• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:

    公开号:AT510105A2
    申请号:T9412011
    申请日:2011-06-28
    公开日:2012-01-15
    发明作者:Volkmar Schulz；Michael Prebio
    申请人:Ruesch Willy Gmbh；
    IPC主号:
    专利说明:

    28/06/2011 16:23 0043-1-526-42-45 BEER & PARTNER ΡώΤΕΝΤΑ p. 03/38
    The invention relates to a tracheostomy tube with a sealing device which encloses the tracheostomy tube transversely to its longitudinal extent.
    Such tracheostomy tubes are used to ventilate patients. In this case, an opening is created in the neck area of the patient to the trachea, in which the Trachostomietubus is used. In order to fix the tracheostomy tube and prevent loss of the supplied air, there is an inflatable balloon-shaped cuff at the insertable end of the tracheostomy tube. This seals the trachea, so that the air supply and -abfuhr must take place via the tracheostomy tube. This causes problems for patients who are conscious but still rely on mechanical ventilation. Due to the inflated cuff, which prevents airflow to the vocal cords, speaking is not possible. However, even with a drained cuff or when using special tracheostomy tubes with so-called speaking valves, it is not possible for some patients to express themselves vocally.
    This is because the artificial opening in the neck for insertion of the tracheostomy tube, the so-called stoma, changes its shape due to infection or tissue changes after irradiation. For example, it happens that the tissue retracts and the stoma assumes an irregular shape. Due to this, the tissue can not completely seal with the inserted tracheostomy tube, so that air can escape in this way. The air is lost through the leakage between the stoma and tracheostomy tube, without being routed through the vocal cords. For some patients, therefore, speaking is not possible at all or only very quietly or indistinctly. Moreover, in individual cases it may also be common in stomas, i. Openings of the trachea without tissue changes occur that no satisfactory 28/06/2011 16:29
    No.: R562 P.003 / 038 28 / Θ6 / 2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA Ξ. 04/38
    Sealing effect between tissue and Tracheostomietubus comes about.
    As a further problem arises in leaky stoma, that with relieved cuff secretions or saliva transported with the air flow upwards and can escape via the leaky stoma.
    From the generic DE 44 01 904 Al is known to postpone a sealing device on the tracheostomy tube, which has a sealing plate, a pressure plate and an intermediate padding. The sealing plate comes into full contact with the neck area extending around the stoma. The pressure plate provides a pressure on the sealing plate, whereby the pad prevents excessive pressure. The force on the pressure plate is exerted by a band that is placed around the neck of the patient.
    The disadvantage of this is that due to the full contact of the sealing plate on Halsbexeich the patient's pressure points may arise, since the padding can not fully adapt to the anatomical shape. In addition, tracheostomized patients often have the problem not to be able to cough up saliva or mucus due to the tracheostomy tube. When speaking the saliva and mucus dissolves, but can not escape due to the stoma opening closed by the sealing plate, but must be sucked off, which can be unpleasant and sometimes painful.
    The document DE 202 04 119 Ul shows a tracheostomy tube with a cuff, which is positioned close to the holding plate.
    The cuff comes to lie within the stoma. The filled cuff can therefore seal the stoma. However, the cuff for sealing must apply a certain force, which can lead to an expansion of the stoma. 28/06/2011 16:29
    No .: R562 P.004 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA S. 05/38
    «* *« · · ♦ 3
    Furthermore, EP 1 486 228 B1 discloses a device which uses lamellae for sealing the stoma. The lamellae lie within the trachea of the patient and come into contact with the tissue surrounding the stoma from the inside.
    It is therefore an object of the invention to provide a tracheostomy tube which allows tracheostomized patients to speak, is comfortable for patients to wear and solves the disadvantages of the prior art.
    For this purpose, the invention provides to provide a Tracheostomietubus with a sealing device which surrounds the tracheostomy tube transversely to its longitudinal extent sealing, wherein the sealing device is designed as a sealing bell, the rear end region of the
    Tracheostomy tube surrounds and the front end region has a sealing lip which can be brought into contact with a neck region of a patient, and the sealing bell forms a receiving space in which an absorbent insert can be received. By means of the formation of the sealing device as a sealing bell with the sealing lip located thereon, the contact area between the neck of the patient and the sealing device is reduced. This makes it easier to adapt the sealing device to the respective anatomical conditions. In addition, the bell-shaped design of the sealing device forms a receiving space into which an absorbent insert, e.g. a compress, can be used to absorb mucus and saliva. This allows mucus and saliva to escape via the stoma in the shortest path and does not have to be sucked off the patient in an unpleasant way. The term sealing bell is to be understood in the broadest sense and includes any bell-shaped or dom, hood or dome-like design which forms a cavity. The sealing bell is designed in such a way that the rear end area is in contact with a region of the tracheostomy tube and is completely sealed 28/06/2011 16:30
    No.: R562 P.005 / 038 28/86/2011 16:23 0043-1-526-42-45
    BEER & PARTNER RATENTA P. 06/38
    extends around this. The front end region also extends completely spaced around the tracheostomy tube.
    As a development of the inventive solution of the problem can be provided that the absorbent insert is received in the receiving space. The absorbent insert can absorb the saliva and / or mucus arising during speech.
    It can further be provided that the front end region of the sealing bell and / or the sealing lip has a three-dimensional shape that is anatomically adapted to the human neck region. For the patient, thereby wearing the tracheostomy tube is more comfortable. The contact pressure is transmitted evenly to the sealing lip or the skin area, so that a uniform and good seal takes place. Pressure points are avoided and the acceptance of the tracheostomy tube increases. An adapted form is understood to be the three-dimensional imitation of a customary human neck area. In this case, different variants can be provided, such. for children, slim adults or less slim adults.
    One possibility for further development of the invention is that the position of the rear end region of the sealing bell on the tracheostomy tube is variable. The rear end region of the sealing bell is the region which is in contact with the breathing tube. If its position on the tube is changed, the position of the entire sealing element relative to the breathing tube is also changed. It is thus possible to move the sealing element in a desired or necessary for sealing position. For example, depending on the thickness of the neck of the patient, the necessary position of the sealing element on the breathing tube can vary, which is why it is advantageous to be able to displace or rearrange the rear area of the sealing bell. 28/06/2011 16:31
    No.: R562 P. 006/038 26/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA P. 07/38 · * «· · · · · * · · · · · ·
    To improve the sealing effect can be provided that the sealing lip is formed like a bead and formed of a soft elastic material. This makes it easier for the sealing lip to attach as extensively as possible to the skin of the patient. Depending on the selected material, the sealing lip may be designed as a solid or hollow body. Due to the soft elastic properties of the material, the bead-like sealing lip can be deformed even at low contact pressure, i. flattened, so that the applied area increases.
    A further improvement of the wearing comfort and the sealing effect can be achieved in that the sealing bell is plastically deformable. In this way, the sealing bell and thus also the attached sealing lip can be adjusted to the respective anatomical conditions. Preferably, the plastic deformability is achieved by the selection of the material or the material combination. The plastic deformability can also be achieved by selecting an elastically deformable material and incorporating or fixing a plastically deformable material which then brings the elastic material into the desired shape.
    A further advantageous embodiment is obtained when the sealing bell has an amplifying device which is elastically and / or plastically deformable. The reinforcing device can be incorporated into the material of the sealing bell, wrapped by this or even put on. The reinforcing device serves as a stability-imparting support structure. The Verstärkseinseinichtung may extend over the entire sealing bell or even be provided in sections. As the material is preferably a material with flexible properties used, which is also highly plastic deformation with appropriate deformation. For this purpose, for example, could be used a wire made of a nickel-titanium alloy. Such 28/06/2011 16:32
    No .: R562 P.007 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA Ξ. 08/38 • · * * * * ··· • I I ·· »·« · · · »• t» »I I Λ · ·
    Alloys are also known under the generic name Nitinol. In general, the use of a material with superelastic properties (so-called pseudoelastic properties) offers itself. Such materials are also referred to as " shape memory alloys " and, in addition to the usual elastic deformation, can withstand a reversible change in shape caused by external force without damage. The selected reinforcing device is preferably deformable in the elastic region with little effort. All materials chosen for the sealing device are skin-friendly and safe for medical use.
    As a development of the tracheostomy tube according to the invention, it can be done that the reinforcing device is formed from a metal wire. In this way, the material of the reinforcing device can be used to save material. The metal wire is provided only in those sections of the sealing bell in which a necessary elastic and / or plastic deformability is necessary. The arrangement of the metal wire while the desired elastic and / or plastic deformability can be ensured. Preferably, the metal wire is also made of one of the previously presented materials for the reinforcing element.
    It is also conceivable that the sealing bell has an opening device which extends between the rear end region and the front end region and allows an opening of the lateral surface of the sealing bell and the sealing lip. By means of the opening device, the sealing bell can be opened. The wall of the sealing bell, i. the lateral surface and the sealing lip are broken, resulting in a continuous opening from the rear end to the front end portion of the sealing bell. The sealing bell is so elastic that the sealing bell can be bent or deformed around the sealing bell by means of the thus created opening from 28/06/2011 16:33
    No .: R562 P.008 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEERSPARTNER PATENTA S. 09/38 • 4 ·
    • • • * • ·
    Remove ventilation tube. However, only the seat of the rear region of the sealing bell on the breathing tube can be loosened by means of the opening device in order to facilitate or enable a change in position of the sealing element on the breathing tube.
    It can also be provided that the opening device allows a repeated opening and closing of the sealing bell and in the closed state an airtight sealing of the lateral surface and sealing lip is present. The opening device allows at least one opening and closing, wherein the sealing element is closed airtight in the closed state by means of the opening device. Preferably, the opening device allows a repeated opening and closing of the sealing bell, without the sealing function of the opening device is lost.
    It is also conceivable that the absorbent insert fills the free volume of the receiving space to at least 50%. The size of the absorbent insert is adapted to the volume of the receiving space, that it has a sufficient capacity.
    In addition, it can be provided that the absorbent insert has a shape adapted to the receiving space of the sealing bell. The shape of the absorbent insert is preferably designed such that the absorbent insert follows the contour of the inner walls of the sealing bell and also closely abuts the breathing tube passing therethrough. The recording room is thereby optimally utilized. In this way it is possible to reduce the size of the sealing bell to the necessary size for sealing the stoma and still accommodate an absorbent insert with sufficient Aufnähmekapazität. 28/06/2011 16:34
    No .: R562 P.009 / 038 28/06/2011 16:23 0043-1-528-42-45
    BEER & PARTNER PATENTA S. 10/38
    To simplify the work of the nursing staff, provision may be made for the absorbent insert to be interchangeable in the sealing bell. The sealing bell is displaceable or positioned in its position on the breathing tube. By moving the sealing bell, the absorbent insert is exposed. To change the absorbent pad, a slot preferably extends from the opening which serves the passage of the breathing tube through the material of the absorbent pad completely to the edge of the absorbent pad. The absorbent insert can therefore be bent up to be removed from the respiratory tube or placed around it again.
    The invention also relates to a sealing device for a tracheostomy tube, wherein the sealing device is designed as a sealing bell whose rear end region is designed to be encompassable around the tracheostomy tube and whose front end region has a sealing lip which can be brought into contact with a neck region of a patient, wherein the sealing bell forms a receiving space , in which an absorbent insert is receivable.
    Furthermore, the invention relates to a use of an absorbent insert for placing in the receiving space of a sealing device of a tracheostomy tube or in a sealing device.
    In the following, the embodiments will be described in more detail with reference to the drawings. Show it:
    Fig. 1 is a schematic sectional view of one of the prior
    Technique known tracheostomy tube inserted into a trachea of a patient,
    Fig. 2 is a schematic side view of a tracheostomy tube according to the invention with a sealing device, 28/06/2011 16:35
    No .: R562 P.010 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA 11/38 # *
    'V
    FIG.
    FIG.
    FIG.
    FIG.
    FIG.
    FIG.
    FIG.
    FIG.
    Fig. 3 is a schematic sectional side view of the tracheostomy tube according to the invention with a sealing device schematically shown inserted into the trachea of a patient, 4 is a schematic partially sectioned side view of an embodiment of the tracheostomy tube, which is inserted into the trachea, 5 is a schematic plan view of the sealing device according to the invention, 6 a 8 shows a schematic front view of a further embodiment of the sealing device, FIG. 9 shows a schematic front view of a further embodiment of the sealing device, FIG. 10 shows a schematic front view of a further embodiment of the sealing device with an opening device, 11 is a schematic detail of an opening device for an embodiment of the Dichteinr release, 28/06/2011 16:36
    No .: R562 P.011 / 038 12/38 28/06/2011 16:23 0043-1-526-42-45 BEERSPARTNER PATENTA S. • ft ft ftft2 · ft ft ·· «« · ·· · Ftft · ft ft · ft
    Fig. 12 is a schematic detail view of a portion of an opening device for the sealing device and
    Fig. 13 is a schematic view of an absorbent insert for the sealing device.
    Fig. 1 shows a tracheostomy tube 100 as known from the prior art. The tracheostomy tube 100 in this illustration is via a stoma, i. an artificially created opening in the neck region of the patient is introduced into the trachea 101 (trachea) of a patient 102. The tracheostomy tube 100 includes a port 103 for a respirator, a tubular tube 104, and a cuff 105. The cuff 105 is positioned at the patient-side end of the tube 104 and is within the trachea of the patient using the tracheostomy tube. A retaining plate 106 is seated on the tube 104 outside the trachea of the patient, near the stoma. Usually, the holding plate 106 is slidably mounted on the tube 104, so that the best possible position can be adjusted. The holding plate 106 serves to protect the tracheostomy tube 100 from slipping by means of a holding band, which is placed around the neck of the patient. In this case, the holding plate 106 usually comes into contact with the neck region of the patient. However, if there is a pathological change in the stoma, an airtight closure between the tissue and the tracheostomy tube is no longer possible.
    To allow the patient to speak, the pressure is released from the cuff 105 so that the exhaled air can flow past the outside of the cuff and enter the larynx. However, in the case of pathologically altered stoma, air can flow out along the outside of the tracheostomy tube 100, which makes it difficult for the patient to speak or makes it impossible. In addition, due to the stoma along the outside of the 28/06/2011 16:37
    No .: R562 P.012 / 038 28/05/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA s. 13/38 • * ίΐ: • * ·
    Tracheostomy tube 100 mucus or secretion exiting, which is uncomfortable for the patient.
    FIG. 2 shows a tracheostomy tube 1 according to the invention. The tracheostomy tube has a respiratory tube 2 which extends from a distal end remote from the patient to a port 3 for a breathing tube to a proximal end 4. At the near-patient end 4, a balloon-shaped cuff 5 is positioned, which can be inflated or filled with fluid by means of a line, not shown, running in the breathing tube 2. The conduit for inflating or filling the cuff 5 leaves the breathing tube 2 in the vicinity of the near-patient end 4 and ends in a connection 6, via which the air or the fluid for filling the cuff 5 can be supplied.
    On the tube 2, a holding plate 7 is positioned. The retaining plate 7 is shown schematically in Fig. 2 and comprises means for securing thereto a tether which is placed around the neck of the patient. By means of the tether unintentional withdrawal or a change in position of the tracheostomy tube 1 is prevented. Subsequent to the holding plate 7 in the direction of the patient, a sealing device 8 is positioned on the breathing tube 2. The sealing device 8 is designed as a sealing bell 9. The sealing bell 9 encloses a region of the respiratory tube 2, which remains in the application of the tracheostomy tube 1 outside the patient. In this case, the sealing bell 9 extends completely around a longitudinal region of the breathing tube 2. The rear end region 23 of the sealing bell 9 corresponds to the bell head 10, i. the usually closed at bells end region which lies opposite the opening. The rear end portion 23 is provided with the sealing bell 9, however, with a circular opening 19 to pass the breathing tube 2. The size of the opening 19 in the rear 28/06/2011 16:38
    No .: R562 P.013 / 038 29/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA S, 14/38 Π2:
    The size of the opening 19 can therefore also be selected to be slightly smaller than the outer circumference of the ventilation tube 2 in order to achieve an airtight sealing of the sealing bell 9 on the tube. To achieve this, the material of the sealing bell 9 is preferably elastic about the opening 19.
    The rear end region 23 of the sealing bell 9 is usually in contact with the retaining plate 7. Preferably both the sealing bell 9 and the retaining plate 7 are movably mounted on the breathing tube 2 in a displaceable manner. The rear end portion 23, i. the bell head 10 closes sealingly with the respiration tube 2, that is, the area of the bell head 10 is airtight with its opening on the entire circumference of the breathing tube 2. For this purpose, e.g. a sealing lip may be provided on the bell head 10. However, the material of the sealing device 8 may also be chosen so as to provide sufficiently elastic properties that cause a sealing effect between the breathing tube 2 and sealing device 8.
    From the bell head 10, the sealing bell 9 extends in a curved bell contour in the direction of the near-patient end 4 of the respiratory tube 2. The sealing bell 9, however, ends before the curvature usually existing in tracheostomy tubes which is necessary for the anatomically correct positioning of the tube in the trachea. Accordingly, the sealing bell 9 extends only in a region of the tracheostomy tube 1, in which the breathing tube 2 has a substantially rectilinear course. The sealing bell 9 terminates in the direction of the near-patient end of the breathing tube 2 as seen in a sealing lip 11 which extends completely along the sealing bell 9. The sealing lip 11 may be formed as an elastic silicone sealing lip. In addition, this may alternatively be made of air-filled rubber, a foamed material with closed 28/06/2011 16:39
    Nr .: R562 P. 014/038 15/38 28/06/2011 16:23 0043-1-526-42-45 BEER & PARTNER PATENTA S. * * «t t ti · • 9 9 · t 9 9 * * * • t * 9 9 * 9 td * * * 33 :: :: :: :::: • 9 * 9 99 9 · 9 * 99 ·
    Surface or hollow be made with trapped air volume. Also, the design similar to the cuff, i. inflatable or fillable are conceivable. Essential is only the airtight seal between the sealing lip 11 and a skin surface of a patient.
    The sealing bell 9 does not necessarily have to be bell-shaped. Also conceivable are a hemispherical or conical shape. Also other designs are possible.
    The receiving chamber 12 forms a free volume and is limited by the inner walls of the sealing bell 9 and the passing through the sealing bell 9 through breathing tube 2. The receiving housing 12 therefore has an im Substantially annular shape and is open in the direction of the near-patient end 4 of the tracheostomy tube 1. All designs and shapes of the sealing bell 9 has in common that they form a receiving space 12.
    In Fig. 3, the tracheostomy tube according to the invention introduced into the trachea of a patient can be seen. The near-patient end 4 of the tracheostomy tube 1 is introduced via a stoma in the neck of the patient in the trachea. The cuff 5 can be seen in the unfilled state. This allows the patient to direct breath to the larynx and vocal cords to speak. The sealing device 8 is thus displaced along the respiration tube 2 in order to contact the sealing lip 11 of the neck region of the patient. In this case, the sealing lip 11 runs along its length completely adjacent to the neck region of the patient around the stoma. A pressing force of the sealing lip 11 is chosen such that a sufficient sealing effect is achieved with the skin of the patient, but without causing skin irritation, bruises or an unpleasant feeling for the patient. 28/06/2011 16:39
    No .: R562 P.015 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA S. 16/38
    m · * * • · t · «· · ·
    The sealing bell 9 is shown in the embodiment shown with rectilinear walls. This serves in the illustration of the simplification. According to the invention for the sealing device 8, any configuration or
    Shaping be selected that forms a receiving aura 12, in which an absorbent insert 13 is positioned. The sealing bell 9 seals in the region of the bell head 10 with the breathing tube 2. In the exemplary embodiment of FIG. 3, a sealing contour 14 can be seen, which can be provided on the sealing bell, in order to achieve an improved seal between the bell head 10 and respiration tube 2. Subsequently to the bell head 10 and standing in contact with this, the holding plate 7 is positioned. The holding plate 7 is so moved along the breathing tube 2 to apply pressure to the sealing device 8 and thus to provide the sealing lip 11 with a necessary contact pressure.
    Alternatively, however, the sealing device 8 may be configured in such a way that the bell head 10 rests firmly on the breathing tube 2 so as to be displaced by hand to set the correct position. However, this can not move by itself along the breathing tube 2, so that by means of the elastic properties of the material of the sealing device 8, a sufficient contact pressure is applied to the sealing lip 11.
    In order to enable a displacement of the sealing device 8 on the tube, but without allowing an independent displacement, it can be provided to provide the sealing device 8 at the rear end with a closable or fixable seal. In this case, the seal can be transferred from a closed position in which the seal is firmly and tightly in contact with the breathing tube in an open position in which a displacement of the sealing device 28/06/2011 16:40
    No.: R562 P.016 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA P. 17/38
    8 on the tube is possible. For this purpose, the sealing device 8 may have lamellar extensions at the rear end region, which extend around the tube and extend away from the rear end region of the sealing bell. On the lamellar projections a releasable closure can be set, which presses the lamellar projections on the tube in the closed position and causes a tight and releasably firm connection with the tube and in the open position allows a displacement of the sealing bell on the tube. The closure can also take over the function of the holding plate, i. Provide devices for fixing a tether. The holding plate can be omitted in this case.
    Alternatively, the seal at the rear end region may also be designed in the manner of a louver aperture, the central opening of which can be expanded and reduced by means of a rotating mechanism. The circularly arranged slats can be moved into one another in such a way that the opening can be adjusted as desired. Again, an air-tight and releasably strong connection with the tube can be created.
    In the receiving space 12 of the sealing bell 9 is a compress, i. an absorbent insert 13 was added. The absorbent pad 13 fills the free volume of the receiving space 12 preferably at least 50%. Preferably, the receiving space 12 is filled by means of the compress 13 between 50% to 95%. Particularly preferably, the receiving space 12 is filled between 70% to 90%. The free volume of the receiving space 12 is determined by the inner sides of the walls of the Dichtgiocke 9 and by the running through the sealing bell 9 breathing tube 2. The absorbent insert 13 is when using the Tracbeostomietubus, i. when sealed by the sealing device 0 stoma completely enclosed by the sealing bell 9 and the neck area of the patient. 28/06/2011 16:41
    No .: R562 P. 017/038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA p. 18/38 ne
    In this case, one side of the absorbent insert 13 is in contact with the neck region of the patient. Preferably, the compress 13 rests against the circumference of the breathing tube 2 and covers the stoma opening along the circumference of the beat tube 2 and the skin area of the patient directly adjoining it. From the stoma escaping secretion or mucus is thereby absorbed by the compress 13. Preferably, the absorbent pad 13 has a configuration that corresponds to the shape of the receiving space 12 with breathing tube 2 passing therethrough. That the compress 13 is formed as an annular insert, which is adapted to the space provided by the receiving space and the sealing bell 9 cavity. This usually results in a frustoconical shape through which a central opening extends. The compress is preferably elastically yielding to match the contour of the neck region or the inner contour of the sealing bell. The absorbent insert can therefore be deformed when used in the tracheostomy tube according to the invention (compare FIGS. 3 and 4).
    As absorbent pad 13 is any type of absorbent material into consideration, which is usually used to absorb body fluids. The compress 13 may be sterilized and made of gauze or nonwoven fabric.
    The absorbent insert 13 is preferably circular in shape and may also be designed as a section of a truncated cone for adaptation to the inner contour of the sealing bell. In the center of the insert 13 extends an opening which is adapted to the diameter or the circumference of the breathing tube. Preferably, the absorbent insert 13 at its location with the largest outer diameter on an outer diameter which corresponds to a maximum of four times the outer diameter of the insert 13 extending through the ventilation tube. Particularly preferably, the absorbent pad 13 in its place with the largest 28/06/2011 16:42
    No .: R562 P.018 / 038 19/38 28/06/2011 16:23 0043-1-526-42-45 BEER & PARTNER PATENTA S. w m i · | | · · · Ft * · «I * ··· # ft ft ft ft 4 ··· * * .17 :: :: :: :::: 4« ft · «· #« ** «·«
    Outer diameter to an outer diameter which corresponds to a maximum of three times the outer diameter of the insert 13 extending through the ventilation tube.
    The thickness of the absorbent pad 13, i. the extent of the insert along the longitudinal axis of the portion of the breathing tube passing through the insert is preferably at most three times the outer circumference of the portion of the breathing tube passing through the insert. More preferably, the thickness of the absorbent pad 13 is between 0.5 and 2 times the outer circumference of the portion of the breathing tube passing through the pad.
    4 shows a further alternative for sealing between the rear end region 23 of the sealing bell 9 with the respiratory tube 2. In the illustration shown, the breathing tube 2 is introduced into the neck region of a patient. The sealing lip 11 is in contact with the neck area of a patient around a stoma. An absorbent pad 13 is placed in the receiving space 12 and is preferably in contact with the neck area around the stoma. The sealing between bell head 10 and respiratory tube 2 takes place in the embodiment shown by means of a sealing region 15 of the bell head 10. The sealing region 15 is in this case as a circumferential flexible region of the bell head 10, i. the rear end portion 23, formed. Due to the flexible properties of the selected material, the sealing area 15 seals airtight around the respiration tube 2. In this case, both the entire bell may be formed from the sealing material and only the sealing area 15,
    According to the invention, the sealing device can also be used as a separate element, i. detachable from the tracheostomy tube 1 and again be fastened to it. The removed from the tracheostomy tube 1 sealing device 8 can be seen in Fig. 5. Here 28/06/2011 16:43
    No.: R562 P.019 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER8PARTNER PATENTA 5. 20/38 ne :::::::::: »» φ 4 | β t · 4 «* * * is also the anatomically adapted shape of the sealing device 8 recognizable. The sealing lip 11 is adapted to the course of the outer contour of the human neck. Particular care is taken to depict the curvature of the neck in the sealing lip and the sealing bell 9. This results in a mask-like shape that resembles the shape of a respiratory mask.
    This reduces the necessary pressing force of the sealing lip against the neck, whereby the wearing of the tracheostomy tube 1 is more comfortable for a patient. It can also be seen from the representation of FIG. 5 how the outer walls of the sealing bell 9 run in order to open the receiving space 12. At the bell head 10, the sealing bell 9 is flattened or cut to form a contact region 16 with the holding plate 7. The sealing device is preferably designed sterilizable.
    6 shows the sealing device 8 applied to a neck region of a patient. The neck region 17 shown schematically has a convex shape. The sealing lip 11 and the sealing bell 9 are correspondingly concave shaped to ensure the largest possible contact area with the neck region 17. However, since the sealing device 8 must be used on a variety of patients, the sealing device 8 is made of an elastic material, which allows the adaptation of the sealing bell 9 and the sealing lip 11 to a plurality of differently shaped neck areas. To adapt the sealing device 8, a force, represented by arrows 18 on one or more areas of the sealing bell and the sealing lip 11 are applied. As a result, the sealing lip 10 seals against the neck of the patient. Usually, it is sufficient, only by means of the positioning of the sealing bell 9 and the holding plate 7 to apply a sufficient compressive force on the sealing lip 11 in order to achieve an airtight seal. 28/06/2011 16:44
    No .: R562 P.020 / 038 21/38 2B / 06/2011 16:23 0043-1-526-42-45 BEERSPARTNER PATENTA S. ··· · · «·· * · · * ·« · * · · * · · · · · «· · · · · * * 19 :: :: :: ::::» «« + · * »· · ♦
    However, it is also conceivable to form the sealing device from an elastically deformable material over large areas, as well as a simultaneously plastically deformable material in order to allow adaptation to any shape of a neck region. As shown in FIGS. 8 and 9, however, plastically deformable reinforcing means 18 can also be provided in the material of the sealing device 8 or attached to the sealing device 8. The reinforcing means 18 may be for example made of an elastically and / or plastically deformable wire. The reinforcing device 18 can be provided both in one piece or in several parts within the sealing device 8. Alternatively, the reinforcing device 18 may also be positioned on a surface of the sealing device 8. Preferably, the reinforcing device extends at least in partial regions of the sealing bell 9 from the opening 19 into the region of the sealing lip 11.
    As shown in Fig. 8, in this embodiment, the reinforcing means 18 is formed of a wire which is arranged in a star shape around an opening 19 of the sealing bell 9. The wire extends in sections completely from a region near the opening 19 to the outer region of the sealing bell 9, i. close to or over the sealing lip 11. Preferably, the amplifying device 18 is designed as a highly flexible wire. It is particularly important to choose this from a corrosion-resistant biocompatible material. This could be, for example, a nickel-titanium alloy.
    Figure 9 shows a variant of the reinforcing device 18 in which a wire is applied in regions along the front end region 24, i. runs near the sealing lip 11. The wire runs at least in sections along the front end region 24 28/06/2011 16:45
    No .: R562 P.021 / 038 22/38 28/06/2011 16:23 0043-1-526-42-45 BEER & PARTNER PATENTA S. «« «·« «· · · ····· · · «· · · · · ·» | · »· · · · · 20 :: :: :: :::: ·· · ♦ | ························································································································
    In order to be able to remove the sealing device 8 from the breathing tube 2, it is provided, as can be seen in FIG. 10, to provide the sealing device 8 with an opening device 20. The opening device 20 extends from the opening 19 on the bell head 10 of the sealing device 8 to the sealing lip 11 and ensures a continuous opening in the wall of the sealing bell. In this way, the circumference of the sealing bell is interrupted and by means of the open bell shell, the sealing bell 9 can be removed from the breathing tube 2. In this case, the opening device 20 breaks through both the body of the sealing bell 9 and the sealing lip 11. The opening device 20 serves both to open the sealing bell 9 and sealing lip 11 as well as to close and seal airtight.
    The opening device 20 may be formed in the region of the sealing lip 11, for example, as a pin-shaped projection 21 which is inserted into a running within the sealing lip 11 opening and is pulled out of this. Circumferential cams are preferably provided on the peg-shaped extension 21, which prevent unintentional slipping out of the opening. In the area of the sealing bell 9, the opening device 20 can be designed as a so-called foil closure (FIG. 11). This is on the one hand a lamellar elevation 26, whereas on the other side to be joined a corresponding recess 27 is provided for receiving the blade 26. In this case, lamella 26 and recess 27 are designed such that a holding force is applied to prevent inadvertent release of the blade 26 from the recess 27.
    The film closure serves on the one hand to connect the two sections of the sealing bell as well as to form a 28/06/2011 16:46
    No .: R562 P.022 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA p. 23/38 • I · · «* · · *« · · ·
    2V airtight seal. Alternatively, the opening device in the region of the sealing bell can also be designed by means of an overlapping sealing extension 25 (FIG. 12). The two ends of the shell of the sealing bell 9 butt butt.
    At one end of the sealing bell 9, however, an overhanging sealing extension 25 is formed, which extends over the other region of the sealing bell and thereby produces an air-tight seal. The holding force is provided in this case only by the integrally formed on the sealing lip peg-shaped extension 21 which is inserted into the opposite opening. Alternatively, a Velcro strip or an adhesive film may be provided to improve the holding force, which connect the two sections of the bell shell to be joined.
    Fig. 13 shows a compress, i. an absorbent insert 13 for insertion into the receiving space 12. In order to change the compress even when inserted tracheostomy tube 1, it is provided to remove the sealing device Θ of the tracheostomy tube to move along the tube or at least partially open and / or fold back. The compress 13 can then be striped and removed via the ventilation tube 2 by means of the slot 22. Likewise, a new compress 13 can be placed back on the breathing tube 2 via a slot 22.
    If the patient no longer needs to be ventilated by means of a respiratory apparatus, the sealing bell can also be pushed in the direction of the distal end of the tube and removed from it. The absorbent insert can anschießend also pushed in the direction of the patient distal end of the tube and removed from this. Then a new absorbent insert and the sealing bell is pushed back. Following this, the sealing means is placed over the absorbent pad 13 in a sealing manner against the neck area of the patient. This way can be a simpler and 28/06/2011 16:47
    No.: R562 P.023 / 038 28/06/2011 16:23 0043-1-526-42-45
    BEER & PARTNER PATENTA p. 24/38 ··· ♦ ········································································································································································································ Do not need to exchange the tracheostomy tube and / or the sealing device.
    The tracheostomy tube can already be supplied with a sealing device to the user. It is also possible to provide the tracheostomy tube only by the user with a sealing device. In this case, it may also be provided to provide different sizes of sealing devices or designs of sealing devices in order to obtain the optimum combination of tracheostomy tube and sealing device for the respective intended use. The sealing device can be sterilized and thus designed to be used repeatedly.
    When using the tracheostomy tube according to the invention, the tracheostomy tube is inserted as usual into the trachea of the patient. If the sealing device is not yet on the breathing tube, it will be put on. For this purpose, the opening device 20 is opened so that a slot-like opening results, which extends from the sealing lip 11 to the opening 19, via which the sealing device 8 can then be positioned on the breathing tube 2.
    Preferably, an absorbent pad 13 is then placed on the breathing tube 2 and pushed against the neck area surrounding the stoma to bring the compress into contact with the neck area. Now the still open sealing device 8 is displaced in the direction of the neck region of the patient and closed by means of the opening device 20.
    Preferably, the sealing device is now attached to the breathing tube 2 in such a way as to close off in the region of the bell head 10 tightly with the breathing tube 2 and still continue to apply force 28/06/2011 16:48
    N °: R562 P.024 / 038 28/06/2011 16:23 0043-1-526-42-45 P. 25/38 BEER & PARTNER PATENTft · ·· »23 • f
    to be able to postpone a doctor or carer. Ire connection thereto, the holding plate 7 is brought into contact with the sealing bell 9, so that it is now substantially secured. On the holding plate 7, the tether is attached and placed around the neck of the patient. If the patient now tries to speak, a loss of breathing air via the stoma is prevented and escaping saliva is absorbed in the absorbent insert. 28/06/2011 16:48
    No .: R562 P.025 / 038
    权利要求:
    Claims (15)
    [1]
    26/38 28/06/2011 16:23 0043-1-526-42-45 BEER & PARTNER PATENTA S. Patent claims: 1. Tracheostomy tube (1) with a sealing device (8) which transposes the tracheostomy tube (1) transversely to its The sealing device (8) is designed as a sealing bell (9) whose rear end region (23) surrounds the tracheostomy tube (1) and whose front end region (24) has a sealing lip which can be brought into contact with a neck region of a patient (11) and the sealing bell (9) forms a receiving space (12) in which an absorbent insert (13) is receivable.
    [2]
    Second tracheostomy tube (1) with a sealing device (8) according to claim 1, characterized in that the absorbent insert (13) is received in the receiving space (12).
    [3]
    3. tracheostomy tube (1) with a sealing device (8) according to claim 1 or claim 2, characterized in that the front end region (24) of the sealing bell (9) and / or the sealing lip (11) has a three-dimensional, anatomically to the human neck area has adapted shape.
    [4]
    4. tracheostomy tube (1) with a sealing device (8) according to one of claims 1 to 3, characterized in that the position of the rear end portion (23) of the sealing bell (9) on the tracheostomy tube (1) is variable.
    [5]
    5. tracheostomy tube (1) with a sealing device (8) according to one of claims 1 to 4, characterized in that the sealing lip (11) is formed like a bead and formed of a soft elastic material. 28/06/2011 16:49 No .: R562 P.026 / 038 27/38 28/06/2011 16:23 0043-1-526-42-45 BEER & PARTNER PATENTA Ξ. · * Μ μ «f» I ♦ «· φ · · * Φ · · ψ φ Φ« · »« # «« · * · 25 :: :: ::.:. *: ·· ·· ♦ · » · * * »« «
    [6]
    6. Tracheostomy tube (1) with a sealing device (8) according to one of claims 1 to 5, characterized in that the sealing bell {9) is plastically deformable.
    [7]
    7. tracheostomy tube (1) with a sealing device (8) according to claim 6, characterized in that the sealing bell (9) has an amplifying means (18) which is elastically and / or plastically deformable.
    [8]
    8. tracheostomy tube (1) with a sealing device (8) according to claim 7, characterized in that the reinforcing device is formed from a metal wire.
    [9]
    9. tracheostomy tube (1) with a sealing device (8) according to one of claims 1 to 8, characterized in that the sealing bell (9) has an opening device (20) between the rear end portion (23) and the front end portion (24 ) and an opening of the lateral surface of the sealing bell (9) and the sealing lip (11) allows.
    [10]
    10. tracheostomy tube (1) with a sealing device (8) according to claim 9, characterized in that the opening device (20) allows a repeated opening and closing of the sealing bell and in the closed state an airtight sealing of lateral surface and sealing lip (11) is present.
    [11]
    11. tracheostomy tube (1) with a sealing device (8) according to one of claims 2 to 10, characterized in that the absorbent insert (13) fills the free volume of the receiving space (12) to at least 50%.
    [12]
    12. tracheostomy tube (1) with a sealing device (8) according to one of claims 2 to 11, characterized in that 28/06/2011 16:50 No .: R562 P.027 / 038 28/06/2011 16:23 0043 BEER & PARTNER PATENTft pp. 28/38 * * * * * * »t I * * * * #» ·· * the absorbent insert (13) one to the receiving space (12) of the sealing bell (9) has an adapted shape.
    [13]
    13. Tracheostomy tube (1) with a sealing device (8) according to one of claims 2 to 12, characterized in that the absorbent insert (13) is exchangeably received in the sealing bell (9).
    [14]
    14. Sealing device (8) for a tracheostomy tube (1) according to one of claims 1 to 13, characterized by a design as a sealing bell (9), the rear end region (23) of the tracheostomy tube (1) is designed umschließbar and whose front end portion ( 24) has a sealing lip (11) which can be brought into contact with a neck region of a patient, wherein the sealing bell (9) forms a receiving space (12) in which an absorbent insert (13) can be received.
    [15]
    15. Use of an absorbent insert (13) for arranging in the receiving space (12) of a sealing device (8) of a tracheostomy tube (1) according to one of claims 1 to 13 or in a sealing device according to claim 14. 28/06/2011 16:51 Nr .: R562 P.028 / 038
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    同族专利:
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US3889688A|1973-12-19|1975-06-17|Precha Eamkaow|Tracheostomy tube with novel retaining means|
    DE4401904A1|1994-01-24|1995-07-27|Matthias Hecht|Blocking seal for trachea cannula|
    IT1318430B1|2000-03-29|2003-08-25|Mallinckrodt Holdings B V|DEVICE FOR PASSIVE HUMIDIFICATION OF TRACHEOSTOMIZED OR INTUBATED PATIENTS.|
    DE20204119U1|2002-03-15|2002-08-29|Haindl Hans|Tracheostoma cannula with a secure seal in the stoma|
    DE10326829B4|2003-06-12|2005-09-29|ADEVA - medical Gesellschaft für Entwicklung und Vertrieb von medizinischen Implantat-Artikeln mbH|tracheal stoma|US20170319803A1|2014-10-03|2017-11-09|Mayo Foundation For Medical Education And Research|Double cuff tracheostomy device|
    CN110237388A|2019-06-28|2019-09-17|中国人民解放军陆军军医大学第二附属医院|A kind of tracheal tube|
    WO2021246938A1|2020-06-02|2021-12-09|Atos Medical Ab|Tracheostoma device holder|
    CN111544722A|2020-06-15|2020-08-18|吉林大学第一医院|Novel first-aid breathing device for internal medicine nursing|
    法律状态:
    2021-02-15| MM01| Lapse because of not paying annual fees|Effective date: 20200628 |
    优先权:
    申请号 | 申请日 | 专利标题
    DE201010025306|DE102010025306A1|2010-06-28|2010-06-28|Tracheostomy tube for use in trachea of e.g. children for artificial respiration, has sealing bell whose front end region comprises seal lip, where sealing bell forms retaining space that retains absorbent insert|
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