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WO1996029111A1 - Catheter a deux lumieres, equipe de valves - Google Patents

Catheter a deux lumieres, equipe de valves Download PDF

Info

Publication number
WO1996029111A1
WO1996029111A1 PCT/CA1996/000160 CA9600160W WO9629111A1 WO 1996029111 A1 WO1996029111 A1 WO 1996029111A1 CA 9600160 W CA9600160 W CA 9600160W WO 9629111 A1 WO9629111 A1 WO 9629111A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
valves
housing
actuators
connectors
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/CA1996/000160
Other languages
English (en)
Inventor
Geoffrey S. Martin
Charles G. Shepherd
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.)
Med Pro Design Inc
Original Assignee
Med Pro Design Inc
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 Med Pro Design Inc filed Critical Med Pro Design Inc
Publication of WO1996029111A1 publication Critical patent/WO1996029111A1/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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075—Valve means
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M5/1582—Double lumen needles

Definitions

  • This application relates to a multi-lumen catheter used in procedures requiring intrusion into the blood circulation system of a patient, and normally referred to as vascular access catheters. More particularly, the invention relates to such catheters having a connection structure at the proximal end in the form of a compact housing which includes valves operable independently to control flows through the respective lumens.
  • Vascular access catheters have been developed as single lumen, dual lumen or multi-lumen catheters and are used for a variety of procedures, all of which involve intrusion into the blood circulatory system.
  • the main body of the catheter is designed for placement in a blood vessel and the body is permanently attached at an outer, or proximal end, to a connector which couples each of the lumens to one of a pair of extension tubes.
  • a connector which couples each of the lumens to one of a pair of extension tubes.
  • extension tubes can be flexible tubing and each of the tubes is fitted with a luer lock connector at its free end for attachment to a fluid line.
  • the connectors can be capped to close and seal the lumens when the catheter is not in use and a further seal is usually provided on each tube in the form of a clamp engaged about the tube and operable to squeeze the tube shut and hold it in this condition.
  • the clamps form a second line of defence and they are made necessary because it is possible that the luer lock and its cap can fail due to misuse or to flaws created during manufacture. It is evident that should both the luer lock and the clamp fail while the catheter is in place, the patient is at risk of bleeding to death or suffering an air embolism if the failure is not detected very quickly.
  • Tube failure is most prevalent on catheters that have thermoplastic tubular extensions made from polyurethane (PIT). Also the problem is exacerbated by the fact that such extensions are attacked in a mild way by organic solvents such as alcohol that is always present in heparin, the anti-coagulant of choice used in catheters to maintain the patency of the catheter when not in use.
  • An alternative to PU is silicone rubber which is not attacked by solvents such as alcohol. Consequently the walls will not stick to one another and this combined with the good rebound properties make it suitable for use as extension tubes.
  • silicone rubber extensions Although some manufacturers do use silicone rubber extensions for this reason, there is a different problem which has resulted in silicone rubber being superseded by PU. This problem relates to the fact that silicone is not thermoplastic and does not bond readily.
  • the catheter may become inefficient due to some form of restriction to flow caused, for example, by occlusion of one of the ports in the catheter. To correct this the catheter is rotated about its axis through about 180 degrees to move any occluded port away from the blood vessel wall or whatever us causing the reduction in flow. If the catheter is to be used in a procedure where such manipulation is desirable, then the actuator must be available from both sides of the catheter so that it can be used no matter how the catheter lies against the patient at the intrusion site.
  • a further object is to provide a catheter having valve actuators located for independent operation and which give the same appearance for use whether or not the catheter is rotated through 180 degrees. It is also an object of the invention to provide external structure having valve actuators which, when in the stored position, have reduced risk of accidental operation.
  • a catheter of the type used for use in procedures requiring vascular access having an elongate main body defining lumens and including proximal and distal ends, the distal end having ports for flow to and from the lumens, and outer structure at the proximal end providing connectors for flow to and from the lumens, the catheter being characterized by the outer structure being compact and comprising: a housing including independent channels connected one to each of the lumens and diverging as they extend away from the main body, connectors being in fluid communication one with each of said channels, valves one in each of the channels adjacent the connectors, and actuators coupled one to each of the valves, the actuators lying against the housing and extending from the valves axially towards the main body when stored with the valve closed, whereby the valves can be opened fully by rotating the actuators through 90 degrees in either direction to provide a visual indication that the valves are open to flow through the channels.
  • Fig. 1 is a frontal view showing the actual size of an exemplary catheter according to a prepared embodiment of the invention
  • Fig. 2 is a view similar to Fig. 1 and showing that portions of the catheter broken away to expose internal detail at a proximal end of the catheter;
  • Fig. 3 is a side view drawn in the direction of arrow "A" shown in Fig. 2 and illustrating the movement of an actuator;
  • Fig. 4 is a view similar to Fig. 2 but showing only a portion of an alternative embodiment of catheter.
  • Fig. 1 illustrates an exemplary catheter incorporating a preferred embodiment of the invention and designated generally by the numeral 20.
  • the catheter includes an elongate main body 22 extending from a tip 24 at the distal end to outer structure 26 at the proximal end and main body is a dual lumen of any suitable form typically having intake openings such as opening 28 and a return opening 30 at the tip.
  • the exact form of the main body is not critical to the invention.
  • the main body is strengthened adjacent the proximal end by a sleeve 32 which meets a rotatable suture wing 34 as is conventional in catheters of this type. As can be seen in Fig. 2, this is done by providing a waist 36 during assembly and the suture wing rotates on this waist located in place by the enlargements to either end of the waist.
  • the structure 26 consists of a housing 38 which is generally Y-shaped and as will be explained, defines channels 40, 42 (Fig. 2) communicating with the main body 22 for fluid flow into and out of the lumens in the main body.
  • the housing accommodates a pair of luer connectors 44, 46 for connection to external equipment.
  • FIG. 1 shows one of the luer connectors 46 having a cap 48 of the type used when the catheter is not in use. Also in Fig. 1 can be seen a pair of actuators 50, 52 associated with valves 51, 53 which are in the form of levers and in the storage position of Fig 1, these levers extend generally axially along sides of the housing 38. The actuators are operable to open the valves which are in the closed position in Fig. 1 and this will be described in more detail with reference to Fig. 2. For the moment it is sufficient to understand that they can be rotated and when they are rotated they stand out from the housing 38 for ready visual indication of the condition of the valves. It is important to note with reference to Fig. 1 the proportions of the other structure in relation to the catheter as a whole.
  • the structure permits the use of actuators quite close to the suture wing 34 because the arrangement permits independent use with minimal likelihood of accidental movement of the other actuator. This contrasts with prior structures where the length of the housing had to be lengthened to ensure that the actuators were separated.
  • the actuators shown in Fig. 1 blend into the overall structure and are less likely to be operated by accident, and when the catheter is not attached to equipment, the compact nature of the outer structure is such that it will present minimal discomfort and inconvenience to the patient.
  • Fig. 2 Reference is next made to Fig. 2 to describe details of the outer structure 26.
  • the channels 40, 42 pass through cylindrical chambers 54, 56 which have axes generally in a common plane.
  • the cylindrical chambers terminate at respective convergent walls 58, 60 provided to trap rotary valve barrels such as barrel 62.
  • the barrel includes a neck 64 which complements the convergent wall 58 to snap fit the barrel in place inside the cylindrical chamber.
  • the barrel includes an opening 66 positioned so that when the valve is operated, this opening is aligned with channel 42 to permit flow, and when the actuator is moved from the active position to the stored position shown in Fig.
  • the barrel 62 is integrally attached to the lever or actuator 52 which is located in the stored position by engagement over a raised detent 70, and there is a similar detent 72 on the opposite side of the housing to accommodate the other actuator 50.
  • the lever has a recess 74 (Fig. 3) provided to accommodate this detent.
  • the outer structure 26 is completed by the inclusion of the luer connectors 44, 46 which are put in place during the moulding operation of the housing 38.
  • the barrels 62 of the rotary valves ride directly in the cylindrical chambers 54, 56 of the housing 38. It is preferable that plastics materials be selected to give some compliancy for better sealing between these parts. It is anticipated that the housing 38 will be made from polyurethane which matches the material of the main body 22, and due to the similar plastic characteristics, makes it possible to form an essentially integral structure.
  • the barrels 62 of the rotary valves would preferably be of polyamide (sold under the trademark NYLON.)
  • Outer housing 38 is essentially of fixed shape, but there will be some resilience and this is enhanced by the inclusion of a slot 74 between branches of the housing. However this is an optional characteristic that is not essential. It does of course also have the advantage also that it reduces the amount of material in the housing and therefore the weight of the structure.
  • Fig. 3 illustrates the operation of the rotary valve in the housing.
  • This view is drawn on arrow "A" of Fig. 2 and shows the actuator 52 both in a stored position and in two active positions shown in ghost outline. These positions are possible because the actuator can be moved to the right or to the left as drawn in Fig. 3 and results in positions which are essentially at 90 degrees to the stored position.
  • the actuator can only be moved until it meets a shoulder 76 provided to limit movement and ensure that the valve is the active or open position.
  • a very important consideration is that when the actuator is in the open position, it is proud of the housing and consequently it is very clearly open and anyone inspecting the structure can see that it is open.
  • the actuator in the stored or closed position, the actuator is positively located using one of the detents 70, 72 where it blends into the overall shape of the housing. It is then evidently in the stored position with the valve closed. It will be evident from a review of these drawings that the overall length of the outer structure is minimized due to the location of the actuators and in fact, the length is dictated by having actuators that are readily operable. It is found that if the actuators could be shorter, then the arrangement could be compressed into a smaller form bringing the valves closer towards the main body 22.
  • a luer connector 80 is formed to include a through opening 82 which is proportioned to match a channel 84 and a transverse opening 86 is provided in alignment with a cylindrical chamber 88 in a housing 90.
  • Catheters according to the invention can be made using established extrusion, moulding and forming techniques commonly used in modern catheter manufacture.
  • the catheter would be used in medical techniques requiring intrusion to withdraw blood from a blood vessel for treatment before returning the blood to the same blood vessel.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un cathéter d'accès vasculaire à deux lumières, possédant un corps principal allongé et une structure extérieure compacte, montée sur le corps principal. La structure extérieure comprend une enveloppe et des valves dans celle-ci. Un dispositif de commande est fixé à chaque valve et peut être actionné pour l'ouvrir et la fermer. Les dispositifs de commande sont logés le long de l'enveloppe, les valves étant fermées, et dépassent de façon visible de cette enveloppe quand on les fait tourner dans un sens ou dans l'autre pour ouvrir les valves.
PCT/CA1996/000160 1995-03-20 1996-03-18 Catheter a deux lumieres, equipe de valves Ceased WO1996029111A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US40661395A 1995-03-20 1995-03-20
US08/406,613 1995-03-20

Publications (1)

Publication Number Publication Date
WO1996029111A1 true WO1996029111A1 (fr) 1996-09-26

Family

ID=23608745

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA1996/000160 Ceased WO1996029111A1 (fr) 1995-03-20 1996-03-18 Catheter a deux lumieres, equipe de valves

Country Status (1)

Country Link
WO (1) WO1996029111A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6592544B1 (en) 1999-11-24 2003-07-15 Edwards Lifesciences Corporation Vascular access devices having hemostatic safety valve
US6827710B1 (en) 1996-11-26 2004-12-07 Edwards Lifesciences Corporation Multiple lumen access device
US7163531B2 (en) 2002-08-19 2007-01-16 Baxter International, Inc. User-friendly catheter connection adapters for optimized connection to multiple lumen catheters

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5324274A (en) * 1992-03-30 1994-06-28 Med-Pro Design, Inc. Catheter having rotary valves

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5324274A (en) * 1992-03-30 1994-06-28 Med-Pro Design, Inc. Catheter having rotary valves

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6827710B1 (en) 1996-11-26 2004-12-07 Edwards Lifesciences Corporation Multiple lumen access device
US6592544B1 (en) 1999-11-24 2003-07-15 Edwards Lifesciences Corporation Vascular access devices having hemostatic safety valve
US7163531B2 (en) 2002-08-19 2007-01-16 Baxter International, Inc. User-friendly catheter connection adapters for optimized connection to multiple lumen catheters

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