Patent ID: 12226288

The diagrams depicted herein are illustrative. There can be many variations to the diagram or the operations described therein without departing from the spirit of the invention. For instance, the actions can be performed in a differing order or actions can be added, deleted or modified. All of these variations are considered a part of the specification.

DETAILED DESCRIPTION

Various embodiments of the invention are described herein with reference to the related drawings. Alternative embodiments of the invention can be devised without departing from the scope of this invention. Various connections and positional relationships (e.g., over, below, adjacent, etc.) are set forth between elements in the following description and in the drawings. These connections and/or positional relationships, unless specified otherwise, can be direct or indirect, and the present invention is not intended to be limiting in this respect. Accordingly, a coupling of entities can refer to either a direct or an indirect coupling, and a positional relationship between entities can be a direct or indirect positional relationship. Moreover, the various tasks and process steps described herein can be incorporated into a more comprehensive procedure or process having additional steps or functionality not described in detail herein.

The following definitions and abbreviations are to be used for the interpretation of the claims and the specification. As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains” or “containing,” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, a mixture, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but can include other elements not expressly listed or inherent to such composition, mixture, process, method, article, or apparatus.

Additionally, the term “exemplary” is used herein to mean “serving as an example, instance or illustration.” Any embodiment or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments or designs. The terms “at least one” and “one or more” may be understood to include any integer number greater than or equal to one, i.e. one, two, three, four, etc. The terms “a plurality” may be understood to include any integer number greater than or equal to two, i.e. two, three, four, five, etc. The term “connection” may include both an indirect “connection” and a direct “connection.”

The terms “about,” “substantially,” “approximately,” and variations thereof, are intended to include the degree of error associated with measurement of the particular quantity based upon the equipment available at the time of filing the application. For example, “about” can include a range of +8% or 5%, or 2% of a given value.

For the sake of brevity, conventional techniques related to making and using aspects of the invention may or may not be described in detail herein. In particular, various aspects of computing systems and specific computer programs to implement the various technical features described herein are well known. Accordingly, in the interest of brevity, many conventional implementation details are only mentioned briefly herein or are omitted entirely without providing the well-known system and/or process details.

FIG.1illustrates an exemplary wound10where a blood vessel12has an opening14from which blood16leaks into a cavity18. The wound10may be any type of wound such as, for example, but not limited to, an open wound or puncture wound where pressure and stoppage of bleeding is desirable. Referring toFIG.2, the wound10is illustrated with a plurality of articles22for applying pressure and stopping the bleeding from the blood vessel12. The articles22may be of any suitable material capable of coming into direct contact with the wound10. For example, an article may be, but not limited to, a wound dressing such as cloth, foam, powder, clear film for transparent dressings, hydrocolloid dressings, hydrogel, alginate, and collagen.

In one or more embodiments, the articles22are liquid-expandable articles which expand upon contact with a liquid such as blood or other liquids used with wounds by medical professionals such as disinfectants, clotting agents and the like. All or some of the articles22may be the same size and shape or some or all may be sized and shaped differently in order to conform to irregular wounds, be received within a wound, or placed in contact with a wound.

Still referring toFIG.2, the articles22may be absorbent material including, but not limited to sponges, cellulose or some other absorbent material. In one or more embodiments, the articles22may be compressed or configured to expand such that when received inside the wound10the articles22release stored mechanical energy and mechanically expand into expanded articles30, as shown inFIG.3, upon contact with liquid inside the wound10.

Referring toFIGS.2and3, the articles22include a chromic material24responsive to at least one stimuli. Some chromic materials24are responsive to more than one stimuli. The articles22are preferable configured to introduce the chromic material24to and/or dress the wound10. The chromic material24may be placed on, soaked on, or sprayed on the surface or the interior of one or more or all of the articles22in any suitable manner sufficient for then allowing stimuli to affect the chromic material24.

As a result of the stimuli affecting the chromic material24, the chromic material24provides a visual indicator, directly discernable by the naked eye, indicating the at least one article is at least partially in contact the wound10. In one or more embodiments, the indicator indicates how long at least one article has been at least partially in contact with the wound10and/or where the at least one article is placed within the wound10. The indicator may be a color change evidencing where the at least one article has been placed within the wound10or the indictor may be a color change indicating a period of time associated with how long the at least one article has been in contact with the wound10. In one or more embodiments, the indicator is a first color corresponding with a first period of time and then changes to a second color corresponding with a second period of time. For example, the articles22inFIG.2have chromic material24with a first color corresponding with the initial contact with the wound10for the first period of time and, as depicted inFIG.3, the articles22have expanded into expanded articles30having chromic material32with a second color corresponding with the second period of time. The chromic material32inFIG.3has changed color due to stimuli such as blood causing expansion of articles32within wound10. In one or more embodiments, because the temperature within a wound varies over time due to healing and variations in the amount of blood present, the indictor is reversible such that the indicator changes from the first color to the second color and then reverts back to the first color later in time compared to the second period of time.

Suitable chromic materials for the indicator are those which involve a change in color as a result of one or more stimuli and that are sometimes referred to as chromisms which may include, but is not limited to: Photochromism (color change caused by light), Thermochromism (color change caused by temperature (heat)), Solvatochromism (color change caused by solvent polarity), Vapochromism (color change caused by vapor of an organic compound due to chemical polarity/polarization), lonochromism (change caused by ions), Halochromism (color change caused by a change in pH), Piezochromism (color change caused by mechanical pressure), Biochromism (color change caused by interfacing with a biological entity), Cryochromism (color change caused by lowering of temperature), Hydrochromism (color change caused by interaction with bulk water or humidity) and Chronochromism (color change indirectly as a result of the passage of time).

There are also multi-stimuli responsive chromic materials which exhibit a color change when exposed to two or more stimuli. For example, thermochromic and photochromic effects can be achieved simultaneously by homogenously mixing powders with appropriate color changing style selection and proper mass ratio as disclosed in “Multi-Stimuli Responsive Chromism With Tailorable Mechanochromic Sensitivity For Versatile Interactive Sensing Under Ambient Conditions” by Songshan Zeng et al., The Royal Society of Chemistry, 2019, which is hereby incorporated by reference in its entirety. Thus, a chromic material introduced to a wound10responsive to a plurality of stimuli such as, for example, heat and light, can be utilized to indicate how long an article has been in contact with the wound10.

For example, thermochromic materials change color due to a change in temperature and can be used while treating wounds and wound healing because the temperature of a wound varies over time, for example, over a period of minutes, hours or over a period of days, especially while healing. In one or more embodiments, the thermochromic material changes color due to the temperature or the temperature change over time of the blood of the wound10. Thermochromatic crystals and leuco dyes are capable of displaying different colors at different temperatures. For example, the color of thermochromic liquid crystals can continuously range from non-reflective (black) through the spectral colors to black again depending on the temperature. Some thermochromic liquid crystals are cholesteryl nonanoate or cyanobiphenyls. Mixtures with 3 to 5 degrees C. span of temperatures and ranges from about 17 to 23 degrees C. to about 37 to 40 degrees C. can be composed from varying portions of cholesteryl oleyl carbonate, cholesteryl nonanoate, and cholesteryl benzoate. For example, the mass ratio of 65:25:10 yields a range of 17 to 23 degrees C. and 30:60:10 yields a range of 37 to 40 degrees C.

Suitable leuco dyes include spirolactones, fluorans, spiropyans and fulgides. Acids which include bisphenol A, parabens, 1,2,3-triazole derivatives, and 4-hydroxycoumarin act as proton donors, changing the dye molecule between its leuco form and its protonated colored form. Stronger acids will make the color change irreversible which facilitates temperature change determinations. Also, organic leuco dyes are available for temperature ranges between minus 5 degrees C. and 60 degrees C. in a wide range of colors.

In one or more embodiments, the chromic material is thermochromic and the indicator is a color change caused by temperature as the at least one stimuli. For example, the article may be a clotting agent where the color change is caused by heat generated by the clotting agent reacting with a liquid associated with the wound such as blood. In one or more other embodiments, the chromic material is chronochromic and the indicator is caused by how long the chromic material has been in contact with the liquid. In other words, the color change of the chromic material is caused by the passage of time.

One or more embodiments may include a kit for dressing a wound10. The kit includes a chromic material22responsive to contact with the wound and at least one article configured to introduce the chromatic material22to the wound10. The kit also includes information for measuring a color change of the chromic material22as a result of the stimuli such as being in contact with the blood of the wound10.FIGS.4A and4Billustrate exemplary embodiments of a chart or table of information40,46for measuring color change of the chromic material.

InFIG.4A, the information40includes a plurality of colors42corresponding to a plurality of temperatures44. In response to identifying the color of the chromic material and, thus, measuring the color change based on ambient temperature of the chromic material prior to contacting a wound versus the subsequent temperature of the chromic material while contacting the wound the length of time may be determined as to how long the at least one article has been in contact with the wound. Alternatively, inFIG.4B, the information46includes the plurality of colors42corresponding to a plurality of time periods48. In one or more embodiments, some or all of both the temperatures44and time periods48could be combined on the same chart or table along with the corresponding colors42. ReferencingFIG.4B, by identifying the color of the chromic material while the article has been in contact with the wound, a length of time may be determined as to how long the at least one article has been in contact with the wound.

In one or more embodiments, one or more of the expanded articles30may be removed from the wound10based on the color change of the chromic material32indicating how long the at least one expanded article30has been at least partially in contact with the wound10and then determining that one or more of the expanded articles30have been in contact with the wound10for too long. For example, in one or more embodiments, introducing the chromic material via at least one article into a wound may be performed by a first medical professional such as a paramedic and then removal of that at least one article with that chromic material from that wound based on the color change of the chromic material may be performed by a second medical professional such as a surgeon. Removal of the at least one article from the wound by the second medical professional may be performed without knowledge of when the first medical professional introduced the chromic material via the at least one article to the wound.

Turning now toFIGS.5,6,7and8,FIG.5depicts an alternative embodiment of an article in the form of an elongated member50defining a plurality of individual liquid expandable articles52wherein the individual liquid-expandable articles52release stored mechanical energy and mechanically expand into expanded articles upon contact with liquid. Although the elongated member50inFIG.5is depicted with a particular number of expandable articles52, the elongated member50may have any number of articles52.

The elongated member50also includes chromic material54on all or on one or more of the articles52. Then the elongated member50may be configured to be at least partially received within the wound10. For example,FIG.6depicts a distal end56of the elongated member50ofFIG.5where a portion58of the distal end56of the elongated member50is manually squeezed, crumpled, crushed or otherwise reduced in size about a circumference or diameter such that the distal end56is then sized to be received inside or within the wound10as shown inFIG.7. The length of the portion58of the elongated member50may be determined by estimating the depth of the wound10.FIG.8then also shows a portion62of the plurality of the individual liquid-expandable articles52of the elongated member50remaining outside the wound10. The distal end56of the elongated member50corresponding with the portion58received inside the wound10may be manually separated from the other portion62of the elongated member50not in contact with the wound10and remaining outside or exterior to the wound10by pulling apart, stretching, tearing, ripping or other suitable method of separating the two portions58,62from one another.

Upon being received within the wound10, all or some of the articles52then mechanically separate from one another. For example, the articles52affected by stimuli, such as coming into contact with liquid or blood, separate from one another due to the stored mechanical energy and mechanical expansion into the expanded articles. The articles52also separate from one another as a result of becoming obstructed or restricted against one another or against the sides of the cavity18while expanding to fill the cavity18of the wound10. Alternatively, the articles52could be held together by a liquid soluble adhesive that dissolves upon contact with liquids such as blood. In one or more embodiments, the articles52separate from one another as a result of the portion58of the elongated member being pushed into the wound10and getting bent against itself within the wound10.

In one or more embodiments, one or more of the articles52once expanded may be removed from the wound10based on the color change of the chromic material54indicating how long the at least one article52has been at least partially in contact with the wound10and then determining that one or more of the articles52after being expanded has then been in contact with the wound10for too long.

In one or more embodiments, a distal end of the portion62may also be manually squeezed, crumpled, crushed or otherwise reduced in size about a circumference or diameter such that another portion of the distal end62is then sized to be received inside or within wound10or a second or different wound. The portion of the distal end62within the wound may then be manually separated from yet another portion of the plurality of articles52not in contact with the wound and still remaining outside or exterior to the wound by pulling apart, stretching, tearing, ripping or other suitable method of separation.

FIG.9depicts an alternative embodiment of an article configured as a wound dressing80having chromic material84over a wound82. The wound dressing may be for example, but not limited to, a cloth dressing and wound82may be, for example, but not limited to, an open wound or an abrasion. In one or more embodiments, the wound dressing80may be pre-cut or in the form of a roll and the chromic material may by sprayed or pasted on after assessing the wound82. Also, in one or more embodiments, the wound dressing80may be a foam combined with the chromic material84.FIG.10then depicts the wound dressing80ofFIG.9in contact with the wound82such that all or part of the chromic material84has had a color change86as a result of stimuli associated with the wound82.

In one or more embodiments, the wound dressing80may be removed from the wound82based on the color change86of the chromic material84indicating how long the wound dressing80has been at least partially in contact with the wound82and then determining that the wound dressing80has been in contact with the wound82for too long.

FIG.11depicts a flow diagram of a method for dressing a wound according to one or more embodiments of the invention. The method100includes process block110for introducing a chromic material via at least one article to the wound and process block120for stimulating the chromic material with a stimuli. The method100then includes process block130for providing a color change in response to stimulating the chromic material and process block140for indicating via a color change of the chromic material how long the at least one article has been at least partially in contact with the wound.

The method100may also include one or more other process blocks. In one or more embodiments, the method100can include indicating where the at least one article is within the wound. The method100can also include measuring the color change from information that include a plurality of colors corresponding to a plurality of time periods where, in response to measuring the color change, a length of time the at least one article has been in contact with the wound is determined. In one or more embodiments, indicating via the color change includes providing a first color change in response to initial contact of the at least one article with the wound and then subsequently providing a second color change in response to prolonged contact of the at least one article with the wound. Also, in one or more embodiments, the at least one article includes an elongated member defining the plurality of individual liquid expandable articles. The method100may also include manually crumpling a distal end of the elongated member such that a portion of the plurality of individual liquid expandable articles are sized to be received within the wound. The method100may then include manually separating the crumpled distal end from another portion of the elongated member not in contact with the wound.

The method100may also include crumpling a distal end of the other portion of the elongated member such that another portion of the plurality of individual liquid expandable articles are sized to be received within a second wound. Then the method100may include manually separating the crumpled distal end of the other portion of the elongated member from yet another portion of the elongated member not in contact with the wound.

The method100may also include removing the at least one article from the wound based on the color change of the chromic material indicating how long the at least one article has been at least partially in contact with the wound.

FIGS.12A and12Bdepict a flow diagram of another method for dressing a wound according to one or more embodiments of the invention. The method200includes process block210for introducing a chromic material via at least one article to the puncture wound and process block220for stimulating the chromic material with a stimuli. The method200also includes process block230for manually crumpling a distal end of a portion of the at least one article such that the distal end of the portion is sized to be received within the puncture wound and process block240for manually separating the crumpled distal end from another portion of the at least one article not within the puncture wound. The method200includes process block250for providing a first color change of the chromic material in response to initial contact of the at least one article with the puncture wound and then subsequently providing a second color change of the chromic material in response to prolonged contact of the at least one article with the wound. Next, the method200includes process block260for measuring color changes of the chromic material from information comprising a plurality of colors corresponding to a plurality of time periods and, in response, determining a length of time the at least one article has been in contact with the puncture wound.

The method200may also include one or more other process blocks. In one or more embodiments, the method200can include process block270for crumpling a distal end of the other portion of the at least one article such that another portion of the at least one article is sized to be received within a second puncture wound. The method200can also include removing the at least one article from the puncture wound based on the color change of the chromic material indicating how long the at least one article has been at least partially in contact with the wound. In one or more embodiments, introducing the chromic material via the at least one article to the puncture wound is performed by a first medical professional and removing the at least one article from the puncture wound based on the color change of the chromic material is performed by a second medical professional. Also, in one or more embodiments, removing the at least one article from the puncture wound by the second medical professional is performed without knowledge of when the first medical professional introduced the chromic material via the at least one article to the puncture wound.

Additional processes may also be included. It should be understood that the processes depicted inFIGS.11,12A and12Brepresent illustrations, and that other processes may be added or existing processes may be removed, modified, or rearranged without departing from the scope and spirit of the present disclosure.

In some alternative implementations, the functions noted in the process blocks may occur out of the order noted in the Figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.

The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments described herein.