CA2201993C - Catheter with marker sleeve - Google Patents

Catheter with marker sleeve Download PDF

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Publication number
CA2201993C
CA2201993C CA002201993A CA2201993A CA2201993C CA 2201993 C CA2201993 C CA 2201993C CA 002201993 A CA002201993 A CA 002201993A CA 2201993 A CA2201993 A CA 2201993A CA 2201993 C CA2201993 C CA 2201993C
Authority
CA
Canada
Prior art keywords
catheter
tube
marker sleeve
distal end
balloon member
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 - Lifetime
Application number
CA002201993A
Other languages
French (fr)
Other versions
CA2201993A1 (en
Inventor
Lucas Joannes Hijlkema
Jan Thalens
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.)
Cordis Europa NV
Original Assignee
Cordis Europa NV
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 Cordis Europa NV filed Critical Cordis Europa NV
Publication of CA2201993A1 publication Critical patent/CA2201993A1/en
Application granted granted Critical
Publication of CA2201993C publication Critical patent/CA2201993C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers

Abstract

The invention relates to a catheter comprising a tube-like basic body with a proximal and a distal end, marking means made of a material opaque to X-radiation arranged close to the distal end. The marking means may be formed by at least one tube-like marker sleeve made of a plastic material opaque to X-radiation arranged around the basic body. At the distal end a balloon member may have been arranged and the marker sleeve may substantially extend over the effective length of the balloon member.

Description

CATHETER WITH MARKER SLEEVE
The invention relates to a catheter comprising in the usual manner a tube-like basic body with a proximal and a distal end. At the distal end, to be inserted into a patient, at least one active element like a balloon member or a sensor has been arranged.
It is known to arrange marking rings, made for instance of gold, close to such an active element. When the catheter is used for the purpose of an investigation or for treatment, the area concerned is visualized by means of X-rays. As the marking rings are opaque to X-radiation, these rings are visible on the X-ray screen, so that the position of the active element can be determined by the physician carrying out the procedure.
These marking rings are difficult to handle and fit when manufacturing the catheter.
This is not the case with the catheter according to the invention. According to the present invention, there is provided a catheter comprising a tube-like body with a proximal and a distal end, marking means arranged close to the distal end made of a material opaque to X-radiation; whereby the marking means are formed by at least one tube-like marker sleeve made of a plastic material opaque to X-radiation, arranged around the basic body; wherein a balloon member has been arranged at the catheter distal end and the marker sleeve extends substantially over the entire length of the balloon member; and wherein the tube-like body comprises an outer element and, received inside and partly sticking out of the outer element at the distal end, an inner tube-like element, the balloon member extending over the protruding section of the inner element and wherein the i I~ i ~ e~.r.iii i ~ rl rr l.,.l~r n" i I
marker sleeve is arranged around the protruding section of the inner element.
As the marker sleeve is made of a plastic material, it is pliable and can consequently have a greater length than the known marking rings without affecting the pliability of the catheter in an unfavorable manner. Due to this greater length the marker sleeve is more manageable when manufacturing the catheter.
Whilst visible on the X-ray screen, the catheter can now be manipulated properly in such a way that the marker sleeve is positioned at the site to be treated. As soon as the sleeve has been positioned carefully at the site to be treated, the balloon member may be expanded, ensuring that exactly the area marked by the marking ring will be treated.
In an embodiment of the catheter, the tube-like body comprises a number of sections with different properties and the marker sleeve has been arranged at the transition points between these sections. A more pliable end-section of the catheter or an end-section with a smaller diameter can for instance be marked in this way.
In another embodiment for marking an active element of the catheter, the catheter comprises at least one element close to its distal end and the marker sleeve is arranged on either side of this element.
By arranging a marker sleeve on either side, the active element becomes recognizable on the X-ray screen as an interruption of a continuous line formed by the two marker sleeves positioned in line with one another.

i I~ i n r. iii i . rl ri Ir,a.r hnr ~ ~~

2a In a further embodiment of the catheter, holes are arranged in the marker sleeve at pre-determined places. Because of the holes, an easily recognisable pattern in the image of the marker sleeve on the X-ray screen becomes detectable, so that the marker sleeve cannot be masked so easily by for instance the image of a guide wire or other artefact.
In the latter embodiment, preferably the holes are arranged at regular intervals on a helical line. As the distance in between the holes is known, it becomes possible to take measurements from the X-ray screen, whereby the measurements obtained can be related to these distances between the holes.
The marker sleeve may be fixed to the basic body by for instance glueing. Preferably the sleeve is however shrunk around the basic body. This may for instance be achieved by first making the marker sleeve swell up in a solvent, as a result of which the sleeve can be pushed easily around the basic body, and by subsequently making this solvent evaporate as a result of which the marker sleeve will resume its original diameter, the size of which will obviously be such, so as to ensure a tight fit of the marker sleeve around the basic body.
The invention will be explained in greater detail with reference to the attached drawings of examples of embodiments.
Figure 1 illustrates a distal end-section of a catheter according to the invention, being a balloon catheter.
Figure 2 shows a partly perspective view of a catheter according to another embodiment of the invention.
Figure 3 shows a perspective view of a marker sleeve arranged around a catheter in a preferred embodiment.
The distal end-section of a catheter 1 illustrated in figure 1 comprises a balloon member 5 which has been arranged on the tube-like basic body 2 of the catheter 1.
The basic body 2 has been made up of an outer tube-like element 3 and an inner tube-like element 4. The inner tube-like element 4 has been received inside a continuous lumen 6 of the outer tube-like element 3. As can be seen in figure 1, the inner tube-like element 4 sticks out of the outer tube-like element 3. The balloon member 5 has been arranged around this protruding section. The balloon member 5 can be expanded by supplying a medium under pressure via the lumen 6.
A marker sleeve 7, made of a plastic material opaque to X-radiation, has been arranged around the inner tube-like element 4 at the site of the balloon member 5.
This marker sleeve 7 may for instance have been manufactured by means of extrusion of a suitable plastic material. When manufacturing the catheter 1, the marker sleeve 7 is pushed over the inner tube-like element 4 and fixed to it. This may be achieved by means of glueing or for instance by first making the marker sleeve swell up in a solvent, then pushing it over the tube-like element 4 and subsequently evaporating the solvent, as a result of which the marker sleeve 7 will resume the original diameter which fits tightly around the inner tube-like element 4. The marker sleeve has thus been shrunk tightly around the basic body.

As can be seen in figure 1, the length of the marker sleeve 7 corresponds to the effective length of the balloon member 5. As it has been made of a plastic material opaque to X-radiation, the position of the marker sleeve 7 will be clearly visible when the end-section of the catheter 1 is made visible on an X-ray screen and it will consequently indicate the position of the active section of the balloon member 5.
As the marker sleeve 7 has been made of a plastic material, it is pliable to such an extent that it does not impede the bending of the basic body of the catheter 1. In addition, the sleeve does not have any sharp edges which could damage the balloon member 5.
The catheter 10 illustrated in figure 2 is of a type comprising two balloon members 12, 13 positioned one after the other. The balloon members 12, 13, illustrated here in non-expanded state, are bounded by marker sleeves 14, 15, 16 respectively, made of a plastic material opaque to X-radiation. The three marker sleeves 14, 15, 16, which are substantially positioned in line with one another, become clearly visible on the X-ray screen, and the spaces in between the visible shadows of these marker sleeves consequently indicate the balloons 12 and 13.
Thus the physician carrying out the procedure can manoeuvre the balloons 12 and 13 accurately in the required position.
Figure 3 shows a marker sleeve 21 arranged around a basic body 20 of a catheter made of a material opaque to X-radiation. This marker sleeve 21 has been provided with holes 22 which are, in the case of this embodiment, positioned on a helical line. The holes 22 have been arranged in a regular fashion, so that they are placed at known distances from one another. The physician carrying out the procedure can take measurements from the X-ray screen, whereby the distances between the holes 22 serve as reference for measurements taken in that area.
In addition, the result of the fact that the holes 22 have been arranged to form a pattern is that the image of the marker sleeve becomes very familiar on the X-ray screen, so that also in the case of difficult visual circumstances, for instance due to the presence of other artefacts in the vicinity of the marker sleeve which form a strong shadow on the X-ray screen, it remains easily recognizable. The property of the marker sleeve that it is opaque to X-radiation can be achieved in a manner known as such, for instance by making the marker sleeve of a plastic material which absorbs the X-rays.
As the marker sleeve can be manufactured in such a way that it does not affect the compliance properties of the catheter to a significant degree, it can be made so as to be unusually long for marking means.

Claims (6)

1. Catheter comprising:
a tube-like body with a proximal and a distal end, marking means arranged close to the distal end made of a material opaque to X-radiation;

whereby the marking means are formed by at least one tube-like marker sleeve made of a plastic material opaque to X-radiation, arranged around the tube-like body;

wherein a balloon member is arranged at the catheter distal end and the marker sleeve extends substantially over the entire length of the balloon member; and wherein said tube-like body comprises an outer element and, received inside and partly sticking out of said outer element at the distal end, an inner tube-like element, the balloon member extending over the protruding section of said inner element and wherein the marker sleeve is arranged around the protruding section of the inner element.
2. Catheter as claimed in claim 1, wherein the tube-like body comprises a number of sections with different properties and said marker sleeve is arranged at the transition points between these sections.
3. Catheter comprising:
a tube-like body with a proximal and a distal end, marking means arranged close to the distal end made of a material opaque to X-radiation;
whereby the marking means are formed by at least one tube-like marker sleeve made of a plastic material opaque to X-radiation, arranged around the tube-like body;
wherein a balloon member is arranged close to the catheter distal end and the marker sleeve is arranged on either side of the balloon member; and wherein said tube-like body comprises an outer element and, received inside and partly sticking out of said outer element at the distal end, an inner tube-like element, the balloon member extending over the protruding section of said inner element and wherein the marker sleeve is arranged around the protruding section of the inner element.
4. Catheter as claimed in any one of claims 1 to 3, wherein holes are arranged in the marker sleeve at pre-determined places.
5. Catheter as claimed in claim 4, wherein the holes are arranged at regular intervals on a helical line.
6. Catheter as claimed in any one of claims 1 to 5, wherein the marker sleeve is shrunk tightly around the tube-like body.
CA002201993A 1996-04-18 1997-04-07 Catheter with marker sleeve Expired - Lifetime CA2201993C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NL1002898A NL1002898C2 (en) 1996-04-18 1996-04-18 Catheter with marker sleeve.
NL1002898 1996-04-18
US08/842,588 US5846199A (en) 1996-04-18 1997-04-15 Catheter with marker sleeve

Publications (2)

Publication Number Publication Date
CA2201993A1 CA2201993A1 (en) 1997-10-18
CA2201993C true CA2201993C (en) 2006-05-09

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002201993A Expired - Lifetime CA2201993C (en) 1996-04-18 1997-04-07 Catheter with marker sleeve

Country Status (4)

Country Link
US (1) US5846199A (en)
EP (1) EP0801956A1 (en)
CA (1) CA2201993C (en)
NL (1) NL1002898C2 (en)

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Also Published As

Publication number Publication date
EP0801956A1 (en) 1997-10-22
CA2201993A1 (en) 1997-10-18
US5846199A (en) 1998-12-08
NL1002898C2 (en) 1997-10-21

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Effective date: 20170407