Publication number: A1. int. Ci.5; A61M 25/00, A61 M 25/01

Transcription

1 Europaisches Patentamt European Patent Office Office europeen des brevets Publication number: A1 EUROPEAN PATENT APPLICATION Application number: int. Ci.5; A61M 25/00, A61 M 25/01 Date of filing: Priority: NL Inventor: Boudewijn, Alexander Christiaan 't Zuden 27 Date of publication of application: NL-9351 LA Leek(NL) Bulletin 93/11 Inventor: Bosma, Gjalt Oudeweg 97 A ^. ± ^ ± ±. 0i, NL-9201 EK Drachten(NL) Designated Contracting States: DE FR GB NL Applicant: CORDIS EUROPA N.V. 0 Representative: 't Jong, Bastiaan Jacobus OCTROOIBUREAU ARNOLD & SIEDSMA Oosteinde 8 Sweelinckplein 1 NL-9301 LJ Roden(NL) NL-2517 GK 's-gravenhage (NL) ( v Double lumen catheter. Method for manufacturing a double-lumen catheter, comprising of receiving into a mould with a Y-shaped mould cavity the end part of a two-channel catheter basic material (1) with core wires (11,12) inserted therein, each wire having a first portion (13) closely fitting in the channels (3,4) and a second portion (14) with a cross section substantially corresponding with the external cross section of the single-channel basic material and a transitional portion therebetween, the shape of the section of which gradually transposes from that of the first portion (13) to that of the lengthwise channel of the single-channel basic material, filling the mould cavity (18) with a curable ma- terial, removing the formed assembly from the mould cavity (18) after the curable material has hardened to a fork piece (22), removing the core wires (11,12) from the fork piece (22), fixing the pieces of single-channel basic material (23,24) in the cavities in the fork piece (22) defined by the second portions (14) of the core wires (11,12), fixing to the other ends of the pieces of singlechannel basic material connecting members (25,26) which can allow passage respectively of a guide wire (32) and an optic fibre bundle (31). < at CM CO Rank Xerox (UK) Business Services (3. 10/3.5x/3.0. 1)

2 1 EP A1 2 The invention relates to a method for manufacturing a double-lumen catheter. According to the invention this method comprises of providing a piece of tube-like catheter basic material with two parallel, mutually separated lengthwise channels, providing two pieces of tube-like catheter basic material each having one lengthwise channel providing two core wires, each with a first portion closely fitting in the channels of the twochannel basic material, a second portion with a cross section substantially corresponding with the external cross section of the single-channel basic material and a transitional portion therebetween, the shape of the section of which gradually transposes from that of the first portion to that of the lengthwise channel of the single-channel basic material, inserting the first portion of each core wire into each channel in the end part of the two-channel basic material, providing a mould with a Y-shaped mould cavity, which is provided with fixing means for enclosed receiving of the end part of the two-channel basic material close to the foot of the Y and with fixing means for enclosed receiving of the second portion of the core wires close to the ends of the arms of the Y, receiving into the mould the end part of the two-channel basic material with the core wires inserted therein, filling the mould cavity with a curable material, removing the formed assembly from the mould cavity after the curable material has hardened to a fork piece, removing the core wires from the fork piece, fixing the pieces of single-channel basic material in the cavities in the fork piece defined by the second portions of the core wires, fixing to the other ends of the pieces of singlechannel basic material connecting members which can allow passage respectively of a guide wire and an optic fibre bundle. The double-lumen catheter according to the invention is particularly intended for angioscopic uses. The two-channel or double-lumen part of the catheter is inserted into a patient. The one channel is used for a guide wire, while an optic fibre bundle, in particular a fibre bundle of an endoscope, is pushed through the other channel. The guide wire and the fibre bundle can be fed in and manipulated separately of one another via the single-lumen parts of the catheter. Achieved with the method according to the invention is that the transition from the singlechannel catheter part to the fork piece and from the fork piece to the two-channel catheter part is uniform, without internally protruding edges which could make the introduction of the guide wire and/or fibre bundle difficult. A further favourable development is characterized in claim 2. By thus giving the core wires a 5 diameter slightly larger than the channels, the material is slightly expanded when the core wires are inserted so that a close-fitting engagement is obtained on the core wires. A very smooth transition is thus obtained after the injection moulding of the io fork piece. The step of claim 3 is preferably applied. When the core wires are pulled out of the formed fork piece, they deform elastically when following the channel formed in the fork piece by the first 75 portion of the core wire, so that the core wires can be taken out easily. A suitable embodiment enabling repeated use is therein characterized in claim 4. With the method according to claim 5 it is 20 possible to feed flushing liquid to the free end of the catheter so that the blood at that location will be flushed away and the wall of the blood vessel can be examined as soon as the optic fibre bundle is pushed out of the end of the catheter. 25 The invention likewise relates to and provides a double-lumen catheter manufactured according to any of the above described embodiments of the method according to the invention. The invention likewise relates to and provides 30 an assembly of such a catheter and a guide wire wherein the guide wire is curved close to its leading end. By rotating the guide wire inserted into the catheter about its longitudinal axis the leading end of the catheter will swivel round, whereby the end 35 of the endoscope fibre bundle can be oriented in a desired direction. A favourable embodiment is herein characterized in claim 8. For inserting the double-lumen catheter use is preferably made of a guide catheter forming part of 40 an assembly as characterized in claim 9. As soon as the mark is moved close to the end of the connecting member of the guide catheter during insertion of the double-lumen catheter into the guide catheter, the person administering treatment 45 can see that the extremity of the double-lumen catheter is on the point of leaving the guide catheter. The invention will be further elucidated in the following description with reference to the annexed 50 figures. Fig. 1 shows a perspective view of a piece of two-channel catheter basic material which is used in the method according to the present invention. Fig. 2 shows on a smaller scale a second step 55 of the embodiment of the method. Fig. 3 shows a third step of the embodiment of the method. 2

3 3 EP A1 4 Fig. 4 shows a simplified top view of a doublelumen catheter manufactured with the method according to the invention. Fig. 6 shows schematically an end part of a double-lumen catheter manufactured with the method according to the invention, in order to elucidate its use. The starting material in applying the method is a piece of tube-like catheter basic material 1, such as that shown in fig. 1, with two parallel channels 3 and 4 mutually separated by a dividing wall 2. These channels have a D-shaped section, as can be seen in fig. 1. In the method according to the invention core wires 11, 12 are inserted into the end parts of the channels 3, 4 as shown in fig. 3. Each of these core wires 11, 12 comprises a first portion 13 with a diameter which is slightly, for example 0.1 mm, larger than the diameter of the channels 3, 4 so that these first portions 13 of the core wires 11,12 slightly expand the basic material when inserted. Each core wire 11, 12 further comprises a second portion 14 having a diameter substantially equal to a piece of single-channel basic material to be described hereinafter which will form a continuous connection with the relevant lengthwise channel of the two-channel basic material 1. Situated between the first portion 13 and the second portion 14 is a transitional portion the sectional shape of which gradually transposes from that of the first portion to that of the lengthwise channel of that single-channel basic material. Each core wire 11, 12 moreover has an end part 15 which is intended for the fixing in a mould. This mould 17 is shown schematically in fig. 3. It can be seen that a Y-shaped mould cavity 18 has been recessed into the mould 17. The end part of the basic material 1 is received close to the stem of the Y with the first portions of the core wires 1 1, 12 inserted into the channels 3, 4. The fixing parts 15 of the core wires 11, 12 are clamped in the extensions of the arms of the Y. As can be seen clearly from fig. 3, the mould cavity 18 defines a fork piece as designated in fig. 4 by 22 wherein a channel connecting precisely onto the end parts of the channels 3, 4 is recessed by the first portions 13 of the core wires 11, 12, which channel transposes into a wider portion which is defined by the second portions 14 and into which pieces of singlechannel catheter basic material 23, 24 (fig. 4) are fixed, for example glued fixedly. Owing to the transition defined by the transitional portion of the core wires the channels of the single-channel parts 23, 24 connect precisely and without abrupt transition onto the channels in the fork piece 22 recessed by the first portions 13 of the core wires 11, 12. The mould 17 is further provided with a feed channel 19 onto which a nozzle 20 of an injection moulding machine 20 can connect. A suitable plastic is injected via this nozzle 20 into the mould cavity 18. After curing, this plastic forms the fork piece The end parts 13 of the core wires 11, 12 are preferably of a flexible material, preferably spring steel. The end wires can hereby easily be removed after the formed assembly has been taken out of the mould 17. After removal of the core wires 11, io 12 the above-mentioned single-channel catheter material 23, 24 is glued into the fork piece 22. Per se known connecting members 25, 26 are fastened, for example fixedly glued, to the other ends of the pieces of single-channel catheter ma- 15 terial 23, 24. The double-channel part of the thus obtained double-lumen catheter can be inserted in a patient. An optic fibre bundle 31 of an endoscope can be introduced via the one channel that is accessible 20 via the connecting member 25. For this purpose the connecting member 25 is provided with a fitting element 27 which is generally known as a haemostasis valve and which has an axial passage for the fibre bundle 31 provided with a sealing co- 25 acting with the fibre bundle 31 and a side channel. Joined to this side channel is a tube 29 which can be connected to a valve 33 which is joined via a conduit 34 to a flushing liquid source. In similar manner a guide wire 32 can be 30 pushed into the other channel of the double-channel catheter part. The single channel catheter part 24 joined in the fork piece 22 to the relevant lengthwise channel of the basic material 1 ends in a corresponding manner in a connecting member which can likewise be provided with a valve 28 which has an axial channel for the guide wire 32 and a side channel, which is likewise connected via a tube 30 to the flushing liquid source. Owing to the uniform transition obtained with 40 the method between both channels of the twochannel catheter part 1 and the single channel catheter parts 23, 24 the insertion of the optic fibre bundle 31 and the guide wire 32 can be performed with no problem without irritation being caused 45 during insertion by protruding edges or steps in the fork piece. In a preferred embodiment of the invention a guide wire is used which is provided with a nonstraight end part, for example an end part curved in a sine shape as shown schematically in fig. 5. When this curved guide wire is placed in the catheter the catheter material will take on a corresponding shape. By rotating the guide wire 39 in its lengthwise direction the tip of the catheter will 55 thus realize a swivelling around movement, whereby the end part of the optic fibre can "look round". The wall of the body vessel into which the catheter is inserted can be accurately examined over the 3

4 5 EP A1 6 whole periphery. By pushing the guide wire far or less far into the end part of the catheter the angle at which the end part of the optic fibre bundle lies relative to the longitudinal axis can moreover be varied. Before the catheter is inserted into a patient, the endoscope fibre bundle will already be arranged in the catheter. A guide catheter will be inserted first. The tip hereof is typically impenetrable by X-ray radiation so that the positioning thereof can be made visible on an X-ray screen in a catheter laboratory. The two-channel part of the catheter is herein provided with a mark at a distance from the free end which is equal to the length of the guide catheter plus a connecting member thereof. Once the guide catheter has been placed in position the double-lumen catheter can be inserted. As soon as the mark reaches the beginning of the connecting member, the person giving treatment knows that the end of the doublelumen catheter is situated at the end of the guide catheter. During use flushing liquid is supplied via the channel of the guide wire, that is, via tube 30, whereby the blood vessel at the leading end of the catheter becomes free of blood. With the thus obtained catheter the guide wire therefore remains in the catheter throughout the entire procedure and does not have to be exchanged for the endoscope fibre bundle. The guide wire can moreover be used therefore for operating the end part of the catheter in a controlled manner in order to control the viewing direction of the endoscope fibre bundle. The guide wire lumen can moreover be used as supply channel for flushing liquid so that it is possible to simultaneously manipulate the catheter and look through the endoscope. Claims 1. Method for manufacturing a double-lumen catheter, comprising providing a piece of tube-like catheter basic material with two parallel, mutually separated lengthwise channels, providing two pieces of tube-like catheter basic material each having one lengthwise channel providing two core wires, each with a first portion closely fitting in the channels of the two-channel basic material, a second portion with a cross section substantially corresponding with the external cross section of the single-channel basic material and a transitional portion therebetween, the shape of the section of which gradually transposes from that of the first portion to that of the lengthwise channel of the single-channel basic material, inserting the first portion of each core wire into each channel in the end part of the twochannel basic material, 5 providing a mould with a Y-shaped mould cavity, which is provided with fixing means for enclosed receiving of the end part of the twochannel basic material close to the foot of the Y and with fixing means for enclosed receiving io of the second portion of the core wires close to the ends of the arms of the Y, receiving into the mould the end part of the two-channel basic material with the core wires inserted therein, is filling the mould cavity with a curable material, removing the formed assembly from the mould cavity after the curable material has hardened to a fork piece, 20 removing the core wires from the fork piece, fixing the pieces of single-channel basic material into the cavities in the fork piece defined by the second portions of the core wires, 25 fixing to the other ends of the pieces of single-channel basic material connecting members which can allow passage respectively of a guide wire and an optic fibre bundle Method as claimed in claim 1, wherein core wires are selected in which the first portion has a diameter substantially 0.1 mm larger than the lengthwise channels of the two-channel basic material Method as claimed in any of the preceding claims, wherein core wires are selected in which the first portion and the transitional portion are elastically flexible Method as claimed in any of the preceding claims, wherein core wires are selected in which the first portion and the transitional portion are manufactured from spring steel Method as claimed in any of the preceding claims, wherein at least for the connecting member for passage of the guide wire, a connecting member is chosen having an axial 50 passage for the guide wire, a sealing which sealingly grips the guide wire close to the open end of the passage and with a side channel connected to the passage and joined to a supply conduit for flushing liquid Double-lumen catheter manufactured with the method as claimed in any of the preceding claims. 4

5 EP A1 7. Assembly of a double-lumen catheter comprising a first portion of tube like catheter material with two parallel, mutually separated lengthwise channels, two portions of tube like catheter material each having one lengthwise chan- 5 nel and a Y-shaped fork piece connecting the two portions of catheter material with one lengthwise channel to the portion with two parallel, lengthwise channels, said fork piece having two internal channels each connecting the 10 channel of a portion of catheter material with one lengthwise channel to one of the channels of the portion of catheter material with two lengthwise channels, and a guide wire having a diameter slightly is less than the inner diameter of one of the channels of the catheter, so that the guide wire can be taken up in said channel, and wherein said guide wire is curved close to its leading end Assembly of a catheter and guidewire as claimed in claim 7, wherein the other channel, not intended for taking up the guide wire, has a slightly larger diameter than the outer diameter 25 of an optical fiber bundle, generally known for use in angioscopy. 9. Assembly as claimed in claim 7 or 8, wherein the guide wire is curved in a sine shape close 30 to its leading end. 10. Assembly as claimed in claim 7-9, further comprising a guide catheter, with a central channel which has a slightly larger diameter 35 than the outer diameter of the two-channel part of the double-lumen catheter and provided with a connecting member and wherein the twochannel part carries a mark at a distance from the free end thereof which is equal to the 40 length of the guide catheter plus connecting member thereof

6 EP A1

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8 Europe Patent Office EUROPEAN SEARCH REPORT Appllcati0,, N*i" EP DOCUMENTS CONSIDERED TO BE RELEVANT Category Citation of document with indication, where appropriate, of relevant passages Relevant to claim CLASSIFICATION OF THE APPLICATION (Int. CI.S ) Y US-A (BAI) 7 A61M25/00 A * abstract; figures 4,14 * 1,6 A61M25/01 * column 11, line 60 - column 12, line 38 * Y US-A (YOCK) 7 A * abstract; figure 1 * 1,6 A EP-A (TERUMO KABUSHIKI KAISHA) 1,6 * abstract; figures 1-4 * A EP-A (SPECTRAMED, INC.) 1,6-8 * abstract; figures 1,2 * A EP-A (CALDERON) 1,6 * abstract; figure 6 * A US-A (KLINE) 6-9 * abstract; figures 1,3,4 * * column 3, line 20 - line 24 * TECHNICAL FIELDS A CA-A (VAS-CATH) 6,7 searched ant. a.5 > * page 9, line 8 - line 24; figures 12-13D * A61M A EP-A (INTERMEDICAT GMBH) 9 * abstract; figure 1 * A EP-A (H.G. WALLACE LIMITED) 10 * abstract; figures 2,3 * The present search report has been drawn up for all claims Place of March THE HAGUE CATEGORY OF CITED DOCUMENTS X particularly relevant if taken alone Y : particularly relevant if combined with another document of the same category A technological background O : non-written disclosure P : intermediate document Date of cmfdcun of uk tearta 11 DECEMBER 1992 ZEINSTRA H. T theory or principle underlying the Invention E : earlier patent document, but published on, or after the filing date D : document cited in the application L : document cited for other reasons A : member of the same patent family, corresponding document