WO2015087029A1 - Tracheal tubes - Google Patents

Tracheal tubes Download PDF

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Publication number
WO2015087029A1
WO2015087029A1 PCT/GB2014/000420 GB2014000420W WO2015087029A1 WO 2015087029 A1 WO2015087029 A1 WO 2015087029A1 GB 2014000420 W GB2014000420 W GB 2014000420W WO 2015087029 A1 WO2015087029 A1 WO 2015087029A1
Authority
WO
WIPO (PCT)
Prior art keywords
tracheal
cuff
sealing member
active substance
tracheal tube
Prior art date
Application number
PCT/GB2014/000420
Other languages
French (fr)
Inventor
Andrew Thomas Jeffrey
Original Assignee
Smiths Medical International Limited
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 Smiths Medical International Limited filed Critical Smiths Medical International Limited
Publication of WO2015087029A1 publication Critical patent/WO2015087029A1/en

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
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • 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
    • 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
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0481—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • This invention relates to tracheal tubes of the kind having a sealing member on its outside towards its patient end that is adapted, during use, to provide a seal with the tracheal wall.
  • Tracheal tubes are used to supply ventilation and anaesthetic gases to a patient, such as during surgery.
  • the tracheal tube may be inserted via the mouth or nose, in the case of an endotracheal tube, or may be inserted via a surgically-made tracheostomy opening in the neck, in the case of a tracheostomy tube.
  • tracheal tubes have some form of a sealing member on their outside which forms a seal between the outside of the tube and the inside of the trachea so that gas flow is confined to the bore of the tube and cannot flow around the outside of the tube, between the tube and the trachea.
  • the most common form of seal is provided by an inflatable cuff that is inflated and deflated via a small bore lumen extending rearwardly along the tube and connected towards its rear end to an inflation line terminated by an inflation indicator, valve and connector.
  • These inflatable cuffs may be of the
  • the cuff is formed of a flexible material moulded with a natural annular or doughnut shape that is inflated without stretching by relatively low- pressure gas supplied via the inflation line.
  • the cuff may be of the low- volume/high-pressure kind where the cuff is of an elastic material that lies close to the tube shaft when uninflated but is inflated and stretched to a larger diameter by relatively high pressure gas supplied via the inflation line.
  • One problem is that the cuff can cause damage to the tracheal lining and the formation of scar tissue, especially if the cuff is used incorrectly, such as with incorrect pressure and inadequate monitoring.
  • the seal on such tracheal tubes need not be formed by an inflatable cuff but could, for example, be provided by a self-inflating foam cuff or by sealing flanges or the like. In all cases, the contact of the sealing means with delicate tracheal tissue may lead to damage and trauma. It is an object of the present invention to provide an alternative tracheal tube.
  • a tracheal tube of the above- specified kind characterised in that the sealing member has an outside surface region adapted to contact the tracheal wall where a part at least of such surface region includes an active substance selected to reduce damage to the trachea.
  • the active substance may be provided by a coating on the outside of the sealing member or by incorporation within the material of the sealing member.
  • the active substance may include an anti-proliferative or immunosuppressant agent, such as including
  • the active substance may be provided in a delivery agent of a polymer.
  • the delivery agent may be a biodegradable or bio-resorbable polymer.
  • the sealing member may include an expansible sealing member such as an inflatable cuff.
  • Figure 1 is a side elevation view of the tube
  • Figure 2 is an enlarged cross-sectional view through a part of the sealing cuff of the tube shown in Figure 1.
  • the tracheostomy tube includes a tubular shaft 1 having a bore 2 extending along its length.
  • the tube is formed with a relatively straight patient end portion 3 and a relatively straight machine end portion 4 linked by a curved intermediate portion 5 so that the patient and machine ends 6 and 7 are angled at about 100° to one another.
  • the shaft 1 is extruded or moulded from a plastics material such as PVC or silicone.
  • the tube Towards its patient end 6 the tube has a sealing member provided by an inflatable cuff 10 embracing the shaft 1.
  • the cuff 10 is of the high- volume/low-pressure kind so that it has a relatively floppy shape when deflated but, when inflated, it fills out at low pressure to a diameter matching the internal diameter of the trachea "T".
  • the cuff 10 is moulded mainly from a conventional plastics material such as PVC or polyurethane.
  • the cuff 10 is attached to the shaft 1 at opposite ends over an opening 11 on the outer surface of the shaft into an inflation lumen 12 extending along the shaft within its wall thickness.
  • the inflation lumen 12 is connected towards the rear end of the tube with a small-bore inflation line 13 that is terminated by a combined inflation indicator, valve and connector 14.
  • the tube At its machine end 7 the tube has a flange 20, to which a neck strap (not shown) is attached, and a standard 15mm female coupling 21.
  • the tube is conventional.
  • the tube differs from existing tubes in that the outer surface of the sealing cuff 10, or at least a major part of the cuff that contacts the surface of the tracheal wall, includes an active substance effective to reduce damage to the trachea.
  • This active substance is preferably provided by a coating 30 on the outer surface of the cuff 10 but could,
  • the coating 30 is shown as being applied to a localised region 31 of the cuff that comes into contact with the tracheal wall in use but could instead be applied over the entire surface of the cuff 10.
  • the coating need not be continuous but could be in the form of a pattern of discrete areas, such as spots or bands.
  • the substance of the coating 30 preferably includes an anti-proliferative agent, that is, an agent effective in reducing the risk of pressure injury stenosis or narrowing of the tracheal passage.
  • the anti-proliferative coating 30 could include drugs or analogues such as immunosuppressants (for example Rapamycin, a derivative of Sirolimus) dissolved into a delivery agent.
  • immunosuppressants for example Rapamycin, a derivative of Sirolimus
  • the coating 30 could be applied to the cuff 10 by spray coating, dip coating or vacuum C0 2 deposition.
  • the delivery agent with which the active agent is combined could be a polymer, such as a bio-degradable or bio- resorbable material, such as Polylactide co-glycocide (PLA) or a non-bio-degradable polyurethane based elastomer.
  • This mixture could be dissolved into a suitable organic high vapour pressure solvent before application to the surface of the cuff 10.
  • the mixture of the polymer and active agent acts to control the release kinetics of the agent allowing it to be released or eluted over the desired time- frame, such as hours, days or weeks thereby inhibiting the formation of cell masses over this period of time.
  • the invention is not confined to use on sealing cuffs inflated by a gas but could be used with foam cuffs, sealing flanges or any other sealing means that contacts the surface of the trachea.
  • the invention could be used in any tracheal tube, not just tracheostomy tubes, and is not limited to tubes for human use but could be used on veterinary tracheal tubes.

Abstract

A tracheostomy tube sealing cuff (10) is coated with an active substance (30) such as an anti-proliferative or immunosuppressant agent selected to reduce damage to the tracheal wall. The cuff is coated over a region (31) that contacts the wall of trachea when it is expanded.

Description

TRACHEAL TUBES
This invention relates to tracheal tubes of the kind having a sealing member on its outside towards its patient end that is adapted, during use, to provide a seal with the tracheal wall.
Tracheal tubes are used to supply ventilation and anaesthetic gases to a patient, such as during surgery. The tracheal tube may be inserted via the mouth or nose, in the case of an endotracheal tube, or may be inserted via a surgically-made tracheostomy opening in the neck, in the case of a tracheostomy tube.
Most, but not all, tracheal tubes have some form of a sealing member on their outside which forms a seal between the outside of the tube and the inside of the trachea so that gas flow is confined to the bore of the tube and cannot flow around the outside of the tube, between the tube and the trachea. The most common form of seal is provided by an inflatable cuff that is inflated and deflated via a small bore lumen extending rearwardly along the tube and connected towards its rear end to an inflation line terminated by an inflation indicator, valve and connector. These inflatable cuffs may be of the
high-volume/low-pressure kind where the cuff is formed of a flexible material moulded with a natural annular or doughnut shape that is inflated without stretching by relatively low- pressure gas supplied via the inflation line. Alternatively, the cuff may be of the low- volume/high-pressure kind where the cuff is of an elastic material that lies close to the tube shaft when uninflated but is inflated and stretched to a larger diameter by relatively high pressure gas supplied via the inflation line. Various problems exist with both forms of cuff. One problem is that the cuff can cause damage to the tracheal lining and the formation of scar tissue, especially if the cuff is used incorrectly, such as with incorrect pressure and inadequate monitoring.
The seal on such tracheal tubes need not be formed by an inflatable cuff but could, for example, be provided by a self-inflating foam cuff or by sealing flanges or the like. In all cases, the contact of the sealing means with delicate tracheal tissue may lead to damage and trauma. It is an object of the present invention to provide an alternative tracheal tube.
According to the present invention there is provided a tracheal tube of the above- specified kind, characterised in that the sealing member has an outside surface region adapted to contact the tracheal wall where a part at least of such surface region includes an active substance selected to reduce damage to the trachea.
The active substance may be provided by a coating on the outside of the sealing member or by incorporation within the material of the sealing member. The active substance may include an anti-proliferative or immunosuppressant agent, such as including
Rapamycin. The active substance may be provided in a delivery agent of a polymer. The delivery agent may be a biodegradable or bio-resorbable polymer. The sealing member may include an expansible sealing member such as an inflatable cuff.
A tracheostomy tube according to the present invention will now be described, by way of example, with reference to the accompanying drawings, in which:
Figure 1 is a side elevation view of the tube; and
Figure 2 is an enlarged cross-sectional view through a part of the sealing cuff of the tube shown in Figure 1.
The tracheostomy tube includes a tubular shaft 1 having a bore 2 extending along its length. The tube is formed with a relatively straight patient end portion 3 and a relatively straight machine end portion 4 linked by a curved intermediate portion 5 so that the patient and machine ends 6 and 7 are angled at about 100° to one another. The shaft 1 is extruded or moulded from a plastics material such as PVC or silicone. Towards its patient end 6 the tube has a sealing member provided by an inflatable cuff 10 embracing the shaft 1. The cuff 10 is of the high- volume/low-pressure kind so that it has a relatively floppy shape when deflated but, when inflated, it fills out at low pressure to a diameter matching the internal diameter of the trachea "T". The cuff 10 is moulded mainly from a conventional plastics material such as PVC or polyurethane. The cuff 10 is attached to the shaft 1 at opposite ends over an opening 11 on the outer surface of the shaft into an inflation lumen 12 extending along the shaft within its wall thickness. The inflation lumen 12 is connected towards the rear end of the tube with a small-bore inflation line 13 that is terminated by a combined inflation indicator, valve and connector 14.
At its machine end 7 the tube has a flange 20, to which a neck strap (not shown) is attached, and a standard 15mm female coupling 21.
As so far described, the tube is conventional.
The tube differs from existing tubes in that the outer surface of the sealing cuff 10, or at least a major part of the cuff that contacts the surface of the tracheal wall, includes an active substance effective to reduce damage to the trachea. This active substance is preferably provided by a coating 30 on the outer surface of the cuff 10 but could,
alternatively, be provided by incorporating the substance within the matrix of the plastics material forming the cuff. The coating 30 is shown as being applied to a localised region 31 of the cuff that comes into contact with the tracheal wall in use but could instead be applied over the entire surface of the cuff 10. The coating need not be continuous but could be in the form of a pattern of discrete areas, such as spots or bands. The substance of the coating 30 preferably includes an anti-proliferative agent, that is, an agent effective in reducing the risk of pressure injury stenosis or narrowing of the tracheal passage. The anti-proliferative coating 30 could include drugs or analogues such as immunosuppressants (for example Rapamycin, a derivative of Sirolimus) dissolved into a delivery agent. When the cuff 10 contacts the wall of the trachea T the drug is delivered locally to the wall of the blood vessels in the region so as to help limit the growth of scar tissue. The coating 30 could be applied to the cuff 10 by spray coating, dip coating or vacuum C02 deposition. The delivery agent with which the active agent is combined could be a polymer, such as a bio-degradable or bio- resorbable material, such as Polylactide co-glycocide (PLA) or a non-bio-degradable polyurethane based elastomer. This mixture could be dissolved into a suitable organic high vapour pressure solvent before application to the surface of the cuff 10. The mixture of the polymer and active agent acts to control the release kinetics of the agent allowing it to be released or eluted over the desired time- frame, such as hours, days or weeks thereby inhibiting the formation of cell masses over this period of time.
The invention is not confined to use on sealing cuffs inflated by a gas but could be used with foam cuffs, sealing flanges or any other sealing means that contacts the surface of the trachea. The invention could be used in any tracheal tube, not just tracheostomy tubes, and is not limited to tubes for human use but could be used on veterinary tracheal tubes.

Claims

1. A tracheal tube having a sealing member (10) on its outside towards its patient end (6) that is adapted, during use, to provide a seal with the tracheal wall, characterised in that the sealing member (10) has an outside surface region adapted to contact the tracheal wall where a part at least of such surface region (31) includes an active substance selected to reduce damage to the trachea.
2. A tracheal tube according to Claim 1 , characterised in that the active substance is provided by a coating (30) on the outside of the sealing member (10).
3. A tracheal tube according to Claim 1 or 2, characterised in that the active substance includes an anti-proliferative or immunosuppressant agent.
4. A tracheal tube according to Claim 3, characterised in that the active substance
includes Rapamycin.
5. A tracheal tube according to any one of the preceding claims, characterised in that the active substance is provided in a delivery agent of a polymer.
6. A tracheal tube according to Claim 5, characterised in that the delivery agent is a biodegradable or bio-resorbable polymer.
7. A tracheal tube according to any one of the preceding claims, characterised in that the sealing member includes an expansible sealing member (10).
8. A tracheal tube according to Claim 7, characterised in that the sealing member is an inflatable sealing cuff (10).
PCT/GB2014/000420 2013-12-11 2014-10-16 Tracheal tubes WO2015087029A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1321877.1 2013-12-11
GBGB1321877.1A GB201321877D0 (en) 2013-12-11 2013-12-11 Tracheal Tubes

Publications (1)

Publication Number Publication Date
WO2015087029A1 true WO2015087029A1 (en) 2015-06-18

Family

ID=50000525

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2014/000420 WO2015087029A1 (en) 2013-12-11 2014-10-16 Tracheal tubes

Country Status (2)

Country Link
GB (1) GB201321877D0 (en)
WO (1) WO2015087029A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105999503A (en) * 2016-07-06 2016-10-12 河南驼人医疗器械集团有限公司 Low-injury ultrathin balloon tracheal intubation
WO2021225473A1 (en) * 2020-04-29 2021-11-11 Obschestvo S Ogranichennoy Otvetstvennostyu “Vladimed” Endotracheal tube

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080092902A1 (en) * 2005-02-28 2008-04-24 Ralf Schnell Device For Supplying Inhaled Air
US20080215034A1 (en) * 2007-03-02 2008-09-04 Jessica Clayton Endotracheal cuff and technique for using the same
US20100051035A1 (en) * 2008-08-29 2010-03-04 Jenkins Shawn E Low-pressure airway management device with active coating and method for patient care
WO2013090619A1 (en) * 2011-12-15 2013-06-20 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for preventing tracheal aspiration

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080092902A1 (en) * 2005-02-28 2008-04-24 Ralf Schnell Device For Supplying Inhaled Air
US20080215034A1 (en) * 2007-03-02 2008-09-04 Jessica Clayton Endotracheal cuff and technique for using the same
US20100051035A1 (en) * 2008-08-29 2010-03-04 Jenkins Shawn E Low-pressure airway management device with active coating and method for patient care
WO2013090619A1 (en) * 2011-12-15 2013-06-20 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for preventing tracheal aspiration

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105999503A (en) * 2016-07-06 2016-10-12 河南驼人医疗器械集团有限公司 Low-injury ultrathin balloon tracheal intubation
WO2021225473A1 (en) * 2020-04-29 2021-11-11 Obschestvo S Ogranichennoy Otvetstvennostyu “Vladimed” Endotracheal tube

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