WO1992014500A1 - Catheter a double lumen et procede de realisation d'un profil d'introduction sur ce catheter - Google Patents

Catheter a double lumen et procede de realisation d'un profil d'introduction sur ce catheter Download PDF

Info

Publication number
WO1992014500A1
WO1992014500A1 PCT/DE1992/000089 DE9200089W WO9214500A1 WO 1992014500 A1 WO1992014500 A1 WO 1992014500A1 DE 9200089 W DE9200089 W DE 9200089W WO 9214500 A1 WO9214500 A1 WO 9214500A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
double
cannula
catheter
lumen catheter
Prior art date
Application number
PCT/DE1992/000089
Other languages
German (de)
English (en)
Inventor
Hanno Tersteegen
Felix Tersteegen
Bernd Tersteegen
Original Assignee
Imt Innovative Medizintechnik Gmbh
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 Imt Innovative Medizintechnik Gmbh filed Critical Imt Innovative Medizintechnik Gmbh
Publication of WO1992014500A1 publication Critical patent/WO1992014500A1/fr

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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
    • 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
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-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
    • A61M2025/0031—Multi-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
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0035—Multi-lumen catheters with stationary elements characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side

Definitions

  • the invention relates to a method for producing an insertion profile on a double lumen catheter made of elastic and / or flexible material with two non-coaxial lumens for percutaneous introduction into a blood vessel, e.g. in hemodialysis, in which the outer wall of the first lumen is removed in the longitudinal direction from the front end at the introducer in the insertion area of the double lumen catheter in such a way that a transition area which gradually rises to the undivided area of the first lumen is produced and such is produced Double lumen catheter.
  • This lumen is closed and the smoothest possible transition to the outside of the lumen remaining up to the introducer is created on the outside of this end region.
  • the lumen ending at a distance from the introducer is provided with lateral inflow openings. Lateral drainage openings are provided in the area of the insertion end of the remaining lumen.
  • Seiderm method is used for the percutaneous introduction of this known double-lumen catheter into a blood vessel. A percutaneous puncture is first performed using a cannula, and then a guide wire is inserted into this cannula.
  • the cannula is "then withdrawn over the guidewire, and it is then, possibly after a dilation which to insertion through the lumen of the double lumen catheter threaded onto the guidewire and then passed ein ⁇ in the blood vessel., The guidewire is then then then Maschinengezo ⁇ gen .
  • US Pat. No. 4,772,268 discloses a method for producing an insertion profile on a double-lumen catheter from a relatively soft material of the type mentioned at the beginning.
  • This manufacturing process leads to a double lumen catheter, in which both lumens are open in the axial direction, whereby the disadvantages associated with lateral openings are avoided.
  • the percutaneous introduction of these known double pellum catheters is, however, even more complicated and complex. since it is not possible to introduce such a double-lumen catheter using the Seidiner method, not because the material is too soft on the one hand and because on the other hand because of the transition area gradually increasing to the undivided area of the first lumen there is no "smooth" outer circumference on the double-lumen catheter is available.
  • US Pat. No. 4,772,268 uses the "Desilet-Hoffman method" described in detail, which is a modified Seldinger method and is even more complex than this. Both introductory methods require assistant staff and a high degree of sterility. In addition, there are relatively large leaks of blood.
  • the invention is based on the object of improving the above-mentioned production method for double-lumen catheters and thus also double-lumen catheters themselves in such a way that as soft or flexible a material as possible can be used as the material for the double-lumen catheter without it being necessary for the percutaneous introduction is necessary to use one of the elaborate methods mentioned.
  • a cut or a slit-shaped opening is made in the exposed lumen partition, which enables the insertion of a cannula brought from the rear end through the first lumen into the remaining second lumen.
  • the outside of the second lumen remaining at the insertion end is brought into an essentially round shape, which gradually tapers from the outside to the inside diameter at the front end, for example by a thermoplastic deformation.
  • the invention further relates to a double lumen catheter, the insertion profile of which is produced by the method according to the invention.
  • An advantage of the invention is that the percutaneous introduction into a blood vessel can be carried out using the method known for inserting a single-vented catheter, which is much simpler than the Seidinger method or the Desilet-Hoffman method.
  • This method consists in introducing a sharpened cannula into a single-lumen catheter in such a way that the tip of the sharpened cannula protrudes beyond the front end of the single-lumen catheter.
  • the cannula is then withdrawn and the single-lumen catheter remains in the blood vessel. Since the inner cannula made of steel stiffens the catheter during the percutaneous insertion in any case, the catheter itself can consist of a relatively soft and flexible material.
  • the insertion method described above for single-lumen catheters can also be used for double lumen catheters according to the invention, This is done by inserting a cannula into the first lumen from the rear end until the cannula tip emerges outwards in the transition region. The tip of the cannula is then in front of the cut or the slit-shaped opening or at the height of the cut or the slit-shaped opening.
  • the cannula is then pushed through the incision or the slit-shaped opening into the interior of the second lumen located at the introducer, namely until the cannula tip emerges at the front end of the double lumen catheter.
  • the percutaneous introduction of the double lumen catheter into a blood vessel can then take place, and it is then only necessary to withdraw the cannula again after the insertion.
  • the edges of the cut or the slit Open opening against each other again, so that the opening formed by the insertion of the cannula through the lumen partition closes again.
  • the measure of bringing the outside of the second lumen remaining at the introducer into an essentially round shape which gradually tapers from the outside to the inside diameter at the front end has the advantage that the introducing end or front end of the double lumen catheter has the round cross-sectional profile corresponds to a single-lumen catheter, and that due to the shape gradually tapering towards the front end from the outer to the inner diameter, a gradual increase in cross-section on the outer cross-section of the second lumen remaining at the outer end takes place during the insertion process.
  • the cut or the slit-shaped opening can also be oval or crescent-shaped in such a way that a tongue is formed in the longitudinal direction of the double-lumen catheter in the direction of the introducer or also rejects it.
  • Fig. 1 The side view of a double lumen catheter blank
  • Fig. 2 is a sectional view taken along the line II-II in Fig. 1;
  • FIG. 3 shows a representation in which the outer wall of the first lumen is removed in the longitudinal direction starting from the front end, a transition region gradually rising to the area not separated being present behind a cut or a slot-shaped opening;
  • Fig. '4 is a sectional view taken along line IV-IV in Fig. 3;
  • Fig. 5 is a sectional view taken along the line V-V in Fig. 3;
  • Fig. 6 is a plan view of the illustration in Fig. 3;
  • FIG. 7 shows a longitudinal sectional view of the arrangement according to FIG. 3; however, the lumen remaining at the introducer is brought into a substantially round shape and gradually tapering from the outside to the inside diameter at the front end;
  • Fig. 8 is a sectional view along the line VIII-VIII in Fig. 7;
  • Fig. 9 is a sectional view taken along the line IX-IX in Fig. 7;
  • FIG. 10 shows a top view of the arrangement according to FIG. 7;
  • FIG. 11 is a sectional view corresponding to FIG. 7, but from the rear end (according to the drawing on the right) through the first (according to FIG. 7 upper) lumen a cannula is inserted which, after emerging from the first lumen through the cut or the slot-shaped opening is inserted into the second lumen remaining at the introducer, namely until the cannula tip has emerged at the front end of the double lumen catheter;
  • FIG. 12 shows a sectional illustration corresponding to the sectional lines XII-XII in FIG. 11;
  • FIG. 13 is a sectional view corresponding to the section line XIII-XIII in FIG. 11;
  • FIG. 14 is a sectional view along the section line XIV-XIV in FIG. 11;
  • Fig. 15 is a sectional view corresponding to the section line XV-XV in Fig. 11;
  • FIG. 16 is a plan view of the arrangement according to FIG. 11.
  • FIG. 1 and 2 show the profile of a known double lumen catheter.
  • the double lumen catheter, designated 1 has a round outer profile overall.
  • a first lumen 2 is separated from a second lumen 3 by a wall 4.
  • the outer wall of the first lumen 2 is separated from the front end 5, specifically so that the dividing wall 4 in this area is exposed.
  • the exposed partition is designated 4a.
  • the second lumen 3 thus continues to end at the front end 5.
  • the first lumen 2 goes from a location denoted by 6 to a transition region 7, which gradually rises to the non-separated region of the first lumen and ends at 8, on the outer wall of the first lumen 2 over. It can also be seen from FIGS. 3 and 6 that a slot 9 or a slot-shaped opening is made in the exposed lumen partition 4a.
  • the second lumen 3 remaining in the separated area in the front end area has been reshaped by preferably thermoplastic deformation in comparison with the illustration in accordance with FIGS. 3 to 6 in such a way that the lumen 3 in a round lumen 3a merges, the transition region of the lumen being designated by 11 in FIG. 7.
  • the profile of the end region 3a of the second lumen is designated by 12.
  • Fig. 8 there is still a small one Part of the first lumen 2 can be seen, as well as the inclined end wall 13 of the first lumen 2.
  • the second lumen 3a also has a shape 14 tapering gradually from the outside to the inside diameter at the end 5.
  • the inflow direction of the blood is designated A in FIG. 7, and the outflow direction is designated B.
  • FIGS. 7 to 10 show a double lumen catheter according to FIGS. 7 to 10, in which, for the purpose of percutaneously inserting the double lumen catheter made of elastic and / or flexible material into a blood vessel, a cannula 15 with a sharply ground tip 16 is introduced from the rear end on the right, as shown in the drawing, in such a way that the sharpened cannula tip protrudes beyond the front end 5.
  • the presence of the cut 9 with the cutting edges 9a and 9b makes it possible to pass the cannula through the first lumen 2 from the (right) rear end until the cannula tip emerges from the rising transition area to the outside.
  • the cannula is then inserted through the slot 9 into the area 3a of the second lumen 3.
  • the slot 9 widens to an opening in such a way that the opening edges 9a and 9b come to lie on opposite sides of the cannula 15, as can be seen from FIG. 11.
  • a cannula tube 17 adjoins the cannula 15 towards the rear end, the outer diameter of which is preferably, but not necessarily, smaller than the outer diameter of the cannula 15.
  • the double-lumen catheter can easily be inserted into a blood vessel in the manner known for inserting a single-lumen catheter.
  • the cannula 15 is then pulled out while the double-lumen catheter is in the blood vessel remains.
  • the deformation caused by the insertion of the cannula into the double-lumen catheter reforms, so that the double-lumen catheter again assumes the shape shown in FIGS. 7 to 10, in which in particular the slit edges 9a and 9b are again opposite. Blood can then flow in the direction of arrow A (FIG. 7) and flow out in the direction of arrow B.

Abstract

Dans un procédé pour la réalisation d'un profil d'introduction sur un cathéter à double lumen (1) réalisé dans un matériau élastique et/ou souple et comportant deux lumens non coaxiaux (2, 3) pour l'introduction percutanée dans un vaisseau sanguin, il est prévu qu'à l'extrémité d'introduction, dans la zone d'introduction du cathéter à double lumen, la paroi extérieure du premier lumen (2) soit éloignée dans le sens longitudinal à partir de l'extrémité frontale (5) de telle manière qu'il se forme une zone de transition (7) qui monte progressivement sur la zone non séparée du premier lumen. Dans la paroi de séparation découverte (4a) des lumens, on pratique une coupe (9) ou une ouverture en forme de fente. Cela permet d'introduire, dans le deuxième lumen (3) restant, une canule (15) amenée depuis l'extrémité arrière à travers le premier lumen, jusqu'à ce que la pointe (16) de la canule dépasse de l'extrémité frontale (5) en direction de l'avant. On peut ainsi introduire sans difficulté la canule à double lumen dans un vaisseau sanguin par la méthode connue appliquée pour l'introduction d'un cathéter à un seul lumen.
PCT/DE1992/000089 1991-02-26 1992-02-08 Catheter a double lumen et procede de realisation d'un profil d'introduction sur ce catheter WO1992014500A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19914105965 DE4105965A1 (de) 1991-02-26 1991-02-26 Doppellumenkatheter sowie verfahren zur herstellung eines einfuehrprofils an diesem
DEP4105965.4 1991-02-26

Publications (1)

Publication Number Publication Date
WO1992014500A1 true WO1992014500A1 (fr) 1992-09-03

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Application Number Title Priority Date Filing Date
PCT/DE1992/000089 WO1992014500A1 (fr) 1991-02-26 1992-02-08 Catheter a double lumen et procede de realisation d'un profil d'introduction sur ce catheter

Country Status (2)

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DE (1) DE4105965A1 (fr)
WO (1) WO1992014500A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5405341A (en) * 1993-06-03 1995-04-11 Med-Pro Design, Inc. Catheter with multiple lumens
WO2004096334A1 (fr) * 2003-03-28 2004-11-11 Sherwood Services Ag Catheter a extremite resistant a l'occlusion
US7090654B2 (en) 2003-03-28 2006-08-15 Sherwood Services Ag Catheter with occlusion resistant tip
US7211074B2 (en) 2003-08-12 2007-05-01 Sherwood Services Ag Valved catheter
US7322953B2 (en) 2003-08-04 2008-01-29 Covidien Ag Catheter device
US7575563B2 (en) 2002-11-20 2009-08-18 Appling William M Blood treatment catheter assembly
US7776005B2 (en) 2003-03-28 2010-08-17 Covidien Ag Triple lumen catheter with occlusion resistant tip
US8876752B2 (en) 2010-09-24 2014-11-04 Covidien Lp Dialysis catheter
US9072867B2 (en) 2011-09-30 2015-07-07 Covidien Lp Catheter with external flow channel
US9155862B2 (en) 2012-09-28 2015-10-13 Covidien Lp Symmetrical tip acute catheter
US9468461B2 (en) 2009-06-26 2016-10-18 Covidien Lp Catheterization system
US9913962B2 (en) 2004-11-04 2018-03-13 Covidien Ag Catheter insertion apparatus
US10058676B2 (en) 2009-09-30 2018-08-28 Covidien Lp Medical catheter having a design providing low recirculation and reversibility

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3114373A (en) * 1962-06-07 1963-12-17 Harold W Andersen Gastrointestinal sump tube assembly
US4098275A (en) * 1975-11-28 1978-07-04 Dante Vincent Consalvo Dual flow cannula set
US4134402A (en) * 1976-02-11 1979-01-16 Mahurkar Sakharam D Double lumen hemodialysis catheter
US4568329A (en) * 1982-03-08 1986-02-04 Mahurkar Sakharam D Double lumen catheter
US4643711A (en) * 1984-05-25 1987-02-17 Cook, Inc. Two lumen hemodialysis catheter

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2643594A1 (de) * 1975-10-06 1977-04-14 Roger Beelen Haemodialyse-nadel
DE3010841A1 (de) * 1980-03-21 1981-10-08 Ulrich Dr.med. 6936 Haag Uthmann Katheder
DE3214397C2 (de) * 1982-04-20 1984-07-26 Karl Dr. 6301 Pohlheim Aigner Perfusions-Doppellumenkatheter

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3114373A (en) * 1962-06-07 1963-12-17 Harold W Andersen Gastrointestinal sump tube assembly
US4098275A (en) * 1975-11-28 1978-07-04 Dante Vincent Consalvo Dual flow cannula set
US4134402A (en) * 1976-02-11 1979-01-16 Mahurkar Sakharam D Double lumen hemodialysis catheter
US4134402B1 (fr) * 1976-02-11 1989-07-25
US4568329A (en) * 1982-03-08 1986-02-04 Mahurkar Sakharam D Double lumen catheter
US4643711A (en) * 1984-05-25 1987-02-17 Cook, Inc. Two lumen hemodialysis catheter

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5405341A (en) * 1993-06-03 1995-04-11 Med-Pro Design, Inc. Catheter with multiple lumens
US7575563B2 (en) 2002-11-20 2009-08-18 Appling William M Blood treatment catheter assembly
WO2004096334A1 (fr) * 2003-03-28 2004-11-11 Sherwood Services Ag Catheter a extremite resistant a l'occlusion
US7090654B2 (en) 2003-03-28 2006-08-15 Sherwood Services Ag Catheter with occlusion resistant tip
US7776005B2 (en) 2003-03-28 2010-08-17 Covidien Ag Triple lumen catheter with occlusion resistant tip
US7322953B2 (en) 2003-08-04 2008-01-29 Covidien Ag Catheter device
US7211074B2 (en) 2003-08-12 2007-05-01 Sherwood Services Ag Valved catheter
US9913962B2 (en) 2004-11-04 2018-03-13 Covidien Ag Catheter insertion apparatus
US10668248B2 (en) 2004-11-04 2020-06-02 Covidien Ag Catheter insertion apparatus
US11504499B2 (en) 2004-11-04 2022-11-22 Covidien Ag Catheter insertion apparatus
US9468461B2 (en) 2009-06-26 2016-10-18 Covidien Lp Catheterization system
US10058676B2 (en) 2009-09-30 2018-08-28 Covidien Lp Medical catheter having a design providing low recirculation and reversibility
US8876752B2 (en) 2010-09-24 2014-11-04 Covidien Lp Dialysis catheter
US9072867B2 (en) 2011-09-30 2015-07-07 Covidien Lp Catheter with external flow channel
US9155862B2 (en) 2012-09-28 2015-10-13 Covidien Lp Symmetrical tip acute catheter
US9526861B2 (en) 2012-09-28 2016-12-27 Covidien Lp Symmetrical tip acute catheter
US11413426B2 (en) 2012-09-28 2022-08-16 Covidien Lp Symmetrical tip acute catheter
US11554247B2 (en) 2012-09-28 2023-01-17 Covidien Lp Symmetrical tip acute catheter

Also Published As

Publication number Publication date
DE4105965C2 (fr) 1993-06-09
DE4105965A1 (de) 1992-08-27

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