US3814137A - Injection site for flow conduits containing biological fluids - Google Patents

Injection site for flow conduits containing biological fluids Download PDF

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US3814137A
US3814137A US32673773A US3814137A US 3814137 A US3814137 A US 3814137A US 32673773 A US32673773 A US 32673773A US 3814137 A US3814137 A US 3814137A
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Prior art keywords
sleeve
elastomeric sleeve
tubing
elastomeric
inner diameter
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Expired - Lifetime
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F Martinez
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Baxter International Inc
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Baxter International Inc
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Application filed by Baxter International Inc filed Critical Baxter International Inc
Priority to US32673773 priority Critical patent/US3814137A/en
Priority claimed from AU64957/74A external-priority patent/AU486661B2/en
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Publication of US3814137A publication Critical patent/US3814137A/en
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    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members

Abstract

An injection site for a flow conduit for biological fluids and the like, such as blood or parenteral solutions, is provided having improved resistance to leakage through needle punctures, even when the pressure within the flow conduit is substantially different from the pressure outside of the conduit. The conduit comprises tubing made of a biologically compatible material, in which a portion of the tubing is surrounded by an elastomeric sleeve injection site. A second elastic sleeve surrounds the first elastomeric sleeve, the second sleeve having an unstretched inner diameter which is less than the outer diameter of the elastomeric sleeve. As a result, the elastomeric sleeve is compressed by the second sleeve, whereby the sealing of the elastomeric sleeve after puncture by a needle is improved.

Description

United States Patent [191 Martinez [75] Inventor: Felix Jesus Martinez, Palatine, Ill.

[73] Assignee: Baxter Laboratories, Inc., Morton Grove, Ill.

[22] Filed: Jan. 26, 1973 [21] Appl. No.: 326,737

[52] US. Cl. 138/103, 138/137 [51] Int. Cl. F161 11/12- [58] Field of Search 138/137, I40,- I47, 103;"

[56] References Cited UNITED STATES PATENTS 2,053,112 9/1936 Schnabel l38/l37 2,907,35l l0/l959 Rohrback et al. l38/l40 X 3,566,868 3/1971 Baptist 138/103 X June 4, 1974 Primary Examiner.lerry W. Myracle Attorney, Agent, or FirmW. Garrettson Ellis 5 7] ABSTRACT rial, in which a portion of the tubing is surrounded by an elastomeric sleeve injection site. A second elastic sleeve surrounds the first elastomeric sleeve, the second sleeve having an unstretched inner diameter which is less than the outer diameter of the elastomeric sleeve. As a result, the elastomeric sleeve is compressed by the second sleeve, whereby the sealing of the elastomeric sleeve after puncture by a needle is improved.

8 Claims, 3 Drawing Figures IJIIIIIIIIIIII {libWIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII/II[III/III] '-svxxsssxxsssas xxxxv i 1 INJECTION SITE FOR FLOW CONDUITS CONTAINING BIOLOGICAL FLUIDS BACKGROUND OF THE INVENTION Parenteral solution administration equipment and blood flow conduits for solution infusion, blood transfusion, or the conveyance of blood between a patient and an artificial kidney or blood oxygenator generally require sites where an injection needle can be inserted into 'theconduit to withdraw samples, or to administer medication or the like. When the injection needle is withdrawn, it is important that therebe no leakage of solution or blood throughthe needle puncture.

Problems can arise with the leakage of blood and solution, particularly when the interior of the conduit is under either a substantially elevated or substantially reduced pressure with respect to the exterior, as in the case of certain oxygenation and artificial kidney blood conduits, and in the case of the pressurized administration of parenteral solution or blood to a patient.

In the conventional arterial and veinous sets for coil dialyzers, which sets are used tov transfer blood between a patient and the coil dialyzer, it is well known to provide an injectionsite which comprises a latex sleeve surrounding a portion of the blood tubing which is made of vinyl plastisol or the like. In this prior art structure, the latex sleeve is stretched over the blood tubing to attempt to provide a fluidtight seal between the latex sleeve and the blood tubing. Thus, when a needle penetrates the latex sleeve and the blood tubing, and is thereafter withdrawn after injecting a medicament or taking a sample, the latex sleeve is intended to provide a seal against fluid leaks which occur through the needle puncture in the blood tubing. I

Unfortunately, it has been found that because the latex sleeve has to be stretched onto the blood tubing to provide a fluid-tight'seal between the two members, the well-known excellent resealing characteristics or the latex are diminished because of the stretching of the latex. The needle puncture in the latex has been observed to sometimes fail to adequately reseal, particularly in the case where there is a pressure differential between the interior and exterior of the flowconduit. It is of course highly undesirable for fluid to leak through the puncture hole, forced out by an elevated fluid pressure in the flow conduit. Furthermore, it can be extremely dangerous for air bubbles to be sucked into the flow line through the needle puncture when the blood tubing interior is at a pressure of less than atmospheric, especially in the case where the blood tubing conveys blood between a dialyzer or an oxygenator and a living patient.

Furthermore, the prior art resealable injection site has also been observed to leak by the passage of fluid between the vinyl blood tubing and the latex sleeve, until fluid appears at the end of the latex sleeve as a continuous slow leak. However, if one uses a smaller diameter latex sleeve to increase the sealing pressure at the interface between the blood tubing and the latex sleeve, the stretching in the latex sleeve is increased, which results in less capability to seal needle punctures.

DESCRIPTION OF THE INVENTION In accordance with this invention, the sealing capability of a fluid conduit of biologically compatable tubing surrounded by an elastomeric sleeve injection site is improved by a second elastic sleeve surrounding the first elastomeric sleeve, in which the second elastic sleeve has an unstretched inner diameter which is less than the outer diameter of the first elastomeric sleeve.

sleeve, whereby the sealing of the elastomeric sleeve after puncture by a needle is improved.

It is preferred for the second elastic sleeve to be longer than the first elastomeric sleeve, and to overlie the ends of the elastomeric sleeve. In this case, the unstretched inner diameter of the second elastic sleeve should be less than the outer diameter of the biologi cally compatible tubing, to seal the ends of the first elastomeric sleeve against fluid leakage between the elastomeric sleeve and the tubing. It is also desirable for the wall thickness of the second sleeve to be less than one-half of the wall thickness of the elastomeric sleeve, and for-the inner diameter of the second sleeve to be less than the inner diameter of the elastomeric sleeve, so that the degree of stretching of the second sleeve is greater than that of the first elastomeric sleeve, and it tightly seals about the ends of the first sleeve. Typically, the' outer diameter of the first elastomeric sleeve as mounted on the tubing is at least about twice the inner diameter of the second elastic sleeve for high compression of the first elastomeric sleeve, although lesser degrees of compression can be used by providing a second sleeve of larger inner diameter.

The first elastomeric sleeve is preferably made of natural latex or any other elastomeric material having excellent needle puncture resealing characteristics. The second elastic sleeve is also conveniently made of natural latex, although any elastic material having generally equivalent tensile strength can be used. However, it is generallydesi rable for the second sleeve to also have excellent I needle puncture resealing characteristics equivalent to natural latex. Alternatively, the second elastic'sleeve can be made of a material which shrinks upon drying of solvent in the material or upon heating,

tubing for blood, dialysis solution, parenteral solution,

or the like, surrounded by the improved injection site of this invention.

FIG. 2 is a longitudinal sectional view taken along line 2-2 of FIG. 1, and enlarged in size.

FIG. 3 is a transverse sectional view taken along line 3-3 of FIG. 1 and enlarged in size.

Referring to the drawings, tubing 10 is shown as a conduit for blood ina medical device such as a conventional arterial or veinous set for an artificial kidney. Such sets are commercially available at the present time from Travenol Laboratories, Inc. of Morton Grove, Ill. Tubing 10 might also be part of a blood line in a blood oxygenation system. Tubing 10 can be made of any needle-puncturable, biologically compatible material, for example, plastic materials including vinyl plastisol or polyurethane, and silicone rubber.

The improved injection site 12 of this invention comprises an elastomeric sleeve 14 surrounding a portion of tubing 10. The unstretched inner diameter of elastomeric sleeve 14 is smaller than the outer diameter of tubing 10 to provide a compressive seal at the interface 22 between sleeve 14 and tubing 10.

Second elastic sleeve 16 overlies the first elastomeric sleeve 14, and is longer than elastomeric sleeve 14, so that overlying portions 18, 20 cover the ends of sleeve 14 and provide sealing against any fluid leakage that takes place along the interface 22 between tubing 10 and elastomeric sleeve 14 after puncture by a needle 24, shown in phantom in FIG. 2. Sleeve 16 has less than half the wall thickness of sleeve 14, to permit it to closely conform about the ends of sleeve 14 for improved sealing.

Second sleeve 16 is proportioned to compress elastomeric sleeve 14, which compression .provides improved sealing of needle puncture holes through sleeve 14 after the puncturing needle 24 has been withdrawn. The inner diameter of second sleeve l6'is less than the unstretched outer diameter of sleeve 14, so that sleeve 14 is substantially compressed.

in one suitable'form, tubing l has an inner diameter of about 0.18 to 0.2 inch and a wall thickness of about 0.06 to 0.07 inch, to give a total outer diameter of about 0.3 to 0.34 inch.

Correspondingly, elastomeric sleeve 14 can have an unstretched inner diameter of about 0.2 to 0.3 inch and a wall thickness'of about 0.09 to 0.1 inch. In onespecific embodiment, the inner diameter is 0.312 inch and the wallthickness 0.094 inch, to give a total outer diameter of 0.5 inch. In the same specific embodiment, the outer diameter of tubing is 0.34 inch. Thus, sleeve 14 exerts a substantial compression upon the outer wall of tubing 10' and is correspondingly stretched in the process.

in the above situation, second elastic sleeve 16 may have an inner diameter of about 0.25 inch and a wall thickness of about 0.03. inch. it can thus be seen in the above specific embodiment that the outer diameter of elastomeric sleeve 14 is about twice the inner diameter of second sleeve .16 in the above specific embodiment. Accordingly, sleeve 14 is placed under quite substantial compression by second sleeve 16, which results in an improvement in the sealing characteristics of sleeve 14. Similarly, since the unstretched inner diameter of second sleeve 16 is less than the outer diameter of tubing 10, an additional pressure seal is applied to tubing 10 by end portions 18, 20, resulting in additional sealing about the ends of elastomeric sleeve 14.

In another suitable configuration, tubing 10 has an inner diameter of 0.187 inch and a wall thickness of 0.063 inch, while elastomeric sleeve 14 has an inner diameter of 0.25 inch and a wall thickness of 0.094 inch. The remaining dimensions are similar to the previous embodiment.

Elastomeric sleeve 14 is generally about 2 to 6 inches long, while second sleeve '16 is about 1 to 3 inches longer than sleeve 14, to provide suitable sealing about the ends of sleeve 14.

Sleeves 14 and 16 can be placed upon tubing 10 simply by expanding them with a suitable expansion fork made of a plurality of rods, and lever means for spreading the rods apart, to stretch the sleeves while threading them onto tubing 10 to the desired position. Then the expansion fork is allowed to collapse, and is withdrawn from the inside of each sleeve. Likewise, sleeves l4, 16 can be threaded upon a suitably sized rigid collet, and threaded on the tubing 10, the collet being then withdrawn.

The above has been offered for illustrative purposes only, and is not intended to limit the invention which is defined in the following claims.

That which is claimed is:

' 1. In a conduit for blood' and the like which comprises needle puncturable, biologically compatible tubing, a portion of said tubing being surrounded by an elastomeric sleeve injection site, the improvement comprising a second, elastic sleeve surrounding said elastomeric sleeve, said second sleeve having an unstretched inner diameter which is less than the outer diameter of said puncturable tubing, to compress said elastomeric sleeve, whereby the sealing of said elastomeric sleeve after puncture by a needle is improved, and in which said second, elastic sleeve is longer than said elastomeric sleeve and overlies the ends of said elastomeric sleeve, to seal the ends of said elastomeric sleeve against fluid leakage between the. elastomeric sleeve and the tubing.

2. The blood conduit of claim 1 in which the wall thickness of said second sleeve is less than one half the wall thickness of said elastomeric sleeve.

3. The blood conduit of claim 2 in which said elastomeric sleeve is made of natural latex. I

4. The blood conduit of claim 3 in which said second sleeve is made of natural latex.

5. The blood conduit of claim 4 in which said tubing is made of a material selected from the group consisting of vinyl plastisol, polyurethane, and silicone.

6. The blood conduit of claim 2 in which said tubing has an inner diameter of about 0.18 to 0.2 inch and a wall thickness of about 0.06 to 0.07 inch; said elastomeric sleeve has an unstretched inner diameter of about 0.2 to 0.3 inch and a wall thickness of about 0.09 to 0.1 inch, and said second, elastic sleeve has an unstretched inner diameter of about 0.25 inch and a wall thickness of about 0.03 inch.

7. The blood conduit of claim 1 in which the unstretched outer diameter of said elastomeric sleeve is at least two times the inner diameter of said secondelastic sleeve.

8. The blood conduit of claim 1 in which the inner diameter of said second sleeve is less than the inner diameter of said elastomeric sleeve.

Claims (8)

1. In a conduit for blood and the like which comprises needle puncturable, biologically compatible tubing, a portion of said tubing being surrounded by an elastomeric sleeve injection site, the improvement comprising a seconD, elastic sleeve surrounding said elastomeric sleeve, said second sleeve having an unstretched inner diameter which is less than the outer diameter of said puncturable tubing, to compress said elastomeric sleeve, whereby the sealing of said elastomeric sleeve after puncture by a needle is improved, and in which said second, elastic sleeve is longer than said elastomeric sleeve and overlies the ends of said elastomeric sleeve, to seal the ends of said elastomeric sleeve against fluid leakage between the elastomeric sleeve and the tubing.
2. The blood conduit of claim 1 in which the wall thickness of said second sleeve is less than one half the wall thickness of said elastomeric sleeve.
3. The blood conduit of claim 2 in which said elastomeric sleeve is made of natural latex.
4. The blood conduit of claim 3 in which said second sleeve is made of natural latex.
5. The blood conduit of claim 4 in which said tubing is made of a material selected from the group consisting of vinyl plastisol, polyurethane, and silicone.
6. The blood conduit of claim 2 in which said tubing has an inner diameter of about 0.18 to 0.2 inch and a wall thickness of about 0.06 to 0.07 inch; said elastomeric sleeve has an unstretched inner diameter of about 0.2 to 0.3 inch and a wall thickness of about 0.09 to 0.1 inch, and said second, elastic sleeve has an unstretched inner diameter of about 0.25 inch and a wall thickness of about 0.03 inch.
7. The blood conduit of claim 1 in which the unstretched outer diameter of said elastomeric sleeve is at least two times the inner diameter of said second elastic sleeve.
8. The blood conduit of claim 1 in which the inner diameter of said second sleeve is less than the inner diameter of said elastomeric sleeve.
US32673773 1973-01-26 1973-01-26 Injection site for flow conduits containing biological fluids Expired - Lifetime US3814137A (en)

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Application Number Priority Date Filing Date Title
US32673773 US3814137A (en) 1973-01-26 1973-01-26 Injection site for flow conduits containing biological fluids

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US32673773 US3814137A (en) 1973-01-26 1973-01-26 Injection site for flow conduits containing biological fluids
CA187,439A CA988441A (en) 1973-01-26 1973-12-05 Injection site for flow conduits containing biological fluids
ZA739284A ZA7309284B (en) 1973-01-26 1973-12-06 Improved injection site for flow conduits containing biological fluids
IL4378773A IL43787A (en) 1973-01-26 1973-12-10 Injection site for flow conduits containing biological fluids
JP14176873A JPS5641251B2 (en) 1973-01-26 1973-12-17
BE139132A BE808946A (en) 1973-01-26 1973-12-21 Improvements to the injection points provided in a duct for the flow of biological fluid
AR25184974A AR207438A1 (en) 1973-01-26 1974-01-01 A conduit for improvements in biological fluids
GB34474A GB1417529A (en) 1973-01-26 1974-01-04 Injection site for flow conduits containing biological fluids
IT1909974A IT1006730B (en) 1973-01-26 1974-01-04 Vessel defining the area iniezio it for you flow ducts contenen biological fluids
IE3074A IE39151B1 (en) 1973-01-26 1974-01-07 Improved injection site for flow conduits containing biological fluids
DE19742402135 DE2402135B2 (en) 1973-01-26 1974-01-17 Line having a puncturable hose
CH63074A CH577322A5 (en) 1973-01-26 1974-01-17
NL7400730A NL161362C (en) 1973-01-26 1974-01-18 Line for blood and the like, provided with an injection site.
BR48974A BR7400489D0 (en) 1973-01-26 1974-01-23 Local application for injection into conduits containing flowing biological fluids
FR7402319A FR2215248B1 (en) 1973-01-26 1974-01-24
SE7401015A SE393536B (en) 1973-01-26 1974-01-25 Conduit for blood and the like comprising a puncturable acids
AU64957/74A AU486661B2 (en) 1973-01-26 1974-01-29 Improved injection site for flow conduits containing biological fluids

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US3814137A true US3814137A (en) 1974-06-04

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US (1) US3814137A (en)
JP (1) JPS5641251B2 (en)
AR (1) AR207438A1 (en)
BE (1) BE808946A (en)
BR (1) BR7400489D0 (en)
CA (1) CA988441A (en)
CH (1) CH577322A5 (en)
DE (1) DE2402135B2 (en)
FR (1) FR2215248B1 (en)
GB (1) GB1417529A (en)
IE (1) IE39151B1 (en)
IL (1) IL43787A (en)
IT (1) IT1006730B (en)
NL (1) NL161362C (en)
SE (1) SE393536B (en)
ZA (1) ZA7309284B (en)

Cited By (47)

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US3898988A (en) * 1974-04-22 1975-08-12 Cobe Lab Extra corporeal blood access site
US4076023A (en) * 1975-08-01 1978-02-28 Erika, Inc. Resealable device for repeated access to conduit lumens
US4184489A (en) * 1976-10-06 1980-01-22 Cordis Dow Corp. Infusion tube access site
US4619641A (en) * 1984-11-13 1986-10-28 Mount Sinai School Of Medicine Of The City University Of New York Coaxial double lumen anteriovenous grafts
US4698061A (en) * 1984-03-02 1987-10-06 Baxter Travenol Laboratories, Inc. Injection site package
US5116318A (en) * 1989-06-06 1992-05-26 Cordis Corporation Dilatation balloon within an elastic sleeve
US5290306A (en) * 1989-11-29 1994-03-01 Cordis Corporation Puncture resistant balloon catheter
US5478320A (en) * 1989-11-29 1995-12-26 Cordis Corporation Puncture resistant balloon catheter and method of manufacturing
US5538510A (en) * 1994-01-31 1996-07-23 Cordis Corporation Catheter having coextruded tubing
US5797877A (en) * 1993-10-01 1998-08-25 Boston Scientific Corporation Medical device balloons containing thermoplastic elastomers
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US5931865A (en) * 1997-11-24 1999-08-03 Gore Enterprise Holdings, Inc. Multiple-layered leak resistant tube
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US6319228B1 (en) 1996-04-26 2001-11-20 Schneider (Europe) A.G. Multilayer interventional catheter
US6659977B2 (en) 1993-10-27 2003-12-09 Schneider (Europe) A.G. Multilayer interventional catheter
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US8663309B2 (en) 2007-09-26 2014-03-04 Trivascular, Inc. Asymmetric stent apparatus and method
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Cited By (89)

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Publication number Priority date Publication date Assignee Title
US3898988A (en) * 1974-04-22 1975-08-12 Cobe Lab Extra corporeal blood access site
US4076023A (en) * 1975-08-01 1978-02-28 Erika, Inc. Resealable device for repeated access to conduit lumens
US4184489A (en) * 1976-10-06 1980-01-22 Cordis Dow Corp. Infusion tube access site
US4698061A (en) * 1984-03-02 1987-10-06 Baxter Travenol Laboratories, Inc. Injection site package
US4619641A (en) * 1984-11-13 1986-10-28 Mount Sinai School Of Medicine Of The City University Of New York Coaxial double lumen anteriovenous grafts
US5116318A (en) * 1989-06-06 1992-05-26 Cordis Corporation Dilatation balloon within an elastic sleeve
US5476476A (en) * 1989-06-06 1995-12-19 Cordis Corporation Dilatation balloon assembly
US6132824A (en) * 1989-09-25 2000-10-17 Schneider (Usa) Inc. Multilayer catheter balloon
US5620649A (en) * 1989-11-29 1997-04-15 Cordis Corporation Puncture resistant balloon catheter
US5478320A (en) * 1989-11-29 1995-12-26 Cordis Corporation Puncture resistant balloon catheter and method of manufacturing
US5613979A (en) * 1989-11-29 1997-03-25 Cordis Corporation Puncture resistant balloon catheter
US5290306A (en) * 1989-11-29 1994-03-01 Cordis Corporation Puncture resistant balloon catheter
US7585289B2 (en) 1991-04-26 2009-09-08 Boston Scientific Scimed, Inc. Co-extruded medical balloon
US6482348B1 (en) 1991-04-26 2002-11-19 Boston Scientific Corporation Method of forming a co-extruded balloon for medical purposes
US6136258A (en) * 1991-04-26 2000-10-24 Boston Scientific Corporation Method of forming a co-extruded balloon for medical purposes
US7781038B2 (en) 1993-10-01 2010-08-24 Boston Scientific Scimed, Inc. Medical device balloons containing thermoplastic elastomers
US6896842B1 (en) 1993-10-01 2005-05-24 Boston Scientific Corporation Medical device balloons containing thermoplastic elastomers
US5797877A (en) * 1993-10-01 1998-08-25 Boston Scientific Corporation Medical device balloons containing thermoplastic elastomers
US6086556A (en) * 1993-10-01 2000-07-11 Boston Scientific Corporation Medical device balloons containing thermoplastic elastomers
US7635347B2 (en) 1993-10-27 2009-12-22 Schneider (Europe) A.G. Catheter with multilayer tube
US20090137954A1 (en) * 1993-10-27 2009-05-28 Schneider (Europe) Gmbh Multilayer Interventional Catheter
US6027477A (en) * 1993-10-27 2000-02-22 Schneider (Europe) A.G. Catheter with multilayer tube
US5843032A (en) * 1993-10-27 1998-12-01 Schneider (Europe) Ag Catheter with multilayer tube
US7485108B2 (en) 1993-10-27 2009-02-03 Schneider (Europe) A.G. Multilayer interventional catheter
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Also Published As

Publication number Publication date
CA988441A (en) 1976-05-04
NL161362B (en) 1979-09-17
IL43787A (en) 1975-12-31
IE39151L (en) 1974-07-26
CH577322A5 (en) 1976-07-15
CA988441A1 (en)
NL161362C (en) 1980-02-15
DE2402135B2 (en) 1977-01-27
IL43787D0 (en) 1974-03-14
SE393536B (en) 1977-05-16
BR7400489D0 (en) 1974-12-03
IE39151B1 (en) 1978-08-16
JPS5641251B2 (en) 1981-09-26
AU6495774A (en) 1975-07-31
AR207438A1 (en) 1976-10-08
NL7400730A (en) 1974-07-30
BE808946A (en) 1974-04-16
BE808946A1 (en)
FR2215248A1 (en) 1974-08-23
ZA7309284B (en) 1974-10-30
IT1006730B (en) 1976-10-20
FR2215248B1 (en) 1980-09-05
DE2402135A1 (en) 1974-08-01
JPS507393A (en) 1975-01-25
GB1417529A (en) 1975-12-10

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