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WO1994005363A1 - Catheter a deux lumieres - Google Patents

Catheter a deux lumieres Download PDF

Info

Publication number
WO1994005363A1
WO1994005363A1 PCT/GB1993/001890 GB9301890W WO9405363A1 WO 1994005363 A1 WO1994005363 A1 WO 1994005363A1 GB 9301890 W GB9301890 W GB 9301890W WO 9405363 A1 WO9405363 A1 WO 9405363A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
catheter
catheter according
outer lumen
inner lumen
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.)
Ceased
Application number
PCT/GB1993/001890
Other languages
English (en)
Inventor
Toby St. John King
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to JP6507014A priority Critical patent/JPH08501003A/ja
Priority to AU49759/93A priority patent/AU682473B2/en
Priority to EP94908831A priority patent/EP0659097A1/fr
Publication of WO1994005363A1 publication Critical patent/WO1994005363A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material

Definitions

  • the present invention relates to a dual-lumen catheter.
  • the dual-lumen catheter of the present invention has particular application for haemodialysis.
  • Dual-lumen catheters have been proposed for use in haemodialysis and are inserted into a vein, usually the jugular, subclavian or femoral vein. Such dual-lumen catheters have a first, arterial lumen through which blood is withdrawn from the vein. The blood is pumped round a dialysis filtration circuit and returned to the vein through a second, venous lumen of the catheter.
  • a dual-lumen haemodialysis catheter is usually fixed in situ on the patient for about two weeks, although in some instances the catheter may be in situ for up to eight months.
  • the catheter is normally only removed when treatment is no longer required or in case of infection at the insertion site or due to catheter malfunction.
  • a dual-lumen catheter comprising an outer lumen and an inner lumen which are joined at an insertion end of the catheter, the inner lumen lying within the outer lumen, the outer lumen being expandable for atraumatically preventing collapse of a vessel into which the catheter is inserted.
  • the outer lumen provides a support which prevents collapse of the vessel into which the catheter is inserted.
  • the outer lumen need not necessarily be expanded so far that it contacts the vessel; rather, it will usually be sufficient that the outer lumen be expanded slightly so that it will keep the vessel open should the vessel begin to collapse.
  • the outer lumen has a plurality of slits around its circumference which forms slats therebetween, withdrawal of the inner lumen relative to the outer lumen causing the slits to open thereby bowing the slats to expand the outer lumen.
  • slits provides a simple mechanism for allowing the outer lumen to be expanded.
  • the slits may also provide an opening through which blood can enter the outer (arterial) lumen.
  • Means are preferably provided for controllably withdrawing the inner lumen relative to the outer lumen.
  • the withdrawing means may comprise a linear mechanism, which may be a ratchet mechanism.
  • the withdrawing means may comprise a rotary mechanism.
  • the rotary withdrawing mechanism may comprise a screw thread on the inner lumen and a nut threaded on said inner lumen screw-thread, the nut being rotatable on said screw thread to withdraw and to advance the inner lumen relative to the outer lumen.
  • the outer lumen may include at least one sac which may be pressurised to expand the outer lumen.
  • Fig. 1 is a perspective view of a first example of the present invention
  • Fig. 2 is a detailed perspective view of the insertion end of the first example
  • Fig. 3 is a longitudinal cross-sectional view of a first example of a withdrawing mechanism
  • Fig. 4 is a perspective cross-sectional view of a second example of a withdrawing mechanism
  • Fig. 5 is a perspective view of a second example of the present invention.
  • Fig. 6 is a perspective view of the second example in an expanded state.
  • a catheter 1 includes a blade 2, which consists of the portion of the catheter which is inserted into the body of the patient, and a hub 3.
  • the blade 2 includes an outer (arterial) lumen 4 and a substantially concentric inner (venous) lumen 5 within the outer lumen 4.
  • the outer and inner lumina 4,5 are joined at the insertion end 6 of the catheter l. At their other ends, the outer and inner lumina 4,5 enter and are fixed to the hub 3 as will be described in more detail below.
  • the outer lumen 4 is provided with a plurality of substantially parallel slits 7.
  • the slits 7 in the example shown are parallel to the longitudinal axis of the blade 2, thereby forming six slats 8 which are substantially parallel to the longitudinal axis of the blade 2.
  • the slits 7 may spiral around the circumference of the outer lumen 4. Furthermore, more or less than the six slits 7 shown in the example may be used according to particular requirements.
  • the inner lumen 5 is advanced relative to the outer lumen 4 so that the slats 8 are preferably flush with the surface of the remainder of the outer lumen 4.
  • the blade 2 of the catheter 1 is then inserted conventionally into the vessel, which is usually one of a jugular, subclavian, or femoral vein. This insertion of the blade 2 is facilitated by the tapered, generally frustoconical shape of the insertion end 6. Once the blade 2 has been inserted sufficiently far, the inner lumen 5 is withdrawn relative to the outer lumen 4 which causes the slats 8 to bow outwards.
  • the overall diameter of the expanded slats 8 will normally be less than the diameter of the vein into which the blade 2 is inserted. Where the diameter of the expanded slats 8 exceeds that of the vein, it is not so large as to cause expansion of the vein beyond its elastic limit, thereby allowing the vein to relax to its natural size when the slats 8 are flattened.
  • the blade 2 can be formed by extruding the outer and inner lumina 4,5 as tubes. Suitable materials include a thermosoftening polymer such as polyurethane, although other materials such as PTFE may be used. The preferred material is radio-opaque "Teco-Flex" (trade mark) medical grade polyurethane.
  • the outer and inner lumina 4,5 are then joined at the tip 9 of the insertion end 6.
  • the outer lumen 4 be blocked at the end of the slits 7 proximate the insertion end 6 to prevent blood stagnating in the space otherwise formed between the outer and inner lumina 4,5 at the insertion end 6, thereby preventing infection or clotting of the blood.
  • This can be achieved by putting the tip ends of the outer and inner lumina 4,5 into a mould which is frustoconically shaped to provide the shaped insertion end 6 and injecting material so that it travels up the outer lumen 4 until it reaches the slits 7.
  • the material of the tip 9 of the blade 2 is generally similar to that of the blade 2, but may be a softer grade to produce an atraumatic tip 9 which reduces the risk of tissue damage on insertion of the blade 2.
  • the inner lumen 5 may be provided with a relatively wider section so that, when the inner lumen 5 is inserted into the outer lumen 4, the wider section forms a blockage at the correct location adjacent the ends of the slits 7 proximate the tip 9.
  • a thermoforming process may be used to make this wider section integral with the outer lumen 4.
  • the arrangement is preferably such that the slats 8 are substantially flush with the outer surface of the outer lumen 4 so as to minimise the risk of tissue damage.
  • the slits are opened to allow blood to flow from the vein into the outer lumen 4 through the gaps created by the slits 7 between the slats 8.
  • the degree of opening of the slits 7 can be varied as will be described further below.
  • the slits 7 may be formed simply by cutting into the outer lumen 4, without removing any material from the outer lumen 4.
  • the slits 7 would be completely closed when the inner lumen 5 is fully advanced relative to the outer lumen 4, creating a seal around the expansion area of the outer lumen 4. This may be helpful in preserving the effectiveness of operation of any anti-coagulant injected into the lumina 4,5 between dialysis to prevent thrombosis within the blade 2.
  • the slits 7 may be formed by removing slithers of material which would leave an opening in the outer lumen 4 even in the unexpanded state. This may help in avoiding tissue damage as the slits 7 are being closed prior to removal of the blade 2 from the vein.
  • Blood removed from the outer lumen 4 is returned, after dialysis, via the inner lumen 5 and returned to the vein through an opening 10 provided in the end of the tip 9. Further openings may be provided in or close to the tip 9 through the side of the blade 2 to facilitate transfer of blood from the catheter 1.
  • a guidewire may be used when inserting the catheter, the guidewire being inserted into the vein and the catheter then being passed along this guidewire with the wire passing up the centre of the inner lumen 5. The guidewire is then removed from the vein through the inner lumen 5 once the catheter 1 is in position.
  • the hub 3 has a generally triangular shape and is hollow along two joined arms 31,32 to form a generally Y-shaped channel.
  • the inner lumen 5 passes through one of the hollow arms 32 to a rotary withdrawing mechanism 20.
  • a screw thread 21 is formed on the end of the inner lumen 5. This screw thread 21 may be cut into or otherwise formed directly on the end of the inner lumen 5 or, alternatively, may be formed on a separate hollow component which is then rigidly fixed to the end of the inner lumen 5.
  • a nut 22 is threaded on the screw thread
  • a plug 23 is fitted in the rear of the hub 3 to retain the rotary withdrawing mechanism 20 within the hub 3.
  • the plug 23 has an elongate guide groove 24 running generally parallel to the direction of travel of the inner lumen 5.
  • a nib 25 is provided on the inner lumen 5 behind the screw thread 21, the nib 25 travelling in the groove 24 which therefore acts as a key-way to prevent rotation of the inner lumen 5 in the hub 3.
  • the nut 22 can be rotated to withdraw or advance the inner lumen 5 in the hub 3 according to need.
  • the nib 25 has limited travel in the groove 24 defined by the ends of the groove 24, which therefore acts to limit the extent of travel of the inner lumen 5 and accordingly the degree of expansion of the slats 8.
  • the outer lumen 4 is connected to the channel 33 formed in the other hollow arm 31. This channel 33 is separated from the channel in the first arm 32 by a diaphragm 34 through which the inner lumen 5 passes. This diaphragm 34 separates the concentric lumina 4,5 into two separate blood lines and prevents leakage of blood and aspiration of air as well as being a bacterial seal.
  • the diaphragm 34 may be made of polyurethane produced by a dipping technique to bond the diaphragm between the hub 3 and the inner lumen 5.
  • a natural rubber plug may be provided around the inner lumen 5 in the hollow arm 32 through which the inner lumen 5 passes.
  • the degree of movement of the inner lumen 5 back and forth relative to the hub 3 can be monitored by determining the number of rotations of the nut 22, for example. Additionally or alternatively, a scale (not shown) may be provided on the back tube 40 which connects the inner lumen 5 to the dialysis machine so that the degree of movement back and forth of the inner lumen 5 can be readily seen.
  • a linear withdrawing mechanism 50 is shown in figure 4.
  • the shape of the hub 3 is generally similar to that of the hub 3 shown in figure 3 although in the figure 4 example, an elongate rubber seal 34a is shown.
  • the inner lumen 5 is rigidly fixed to a ratchet block 51 which is provided with a plurality of teeth 52 along one edge.
  • the hub 3 is provided with a corresponding set of teeth 53 over which the teeth 52 on the ratchet block 51 ride.
  • the ratchet block 51 can be retained in the hub 3 by elongate ribs (not shown) on the block 51 running in elongate grooves (not shown) in the hub 3, for example.
  • the ratchet block 51 is simply moved backwards and forwards as required, the teeth 52 on the block 51 riding over the teeth 53 in the hub 3.
  • friction in the system is likely to be sufficient to prevent collapse of the expanded slats 8, particularly where a rubber seal 34a is used in the hub 3. If necessary, an extra lock can be provided so that the relative positions of the inner and outer lumina 4,5 can be maintained.
  • flanges 42,43 can be provided on the back tubes 40,41 with which the inner and outer lumina 5,4 are respectively in fluid communication, the flanges 42,43 facilitating connection to a blood line.
  • Each of the back tubes 40,41 is terminated with a conventional female luer connector 44.
  • Clamps 45 may also be provided on the back tubes 40,41 and suture wings (not shown) may be provided on or near the hub 3 to allow the catheter to be stitched to a patient's skin.
  • the outer lumen 4 is provided with closed pockets or sacs 60.
  • two diagonally opposite sacs 60 are shown, although more or less sacs may be provided.
  • An opening 61 is provided in the outer lumen 4, the opening 61 allowing withdrawal of blood from the vein 62 in which the catheter 1 is inserted.
  • a similar opening 61 may be provided on the diagonally opposite side of the outer lumen 4.
  • air or another fluid under pressure is introduced into the sacs 60.
  • the material of the outer lumen 4 is elastic, or at least that portion around the hole or holes 61 is elastic, so that the outer lumen 4 expands in this region to prevent the vein 62 from collapsing.
  • the blade 2 of the catheter 1 of the examples described above i.e. the portion from the hub 3 to the insertion end 6, may be 120 to 200mm long, although a paediatric catheter may be shorter.
  • the diameter of the blade 2 would be between about 3.33 to 4mm; other sizes may be used.
  • the ends of the slits 7 proximate the insertion end 6 of the catheter 2 may be approximately 30mm from the insertion end 6 of the catheter 1 and the slits 8 may be 10 to 15mm long.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne un cathéter de traitement sanguin (1) à deux lumières qui se compose de deux lumières (4, 5) s'ouvrant vers l'extrémité côté patient du cathéter afin de permettre l'extraction et le renvoi du sang dans le patient. Le cathéter comprend des éléments dilatables (8, 60) situés vers l'extrémité côté patient du cathéter conçus pour empêcher de manière atraumatique l'affaissement du vaisseau dans lequel le cathéter est inséré de manière à permettre une libre circulation du sang à l'entrée et à la sortie du cathéter. Les deux lumières peuvent être une lumière externe (4) et une lumière interne (5), la lumière interne (5) s'étendant dans la lumière externe (4). La lumière externe (4) présente une pluralité de fentes (7) sur sa circonférence qui forment des lamelles (8) intermédiaires. Le retrait de la lumière interne (5) par rapport à la lumière externe (4) entraîne l'ouverture des fentes (4), ce qui fait plier les lamelles (8) et les fait sortir de la lumière externe.
PCT/GB1993/001890 1992-09-08 1993-09-07 Catheter a deux lumieres Ceased WO1994005363A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP6507014A JPH08501003A (ja) 1992-09-08 1993-09-07 二重管腔カテーテル
AU49759/93A AU682473B2 (en) 1992-09-08 1993-09-07 A dual-lumen catheter
EP94908831A EP0659097A1 (fr) 1992-09-08 1993-09-07 Catheter a deux lumieres

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9218994.3 1992-09-08
GB929218994A GB9218994D0 (en) 1992-09-08 1992-09-08 Expandable catheter

Publications (1)

Publication Number Publication Date
WO1994005363A1 true WO1994005363A1 (fr) 1994-03-17

Family

ID=10721581

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1993/001890 Ceased WO1994005363A1 (fr) 1992-09-08 1993-09-07 Catheter a deux lumieres

Country Status (5)

Country Link
EP (1) EP0659097A1 (fr)
JP (1) JPH08501003A (fr)
AU (1) AU682473B2 (fr)
GB (1) GB9218994D0 (fr)
WO (1) WO1994005363A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3503706B2 (ja) 1994-02-04 2004-03-08 シーエムエー マイクロダイアリシス ホールディング アーベー 補強された微小透析探針
US7163531B2 (en) 2002-08-19 2007-01-16 Baxter International, Inc. User-friendly catheter connection adapters for optimized connection to multiple lumen catheters
CN107007920A (zh) * 2017-05-26 2017-08-04 南通大学附属医院 多功能防堵塞防尿道损伤膀胱冲洗导尿管

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5356382A (en) * 1992-10-23 1994-10-18 Applied Medical Research, Inc. Percutaneous tract measuring and forming device
JP2002052084A (ja) * 2000-08-08 2002-02-19 Asahi Optical Co Ltd 内視鏡用拡張具

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3108595A (en) * 1960-08-08 1963-10-29 Alfred P Overment Retention catheter
US3938530A (en) * 1974-11-15 1976-02-17 Santomieri Louis Catheter
FR2297640A1 (fr) * 1975-01-15 1976-08-13 Rhone Poulenc Ind Catheter
EP0025704A1 (fr) * 1979-09-17 1981-03-25 Sorenson Research Co. Inc. Cathéter à double lumière
EP0301854A2 (fr) * 1987-07-29 1989-02-01 LAUB, Glenn W. Cathéter transdermal utilisé dans les veines pour le bypass cardio-pulmonaire
EP0368473A2 (fr) * 1988-10-12 1990-05-16 Bard Limited Cathéter avec structure de rétention

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3108595A (en) * 1960-08-08 1963-10-29 Alfred P Overment Retention catheter
US3938530A (en) * 1974-11-15 1976-02-17 Santomieri Louis Catheter
FR2297640A1 (fr) * 1975-01-15 1976-08-13 Rhone Poulenc Ind Catheter
EP0025704A1 (fr) * 1979-09-17 1981-03-25 Sorenson Research Co. Inc. Cathéter à double lumière
EP0301854A2 (fr) * 1987-07-29 1989-02-01 LAUB, Glenn W. Cathéter transdermal utilisé dans les veines pour le bypass cardio-pulmonaire
EP0368473A2 (fr) * 1988-10-12 1990-05-16 Bard Limited Cathéter avec structure de rétention

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3503706B2 (ja) 1994-02-04 2004-03-08 シーエムエー マイクロダイアリシス ホールディング アーベー 補強された微小透析探針
US7163531B2 (en) 2002-08-19 2007-01-16 Baxter International, Inc. User-friendly catheter connection adapters for optimized connection to multiple lumen catheters
CN107007920A (zh) * 2017-05-26 2017-08-04 南通大学附属医院 多功能防堵塞防尿道损伤膀胱冲洗导尿管

Also Published As

Publication number Publication date
AU4975993A (en) 1994-03-29
EP0659097A1 (fr) 1995-06-28
AU682473B2 (en) 1997-10-09
JPH08501003A (ja) 1996-02-06
GB9218994D0 (en) 1992-10-21

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