of ordinary skill in the art.
According to one method of wound treatment or therapy utilizing the devices described herein, a device having a housing with a liquid-retention chamber is positioned above at least a portion of the wound. Negative pressure may be applied to the wound using the vacuum source. Wound liquids or exudate may be collected in the liquid-retention chamber. Additionally, the device may be replaced when it is filled with liquid. In modular embodiments, the liquid-retention chamber or the vacuum source may be replaced as needed.
In some of the embodiments disclosed, the devices may be adapted to be inexpensive, light-weight, and either partially or entirely disposable. Further, the devices may be adapted to be simple to operate, such that in some instances, a patient could place the device with some reduced degree of medical supervision. In addition to the above, the devices may be constructed so as to be used without attention to their orientation.
It is contemplated that the devices may take a variety of forms, including those that are completely disposable when full, or partially disposable such as, for example, either the vacuum source or the liquid-retention chamber. In embodiments such as device 10 of
Such methods and apparatus may also be useful in the treatment of skin grafts. Additionally, such a device may be useful when applying sub-dermal materials, such as dermal regeneration templates, intended to serve as a matrix for tissue to enter in the healing process of burns and wounds.
It should be noted that although the housings disclosed have been illustrated in particular shapes, such as being generally rounded, the housings are not necessarily limited to particular shape, and may be constructed in any advantageous shape. In some embodiments, the devices may be sized and shaped such that the vacuum chamber or liquid-retention chamber is capable of sealing over the patient's wound, at least in part. The housings and the seals disclosed may be configured to hold a vacuum when the device is placed and sealed over at least a portion of a wound on a patient's body surface. Such seals may be substantially airtight to prevent the entry of microbes but do not need to be absolutely impermeable. Although it is contemplated that vacuum pressure will either be continuously or periodically applied to maintain a therapeutic negative pressure therapy range.
Power sources referred to herein may be, for example, electrical outlets, batteries, and/or rechargeable batteries and the like. By way of example, the batteries may be integral (non-replaceable), replaceable (by a user or clinician) and/or rechargeable.
When the vacuum is switched on after placing the device on a patient's wound, air is removed around the wound, generating a vacuum within the housing cavity. At the same time, wound-liquid absorbing material may begin absorbing the exudate/liquids in the wound. Sustained negative pressure over a wound region may promote tissue migration and wound closure. In some embodiments, the devices may be shaped like a patch or bandage that may be changed more than once a day.
Additionally, the device may contain a fill indicator that senses the presence of free moisture in the liquid-retention chamber that signals that the optional porous pad has reached its absorptive capacity. The fill indicator may in turn be coupled to an over-flow valve to prevent wound liquids from reaching the vacuum pump or it may provide a signal used to prompt disabling the pump.
In all of the above embodiments, when the devices are adapted to be disposable, they may be discarded after use in part or in whole. Indeed multiple disposable devices can be provided to a patient for a treatment plan, which may consist of a plurality of individual treatments with disposable devices over a predetermined period.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present disclosure to its fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure provided herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Note that elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. § 112 ¶6. The scope of the invention is therefore defined by the following claims.
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