MXPA97007304A - Tracheal hose with automatic truck handle clamp - Google Patents

Abstract

The present invention relates to a tracheal hose comprising: a hose having an outer surface, an inner surface, a proximal end and a distal end, a clamp mounted on the hose near the distal end, the clamp has: a tubular tray flexible with two edges arranged in the hose in relation to it and the edges fixed to the surface of the hose to define a volume around it, and one or more resistant support parts within the volume, each part of resistant support it includes a ring that surrounds the hose, the ring is made of a resistant material, and one or more passages to communicate air pressure close to said distant end, to the interior of the clamp.

Description

TRACHEAL HOSE WITH SELF-SUFFOCATION TRACHEAL HOSE CLAMP TECHNICAL FIELD The invention relates to endotracheal and tracheostomy hoses with inflatable clamps.

PREVIOUS TECHNIQUE When the support or the ventilatory protection of the airways is indicated, the hoses have been the apparatus of choice. The traditional tracheal hose ("breathing hose", "endotracheal hose" or "ETT") is placed in the patient's windpipe through the mouth or nose to assist in breathing. It consists of a length of flexible and stretched PVC hose (or silicone rubber or other rubber) that has a connector at its proximal end to connect with a means of ventilation. Near the far end there is an inflatable circumferential clamp or balloon that seals against the walls of the trachea when it is inflated. This seal between the clamp and the tracheal wall allows positive pressure from the lungs and prevents the vomited content of the stomach from leaking and flooding the lungs from above.

The alternative method of placement of the tracheal hose is through the tracheotomy (a surgical hole through the skin of the neck and directly into the trachea). This type of tracheal hose is called a "tracheostomy hose." The distal end and the inflatable clamp sealing means of both tracheal and tracheostomy hoses are identical.

The standard tracheal hoses currently used have clamps that resemble donuts near the far end. The clamps are usually made of a thin PVC film or any material from which the hose is made. The clamps are manually inflated with pressurized air from a syringe through a small pilot "pilot hose". The air is injected into the proximal end of the pilot hose, which is a thin piece of hose for its proximal half and a small diameter channel molded into the side wall of the tracheal hose for its distal half. The pilot hose ends at its far end inside the inflatable clamp of the tracheal hose. The pilot hose has a unidirectional valve at its proximal end to maintain pressure within the system.

To prevent air leakage between the inflated clamp and the tracheal wall during mechanical ventilation, the pressure in the clamp must be equal to or greater than the maximum inspiratory pressure within the air passage. Maximum inspiratory pressures are only reached for 10% -25% of the ventilatory cycle but can be as high as 50 mm of mercury. Since the pressure inside the standard clamp is static, the clamp pressure must be maintained at this relatively high pressure (equal to or greater than the maximum air pressure) throughout the ventilatory cycle, to prevent leakage during the pressure portion. highest of the cycle.

Clamps that contain relatively high static pressures transmit the same pressure to the adjacent tissue of the wall of the trachea. As the clamp pressure exceeds the capillary blood pressure of the tracheal tissues, typically 25 mm of mercury, tissue ischemia or inadequate blood flow occurs. Prolonged ischemia can cause various degrees of injury ranging from mild erosion of the mucosa, to destruction of the tracheal cartilage chains, to segmental tracheomalacia with dilation of the trachea. Even more dramatic is the erosion of full thickness that can result in perforation of the previously nominated artery or subsequent perforation of the esophagus. Subsequent complications of tracheal stenosis, from mild to disabling obstructions, are noted in the majority of patients who require ventilatory support for prolonged periods. Again, the problem is not with the pressure itself but the pressure is applied in a static way for a prolonged period of time. Short-term occlusion of blood flow does not damage most tissues but prolonged occlusion causes tissue ischemia and cell death.

During surgery the problem of excessive clamp pressures is exacerbated because the nitrous oxide anesthetic gas is dispersed in the clamp material and inside the clamp. The volume of gas inside the clamp can be more than doubled during an operation due to the diffusion of nitrous oxide. Obviously the diffusion of nitrous oxide inside the clamp increases the pressure inside the clamp and therefore the pressure against the tissue of the tracheal wall also increases. This slow increase in clamp pressure can not be detected by the clinician.

To prevent tissue damage caused by prolonged clamp pressure, doctors and nurses can deflate and reinflate the clamp periodically. However, this procedure is rarely carried out frequently enough or for a period long enough to allow adequate tissue reperfusion. Therefore, this method does not prevent the ischemia of the tracheal wall dependently. It is also a nuisance for doctors.

A variety of pressure regulating devices have been developed to be attached to the pilot hose to regulate the pressure of the clamp. These include protruding valves, cameras and balloons to visualize the amount of pressure in automatic inflator / deflators. None of these devices has reliably resulted in the clamp pressure problem.

The second practical problem with the current design of tracheal hoses and inflatable clamps is that the assembly of the pilot hose and the valve requires many parts with many connections, resulting in many chances of failure, longer assembly time and higher manufacturing costs. . Because the pilot hose and clamp are a relatively high closed pressure system that must maintain its integrity for hours and even days, any leakage or manufacturing defect will result in deflation of the clamp and failure of the hose. The need for high levels of quality control during the manufacturing process of this life support apparatus obviously adds to the cost of the apparatus. In addition to occasional manufacturing defects, leaks often develop during prolonged use, necessitating hose replacement. The replacement of the hose in a critically ill patient itself can be a life-threatening procedure.

These many problems can be eliminated or at least minimized by abandoning the use of the traditional statically inflatable clamp as the sealing means. Clearly, there is a need for an improved sealing means for use with tracheal and tracheostomy hoses.

DISCOVERY OF THE INVENTION My invention includes tracheal hoses with an inflatable clamp. A tracheal hose according to the invention is made of a flexible and stretched hose length (preferably of PVC plastic, but could be another plastic or silicone rubber or other rubber or metal) of size to fit inside the human trachea. At the proximal end there is a standard connector for connecting the tracheal hose to a breathing apparatus or ventilation medium. Near the far end there is an inflatable circumferential clamp or balloon that seals against the walls of the trachea when it is inflated. The clamp is made of a thin plastic or rubber film, formed in an annular shape that borders the hose and that is sealed along its edges near and distant to the hose. The combination of clamp and hose sealed at the edges of the clamp creates an inflatable "donut" or a bulbous annular sealing means.

My invention includes a combination of two parts that is not present in the standard tracheal hose and also comes with a standard part.

First, in my invention, the clamp, at rest, it is maintained in an upright position by one or more compressible and resistant parts within the clamp acting between the tracheal hose and the clamp. Said parts may be, for example, compressible and annular plastic foam or rubber foam discs or washers surrounding the hose, inside the clamp. At least one of the discs may be slightly larger in diameter than the larger human trachea for which the hose is dimensioned and will therefore be radially compressed (without bending) when the hose is inserted into the patient's trachea. The compressed foam disc (s) create a static low pressure seal between the clamp and the tracheal wall, throughout the respiratory cycle.

Second, the clamp in my invention is self-inflating, to automatically increase the seal between the clamp and the trachea during the high-pressure phase of ventilation. There is one or more gaps or passages that communicate directly between the air path space where the distal end of the hose is placed and the inside of the clamp. Preferably these gaps pass through the wall of the hose in communication with the interior opening. As an alternative, these holes can pass through the clamp on its distant side, "downstream" in the trachea. These gaps allow air under high pressure, within the air path during the respiratory phase of positive pressure ventilation, to flow into the clamp, expanding the clamp and increasing the seal against the tracheal wall. As the pressure in the air path decreases, which decreases the demand on the seal, the pressure inside the clamp decreases simultaneously. Therefore, this design creates a unique high pressure seal that corresponds with each respiratory cycle. During the low pressure ventilation phase the seal is maintained only by the low pressure of the resistant parts. Because resistant parts only require sealing during the low pressure breathing phase, these parts can be made of a soft, lightweight, low density, easily compressible foam. This static seal of very low pressure against the tracheal wall allows normal blood flow in the tracheal tissues during most of the ventilatory cycle.

My design lacks pilot hose and external means for inflation and deflation of the clamp. This significantly reduces the number of parts in the hose, simplifies assembly and reduces the number of sealed joints in the air that must have a highly reliable quality control.

A principal objective of this invention is to provide a tracheal hose that is equal to or greater than the maximum air pressure during positive pressure ventilation (to prevent leakage of inspiratory air pressure around the hose).

Importantly, the inflatable seal member maintains at least a minimal static seal with the trachea during the entire respiratory cycle (to prevent flooding of the lungs with vomit or blood from above).

A significant advantage of the tracheal hose of this invention is that the inflatable seal member does not maintain high static pressures during the expiratory or low pressure phase in the respiratory tract of the ventilatory cycle (to allow tissue reperfusion). In this regard, the inflatable sealing member provides dynamically changing pressures in the clamp corresponding to the air pressures against which it seals. In addition, the inflatable sealing member will not over-inflate or allow nitrous oxide diffusion to be trapped in the clamp.

Significantly, the inflatable sealing member is easily and completely deflatable for easy and non-traumatic insertion through the vocal cords and trachea.

The tracheal hose of this invention is cheaper to manufacture and more reliable than the current standard tracheal hose with an inflatable clamp.

BRIEF DESCRIPTION OF THE DRAWING The objects, advantages and characteristics of this invention will be more easily appreciated from the following detailed description, when read in conjunction with the attached drawing, in which: Figure 1 is a perspective view of a first example of the invention showing three foam discs, which cover the gaps in the sight hose. The cover that protects the discs is transparent in this view.

Figure 2 is a sectional perspective view of the first copy.

Figure 3 is a cross-sectional view through a foam disk (along the lilily in Figure 1), showing two of the passages for communicating the air pressure inside the clamp.

Figure 3A is a cross-sectional view through a foam disk when inserted into the trachea of a patient.

Figures 4 and 5A-5B show the second and third copies respectively, of the invention exhibiting different disk and hollow combinations.

Figure 6 is a perspective view of a fourth example of the invention exhibiting different disc diameters.

Figure 7 is a sectional perspective view of the first copy, showing a filter covering the passages to communicate the air pressure inside the clamp.

Figure 8 is a perspective view of a fifth example of the invention with passages for communicating air pressure inside the clamp being hollow in the clamp itself.

Figures 9A and 9B are side views of the fifth exemplary embodiment of the invention shown in Figure 8. These diagrams show the gas entering and exiting through the passages, alternatively inflating and deflating the clamp.

DISCUSSION OF THE PREVIOUS TECHNIQUE a) self-inflatable clamps: A variety of tracheal and tracheostomy hoses with clamps or structures similar to self-inflating clamps are known in the prior art. These many designs exhibit varying degrees of effectiveness in creating a reliable seal during the high peak pressure phase. Most of these designs fail to seal the air passage during the low pressure phase. To overcome this deficiency, some include butterfly valves or a second inflatable clamp, in which case the sealing means is not dynamic.

U.S. Patent No. 1,113,484 shows a self-inflating clamp that connects with the gaps through the wall of a tracheal hose. In addition, there is a constriction of the caliber of the hose to create a pressure gradient. The gaps that inflate the clamp are upstream of the constriction in the high pressure zone.

U.S. Patent 3,481,339 shows a mechanism of dual clamps, one clamp within the other. The outer clamp is inflated through a pilot hose. The inner clamp is in communication with the inside of the hose and responds to the pressure of the air passage. The primary occlusion mechanism with this design is the clamp inflated outwardly, therefore the problem of high static pressures in the clamp has not been solved. 2 U.S. Patent No. 3,460,541 shows a self-inflating clamp with an inflation opening through the wall of the hose. It also includes a butterfly valve that covers the opening preventing deflation of the clamp during the exhalation phase.

U.S. Patent No. 3,504,676 shows a clamp mechanism that includes a pilot hose coupled to a balloon that is within the air passage and responds to the pressure of the air passage, increasing the pressure in the clamp in response to high air pressure. passage of air. The primary occlusion mechanism with this design is the clamp, therefore the problem of static high pressure in the clamp has not been solved. The maximum airflow pressures are simply added to the static pressures of the clamp. In addition, the time constant of the low-caliber pilot hose does not allow enough air to be transferred fast enough to respond to the rapid increase in airflow pressure during inspiration.

U.S. Patent No. 3,565,079 shows an auto inflatable clamp design that "remains inflated throughout the expiration." The above is achieved with two basic designs. 1. A series of slots or openings at the distal end of the clamp itself, open to the pressure of the remote air passage; 2. A gap between the hose and clamp to inflate the clamp during maximum airflow pressures and the gap is covered with a butterfly valve to prevent air outflow, on each specimen.

U.S. Patent No. 3,707,151 shows a self-inflatable clamp design wherein the interior of the clamp is in direct communication with the pressure of the air passage inside the hose. This patent mentions the need to maintain the inflation of the clamp throughout the respiratory cycle and tries to achieve the above with inclined inflation passages and / or butterfly valves that occlude the passages. With zero pressure and a communication passage without valve, the clamp will deflate and lose the tracheal seal without taking into account the angle of air passage. The version with butterfly valve runs a high risk of catching pressure in the high, maximum air passage inside the clamp and keeping it there throughout the respiratory cycle.

U.S. Patent No. 4,278,081 shows a self-inflatable tracheotomy clamp wherein the inside of the clamp is in communication with the air passage pressure. Figure 9 clearly shows the collapse of the clamp during exhalation. As stated in column 3, line 46; "to solve the problem of inadvertent travel of stomach acids and similar undesirable fluids from the stomach and esophagus to the trachea and lungs, a plug is provided for insertion above the implantation point for the tracheal hose." The problem of leaks is solved by placing a plug at the base end of the trachea above the site of the tracheotomy, outside the inflatable chamber.

U.S. Patent No. 4,791,923 shows a dual clamp mechanism, one clamp within another. The internal clamp is inflated through a pilot hose. The outer clamp is in communication with the inside of the hose by another pilot hose and responds to the pressure of the air passage. The primary occlusion mechanism with this design is the clamp statically inflated, therefore the problem of static high pressure clamps has not been solved. In addition, the time constant (air movement rate) of the small gauge pilot hose would not allow enough air to be transferred into the clamp fast enough to respond to the rapid increase in air passage pressure during inspiration. b) inflatable skirts; To solve some of the problems associated with traditional clamp tracheal hose, a number of skirt-like sealing means have been developed. In theory these are autoinflables during the maximum pressures in the passage of air.

U.S. Patent No. 3,616,799 shows a skirt (no clamp) extending beyond the end of the hose with its open end pointing downstream. The pressure of the increased remote air passage is trapped inside and extends the skirt outwardly within a seal with the windpipe. The design includes an external "edge" or seal that creates the seal throughout the respiratory cycle. The inventor recognizes that if the "edge" is strong enough to reliably create a seal in the air passage, it would also be very difficult to insert it through the vocal cords and would probably apply considerable static pressure to the tracheal mucosa.

U.S. Patent No. 3,709,227 shows an inflatable chamber that is specifically in communication with the downstream of the air passage, through directed passages within the downstream trachea instead of the opening of the hose. This patent teaches an additional "flexible annular lip", external to the inflatable chamber, to provide the seal with the trachea during the entire respiratory cycle. This lip would be difficult to insert through the vocal cords.

U.S. Patent No. 3,769,983 shows a self-inflating tent flap with a distal end open in communication with the air passage pressure. This apparatus does not have an additional sealing means and the inventor notes, "In an instant of time the air flow may be at rest ... the tent relaxes from its unattended position by yielding from the surface lining." (Column 7, line 43) A problem with this apparatus is that a significant portion of the respiratory cycle is near zero pressure in the air passage and this apparatus does not occlude the passage of air during that period.

U.S. Patent No. 4,979,505 shows two parabolic skirts with inverted open ends to each. The distant skirt is self-inflatable in response to the pressure of the air passage. The distant skirt extends beyond the end of the tracheal hose and therefore must be self-supported. Means for holding the open end of the skirt in contact with the tracheal wall are not taught. Since the skirt would have to be larger in size to accommodate a variety of tracheal sizes, the skirt would fold over in many cases and leak during the low pressure phase. These skirts would be very difficult to insert through the vocal cords. c) disc-like sealing means: A number of tracheal hoses have been developed with one or more sealing means with disc-like flanks. In these designs, if the discs are rigid and strong enough to create a reliable seal with the trachea, they will be difficult to insert beyond the vocal cords and will bend rather than compress. Folding a disc will create leaks.

U.S. Patent No. 3,659,611 shows one or more "flanks similar to thin, solid, and strong discs" as the sealing means.

U.S. Patent No. 5,305,740 shows a sealing means made of multiple "wing collars" or "flank collars". Each fin or flank is a thin (eg, 0.002 inch), soft, foldable element (eg, plasticized vinyl sheet). Each fin has a collar portion to assist in attaching to the hose.

U.S. Patent No. 5,322,062 discloses a sealing means made of one or more thin, flexible, resilient annular discs having a series of partial openings extending radially outwardly to the rim and larger than the diameter of the passage air. d. Cell foam foam clamps: A variety of foam-filled clamps have been developed in an attempt to create a low pressure seal with the trachea. The expanding bulbous foam sealing structure in expansion of these designs creates a gentle seal throughout the respiratory cycle. It has been recognized that increased sealing pressure may be necessary at the time of the maximum pressures in the passage of air and some of these designs include self-inflating mechanisms to solve this problem. The relatively large bulbous foam masses described in each of these patents would not be easily compressed for insertion through the vocal cords and therefore the inventors have added a suction means to the inventions to forcefully collapse the sealing means of the bulbous foam during insertion.

U.S. Patent No. 3,640,282 shows a tracheal hose with a foam-filled clamp. The strong foam inside the clamp "preferably fills the cover 9 completely between the end portions 11 and 12", (Column 13, line 55). It is recognized that this foam mass would not be passively compressed during insertion. Therefore, the apparatus incorporates a pilot hose to transmit a suction inside the clamp, to cause it to be compressed by forcefully collapsing the foam, for easy insertion into the trachea. The clamp does not communicate with the pressure of the air passage. U.S. Patent No. 3,799,173 shows a similar arrangement.

European Patent Number 0,072,230 (U.S. Patent No. 4,495,948) shows a tracheal hose with a foam-filled clamp. This foam mass would not passively compress during insertion. Therefore, the apparatus incorporates a pilot hose to transmit a suction into the clamp, to cause it to be compressed by strongly collapsing the foam, for easy insertion into the trachea, in all independent claims. In addition, the pilot hose can communicate with the pressure of the air passage through a coupling at the proximal end of the hose and is therefore intended to be a self-inflating design. However, the time constant of the small gauge pilot hose would not allow enough air to be transferred fast enough to respond to the rapid increase in air passage pressure during inspiration.

PARALLEVARACABOLAINVENTION Widely, the present invention relates to a tracheal or tracheostomy hose (hereinafter a "tracheal hose") with a distal end bordered by a clamp that is resiliently and selectively inflated in a novel arrangement. Specifically, the inflatable clamp is self-inflatable, under the pressure provided by holes arranged in the hose or clamp itself. In addition, one or more resistant parts act between the outer surface of the tracheal hose and the clamp to maintain a minimum sealing pressure when the tracheal hose is inserted into a trachea.

Figure 1 illustrates the various components of a first exemplary tracheal hose 100 according to the invention. The tracheal hose 100 comprises a length of flexible hose 102 and a proximal end 104 and a distal end 106. The flexible hose 102 preferably comprises a length of flexible and stretched hose such as PVC plastic or other plastic, silicone rubber or other sufficiently flexible material, of size that fits inside the human trachea. The proximal end 104 of the tracheal hose 100 includes a connector for connecting the tracheal hose 100 to an appropriate breathing apparatus or ventilator. If desired, connector 108 may have a standard size, to correspond conveniently with commercially available breathing equipment.

At the distal end 106 of the tracheal hose 100, an inflatable clamp 110 lines the flexible hose 102. The clamp 110 comprises a flexible, circumferential inflatable balloon or clamp that seals against the walls (not shown) of a trachea as shown below . Clamp 110 is preferably made of a plastic, rubber or other flexible material, formed in an annular shape that surrounds by way of seal the flexible hose 102. More particularly, the clamp 110 is sealed along its distal end. the flexible hose 102. The combination of the clamp 110 creates an inflatable "donut" or bulbous ring sealing apparatus.

The structure of the clamp 110 further includes one or more compressible parts, such as the annular support parts 112, which act between the outer surface of the flexible hose 102 and the clamp 110. When the clamp 110 is not inflated, the clamp 110 however, it occupies a certain volume, due to the outlet pressure of the support parts 112. Each support member 112 preferably comprises an apparatus of plastic foam or annular rubber foam, such as a disk-shaped apparatus or washer, having a central hollow (not shown) through which flexible hose 102 passes. Each support member 112 preferably comprises a low or medium density plastic foam material with a thickness between about 0.18 to 0.5 inches, so that the support portions 112 are sufficient to serve as a support partition within the clamp 110. Preferably, at least one of these support parts 112 has a size sufficiently larger in diameter to the human trachea for which the tracheal hose 100 is designed. However, due to the low or medium density of the material from which the support parts 112 are made, the parts 1 12 can be compressed substantially, without bending, while the tracheal hose 100 is inserted into the patient's trachea.

The clamp 110 is self-inflatable due to a number of features of the present invention. As illustrated in Figure 2, for example, the first specimen of the tracheal hose 100 includes one or more recesses 200 in the portion of the flexible hose 102 surrounded by the clamp 110. The relationship between the recesses 200, clamp 110 and the flexible hose 102 is further illustrated in Figure 3. During the inspiratory phase of positive pressure ventilation, the recesses 200 allow the higher pressure air within the air passage to flow into the clamp 100, thereby expanding the clamp 110 and increasing the effectiveness of the clamp seal against the tracheal wall. The foregoing can be more easily seen with reference to Figure 3A, which illustrates a cross-sectional view of the tracheal hose 100 inserted into a patient's rachis. More particularly, Figure 3A shows the clamp 110 in its fully inflated state, in tight seal against the trachea 300 of the patient. For perspective, Figure 3A also shows a vertebra 302 of the musculature 304 of the patient's neck and skin 306 of the patient's neck.

As the pressure within the air passage decreases, decreasing the demand for sealing, the pressure within the clamp 110 decreases simultaneously. Therefore, clamp 1 10 automatically creates the appropriate seal, which corresponds dynamically to the pressure of the ascending and descending air passage that occurs during each respiratory cycle. During the low pressure phase of the ventilation, a static low pressure seal between the clamp 110 and the trachea 300 is maintained by means of one or more support parts 112. This static seal of low pressure against the tracheal wall 300 facilitates the Normal blood flow in the tracheal tissues during most of the respiratory cycle.

Figure 4 shows a tracheal hose 400, according to a second example of the present invention. The tracheal hose 400 includes a number of the components found in the tracheal hose 100, such as the flexible hose 102, the clamp 110, the connector 108 and the proximal and distal ends 104 and 106. However, the clamp structure of the tracheal hose 400 differs from the tracheal hose 100 by the use of a single flexible and compressible support part 402 acting between the flexible hose 102 and the clamp 110. In this example, the recesses 404 can be defined in the flexible hose 102 at opposite ends of the support part 402, for example.

Figures 5A-5B teach a tracheal hose 500 in accordance with a third copy of the present invention. As illustrated in Figures 5A-5B, the tracheal hose 500 includes a number of components that are located in the tracheal hose 100 of Figure 1. However, the clamp 110 includes two, instead of one, compressible support portions. 502. In this example, recesses 504 are preferably defined in the flexible hose 102 so that the recesses 504 are covered by the support portions 502. In this configuration, the internal air of the flexible hose 102 is distributed through the recesses 504. holes 504 within pores of the support portions 502, which consistently distribute air within the clamp 110. The foregoing prevents potential uneven inflation of the clamp 110 along the length of the flexible hose 102.

Figure 6 illustrates a tracheal hose 600 in accordance with a fourth example of the invention. The tracheal hose 600 includes a number of components that are located in the tracheal hose 100. However, the tracheal hose 600 includes flexible and compressible support portions 601-603 of various sizes within the clamp 1 10. In this example, the support portions 601-603 preferably have sizes such that the proximal support portions 603 and distal 601 are smaller in diameter than the central support portion 602. The foregoing effectively delimits the clamp 110 when the clamp is not inflated, aiding in the insertion and removal of tracheal hose 600 in and from the patient's trachea.

Figure 7 illustrates a tracheal hose 700, incorporating a feature that is applicable to all specimens of the present invention. The tracheal hose 700 includes a number of similar components found in the tracheal hose 100 of Figure 1. However, the tracheal hose 700 includes a filter 102 that covers the voids 102. The filter 702 preferably comprises a layer of material fibrous, wrapped around or as a liner around the flexible hose 102. However, the filter 702 may otherwise be incorporated in another arrangement, as are multiple mini-filters (not shown) arranged individually within the holes 200. The filter 702 it prevents the passage of mucosa or other foreign matter into the voids 200 and into the bracket 110. By preventing the introduction of foreign matter through the interior of the bracket 110, the filter 702 facilitates proper deflation of the bracket 110.

Figure 8 illustrates a tracheal hose 800 in accordance with a fifth copy of the present invention. This specimen includes a number of components that are located in the tracheal hose 100 (including, however, only two resistant and compressible support portions 112). However, the tracheal hose 800 lacks the gaps 200, defining in turn one or more gaps 802 at one end 809 of an inflatable bracket 810. In this example, the bracket 810 is not inflated by the internal air pressure at the flexible hose 102. Instead, clamp 810 is inflated by back pressure in the lungs, created during the inspiratory phase of breathing. However, as with the clamp 110, the pressure in the clamp 810 is substantially the same as the pressure in the trachea below the clamp 810; that is, as in all previous instances, there is at least one open passageway between the interior of the clamp and a space occupied by the distal end 106. More particularly, as pressure builds up in the patient's lungs, air flows upward through the patient's windpipe around the flexible hose 102 and through the holes 802, thereby inflating the clamp 810. Therefore, the clamp 810 is automatically inflated during the breathing phase where a seal between the tracheal hose 800 and the trachea is more important. The foregoing is shown in greater detail in Figures 9A-9B. As shown in Figure 9B, during the inspiratory phase of breathing, a stream of air flows through the flexible hose 102 in the direction illustrated by small arrows 902. Accordingly, air with return flow flows to through gaps 802, inflating clamp 810 to seal against the tracheal walls of patient 904. During the expiatory breath cycle, the patient's lungs force air upwardly through flexible hose 102 in a direction as is illustrated by the large arrows 906 in Figure 9 A. At this point, the flexible hose 102 allows the patient's lungs to move air freely in the direction 906. Accordingly, the pressure that previously causes the air flow in the address 902 through holes 802 missing. And, as a result, a reverse flow of air occurs through the voids 802 in a direction as illustrated by the small arrows 908.

To ensure the collapsing of the supporting parts for an easy and non-traumatic insertion through the vocal cords and the trachea, without the need to attract a vacuum to collapse the parts, I have found that the use of a low polymer foam or Median pressure is desirable. The support parts can be made of such material. Relatively, to a greater mass of the support parts, they are less compressible. Thus, generally, it can be said that two disc-shaped support parts made from low density foam material exhibit greater compressibility, either in terms of the smallest circumference to which they can be compressed and a minimum amount of force necessary to compress them. On the other hand, a three-disc cylinder or annular solid of foam material made of medium density foam is compressed to larger diameters in response to relatively higher radial forces than the low density two-disc support parts. However, the selection of material is a design option, and depends entirely on the intended use.

Referring now to Figures 1, 2, 3 and 3A, the method for tracheal ventilation according to my invention will be described. First, an opening of the trachea is exposed. This opening can be through the patient's mouth or nose or through an open hole directly through the patient's neck for a tracheotomy. Next, the far end 106 of my tracheal hose 100 is inserted through the opening, without attracting a vacuum in the clamp to compress the support parts 112 and the clamp 110. The tracheal hose 100 is then advanced, the distal end 106 first until the clamp 110 is fully within the trachea. There, a low pressure seal is formed between the trachea and the clamp 110 by the compressible and resilient support portions 112 which act between the outer surface of the hose 100 and the clamp 110. A venting pressure is introduced into the proximal end 104 which causes the patient's lungs to breathe. In response to breathing of the patient's lungs, a varying pressure is introduced into the clamp 110 through the holes 200. The varying pressures vary the pressure of the seal between the clamp 1 10 and the trachea. After ventilation, the tracheal hose is removed by withdrawing it through the opening. This method can be practiced with all the copies of my invention.

Clearly, although many examples have been described, other examples and modifications of the present invention may occur to those of ordinary skill in the art in view of the present teachings. Therefore, this invention will be limited only by the following claims, which include all these copies and modifications.

Claims (22)

1. CLAIMS 1. A tracheal hose that comprises. a hose having an outer surface, an inner surface, a proximal end and a distal end; a clamp mounted on the hose near the far end; the clamp has: a flexible tubular cover with two edges arranged in the hose in relation surrounding it and the edges fixed to the outer surface of the hose to define a volume around it; and one or more resistive parts within and partially filling the volume each support part includes a ring that surrounds the hose, the ring is made of a resistant material; and one or more passages for communicating air pressure proximate said remote end, to the interior of the clamp.
2. 2. The tracheal hose of Claim 1, wherein an uncompressed volume of the resistant support portions is less than one-half of a volume defined by the cover.
3. 3. The tracheal hose of Claim 1, wherein at least one of the resistive supporting portions is a disc with a diameter greater than the diameter of a trachea in which the tracheal hose should be inserted.
4. 4. The tracheal hose of Claim 1, wherein each sturdy supporting part is a disc-like ring greater than 0.18 inches and less than 0.75 inches thick.
5. 5. The tracheal hose of Claim 1, wherein each resistant supporting part is made of a low or medium density polymeric foam.
6. 6. The tracheal hose of Claim 1, wherein each passage includes: a gap through the hose connecting the inner surface with an outer surface; and the hole made inside the volume.
7. 7. The tracheal hose of Claim 6, wherein the gap is covered on the outer surface by an air flow filter.
8. 8. The tracheal hose of Claim 6, wherein the gap is covered on the outer surface by a resistive support part.
9. 9. The tracheal hose of Claim 1, wherein the passage comprises: a gap through the cover connecting the inner surface with the outer surface; and the gap is positioned near an edge of the cover near the far end.
10. 10. The tracheal hose of Claim 9, wherein the gap is covered on the inner surface by an air flow filter.
11. The tracheal hose of claim 9, wherein the gap is covered on the inner surface by a resistant support part.
12. 12. A tracheal hose, comprising: a flexible hose with external and internal surfaces and with proximal and distant ends; an inflatable clamp mounted on the outer surface, near the far end; one or more passages that open between an interior volume of the inflatable clamp and a space occupied by the distant end; and 3 one or more resistant and compressible support parts in the inner volume defined by the inflatable clamp, acting between the outer surface and the inflatable clamp.
13. 13. The tracheal hose of Claim 12, wherein each resistant supporting part is an annular part and exerts a low sealing pressure on the inflatable clamp.
14. 14. The tracheal hose of Claim 12, wherein each resistant and compressible support part is a disc placed on the outer surface and exerts a low sealing pressure on the inflatable clamp.
15. 15. The tracheal hose of Claims 13 and 14, wherein the resistant and compressible support part is made of a low density foam material.
16. 16. The tracheal hose of Claim 12, wherein a passage is opened between the outer and inner surfaces.
17. 17. The tracheal hose of Claim 12, wherein a passage is opened through the inflatable clamp.
18. 18. The tracheal hose of Claim 12, wherein one or more resistant and compressible parts exerts a low sealing pressure on the inflatable clamp.
19. 19. The tracheal hose of Claim 18, wherein a passage opens between the outer and inner surfaces.
20. 20. The tracheal hose of Claim 18, wherein a passage is opened through the inflatable clamp.
21. 21. A method for tracheal ventilation using a tracheal hose with distant and proximal ends, a self-inflatable clamp on the tracheal hose near the far end and one or more compressible and resistant support parts mounted on the tracheal hose, inside the self-inflatable clamp , the method comprises the steps of: exposing an opening within the patient's trachea; insert the tracheal hose, the far end first through the opening; advance the tracheal hose, the far end first, into the trachea until the self-inflating clamp is completely inside the trachea; forming a low pressure seal between the trachea and the self-inflating clamp by means of the action of the support parts; and ventilating the patient's lungs by introducing a variant respiratory pressure through the distant end.
22. 22. The method of Claim 21, wherein the insertion step is carried out without attracting a vacuum in the self-inflating clamp to compress the support parts.