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EP1135184A1 - Tube avec manchon etancheifie - Google Patents

Tube avec manchon etancheifie

Info

Publication number
EP1135184A1
EP1135184A1 EP99960903A EP99960903A EP1135184A1 EP 1135184 A1 EP1135184 A1 EP 1135184A1 EP 99960903 A EP99960903 A EP 99960903A EP 99960903 A EP99960903 A EP 99960903A EP 1135184 A1 EP1135184 A1 EP 1135184A1
Authority
EP
European Patent Office
Prior art keywords
tube according
coating
cuff
tube
sleeve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP99960903A
Other languages
German (de)
English (en)
Inventor
F. Waldeck
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
TRACOE Gesellschaft fur Medizinische Bedarfsgegenstande mbH
Original Assignee
TRACOE Gesellschaft fur Medizinische Bedarfsgegenstande mbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by TRACOE Gesellschaft fur Medizinische Bedarfsgegenstande mbH filed Critical TRACOE Gesellschaft fur Medizinische Bedarfsgegenstande mbH
Publication of EP1135184A1 publication Critical patent/EP1135184A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0443—Special cuff-wall materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0445—Special cuff forms, e.g. undulated

Definitions

  • the present invention relates to a tube for insertion into a patient's trachea, with a central lumen for respiration or breathing and with at least one inflatable sleeve provided on the outside of the tube, which serves to seal the outside of the tube against the wall of the trachea.
  • Such a tube can be a tracheotomy tube, which is inserted through a tracheal incision, or an endotracheal tube, which is used through the mouth or nose to ventilate an anesthetized patient or in a coma.
  • the secretions that form and accumulate, for example, above the cuff in the area around the tube are very good breeding grounds for the most diverse types of bacteria and other pathogens under the prevailing conditions of temperature and humidity.
  • a lung infection is nevertheless prevented because the cuff lies close to the wall of the trachea and thus prevents the secretion, which is highly enriched with pathogens and accumulates on the outward-facing end of the cuff, from entering the deep bronchi can penetrate, but it has been found that pneumonia still occurs again and again, which is to a large extent attributable to the use of such a tube.
  • the present invention has for its object to provide a tube with a corresponding inflatable cuff, which eliminates the problem of inadequate sealing and yet is neither particularly sensitive nor requires particularly high inflation pressures.
  • the sleeve has a coating on its outer surface which is swellable and / or has limited flowability.
  • any leaks that may still be present are closed by the swelling material.
  • the coating material which may be in any folds and the like, swells, so that these folds no longer form channels through which anything else can pass the cuff.
  • the coating is not necessarily swellable, but at least has a limited flow, a similar effect can be achieved, namely the coating material at mechanically stressed points, for example along the crease lines or the outer surfaces pressed against one another in the area of folds or the like is displaced and distributed to other, non-binding areas.
  • Wrinkles are filled with the coating material, so that the formation of any transport channels in the longitudinal direction of these sleeves can be prevented. It goes without saying that the coating material must have a sufficiently good adhesion to the material of the cuff, in order not to be displaced from the sealing surface into the end face regions of the cuff by the small pressure differences that can occur in the trachea between the two ends of the cuffs be so that the sealing function could be lost.
  • the material should not be too free-flowing and could, for example, have the consistency of a gel or cream, possibly even a very viscous oil, when in use.
  • the coating material can also more or less form a unit with the material of the cuff, for example by partially diffusing the coating material into the wall of the cuff or by inducing it to diffuse or by forming a chemical bond with the material of the cuff.
  • thin binding layers can also be applied to the sleeve material in a targeted manner, which in turn adhere well to the sleeve material, but at the same time also offer a good adhesive base for the sealing coating.
  • the transition from the elastic material of the sleeve to the coating material which is as tear-resistant and practically non-flowable as possible, can therefore be more or less fluid, which improves the adhesion properties of the coating material to the sleeve material.
  • the coating material can also be one in which neither swelling takes place during normal storage at room temperature nor is there any appreciable flowability (in the range between 1 and 10 Pas).
  • the swellability or flowability can be triggered, for example, by moisture and heat, in particular by the moisture and temperature conditions that are present inside the trachea, but also by reagents, by catalysts, by radiation with X-rays, UV radiation, light or ultrasound or by other mechanical treatment. Otherwise, reagents, catalysts and radiation or mechanical treatments of the aforementioned type can also be used to achieve a good bond between the coating and the base material of the membrane.
  • An embodiment of the invention is particularly preferred in which the coating material is swellable with water, the swollen coating material also being able to flow to a limited extent.
  • the wall of the cuff itself is preferably made of a polymer and, if possible, is relatively thin, i.e. the thickness of the wall should preferably be no more than 500 ⁇ m, better still no more than 200 ⁇ m and particularly preferably no more than 30 ⁇ m.
  • Very diverse substances can be considered as coating materials, in particular mucilages and slime formers or gel formers, as well as foaming agents.
  • these are non-ionogenic mucilages, such as, for example, Salep Mannan, guaran, carobin, starch from wheat, maize, etc., xanthan gum, chitosan, collagen, carmellose, hypromellose, macrogoie, etc.
  • Carrant gum karaya gum, pectins, alginic acid, carragen, agar, agarose, in particular rehydrable agarose gels, type B gelatin and carboxymethyl cellulose.
  • Cation-active mucilages (gelatin type A) can also be used for the coating.
  • mucilages from drugs such as Radix Althaeae, Semen Lini, Semen Psylli, Semen Foenugreci, Semen Isphaghulae, seed husks from Plantago Ovata, inorganic gel formers and water-swellable gels from gel formers of synthetic origin, their modification products and combinations of all of the above substances.
  • drugs such as Radix Althaeae, Semen Lini, Semen Psylli, Semen Foenugreci, Semen Isphaghulae, seed husks from Plantago Ovata, inorganic gel formers and water-swellable gels from gel formers of synthetic origin, their modification products and combinations of all of the above substances.
  • all water-swellable gels, natural or synthetic substances, polymers or combinations thereof can be used.
  • Thixotropic substances are also particularly suitable, i.e. Materials that change their flow behavior under load, i.e. are easier to flow at higher loads and when shear forces occur than at lower loads.
  • the foaming agents already mentioned can also improve the property of the sealing layer.
  • polymeric foams are particularly suitable for the coatings according to the invention.
  • those foams which, if possible, consist of the same or a very similar base material as the wall of the membrane itself on the other hand, as already mentioned, the foam layer effectively prevents any Chen secretion flow between the outer wall of the membrane and the wall of the trachea, as well as in the channels formed in folds of the membrane.
  • Open-pore foams or foam layers are particularly suitable.
  • the foam layers also have the advantageous property that they are very highly compressible and in that they are well suited to fill the cavities forming in folds, while the foam is strongly compressed and compressed in some fold areas, it can be used in areas with larger cross sections, which are typically arise at the bottom of corresponding folds, remain extended and thus completely fill the resulting cavity.
  • hydrophobic, spreadable preparation forms with a sufficient viscosity, for example hydrocarbon gels, such as lipogels or silicone gels, as are known as solution, suspension, emulsion or suspension emulsion lipogels.
  • hydrocarbon gels such as lipogels or silicone gels
  • Stearate ointments or creams are also suitable as coatings. It is useful if the coating is relatively firm and not very flowable at room temperature, but melts or softens at body temperature.
  • the cuffs should be wrinkle-free when they are inflated and nestle against the wall of the windpipe, with thin-walled cuffs being an advantage.
  • the pressures applied should be well below 1 bar.
  • the cuff consists of an elastic material and is dimensioned such that it lies practically without folds and relatively close to the outer wall of the tube when not inflated, while in an inflated state under a Inflation pressure between 20 and 30 millibars has a diameter - to be measured perpendicular to the axis of the tube - which is at least 50% larger than the outside diameter of the tube or the previous diameter of the cuff in the non-inflated state, this diameter also in the inflated state can be 100% larger.
  • coatings made of water-swellable gels from gel formers with non-covalent linkage of the polymer chains have proven to be very suitable.
  • Another group of suitable coatings consists of hydrophobic, spreadable preparation forms with a viscosity of 2 Pas and more (for example hydrocarbon gels such as lipogels or silicone gels in the form of solution, suspension, emulsion or suspension emulsion lipogels and stearate ointments or creams).
  • most of the coatings in question can be classified into at least one of the following groups, although the properties in question should of course also be permanently retained in the trachea.
  • the viscosity of the coating (in the state in the trachea and under the prevailing temperature and / or humidity conditions) is at least 2 Pas, better still at least 10 Pas, z. B. 40 Pas or more.
  • the coating material has a relatively large adhesive force on the material of the sleeve, this adhesive force being so great, for example, that a pressure difference of, for example, 30 millibars at the ends of a sealing gap, for example 200 ⁇ m wide, does not cause the layer material to flow out leads to the gap, c) the material is highly swellable (at least a 5-fold increase in volume), d) the material is applied in a foam layer (with a minimum thickness of, for example, 200 ⁇ ) and it is tens of times at low surface pressures millibars compressible by at least a factor of 3.
  • FIG. 1 shows schematically a tube according to the invention with an inflated cuff
  • Figure 2 is a sectional view looking in the direction of the axis of the tube and with a
  • Section plane which runs approximately along the dash-dotted line designated in FIG. 1 and
  • Figure 3 shows an enlarged section corresponding to the circle labeled III in Figure
  • an endotracheal or tracheotomy tube 1 which essentially consists of a tube or a tube 1, on the outer circumference of which an inflatable cuff 2 is provided in a central section.
  • the cuff 2 can optionally be firmly welded to the hose or tube 1, but it can also be glued or made in one piece with the tube 1.
  • a provided in the wall of the tube 1, here not recognizable channel has in the outer wall of the tube 1 an opening in the area of the cuff 2, so that the cuff 2 inflatable via this outlet opening of the channel provided in the wall of the tube 1, but possibly also is ventable. Breathing or ventilation takes place through the central lumen 4 of the tube 1.
  • Figures 1 to 3 show the subject of the invention only very schematically and the formation of folds 3, which can be seen in all three figures, is only shown schematically here and the folds do not of course have to be uniform over the entire longitudinal extent of the cuff to have.
  • the tube in the area of the cuff 2 is shown in section.
  • a corresponding channel 5 also opens into the outer wall of the tube 1 in the area of the cuff 2.
  • the inflated cuff which can rest against the wall of an air pipe in the state shown, is shown with a whole series of longitudinal folds 3. It goes without saying that these folds 3 do not all have to run parallel and that such folds do not necessarily have to extend over the full length of the sleeve 2. Rather, the illustration is only schematic and is intended to show that there are any folds 3 at all and that due to these folds 3 there can also be channels, albeit with a very small cross-section, along which possibly secretions from the area above the cuff 2 into the Area below the cuff 2 can flow, causing pathogens, especially above the cuff can find favorable growth conditions in the secretion, can penetrate into the deeper respiratory tract and can cause pneumonia.
  • FIG. 3 shows the area encircled in FIG. 2 in a further enlarged state, the illustration here also being only schematic and in particular the thickness of the coating layer 6 in relation to the thickness of the wall of the sleeve 2 shown only as a line is possibly exaggerated, but on the other hand, corresponding thickness ratios should not be excluded.
  • FIG. 3 In the enlarged area of FIG. 3, two folds 3 can be seen, namely a slightly less deep fold 3 on the left in FIG. 3 and a comparatively deep fold 3 on the right in FIG. 3.
  • a coating 6 is also shown hatched, which for example consists of a water-swellable gel consists.
  • the layer 6 is still very thin and hardly recognizable, i.e. one would probably only recognize them in the illustration in FIG. 3 as a layer which, together with the wall of the sleeve 2, could only be represented by a slightly larger line width.
  • this coating material can swell to form a layer 6, which is shown in broken lines in FIG.
  • the individual folds 3 form a cavity or a channel with the cross section of a drop, especially in the vicinity of their base, where the wall material of the sleeve has the greatest curvature.
  • the coating material 6 also swells in the areas where the wall sections of the cuff 2 abut against one another with their outer surfaces in the fold area, and possibly push them apart a little there, so that the layer material 6 is continuously formed in all folds and on Any folds that may be forming are sealed.
  • the same goes for Incidentally, also in the gusset area at the transition of the outer, more or less cylindrical circumference of the cuff to one of these folds 3.
  • the swelling layer 6 also expands there and forms a continuous, homogeneous layer which lies between the inner surface of the trachea and the cuff material 2 .
  • a similar effect is also achieved if the layer is spread thinly on the outer surface of the sleeve 2 as a more or less flowable layer in the form of a cream or a gel. Due to the pressure that the adjacent wall sections of a fold 3 exert on the flowable coating material 6, this coating material 6 is partly squeezed out of the fold area, but partly also pressed into the bottom of the fold 3, where otherwise the channels already described above typically form . Corresponding channels are thereby blocked or prevented. The coating material is distributed on the surface between the trachea and cuff wall 2 in accordance with the available space.
  • the coating 6 is relatively firm and in particular abrasion-resistant during storage at room temperature and in the dry state, and these layers only obtain the desired flowability and by means of irradiation, moisture, heat, a reagent or also in connection with catalysts
  • the coatings can also permanently have the gel-like, flowable state and they can then be covered for the purpose of storage and transport, for example with a thin protective film or protective sleeve, which extend over the cuff and possibly also take up the entire tube.
  • a sleeve or cover preferably then consists of a material which in any case has no greater adhesiveness or adhesive force in relation to the coating agent than the sleeve material.
  • the latter preferably consists of a polymeric material. If, moreover, the wall material of the sleeve 2 is as thin-walled as possible, it is ensured that the channels which may be present in the form of the folds 3 have a very small cross-section from the outset, so that these small cross-sections can be filled particularly easily and with little coating material.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un tube (1) destiné à être introduit dans la trachée d'un patient. Ce tube comprend une lumière centrale (4), pour permettre la respiration, et au moins un manchon (2) gonflable, placé sur le côté extérieur du tube (1). Ce manchon (2) sert à étanchéifier le côté extérieur du tube vis-à-vis de la paroi de la trachée, et présente, sur sa surface extérieure, un revêtement (6) qui peut gonfler et/ou est coulant de manière limitée. Il est ainsi possible de résoudre le problème posé par une étanchéité insuffisante. Le manchon (2) n'est pas particulièrement sensible et le recours à des pressions de gonflage particulièrement élevées n'est pas nécessaire.
EP99960903A 1998-12-02 1999-11-09 Tube avec manchon etancheifie Withdrawn EP1135184A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19855521 1998-12-02
DE19855521A DE19855521A1 (de) 1998-12-02 1998-12-02 Tubus mit abgedichteter Manschette
PCT/DE1999/003646 WO2000032262A1 (fr) 1998-12-02 1999-11-09 Tube avec manchon etancheifie

Publications (1)

Publication Number Publication Date
EP1135184A1 true EP1135184A1 (fr) 2001-09-26

Family

ID=7889687

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99960903A Withdrawn EP1135184A1 (fr) 1998-12-02 1999-11-09 Tube avec manchon etancheifie

Country Status (8)

Country Link
EP (1) EP1135184A1 (fr)
JP (1) JP2002531187A (fr)
AU (1) AU1771400A (fr)
CA (1) CA2353007A1 (fr)
DE (1) DE19855521A1 (fr)
HU (1) HUP0104580A2 (fr)
TW (1) TW458789B (fr)
WO (1) WO2000032262A1 (fr)

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US7236811B2 (en) 2001-03-16 2007-06-26 Nellcor Puritan Bennett Incorporated Device and method for monitoring body fluid and electrolyte disorders
US7239902B2 (en) 2001-03-16 2007-07-03 Nellor Puritan Bennett Incorporated Device and method for monitoring body fluid and electrolyte disorders
US7277741B2 (en) 2004-03-09 2007-10-02 Nellcor Puritan Bennett Incorporated Pulse oximetry motion artifact rejection using near infrared absorption by water
US7657292B2 (en) 2001-03-16 2010-02-02 Nellcor Puritan Bennett Llc Method for evaluating extracellular water concentration in tissue
US7950393B2 (en) 2006-09-29 2011-05-31 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US8109882B2 (en) 2007-03-09 2012-02-07 Nellcor Puritan Bennett Llc System and method for venous pulsation detection using near infrared wavelengths
US8135448B2 (en) 2001-03-16 2012-03-13 Nellcor Puritan Bennett Llc Systems and methods to assess one or more body fluid metrics
US8175665B2 (en) 2007-03-09 2012-05-08 Nellcor Puritan Bennett Llc Method and apparatus for spectroscopic tissue analyte measurement
US8180419B2 (en) 2006-09-27 2012-05-15 Nellcor Puritan Bennett Llc Tissue hydration estimation by spectral absorption bandwidth measurement
US8196584B2 (en) 2006-06-22 2012-06-12 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US8280469B2 (en) 2007-03-09 2012-10-02 Nellcor Puritan Bennett Llc Method for detection of aberrant tissue spectra
US8307830B2 (en) 2006-09-29 2012-11-13 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US8346327B2 (en) 2007-03-09 2013-01-01 Covidien Lp Method for identification of sensor site by local skin spectrum data
US8434487B2 (en) 2006-06-22 2013-05-07 Covidien Lp Endotracheal cuff and technique for using the same
US8561614B2 (en) 2006-09-28 2013-10-22 Covidien Lp Multi-layer cuffs for medical devices
US8590534B2 (en) 2009-06-22 2013-11-26 Covidien Lp Cuff for use with medical tubing and method and apparatus for making the same
US8684175B2 (en) 2006-09-22 2014-04-01 Covidien Lp Method for shipping and protecting an endotracheal tube with an inflated cuff
US8690864B2 (en) 2007-03-09 2014-04-08 Covidien Lp System and method for controlling tissue treatment
CN106039391A (zh) * 2016-06-21 2016-10-26 林春梅 一种抗菌高粘合医用胶水及其制备方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7239902B2 (en) 2001-03-16 2007-07-03 Nellor Puritan Bennett Incorporated Device and method for monitoring body fluid and electrolyte disorders
US7657292B2 (en) 2001-03-16 2010-02-02 Nellcor Puritan Bennett Llc Method for evaluating extracellular water concentration in tissue
US8509866B2 (en) 2001-03-16 2013-08-13 Covidien Lp Device and method for monitoring body fluid and electrolyte disorders
US8457722B2 (en) 2001-03-16 2013-06-04 Covidien Lp Device and method for monitoring body fluid and electrolyte disorders
US8135448B2 (en) 2001-03-16 2012-03-13 Nellcor Puritan Bennett Llc Systems and methods to assess one or more body fluid metrics
US7236811B2 (en) 2001-03-16 2007-06-26 Nellcor Puritan Bennett Incorporated Device and method for monitoring body fluid and electrolyte disorders
US8229529B2 (en) 2001-03-16 2012-07-24 Nellcor Puritan Bennett Llc Device and method for monitoring body fluid and electrolyte disorders
US8195263B2 (en) 2004-03-09 2012-06-05 Nellcor Puritan Bennett Llc Pulse oximetry motion artifact rejection using near infrared absorption by water
US7277741B2 (en) 2004-03-09 2007-10-02 Nellcor Puritan Bennett Incorporated Pulse oximetry motion artifact rejection using near infrared absorption by water
US8175670B2 (en) 2004-03-09 2012-05-08 Nellcor Puritan Bennett Llc Pulse oximetry signal correction using near infrared absorption by water
US10485942B2 (en) 2006-06-22 2019-11-26 Covidien Lp Endotracheal cuff and technique for using the same
US8196584B2 (en) 2006-06-22 2012-06-12 Nellcor Puritan Bennett Llc Endotracheal cuff and technique for using the same
US9289567B2 (en) 2006-06-22 2016-03-22 Covidien Lp Endotracheal cuff and technique for using the same
US10076623B2 (en) 2006-06-22 2018-09-18 Covidien Lp Endotracheal cuff and technique for using the same
US9032957B2 (en) 2006-06-22 2015-05-19 Covidien Lp Endotracheal cuff and technique for using the same
US8434487B2 (en) 2006-06-22 2013-05-07 Covidien Lp Endotracheal cuff and technique for using the same
US8636010B2 (en) 2006-06-22 2014-01-28 Covidien Lp Endotracheal cuff and technique for using the same
US10888677B2 (en) 2006-06-22 2021-01-12 Covidien Lp Endotracheal cuff and technique for using the same
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US8346327B2 (en) 2007-03-09 2013-01-01 Covidien Lp Method for identification of sensor site by local skin spectrum data
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CN106039391A (zh) * 2016-06-21 2016-10-26 林春梅 一种抗菌高粘合医用胶水及其制备方法

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TW458789B (en) 2001-10-11
JP2002531187A (ja) 2002-09-24
WO2000032262A1 (fr) 2000-06-08
AU1771400A (en) 2000-06-19
HUP0104580A2 (en) 2002-12-28
DE19855521A1 (de) 2000-06-08

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