Airway management device

Abstract

To provide a device capable of quickly, easily and accurately inserting an infraglottic airway device (or an imaging device).SOLUTION: There is disclosed a device for inserting an infraglottic airway, or an imaging device into a patient. The insertion device includes: (a) an open channel which is curved along its length, and may have two bumps at different positions along the channel length, preventing catching on the channel along the curved channel by bringing the infraglottic airway, or the imaging device into contact with both bumps, and directing the infraglottic airway, or the imaging device; (b) a handle part which is provided at a first end of the device; and (c) a configuration where a second end part of the device extends up to an opening of a patient's airway in use, one of the two bumps is arranged on the channel near the second end part of the device and the other bump is arranged between the first end part of the device and the other bump, away from the second end part of the device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to an airway management device that can be used to secure an airway, i.e., a device for inserting a subglottic airway device or a fiber optic imaging device into a patient. Further, the present invention relates to an improved subglottic airway device.

Background Art

[0002] A supraglottic airway device (SAD) is a device that secures the upper airway of a human or animal so as not to impede ventilation. The SAD (also referred to as a supraglottic or extraglottic / laryngeal mask airway device) is an airway device that can be inserted into the pharynx of a patient so that ventilation, oxygen supply, and / or administration of anesthetic gas can be performed. Since the SAD is designed to be attached to the hypopharynx of the patient and cover the supraglottic structure, the trachea can be relatively separated without the need for endotracheal intubation.

[0003] Examples of SADs include the laryngeal mask airway, Baska mask, laryngeal tube LTS-D, King tube, and 1-Gel® supraglottic airway device.

[0004] However, since the supraglottic airway device is installed above the trachea of the patient, the space between the supraglottic device and the patient's trachea is not completely sealed. This means that not all of the gas passing through the supraglottic device enters the patient's trachea. Also, due to the position of the supraglottic airway device, it is likely to become detached due to the patient's movement (e.g., when performing chest compressions with the supraglottic airway inserted).

[0005] A subglottic airway device is a more advanced airway management device that delivers air or gas directly into the trachea of a patient and is a preferred method for securing and managing the patient's airway.

[0006] Tracheal intubation, often simply called intubation, involves placing a subglottic device into a patient's airway. For example, a flexible plastic or rubber tube is placed into the patient's trachea to maintain an open airway and ensure proper ventilation. This tube functions as a conduit through which medications such as oxygen and anesthetics can be administered. Tracheal intubation is frequently performed on critically ill patients, the sick, and anesthetized patients to facilitate lung ventilation (including mechanical ventilation) and prevent the possibility of asphyxiation or airway obstruction.

[0007] These subglottic devices typically include an inflatable seal that surrounds a portion of the tube and expands after the tube is positioned within the trachea to enclose the tube within the trachea and hold the subglottic device in place.

[0008] As an intubation method, nasotracheal intubation, which passes a tracheal tube through the nose and into the laryngeal organs within the trachea, may be used, but more commonly, the oral route is employed, in which case the tube is passed through the mouth and into the laryngeal organs.

[0009] However, currently, tracheal intubation requires a laryngoscope for insertion (e.g., a laryngoscope blade). This laryngoscope is used to open the airway and enable medical personnel to visualize the airway so that the tracheal tube can be directly guided into the trachea. Laryngoscopes are large in shape and are often made of stainless steel. In certain situations, the use of such metal laryngoscopes can cause damage to the patient's oral cavity or teeth (including mucosal lesions, tooth damage, and temporary damage to the lingual or hypoglossal nerves).

[0010] Also, tracheal intubation often has to be performed by highly skilled and well-trained medical personnel, and even such medical personnel may take several minutes to perform the intubation. Since every moment counts when the airway is blocked, it is important to insert the airway device quickly and accurately.

[0011] Similar procedures and instruments are also used in endoscopic medical imaging (e.g., bronchoscopy, which uses a medical imaging device to image a patient's airway).

Summary of the Invention

Problems to be Solved by the Invention

[0012] Therefore, there is still a need for an alternative, preferably improved, device for inserting a subglottic airway device (or imaging device), particularly a device that enables rapid, easy and accurate insertion of a subglottic airway device (or imaging device).

[0013] Furthermore, when a subglottic airway is used on a patient for an extended period of time (e.g., during a long operation), the inflated seal may continue to pressurize the inner wall of the patient's trachea, which may cause tissue damage. Therefore, there is also a need for an alternative subglottic airway device, particularly a subglottic airway device that reduces the potential for tissue damage during extended use.

Means for Solving the Problems

[0014] The present invention relates to a device that can be used for rapidly, easily and accurately intubating a subglottic airway device, such as an endotracheal tube, into a patient or for inserting an imaging device into a patient's throat.

[0015] Accordingly, the present invention provides a device for inserting a subglottic airway or imaging device into a patient, the device comprising an open groove that curves along its length, a first end of the device comprising a handle portion, and a second end of the device configured to extend into the opening of the patient's trachea during use.

[0016] The device is only used for inserting a subglottic airway or imaging device, and once the subglottic airway or imaging device is inserted, the device of the present invention can be removed leaving the subglottic airway or imaging device in place. The device itself is not a subglottic or supraglottic airway device that is left in place in the patient's body to supply oxygen to the patient's lungs.

[0017] The device can be used to insert into a patient a subglottic airway such as an endotracheal tube. The device is also similarly suitable when inserting into a patient an imaging device including an optical fiber imaging device such as a laryngoscope or a nasopharyngoscope. For example, the optical fiber imaging device may be an optical fiber bronchoscope or an optical fiber laryngoscope. Hereinafter, the use of this device will be described by taking the insertion of the subglottic airway as an example. However, it is obvious that the mention of the use of the device for inserting the subglottic airway may also be relevant to the use of the device for inserting the imaging device.

[0018] The device includes a base integrally formed with a side wall and has a groove which is an open groove with an upper opening.

[0019] The side wall may be provided with a reinforcing member that gives further structural support or rigidity to the groove. For example, ribs may be provided on the side wall, or a reinforcing panel may be provided. The reinforcing member (such as a rib or a panel) may be integrally formed with the groove.

[0020] The side wall helps to lift the fold of the thyroid cartilage (located near the opening of the trachea) so that the fold does not drop inside and block the open groove in the device.

[0021] The groove is curved along its length. The groove is typically curved at an angle of 70° to 120°, for example 80° to 100°. In other words, the second end of the groove extends at an angle of 70° to 120°, for example 80° to 100°, with respect to the first end of the groove. The device can be manufactured from a material with a certain degree of flexibility, but the curvature angle is measured in the absence of an external force (which can distort the shape) on the device.

[0022] As part of its curved shape, the groove also has an upwardly curved end. This curved end guides the tube into the patient's trachea. The curved end is shaped not only to guide the subglottic airway into the trachea but also to seal or occlude the patient's esophagus. This is schematically shown in FIG. 6. In this way, the end closes and preferably seals the opening of the esophagus. Sealing the esophagus helps to hold the inserted device in position within the patient's larynx after insertion and reduces the likelihood of the inserted trachea deviating from the tracheal inlet. Further, sealing the esophagus prevents body fluids (e.g., vomitus or blood) from the esophagus from passing through during intubation, thereby avoiding bronchial aspiration.

[0023] The shape of the groove (particularly the upwardly curved end) is important for reliably positioning the device within the patient's larynx and guiding the endotracheal tube into the patient's trachea.

[0024] The length of the groove depends on the patient's size but is typically 150 mm to 250 mm, for example 180 mm to 230 mm. Also, the groove typically has a depth (measured from the upper surface of the base of the groove to the tip of the side wall) of 15 mm to 30 mm, preferably 18 mm to 25 mm.

[0025] The inner width of the groove is typically 10 mm to 25 mm, for example 15 mm to 25 mm, and the outer width of the groove is usually 25 mm to 40 mm, for example 30 mm to 40 mm.

[0026] The groove may also include one or more inclined portions or ridges at positions along the length of the groove to further assist in guiding the endotracheal tube into the patient's trachea. These inclined portions and ridges help to guide the endotracheal tube along the curved groove and prevent the tube from getting stuck in the curved portion of the groove. The inclined portion or ridge can take the form of a bump, protrusion, or inclined surface in the groove (preferably at the base of the groove).

[0027] The device is formed from a material that is rigid enough to open the patient's airway and insert the tube from the patient's airway into the trachea while having sufficient flexibility to facilitate insertion of the device into the patient's mouth or throat. For example, the device is typically formed from a thermoplastic elastomer (preferably a silicone thermoplastic elastomer), styrene ethylene butadiene styrene (SEBS), or polyvinyl chloride (PVC). Preferably, the material used is a medical material such as a medical grade silicone thermoplastic elastomer. Thermoplastic elastomers suitable for use in medical devices are well known to those skilled in the art and include styrenic block copolymers, styrene ethylene butadiene styrene (SEBS), polycarbonates, and acrylonitrile butadiene styrene (ABS) polymers. Depending on the material used, the device can be a disposable device or a reusable device.

[0028] The material may have a Shore hardness (using the Shore 00 hardness scale) of 30 or greater, such as 40 or greater, for example 50 or greater. Typically, the Shore hardness of the material is 90 or less, typically 80 or less, such as 70 or less for example. For example, the Shore hardness of the material may be in the range of 40 to 80, preferably 50 to 70.

[0029] The material may also include a lubricating additive (such as a wax additive) to reduce friction between the device and the patient's mouth or throat when inserting the device.

[0030] The handle portion of the device may be a knob extending from the device. The knob is intended to be held between the user's thumb and first and second fingers. The knob may include a stopper (such as a protrusion) to prevent the user's thumb from slipping off the end of the knob when the user pulls on the device.

[0031] The device may also include a soft tongue at the second end of the device. The tongue is made of a softer material than other parts of the flexible device such that when positioned, the soft tongue is inserted into the opening of the esophagus. Thus, this soft tongue reduces the likelihood that the device will damage or irritate the esophagus (or other tissue of the throat). In some embodiments, the soft tongue also acts to seal the opening of the esophagus. The soft tongue may cover the sides and underside of the second end (i.e., the convex base of the second end that is positioned above the esophageal opening during use). Alternatively, the soft tongue may extend around the perimeter of the sides of the second end while maintaining the underside of the second end exposed.

[0032] In addition to the soft tongue, other regions of the device, particularly regions that may come into contact with delicate portions of the tissue within the patient's airway during use, may include a buffer. The buffer may be formed from a medical material such as a thermoplastic elastomer, polyvinyl chloride (PVC), silicone, rubber, polyurethane, polyphthalate, or a mixture thereof.

[0033] The Shore hardness (using the Shore 00 hardness scale) of the soft tongue and / or buffer may be 10 or greater, such as 20 or greater, for example 25 or greater. Typically, the Shore hardness of the material is 50 or less, typically 40 or less, such as 35 or less. For example, the Shore hardness of the tongue / buffer may be in the range of 10 to 50, such as 20 to 40. In one embodiment, the value of the Shore hardness of the buffer is 30% to 50% less than the Shore hardness of the groove and sidewalls. The Shore hardness of the material can be measured using a durometer.

[0034] Preferably, the groove (including the sidewalls) and the handle are integrally formed from the same material. Typically, the entire device is manufactured by molding a polymeric material. Thus, advantageously, the device of the present invention can be formed from a single molded piece and the device also does not include separate moving parts or movable parts that would complicate its manufacture.

[0035] However, in some embodiments, the entire device excluding the buffer portion is integrally formed. If the buffer portion is not integrally formed with the other parts of the device, the buffer portion may be attached to the groove / sidewall using an adhesive.

[0036] The device may comprise an imaging device such as a camera, for example, which may be useful for directly visualizing the glottis. The camera is preferably attached to the upper side of the second end of the device so as to be positioned at a suitable location for imaging the glottis when inserted into the patient. The camera may be a wireless camera capable of wirelessly transmitting the imaging data to a wireless receiver so that the imaging data can be viewed on a display device.

[0037] The device may also comprise an indication or scale on the groove indicating how far the device should be inserted into the patient. For example, the device may include a scale on the groove that indicates to the user that the appropriate depth for insertion corresponds to the position of the device when the scale on the groove is aligned with the user's lips.

[0038] Also, this specification provides a method of intubating a patient, comprising: i) inserting the device described herein into the patient's throat; ii) inserting an airway device (preferably a subglottic airway device) into the patient by passing it along the open groove of the device; iii) fixing the airway device within the patient's body; iv) removing the device described herein from the patient.

[0039] Insertion step i) typically includes inserting the device described herein into the patient such that the second end of the device seals the esophagus and the groove is positioned to guide the airway device to the patient's trachea.

[0040] The fixing step iii) depends on the characteristics of the subglottic device used. As an example, if the subglottic device includes an inflatable cuff for holding the subglottic airway device within the patient's trachea, the fixing step iii) will include inflating the inflatable cuff.

[0041] The removal step iv) can be easily performed by pulling the device out of the patient's throat (using the handle). Due to the shape of the release groove, the device can be removed without shifting the fixed airway device.

[0042] Similarly, a method of inserting an imaging device into a patient (more specifically, into the patient's throat) is provided. The method corresponds to the intubation method described above, except that the airway device is replaced by the imaging device.

[0043] The device of the present invention, compared to conventional devices used to achieve a similar purpose, · avoids the use of a rigid laryngoscope, · has less invasion of the respiratory system, · causes less damage to the airway and less irritation to the patient, · is more tolerable for the patient, · is easier to place, · in an emergency situation, the time required to stabilize the patient's airway is improved (i.e., shortened), · can be easily placed even by less experienced personnel, · in a procedure that requires endotracheal intubation (such as planned anesthesia or emergency airway management or mechanical ventilation), reduces (or eliminates) the need to use a muscle relaxant and provides numerous advantages.

[0044] Furthermore, the present invention provides an improved endotracheal tube that can be used with the above device.

[0045] Conventional endotracheal tubes are equipped with an inflatable cuff that seals the tube inside the patient's trachea to prevent the tube from coming out. However, in long-term use (for example, during long surgical operations), the inner wall of the patient's trachea may be damaged due to continuous pressure on the inflated cuff. Therefore, the inventor of the present application has also devised an endotracheal tube having two adjacent inflatable cuffs that can be inflated alternately to reduce tracheal compression trauma.

[0046] Accordingly, the present invention further provides a subglottic airway device comprising an endotracheal tube and two annular inflatable cuffs, each cuff comprising an inflation line capable of inflating or deflating the cuff.

[0047] The annular inflatable cuffs are typically adjacent to each other such that both cuffs are located inside the patient's trachea when the endotracheal tube is inserted, and are spaced apart by a distance of, for example, 2 cm or less, preferably 1 cm or less. Thereby, regardless of which cuff is used, the airway can be sealed and the endotracheal tube can be fixed at an appropriate position inside the patient's trachea.

[0048] Hereinafter, the present invention will be described based on specific examples with reference to the accompanying drawings, which should not be construed as limiting the scope of the present invention.

Brief Description of the Drawings

[0049]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Best Mode for Carrying Out the Invention

[0050] One embodiment of the present invention will be described below (see the attached FIGS. 1 to 6).

[0051] As described in this specification, the present invention provides a device (10) for inserting an endotracheal tube.

[0052] The device (10) includes a base having a standing wall (14) integrally formed on either side of the base to form an open groove (12). The standing wall (14) is integrally formed with the base such that adjacent portions are rounded to avoid sharp edges.

[0053] As shown in FIG. 3, the device is curved at an angle of approximately 90° along the length of the groove.

[0054] At the upper end of the groove (12), there is a knob (16) intended to function as a handle during use of the device. The knob (16) is provided with a protrusion (18) to assist in gripping the device. During use, the knob (16) is typically held between the thumb and the first and second fingers, and the protrusion (18) prevents the thumb from slipping off the knob (16) when pulling the device (10).

[0055] At the lower end of the groove (12), there is a spoon-shaped end (20) having a convex surface and a concave surface. This end is curved upward and guides the endotracheal tube into the patient's trachea during use.

[0056] Also, along the length of the groove on the base, there are upper bumps (22) and lower bumps (24). The bumps are integrally formed as part of the groove (12) (more specifically, the base of the groove). It has been found that the bumps are advantageous for guiding the endotracheal tube along the curved groove and preventing the tube from getting caught within the curved region of the groove (12). In some examples where there are no bumps (22, 24), when the endotracheal tube is being guided downward of the device, if the tube catches on the base of the groove and additional force is applied to the tube, instead of being pushed along the groove, the tube is simply pushed into the base of the groove.

[0057] The groove (12) (and side wall (14)), knob (16), protrusion (18), and end (20) are all integrally formed by a medical silicone thermoplastic elastomer (such as styrene ethylene butadiene styrene) with a Shore 00 hardness value of approximately 60.

[0058] Below and around the front and side surfaces of the end (20), there is a soft cushioning portion (26) made of a medical silicone thermoplastic elastomer with a Shore 00 hardness value of approximately 30. When fully inserted into the patient's larynx, the end is placed within the opening of the esophagus, and by using a softer cushioning portion, tissue damage to the esophageal opening and surrounding areas is reduced. A cushioning portion (30) is also provided on the upper edge of the side wall (14) and on the back of the device (not shown) to avoid damage to the tissue within the patient's larynx.

[0059] In another embodiment shown in FIG. 4, the cushioning portion (26) surrounds the end (20) while leaving the convex and concave surfaces of the end exposed. In this embodiment, during use, the convex portion of the end (20) occludes and preferably seals the patient's esophagus, while the surrounding cushioning portion reduces tissue damage in the area around the esophageal opening.

[0060] The cushioning portion (26) has a hollow opening (28) that makes the end of the cushioning portion (26) more easily compressible (for example, to seal the opening of the esophagus). This makes the end of the device (10) more flexible and reduces tissue damage in the esophagus.

[0061] This device is used to insert an endotracheal tube into an unconscious patient by guiding the tube of the endotracheal tube from the patient's pharynx into the trachea.

[0062] The endotracheal tube includes a tube and an inflatable annular cuff attached to and surrounding the tube. The inflatable cuff is provided with an inflation line through which gas can be supplied (for example, using a syringe) to inflate the cuff.

[0063] During use, the user (i.e., the person inserting the endotracheal tube into the patient) opens the patient's mouth to make it easier to view the patient's pharynx. Then, the device is inserted into the patient's mouth and then below the pharynx. Due to the curved shape of the device, when fully inserted, the lower end of the device is positioned at the opening of the trachea (with the open end of the groove facing the trachea), and the buffer portion (26) of the end (20) of the device closes / covers the entrance to the esophagus. This is schematically shown in FIG. 6. This figure is for illustrative purposes only and is not intended to accurately represent human anatomy or the device of the present invention. When the device (10) is inserted into the patient's airway, the ends of the device (26, 28) close and seal the esophagus (200). Due to the curved nature of the device (and the bump of the groove), the endotracheal tube is guided upward in the direction of the curved arrow shown in FIG. 6 and into the trachea (100).

[0064] When the device is in the proper position, there is a clear passage through the patient's larynx through which the endotracheal tube can be passed. Thus, the tube (along with the inflation line) is assisted by the curved shape of the device and the upper and lower bumps (22, 24) and is fed through the groove into the trachea so that the end of the tube and the annular cuff are positioned within the trachea.

[0065] Next, the annular cuff is inflated to seal between the patient's trachea. This not only prevents movement of the endotracheal tube but also provides an airtight seal so that gas can be effectively delivered to the trachea and lungs.

[0066] When the annular cuff is inflated with the endotracheal tube inserted, the device can be easily withdrawn from the patient while keeping the endotracheal tube in place.

[0067] A similar procedure can be used when inserting an optical fiber imaging device into the body through the patient's throat.

[0068] By using the device of the present invention, it has been found that even a user who has not received formal medical training can insert an endotracheal tube into a patient within 5 seconds (thus securing the airway). In studies on cadavers, the median insertion time was 8 seconds.

[0069] Thus, the present invention provides a novel device for inserting a subglottic airway.

[0070] The present invention also provides a subglottic airway device that can be used in combination with the above insertion device.

[0071] Conventional subglottic airways include an endotracheal tube and an inflatable cuff. However, in long-term use, the pressure exerted by the inflatable cuff on the inner wall of the trachea can cause tissue damage.

[0072] Also described herein is an improved subglottic airway device having two inflatable cuffs. The device comprises a flexible plastic tube formed of medical grade polyvinyl chloride (PVC). A length scale is provided along the length of the tube so that the user can visually see how far into the patient's throat the tube has been inserted during use. At one end (upper end) of the tube is a connector that allows for an airtight connection to a source of gas (e.g., a gas containing a drug such as oxygen or anesthetic) to be delivered to the patient's trachea. At the other end (lower end) of the tube are two inflatable bags adjacent to each other, which function as inflatable cuffs. The bags are annular and surround the tube. Each tube comprises a pilot line in fluid communication with the interior of the bag to inflate or deflate the bag. At the end of each pilot line is a connector to connect the pilot line to a source of gas (e.g., a syringe) for inflating the bag.

[0073] During use, the subglottic airway is inserted into the patient's trachea (e.g., using the device shown in FIGS. 1 - 5), and one of the inflatable cuffs is inflated by injecting a large amount of air into the pilot line using a syringe. The inflated cuff forms an airtight seal between the tube and the inner wall of the patient's trachea. To prevent damage to the inner wall of the trachea, the uninflated cuff can be inflated and the inflated cuff deflated so that an airtight seal is formed along another portion of the tube (thereby applying pressure to another portion of the patient's trachea) during prolonged intubation.

[0074] Accordingly, the present invention further provides a novel subglottic airway device.

Claims

1. 1. A device for inserting a subglottic airway or an imaging device into a patient, comprising: (a) an open channel curved along its length, the channel having two humps at different locations along the length of the channel, the humps contacting both of the humps to prevent snagging of the channel and to orient the subglottic airway or imaging device along the curved channel; (b) a first end of the device comprising a handle portion; (c) a second end of the device configured to extend to an opening of the patient's trachea in use; A device, wherein one of the two humps is disposed on the groove near the second end of the device, and the other hump is disposed away from the second end of the device and between the first end of the device and the one hump.

2. The device of claim 1 , wherein the second end is configured to occlude the patient's esophagus.

3. 3. The device of claim 1 or 2, wherein the groove is curved along its length at an angle of between 70° and 120°.

4. 4. A device according to any preceding claim, wherein the groove is curved along its length at an angle of between 80° and 100°.

5. 5. A device as claimed in any preceding claim, wherein the length of the groove is between 150mm and 250mm.

6. 6. A device according to any preceding claim, wherein the depth of the groove is between 15mm and 30mm.

7. 7. The device of claim 1 formed from a material having a Shore 00 hardness of 40 to 80.

8. 8. The device of claim 1 formed from a thermoplastic elastomer.

9. 9. The device of claim 1 formed from a silicone thermoplastic elastomer.

10. 10. A device according to any preceding claim, wherein the device comprises a buffer in one or more areas of the device.

11. The device of claim 10 , wherein the dampening is in the form of a soft flange at the second end of the device.

12. 12. A device as claimed in claim 10 or 11, wherein the buffer is provided at the second end of the device in the form of a hollow opening.

13. 13. The device of claim 10, wherein the buffer portion has a Shore 00 hardness in the range of 20 to 40.

14. 14. The device of claim 1, wherein the handle portion includes a knob extending from the device, the knob including a stopper to prevent the user's thumb from slipping off the end of the knob when the user pulls on the device.

Images