CA2244038A1 - Prepared catheter - Google Patents

Prepared catheter Download PDF

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Publication number
CA2244038A1
CA2244038A1 CA2244038A CA2244038A CA2244038A1 CA 2244038 A1 CA2244038 A1 CA 2244038A1 CA 2244038 A CA2244038 A CA 2244038A CA 2244038 A CA2244038 A CA 2244038A CA 2244038 A1 CA2244038 A1 CA 2244038A1
Authority
CA
Canada
Prior art keywords
balloon
catheter
inflation
shaft
lumen
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.)
Abandoned
Application number
CA2244038A
Other languages
French (fr)
Inventor
Michael Schwager
Cirillo Ghielmetti
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.)
Schneider Europe GmbH
Original Assignee
Schneider Europe 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 Schneider Europe GmbH filed Critical Schneider Europe GmbH
Publication of CA2244038A1 publication Critical patent/CA2244038A1/en
Abandoned 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
    • 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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183Rapid exchange or monorail catheters
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1072Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1084Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1086Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • 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
    • A61M25/1002Balloon catheters characterised by balloon shape

Abstract

In the case of a prepared catheter for intraluminal treatment of a vessel section, which catheter has an elongate shaft (1) with a proximal end and a distal end (2), a balloon (8) which is arranged at the distal end (2) of the shaft (1) and can be inflated to a maximum use volume, and an inflation lumen (7) which runs through the shaft(1) and opens into the balloon (8), and which catheter is filled with an inflation medium (9) for applying pressure to the balloon (8), if the inflation medium (9) has a viscosity which is lower than that of water, and if the inflation lumen (7) has, along the greater part of the length lying within the patient's body during treatment, a cross-sectional area having a value in mm2 not greater than the maximum use volume of the balloon (8) in mm3 divided by 1200, then a reduction in the overall profile of the catheter is achieved while at the same time retaining the desireddeflation times for the balloon (8).

Description

Pa 97120 CO2 Shaft Description 5 The invention relates to a prepared catheter for intraluminal treatment of a vessel section, which catheter has an elongate shaft with a proximal end and a distal end, a balloon which is arranged at the distal end of the shaft and can be inflated to a maximum use volume, and an inflation lumen which runs through the shaft and opens into the balloon, and which catheter is hlled with an inflation medium for10 applying pressure to the balloon.

Balloon catheters are used, for example, for axial sealing or radial expansion of vessels of the body. A common and typical intervention using a balloon catheter is percutaneous transluminal angioplasty in the peripheral or coronary blood vessel15 system. In these vessels, stenosed areas formed by deposits are widened by inflating a dilation balloon in order to restore an adequate cross-section of flow to the blood. In addition, balloon catheters are also used as transport and expansion means for balloon-expandable stents. These involve a small support tube which isfor the most part made of metal and which, during or after balloon dilation, is plastically deformed by the expanding balloon. With the aid of the plastic deformation, it is implanted in the widened vessel section and is intended to prevent restenosis of this vessel section. It is also known to seal off a section of a blood vessel by means of two occlusion balloons which are arranged one behind the other on a balloon catheter and to infuse into the interspace a medicinal product for treating the vessel, and to suction off possible reaction products from the interspace.

Balloon catheters generally have a lumen running along their entire length, or along only a distal section, and receiving a guide wire which has been positioned 30 beforehand in the vessel and along which the balloon catheter is advanced until it reaches the vessel section that is to be treated. In so doing, the balloon catheter passes through a guide catheter which has similarly been put into position beforehand and which bridges the puncture site and the large-lumen portion of the vessel During treatment, contrast medium for fluoroscopic visualization of the 35 catheter positions, and of the success of the treatment, is injected through the annular lumen between balloon catheter and guide catheter.
Once the balloon catheter has been brought into position the balloon ls filled with physiological saline solution or contrast medium via an inflation lumen and is pressurized ! as a result of which the balloon expands.
The increasing importance of minimally invasive surgery and the treatment of ever narrower blood vessels demand guide catheters! and consequently balloon catheters, of ever smaller profile. Flexlbility as well as thrust and torsion transmission of guide wire! balloon catheter and guide catheter must be guaranteed, as well as low friction between guide wire and balloon catheter. An adequately short deflation tlme for the balloon and a sufflclently large annular lumen for the flow of contrast medlum are also necessary.
If the inflation lumen is too narrow! the inflation medium can no longer flow quickly enough out of the balloon.
A catheter with slow emptying of the balloon blocks the bloodstream for longer and thus, for example, also precludes the possibility of responding quickly to an ischaemic reaction on the part of the patient during treatment.
The invention is therefore based on the obiect of providing a balloon catheter of the type mentioned in the introduction, which balloon catheter has short deflation times and has a small overall profile.
The invention provides prepared catheter for intraluminal treatment of a vessel section, which catheter has an elongate shaft with a proximal end and a distal end, a balloon which is arranged at the distal end of the shaft and can be inflated to a maximum use volume, and an inflation lumen which runs through the shaft (1? and opens into the balloon, and which catheter is filled with an inflation medium for applying pressure to the balloon! characterized in that the inflation medium has a viscoslty which is lower than that of water ! and in that the inflation lumen has ! along the greater part of the length lying within the patient's body lG during treatment, a cross-sectional area having a value in mm not greater than the maximum use volume of the balloon in mm divided by 1200. Use of an inflation medium with a lower viscosity than water makes it possible, while having essentially the same deflation timef for the inflation lumen to be made smaller in cross-section along the greater part of its length running within the patient during treatment, with great advantages for all other properties of the catheter.
For example, as a result of the smaller overall profile, the flow of contrast medium is improved, while at the same time, however, the flexibility and the kink resistance are also improved, since with smaller shaft diameters the wall thickness can be reduced. The re~uction in cross-section which can be achieved by means of the invention can either be specified in absolute values, or, as a function of the maximum use volume of the balloon which has to be deflated.
If a gas is used as inflation medium, the advantages of the invention become especially evldent. Gas-filled -3a-balloons have up to about three times shorter deflation times compared to balloons which have been inflated with liquid.
Accordingly, the cross-sectional area of the lnflatlon lumen can be reduced ln this case.
In a preferred embodiment of the inventlon, the inflation medium is carbon dioxide. In the treatment of blood vessels, lt ls posslble, ln the event of a leaking or defective balloon, for the blood to absorb a certain amount of carbon dloxide without harming the patient. Since carbon dioxide is transported anyway in the blood, its biological tolerability in humans is not ln questlon.
Further properties of a catheter according to the invention will become apparent from an illustratlve embodiment which is descrlbed ln detall herelnbelow wlth reference to the drawlng. Thls example lnvolves a catheter for lntralumlnal treatment of a vessel sectlon with lonlzing radiation.
Controlled deflatlon tlmes, wlth a small shaft cross-sectlon, are of particular interest here. In the case of protracted irradiation times, as can result from the abating energy of the emltter, the burden on the patlent is minimized by interruptlng the flow of blood. The advantages of the invention are seen not only ln this application, however, but in all balloon catheters whose deflation time and whose overall profile are of lnterest, such as in the case of the catheters mentioned ln the lntroduction, ln the case of dilatiGn catheters or occlusion catheters for use in coronary or peripheral blood vessels or in neurology, and in the case -3b-of other catheters. In the drawing:

FIG. 1 shows ! in a longitudinal cutaway, the distal section of a catheter according to the invention.
According to FIG. 1! a catheter according to the invention for intraliminal treatment of a vessel section with ionizing radiation has a three-lumen shaft 1 which has a proximal end (not shown) and a dlstal end 2, and serves as transluminal access to the vessel section. The shaft 1 is made up of an outer shaft lb and an inner shaft la which runs coaxially inside the latter and pro~ects distally from it. In a tip 3 of the inner shaft 1a there is a short guide-wire lumen 4 for receiving a guide wire (not shown, course indicated by dot-and-dash line 5), onto which the catheter is threaded in order to be advanced through the vessel system. During the insertion of the catheter, a central lumen 6 which is closed distally is used for receiving a5 stiffening wire (not shown) which transmits axial thrust to the tip 3 as the shaft 1 is being advanced. An annular inflation lumen 7 running between inner shaft 1a and outer shaft 1b opens into a balloon 8 arranged at the distal end 2 of the shaft 1, which balloon 8 is filled, via the inflation lumen 7, with an inflation medium 9, for example carbon dioxide, and is thereby inflated. With approximately the same 10 emptying time for the balloon 8, the use of carbon dioxide as inflation medium permits a reduction in the cross-sectional area of the inflation lumen 7, for example to values of less than 0.300 mm2, although cross-sectional areas of less than 0.200 mm2 have already been produced. The achievable ratio between the maximum use volume of the balloon and the cross-sectional area of the inflation lumen, with tolerable emptying times, is approximately 1200:1. In order to obtain a thin outer shaft 1b, the emptying times evolving from a ratio of 1600:1 have also been accepted in some cases. The inflated balloon 8 is subdivided into a plurality ofballoon segments by constrictions which are formed by ring elements 10, as a result of which the central lumen 6 is radially centred even in the event of deformation of 20 the inner shaft 1a. When the balloon catheter has been positioned, the stiffening wire is removed from the central lumen 6 and replaced by a source wire 11 into which a source 12 of ionizing radiation is incorporated distally. The source 12 is, for example, a filament of yttrium-90.

25 The carbon dioxide used as inflation medium is, for example, kept ready in gas bottles at a pressure of 11 bar, for example. The gas pressure can be reduced via a reducing valve, so that an inflation syringe can also be filled with carbon dioxide in the sterile area of a catheter laboratory. Air is removed from the balloon and inflation lumen of the catheter in a customary manner, for instance with a syringe 30 creating a vacuum. The balloon can thereafter be inflated with the carbon dioxide taken up by the inflation syringe.

List of references 1 Shaft 1 a Inner shaft 5 1 b Outer shaft
2 Distal end
3 Tip
4 Guide-wire lumen
5 Guide-wire course 0 6 Central lumen 7 Inflation lumen 8 Balloon 9 Inflation medium, carbon dioxide 10 Ring element 15 1 1 Source wire 1 2 Source

Claims (6)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. Prepared catheter for intraluminal treatment of a vessel section, which catheter has an elongate shaft with a proximal end and a distal end, a balloon which is arranged at the distal end of the shaft and can be inflated to a maximum use volume, and an inflation lumen which runs through the shaft and opens into the balloon, and which catheter is filled with an inflation medium for applying pressure to the balloon, characterized in that the inflation medium has a viscosity which is lower than that of water, and in that the inflation lumen has, along the greater part of the length lying within the patient's body during treatment, a cross-sectional area having a value in mm2 not greater than the maximum use volume of the balloon in mm divided by 1200.
2. Prepared catheter according to Claim 1, characterized in that the inflation lumen has, along the greater part of the length lying within the patient's body during treatment, a cross-sectional area having a value in mm2 not greater than the maximum use volume of the balloon in mm3 divided by 1600.
3. Prepared catheter according to the preamble of Claim 1, characterized in that the inflation medium has a viscosity which is lower than that of water, and in that the inflation lumen has, along the greater part of the length lying within the patient's body during treatment, a cross-sectional area of at most 0.300 mm2.
4. Prepared catheter according to Claim 3, characterized in that the inflation medium has a viscosity which is lower than that of water, and in that the inflation lumen has, along the greater part of the length lying within the patient's body during treatment, a cross-sectional area of at most 0.200 mm2.
5. Prepared catheter according to any one of claims 1 to 4, characterized in that the inflation medium is a gas.
6. Prepared catheter according to Claim 5, characterized in that the inflation medium is carbon dioxide.
CA2244038A 1997-09-26 1998-07-28 Prepared catheter Abandoned CA2244038A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP97202958.1 1997-09-26
EP97202958A EP0904799A1 (en) 1997-09-26 1997-09-26 Dilation catheter with balloon having a determined ration of balloon volume and square surface of the inflation lumen

Publications (1)

Publication Number Publication Date
CA2244038A1 true CA2244038A1 (en) 1999-03-26

Family

ID=8228758

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2244038A Abandoned CA2244038A1 (en) 1997-09-26 1998-07-28 Prepared catheter

Country Status (4)

Country Link
EP (1) EP0904799A1 (en)
JP (1) JPH11114067A (en)
AU (1) AU7182798A (en)
CA (1) CA2244038A1 (en)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69326455T2 (en) 1993-07-01 2000-01-20 Schneider Europ Gmbh Buelach Medicinal devices for the treatment of blood vessels by means of ionization radiation
EP0686342B1 (en) 1994-06-10 1998-09-09 Schneider (Europe) GmbH A medical appliance for the treatment of a portion of body vessel by ionising radiation
ATE196742T1 (en) 1994-06-24 2000-10-15 Schneider Europ Gmbh MEDICINAL DEVICE FOR THE TREATMENT OF A PART OF A BODY VESSEL USING IONIZATION RADIATION
ATE236683T1 (en) 1995-12-05 2003-04-15 Schneider Europ Gmbh THREAD FOR RADIATION OF A LIVING BODY AND METHOD FOR PRODUCING A THREAD FOR RADIATION OF A LIVING BODY
US5855546A (en) 1996-02-29 1999-01-05 Sci-Med Life Systems Perfusion balloon and radioactive wire delivery system
US6234951B1 (en) 1996-02-29 2001-05-22 Scimed Life Systems, Inc. Intravascular radiation delivery system
US6676590B1 (en) 1997-03-06 2004-01-13 Scimed Life Systems, Inc. Catheter system having tubular radiation source
US6019718A (en) 1997-05-30 2000-02-01 Scimed Life Systems, Inc. Apparatus for intravascular radioactive treatment
EP0904798B1 (en) 1997-09-26 2002-11-06 Schneider ( Europe) GmbH Carbon dioxide inflated radio-therapy balloon catheter
US6264596B1 (en) 1997-11-03 2001-07-24 Meadox Medicals, Inc. In-situ radioactive medical device
US6048350A (en) * 1999-06-14 2000-04-11 Scimed Life Systems, Inc. Segmented balloon delivery system
US6203485B1 (en) 1999-10-07 2001-03-20 Scimed Life Systems, Inc. Low attenuation guide wire for intravascular radiation delivery
US6398709B1 (en) 1999-10-19 2002-06-04 Scimed Life Systems, Inc. Elongated member for intravascular delivery of radiation
US6416457B1 (en) 2000-03-09 2002-07-09 Scimed Life Systems, Inc. System and method for intravascular ionizing tandem radiation therapy
US6302865B1 (en) 2000-03-13 2001-10-16 Scimed Life Systems, Inc. Intravascular guidewire with perfusion lumen
US20070250104A1 (en) * 2004-03-08 2007-10-25 Medilator Catheter and Method for Dilating a Body Passageway

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4773899A (en) * 1982-11-23 1988-09-27 The Beth Israel Hospital Association Method of treatment of artherosclerosis and balloon catheter the same
US5135486A (en) * 1990-08-31 1992-08-04 Endosonics Corporation Self-venting balloon dilitation catheter
US5584803A (en) * 1991-07-16 1996-12-17 Heartport, Inc. System for cardiac procedures

Also Published As

Publication number Publication date
AU7182798A (en) 1999-04-15
JPH11114067A (en) 1999-04-27
EP0904799A1 (en) 1999-03-31

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