CA1167727A - Cannula - Google Patents

Cannula

Info

Publication number
CA1167727A
CA1167727A CA000390997A CA390997A CA1167727A CA 1167727 A CA1167727 A CA 1167727A CA 000390997 A CA000390997 A CA 000390997A CA 390997 A CA390997 A CA 390997A CA 1167727 A CA1167727 A CA 1167727A
Authority
CA
Canada
Prior art keywords
cannula
lumen
lumens
septum
wall
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.)
Expired
Application number
CA000390997A
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
Vas Cath of Canada Ltd
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 Vas Cath of Canada Ltd filed Critical Vas Cath of Canada Ltd
Application granted granted Critical
Publication of CA1167727A publication Critical patent/CA1167727A/en
Expired 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
    • A61M25/0023Catheters; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M5/1582Double lumen needles
    • 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
    • A61M2025/0037Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side

Abstract

ABSTRACT OF THE DISCLOSURE

A dual lumen cannula particularly for use in haemodialysis by inserting the cannula into the subclavian or femoral vein of a patient to contemporaneously remove blood from the vein for treatment and to return treated blood to the vein downstream from the point of removal. The cannula includes a pair of lumens separated by a septum. Blood is withdrawn through one of the lumens and treated blood is returned through the other lumen. The cannula is formed from a flexible thermo-plastic material and is sufficiently flexible to permit bending to conform to the shape of the vein without damage or kinking. The cannula has a peripheral generally cylindrical wall with a septum extending between spaced locations on the interior surface of the wall to define a pair of discrete lumens and at least one of the lumens is deformed by increasing its wall thickness at its end to facilitate insertion.

Description

i'7~
This invention rel~tes to a dual lumen cannula, and more particularly to such a cannula for insertion into the subclavian or ~emoral veins of a patient to facilitate haemodialysis treatments.
For regular haemodialysis, permanent vascular access i5 normally provided by means of a surgically constructed arterio-venous fistula, created if possible in advance of need.
The conventional method of conducting haemodialysis on a patient is to introduce into an arterialized vein, normally a lower arm vein, one or two blood flow needles. Blood is removed from the patient to an exterior haemodialysis machine and then the treated blood is returned to the patient at substantially the same location. At least one puncture of the vein needs to be made for such catheter insertion whenever the patient undergoes a haemodialysis treatment. Commonly two separate needle devices are used, one for blood outflow and the other for blood return, although there is a growing interest in dual lumen catheters which have the advantage that they require only one vein puncture. Examples of conventional co-axially arranged metal cannulae for use in a limb of the patient are to be found in U.S0 Patents 4,037,599 to Raulerson; 4,073,297 to Koop;
4,134,402 to Mahurkar; and 4,096,860 to McLaughlin. All of these examples of prior art show a rigid, metal needle-type cannula for temporary use during the actual haemodialysis or transfusion etc. ~hese devices are removed once the procedure is completed. ~one of the devices is suitable for insertion into a subclavian vein.

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~ lthough t~le arterio-venous fistula is the standard and accepted method for permanerlt vascular access, some patients experi0nce end stage renal failure without warning, and established fistulae may fail unexpectedly. With the growth of large programmes for long-term peritoneal dialysis, an increasing number of patients must be transferred at short notice to haemodialysis because of peritonitis. Such patients do not usually have arterio-venous fistulae constructed in advance, since many of them will never need them. Patients on long-term peritoneal dialysis may also need short-term haemodialysis while they undergo abdominal surgery. Transplant recipients whose arterio-venous fistulae have thrombosed may develop acute renal failure. For all these categories of patients, the silastic TEFLON ( ) shunt, though immediately usable, wastes blood vessels and may not be feasible in patients whose access sites have already been used. ~emporary peritoneal dialysis is not always a suitable alternative.
There is thus a need for a simple, i~mediately usable vascular access method which does not destroy blood vessels, and does not limit the patient's mobility. A suitable structure would incorporate the extraction and return lumens into a single cannula made of a flexible material. Whilst various proposals have been made for such cannulas, none have been entirely satisfactory, mainly because the materials that provide the necessary flexibility do not exhibit sufficient rigidity to allow insertion of the cannula.

( )registered trade mark ' 7;~7 According to ti~e present invention there is provided a cannula having cl peripheral wall defined by continuous interior and exterior surfaces and a septum extending between spaced points on said interior surface to divide said cannula into a pair of discrete lumens, one end.of said cannula being stiffened for insertion into a patient by dei.ormation of at least one of the lumens by increasing its wall thickness at this end.
An embodiment of the invention will now be described by way of example only with reference to the accompanying drawings in which:
Figure 1 i.s a diagrammatic view showing a dual lumen cannula inserted into a patient;
Figure 2 is a plan view of a prepared embodiment of the end of the cannula;
Figure 3 is a sectional side view on lines 3-3 of Figure 2;
Figure 4 is an end view of the cannula looking from the right of Figure 2;
Figures 5 and 6 are respective sectional end views on lines 5-5 and 6-6 of Fi.gure 3;
Figure 7 is a cross-sectional side view of the other end of the cannula which protrudes from the patient together with the fitting to permit attachment of external tubes to the cannula;
Figure 8 is a view similar to Figure 3 showing an alternative embodiment of the dual lumen cannula according to the invention;

:1 ~l t i 7 7~ ~

Figure 9 i8 a plan vie~ of the cannula shown ln Figure 8;
Figure~ 10 and 11 are re~pective sectional end view~ on lines 10-10 and 11-11 of Fi~ure 9; and Figure 12 is an end view of the cannula looking from the right of Figure 90 Reference iB first made to Figure 1 which shows the pre~erred embodiment of cannula 22 used in a ~ubclavian haemodialysis. It is shown on a piatient in a mode between haemoclialysifi treatments. The cannula is secured in position by means of a conventional adhe~ive dressing 2~ with the cannula 22 positioned through the dressing 20. One end ~4 of the cannula 22 is introduced into the ~ubclavian vein and the other end 26 protrudes from the patient and is secured by the dressing 20.
The one end 24 may best be seen with reference to Figures 2 through 6. The cannula 22 comprises a peripheral wall 28 having continuous outer and inner surfaces 30, 32 respectively~ The peripheral wall 28 is generally circular in cross-section so that the main body of the cannula is cylindrical. A septum 34 extends diametrically across the interior of the cannula and is connected to the peripheral wall 28 at spaced locations. The septum therefore divides the cannula 22 in a pair of discrete lumens 36, 38 respectively.
The lumen 36 serves to return blood to the vein whereas the lumen 38 serves to extract blood from the vein.
The cannula is formed from a flexible thermo-plastic material such as polyethylene, polyurethane or TEFLON( ) tubing ( )registered trade mark 7~7 which is extruded in any conventional manner with the peripheral wall 28 and sep-tum 34 integrall~ formed. As such it is inherently flexible and therefore may confor~ to the shape of the subclavian vein and may also be left in the patient between treatments without causing undue cliscomfort. ~owever the flexible nature of the material makes feeding of the cannula difficult when initially inserted.
To overcome the above disadvantage, the end 2~ of the cannula 22 is stiffened by deformation of the peripheral wall and septum adjacent the end 24.
In the preferred emodiment, shown in figures 2 to 6, the sep-tum 34 is deformed so that it merges with the inner surface 32 of the portion of the peripheral wall 28 defining the lumen 38 at the tip 42 of the end 24 of the cannula 22.
The sep~um 34 is deformed such that the cross-sectional area of the lumen 38 gradually decreases until it is sealed by merging of the septum 34 with the wall 28. The cross section of the lumen 36 at the tip 42 is circular but of smaller diametex than the body of the cannula 22.
2~ This deformation is achieved b~ placing a mandrel indicated at 46 in chain-dot lines in Fi~ure 3 into the lumen 36 and b~ sliding a silicon rubber tube 48, also shown in chain-dot lines; over the outer surface 30 of the cannula 22. The diameter of the silicon tube is equal to the smallest outside diameter required on the finished portion of the lumen 36 and the mandrel 46 is shaped to the required internal configuration of the lumen 36. The silicon rubber is elastic and therefore 7Z,l~
will exert a peripheral force uniformally around the lumen 3~.
Heat is gen-tly applied by means of a hot air gun, and passes through the silicon tubing and into the thermo-plastic material defining the wall of the cannula. The thermo plastic material melts although the silicon tubing is unaffected by the heat.
The pressure exerted by the silicon tubing then forces the melted thermo-plastic material to the shape defined by the mandrel and the excess material due to the decrease in the circumference of the lumen results in an increased thickness of the wall.
The deformed end 24 is then cooled to set the thermo-plastic material and the silicon tubing 48 and mandrel 46 removed. The gradual increase in cross-sectional area of the lumen 36 toward the tip ~2 permits the mandrel 46 to be inserted and removed from the tip 42 of the cannula 22.
A plurality of holes 68 are formed in the peripheral wall 28 of the lumen 38 to allow blood to flow from the vein into the lumen 38. The passageway defined by these holes is therefore located upstream from the tip 42 of lumen 3~ which acts as an exit passageway for -the return flow of blood into the vein.
As seen in Figure 7, the outer end of the cannula is provided with a fitting 50 which enables the two discrete blood flows to be transferred to a treatment machine. The fitting 50 comprises a chamber 52 with an inlet port 54 and a pair of outlet ports 5~, 58 respectively. The inlet port 54 is dimensioned to be a snug f it on the outer surface 30 of the cannula 22 so that a seal is provicled between the fitting and the cannula. The outlet port 56 communicates with the interior of the chamber 52 and provides a stub 60 to which a fle~ible tube 62 may be attached. A similar stub 64 is provided adjacent the outlet port 58 to receive a second length oE flexible tubing 66. A portion of the peripheral wall 28 surrounding the lumen 38 is removed, as indicated at 70, to provide a passageway for blood in the lumen 38 to flow out of the outlet port 56. The end oE the cannula 38 is sealed b,y deformation of the septum 3 in a manner similar to that described above by means of a mandrel and silicon so that a single circular opening of reduced diameter is provided for the lumen 36. ~he outlet port 58 is dimensioned to be a snug fit around the finished diameter of the lumen 36 so that blood flowing from the apparatus back through the lumen 36 is maintained separate rom blood being removed through the lumen 38 and the tube 62. The fitting 50 may be made through -ths luman 38 and the tube 62 and is of any suitable plastic material formed by injection molding. In addition a deformation of the end 26 of the cannula increases its stiffness to assist in insertion of the tube in the fitting 50. If preferred, the outlet port 50 may be formed with a nipple extending into the chamber 52 so that the lumen 36 fits over the nipple to provide a seal~
It will be sean therefore that a flexible cannula is provided with a pair of discrete lumens to remove and replace blood from the vein. The deformation of the end of the cannula ~ ~ ~i'7~
increases its stiffness to facilitate insertion into the vein with rendering the ~ody of the cannula inflexible.
An alternative embodiment of the end of the cannula i5 shown in Figures 8-12. Similar reference numerals are used to indicate components equivalent to those described with reference to Figures 2-6 with a suffi~ 'a' added for clarity of descripkion.
In this embodiment, the end 24a is formed by removing the portion of the peripheral wall 28a definin~ the lumen 38a.
The peripheral wall is cut to define a curved end surface 40a for the lumen 38a and to merge smoothly with the septum 34a at the intersection of the septum with the inner surface 32a. The septum 34a is then deformed to provide a circular cross-section at the -tip 42a of the lumen 36a. The deformation of the septum and the portion of the peripheral wall defining the lumen 36a results in a gradual increase in the thickness of the peripheral wall 28a as the tip 42a is approached. Ihe increased wall thickness therefore stiffens the tip 42a and facilitates insertion of the cannula.
As can best be seen in Figures 9-12, the cross-section of the lumens 36a, 38a is initially semi-circular at the point at which the lumen 38 and smoothly tapers to provide a circular cross-section at the tip 42a of the lumen 36a.
Because of the reduction in the diameter of the extreme end 42a of the lumen 38a a plurality oE holes 44a are formed in the peripheral wall 28a to increase the cross-section of the lumen for blood to flow out. Once again, the deformation o the _ g _ ' :

.

:3.~
wall 28a -to provide an increased thickness at the ~ip 42a results in the required stiffness of the end 24a of the cannula 22a. In this embodiment however the mandrel 46a must he inserted from the other end 26a of the cannula 22a because of the gradual reduction in cross-section toward the tip 42a~ The end 26a of the cannula 22a may be formed as shown in Figure 7 after the mandrel 46a has been removed.
Although the cannula has been described in use in a subclavian vein, it can also be used in a femoral vein. It will be evident that to facilitate such insertion a needle can be entered into the lumen 36 (Fig. 7) and out the other end of the cannula shown in Fig. 3. After insertion the needle is withdrawn in the usual way leaving the cannula in place.
Similarly, the cannula can be used at other locations for other purposes.

Claims (11)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A flexible cannula having a peripheral wall defining interior and exterior surfaces and a septum extending between spaced points on the interior surface to divide the cannula into a pair of discrete lumens, one end of the cannula being stiffened by deformation of both part of the peripheral wall defining one lumen and the septum adjacent this part of the peripheral wall to facilitate safe insertion into a patient without collapsing the end of the cannula.
2. A cannula according to claim 1 wherein the deformation of the septum seals the other of the lumens at the one end.
3. A cannula according to claim 2 wherein a plurality of holes are formed in the peripheral wall of the other of the lumens adjacent the one end to permit flow of blood into the other of the lumens.
4. A cannula according to claim 1 wherein the one lumen extends beyond the other of the lumens and the septum is deformed to provide a circular cross-section for the one lumen.
5. A cannula according to claim 4 wherein a plurality of holes are formed in the one lumen to increase the cross sectional area of this lumen at the one end.
6. A flexible cannula having first and second lumens defined by an outer wall and a septum separating the lumens, the first lumen terminating at an end having a generally cylindrical cross-section and having an increased wall thickness in the region of the tip to provide a tip stiffer than the remainder of the cannula and the second lumen having at least one communicating opening short of said end.
7. A cannula as claimed in claim 6 in which the outer wall and the septum are deformed at said end such that the septum is in engagement with the outer wall to close the end of the second lumen and in which said communicating opening is in the outer wall.
8. A cannula as claimed in claim 6 in which the outer wall is cut away short of said end and where it forms part of the second lumen to provide said communicating opening.
9. A method of increasing the stiffness of one end of a flexible cannula having a peripheral wall defined by continuous interior and exterior surfaces with a septum extending between spaced points on the interior surface to divide the cannula into a pair of discrete lumens, the method comprising the step of deforming the septum at the one end to merge the septum with the peripheral wall and to thereby provide a region of increased stiffness.
10. A method according to claim 9 wherein said deformation is performed by forming said cannula from a thermo-plastic material, inserting a mandrel of desired shape into the one lumen, applying peripheral pressure to the wall, heating the wall to deform it to the shape of the mandrel, cooling the wall and removing the mandrel.
11. A cannula having a peripheral wall defined by continuous inner and outer surfaces, a septum extending between spaced points on said inner surface to divide the cannula into a pair of discrete lumens, each of the lumens having an opening adjacent one end of the cannula to permit flow of blood between a blood vessel in which the cannula is located and the lumen, the openings being spaced along the axis of the cannula to permit replacement of blood through one of the lumens downstream of removal of blood through the other of the lumens, the septum being deformed adjacent the one end to combine with the peripheral wall to provide the opening for said one lumen and to increase the axial stiffness of the cannula.
CA000390997A 1981-07-24 1981-11-26 Cannula Expired CA1167727A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/286,589 US4451252A (en) 1981-07-24 1981-07-24 Cannula
US06/286,589 1981-07-24

Publications (1)

Publication Number Publication Date
CA1167727A true CA1167727A (en) 1984-05-22

Family

ID=23099286

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000390997A Expired CA1167727A (en) 1981-07-24 1981-11-26 Cannula

Country Status (6)

Country Link
US (1) US4451252A (en)
AU (1) AU569500B2 (en)
CA (1) CA1167727A (en)
DE (1) DE3411810A1 (en)
FR (1) FR2569113B1 (en)
GB (1) GB2156220B (en)

Cited By (13)

* Cited by examiner, † Cited by third party
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US4692141A (en) * 1982-03-08 1987-09-08 Mahurkar Sakharam D Double lumen catheter
US4770652A (en) * 1985-02-12 1988-09-13 Mahurkar Sakharam D Method and apparatus for using dual-lumen catheters for extracorporeal treatment
US4808155A (en) * 1986-02-27 1989-02-28 Mahurkar Sakharam D Simple double lumen catheter
US5197951A (en) * 1983-12-14 1993-03-30 Mahurkar Sakharam D Simple double lumen catheter
US5221255A (en) 1990-01-10 1993-06-22 Mahurkar Sakharam D Reinforced multiple lumen catheter
US5374245A (en) 1990-01-10 1994-12-20 Mahurkar; Sakharam D. Reinforced multiple-lumen catheter and apparatus and method for making the same
US5797869A (en) 1987-12-22 1998-08-25 Vas-Cath Incorporated Multiple lumen catheter
US6280423B1 (en) 1998-02-24 2001-08-28 Scimed Life Systems, Inc. High flow rate dialysis catheters and related methods
US6332892B1 (en) 1999-03-02 2001-12-25 Scimed Life Systems, Inc. Medical device with one or more helical coils
US6620202B2 (en) 2001-10-16 2003-09-16 Scimed Life Systems, Inc. Medical stent with variable coil and related methods
US6656146B1 (en) 1995-11-07 2003-12-02 Scimed Life Systems, Inc. Medical device with tail(s)
US7678154B2 (en) 1995-11-07 2010-03-16 Boston Scientific Scimed, Inc. Ureteral stent for improved patient comfort
US7951206B2 (en) 2001-04-02 2011-05-31 Boston Scientific Scimed, Inc. Medical stent

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US4626240A (en) * 1981-11-06 1986-12-02 Shiley Incorporated Dual lumen subclavian cannula
US4568329A (en) * 1982-03-08 1986-02-04 Mahurkar Sakharam D Double lumen catheter
US4583968A (en) * 1983-10-03 1986-04-22 Mahurkar Sakharam D Smooth bore double lumen catheter
CA1219785A (en) * 1984-05-24 1987-03-31 Geoffrey S. Martin Dual lumen cannula
US4643711A (en) * 1984-05-25 1987-02-17 Cook, Inc. Two lumen hemodialysis catheter
US4772268A (en) * 1984-05-25 1988-09-20 Cook Incorporated Two lumen hemodialysis catheter
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US4623327A (en) * 1985-02-12 1986-11-18 Mahurkar Sakharam D Method and apparatus for using dual-lumen catheters for extracorporeal treatment
US4817624A (en) * 1985-12-20 1989-04-04 The General Hospital Corporation Mini-bolus technique for thermodilution cardiac output measurements
US4755176A (en) * 1987-06-11 1988-07-05 Patel Piyush V Catheter with side hole
US4961809A (en) * 1988-04-21 1990-10-09 Vas-Cath Incorporated Method of producing a dual lumen catheter including forming a flare
US5098393A (en) * 1988-05-31 1992-03-24 Kurt Amplatz Medical introducer and valve assembly
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US5209723A (en) 1990-01-08 1993-05-11 The Curators Of The University Of Missouri Multiple lumen catheter for hemodialysis
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AU569500B2 (en) 1988-02-04
FR2569113A1 (en) 1986-02-21
AU2616584A (en) 1985-10-03
GB8407903D0 (en) 1984-05-02
US4451252A (en) 1984-05-29
FR2569113B1 (en) 1988-07-08
GB2156220B (en) 1987-08-05
DE3411810A1 (en) 1985-10-10
GB2156220A (en) 1985-10-09

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