Single-use, folded and non-folded medical scope protective shields and dispenser

Abstract

Disclosed are transmissible disease stethoscope protective barrier / shield devices. A device for transmissible disease protection is described. The device can include a shield or barrier and a dispenser. The shield or barrier may be housed within the dispenser. The shield or barrier may be foldable, folded, or unfolded around a stethoscope.

Description

Atty Dkt No.: 52243-706601SINGLE-USE, FOLDED AND NON-FOLDED MEDICAL SCOPE PROTECTIVE SHIELDS AND DISPENSERCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 701,307 filed on September 30, 2024, which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] Healthcare-associated infections (HAI’s) pose a threat to the health and safety of patients entering hospitals, emergency rooms, trauma centers, as well as patients located in clinics, offices, and urgent cares, skilled nursing facilities, long-term care, assisted living, board and care, long term acute care hospitals, schools, ambulances, and emergency medical transfer which may also include helicopters. Many of these HAI’s are considered to be spread from contact in such aforementioned locations , where a primary method of spread may come from stethoscope usage. Stethoscopes are used billions of times per year in the United States and internationally. According to the Centers for Disease Control (CDC), healthcare professionals (including physicians, nurses, nurse practitioners, emergency medical teams) are recommended to sanitize their stethoscope between patient visits to avoid cross-contamination, but many healthcare professionals often do not follow this best practice. Further, the Centers for Disease Control has recognized that healthcare associated infections (HAI's) are one of the major problems in US healthcare institutions, thus, a significant need exists for protection from one of the major vectors of transmission that contribute to the risk of spread of HAIs to patients, and to healthcare professionals as well.

[0003] Stethoscope-acquired infections (SAIs) refer to infections transmitted to patients through contaminated stethoscopes. Stethoscopes, frequently used by healthcare professionals, come into direct contact with patients' skin and clothing, making them potential vectors for pathogens. Studies have shown that stethoscopes can harbor a variety of bacteria, including Staphylococcus aureus (including MRSA), and other potentially harmful microorganisms. This is also referred to as stethoscope acquired infections or SAI’s.

[0004] While some protections are afforded to healthcare professionals and patients through the use of gloves and hand sanitizer, the stethoscope itself remains an unsolved vector of disease transmission.SUMMARY

[0005] The devices, including dispensers, and methods described herein are configured to address numerous issues associated with HAI’s and SAI’s as well as other concerns within theAtty Dkt No.: 52243-706601 medical field. Stethoscopes are not sufficiently cleaned and disinfected between each patient visit and are a primary factor and vector in HAI’s and SAI’s. Many common methods for preventing stethoscope-based infections, may be bulky, ineffective, time insensitive, costly, not simple, overengineered (for example, reusable or with electronics / batteries associated) disruptive of workflow, and may have significant impact on sound transmission, such as muffling or distortion, which is the key functionality of stethoscopes. Common methods may also not provide a complete seal around the stethoscope head. Further, common methods of stethoscope disease prevention have high environmental impact. The devices and methods discussed herein address these and other benefits. The devices described herein can be single-use, disposable, foldable, folded, or non-folded, or any combination thereof.

[0006] In accordance with the purposes of the disclosed devices and methods as embodied and broadly described herein, the disclosed subject matter relates to medical device (e.g., stethoscope) barriers / shields and dispensers, and methods of use thereof. Applicant has recognized that there is an unmet need for new methods and uses of stethoscope barriers / shields and dispensers.

[0007] In an aspect, the present disclosure provides a device for transmissible disease protection. In some embodiments, the device comprises a shield or barrier; and a dispenser, wherein the shield or barrier is housed within the dispenser, wherein the shield or barrier is foldable, folded, or unfolded around a stethoscope.

[0008] In some embodiments, the shield or barrier comprises at least two layers of material.

[0009] In some embodiments, the at least two layers of material are identical material.

[0010] In some embodiments, the shield or barrier is configured to be coupled to a stethoscope.

[0011] In some embodiments, the stethoscope is an acoustic stethoscope.

[0012] In some embodiments, the stethoscope is a digital stethoscope.

[0013] In some embodiments, the stethoscope is configured to be positioned between the at least two layers of material.

[0014] In some embodiments, the shield or barrier further comprises a pouch or opening.

[0015] In some embodiments, the pouch is configured to fully encompass the stethoscope.

[0016] In some embodiments, the pouch is configured to encompass a surface of the stethoscope.

[0017] In some embodiments, the opening is configured to comprise an elastic material to create a seal.

[0018] In some embodiments, the opening is a slit, wherein at least a portion of the stethoscope is positioned within the slit.

[0019] In some embodiments, the shield or barrier further comprises excess material shaped or configured to be contacted by a user.Atty Dkt No.: 52243-706601

[0020] In some embodiments, the shield or barrier housed with the dispenser is coupled to a roll of material.

[0021] In some embodiments, the roll of material comprises paper material.

[0022] In some embodiments, the dispenser is configured to hold both the shields or barriers and gloves simultaneously.

[0023] In some embodiments, the dispenser further comprises a marking, such as a code.

[0024] In some embodiments, the shield or dispenser is configured to fold over the stethoscope.

[0025] In some embodiments, the shield or dispenser is configured to contact a surface of the stethoscope while unfolded around the stethoscope.

[0026] In an aspect, the present disclosure provides a method for transmissible disease protection. In some embodiments, the method comprises: providing a shield or barrier for a stethoscope, wherein the shield or barrier is with or without a rolled bottom sleeve; providing a box or dispenser for the shield or barrier; inserting the stethoscope into the shield or barrier, ensuring that contact between the stethoscope and at least a portion of the outer surface of the shield or barrier does not occur; rolling the rolled bottom sleeve of the shield or barrier to cover the stethoscope detection surface and tube, wherein the rolled bottom sleeve is configured to remain flat against the stethoscope detection surface; removing the shield or barrier from the stethoscope after use; and disposing of the shield or barrier after use.

[0027] Additional advantages of the disclosed devices, systems, and methods will be set forth in part in the description which follows, and in part will be obvious from the description. The advantages of the disclosed devices, systems, and methods will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosed devices, systems, and methods, as claimed.INCORPORATION BY REFERENCE

[0028] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.Atty Dkt No.: 52243-706601BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:

[0030] FIG. 1 is an exemplary stethoscope shield or barrier design, where the shield or barrier is constructed of nitrile, a commonly accepted material for stethoscope use, where the lines depicted indicate striations and folds to ensure a flat contact surface.

[0031] FIG. 2 is a second exemplary stethoscope shield or barrier design, where the shield or barrier is constructed of nitrile, a commonly accepted material for stethoscope use.

[0032] FIG. 3 is the third exemplary stethoscope shield or barrier design, where the lines depicted indicate striations and folds to ensure a flat contact surface for stethoscopes.

[0033] FIG. 4 is an example swatch of stethoscope shield or barrier material, made of nitrile for stethoscopes.

[0034] FIG. 5 is an example stethoscope shield or barrier, constructed of nitrile material in a way to have an opening on the rear surface of the shield or barrier for stethoscopes.

[0035] FIG. 6 is a demonstration of how the stethoscope shield or barrier is intended to fit / be applied over the stethoscope..

[0036] FIG. 7A is a front side view of a portable embodiment of a stethoscope shield or barrier.

[0037] FIG. 7B is a contact side view of a portable embodiment of the stethoscope shield or barrier.

[0038] FIGs. 7C and 7D are contact side views of a portable embodiment of the stethoscope shield or barrier.

[0039] FIGs. 8A to 8D are example portable stethoscope shield or barrier packages.

[0040] FIGs. 8E and 8F show the steps to open a portable stethoscope shield or barrier package and access the stethoscope shield or barrier for use.

[0041] FIG. 9 is a representation of exemplary material for the stethoscope shield or barrier, with a pattern to help ensure the stethoscope shield or barrier lies flat, using a polyethylene or polypropylene material.

[0042] FIGs. 10A to 10D depict a method for removing a stethoscope shield or barrier from a box dispenser, applying a stethoscope shield or barrier, removing the shield or barrier, and disposing of the stethoscope shield or barrier following use.

[0043] FIGs. 11A to 11C are exemplary embodiments of stethoscope barrier / shield dispensers.Atty Dkt No.: 52243-706601

[0044] FIGs. 12A and 12B are exemplary embodiments of folded and non-folded nitrile stethoscope shields / barriers.

[0045] FIGs. 13A to 13C are exemplary embodiments of folded and non-folded polyethylene or polypropylene stethoscope shields / barriers.

[0046] FIG. 14 is an exemplary embodiments of a stethoscope barrier / shield dispenser.DETAILED DESCRIPTION

[0047] The devices, methods, and systems described herein may be understood more readily by reference to the following detailed description of specific aspects of the disclosed subject matter and the Examples included therein. In this specification and in the claims that follow, reference will be made to a number of terms, which shall be defined to have the following meanings.

[0048] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0049] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0050] Certain inventive embodiments herein contemplate numerical ranges. When ranges are present, the ranges include the range endpoints. Additionally, every sub range and value within the range is present as if explicitly written out.

[0051] The term “about” or “approximately” may mean within an acceptable error range for the particular value, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, “about” may mean within 1 or more than 1 standard deviation, per the practice in the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.

[0052] The following abbreviations are used throughout the specification: acceptable quality level (AQL); American Society for Testing and Materials (ASTM); American Society for Testing and Materials regulations for miscellaneous materials (ASTM D); American Society for Testing and Materials regulations for materials for pre-defined applications (ASTM F); BrazilianAtty Dkt No.: 52243-706601Health Regulatory Agency (ANVISA); Centers for Disease Control and Prevention (CDC); Clostridium Difficile (C. Diff); Code of Federal Regulations (CFR); customer relationship management (CRM); decibel (dB); electrocardiogram (EKG); electronic health records (EHR); electronic medical records (EMR); European Centre for Disease Prevention and Control (ECDC); European Commission Regulation (EU); European Standard (EN); European Union Regulation (EC); Food and Drug Administration (FDA); healthcare-associated infections / hospital associated infections (HAI); hertz (Hz); Industrie-Studien Und Entsorgungsgesellschaft GmbH (ISEGA); International Organisation for Standardisation (ISO); International Organisation for Standardisation adopted by the European Union (EN ISO); Japanese Good Manufacturing Practices (JGMP); Medical Devices Directive (MDD); Methicillin-resistant Staphylococcus aureus (MRSA); National Fire Protection Association (NEP A); National Institutes of Health (NIH); Occupational Health and Safety Assessment Series (OHS AS); personal protective equipment (PPE); PPE regulation in the European Union (PPE (EU)); Polyhexamethylene biguanide (PHMB); Regulation on Medical Devices (MDR); ultraviolet (UV); Underwriters Laboratories, Inc. (UL); United States Food and Drug Administration (U.S. FDA)

[0053] Figure 1 is an exemplary stethoscope shield or barrier design, where the shield or barrier is constructed of nitrile, a commonly accepted material for medical purposes. The stethoscope shield or barrier here has a long sleeve along the opening, allowing it to be folded up when first accessed and folded down, as depicted, once applied to a stethoscope. Here, the lines depicted indicate striations and folds to ensure a flat contact surface with the stethoscope and to help lay flat in the box.

[0054] Figure l is a second exemplary stethoscope shield or barrier design, where the stethoscope shield or barrier is constructed of nitrile, a commonly accepted material for medical purposes. The stethoscope shield or barrier here has a short, or no, sleeve, which allows rapid application to the stethoscope. Here, the lines depicted indicate striations and folds to ensure a flat contact surface with the stethoscope and to help lay flat in the box.

[0055] Figure 3 is a third exemplary shield or barrier design. Here, the lines depicted indicate striations and folds to ensure a flat contact surface with the stethoscope and to help lay flat in the box. The shield or barrier is constructed of nitrile, a commonly accepted material for medical purposes. The shield or barrier here has a short, or no, sleeve, which allows rapid application to the stethoscope.

[0056] Figure 4 is an example swatch of shield or barrier material. In this example, the swatch material is nitrile, a commonly accepted material for medical purposes including stethoscope, to help minimize the spread of transmissible diseases.Atty Dkt No.: 52243-706601

[0057] Figure 5 is an example stethoscope shield or barrier, constructed of nitrile material in a way to have an opening on the real surface of the shield or barrier.

[0058] Figure 6 is a demonstration of how the shield or barrier is intended to fit over the stethoscope. In this configuration, the nitrile shield or barrier, not equipped with an extended sleeve, is placed over the stethoscope with the stethoscope diaphragm, stethoscope bell, stethoscope neck inserted into the shield or barrier. Once the interaction with the subject has concluded, the healthcare professional may then contact the inside of the shield or barrier to remove it.

[0059] Figure 7A is a front side view of a portable embodiment of a stethoscope scope shield or barrier. Here, the shield or barrier is intended to be individually wrapped for easy access when a healthcare professional is traveling.

[0060] Figure 7B is a contact side view of a portable embodiment of the stethoscope shield or barrier. Here, the “12” is indicative of the top contact point with the inside of the stethoscope barrier / shield, while 6 is indicative of the bottom contact point with the inside of the barrier / shield. Here, a tab can be shown that, when removed, comes in contact with the inside of the stethoscope barrier / shield.

[0061] Figures 7C and 7D are contact side views of a portable embodiment of the stethoscope shield or barrier. Here, the stethoscope shield or barrier is folded to allow for the stethoscope shield or barrier to remain in a small package for portable use.

[0062] Figures 8A to 8D are example portable stethoscope shield packages, as the portable stethoscope shield or barrier packaging is intended to be similar to band aid wrappers. Here, Figure 8A and Figure 8B are front and back side representations of a potential portable stethoscope shield or barrier package, while Figure 8C shows where the potential portable stethoscope shield or barrier would be opened and Figure 8D shows the portable stethoscope shield / barrier slightly opened.

[0063] Figures 8E and 8F show the steps to open a stethoscope portable shield or barrier package and access the stethoscope shield or barrier for use. In Figure 8E, the portable stethoscope shield or barrier package is partially opened, exposing the stethoscope shield or barrier cover. In Figure 8F, the portable stethoscope shield or barrier is more completely opened, allowing further access to the stethoscope shield or barrier cover for removal.

[0064] Figure 9 is a representation of exemplary material made of polyethylene or polypropylene for the single-use, disposable stethoscope shield or barrier. Here, the lines depicted indicate striations and folds to ensure a flat contact surface with the stethoscope and to help lay flat in the box.Atty Dkt No.: 52243-706601

[0065] Figures 10A to 10D depicts a method for removing, applying, and disposing a shield or barrier. In Figure 10A, a stethoscope barrier / shield dispenser is provided where a shield or barrier may be removed in this method by the healthcare professional . In Figure 10B, the stethoscope shield or barrier is applied by the healthcare professional, where the opening of the stethoscope barrier / shield is rolled up to allow for the user to handle the shield or barrier from the inside surface. The stethoscope shield or barrier is applied from the inside of the shield or barrier stethoscope diaphragm (front & back), and the stethoscope tube, without touching the stethoscope itself, helping to ensure the stethoscope shield or barrier remains “clean.” In Figure 10C, the stethoscope, is inserted into the stethoscope shield or barrier, where the stethoscope comes in contact only with the inside of the stethoscope shield or barrier. In Figure 10D the stethoscope shield or barrier is disposed of in a medical waste receptacle following use.

[0066] Figures 11A to 11C and Figure 14 are exemplary embodiments of single use stethoscope shield or barrier dispensers. In Figure 11A and Figure 11B, stethoscope shield or barrier dispensers are provided where a user may either manually remove the stethoscope shield or barrier from the stethoscope shield or barrier dispenser or may insert the stethoscope scope into the stethoscope shield or barrier dispenser and remove the stethoscope with the stethoscope shield or barrier on it. In Figure 11C, a combination stethoscope barrier / shield dispenser is provided, where both stethoscope barrier / shield and gloves are available and accessible. In Figure 14, a stethoscope shield or barrier is provided where a user may manually remove or insert the stethoscope scope into the shield or barrier dispenser and remove the stethoscope with a shield or barrier on it.

[0067] Figures 12A and 12B are exemplary embodiments of a stethoscope shield or barrier made of nitrile. Figure 12A is a nitrile stethoscope barrier / shield rolled up halfway (like a sock) so that the stethoscope shield or barrier can be picked up / donned, touching only the inside of the stethoscope shield or barrier. Figure 12B is an additional embodiment of the single-use, disposable, nitrile stethoscope shield or barrier.

[0068] Figures 13A to 13C are exemplary embodiments of a stethoscope shield or barrier made of polyethylene or polypropylene. Figure 13A is a polyethylene or polypropylene, single-use, disposable stethoscope scope barrier / shield, rolled up like a sock, so the user can apply / don the stethoscope shield or barrier touching only the inside of the stethoscope shield or barrier. Here, the lines depicted indicate striations and folds to ensure a flat contact surface. Figure 13B is a polyethylene or polypropylene, single-use, disposable stethoscope scope barrier / shield, removed from the box, applied to a spoon to represent the stethoscope diaphragm (front & back), and the stethoscope tube. Figure 13C is a polyethylene or polypropylene, single-use, disposable stethoscope scope barrier / shield, removed from the box, applied to a spoon to represent theAtty Dkt No.: 52243-706601 stethoscope diaphragm (front & back), rolled up / pulled up over the stethoscope diaphragm (front & back), and the stethoscope tube, without touching the stethoscope itself, ensuring the stethoscope shield or barrier remains “clean.”

[0069] In some embodiments, a cover may be provided for a stethoscope. In some embodiments, the stethoscope cover may be referred to as a shield . In some embodiments, the stethoscope cover may be referred to as a barrier. In some embodiments, the stethoscope cover may be referred to as a guard. In some embodiments, the stethoscope cover may be referred to as a protector. In some embodiments, the stethoscope cover may be referred to as an enclosure. In some embodiments, the stethoscope cover may be referred to as an envelope. In some embodiments, the stethoscope cover may be referred to as a screen. In some embodiments, the stethoscope cover may be referred to as a shield / barrier. In some embodiments, the stethoscope cover may be referred to as a barrier / shield. In some embodiments, the stethoscope cover may be referred to as a shield or barrier. In some embodiments, the stethoscope cover may be referred to as a protector. In some embodiments, the stethoscope cover may be referred to as an enclosure. In some embodiments, the stethoscope cover may be referred to as an envelope. In some embodiments, the stethoscope cover may be referred to as a screen. In some embodiments, the stethoscope cover may be referred to as a guard.

[0070] In some embodiments, the shield or barrier may be fitted, or coupled, for an auscultation device. In some embodiments, the shield or barrier can comprise a stethoscope shield or barrier. In some embodiments, the shield or barrier may be fitted, or coupled, for a stethoscope. In some embodiments, the shield or barrier may be fitted for an acoustic stethoscope. In some embodiments, the acoustic stethoscope may be a single-head acoustic stethoscope, dual-head acoustic stethoscope, triple-head acoustic stethoscope, or non-tunable acoustic stethoscope. In some embodiments, the shield or barrier may be fitted for an Al enabled stethoscope. In some embodiments, the shield or barrier may be fitted for an amplifying stethoscope. In some embodiments, the shield or barrier may be fitted for a cardiology stethoscope. In some embodiments, the cardiology stethoscope may be a high-fidelity cardiology stethoscope, tunable diaphragm stethoscope, or digital cardiology stethoscope. In some embodiments, the shield or barrier may be fitted for an analog stethoscope. In some embodiments, the shield or barrier may be fitted for a digital stethoscope. In some embodiments, the digital stethoscope may be a basic digital stethoscope, digital stethoscope with noise-cancellation, wireless / Bluetooth digital stethoscope, digital stethoscope with visual display, or a cardiology digital stethoscope. In some embodiments, the shield or barrier may be fitted for a digitalization stethoscope. In some embodiments, the shield or barrier may be fitted for a doppler stethoscope. In some embodiments, the shield or barrier may be fitted for an EKGZECG (electrocardiogram) enabledAtty Dkt No.: 52243-706601 stethoscope. In some embodiments, the shield or barrier may be fitted for an electronic stethoscope. In some embodiments, the shield or barrier may be fitted for a fetal, or obstetrical, stethoscope. In some embodiments, the fetal stethoscope may be a pinard horn stethoscope, fetal doppler stethoscope, electronic fetal stethoscope, or fetal monitor with a built-in stethoscope. In some embodiments, the shield or barrier may be fitted for a flexible endoscope stethoscope. In some embodiments, the shield or barrier may be fitted for an infant stethoscope. In some embodiments, the shield or barrier may be fitted for a neonatal stethoscope. In some embodiments, the shield or barrier may be fitted for a pediatric stethoscope. In some embodiments, the pediatric stethoscope may be a pediatric acoustic stethoscope or electronic pediatric stethoscope. In some embodiments, the shield or barrier may be fitted for a phonocardiograph. In some embodiments, the shield or barrier may be fitted for a recording stethoscope. In some embodiments, the shield or barrier may be fitted for a surgical stethoscope, such as a surgical acoustic stethoscope or intraoperative stethoscope. In some embodiments, the shield or barrier may be fitted for a teaching stethoscope. In some embodiments, the shield or barrier may be fitted for a traditional stethoscope. In some embodiments, the shield or barrier may be fitted for a veterinary stethoscope. In some embodiments, the veterinary stethoscope may be a veterinary acoustic stethoscope, veterinary digital stethoscope, or specialized equine stethoscope. In some embodiments, the shield or barrier may be fitted for a wired stethoscope. In some embodiments, the shield or barrier may be fitted for a wireless stethoscope. In some embodiments, the shield or barrier may be fitted for an ergonomic stethoscope, such as an ergonomic acoustic stethoscope or an ergonomic digital stethoscope. In some embodiments, the shield or barrier may be fitted for a single-use, or disposable, acoustic stethoscope or a stethoscope with another barrier. In some embodiments, the shield or barrier may be fitted for a telemedicine stethoscope, integrated stethoscope system, or smart stethoscope. In some embodiments, the shield or barrier may be fitted for a stethoscope with a built-in pulse oximeter. In some embodiments, the shield or barrier may be fitted for an infant chest piece. In some embodiments, the shield or barrier may be fitted for a neonatal chest piece. In some embodiments, the shield or barrier may be fitted for an integrated chest-piece system. In some embodiments, the shield or barrier may be fitted for a stethoscope barrier / shield. In some embodiments, the shield may be fitted for a stethoscope shield or barrier. An example of the shield fitted to a traditional stethoscope may be seen in FIG. 4.

[0071] In some embodiments, the stethoscope barrier / shield material (also referred to herein as a “shield” or “barrier” or a “film”) may comprise one or more layers. In some embodiments, the stethoscope shield or barrier may comprise a single layer. In some embodiments, the stethoscope shield or barrier may comprise two or more layers. In some embodiments, the stethoscope shieldAtty Dkt No.: 52243-706601 or barrier may be sandwiched between two different layers of stethoscope barrier / shield material. In some embodiments, the two different layers of stethoscope barrier / shield material may comprise a top layer and a bottom layer, folded or unfolded, with the stethoscope shield or barrier disposed between the top layer and the bottom layer. In some embodiments, the stethoscope shield or barrier and / or the one or more layers of the stethoscope shield or barrier may comprise any glove or glove-like material, including, for example, polyethylene or polypropylene, vinyl, and / or nitrile. In some embodiments, the stethoscope shield or barrier design may comprise three layers. In some embodiments, the layers are identical. In some embodiments, the layers may be identical in size. In some embodiments, the layers may be identical in material. In some embodiments, the layers may be identical in thickness. In some embodiments, the at least two of the layers may be identical. In some embodiments, the layers are distinct. In some embodiments, the layers may be distinct in size. In some embodiments, the layers may be distinct in material. In some embodiments, the layers may be distinct in thickness. In some embodiments, the at least two of the layers may be distinct. In some embodiments, the stethoscope shield or barriers design may unfolded. In some embodiments, the stethoscope shield or barriers design may be folded. In some embodiments, the shield or barrier may comprise a pouch on the front side of the shield or barrier and a half pouch on the other side of the shield or barrier. In some embodiments the stethoscope shield or barrier may be folded or unfolded, single layer or multiple layer. Exemplary shields / barriers may be seen in FIG. 1, FIG. 2, FIG. 3, FIG. 4, FIG. 5, FIG 6, FIGS. 7A - 7D, FIGS. 8A - 8F, FIG. 9, FIGS. 10A - 10D, FIG. 11B, FIG. 11C, FIGS. 12A - 12B, FIGS. 13A - 13C.

[0072] In some embodiments, the stethoscope shield or barrier may comprise one or more pouches or inner volumes. In some embodiments, the one or more pouches or inner volumes may be enclosed or partially enclosed to provide a stethoscope barrier / shield between (i) a person, an object, or an external environment and (ii) a scope that is inserted into and / or at least partially covered or enveloped by the one or more pouches. In some embodiments, the stethoscope shield or barrier may comprise a cross-sectional shape. In some embodiments, the stethoscope barrier / shield cross-sectional shape may comprise, for example, a circle, an oval, an ellipse, a triangle, a square, a rectangle, a pentagon, a hexagon, a heptagon, an octagon, or any polygon comprising three or more sides. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise one or more straight edges and / or one or more curved edges. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise a teardrop shape. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise a star shape or a heart shape. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise a repeating feature or pattern that extendsAtty Dkt No.: 52243-706601 periodically around an edge or perimeter of the cross-sectional shape stethoscope barrier / shield. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise a cloud shape. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise a regular shape. In some embodiments, the cross-sectional shape of the stethoscope barrier / shield may comprise an irregular or amorphous shape. In some embodiments, the stethoscope shield or barrier may comprise one or more pouches having an inner volume in which at least a portion of a stethoscope may be inserted. In some embodiments, the stethoscope shield or barrier may comprise one or more portions having different sizes and / or shapes. In some embodiments, a first region or volume of the stethoscope shield or barrier may comprise a first shape or a first dimension and a second region or volume of the stethoscope shield or barrier may comprise a second shape or a second dimension. In some embodiments, the first dimension and the second dimension of the stethoscope shield or barrier may correspond to a length, a width, a height, or a thickness. In some embodiments, the first dimension of the stethoscope shield or barrier may be different than the second dimension. In some embodiments, the stethoscope shield or barrier may comprise a shoe cover or hair net design. In some embodiments, the stethoscope shield or barrier may comprise a surface that is sized and shaped to cover or envelope a head of a stethoscope, and an opening in which the head of the scope may be inserted into the stethoscope barrier / shield. In some embodiments, the opening may be located along the bottom of the stethoscope shield or barrier, allowing the device to slide into the sleeve of the stethoscope shield or barrier. In some embodiments, the opening may comprise an elastic material (e.g., an elastic band or wire) that is configured to tighten around a back portion of the head of the stethoscope to provide a secure and sealed barrier / shield that is not easily removable. In some embodiments, the opening may comprise rolling of the stethoscope shield or barrier material (similar to a finger cot, or condom) configured to tighten around a back portion of the head of the stethoscope to provide a secure and sealed shield or barrier that is not easily removable. In some embodiments, the stethoscope shield or barrier may comprise a two-dimensional sheet of material. In some embodiments, the stethoscope shield or barrier may comprise a three-dimensional structure comprising any stethoscope shield or barrier material as described elsewhere herein. In some embodiments, the three-dimensional stethoscope shield or barrier structure may comprise an inner volume in which a head of a stethoscope is insertable.

[0073] In some embodiments, the stethoscope shield or barrier may comprise an opening or a slit through which at least a portion of the scope may be inserted. In some embodiments, the opening or slit may provide access to an inner volume or region of the stethoscope shield or barrier. In some embodiments, the stethoscope shield or barrier may comprise a horizontal opening. InAtty Dkt No.: 52243-706601 some embodiments, the stethoscope shield or barrier may comprise a vertical opening. In some embodiments, the stethoscope shield or barrier may comprise an opening at one end of the stethoscope shield or barrier.

[0074] In some embodiments, the stethoscope shield or barrier opening may comprise excess barrier / shield material. In some embodiments, the excess stethoscope shield or barrier material may form a sleeve. In some embodiments, the excess stethoscope shield or barrier material may be folded. In some embodiments, the excess stethoscope shield or barrier material may be unfolded. In some embodiments, the excess material may be the point of contact by a user.

[0075] In some embodiments, the stethoscope shield or barrier material may be formed into a pouch. In some embodiments, the pouch shape or configuration of the stethoscope shield or barrier material may provide an inner volume or region in which the stethoscope shield or barrier material may be placed. In some embodiments, the inner volume or region of the stethoscope shield or barrier material may partially encapsulate the scope or the head of the scope. In some embodiments, the inner volume or region of the stethoscope shield or barrier material may completely encapsulate or cover the scope or the head of the scope such that a plurality of surfaces of the scope is covered by the stethoscope shield or barrier. In some embodiments, the dimensions of the inner volume or region of the stethoscope shield or barrier material may be adjustable to cover multiple different types of scopes or other tools or instruments. In some embodiments, the pouch of the stethoscope shield or barrier material may comprise a symmetrical shape. In some embodiments, the pouch of the stethoscope shield or barrier material may not or need not comprise a symmetrical shape. In some embodiments, the stethoscope shield or barrier may comprise an elongated shape having a length that is greater than a width or a height of the stethoscope shield or barrier. In some embodiments, the stethoscope shield or barrier may comprise a shape having a width or a height that is greater than a length of the stethoscope shield or barrier. In some embodiments, the stethoscope shield or barrier may be sized and shaped to cover different types of instruments or tools having a range of different shapes and sizes.

[0076] In some embodiments, the stethoscope shield or barrier may comprise a single layer design. In some embodiments, the single layer stethoscope shield or barrier may comprise a two- dimensional film or stethoscope shield or barrier material that can be wrapped around a tool or an instrument, similar to a cling wrap off a roll or a sheet of barrier / shield material.

[0077] In some embodiments, the stethoscope shield or barrier may comprise a two layer design. In some embodiments, the stethoscope shield or barriers two layer design may comprise a top layer and a bottom layer configured to cover a top portion, a bottom portion, and / or one or more side portions of the tool or instrument. In some embodiments, the stethoscope shield or barrierAtty Dkt No.: 52243-706601 shield may comprise a pouch shaped enclosure, similar to a shoe cover or a hair net. In some embodiments, the stethoscope shield or barrier may have a two layer design comprising a rolled solution, similar to a finger cot or a condom. In some embodiments, the stethoscope shield or barrier rolled solution may be rolled over or around a tool or instrument to provide coverage for a top portion and / or a bottom portion of the tool or instrument. In some embodiments, the stethoscope shield or barrier rolled solution may also provide coverage for one or more side portions of the tool or instrument. In some embodiments, the stethoscope shield or barrier may comprise a pouch. In some embodiments, the stethoscope shield or barrier may be a folded / two layer stethoscope shield or barrier design may comprise an envelope configuration. In some embodiments, a stethoscope may be placed inside the envelope to cover a bottom portion of the scope, and a flap disposed above the opening of the stethoscope shield or barrier may be used to cover the remaining portions of the stethoscope. In some embodiments, the stethoscope shield or barrier may comprise a combination thereof.

[0078] In some embodiments, the stethoscope shield or barrier may comprise a three layer design.

[0079] In some embodiments, the stethoscope may be positioned in relation to the shield or barrier. In some embodiments, the stethoscope may be coupled to the shield or barrier. In some embodiments, the stethoscope may be fitted to the shield or barrier. In some embodiments, the stethoscope may be positioned between layers of material of the shield or barrier. In some embodiments, the stethoscope may be positioned within at least two layer materials wherein at least two layers of shield or barrier are present. In some embodiments, the stethoscope may be positioned within a pouch of the shield or barrier. In some embodiments, the stethoscope may be fully encompassed. In some embodiments, the stethoscope may be partially encompassed by the shield or barrier. In some embodiments, a surface of the stethoscope may be encompassed by the shield or barrier.

[0080] In some embodiments, the stethoscope shield or barrier may be a thin film or a membrane, and may be made of a polymer such as polyurethane, polyethylene, polypropylene, or any other medical-grade or food-grade plastics. In some embodiments, the stethoscope shield or barrier film may comprise elastomeric materials. In some embodiments, the stethoscope shield or barrier shield film may be latex free. In some embodiments, the stethoscope shield or barrier shield film may comprise latex, nitrile, plastic, cellophane, vinyl, acetate, acrylic, natural material, fiber, bamboo fiber, lambskin, silicone, hydrogel, graphene, neoprene, chloroprene, polyisoprene, polyethylene acrylic, polypropylene, polyethylene, polypropylene, polyvinyl alcohol (PVA), polyvinyl chloride (PVC), thermoplastic rubber (TPR), thermoplastic elastomer (TPE), natural rubber, butyl rubber, ethylene-vinyl acetate, natural rubber, a nitrile, nitrileAtty Dkt No.: 52243-706601 powdered, latex powdered, latex polymer, polymer, polyisoprene powder free, polyisoprene powdered, silicone rubber, Nitrile Clean Room Class 100, Clean Room Class 100, latex powder free chlorinated, colloidal oatmeal, accelerator-free, biodegradable, biocompatible (nonsensitizing & low dermatitis potential, non-toxic, non-cytotoxic, non-irritating, non-sensitizing, sensitizing), metal detectable, surgical, specialty, industrial, commercial, a styrene block copolymer, a vinyl ether, or a tackifier. In some embodiments, the stethoscope shield or barrier may comprise natural rubber latex (NRL), pre-vulcanized latex, powdered latex, or black latex. In some embodiments, the stethoscope shield or barrier may comprise a synthetic, wherein the synthetic may be a blend designed to optimize performance. In some embodiments, the stethoscope shield or barrier may comprise a non-latex, non-polyurethane synthetic. In some embodiments, the stethoscope shield or barrier may comprise antimicrobial, antiseptic, aseptic, and / or antiviral materials. In some embodiments, the antimicrobial, antiseptic, aseptic, and / or antiviral materials may include but are not limited to: sodium bicarbonate; hydrogen peroxide; benzalkonium chloride; chlorohexidine; hexachlorophene; iodine compounds; and combinations thereof. In some embodiments, the stethoscope shield or barrier shield may include antimicrobial, antiseptic, antifungal, citrus-based, silver-based, or aseptic materials, or alcohols (such as ethanol, 1-propanol and 2-propanol / isopropanol or mixtures of these alcohols), since solvents / alcohols may promote the airborne transmission of certain types of micro-organisms, and certain type of microbes may be resistant to alcohols. For example, certain types of microorganisms (e.g., Clostridium Difficile (C. Diff)) can cause spores and facilitate airborne transmission when interacting with solvents. Depending upon the film material and properties selected, the barrier / shield may comply with a variety of standards (e.g., Modified-Draize-95 Test, ASTM F 1671, ASTM F 1671-13, EN ISO 374-5, ASTM D5151, ASTM D6319, ASTM D7907, AQL 1.5, EN 455-1, EN 455-2, EN 455-3, ASTM D6124-06, PPE (EU) 2016 / 425, EN 374-2, EN 374-4, EN 420, EN ISO 374-5, ASTM D6978, EC 1935 / 2004, EU 10 / 2011, Japan Sanitation Law, 21 CFR 177.2600, ASTM F1671, EN ISO 374-1, ISO 16523-1, ISO 9001, ISO 14001, OHSAS 18001, ISO 13485, EN ISO 13485, EC, JGMP, U.S. FDA, U.S. FDA 510(K), U.S FDA 510(K) exempt, China FDA, UL Certification, NFPA, ANVISA, ISEGA, PPE Certification(s), ISO 10282, ISO 10993, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993- 11, ISO 16604, Malaysian Rubber Board (MRB) In House Method, European Union MDD 93 / 42 / EEC Annex IX: Class I (Rule 5), European Union MDR 2017 / 745 Annex VIII Rule 14, point 2 of Article 1 of Directive 2001 / 83 / EC, bacteriological testing, bacteriophage penetration testing, University testing, private lab testing, public lab testing, lab testing, Institutional Review Board (I.R.B.), watertight testing, waterproof testing, water resistant testing, viral penetration testing, protection from penetration by blood-borne pathogens, Phi-X174 virus, Phi -XI 74Atty Dkt No.: 52243-706601Bacteriophage, Covid, 2019-nCov, SARS-CoV-2, SARS-CoV-2 variants (e.g., Alpha (B.l.1.7), Beta (B.1.351, B.1.351.2, B.1.351.3), Delta (B.1.617.2, AY. l, AY.2, AY.3), Gamma (P. l, P.1.1, P.1.2), Mu (e.g., lineage B.1.621 or VUI-21 JUL-1), T95I, Y144S, Y145N, R346K, E484K or the escape mutation, N501Y, D614G, P681H, and D109N and all future mutations and related strain(s) / virus(es)), Enterococcus faecalis (VRE), Enterococcus faecium, MRSA, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, and other microbe(s). The film may include antimicrobial, antiviral, germicidal, antipathogenic, antiseptic, aseptic, antibacterial, antifungal, antiparasitic, fungicidal, virucidal, disinfectant, and / or bactericidal properties. The stethoscope shield or barrier shield film may or may not include silver, copper, titanium, other metals, formulas, or compounds. The stethoscope shield or barrier shield film may also include any other antimicrobial formula, property, surface, or agent that is designed to help reduce concentrations of microbes, viruses, germs, pathogens, microorganisms, disease, microbe-killing, or bacteria on the stethoscope head, including, for example, materials, substances, products, or compounds that are citrus-based, water-based, alkaline, non-alkaline material, 1,2-Hexanediol, Air, Ammonium bicarbonate, Ammonium carbonate, bleach, chlorine dioxide, citric acid, Dodecylbenzenesulfonic acid, Ethanol (Ethyl alcohol), Ethanol, Glutaraldehyde, Glycolic acid, Hydrochloric acid, Hydrogen chloride, Hydrogen peroxide, Hypochlorous acid, Iodine, Isopropanol (Isopropyl alcohol), lactic acid, L- Lactic acid, Octanoic acid, Octanoic acid, Oxygen, Peracetic acid, Peroxyacetic acid, Peroxyoctanoic acid, Phenolic, PHMB, Potassium peroxymonosulfate, Quaternary ammonium, silver ion, silver, Sodium carbonate peroxyhydrate, Sodium carbonate, Sodium chlorite, Sodium dichloroisocyanurate dihydrate, Sodium dichloroisocyanurate, Sodium hypochlorite, Tetraacetyl ethylenediamine, Thymol, Triethylene glycol, UV, non-leaching antimicrobial materials, leaching antimicrobial materials, photosensitizer, photosensitizer reacting with oxygen in the immediate area to generate singlet oxygen, oxidizers, or materials that facilitate photodynamic reactions leading to microbial cell death. An exemplary nitrile swatch is shown in FIG. 3A.

[0081] In some embodiments, the stethoscope shield or barrier may comprise further additives. In some embodiments, the stethoscope shield or barrier may comprise a lubricant. In some embodiments, the stethoscope shield or barrier may comprise a spermicide. In some embodiments, the stethoscope shield or barrier may comprise colorants. In some embodiments, the stethoscope shield or barrier may comprise flavorings. In some embodiments, the stethoscope shield or barrier may other additives to further improve stethoscope function.

[0082] In some embodiments, the stethoscope shield or barrier may be produced to varying specifications. In some embodiments, the stethoscope shield or barrier may have a grade, such as medical examination, industrial, or any other representative standard grade. In someAtty Dkt No.: 52243-706601 embodiments, the stethoscope shield or barrier may have texture, wherein the texture may be formed by the material or specific use case. In some embodiments, the stethoscope shield or barrier may have a thickness, wherein the thickness may range from about 0.1 millimeter (mm) to about 1 cm. In some embodiments, the thickness may range from about 0.1 mm to about 1 mm, from about 1 mm to about 10 mm, from about 10 mm to about 50 mm, or from about 50 mm to about 100 mm. In some embodiments, the specifications may be determined based on use case, paired stethoscope, regional material availability, formulation, construction preferences, or regional regulations.

[0083] In some embodiments, the stethoscope shield or barrier may be folded. In some embodiments, the stethoscope shield or barrier folds may be to increase scope cover. In some embodiments, the stethoscope shield or barrier folds may be to ensure a flat detection surface across the scope. In some embodiments, the stethoscope shield / barrier may be flattened or smoothed. In some embodiments, the stethoscope shield / barrier folds may be considered origami-like, where origami-like indicates that the folding creates a shape or embeds functionality to the material. In some embodiments, the stethoscope shield or barrier may have striations. An example of the stethoscope shield or barrier striations may be seen in FIG. 7.

[0084] In some embodiments, the stethoscope shield / barrier may be thermally heat bonded. In some embodiments, the stethoscope shield / barrier may be embossed.

[0085] In some embodiments, the stethoscope shield or barrier may be designed to be portable. In some embodiments, the stethoscope shield or barrier may be designed for use by healthcare professionals who work away from an office. In some embodiments, the stethoscope shield or barrier may be designed to fit in a practitioner’s pocket or bag. In some embodiments, the portable stethoscope shield or barrier may be designed to cover only the scope detection surface. In some embodiments, the portable stethoscope shield or barrier may be designed to cover the detection surface and additional stethoscope scope area. In some embodiments, the portable stethoscope shield or barrier may be packaged individually. In some embodiments, the portable stethoscope shield or barrier may be packaged in a wrapper, much like a band aid wrapper. In some embodiments, the portable stethoscope shield or barrier may be flat in the wrapper. In some embodiments, the portable stethoscope shield or barrier may be folded in the wrapper. The portable shield or barrier sheath may be seen in FIGS. 8A - 8F.

[0086] In some embodiments, the stethoscope shield or barrier may be contained within a dispenser. In some embodiments, the dispenser may be configured with one opening. In some embodiments, the dispenser may be configured with more than one opening. In some embodiments, the dispenser may be a three dimensional shape. In some embodiments, the dispenser may contain a stethoscope shield or barrier. In some embodiments, the dispenser mayAtty Dkt No.: 52243-706601 contain a plurality of stethoscope shield or barrier. In some embodiments, the dispenser may contain packaged stethoscope shield or barrier. In some embodiments, the dispenser may contain a roll of stethoscope shield or barrier. In some embodiments, the dispenser may contain separated stethoscope shield or barrier. In some embodiments, the stethoscope shield or barrier dispenser may enable a user to remove a stethoscope shield or barrier manually. In some embodiments, the stethoscope barrier / shield dispenser may be configured to allow the stethoscope to be placed into the dispenser. In some embodiments, the stethoscope barrier / shield dispenser may be configured to allow the scope to be placed into the stethoscope shield or barrier while within the stethoscope barrier / shield dispenser. In some embodiments, the stethoscope barrier / shield dispenser may be configured to allow the stethoscope shield or barrier to be removed together from the dispenser. In some embodiments, the dispenser may be configured to hold only stethoscope shields / barriers. In some embodiments, the dispenser may be configured to hold more than one product. In some embodiments, the dispenser may be configured to hold both stethoscope shield or barrier and gloves simultaneously. In some embodiments, the dispenser may be configured to allow access to multiple products simultaneously. In some embodiments, the dispenser may be configured to allow access to both the stethoscope shield or barrier and gloves simultaneously. In some embodiments, the dispenser may be configured to dispense other medical use products. Exemplary dispensers are shown in FIGS. 8A-8F, 10A, 11A-11C, and 14.

[0087] In some embodiments, the dispenser may have markings. In some embodiments, the dispenser may be adorned with specific markings. In some embodiments, the dispenser may be adorned with a code. In some embodiments, the dispenser may be adorned with a QR code. In some embodiments, the dispenser may be adorned with a barcode.

[0088] In some embodiments, the stethoscope shield or barrier may be configured to cover the detection surface of the scope. In some embodiments, the stethoscope shield or barrier may be configured to cover the detection surface without losing sensitivity.

[0089] In some embodiments, the stethoscope shield or barrier may be constructed out of nitrile. Research has been completed to investigate the efficacy of an example material for the aforementioned stethoscope shield or barrier. In the case of nitrile, extensive research has been completed. In the case of nitrile gloves, performance requirements and testing methods are required to protect those in healthcare environments from bloodborne pathogens, chemicals, and microorganisms. In that case, the CDC and ECDC have recommended use of gloves made of nitrile for subject care and fluid contact due to its efficacy in prevention of microorganism transfer. Due to the high contamination due to stethoscopes, the aforementioned shield or barrierAtty Dkt No.: 52243-706601 material was studied, aggregated, and analyzed under three data sets to determine its high efficacy.

[0090] In some embodiments, a method for applying a protective stethoscope shield or barrier may be disclosed, as shown in FIGS. 1, 2, 3, 5, 6, 9, 10A, 10B, 10C, 11B, 11C, 12A, 12B, 13A, 13B, 13C. In some embodiments, the method may include the possession of a dispenser containing one or more stethoscope shields / barriers. In some embodiments, the method may include removing one stethoscope shield or barrier from the dispenser. In some embodiments, the method may include insertion of a stethoscope into the shield or barrier. In some embodiments, the method may include pulling the excess, rolled up stethoscope shield or barrier to cover the entire stethoscope chestpiece and where the chestpiece and the stethoscope tube are joined. In some embodiments, the method may include removing the stethoscope shield or barrier after use from the stethoscope.

[0091] In some embodiments, the method may be part of a medical examination. In some embodiments, the method may be used to listen to heart sounds. In some embodiments, the method may be used to listen to blood flow. In some embodiments, the method may be used to listen to bowel sounds. In some embodiments, the method may be used to measure liver size. In some embodiments, the method may be used to measure blood pressure. In some embodiments, the method may be used to detect bruits. In some embodiments, the method may be used to listen to breathing. In some embodiments, the method may be used to listen to the lungs.

[0092] In some embodiments, the method may be part of a medical examination (exam). In some embodiments, the method may be used as part of an emergency exam. In some embodiments, the method may be used as part of a triage situation. In some embodiments, the method may be used as part of a preventative check. In some embodiments, the method may be used as part of a physical exam. In some embodiments, the method may be used as part of a diagnostic exam. In some embodiments, the method may be used as part of a blood pressure screening.

[0093] In some embodiments, the method may be performed by a medical professional. In some embodiments, the method may be performed by a physician. In some embodiments, the method may be performed by a medical doctor. In some embodiments, the method may be performed by an obstetrician. In some embodiments, the method may be performed by a gynecologist. In some embodiments, the method may be performed by a nurse practitioner. In some embodiments, the method may be performed by a physician assistant. In some embodiments, the method may be performed by a licensed nurse. In some embodiments, the method may be performed by a registered nurse. In some embodiments, the method may be performed by a clinical nurse specialist. In some embodiments, the method may be performed by certified midwife. In some embodiments, the method may be performed by a specialist health care provider or medicalAtty Dkt No.: 52243-706601 professional. In some embodiments, the method may be performed by anyone authorized under applicable Federal or State law.

[0094] In some embodiments, the method may be performed in a healthcare environment. In some embodiments, the method may be performed in another environment where stethoscopes are commonly used. In some embodiments, the environment may be an acute care center, airport, aviation medicine location, allergy or immunology clinic, ambulance, paramedic setting, ambulatory clinic in homeless shelter, ambulatory surgery center, clinical nutrition or dietitian clinic, medical clinic, collective / conjugal living location, correctional facility, correctional medical unit, dental clinic, remote area, developing country, disaster relief or humanitarian center, educational institution, emergency shelter, emergency kit use location, fire department, genetic counseling center, geriatric assessment center, global health or travel medicine location, health and wellness center, hearing clinic, home care setting, hospital, infections disease clinic, lactation consultant center, lymphatic clinic, medical research or clinical trial setting, military or combat medicine setting, military and civilian air evacuation setting, mining or industrial health clinic, mobile health clinic, museum, nursing home, long term care facility, occupational health clinic, outpatient setting, pain management clinic, palliative care or hospice setting, pediatric home care setting, pregnancy and maternity clinic, prison, jail, detention center, psychiatric hospital or clinic, public event, public health surveillance setting, research laboratory, rural or remote health setting, school or college health center, sleep clinic, sports medicine or athletic training setting, substance abuse treatment center, telemedicine or remote healthcare setting, transplant center, travel medicine clinic, veterinary clinic, animal hospital, wellness or preventive care center, wound care clinic, wildlife center, zoo, or private / personal use.

[0095] In some embodiments, the method may require appropriate cleaning or sterilization. In some embodiments, the cleaning or sterilization may require the practitioner to wash their hands. In some embodiments, the cleaning or sterilization may require the practitioner to wash their hands with disinfectant soap. In some embodiments, the cleaning or sterilization may require the practitioner to wash their hands with warm water. In some embodiments, the cleaning or sterilization may require the practitioner to air dry their hands. In some embodiments, the cleaning or sterilization may require the practitioner to apply Personal Protective Equipment (PPE). In some embodiments, the PPE may include safety glasses, goggles, laser protective eyewear, a face shield or barrier, a mask, exam gloves, shoe coverings, fluid resistant gowns, splash suit, respirators, surgical masks, stethoscope protective barriers / shields, or a combination thereof. In some embodiments, the cleaning or sterilization may require the practitioner to perform a combination thereof. In some embodiments, non-sterile equipment may be removed.Atty Dkt No.: 52243-706601In some embodiments, the cleaning or sterilization should follow accepted protocols by the CDC, NIH, or other similar organizations.

[0096] In some embodiments, the method may require full cleaning and / or sterilization. In some embodiments, the cleaning or sterilization may take place at the beginning of the workday. In some embodiments, the cleaning or sterilization may take place before seeing the first patient. In some embodiments, the cleaning or sterilization may take place between every patient. In some embodiments, the cleaning or sterilization may take place before every patient. In some embodiments, the cleaning or sterilization may take place after every patient. In some embodiments, the cleaning and sterilization may take place at the end of the workday.

[0097] In some embodiments, the method may utilize software. In some embodiments, the method may require practitioners to enter data into software. In some embodiments, the method may require practitioners to enter data into CRM / EMR / EHR. In some embodiments, the method may require data analysis. In some embodiments, the method may require a periodic data audit. In some embodiments, the method may require a quarterly data audit. In some embodiments, the audit may analyze actual healthcare-associated infection data. In some embodiments, the audit may analyze actual germ / bug count reduction data. In some embodiments, the audit may compare actual healthcare-associated infection data to goal healthcare-associated infection reduction. In some embodiments, the audit may compare actual healthcare-associated infection data to expected healthcare-associated infection data. In some embodiments, the audit may compare actual germ / bug count reduction data to goal germ / bug count reduction data. In some embodiments, the audit may compare actual germ / bug count reduction data to expected germ / bug count reduction data.

[0098] In some embodiments, a single-use, disposable stethoscope shield or barrier comprising a foldable or non-foldable structure with an opening configured to receive a stethoscope head and a shield or barrier / sleeve extending from said opening, wherein said sleeve is adaptable to be rolled or folded to secure the shield or barrier / sleeve to the stethoscope, may be provided.

[0099] In some embodiments, a stethoscope shield or barrier / sleeve dispenser comprising a housing with an opening configured to dispense individual, single-use, disposable stethoscope barriers / shields, wherein said barriers / shields are foldable or non-foldable and have an opening and a sleeve adapted to secure the barrier / shield to a stethoscope, may be provided.

[0100] In some embodiments, the stethoscope shield or barrier is constructed from a material selected from the group consisting of nitrile, polyethylene, and polypropylene, and further wherein said material exhibits antimicrobial / antibacterial / antifungal properties.Atty Dkt No.: 52243-706601

[0101] In some embodiments, the stethoscope shield or barrier is configured to provide a balance of infection control, sound transmission, cost efficiency, and user familiarity with materials that are time-tested in healthcare, complementing existing workflows.

[0102] In some embodiments, the stethoscope shield or barrier material may be selected to achieve a balance of infection control, sound transmission, and user comfort. In some embodiments, the stethoscope shield or barrier material may be selected due to their inherent antimicrobial properties, flexibility, and cost effectiveness, time tested in healthcare. In some embodiments, the stethoscope shield / barrier material may be selected due to its sound transmission characteristics, ensuring that healthcare professionals can accurately auscultate patients without interference. In some embodiments, the stethoscope shield / barrier material may be selected due to its softness and comfort against the patient’s skin during examination. In some embodiments, the stethoscope shield / barrier material may be selected due to its antimicrobial properties, flexibility, and user comfort. In some embodiments, the stethoscope shield / barrier material may be nitrile, polyethylene, or polypropylene.

[0103] The foldable / non-foldable design and adaptable sleeve enable quick and easy application and removal of the shield or barrier, streamlining workflow for healthcare professionals. The innovative foldable / non-foldable design, coupled with the adaptable sleeve, facilitates rapid and effortless application and removal of the barrier / shield, promoting efficiency in healthcare settings.

[0104] The thin and flexible material minimizes sound attenuation, ensuring accurate auscultation and diagnosis. The carefully selected materials and thin profile of the shield or barrier minimize sound attenuation, ensuring accurate and reliable auscultation for confident diagnoses.

[0105] The comprehensive seal around the stethoscope head and antimicrobial properties of the material provide a robust barrier against pathogen transmission, reducing the risk of healthcare- associated infections. The comprehensive seal around the stethoscope head, combined with the inherent antimicrobial properties of the materials, creates a formidable barrier against pathogen transmission, significantly reducing the risk of healthcare-associated infections and stethoscope acquired infections.

[0106] The single-use, disposable design eliminates the need for cleaning and disinfection, reducing the use of harsh chemicals and water resources. The materials used are also recyclable, further minimizing environmental impact. The single-use, disposable nature of the shield or barrier eliminates the need for cleaning and disinfection, conserving water resources and reducing the use of harsh chemicals. Furthermore, the materials used are recyclable, promoting environmental sustainability.Atty Dkt No.: 52243-706601

[0107] In some embodiments, the stethoscope shield or barrier may be shaped to accommodate different stethoscope head sizes and shapes.

[0108] In some embodiments, the dispenser may be adapted to hold different quantities of stethoscope shields or barriers or to be wall-mounted or portable.

[0109] In some embodiments, the stethoscope shield or barrier material may incorporate additional features. In some embodiments, the stethoscope shield or barrier material may provide color-coded indicators. In some embodiments, the stethoscope shield or barrier material may communicate that the dispenser is running low. In some embodiments, the stethoscope shield or barrier material may be red, indicating that a low number of barriers / shields remain in the dispenser.

[0110] In some embodiments, the stethoscope shield or barrier and dispenser may be packaged and sold in a manner that promotes convenience, cost efficiency, ease of use, workflow, and hygiene. In some embodiments, the dispenser may be designed for easy wall mounting or countertop placement, and may have a clear window to indicate the remaining quantity of barriers / shields. In some embodiments, the barriers / shields may also be individually packaged in “clean” wrappers / pouches to maintain their cleanliness and integrity. In some embodiments, the dispenser, packaging, or training materials may include clear instructions for use and disposal, along with relevant regulatory information. In some embodiments, the stethoscope shield or barrier and dispenser may be envisioned to be packaged and marketed in a manner that prioritizes convenience, hygiene, cost-efficient, ease of use, workflow, use of time-tested materials, time-tested dispensers, and user-friendliness. In some embodiments, the dispenser may be designed for effortless installation, featuring options for wall mounting, cart mounting, surface mounting, or countertop placement, and may incorporate a clear window to indicate the remaining quantity of barriers / shields. In some embodiments, the barriers / shields themselves may be individually packaged and box-packed to ensure their cleanliness and integrity until use. In some embodiments, the packaging may include instructions for proper application, removal, and disposal, as well as any relevant regulatory information.[oni] In some embodiments, the barrier / shield may be adhered to the roll or packaging. In some embodiments, the roll may be a roll of material. In some embodiments, the packaging may be of a material. In some embodiments, the barrier / shield may be thermally bonded to the roll or packaging. In some embodiments, the barrier / shield may be embossed to the roll or packaging. In some embodiments, the roll or packaging may be paper, non-paper, or hybrid paper material.

[0112] In some embodiments, the stethoscope shield or barrier dispenser may be similar in concept to box used for dispensing gloves. In some embodiments, the stethoscope barriers / shields dispenser may provide a convenient and hygienic storage and dispensing mechanism forAtty Dkt No.: 52243-706601 the single-use shield or barrier, ensuring their accessibility and minimizing risks for contamination. Like a glove box, the dispenser features an opening that allows for easy access to the shields or barriers. The shields or barriers may be stacked or rolled within the dispenser, similar to how gloves are arranged in their box. Additionally, the dispenser may be designed for wall mounting or countertop placement, akin to the common glove box configurations. However, the stethoscope shield or barrier dispenser is specifically tailored to the unique shape and size of the barriers / shields. The opening may be designed to accommodate the folded (foldable) or nonfolded (unfolded) configuration of the barriers, and the internal structure may be optimized for efficient dispensing of individual barriers / shields. The stethoscope barrier / shield dispenser is also envisioned to have one side dispensing gloves and the other side dispensing stethoscope shields.EXAMPLES

[0113] The following examples are provided to further illustrate some embodiments of the present disclosure, but are not intended to limit the scope of the disclosure; it will be understood by their exemplary nature that other procedures, methodologies, or techniques known to those skilled in the art may alternatively be used.Example 1: Sound Transmission Efficacy of Shield or Barrier Material

[0114] Testing was completed to compare the audio transmission of a stethoscope equipped with an aforementioned shield or barrier to those stethoscopes not adorned with a shield or barrier, as scene below in Table 1. Testing was completed at the following frequencies: 250 Hz, 500 Hz, 1000 Hz, and 2000 Hz. To determine the level of potential hearing loss, audio cues were presented at various decibel levels: 10 dB, 20 dB, 30 dB, and 40 dB. Further, to ensure that the stethoscope shield or barrier may be utilized by a wider array of healthcare professionals in a healthcare facility, testing was completed using a Prestige Medical stethoscope and a Littman Cardiology stethoscope. The resultant audio decibels are displayed in Table 1.

[0115] After data collection, the average decibel levels detected with the disclosed shield or barrier and the average decibel levels detected without the shield or barrier configured to the scope. The average variations between the two were analyzed as well, to determine overarching differences. The resultant aggregated average variation across all frequencies was found to be 0.7 dB.

[0116] Additionally, the following values were provided for further context: Normal Heart Sounds = 75 dB at ear pieces; Normal Lung Sounds = 60-75 dB at ear pieces; Normal Bowel Sounds = 50 dB at ear pieces; Normal Speech = 55-60 dB; Normal Whisper = 40 dB; Safe dB levels for human ears over a prolonged time = 70 dB.Atty Dkt No.: 52243-706601Table 1

[0117] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternativesAtty Dkt No.: 52243-706601 to the embodiments of the present disclosure may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the present disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

Atty Dkt No.: 52243-706601CLAIMSWhat is claimed is:

1. A device for transmissible disease protection, the device comprising: a. a shield or barrier; and b. a dispenser, wherein the shield or barrier is housed within the dispenser, c. wherein the shield or barrier is foldable, folded, or unfolded around a stethoscope.

2. The device of claim 1, wherein the shield or barrier comprises at least two layers of material.

3. The device of claim 2, wherein the at least two layers of material are identical material.

4. The device of claim 1, wherein the shield or barrier is configured to be coupled to a stethoscope.

5. The device of claim 4, wherein the stethoscope is an acoustic stethoscope.

6. The device of claim 4, wherein the stethoscope is a digital stethoscope.

7. The device of claim 4, wherein the stethoscope is configured to be positioned between the at least two layers of material.

8. The device of claim 1, wherein the shield or barrier further comprises a pouch or opening.

9. The device of claim 8, wherein the pouch is configured to fully encompass the stethoscope.

10. The device of claim 8, wherein the pouch is configured to encompass a surface of the stethoscope.

11. The device of claim 8, wherein the opening is configured to comprise an elastic material to create a seal.

12. The device of claim 8, wherein the opening is a slit, wherein at least a portion of the stethoscope is positioned within the slit.

13. The device of claim 1, wherein the shield or barrier further comprises excess material shaped or configured to be contacted by a user.

14. The device of claim 1, wherein the shield or barrier housed with the dispenser is coupled to a roll of material.

15. The device of claim 14, wherein the roll of material comprises paper material.

16. The device of claim 1, wherein the dispenser is configured to hold both the shields or barriers and gloves simultaneously.

17. The device of claim 1, wherein the dispenser further comprises a marking, such as a code.Atty Dkt No.: 52243-70660118. The device of claim 1, wherein the shield or dispenser is configured to fold over the stethoscope.

19. The device of claim 1, wherein the shield or dispenser is configured to contact a surface of the stethoscope while unfolded around the stethoscope.

20. A method for transmissible disease protection, the method comprising: a. providing a shield or barrier for a stethoscope, wherein the shield or barrier is with or without a rolled bottom sleeve; b. providing a box or dispenser for the shield or barrier; c. inserting the stethoscope into the shield or barrier, ensuring that contact between the stethoscope and at least a portion of the outer surface of the shield or barrier does not occur; d. rolling the rolled bottom sleeve of the shield or barrier to cover the stethoscope detection surface and tube, wherein the rolled bottom sleeve is configured to remain flat against the stethoscope detection surface; e. removing the shield or barrier from the stethoscope after use; and f. disposing of the shield or barrier after use.

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