WO2019016497A1 - Tube assemblies and insulating sleeves - Google Patents

Tube assemblies and insulating sleeves Download PDF

Info

Publication number
WO2019016497A1
WO2019016497A1 PCT/GB2018/000102 GB2018000102W WO2019016497A1 WO 2019016497 A1 WO2019016497 A1 WO 2019016497A1 GB 2018000102 W GB2018000102 W GB 2018000102W WO 2019016497 A1 WO2019016497 A1 WO 2019016497A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubing
sleeve
side walls
length
assembly
Prior art date
Application number
PCT/GB2018/000102
Other languages
French (fr)
Inventor
Anthony Lucio BELISARIO
Paul James Leslie Bennett
Robert James Burchell
Mohammad Qassim Mohammad KHASAWNEH
Jeanne POUQUET
Ria MEHRA
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
Priority to GB1711748.2 priority Critical
Priority to GBGB1711748.2A priority patent/GB201711748D0/en
Application filed by Smiths Medical International Limited filed Critical Smiths Medical International Limited
Publication of WO2019016497A1 publication Critical patent/WO2019016497A1/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
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/36General characteristics of the apparatus related to heating or cooling
    • A61M2205/3633General characteristics of the apparatus related to heating or cooling thermally insulated
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube

Abstract

Tubing (40) extending from the patient end of a heat exchanger (2) is insulated by an outer sleeve (6) extending along most of the length of the tubing. The sleeve (6) is moulded of a transparent flexible plastics with a series of separate, isolated annular air pockets (68) or channels each formed by a pair of radially-extending side walls (61) and an outer wall (63). The side walls (61) of adjacent channels are flexibly joined at their inner ends so that the walls can hinge at the join (62) when the tubing (40) and its outer sleeve (6) are bent. Adjacent side walls (61) are naturally angled away from one another at an angle of about 45° but are bent towards one another when the sleeve (6) is axially compressed by assembly on the tubing (40) and held between opposite end fittings (41) and (42) on the tubing.

Description

TUBE ASSEMBLIES AND INSULATING SLEEVES

This invention relates to tube assemblies of the kind having a length of transparent flexible tubing arranged to be supplied at one end with infusion liquid and having a coupling at its opposite end for connection with an infusion catheter or needle.

Patients usually receive some form of intravenous fluids during or after surgery, such as saline, blood or liquid drugs. It is well established that the patient usually benefits considerably if such fluids are not supplied at room temperature or at a refrigerated storage temperature but are instead warmed close to body temperature (around 37°C). There are various ways in which the fluid can be warmed. For example, the fluid container could be placed in a warmed water bath before use, an electrical heating element could be placed in contact with the fluid container or the path from the container to the patient. Alternatively, the flow path from the container to the patient could act as a heat exchanger, having an outer jacket with one or more lumens through which warmed fluid is circulated around the outside of the infusion fluid flow path along the tubing. Such an arrangement is sold by Smiths Medical under the Hotline® trade mark (Hotline is a registered trade mark of Smiths Medical). The problem with all these arrangements is the difficulty of preventing heat loss from the tubing after the fluid has been warmed. Even where the tubing itself is warmed by an outer jacket it is not possible for this to extend up to the patient because of the bulk and weight of the warming jacket. Instead, most warming systems include an extension tube connected via a coupling at one end to the outlet of the fluid warmer and connected at its opposite end via a coupling to the hub of the IV catheter or needle. This extension kit is not heated so there is heat loss from the infusion fluid along its length, causing a drop in temperature along its length. Although it would be possible to insulate the extension kit to some extent by means of a neoprene or foam sleeve this has various disadvantages in that it would prevent the clinician seeing the fluid flow along the extension tubing, thereby preventing the clinician confirming flow, checking for blood flash-back or checking for air bubbles. There is an additional problem in that the insulating sleeve would prevent the use of conventional slide clamps used to close the tubing. It is an object of the present invention to provide an alternative tube assembly and insulating sleeve.

According to one aspect of the present invention there is provided a tube assembly of the above-specified kind, characterised in that the assembly includes a thermally-insulating outer sleeve extending externally along the major part of the length of the tubing, that the sleeve is moulded of a transparent flexible plastics material and has multiple annular channels along its length, that each channel has an outer wall of circular section together forming the outer surface of the assembly and supported by two generally radially-extending side walls projecting inwardly from opposite edges of the outer wall, that the inner end of the side walls extend close to or in contact with the outer surface of the tubing, and that the inner end of side walls of adjacent channels are joined with one another to form a flexible join enabling adjacent side walls to hinge towards or away from one another as the assembly is bent, with the channels providing individual air pockets separate from one another along the length of the outer sleeve.

The assembly preferably includes an end fitting at opposite ends of the tubing, the end fittings being contacted by opposite ends of the outer sleeve. The assembly may include a slide clamp for closing the tubing. The slide clamp is preferably in the form of a plate with a tapering elongate aperture large enough at one end to be positioned along the length of the outer sleeve and being slidable along the length of the aperture between the side walls of adjacent channels so as to compress both the outer sleeve in the valley between the side walls and the underlying tubing to prevent fluid flow along the tubing. The outer wall is preferably substantially flat across its width on its outer surface. The outer sleeve in its natural state where it is not compressed axially preferably has its adjacent side walls inclined at an angle of about 45° to one another.

According to another aspect of the present invention there is provided an outer sleeve for an assembly according to the above one aspect of the present invention.

According to a third aspect of the present invention there is provided an outer sleeve for thermally insulating the outside of a part at least of the length of medical tubing, characterised in that the sleeve is moulded of a transparent flexible plastics material and has multiple annular channels along its length, that each channel has an outer wall of circular section together forming the outer surface of the assembly and supported by two generally radially-extending side walls projecting inwardly from opposite edges of the outer wall, that the inner ends of adjacent side walls extend close to or in contact with the outer surface of the tubing, and are joined with one another to form a flexible join enabling adjacent side walls to hinge towards or away from one another as the assembly is bent, with the channels providing individual air pockets separate from one another along the length of the sleeve, and that the sleeve in its natural state before assembly on the medical tubing is axially uncompressed with the adjacent side walls being inclined at an angle to one another.

According to a fourth aspect of the present invention there is provided an assembly including an outer sleeve according to the above third aspect of the present invention assembled to extend along a length of medical tubing, characterised in that the outer sleeve is held in axial compression on the medical tubing between end fittings at opposite ends of the tubing.

A fluid warming system including a tube assembly according to the present invention will now be described with reference to the accompanying drawings, in which:

Figure 1 illustrates the fluid warming system schematically;

Figure 2 is a perspective view of a conventional tube extension;

Figure 3 is a perspective, cut-away view to an enlarged scale of a part of the tube assembly of the present invention;

Figure 4 is a cross-sectional view of a part of the tube sleeve as moulded;

Figure 5 is a cross-sectional view of tube sleeve assembled on the infusion tube; Figure 6 is a perspective view showing a part of the tube assembly with a slide clamp in an open state;

Figure 7 is a perspective view showing a part of the tube assembly with the slide clamp in a closed state; and

Figure 8 is an enlarged cross-sectional side elevation view through a part of the tube assembly illustrating heat transfer.

Figure 1 shows an infusion fluid warming system including a source of infusion fluid, such as a saline bag 1 suspended above the patient on a pole (not shown). The outlet 10 of the bag 1 is connected to the inlet 20 of a heat exchanger 2 having a central lumen through which the infusion liquid flows and two outer lumens (not visible) of C-shape in section surrounding the central lumen and connected together to provide a path for warming liquid flowed through the heat exchanger. The warming liquid is warmed and pumped through the heat exchanger 2 by an electrical warming unit 3 mounted adjacent the upper end of the heat exchanger and connected with the upper end of the heat exchanger 2 via tubing 30. At its lower end the heat exchanger 2 has an outlet 21 through which the warmed infusion liquid flows out of the exchanger. The heat exchanger 2 may be of a conventional kind sold by Smiths Medical under the Hotline® mark and described in US5063994 and US5097898, although a detailed understanding of the heat exchanger is not needed for an understanding of the present invention. Alternative arrangements for heating the infusion liquid could be used, such as those employing an electrical heating element in thermal contact with the infusion liquid flow path, such as described in US6641556. The source of infusion fluid need not be a suspended bag but could be of any conventional kind, such as an infusion pump.

Because of the bulk and weight of conventional heat exchangers when filled with the liquid heat exchange medium it is usual not to connect the outlet of the heat exchanger directly with the infusion catheter or needle but instead to use an extension kit 4 of the kind shown in Figure 2. This includes a length of flexible, transparent plastic tubing 40 having end fittings in the form of luer connectors 41 and 42 at opposite ends and a simple slide clamp 43 in the form of a plate 44 with a tapering aperture 45 through which the tubing is threaded. In its normal position with the tubing 40 extending through the larger end of the aperture 45, the tubing is open to allow free flow of liquid along it. If the clamp 43 is slid along its length across the tubing 40, so that the tubing is forced into the narrow end of the aperture 45, this compresses and clamps closed the tubing to prevent flow. In use, one of the connectors 41 is coupled to the outlet 21 of the heat exchanger 2 and the other connector 42 is coupled to a connector or hub 50 at the rear or machine end of the infusion catheter or needle 5, such as an IV infusion catheter or needle.

As so far described the fluid warming system is conventional.

The system of the present invention differs from conventional systems by the addition of a thermally-insulating outer sleeve 6 extending along the extension kit 4 as shown in Figures 3 to 7. The sleeve 6 is moulded from a transparent plastics material, such as silicone, with an undulating profile formed by a linked series of hollow annular hoops or channels 60 of substantially square section. The hoops 60 are formed by radially-extending walls 61 joined to adjacent walls at their inner ends to provide flexible joins 62 enabling the walls to hinge outwardly and inwardly towards and away from one another. The outer edge of the walls 61 of each hoop 60 is linked by and supports an integral annular band, outer wall or roof 63 presenting an outer flat surface 64 across its width and an undulating inner surface 65 having a central convex projection 66 bordered by shallow concave recesses 67 along opposite sides. The external diameter of the sleeve 6 is about 2.0 to 2.5 times the external diameter of the extension tubing 40 and the length "1" of each hoop 60 is about 0.5 to 0.7 times the external diameter of the extension tubing. The wall thickness of the sleeve 6 varies, being thicker in the region of the roof 63 than in the region of the walls 61 so that the roof is stiffer and maintains a flat external profile. The internal diameter of the sleeve 6 at the joins 62 between the walls 61 is equal to or slightly greater than the external diameter of the extension tubing 40 so that the sleeve can move freely along the tubing. The sleeve 6 is moulded in the form shown in Figure 4 with the walls 61 projecting inwardly from the rooves 63 and inclined outwardly at the joins 62 at an angle Θ of about 45°. The natural state of the sleeve 6 (where it is not axially compressed) is, therefore, with the walls 61 at this angle and the sleeve extended in length. When the sleeve 6 is loaded onto the tubing 40 it is axially compressed, as shown in Figure 5, so that the angle between adjacent walls 61 closes resiliently and they lie parallel in contact or closely adjacent with one another. The length of the sleeve 6 as moulded exceeds the length of the tubing 40 on which it is to be fitted but when slid along the tubing and compressed axially between the end connectors 41 and 42 its compressed length is such that the opposite ends of the sleeve resiliently engage the connectors as shown in Figure 3.

Figure 8 shows that the annular shape of the channels or hoops 60 produces multiple separate annular air pockets 68 between the sleeve 6 and the extension tubing 40 that are isolated from one another. The volume of these multiple discrete air pockets 68 is less than would be produced by, for example a helically-corrugated sleeve with a single continuous air pocket along its length. The result of this is that thermal convection losses from the warm extension tubing 40 can be very low compared with arrangements with a single large air pocket enabling the establishment of convective flow patterns. By arranging for the walls 61 of adjacent hoops 60 to lie close to one another in use it ensures that the maximum proportion of the length of the extension tubing 40 is insulated by the full depth of air in the air pockets and that the area through which heat could leak out is minimised. The increased thickness of the roof 63 of each channel 60 further helps reduce heat loss from the sleeve 6. An alternative sleeve with an undulating, sinewave, profile, by contrast, would have air pockets that vary in thickness along their length and regions where the air pockets would be relatively thin and allow a greater heat loss.

The transparent nature of the insulating sleeve 6 enables the extension tube 40 to be viewed through the sleeve so that liquid flowing along the tube can be seen. This enables the clinician to identify any air bubbles, blood flash-back or interruption to flow. The annular, hooped configuration of the insulating sleeve 6 enables adjacent walls 61 to open and close and the inner joins 62 between the walls to slide freely along the extension tube 40. This ensures that the extension tube 40 is completely flexible so that it can be positioned freely without loading the IV site.

The annular configuration of the sleeve 6 also enables a slide clamp 7 similar to the conventional clamp 43 (Fig 2) to be used, as shown in Figures 6 and 7. The slide clamp 7 comprises a rigid rectangular plastics plate 70 with a tapering aperture 71 that differs from conventional clamps only in that the width of aperture 71 is wider than usual, being able to receive the external diameter of the insulating sleeve 6 freely at its wider end. The clamp 7 is used in the manner shown in Figures 6 and 7 by positioning the clamp in a gap between adjacent hoops 60 and then sliding the clamp along its length to move the extension tubing 40 and the sleeve 6 to the narrow end of the aperture 71. The flexible nature of the sleeve 6 enables the underlying tube 40 to be clamped easily in this way.

Instead of a separate extension tube, the heat exchanger could have an integral small bore extension tube or tail that would also benefit from an insulating sleeve of the present invention.

The insulating sleeve could be made of various different materials and have different dimensions. The sleeve could have alternative profiles providing separate air pockets, for example, the roof of each hoop need not be flat but could be curved. The present invention could also be used where a cooled fluid is infused to a patient since it would reduce warming of the fluid caused by exposure to an environment at room temperature.

Claims

1. A tube assembly having a length of transparent flexible tubing (40) arranged to be supplied at one end with infusion liquid and having a coupling (42) at its opposite end for connection with an infusion catheter or needle (5), characterised in that the assembly includes a thermally-insulating outer sleeve (6) extending externally along the major part of the length of the tubing (40), that the sleeve (6) is moulded of a transparent flexible plastics material and has multiple annular channels (60) along its length, that each channel (60) has an outer wall (63) of circular section together forming the outer surface of the assembly and supported by two generally radially- extending side walls (61) projecting inwardly from opposite edges of the outer wall (63), that the inner end of the side walls (61) extend close to or in contact with the outer surface of the tubing (40), and that the inner end of side walls (61) of adjacent channels (60) are joined with one another to form a flexible join (62) enabling adjacent side walls to hinge towards or away from one another as the assembly is bent, with the channels (60) providing individual air pockets separate from one another along the length of the outer sleeve (60).
2. An assembly according to Claim 1, characterised in that the assembly includes an end fitting (41, 42) at opposite ends of the tubing, and that the end fittings are contacted by opposite ends of the outer sleeve (6)
3. An assembly according to Claim 1 or 2, characterised in that the assembly includes a slide clamp (7) for closing the tubing (40).
4. An assembly according to Claim 3, characterised in that the slide clamp (7) is in the form of a plate (70) with a tapering elongate aperture (71) large enough at one end to be positioned along the length of the outer sleeve (6) and being slidable along the length of the aperture (71) between the side walls (61) of adjacent channels (60) so as to compress both the outer sleeve in the valley between the side walls and the underlying tubing (40) to prevent fluid flow along the tubing.
5. An assembly according to any one of the preceding claims, characterised in that the outer wall (63) is substantially flat across its width on its outer surface.
6. An assembly according to any one of the preceding claims, characterised in that the outer sleeve (6) in its natural state where it is not compressed axially has its adjacent side walls (61) inclined at an angle (Θ) of about 45° to one another.
7. An outer sleeve (6) for an assembly according to any one of the preceding claims.
8. An outer sleeve (6) for thermally insulating the outside of a part at least of the length of medical tubing (40), characterised in that the sleeve is moulded of a transparent flexible plastics material and has multiple annular channels (60) along its length, that each channel (60) has an outer wall (63) of circular section together forming the outer surface of the assembly and supported by two generally radially-extending side walls (61) projecting inwardly from opposite edges of the outer wall (63), that the inner ends of adjacent side walls extend close to or in contact with the outer surface of the tubing, and are joined with one another to form a flexible join (62) enabling adjacent side walls (61) to hinge towards or away from one another as the assembly is bent, with the channels providing individual air pockets (60) separate from one another along the length of the sleeve (6), and that the sleeve in its natural state before assembly on the medical tubing (40) is axially uncompressed with the adjacent side walls (61) being inclined at an angle to one another.
9. An assembly including an outer sleeve (6) according to Claim 8 assembled to extend along a length of medical tubing (40), characterised in that the outer sleeve (6) is held in axial compression on the medical tubing (40) between end fittings (41 and 42) at opposite ends of the tubing.
PCT/GB2018/000102 2017-07-21 2018-07-04 Tube assemblies and insulating sleeves WO2019016497A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB1711748.2 2017-07-21
GBGB1711748.2A GB201711748D0 (en) 2017-07-21 2017-07-21 Tubes and tube insulation

Publications (1)

Publication Number Publication Date
WO2019016497A1 true WO2019016497A1 (en) 2019-01-24

Family

ID=59771823

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2018/000102 WO2019016497A1 (en) 2017-07-21 2018-07-04 Tube assemblies and insulating sleeves

Country Status (2)

Country Link
GB (1) GB201711748D0 (en)
WO (1) WO2019016497A1 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5063994A (en) 1990-06-26 1991-11-12 Level 1 Technologies, Inc. Reflux fluid heated patient line
US6641556B1 (en) 1999-07-06 2003-11-04 Respiratory Support Products, Inc. Intravenous fluid heating system
DE10324116A1 (en) * 2003-05-26 2005-01-05 Volker Barkey Device for thermal insulation and protection of hoses, particularly medical infusion hoses, folds in a concertina-like manner to be highly compact when not in use
WO2012033421A1 (en) * 2010-09-10 2012-03-15 Fisher & Paykel Healthcare Limited A component for conveying gases
WO2012164407A1 (en) * 2011-06-03 2012-12-06 Fisher & Paykel Healthcare Corporation Limited Medical tubes and methods of manufacture
CN102052528B (en) * 2009-10-29 2015-05-20 柔性塑料集团 Elastic flexible pipe capable of flexible telescoping

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5063994A (en) 1990-06-26 1991-11-12 Level 1 Technologies, Inc. Reflux fluid heated patient line
US5097898A (en) 1990-06-26 1992-03-24 Level 1 Technologies, Inc. End caps for reflux fluid heated patient line
US6641556B1 (en) 1999-07-06 2003-11-04 Respiratory Support Products, Inc. Intravenous fluid heating system
DE10324116A1 (en) * 2003-05-26 2005-01-05 Volker Barkey Device for thermal insulation and protection of hoses, particularly medical infusion hoses, folds in a concertina-like manner to be highly compact when not in use
CN102052528B (en) * 2009-10-29 2015-05-20 柔性塑料集团 Elastic flexible pipe capable of flexible telescoping
WO2012033421A1 (en) * 2010-09-10 2012-03-15 Fisher & Paykel Healthcare Limited A component for conveying gases
WO2012164407A1 (en) * 2011-06-03 2012-12-06 Fisher & Paykel Healthcare Corporation Limited Medical tubes and methods of manufacture

Also Published As

Publication number Publication date
GB201711748D0 (en) 2017-09-06

Similar Documents

Publication Publication Date Title
KR101838530B1 (en) Enclosure for containing a portable hemodialysis unit
ES2559667T3 (en) Ultrafiltration apparatus comprising a long venous cannula peripherally blood collection
ES2550797T3 (en) Apparatus and method to prevent free flow in an infusion line
EP2497512B1 (en) Air trap for an infusion cartridge
US6620131B2 (en) Dual balloon central venous line catheter temperature control system
US8366655B2 (en) Peritoneal dialysis sensor apparatus systems, devices and methods
US2910981A (en) Replacement blood transfusion apparatus
US6530946B1 (en) Indwelling heat exchange heat pipe catheter and method of using same
US6755026B2 (en) Thermoelectric system to directly regulate the temperature of intravenous solutions and bodily fluids
US4231425A (en) Extracorporeal circuit blood heat exchanger
US4735609A (en) IV fluid warmer
US5378230A (en) Triple-lumen critical care catheter
US8403876B2 (en) Indwelling heat exchange catheter and method of using same
US8803044B2 (en) Dialysis fluid heating systems
US8078333B2 (en) Dialysis fluid heating algorithms
US20050065581A1 (en) Flexible heat exchangers for medical cooling and warming applications
EP2246080A2 (en) An extracorporeal blood flow system
US4588402A (en) Connector for medical tubing and medical solution bag device using the connector
CA2368243C (en) Central venous line catheter having temperature control system
ES2397792T3 (en) central venous catheter with heat exchange properties
US6261261B1 (en) Infrared heating device for prewarming IV solutions
US20040186444A1 (en) Pressure responsive slit valve assembly for a plurality of fluids and uses thereof
ES2242652T3 (en) Muscular device access security hemostasis valve.
CA1086714A (en) Heat exchanger apparatus and method for regulating the temperature of blood in an extracorporeal circuit
US6733517B1 (en) Angling introducer sheath for catheter having temperature control system

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: 18742537

Country of ref document: EP

Kind code of ref document: A1