Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
1999-07-07
2001-04-17
Ruhl, Dennis (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S200240
Reexamination Certificate
active
06216696
ABSTRACT:
The invention relates to an artificial respiration device for giving artificial respiration to a human being or mammal, comprising a tube, having a proximal end and a distal end, the distal end to be passed through the mouth and the pharynx towards the end of the trachea.
Artificial respiration devices designed for passing beyond the vocal chords are generally known in medical practice. They are used in numerous operations and in intensive care, in order to guarantee a good air passage between the lips and the windpipe, or trachea. At the same time, the artificial respiration devices ensure that no moisture, for example from the gullet, can pass into the trachea. An artificial respiration device generally comprises a flexible plastic tube which is inserted through the mouth and the pharynx into the trachea. In order to facilitate its insertion, the tube has a certain curvature. A balloon is fixed around the far end of the tube to be moved towards the lungs, near the end. The tube is inserted into the trachea so far that said balloon has passed the vocal chords in its entirety. After placing of the tube, the balloon is inflated by means of a hose, so that the space between the outside wall of the tube and the walls of the trachea is shut off in an airtight manner. Thereafter, air pressure can be built up by artificial respiration means in the trachea and in the lungs lower down.
Artificial respiration devices designed for passing beyond the vocal chords generally guarantee great operational reliability. These artificial respiration devices are therefore employed when a patient has to be given artificial respiration for a long time, or when the artificial respiration device itself is difficult to reach during the artificial respiration. This is the case, for example, when a patient is lying on his stomach during an operation.
The use of artificial respiration devices according to the prior art designed for passing through the mouth and the pharynx towards the entrance of the trachea until beyond the vocal chords have a major disadvantage. The balloon on the end of the tube has to be inflated at a relatively high pressure, in order to guarantee that the trachea is adequately shut off. That pressure is of the order of 20-30 cm water (approx. 2000-3000 Pa). This high pressure at which the balloon is pressed against the mucous membrane on the inside of the trachea can press the blood vessels shut, which impedes the supply of blood to the mucous membrane. As a result of this, if an endotracheal tube is used for a long period, the mucous membrane can die off, ulcers can form on the mucous membrane and subsequently holes may even appear in the wall of the trachea.
Another disadvantage of the artificial respiration devices according to the prior art designed for passing beyond the vocal chords is that these tubes can damage the vocal chords during insertion. For the tubes to work, the far end of the tube with the balloon around it has to be inserted between the vocal chords. That means that a relatively large volume has to be forced through between the very fragile vocal chords. If the vocal chords are damaged by the tube, this can lead to infections, the formation of scar tissue, blockage of the trachea or permanent hoarseness for the patient.
The object of the present invention is to make an artificial respiration device which does not have the disadvantages of the known artificial respiration devices according to the prior art designed for passing beyond the vocal chords. The invention aims in particular to make an artificial respiration device which shuts off the trachea well and can be inserted in a simple manner, without running the risk of the tube damaging the larynx or the upper air passages.
That object is achieved by the fact that the distal end of the tube opens out in a flexible hose, wherein the proximal end of the hose is fixed to the distal end of the tube, and the distal end of the hose extending away from the tube, said hose being made of a material or materials with certain memory, and in that the device comprises an insertion element movably mounted inside the tube, said insertion element having a proximal end and a distal end, the distal end of the insertion element being fixed to the distal end of the hose, and the proximal end of the insertion element protruding from the proximal end of the tube, wherein the insertion element by means of the proximal end thereof is movable with respect to the tube from a first position wherein the distal end of the insertion element in essence exerts no pulling force on the distal end of the hose, to a second position, towards the distal end of the tube wherein the distal end of the insertion element exerts a pulling force on the distal end of the hose in order to make the hose constrict.
During the insertion of the artificial respiration device according to the present invention. the hose can be constricted by means of a pulling force. That means that the hose fixed on the distal end of the tube can pass the vocal chords with a relatively small diameter. The risk of damage to the vocal chords is consequently reduced. After the hose has passed the vocal chords with a relatively small diameter, the pulling force on the hose is removed. The memory action of the material of the hose causes the hose subsequently to assume substantially its original shape. With the outside wall, the hose then nestles against the mucous membrane on the inside wall of the trachea. The sealing of the trachea is therefore not—as in the artificial respiration devices according to the prior art—ensured by in inflatable element on which high pressure is exerted but by the hose pressing with a relatively low force against the mucous membrane on the inside wall of the trachea. A pressure of approx. 5 cm water (approx. 500 Pa) is sufficient to guarantee that the trachea is shut off. At such a low pressure the blood circulation of the mucous membrane will not be endangered. Since only the hose on the end of the tube, and not the tube itself, is passed through the vocal chords, an additional advantage of the artificial respiration device according to the present invention is that the inside diameter of the tube is selected to be just about the same as the outside diameter of artificial respiration devices according to the prior art. The resistance to the air flow through the artificial respiration device according to the present invention will be relatively low, compared with the resistance to the air flow through artificial respiration devices according to the prior art. Because of the presence of the insertion element, which insertion element can act upon the distal end of the hose, applying a longitudinal force to the hose and removing the longitudinal force from the opening of the tube can be regulated from the from the proximal end of the tube,
The use of the artificial respiration device according to the present application is improved if the distal end of the insertion element is detachably fixed to the distal end of the hose. According to the invention it is possible that the distal end of the hose comprises openings, and the distal end of the insertion element comprises hooks which can project through the openings of the hose,
The insertion element can engage in the openings on the hose, by means of the hooks at the distal end thereof. This has the advantage that the longitudinal force on the hose, which is necessary for constricting the hose, can be transmitted to the hose by means of the insertion element. The distal end of the hose can be fixed to the insertion element, in order to exert a pulling force thereon.
The memory action of the hose is reinforced if the distal end of the tube is provided with flaps. The flaps, which are moved towards each other with a certain resilience during the insertion, with their resilience help the hose to assume its original shape after the pulling force on the hose has been removed.
It is advantageous to construct the hose from a reticulated base, covered with a thin flexible film. The reticulated base, for example o
Ideamed N.V.
Patel Mital
Ruhl Dennis
Young & Thompson
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