CA1329748C - Balloon catheter suitable for use in recanalising stenoses in body canals, more particularly coronary blood vessels and peripheral arterial vessels - Google Patents

Balloon catheter suitable for use in recanalising stenoses in body canals, more particularly coronary blood vessels and peripheral arterial vessels

Info

Publication number
CA1329748C
CA1329748C CA000593410A CA593410A CA1329748C CA 1329748 C CA1329748 C CA 1329748C CA 000593410 A CA000593410 A CA 000593410A CA 593410 A CA593410 A CA 593410A CA 1329748 C CA1329748 C CA 1329748C
Authority
CA
Canada
Prior art keywords
balloon
balloon catheter
microwave
stenoses
vessels
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 - Fee Related
Application number
CA000593410A
Other languages
French (fr)
Inventor
Andreas Zeiher
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.)
Individual
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
Priority to DE19873743578 priority Critical patent/DE3743578A1/en
Priority to DE89900572T priority patent/DE3869126D1/de
Priority to PCT/DE1988/000769 priority patent/WO1989005609A1/en
Priority to EP89900572A priority patent/EP0344279B1/en
Priority to JP1500295A priority patent/JP2716229B2/en
Priority to US07/393,921 priority patent/US5061267A/en
Application filed by Individual filed Critical Individual
Priority to CA000593410A priority patent/CA1329748C/en
Application granted granted Critical
Publication of CA1329748C publication Critical patent/CA1329748C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001Angioplasty, e.g. PCTA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • 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
    • A61M2025/0025Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter having a collapsible lumen
    • 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
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0063Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body

Abstract

A B S T R A C T

A balloon catheter suitable for use in the recanalisation of stenoses in bodily canals, in particular coronary blood vessels and peripheral arterial vessels, is provided with a microwave antenna (9) arranged on the inside of said balloon, said antenna being connected to a microwave generator by means of a coaxial cable (8). The irradiation by microwaves of a microwave-absorbing dilation liquid and/or a metallic balloon skin coating causes said balloon catheter to be heated which in turn allows the vessel wall to be subjected to a thermal post-treatment required to prevent the reoccurrence of stenosis.

Description

~32~7~8 ~;~ BALLOON CATHETER SUITABLE FOR US~ IN RECAN~LISING STENOSES
IN BODY CANALS, ~ORE PARTICULARLY CORONARY BLOOD ~ESSELS
AND PERIPH~RAL ARTERIAL VESSELS

The present invention relates to a balloon catheter employed in recanalising stenoses in body canals, more particularly in coronary blood vessels and periph~ral arterial vessels, such a catheter having a balloon, through which extends a guide tube conducting a guide wire and which is furthermore capable of being dilated by means of a tube inflatable with a gas or liquid flowing through the interior of such balloon.
;' Balloon catheters have for some time been used by cardio-logists in the recanalisation of stenoses in coronary blood vessels. However, reconstriction, which occurs in up to 35% of all cases, remains the most common post-procedural complication resulting from the employment of this clinically approved . method. This problem has given rise to the suggestion that a lightwave conductor be employed for the purpose of focusing a laser beam on the affected tissue area in order to provide thermal treatment following balloon dilation (The American Journal of Cardiology, Vol.56, Page 953.) ~ , . .
IN EP-A2 182 689, a balloon catheter permits the surrounding tissue to be heated by means of a laser beam ,, ,,. ' , ~
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1 32~74g conducted through the balloon9 Also described in this patent is a method involving the fitting, in the vicinity of the distal end of the guide wire, of an electrical heating element which, being enveloped by the halloon, heats the liquid present inside the balloon. The diameter of the guide tube, which runs through the balloon, is, in order to pre~lude coagulation of the blood flowing into the guid~ tube, slightly greater than that of the guide wire.
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~ Known from Biomedizinische Technik Vol.32, September 1987, ~ ' Sùpplement, pgs 33 to 36, is a method of using high-frequency energy to maintain balloon dilation. Thus it is proposed that ; the balloon catheter be provided with a bipolar electrode configuration comprising two strip electrodes connected to a generator producing a frequency of between 0.5 and lMhz for a period of 38 seconds and having a maximum output rating of 50W.
Experiments performed on animals, in which high-frequency coagulation occurs in the region of the electrodes, should j serve to indicate whether or not such methods improve dilation Gl maintenance.
. ~ .
Described in US-A 4 658 836 is a device used to thermally 3 treat, with the aid of temperature control devices, the tissue enveloping body cavities, whereby body tissue is heated ' - directly by means of electromagnetic radiation in the frequency range of radio or microwaves.

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~L32~7~8 Disclosed in DE-C2 30 11 322 is a radiation probe employed in conjunction with a device used in the microwave treatment oE
body tissues and permitting both radiotherapy treatment and hyperthermal treatment, whereby the tissue is irradiated with microwave energy. The latter is concentrated upon the desired tissue area with the assistance of a coaxial cable, which, ~; being fitted to a radiation probe capable of being inserted inside body cavities, is unsymmetrically enclosed by a piston-shaped body at its bare end situated inside the radiation probe.

US-A 662 383 describes a balloon catheter used in the hypothermia of tumours and loaded through a feed line with a cooling fluid that is permitted to flow out of the interior of the balloon through a discharge tube. Provided on the inside of the balloon is a microwave antenna capable of irradiating a 3 zone that encompasses the surrounding tissue~ Employed as -l, coolants are liquids having a low microwave absorption coefficient, the result of which being an in~rease in microwave ~3 penetration of the surrounding tissue.

Based on the above-mentioned prior art systems, the present invention is aimed at creating a balloon catheter capable of providing both non-destructive, homogenous heat treatment and a variable and well-controlled thermal penetration depth.

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This object is satisfied by a balloon catheter of the type first-mentioned, whereby a microwave antenna arranged on the inside of the balloon can be attached through a coaxial cable to a microwave generator.

The microwave antenna located on the inside of the balloon serves firstly to heat the liquid used to dilate the balloon skin. Such liquid, which should readily absorb microwaves, can for example, bs a mixture of sodium chloride solution and an iodine-containing agent, to which, if required, other substances can be added in order to raise the microwave absorptivity. Typical of such additives are metal particles, which are suspended in the liquid. The radial-symmetrical diffusion of the microwaves promotes a homogenous radial-symmetrical warming of the liquid.

In ordar to prevent the direct penetration by microwaves of the tissue surrounding the balloon catheter, the latter is provided preferably with a metal coating. In order to prevent, wh~n the generator is operating, coagulation of the blood present inside the guide tube traversing the balloon catheter, the guide tube is designed so as to be capable of being pinched together by the pressure of the liquid being employed to dilate the balloon catheter. Such an arrangement obviates the requirement for a protective metal coating on the guide tube, '` ~

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132~7~8 which would interfere with the uniform diffusion of microwave energy inside the balloon.

An advantageous embodiment of the present invention comprises that the microwave antenna comprises the leading end of a coaxial cable that has been deprived of its protective covering. In this arrangement, the metallic inner conductor extends along the medial longitudinal axis of the expanded , balloon, in order to permit uniform separation from the balloon wall and thus uniform thermal treatment.

In one broad aspect the present invention relates to a balloon catheter suitable for recanalising stenoses occurring in bodily canals, in particulax inside coronary vessels and peripheral arterial vessels, said balloon catheter having a balloon, through which extends a guide tube guiding a guide wire, and which can be dilated by means of an inflatable tube ending in the inner cavity of said balloon, with the aid of a gas or a liquid, whereby a microwave antsnna is arranged on the inside of said balloon, said microwave antenna capable of being connected to a -microwave generator through a coaxial cable.
.... . .
Advantageous designs and alternative versions of the present invention are set out in the subsidiary claims.

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~6- ~32~7~8 An embodiment example of the present invention will next be described in greater detail by means of the attached drawings.
Shown are:
1 5 Figure 1 a proposed balloon catheter in longitudinal section;
Figure 2 a proposed balloon catheter in an expanded state, shown partially in section and partially in cut away perspectiv~; and Figure 3 a cross section through the central region of the expanded balloon skin of the proposed balloon catheter.

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~l Figure 1 shows a longitudinal section of a balloon ~,~ catheter employed in the recanalisation of stenoses occurring in coronary blood vessels. The proposed balloon catheter possesses a balloon comprising a balloon skin 1 comprising a flexible, heat-resistant synthetic material. Balloon skin 1 is `'` provided on the outside and/or inside with a (not visible in :`:;! the figure) metallic coating comprising preferably a gold, silver, chromium, chromium-nickel or copper film and having either a continuously uniform thickness or a fine lattice ~`, construction featuring discontinuities embodied, for example, as strips. Such coating serves to block the diffusion to the ., ~ outside of microwaves produced inside balloon skin 1, and to :., ..
,~ ' )( ."

' ; ,.:.. i ~32~7~8 protert the heating area that has been heated by microwave absorpkion.

~, Balloon skin 1 envelopes a flexible, squeezable guide tube 2, which, depending on the embodiment of the balloon catheter, is only slightly longer than the balloon skin. Guide tube 2 serves to direct guide wire 3 as it is being pushed along the proposed balloon catheter into the operating area.

Serving to expand balloon skin 1 with the aid of a liquid forced into the cavity 4 o~ balloon skin 1, is an inflatable ' 10 tube 5 represented in Figure 1 by a broken line and in Figure ',,,, 2 shown par,tially in perspective. Featured on the leading end '~ of inflatable tube 5 are apertures 6, which provide a connection of the inner lumen of inflatable tube 5 with cavity 4 of balloon skin 1, so that the liquid can be forced in the direction of arrows 7 into cavity 4 of balloon skin 1.
~''' '~, When balloon skin 1 of the proposed balloon catheter lies ~, in the zone of the stenosis to be recanalised inside a coronary ,', blood vessel of a patlent, guide wire 3 is retracted to ~ approximately the position indicated in Figure 2.
i;,~, As Figure 2 indicates, the length of the guide tube at the le~t-hand ends shown in Figures 1 and 2 is sufficient to . ~
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prevent guide wire 3, while being retracted, from sliding out :~ of guide tube 2.
:
When cavity 4 of balloon skin 1 is loaded with pressurized liquid in the manner suggested by Figures ~ and 3, guide tube 2 is pressed together inside balloon skin 1 in the manner suggested by Figures 2 and 3, the result of which being that no heat-coagulated blood is permitted to flow through guide tube 2 in the direction of the retracted guide wire 3.

~: In Figures 1, 2 and 3 can be seen a coaxial cable 8 positioned above guide tube 2 and inflatable tube 5. Metallic inner conductor 9 of coaxial cable 8 extends along medial line ;~
10, appearing in Figures 1 and 2, up to the vicinity of balloon skin 1, whereby however a space exists between the leading end of inner conductor 9 appearing at the right of Figures 1 and 2, and the expanded balloon skin 1.
:, 1i Inner conductor 9 of coaxial cable 8 is enveloped hy insulation 11 serving to electrically insulate leading end 12 of inner conductor 9 from the liquid which may, for example, be present in cavity 4. Protective covering 13 of coaxial cable -I 20 ~ extends, by a distance corresponding roughly to the gap existing between leading end 12 of metallic inner conductor 9 and balloon skin 1, into cavity 4 of balloon skin l. In a ;~ manner common to coaxial cables, protective covering 13 of :--'.
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g coaxial cable 8 is surrounded by an external protective covering 14. Coaxial cable 8 extends, together with guide wire 3 and inflatable tube 5, through a guide catheter (not illustrated) which may, for example, end in the inguinal region of the patient, to a microwave generator operating in a frequency range of 400 Mhz to 10 Ghz. The output energy as well as switch-on times for the microwave generator can be preset, whereby it is preferable that a not-illustrated pressure switch actuated by pressure changes inside balloon skin 1 be provided in order to permit the microwave generator to be turned on only under dilation pressure, whereby guide tube 2 is pinched together in order to prevent the blood present inside guide tube 2 ~rom coagulating in the presence of microwaves radiation. The microwave generator can be designed especially to provide pulsiform high frequency microwaves, whereby furthermore the type of impulse probe and pulse interval can be modified in accordance with prevailing operating conditions.

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once balloon skin 1 has assumed the ~uasi-cylindrical :.
shape illustrated in Figures Z and 3 and inner conductor 9 has been positioned along the medial axis o~ the expanded blood vessel, switching-on of the microwave generator causes the liquid surrounding inner conductor 9, which serves as an antenna, to become a thermal reservoir, which in turn heats, through heat transfer, the inner wall of such blood vessel.
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This process permits the thermal post-treatment of the mechanically expanded blood vessel wall, or more particularly, the coagulation of the blood vessel wall and thus either reduces tension occurring in such blood vessel wall or coagulates lesions having occurred therein. The liquid is heated due to absorption of microwave energy. In order to raise absorptivity, it is useful to employ as a liquid a solution of sodium chloride to which can be added an X-ray contrasting agent. In addition, metal particles or other microwave-absorbing substances can be added to the solution.
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The extent of the heated zone can be changed in accordance with varying operakional requirements by modifying the type of liquid, microwave frequency, output and impulse form.
Adaptation is also facilitated by the above-mentioned metallic coating on balloon skin 1. Depending on the liquid employed, and the construction of the coating material, the latter can either serve to merely protect balloon skin 1 or be itself heated and in turn transfer to the outside its own heat or heat transferred from the liquid.
, - 20 Following the heat treatment procedure, balloon skin 1 is collapsed and the balloon catheter withdrawn, together with guide wire 3, from the treatment site.

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~32~7~8 Retraction of guide wire 3 prior to turning on of the microwave generator ensures that the microwaves emitted in the unprotected region of inner conductor 9 are not blocked by guide wire 3, which is thus not heated.

Balloon skin 1 is fused at the right-hand end shown in Figures 1 and 2 to guide tube 2. At the rear end shown to the right of Figures 1 and 2, balloon skin 1 is tightly fused together with guide tube 2 and external protective covering 14 of aoaxial cable 8.

., The above-described microwave-heatable balloon catheter permits energy to be fed into the balloon and in the liquid and/or balloon skin coating converted into heat, without the patient's being subjected to any electrical current and without the occurr~nce of a galvanically-closed circuit.

~ 15 The proposed balloon catheter is well suited for use ;; inside coronary blood vessels. It is also possible to enlarge i the diameter of the proposed balloon catheter for the purpose ,;
of widening other arterial vessels as well as any type of bodily canal or cavity.
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Claims (2)

1. A balloon catheter for rechanneling stenoses in body passages, in particular of coronary and peripheral arterial vessels, said catheter comprising a balloon having an interior through which a guide hose to be guided by a guide wire extends, said balloon including an inflation tube opening into the interior of the balloon, wherein a microwave antenna is located, said antenna coupled to a coaxial cable, the balloon including means for absorbing and/or shielding microwave radiation, and further wherein the guide hose consists of a readily deformable material and hence can be clamped off upon inflation of the balloon.
2. A balloon catheter of claim 1 including a pressure sensor means for generating a signal when the internal balloon pressure exceeds a predetermined threshold, whereby the microwave generator is controllable so as to be switched on only at sufficient pressure to squeeze the guide hose flat.
CA000593410A 1987-12-22 1989-03-10 Balloon catheter suitable for use in recanalising stenoses in body canals, more particularly coronary blood vessels and peripheral arterial vessels Expired - Fee Related CA1329748C (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
DE19873743578 DE3743578A1 (en) 1987-12-22 1987-12-22 BALLOON CATHETER FOR RECANALIZING STENOSES IN BODY CHANNELS, IN PARTICULAR CORONARY VESSELS AND PERIPHERAL ARTERIAL VESSELS
DE89900572T DE3869126D1 (en) 1987-12-22 1988-12-19
PCT/DE1988/000769 WO1989005609A1 (en) 1987-12-22 1988-12-19 Inflatable catheter for dilating stenosis in body channels
EP89900572A EP0344279B1 (en) 1987-12-22 1988-12-19 Inflatable catheter for dilating stenosis in body channels
JP1500295A JP2716229B2 (en) 1987-12-22 1988-12-19 Balloon catheter used for recanalizing stenosis of human arteries such as coronary vessels and peripheral arteries
US07/393,921 US5061267A (en) 1987-12-22 1988-12-19 Balloon catheter for rechanneling stenoses in body passages, in particular of coronary and peripheral arterial vessels
CA000593410A CA1329748C (en) 1987-12-22 1989-03-10 Balloon catheter suitable for use in recanalising stenoses in body canals, more particularly coronary blood vessels and peripheral arterial vessels

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19873743578 DE3743578A1 (en) 1987-12-22 1987-12-22 BALLOON CATHETER FOR RECANALIZING STENOSES IN BODY CHANNELS, IN PARTICULAR CORONARY VESSELS AND PERIPHERAL ARTERIAL VESSELS
CA000593410A CA1329748C (en) 1987-12-22 1989-03-10 Balloon catheter suitable for use in recanalising stenoses in body canals, more particularly coronary blood vessels and peripheral arterial vessels

Publications (1)

Publication Number Publication Date
CA1329748C true CA1329748C (en) 1994-05-24

Family

ID=25672515

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000593410A Expired - Fee Related CA1329748C (en) 1987-12-22 1989-03-10 Balloon catheter suitable for use in recanalising stenoses in body canals, more particularly coronary blood vessels and peripheral arterial vessels

Country Status (6)

Country Link
US (1) US5061267A (en)
EP (1) EP0344279B1 (en)
JP (1) JP2716229B2 (en)
CA (1) CA1329748C (en)
DE (2) DE3743578A1 (en)
WO (1) WO1989005609A1 (en)

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WO1989005609A1 (en) 1989-06-29
EP0344279B1 (en) 1992-03-11
JP2716229B2 (en) 1998-02-18
DE3869126D1 (en) 1992-04-16
US5061267A (en) 1991-10-29
DE3743578C2 (en) 1991-07-18
JPH02502613A (en) 1990-08-23
EP0344279A1 (en) 1989-12-06
DE3743578A1 (en) 1989-07-13

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