This disclosure relates generally to treatment of wounds and, in particular, to materials and methods for debriding a wound.
Debridement is a well-known and important procedure of removing undesired (e.g., dead, damaged, infected, or the like) tissue from a wound to promote the healing of healthy tissue in and around the wound. While surgical (e.g., scalpel, laser, etc.) and mechanical (e.g., irrigation, suction, hand tools, etc.) debridement are most commonly employed, it is not uncommon for fabric-based wound cleaning materials (e.g., pads, cloths, etc.) to be used for manual cleaning and debridement of a wound when surgical or mechanical debridement is not practical.
Fabric-based wound cleaning materials are advantageous in that they are low cost and reasonably effective to manually debride a wound. A major challenge presented by such fabric-based wound debriding materials is that they are prone to either partially disintegrating or otherwise leaving some of its material (e.g., fibers) in the wound during debridement, especially when they are used to debride tough (e.g., necrotic) tissues. This requires the caregiver (e.g., a nurse, a doctor, or the like) to incorporate an additional step of flushing the wound (e.g., with water, saline, or the like) with the hope that the flushing would wash away any fibers or polymeric material left in the wound. However, flushing the wound is not always effective to wash away all of the small fabric and/or polymer materials from the surface of the wound and/or around the wound. As a result, some fibers of the debriding material may be undesirably left in the wound, potentially impeding the healing of the wound and/or leading to an infection.
Disclosed herein are embodiments of systems, apparatuses, methods, and systems pertaining to wound debridement using wound debridement materials. This description includes drawings, wherein:
Elements in the figures are illustrated for simplicity and clarity and have not been drawn to scale. For example, the dimensions and/or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present invention. Certain actions and/or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. The terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein.
The following description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of exemplary embodiments. Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
Generally, pursuant to various embodiments, materials and methods are provided for wound debridement. In some embodiments, a method of debriding a wound of a patient includes applying a wound debridement material in frictional contact across at least a portion of a wound surface of the patient. The wound surface includes tissue to be removed and the wound debridement material includes a solid porous foam soaked by a fluid. The method further includes removing, at least a portion of the tissue from the wound surface via adherence of the at least the portion of the tissue to the wound debridement material without leaving solid debris of the foam on the wound surface after the applying step. Without wishing to be limited by theory, the tissue is removed from the surface of the wound as a result of friction between the surface of the wound debridement material and the surface of the wound that contains tissue to be removed and/or due to the wetness of the wound debridement material that facilitates the adherence of at least some of the tissue to the wound debridement material and/or via absorption of at least some of the tissue, exudate, or the like from the wound surface into the surface of the wound debridement material.
In some embodiments, a method of facilitating debridement of a wound of a patient includes: providing a package including a wound debridement material comprising a solid porous foam soaked by a fluid such that the moisture content of the foam is between about 20 wt. % and about 60 wt. %; and providing instructions, on the package, instructing a user to apply the wound debridement material across at least a portion of a wound surface of the patient in order to remove tissue from the wound surface via adherence of the tissue to the wound debridement material.
In some embodiments, a method of making a packaged wound debridement material for debriding a wound of a patient includes: providing a wound debridement material comprising a solid porous foam; soaking the foam in a fluid such that the moisture content of the foam is between about 20 wt. % and about 60 wt. %; inserting the soaked foam into a package; and sealing the package.
In some embodiments, a wound debridement material includes a solid porous foam soaked by a fluid such that the foam has a moisture content from about 20 wt. % to about 60 wt. % and has a texture that permits the wound debridement material, when applied across at least a portion of a wound surface of a patient including tissue to be removed, to remove the tissue from the wound surface via adherence of the tissue to the wound debridement material without leaving solid debris of the foam on the wound surface.
The wound debridement material 100 illustrated in
In some embodiments, the wound debridement material 100 is WhiteFoam® (available from Kinetic Concepts, Inc. of San Antonio, Tex.), which is a white, open-celled, non-reticulated polyvinyl alcohol-based solid foam having a hydrophilic (i.e., moisture-retaining) structure and pores having a diameter from about 200 to about 1000 microns. In certain embodiments, the wound debridement material 100 is formed of a material including but not limited to: polyvinyl alcohol (PVA); polyurethanes (e.g., polyurethane-polyester, polyurethane-polyether, or the like); polyolefins (e.g., polypropylenes (PP), polyethylenes (PE), or the like), silicone elastomers and copolymers; polyvinylchloride (PVC); polyamides; polyesters; acrylics; thermoplastic elastomers (e.g., styrene-butene-styrene (SBS), styrene-ethylene-butene-styrene (SEBS), or the like); polyether-amide block copolymers (PEBAX); elastomers (e.g., styrene butadiene rubber (SBR); ethylene propylene rubber (EPR); ethylene propylene diene modified rubber (EPDM); natural rubber (NR); vinyl acetate, ethylene vinyl acetate (EVA); polyvinyl acetal; polyvinyl butyral (PVB), or the like).
In some aspects, the wound debridement material 100 of
In certain aspects, the porosity of the solid foam of
In some embodiments, the wound debridement material 100 has a density from about 100 kg/m3 to about 300 kg/m3, and, in some aspects, from about 145 kg/m3 to about 270 kg/m3. In some embodiments, the wound debridement material 100 has a stiffness of about 30 Shore A durometer to about 70 Shore A durometer. In some aspects, the wound debridement material 100 is mechanically compressed to increase its density at ambient pressure. In certain embodiments, a compression stiffness of the would debridement material 100 is from about 4.0 kPa at 25% compression to about 9.0 kPa at 50% compression.
Generally, a compressed foam may be characterized by a firmness factor (FF) that is defined as a ratio of the density of a foam in a compressed state to the density of the foam in an uncompressed state. For example, a firmness factor (FF) of 5 may refer to a compressed foam having a density that is five times greater than a density of the same foam in an uncompressed state. Mechanically or chemically compressing a foam may reduce a thickness of the foam at ambient pressure when compared to the same foam that has not been compressed. Reducing a thickness of a foam by mechanical or chemical compression may increase a density of the foam, which may increase the firmness factor (FF) of the foam. In some embodiments, the wound debridement material 100 is configured to absorb moisture (e.g., exudate, pus, blood, etc.) and/or remove up dry tissue from a wound of a patient by drawing or wicking such moisture and/or lifting (e.g., by adherence to the moist surface(s) of the wound debridement material 100) the dry tissue up from the surface of the wound and/or around the wound.
In some embodiments, the wound debridement material 100 is a foam having a moisture content from about 20 wt. % to about 60 wt. %. Without wishing to be limited by theory, the moisture content of the foam in such embodiments provides the foam with a texture that permits the wound debridement material, applied in frictional contact (e.g., rubbing) across at least a portion of surface of a wound of a patient, to remove tissue from the surface of the wound and/or around the wound via friction between the surface of the wound debridement material 100 and the surface of the wound and/or due to the wetness of the wound debridement material 100 that facilitates the adherence of at least some of the dry and/or wet tissue to the wound debridement material 100 and/or via absorption of at least some of the tissue from the wound surface into the surface of the wound debridement material 100.
In some aspects, the fluid that provides the wound debridement material 100 with its moisture content is a liquid that includes but is not limited to: water, saline, polyhydric alcohol, mixtures thereof, or the like. Given that the wound debridement material 100 is configured for application to a wound of a patient in a medical setting, in some embodiments, the liquid is sterile.
In some configurations, the wound debridement material 100 may be pre-moistened and retained in sealed packaging (e.g., package 500 of
For example, a wound debridement material 100 selected to debride a wound having a greater amount of harder tissue (e.g., eschar) to be removed would be adjusted to have a lower moisture content (e.g., from about 20 wt. % to about 40 wt. %).Conversely, a wound debridement material 100 selected to debride a wound having a comparatively lesser amount of harder tissue to be removed would be adjusted to have a higher moisture content (e.g., from about 40 wt. % to about 60 wt. %). In other words, a wound debridement material 100 having a lower moisture percentage is likely to be more effective in debriding a wound having more dry, harder tissue than a wound debridement material 100 having a comparatively higher moisture percentage.
With reference to
As can be seen in
As mentioned above, the wound debridement material 100 is configured (e.g., by having a moisture level within a predetermined range and by having a suitable texture as a result having such a moisture level) to remove tissue from the surface of the wound 202 and/or around the wound 2020 via frictional contact (e.g., achieved by a user rubbing the wound debridement material 100 across the surface of the wound 202) between the surface of the wound debridement material 100 and the surface of the wound and/or due to the wetness of the wound debridement material 100 that facilitates the adherence of at least some of the dry and/or wet tissue to the wound debridement material 100 and/or via absorption of at least some of the tissue from the wound surface into the surface of the wound debridement material 100.
In the exemplary embodiment illustrated in
With reference to
In one approach, the method includes instructing a user to apply (e.g., rub) the wound debridement material 100 in frictional contact across at least a portion of a surface of a wound 202 of the patient in order to remove tissue 204 from the surface of the wound 202 via adherence of the tissue 204 to the wound debridement material 100. In some aspects, the package 500 includes a notification that the application of the wound debridement material 100 to at least a portion of the surface of the wound 202 of the patient to remove at least a portion of the tissue 204 from the surface of the wound 202 via adherence of the tissue 204 to the wound debridement material 100 will not leave solid debris of the wound debridement material 100 on or around the surface of the wound 202.
In some embodiments, the package 500 containing the wound debridement material 100 is hermetically sealed such that the wound debridement material 100 is sealed and soaked by a fluid as described above and retains its initial moisture content due to being sealed and not exposed to ambient air while in the package 500. In such embodiments, prior to the application of the wound debridement material 100 across at least a portion of the surface of the wound 202, the method of debriding the wound 202 of the patient further includes removing the wound debridement material 100 from a sealed package 500 containing the wound debridement material 100 soaked by the fluid.
In some embodiments, the wound debridement material 100 is soaked with the fluid in the sealed package 500 such that the wound debridement material 100 has a moisture content of about 20% to about 60% by total weight of the wound debridement material 100. In such embodiments, after the opening of the package 500 (e.g., by tearing away a portion of the package 500) and the removal of the wound debridement material 100 from the package 500, the next step of the method of debriding the wound 202 would include applying (e.g., by rubbing) the wound debridement material 100 removed from the package 500 in frictional contact across at least a portion of the surface of the wound 202 of the patient, as described above, to remove at least a portion of the tissue 204 from the surface of the wound 202 via adherence of the tissue 204 to the wound debridement material 100 and without leaving solid debris of the wound debridement material 100 on or around the surface of the wound 202.
In some embodiments, the wound debridement material 100 is soaked with the fluid in the package 500 such that the wound debridement material 100 has a moisture content of above 60 wt. % (e.g., from about 60 wt. % to about 100 wt. %). Since the wound debridement material 100, when soaked with a fluid such that it has a moisture above 60 wt. % does not possess optimal surface friction coefficient for debriding the tissue 204 from the surface of the wound 202, in such embodiments, after the removal of the wound debridement material 100 from the package 500, the next step of the method of debriding the wound 202 would include removing at least a portion of the fluid absorbed in the wound debridement material 100 until the wound debridement material 100 has a moisture content between about 20 wt. % and about 60 wt. %. In some aspects, the fluid may be removed from the wound debridement material 100 simply by squeezing (or otherwise applying pressure to) the wound debridement material 100 such that the fluid is ejected therefrom.
In some embodiments, after fluid is removed from the wound debridement material 100 to bring the moisture level of the wound debridement material to a moisture percentage with the range of about 20 wt. % to about 60 wt. %, the next step of the method of debriding the wound 202 would include applying (e.g., rubbing) the wound debridement material 100 removed from the package 500 (and having its moisture content decreased to a moisture content between about 20 wt. % and about 60 wt. %) in frictional contact across at least a portion of the surface of the wound 202 of the patient, as described above, thereby removing at least a portion of the tissue 204 from the surface of the wound via adherence of the tissue 204 to the wound debridement material 100 and without leaving solid debris of the wound debridement material 100 on or around the surface of the wound 202.
In some embodiments, the wound debridement material 100 is provided in the package 500 such that the wound debridement material 100 has a moisture content of 0, i.e., the wound debridement material 100 is completely dry. Given that the wound debridement material 100, when completely dry, has a hard texture and thus a friction coefficient that may lead to irritation of the surface of the wound 202 of the patient, in such embodiments, after the removal of the wound debridement material 100 from the package 500, the next step of the method of debriding the wound 202 would include applying a fluid (e.g., water, saline, polyhydric alcohol, or the like) to at least a portion of the wound debridement material 100 until the wound debridement material 100 has a moisture content between about 20% and about 60% based on total weight of the wound debridement material 100. In some aspects, the fluid is applied onto the wound debridement material 100 by pouring the fluid from a suitable container (e.g., bottle) or device. In other aspects, the fluid is applied onto the wound debridement material 100 by soaking the wound debridement material 100 in the fluid contained in a suitable receptacle (e.g., tub).
The next step of such a method would be applying (e.g., rubbing) the wound debridement material 100 removed from the package 500 (and having its moisture content increased to a moisture content between about 20 wt. % and about 60 wt. %) in frictional contact across at least a portion of the surface of the wound 202 of the patient, as described above, to remove at least a portion of the tissue 204 from the surface of the wound via adherence of the tissue 204 to the wound debridement material 100 and without leaving solid debris of the wound debridement material 100 on surface of the wound 202.
In some embodiments, the wound debridement material 100 is applied (e.g., placed into direct contact and rubbed) across at least a portion of the wound surface of the patient at a pressure of about 100 kPa to about 150 kPa. Generally, the pressure at which the wound debridement material 100 is applied to the surface of the wound 202 can be adjusted based on the moisture content of the wound debridement material 100. In other words, in some aspects, a wound debridement material 100 having a higher moisture content (e.g., from about 40 wt. % to about 60 wt. %) would be applied to the surface of the wound 202 at a higher pressure (e.g., from about 125 kPa to about 150 kPa). Conversely, a wound debridement material 100 having a moisture content that is lower (e.g., from about 20 wt. % to about 40 wt. %) would be applied to the surface of the wound 202 at a lower pressure (e.g., from about 100 kPa to about 125 kPa).
In certain embodiments, a method of making a packaged wound debridement material 100 for debriding a wound of a patient is also provided. The exemplary method includes providing a wound debridement material 100 comprising a solid porous foam. As discussed above, the wound debridement material 100 may be a solid polyvinyl alcohol open-celled foam. The next step of such an exemplary method includes soaking the solid foam in a fluid such that the foam absorbs the fluid and achieves a moisture content of between about 20% and about 60% by total weight of the solid foam. The method then includes inserting the soaked solid foam into a package 500 and sealing the package 500. In some aspects, the soaked solid foam is hermetically sealed in the package 500.
In some aspects and with reference to
The methods and materials described herein facilitate debridement of wounds of patients without leaving solid pieces of the wound debridement materials in or on the wound. This advantageously reduces infections following surgical procedures and obviates the need for medical personnel to take extra steps in washing a wound surface following a surgical procedure.
Those skilled in the art will recognize that a wide variety of other modifications, alterations, and combinations can also be made with respect to the above described embodiments without departing from the scope of the invention, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept.
This application claims the benefit, under 35 U.S.C. § 119(e), of the filing of U.S. Provisional Patent Application Ser. No. 62/540,423, entitled “SYSTEMS AND METHODS FOR WOUND DEBRIDEMENT,” filed Aug. 2, 2017, which is incorporated herein by reference for all purposes.
Filing Document | Filing Date | Country | Kind |
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PCT/US2018/044661 | 7/31/2018 | WO | 00 |
Number | Date | Country | |
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62540423 | Aug 2017 | US |