GB2088215A - Improvements in intravascular devices - Google Patents

Improvements in intravascular devices Download PDF

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Publication number
GB2088215A
GB2088215A GB8117245A GB8117245A GB2088215A GB 2088215 A GB2088215 A GB 2088215A GB 8117245 A GB8117245 A GB 8117245A GB 8117245 A GB8117245 A GB 8117245A GB 2088215 A GB2088215 A GB 2088215A
Authority
GB
United Kingdom
Prior art keywords
device according
hub
flexible tube
limb
fine bore
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
GB8117245A
Other versions
GB2088215B (en
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
WALLACE H G Ltd
Wallace Ltd H G
Original Assignee
WALLACE H G LTD
WALLACE LTD H G
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 GB8018935 priority Critical
Application filed by WALLACE H G LTD, WALLACE LTD H G filed Critical WALLACE H G LTD
Priority to GB8117245A priority patent/GB2088215B/en
Publication of GB2088215A publication Critical patent/GB2088215A/en
Application granted granted Critical
Publication of GB2088215B publication Critical patent/GB2088215B/en
Application status is Expired legal-status Critical

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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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0606"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members

Abstract

An intravascular device comprises a cannula 1 and a hub 2, said hub having a straight limb 3 for reception of an introducing needle (not shown), and a side limb 4 connected to a sinuous fine bore flexible tube 9 terminating in means 10 for connection to a source of fluid medicament. The flexible tube 9 preferably terminates in an injectable rubber diaphragm 11 through which intermittent injections may be administered. <IMAGE>

Description

SPECIFICATION Improvements in intravascular devices This invention concerns improvements in intravascular devices and more particularly concerns an improved two-way intravascular device.

It is customary to introduce a plastics cannula into a vein or artery by means of an introducing needle which, when withdrawn, leaves the cannula in situ to be coupled to equipment for supplying fluid for withdrawal or monitoring of blood.

A problem arises when it is desired to effect more than one procedure by means of a single cannula, for example when it is necessary to give repeated administration of drugs or to alternate drugs and fluid. A rubber self-sealing portion which is routinely fitted to infusion sets partially overcomes this problem. However when fluid is not required, intermittent administration of drugs must be made by a connection to the indwelling cannula, and this presents further problems. It is possible to fit an injectable diaphragm or nonreturn valve to the hub of the cannula, allowing intermittent injections. However it is a hazard to place such a multiple-use injection site close to the venepuncture site and close to the bedclothes, which are a common source of contamination in hospitals.There is a significant risk that the injection site will become contaminated, and that such contamination will be introduced into the patient.

When an injectable diaphragm is fitted to the hub of the cannular through which the introducing needle can be inserted, and the needle is withdrawn, the injectable diaphragm left in place can be used for the intermittent administration of drugs. However there is a "dead space" on the distal side of this diaphragm. In the intervening periods between injections, blood can coagulate in this dead space and the resulting blood clots can be propelled into the vascular system during the next injection. A further difficulty is that when a needle is left located through the diaphragm, it is common for back leakage to result.

It is also known to provide a cannula with an integral site for multiple injections but this has the same hazard of contamination mentioned above.

Furthermore when the integral site is situated at any point distal to the cannula hub, a dead space results when fluid is not passing through the cannula and the same danger of clotting, discussed above, can arise. Such clots can of course present a serious hazard to critical areas of the circulatory system.

A further alternative available is a diaphragm fitted direct to an indwelling needle or an extension tube from the needle. This device carries the same hazards discussed above plus a further hazard of a sharp needle indwelling in a vein.

In one respect our invention provides an intravascular device comprising a cannula and a hub, said hub having a straight limb for reception of an introducing needle, and a side limb connected to a sinuous fine bore flexible tube terminating in means for connection to a source of fluid medicament.

The flexible, fine bore tubing which is connected to the side limb of the hub allows intermittent or continuous administration of drugs or fluid remote from the venepuncture site and from sources of contamination, i.e. the skin of the patient and the bedclothes. The fine bore of the tube minimises retention of administered drugs.

Most suitably the bore is less than 1.5 mm, e.g. in the range 0.5 to 1 mm.

The flexible tube preferably terminates in an injectable rubber diaphragm having a surface which can be disinfected with a sterilising fluid. In one embodiment, the diaphragm is removable to expose a standard connector such as a luer/luerlock record/record-lock or other tapered joint connector to mate with an infusion set or diagnostic equipment.

The flexible fine bore tube should be long enough to distance the injection site from sources of contamination, without being so long that it is impracticable. A length of at least 4 cm, e.g.

5-1 5 cm is generally suitable. The tube is preferably sealed non-detachably to the hub, e.g.

by moulding the hub around it or by adhesive.

Means may be provided to clamp off the tube, e.g. a sliding clamp having a tapered slot through which the tube passes.

For some applications it may be useful to provide two or more side limbs, each connected to a sinuous fine bore flexible tube terminating in means for connection to a source of fluid medicament. This embodiment permits simultaneous multiple administration of medicaments.

The straight limb of the device may be closed by a self-sealing elastomeric plug whose distal end terminates adjacent the junction with the side limb, thus effectively minimising the dead space in the hub.

The elastomeric plug, made e.g. of silicone rubber, is slightly compressed with the hub and seals tightly round the introducing needle.

Moreover when the needle is withdrawn the plug is compressed shut and no leakage or ingress of contamination can take place. The device of our invention is also versatile in that when the elastomeric plug is omitted, suitable connection can be made to pressure monitoring equipment or the like. The straight limb, without the plug, may be coupled to e.g. a luer-lock fluid administration set. For this purpose the proximal end of the straight limb may be provided with ears or the like to engage with a male luer-lock, record-lock or other tapered joint connector.

When using the device of the present invention to give intermittent injections, a needle is not left in the patient's vein, thus minimising the risk of extravasation. The diameter of the cannula will vary in accordance with intended use, e.g.

sufficiently small to be accommodated by the vein of a child patient, thus avoiding the need for special paediatric equipment.

The device has been found to be extremely useful in the surgical ward for intermittent injection of e.g. anaesthetic or antibiotics; for the management of acute emergency cases, e.g. the diabetic who needs a dextrose drip and insulin infusion from a syringe pump; for continuous infusion e.g. of heparin, using a syringe pump; for treatment of neonates and children; and for arterial pressure measurement. In the latter use, the pressure waveform may be monitored via the side tube and the straight limb used for flushing and sampling. The device is moreover extremely useful in experimental work and animal research.

The whole device may be made from suitable plastics materials. It is preferred that the hub is made of relatively soft flexible plastics material so that it causes less trauma to patients with delicate skin, e.g. children and burn cases.

Three embodiments of the invention are now described by way of example only with reference to the accompanying drawings.

Figure 1 illustrates an exemplary intravascular device in cross-section.

Figure 2 illustrates a modification of the device of Figure 1,in plan view.

Figure 3 illustrates a perspective view of a further modification.

The device of Figure 1 comprises a cannula 1 for insertion into a vein or artery and a hub portion 2. The hub comprises a straight limb 3 and a side limb 4. The straight limb 3 is closed by a solid plug 5 of silicone rubber whose proximal end 6 terminates adjacent the junction with the side limb 4. If desired the proximal end 6 may be angled as shown or rounded to reduce dead space still further; care must then be taken to insert the plug in the correct orientation.

The side limb 4 is joined to the fine bore tubing 9 having a bore about 1 mm and a length of about 75 mm. The tube 9 terminates in a female Luer lock hub 10 having a removable self-sealing diaphragm 1 1 which serves as the site for multiple injections. The surface of the diaphragm can be disinfected with a sterilising fluid. The diaphragm comprises a skirt which fits closely over the end of the hub and may be extended over the outside of the hub in a distal direction and locked with a shrink ring (see Figure 3). An annular projecting portion fitting tightly inside the hub improves the security still further.

Prior to the use of the device, the introducing needle has been inserted through plug 5 until its tip emerges from the distal end of cannula 1. The device is then placed in the body and the introducing needle is withdrawn. Plug 5 provides a fluid-tight seal at all times. Injections may then be administered through diaphragm 11 which can be located and protected in a clean site away from the patient's bedclothes.

When the diaphragm is removed, infusion fluids or the like may be administered through the fine bore tube 9 from a luer/luer-lock administration set, when a slow drip is required, or the hub 10 may be coupled to the nozzle of a syringe without needle.

Referring now to Figure 2, the device of Figure 1 has been modified by providing projecting webs or wings 1 2 to facilitate strapping of the device to the patient's body. Also shown is the needle hub 13.

In Figure 3 a device is shown without the plug 5. The web between the straight limb and side limb may be gripped conveniently during insertion, and after insertion may be turned down to lie against the patient's body, thus facilitating secure strapping of the device. The inserting needle 15 has a hub 13 which is a tight push fit into the straight limb of the device. After insertion into a patient's vein, the backflow of blood down the needle is visible through the transparent plastics material of hub 13, but spillage of blood is minimised by the filter member 16. For arterial cannulation, filter 16 is omitted and a syringe is connected to the needle hub 13. This procedure gives better control of arterial blood (which has a higher pressure than venous blood). The hub 13 has luer-lock ears 19.

The fine bore tubing 9 passes through a sliding clamp 17 having a tapered slot 18. The tube can be clamped off by wedging it into the narrow end of slot 18. The tube 9 terminates in a female luer/luer-lock hub 10, to which the self-sealing diaphragm 11 is secured by a removable shrink ring 14. The tube 9 has a length of about 60 mm.

The distance between the diaphragm 11 and the central bore of the cannula hub is about 90 mm, and the dead space is only about 0.15 ml.

Claims (10)

1. An intravascular device comprising a cannula and a hub, said hub having a straight limb for reception of an introducing needle, and a side limb connecte#d to a sinuous fine bore flexible tube terminating in means for connection to a source of fluid medicament.
2. A device according to claim 1 wherein said fine bore flexible tube has a bore in the range 0.5 to 1.5 mm.
3. A device according to claim 1 or 2 wherein said fine bore flexible tube has a length of at least 4cm.
4. A device according to any of the preceding claims wherein said fine bore flexible tube terminates in an injectable rubber diaphragm.
5.. A device according to claim 4 wherein said injectable rubber diaphragm is removable to expose a tapered joint connector.
6. A device according to any of the preceding claims wherein means are provided to clamp off said fine bore flexible tube.
7. A device according to claim 6 wherein said means comprises a sliding clamp having a tapered slot into which the tube may be wedged to clamp it off.
8. A device according to any of the preceding claims comprising two or more side limbs, each being connected to a sinuous fine bore flexible tube terminating in means for connection to a source of fluid medicament.
9. A device according to any of the preceding claims wherein the straight limb of said hub is closed by a self-sealing elastomeric plug whose distal end terminates adjacent the junction with the side limb.
10. A device according to any of the preceding claims wherein the proximal end of the straight limb is provided with means to engage a tapered joint connector.
GB8117245A 1980-06-10 1981-06-05 Improvements in intravascular devices Expired GB2088215B (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB8018935 1980-06-10
GB8117245A GB2088215B (en) 1980-06-10 1981-06-05 Improvements in intravascular devices

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB8117245A GB2088215B (en) 1980-06-10 1981-06-05 Improvements in intravascular devices

Publications (2)

Publication Number Publication Date
GB2088215A true GB2088215A (en) 1982-06-09
GB2088215B GB2088215B (en) 1984-11-28

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Family Applications (1)

Application Number Title Priority Date Filing Date
GB8117245A Expired GB2088215B (en) 1980-06-10 1981-06-05 Improvements in intravascular devices

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Country Link
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Cited By (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2225950A (en) * 1988-11-28 1990-06-20 Stephen James Griffiths Syringe needle mount
US5073168A (en) * 1988-10-05 1991-12-17 Danforth John W Y-adaptor and percutaneous sheath for intravascular catheters
US5334161A (en) * 1993-05-21 1994-08-02 Simon Gurmarnik Catheter with needle trap
WO1994023784A1 (en) * 1993-04-15 1994-10-27 Chin Rong Hwang Vascular catheterism device
WO1995006488A2 (en) * 1993-08-24 1995-03-09 Chin Rong Hwang Single outlet vascular catheterism device
EP0732120A1 (en) * 1995-03-16 1996-09-18 Becton Dickinson and Company Control forward/flashback forward one hand introducer needle and catheter assembly
US5676656A (en) * 1995-03-16 1997-10-14 Becton Dickinson And Company Control forward introducer needle and catheter assembly
US5738664A (en) * 1996-09-30 1998-04-14 Becton Dickinson And Company Self-healing seal for use in medical devices
US5810780A (en) * 1996-05-10 1998-09-22 Becton Dickinson And Company Multiple cross section needle and elastic plug assembly for a medical device
US6090074A (en) * 1997-09-23 2000-07-18 Becton, Dickinson And Company Eccentric rotary high pressure seal
WO2004032995A2 (en) 2002-10-10 2004-04-22 Becton, Dickinson And Company Method of delivering local anesthesia
EP1864688A2 (en) * 2006-06-08 2007-12-12 Belgian Diagnostic Company S.A. Stopper for blocking a hollow catheter inlet
US7867200B2 (en) 2004-12-10 2011-01-11 Unomedical A/S Inserter
US7985199B2 (en) 2005-03-17 2011-07-26 Unomedical A/S Gateway system
US8012126B2 (en) 2006-10-31 2011-09-06 Unomedical A/S Infusion set
US8062250B2 (en) 2004-08-10 2011-11-22 Unomedical A/S Cannula device
US8152771B2 (en) 2001-09-27 2012-04-10 Unomedical A/S Injector device for placing a subcutaneous infusion set
US8221355B2 (en) 2004-03-26 2012-07-17 Unomedical A/S Injection device for infusion set
US8246588B2 (en) 2007-07-18 2012-08-21 Unomedical A/S Insertion device with pivoting action
US8303549B2 (en) 2005-12-23 2012-11-06 Unomedical A/S Injection device
US8430850B2 (en) 2007-07-03 2013-04-30 Unomedical A/S Inserter having bistable equilibrium states
US8439838B2 (en) 2006-06-07 2013-05-14 Unomedical A/S Inserter for transcutaneous sensor
US8486003B2 (en) 2007-07-10 2013-07-16 Unomedical A/S Inserter having two springs
US8562567B2 (en) 2009-07-30 2013-10-22 Unomedical A/S Inserter device with horizontal moving part
US8790311B2 (en) 2006-06-09 2014-07-29 Unomedical A/S Mounting pad
CN104274254A (en) * 2013-07-08 2015-01-14 王薇 Accurate quantification device for animal vein puncture dosing
US8945057B2 (en) 2006-08-02 2015-02-03 Unomedical A/S Cannula and delivery device
US9186480B2 (en) 2007-06-20 2015-11-17 Unomedical A/S Apparatus for making a catheter
US9211379B2 (en) 2006-02-28 2015-12-15 Unomedical A/S Inserter for infusion part and infusion part provided with needle protector
US9254373B2 (en) 2008-12-22 2016-02-09 Unomedical A/S Medical device comprising adhesive pad
US9415159B2 (en) 2010-03-30 2016-08-16 Unomedical A/S Medical device
US9440051B2 (en) 2011-10-27 2016-09-13 Unomedical A/S Inserter for a multiplicity of subcutaneous parts
US9533092B2 (en) 2009-08-07 2017-01-03 Unomedical A/S Base part for a medication delivery device
US9566384B2 (en) 2008-02-20 2017-02-14 Unomedical A/S Insertion device with horizontally moving part
US9724127B2 (en) 2010-09-27 2017-08-08 Unomedical A/S Insertion system and insertion kit
WO2017212101A1 (en) * 2016-06-08 2017-12-14 Servicio Andaluz De Salud Device for inserting a flexible cannula

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2146709T3 (en) 1991-08-21 2000-08-16 Smith & Nephew Inc Fluid control system.
US20080033370A1 (en) 2006-08-03 2008-02-07 Becton, Dickinson And Company Binary needle attachment mechanisms

Cited By (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5073168A (en) * 1988-10-05 1991-12-17 Danforth John W Y-adaptor and percutaneous sheath for intravascular catheters
GB2225950A (en) * 1988-11-28 1990-06-20 Stephen James Griffiths Syringe needle mount
WO1994023784A1 (en) * 1993-04-15 1994-10-27 Chin Rong Hwang Vascular catheterism device
US5334161A (en) * 1993-05-21 1994-08-02 Simon Gurmarnik Catheter with needle trap
WO1995006488A2 (en) * 1993-08-24 1995-03-09 Chin Rong Hwang Single outlet vascular catheterism device
WO1995006488A3 (en) * 1993-08-24 1995-03-23 Chin Rong Hwang Single outlet vascular catheterism device
US5879334A (en) * 1995-03-16 1999-03-09 Becton Dickinson And Company Control forward introducer needle and catheter assembly
US5676656A (en) * 1995-03-16 1997-10-14 Becton Dickinson And Company Control forward introducer needle and catheter assembly
US5697914A (en) * 1995-03-16 1997-12-16 Becton Dickinson And Company Control forward/flashback forward one hand introducer needle and catheter assembly
US5935110A (en) * 1995-03-16 1999-08-10 Becton Dickinson And Company Control forward/flashback forward one hand introducer needle and catheter assembly
EP0732120A1 (en) * 1995-03-16 1996-09-18 Becton Dickinson and Company Control forward/flashback forward one hand introducer needle and catheter assembly
US5810780A (en) * 1996-05-10 1998-09-22 Becton Dickinson And Company Multiple cross section needle and elastic plug assembly for a medical device
US5738664A (en) * 1996-09-30 1998-04-14 Becton Dickinson And Company Self-healing seal for use in medical devices
US6090074A (en) * 1997-09-23 2000-07-18 Becton, Dickinson And Company Eccentric rotary high pressure seal
US8152771B2 (en) 2001-09-27 2012-04-10 Unomedical A/S Injector device for placing a subcutaneous infusion set
US8172805B2 (en) 2001-09-27 2012-05-08 Unomedical A/S Injector device for placing a subcutaneous infusion set
US8162892B2 (en) 2001-09-27 2012-04-24 Unomedical A/S Injector device for placing a subcutaneous infusion set
EP1572262A2 (en) * 2002-10-10 2005-09-14 Becton, Dickinson and Company Method of delivering local anesthesia
EP1572262A4 (en) * 2002-10-10 2008-05-28 Becton Dickinson Co Method of delivering local anesthesia
US7713257B2 (en) 2002-10-10 2010-05-11 Becton, Dickinson And Company System and method of delivering local anesthesia
WO2004032995A2 (en) 2002-10-10 2004-04-22 Becton, Dickinson And Company Method of delivering local anesthesia
US7713256B2 (en) 2002-10-10 2010-05-11 Becton, Dickinson And Company System and method of delivering local anesthesia
US8221355B2 (en) 2004-03-26 2012-07-17 Unomedical A/S Injection device for infusion set
US8287516B2 (en) 2004-03-26 2012-10-16 Unomedical A/S Infusion set
US8062250B2 (en) 2004-08-10 2011-11-22 Unomedical A/S Cannula device
US7867200B2 (en) 2004-12-10 2011-01-11 Unomedical A/S Inserter
US7867199B2 (en) 2004-12-10 2011-01-11 Unomedical A/S Inserter
US7985199B2 (en) 2005-03-17 2011-07-26 Unomedical A/S Gateway system
US9278173B2 (en) 2005-12-23 2016-03-08 Unomedical A/S Device for administration
US8303549B2 (en) 2005-12-23 2012-11-06 Unomedical A/S Injection device
US9211379B2 (en) 2006-02-28 2015-12-15 Unomedical A/S Inserter for infusion part and infusion part provided with needle protector
US8439838B2 (en) 2006-06-07 2013-05-14 Unomedical A/S Inserter for transcutaneous sensor
EP1864688A2 (en) * 2006-06-08 2007-12-12 Belgian Diagnostic Company S.A. Stopper for blocking a hollow catheter inlet
EP1864688A3 (en) * 2006-06-08 2008-03-12 Belgian Diagnostic Company S.A. Stopper for blocking a hollow catheter inlet
US8790311B2 (en) 2006-06-09 2014-07-29 Unomedical A/S Mounting pad
US8945057B2 (en) 2006-08-02 2015-02-03 Unomedical A/S Cannula and delivery device
US8012126B2 (en) 2006-10-31 2011-09-06 Unomedical A/S Infusion set
US9186480B2 (en) 2007-06-20 2015-11-17 Unomedical A/S Apparatus for making a catheter
US9320869B2 (en) 2007-06-20 2016-04-26 Unomedical A/S Apparatus for making a catheter
US8430850B2 (en) 2007-07-03 2013-04-30 Unomedical A/S Inserter having bistable equilibrium states
US8486003B2 (en) 2007-07-10 2013-07-16 Unomedical A/S Inserter having two springs
US8246588B2 (en) 2007-07-18 2012-08-21 Unomedical A/S Insertion device with pivoting action
US9566384B2 (en) 2008-02-20 2017-02-14 Unomedical A/S Insertion device with horizontally moving part
US9254373B2 (en) 2008-12-22 2016-02-09 Unomedical A/S Medical device comprising adhesive pad
US8562567B2 (en) 2009-07-30 2013-10-22 Unomedical A/S Inserter device with horizontal moving part
US9533092B2 (en) 2009-08-07 2017-01-03 Unomedical A/S Base part for a medication delivery device
US9415159B2 (en) 2010-03-30 2016-08-16 Unomedical A/S Medical device
US9724127B2 (en) 2010-09-27 2017-08-08 Unomedical A/S Insertion system and insertion kit
US9440051B2 (en) 2011-10-27 2016-09-13 Unomedical A/S Inserter for a multiplicity of subcutaneous parts
CN104274254A (en) * 2013-07-08 2015-01-14 王薇 Accurate quantification device for animal vein puncture dosing
CN104274254B (en) * 2013-07-08 2016-06-01 中国医学科学院北京协和医院 Animals administered intravenous puncture precise dosing device
WO2017212101A1 (en) * 2016-06-08 2017-12-14 Servicio Andaluz De Salud Device for inserting a flexible cannula

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732E Amendments to the register in respect of changes of name or changes affecting rights (sect. 32/1977)
PCNP Patent ceased through non-payment of renewal fee

Effective date: 20000605