CA2028897C - Stent and catheter for the introduction of the stent - Google Patents

Stent and catheter for the introduction of the stent

Info

Publication number
CA2028897C
CA2028897C CA002028897A CA2028897A CA2028897C CA 2028897 C CA2028897 C CA 2028897C CA 002028897 A CA002028897 A CA 002028897A CA 2028897 A CA2028897 A CA 2028897A CA 2028897 C CA2028897 C CA 2028897C
Authority
CA
Canada
Prior art keywords
stent
balloon
catheter
fact
celsius
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
CA002028897A
Other languages
French (fr)
Other versions
CA2028897A1 (en
Inventor
Andreas Beck
Norbert A. Nanko
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 CA2028897A1 publication Critical patent/CA2028897A1/en
Application granted granted Critical
Publication of CA2028897C publication Critical patent/CA2028897C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/92—Method or apparatus for preparing or treating prosthetic
    • Y10S623/921—Blood vessel

Abstract

A stent which is a hollow, cylindrical structure made of a synthetic substance which becomes plastic and malleable in a temperature range from 45 to 75°
Celsius. The stent is brought to the desired site, for example a stenosed section of an artery, by means of a heatable balloon catheter. The stent is heated at the site to be treated and whilst in the plastic state is expanded through dilatation of a balloon. After being cooled to body temperature the expanded stent retains the form achieved. The body fluids bring about complete biodegradation of the implanted stent.

Description

This discovery concerns a stent for angioplasty, and also a balloon catheter for the lntroduction of the stent.
Stents and more speclflcally lntravascular stents for angloplasty have largely proved useful ln medlcal practice for the preventlon of occluslons or re-stenosls after translumlnal angloplasty. A known stent conslsts of a cartrldge-shaped lattlce made of stalnless steel. The stent, whlch measures 1.6 or 3 mm ln clrcumferences, is attached to a folded balloon catheter and ls brought to the desired site of the blood vessel percutaneously. The stent ls wldened to a diameter of about 3 mm by dilatlng the balloon catheter. The inserted and flxed stent ls left ln the vessel and as a rule becomes covered wlth newly formed lntlma. The artlcle by Jullo C. Plamaz ln the ~ournal Radlology, July 1988, 150:
1263-1269 deals wlth the state of the art in respect of thls technlque.
The ob~ectlve behlnd the dlscovery was to produce a stent of the klnd described which would be even more safe and simple to use but which nevertheless could be manufactured at a lower cost.
The present lnventlon provldes a stent, more speclfically intravascular stent for angioplasty, which can be used percutaneously attached to the balloon of a balloon catheter and which, for its fixation, can be widened through dilatatlon of the balloon, sald stent made out of a materlal whlch has a melting point or a softening range in the range from 45 to 75 Celslus.
The present lnvention also provides an lntravascular stent, adapted for attachment to a balloon of a balloon 1 - ~,L

B ~ 64680-580 catheter, the stent comprlslng a hollow cyllndrlcal structure wlth a length of about 2 to 10 cm made of a materlal havlng a meltlng polnt or a softenlng range ln the range from 45 to 75 Celslus.
The dlscovered stent ls pushed on to the balloon of the balloon catheter at room temperature and ls comparatlvely rlgld and stlff here. The stent can be flxed on to the catheter by sllghtly dllatlng the balloon. Once the stent has been pushed forwards to the deslred slte, for example ln a stenosed sectlon of an artery, lt ls heated through a heatlng faclllty arranged ln the catheter, untll lt can be wldened radlally through dllatatlon of the balloon. The stent - la -D , 64680- 580 D ~

is widened until it sits closely up against the inner wall of the vessel with slight pressure. The heating of the catheter is now stopped, whereupon the stent changes into the solid state comparatively rapidly and retains the dilated form here. In the implanted state the wall-thickness of the stent is less than in its original state so that it is somewhat more flexible.
The stent can therefore adapt to the course of the vessel, within certain limits, in the implanted state.
The discovered stent can be made of a synthetic substance which is presumably better tolerated than metal. Here the inside of the stent can be completely smooth, which reduces the danger of thrombosis.
The discovered stent is particularly suitable for coronary and peripheral angioplasty, but other applications are also conceivable. For example, the discovered stent would be suitable for use whenever it is a question of keeping a passageway permanently or temporarily open. Examples of such passageways are the cystic duct and the urethra.
The stent can be manufactured, for example through extrusion, in a great variety of lengths and also external and internal diameters. A stent of the most suitable dimensions can thus be supplied in every case.
A stent with smaller external - and internal diameters is chosen for the treatment of a coronary artery for example, than for the treatment of a peripheral artery. Similarly, a comparatively short stent is generally used for the treatment of a curved section of vessel.
Following further development of the discovery, the stent is made of a material which is completely biodegradable in body fluids. Aliphatic polyester materials are particularly suitable for this and more specifically materials made of poly (e-caprolactone).
The biological degradation of these synthetic substances is known. Such substances are already used in medicine for the fixation of prostheses and as capsules for the controlled delivery of drugs. The rate of degradation of the material used to manufacture the discovered stent is roughly such that it is completely or largely dissolved within about 2 to 6 months. Since the stent is no longer present at the treated site after a comparatively short period of time, in the case of treatment for a stenosis the risk of thrombosis is less than with a permanently indwelling stent.
A model specimen of the discovery is explained in more detail on the basis of the following drawings:
Fig. 1 shows a perspective view of a stent, as per the discovery, Figs. 2a and 2b show the front end of a balloon catheter with a stent, as per the discovery, before and after dilatation, and Figs. 3a and 3b show diagrammatically a section through a vessel with the stent inserted before and after dilatation.
The stent shown in Figure 1 is a hollow cylindrical structure with a length C of, for example, 2 to 10 cm. For the treatment of a coronary artery the internal diameter B would be 1.0 0.005 mm for example, and the external diameter A 1.6 mm. For the treatment of a peripheral artery the internal diameter B would be 2.0 mm for example, and the external diameter A 3.0 mm. The stent 1 can be manufactured by extrusion. A synthetic substance which melts or which changes into the plastic state through gradual softening in the temperature range from 45 to 75 -202~897 Celsius is suitable as the manufacturing material.
Aliphatic polyesters and in particular poly (E-caprolactone) are a suitable material. Also suitable are polymers which are solid below a temperature of 45 Celsius and which change into a non-crystalline state at least above a temperature of about 70 Celsius.
Suitable polymers are polycaprolactones, polyurethanes and polyamides.
Out of these polymers, those which are biodegradable in body fluids are particularly suitable.
Poly (E-caprolactone) is particularly suitable here, the in vivo degradation of which has been described in the Journal of Applied Polymer Sciences, Vol. 26, 3779-3787 (1981).
A heatable balloon catheter 3 is used in order to bring the stent 1 to the desired treatment site. This catheter has a shaft 2, with three lumina, one lumen 2a being used for the passage of a guidewire.
A salt solution circulates in the other two lumina 2b and 2c, this flowing into and out of the internal space of the balloon 3 through openings which are not shown here. The salt solution is heated and conveyed by a heating - and pump - facility arranged at the proximal end of the shaft 2. Balloon catheters which are heated in the usual known way electrically, with high frequency or micro-waves, could also be used here however.
In order to fix the stent 1 on to the balloon catheter it is pushed on to the folded balloon from the distal end. In many cases the stent 1 is fixed sufficiently to prevent displacement in a longitudinal direction through the fact that its inside la rubs against the cutside 3a of the balloon 3. In other cases the pressure is increased slightly in the balloon 3. As shown in Fig. 2a, the length of the balloon 3 is selected in such a way that this is somewhat longer than the length C of the stent 1. The entire internal surface la of the stent 1 thus lies up against the external surface 3a of the balloon. When the balloon catheter is not yet heated the stent 1 is comparatively rigid and stiff and is not expanded, even when there is comparatively high pressure in the balloon 3.
The catheter, with the stent 1 placed on it, is introduced in the usual known way. For the treatment of a stenosis the catheter is introduced percutaneously with the aid of a guidewire, which is not shown here.
The position of the stent 1 can be monitored radiographically, for example using know marking strips 4.
once the stent 1 has been brought to the desired site with the balloon catheter, the balloon 3 is heated and the stent 1 is brought to a temperature at which plastic expansion becomes possible through dilatation of the balloon 3. For the treatment of a coronary artery, for example, the internal diameter is increased to 2.7 mm and the external diameter to 3.0 mm. In the case of a peripheral artery the internal diameter of the dilated stent is 5.4 mm for example, and the external diameter is 6.0 mm. The wall-thickness of the dilated stent 1' is considerably smaller than that of the original stent 1, as may be seen from Figs. 2a and 2b.
The stent 1 is dilated until its outer surface lies up against the inside of the vessel with slight pressure. This is shown in diagram form in Figs. 3a and 3b. In this case the vessel 5, for example, is a stenosed section of artery 5.
Once the stent 1' is fixed in the vessel the 2û28897 heating of the catheter is stopped, and the temperature of the stent 1' then falls to body temperature, once again assuming the solid state here. The pressure in the balloon 3 is then reduced and the catheter is removed from the vessel in the usual known way.
If the stent 1' is made of poly (E-caprolactone), then auto-catalytic degradation takes place through hydrolytic outer cleavage and it is broken down completely in about 2 to 6 months.

Claims (10)

1. Stent, more specifically intravascular stent for angioplasty, which can be used percutaneously attached to the balloon of a balloon catheter and which, for its fixation, can be widened through dilatation of the balloon, said stent made out of a material which has a melting point or a softening range in the range from 45 to 75° Celsius.
2. Stent as claimed in claim 1, characterized by the fact that the material of which it is made is biodegradable in body fluids.
3. Stent as claimed in claim 2, characterized by the fact that the material of which it is made is a polymer.
4. Stent as claimed in claim 3, characterized by the fact that the material of which it is made is an aliphatic polyester.
5. Stent as claimed in claim 4, characterized by the fact that the material of which it is made is polycaprolactone.
6. Stent as claimed in claim 4, characterized by the fact that the material of which it is made is poly (E-caprolactone).
7. Stent as claimed in any one of claims 1 to 6, characterized by the fact that it is a hollow cylindrical structure.
8. An intravascular stent, adapted for attachment to a balloon of a balloon catheter, the stent comprising a hollow cylindrical structure with a length of about 2 to 10 cm made of a material having a melting point or a softening range in the range from 45 to 75° Celsius.
9. The stent of claim 8 comprising an aliphatic polyester.
10. The stent of claim 8 comprising poly (E-caprolactone).
CA002028897A 1989-11-01 1990-10-30 Stent and catheter for the introduction of the stent Expired - Fee Related CA2028897C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH394689 1989-11-01
CH3946/89 1989-11-01

Publications (2)

Publication Number Publication Date
CA2028897A1 CA2028897A1 (en) 1991-05-02
CA2028897C true CA2028897C (en) 1996-06-25

Family

ID=4266886

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002028897A Expired - Fee Related CA2028897C (en) 1989-11-01 1990-10-30 Stent and catheter for the introduction of the stent

Country Status (12)

Country Link
US (1) US5147385A (en)
EP (1) EP0428479B1 (en)
JP (1) JPH03155869A (en)
AT (1) ATE114233T1 (en)
AU (1) AU640422B2 (en)
CA (1) CA2028897C (en)
DE (2) DE9014845U1 (en)
DK (1) DK0428479T3 (en)
ES (1) ES2063325T3 (en)
FI (1) FI905338A0 (en)
IE (1) IE61207B1 (en)
NO (1) NO179700C (en)

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AU6574190A (en) 1991-05-09
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US5147385A (en) 1992-09-15
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