WO2018134548A1 - Medico-surgical tubes and their manufacture - Google Patents

Medico-surgical tubes and their manufacture Download PDF

Info

Publication number
WO2018134548A1
WO2018134548A1 PCT/GB2017/000182 GB2017000182W WO2018134548A1 WO 2018134548 A1 WO2018134548 A1 WO 2018134548A1 GB 2017000182 W GB2017000182 W GB 2017000182W WO 2018134548 A1 WO2018134548 A1 WO 2018134548A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
tube
elements
reinforcement
flexible
Prior art date
Application number
PCT/GB2017/000182
Other languages
French (fr)
Inventor
Timothy Bateman
Stephen James Field
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 WO2018134548A1 publication Critical patent/WO2018134548A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0465Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08Tubes; Storage means specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production

Definitions

  • This invention relates to medico-surgical tubes of the kind including a shaft having a patient end adapted for location in the body and a machine end adapted for location outside the body.
  • Tracheostomy tubes are used to enable ventilation or respiration of a patient.
  • the tube is inserted into the trachea via a surgically-formed opening in the neck so that one end locates in the trachea and the other end locates outside the patient adjacent the neck surface.
  • Various types of different tracheostomy tubes are presently available to suit different needs.
  • Tracheostomy tubes are also available including an inner cannula so that this can be removed and replaced periodically to prevent the build-up of secretions and avoid the need to replace the tube itself.
  • Tracheostomy tubes can be inserted by different techniques, such as the surgical cut down procedure carried out in an operating theatre or a percutaneous dilatation procedure, which may carried out in emergency situations.
  • Tracheostomy tubes are usually made by extruding a shaft and then post forming to the desired shape. It can be difficult to ensure tight tolerances and to control the length of a tube accurately when it is extruded.
  • tracheostomy tubes can be moulded, which allows for tighter control of tolerances.
  • multiple mould cavities and tooling are needed, thereby adding to the cost of manufacture.
  • the wall of the tube can also be advantageous, especially with inner cannulae of tracheostomy tubes, for the wall of the tube to be as thin as possible to enable maximum airflow and still resist kinking and deformation.
  • the tube can also be advantageous, especially with inner cannulae of tracheostomy tubes, for the wall of the tube to be as thin as possible to enable maximum airflow and still resist kinking and deformation.
  • medico-surgical tubes where it is advantageous for the tube to be flexible but also resist crushing forces
  • a tube of the above-specified kind characterised in that the shaft includes one or more reinforcing elements flexibly linked with one another or itself around the shaft such as to enable the shaft to bend, and that a layer of a flexible sealing material on the or each reinforcing element provides a sealed shaft.
  • the reinforcing element or elements may be elongate and extend circumferentially around the shaft and may be linked together by weaving, knitting or braiding. Alternatively, the reinforcement elements may be provided by multiple rings.
  • the or each reinforcement element is preferably of a stiff plastics or metal that is stiffer than the layer of flexible sealing material.
  • the reinforcement element or elements may be a wire of a stiff plastics or metal.
  • the flexible sealing material is preferably a layer of a flexible plastics material along the shaft on the inside or outside of the or each reinforcement element or both.
  • the tube may be a tracheostomy tube.
  • a method of manufacturing a medico-surgical tube including the steps of flexibly linking together one or more reinforcement elements around the tube to provide a flexible shaft, and providing a layer of flexible plastics material to the or each reinforcement element before or after linking.
  • the or each reinforcement element may be elongate and the method may include the steps of winding one or more elongate reinforcement elements circumferentially and flexibly linking turns of the or each element together to provide the flexible shaft.
  • the or each reinforcement element may be linked by weaving, knitting or braiding.
  • Figure 1 is side elevation view of the tube
  • FIG. 1 illustrates in greater detail linked sections of the tube
  • Figure 3 is a perspective view of an alternative reinforcing arrangement
  • Figure 4 shows a modification of the arrangement of Figure 3.
  • the tube has a shaft 1 with an inflatable sealing cuff 2 close to its patient end 3, and a flange 4 and connector 5 at its machine end 6.
  • a small bore inflation tube 7 extends along the shaft 1 opening at its patient end into the cuff 2 and being connected with a combined connector and inflation indicator 8 at its opposite end.
  • the shaft 1 is made up of one or more elongate reinforcing elements 10 extending helically and circumferentially around the shaft. Turns of the or each element 10 are flexibly linked with one another in a manner that enables the different turns of the elements to move relative to one another.
  • the or each elongate element 10 is preferably of a stiff and strong plastics or metal material.
  • the or each element 10 may be of a flat section resembling a strip or it could be of a square, circular or any other shape section.
  • different turns of the reinforcing element 10 are formed into loops 11 and are intertwined or knitted with one another to form an arrangement resembling chainmail.
  • the element could be provided in an initially straight shape and formed into the loops during the winding process. Alternatively, the element could be preformed into the undulating loops 11.
  • the reinforcing elements 10 or different turns of the same element can be linked with one another, such as by weaving, knitting or braiding.
  • such an arrangement of linked reinforcement elements would have a relatively porous structure so, it would usually be necessary to make the shaft gas-tight, such as by coating the tube of linked reinforcing elements with an inner or outer layer 12, or both, of a plastics material, or by forming such a layer in some other way, such as by heat shrinking.
  • the reinforcing element or elements could be wound and interlinked on top of a pre-formed inner sleeve on a mandrel and could be given an outer flexible layer, such as by dipping, extrusion, spraying, painting or the like.
  • This linked element arrangement can give a high resistance to radial or lateral crushing from forces within the tracheal stoma and protect against kinking and collapse with a relatively thin wall, whilst still providing sufficient flexibility to conform to the tracheal anatomy.
  • the reinforcing elements could be provided in the manner shown in Figure 3, by multiple rings 20 connected together. These rings could be of metal or plastic and could be circular, square or of other shapes.
  • Figure 4 shows a ring arrangement where the rings 30 have an internal lug 31 to reduce longitudinal compression.
  • the tube need not have a fixed flange but could have a flange that is adjustable along the length of the shaft.
  • the high strength construction of the tube enables flanges that grip the tube to be used since the shaft would be resistant to deformation by such a flange.
  • the invention could be used in both outer tracheostomy tubes, in inner tracheostomy cannulae and in assemblies including both an outer tube and an inner cannula.
  • the invention could be used to produce tubes with a thinner wall but with similar strength to thicker tubes of a conventional construction. This enables tubes with a higher internal/external diameter ratio to be made, or enables tubes to be made with a standard wall thickness but having greater flexibility. This could be particularly useful in inner cannulae. A larger internal diameter enables a higher gas flow through the tube.
  • the invention is not confined to tracheostomy tubes but could be used in various other medico-surgical tubes.

Landscapes

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

Abstract

The shaft (1) of a tracheostomy tube is formed by an elongate reinforcement element (10) of a stiff plastics or metal wound around the shaft and formed into loops (11) that are linked together such as by knitting. Alternatively, the shaft may be formed by linked rings (20) or (30). The shaft (1) is sealed by a flexible plastics layer (12) on the inner or outer surface of the reinforcement element.

Description

MEDICO-SURGICAL TUBES AND THEIR MANUFACTURE
This invention relates to medico-surgical tubes of the kind including a shaft having a patient end adapted for location in the body and a machine end adapted for location outside the body.
Tracheostomy tubes are used to enable ventilation or respiration of a patient. The tube is inserted into the trachea via a surgically-formed opening in the neck so that one end locates in the trachea and the other end locates outside the patient adjacent the neck surface. Various types of different tracheostomy tubes are presently available to suit different needs. Tracheostomy tubes are also available including an inner cannula so that this can be removed and replaced periodically to prevent the build-up of secretions and avoid the need to replace the tube itself. Tracheostomy tubes can be inserted by different techniques, such as the surgical cut down procedure carried out in an operating theatre or a percutaneous dilatation procedure, which may carried out in emergency situations.
Tracheostomy tubes are usually made by extruding a shaft and then post forming to the desired shape. It can be difficult to ensure tight tolerances and to control the length of a tube accurately when it is extruded. Alternatively, tracheostomy tubes can be moulded, which allows for tighter control of tolerances. In order to provide the range of sizes and shapes of tubes needed by the clinician, and the fixed or adjustable flange versions, multiple mould cavities and tooling are needed, thereby adding to the cost of manufacture. It is also difficult to provide a tracheostomy tube with the strength needed to resist the pressure from the tracheal cartilage rings without collapsing and that is also sufficiently flexible to reduce damage caused to the tracheal lining during insertion and use. It can also be advantageous, especially with inner cannulae of tracheostomy tubes, for the wall of the tube to be as thin as possible to enable maximum airflow and still resist kinking and deformation. There are various other medico-surgical tubes where it is advantageous for the tube to be flexible but also resist crushing forces
It is an object of the present invention to provide an alternative medico-surgical tube and method of manufacture. According to one aspect of the present invention there is provided a tube of the above-specified kind, characterised in that the shaft includes one or more reinforcing elements flexibly linked with one another or itself around the shaft such as to enable the shaft to bend, and that a layer of a flexible sealing material on the or each reinforcing element provides a sealed shaft.
The reinforcing element or elements may be elongate and extend circumferentially around the shaft and may be linked together by weaving, knitting or braiding. Alternatively, the reinforcement elements may be provided by multiple rings.
The or each reinforcement element is preferably of a stiff plastics or metal that is stiffer than the layer of flexible sealing material. The reinforcement element or elements may be a wire of a stiff plastics or metal. The flexible sealing material is preferably a layer of a flexible plastics material along the shaft on the inside or outside of the or each reinforcement element or both. The tube may be a tracheostomy tube.
According to another aspect of the present invention there is provided a method of manufacturing a medico-surgical tube including the steps of flexibly linking together one or more reinforcement elements around the tube to provide a flexible shaft, and providing a layer of flexible plastics material to the or each reinforcement element before or after linking.
The or each reinforcement element may be elongate and the method may include the steps of winding one or more elongate reinforcement elements circumferentially and flexibly linking turns of the or each element together to provide the flexible shaft. The or each reinforcement element may be linked by weaving, knitting or braiding.
According to a further aspect of the present invention there is provided a tube made by a method according to the above other aspect of the present invention. An outer tube for use in a tracheostomy and a method of manufacture, according to the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which:
Figure 1 is side elevation view of the tube;
Figure 2 illustrates in greater detail linked sections of the tube;
Figure 3 is a perspective view of an alternative reinforcing arrangement; and
Figure 4 shows a modification of the arrangement of Figure 3.
With reference to Figures 1 and 2, the tube has a shaft 1 with an inflatable sealing cuff 2 close to its patient end 3, and a flange 4 and connector 5 at its machine end 6. A small bore inflation tube 7 extends along the shaft 1 opening at its patient end into the cuff 2 and being connected with a combined connector and inflation indicator 8 at its opposite end.
The shaft 1 is made up of one or more elongate reinforcing elements 10 extending helically and circumferentially around the shaft. Turns of the or each element 10 are flexibly linked with one another in a manner that enables the different turns of the elements to move relative to one another. The or each elongate element 10 is preferably of a stiff and strong plastics or metal material. The or each element 10 may be of a flat section resembling a strip or it could be of a square, circular or any other shape section. As shown in Figure 2, in one example, different turns of the reinforcing element 10 are formed into loops 11 and are intertwined or knitted with one another to form an arrangement resembling chainmail. The element could be provided in an initially straight shape and formed into the loops during the winding process. Alternatively, the element could be preformed into the undulating loops 11. There are various techniques by which the reinforcing elements 10 or different turns of the same element can be linked with one another, such as by weaving, knitting or braiding. By itself, such an arrangement of linked reinforcement elements would have a relatively porous structure so, it would usually be necessary to make the shaft gas-tight, such as by coating the tube of linked reinforcing elements with an inner or outer layer 12, or both, of a plastics material, or by forming such a layer in some other way, such as by heat shrinking. The reinforcing element or elements could be wound and interlinked on top of a pre-formed inner sleeve on a mandrel and could be given an outer flexible layer, such as by dipping, extrusion, spraying, painting or the like.
This linked element arrangement can give a high resistance to radial or lateral crushing from forces within the tracheal stoma and protect against kinking and collapse with a relatively thin wall, whilst still providing sufficient flexibility to conform to the tracheal anatomy.
In an alternative arrangement, the reinforcing elements could be provided in the manner shown in Figure 3, by multiple rings 20 connected together. These rings could be of metal or plastic and could be circular, square or of other shapes. Figure 4 shows a ring arrangement where the rings 30 have an internal lug 31 to reduce longitudinal compression.
The tube need not have a fixed flange but could have a flange that is adjustable along the length of the shaft. The high strength construction of the tube enables flanges that grip the tube to be used since the shaft would be resistant to deformation by such a flange.
The invention could be used in both outer tracheostomy tubes, in inner tracheostomy cannulae and in assemblies including both an outer tube and an inner cannula.
The invention could be used to produce tubes with a thinner wall but with similar strength to thicker tubes of a conventional construction. This enables tubes with a higher internal/external diameter ratio to be made, or enables tubes to be made with a standard wall thickness but having greater flexibility. This could be particularly useful in inner cannulae. A larger internal diameter enables a higher gas flow through the tube.
The invention is not confined to tracheostomy tubes but could be used in various other medico-surgical tubes.

Claims

1. A medico-surgical tube including a shaft (1) having a patient end (3) adapted for location in the body and a machine end (6) adapted for location outside the body, characterised in that the shaft (1) includes one or more reinforcing elements (10, 20, 30) flexibly linked with one another or itself around the shaft such as to enable the shaft to bend, and that a layer (12) of a flexible sealing material on the or each reinforcing element (10, 20, 30) provides a sealed shaft (1).
2. A tube according to Claim 1 , characterised in that the reinforcing element or
elements (10) are elongate and extend circumferentially around the shaft (1).
3. A tube according to Claim 2, characterised in that the or each reinforcing elements (10) are linked together by weaving, knitting or braiding.
4. A tube according to Claim 1 , characterised in that the reinforcement elements are provided by multiple rings (20, 30).
5. A tube according to any one of the preceding claims * characterised in that the or each reinforcement element (10, 20, 30) is of a stiff plastics or metal that is stiffer than the layer (12) of flexible sealing material.
6. A tube according to Claims 5 and Claim 2 or 3, characterised in that the
reinforcement element or elements (10) is a wire of a stiff plastics or metal.
7. A tube according to any one of the preceding claims, characterised in that the flexible sealing material is a layer (12) of a flexible plastics material along the shaft (1) on the inside or outside of the or each reinforcement element or both (10, 20, 30).
8. A tracheostomy tube according to any one of the preceding claims.
9. A method of manufacturing a medico-surgical tube including the steps of flexibly linking together one or more reinforcement elements (10, 20, 30) around the tube to provide a flexible shaft (1), and providing a layer (12) of flexible plastics material to the or each reinforcement element (10, 20, 30) before or after linking.
10. A method according to Claim 9, characterised in that the or each reinforcement
element (10, 11) is elongate, and that the method includes the steps of winding one or more elongate reinforcement elements (10) circumferentially and flexibly linking turns of the or each element together to provide the flexible shaft (1).
11. A method according to Claim 10, characterised in that the or each reinforcement element (10) is linked by weaving, knitting or braiding.
12. A tube made by a method according to any one of Claims 9 to 11.
PCT/GB2017/000182 2017-01-18 2017-12-22 Medico-surgical tubes and their manufacture WO2018134548A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1700843.4 2017-01-18
GBGB1700843.4A GB201700843D0 (en) 2017-01-18 2017-01-18 Tubes for tracheostomy and their manufacture

Publications (1)

Publication Number Publication Date
WO2018134548A1 true WO2018134548A1 (en) 2018-07-26

Family

ID=58463429

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2017/000182 WO2018134548A1 (en) 2017-01-18 2017-12-22 Medico-surgical tubes and their manufacture

Country Status (2)

Country Link
GB (1) GB201700843D0 (en)
WO (1) WO2018134548A1 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5527325A (en) * 1993-07-09 1996-06-18 Device For Vascular Intervention, Inc. Atherectomy catheter and method
CA2167708C (en) * 1993-08-18 2001-12-11 Carey V. Campbell A thin-wall polytetrafluoroethylene tube
US7279208B1 (en) * 1993-08-18 2007-10-09 Gore Enterprise Holdings, Inc Thin-wall polytetrafluoroethylene tube
US20090320853A1 (en) * 2008-06-27 2009-12-31 Mike Kenowski Tracheostomy Tube
EP1871451B1 (en) * 2005-03-19 2011-09-21 Smiths Group plc Tracheostomy tube
ES2532091T3 (en) * 2012-03-29 2015-03-24 Willy Rüsch GmbH Tracheostomy tube

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5527325A (en) * 1993-07-09 1996-06-18 Device For Vascular Intervention, Inc. Atherectomy catheter and method
CA2167708C (en) * 1993-08-18 2001-12-11 Carey V. Campbell A thin-wall polytetrafluoroethylene tube
US7279208B1 (en) * 1993-08-18 2007-10-09 Gore Enterprise Holdings, Inc Thin-wall polytetrafluoroethylene tube
EP1871451B1 (en) * 2005-03-19 2011-09-21 Smiths Group plc Tracheostomy tube
US20090320853A1 (en) * 2008-06-27 2009-12-31 Mike Kenowski Tracheostomy Tube
ES2532091T3 (en) * 2012-03-29 2015-03-24 Willy Rüsch GmbH Tracheostomy tube

Also Published As

Publication number Publication date
GB201700843D0 (en) 2017-03-01

Similar Documents

Publication Publication Date Title
AU644638B2 (en) Reinforced medico-surgical tubes
US8196584B2 (en) Endotracheal cuff and technique for using the same
WO1999015219A1 (en) Catheter having a high tensile strength braid wire constraint and method of manufacture
EP3102268A1 (en) Tracheostomy tube assemblies, inner cannulae and methods of making inner cannulae
WO2015136232A1 (en) Tracheostomy tube assemblies, inner cannulae and methods of manufacture
WO2014132016A1 (en) Tracheostomy tube assemblies and inner cannulae
US20150374942A1 (en) Tracheostomy tube assemblies and inner cannulae
US20230293837A1 (en) Medico-surgical tubes
WO2018134548A1 (en) Medico-surgical tubes and their manufacture
WO2010089523A1 (en) Medico-surgical tubes
EP4135808B1 (en) Reinforced medico-surgical tubes and their manufacture
US20180236194A1 (en) Tracheostomy tube assemblies and inner cannulae
AU2004237786A1 (en) Laryngeal mask assemblies
CN212235579U (en) Medical elastomer hose
WO2017068314A1 (en) Medico-surgical tubes and their manufacture
JPS6323786B2 (en)
US20240198025A1 (en) Reinforced tubes
WO2021219972A1 (en) Reinforced medico-surgical tubes and their manufacture
JP2010179106A (en) Method for manufacturing cuff on plastic tube provided with outer sheath
US20180250868A1 (en) Tubes and their manufacture
JPH0747118A (en) Reinforcing medical surgical tube and its production
CN112057725A (en) Medical elastomer hose and preparation method thereof
JP2023132863A (en) Tube with double spiral structure having alternately spiral soft part and spiral hard part
WO2020025911A1 (en) Tracheal tube and method of making said tube
WO2020025913A1 (en) Tracheal tube and method of assembling a tracheostomie tube

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17826536

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 17826536

Country of ref document: EP

Kind code of ref document: A1