SELF WARMING MEDICAL PRODUCTS, GELS, AND FLUIDS

TECHNICAL FIELD

Aspects of this document relate generally to packaging for medical gels and fluids, and more specifically to medical packaging that includes a warming feature.

BACKGROUND

Undergoing any medical procedure often causes the patient to experience anxiety and discomfort prior to or during the procedure. This anxiety and discomfort are exacerbated by any conditions which negatively affect the patient's body. For example, if the patient is uncomfortably cold, this can affect how the patient is feeling about the procedure.

One common source of discomfort and shock is when a medical professional places a device or product on the patient, such as electrocardiogram (ECG) electrodes or ultrasound gel. Because operating rooms and other locations within a hospital or doctor's office are kept at around 64-72 degrees, these devices and products tend to be very cold and cause the patient to tense up on contact due to the unexpected temperature change. This may increase the anxiety, discomfort, and apprehension of the patient.

SUMMARY

Aspects of this document relate to a medical fluid warming system comprising a warmer having an exothermic warming composition, a medical fluid configured to be applied to a patient's body during a medical procedure, wherein the medical fluid is packaged within a single-use packet, the single-use packet is bonded to the warmer with an adhesive, and the medical fluid is thermally connected to the warmer, and a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is removable by a user to allow the reactant composition to contact the exothermic warming composition and wherein contact between the reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat.

Particular embodiments may comprise one or more of the following features. The warmer may be configured to warm the medical fluid to at least a selected temperature within twenty minutes and maintain the medical fluid at or above the selected temperature for at least ten minutes. The selected temperature may be 98 degrees Fahrenheit. The warmer may further have a casing with at least one hole, the exothermic warming composition may be positioned inside of the casing, and a seal may be removably adhered to the casing and may cover the at least one hole to form the barrier.

Aspects of this document relate to a medical fluid warming system comprising a warmer having an exothermic warming composition, a medical fluid configured to be applied to a patient's body during a medical procedure, wherein the medical fluid is thermally connected to the warmer, and a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is removable by a user to allow the reactant composition to contact the exothermic warming composition and wherein contact between the reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat.

Particular embodiments may comprise one or more of the following features. The medical fluid may be packaged within a single-use packet. The packet may be bonded to the warmer. The packet may be bonded to the warmer with an adhesive. The barrier may be an envelope configured to encase the warmer and the reactant composition may be ambient air. The warmer may be configured to warm the medical fluid to at least a selected temperature within twenty minutes and maintain the medical fluid at or above the selected temperature for at least ten minutes. The selected temperature may be 98 degrees Fahrenheit. The warmer may further have a casing with at least one hole, the exothermic warming composition may be positioned inside of the casing, and a seal may be removably adhered to the casing and may cover the at least one hole to form the barrier.

Aspects of this document relate to a medical fluid warming system comprising a warmer having an exothermic warming composition, and a medical fluid configured to be applied to a patient's body during a medical procedure, wherein the medical fluid is removably and thermally connected to the warmer.

Particular embodiments may comprise one or more of the following features. The exothermic warming composition may be air-activated. The medical fluid warming system may further comprise a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is removable by a user to allow the reactant composition to contact the exothermic warming composition. The barrier may be an envelope configured to encase the warmer and the reactant composition may be ambient air. Contact between a reactant composition and the exothermic warming composition may cause the exothermic warming composition to release heat. The medical fluid may be packaged within a single-use packet bonded to the warmer. The warmer may be configured to warm the medical fluid to at least a selected temperature within twenty minutes. The warmer may be configured to maintain the medical fluid at or above a selected temperature for at least ten minutes.

Aspects of this document relate to an electrocardiogram (ECG) electrode warming system comprising a warmer having an exothermic warming composition, at least one ECG electrode configured to attach to a patient's body to detect electric signals, wherein the at least one ECG electrode is thermally connected to the warmer, an insert positioned between the at least one ECG electrode and the warmer, wherein the at least one ECG electrode is removably connected to the insert and the warmer is bonded to the insert with an adhesive, and a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is breakable by a user to allow the reactant composition to contact the exothermic warming composition and wherein contact between the reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat.

Particular embodiments may comprise one or more of the following features. The warmer may be configured to warm the at least one ECG electrode to at least a selected temperature within five minutes and maintain the at least one ECG electrode at or above the selected temperature for at least 45 minutes. The selected temperature may be 120 degrees Fahrenheit. The exothermic warming composition may be packaged within a fabric with a weight of at least 50 grams per square meter.

Aspects of this document relate to an electrocardiogram (ECG) electrode warming system comprising a warmer having an exothermic warming composition, at least one ECG electrode configured to attach to a patient's body to detect electric signals, wherein the at least one ECG electrode is thermally connected to the warmer, and a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is breakable by a user to allow the reactant composition to contact the exothermic warming composition and wherein contact between the reactant composition and the exothermic warming composition causes the exothermic warming composition to release heat.

Particular embodiments may comprise one or more of the following features. The warming system may further comprise an insert positioned between the at least one ECG electrode and the warmer, wherein the at least one ECG electrode is removably connected to the insert. The warmer may be bonded to the insert. The warmer may be bonded to the insert with an adhesive. The barrier may be an envelope configured to encase the warmer and the reactant composition is ambient air. The warmer may be configured to warm the at least one ECG electrode to at least a selected temperature within five minutes and maintain the at least one ECG electrode at or above the selected temperature for at least 45 minutes. The selected temperature may be 120 degrees Fahrenheit. The exothermic warming composition may be packaged within a fabric with a weight of at least 50 grams per square meter.

Aspects of this document relate to an electrocardiogram (ECG) electrode warming system comprising a warmer having an exothermic warming composition and at least one ECG electrode configured to attach to a patient's body to detect electric signals, wherein the at least one ECG electrode is removably and thermally connected to the warmer.

Particular embodiments may comprise one or more of the following features. The exothermic warming composition may be air-activated. The ECG electrode warming system may further comprise a barrier configured to separate the exothermic warming composition from a reactant composition, wherein the barrier is breakable by a user to allow the reactant composition to contact the exothermic warming composition. The barrier may be an envelope configured to encase the warmer and the reactant composition may be ambient air. Contact between a reactant composition and the exothermic warming composition may cause the exothermic warming composition to release heat. The ECG electrode warming system may further comprise an insert positioned between the at least one ECG electrode and the warmer, wherein the at least one ECG electrode is removably connected to the insert and the warmer is bonded to the insert. The warmer may be configured to warm the at least one ECG electrode to at least a selected temperature within five minutes. The warmer may be configured to maintain the at least one ECG electrode at or above a selected temperature for at least 45 minutes.

The foregoing and other aspects, features, applications, and advantages will be apparent to those of ordinary skill in the art from the specification, drawings, and the claims. Unless specifically noted, it is intended that the words and phrases in the specification and the claims be given their plain, ordinary, and accustomed meaning to those of ordinary skill in the applicable arts. The inventors are fully aware that they can be their own lexicographers if desired. The inventors expressly elect, as their own lexicographers, to use only the plain and ordinary meaning of terms in the specification and claims unless they clearly state otherwise and then further, expressly set forth the “special” definition of that term and explain how it differs from the plain and ordinary meaning. Absent such clear statements of intent to apply a “special” definition, it is the inventors' intent and desire that the simple, plain and ordinary meaning to the terms be applied to the interpretation of the specification and claims.

The inventors are also aware of the normal precepts of English grammar. Thus, if a noun, term, or phrase is intended to be further characterized, specified, or narrowed in some way, then such noun, term, or phrase will expressly include additional adjectives, descriptive terms, or other modifiers in accordance with the normal precepts of English grammar. Absent the use of such adjectives, descriptive terms, or modifiers, it is the intent that such nouns, terms, or phrases be given their plain, and ordinary English meaning to those skilled in the applicable arts as set forth above.

Further, the inventors are fully informed of the standards and application of the special provisions of 35 U.S.C. § 112(f). Thus, the use of the words “function,” “means” or “step” in the Detailed Description or Description of the Drawings or claims is not intended to somehow indicate a desire to invoke the special provisions of 35 U.S.C. § 112(f), to define the invention. To the contrary, if the provisions of 35 U.S.C. § 112(f) are sought to be invoked to define the inventions, the claims will specifically and expressly state the exact phrases “means for” or “step for”, and will also recite the word “function” (i.e., will state “means for performing the function of [insert function]”), without also reciting in such phrases any structure, material or act in support of the function. Thus, even when the claims recite a “means for performing the function of . . . ” or “step for performing the function of . . . ,” if the claims also recite any structure, material or acts in support of that means or step, or that perform the recited function, then it is the clear intention of the inventors not to invoke the provisions of 35 U.S.C. § 112(f). Moreover, even if the provisions of 35 U.S.C. § 112(f) are invoked to define the claimed aspects, it is intended that these aspects not be limited only to the specific structure, material or acts that are described in the preferred embodiments, but in addition, include any and all structures, materials or acts that perform the claimed function as described in alternative embodiments or forms of the disclosure, or that are well known present or later-developed, equivalent structures, material or acts for performing the claimed function.

The foregoing and other aspects, features, and advantages will be apparent to those of ordinary skill in the art from the specification, drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Implementations will hereinafter be described in conjunction with the appended drawings, where like designations denote like elements, and:

FIG. 1 is a perspective view of a medical warming system;

FIG. 2 is a perspective view of the warmer, insert, and electrodes of a particular embodiment of the medical warming system shown in FIG. 1 that is an electrocardiogram (ECG) electrode warming system;

FIG. 3 is an exploded view of the ECG electrode warming system shown in FIG. 2;

FIG. 4 is a top view of an electrode of the ECG electrode warming system shown in FIG. 2;

FIG. 5 is a cross section view of the electrode shown in FIG. 4 taken along line 5-5;

FIG. 6 is process diagram illustrating a method of warming an ECG electrode using the system shown in FIGS. 1-5;

FIG. 7 is a process diagram illustrating a method of assembling the ECG electrode warming system shown in FIGS. 1-5;

FIG. 8A is a perspective view of a particular embodiment of the warmer with a casing and a seal adhered to the casing;

FIG. 8B is a perspective view the warmer shown in FIG. 8A with the seal removed;

FIG. 9 is a perspective view of the warmer and packet of medical fluid of another embodiment of the medical warming system shown in FIG. 1 that is a medical fluid warming system;

FIG. 10 is a process diagram illustrating a method of warming a medical fluid using the system shown in FIG. 9; and

FIG. 11 is a process diagram illustrating a method of assembling the medical fluid warming system shown in FIG. 9.

Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of implementations.

DETAILED DESCRIPTION

This disclosure, its aspects and implementations, are not limited to the specific material types, components, methods, or other examples disclosed herein. Many additional material types, components, methods, and procedures known in the art are contemplated for use with particular implementations from this disclosure. Accordingly, for example, although particular implementations are disclosed, such implementations and implementing components may comprise any components, models, types, materials, versions, quantities, and/or the like as is known in the art for such systems and implementing components, consistent with the intended operation.

The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” or as an “example” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matter or relevant portions of this disclosure in any manner. It is to be appreciated that a myriad of additional or alternate examples of varying scope could have been presented, but have been omitted for purposes of brevity.

While this disclosure includes a number of implementations that are described in many different forms, there is shown in the drawings and will herein be described in detail particular implementations with the understanding that the present disclosure is to be considered as an exemplification of the principles of the disclosed methods and systems, and is not intended to limit the broad aspect of the disclosed concepts to the implementations illustrated.

In the following description, reference is made to the accompanying drawings which form a part hereof, and which show by way of illustration possible implementations. It is to be understood that other implementations may be utilized, and structural, as well as procedural, changes may be made without departing from the scope of this document. As a matter of convenience, various components will be described using exemplary materials, sizes, shapes, dimensions, and the like. However, this document is not limited to the stated examples and other configurations are possible and within the teachings of the present disclosure. As will become apparent, changes may be made in the function and/or arrangement of any of the elements described in the disclosed exemplary implementations without departing from the spirit and scope of this disclosure.

The present disclosure is related to a medical warming system that may be an electrocardiogram (ECG) electrode warming system 100, a medical fluid warming system 400, or a system for warming another medical product. The warming system 100 comprises a warmer 102 and ECG electrodes 104 packaged together, as shown in FIGS. 1-3. The warmer 102 and the electrodes 104 may be packaged in a material that comprises an inner aluminum layer and an outer paper layer. Any number of ECG electrodes 104 may be included in the system 100. For example, the warming system 100 may have at least one ECG electrode 104, at least two ECG electrodes 104, or a plurality of ECG electrodes 104. In a particular embodiment, the warming system 100 has six ECG electrodes 104. The ECG electrodes 104 are configured to attach to a patient's body to detect electrical signals. For example, the ECG electrodes 104 may be used to detect electrical signals generated by the patient's heart or brain.

The warming system 100 is designed and configured to warm up the ECG electrodes 104 prior to placing them on the patient's body. This promotes patient health by keeping the patient comfortable, rather than shocking the patient's body with cold electrodes 104. This in turn improves the outcome of the medical procedure. For example, an ECG is affected by movement of the patient, even slight movement such as shivering. The more still the patient is, the more accurate the ECG results are. By helping the patient to be more relaxed and warmer, the warmed ECG electrodes 104 increase the accuracy of the ECG results.

The ECG electrodes 104 may be removably and/or thermally connected to the warmer 102. This allows the ECG electrodes 104 to be easily detached from the warmer 102 to be applied to a patient's body while keeping the ECG electrodes 104 close to the warmer 102 so that the warmer 102 can effectively warm the ECG electrodes 104. Each ECG electrode 104 may have an adhesive pad 106, a sponge 108, and a snap 110, as shown in FIGS. 4-5. The adhesive pad 106 may have a cavity in its center and the sponge 108 may be positioned within the cavity of the adhesive pad 106 and may be soaked in a conductive gel such as a silver chloride gel. In some embodiments, the ECG electrode 104 may not have a sponge 108, and instead, the cavity may be filled with gel. The snap 110 is conductive and is in contact with the sponge 108 or the gel. The snap 110 also has a protrusion 112 extending away from the cavity. An external snap, such as on the end of a wire (not shown), may couple with the protrusion 112 and carry a signal entering the electrode 102 through the sponge 108 or the gel away from the electrode 104 to be measured.

Returning to FIG. 3, the warmer 102 comprises an exothermic warming composition 114. The exothermic warming composition 114 may be any composition that undergoes an exothermic process to release heat and warm its surroundings. To control the timing of when the heat is released, the warming composition 114 may be separated or isolated from a reactant composition 116 that is configured to initiate and perpetuate the exothermic process. For example, the warming composition 114 may be air-activated and the reactant composition 116 may be ambient air. By separating the air-activated warming composition 114 from ambient air, the exothermic process experienced by the warming composition 114 may be paused until desired.

The warming system 100 may comprise a barrier 118 to separate the warming composition 114 from the reactant composition 116. In some embodiments, the barrier 118 is breakable by a user, and therefore is removable. Once broken, the barrier 118 is removed as a barrier, and thus no longer separates the warming composition 114 from the reactant composition 116 and contact between the reactant composition 116 and the warming composition 114 is allowed. As explained above, this causes the exothermic process to take place, releasing heat from the warming composition 114.

The barrier 118 may have any shape. For example, the warming composition 114 and the reactant composition 116 may be packaged together, with the barrier 118 extending between them as a sheet. Once this sheet is broken, the warming composition 114 and the reactant composition 116 are able to mix within the packaging, initiating the exothermic process. As another example, the barrier 118 may be the packaging itself, such as an envelope that encases the warmer 102 and the warming composition 114, as shown in FIGS. 1 and 3. The reactant composition 116 may be positioned outside of the barrier 118 so that, when the envelope is opened, the warming composition 114 and the reactant composition 116 can mix. In embodiments where the warming composition 114 is air-activated, ambient air contacts the warming composition 114 when the envelope is opened, initiating the exothermic process.

As yet another example, the barrier 118 may be replaced by the barrier 418, which may be a combination of a casing 122 and a seal 124 adhered to the casing 122, as shown in FIGS. 8A and 8B as incorporated into warmer 402 discussed in more detail below. The casing 122 may have one or more holes 126 extending through the casing 122 that are configured to allow fluid outside of the casing 122 to enter the casing 122 and mix with the contents of the casing 122, such as the warming composition 114. The seal 124 is configured to cover the holes 126 so that, when the seal 124 is attached to the casing 122, the warming composition 114 is separated from the reactant composition 116. Thus, to break the barrier 118 in this case, the seal 124 can be punctured, removed, or peeled off to allow airflow through the holes 126 of the casing 122. In particular embodiments, the barrier 118 may be broken by tearing, puncturing, removing, peeling, splitting, cutting, cracking, opening, or otherwise providing a pathway for the reactant composition 116 and the warming composition 114 to make contact with each other. Thus, within this disclosure, any reference to one of these actions is meant to encompass any of the others as well.

The exothermic process may be an oxidation process. Thus, the warming composition 114 may oxidize to release heat and warm the ECG electrode 104. The warming composition 114 may include ingredients such as iron, salt, water, activated charcoal, vermiculite, and/or saw dust. The warming composition 114 may be enclosed in an outer layer formed of a material that is permeable to the reactant composition 116. Additionally, the warming composition 114 may be enclosed in an outer layer formed of a material that helps prevent the warming composition 114 from passing through the outer layer. Heavier fabrics may help to prevent the warming composition 114 from passing through the outer layer, while remaining permeable to the reactant composition 116. Thus, the warming composition 114 may be packaged within an outer layer formed of a fabric with a weight of at least 50 grams per square meter (GSM). In some embodiments, the fabric may have a weight of at least 60 GSM, 70 GSM, 75 GSM or 80 GSM. In particular embodiments, the warming composition 114 is packaged within a polypropylene fabric. Other materials may also be implemented.

Some embodiments of the warming system 100 comprise an insert 120. The insert 120 provides a surface to which the ECG electrodes 104 can be removably attached. The insert 120 may be formed of a clear plastic material and may be a thin sheet of material. The insert 120 has a first side and a second side opposite the first side. The ECG electrodes 104 are attached to the first side. In some embodiments, the warmer 102 may be bonded to the second side of the insert 120. This may help to keep the warmer 102 in thermal contact with the ECG electrodes 104. In some embodiments, an adhesive is used to bond the warmer 102 to the insert 120. The adhesive may be any adhesive known in the art, and may be rolled onto the insert 120 or sprayed onto the insert 120. Other methods of applying the adhesive may also be implemented. In some embodiments, the adhesive is a polymer adhesive, an acrylic adhesive, a hot melt adhesive, or a resin adhesive. In a particular embodiment, the adhesive is a polyurethane glue. Other methods of bonding the warmer 102 to the insert 120 may also be implemented, such as using tape, double-sided tape, clips, rivets, staples, and the like.

The warming system 100 is configured to warm the ECG electrodes 104 to a comfortable temperature so that, when applied to the patient's body, the ECG electrodes 104 are not cold or uncomfortable. The warmer 102 may be configured to warm the ECG electrodes 104 to a selected temperature within a first time period. Additionally, the warmer 102 may be configured to maintain the ECG electrodes 104 at or above the selected temperature for a second time period. These two time periods help the user to know that the ECG electrodes 104 will be sufficiently warm during a specific time period, providing flexibility to the user if the exact moment when the electrodes 104 will be applied is unknown. The selected temperature may be selected to allow for some heat loss between the time that the electrodes 104 are removed from the warmer 102 and the time that the electrodes 104 are applied to the patient. For example, the selected temperature may be 120 degrees. Because the electrodes 104 quickly drop in temperature once removed from the warmer 102, in some cases by as much as 10-15 degrees, this selected temperature allows the electrodes 104 to still be around 105-110 degrees Fahrenheit when they are applied to the patient. If the selected temperature is too low, the electrodes 104 may not be sufficiently warm by the time they are applied to the patient.

For some embodiments, the first time period is two minutes, and the warmer 102 is configured to warm the ECG electrodes 104 to the selected temperature within two minutes. For some embodiments, the first time period is five minutes, and the warmer 102 is configured to warm the ECG electrodes 104 to the selected temperature within five minutes. For some embodiments, the first time period is ten minutes, and the warmer 102 is configured to warm the ECG electrodes 104 to the selected temperature within ten minutes. Other time periods may also be selected for the first time period. For some embodiments, the second time period is at least 45 minutes, and the warmer 102 is configured to maintain the ECG electrodes 104 at or above the selected temperature for at least 45 minutes. For some embodiments, the second time period is at least 90 minutes, and the warmer 102 is configured to maintain the ECG electrodes 104 at or above the selected temperature for at least 90 minutes. For some embodiments, the second time period is at least 120 minutes, and the warmer 102 is configured to maintain the ECG electrodes 104 at or above the selected temperature for at least 120 minutes. Other time periods may also be selected for the second time period. The selected temperature may be 110 degrees Fahrenheit, 120 degrees Fahrenheit, 130 degrees Fahrenheit, 140 degrees Fahrenheit, or any other temperature. It is desirable for the selected temperature to be high enough that the ECG electrodes 104 are warm to the touch for the patient.

In a particular embodiment of the warming system 100, if the ECG electrodes 104 begin at 70 degrees Fahrenheit, the warmer 102 is configured to warm the ECG electrodes 104 to 85 degrees Fahrenheit within one minute, 100 degrees Fahrenheit within two minutes, 110 degrees Fahrenheit within three minutes, 120 degrees Fahrenheit within four minutes, 130 degrees Fahrenheit within five minutes, 135 degrees Fahrenheit within six minutes, 140 degrees Fahrenheit within seven minutes, 145 degrees Fahrenheit within eight minutes, and/or 150 degrees Fahrenheit within nine minutes. The warmer 102 may be configured to warm the ECG electrodes 104 to 145 degrees Fahrenheit within 10 minutes, 150 degrees Fahrenheit within 11 minutes, and/or 155 degrees Fahrenheit within 12 minutes.

The warming system 100 may also be assembled as a kit. In such an embodiment, the separate components of the warming system 100 may be packaged together, but not assembled to the same degree as described above. For example, the kit may comprise at least one ECG electrode 104 and a warmer 102 as described above, the kit may comprise at least one ECG electrode 104, a warmer 102, and an insert 120, or the kit may comprise at least one ECG electrode 104, a warmer 102, an insert 120, and an adhesive, but these components may not be coupled together in the kit. Instead, the components of the kit together are made available to the user, who can then use the components as needed to warm the ECG electrodes. For example, the adhesive may be used to bond the warmer 102 to the insert 120 and the ECG electrodes 104 may be removably connected to the insert 120, thus allowing the warmer 102 to warm the ECG electrodes 104.

The present disclosure is also related to a method 200 of warming an electrocardiogram (ECG) electrode 104, illustrated in FIG. 6. Method 200 comprises providing ECG electrodes 104 as described above and thermally connecting the ECG electrodes 104 to a warmer 102 as described above. The method 200 may further comprise warming the provided ECG electrodes 104. The method 200 may be used to warm any number of ECG electrodes, including at least one ECG electrode 104, at least two ECG electrodes 104, a plurality of ECG electrodes 104, or six ECG electrodes 104, depending on the number of ECG electrodes 104 provided. Method 200 may further comprise removing the ECG electrodes 104 from the warmer 102 and/or placing the ECG electrodes 104 on the patient's body. Thus, method 200 may encompass providing the ECG electrode 104 and warmer 102, warming up the ECG electrode 104 with the warmer 102, removing the ECG electrode 104 from the warmer 102, and/or placing the ECG electrode 104 on the patient.

As mentioned above, the warmer 102 comprises an exothermic warming composition 114. Method 200 may further comprise exposing the warming composition 114 to the reactant composition 116, as disclosed above, to release heat, and may also comprise using the heat from contact between the warming composition 114 and the reactant composition 116 to warm the ECG electrodes 104. Method 200 may also comprise separating the warming composition 114 from the reactant composition 116 with the barrier 118, as discussed in more detail above. Additionally, method 200 may comprise breaking the barrier 118 to allow contact between the warming composition 114 and the reactant composition 116. As discussed above, in some embodiments, the warming composition 114 is air-activated and the reactant composition 116 is ambient air. In such an embodiment, the method 200 may also comprise oxidizing the warming composition 114.

The method 200 may comprise providing the warmer 102 encased within an envelope or providing both the warmer 102 and the ECG electrode 104 encased within the envelope. The ECG electrode 104 may be physically connected to the warmer 102, either directly or through an insert 120 as described above. The method 200 may also comprise warming the ECG electrode 104 to the selected temperature as described in detail above. By warming the ECG electrodes 104 to a comfortable temperature, the ECG electrodes 104 are not cold or uncomfortable when applied to the patient's body. The method 200 may comprise warming the ECG electrodes 104 to the selected temperature within the first time period and may comprise maintaining the ECG electrodes 104 at or above the selected temperature for the second time period. As mentioned above, the first time period and the second time period provide flexibility to the user by allowing the user to prepare the ECG electrodes 104 either when they are needed, knowing that the electrodes 104 will warm up within a reasonable amount of time (the first time period), or before they are needed, knowing that the electrodes 104 will remain warm for a specific amount of time (the second time period).

For some embodiments, the first time period is two minutes, and the method 200 comprises warming the ECG electrodes 104 to the selected temperature within two minutes. For some embodiments, the first time period is five minutes, and the method 200 comprises warming the ECG electrodes 104 to the selected temperature within five minutes. For some embodiments, the first time period is ten minutes, and the method 200 comprises warming the ECG electrodes 104 to the selected temperature within ten minutes. Other time periods may also be selected for the first time period. For some embodiments, the second time period is at least 45 minutes, and the method 200 comprises maintaining the ECG electrodes 104 at or above the selected temperature for at least 45 minutes. For some embodiments, the second time period is at least 90 minutes, and the method 200 comprises maintaining the ECG electrodes 104 at or above the selected temperature for at least 90 minutes. For some embodiments, the second time period is at least 120 minutes, and the method 200 comprises maintaining the ECG electrodes 104 at or above the selected temperature for at least 120 minutes. Other time periods may also be selected for the second time period. The selected temperature may be 110 degrees Fahrenheit, 120 degrees Fahrenheit, 130 degrees Fahrenheit, 140 degrees Fahrenheit, or any other temperature. It is desirable for the selected temperature to be high enough that the ECG electrodes 104 are warm to the touch for the patient.

The present disclosure is also related to a method 300 of assembling the electrocardiogram (ECG) electrode warming system or kit 100, illustrated in FIG. 7. The method 300 comprises providing at least one ECG electrode 104 as disclosed above and a warmer 102 as disclosed above and packaging the at least one ECG electrode 104 and the warmer 102 together. Method 300 can involve any number of ECG electrodes, including at least one ECG electrode 104, at least two ECG electrodes 104, a plurality of ECG electrodes 104, or six ECG electrodes 104, depending on the number of ECG electrodes 104 provided. Method 300 may comprise additional components. For example, the method 300 may comprise removably connecting the ECG electrode 104 to the warmer 102, separating the warming composition 114 of the warmer 102 from the reactant composition 116, and/or placing a barrier 118 between the warming composition 114 and the reactant composition 116. As discussed above, the barrier 118 may be breakable by a user to allow the reactant composition 116 to contact the warming composition 114, and contact between the reactant composition 116 and the warming composition 114 may cause the warming composition 114 to release heat. The warming composition 114 may be air-activated and the reactant composition 116 may be ambient air. The method 300 may also comprise configuring the warmer 102 to warm the ECG electrode 104 when the barrier 118 is broken, encasing the warmer 102 in an envelope configured to separate the warmer 102 from ambient air, encasing the ECG electrode 104 in the envelope with the warmer 102, and/or preventing the warming composition 114 from oxidizing by separating the warming composition 114 from ambient air.

Method 300 may also comprise positioning the insert 120 between the ECG electrode 104 and the warmer 102 and/or removably connecting the ECG electrode 104 to the insert 120. Additionally, method 300 may comprise bonding the warmer 102 to the insert 120. Bonding the warmer 102 to the insert 120 may comprise applying an adhesive to the warmer 102 or to the insert 120, and applying an adhesive to the warmer 120 or to the insert 120 may comprise rolling the adhesive onto the warmer 102 or the insert 120 or spraying the adhesive onto the warmer 102 or the insert 120. As explained above, the adhesive may be a polyurethane glue.

The method 300 may also comprise packaging the warming composition 114 in a material that is permeable to the reactant composition 116 to facilitate contact between the warming composition 114 and the reactant composition 116 once the barrier 118 is removed or broken. The material used may also be selected to help prevent the warming composition 114 from passing through the material, while remaining permeable to the reactant composition 116. Because heavier fabrics may help in this regard, method 300 may comprise packaging the warming composition 114 in a fabric with a weight of at least 50 grams per square meter (GSM), at least 60 GSM, 70 GSM, 75 GSM or 80 GSM. The fabric may be a polypropylene fabric. Other materials and weights may also be implemented.

The method 300 may also comprise configuring the warmer 102 to warm the ECG electrode 104 to the selected temperature as described in detail above. By warming the ECG electrodes 104 to a comfortable temperature, the ECG electrodes 104 are not cold or uncomfortable when applied to the patient's body. The method 300 may comprise configuring the warmer 102 to warm the ECG electrodes 104 to the selected temperature within the first time period and may comprise configuring the warmer 102 to maintain the ECG electrodes 104 at or above the selected temperature for the second time period. As mentioned above, the first time period and the second time period provide flexibility to the user by allowing the user to prepare the ECG electrodes 104 either when they are needed, knowing that the electrodes 104 will warm up within a reasonable amount of time (the first time period), or before they are needed, knowing that the electrodes 104 will remain warm for a specific amount of time (the second time period). The selected temperature, the first time period, and the second time period are all dependent on the formulation of the warming composition 114 and/or the reactant composition 116. Thus, method 300 may also comprise selecting the ratios and amounts of the components of the warming composition 114 and/or the reactant composition 116.

For some embodiments, the first time period is five minutes, and the method 300 comprises configuring the warmer 102 to warm the ECG electrodes 104 to the selected temperature within five minutes. For some embodiments, the first time period is ten minutes, and the method 300 comprises configuring the warmer 102 to warm the ECG electrodes 104 to the selected temperature within ten minutes. Other time periods may also be selected for the first time period. For some embodiments, the second time period is at least 45 minutes, and the method 300 comprises configuring the warmer 102 to maintain the ECG electrodes 104 at or above the selected temperature for at least 45 minutes. For some embodiments, the second time period is at least 90 minutes, and the method 300 comprises configuring the warmer 102 to maintain the ECG electrodes 104 at or above the selected temperature for at least 90 minutes. For some embodiments, the second time period is at least 120 minutes, and the method 300 comprises configuring the warmer 102 to maintain the ECG electrodes 104 at or above the selected temperature for at least 120 minutes. Other time periods may also be selected for the second time period. The selected temperature may be 110 degrees Fahrenheit, 120 degrees Fahrenheit, 130 degrees Fahrenheit, 140 degrees Fahrenheit, or any other temperature. It is desirable for the selected temperature to be high enough that the ECG electrodes 104 are warm to the touch for the patient.

The warming system 400 comprises a warmer 402 and a packet of medical fluid 404 packaged together, as shown in FIG. 9. The warmer 402 and the medical fluid 404 may be packaged in a material that comprises an inner aluminum layer and an outer paper layer. The medical fluid 404 is configured to be applied to a patient's body during a medical procedure. For example, the medical fluid 404 may be an ultrasound gel applied to the skin of a patient during an ultrasound, a body lubricant for medical use, a medical lubricant, such as a vaginal lubricant, or a lubricating jelly. Any other medical fluid 404 known in the art may also be included in the warming system 400.

The warming system 400 is designed and configured to warm up medical fluid 404 prior to applying it to the patient's body. This promotes patient health by keeping the patient comfortable, rather than shocking the patient's body with a cold fluid. This improves the comfort of the patient and may improve the outcome of the medical procedure.

The medical fluid 404 may be removably and/or thermally connected to the warmer 402. This allows the medical fluid 404 to be easily applied to a patient's body while keeping the medical fluid 404 close to the warmer 402 so that the warmer 402 can effectively warm the medical fluid 404. The warmer 402 may have any of the characteristics discussed above regarding the warmer 102. Thus, the warmer 402 may comprise an exothermic warming composition 414 which may have any or all of the characteristics of the exothermic warming composition 114 discussed above. Additionally, as with the warming composition 114, the warming composition 414 may be separated or isolated from a reactant composition 416 that is configured to initiate and perpetuate the exothermic process. The warming composition 414 may be air-activated and the reactant composition 416 may be ambient air. By separating the air-activated warming composition 414 from ambient air, the exothermic process experienced by the warming composition 414 may be paused until desired.

The warming system 400 may comprise a barrier 418 to separate the warming composition 114 from the reactant composition 116. The barrier 418 may have any or all of the same characteristics as the barrier 118 discussed above.

Some embodiments of the warming system 400 comprise a packet 420 that contains the medical fluid 404. The packet 420 may be formed of any material known in the art for containing fluids and may be manually openable. In some embodiments, the warmer 402 may be bonded to the packet 420. This may help to keep the warmer 402 in thermal contact with the medical fluid 404. In some embodiments, an adhesive is used to bond the warmer 402 to the packet 420. The adhesive may have any of the same characteristics as the adhesive used to bond the warmer 102 to the insert 120 discussed above.

The warming system 400 is configured to warm the medical fluid 404 to a comfortable temperature so that, when applied to the patient's body, the medical fluid is not cold or uncomfortable. The warmer 402 may be configured to warm the medical fluid 404 to a selected temperature within a first time period. Additionally, the warmer 402 may be configured to maintain the medical fluid 404 at or above the selected temperature for a second time period. These two time periods help the user to know that the medical fluid 404 will be sufficiently warm during a specific time period, providing flexibility to the user if the exact moment when the medical fluid 404 will be applied is unknown. The selected temperature may be selected to allow for some heat loss between the time that the medical fluid 404 is removed from the warmer 402 and the time that the medical fluid 404 is applied to the patient. However, the medical fluid 404 may retain more heat than the electrodes described above. Thus, heat loss during this time period may be less of a concern. For this same reason, the selected temperature may be lower for embodiments with medical fluid 404 as compared to embodiments with electrodes 104.

For some embodiments, the first time period is ten minutes, and the warmer 402 is configured to warm the medical fluid 404 to the selected temperature within ten minutes. For some embodiments, the first time period is 20 minutes, and the warmer 402 is configured to warm the medical fluid 404 to the selected temperature within 20 minutes. Other time periods may also be selected for the first time period. For some embodiments, the second time period is at least ten minutes, and the warmer 402 is configured to maintain the medical fluid 404 at or above the selected temperature for at least ten minutes. For some embodiments, the second time period is at least 45 minutes, and the warmer 402 is configured to maintain the medical fluid 404 at or above the selected temperature for at least 45 minutes. For some embodiments, the second time period is at least 90 minutes, and the warmer 402 is configured to maintain the medical fluid 404 at or above the selected temperature for at least 90 minutes. Other time periods may also be selected for the second time period. The selected temperature may be 98 degrees Fahrenheit, 102 degree Fahrenheit, 105 degrees Fahrenheit, 110 degrees Fahrenheit, or any other temperature. It is desirable for the selected temperature to be high enough that the medical fluid 404 is warm to the touch for the patient, but not so hot that contact with the medical fluid 404 causes pain or burns. In particular embodiments, the selected temperature is between 95 degrees and 105 degrees Fahrenheit. In some embodiments, the medical fluid may increase in temperature by at least 5 degrees within five minutes of warming.

The warming system 400 may also be assembled as a kit. In such an embodiment, the separate components of the warming system 400 may be packaged together, but not assembled to the same degree as described above. For example, the kit may comprise medical fluid 404 and a warmer 402 as described above or the kit may comprise at least one packet 420 of medical fluid 404, a warmer 102, and an adhesive, but these components may not be coupled together in the kit. Instead, the components of the kit together are made available to the user, who can then use the components as needed to warm the medical fluid 404. For example, the adhesive may be used to bond the warmer 402 to the packet 420, thus allowing the warmer 402 to warm the medical fluid 404.

The present disclosure is also related to a method 500 of warming medical fluid 404, illustrated in FIG. 10. Method 500 may comprise any of the actions or steps mentioned regarding method 200 above but replaces the ECG electrodes 104 with a medical fluid 404. For example, method 500 comprises providing medical fluid 404 as described above and thermally connecting the medical fluid 404 to a warmer 402 as described above. The method 500 may further comprise warming the provided medical fluid 404. Method 500 may further comprise removing the medical fluid 404 from the warmer 402 and/or applying the medical fluid 404 to the patient's body.

As mentioned above, the warmer 402 comprises an exothermic warming composition 414. Method 500 may further comprise exposing the warming composition 414 to the reactant composition 416, as disclosed above, to release heat, and may also comprise using the heat from contact between the warming composition 414 and the reactant composition 416 to warm the medical fluid 404. Method 500 may also comprise separating the warming composition 414 from the reactant composition 416 with the barrier 418, as discussed in more detail above. Additionally, method 500 may comprise breaking and/or removing the barrier 418 to allow contact between the warming composition 414 and the reactant composition 116. As discussed above, in some embodiments, the warming composition 414 is air-activated and the reactant composition 416 is ambient air. In such an embodiment, the method 500 may also comprise oxidizing the warming composition 414.

The method 500 may comprise providing the warmer 402 encased within an envelope or providing both the warmer 402 and the medical fluid 404 encased within the envelope. The medical fluid 404 may be physically connected to the warmer 102. The method 500 may also comprise warming the medical fluid 404 to the selected temperature as described in detail above. By warming the medical fluid 404 to a comfortable temperature, the medical fluid 404 is not cold or uncomfortable when applied to the patient's body. The method 500 may comprise warming the medical fluid 404 to the selected temperature within the first time period and may comprise maintaining the medical fluid 404 at or above the selected temperature for the second time period. As mentioned above, the first time period and the second time period provide flexibility to the user by allowing the user to prepare the medical fluid 404 either when it is needed, knowing that the medical fluid 404 will warm up within a reasonable amount of time (the first time period), or before it is needed, knowing that the medical fluid 404 will remain warm for a specific amount of time (the second time period).

The present disclosure is also related to a method 600 of assembling the medical fluid warming system or kit 400, illustrated in FIG. 11. Method 600 may comprise any of the actions or steps discussed above regarding method 300, but replaces the ECG electrodes 104 with a packet 420 of medical fluid 404. The method 600 comprises providing medical fluid 404 as disclosed above and a warmer 402 as disclosed above and packaging the medical fluid 404 and the warmer 102 together. Method 600 may comprise additional components. For example, the method 600 may comprise removably connecting the medical fluid 404 to the warmer 402, separating the warming composition 414 of the warmer 402 from the reactant composition 416, and/or placing a barrier 418 between the warming composition 414 and the reactant composition 416. As discussed above, the barrier 418 may be breakable or removable by a user to allow the reactant composition 416 to contact the warming composition 414, and contact between the reactant composition 416 and the warming composition 414 may cause the warming composition 414 to release heat. The warming composition 414 may be air-activated and the reactant composition 416 may be ambient air. The method 600 may also comprise configuring the warmer 402 to warm the medical fluid 404 when the barrier 418 is broken, encasing the warmer 402 in an envelope configured to separate the warmer 402 from ambient air, encasing the medical fluid 404 in the envelope with the warmer 402, and/or preventing the warming composition 414 from oxidizing by separating the warming composition 414 from ambient air.

Method 600 may also comprise inserting the medical fluid 404 in the packet 420. Additionally, method 600 may comprise bonding the warmer 402 to the packet 420. Bonding the warmer 402 to the packet 420 may comprise applying an adhesive to the warmer 402 or to the packet 420, and applying an adhesive to the warmer 420 or to the packet 420 may comprise rolling the adhesive onto the warmer 402 or the packet 420 or spraying the adhesive onto the warmer 402 or the packet 420. As explained above, the adhesive may be a polyurethane glue.

The method 600 may also comprise packaging the warming composition 414 in a material that is permeable to the reactant composition 416 to facilitate contact between the warming composition 414 and the reactant composition 416 once the barrier 418 is removed or broken. The material used may also be selected to help prevent the warming composition 414 from passing through the material, while remaining permeable to the reactant composition 416.

The method 600 may also comprise configuring the warmer 402 to warm the medical fluid 404 to the selected temperature as described in detail above. By warming the medical fluid 404 to a comfortable temperature, the medical fluid 404 is not cold or uncomfortable when applied to the patient's body. The method 600 may comprise configuring the warmer 402 to warm the medical fluid 404 to the selected temperature within the first time period and may comprise configuring the warmer 402 to maintain the medical fluid 404 at or above the selected temperature for the second time period. As mentioned above, the first time period and the second time period provide flexibility to the user by allowing the user to prepare the medical fluid 404 either when it is needed, knowing that the medical fluid 404 will warm up within a reasonable amount of time (the first time period), or before it is needed, knowing that the medical fluid 404 will remain warm for a specific amount of time (the second time period). The selected temperature, the first time period, and the second time period are all dependent on the formulation of the warming composition 414 and/or the reactant composition 416. Thus, method 600 may also comprise selecting the ratios and amounts of the components of the warming composition 414 and/or the reactant composition 416.

It will be understood that implementations of a medical warming package are not limited to the specific assemblies, devices and components disclosed in this document, as virtually any assemblies, devices and components consistent with the intended operation of a medical warming package may be used. Accordingly, for example, although particular medical warming packages, and other assemblies, devices and components are disclosed, such may include any shape, size, style, type, model, version, class, measurement, concentration, material, weight, quantity, and/or the like consistent with the intended operation of medical warming packages. Implementations are not limited to uses of any specific assemblies, devices and components; provided that the assemblies, devices and components selected are consistent with the intended operation of a medical warming package.

Accordingly, the components defining any medical warming package may be formed of any of many different types of materials or combinations thereof that can readily be formed into shaped objects provided that the materials selected are consistent with the intended operation of a medical warming package. For example, the components may be formed of: polymers such as thermoplastics (such as ABS, Fluoropolymers, Polyacetal, Polyamide; Polycarbonate, Polyethylene, Polysulfone, and/or the like), thermosets (such as Epoxy, Phenolic Resin, Polyimide, Polyurethane, Silicone, and/or the like), any combination thereof, and/or other like materials; glasses (such as quartz glass), carbon-fiber, aramid-fiber, any combination thereof, and/or other like materials; composites and/or other like materials; metals, such as zinc, magnesium, titanium, copper, lead, iron, steel, carbon steel, alloy steel, tool steel, stainless steel, brass, nickel, tin, antimony, pure aluminum, 1100 aluminum, aluminum alloy, any combination thereof, and/or other like materials; alloys, such as aluminum alloy, titanium alloy, magnesium alloy, copper alloy, any combination thereof, and/or other like materials; any other suitable material; and/or any combination of the foregoing thereof. In instances where a part, component, feature, or element is governed by a standard, rule, code, or other requirement, the part may be made in accordance with, and to comply under such standard, rule, code, or other requirement.

Various medical warming packages may be manufactured using conventional procedures as added to and improved upon through the procedures described here. Some components defining a medical warming package may be manufactured simultaneously and integrally joined with one another, while other components may be purchased pre-manufactured or manufactured separately and then assembled with the integral components. Various implementations may be manufactured using conventional procedures as added to and improved upon through the procedures described here.

Accordingly, manufacture of these components separately or simultaneously may involve extrusion, pultrusion, vacuum forming, injection molding, blow molding, resin transfer molding, casting, forging, cold rolling, milling, drilling, reaming, turning, grinding, stamping, cutting, bending, welding, soldering, hardening, riveting, punching, plating, and/or the like. If any of the components are manufactured separately, they may then be coupled with one another in any manner, such as with adhesive, a weld, a fastener (e.g. a bolt, a nut, a screw, a nail, a rivet, a pin, and/or the like), wiring, any combination thereof, and/or the like for example, depending on, among other considerations, the particular material forming the components.

It will be understood that methods for manufacturing or assembling medical warming packages are not limited to the specific order of steps as disclosed in this document. Any steps or sequence of steps of the assembly of a medical warming package indicated herein are given as examples of possible steps or sequence of steps and not as limitations, since various assembly processes and sequences of steps may be used to assemble medical warming packages.

The implementations of a medical warming package described are by way of example or explanation and not by way of limitation. Rather, any description relating to the foregoing is for the exemplary purposes of this disclosure, and implementations may also be used with similar results for a variety of other applications employing a medical warming package.

	Number	Date	Country
Parent	18147597	Dec 2022	US
Child	18537982		US

SELF WARMING MEDICAL PRODUCTS, GELS, AND FLUIDS

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