CA2149402A1 - Bent co-axial catheter - Google Patents

Bent co-axial catheter

Info

Publication number
CA2149402A1
CA2149402A1 CA002149402A CA2149402A CA2149402A1 CA 2149402 A1 CA2149402 A1 CA 2149402A1 CA 002149402 A CA002149402 A CA 002149402A CA 2149402 A CA2149402 A CA 2149402A CA 2149402 A1 CA2149402 A1 CA 2149402A1
Authority
CA
Canada
Prior art keywords
catheter
section
outer tube
intake
inner tube
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.)
Abandoned
Application number
CA002149402A
Other languages
French (fr)
Inventor
Geoffrey S. Martin
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.)
Vas Cath Inc
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
Publication of CA2149402A1 publication Critical patent/CA2149402A1/en
Abandoned legal-status Critical Current

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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659Cannulae pertaining to extracorporeal circulation
    • A61M1/3661Cannulae pertaining to extracorporeal circulation for haemodialysis
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/003Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0034Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0039Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • 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
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0253Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • 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
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0637Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)

Abstract

The invention provides a co-axial dual lumen catheter (20) having a main section (37), a tip section (38), and a U-shaped proximal portion (34) extending from the main section and ending at a junction (32) where intake and outlet tubes (26, 28) are connected to the proximal portion. An inner tube (48) extends from the function to the tip section (38) of the catheter to define a return lumen (52), and combines with respective outer tubes (46, 60) in the main section (37) and the proximal portion (34) to define an intake lumen (50). The inner tube (48) is thin walled relative to the wall thickness of the first outer tube (46) used in the main section (37), and a second outer tube (60) used in the proximal portion (34) has a greater cross-sectional area than the first outer tube. A proximal end structure is also described in which the intake and outlet tubes extend generally parallel with the main body and to one side of the main body.

Description

21~402 DESCRIPTTON
CO-AXIAL CATHETER
TECHNICAL FIELD
This invention relates to co-axial dual lumen catheters for use in haemodialysis treatments and more particularly to such a catheter fQr placement in a jugular vein.

BACKGROUND ART
Haernodialysis treatments ha~e been de~eloped since the early 1960s using a variety of combinations and arrangements of cathe~ers. The earliest treatments were conducted using two needles in the same vein and this subsequently let to pioneer work done by Dr. Shaldon in England who used tWO flexible catheters which could be left in place for limited periods. It was recognized by some practitioners that it would ~be preferable to use a single incision rather than to use two and thic led to the de~elopment of techniques involving dual flow catheters. There are two basic types. The first tO be atternpted was a co-axial catheter with the intake lumen surrounding the return lumen. An exa~ple of this is tO be found in European Patent Publication 0025704A1 which shows a double lumen co-axial catheter which is elongate and ~ormed to have a tip, and also includes proxlmal end stmcture to make connec~ions to the-lumens.
Another approach is to use side-by-side lumens either in individual tubes connected to one another or in a single tube di~ided by an interior septum so that the lumens are D-shaped. Although such structures have become popular with miany surgeons, they also had disad~arltages. The most notable disadvantage is that because th~ lumens are side-by-slde, the intake openings must be on one side 0 ~ ~ of the catheter. As a consequence of this, there is a tendency for : : AMEN~ED SHEg~J
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1 i 2149~02 the suction at the openings to draw the catheter towards the wall of a blood ~essel with the result that the flow could stop. A doctor must then be called to move the catheter by rotating it until blood again ~lows. The side-by-side structures have advantages in S manufacture due to the fact that the two lumens can be created simultaneously in an extrusion. This has led to great activity in de~eloping devices having side-by-side D-shaped lumens at the expense of co-axial structures and one more recent example is to be found in European Patent Publication 0346613A1. The structure in this patent enhances the utility of a side-by-side lumer~ structure by . including permanently bent connecting tubes.
Due to the inherent disadvantages of the side-by-side structures, there has~ been renewed interest in developing suitable co-~; ~ axial devices. This is particularly because the intàke lumen can have c,penings in any par~ of the wall of the catheter.
`; ~ Dialysis catheters are commonly inserted in either the subclavian or )ugular veins. It has been found that the subclavian vein is more desirable *om the standpoint of patient acceptance due primarily tO the fact that the proximal~(i.e. external) portions of the 20 ~ catheter can be readily taped to the patient without interfering ~ significantly with the patient's movements. However, jugular Z` ~ placement has resulted in less vein s~enosis, and consequently jugular ; ~ placement is finding more favour among surgeons although the Zi p`roximal por~ions of the catheter can be an irritant for the patient i ~ ~ 25 ~ ~ because the~ port,ions tend to project upwardly near~ the ear of the ¦~ patient.

D15CI OSURE QF THE ~VENTION~
Z~ It` is therefore an objéct o~ the present inven~ion to provide a co-axial cathe~er particularly for placement in a jugular AMNDED SHEET
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` ~ 2149402 vein and which has a minimal upwardly projecting proximal pOItiOIl.
Aecordingly, in one of its aspects, ~he invention pro~rides a co-axial dual lumen catheter comprising a main section having proximal and distal ends and including a first outer tube; a tip section at said distal end; a U-shaped proximal portion having a distal end attached tO the main section at said proximal end of the main section and having a proximal end, the proximal portion including a second ou~er tube; a junction attached to the proximal end of the proximal portion; an inner tube e~tending loosely inside the first and second outer tubes and anchored at the tip and the junction to define a return lumen and combining with the first and second ou~er tubes to define an annular intake iumen; intake and outlet lumens a~tached to the junction, the tubes extending generally in parallel with the main section and to one side of the main section and being coupled to the respective intake and return lumens; and the inner tube being thin walled relatlve to the wall thickness of the first outer tube, and the second outer tube having a greater cross-I ~ sectional area than the first outer tube.9 This and other aspects of the invention will be better understood with reference tO the drawings.
:
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a side view of a catheter according to a preferred embodi~ent ~ the,inventi~n;
Fig. 2 is a sectional ~riew on line 2-2 of Fig. 1 and drawn to a larger scale;
Fig. 3 is a sectional view on line 3-3 of Fig. 1 and drawn tO the same scale as Fig. 2;
Figs. 4 and 5 are diagrammatic v;ews illustrating the AMENDg~D StlEE~T
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` S~ a 2149402 procedure of manufacturing the distal end (tip end) of the catheter;
Fig. 6 is a sèctional view drawn to a smaller scale than Fig.
2 and Illustrating a step in the manufacture of a U-shaped proximal portion of the catheter; and Fig. 7 is a pa~ially sectional view to the same scale as Fig.
2 and showing a junctlon at the proximal end of the catheter and demonstrating both the structure and a method of making the lunctlon.

.. .
BEST MODE FOR CARRYING OUT THE INVENTION
Reference is first made to Fig. I which illustrates a co-axial ^ - catheter designated generally by the numeral 20 and useful for .''! withdrawing blood through an intake 22 and returning treated blood through an outlet 24. The intake and outlet include a pair of flexible tubes 26, 28 which can be clamped using conventional devices such as device 30 shown on tube 28 and which terminate at ,~
respective luer connectors 27, 29. The tubes meet a~ a junction 32 at the proximal end of a U-shaped~proximal portion 34 which '1 ' ~: terminates at its distal end in a proxima~ transition portion 36 leading to a main sec~ion 37 and hence ~o a tip section 38 which meets the main body at a distal transition portion 3g. Blood is withdrawn through side openings 40 and returns through further side openings 42 and end opening 44. As a result of this .~
arrangement the tubes 26, 28 extend generally in parallel with the main sectlon 37 and lie to one side of the section 37.
As séen in Fig. 2, thé main section 37 includes an` outer tube 46 con~aining an inner tube 48 which also extends through l:he proximal portion 36 as will be explained. The in~er tube 48 is ` ~ : therefore continuous ha~ing ~a first part inside outer tube 46 in the main section 37 and a second :part inside the outer tube 60 forming A~AEN~ D SHEET
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- 5- 21~9402 part of the proximal portion 34. The inner tube 48 is free but for attachments at its ends as will be explained. The openings 40, shown in Fig. 1, supply blood to an intake lumen S0 formed between the tubes 46, 48 and in the proximal portion, between tubes 60 and 48. Blood returns by a return lumen 52 defined by the inner tube 48. The junction 32 at the proximal end of the U-shaped proximal portion 34 connects tubes 48, 60 tO the tubes 26, 28 (as will be e~plained) a~d the catheter is completed by provision of an attachment in the form of a wing structure 54 tO hold the catheter . 10 i.n place in a patient in conventional fashion. It is preferable that . the wing structure be rotatable on the catheter and provision is made for this with longitudinal location provided by a tapered ,j sleeve 56 and a distal end of the portion 34. These parts are elements of the.transition portion 36 as will be explained with :: 15 reference to Fig. 3.
l ~ The side openings 40 and 42 are typical of openings that l f can be provided a.round the periphery of the catheter tO ensure flow into and out of the catheter from arlywhere about the catheter.
Consequently, if the catheter should be~positioned so that some of 0 the openings are occluded by engagement with the wall of the 1~: b~ood vessel, other openings will provide the essential flow.
`I ~ Reference is next made to Fig. 3 to describe a preliminary : ` step in the manufacture of the cathe~er. As seen in Fig. 3, outer tube 46 extends through the tapered sleeve 56, then through a tubular central E~artl 58 of the wing structure 54, and ends jnside a ~:: distal end of the outer ~ube 60 of the proximal portion 34. Details of this arrangement will ~ecome evident as the method of assembly is described.: : .
3~ As a preliminary, the outer tube 46 is placed in a suitable 30: ~conventional injection moul&ng machine and positioned suitably to ~:
AMEN~)ED SHEET
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mold the sleeve 56 about the tube. The materials are compatible thermoplastics so that the sleeve becomes an integral part of the tube 46. Next~ the outer tube is used in an assembly shown in Fig., 4. In this step the inner tube 48 has a leading part indicated by S numeral 6g within a corresponding part 70 of the tip section 38.
These parts can of course be deformed to fit together in this way, but as shown, round tubing is selected for these par~s so that they fit within one another quite readily but at the same time quite closely. If preferred, the parts can be attached to one another using ` 10 a suitable adhesive. After this step has been completed, the outer tube 46 is placed about the inner tube 48 and a leading part 72 of the outer tube overlaps part 70 of the tip section. Consequently the parts 68, 70 and 72 are located about one another. Again an adhesi~e can be used to fix the assembly.
A tubular cylindrical mandrel 74 is proportioned to fit inside the outer tube 46 and about the mner tube 48. Typiçally all of the Inner and outer tubes and the ~ip section are polyurethane with the selection of the grades of the materials being chosen tO give the physical characteristics desired. Fo4r instance if a soft tip is required, then a material of a suitable Durometer is provided for ~he tip section 38. Of course sufficient rigidity must be provided in the ; ~ ou~er tube 48 to ensure that the catheter is stable both during insertion and when in place, and a suitable grade is selected for this.
` It should be noted that the inner tube is protected against collapse 25 1 so that the inne,r ~ube c!anl be of a relatiyely soft thin walled polyurethane which minimizes the sizes needed for integrity. Also, as will be described, this assists In forming;the U-shaped proximal portion 34 as well as maximizing the space available for flow in the catheter.
: ~ :
A solid second mandrel 76 is provided to support the AMENI:)~D SHE~
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Ç~i ^ -~ 21~9402 inner tube so that this tube extends between the mandrels 74 and 76. Mandrel 74 has a rounded end and stops against the part 70 of ehe tip section 38 whereas the inner mandrel 66 projects in~o the tip section 38. This provides support along the space occupied by two halves of a mold 78 which are operable to move into contact with the assembly.
The mold 78 is used to form the transition portion 39 by moving the mold halves into contact with the assembly shown in ' Fig. 4 under the influence of heat and pressure sufficient to cause the material of the parts 68, 70, and 72 to flow. Once this is ~ completed the structure is allowed to cool and the mandrels ,'¦ ~ removed. The result is shown in Fig. 5.
As seen in Fig. 5, the intake lumen 50 terminates at a '~ blind annular end wall 80 at the transition portion 39. The intake lumen 50 is contained between outer tube 46 and inner tube 48 and the openings 40 are provIded immediately- adjacent the transition portion 39 to allow blood flow into the lumen 50. More openings ~ ~ can of course be provided further away from the transition portion ;~ (as seen in Fig. 1) if required.
. ~ 20 The return lumen 52 formerly described with reference to the înner tube 48, now continues through the transition portion 39, and through the tip section 38. The transition portion ends the intake lumen 50 and blends smoothly from the outer surface of the tip section to the outer surface of the main section, and in particular tQ the ou~er su,rface of th je ~outer tube 46.
It should be noted in Fig. 5 that ~he three parts, narnely ; the outer and inner tubes 46, 48 and ~he tip section 38, are shown as , ~ ~ three mdniduàl parts by the shading. Where they meet at the transition portion 39, the shading has been omitted because this is a portion where the materials flow int~ one another and it is ` ~ AMEND~D St IEE~
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- 8 214940~
indefinite where the par~s begin and end after molding. However by cornparison between Figs. 4 and 5 it is evident that the parts 68, 70 blend into one as do the parts 70 and 72 resulting in the transil:ion portion 36. Preferably, the parts are all polyurethane with the grades and sizes being chosen to provide the desired physical characteristics such as a soft pliable tip section and a stiffer outer tube with a thin walled inner tube.
After the assembly has been molded as demonstrated iIl Figs 4 and S~ the tip section is deformed in a conventional manner to create a tapered tip 82 about the end opening 44.
Next the proximal end transition portion 36 is completed.
Referring to Fig. 3, the standard wing structure 54 is slipped over the outer tube 46 into engagement with the tapered sleeve 56. Next the proximal outer tube 60 of the U-shaped proximal portion 34 is slipped over the inner tube 48 (not shown in Fig. 3) and engaged on the tube 46. The tube 60 is held in place by chemical bonding or heat sealing ;n a position which permits the wing struc~ure tO rotate.
This assembly takes place before the tube 60 is bent. It should be noted that the numeral 54 could also in~icate a conventional cuff ~ ~ 20 which would be located in the same wa~ as the wing structure.
; The assembly is now complete from the proximal transition portion 36 to the dlstal end of the catheter. The outer : :
tube 60 of the portion 34 contains part of the inner tube 48 which, as was descrlbed, ends at and is anchored in, the distal transition 25 ; porti,on 39. The next step is to give the proximal portion 34 its U-shape. To do this, a flexible tubular mandrel indicated as 86 in Fig.
6 is engaged over the inner tube 48 and inside the outer tube 60.
The mandrel is of a synthetic elastomeric material, preferably that sold under the trademark TEFI.ON.
As seen in Fig. 6, the mandrel 86 is pushed until it reaches ~: :
AEND~D SHEE~T

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~ - 9 2149402 the proximal transition portion 36 and then the portion 34 is curved manùally to fit into a die indicated diagrammatically by numeral 87.
This die has a channel 60 to receive the portion 34 and a similar part of the die closes over the first part to trap the portion 34 in the desired U-shaped con~iguration. The die and catheter are then subjected to heating to about 120 degrees C. (250 degrees F.) to cause the inner tubes to take a new set. The mandrel resists this temperature.
After cooling in the die, the proximal portion 34 has a U-shaped configuration as seen in ~igs. 1 and 6.
The last step is to form the proximal end structure or junction 32. Reference is now made to Fig. 7. After trimming the inner and outer tubes 48, 60 as required, the assembly is prepared by `~ first positioning a proximal end of the proximaI portion 34 in a ~;l 15 mold (indicated in ghost outline) which is to create the junction 32 . by injection molding using conventional techniques. The portion 34 is positioned using first and second mandrels 94, 96. The mandrel 96 has a cylindrical portion 98 blending into a converging generally conical portion 100, which in turn blen~ls into a cylindrical end part 102 angled with respect to the portion lC0. The part 102 fits closely inside a proximal end of the inner tube 48 and this tube is maintained in a posi~on in engagement with the outer tube 60 by the mandrels 94, 96.
The mandrel 94 has an outer cylindrical portion 104 2S which blends into a con~erging and generally conical portion 106 ending in a projection 108. This projection has a generally U-shaped cross-section (as will be explained~ and is angled with respect to the conical portion 106. ~
The projection 108 on the end of the mandrel 94 is shaped to fit ~he space provided when thé inner tube 4~ is held against the ND~D S~IEET
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- .214 9 41) 2 inner surface of the outer tube 60. As a result it has a generally U-shaped configuration. The angular offsets of the projection 108 and the end par~ of 102 of mandrel 96 result in the projection and end part 102 extending in parallel axially with respect to the proximal portion 34. The cylindrical portlons 98 and 104 diverge sufficiently i with respect to the axial main section that the ends of the respective intake and outlet tubes 26, 28 can be accommodated on the mandrels with the ends positioned in the mold ~o become entrapped as the junction 32 is molded.
`j 10 Once the ~assembly shown in Fig. 7 has been completed, ; the mold is closed and injection takes place to form the junction 32.
- The mandrel is preferably polyu~ethane although other materials can be used provided that the usual re~uirements of compatibility etc.
~1 are met.
., The mandrels are removed, and because there is some ~lexibility in the materiaI, the mandrels can be pulled out without causing any damage.
The structure shown in Fig. 7 has particular significance in the resulting flow through the catheter~ Unlike prevlous co-axial ; 20 catheters, the flow tends to remain linear due to the fact that the` ~ intake and return tubes 26, 28 are generally in line with the portion ~ 34. Previously, one of these tubes was in line and the other was ;` ~ ~ ~ connected through the side of the junction so that the flow must pass through a significant angle which in some instances approached ; 25 90 degrees. This is most undesirable because any changes in ; direction of this kind wili result~'in turbulence in the blood flow with potential for damage to the ;blood. It is well established that pressure fluctuatlons in blood flow paths should minimized, and ~h~s stmcture tends to limit such~ variations.
~ ~ The ~angle shown ~as "A" in Fig. 7 indicates the divergence l ~ ~ .
: AMENDED SHEET:
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between the tubes 26,28 are as they meet the junction 32. Because of the construction it is possible to maintain this angle in the order of 15 tO 20 degrees and is readily maintained below 30 degrees. As a result, the flow in~o and out of the catheter is essentially axial S with reference to the portion 34 at all times. This is because the angle of each of the tubes 26,28 with reference to the axis of the portion 34 where it meets the junction 32is half of the range up to 30 degrees.
The catheter shown as a preferred embodiment is typical of catheters that could be made in accordance with the invention.
As mentioned earlier it is possible tO proportion the tip and/or provide sof~ material for the tip to ensure that after insertion the tip will flex and will not damage veins. At the same time, there is sufficient rigidity in the transition portion to maintain the ; 15 relatlonship be~ween the tip and the inner and outer tubes so that he intakè lumen S0 remains patent while the insertion takes place and during use.
The proportions of the parts can be ~aried and it would be possible tO do some preforming before assembly.
In a typical embodiment the various tubes used in the structure are pol~urethane. The outer tube 46 is a firm polyurethaIle ha~ing a 65D Durometer. It is 3.175mm inside . :
diameter and 3.734mm outslde diameter. The tip section is also 65D
with an inside diameter of 1.727mm and an outside diameter of 2.667m m. The inner tuhe~ has a w~l thickness of 0.19nnm jand is 65D Durometer polyurethane dimensioned ~o be fitted into the assembly shown in F~g. 39 and the tube 60, is proportioned to fi~
over the outer tube 46. The tube 60 has a wall thickness of about 1.31mm and a hardness of 85A Durometer which gives it good memory propertles to hold ~he curve and also tO rninimize the risk :~ : AA~ N D E D S H EET
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of kinking.
It is important to note that this catheter overcomes ; disadvantages in the art. Firstly, the structure is such that the inner tube can be thin walled because it is protected by the stiffer outer tube 46 inside the main section 37 and also because it is protected inside the U-shaped proximal portion 34. This portion is made to `l; be larger in cross-section and stiffer so that it will both resist bending and also to increase the modulus by increasing the cross-section so that it will also exhibit less likelihood to kinking when blending forces are applied. This feature is significant since a thin walled inner tube 48 can be used because the tube is protected and - therefore not required to have any great resistance or kinking.
~, Another advantage is that the thin walled soft inner tube takes up ;l minimal cross-sectional space in the main section 37 thereby permitting this portion of the co-axial catheter to have a smaller ,~ cross-section for ease of insertlon. Yet another feature is the fact that there is minimum of upwardly extending structure beyond the attachment 36 when the catheter is placed in a jugular vein. This is very important to the comfort of the ~tient. Also, because attachment takes place where the c~theter exits the incision, manipulation of the tubes to make connections etc. will ha~e less likelihood of dislodging or moving the catheter.
It will be apparent that the structure can be varied within the scope of the inventlon. In particular, the tip section need not be tapered and in some cases (depending upon requirements) the distal end of the catheter coul~ be closed. Aiso, the proximal transition ~, portion could be arranged with a cuff instead of the wing stmcture '1 :
20. Either of these attachments c~ be used ad~antageously.
~; The invention incorpora~es all variati,,,~,ns within the scope ~ ~ 30 of the claims and is n,z,t restricted to the embodiments disclosed.
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1~ ag~02 INDUSTRIAL CAPABILITY
The catheter is useful for dialysis by jugular access. At th;s site the intake and outlet tubes will rest downwardly where connectivns can be made away from the patient's ear, thereby enhancing making such access more acceptable. Also, because of the arrangements of sizes of parts of the catheter there is reduced likelihood of flow disruption by kinking of the parts of the catheter normally exposed during use of ~he catheter in place in the jugular of a patient.

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1~.. 21~9402 INDEX OF REFERENCE SIGNS
Co-axial catheter 22 Intake ?4 Outlet 26 Flexible tube 27 Luer connector 28 Flexible tube 29 Luer connector 30 Clamp Device Y 32 Junction 34 Proximal portion 36 Transition portion 38 Tip section Side openings 42 Side openings 4 End opening 46 Outer tube ~ 10 48 Inner tube 50 Intake lumen :~, 52 Return lumen 54 Wing structure 56 Sleeve 58 Central part Outer tube 68 Leading part 70 . Part of tip section 72 Leading part ~ .
:: lS 74 :Mandrel 76 Mandrel ~` 78 Mold : 80 End wall 82 Tapered tip ~ ~ 86 Mandrel ~ :: 94 First mandrel 96 Second mandrel ; ; ~ ~ 98 Cylindrical~portion l00 Conical por~lon 102 End part 104 Cylindrical portion 106 Conical portion 108 Pr~jection ~ ~ .
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AI~END~D SHEET
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Claims (11)

- 16 -
1. A co-axial dual lumen catheter which includes a main section (37) having proximal and distal ends and a first outer tube (46), a tip section (38) at the distal end, an inner tube (48), and intake and outlet tubes (22, 24) attached to a junction (32) characterized in that the catheter includes a U-shaped proximal portion (34) having a distal end attached to the main section at said proximal end of the main section and having a proximal end attached to the junction, the proximal portion including a second outer tube (60) having a greater cross-section than that of the first outer tube, and an inner tube (48) extending loosely inside the first and second outer tubes (46, 60) and anchored at the tip and at the junction to define a return lumen (52) and combining with the first and second outer tubes to define an annular intake lumen (50), the intake and outlet tubes (22, 74) extending generally in parallel with the main section (37) and to one side of the main section and being coupled to the respective intake and return lumens (50, 52).
2. A catheter as claimed in claim 1 in which the inner tube (48) is thin walled relative to the wall thickness of the first outer tube (46), and the second outer tube (60) has a greater cross-sectional area than the first outer tube to provide improved resistance to kinking and to protect the thin walled inner tube which has minimal resistance to kinking.
3. A catheter as claimed in claims 1 or 2 and further comprising an attachment (54) at said proximal end for anchoring the catheter to a patient.
4. A catheter as claimed in claims 2 or 3 in which the attachment is a rotatable wing.
5. A catheter as claimed in claims 2 or 3 in which the attachment is a cuff.
6. A catheter as claimed in claims 1 or 2 in which the first outer tube (46) defines intake openings (40) providing access into the intake lumen (50), and the tip section (38) is of smaller cross-section than the main section (37), the tip section having at least one return opening (42,44).
7. A catheter as claimed in claims 1 or 2 in which the first outer tube (46) defines intake openings (40) providing access into the intake lumen (50), and the tip section (38) is of smaller cross-section than the main section (37), the tip section having at least one return opening (42,44), and further comprising a transition portion (39) at the distal end of the main section (37), the transition portion (39) being formed of material provided in overlapping parts of the inner tube (48), the tip section (38) and the first outer tube (46), the inner tube being inside the tip section which is inside the first outer tube, the inner tube blending smoothly internally into the tip section at the transition portion and the outer tube blending smoothly externally into the tip section with the intake lumen (50) ending at the transition portion, the tip section forming a continuation of the return lumen (52) and the return lumen ending at said end opening (44).
8. A catheter as claimed in claims 1 or 2 in which the inner tube (48), first and second outer tubes (46, 60) and tip section (38) are round in cross-section.
9. A catheter as claimed in claims 1 or 2 in which the diameter of the tip section (38) is greater than that of the inner tube (48) and less than that of the first outer tube (46).
10. A catheter as claimed in claims 1 or 2 in which the inner tube (48) and the first outer tube (46) are spaced from one another radially where the intake lumen (50) terminates.
11. A catheter as claimed in claims 1 or 2 in which the intake and outlet tubes (26, 28) leave the junction (32) generally parallel with the main section(37) and to one side of the main section and with an angle of divergence between the intake and the outlet tubes of less than about 30 degrees and spaced substantially equally to either side of the junction.
CA002149402A 1992-12-22 1993-12-22 Bent co-axial catheter Abandoned CA2149402A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/995,213 US5350358A (en) 1992-12-22 1992-12-22 Bent co-axial catheter
US07/995,213 1992-12-22
PCT/CA1993/000559 WO1994014493A1 (en) 1992-12-22 1993-12-22 Bent co-axial catheter

Publications (1)

Publication Number Publication Date
CA2149402A1 true CA2149402A1 (en) 1994-07-07

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CA002149402A Abandoned CA2149402A1 (en) 1992-12-22 1993-12-22 Bent co-axial catheter

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US (2) US5350358A (en)
EP (1) EP0675743B1 (en)
JP (3) JPH08504627A (en)
AU (1) AU5691494A (en)
CA (1) CA2149402A1 (en)
DE (1) DE69321257T2 (en)
ES (1) ES2125432T3 (en)
WO (1) WO1994014493A1 (en)

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Also Published As

Publication number Publication date
AU5691494A (en) 1994-07-19
DE69321257T2 (en) 1999-02-18
JPH08504627A (en) 1996-05-21
USRE41462E1 (en) 2010-07-27
ES2125432T3 (en) 1999-03-01
EP0675743A1 (en) 1995-10-11
DE69321257D1 (en) 1998-10-29
EP0675743B1 (en) 1998-09-23
JP2004358217A (en) 2004-12-24
JP2008178720A (en) 2008-08-07
US5350358A (en) 1994-09-27
WO1994014493A1 (en) 1994-07-07

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