WO2011020985A1 - Ventilation and suction systems and assemblies - Google Patents

Ventilation and suction systems and assemblies Download PDF

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Publication number
WO2011020985A1
WO2011020985A1 PCT/GB2010/001412 GB2010001412W WO2011020985A1 WO 2011020985 A1 WO2011020985 A1 WO 2011020985A1 GB 2010001412 W GB2010001412 W GB 2010001412W WO 2011020985 A1 WO2011020985 A1 WO 2011020985A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
port
connector
end fitting
suction catheter
Prior art date
Application number
PCT/GB2010/001412
Other languages
French (fr)
Inventor
Vanessa Ruth Bothwell
Richard Hingley
David Phillip Lingham
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 WO2011020985A1 publication Critical patent/WO2011020985A1/en

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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
    • A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069—Tip not integral with tube
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/585—Means for facilitating use, e.g. by people with impaired vision by visual feedback having magnification means, e.g. magnifying glasses

Definitions

  • This invention relates to closed system suction catheter assemblies of the kind including a patient end fitting, a machine end fitting at an opposite end, a suction catheter extending from the machine end fitting through a wiper seal in the patient end fitting and a protective, flexible envelope extending around and along the suction catheter and attached to the machine end ⁇ fitting at one end and to the patient end fitting at the other end.
  • a conventional suction catheter can be used for this purpose but it is usually preferred to use a closed system suction catheter assembly.
  • a closed system assembly comprises a manifold at the patient end with a sliding, wiper seal through which a suction catheter can be advanced and withdrawn.
  • a flexible envelope is joined at one end to the manifold and encloses the catheter along its length. The other end of the envelope and the catheter is joined with a machine end component including a suction control valve and a connector.
  • the connector connects the catheter to a suction source; the valve enables the clinician to control the suction applied by the catheter. Examples of closed system suction catheters are described in US5269728, US5300043, US4569344, US4638539, US4872579,
  • suction catheter assemblies for paediatric use that there should be a minimum deadspace and that the suction catheter be insertable to a carefully controlled extent
  • a closed system suction catheter assembly of the above-specified kind, characterised in that the assembly includes a separate patient end connector that is connectible to and removable from the patient end fitting, that the connector includes three ports, a first port that is connectible with the patient end fitting, a second port that is axially aligned with the first port and is adapted for mounting with a coupling at a machine end of a tracheal tube, a third port extending at an acute angle to the first port, and that the connector includes a magnifying viewing window adjacent the forward end of the first port by which markings on the suction catheter can be viewed as the catheter is inserted into the second port.
  • the magnifying viewing window may be formed by a thickened portion of the wall of the connector and is preferably provided by an annular portion of semicircular section extending around the connector.
  • the markings on the catheter are preferably coloured markings extending around the catheter and spaced along a part at least of the length of the catheter.
  • the patient end fitting preferably includes a flushing chamber, the wiper seal being located at the rear end only of the flushing chamber and the flushing chamber having an opening at the forward end without a wiper seal.
  • the suction catheter preferably has a forward end portion that is softer than the remainder of the catheter.
  • a ventilation and suction system including a tracheal tube, a ventilator, a suction catheter assembly and a connector, characterised in that the connector has three ports, a first port being fitted with a patient end fitting on the suction catheter assembly, a second port axially aligned with the first port and being fitted with a coupling at a machine end of the tracheal tube and a third port extending at an angle to the first port, that the third port is connected to the ventilator, and that the connector includes a magnifying viewing window between the first and second ports such that a suction catheter in the suction catheter assembly can be viewed in the window as it is extended from the suction catheter assembly through the first port and into the second port.
  • a closed system suction catheter assembly including a patient end fitting, a machine end fitting at an opposite end, a suction catheter extending from the machine end fitting through the patient end fitting and a protective, flexible envelope extending around and along the suction catheter and attached to the machine end fitting at one end and to the patient end fitting at the other end, characterised in that the patient end fitting includes a flushing chamber having a wiper seal at the rear end only and an opening at the forward end without a wiper seal, that the catheter has a forward end portion that is softer than the remainder of the catheter.
  • the forward end portion of the catheter is preferably formed separately and attached to the remainder of the catheter.
  • a ventilation and suction system including a closed system suction catheter assembly for paediatric use and its method of operation, according to the present invention, will now be described, by way of example, with reference to the
  • FIG. 1 shows the system schematically
  • Figure 2 is a perspective view of the suction catheter assembly
  • Figure 3 is an enlarged cross-sectional side elevation view of a connector
  • Figure 4 is an enlarged cross-sectional side elevation view of the forward end of the patient end fitting.
  • the system includes a closed system suction catheter assembly 1 connected at its patient end 20 to an endotracheal tube 2 via a three- port connector 4 and connected at its machine end to a conventional suction source 5.
  • the connector 4 also connects the endotracheal tube 2 with a conventional ventilator 6.
  • the patient end of the suction catheter assembly 1 is provided by a patient end fitting 20 with a tapered nose 21 adapted to connect to a first port 41 on the connector 4.
  • the forward, patient end of the nose 21 is rounded and has a small axial opening 22 just large enough to allow passage of a suction catheter 23.
  • the internal diameter of the nose 21 is larger than the external diameter of the catheter 23 so as to define a flushing chamber around the catheter.
  • the patient end fitting 20 includes a wiper seal 120 located at the rear end of the flushing chamber 21, which resiliently embraces the suction catheter 23 substantially to prevent flow of gas or liquid rearwardly from the flushing chamber; it also serves to wipe secretions from the outside of the catheter into the flushing chamber as the catheter is pulled back through the wiper seal.
  • the suction catheter 23 is flexible, typically being 300 to 500mm long and having an external diameter of about 1.5mm to 5mm.
  • the tip or forward end portion 27 of the catheter 23 locates inside the flushing chamber 21 just forwardly of the wiper seal.
  • the tip 27 is preferably softer than the main part of the catheter 23 rearwardly of the tip so as to reduce trauma during use where it might contact delicate paediatric tissue.
  • the soft tip 27 may be provided in various ways but is preferably made by attaching a short length of a softer material to the forward end of the shaft of the catheter.
  • the soft tip 27 is preferably attached by RF welding in a mould.
  • the soft tip is not essential; the suction catheter could be of the same softness along its length.
  • a flexible, protective envelope 28 extends around and along the catheter 23, being joined at its forward end to the patient end fitting 20 and at its rear end to a machine end fitting 29.
  • the flexible nature of the envelope 28 is such as to enable the catheter 23 to be manipulated through the envelope so that it can be pushed forwardly or pulled rearwardly through the wiper seal.
  • the length of the envelope 28 is chosen such that, when the patient end fitting 20 and machine end fitting 29 are at their maximum spacing, the tip 27 of the catheter 23 locates inside the flushing chamber 21 and is not pulled through the wiper seal.
  • the rear, machine end 31 of the catheter 23 is connected to the machine end fitting 29.
  • the machine end fitting 29 includes a suction control valve 30 of the kind described in GB2400160 and that connects to the suction source 5.
  • the connector 4 is a unitary moulding of a rigid, transparent plastics material such as ABS.
  • the connector 4 has three ports 41, 42 and 43.
  • the first port 41 at the rear end of the connector, has a female tapered bore 44 dimensioned to make a secure, sealing slip fit on the outside of the nose 21 of the patient end fitting 20.
  • the rear end of the first port 41 is closely spaced from the flushing port 24 so that the nose fills a maximum volume within the port to keep the deadspace to a minimum.
  • the second port 42 is located at the patient end of the connector 4 and is axially aligned with the first port 41 so that the suction catheter 23 can be advanced freely between the two ports with obstruction or deformation.
  • the second port 42 has an 8.5mm female tapered bore 45 and this is fitted on a male connector 46 mounted in the machine end of the endotracheal tube 2.
  • the third port 43 is inclined away rearwardly at an angle of about 60° to the axis of the first and second ports 41 and 42 and opens into the connector 4 adjacent the second port 42.
  • the third port 43 is a standard 15mm ISO male coupling adapted to fit within a mating female coupling 47 at one end of flexible tubing 48 extending to the ventilator 6.
  • the connector 4 also includes a magnifying viewing window 50 located at the forward end of the first port 41, that is, just rearwardly of the junction with the third port 43.
  • the viewing window 50 is formed by a thickened portion of the wall of the connector forming a raised annular portion of rounded profile and semicircular section extending around the outside of the connector 4 forming a magnifying lens of plano-convex section.
  • the window 50 is moulded integrally with the wall of the connector 4.
  • the shape of the viewing window 50 produces a distorted magnified image of depth markings 51 spaced apart along the length of the rear end of the catheter 23. For this reason the depth markings 51 take the form of coloured bands extending around the catheter 23, rather than numerical markings.
  • the viewing window 50 on the connector 4 is located as close as possible to the location at which the suction catheter 23 enters the endotracheal tube connector 46, thereby enabling the user to ascertain most accurately the correct extent of insertion of the catheter from any angle around the connector. This is particularly important in paediatric applications since tissue in the respiratory passages of infants is particularly delicate and would be prone to damage by over insertion of a suction catheter.
  • Figure 2 shows an alternative connector 4' identical to the connector 4 described above except with a larger, 15mm diameter, female port 42' for use with larger diameter endotracheal tube connectors.
  • the system is set up as described above with the suction catheter assembly 1 and ventilator 6 both connected to the endotracheal tube 2 via the respective ports 41 and 43 on the connector 4.
  • the suction catheter assembly 1 can remain attached to the tracheal tube 2 without impeding ventilation.
  • the suction catheter 23 In its normal state, the suction catheter 23 is fully retracted within the envelope 28 with its tip 27 located in the flushing chamber 21 and with the flushing port 26 capped.
  • the clinician grips the suction catheter 23 through the envelope 28 and pushes it forwardly through the wiper seal and through the opening 22 at the forward end of the flushing chamber 21.
  • This material is removed by uncapping the flushing port 26 and dispensing a small quantity of saline into the flushing chamber 21, such as from a syringe, while suction continues to be applied through the catheter 23.
  • the saline flows into the chamber 21 dissolving and loosening the wiped secretions, which are then drawn through the bore of the suction catheter 23. Flow of fluid along the bore of the catheter 23 also helps clean this bore and reduce the build up of bacteria in the catheter.
  • the present arrangement has an advantage of avoiding the need for any manually- operated isolation valves of the kind used in some prior assemblies, which add to the cost and complexity of such assemblies and make their use more complicated.
  • the efficient cleaning possible with the present arrangement enables the assembly to be used safely on the same patient for up to around 72 hours before replacement is needed.
  • the absence of a wiping seal with the suction catheter 23 at the forward end of the flushing chamber 21 reduces the amount of secretions on the outside of the catheter that are wiped off the catheter outside the flushing chamber when the catheter is retracted.
  • the absence of a wiping seal at the forward end of the flushing chamber 21 enables the suction catheter 23 to have a soft tip 27 without the risk that this would be damaged or deformed by having to be forced through a wiper seal. It will also be appreciated that, if a soft tip catheter were used with a wiper seal such that the tip had to be pushed through the seal, there would be a risk that the tip would fold over and impede passage through the seal, making extension of the catheter
  • the system of the present invention also enables a treatment agent or medication, such as a surfactant to be administered without the need to interrupt ventilation. This is achieved simply by unplugging the suction catheter assembly 1 from the connector 4, while leaving the connector connected to the endotracheal tube 2 and ventilator 6. A small bore treatment delivery catheter (not shown) is then inserted through the connector 4 into the endotracheal tube 2. The machine end of the catheter is connected to a source of the treatment agent, such as a syringe containing a surfactant. Again, the depth of insertion of the treatment agent delivery catheter can be accurately controlled by observing depth markings on the catheter via the viewing window 50 on the connector 4. When the medication has been administered, the treatment agent delivery catheter is removed and the suction catheter assembly 1 is reconnected.
  • a treatment agent or medication such as a surfactant

Abstract

A closed system suction catheter assembly has a suction catheter (23) with its rear end connected to a machine end fitting (29). The opposite end of the catheter has a soft tip (27) and extends through a wiper seal (120) at the rear end of a flushing chamber (21) within a patient end fitting (20). A flexible envelope (28) extends between the machine end and patient end fittings (29 and 20). A connector (4, 4') has three ports, a first (41) of which is fitted on the patient end fitting (20), a second (42, 42') of which is fitted to the connector (46) at the machine end of a paediatric tracheal tube (2), and the third (43) of which extends at an acute angle to the first port. The wall of the connector (4, 4') is thickened to form an annular portion of semicircular section extending around the connector providing a magnifying viewing window (50) adjacent the forward end of the first port (41). The window (50) enables coloured distance markers (51) along the suction catheter (23) to be viewed as the catheter is extended through the connector (4, 4').

Description

VENTILATION AND SUCTION SYSTEMS AND ASSEMBLIES
This invention relates to closed system suction catheter assemblies of the kind including a patient end fitting, a machine end fitting at an opposite end, a suction catheter extending from the machine end fitting through a wiper seal in the patient end fitting and a protective, flexible envelope extending around and along the suction catheter and attached to the machine end^fitting at one end and to the patient end fitting at the other end.
During intubated ventilation of a patient it is necessary periodically to remove secretions that collect in the respiratory passages or in the tracheal tube. A conventional suction catheter can be used for this purpose but it is usually preferred to use a closed system suction catheter assembly. A closed system assembly comprises a manifold at the patient end with a sliding, wiper seal through which a suction catheter can be advanced and withdrawn. A flexible envelope is joined at one end to the manifold and encloses the catheter along its length. The other end of the envelope and the catheter is joined with a machine end component including a suction control valve and a connector. The connector connects the catheter to a suction source; the valve enables the clinician to control the suction applied by the catheter. Examples of closed system suction catheters are described in US5269728, US5300043, US4569344, US4638539, US4872579,
US5167622, US5779687, US5325850, US5490503, US5419769, US5460613,
US5349950, GB2394761, GB2400160, US6109259, US6227197, EP801577B,
WO96/09082, EP1239907B, EP1478424B, US6588427, EP1620148B,
US2004/0221852, EP1911482A, EP1795217A, US2007/0282250, WO2007/143502, US2008/0188833, US6227200, US6543451, EP1239909B, US6602219, EP1347798, WO02/49680, US6609520, WO/055143, US6805125, US6923184, US7021313, US7191782, WO2004/101045, US7263997, WO2004/103448, WO00/15276,
EP637257B, EP1113835B, EP1210957A, EP1237612B, US7152603, EP1267957B, US6978783, US2004/0007236, US2005/0211253, US2005/0211245, US2005/0235987, US7059322, WO2004/032817, US2008/0135051, US4836199, US4850350,
US4967743, US5025806, US5083561, US5220916, US5215522, US5255676,
US5277177, US5309902, US5333606, US5343857, US5487381, US5513628,
US5791337, EP1343552A, WO02/49699, US6612304, EP1322371A, WO02/28463, US6629530, WO02/051485, US6769430, EP1330284, WO02/36191, US6886561, WO2004/034946, US7188623, WO2006/014431, US7341059, WO2005/094925, WO2006/103233, WO2007/030388, WO2009/003135, US4838255, US5107829, US5133345, US5642726, US6702789, US7458955, US7273473, US5139018,
US4327723, US4515592, US6099519, EP695556B, US5065754, US5730123,
US5207220, US5309903, US7086402 and GB0905219.2. Closed system suction catheters are available from various manufacturers including Smiths Medical, Kimberley Clark, Covidien and Viasys.
It is particularly important with suction catheter assemblies for paediatric use that there should be a minimum deadspace and that the suction catheter be insertable to a carefully controlled extent
It is an object of the present invention to provide an alternative ventilation and suction system and assembly.
According to one aspect of the present invention there is provided a closed system suction catheter assembly of the above-specified kind, characterised in that the assembly includes a separate patient end connector that is connectible to and removable from the patient end fitting, that the connector includes three ports, a first port that is connectible with the patient end fitting, a second port that is axially aligned with the first port and is adapted for mounting with a coupling at a machine end of a tracheal tube, a third port extending at an acute angle to the first port, and that the connector includes a magnifying viewing window adjacent the forward end of the first port by which markings on the suction catheter can be viewed as the catheter is inserted into the second port.
The magnifying viewing window may be formed by a thickened portion of the wall of the connector and is preferably provided by an annular portion of semicircular section extending around the connector. The markings on the catheter are preferably coloured markings extending around the catheter and spaced along a part at least of the length of the catheter. The patient end fitting preferably includes a flushing chamber, the wiper seal being located at the rear end only of the flushing chamber and the flushing chamber having an opening at the forward end without a wiper seal. The suction catheter preferably has a forward end portion that is softer than the remainder of the catheter.
According to another aspect of the present invention there is provided a ventilation and suction system including a tracheal tube, a ventilator, a suction catheter assembly and a connector, characterised in that the connector has three ports, a first port being fitted with a patient end fitting on the suction catheter assembly, a second port axially aligned with the first port and being fitted with a coupling at a machine end of the tracheal tube and a third port extending at an angle to the first port, that the third port is connected to the ventilator, and that the connector includes a magnifying viewing window between the first and second ports such that a suction catheter in the suction catheter assembly can be viewed in the window as it is extended from the suction catheter assembly through the first port and into the second port.
According to a further aspect of the present invention there is provided a connector for an assembly or system according to the above one or other aspect of the present invention.
According to yet another aspect of the present invention there is provided a closed system suction catheter assembly including a patient end fitting, a machine end fitting at an opposite end, a suction catheter extending from the machine end fitting through the patient end fitting and a protective, flexible envelope extending around and along the suction catheter and attached to the machine end fitting at one end and to the patient end fitting at the other end, characterised in that the patient end fitting includes a flushing chamber having a wiper seal at the rear end only and an opening at the forward end without a wiper seal, that the catheter has a forward end portion that is softer than the remainder of the catheter.
The forward end portion of the catheter is preferably formed separately and attached to the remainder of the catheter.
A ventilation and suction system including a closed system suction catheter assembly for paediatric use and its method of operation, according to the present invention, will now be described, by way of example, with reference to the
accompanying drawings, in which:
Figure 1 shows the system schematically;
Figure 2 is a perspective view of the suction catheter assembly and
connectors;
Figure 3 is an enlarged cross-sectional side elevation view of a connector;
and
Figure 4 is an enlarged cross-sectional side elevation view of the forward end of the patient end fitting.
With reference first to Figure 1 , the system includes a closed system suction catheter assembly 1 connected at its patient end 20 to an endotracheal tube 2 via a three- port connector 4 and connected at its machine end to a conventional suction source 5. The connector 4 also connects the endotracheal tube 2 with a conventional ventilator 6.
With reference now also to Figures 2 and 4, the patient end of the suction catheter assembly 1 is provided by a patient end fitting 20 with a tapered nose 21 adapted to connect to a first port 41 on the connector 4. The forward, patient end of the nose 21 is rounded and has a small axial opening 22 just large enough to allow passage of a suction catheter 23. The internal diameter of the nose 21 is larger than the external diameter of the catheter 23 so as to define a flushing chamber around the catheter. Towards its rear end a flushing port 24 opens into the flushing chamber 21 and connects with a short tube 25 terminated by a coupling and tethered cap 26. This coupling 26 is used to supply flushing liquid to the flushing chamber 21. About midway along its length the patient end fitting 20 includes a wiper seal 120 located at the rear end of the flushing chamber 21, which resiliently embraces the suction catheter 23 substantially to prevent flow of gas or liquid rearwardly from the flushing chamber; it also serves to wipe secretions from the outside of the catheter into the flushing chamber as the catheter is pulled back through the wiper seal. The suction catheter 23 is flexible, typically being 300 to 500mm long and having an external diameter of about 1.5mm to 5mm. In its normal state while it is not being used, the tip or forward end portion 27 of the catheter 23 locates inside the flushing chamber 21 just forwardly of the wiper seal. The tip 27 is preferably softer than the main part of the catheter 23 rearwardly of the tip so as to reduce trauma during use where it might contact delicate paediatric tissue. The soft tip 27 may be provided in various ways but is preferably made by attaching a short length of a softer material to the forward end of the shaft of the catheter. The soft tip 27 is preferably attached by RF welding in a mould. The soft tip, however, is not essential; the suction catheter could be of the same softness along its length. A flexible, protective envelope 28 extends around and along the catheter 23, being joined at its forward end to the patient end fitting 20 and at its rear end to a machine end fitting 29. The flexible nature of the envelope 28 is such as to enable the catheter 23 to be manipulated through the envelope so that it can be pushed forwardly or pulled rearwardly through the wiper seal. The length of the envelope 28 is chosen such that, when the patient end fitting 20 and machine end fitting 29 are at their maximum spacing, the tip 27 of the catheter 23 locates inside the flushing chamber 21 and is not pulled through the wiper seal. The rear, machine end 31 of the catheter 23 is connected to the machine end fitting 29. The machine end fitting 29 includes a suction control valve 30 of the kind described in GB2400160 and that connects to the suction source 5.
With reference now also to Figure 3, the connector 4 is a unitary moulding of a rigid, transparent plastics material such as ABS. The connector 4 has three ports 41, 42 and 43. The first port 41, at the rear end of the connector, has a female tapered bore 44 dimensioned to make a secure, sealing slip fit on the outside of the nose 21 of the patient end fitting 20. When fitted on the nose 21, the rear end of the first port 41 is closely spaced from the flushing port 24 so that the nose fills a maximum volume within the port to keep the deadspace to a minimum. The second port 42 is located at the patient end of the connector 4 and is axially aligned with the first port 41 so that the suction catheter 23 can be advanced freely between the two ports with obstruction or deformation. The second port 42 has an 8.5mm female tapered bore 45 and this is fitted on a male connector 46 mounted in the machine end of the endotracheal tube 2. The third port 43 is inclined away rearwardly at an angle of about 60° to the axis of the first and second ports 41 and 42 and opens into the connector 4 adjacent the second port 42. The third port 43 is a standard 15mm ISO male coupling adapted to fit within a mating female coupling 47 at one end of flexible tubing 48 extending to the ventilator 6.
The connector 4 also includes a magnifying viewing window 50 located at the forward end of the first port 41, that is, just rearwardly of the junction with the third port 43. The viewing window 50 is formed by a thickened portion of the wall of the connector forming a raised annular portion of rounded profile and semicircular section extending around the outside of the connector 4 forming a magnifying lens of plano-convex section. The window 50 is moulded integrally with the wall of the connector 4. The shape of the viewing window 50 produces a distorted magnified image of depth markings 51 spaced apart along the length of the rear end of the catheter 23. For this reason the depth markings 51 take the form of coloured bands extending around the catheter 23, rather than numerical markings. By positioning the viewing window 50 on the connector 4 adjacent the rear end of the third port 42, it is located as close as possible to the location at which the suction catheter 23 enters the endotracheal tube connector 46, thereby enabling the user to ascertain most accurately the correct extent of insertion of the catheter from any angle around the connector. This is particularly important in paediatric applications since tissue in the respiratory passages of infants is particularly delicate and would be prone to damage by over insertion of a suction catheter.
Figure 2 shows an alternative connector 4' identical to the connector 4 described above except with a larger, 15mm diameter, female port 42' for use with larger diameter endotracheal tube connectors.
In use, the system is set up as described above with the suction catheter assembly 1 and ventilator 6 both connected to the endotracheal tube 2 via the respective ports 41 and 43 on the connector 4. The suction catheter assembly 1 can remain attached to the tracheal tube 2 without impeding ventilation. In its normal state, the suction catheter 23 is fully retracted within the envelope 28 with its tip 27 located in the flushing chamber 21 and with the flushing port 26 capped. When suctioning is required, the clinician grips the suction catheter 23 through the envelope 28 and pushes it forwardly through the wiper seal and through the opening 22 at the forward end of the flushing chamber 21.
Continued advancement causes the tip 27 of the catheter 23 to pass axially through the connector 4 and to enter the tracheal tube connector 46 and the tracheal tube 2 itself. The clinician actuates the valve 30 to start suctioning as soon as the tip 27 of the catheter 23 enters the tracheal tube 2, while viewing the extent of insertion through the window 50. When suctioning has been completed, the suction catheter 23 is pulled back until its tip 27 is just inside the flushing chamber 21. The wiping action of the seal causes material collected on the outside of the catheter 23 to be wiped off into the flushing chamber 21. This material is removed by uncapping the flushing port 26 and dispensing a small quantity of saline into the flushing chamber 21, such as from a syringe, while suction continues to be applied through the catheter 23. The saline flows into the chamber 21 dissolving and loosening the wiped secretions, which are then drawn through the bore of the suction catheter 23. Flow of fluid along the bore of the catheter 23 also helps clean this bore and reduce the build up of bacteria in the catheter.
The present arrangement has an advantage of avoiding the need for any manually- operated isolation valves of the kind used in some prior assemblies, which add to the cost and complexity of such assemblies and make their use more complicated. The efficient cleaning possible with the present arrangement enables the assembly to be used safely on the same patient for up to around 72 hours before replacement is needed. The absence of a wiping seal with the suction catheter 23 at the forward end of the flushing chamber 21 reduces the amount of secretions on the outside of the catheter that are wiped off the catheter outside the flushing chamber when the catheter is retracted. Also, the absence of a wiping seal at the forward end of the flushing chamber 21 enables the suction catheter 23 to have a soft tip 27 without the risk that this would be damaged or deformed by having to be forced through a wiper seal. It will also be appreciated that, if a soft tip catheter were used with a wiper seal such that the tip had to be pushed through the seal, there would be a risk that the tip would fold over and impede passage through the seal, making extension of the catheter difficult.
The system of the present invention also enables a treatment agent or medication, such as a surfactant to be administered without the need to interrupt ventilation. This is achieved simply by unplugging the suction catheter assembly 1 from the connector 4, while leaving the connector connected to the endotracheal tube 2 and ventilator 6. A small bore treatment delivery catheter (not shown) is then inserted through the connector 4 into the endotracheal tube 2. The machine end of the catheter is connected to a source of the treatment agent, such as a syringe containing a surfactant. Again, the depth of insertion of the treatment agent delivery catheter can be accurately controlled by observing depth markings on the catheter via the viewing window 50 on the connector 4. When the medication has been administered, the treatment agent delivery catheter is removed and the suction catheter assembly 1 is reconnected.
Although the above invention is described for paediatric application where it has particular advantages, it can be seen that it could also be used in adult applications.

Claims

1. A closed system suction catheter assembly including a patient end fitting (20), a machine end fitting (29) at an opposite end, a suction catheter (23) extending from the machine end fitting (29) through a wiper seal (120) in the patient end fitting and a protective, flexible envelope (28) extending around and along the suction catheter (23) and attached to the machine end fitting (29) at one end and to the patient end fitting (20) at the other end, characterised in that the assembly includes a separate patient end connector (4, 4') that is connectible to and removable from the patient end fitting (20), that the connector (4, 4') includes three ports, a first port (41) that is connectible with the patient end fitting (20), a second port (42, 42') that is axially aligned with the first port (41) and is adapted for mounting with a coupling (46) at a machine end of a tracheal tube (2), a third port (43) extending at an acute angle to the first port (41), and that the connector (4, 4') includes a magnifying viewing window (50) adjacent the forward end of the first port (41) by which markings (51) on the suction catheter (23) can be viewed as the catheter is inserted into the second port (42, 42').
2. An assembly according to Claim 1, characterised in that the magnifying viewing window (50) is formed by a thickened portion of the wall of the connector (4, 4').
3. An assembly according to Claim 2, characterised in that the viewing window (50) is provided by an annular portion of semicircular section extending around the connector (4, 4').
4. An assembly according to any one of the preceding claims, characterised in that the markings (51) on the catheter (23) are coloured markings extending around the catheter and spaced along at part at least of the length of the catheter.
5. An assembly according to any one of the preceding claims, characterised in that the patient end fitting (20) includes a flushing chamber (21), that the wiper seal (120) is located at the rear end only of the flushing chamber (21), and that the flushing chamber has an opening (22) at the forward end without a wiper seal.
6. An assembly according to any one of the preceding claims, characterised in that the suction catheter (23) has a forward end portion (27) that is softer than the remainder of the catheter.
7. A ventilation and suction system including a tracheal tube (2), a ventilator (6), a suction catheter assembly (1) and a connector (4, 4'), characterised in that the connector (4, 4') has three ports, a first port (41) being fitted with a patient end fitting (20) on the suction catheter assembly (1), a second port (42, 42') axially aligned with the first port (41) and being fitted with a coupling (46) at a machine end of the tracheal tube (2) and a third port (43) extending at an angle to the first port (41), that the third port (43) is connected to the ventilator (6), and that the connector (4, 4') includes a magnifying viewing window (50) between the first and second ports (41 and 42) such that a suction catheter (23) in the suction catheter assembly (1) can be viewed in the window (50) as it is extended from the suction catheter assembly (1) through the first port (41) and into the second port (42).
8. A system according to Claim 7, characterised in that the magnifying viewing window (50) is formed by a thickened portion of the wall of the connector (4, 4').
9. A system according to Claim 8, characterised in that the viewing window (50) is provided by an annular portion of semicircular section extending around the connector (4, 4').
10. A system according to any one of Claims 7 to 9, characterised in that the suction catheter (23) has coloured markings (51) extending around the catheter and spaced along at part at least of the length of the catheter, and that the coloured markings (51) are visible as they move past the viewing window (50).
11. A system according to any one of Claims 7 to 10, characterised in that the patient end fitting (20) includes a flushing chamber (21) having a wiper seal (120) at the rear end only and an opening (22) at the forward end without a wiper seal.
12. A system according to any one of Claims 7 to 11, characterised in that the catheter (23) has a forward end portion (27) that is softer than the remainder of the catheter.
13. A connector for an assembly or system according to any one of the preceding claims.
14. A closed system suction catheter assembly including a patient end fitting (20), a machine end fitting (29) at an opposite end, a suction catheter (23) extending from the machine end fitting (29) through the patient end fitting (20) and a protective, flexible envelope (28) extending around and along the suction catheter (23) and attached to the machine end fitting (29) at one end and to the patient end fitting (20) at the other end, characterised in that the patient end fitting (20) includes a flushing chamber (21) having a wiper seal (120) at the rear end only and an opening (22) at the forward end without a wiper seal, that the catheter (23) has a forward end portion (27) that is softer than the remainder of the catheter.
15. An assembly according to Claim 14, characterised in that the forward end portion (27) of the catheter (23) is formed separately and attached to the remainder of the catheter.
PCT/GB2010/001412 2009-08-20 2010-07-26 Ventilation and suction systems and assemblies WO2011020985A1 (en)

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