The present disclosure generally relates to anesthesia devices. In embodiments, the present disclosure relates to a mentum securement device and methods of using the same for securement of a mentum of a patient at an angle.
Anesthesia may cause airway obstruction of a patient due to relaxation of the larynx and associated upper airway muscles and structures, due to suppression of protective arousal responses, and due to decreases in respiratory reserve resulting from relaxation of the lung. Patients undergoing anesthesia may undergo orotracheal intubation to maintain an open airway. Intubation and subsequent extubating may cause minor injury such as dysphonia, aphonia and dysphagia. More severe intubation-related laryngeal trauma may include, for example, scarring of the larynx and chronic laryngeal stenosis, all of which may be associated with significant morbidity and can be life-threatening.
Certain medical procedures do not require intubation, and the patient may merely undergo sedation anesthesia. Generally, the need for intubation is determined by one or more of: the duration of the medical procedure, degree of painful stimuli, the use of muscle relaxants during the procedure and the type of procedure, to name a few. By way of example, certain surgeries result in significant blood loss and/or significant changes in the patient's breathing, blood pressure or heart rate, and therefore require general anesthesia and intubation. However, the risk of airway obstruction is still present even under sedation anesthesia.
Practitioners administering the anesthesia monitor the vital signs of the patient (such as heartbeat, breathing rate, temperature, and blood pressure) while controlling the delivery of anesthesia to the patient. In instances where an airway obstruction of the patient is occurring, the practitioner may have to intervene while continuing to monitor the breathing quality of the patient such that the airway remains open. This may last for a few seconds to minutes, or up to the remaining duration of the medical procedure. The intervention may be burdensome for the practitioner, and interferes with the monitoring of anesthesia delivery to the patient.
An object of the present invention is to provide a mentum securement device for passively managing, reducing, and potentially preventing obstruction of the airway of a patient during non-intubated anesthesia enabling the practitioner freedom from airway management tasks so that vital signs can be adequately monitored and delivery of anesthesia to the patient can be controlled.
In embodiments, a mentum securement device is disclosed. The mentum securement device comprises: a mentum strap defined by opposing distal portions, a superior end and an opposing inferior end, and a first surface configured to be positioned on a mentum of a patient undergoing anesthesia; and, a pair of securement straps each having a proximal portion attached to a respective opposing distal portion of the mentum strap and a distal portion securable to a respective anchor point, wherein the mentum strap and the pair of securement straps are configured to position the mentum of the patient to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient, wherein in a resting state the mentum of the patient is at a resting angle relative to a neck of the patient, wherein the extended angle is greater than the resting angle.
In embodiments, an airway passage of the patient is unobstructed in the extended state.
In embodiments, a tilt angle is defined as the difference between the extended angle and the resting angle.
In embodiments, the tilt angle in the extended state is in the range of 10° to 30°.
In embodiments, in use during an anesthetic procedure, securement of the mentum in the extended state prevents obstruction of an airway passage of the patient.
In embodiments, the tilt angle is set by adjustment of a respective length of the pair of securement straps.
In embodiments, each of the pair of securement straps comprise a webbing and buckle configuration to adjust the respective lengths of the pair of securement straps.
In embodiments, the pair of securement straps further comprise a hook-and-loop portion at the distal portion configured for adjustment of the respective lengths of the pair of securement straps by interlocking the hook-and-loop portion at one or more positions along lengths of the pair of securement straps.
In embodiments, each of the distal portions of the pair of securement straps comprise a hook-and-loop portion configured to removably secure the distal portions to respective anchor points in a hook-and-loop securement.
In embodiments, the respective anchor point is a portion of a siderail of a surgical stretcher.
In embodiments, respective anchor point is a tie-down d-ring of a surgical stretcher.
In embodiments, each of the distal portions of the pair of securement straps comprise a tacky first surface to removably secure the distal portions to respective anchor points.
In embodiments, each of the pair of securement straps are configured to fail upon application of a tension force.
In embodiments, the tension force is in the range of 0.1 to 10 lbs-ft.
In embodiments, the tension force is selected such that the tilt angle cannot exceed the range of 10° to 30° relative to a resting state of the mentum.
In embodiments, a hook-and-loop portion of the pair of securement straps is configured to detach upon application of the tension force.
In embodiments, the mentum strap is comprised of an elastomeric material.
In embodiments, the elastomeric material comprises a material selected from the group consisting of: medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and liquid silicone rubber (LSR) elastomer.
In embodiments, the elastomeric material has a tensile strength value.
In embodiments, the elastomeric material has a Young's modulus value.
In embodiments, at least a portion of the first surface comprises a tacky surface configured to be removably adhered to the mentum of the patient.
In embodiments, the first surface comprises an adhesive coating.
In embodiments, the mentum strap is comprised of a tacky elastomeric material.
In embodiments, the elastomeric material has a tackiness index in the range.
In embodiments, the mentum strap further comprises a plurality of perforations.
In embodiments, a method of preventing obstruction of an airway passage of a patient undergoing an anesthetic procedure is disclosed. The method comprises: evaluating breathing quality of the patient when a mentum of the patient is in a resting state defined by a resting angle of the mentum of the patient relative to a neck of the patient; positioning a mentum strap of a securement device on the mentum of the patient, the mentum securement device comprising a pair of securement straps each having a proximal portion attached to a respective opposing distal portion of the mentum strap; securing distal portions of the pair of securement straps to respective anchor points of a surgical stretcher; and, adjusting lengths of the pair of securement straps so that the mentum of the patient is moved from the resting state to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient and the patient no longer has obstructed breathing, wherein the extended angle is greater than the resting angle.
In embodiments, the breathing quality of the patient is evaluated by detecting one or more of labored breathing, obstructed breathing, and snoring.
In embodiments, the breathing quality of the patient is evaluated by monitoring carbon dioxide readings from a gas sampling device attached to the patient.
A mentum securement device according to an exemplary embodiment of the present invention comprises: a mentum strap defined by opposing distal portions, a superior end and an opposing inferior end, and a first surface configured to be positioned on and in facing relation to a mentum of a patient undergoing anesthesia; and two or more securement straps each having a proximal portion attached to a respective opposing distal portion of the mentum strap and a distal portion configured for securement to a an anchor point, wherein the mentum strap and the two or more securement straps are configured to position the mentum of the patient to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient, wherein in a resting state the mentum of the patient is at a resting angle relative to a neck of the patient, wherein the extended angle is greater than the resting angle.
In exemplary embodiments, an airway passage of the patient is unobstructed in the extended state.
In exemplary embodiments, a tilt angle is defined as the difference between the extended angle and the resting angle, and the tilt angle in the extended state is in the range of 100 to 300.
In exemplary embodiments, the tilt angle is set by adjustment of a respective length of the pair of securement straps.
In exemplary embodiments, each of the pair of securement straps comprise a webbing and buckle configuration to adjust the respective lengths of the pair of securement straps.
In exemplary embodiments, the pair of securement straps further comprise a hook-and-loop portion at the distal portion configured for adjustment of the respective lengths of the pair of securement straps by interlocking the hook-and-loop portion at one or more positions along lengths of the pair of securement straps.
In exemplary embodiments, each of the distal portions of the pair of securement straps comprise a hook-and-loop portion configured to removably secure the distal portions to respective anchor points in a hook-and-loop securement.
In exemplary embodiments, the respective anchor point is a portion of a siderail of a surgical stretcher.
In exemplary embodiments, the respective anchor point is a tie-down d-ring of a surgical stretcher.
In exemplary embodiments, each of the distal portions of the pair of securement straps comprise a tacky first surface to removably secure the distal portions to respective anchor points.
In exemplary embodiments, the two or more securement straps are configured to fail upon application of a predetermined tension force.
In exemplary embodiments, the tension force is in the range of 0.1 to 10 lbs-ft.
In exemplary embodiments, the tension force is selected such that the tilt angle cannot exceed the range of 10° to 30° relative to a resting state of the mentum.
In exemplary embodiments, a hook-and-loop portion of the pair of securement straps is configured to detach upon application of the tension force.
In exemplary embodiments, the mentum strap is comprised of an elastomeric material.
In exemplary embodiments, the elastomeric material comprises a material selected from the group consisting of: medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and liquid silicone rubber (LSR) elastomer.
In exemplary embodiments, the elastomeric material has a tensile strength value in the range of 0.5 to 15 MPa.
In exemplary embodiments, the elastomeric material has an Young's modulus value in the range of 0.0005 to 0.1 GPa.
In exemplary embodiments, at least a portion of the first surface comprises a tacky surface configured to be removably adhered to the mentum of the patient.
In exemplary embodiments, the first surface comprises an adhesive coating.
In exemplary embodiments, the mentum strap is comprised of a tacky elastomeric material.
In exemplary embodiments, the mentum strap further comprises a plurality of perforations.
In exemplary embodiments, the mentum strap comprises one or more pleats.
In exemplary embodiments, the device further comprises a brace comprising a proximal end portion configured for attachment to the two or more securement straps.
In exemplary embodiments, the brace further comprises a distal end portion configured for attachment to the anchor point.
In exemplary embodiments, the device further comprises a clamping mechanism configured for attachment to the distal end portion of the brace and the anchor point.
In exemplary embodiments, the device further comprises an adjustable tension device disposed between the clamping mechanism and the brace.
In exemplary embodiments, the device further comprises two or more rods each comprising a proximal end portion configured for attachment to a corresponding one of the two or more securement straps and a distal end portion configured for attachment to respective anchor points.
In exemplary embodiments, the two or more rods are adjustable in length.
In exemplary embodiments, an angle at which the two or more rods extend relative to the respective anchor points is adjustable.
According to an exemplary embodiment of the present invention, a method of preventing obstruction of an airway passage of a patient undergoing an anesthetic procedure comprises: evaluating breathing quality of the patient when a mentum of the patient is in a resting state defined by a resting angle of the mentum of the patient relative to a neck of the patient; positioning a mentum strap of a securement device on the mentum of the patient, the mentum securement device comprising two or more securement straps each having a proximal portion attached to a respective opposing distal portion of the mentum strap; securing distal portions of the two or more securement straps to respective anchor points of a surgical stretcher; and adjusting lengths of the two or more securement straps so that the mentum of the patient is moved from the resting state to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient and the patient no longer has obstructed breathing, wherein the extended angle is greater than the resting angle.
In exemplary embodiments, the breathing quality of the patient is evaluated by detecting one or more of labored breathing, obstructed breathing, and snoring,
In exemplary embodiments, the breathing quality of the patient is evaluated by monitoring carbon dioxide readings from a gas sampling device attached to the patient.
A mentum securement device according to an exemplary embodiment of the present invention comprises: a mentum strap defined by opposing distal portions, a superior end and an opposing inferior end, and a first surface configured to be positioned on and in facing relation to a mentum of a patient undergoing anesthesia; and two or more securement straps each having a proximal portion attached to a respective opposing distal portion of the mentum strap and a distal portion; and means for securing the distal portions of the two securement straps to an anchor point, wherein the mentum strap and the two or more securement straps are configured to position the mentum of the patient to an extended state, wherein in the extended state the mentum of the patient is at an extended angle relative to a neck of the patient, wherein in a resting state the mentum of the patient is at a resting angle relative to a neck of the patient, wherein the extended angle is greater than the resting angle.
Other and further objects will be explained hereinafter and more particularly delineated in the appended claims.
In the drawings, exemplary embodiments of the invention are illustrated by way of example, it being expressly understood that the description and drawings are only for the purpose of illustration of exemplary embodiments and are not intended as a definition of the limits of the invention.
The following description is presented to enable a person of ordinary skill in the art to make and use the invention, and is provided in the context of particular applications and their requirements. Various modifications to the embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. In the following description, numerous details are set forth for the purpose of explanation. However, one of ordinary skill in the art will realize that the invention may be practiced without the use of these specific details. In other instances, well-known structures and devices are shown in block diagram form in order not to obscure the description of the invention with unnecessary detail. Thus, the present disclosure is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein.
There is an increased risk of an airway obstruction of a patient undergoing non-intubated anesthesia relative to intubated anesthesia. In intubated anesthesia, the endotracheal tube inserted through the larynx of the patient maintains the airway open. In exemplary embodiments, the present invention relates to a mentum securement device and methods of using the same for securing at an angle a mentum of a patient undergoing non-intubated anesthesia or other medical procedure at an angle such that obstruction of an airway of the patient is prevented. The mentum device includes a mentum strap and one or more (e.g., a pair) of securement straps. The mentum strap is defined by opposing distal portions, a superior end and an opposing inferior end, and a first surface configured to be positioned on a mentum of a patient undergoing anesthesia. The securement straps each having a proximal portion attached directly or indirectly to a respective opposing distal portion of the mentum strap and a distal portion securable to a respective anchor point. The mentum strap and the securement straps are configured to position the mentum of the patient to an extended state. In the extended state the mentum of the patient is at an extended angle relative to a neck of the patient. In a resting state the mentum of the patient is at a resting angle relative to a neck of the patient, and the extended angle is greater than the resting angle. A tilt angle is defined as the difference between the extended angle and the resting angle.
As used herein, the terms “lateral,” “medial,” “superior,” “inferior,” “distal” and “proximal” are relative positional terms each having their respective plain meaning, and are not intended to be limiting.
In embodiments, the elastomeric material may include medical grade silicone, heat cured rubber (HSR) elastomer, high temperature vulcanizing silicone rubber, and/or liquid silicone rubber (LSR) elastomer, to name a few. In embodiments, the elastomeric material has a tensile strength value of for example in the range of 0.5 to 15 MPa. In embodiments, the elastomeric material has a Young's modulus value of for example in the range of 0.0005 to 0.1 GPa. It is understood that the above ranges are merely exemplary and are not intended to be limiting, and the values may be less or more than the disclosed ranges. In embodiments, the mentum strap 110 is comprised of a tacky elastomeric material. In embodiments, the elastomeric material has a tackiness index. In embodiments, the material of the mentum strap 110, the tensile strength value and the Young's modulus value are selected and configured such that the mentum strap 110 is adequately flexible to conform to the shape of the mentum of the patient without significantly deforming or stretching.
As shown in
With reference to
In embodiments, the mentum strap 210 may be made of materials used in conventional medical or surgical masks, such as, for example, plastic, paper and nonwoven fabric, to name a few. The material may be fixed to one more malleable wires 219 so as to provide the mentum strap 210 with structural support and allow it to better conform to the mentum of a patient during use. For example, a malleable wire 219 may be disposed at the superior end 226 and/or the inferior end 228 of the mentum strap 210. The mentum strap 210 may include one or more pleats 240 to allow a user to adjust the mentum strap 210 from a flat configuration to a more cup-like configuration for better fit on the mentum of the patient. In embodiments, the first surface 212 of the mentum strap 210 may be at least partially coated with tacky material 250, such as, for example, foam, silicone and/or other types of polymeric materials, to name a few. The tacky material 250 may be applied in a pattern such as, for example, in a regular repeating pattern extending at least partially across the first surface 212 or in strips along one or more edges of the mentum strap 210.
In embodiments, the securement straps 230 may be elastics, and may be made of materials, such as, for example, fabric, polyester, spandex, elastodiene, or thermoplastic polyurethane (TPU), to name a few. Each securement strap 230 may be made of a single piece of material or more than one piece of material with the pieces of material configured for releasable attachment to one another (e.g., by tying or adhering distal end portions of the pieces together). In embodiments, the securement straps 230 are non-removably attached or otherwise secured to the mentum strap 210. For example, the pair of securement straps 230 may be sonic welded to the mentum strap 210 or otherwise adhered to the mentum strap 210. In embodiments, the mentum strap 210 and the pair of securement straps 230 are of a unitary body.
As shown, the mentum strap 110, 210 is secured to the mentum 12 of the patient 10 and distal portions 132, 232 of the pair of securement straps 130 are removably securable to a siderail 22 of the surgical stretcher 20. In embodiments, the siderail 22 of the surgical stretcher 20 is located at a position that is spaced from the head 14 of the patient 10 and is oriented perpendicularly to a length of the surgical stretcher 20. It is understood that the configuration of the siderail 22 is merely exemplary and is not intended to be limiting. By way of example, but not limitation, siderails may extend parallel to length of the surgical stretcher on either side of the patient 10, and the pair of securement straps 130 may be secured to each of the siderails.
The positions to which the distal portions 132 of the pair of securement straps 130 are secured to the siderail 22 define anchor points 24 of the surgical stretcher 20. In embodiments, the anchor points 24 may be a tie-down point integral to the surgical stretcher 20 or integral to the siderail 22. By way of example, the siderail 22 may include tie-down d-rings for securing the distal portions 134 of the pair of securement straps 130.
Referring back to
As shown in
To prevent overextension of the mentum 12 of the patient 10, in embodiments, the pair of securement straps 130 are configured to fail or snap upon application of excessive tension forces. In embodiments, the excessive tension force is in the range of 12-15 lbs-ft. In embodiments, the tension force is selected such that the tilt angle θ in the extended state cannot exceed the above referenced ranges of 10° to 35° relative to the resting state of the mentum 12. In embodiments, the attachment points 122 of the mentum strap 110 may be configured to fail upon application of the excessive tension forces. In embodiments, the hook-and-loop portion 131 of the proximal portion 132 of the securement strap 130 or the hook-and-loop portion 136 of the distal portion 134 of the securement strap 130 may be configured to fail or otherwise detach upon application of the excessive tension forces.
The mentum securement device 200 may be attached to a brace 310. As shown more clearly in
As shown in
In exemplary embodiments, the brace 310 is attached to an adjustable spring mechanism 320, which in turn is attached to a clamping mechanism 330. The adjustable spring mechanism 320 may be, for example, a tension spring that is adjustable by lengthening or shortening the distance between the brace 310 and the clamping mechanism 330. For example, the tension spring may include a screw mechanism that can be turned to shorten or lengthen the spring. In this regard, turning the screw in a first direction may lengthen the spring to increase pulling force while turning the screw in the opposite direction may shorten the spring to decrease the pulling force. In exemplary embodiments, the clamping mechanism 330 may be, for example, a spring clamp, a quick action clamp, a C-clamp, an F-clamp, or a screw clamp, to name a few. The clamping mechanism 330 is configured for attachment to a portion of a surgical stretcher 20, such as, for example, a side rail 22.
Although
The mentum securement device 200 may be attached to the surgical stretcher 20 by rigid rods 410. The length of the rods 410 may be adjustable. In this regard, the rods 410 may have telescoping portions that are adjustable relative to one another using length adjustment mechanisms, such as, for example, detent mechanisms, screws, or threaded attachment between the telescoping portions, to name a few. Distal end portions of the rods 410 are attached to the stretcher 20 by clamping mechanisms 430 while proximal end portions of each rod 410 are attached to a corresponding one of the securement straps 230. In this regard, the proximal end portions of the rods 410 may include clips to aid in attachment to the securement straps 430. As shown more clearly in FIG. In exemplary embodiments, the clamping mechanisms 430 allow for angular adjustment of the rods 410 using, for example, a lockable pivot joint 412. The angular adjustment allows the rods 410 to be positioned so as to apply a pushing force, thereby pivoting the patient's head upwards to open the patient's airway.
While this invention has been described in conjunction with the exemplary embodiments outlined above, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the exemplary embodiments of the invention, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention.
Now that embodiments of the present disclosure have been shown and described in detail, various modifications and improvements thereon can become readily apparent to those skilled in the art. Accordingly, the exemplary embodiments of the present disclosure, as set forth above, are intended to be illustrative, not limiting. The spirit and scope of the present disclosure is to be construed broadly.
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/621,257, filed Jan. 16, 2024 and entitled MENTUM SECUREMENT DEVICE AND METHOD OF USING THE SAME, the contents of which are incorporated herein by reference in their entirety.
Number | Date | Country | |
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63621257 | Jan 2024 | US |