The present invention relates to a probe for intubation of patients in several medical/surgical procedures (for example, oro- and nasotracheal, tracheostomy intubation probe, etc.) of the type basically consisting of a tube through which air is supplied into a patient's body, and an inflatable cuff used for preventing extravasation of the supplied air, causing the air flow to go in and out always through the tube (and not through the region between the tube and the intubated tubular organ); for controlling the internal pressure of the airways and further for fixing the probe to the walls of a passageway of the human body, and located around part of the external wall of the tube.
Several types of probes, which are used for intubating patients, are known.
A serious drawback of the probes of the prior art is that said cuff, which accounts for fixing the probe at a determined place on the human body, remains inflated throughout the intubating period, which may cause injuries to the patients if said period is prolonged, by reason of the total or partial stoppage of blood circulation in the region where the cuff exerts pressure on the walls of the passageway of the human body where the intubation is made, for example, the trachea of a patient. Moreover, in some cases, the cuff is inflated by inserting a fluid (usually iodine) into it by means of a syringe. This procedure is not carried out in a totally precise and safe way. Excessive inflation of the cuff is another factor that contributes to the occurrence of said mentioned injuries.
Moreover, in the case of the probes of the prior art, the conformation of the probe for introduction into the human body is carried out with the help of a metallic thread, inserted into the probe tube. The insertion of the metallic thread into the probe tube may damage some organ or some tissue of the patient, in case the metallic thread exceeds the length of the probe tube.
U.S. Pat. No. 4,697,574 deals with a coronary and circulatory assistance pump that uses cuffs for blocking the aorta and the coronary arteries in diastole. According to that patent, the passageway for blood from the aorta is kept opened by means of a system of two cuffs that are sequentially inflated and deflated, the sequence being determined by signals from an electrocardiogram apparatus, which are used as commands for sequentially inflating and deflating the two cuffs for the purpose of never interrupting the flow of blood in the aorta, which would obviously cause the death of the patient. This solution, however, besides being specific for use in the aorta, is of technically complex construction, needing two cuffs and, chiefly, imposing an artificial rhythm of opening and closing the blood-circulation passageway, which is undesirable from the physiological point of view.
U.S. Pat. No. 4,791,923 deals with a tracheal probe composed of an outer cuff and an inner cuff, the latter being located inside the outer cuff, said cuffs being non-physiologically inflated by conduits. Since they are very thin, they only work under high pressure; besides, these cuffs do not inflate, if they are connected to the lumen of the tube. This probe has the purpose of sealing the trachea completely with the outer cuff during inspiration and expiration in pressure peaks, without letting the gases leak. However, due to the elasticity of the trachea and its consequent dilatation, the inflated gases leak.
EP-A-0,766,976 describes a probe with only a suction system that only sucks the interior of the tube. This probe prevents contamination and respiratory problems during the suctions, as well as carries out these suctions uninterruptedly. Since it has an internal cannula for uninterrupted suction, the probe lumen is reduced. Said probe dispenses with the use of a connector with the Y for introduction of the suction catheter.
WO-A-99/38548 deals with a probe that has a lumen dedicated to the suction trigger for aspirating secretions from the trachea. This probe does not have a valve, or tap, for connection of the internal and external aspirations; these aspirations could be effected simultaneously or alternatively, in case the probe had a valve.
U.S. Pat. No. 5,452,716 describes a tracheal tube for assisting the breathing of patients with respiratory insufficiency, as long as they are with their breathing under control.
Document WO-A-99/66975 describes an intratracheal ventilation catheter. In this catheter, the whole sucked air passes through the cuff, with the air flowing to the distal end of the catheter until it reaches the trachea, and the expired air is made outside the tube. In this instrument, the outlet for air from the cuff is the same air inlet.
U.S. Pat. No. 6,463,927 describes a guide for an endotracheal tube made from a plastic material containing a bendable rod.
FR-A-2,826,283 deals with an endotracheal medical surgical probe adaptable only to the morphologies of oral regions and external segments of the patients' mouth.
An objective of the present invention is to prevent injuries caused by prolonged intubation of a patient with a probe provided with an inflatable cuff.
Another objective of the present invention is to provide more tranquility to the physician in performing surgeries that require a longer time for intubating the patient, as well as to provide a probe suitable for facilitating intubation in emergency situations.
A further objective of the present invention is to prevent possible injuries caused by inserting the metallic thread into the tube in order to conform the probe.
The invention also has the objective of preventing the use of a laryngoscope.
A further objective of the present invention is to prevent the cuff from being excessively inflated, which would cause injuries to the patient.
Another objective of the invention is to provide a probe especially for patients who remain intubated for a long time, independent of its duration.
The above-described objectives of the invention are achieved by means of the probe that will be described in greater detail later.
The present invention has achieved the above-cited objectives by means of a probe for medical use, which basically consists of a tube designed for receiving blown air, and a first cuff arranged around the tube in a region of its external wall, said first cuff being inflatable by means of a first conduit located at the tube wall, which account for communication of the inside of the first cuff with the inside of the tube. Thus, the insufflation of the first cuff is commanded by the flow of air injected into the tube during the inspiratory movement, causing the probe to be fixed to the walls of the passageway of the human body that is being intubated; whereas the deflation of said first cuff takes place when the air is expelled from the patient's lung through the tube during the expiratory movement. This causes the first cuff to deflate temporarily, thus alleviating the mechanical pressure on the walls of said passageway of the human body and making blood circulation possible until a new flow of air is injected, which may come from an artificial breathing apparatus or from the normal breathing of the patient.
Thus, said first cuff is inflated during the inspiration and deflated during the expiration at the natural rhythm of the patient's respiration or artificial breathing apparatus. In this way the above-mentioned problems of the prior art are eliminated and the probe of the present invention has an ideal performance from the physiological point of view. Further, said first cuff may be inflated from a conduit that is not connected to the tube lumen, but rather to one of the legs of the Y connector, connected to the probe or else directly from a source coming from the respirator or another mechanism that follows the same cycle of the respirator.
According to a preferred embodiment of the invention, the probe further comprises means that provide the tube with an elastic memory, located on the tube wall and consisting of a guide thread made from a radiopaque flexible and malleable material. Such means simultaneously allow one to mold the probe tube and to view the probe on an X-ray photograph, for instance, besides enabling one to mold the probe, adapting its exit to the mouth, nose or tracheostomy orifice, to prevent known lesions caused by probes to lips, gums, teeth, tongue, nose wings and neighboring structures of the tracheotomies. These means having elastic memory enable a simple, rapid non-traumatic intubation, and even without laryngoscope.
According to another embodiment of the invention, the probe for medical use comprises, in addition to the tube, the first cuff and the first conduit in the tube wall that communicates the interior of the tube with the interior of the cuff, a second and a third conduits in the tube wall, which extend along the length of the tube and are to be coupled to an external aspiration device.
The second conduit has bores close to an end, which provide communication of the inside of the second conduit with the inside of the tube, the other end being connectable to a suction device, thus allowing the secretions existing inside the probe tube to be sucked, which prevents the tube from being clogged. The orifices remain in the back wall of the tube 1, at a distance of 1 centimeter from each other and extend from the cuff to the distal end of the tube. Their diameters are equal to or smaller than that of the conduit that has given rise to them.
The third conduit, on its turn, has bores close to one of its ends, which provide communication of the inside of the third conduit with the external region of the tube, the other end being connectable to a suction device, so that the secretions existing inside the tube can also be sucked. The orifices also remain in the back wall of the tube that is related to the back wall of the trachea, have a diameter equal to or smaller than that of the conduit that has given rise to them, and are in number of three in the oropharynx and three in the trachea, over the cuff 1 by one centimeter when the latter is totally inflated, and are away from each other by 1.5 centimeters.
In addition, the second and third conduits are connectable by their ends to a first 3-way connection means, coupled to the external suction device and provided with a switch that permits suction at each of the conduits separately or at both conduits at the same time. In this way, depending upon the position of the switch, either the secretions existing inside the tube alone can be sucked (through the second conduit) or the secretions existing in the external region of the tube (through the third conduit), as well as the secretions of both regions at the same time.
According to an embodiment of the present invention, the first conduit is connectable to a second 3-way connection means, provided with a switch that enables one to control the operation mode of the probe. In this way, the probe may also be used in the conventional manner, with non-physiological pressure, depending upon the position of the switch. In this case, the cuff is inflated by injecting a fluid into one of the ways of the connection means and remains permanently inflated.
The probe is further provided with a second monitoring cuff, located around the first conduit, also linked to the inside of the first conduit in the region close to the opening of the tube that receives air insufflation, which is inflated and deflated at the same rhythm as the inflation and deflation of the first cuff takes place. The second cuff is used for monitoring the functioning of the first cuff, since it will only be inflated if the first cuff is intact. It is used mainly as a hypertension relief valve, since the cuff is elastic and extensible, absorbing any excess pressure, so that the cuff, at most, only rests against the trachea without damaging it. The trachea is more resistant than the satellite cuff. For this reason, the satellite cuff expands and even blows out in cases of too high pressure, making impossible the barotraumas over the trachea walls.
Another probe embodiment is also provided, the probe having two tubes coupled side by side, one of them being longer than the other, permitting selective insulation of one lung, for example, by connecting an artificial breathing apparatus to one of the probe tubes and simultaneously inflating the first cuffs of each tube, the first cuff of the first tube being close to the bronchia, and the first cuff of the second tube being in the trachea region, surrounding the two tubes altogether. For this purpose, the air outlet of the tube cuff that is not connected to the artificial breathing apparatus should be kept closed. If, on the other hand, one wishes to effect the selective inflation of the other lung, for example, one connects the artificial breathing apparatus to the other tube, closing the air outlet of the tube cuff that is not connected to said breathing apparatus.
In addition,
This elastic memory imports to the tube an important purpose: making it a first option in emergency procedures such as CRA (cardio respiratory arrest) and/or polytraumatisms and facial and cervical injuries, because it dispenses with the guide thread and the laryngoscope.
The probe of this second embodiment, illustrated in
In the probe embodiment of
Another embodiment of the probe for medical use is shown in
In addition, the probe embodiment shown in
According to an embodiment of the present invention, the first conduit 5 is connectable to a second 3-way connection means 14, provided with a switch 15 that enables one to control the probe operation mode. In this way, the probe may also be used in the conventional manner, with non-physiological pressure, depending upon the position of the switch 15, the first cuff 3 being inflated, in this case, by inserting a fluid into one of the ways for the second connection means 14, and remaining permanently inflated, or else with passive inflation of the first cuff 3 at the time of inspiration, with physiological pressure of the airways, the backflow of air and the deflation of the first cuff 3 being prevented by closing the connection means 14. In this way, the first cuff 3 remains permanently inflated, but with the physiological pressure of the airways.
The probe shown in
The conduits 5 and 18 which communicate the inside of the probe with the cuffs and that carry part of the inspired air to inflate them, should compulsory show expansion at the rate of about ⅓ of the probe gage, being located at the thickness of the probe wall, so that they will project inwards or outwards. This great gage, quite larger than that of conventional probes, will cause the air-flow resistance to be low and the cuffs to be inflated long before the air reaches the end of the probe, guaranteeing that the trachea will be sealed and preventing waste of the inspired gases. If the gage of these conduits is small, equal to that of conventional probes, the resistance is great and the cuffs will not be inflated and so the whole air inspired will leak around the probe making it ineffective and inadequate for use.
In addition, the location of the air inlet of these ducts has to be either at the proximal end of the probe or at a Y-connector, never near the cuff, be it tracheal or bronchial, for the following reasons:
Embodiments—The following list includes particular embodiments of the present invention. But the list is not limiting and does not exclude embodiments otherwise described herein or alternate embodiments, as would be appreciated by one of ordinary skill in the art.
1. An atraumatic cuff for use with a medical probe comprising:
a cuff conduit having an end adapted to link to a conduit of a tube having at least one opening for receiving air insufflation, the cuff conduit having an opening;
a cuff arranged around the cuff conduit in a region of its external wall and in communication with the opening; said cuff being inflatable through the opening;
wherein the cuff conduit is adapted to be laterally coupled to an opening in a first tube of a medical probe through an inward hole in the proximal area of a tube of a medical probe in the region of the tube close to an opening for receiving air insufflation, and the cuff is adapted to inflate and deflate together with a second cuff on the medical probe.
2. The atraumatic cuff of embodiment 1, wherein the cuff is elastic and is distensible at low pressure.
3. The atraumatic cuff of any one or more of the preceding embodiments, wherein the atraumatic cuff is capable of monitoring the function of the second cuff, wherein the atraumatic cuff is only inflated when the second cuff is intact.
4. The atraumatic cuff of any one or more of the preceding embodiments, wherein the atraumatic cuff is adapted to absorb excess airway pressure in the second cuff.
5. The atraumatic cuff of any one or more of the preceding embodiments, wherein the cuff conduit includes a concertina portion extending from the cuff and toward the end adapted to link to the conduit of the tube of the medical probe.
6. A probe with an atraumatic cuff for medical use comprising:
a first tube having at least one opening for receiving air insufflation;
a first cuff for the first tube arranged around the first tube in a region of its external wall; said first cuff being inflatable through a first conduit, wherein the first conduit of the first tube is in communication with the interior of the first tube and is in communication with the interior of the first cuff;
a cuff conduit having a cuff conduit opening in a wall of the cuff conduit, and coupled to the first tube through an inward hole in an area of the tube proximal to the opening for receiving air insufflation, that connects to the first conduit; and
a second cuff arranged around the cuff conduit in a region of its external wall and in communication with the cuff conduit opening, said second cuff being inflatable through the first conduit;
wherein the second cuff is adapted to inflate and deflate together with the first cuff of the first tube.
7. The probe of embodiment 6, wherein the first conduit of the first tube is a passageway made in the wall of the first tube.
8. The probe of any one or more of embodiments 6-7, wherein the cuff conduit includes a concertina portion between the second cuff and the inward hole.
9. The probe of any one or more of embodiments 6-8, wherein the second cuff is elastic and is distensible at low pressure.
10. The probe of any one or more of embodiments 6-9, wherein the second cuff is inflated when the first cuff is intact.
11. The probe of any one or more of embodiments 6-10, wherein the second cuff functions as a relief valve for excess airway pressure in the first cuff.
12. The probe of any one or more of embodiments 6-11, comprising radiopaques located along the wall of the first tube, wherein the radiopaques have elastic memory.
13. The of any one or more of embodiments 6-12, comprising a second conduit at the first tube wall, which extends along the length of the first tube, being coupable to an external aspiration device, and having, close to one of the second conduit's ends, bores that communicate the interior of the first tube with the interior of the second conduit.
14. The probe of embodiment 13, further comprising a third conduit at the first tube wall, which extends along the length of the first tube, being coupable to an external aspiration device, and having, close to one of the third conduit's ends, bores that communicate the interior of the third conduit with the external region of the first tube.
15. A probe according to embodiment 14, wherein the second and third conduits are couplable to a 3-way connector, the connector being connected to the external aspiration device and having a switch that controls aspiration of the second and third conduits.
16. A probe with an atraumatic cuff for medical use comprising:
a first tube having at least one opening for receiving air insufflation;
a first cuff, for the first tube arranged around the first tube in a region of its external wall; the first cuff being inflatable through a first conduit;
a second tube having at least one opening for receiving air insufflation; the second tube being laterally coupled to the first tube;
a first cuff for the second tube, arranged around both the first tube and the second tube in a region of their external walls, the first cuff for the second tube being inflatable through a first conduit of the second tube, wherein the first conduit of the first tube has an opening into the interior of the first cuff for the first tube and another opening into the interior of the first tube; and the first conduit of the second tube has an opening into the interior of the first cuff for the second tube and another opening into the interior of the second tube and extends into the inside of the first cuff for the first tube;
a cuff conduit having a cuff conduit opening in a wall of the cuff conduit, and coupled to the first tube through an inward hole in an area of the tube proximal to the opening for receiving air insufflation of the first tube that connects to the first conduit of the first tube; and
a cuff for the cuff conduit arranged around the cuff conduit in a region of its external wall and in communication with the cuff conduit opening, the cuff for the cuff conduit being inflatable through the first conduit of first tube.
17. The probe of embodiment 16, wherein the cuff for the cuff conduit is adapted to inflate and deflate in conjunction with the first cuff for the first tube and the cuff for the cuff conduit is located in the region proximal to where the first tube receives air insufflation.
18. The probe of any one or more of embodiments 16-17, wherein the cuff for the cuff conduit has elasticity and is distensible at low pressure.
19. The probe any one or more of embodiments 16-18, wherein the cuff for the cuff conduit is inflated when the first cuff is intact and functions as a relief valve for excess airway pressure in the first cuff.
It should be understood that the probe for medical use and its components described above are only a few embodiments that might exist. The real scope of the object of the invention is defined in the accompanying claims.
CROSS REFERENCE TO RELATED APPLICATION(S) This application is a continuation-in-part of U.S. patent application Ser. No. 10/566,208, filed May 16, 2008, which was the National State Entry of PCT/BR2003/000109, filed Jul. 28, 2003, both of which are incorporated by reference as if fully set forth.
Number | Date | Country | |
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Parent | 10566208 | May 2008 | US |
Child | 14313206 | US |