WO2024095671A1 - Tracheal intubation device - Google Patents

Abstract

Provided is a tracheal intubation device which enables easy, rapid and safe tracheal intubation. The tracheal intubation device (1) is provided with a tracheal tube (2) that is inserted into a trachea and an insertion section (3) that is inserted into the tracheal tube (2). The insertion section (3) has an observation section (4) that acquires an image of a part in the vicinity of a tip part of the tracheal tube (2) and has a function as a stylet. The tracheal tube (2) in which the insertion section (3) is inserted has such stiffness that a molded shape can be retained until the tracheal tube (2) is inserted to a laryngeal portion, and has such flexibility that the tracheal tube (2) can have a shape along an inside wall (20) of the trachea (19) when the tracheal tube (2) is inserted deeper than a glottis (17) and is subjected to a force from the inside wall (20).

Description

Tracheal intubation device

The present invention relates to a tracheal intubation device suitable for tracheal intubation.

During surgery, etc., general anesthesia may be administered. In this case, the anesthetized patient is forced to stop breathing spontaneously, so it is necessary to forcibly ventilate from the outside to simulate and maintain a breathing state. Generally, a soft plastic tube called a tracheal tube (endotracheal tube) is inserted through the oral or nasal cavity and placed in the trachea, and the opposite end outside the oral cavity is connected to an artificial ventilator.

　The time allowed for tracheal intubation in general anesthesia is one to two minutes after the onset of the anesthetic effect, and connection to a ventilator must be made within this time. In addition to the above, there are many other situations where an emergency connection to a ventilator is required due to accidents, illness, etc. In these cases, as in the above, rapid tracheal intubation and connection to a ventilator are required.

Tracheal intubation is an essential technique in cardiopulmonary resuscitation, long-term ventilator management, general anesthesia, etc., but because there are individual differences in the anatomical route and insertion can be difficult due to illness, rapid tracheal intubation may not be possible without the use of experienced personnel or expensive equipment.

When intubating, the tracheal tube is inserted and placed in the trachea via the oral cavity, pharynx, and glottis. To ensure reliable intubation, the glottis should be observed to be in a straight line with the axes of the oral cavity, pharynx, and larynx aligned. However, anatomically, these axes do not line up in the normal vertical position, so the patient is placed in what is called the sniffing position, which is similar to a sleeping position with a pillow, and the top of the head is tilted back toward the shoulder to line up the axes.

If the pharynx is observed in this state, the glottis cannot be seen, as it is hidden behind the epiglottis. For this reason, when actually observing the pharynx, an instrument called a laryngoscope is used, with the tip of the blade placed against the vallecula, which indirectly lifts the epiglottis and opens the larynx, allowing the glottis to be confirmed (see, for example, Patent Document 1).

After going through this procedure, a tool called a stylet is inserted into the tracheal tube, and the tip of the stylet is bent as desired before the tracheal tube is advanced into the glottis using the laryngoscope blade as a guide. After entering the glottis, the stylet is withdrawn from the tracheal tube, and the tracheal tube is advanced, completing intubation. After this, a bag for artificial respiration is attached and air is sent in, while auscultation is used to check that the esophagus has not been intubated or that only one lung has been ventilated.

Furthermore, a syringe is used to send a specified amount of air into the cuff of the tracheal tube, inflating it and thereby preventing backflow, etc. Finally, to prevent damage to the tracheal tube, a bite block is placed on the patient and the two are secured in place with special tape, after which the tracheal tube is secured to the corners of the patient's mouth with special tape.

Since such procedures require speed and precision, various dedicated tools and equipment have been proposed and put to practical use. One example of a commonly used tool is the video laryngoscope (see, for example, Patent Document 2), which has a CCD camera attached to the tip of the laryngoscope and allows observation of the deployed state of the pharynx without direct visual inspection. Various models are sold and in widespread use, but the field of view is limited to the pharynx, and it has the disadvantage that it is difficult to instantly determine events such as erroneous intubation of the esophagus after passing through the glottis. In addition, rigid laryngoscopes are used by contacting the hard blade with the teeth, so they can be difficult to use depending on the condition or missing state of the patient's teeth, as they can cause damage.

Another example is an endoscopic device called a fiberscope (see, for example, Patent Document 3). It can be inserted into a tracheal tube and used to observe the affected area even after it has passed through the glottis, but it does not have the shape memory of a stylet and requires the same manipulation as an endoscope to maintain its shape during treatment, which requires the practitioner to be highly skilled and has the disadvantage that it cannot be used for general purposes. In any case, existing devices are expensive, and there is a problem that it is difficult to equip them in sufficient quantities in medical settings and emergency facilities where they are needed.

[Problems with existing technology]
Since tracheal intubation procedures are directly related to life, there is a strong desire to make the procedure easier and safer. In response to this background, various techniques and tools have been developed to improve the procedure, but even today, the success or failure of the procedure is largely determined by the prior information confirmation and the skill and experience of the surgeon. Various tools and equipment have been devised and are being used, but the range of effectiveness is limited compared to the importance of the purpose, and there are no devices that comprehensively improve the efficiency and safety of the procedure.

For example, rigid laryngoscopes are equipped with video cameras and monitors that make it easier to check the glottis and improve visibility when intubation begins, but endoscopic confirmation after passing the glottis is not possible, and erroneous intubation cannot be prevented. With flexible endoscopes, it is possible to deform specific areas as necessary, and it is also possible to check the affected area when intubation is difficult, but skilled operating techniques are required for the procedure.

It is assumed that incidents and accidents occurring during such procedures are unlikely to show up in medical statistics, but considering that there are cases where an experienced person is not necessarily present when such procedures are required, it is possible that tragedies occur with a certain frequency. Clinical medical practitioners are looking forward to the development of a safe and simple tracheal intubation tool that surpasses existing equipment, is easy to operate, does not require expertise, and is easy to use.

As a medical procedure within a hospital, the merits of nurses performing tracheal intubation have been debated for many years. In general, tracheal intubation within a surgical hospital is often performed for the purpose of surgery that requires general anesthesia, and is essentially a planned and prepared procedure. Planned and prepared tracheal intubation is performed using a combination of the main anesthetic with painkillers and muscle relaxants, with an eye toward managing the patient's condition and postoperative recovery.

This procedure requires highly specialized knowledge and skills, so intubation and extubation are also performed with careful consideration. Furthermore, even for qualified doctors, the reality is that not all doctors can perform this procedure with confidence, and only a small number of anesthesiologists and emergency room physicians have the proper practical skills.

For this reason, although it is a physically minimally invasive medical procedure, the speed and accuracy of the procedure are directly related to life and death and also affect the prognosis, so intubation by nurses is often considered undesirable. Except in emergency resuscitation, intubation is a procedure that should be performed under strict planning and management. Even anesthesiologists who have ample practical skills in performing medical procedures within hospitals are not satisfied with or have complete confidence in the current tracheal intubation technique tools, and many doctors hope for the emergence of a tracheal intubation technique tool that is more reliable, contains more information, and is safer and faster.

In the past, ventilation with tracheal intubation was limited to doctors in emergency medical care due to the expertise required for the procedure. However, now that there is hope for improved survival rates and improved/maintained patient condition at the time of transport, it is recognized as "a resuscitation procedure that is only possible in limited circumstances of cardiac arrest in pre-hospital medical care where it is not possible for a doctor to perform it," and from July 2004 it has been officially recognized as "certified emergency medical technicians who have completed certain courses and hospital training, provided that a system of medical control is in place before and after the incident."

　Although the performance of procedures by unskilled personnel in the absence of a physician increases the frequency of errors such as one-lung intubation or esophageal intubation, it is extremely useful as an emergency resuscitation procedure. Relaxing restrictions on intubation procedures in emergency resuscitation procedures would increase the resuscitation survival rate, and there is a need for safe and simple tracheal intubation procedure tools that are easier to operate than existing equipment and do not require expertise, even in emergency medical care settings.

Some emergency vehicles are now equipped with ventilators and intubation equipment, and certified emergency medical technicians are now able to perform intubation, but the reality is that the use of video laryngoscopes and other equipment is not spreading rapidly due to their high cost and limited availability. Intubation at the scene of an emergency can be extremely difficult, and it is estimated that there are many cases where intubation is difficult, even when performed by an anesthesiologist.

In many cases, intubation procedures in such situations would be thought to be easier and quicker with a video laryngoscope than with a (direct) laryngoscope, but in reality, (direct) laryngoscopes are the certified specifications for emergency medical technicians, and conversely, the use of a video laryngoscope requires additional training and practice. This case is presumably due to the excessively high price of video laryngoscopes, which makes them difficult to deploy in large quantities, and shows that in addition to improving the functionality of the device, the price also needs to be sufficiently reduced.

In the certification of intubation qualification for paramedics, in addition to training using dummies, practical training is conducted in the presence of a doctor and with the patient's consent, but in many cases there is no opportunity to perform the complicated procedure after obtaining qualification, making it difficult to maintain proficiency. In this regard, there is a need for a safe and simple tracheal intubation technique tool that is easier to operate than existing devices and does not require skill, and approval for its use is also desired.

In emergency rescue (cardiopulmonary resuscitation = CPR) for citizens, basic life support (BLS) without the use of equipment or medicine is based on chest compressions, and airway management and mouth-to-mouth ventilation are only performed if the rescuer has been trained in artificial respiration and has the skills and will to do so. When a doctor or paramedic arrives and BLS is ineffective, tracheal intubation, oxygen inhalation, connection to a ventilator, etc. are classified as advanced life support (ALS), but automated external defibrillators (AEDs) are widespread in modern urban areas, and there are an increasing number of cases where citizens are trying to use AEDs at the BLS stage.

The human brain constantly requires oxygen, and after about four to six minutes of breathing stops, the patient will fall into a fatal hypoxic state. In general, if cardiopulmonary resuscitation is started within two minutes, the survival rate is said to be around 90%, but after four minutes, it is 50%, and after five minutes, it is around 25%. Securing the airway and performing mouth-to-mouth ventilation require training, and it is difficult to continue ventilation for long periods of time. Furthermore, in real-life situations, there is a tendency to hesitate to perform CPR due to concerns about infection or exposure to poisons, as well as psychological resistance to the procedure, so there is an aspect to the fact that performing ventilation, which is actually useful, has been downgraded to a voluntary effort.

The pros and cons of intubation by citizens should be carefully discussed, but it is also considered a mistake not to take effective ventilation measures when AEDs, which are beyond the scope of the BLS definition, are being used. In particular, in the event of a disaster or large-scale accident, or in suburban or remote island areas, it is expected that the time it takes for citizens to perform CPR and transport patients will be long, so it is assumed that at least manual ventilation using a self-inflating resuscitation bag (bag valve mask) or the like will be combined. The ultimate goal is intubation ventilation by trained citizens under the instructions of a doctor, which could be the best ventilation implementation measure. It will improve resuscitation difficulties caused by oxygen deficiency due to no ventilation, and it is also thought to be useful in reducing the occurrence of sequelae caused by oxygen deficiency in the brain after rescue. To achieve this, it is essential to develop a safe and simple tracheal intubation tool that is easy to operate and does not require skill, which is superior to existing equipment.

Injuries such as tooth fracture, dislocation, and oral cavity damage occur with a certain frequency during procedures using rigid laryngoscopes. The use of rigid laryngoscopes has a structural and physical drawback in that the hard blade comes into contact with the maxillary anterior teeth and can act as a fulcrum, and even if the teeth are in a healthy condition, the risk of dislocation, subluxation, or fracture due to excessive load cannot be eliminated.

　Apart from this, in modern times, when general anesthesia is required and the surgery is not urgent, a dental examination and treatment is performed in advance to reduce infections and complications during and after surgery. If speed of surgery is a priority, a personalized mouthpiece called a splint is created and worn by the patient, or intubation is performed using a flexible laryngoscope, which is difficult to operate. Considering the weakening of the immune system after surgery, improving the condition of the teeth and mouth is desirable, but improvements and treatment take time, and there are cases where the creation of a splint cannot be done immediately.

As a second best solution, front teeth protectors for tracheal intubation are available on the market, but they are designed based on the general dental structure of adults and have the disadvantage that they are not necessarily universally applicable.

JP 2022-093553 A JP 2015-166019 A JP 2003-033318 A

As mentioned above, tracheal intubation using a rigid laryngoscope (see, for example, Patent Document 1) does not allow visual confirmation after passage through the glottis, so fatal accidents such as one-lung intubation or esophageal intubation cannot be prevented. On the other hand, endoscopic observation of the stomach, etc., which can be considered to be an oral intubation procedure equivalent to tracheal intubation, is a safe examination procedure that is frequently used in general regular health checkups. There are almost no cases of erroneous intubation of the trachea during so-called gastroscopy examinations, and this difference can be seen as creating an extreme disparity in safety depending on whether or not it is possible to see inside after passage through the glottis. There are fiberscope products as flexible laryngoscopes for this purpose (see, for example, Patent Document 2), but they are very expensive and require advanced skills to operate, so their use is limited to cases where particularly difficult cases are expected.

In either case, rigid laryngoscopes have the disadvantage that the rigid blade carries the risk of damaging teeth, lips, tongue, and the inside of the mouth, and that even maxillary protrusion requires careful handling. The more inexperienced a person is, the more likely they are to have a psychological misunderstanding when inserting the fixed, bent blade, which causes them to tilt their head back even more, which can easily lead to damage to the cervical vertebrae or teeth. Furthermore, if a patient has missing front teeth, the rigid laryngoscope will be embedded in the missing tooth and move in position, which can interfere with laryngeal expansion and cause damage to the gums.

In emergency cardiopulmonary resuscitation, laryngeal tubes and esophageal closed airways tend to be attempted first due to their ease of use, but in some cases, securing the airway is difficult, requiring time for re-intubation, and there are occasional cases in which aspiration occurs or residual damage is caused to the trachea and esophagus because the airway cannot be completely protected from reflux and aspiration of gastric contents compared to tracheal intubation. Tracheal intubation is the most reliable method of securing the airway, and if the difficulty of tracheal intubation can be reduced by using products that enable simple, quick, and safe tracheal intubation, the fastest, most reliable, and most effective emergency cardiopulmonary resuscitation attempts can be realized.

　AEDs (automated external defibrillators) are becoming more common in emergency CPR among residents, and the number of people who have taken courses on how to use them is on the rise. On the other hand, ventilation (artificial respiration) is neglected because no automated equipment exists. In urban areas, it is expected that it will take an ambulance team a few minutes to arrive, so it seems appropriate to try CPR mainly using AEDs and chest compressions (cardiac massage). However, in non-urban areas such as rural areas and mountainous islands, it is likely that it will take a considerable amount of time for the ambulance team to arrive and transport the patient, and there are concerns that the time before the patient can arrive at the hospital will be long.

In these cases, it is especially desirable to use an AED and chest compressions in addition to securing the airway and ventilation. The situation is similar during large-scale disasters and wars, and if products that allow for simple, quick, and safe intubation were to become more widespread and available only to qualified citizens for emergency cardiopulmonary resuscitation, the opportunities for saving lives would increase, contributing to the saving of lives that would otherwise be lost due to a drop in blood oxygen levels.

In view of the above, the object of the present invention is to provide a tracheal intubation device that enables simple, quick and safe tracheal intubation, thereby preventing accidents in clinical medicine while providing quick and easy examination for organ intubation, thereby improving prognosis.

The tracheal intubation device of the present invention is
A tracheal tube that is intubated into the trachea;
an insertion portion that is inserted into the tracheal tube,
the insertion section has an observation section for acquiring an image of the vicinity of a tip portion of the tracheal tube when the insertion section is inserted into the tracheal tube, and also has a function as a stylet for guiding the tracheal tube to the trachea;
The tracheal tube into which the insertion portion is inserted is
The insertion portion has a rigidity that maintains its shape due to the shaping until it is inserted into the larynx,
When inserted deep below the glottis and subjected to force from the inner wall of the trachea, it has the characteristic of having flexibility that allows it to conform to the shape of the inner wall.

In the present invention, when performing tracheal intubation, an insertion section with a stylet function is inserted into a tracheal tube that is slightly curved in an unloaded state and is easily deformable. At this time, the tracheal tube is maintained in a nearly straight shape by the insertion of the insertion section, and the tip is shaped to any angle or shape according to the practitioner's various intentions and that shape is maintained.

In this state, the elasticity and shape recovery force of the tracheal tube and the rigidity of the insertion part are in opposition, so the arbitrary shape is maintained unless an external force strong enough to destroy this opposition is applied. Then, with the insertion part inserted, the tracheal tube's tip reaches the glottis of the larynx and is inserted while maintaining this formed shape.

Up to this stage, the insertion section functions similarly to a conventional stylet in that its rigidity helps the surgeon guide the tracheal tube to the glottis. Also, at this time, the image obtained by the observation section at the tip of the insertion section helps the surgeon insert the tracheal tube in the direction that its tip passes through the glottis of the trachea.

Then, when the tracheal tube with the insertion part inserted is inserted deep below the glottis and receives force from the straight inner wall of the trachea, the flexibility of the insertion part breaks down the antagonism between the elastic force of the tracheal tube and the internal stress of the insertion part, and the tube assumes a shape that conforms to the inner wall. When it is further inserted along the inner wall to a specified position, the insertion part is pulled out of the tracheal tube along with specified measures such as inflating the cuff and fixing the tracheal tube, and intubation of the tracheal tube is completed.

During this time, the images obtained through the observation section at the tip of the insertion section serve to prevent incorrect intubation of the esophagus and one-sided intubation, and ensure that the tracheal tube is placed in the correct position. In addition, because the insertion section is flexible, it can be easily removed from the tracheal tube.

Therefore, according to the present invention, it is possible to reliably and easily intubate a tracheal tube without requiring any special skill while monitoring the intubation status using images obtained from the observation section. This provides a tracheal intubation device that enables simple, quick, and safe tracheal intubation, and provides quick and easy examination for organ intubation while preventing accidents in clinical medicine, thereby resulting in a good prognosis.

In the present invention, the insertion section may include an outer covering made of a flexible fluororesin or coated with a fluororesin, a bendable metal sheath section inserted into the outer covering, a core metal section inserted into the metal sheath section to allow bending due to deformation of the insertion section, and a transmission path provided within the metal sheath section and leading to the observation section.

As a result, because the outer covering has a fluororesin surface, the insertion part has high lubricity relative to the tracheal tube, allowing the insertion part to be smoothly inserted into the tracheal tube and removed from the tracheal tube. In addition, the transmission path leading to the observation part can be protected by the metal sheath. Furthermore, the insertion part can function as a stylet, mainly due to the core metal part.

In this case, the metal sheath portion may be composed of a spiral tube made in part or in whole of a shape memory alloy or a superelastic alloy.

Accordingly, if the spiral tube is made of a shape memory alloy, the part of the spiral tube that has become bent due to plastic deformation during use can be restored to the product's original shape by exerting its shape memory function through heating during regeneration and disinfection, etc.

In addition, if the helical tube is made of a general metallic material, there is a concern that the shape deformation caused to the helical tube during treatment can easily cause the helical tube to collapse in the cross-sectional direction, leading to breakage of the transmission line, etc. However, by forming the helical tube from a superelastic alloy, it is possible to reduce the deformation in the cross-sectional direction of the helical tube and prevent breakage.

The metal sheath may also be made of a cylindrical member that is made in whole or in part of a pipe material made of Nitinol alloy, titanium or titanium alloy, or stainless steel, and that has been processed to have a spiral or spring shape, or to have flexibility.

This allows the construction of a metal sheath portion that is flexible while preventing buckling or deformation in the cross-sectional direction. It also makes it easy to achieve the rigidity required for the tracheal tube with the insertion portion inserted to maintain the desired shape described above and the flexibility to conform to the shape of the tracheal wall.

The core metal portion may be made of titanium or a titanium alloy that has been refined using a thermomechanical treatment process, or stainless steel, and may be coated with a fluororesin. By appropriately selecting the hardness and shape retention properties of these metals, the rigidity and flexibility described above can be achieved even more easily.

The outer sheath may be made of a fluororesin such as polytetrafluoroethylene (PTFE) or tetrafluoroethylene-perfluoroalkoxyethylene copolymer resin (PFA), or may be made of a material with a surface coating of the fluororesin.

This ensures that the lubricity with the tracheal tube is improved. In other words, when the insertion part is pulled out from the tracheal tube, the best lubricity is effectively exerted for the tracheal tube, which is generally made of silicone resins that have some adhesiveness and friction, making it easier to remove. If other materials were used, it is expected that resistance would occur, causing the tracheal tube to move from its placement location or requiring unnecessary time to remove.

The observation unit may also include an illumination means for illuminating the vicinity of the tip of the tracheal tube and an image sensor for capturing an image of the vicinity of the tip, or may be configured using optical fibers for transmitting illumination light and images. This makes it easy to configure the observation unit.

1 is a perspective view showing a schematic diagram of a tracheal intubation device according to one embodiment of the present invention; FIG. 2 is a cross-sectional view of the tracheal intubation device of FIG. 1. 1 is an explanatory diagram for illustrating a state in which a tracheal tube into which an insertion portion of the tracheal intubation device of FIG. 1 has been inserted is inserted up to the glottis of the larynx of an intubation target who is in a sniffing position. FIG. FIG. 2 is a schematic diagram showing a state when an intubation procedure using the tracheal intubation device of FIG. 1 is completed. This figure shows that rigid laryngoscopes have a structural and physical drawback in that the rigid blade comes into contact with the upper front teeth and can act as a fulcrum.

The following describes an embodiment of the present invention with reference to the drawings. Fig. 1 is a perspective view of a tracheal intubation device according to one embodiment of the present invention. As shown in Fig. 1, this tracheal intubation device 1 comprises a tracheal tube 2 that is intubated into the trachea of a person to be intubated, and an insertion section 3 that is inserted into the tracheal tube 2.

In an unloaded state with the insertion section 3 not inserted, the tracheal tube 2 has an arc-shaped configuration that is approximately 1/3 of a circle. When the tracheal tube 2 is deformed, it has a shape recovery stress that returns it to an arc-shaped configuration when unloaded due to its tendency to curl and the elasticity of the material.

The insertion section 3 is equipped with an observation section 4 for acquiring an image of the area near the tip of the tracheal tube 2 when inserted into the tracheal tube 2, and also functions as a stylet for guiding the tracheal tube 2 into the trachea. Since it is preferable that the shape of the tracheal tube 2 be straight except for a portion on the tip side during the intubation procedure, the function of this stylet is to insert it into the tracheal tube 2 and shape the tracheal tube 2 into this shape.

The tracheal tube 2 with the insertion section 3 inserted has the rigidity to maintain the formed shape until it is inserted into the larynx. In other words, in this case, the insertion section 3 functions as a stylet. Figure 1 shows the tracheal tube 2 with the insertion section 3 inserted and in the arbitrary shape described above.

On the other hand, when the tracheal tube 2 with the insertion section 3 inserted is inserted deep below the glottis and receives force from the linear inner wall of the trachea, it has the flexibility to assume a shape that conforms to the inner wall. In other words, in this case, the insertion section 3 functions to cause the tracheal tube 2 to assume a shape that conforms to the inner wall, without maintaining the arbitrary shape described above.

Figure 2 shows a cross section of the insertion section 3. As shown in Figure 2, the insertion section 3 includes an outer cover 5 made of flexible fluororesin or having a fluororesin coating, a bendable metal sheath section 6 inserted into the outer cover 5, a core metal section 7 inserted into the metal sheath section 6 to allow bending due to plastic deformation of the insertion section 3, and a transmission path 8 provided within the metal sheath section 6 and connected to the observation section 4.

The metal sheath portion 6 is composed of a spiral tube made entirely or in part from a shape memory alloy or a superelastic alloy. Specifically, the metal sheath portion 6 is composed of a cylindrical member made of a pipe material made entirely or in part from a nitinol alloy, titanium or titanium alloy, or stainless steel, which has been processed to have a spiral or spring shape, or to have flexibility.

In this embodiment, the metal sheath portion 6 has a tip side spiral tube portion 9 and a rear side spiral tube portion 10 made of such a cylindrical member at its tip and rear side.

The outer covering 5 is made of a fluororesin such as polytetrafluoroethylene (PTFE) or tetrafluoroethylene-perfluoroalkoxyethylene copolymer resin (PFA), or is made of a material with a surface coating of the fluororesin. The observation unit 4 includes an illumination means for illuminating the area near the tip of the tracheal tube 2, and an imaging element for capturing an image of the area near the tip.

A stopper 11 is provided at the rear end of the insertion section 3 to prevent the insertion section 3 from being exposed inside the body of the person to be intubated from the tip of the tracheal tube 2. The stopper 11 is provided with a manual screw 12 for fixing the stopper 11 so that the rear end of the insertion section 3 is positioned in an optimal position. In addition, an end cap 13 is provided at the rear end of the insertion section 3 to close the rear end. The transmission path 8 connected to the observation section 4 is led out to the outside via the end cap 13.

In this configuration, when intubating the tracheal tube 2 into the trachea of a patient to be intubated, the insertion section 3, which has a stylet function, is first inserted into the tracheal tube 2, which has an arc shape in an unloaded state and is easily elastically deformable, until the connector 14 at the rear end of the tracheal tube 2 abuts against the stopper 11. The insertion section 3 is positioned at an optimal insertion position relative to the tracheal tube 2 so that it does not protrude from its tip, and is fixed in place with the manual screw 12.

At this time, the tracheal tube 2 is shaped and held in a nearly straight line by the insertion of the insertion section 3. Then, the tracheal tube 2 with the insertion section 3 inserted is shaped against the shape recovery force of the tracheal tube 2 so that the tip of the tracheal tube 2 with the insertion section 3 inserted takes an arbitrary shape suitable for insertion up to the larynx of the person to be intubated who is in the sniffing position. This arbitrary shape is, for example, a shape as shown in Figure 1, with the tip bent at approximately 35° to 90°.

In this state, the shape recovery force of the tracheal tube 2 and the rigidity of the insertion section 3 after shaping are in opposition, so the arbitrary shape of the tracheal tube 2 is maintained unless an external force strong enough to destroy this opposition is applied. Then, with this arbitrary shape maintained, the tracheal tube 2 with the insertion section 3 inserted is inserted up to the glottis 16 of the larynx of the intubation target 15, who is in the sniffing position, with the tip of the tube 2 in this state.

Figure 3 shows the state when the tracheal tube 2 with the insertion portion 3 inserted is inserted up to the glottis 16 of the larynx of the intubation target 15 who is in the sniffing position. In this state, the tracheal tube 2 is maintained in the above-mentioned arbitrary shape, and the tip of the tracheal tube 2 is in a shaped state according to the intention of the surgeon (operator).

In other words, up to this stage, the insertion section 3 functions similarly to a conventional stylet in that its rigidity helps the surgeon (operator) guide the tracheal tube 2 to the glottis 16. Next, the surgeon inserts the tip of the tracheal tube 2 in the direction passing through the glottis 17. At this time, the image obtained by the observation section 4 at the tip of the insertion section 3 prevents erroneous intubation of the esophagus 18 and intubation of one lung.

When the tracheal tube 2 with the insertion section 3 inserted is subsequently inserted deeper than the glottis 17 and receives force from the linear inner wall 20 of the trachea 19, the antagonistic relationship that maintained the regular shape is lost due to flexibility, and the shape conforms to the inner wall 20.

Furthermore, the tracheal tube 2 with the insertion portion 3 inserted is inserted along the inner wall 20 to a predetermined position as shown in FIG. 4, and after predetermined procedures such as inflating the cuff 21 and fixing the tracheal tube 2 to the intubation target 15 are performed, the insertion portion 3 is pulled out from the tracheal tube 2.

The insertion part 3 can be easily removed because the outer cover 5 of the insertion part 3 is made of flexible fluororesin or has a fluororesin coating, which provides good lubrication. By removing the insertion part 3, the tip of the tracheal tube 2 is placed in the trachea 19. The person 15 to be intubated is then placed in the normal supine position, completing the intubation. Figure 4 shows the state when intubation is complete.

As described above, according to the tracheal intubation device 1 of this embodiment, the tracheal tube 2 with the insertion section 3 inserted has the rigidity to maintain any shape that can be shaped when inserted up to the larynx (glottis 16), and has the flexibility to conform to a shape that conforms to the inner wall 20 of the trachea 19 when subsequently inserted deeper than the glottis 17, thereby enabling simple, quick and safe tracheal intubation to be achieved.

In other words, the tracheal tube 2 with the insertion section 3 inserted can be freely shaped into any desired bent shape to easily achieve intubation along the intubation route intended by the surgeon, and can easily deform when subjected to excessive force to prevent injury.

Also, as shown in Figure 5, conventional rigid laryngoscopes 22 have structural and physical disadvantages in that the hard blade 23 comes into contact with the maxillary anterior teeth 24 and can act as a fulcrum, and the hard blade 23 is prone to come into contact with teeth and oral tissues. In contrast, the tracheal intubation device 1 allows intubation along the intended intubation route and is easily deformable (flexible), making it easy to perform intubation procedures even on intubation subjects 15 who have missing teeth or loose teeth, etc.

In addition, even when emergency intubation is required during resuscitation or other such situations where the patient's dental condition is poor, the wide range of applicable conditions means that the intubation procedure can be performed without hesitation. This is thought to be particularly useful in countries where the population is aging, as the number of people in need of medical assistance who are missing teeth or have poor dental condition is increasing.

In addition, since the insertion portion 3 includes the above-mentioned outer jacket portion 5, metal sheath portion 6, core metal portion 7, and transmission path 8, it is possible to smoothly insert the insertion portion 3 into the tracheal tube 2, smoothly deform the insertion portion 3 and the tracheal tube 2 when the insertion portion 3 is inserted into the tracheal tube 2, and smoothly pull out the insertion portion 3 from the tracheal tube 2.

In addition, the transmission path 8 leading to the observation section 4 can be protected by the metal sheath section 6. Furthermore, the core metal section 7 mainly provides the insertion section 3 with the function of a stylet.

In addition, if part or all of the metal sheath portion 6 is made of a spiral tube made of a shape memory alloy, the portion of the spiral tube that has become bent due to plastic deformation caused by use can be restored to its original shape by utilizing the shape memory function of the shape memory alloy when the insertion portion 3 is heated, for example, during disinfection.

In addition, if all or part of the spiral tube of the metal sheath portion 6 is made of a general metal material, there is concern that the spiral tube may be easily crushed in the cross-sectional direction due to the shape deformation applied to the spiral tube during treatment, causing the transmission line 8 to rupture, etc. However, if the spiral tube is made of a superelastic alloy, it is possible to reduce the deformation of the spiral tube in the cross-sectional direction and prevent the transmission line 8 from rupturing.

In addition, because the metal sheath portion 6 is made of a cylindrical member made of pipe material made of a Nitinol alloy or the like that has been processed into a spiral shape or the like, it is flexible while structurally preventing buckling or deformation in the cross-sectional direction. In addition, it is easy to achieve the rigidity required for the tracheal tube 2 with the insertion portion 3 inserted therein to maintain the desired shape described above, and the flexibility to form a shape that conforms to the inner wall 20 of the trachea 19.

The core metal portion 7 is made of titanium or titanium alloy, or stainless steel, which has been refined using a thermomechanical treatment process, and is coated with a fluororesin. By appropriately selecting and adjusting the hardness and shape retention properties of these metals, the rigidity and flexibility described above can be selected from an extremely wide range of options, and can be provided according to the surgeon's preferences and the characteristics of the tracheal tube 2 to be used, making it particularly suitable for practical use.

In addition, the outer covering 5 is made of a fluororesin or a material with a surface coating of the fluororesin, which ensures high lubricity with the tracheal tube 2. This allows the insertion section 3 to effectively exert optimal lubricity on the tracheal tube 2, which is often made of silicone resins that generally have some adhesiveness and friction, making removal easy.

In addition, the observation unit 4 is equipped with an illumination means for illuminating the area near the tip of the tracheal tube 2 and an imaging element for capturing images of the area near the tip, providing clear observation.

The present invention is not limited to the above-described embodiment. For example, the observation unit 4 may be configured using optical fibers for transmitting illumination light and images. In this case, unlike when the observation unit 4 is configured with an illumination means and an image sensor, there is an advantage in that no heat is generated. Furthermore, the tracheal intubation device 1 can be used when performing nasotracheal intubation while enjoying the same advantages as in oral tracheal intubation.

1...tracheal intubation device, 2...tracheal tube, 3...insertion section, 4...observation section, 5...outer jacket section, 6...metal sheath section, 7...core section, 8...transmission line, 9...tip spiral tube section, 10...rear spiral tube section, 11...stopper, 12...manual screw, 13...end cap, 14...connector, 15...intubation subject, 16...glottis section, 17...glottis, 18...esophagus, 19...trachea, 20...inner wall, 21...cuff, 22...rigid laryngoscope, 23...rigid blade, 24...upper front teeth.

Claims (8)

A tracheal tube that is intubated into the trachea;
an insertion portion that is inserted into the tracheal tube,
the insertion section has an observation section for acquiring an image of the vicinity of a tip portion of the tracheal tube when the insertion section is inserted into the tracheal tube, and also has a function as a stylet for guiding the tracheal tube into the trachea;
The tracheal tube into which the insertion portion is inserted is
The insertion portion has a rigidity that maintains its shape due to the shaping until it is inserted into the larynx,
A tracheal intubation device characterized in that, when inserted deep below the glottis and subjected to force from the inner wall of the trachea, it has flexibility such that it conforms to the shape of the inner wall. The tracheal intubation device according to claim 1, characterized in that the insertion section comprises an outer covering made of a flexible fluororesin or coated with a fluororesin, a bendable metal sheath section inserted into the outer covering, a core metal section inserted into the metal sheath section to maintain the bending of the insertion section due to shaping, and a transmission line provided within the metal sheath section and connected to the observation section. The tracheal intubation device according to claim 2, characterized in that the metal sheath portion is composed of a spiral tube made in part or in whole of a shape memory alloy or a superelastic alloy. The tracheal intubation device according to claim 2 or 3, characterized in that the metal sheath is made of a cylindrical member that is made of a pipe material made of Nitinol alloy, titanium or titanium alloy, or stainless steel, partially or entirely, and that has been processed to have a spiral or spring shape or to have flexibility. The tracheal intubation device according to claim 2, characterized in that the core metal portion is made of titanium or titanium alloy, or stainless steel, which has been refined using a thermomechanical treatment process, and is coated with a fluororesin. The tracheal intubation device according to claim 2, characterized in that the outer covering is made of a fluororesin such as polytetrafluoroethylene (PTFE) or tetrafluoroethylene-perfluoroalkoxyethylene copolymer resin (PFA), or is made of a material with a surface coating of the fluororesin. The tracheal intubation device according to claim 1, characterized in that the observation unit includes an illumination means for illuminating the vicinity of the tip of the tracheal tube, and an imaging element for acquiring an image of the vicinity of the tip. The tracheal intubation device according to claim 1, characterized in that the observation section is constructed using optical fibers for transmitting illumination light and images.

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