Patent Grant
10271981
The present disclosure is directed to a combination wound and injury treatment apparatus, and more particularly, to a pressurized wound and injury treatment apparatus that may include thermal packs that may be positioned on a patient's body part to provide circumferential thermal treatment at a desired location on the body part and/or pressurized sterile material for the treatment of wounds and/or injuries.
The generally accepted first aid treatment for injuries such as, for example, strains, sprains, contusions, dislocations, uncomplicated fractures and other non-acute injuries to human body parts may be often referred to by the acronym RICE, which stands for rest, ice, compression and elevation. Rest may be prescribed because continued activity may cause further injury to the body part thereby delaying the healing process, increasing pain, and stimulating internal bleeding. Ice may be prescribed because blood vessels contract when exposed to cold temperatures, which helps reduce swelling in the injured body part and also helps to reduce the extent of internal bleeding from injured capillaries and blood vessels. Compression may be prescribed because it tends to hasten healing time by reducing swelling around the injury. And, elevation of the body part above the heart may be prescribed because it tends to reduce swelling in the body part and also tends to reduce pain.
Although ice may be prescribed to treat injured body parts, ice may cause discomfort when placed between a compressive wrap and an injured body part because it may be a rigid non-conforming solid. Ice may be also difficult to position on an injured body part, and it tends to melt quickly, which results in a loss of the desired cold treatment and/or frequent disturbance of the injured body part to apply more ice. In view of these and other disadvantages, temperature-retaining gel-filled thermal packs may be frequently used instead of ice in the first aid treatment of injured body parts. The gels used in such packs tend to remain cold for a longer period of time than ice, and such gels also preferably remain viscous at low temperatures, which allow them to more comfortably conform to the contours of the injured body part when placed between a compressive wrap and the injured body part.
Flat packs, while widely used to provide first aid treatment to injured body parts, present certain problems and disadvantages. One problem with flat packs may be that they do not provide circumferential thermal treatment to injured body parts (i.e., thermal treatment completely surrounding the injured body part at the location of the injury). Flat packs may be effective in applying cold treatment to injured body parts only insofar as they may be placed into contact with the injured body part. Thus, in order to provide circumferential or radial thermal treatment to an injured body part, it may be typically necessary to apply more than one flat pack to the injured body part, which may present placement and retention problems. In addition, it may be sometimes very difficult and time consuming to secure flat packs to an injured body part, even when the flat pack may be provided with straps or other securing means
Concerning wounds, one of the leading causes of death on military battlegrounds and in hospital trauma units may be severe blood loss and the associated shock that it produces. Therefore, one of the most vital priorities of caregivers (medics, first responders, and medical providers) may be to control and stop bleeding. There are many devices and methods that may be employed to control bleeding. One of the most commonly used devices for bleeding control may be the elastic bandage.
Elastic bandages have been known in the prior art for many years. These bandages may be sometimes called “roller” bandages or “wraps” and come in rolls having various fasteners, such as Velcro®, metal clips, or tape. They may be sold under brand names such as ACE® wrap.
Elastic bandages may be a preferred wound dressing by caregivers ranging from physicians and trained medics to individual first responders with minimal first aid training. Elastics bandages may be highly adaptable to treat a range of wounds and conform to virtually any body part. Elastic bandages provide many benefits at the wound site, including applying varying degrees of compression and support to the wound, as well as providing a sterile barrier around the wound. Compression and support may be effective in controlling bleeding, and reducing pain and swelling in the area around the wound. The sterile barrier reduces the risk of contamination and infection of the wound.
Elastic bandages may be also effective in applying and securing other treatment medicaments and materials to the wound site. One material that may be often used in wound dressing and treatment may be a woven fabric or gauze. Gauze may be effective in controlling bleeding and may be placed directly on the wound to provide focused treatment at the wound site. Gauze may be also used as a sterile material to remove foreign matter from the wound site.
Many currently available bandages act to cover the wound site. Their main function may be to keep the wound site clean, not to control hemorrhage. In order to control hemorrhage, another material, such as gauze, must be used at the wound site. The gauze may then be covered and wrapped by the bandage. These bandages require the introduction and use of other materials to properly treat at least one of a wound and an injury.
There may be presently available hemostatic dressings that may be designed to promote the accelerated clotting of blood at wounds. Examples of these dressing may be the HemCon® bandage (HemCon Inc., Tigard, Oreg., U.S.A) and QuickClot® (Z-Medica Corporation, Wallingford, Conn., U.S.A.). While these products generally promote clotting, they still require the application of direct pressure to the wound site in order to be effective.
Notwithstanding the usefulness of the above-described treatments, a need still exists for a fully integrated systems and methods for wound and/or injury treatment, systems and methods for treating wounds and/or injuries relatively quickly and effectively while reducing the risk of contamination and infection.
In one embodiment, the present disclosure provides a combination wound and injury treatment apparatus that may include thermal packs that may be positioned onto a patient's body part to provide circumferential thermal treatment. A combination wound and injury treatment apparatus in accordance with the disclosure comprises a tubular body having a first opening, a second opening, an inner surface and an outer surface. The first opening, the inner surface and the second opening cooperate to define a passage through the tubular body for the body part. The inner surface of the tubular body may be defined by a continuous flexible material such as, for example, a copolymer of polyester and polyurethane. The outer surface may be defined by similar material or related less flexible material. A temperature-retaining fluid such as a water-based gel may be received between the inner surface. A selectively pressurizable compartment may be formed by the inner surface and the outer surface of the tubular body. When inflated, the air pressurizable compartment circumferential compresses and supports for the body part. An insulating layer (e.g., a fabric wrap such as gauze) may be disposed between the inner surface of the combination wound and injury treatment apparatus and the patient's body part to protect the patient's skin from frostbite and/or to stop the bleeding.
The present disclosure also provides a method of treating an injured body part. The method according to the disclosure comprises providing a combination wound and injury treatment apparatus in accordance with the disclosure, positioning the passage through the tubular body of the combination wound and injury treatment apparatus around the injured body part, and positioning the combination wound and injury treatment apparatus on the injury and/or wound of the body part at a location where circumferential thermal treatment and/or compression may be desired. The diameter of the passage through the combination wound and injury treatment apparatus may be substantially the same size or larger than the diameter of the injured body part. When the diameter of the passage through the combination wound and injury treatment apparatus may be substantially the same size relative the diameter of the injured body part, the inner surface of the tubular body may make loose contact with the body part or an insulating layer disposed between the inner surface of the tubular body and the body part, causing the continuous flexible material to surround the body part. The tubular body gently conforms to the contours of the body part and provides substantially even compression to the body part, but, once pressurized, does not slide relative to the surface of the body part. The pressurizable compartment may be inflated to provide compression for the body part and also to insure that the inner surface of the combination wound and injury treatment apparatus may be positioned circumferentially into contact with the body part or an insulating layer disposed between the body part and the inner surface of the combination wound and injury treatment apparatus.
As noted, a combination wound and injury treatment apparatus according to the disclosure may be positioned at the desired location on a body part simply by positioning the combination wound and injury treatment apparatus around the body part proximate to the injury and/or wound. During positioning, the continuous flexible material may loosely engage the surface of the body part in a gentle but not compressive manner, but does not slide relative to the surface body part as the combination wound and injury treatment apparatus may be positioned around the injured and/or wounded body part. Once the pressurized compartment is inflated, the continuous flexible material may stretch and conform to the shape of the body part, providing compressive force and circumferential thermal treatment at the desired location. The combination wound and injury treatment apparatus according to the disclosure may be retained in the desired location on the injured body part without the need for additional securing means or over-wrapping, and thus may be quickly and easily installed by a patient using. This allows for quick easy treatment of injured body parts.
A first aspect of the present disclosure is a combination wound and injury treatment apparatus, comprising: at least one outer wall having an outer surface and an inner surface and an upper end a lower end; at least one inner wall having an outer surface and an inner surface and an upper end and a lower end; at least one upper end member having an inner surface and an outer surface; at least one lower end member having an inner surface and an outer surface, the upper end member and the lower end member operatively connecting the outer wall and the inner wall such that the inner surface of the outer wall, the inner surface of the inner wall, the inner surface of the upper wall and the inner surface of the lower wall cooperate to form at least one chamber therebetween, the outer surface of the inner wall being configured to encase at least a portion of a patient's body wherein at least a portion of outer surface of the inner wall includes a sterile material operatively associated therewith for contacting at least one of a wound and an injury; and wherein the at least one chamber is capable of being pressurized such that the sterile material of the outer surface of the inner wall is capable of selectively applying pressure to the wound on the patient.
A second aspect of the present disclosure is a combination wound and injury treatment method, comprising: providing a combination wound and injury treatment apparatus configured to accept an open wound portion of a patient, the apparatus comprising: at least one outer wall having an outer surface and an inner surface and an upper end a lower end; at least one inner wall having an outer surface and an inner surface and an upper end and a lower end; at least one upper end member having an inner surface and an outer surface; at least one lower end member having an inner surface and an outer surface, the upper end member and the lower end member operatively connecting the outer wall and the inner wall such that the inner surface of the outer wall, the inner surface of the inner wall, the inner surface of the upper wall and the inner surface of the lower wall cooperating to form at least one chamber therebetween, the outer surface of the inner wall being configured to encase at least a portion of a patient's body wherein at least a portion of outer surface of the inner wall includes a sterile material operatively associated therewith for contacting at least one of a wound and an injury; and wherein the at least one chamber is capable of being pressurized such that the sterile material of the outer surface of the inner wall is capable of selectively applying pressure to the wound on the patient's body; placing the wound treatment apparatus over at least one of a wound and an injured area of a patient's body; and applying pressure to the wound with the combination wound and injury treatment apparatus.
A third aspect of the present disclosure is a combination wound and injury treatment apparatus comprising: a plurality of modular combination wound and injury treatment apparatus, each modular combination wound and injury treatment apparatus comprising: at least one outer wall having an outer surface and an inner surface and an upper end a lower end; at least one inner wall having an outer surface and an inner surface and an upper end and a lower end; at least one upper end member having an inner surface and an outer surface; at least one lower end member having an inner surface and an outer surface, the upper end member and the lower end member operatively connecting the outer wall and the inner wall such that the inner surface of the outer wall, the inner surface of the inner wall, the inner surface of the upper wall and the inner surface of the lower wall cooperating to form at least one chamber therebetween, the outer surface of the inner wall being configured to encase at least a portion of a patient's body wherein at least a portion of outer surface of the inner wall includes a sterile material operatively associated therewith for contacting at least one of a wound and an injury; and wherein the at least one chamber is capable of being pressurized such that the sterile material of the outer surface of the inner wall is capable of selectively applying pressure to the wound on the patient's body.
A fourth aspect of the present disclosure is a combination wound and injury treatment apparatus comprising: a tubular body having a first opening, a second opening, a relatively inflexible outer wall having an outer surface and an inner surface, a relatively flexible inner wall having an inner surface and an outer surface, an upper end member having an inner surface and an outer surface and a lower end member having an inner surface and an outer surface, the first opening, the inner surface of the relatively flexible inner wall and the second opening define a passage through the tubular body for receiving a body part; structure formed between the inner surface and the outer surface of the inner wall, the structure being capable of receiving a temperature retaining fluid; a chamber, operatively formed between the inner surface of the outer wall and the outer surface of the inner wall, the chamber being capable of being pressurized; at least one valve, operatively positioned in the outer wall, the at least one valve being capable of regulating the pressure inside the chamber; and a sterile substance, operatively positioned contiguous with the outer surface of the inner wall and being capable of being positioned proximate at least one of a wound and an injury.
The foregoing and other features of the disclosure may be hereinafter more fully described and particularly pointed out in the claims, the following description setting forth in detail certain illustrative embodiments of the disclosure, these being indicative, however, of but a few of the various ways in which the principles of the present disclosure may be employed.
The subject matter which may be regarded as the disclosure may be particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other features and advantages of the disclosure may be apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
A detailed description of the hereinafter described embodiments of the disclosed apparatus and method may be presented herein by way of exemplification and not limitation with reference to the Figures.
With reference to
The continuous relatively flexible material may be a polymeric film that remains flexible over a relatively broad temperature range of from about 0° F. to about 130° F., although the disclosure is not limited in this regard. A large number of polymeric films that remain flexible over such a temperature range are known to those skilled in the art. It will be appreciated that polymeric materials used in the disclosure may be single layer films or multi-layer structures, although the disclosure is not limited in this regard. Regardless of the number of layers, the polymeric materials must be capable of preventing air from moving from one side 26 of the polymeric materials through the polymeric materials and escaping out the other side 24 of the polymeric materials, although the disclosure is not limited in this regard.
In one embodiment, the continuous relatively flexible material may exhibit a Shore A durometer hardness of about 85 as measured in accordance with the ASTM 2240.00 standard, although the disclosure is not limited in this regard. In another embodiment, the continuous flexible material may exhibit a Shore A durometer hardness of about 93 as measured in accordance with the ASTM 2240.00 standard, although the disclosure is not limited in this regard. Polymeric materials possessing such properties may be advantageously puncture resistant and capable of preventing the flow of air there through, yet remain flexible, although the disclosure is not limited in this regard.
In one embodiment, the continuous flexible material preferably may have a thickness of from about 3 to about 15 mils, although the disclosure is not limited in this regard. In another embodiment, the continuous flexible material may have a thickness of about 5.0 mils, although the disclosure is not limited in this regard. It will be appreciated that flexible material thickness is not per se critical, and that a variety of flexible material thicknesses may be used to fabricate the inner wall 22 a combination wound and injury treatment apparatus in accordance with the disclosure as long as the combination wound and injury treatment apparatus may be conformable to the particular body part and may be capable of applying compression against injuries and/or wounds, although the disclosure is not limited in this regard.
In another embodiment of the disclosure, the continuous relatively flexible material may comprise a 5 mil thick copolymer of polyester and polyurethane having a Shore A durometer hardness of about 95 as measured in accordance with the ASTM 2240.00 standard, although the disclosure is not limited in this regard. This relatively flexible material provides several advantages. It may be heat-sealed to itself, which facilitates fabrication of the combination wound and injury treatment apparatus, although the disclosure is not limited in this regard. It does not irritate human skin on contact. And, it remains smooth and flexible over the temperature range of from about 0° F. to about 130° F., although the disclosure is not limited in this regard.
A temperature-retaining fluid may be received into the space 60 between the inner surface 24 and the outer surface 26 of the inner wall 22, although the disclosure is not limited in this regard. Throughout the instant specification and in the appended claims, the term “temperature-retaining fluid” means any non-gaseous material that changes shape or direction uniformly in response to an external force imposed upon it and that may have the capacity to retain heat or cold for transfer to a body part, although the disclosure is not limited in this regard. The term applies not only to liquids, but also to finely divided solids, gels and combinations of liquids and solid particles having such properties, although the disclosure is not limited in this regard. In one embodiment, the temperature-retaining fluid may be a gel, and in another embodiment, a water-based gel, although the disclosure is not limited in this regard.
Water-based gels may be formulated so as to provide a temperature-retaining fluid that may be more viscous than water and does not become a hard solid within the temperature range of from 0° F. and 32° F., although the disclosure is not limited in this regard. Such gels may conform to the contours of the injured body part more comfortably than ice, although the disclosure is not limited in this regard. In addition, such gels tend to retain their desired thermal properties for a longer period of time than water, although the disclosure is not limited in this regard. The gel-filled combination wound and injury treatment apparatus may be pre-heated or pre-chilled, depending upon the type of thermal treatment to be provided, although the disclosure is not limited in this regard. The composition of the gel may be not per se critical, but preferably a non-toxic formulation may be used to minimize potential injury in the event of exposure, although the disclosure is not limited in this regard.
In another embodiment of the disclosure, water-filled capsules may be dispersed in the temperature-retaining fluid, although the disclosure is not limited in this regard. When the combination wound and injury treatment apparatus is pre-chilled (e.g., through storage in a conventional freezer), the water in the water-filled capsules freezes and becomes solid ice, although the gel remains a viscous fluid, although the disclosure is not limited in this regard. The frozen water-filled capsules extend the period of time during which the combination wound and injury treatment apparatus remains cold, although the disclosure is not limited in this regard. The water-filled capsules may be preferably small, such as the size of peas, and substantially spherical, which allows the combination wound and injury treatment apparatus to comfortably conform to body parts, although the disclosure is not limited in this regard.
Other free-flowing solid structures may be dispersed in the temperature-retaining fluid. Examples include inorganic particulates (e.g., sand and/or ceramic particles), spherical structures (e.g., glass and/or metal spheres), magnets and combinations thereof, although the disclosure is not limited in this regard. It will be appreciated that virtually any relatively small substantially free-flowing solid structure may be dispersed in the temperature-retaining fluid, but water-filled capsules may be most preferred in view of cost, safety, and effectiveness, although the disclosure is not limited in this regard.
It may be often desirable to dispose an insulating layer between the body part and the combination wound and injury treatment apparatus, particularly when the temperature retaining combination wound fluid positioned in the injury treatment apparatus 60 may have been pre-chilled below the freezing point of water, although the disclosure is not limited in this regard. The insulation layer 62 having an inner surface 64 and an outer surface 66, which may be formed of fabric, such as, for example, a sterile material possibly in combination with a polymeric foam, may prevent frostbite among other conditions, although the disclosure is not limited in this regard. In one embodiment, the insulation layer 62 may be disposed as a removable layer inside the tubular body of the combination wound and injury treatment apparatus 10 so as to be coextensive with the inner surface 22 of the tubular body, although the disclosure is not limited in this regard. In another embodiment, additional insulation layer 62 may be wrapped around the body part prior to applying the combination wound and injury treatment apparatus (e.g. a sleeve, a sock or an ACE bandage), although the disclosure is not limited in this regard.
It will be appreciated that the combination wound and injury treatment apparatus 10 according to the disclosure may be formed with passages having various configurations depending upon the intended use, although the disclosure is not limited in this regard. In order to insure that the proper compressive force may be applied to the body part, the combination wound and injury treatment apparatus should be properly sized, although the disclosure is not limited in this regard. Larger sized combination wound and injury treatment apparatus may be used on legs, and smaller sized combination wound and injury treatment apparatus may be used on arms and children, although the disclosure is not limited in this regard. Combination wound and injury treatment apparatus according to the disclosure may be custom-sized to provide injury and/or wound treatment to human hands, fingers, wrists, elbows, forearms, upper arms, feet, ankles, calves, knees, and thighs, as well as other body parts, although the disclosure is not limited in this regard. A combination wound and injury treatment apparatus having a longitudinal length of about 4.0 inches and an inner diameter of about 1.0 inch may be particularly suitable for use in providing thermal treatment to a human finger, although the disclosure is not limited in this regard. In addition, combination wound and injury treatment apparatus according to the disclosure may be customized to provide combination wound and/or injury treatment to the body parts and/or bodies of non-human animals, as would be understood by those skilled in the art, although the disclosure is not limited in this regard.
When configured for use on a human wrist, the passage through the tubular body may be preferably substantially cylindrical in shape with an inner diameter within the range of from about 2.5 to about 4.0 inches, although the disclosure is not limited in this regard. The passage through the tubular body preferably may have a length of from about 4.0 to about 6.0 inches, although the disclosure is not limited in this regard. Approximately 16 ounces of water-based gel material may be disposed into the space between the inner surface and the outer surface, which results in a gel layer that may be about 0.5 inches thick around the entire wrist when the combination wound and injury treatment apparatus may be positioned on the patient's wrist, although the disclosure is not limited in this regard.
Combination wound and injury treatment apparatus configured for use on an elbow generally have a passage through the tubular body that may be larger in diameter and greater in length than a combination wound and injury treatment apparatus configured for use on a wrist, although the disclosure is not limited in this regard. Combination wound and injury treatment apparatus configured for use on forearms preferably have a tapered passage, which may result of the combination of a plurality of individual combination wound and injury treatment apparatus, although the disclosure is not limited in this regard. Combination wound and injury treatment apparatus configured for elbows (not shown), ankles, knees (not shown), calves, thighs (not shown), and other body parts may be preferably shaped and sized so as to be comfortable when positioned thereon, although the disclosure is not limited in this regard. It will be appreciated that the size of the passage and the amount of gel disposed into the space between the inner surface and the outer surface may be adjusted to suit a particular end use application, although the disclosure is not limited in this regard.
A plurality of combination wound and injury treatment apparatus each interconnected to the other is illustrated in
As stated above,
As illustrated in
In view of the foregoing, a combination wound and injury treatment apparatus according to the disclosure provides many advantages. The circular shaped tubular body allows the combination wound and injury treatment apparatus to be gently positioned proximate the patient's body part quickly and easily, although the disclosure is not limited in this regard. The combination wound and injury treatment apparatus does not normally require the use of auxiliary attachment means such as straps or wraps, although the disclosure is not limited in this regard. The combination wound and injury treatment apparatus provides radial compression to the body part, which reduces swelling and speeds up the recovery time. And, the combination wound and injury treatment apparatus provides circumferential thermal treatment to an injured body part, although the disclosure is not limited in this regard.
Elements of the embodiments have been introduced with either the articles “a” or “an.” The articles may be intended to mean that there may be one or more of the elements. The terms “including” and “having” and their derivatives may be intended to be inclusive such that there may be additional elements other than the elements listed. The conjunction “or” when used with a list of at least two terms may be intended to mean any term or combination of terms. The terms “first” and “second” may be used to distinguish elements and may be not used to denote a particular order.
While the disclosure may have been described in detail in connection with only a limited number of embodiments, it should be readily understood that the disclosure may be not limited to such disclosed embodiments. Rather, the disclosure may be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described, but which may be commensurate with the spirit and scope of the disclosure. Additionally, while various embodiments of the disclosure have been described, it may be to be understood that aspects of the disclosure may include only some of the described embodiments. Accordingly, the disclosure may be not to be seen as limited by the foregoing description, but may be only limited by the scope of the appended claims.
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