The invention relates to an apparatus and method for managing a wound in an animal subject, and a self-contained kit for managing a wound. More specifically, the invention relates to an expandable, electrically conductive wound conforming device, a method for delivering an ionizable wound healing agent into the wound tissue, and a kit comprising a wound conforming device and employing the method for delivering an ionizable wound healing agent for wound management in the field.
Wounds or skin lesions are common injuries that often require immediate medical attention. Once a wound has been cleaned and the bleeding, if any, has been sufficiently slowed, the wound may require a wound healing agent to prevent infection of the affected area. Common wound healing agents include topical antibiotics and nontoxic antiseptics. Even distribution of the wound healing agent over the entire wound tissue can have a positive effect on the rate of healing of a wound.
Despite the use of topical wound healing agents, wound infections and chronic wounds are prevalent in the medical field. Wound infections and chronic wounds can be the result of insufficient treatment of an open wound. Commonly used topical antibiotics and nontoxic antiseptics may be at a disadvantage due to the wound tissue's limitation in absorbing the topical wound healing agent. Deep tissue absorption of a wound healing agent can potentially decrease the likelihood of an infection and the prevalence of chronic wounds by treating the wound beneath the surface. In addition, healing time of a wound may be decreased by eliminating the need for further treatments.
Serious wounds require immediate medical attention that is not always readily available. For example, wounds are common in the military field where hospitals and intricate medical equipment may be inaccessible. A topical wound healing agent applied in this environment may not be sufficient to prevent the development of a life-threatening wound infection or chronic wound. By delivering a wound healing agent deep below the surface of the wound tissue, the serious wound may be sufficiently managed until a more thorough medical procedure can be performed.
One aspect of the invention comprises an apparatus for managing a wound in an animal subject. The apparatus generally comprises a source of a wound healing agent, an irrigation system to deliver the wound healing agent into the wound cavity, an expandable wound conforming device to overlie and contact the wound tissue cavity, and a power source in electrical communication with the expandable wound conforming device to deliver a current to the wound healing agent.
Another aspect of the invention comprises a method for managing a wound in an animal subject. The method generally comprises delivering a wound healing agent into the wound cavity, wherein the wound healing agent contains an ionizable compound, placing an expandable wound conforming device over the wound tissue, expanding the expandable wound conforming device to overlie and contact the wound tissue, and applying a current to the expandable wound conforming device. According to one embodiment of the invention, the method for managing a wound in an animal subject can further comprise shrinking the expandable wound conforming device and removing the excess wound healing agent and debris. Optionally, some or all of these steps can be repeated until the wound is sufficiently healed.
Another aspect of the invention comprises a self-contained kit for managing a wound in an animal subject. The kit generally comprises a reservoir containing a wound healing agent, wherein the wound healing agent contains an ionizable compound, an injector for delivering the wound healing agent from the reservoir to the wound cavity, an expandable wound conforming device to overlie and contact the walls of the wound tissue cavity, and a self-contained, portable power source in electrical communication with the expandable wound conforming device.
The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
In the drawings:
The invention relates to an apparatus and method for managing a wound in an animal subject, and a self-contained kit for managing a wound. More specifically, the invention relates to an expandable, electrically conductive wound conforming device, a method for delivering an ionizable wound healing agent into the wound tissue, and a kit comprising a wound conforming device and employing the method for delivering an ionizable wound healing agent for wound management in the field. The invention can be used to increase the penetration of a wound healing agent into the wound tissue, and thus potentially decrease healing time, likelihood of infection, and prevalence of chronic wounds. The invention can also be used to degrade biofilm tissue in and around a wound.
One aspect of the invention comprises an apparatus for managing a wound in an animal subject. As used herein, an “animal subject” is any animal or human in need of wound management. As representative of one aspect of the invention,
The source of the wound healing agent 11 may be a reservoir, such as a flask, a bottle or a vial, wherein the wound healing agent 21 is delivered to the wound cavity 24 by a wound healing agent delivery line 12, as illustrated in
The wound healing agent 21 can be liquid or semi-liquid, including gels, or any sufficiently fluid form that may be delivered by an irrigation system and distributed to contact a substantial portion of the wound tissue by expanding the expandable wound conforming device. The wound healing agent 21 can be an aqueous solution, can be prepared from an anhydrous powder and water, or can be prepared by any other means of preparing a liquid or semi-liquid wound healing agent. According to one embodiment of the invention, the wound healing agent 21 comprises a compound having metal cations or anions. For example, the metal cations may be selected from Ag, Cu, Au and Pt. Equally, the wound healing agent 21 may comprise a compound having anions, for example I. According to a preferred embodiment of the invention, the wound healing agent 21 is an antimicrobial ion solution, for example silver dihydrogen citrate (SDC). It will be understood that the wound healing agent 21 can be any wound healing agent that would be employed to advance the healing of a wound and contains an ionizable compound or can be carried as a charged particle.
As illustrated in
According to one embodiment of the invention, all or a portion of the expandable wound conforming device 13 is an inflatable membrane, preferably a non-porous inflatable membrane. The inflatable membrane may be inflated by any means, for example by devices such as a connected air tank or a hand pump. Equally, the expandable wound conforming device 13 may be mechanically expanded with moving parts that expand to reach the exposed wound tissue 20.
The expandable wound conforming device 13 can further contain at least one embedded electrode 15. The at least one embedded electrode 15 can deliver a current 18 to the wound healing agent 21 to drive wound healing ions 25 of the wound healing agent 21 into the wound tissue 20.
According to another embodiment of the invention, the expandable wound conforming device 13 may be an electrically conductive polymer membrane. The electrically conductive polymer membrane can deliver a current 18 to the wound healing agent 21 to drive wound healing ions 25 of the wound healing agent 21 into the wound tissue 20. For example, all or a portion of the expandable wound conforming device 13 may be a conductive metallic membrane, such as a Mylar® membrane having a metallic coating. The electrically conductive polymer membrane may be inflated, for example by a connected air tank or a hand pump, or may be mechanically expanded.
The current 18 that drives the wound healing ions 25 of the wound healing agent 21 into the wound tissue 20 is delivered by the power source 14 in electrical communication 19 with the expandable wound conforming device 13. A current of 0.5 mA-3.0 mA is sufficient to reach a desired penetration depth of the wound healing agent 21 in a tissue. It will be understood that the power source 14 can be any power source capable of delivering the necessary current and voltage to the expandable wound conforming device 13. More specifically, the power source 14 is capable of delivering a current of 0.5 mA-16 mA to the electrodes 15 in the expandable wound conforming device 13 or to the electrically conductive polymer membrane. The maximum current of 16 mA is safe for human contact, and well below the let-go threshold. Preferably, the power source 14 is capable of delivering 0.5 mA-16 mA of current at 10 V. For example, the power source can be an electrophoresis power supply, such as those distributed by Bio-Rad, an iontophoresis power supply, or a self-contained battery pack, such as the electrophoresis battery pack distributed by Invitrogen.
The irrigation system delivers the wound healing agent 21 from a reservoir containing the wound healing agent 11 to the wound cavity 24. According to one embodiment of the invention, as illustrated in
Another aspect of the invention comprises a method for managing a wound in an animal subject. The method generally comprises delivering a wound healing agent 21 into the wound cavity 20, wherein the wound healing agent 21 contains an ionizable compound, and delivering a current 18 to the wound healing agent 21 to drive wound healing ions 25 of the wound healing agent 21 into the wound tissue 20.
As representative of one embodiment of the invention,
It will be understood that the wound healing agent 21 can be any wound healing agent that would be employed to advance the healing of a wound and contains an ionizable compound or can he carried as a charged particle. The wound healing agent 21 may be any of the embodiments of a wound healing agent previously described.
One step of the method for managing a wound in an animal subject, as illustrated in
Another step of the method for managing a wound in an animal subject, as illustrated in
As illustrated in
Another step of the method for managing a wound in an animal subject, as illustrated in
According to one embodiment of the invention, the method for managing a wound in an animal subject can further comprise shrinking the expandable wound conforming device 13, as illustrated in
Shrinking the expandable wound conforming device 13 may allow the excess wound healing agent and wound debris 22 to pool at the bottom of the wound cavity 24. The excess wound healing agent is any amount of the wound healing agent that has not penetrated the wound tissue 20. The wound debris is any animal tissue or fluid (exudate) that has been debrided, exuded or otherwise dislodged from the wound tissue 20. The excess wound healing agent and wound debris 22 can be removed by any means, including, but not limited to suction, for example provided by a vacuum or a hand pump.
According to yet another embodiment of the invention, the method for managing a wound in an animal subject can further comprise repeating some or all of the steps of delivering the wound healing agent 21 into the wound cavity 24, placing the expandable wound conforming device 13 over the wound cavity 24, expanding the expandable wound conforming device 13 to overlie and contact the wound tissue 20, applying the current 18 to the expandable wound conforming device 13, shrinking the expandable wound conforming device 13 and removing the excess wound healing agent and debris 22. The repetition of some or all of the foregoing steps may take place as often as possible or as necessary until the wound is sufficiently healed. As used herein, the term “sufficiently healed” can refer to any desired level of healing of the wound, or simply sufficient penetration of the wound healing agent 21 into the wound tissue 20, and need not refer to any visibly noticeable healing of the wound tissue 20.
Another aspect of the invention comprises a self-contained kit for managing a wound in an animal subject. As representative of one aspect of the invention,
As illustrated in
In one embodiment of the invention, the wound healing agent 21 may be substantially similar to the wound healing agent previously described. Equally, the expandable wound conforming device 13 may be substantially similar to those previously described.
The current 18 that drives the wound healing ions 25 of the wound healing agent 21 into the wound tissue 20 is delivered by the self-contained, portable power source 27 in electrical communication 19 with the expandable wound conforming device 13. In a preferred embodiment of the invention, the self-contained, portable power source 27 is a battery pack. For example, the power source can be a self-contained battery pack, such as the electrophoresis battery pack distributed by Invitrogen. It will be understood that the power source 27 can be any self-contained, portable power source capable of delivering the necessary current and voltage to the expandable wound conforming device 13. More specifically, the self-contained, portable power source 27 is capable of delivering a current of 0.5 mA-16 mA to the electrodes 15 in the expandable wound conforming device 13 or to the electrically conductive polymer membrane.
According to one embodiment of the invention, the self-contained kit for managing a wound in an animal subject further comprises an adhesive bandage 23 for adhering the kit to an area around the wound cavity 24. The adhesive bandage 23 allows for simple and rapid management of a wound in the field, until the wound can be further treated in a medical care setting. Equally, the self-contained kit for managing a wound in an animal subject may further comprise other elements capable of adhering the kit to an area around the wound cavity 24, for example gauze pads, rolled gauze or cloth tape.
Wound Healing Agent Contact with Wound Tissue
In a demonstration of maximizing the contact of the wound healing agent to the wound tissue, an apparatus for managing a wound in an animal subject was placed over a flask, the flask representing the wound cavity. The expandable wound conforming device was placed in the flask and the wound healing agent was delivered to the flask by an irrigation system. The wound healing agent pooled at the bottom of the flask and did not contact the entire inner surface of the flask. The expandable wound conforming device was then expanded by inflation to substantially fill the flask.
Upon expansion of the expandable wound conforming device, the wound healing agent contacted substantially the entire inner surface of the flask, representing the contact that can be made with wound tissue.
The expandable wound conforming device was then shrunk, and the wound healing agent, representing the excess wound healing agent and debris, was removed from the flask by suction.
Electrophoretic migration of SDC was tested in an agarose gel. SDC was added to the surface of an agarose gel and allowed to permeate the gel for 15 minutes.
SDC was added to a second agarose gel and an electrophoretic field of 10V was applied to the vertically oriented 8 cm gel for 15 minutes.
Iontophoretic migration of SDC was tested in a 1 cubic centimeter sample of raw pork. A 1 mL sample of SDC was added to the surface of a 1 cubic centimeter sample of raw pork held in a cuvette. In the control sample, the SDC was allowed to permeate the raw pork for 10 minutes with no current applied. In an experimental sample as above, a constant iontophoretic current of 125 μA at 10 V was applied to the sample for 10 minutes. The current/voltage combination was chosen because it was shown in previous experiments that it caused no heating or denaturing of an albumin solution.
The above-treated samples were removed from the cuvettes and sliced vertically with a scalpel to give cross sections. The cross sections were analyzed in a scanning electron microscope with energy dispersive X-ray detection to produce
It will be appreciated by those skilled in the art that changes could be made to the embodiments and examples described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
This application claims priority from U.S. Provisional Patent Application No. 62/031,400, filed Jul. 31, 2014, the disclosure of which is hereby incorporated by reference herein in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US15/43094 | 7/31/2015 | WO | 00 |
Number | Date | Country | |
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62031400 | Jul 2014 | US |