Cricothyroidotomy device and methods thereof

Abstract

A cricothyroidotomy device configured for use in emergency airway procedures by a responder-provider, the device comprising a structure configured to cover and secure over the laryngeal skeleton region; an accessible opening for intubation; lateral fixation arms with pre-loaded fastening means; an integrated cutting element; and a mechanism configured to maintain traction during the procedure. Further provided are methods of using the device and a kit comprising the device.

Description

CRICOTHYROIDOTOMY DEVICE AND METHODS THEREOFFIELD OF THE INVENTION

[0001] The present invention generally relates to a device, a method, and a kit for cricothyroidotomy and and / or tracheotomy.BACKGROUND OF THE INVENTION

[0002] The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Cricothyroidotomy, also termed cricothyrotomy or coniotomy, is a crucial technique for managing emergent airway access. It is typically performed in emergency situations where immediate access to the airway is crucial. It is often used when there is a sudden blockage or severe injury to the airway itself or to adjacent structures that hamper airway access. For example, cricothyroidotomy is used during airway obstruction incidents, airway trauma, burns, anaphylaxis, maxillofacial trauma or loss of anatomy, and repeated and / or failed oral or nasal intubation attempts. While cricothyroidotomy is an emergency procedure, tracheotomy is usually used for long-term intubation and breathing assistance.

[0004] Cricothyroidotomy is considered to be the final step in "cannot intubate, cannot oxygenate or ventilate” (CICOV) scenarios. It becomes necessary to open the airway in less than 1% of prehospital trauma patients (Mabry RL, Frankfurt A, Kharod C, Butler FK Jr. Emergency Cricothyroidotomy in Tactical Combat Casualty Care. J Spec Oper Med. 2015; 15:11-19). However, due to the technical challenges and lack of experience associated with the procedure, it is avoided whenever possible, and regrettably, sometimes even when necessary.

[0005] The most common challenge encountered during cricothyroidotomy is improper anatomical placement, affecting nearly half of patients. Despite training and simulation programs, even well- trained physicians often struggle with the procedure. Interestingly, trauma surgeons perform 75%of cricothyrotomies, but their anatomical accuracy rate stands at 66.7% (Moroco AE, Armen SB, Goldenberg D. Emergency Cricothyrotomy: A 10-Year Single Institution Experience. Am Surg. 2023; 89: 1243-1246).

[0006] U.S. Pat. No. 16793057 discloses an automatic tracheotomy / cricothyroidotomy box-shaped device that automates the process of inserting a tracheotomy tube by using a pressure sensor and an ultrasonic sensor to locate the incision area. The device then automatically injects an obturator / tube into the airway. The device disclosed in 16793057 is intended for use by a non-professional user in cricothyroidotomy procedures. However, the incision area in 16793057 is covered by the boxshaped device and cannot be seen by the user. It is questionable whether the proper anatomical incision area can be accurately identified by relying solely on pressure and ultrasonic sensors without any visual confirmation of the neck or the ability for the user to palpate it. Moreover, the device is not designed to locate anatomical structures in the neck, nor is it fixated on the subject's neck or capable of imposing the traction and counter-traction forces necessary for the procedure itself.

[0007] There is an unmet need for new devices and methods aimed at assisting professional and nonprofessional aid responders in cricothyroidotomy and / or tracheotomy procedures. The device should assist in: a) locating and marking the anatomical incision site for cricothyroidotomy; b) fixating and creating traction and counter-traction forces needed for the incision; and, c) allowing intraluminal guided intubation, and optionally d) definitive and secure airway protection. Ideally, the procedure should be simplified to the level of automatic defibrillators.SUMMARY OF THE INVENTION

[0008] It is hence an object of the invention to disclose a cricothyroidotomy device for performing cricothyroidotomy in a subject in need thereof, conducted by a responder-provider (RP), said device comprising: a. a central body 104 having an upper central portion 102 configured to be placed upon the neck of said subject on or right below the thyroid prominence 12; and, b. two lateral fixation arms 103a, 103b extending from said central body 104 to at least partially encompass the thyroid cartilage area 13; wherein once said upper central portion 102 is positioned by said RP on or right below said thyroid prominence 12, said two lateral fixation arms 103a applytraction and counter-traction forces to the neck's skin, and an accessible area of said device is positioned to expose the cricothyroid membrane 14 for making a cricothyroidotomy incision.

[0009] It is another object of the invention to disclose a cricothyroidotomy device as defined above, further comprising a lower portion 105 configured to at least partially cover the cricoid cartilage area 15 of said subject.

[0010] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the accessible area comprises a discrete opening 101 configured for insertion of an intubation tube.

[0011] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, further comprising fastening means attached to said lateral fixation arms 103a, 103b for securing the device in place once properly positioned, allowing hands-free maximal traction forces on the neck's skin.

[0012] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the fastening means are selected from the group consisting of staples, sutures, elastic bands, adhesive pads or strips, magnetic fasteners, clips or clasps, and Velcro straps.

[0013] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the two lateral fixation arms 103a, 103b comprise a securing actuating mechanism and are pre-loaded with said fastening means, configured to secure the device in place, eliminating the need to hold the device during the cricothyroidotomy procedure.

[0014] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the securing actuating mechanism comprises a spring mechanism 109a and 109b which drives said pre-loaded fastening means into the subject’s neck tissue.

[0015] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, further comprising a breakaway tab 110 configured to allow the device to be separated into two parts, thereby facilitating removal of the device from the neck once the cricothyroidotomy procedure has been completed and the airway has been secured.

[0016] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, further comprising an integrated cutting element 114.

[0017] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, comprising a rotation mechanism 112, coupled to a cutting element actuator 113, which operates to deploy said cutting element 114 in a rotational manner.

[0018] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the cutting element 114 is curved in a semicircular shape to accommodate an intubation tube, allowing the tube to be inserted simultaneously with the incision of the airway.

[0019] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, further comprising a separate cutting element 200 having a gripping portion 201, an elongated portion 202, and a distal blade portion 203 configured to create an incision through the cricothyroid membrane.

[0020] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the blade portion 203 comprises three serrated blades extending distally and converging at a common point to form a triangular cutting configuration configured to generate a three-point incision profile that facilitates subsequent expansion of the airway opening.

[0021] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, further comprising a deployable cover 204 configured to enclose at least a portion of the blade portion 203 during insertion and to transition from a closed state to an expanded state upon advancement of an intubation tube, thereby maintaining an access opening in the airway and guiding the tube into position.

[0022] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, made of or comprising a rigid material.

[0023] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, made of or comprising a flexible or semi-rigid material.

[0024] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the material is selected from the group consisting of: polyurethane; thermoplastic elastomers (TPE); silicone rubber; polyvinyl chloride (PVC); polyethylene (PE); polytetrafluoroethylene (PTFE); and ethylene vinyl acetate (EVA).

[0025] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, made of or comprising flexible material that can be molded to fit the subject's neck andhardened to impose traction and counter-traction forces required for the cricothyroidotomy procedure.

[0026] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein flexible material that can be molded to fit the subject's neck is selected from the group consisting of: a thermoplastic polymer; resins; ceramics; calcium sulfate hemihydrate; gypsum; and any combination thereof.

[0027] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, made of or comprising a flexible material that can be hardened while positioned on the subject's neck and dehardened for repositioning of the device.

[0028] It is another object of the invention to disclose a cricothyroidotomy device as defined in any of the above, wherein the flexible material that can be hardened and dehardened is selected from the group consisting of shape-memory polymers (SMPs), specialized thermoplastics, nitinol, and any combination thereof.

[0029] It is another object of the invention to disclose a method for performing cricothyroidotomy in a subject in need thereof, the method comprising: a. obtaining the cricothyroidotomy device disclosed herein; b. palpating the subject’s neck to identify at least one anatomical compartment selected from the group consisting of the thyroid prominence 12, the thyroid ala 13a, 13b, and the cricoid cartilage 15; c. placing the device on the identified anatomical compartments accordingly, such that the opening for the cricothyroidotomy incision 101 is anatomically positioned on the skin covering the cricothyroid membrane 14 of the subject; d. performing a cricothyroidotomy incision; and, e. intubating and securing the subject for transport.

[0030] It is another object of the invention to disclose the method as defined above wherein palpating the neck of the subject in step (b) is to identify the thyroid prominence 12, and placing the device in step (c) is placing the upper central endpoint 102 of the device on or right below said thyroid prominence 12 of the subject.

[0031] It is another object of the invention to disclose the method as defined in any of the above, wherein the cricothyroidotomy device comprises a securing actuating mechanism and pre-loaded fastening means, and the method further comprises a step of pressing the actuating mechanism after step (c) which in turn inserts the fastening means into the subject's laryngeal skeleton, to secure the devicein place while maintaining the traction and counter-traction forces, eliminating the need to hold the device during the cricothyroidotomy procedure.

[0032] It is another object of the invention to disclose the method as defined above, wherein said cricothyroidotomy device comprises a breakaway tab 110, further comprising removing the device from the neck after the cricothyroidotomy incision has been made and an intubation tube has been inserted through the incision opening 101.

[0033] It is another object of the invention to disclose the method as defined above, wherein the cricothyroidotomy device comprises an integrated cutting element 114, wherein step (d) comprises a step of actuating the cutting element actuator 113, causing the cutting element 114 pre-loaded with an intubation tube, to incise the skin and subcutaneous tissue within the opening 101, simultaneously enabling insertion of an intubation tube into the airway to secure and ventilate the subject.

[0034] It is another object of the invention to disclose a cricothyroidotomy kit, comprising: a. the cricothyroidotomy device disclosed herein; b. a cutting element; c. a cricothyroidotomy, tracheotomy or intubation tube or needle designed to be inserted into the airway through the incision to maintain an airway; d. means for securing at least one member selected from the group consisting of cricothyroidotomy device, cricothyroidotomy tube, tracheotomy tube, intubation tube and any combination thereof; and, e. means for ventilating said subject.

[0035] It is another object of the invention to disclose the cricothyroidotomy kit, comprising: wherein said cutting element is an automatic knife or scalpel, and said kit further comprises an automatic mechanism that enables the incision to be made automatically.

[0036] It is another object of the invention to disclose the cricothyroidotomy kit, further comprising means for heating the device to change its configuration from flexible to rigid once attached to the subject's neck and / or from rigid to flexible.

[0037] It is another object of the invention to disclose the cricothyroidotomy kit, further comprising illuminating means to enable the procedure to be performed in low-light or dark environments.

[0038] It is another object of the invention to disclose the cricothyroidotomy kit, further comprising at least one sensor configured to identify the proper location for the incision or to determine if the airway is obstructed and / or the location of the obstruction.

[0039] It is another object of the invention to disclose the cricothyroidotomy kit, wherein the at least one sensor is selected from the group consisting of: ultrasonic sensor, pressure sensor, oxygen (02) oximeter sensor, CO2 sensor, and flow sensor.

[0040] It is another object of the invention to disclose the cricothyroidotomy kit, wherein the means for ventilating are selected from the group consisting of bag -valve mask and airway connector used to attach said cricothyroidotomy tube or tracheotomy tube to said ventilation device.BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The accompanying drawings and descriptions herein are for illustrative purposes and are intended to facilitate understanding of certain embodiments of the invention. These drawings and descriptions shall not be interpreted as limiting the scope of the invention, which is defined by the appended claims. Additional features and advantages may become apparent upon further of the figures and embodiments referenced herein.

[0042] Other characteristics and advantages will become apparent on reading two preferred embodiments described with reference to the figures in which:

[0043] Fig. 1 is a front view schematic illustrating the anatomical structures of the neck relevant to a cricothyroidotomy procedure, including the thyroid prominence 12; the thyroid cartilage 13; the cricothyroid membrane 14; and the cricoid cartilage 15;

[0044] Fig. 2 is a front view of a cricothyroidotomy device positioned on the neck, demonstrating the alignment of the upper central endpoint 102, lateral fixation arms 103a, 103b, incision opening 101, and securing openings 107a, 107b in relation to the thyroid prominence 12 and cricothyroid membrane 14;

[0045] Fig. 3 is a front view of a cricothyroidotomy device, comprising lateral fixation arms 103a, 103b, a central body with an incision opening, a lower portion 105 and two lower lateral arms 106a and 106b configured to at least partially cover the cricothyroid membrane;

[0046] Figs. 4A and 4B demonstrate a cricothyroidotomy device comprising a central body with lateral fixation arms 103a, 103b, actuating elements 108a, 108b, spring mechanisms 109a, 109b, and a breakaway tab 110, in its open configuration. Fig. 4C is another perspective view showcasingadditional aspects of the cricothyroidotomy device in its closed configuration, showing the fastening means 11 la, when attached to a subject's neck;

[0047] Fig. 5 is a perspective view illustrating a cricothyroidotomy device, comprising lateral fixation arms 103a, 103b, an upper central endpoint 102, a cutting element actuator 113, and an integrated cutting element 114 with a rotation mechanism; and,

[0048] Figs. 6A and 6B show a perspective view of a cutting element 200 comprising a gripping portion 201 and an elongated portion 202 terminating in a blade portion 203.

[0049] Fig. 6C is a top view of a deployable cover 204, illustrating its configuration for enclosing the blade portion of the cutting element.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention. The present invention may be practiced according to the claims without some or all of these specific details. For clarity, technical material that is known in the technical fields related to the invention has not been described in detail so that the present invention is not unnecessarily obscured.

[0051] During cricothyroidotomy, an incision is made through the skin that covers the area of the cricothyroid membrane and then through the cricothyroid membrane itself to establish a patent airway during certain life-threatening situations, such as airway obstruction, burns, anaphylaxis, maxillofacial trauma, or loss of anatomy. Cricothyroidotomy is one of the possibilities used when other means of endotracheal intubation or ventilation are impossible or impractical.

[0052] Tracheotomy is a surgical procedure that creates an opening in the trachea. Compared with tracheotomy, cricothyroidotomy is quicker and does not require manipulation of the cervical spine or sophisticated equipment. However, while cricothyroidotomy may be life-saving, this technique is usually intended to be a temporizing measure until a definitive and secure airway can be established. Tracheotomy is a more complex procedure than cricothyrotomy because part of at leastone ring of the trachea is usually penetrated to allow tube placement. Tracheotomy is preferably done in an operating room by a trained surgeon. In emergencies, the procedure has a higher rate of complications than cricothyroidotomy and offers no advantage. However, it is the preferred procedure for patients requiring long-term ventilation (Dillon JK, Christensen B, Fairbanks T, Jurkovich G, Moe KS. The emergent surgical airway: cricothyrotomy vs. tracheotomy. Int J Oral Maxillofac Surg. 2013; 42:204-208).

[0053] The main challenge in performing a cricothyroidotomy is the difficulty in identifying the anatomical landmarks for the incision, as well as the procedure itself. The risks associated with this procedure, combined with its low incidence rate, result in limited opportunities to train physicians in real-world cases. This leads to reluctance in performing the procedure, even among experienced surgeons. The device disclosed herein is designed to: a) assist in locating and marking the anatomical site for the incision; b) facilitate fixation and create the traction and counter-traction forces necessary for the incision; and c) enable guided intraluminal intubation, with the option for definitive and secure airway protection.

[0054] It is understood that while the primary use of the device is for emergent cricothyroidotomy, it may also be adapted for tracheotomy and and / or tracheostomy, with proper adjustments, to provide definitive airway protection and support long-term ventilation. Although the incision for tracheotomy or tracheostomy is made at a different location compared to cricothyroidotomy, the device disclosed herein may be designed to accommodate either procedure. Therefore, it may be described as an airway-opening device. As used herein, the terms cricothyroidotomy, coniotomy, and cricothyrotomy are interchangeable.

[0055] Reference is now made to Fig. 1, illustrating the anatomical area incised during cricothyroidotomy. The anatomical compartments within a subject's neck include, from upper or cranial to lower or caudal order: hyoid cartilage 10; thyrohyoid membrane 11; thyroid prominence 12 (or "Adam's apple"); thyroid cartilage 13; cricothyroid membrane 14; cricoid cartilage 15; pyramidal lobe of thyroid 16; and thyroid gland 17. The thyroid cartilage 13 is composed of two halves (i.e., thyroid ala 13a and 13b). The area that is incised during cricothyroidotomy is the cricothyroid membrane 14 between both cartilages: the thyroid cartilage 13 and the caudal cricoid cartilage 15.

[0056] In a cricothyroidotomy procedure, the user, or as also termed herein, the responder-provider (RP), is trained to identify, either by visualization or by palpation, the anatomical structures surroundingthe cricothyroid membrane 14, including the thyroid prominence 12; the thyroid ala 13a, 13b; and the cricoid cartilage 15. With the nondominant hand, the RP should then stabilize the area using the first and third digits on either side of the thyroid ala 13a and 13b, stabilizing and fixating the laryngeal skeleton area, and leaving the index finger to palpate the membrane and mark the incision location.

[0057] As used herein, the term “responder-provider (RP)” refers to any trained, semi-trained, and / or non-trained, individual, performing emergency airway access, including but not limited to physicians, paramedics, combat medics, or first responders.

[0058] Traction and counter-traction are essential concepts in all surgical procedures. To make an accurate incision, it is necessary to create enough tension on the tissue. This ensures that the incision is precise in terms of size, location, and depth. When performing the incision, tension must be applied from both sides of the target area to ensure no movement during the incision. This approach helps to quickly and accurately penetrate the skin and connective tissue under the skin and above the airway, causing minimal damage to surrounding tissues. This precision is crucial to minimize bleeding, which can impair further identification, and prevent misaligned cuts, which are critical for securing an emergent airway.

[0059] The term “traction and counter-traction” refers to opposing forces applied to the skin and underlying tissues to stabilize the surgical field and maintain alignment during incision.

[0060] In the context of performing cricothyroidotomy, additional challenges may arise. Typically, the RP uses one hand for locating and fixing the target area, leaving limited resources for applying traction and counter-traction or for obtaining the needed surgical instruments without additional assistance. This limitation can lead to imprecise incisions, causing the loss of clear anatomical landmarks and potentially resulting in delay and / or failure of the procedure. This is particularly critical in emergency situations where the patient faces imminent death due to an inability to oxygenate, ventilate, and intubate, leading to suffocation.

[0061] Once the RP identifies and fixates the cricothyroid membrane site 14 using the non-dominant hand, the RP uses the dominant hand to perform a midline vertical incision, approximately 2-3 cm long, through the skin and subcutaneous tissues covering the cricothyroid membrane 14. The cricothyroid membrane 14 is then exposed by retracting the skin and subcutaneous tissue. Ahorizontal incision is made through the cricothyroid membrane 14 to create an opening into the airway.

[0062] According to some embodiments, the cricothyroidotomy or tracheotomy device 100 disclosed in the present invention facilitates the identification of the cricothyroid membrane site 14. In some embodiments, the device 100 enables the cricothyroidotomy procedure without the need to palpate the thyroid cartilage 13, the cricoid cartilage 15, and the cricothyroid membrane 14 in between. In some embodiments, the device 100 facilitates localization of the cricothyroid membrane site 14 by allowing the RP to identify only one of the subject's neck anatomical compartments. In some embodiments, the device 100 fixates and / or stabilizes the incision site by applying the traction and counter-traction forces that are typically exerted by the RP using the non-dominant hand. In some embodiments, the device 100 marks the incision site. The ability of the device 100 to locate the incision area, apply the required traction and counter-traction forces, and mark the incision site, enables the RP to use both hands during the entire procedure. The device 100 thus reduces the workload for a single RP, potentially increasing the procedure's success rate and minimizing possible complications (e.g., bleeding, incorrect placement, obstruction, esophageal or mediastinal perforation, vocal cord injury, laryngeal injury, pneumothorax, and pneumomediastinum). The device's simplicity, ease of use, ease of manufacture, and relatively low manufacturing and maintenance costs enable its widespread availability in any cricothyroidotomy kit and in any first aid and / or RP kit.

[0063] Reference is now made to Figs. 2 and 3 showing the device 100, according to some embodiments of the invention, and its compatibility with the anatomical compartments. The device 100, in some embodiments, is made of a rigid, semi-rigid, or flexible material.

[0064] In some embodiments, the RP using the device 100 disclosed herein needs to identify only one of the neck's anatomical compartments. In some embodiments, at least one anatomical compartment is selected from the group consisting of the thyroid prominence 12, the thyroid ala 13a, 13b, and the cricoid cartilage 15. Once identified, the RP can attach the device to the identified anatomical compartment accordingly. In some embodiments, the RP may need to identify only the thyroid prominence 12 and to attach the upper central endpoint 102 of the device to the subject's neck, on or just below the thyroid prominence 12. The device is designed so that once the upper central endpoint 102 is properly located and touches the thyroid prominence bulge 12 from the caudaldirection, the central body of the device 104 covers the thyroid cartilage area. In some embodiments, the lower portion 105 at least partially covers the cricoid cartilage 15, and an opening 101 between them is positioned right above the cricothyroid membrane site 14, marking the required incision area.

[0065] Preferably, device 100 features two lateral fixation arms 103a, 103b, which extend from the central body 104 and may be butterfly- shaped. These lateral fixation arms 103a, 103b are designed to partially encompass or encircle the thyroid cartilage area 13 of the subject, and therefore can be termed 'thyroid-encompassing wings' 103a and 103b. In some embodiments, these lateral fixation arms 103a, 103b are used to apply the traction and counter-traction forces needed to fixate or stabilize the device on the subject's neck.

[0066] The lateral fixation arms 103a and 103b may include securing openings configured to enable direct contact with, and exposure of, the subject’s neck, while providing the necessary traction and counter-traction forces for fixation. This arrangement allows maximal visualization of the neck during and / or after the procedure, as well as the use of fastening means to secure the device in place. In some embodiments, additional fixation may be performed after the procedure to maintain a secured airway and / or to facilitate transfer of the patient.

[0067] For example, the device may include securing openings, such as 107a, 107b, and 107c, sized and positioned for fastening with surgical staples and / or sutures. The lateral fixation arms 103a and 103 b may terminate, at their lower portion, above the opening 101 on the cricothyroid membrane 14. Alternatively, the lateral fixation arms may extend along the full length of the thyroid cartilage 13 and terminate below the opening 101 or encompasses the entire neck.

[0068] As used herein, the term "securing opening" refers to an opening designed to secure or attach the device to the subject's neck by allowing the use of fastening means. In some embodiments, the securing opening enables better visualization of the subject's neck. In some embodiments, fastening means are selected from the group consisting of staples, sutures, elastic bands, adhesive pads or strips, magnetic fasteners, clips or clasps, and Velcro straps.

[0069] Reference is now made to Fig. 3. In some embodiments, the device further comprises two lower lateral arms 106a and 106b on each side of the lower portion 105. These lower lateral arms 106a and 106b are configured to at least partially encircle the cricoid cartilage area 15 of the subject, and therefore can be termed 'cricoid-encompassing winglets' 106a and 106b. In some embodiments, thepresence of the lower lateral arms 106a and 106b enables better stabilization and fixation derived from additional traction and counter-traction forces imposed on the subject's neck.

[0070] It is understood that the lateral fixation arms 103a and 103b and / or the lower lateral arms 106a and 106b may be integrally formed as a continuation of the central body 104 of the device and composed of the same material, or alternatively, may be separate components made from a different material. Moreover, although the incision opening 101 may be designed in various shapes, such as oval, rectangular, square, or irregular, as long as it allows the incision required for a cricothyroidotomy through the cricothyroid membrane 14 and permits the insertion of an intubation tube and / or other ventilation means, it is preferably round in shape. The dimensions and contour of the opening are preferably adapted to ensure an optimal fit with the intubation tube, thereby preventing air leakage.

[0071] In some embodiments, the cricothyroidotomy device 100 or kit disclosed herein further comprises fastening means attached to the lateral fixation arms 103a and 103b, to the lower lateral arms 106a and 106b, or both, for fixating the device to the neck of the subject.

[0072] Reference is now made to Figs. 4A-4C, which illustrate a perspective view of a cricothyrotomy device configured to secure and facilitate an incision on a subject’s neck, according to some embodiments.

[0073] The device includes a central body 104 that provides structural alignment with the anatomical features of the neck. The central body 104 has an upper central endpoint 102, which serves as a reference point for aligning the device with the thyroid prominence 12.

[0074] An accessible area or incision opening 101 is defined within the central body 104, allowing precise access to the cricothyroid membrane 14 to facilitate the cricothyrotomy procedure. The incision opening 101 is positioned between the upper central endpoint 102 and a lower portion 105, the latter being shaped to at least partially cover the cricoid cartilage area 15. The lower portion 105 extends downward to complement the structural contour of the neck and enhance stability during use.

[0075] The device further comprises two lateral fixation arms 103a and 103b extending from the central body 104 to provide stabilization and apply traction forces to the neck’s skin. Each lateral fixation arm 103a and 103b may include a securing actuating mechanism configured to fix the device inplace and enable traction and counter-traction. The securing actuating mechanism may comprise spring mechanisms 109a and 109b operatively connected to actuating elements 108a and 108b.

[0076] In a preferred embodiment, the device also includes pre-loaded fastening means to secure it in place. For example, the fastening means may comprise sharp pins or staples 11 la-1 l id positioned within the lateral fixation arms. The spring mechanisms 109a and 109b are configured to generate an actuating force when compressed. During operation, the user presses the actuating elements 108a and 108b, thereby compressing the spring mechanisms 109a and 109b. This compression drives the pre-loaded fastening means 11 la-1 l id through securing openings 107 in the lateral fixation arms and into the subject’s laryngeal skeleton, e.g., the thyroid cartilage. In this embodiment, the spring mechanisms 109a and 109b further include locking mechanisms that maintain the compressed state, thereby securing the device in place and ensuring continuous traction on the neck’s surface throughout the procedure.

[0077] When the RP places the device 100 on the subject’s neck, it is in an open configuration, as shown in Figs. 4A and 4B. Once the device is properly positioned, guided by the upper central endpoint 102, the incision opening 101 is aligned directly above the cricothyroid membrane 14. The RP then presses the actuating elements 108a and 108b, compressing the spring mechanisms 109a and 109b and inserting the fastening means 11 la-1 l id into the subject’s neck (Fig. 4C). The compressed spring mechanisms may remain locked in place by the locking mechanism and can be released once the cricothyrotomy procedure is complete. Releasing the spring mechanisms after the cricothyrotomy enables the device to be re-configured or replaced with another fixation method, for example the fixation required for performing a coniotomy procedure, if needed.

[0078] The lower portion 105 may further include a breakaway tab 110 configured to facilitate removal of the device from the neck after the cricothyrotomy incision has been made and an intubation tube has been inserted through the incision opening 101. The breakaway tab 110 enables quick and safe detachment of the device, allowing the intubation tube to remain in place while the device is removed, thus securing the airway and allowing the device to be removed safely without jeopardizing the established airway.

[0079] Overall, Figs. 4A- C illustrate an integrated system of structural and mechanical components designed to enhance the precision, stability, and effectiveness of cricothyroidotomy procedures byproviding accurate anatomical alignment, secure fixation through user-activated pre-loaded stapling, and facilitated removal after intubation has been established.

[0080] According to some embodiments, the device 100 may further comprise an integral cutting element to allow precise cricothyroidotomy.

[0081] Reference is made to Fig. 5, which illustrates an example of an integrated cutting element. Once the RP positions the device correctly, guided by the upper central endpoint 102, the accessible area 101 is aligned above the cricothyroid membrane 14. In this example, the incision opening is not delimited by borders, as the integrated cutting element is specifically designed to make a precise incision through the cricothyroid membrane 14.

[0082] Lateral fixation arms 103a and 103b extend from the central structure of the device, providing means for securing the device to the subject’s neck. A rotation mechanism 112, also termed radial mechanism, is located centrally within the device, and facilitates engagement of the cutting element. This mechanism is coupled to a cutting element actuator 113, which operates to deploy the cutting element 114 in a rotational manner.

[0083] The cutting element 114 is designed to perform precise incisions through the incision opening 101, thereby enhancing the efficiency of the cricothyroidotomy procedure by enabling rapid and controlled access to the airway. The cutting element may be curved in a semicircular shape to accommodate an intubation tube, allowing the tube to be inserted simultaneously with the incision of the airway. After insertion, the cutting element can be removed, leaving the intubation tube securely in place. Alternatively, the cutting element may be covered by a protective sheet and then be left within the airway.

[0084] In addition to the rotation mechanism that enables radial insertion of the cutting element, the cutting element actuator may also include a linear mechanism. This mechanism allows the cutting element to be advanced forward toward the incision opening, e.g., along rails, prior to the rotational movement, thereby increasing the applied force on the subject’s neck and improving the effectiveness of the incision. This linear mechanism further enables bi-manual operation, allowing the RP to apply force with both hands, thereby achieving maximal fixation of the device against the neck and improved subsequent visualization of the anatomical landmarks.

[0085] In addition to the rotation mechanism that enables radial insertion of the cutting element, the cutting element actuator may also include a linear mechanism. This mechanism allows the cutting element to be advanced forward toward the incision opening, e.g., by rails, before the rotational movement, thereby increasing the applied force on the subject’s neck and improving the effectiveness of the incision.

[0086] Reference is now made to Figs. 6A-6C, showing an example of a separate cutting element 200 comprising a gripping portion 201 and an elongated portion 202 terminating in a blade portion 203 (Figs. 6A-6B), and a deployable cover 204 (Fig. 6C), with its unique configuration for enclosing the blade portion of the cutting element. The blade portion 203 includes three serrated blades extending distally and converging at a common tip to form a triangular cutting geometry. This triangular configuration allows the cutting element 200 to penetrate the cricothyroid membrane efficiently while simultaneously creating a defined three-point incision profile suitable for subsequent expansion.

[0087] The deployable cover 204 is dimensioned and shaped to surround the blade portion 203 in its closed state, thereby protecting surrounding tissues during insertion and guiding the cutting element to the target site. Once the cutting element 200 has created the incision and is withdrawn, the deployable cover 204 remains positioned within the opening formed in the airway. When an intubation tube is subsequently advanced through the central passage of the deployable cover 204, the distal end of the tube engages the inner surfaces defined by the triangular incision. As the tube progresses further, the tube forces the deployable cover 204 into an outwardly expanded configuration, effectively opening the cover and maintaining the airway access channel in a widened and stable state.

[0088] This controlled expansion provided by the unique three-blade triangular arrangement ensures that the deployable cover 204 transitions smoothly from its closed, protective state to its expanded, tube-supporting state. As a result, the intubation tube becomes securely seated within the airway and is prevented from unintentional dislodgement, thereby enabling rapid, stable, and reliable airway access during emergency coniotomy procedures and patient transport.

[0089] It is noted that the deployable cover 204, although exemplified herein in association with a separate cutting element 200, may likewise be configured and dimensioned to enclose the blade portion of an integrated knife or integrated cutting element 114, mutatis mutandis. In such embodiments, thedeployable cover functions in a similar manner, surrounding the blade portion during insertion, remaining positioned within the incision after withdrawal of the blade, and expanding upon advancement of an intubation tube to maintain and stabilize the airway opening.

[0090] According to some embodiments, the inner portion of the device, comprising the central body of the device 104 and lateral fixation arms 103a and 103b, is designed to fit the dimensions of the thyroid according to gender, age and / or weight. The device may be customized for various populations, including adult males, adult females, pediatric patients, and premature infants. For example, the width of an adult male thyroid ranges from 30.8 mm to 57.3 mm, while that of an adult female thyroid ranges from 27.1 mm to 45.3 mm (as detailed in Savitha V, Sharada B Menasinkai. Morphometric Study of Thyroid and Cricoid Cartilages in Adults by CT Method. Indian J Anat. 2020; 9:118-122, incorporated herein by reference in its entirety).

[0091] In some embodiments, the diameter of the opening 101 fits the dimensions of the required transverse incision. In some embodiments, the diameter of the opening 101 is in the range between about 1 cm and about 3 cm, between about 1 cm and about 2.5 cm, between about 1 cm and about 2 cm, between about 1.5 cm and about 3 cm, between about 1.5 cm and about 2.5 cm, between about 1.5 cm and about 2 cm, between about 2 cm and about 3 cm, or between about 2 cm and about 2.5 cm. Each possibility represents a separate embodiment of the present invention. In some embodiments, the diameter of the opening 101 fits that of a cricothyroidotomy, tracheotomy, or intubation tube. It is understood that adaptors may be used for adapting the opening 101 size to various sizes of cricothyroidotomy, tracheotomy, and / or intubation tubes. It is also understood that opening 101 may be left unconnected or connected to any other means of ventilation.

[0092] In some embodiments, the diameter of opening 101 corresponds to the dimensions of the required intubation tube, and the edge of opening 101 is configured to form a seal around the circumference of the ventilation tube to prevent air leakage.

[0093] In some embodiments, the device disclosed herein is made of flexible material. Biocompatible flexible materials suitable for medical devices or instruments are known in the art. In some embodiments, the device can be made of a material selected from the group consisting of: polyurethane; thermoplastic elastomers (TPE); silicone rubber; polyvinyl chloride (PVC); polyethylene (PE); polytetrafluoroethylene (PTFE); and ethylene vinyl acetate (EVA).

[0094] The term “biocompatible material” refers to any material that, when in contact with living tissue, does not produce toxic, injurious, or immunological responses and complies with ISO 10993 standards.

[0095] In other embodiments, the device is composed of or comprises a semi-rigid or flexible material that can be molded to fit the subject's neck. Once positioned, the material can be hardened to transform into a rigid structure, enabling it to impose the traction and counter-traction forces required for the procedure. In some embodiments, the device is flexible and becomes rigid upon curing, exposure to heat, or both. In certain embodiments, the device may be re-softened, e.g., by heat or another trigger, allowing it to become flexible again so that it can be re-shaped or removed as needed.

[0096] For example, thermoplastics are commonly used in splints due to their ability to be heated, shaped, and hardened to maintain a specific form. The choice of thermoplastics depends on factors such as flexibility, rigidity, durability, and comfort for both the RP and patient. Examples of thermoplastic polymers include polypropylene (lightweight, rigid, and durable), polyethylene, polycarbonate (strong and highly impact-resistant), and low-temperature thermoplastics like polycaprolactone (e.g., the commercially available Aquaplast). Rigid splints are best constructed from materials like polypropylene, polycarbonate, or polyethylene. Polycaprolactone is particularly suitable for direct molding and may be used as an additional embodiment.

[0097] In some embodiments, the device is composed of or comprises a thermoplastic polymer, resins, ceramics, calcium sulfate hemihydrate, or gypsum, including any combination thereof. Nonlimiting examples of resins include, but are not limited to, epoxy resin, polyurethane resin, silicone resins, or acrylic resins, including any combination thereof. Non-limiting examples of thermoplastic polymers include, but are not limited to, polypropylene, polycarbonate, polyethylene, polycaprolactone, nylon, or ethylene vinyl acetate, including any combination thereof. In some embodiments, the device is or comprises polycaprolactone.

[0098] In some embodiments, the device is made from or comprises a flexible material that can be hardened while positioned on the subject's neck. In some embodiments, the material can be dehardened and re-hardened as needed to allow for repositioning of the device and / or for any other purpose.

[0099] For example, shape-memory polymers (SMPs) or specialized thermoplastics designed for reversibility can repeatedly switch between flexible and rigid states by responding to stimuli likeheat, light, or electricity. Alternatively, nitinol, a metal alloy of nickel and titanium, is known as a smart material with shape-memory properties and superelasticity that can transition between flexible and rigid states under specific conditions. At lower temperatures, nitinol exists in its martensitic phase, which is more flexible and easier to deform. When heated above its transition temperature, nitinol shifts to its austenitic phase, becoming more rigid and "remembering" its original shape. Heating can be achieved by applying direct heat (e.g., body temperature, warm water) or electrical currents. Upon cooling, nitinol reverts to the martensitic phase, becoming flexible again if the material is designed for repeated transitions.

[0100] In some embodiments, the device is designed to be disposable, ensuring single use to minimize the risk of cross-contamination. In other embodiments, the device may be designed to be reusable for procedures in an operating surgical setting. In this concept, the materials used in the construction of the device, such as certain thermoplastics and resins, should be selected to withstand sterilization processes such as autoclaving, gamma radiation, or ethylene oxide treatment, ensuring the device is sterile before use. In some embodiments, the device is disposable. The disposable nature of the device ensures that it remains cost-effective for single-use procedures, while also reducing the need for reprocessing and minimizing the risk of contamination during multiple uses.

[0101] The materials used in constructing the device are selected for biocompatibility, sterilization resistance, and mechanical performance. Suitable materials must comply with ISO 10993 standards for biological evaluation of medical devices and be capable of withstanding sterilization by autoclaving, ethylene oxide, or gamma irradiation without degradation of structural integrity.

[0102] In preferred embodiments, the device components that contact skin or tissue are made of medicalgrade thermoplastic elastomers (TPE), silicone rubber, or polyurethane having a Shore A hardness between about 40 and about 80. Structural components such as the central body or fixation arms may be formed from polycarbonate or polypropylene with tensile strength exceeding 30 MPa and flexural modulus between 800 and 1500 MPa.

[0103] In embodiments employing shape-memory materials, the transition temperature of the polymer or alloy is preferably between 30°C and 45 °C, allowing activation by body heat or mild external warming. All materials are non-toxic, hypoallergenic, and compliant with FDA and CE medical device material standards.

[0104] It is understood that the device disclosed herein may be used for emergent cricothyroidotomy in field conditions, as well as in sterile operating room environments within a hospital setting.

[0105] According to another aspect, there is provided a method for performing a cricothyroidotomy or tracheotomy in a subject in need thereof, the method comprising: a. obtaining the cricothyroidotomy device disclosed herein; b. palpating the subject’s neck to identify at least one anatomical compartment selected from the group consisting of the thyroid prominence 12, the thyroid ala 13a, 13b, the cricoid cartilage 15, and the cricothyroid membrane 14; and c. placing the device on the identified anatomical compartments accordingly, such that the opening for the cricothyroidotomy incision 101 is anatomically positioned on the skin covering the cricothyroid membrane 14 of the subject. At this stage, the device stretches the skin across all relevant surgical planes, allowing traction and counter-traction forces to be applied to the incision area.

[0106] In some embodiments, the method further comprises pressing the actuating elements 108a, 108b, which in turn insert the fastening means 11 la-111 d to secure the device in place while maintaining the traction and counter-traction forces, thereby eliminating the need to hold the device in place, converting the procedure from a one-handed to a two-handed operation.

[0107] Once properly positioned and fixed in place, the RP may perform either a vertical and / or horizontal incision. The device may be removed prior to insertion of the intubation tube or may remain on the subject’s neck, allowing the tube to be inserted through the opening 101 in the device and maintaining a secure airway during patient transport.

[0108] Alternatively, the RP may press the cutting element actuator 113, causing the cutting element 114, pre-loaded with an intubation tube, to incise the skin and subcutaneous tissue within the opening 101, thereby simultaneously enabling insertion of the intubation tube into the airway to secure and ventilate the subject, and to maintain a secure airway during patient transport.

[0109] It is understood that the term "intubation tube" as used herein, refers to any suitable cricothyroidotomy tube, tracheotomy tube, intubation tube, or any other ventilation means required to secure the airway and ventilate the subject.

[0110] In some embodiments, step b) comprises identifying only the thyroid prominence 12; and step c) comprises placing the upper central endpoint 102 of the device on or right below the thyroid prominence 12.

[0111] According to another aspect, there is provided a cricothyroidotomy and / or tracheotomy kit, comprising: a) the cricothyroidotomy device 100 disclosed herein; b) a cutting element (e.g., knife or scalpel); c) a cricothyroidotomy or tracheotomy tube or needle designed to be inserted into the airway through the incision to maintain an airway; d) means for securing the cricothyroidotomy device to the neck, the cricothyroidotomy or tracheotomy tube, or needle, or both; and e) means for ventilating the subject.

[0112] In some embodiments, the cutting element is an automatic cutting element. In some embodiments, the automatic cutting element is either temporarily or permanently attached to the device or to the cricothyroidotomy or tracheotomy tube. The knife may also be detachable. In some embodiments, the kit may include an automatic mechanism that enables the incision to be made automatically with the automatic knife once the cricothyroidotomy device is appropriately positioned on the subject's neck.

[0113] Automatic mechanisms for activating cutting elements are known in the art. Non-limiting examples include spring-loaded actuators, motorized systems using a small electric or pneumatic motor, hydraulic or pneumatic actuation, integrated knife-tube mechanisms where the knife is housed in or attached to a tube and / or to the device and deploys automatically when the tube is pressed against the skin, and rotational blade deployment, where the knife is mounted on a pivot and swings into position when activated.

[0114] The term “automatic cutting mechanism” refers to any mechanical, electrical, pneumatic, or spring-driven system integrated into the device that performs or assists in performing the incision without continuous manual force.

[0115] In some embodiments, the kit further comprises means for heating the device to change its configuration from flexible to rigid once attached to the subject's neck. Non-limiting examples include UV light, infrared heat, a heated water bath or steam, hot air, or other thermal methods.

[0116] In some embodiments, the kit further comprises illuminating means to enable the procedure to be performed in low-light, dark, or other low-visibility environments. For example, the edge of the opening 101 may be designed to glow in the dark, and / or to fluoresce, or the device may include integrated LED lighting systems to illuminate the procedural area. These lighting elements could be powered by small batteries or other portable power sources, ensuring that the procedure can beconducted effectively even in emergency or field conditions where external lighting is not available.

[0117] In some embodiments, the kit further comprises at least one sensor configured to identify the proper location for the incision or to determine if the airway is obstructed and / or to identify the location of the obstruction. In some embodiments, the sensor(s) may include one or more of the following: ultrasonic sensors, pressure sensors, oxygen (O2) oximeter sensors, CO2 sensors, lactate sensors, and flow sensors. For example, during a cricothyroidotomy, an ultrasonic sensor could help in locating anatomical compartments by providing real-time imaging or feedback and visualizing the tissue layers to ensure that the incision is made in the correct location. A pressure sensor can detect changes in pressure as the device is applied to the neck. When the incision site is correctly located, the pressure applied by the sensor could be measured to determine if the airway is being accessed. If the pressure reading does not change as expected during the incision, it may indicate that the airway is not properly engaged, helping the RP adjust their approach. A pulse oximeter sensor can monitor the oxygen saturation (SpCh) levels in the patient’s blood. During a cricothyroidotomy, if the airway is obstructed or not properly secured, oxygen levels could drop, signaling the need for immediate intervention. The oximeter could also provide ongoing monitoring of the patient's respiratory status throughout the procedure. In some embodiments, each of the sensors may be attached directly to the device 100 or integrated into its design. During cricothyroidotomy, CO2 detection can be used to identify and locate airway obstructions, as well as confirm that the airway has been properly accessed and that ventilation is effective. A lack of detectable CO2 may indicate that the incision is incorrectly placed or that there is an obstruction preventing air exchange. Similarly, flow sensors can assist in identifying the airway location and if it is obstructed, and verifying effective ventilation after the procedure. A sudden decrease or absence of airflow may suggest a blockage or improper tube placement, prompting immediate corrective action. A lactate sensor may be used to monitor or detect oxygenation problems or tissue stress at the incision site.

[0118] Other sensors that may be used include electromyography (EMG) sensors to detect muscle activity in the neck and help avoid accidental injury to vital structures like the vocal cords or surrounding muscles during incision; thermal sensors that can provide information about blood flow changes to help detect bleeding or tissue damage; optical coherence tomography (OCT) sensors that could provide cross-sectional images of the tissue layers; bioimpedance sensors that measure the resistance of tissues to electrical currents, which can help in determining the tissue type or providereal-time data about the airway's condition; and infrared (IR) sensors that could be used to monitor changes in blood oxygen levels in the surrounding tissue.

[0119] The kit may include adaptors that allow the device to fit different neck sizes, anatomical variations, or injured areas and to connect with various ventilation systems, ensuring proper alignment and effective ventilation.

[0120] In some embodiments, the kit further comprises instructions to perform cricothyroidotomy procedure using the device disclosed herein.

[0121] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0122] While the technology is described in conjunction with various embodiment(s), it is understood that it is not intended to limit the present technology to these embodiments. On the contrary, the present technology is intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the various embodiments as defined by the appended claims.

[0123] Furthermore, in the description of embodiments, numerous specific details are set forth in order to provide a thorough understanding of the present technology. However, the present technology may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the present embodiments.

[0124] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and the above detailed description. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A cricothyroidotomy device for performing cricothyroidotomy in a subject in need thereof, conducted by a responder- provider (RP), said device comprising: a. a central body 104 having an upper central portion 102 configured to be placed upon the neck of said subject on or right below the thyroid prominence 12; and b. two lateral fixation arms 103a, 103b extending from said central body 104 to at least partially encompass the thyroid cartilage area 13; wherein once said upper central portion 102 is positioned by said RP on or right below said thyroid prominence 12, said two lateral fixation arms 103a apply traction and countertraction forces to the neck's skin, and an accessible area of said device is positioned to expose the cricothyroid membrane 14 for making a cricothyroidotomy incision.

2. The cricothyroidotomy device of claim 1, further comprising a lower portion 105 configured to at least partially cover the cricoid cartilage area 15 of said subject.

3. The cricothyroidotomy device of claim 1 or 2, wherein said accessible area comprises a discrete opening 101 configured for insertion of an intubation tube.

4. The cricothyroidotomy device of any one of claims 1 to 3, further comprising fastening means attached to said lateral fixation arms 103a, 103b for securing the device in place once properly positioned, allowing hands-free maximal traction forces on the neck's skin.

5. The cricothyroidotomy device of claim 4, wherein said fastening means are selected from the group consisting of staples, sutures, elastic bands, adhesive pads or strips, magnetic fasteners, clips or clasps, and Velcro straps.

6. The cricothyroidotomy device of claim 4 or 5, wherein said two lateral fixation arms 103a, 103b comprise a securing actuating mechanism and are pre-loaded with said fastening means, configured to secure the device in place, eliminating the need to hold the device during the cricothyroidotomy procedure.

7. The cricothyroidotomy device of claim 6, wherein said securing actuating mechanism comprises a spring mechanism 109a and 109b which drives said pre-loaded fastening means into the subject’s neck tissue.

8. The cricothyroidotomy device of any one of claims 1 to 7, further comprising a breakaway tab 110 configured to allow the device to be separated into two parts, thereby facilitating removal of the device from the neck once the cricothyroidotomy procedure has been completed and the airway has been secured.

9. The cricothyroidotomy device of any one of claims 1 to 8, further comprising an integrated cutting element 114.

10. The cricothyroidotomy device of claim 9, comprising a rotation mechanism 112, coupled to a cutting element actuator 113, which operates to deploy said cutting element 114 in a rotational manner.

11. The cricothyroidotomy device of claim 9, wherein said cutting element 114 is curved in a semicircular shape to accommodate an intubation tube, allowing the tube to be inserted simultaneously with the incision of the airway.

12. The cricothyroidotomy device of any one of claims 1 to 8, further comprising a separate cutting element 200 having a gripping portion 201, an elongated portion 202, and a distal blade portion 203 configured to create an incision through the cricothyroid membrane.

13. The cricothyroidotomy device of claim 12, wherein the blade portion 203 comprises three serrated blades extending distally and converging at a common point to form a triangular cutting configuration configured to generate a three-point incision profile that facilitates subsequent expansion of the airway opening.

14. The cricothyroidotomy device of any one of claims 9 to 13, further comprising a deployable cover 204 configured to enclose at least a portion of the blade portion 203 during insertion and to transition from a closed state to an expanded state upon advancement of an intubation tube, thereby maintaining an access opening in the airway and guiding the tube into position.

15. The cricothyroidotomy device of any one of claims 1 to 14, made of or comprising a rigid material.

16. The cricothyroidotomy device of any one of claims 1 to 14, made of or comprising a flexible or semi-rigid material.

17. The cricothyroidotomy device of claim 15 or 16, wherein said material is selected from the group consisting of: polyurethane; thermoplastic elastomers (TPE); silicone rubber;polyvinyl chloride (PVC); polyethylene (PE); polytetrafluoroethylene (PTFE); and ethylene vinyl acetate (EVA).

18. The cricothyroidotomy device of any one of claims 1 to 14, made of or comprising flexible material that can be molded to fit the subject's neck and hardened to impose traction and counter-traction forces required for the cricothyroidotomy procedure.

19. The cricothyroidotomy device of claim 18, wherein said flexible material that can be molded to fit the subject's neck is selected from the group consisting of: a thermoplastic polymer; resins; ceramics; calcium sulfate hemihydrate; gypsum; and any combination thereof.

20. The cricothyroidotomy device of any one of claims 1 to 14, made of or comprising a flexible material that can be hardened while positioned on the subject's neck and dehardened for repositioning of the device.

21. The cricothyroidotomy device of claim 20, wherein said flexible material that can be hardened and dehardened is selected from the group consisting of shape-memory polymers (SMPs), specialized thermoplastics, nitinol, and any combination thereof.

22. A method for performing cricothyroidotomy in a subject in need thereof, the method comprising: a. obtaining the cricothyroidotomy device according to any one of claims 1 to 21; b. palpating the subject’s neck to identify at least one anatomical compartment selected from the group consisting of the thyroid prominence 12, the thyroid ala 13a, 13b, the cricoid cartilage 15, and the cricothyroid membrane 14; c. placing the device on the identified anatomical compartments accordingly, such that the opening for the cricothyroidotomy incision 101 is anatomically positioned on the skin covering the cricothyroid membrane 14 of the subject; d. performing a cricothyroidotomy incision; and, e. intubating and securing the subject for transport.

23. The method of claim 22, wherein said palpating the neck of said subject in step (b) is to identify the thyroid prominence 12, and said placing the device in step (c) is placing the upper central endpoint 102 of said device on or right below said thyroid prominence 12 of said subject.

24. The method of claim 22, wherein said cricothyroidotomy device comprises a securing actuating mechanism and pre-loaded fastening means, and the method further comprises a step of pressing said actuating mechanism after step (c) which in turn inserts said fastening means into the subject's laryngeal skeleton, to secure the device in place while maintaining the traction and counter-traction forces, eliminating the need to hold the device during the cricothyroidotomy procedure.

25. The method of claim 22, wherein said cricothyroidotomy device comprises a breakaway tab 110, further comprising removing the device from the neck after the cricothyroidotomy incision has been made and an intubation tube has been inserted through the incision opening 101.

26. The method of claim 19, wherein said cricothyroidotomy device comprises an integrated cutting element 114, wherein said step (d) comprises a step of actuating the cutting element actuator 113, causing the cutting element 114 pre-loaded with an intubation tube, to incise the skin and subcutaneous tissue within the opening 101, simultaneously enabling insertion of an intubation tube into the airway to secure and ventilate the subject.

27. A cricothyroidotomy kit, comprising: a. the cricothyroidotomy device of any one of claims 1 to 21; b. a cutting element; c. a cricothyroidotomy, tracheotomy or intubation tube or needle designed to be inserted into the airway through the incision to maintain an airway; d. means for securing at least one member selected from the group consisting of cricothyroidotomy device, cricothyroidotomy tube, tracheotomy tube, intubation tube and any combination thereof; and, e. means for ventilating said subject and securing the airway for transport.

28. The cricothyroidotomy kit of claim 27, wherein said cutting element is an automatic knife or scalpel, and said kit further comprises an automatic mechanism that enables the incision to be made automatically.

29. The cricothyroidotomy kit of claim 27 or 28, further comprising means for heating the device to change its configuration from flexible to rigid once attached to the subject's neck and / or from rigid to flexible.

30. The cricothyroidotomy kit of any one of claims 27 to 29, further comprising illuminating means to enable the procedure to be performed in low-light or dark environments.

31. The cricothyroidotomy kit of any one of claims 27 to 30, further comprising at least one sensor configured to identify the proper location for the incision or to determine if the airway is obstructed and / or the location of the obstruction.

32. The cricothyroidotomy kit of claim 31, wherein said at least one sensor is selected from the group consisting of: ultrasonic sensor, pressure sensor, oxygen (02) oximeter sensor, CO2 sensor, and flow sensor.

33. The cricothyroidotomy kit of any one of claims 27 to 32, wherein said means for ventilating are selected from the group consisting of bag-valve mask and airway connector used to attach said cricothyroidotomy tube or tracheotomy tube to said ventilation device.

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