Patent Application
20230122165
Protecting a patient’s face during a medical treatment (e.g., a surgery) when the patient is lying in the supine or the reclined position is an important concern. As described herein, the supine position is when the patient is lying horizontally on their back and their face and torso are facing substantially upward. In addition, the reclined position includes positions where the patient is lying on their back such that the patient’s face is oriented within 45 degrees of horizontal. In either the supine or the reclined positions, localized or uneven pressures applied to a patient’s face during a medical treatment can lead to decreased blood flow, compression injuries, and to nerve damage. For example, pressures applied to the ocular structures can cause severe nerve damage and even blindness. Additionally, compression injuries may also occur for example to portions of the forehead, nose, ears, cheeks, and mouth. Once general anesthesia is administered, a patient becomes progressively less able to respond to stimulus that would otherwise trigger discomfort or pain. Therefore constant vigilance is needed by the anesthesia provider and by the other clinical staff to protect the patient’s vital facial and head structures during medical treatments.
U.S. Pat. No. 9,723,881 (the ‘881 Patent), the entirety of which is incorporated herein by reference, disclosed a protective device for protecting the face and/or head of a patient receiving medical treatment in the supine position. The ‘881 Patent discloses a device including a face portion having an exterior surface, an interior surface, and an aperture extending from the exterior surface to the interior surface. The device includes a pair of opposed flexible side portions extending outwardly from the face portion. The face portion was configured to be positioned about the patient’s face with at least a portion of the face exposed by the aperture. The side portions were configured to be wrapped around and completely surround the patient’s head such that at least one of the side portions was positioned underneath the patient’s head. While the ‘881 Patent has provided many valuable solutions to users treating patients in the supine position, the clinical usage has also shown that the user’s experience, particularly for example an anesthesia provider’s experience, can be improved. For example, the side portions that were configured to be wrapped completely around the patient’s head limited the utility of the device. Accordingly, there is a need for an improved head and facial protection device as described herein.
The present disclosure relates generally to a protective device for a patient’s head and/or face that may be used during surgery and other procedures.
In light of the present disclosure, and without limiting the scope of the disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, a protective device for protecting a face and/or head of an individual receiving medical treatment in a supine or reclined position. The protective device includes a body including a top portion with an exterior surface and a base portion with an interior surface. The top portion includes opposing side edges, and the base portion includes opposing bottom side edges extending outwardly from the top side edges. The base portion is flexible and is configured to wrap partially around the individual’s head, and the body includes an aperture extending between the exterior surface and the interior surface to provide access to at least one of the individual’s eyes, nose, or mouth. A strap spanning the side edges of the top portion of the body and configured to wrap behind the base portion of the body and the individual’s head to secure the interior surface of the base portion into proximate contact with the face and/or head, and wherein the strap is configured to detachably couple to the exterior surface of the top portion along a plurality of connection positions.
In accordance with a second aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the protective device further includes an eye protection shield configured to detachably couple to the exterior surface of the top portion and to at least partially obstruct the aperture.
In accordance with a third aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the plurality of connection positions includes four connection points on the exterior surface of the top portion, and wherein the strap is formed from a continuous piece of material.
In accordance with a forth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the plurality of connection positions includes four segments of hook fabric on the exterior surface of the top portion, and the strap is formed from a continuous piece of loop fabric and is configured to equalize pressure between the plurality of connection positions.
In accordance with a fifth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion is monolithically formed with the base portion.
In accordance with a sixth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion is thicker than the base portion.
In accordance with a seventh aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the exterior surface further includes a slit extending partially through a thickness of the top portion, wherein opposing surfaces forming the slit are configured to frictionally grip tubing or electrically conductive wires placed within the slit.
In accordance with a eighth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion and the base portion are adhesively coupled.
In accordance with a ninth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion is formed from a first foam that is stiffer than a second foam forming the base portion.
In accordance with a tenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, a protective device for protecting a face and/or head of an individual receiving medical treatment in a supine or reclined position. The protective device including a body comprising a top portion with an exterior surface and a base portion with an interior surface. The top portion includes opposing side edges, and the base portion includes opposing bottom side edges extending outwardly from the top side edges. The base portion is flexible and is configured to wrap partially around the individual’s head. The top portion is not configured to wrap partially around the individual’s head. The body includes a first aperture extending between the exterior surface and the interior surface to provide access to the individual’s eyes, and a second aperture extending between the exterior surface and the interior surface to provide access to the individual’s nose and mouth. The protective device also includes a strap spanning the side edges of the top portion of the body and configured to wrap behind the individual’s head to secure the interior surface of the base portion into proximate contact with the face and/or head. The strap is configured to detachably couple to the exterior surface of the top portion along a plurality of connection positions.
In accordance with an eleventh aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the plurality of connection positions includes four segments of hook fabric on the exterior surface of the top portion, and the strap is formed from a continuous piece of loop fabric.
In accordance with a twelfth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion is monolithically formed with the base portion.
In accordance with a thirteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the exterior surface further includes a slit extending partially through a thickness of the top portion, and opposing surfaces forming the slit are configured to frictionally grip tubing or electrically conductive wires placed within the slit.
In accordance with a fourteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion and the base portion are adhesively coupled.
In accordance with a fifteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the top portion is formed from a first foam that is stiffer than a second foam forming the base portion.
In accordance with a sixteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, further including an eye protection shield configured to detachably couple to the exterior surface of the top portion and fully obstruct the first aperture.
In accordance with a seventeenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, the eye protection shield is formed from a clear and fog-free material.
In accordance with an eighteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, a method of protecting a face and/or head of an individual receiving medical treatment in a supine or reclined position. The method includes providing a device with a body including a top portion and a base portion. The top portion includes opposing side edges, and the base portion includes opposing bottom side edges extending outwardly from the top side edges. The method further includes providing a strap behind the individual’s head, and opposing ends of the strap extend beyond the sides of the individual’s head. The method further includes placing an interior surface of the base portion into proximate contact with the face and/or head of the individual, positioning the body so that an aperture provides access at least one of the individual’s eyes, nose, or mouth to an exterior surface, and wrapping at least a portion of the base portion partially around the individual’s head. The top portion is not configured to wrap partially around the individual’s head. Still further the method includes attaching the ends of the strap to the side edges of the top portion of the device and coupling the strap to the exterior surface of the top portion along a plurality of connection positions to secure the body to the individual’s face and/or head.
In accordance with a nineteenth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, a method further including coupling an eye protection shield to the exterior surface of the top portion to at least partially obstruct the aperture.
In accordance with a twentieth aspect of the present disclosure, which may be used in combination with any other aspect listed herein unless stated otherwise, a method further including pressing tubing or electrically conductive wires into a slit formed in the exterior surface of the top portion, wherein the slit extends partially through a thickness of the top portion, and holding the tubing or electrically conductive wires in a fixed position with friction of opposing surfaces forming the slit.
Additional features and advantages of the disclosed apparatus, system and method are described in, and will be apparent from, the following detailed description and figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Also, any particular embodiment does not have to have all of the advantages listed herein. Moreover, it should be noted that the language used in the specification has been selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.
These and other features, aspects, and advantages of certain embodiments will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:
The present disclosure relates generally to a protective device for a patient’s head and/or face that may be used during surgery and other procedures. Specifically, the present disclosure provides protective devices and methods for protecting the head and/or face of a patient undergoing a procedure while lying in the supine position. In addition, the present disclosure includes a reusable, replaceable mask strap that may be used to securing the protective device to the patient. In an embodiment, the mask strap is also used to support a mask for administering gases (e.g., oxygen, nitrous oxide, or various inhalation anesthetics) to the patient before, during, or after a surgical or other medical procedure.
Referring to
Referring to
Referring to
The base portion 20 may be made from a soft foam material that helps to reduce abrasiveness or roughness against the patient’s face, while also providing effective comfort and pressure management as loads applied to the base portion 20 are distributed. The bending stiffness (e.g., rigidity) of the base portion 20 material is also selected such that the portions of the base portion 20 away from the seam 16 are flexible and capable of wrapping partially around the patient’s head. In an example, the base portion 20 foam may be a pneumatic foam, a “non-memory” foam, a viscoelastic “memory” foam, a slow recovery foam, a polyurethane foam, a fire retardant polyurethane foam, or a plastic or polymeric material. In some embodiments, the material of the base portion 20 provides at least some indentation load deflection, correlating to a minimum amount of weight needed to depress the material. In one embodiment, the base portion 20 has an indentation load deflection of between about 15 and about 25. In some embodiments, the material includes a viscoelastic gel having a viscosity that changes depending on the environment. For example, a material may become more stiff in cooler environments such as an operating room, requiring direct warmth from the patient to decrease the viscosity and become pliable. Additionally, the interior surface 24 of the base portion 20 interfacing with the patient 1 may have a high stiction factor to reduce the risk of slipping.
As an example, Table 1 below provides example foam properties that may be used for the foam of the base portion 20.
The top portion 18 may also be made of a foam material that provides further protection and pressure management to the patient’s face by distributing localized forces applied to the exterior surface 22. In an example, the foam of the top portion 18 may be a pneumatic foam, a “non-memory” foam, a viscoelastic “memory” foam, a polyurethane foam, a fire retardant polyurethane foam, or a plastic or polymeric material. In one embodiment, the top portion 18 has an indentation load deformation of between about 40 and about 45. For example, the material of the top portion 18 may be a 1.2 lb polyurethane. In some embodiments, the foam of the top portion 18 may be selected to have a higher density and/or a higher stiffness than the foam of the base portion 20, and is therefore more resistant to bending, pressure, or other deformation than the base portion 20. The foam of the top portion 18 may also have a thickness 30 that is greater than a thickness 32 of the foam of the base portion 20. In an embodiment, the thickness 30 of the top portion 18 is approximately twice the thickness 32 of the base portion 20. In another embodiment, the thickness 30 of the top portion 18 is more than twice the thickness 32 of the base portion 20. By using thicker, denser, and/or higher stiffness foam for the top portion 18, relative to the base portion 20, the bending stiffness of the top portion 18 will be higher than the bending stiffness of the base portion 20. As best shown in
Alternatively, the top portion 18 and the base portion 20 may also be formed from a single type of foam in some embodiments. For example, the base portion 20 may include cavities or openings to reduce stiffness and allow the side portions to bend easily around the patient’s head. Still further, some embodiments may omit the seam 16 and the top portion 18 may be monolithically formed with the base portion 20 from a single piece of foam.
Referring still to
Additionally, the top portion 18 may further comprise one or more slits 36 that extend from the exterior surface 22 toward the base portion 20. The slits 36 may be of varied depth or may be a constant depth. In an embodiment, the slits 36 only extend partially through the thickness 30 of the top portion 18. The slits 36 are formed by parting (e.g., slicing, sawing, etc.) the top portion 18 such that minimal material is removed by the kerf of the parting tool and thus the opposing surfaces forming the slit 36 remain in close proximate contact or direct touching contact when the body 10 is in the relaxed state. In an example, the opposing surfaces forming the slits 36 are spaced apart 1/32 inches (0.79 mm) or less. Alternatively, the opposing surfaces forming the slits 36 are spaced apart 1/64 inches (0.40 mm) or less. Alternatively, the opposing surfaces forming the slits 36 are not spaced apart, and are thus in direct touching contact. During use, the slits 36 are configured to accept accessory items (e.g., tubing, electrically conductive wires, medical equipment, other accessories, etc.) and allow the positioning of the accessory items to be fully or partially below the exterior surface 22 of the top portion 18. In addition, the opposing surfaces forming the slits 36 may be configured to frictionally grip the accessory items placed within the slits 36.
Referring to
Referring to
The arms are connected to the side edges of the top portion in order to equalize the pressure applied to the patient’s face along the interior surface 24 of the body 10. The plurality of connection positions 34 in combination with the interior surface 24 having a high stiction factor also better anchors the body 10 onto the patient’s face so that the protection device 100 does not shift or slip during operation.
In an example, the strap 12 is formed from a continuous piece of loop fabric such as Veltex® fabric that secures easily to the hook material of the connection positions 34 of the body 10. Thus the arms 46 may be connected to the connection positions 34 along an infinite number of positions along the lengths of the arms 46 to adjust the tension on the strap 12. In other embodiments, the strap 12 is formed of a flexible material that includes hook and loop material near the ends of the arms 46 such that the arms 46 extend through rings of the connection positions 34 and are tightened using the hook and loop attachment means at each end. In another embodiment, the strap 12 includes openings on the arms 46 that engage with protrusions or hooks at the connection positions 34 of the body 10. In still further embodiments, the arms 46 of the strap 12 may include any other suitable mechanism for attaching the strap 12 to the top portion 18 of the body 10.
In addition, the strap 12 may also be used during a medical treatment before the body 10 is affixed to the patient 1 or after the body 10 is removed from the patient 1. In particular, as shown in
Referring to
The device 10, 60 and method of using the device 10, 60 according to the present disclosure provides protection for the patient 1 undergoing surgery in the supine or reclined positions by allowing forces to the patient’s head or face to be distributed. A flexible foam construction also provides a relatively light weight device 100 that promotes the prevention of injury to the patient 1 relative to stiffer and/or heavier protective devices. In addition, the placement of the base portions 20, 72 along the sides of the head, rather than also behind the head, also promotes a rotationally stable construct that maintains the position of the patient’s head. By maintaining the patient’s head in a stable position, the device 100 and method disclosed also further reduces the risks of decreased blood flow and possible nerve damage. Still further, by using the strap 12 that can connect to both the anesthesia face mask 52 and to the bodies 10, 60, the strap 12 may stay in place as the patient’s head remains in a stationary and stable position, and thus still further reduce the risks of decreased blood flow and possible nerve damage. The device 10, 60 and methods of using the device 10, 60 therefore, provide increased protection to the patient 1 over conventional practices.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the claimed inventions to their fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles discussed. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. For example, any suitable combination of features of the various embodiments described is contemplated.
This application claims priority to and the benefit of U.S. Provisional Pat. Application No. 63/257,443 filed Oct. 19, 2021, the entire contents of which are incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63257443 | Oct 2021 | US |
