JPH05205Y2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Background This invention relates to a tracheostomy valve for use with a tracheostomy tube, and it also relates to a method of restoring and improving physiological function in a patient with a tracheostomy tube. It is. The general background of this invention is set forth in Birch Patent No. 3,844,290 and Tabor Patent Nos. 3,137,299 and 4,325,366, which also exemplify the prior art.
Prior art tends to prevent air from passing externally through the tracheostomy tube during exhalation, but prevents air from passing into the interior of the lung through the tracheostomy tube during inhalation. We will describe the valve that makes this possible.

The inventors believe that many undesirable effects occur during all or part of the expiratory phase of the breathing cycle.
We have discovered that this results from not completely sealing off the airflow through the tracheostomy valve. During the expiratory phase,
Partial airflow through the valve is Taber's '366
is required by the same invention and can be produced using equipment such as Birch's '290. The passage of humid breath into the surrounding air through the tracheostomy tube tends to create deposits of moisture and mucus on the walls of the valve housing. Such deposits tend to increase friction and make it more difficult to open the valve during inhalation. Partial airflow can also act as a culture medium for pathogens such as pseudomonas bacteria. Additionally, such valves tend to click and vibrate, especially when used at the beginning of an exhalation cycle, which is disconcerting to the patient. Finally, the language of users using such valves is not normal and often incomprehensible.

Although some prior art devices, such as Taber's '299, may be assumed to provide a one-way tracheostomy valve that completely blocks airflow during the exhalation phase; It is noted that , does not very clearly teach that complete blockage of airflow during the expiratory phase is important or beneficial. Additionally, other prior art devices, such as the Taber '366, explicitly teach leaving a certain amount of valve opening to provide airflow in reverse, ie, at the beginning and end of the exhalation cycle. As a result of prior art devices blocking any airflow through the tracheostomy valve except during inhalation;
It is believed that there is no teaching of any structure that does not teach a beneficial outcome to tracheostomized patients and is clearly designed to ensure such prevention.

It has been observed clinically that tracheostomized patients often have one or more of the following problems that adversely affect their normal physiological function and result from the tracheostomy.

(1) Language loss. This occurs by diverting air through the tracheostomy tube, bypassing the larynx, oral cavity, and nasal cavity.

(2) Loss of sense of smell. This is thought to occur by diverting air aside in the same way. Loss of smell can negatively affect appetite and result in weight loss.

(3) Increased nasal and oral secretions. This occurs by diverting air away from the oral cavity and also by diverting air away from the nasal cavity. Air diverted aside facilitates the evaporation of these secretions in other ways.

(4) Decreased blood oxygen saturation phenomenon. The inventors believe that this phenomenon results from the reduced pressure created in the alveoli as a result of the open exit path (or path of lower resistance) for air through the tracheostomy tube.

(5) increasing respiratory tract infections; The inventor believes that this occurs for several reasons. One reason is that manual occlusion of the tracheostomy valve is a common practice among tracheostomized patients; I believe that this custom arises because of the fact that people embrace it and therefore do not use it. The action of closing the valve with your fingers is
Facilitating infection due to contaminated material that may be present on the hands. The second factor is the lack of filtration of the inhaled air, since it does not cross the nasal cavity. These factors are thought to promote pneumonia. The inventors believe that other factors that further increase infection are the accumulation of moisture and mucus in existing tracheostomy devices, which provide a breeding ground for pathogens. The increased oral and nasal secretions mentioned above may also be responsible for the same form.

(6) Difficulty swallowing. This is associated with aspiration of food and liquids and can result in pneumonia or upper respiratory infection. Although the inventor does not believe that the literature relates this to the characteristics of the tracheostomy device, the inventor believes that this results from an imbalance of pressure within the throat as a result of tracheostomy as follows.

(7) Abnormal protrusion. Tracheostomized patients were observed to exhale sputum into and through their tracheostomy tubes. When a person coughs, mucus, fluid or other material is expelled upward from the lungs into the trachea. In a normal person, this material passes through the trachea, past the epiglottis, and upward into the mouth.
and is discharged from it. However, for tracheostomized patients, there is a low resistance parallel path through the tracheostomy tube. this is,
Allowing material to be driven from the lungs into the tube and occasionally expelled from the tube.

(8) Difficulties with extubation method Extubation method is a method in which the tracheostomy tube is removed once its presence is no longer medically necessary. It has been observed in clinical practice that it is often difficult to extubate patients, especially pediatric patients, because the patient fears that they will not be able to breathe without the tube. This makes it difficult for such patients to recover.

These effects are not known to be correlated to the characteristics or structure of the tracheostomy tube or related devices.

SUMMARY OF THE INVENTION The inventors have found that the above problems can be eliminated or overcome by tightly and securely closing the tracheostomy valve so that the valve is always closed except during inhalation. . This result shows that a pressure difference of approximately 8 to 15 mm of water head is required to displace the valve bulkhead from the valve seat.
This is achieved by providing a slight bias on the valve. The valve is thus fully closed during the exhalation phase of the breathing cycle and also at the very beginning and end of the inhalation phase of the cycle. The inventor is
We believe that this mode of operation is very important in eliminating various physiological functions related to tracheostomy. A preferred embodiment of this invention is that by compressing the rivet to a predetermined length,
This is achieved by preloading the elastic diaphragm against the valve seat.

This change in the structure of the tracheostomy valve has been found to make the language of tracheostomized patients more and more intelligible, allowing those who are traditionally unable to communicate verbally, such as the inventor, to communicate normally or with improved speech. language can now be continued.
At the same time, valve noise and vibrations were thereby eliminated, and also the accumulation of secretions in the valve device was eliminated.

Additionally, the inventors have discovered that a number of surprising and unexpected additional beneficial effects have resulted from utilizing this type of valve. These include clearer and more forceful speech, considerably improved aeration of the lower respiratory tract, improved sense of smell and later improvement of appetite, improved swallowing, reduced aspiration of food and liquids, and improved aspiration of blood in the pulmonary arteries. including oxygen saturation, and reduced upper respiratory infections. It has also been observed that the use of a valve of this invention facilitates extubation of a tracheostomy patient and its rehabilitation to normal breathing.

DETAILED DESCRIPTION OF THE INVENTION The inventors have found that by obstructing any airflow through the tracheostomy valve during the exhalation cycle, a number of beneficial results for the tracheostomy patient are produced. Although the inventor's initial purpose and motivation was to facilitate one's own language by means of an automatic tracheostomy device capable of restoring intelligible speech, the device also provided important physiological benefits. We have found that it provides advantages.
It is believed that these advantages were previously undiscovered. This is because researchers in the technical field of the present invention believe that the inventor's motives were:
This was because they lacked the motivation to point them in the direction of these discoveries. A short narrative description of how this invention arose makes it easier to understand the structure of the device, the results it provides, and the relationship of the results to the structure.

The inventor is a quadriplegic patient suffering from muscular dystrophy. He requires a permanent tracheostomy tube to breathe. Tracheostomized patients usually place their fingers against their neck to block the tracheostomy opening (ostium) and thereby redirect the air through the larynx and then through the mouth and nose. talk. However, the inventor was unable to do this because he was unable to move his arms properly. Thus, no one can speak unless someone else places a finger on the creator's mouth or the creator is otherwise provided with a self-closing mechanism. The inventors therefore attempted to procure an automatic tracheostomy valve, but it was not possible to obtain such a device on the market. Not being able to discover any such device, the inventor devised this device to enable him to speak.

The inventor's first product was somewhat similar to the device described in the Taber '299 patent. (Such a device is not available on the market to the inventor's knowledge.) However, the first device did not provide an intelligible, natural-sounding language. Instead, it produced whistles, exhalation sounds, and rumbling sounds during operation, especially when exhalation pressure pulses hit the septum. This not only interferes with the clarity of speech, but also makes the user anxious, embarrassed, and debilitated, and thwarts the user's attempts at self-rehabilitation. After considerable experimentation, the inventors determined that the lack of positive closure of the septum at the beginning of the exhalation pulse caused this problem, and that providing positive closure alleviated the problem. That deduction enabled the inventors to devise an automatic tracheostomy valve that restores intelligible speech to tracheostomized patients.

However, many other elements must be combined to give the desired effect. First, a very soft and flexible septum for the valve is required. For this purpose, the inventor created a certain silicone rubber (product silica)
It has been discovered that the material has suitable properties. The ratio of diameter and thickness, as well as the relative size of the diameter and support rivet, is important to provide adequate resiliency. These points are discussed in more detail below.

It is important to provide a slight positive bias of the septum relative to the valve seat to ensure that airflow is completely blocked except during inhalation. However, too much deflection may make it difficult for the patient to breathe, or during an inhalation.
Airflow may become discontinuous. It gives rise to possible vibrations and/or noise and obstructs breathing. As discussed more fully below, the inventors have found that a head excursion (pressure) of approximately 8 to 15 mm provides optimal excursion and resistance to airflow.

As a result of these efforts, the inventor provided himself with a new and improved tracheostomy valve device to facilitate conversation and improve speech strength and clarity. The tracheostomy valve device described above was developed by its inventor (and many others)
It made it possible for him to recover his ability to understand language.
Knowing that such a device was not available on the market, the inventor wished to share his improvements with others who needed such a device. The inventor then discovered many unexpected benefits to himself and also to many others resulting from the use of this device.
Although these results were not anticipated before the new valve device was developed, we now recognize with hindsight that they arose from the improved talking valve structure of this invention, and how It is possible to explain why that result occurred.

This invention therefore incorporates a new mechanical structure devised by the inventor to provide an improved tracheostomy valve device as described below, as well as various discoveries made by the inventor while testing and improving the new device. It is contemplated to include both new methods that provide physiological benefits. The method, believed to be hitherto unknown, involves the alleviation of many of the impairments caused by tracheostomy and the improvement of many physiological functions, although impairment and function are often a pair of interrelated terms. In some cases normal use involves only one or the other of the two.

The inventor first used the physiological method he discovered,
and then describes the mechanical structure designed to achieve those results. These methods are not necessarily stated in order of their importance or value, which requires hindsight evaluation of their discoveries, but rather by how the inventors came to discover them. It is noted that several advantages directly result from and are caused by the improved construction of the new valve, which completely blocks all airflow except during inhalation. Other advantages arise indirectly from the structure. That is, those benefits arise from the use of a valve as opposed to a non-valved tracheostomy tube, and to some extent benefits are recognized with valves that are not biased for positive closure. obtain. However, these benefits are believed to result indirectly from the improved structure in that patients have no incentive to use the valve without new valve improvements and direct benefits. This is because conventional valves have been ineffective at improving speech or otherwise motivating patients to use them. In contrast, a new valve creates an incentive to utilize the valve, which in turn leads to the perception of indirect benefits as well as direct benefits.

Method Language Improvement As mentioned above, the original purpose of this invention was to restore language ability to people who had been deprived of it through tracheostomy. This invention restored language to many people (like its creator) who were unable to speak intelligibly using other means. It also provides clearer, more powerful, and more intelligible language to tracheostomized patients who were previously able to speak to some extent utilizing other means (such as finger closure). give.

Improved sense of smell As mentioned above in the background section of this specification, the sense of smell is typically lost in tracheostomized patients. This is because their upper airways (venous sinuses) lack regular airflow. Loss of the sense of smell is known to cause loss of appetite. After using this device, the inventor found that the ability to smell returned and that this was associated with improved appetite. The inventor has discovered that other users of his invention report the same results.

It is believed that this may be attributable to the regular redirection of airflow through the upper airways, nose and mouth caused by the automatic valving of the invention. It is known that sensory cells for the sense of smell are located in this part of the body. The inventor drew this and further observations to the attention of medical professionals in this field. Experts have corroborated them by clinical observations on the patient and, in some cases, by appropriate tests.

Reduced nasal and oral secretions The inventor also noticed that his oral and nasal secretions were significantly reduced. This reduction is attributed to the automatic and continuous reorientation of air through these cavities by this device to evaporate such secretions. This device is thus believed to restore normal physiological function (evaporation of secretions) impaired by tracheostomy.

Improved Oxidative Saturation The inventors and others have experienced an increased sense of well-being due to improved oxidative saturation resulting from the use of this invention. Since the valve is closed at all times except while inhaling air, back pressure is increased in the lungs and ultimately in the alveoli. Increased pulmonary backpressure is believed to increase gas exchange and oxygen absorption in the alveoli. Research and experience to confirm these observations is currently underway at California Irvine University.

Reducing Chronic Infections The inventors and others have experienced a reduction in the frequency of infections, a chronic problem in tracheostomy patients. Both proboscisal and pulmonary infections are associated with tracheostomy. As indicated in the background section of this specification, one cause is contaminating bacteria on the fingers used to occlude unvalved tracheostomy tubes. The valve device of this invention eliminates finger closure, thereby eliminating this medium of infection.

Additionally, the increased backpressure from the valve device of the present invention provides better ventilation of both the lower airways (eg, lungs) and upper airways (eg, venous sinuses).
To the extent that this accelerates the evaporation of secretions and reduces its accumulation in the respiratory tract, there is no culture medium for bacteria. Additionally, this invention generally provides a drier tracheostomy tube and valve device, which also tends to be less likely to harbor and breed pathogens, further reducing the likelihood of infection. be.

The inventors observed that the valves often had to be cleaned to remove dust and dirt buildup. This substance is contained in the atmosphere. A normal person is able to filter much of this material from the air breathed in through their nasal cavities, but tracheostomy bypasses these natural filters. However, the construction of the valve of this invention causes it to act as a filter, as evidenced by the dust and dirt accumulation mentioned above. Thus, this device helps reduce pneumonia and other pulmonary infections by filtering sources of infection from inhaled air.

Finally, it may be noted that the presence of the valve prevents pediatric patients from placing small objects under their tracheostomy tube. In particular, this reduces the chance of infection occurring.

Improved Swallowing Apparatus improves swallowing. The swallowing mechanism requires compression (muscular constriction waves) followed by closure of the epiglottis, which moves down the throat and as this occurs, lowers the resistance of the compressed air in the airways. Pushing food lumps or other substances into the stomach as a background. In tracheostomized patients, the opening of the trachea to the atmosphere prevents the generation of compressed air. This is because there is no pressure in the airways relative to the atmosphere. This effect can also occur in valves that do not close reliably.

However, the valve arrangement of the present invention prevents that effect from occurring. Once the epiglottis closes the trachea at the top and the compression waves begin to travel down the trachea, there is no longer any exit path from the trachea as the valve of this invention closes the only other outlet. Users of this device have indicated that they experience improved swallowing and aspirating less food or liquid. This result is
This is thought to be caused by the mechanical structure of the new valve device.

Several other beneficial effects follow improved swallowing. First, eating becomes easier and more normal and comfortable. Second, when the swallowing reflex occurs, little food and water or mucus is aspirated because its action works properly instead of being compromised by the exit of pressure through the tracheostomy opening. Therefore, food and water are swallowed into the esophagus rather than being sucked into the trachea. Such aspiration is a potential cause of pneumonia, and eliminating aspiration would make pneumonia less likely in tracheostomized patients.

Normalization of ejection The new valve provides a more normal ejection, so the patient does not expel mucus and other material through the tracheostomy tube. If there is no valve device,
Or, if the valve device is not tightly closed at all times except during inhalation, exhaled material can be forced into the tracheostomy tube and expelled from the tube to the environment. However, the valve of this invention cannot produce this phenomenon.
The air cushion in the closed tracheostomy tube prevents exhaled sputum or other material from entering the tube so that it flows past the tube and into the trachea for normal expiration. This has been observed to significantly improve both the patient's normal physiology and normal hygiene, and possibly eliminate unpleasant experiences for those in the patient's vicinity.

Improving Extubation Techniques As mentioned above, extubation techniques sometimes cause anxiety and are therefore disliked by patients. Utilization of this device has been found to facilitate extubation because it re-accustomes the patient to airflow through the upper airway without interfering with inspiration through the tracheostomy tube. This facilitates patient rehabilitation. This is because re-accustoming the patient to airflow through the upper airway allows extubation and normal breathing, and helps reassure the patient that he will not suffocate even if the tube is removed. be.

Improving the language of using in-line breathing machines Although one-way valves exist for use with in-line breathing machines, the previously available valves have not been useful for conversation. Those valves are
They tended to clog and peck due to the build-up of moisture and other materials, and had an extra drag coefficient and resistance. It has been found that this invention can be successfully used in an in-line breathing machine, allowing patients to have conversations that were previously not possible.

Apparatus Having described the advantageous results of the invention and what the inventor considers to be the rationale for explaining those results, the structure of the apparatus believed to achieve these results will now be described in more detail. It can be stated. The following description is based on the inventor's preferred embodiment of the invention, which is the same as the inventor's current commercially available device.

1 and 5 illustrate the overall system of a tracheostomy valve device. FIG. 1 illustrates the improved tracheostomy valve device 10 of the present invention, shown in conjunction with a tracheostomy tube assembly 22. As shown in FIG. FIG. 5 illustrates how the entire system is positioned with respect to the patient's airway.

The preferred embodiment of this invention consists of five main parts: connector 12, valve base 14,
A tracheostomy valve device 10 having a support 16, a septum 18, and a rivet 20. Figure 3 shows
Figure 3 is a cross-sectional view of the tracheostomy valve device showing these parts. FIG. 1 is a perspective view showing these parts excluding the partition wall 18.

As shown in FIG. 1, tube assembly 22 has a tracheal end 24. As shown in FIG. As shown in FIG. 5, this end of the tube assembly 22 is inserted into the trachea 44 of the patient 28. The other end of the tube assembly 22 is removably secured to and frictionally engaged with the connector 12 of the tracheostomy valve device 10 as shown in FIG. Connector 12 is constructed from a high impact plastic material and is shown in cross-section in FIG. Connector 12 has an outer diameter (OD) of approximately 20.3 mm.

Connector 12 is secured within a tubular valve base 14 as shown in FIG. Valve base 14 is made from the same plastic material as connector 12, and the two parts are held together by hand pressure and bonded using a solvent such as methyl ethyl ketone. Valve base 14 OD
is approximately 22.9 mm, and its inner diameter (ID) is approximately 20.3 mm. The height of the valve base 14 is approximately 16.5 mm. Connector 12 preferably has a slight external taper to facilitate pressing it into valve base 14. (Connector 12 also has a tapered shape on its inner surface to facilitate receiving a tracheostomy tube assembly 22, as described below.) FIG. 2 shows a plan view of valve base 14 as seen from the end of the valve assembly opposite assembly 22. FIG. (Outer end 26 is also sometimes referred to below as the proximal end of the valve assembly.)
This figure corresponds to number 26 in Figures 3 and 4.
FIG. The outer end 26 of the valve base 14 includes a support 16 that includes a four-armed crosspiece 28 that divides the interior of the outer end 26 into four air ports 30.
It is a ring-shaped member having a shape. The support 16 and the air port constitute a valve device inlet.
The crosspiece 28 has a disc-shaped member 32 in the center, through which an axial hole 34 passes, and through which the rivet 20 passes. The support part 16 is effectively
A wall that crosses the valve base housing.
Extending radially inwardly from its interior wall. In the preferred embodiment of this invention, the valve base 14 is one
It is shaped to include support 16 and crosspiece 28 and member 32 as a separate, integrated device.

As seen more clearly in FIGS. 3 and 4, the support 16 has a seat ring 36 around the outer periphery of its air port 30, and the septum 18 is adapted to provide a positive closing contact. seat ring 36
The rivet 20 presses against the rivet 20. Bulkhead 1
8 is a member 32 of the support portion 16 by the rivet 20.
will be installed on the The air port 30, the partition wall 18, and the seat ring 36 constitute a conduction means. The septum is of silastic material, the thickness of approximately 0.4 mm is approximately 1/50th the OD of the septum, and the septum has an axial hole through which the rivet 20 passes. The bulkhead is
Specifically, transparent low-rate silicone sheet, Dow
Corning Silastic, medical grade.

Rivet 20 is made from the same material as the valve base and connector. It is illustrated in more detail in FIG. 4, and it is shown compressed in its final shape. The rivet 20 connects to the shaft-shaped hole in the partition wall and the supporting disc-shaped member 32.
The head 20a and shank 20b are approximately 3.0 mm long when initially inserted through the axial bore 34 and before being compressed.
After being compressed, a portion of shank 20b "expands" into a fixed end 20c. (Head 20a remains unchanged.) As mentioned above, this invention requires septum 18 to be biased and closed. This is accomplished as follows. That is, as shown in FIGS. 3 and 4, support 16 has a raised seat ring 36 on its interior surface. The bulkhead was initially constructed with "floating rivets" arranged longitudinally in the form of an axis.
It is fixed to the cross member using. This allows the septum to initially "float" axially over the rivet, ie within the valve base 14.
The rivets are then compressed to bias the septum against the seat ring which is slightly raised towards the septum relative to the interior surface of the cross member 28. The more the rivet is compressed, the more firmly the bulkhead is pulled up against the seat ring. This biases the septum increasingly more forcefully against the seat ring against leakage airflow at the beginning of exhalation.

In the preferred embodiment, seat ring 36 is raised from the interior surface of support 16 by approximately 0.40 mm. (As shown in FIGS. 3 and 4, the bottom of the seat ring 36 lies above the remaining bottom surface of the support 16, such as the bottom of the crosspiece 28, by a distance here identified as approximately 0.40 mm. (extending downward).
Thus, if the rivet 20 is 0.18 after compression
Given an end play of mm, this preloads the bulkhead 18 towards the seat ring 36 by approximately 0.20 mm. (As shown in FIG. 3, if the upper part of the partition 18 and the cross member 2 of the support part
8 is 0.18 mm, then the bulkhead 18 with a thickness of 0.20 mm [the whole
0.40 mm thick], must be moved over the bottom of the seat ring 36 and into the space enclosed within the seat ring. The movement occurs because the distance between the bottom of the cross member 28 and the bottom of the seat ring 36 is 0.40 mm. ) This amount of preload was found to produce an excursion equal to approximately 8 to 15 mm of water head in the bulkhead of the 0.40 silicate material described above. It is also
The partition wall 18 is brought into complete contact with the seat ring 36. In this way, the biased septum 18 and the seat ring 36 constitute a blocking means. It is also noted that when this amount of preload is used, approximately half the thickness of the septum is pushed beyond the plane of the bottom of the seat ring in the central portion of the septum. That is, approximately half the thickness of the central portion of the septum is displaced within the seat ring.
This has been found to produce an effective closure that maintains reliable, uninterrupted contact along the seat ring. The seat ring constitutes valve seat means.

Rivet head 20 with adjustable support
By fixing a, the effective length of the rivet 20 is established, while at the same time the end 20
Heat c. Adjustment of the adjustable support then compresses the rivet 20 and creates a heated end 20c, thereby attaching the septum 18 to the support 16 and preloading the septum 18. Heating machines may be designed for this purpose using conventional technology, with heat up to 350〓 and 10°
should be selected within the range of

Returning to FIG. 3, it can be seen that the connector 12 has a mating section 38 for frictionally engaging the tracheostomy tube assembly 22. In the preferred embodiment, section 38 has a standard hub of 15 mm and is tapered so that it can be mounted on all tracheostomy tubes with diameters ranging from 14.9 mm to 15.4 mm. This means that at point A
This is accomplished by a tapered inlet from an initial ID of 15.5 mm until it intersects a cylindrical bore of approximately 15.3 mm at point B, and the cylindrical bore continues to point C.
This construction provides sufficient room to compress the tracheostomy tube and expand the housing for a frictionally tight fit to the various ID tracheostomy tubes shown. All of the different tubes extend approximately the same amount into the housing and are rigidly connected to the housing at their outwardly directed ends without interfering with valve closure.

This feature allows the modified valve assembly to be universally adapted on all standard tracheostomy tubes in general use, thus limiting the invention to use with any particular type of tracheostomy tube. Not done. This invention has also been found useful with in-line breathing machines. Until this invention, it is believed that it was not possible to use a tracheostomy tube valve on a breathing machine in a manner that provided easy-to-understand language.

FIG. 5 shows patient 28. Patient 28 has a tracheostomy neck opening 40 that is below the patient's larynx 42 and extends into the patient's trachea 44 . Tracheostomy tube 22 is inserted through neck opening 40 and retained in any suitable manner. As mentioned above, tracheostomy valve device 10 is removably mounted onto tube assembly 22. When the patient inhales, the valve device allows airflow into the trachea 44. When the patient exhales, the valve device completely blocks airflow from the trachea 44 through the valve device to the atmosphere, and at the same time the valve device is directed toward the larynx 42 and epiglottis 46 toward the sinus 48 and the mouth 50. Redirect the airflow upward.

Although the inventor has described a preferred embodiment and illustrated it with his actual commercially available equipment, it is understood that the scope of the invention is not limited to that description. Changes and modifications may occur to those of ordinary skill in the art and may be made without departing from the spirit and scope of the invention. In particular, other means may be provided to completely prevent air from escaping from the trachea during exhalation while allowing entry of air for inhalation, thereby achieving the desired effect of this invention. It occurs to those skilled in the art that physiological effects are achieved. This invention includes methods for achieving those results and structures designed to achieve them when the means to achieve them substantially completely prevent all air from escaping during exhalation. it is conceivable that.

As used in the scope of utility model registration claims,
“Tightly seated and positive closing contact” or similar terms refers to positive biased contact such as that produced by preloading the bulkhead with rivets that bias the bulkhead against the seat ring as described above. is connected with.

As used in the scope of utility model registration claims,
"biased against said valve seat means by a rivet which is axially compressed to a predetermined length"
or similar terms, the bulkhead on the rivet is seated at a slight distance from the support member to which it is attached so that the bulkhead cannot float freely in the axial direction of the rivet when the rivet is compressed to a certain length. Concerning being raised. Instead, the center of the surface of the septum facing the seat ring is located between the tracheal plane of the seat ring and the tracheal plane of the support, thereby allowing the septum to open in a manner similar to that described above. Preload.

When reference is made to displacing the central portion of the septum within the valve seat means by a particular distance, or when reference is made to the plane of the seat ring, the seat ring and septum are actually three-dimensional rather than two-dimensional. The original elements, and therefore the relevant planes in question, are (1) that surface of the septum facing the seat ring, and (2) that surface of the seat ring facing the septum, i.e. the tracheal surface of the ring. One thing should be understood.

When reference is made to the "rest" position of the septum, that position refers to the position of the septum when there is no inhalation or exhalation, so that the only pressure gradient across the septum is such that it preloads the septum. It is produced by compressing the rivet.

[Brief explanation of the drawing]

FIG. 1 is an exploded perspective view of a tracheostomy valve assembly and associated tracheostomy tube assembly. FIG. 2 is a plan view of the valve assembly looking at the valve device from the atmospheric side (i.e., from outside the patient using the device). FIG. 3 is a cross-sectional view of the valve assembly. The cross section is
This is along line 3-3 in FIG. Fourth
The figure is a detailed cross-sectional view (along a different cross-sectional line) of the part of FIG. 3 in which the deflection control rivet through the septum is located. This drawing exaggerates the deflection and curvature of the valve septum to facilitate recognition of its features. FIG. 5 is a cross-sectional view of a patient using a tracheostomy tube fitted with the valve of this invention. In the figure, 10 is a tracheostomy valve device, 22
12 is a tracheostomy tube assembly, 12 is a connector, 14 is a valve base, 16 is a support portion, 18 is a septum, 20 is a rivet, 20a is a head, 20b
is the shank, 20c, 24 and 26 are the ends, 2
8 is a patient, 30 is an air port, 32 is a member, 34 is a hole, 36 is a seat ring, 38 is a joining section, 40 is a tracheostomy neck opening, 42 is a larynx, 44 is a trachea, 46 is an epiglottis, 48 is a vascular sinus , 50 is the mouth.

Claims (1)

[Claims for Utility Model Registration] (1) A tracheostomy valve device adapted to cooperate with a tracheostomy tube inserted into the trachea of a patient, for connection to the free end of said tracheostomy tube. a first end and a second end adapted to be connected to each other; a valve device inlet located at the second end of the valve device; and a valve device inlet located at the second end of the valve device when the patient inhales. a conduit for allowing airflow through the device and thence through the tube to the patient's trachea; and a complete, uninterrupted closed contact with the valve device inlet, and thereby ,
completely blocking airflow from the tube through the conducting means and through the valve device inlet whenever the patient exhales and at all times except when the patient inhales; A tracheostomy valve device, comprising: a blocking means for maintaining the contact force of the closing contact at a predetermined value or more. (2) Claims of the Utility Model Registration, wherein said blocking means comprises a thin flexible bulkhead firmly seated against and in positive continuous closing contact with said valve seat means within said valve arrangement. The tracheostomy valve device according to clause 1. (3) The tracheostomy valve device of claim 2, wherein the septum is made of silicone sheet material. (4) The tracheostomy valve device of claim 2, wherein said septum is biased to press against said valve seat means at a pressure of approximately 8 to 15 mm of water head. (5) A utility model registration claim, wherein an axially disposed rivet is axially compressed to a predetermined length to bias said septum so as to press said septum against said valve seat means. The tracheostomy valve device according to item 2. (6) The tracheostomy valve device of claim 5, wherein a central portion of the septum is displaced within the valve seat means by approximately half the thickness of the septum. (7) said septum has a diameter of approximately 15.2 mm, a thickness of approximately 0.4 mm, and is made from a low-modulus silicone sheet material, and said septum has a diameter of approximately 0.2 mm;
A tracheostomy valve device according to claim 5, wherein the tracheostomy valve device is preloaded against said valve seat means by displacing a central portion of said septum within said valve seat means by mm. (8) The conduction means has a cylindrical inner wall and at least one air port extending radially inward from the inner wall and extending in the axial direction, transversely to the axial direction. a tube structure having a lateral wall in a direction to an annular ring mounted on a surface, said ring extending from said lateral wall towards said trachea and providing a plane in a direction towards said trachea; an inner edge radially outwardly from the air vents, such that each said air vent is entirely within said ring, and said rivet is in a "rest" position of said septum, said inner edge of said ring; pressing the septum against a plane so that the septum completely blocks each of the air ports; The tracheostomy valve device of claim 2, wherein the tracheostomy valve device is axially compressed to the extent of compressing the central portion of the septum to an intermediate point. (9) the tube structure has a first internal diameter that is further within the structure and is greater than a first internal diameter of the structure that is further away from the tracheal end, which is the tracheal end of the tracheostomy tube; a circular cross-sectional shape and an internal tapered shape on the tracheal end side such that the second internal diameter is larger than the external diameter of the tracheostomy tube; and the first interior diameter is less than the exterior diameter of the tracheostomy tube such that the valve device slidably receives and frictionally engages the exterior end of the tube, and the valve device slidably receives and frictionally engages the exterior end of the tube. The tracheostomy valve device of claim 7, wherein the device is removably mounted on the tube. (10) The tracheostomy valve device according to claim 9, wherein the second internal diameter is approximately 15.5 mm and the first internal diameter is approximately 14.3 mm. (11) Claim 2, wherein the valve device inlet is connected to a breathing machine, such that the valve device is inserted in line between the breathing machine and the tracheostomy tube.
Tracheostomy valve device as described in Section.