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WO2014064181A1 - Stent tressé et procédé de fabrication dudit stent tressé - Google Patents

Stent tressé et procédé de fabrication dudit stent tressé Download PDF

Info

Publication number
WO2014064181A1
WO2014064181A1 PCT/EP2013/072242 EP2013072242W WO2014064181A1 WO 2014064181 A1 WO2014064181 A1 WO 2014064181A1 EP 2013072242 W EP2013072242 W EP 2013072242W WO 2014064181 A1 WO2014064181 A1 WO 2014064181A1
Authority
WO
WIPO (PCT)
Prior art keywords
filaments
stent
sleeves
segments
stent according
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.)
Ceased
Application number
PCT/EP2013/072242
Other languages
German (de)
English (en)
Inventor
Gerd Eisold
Stefan Kunz
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.)
Joline GmbH and Co KG
Original Assignee
Joline GmbH and Co KG
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 Joline GmbH and Co KG filed Critical Joline GmbH and Co KG
Publication of WO2014064181A1 publication Critical patent/WO2014064181A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61F2/82—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
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/06—Vascular grafts; stents

Definitions

  • the invention relates to a stent made of a plurality of intertwined filaments that intersect each other, parallel filaments being spaced a predetermined distance, and a method for producing such a stent and an endless braid from which such stents are obtained can.
  • Stents or stents are used in medicine for a variety of purposes. Above all cardiovascular stents are known, which are used to keep arteries open in the cardiovascular area. In the meantime, however, stents are increasingly being used in the cerebral area and in the periphery, as well as for the support of hollow organs, for example in the trachea and in the intestinal area.
  • the placement of stents depends primarily on the radial force and less on the flexibility.
  • peripheral stents as well as stents in organs which are subject to constant movement and stents, which are introduced into strongly tortuous vessels, require a high degree of flexibility.
  • rigid stents as they are usually placed on balloon catheter out of place.
  • stents which consist of a wattle of individual filaments and in this way on the one hand have high flexibility and adaptability and on the other hand develop the necessary radial force.
  • Materials suitable for this are in addition to spring steels so-called shape memory materials, in particular nickel titanium alloys. Preferred material for this is nitinol.
  • Braided stents are indicated in particular in the region of joints of the extremities and in the cerebral area. They can be used arterially and venously. Only braided stents provide the required mix of radial force and flexibility. In addition, from a certain stent length on the movement of the limb considerable stretching and compression forces occur, which must be compensated. The stent length should not change substantially. Such stents are known in a variety of embodiments and have proven themselves. One problem, however, is always the fixation of the filament ends. On the one hand, the filament ends must be converted atraumatically. On the other hand, it must be prevented that the weave of the stent loosens over loose ends over time or dissolves. Finally, a problem is also the x-ray marking of the stents, which alone allows precise placement. The treating physician must recognize during implantation whether the stent has found its right place and can also find the stent during check-ups.
  • the filament ends of the braided stents are fixed, for example, via welding points which simultaneously serve for the atraumatic transformation.
  • Another method is the braiding of the filament ends in the stent body, but which usually leads to an undesirable stiffening of the body in the edge region.
  • the invention has for its object to provide a braided stent, which is made of a plurality of intersecting filaments and in which the filament ends are umgewnadad atraumatic and fixed radiopaque.
  • a braiding stent should be simple and inexpensive to produce and at the same time be easily adaptable to the different circumstances, in particular as regards the braiding density and the radial force.
  • the stents according to the invention can be used vascularly (venous and arterial), but also in other body products (trachea, intestine).
  • the stent according to the invention consists of a multiplicity of interwoven filaments.
  • the filaments are usually made of wire, the thickness may for example be in the range of 0.10 to 0.30 mm.
  • the wire consists of a spring material, such as spring steel, but in particular of a shape memory material.
  • Particularly suitable shape memory materials are nickel titanium alloys, for example nitinol.
  • the number of filaments is generally in the range of 8 to 32, but may well be higher. It is preferred that the number of filaments is even, so that they can be connected end to end in pairs.
  • the interwoven filaments form the round stent body, with one half of the filaments running helically in a clockwise direction, the other half also helically but counterclockwise.
  • the rectified filaments preferably maintain a substantially equal distance from each other in fully expanded, stress-free condition. Accordingly, the pitch angle of the filament, relative to the longitudinal axis of the stent, is constant.
  • the same directional filaments can comply with mutually varying distances, ie forming regions with denser and less dense braid.
  • the distance between the parallel filaments to each other for example, in the range of 0.5 to 4 mm.
  • the pitch angle is, for example, between 50 and 75 °, wherein the pitch angle is the angle between the longitudinal axis of the stent and the course of the filament. The smaller the distance between parallel filaments to each other and the steeper the pitch angle, the stiffer the stent and the greater its radial force.
  • the degree of coverage of the vessel wall by the stent can be controlled via the distance and the pitch angle.
  • the filaments are connected in pairs to a cuff at least at one end of the stent, but preferably at both ends of the stent.
  • pairs means that two opposing filaments, ie a filament that runs in a clockwise direction and a filament that runs counterclockwise, are brought together at the stent end in such a way that they run a short distance in the same direction and almost parallel, and end in a cuff.
  • the cuff itself has approximately the shape of an oval on the longitudinal sides on both sides impressed oval or the shape of an eight and surrounds the two filament ends positive and non-positive.
  • the filaments themselves end at the outer edge of the cuff, which forms the frontal boundary of the stent.
  • the filament ends are crimped to the cuff.
  • a sleeve tube is slipped over the filament ends and pressed together with a suitable pliers.
  • Such crimp connections are known, for example, from electrical engineering and lead to positive and non-positive connection of the two filament ends.
  • Cuff material can be any biocompatible metals, for example medical steel.
  • the cuff preferably consists of a radiopaque material, such as tantalum, tungsten or a platinum metal or alloys of these metals. Preference is given to tantalum, which has good radiopacity in comparison with steel and is well tolerated by the body.
  • tantalum which has good radiopacity in comparison with steel and is well tolerated by the body.
  • the atraumatic closure of the filaments is accomplished by remelting the filament ends and simultaneously welding them to the cuffs.
  • lasers can be used.
  • the braided stents according to the invention are basically available in every length. Common lengths are, for example, for peripheral applications 20 to 250 mm. Standard lengths of 20 to 200 mm have been proven in 20-steps. The diameter of the corresponding stents amounts, in the expanded state, to 2 to 20 mm, with standard diameters in the core being 5 to 15 mm. Cerebral stents are generally shorter with significantly smaller diameters.
  • the placement of the stents according to the invention takes place in a manner known per se by means of a catheter through which the stent is pushed and / or pulled at its place of use.
  • the braided structure causes the stent to elongate and tighten under tension, allowing or facilitating transport through the catheter and into narrow vessels.
  • the invention further relates to a method for producing a stent of the type described above, comprising the following steps:
  • the inventive method allows the production of a starting material as a continuous braid.
  • the endless braid consists of a sequence of connecting segments consisting of a plurality of twisted pairs of filaments, and braiding segments in which the filaments are interlaced with each other crossing each other.
  • the connecting segments consist of a plurality of twisted or twisted filament pairs, which are arranged in a circle around a longitudinal axis.
  • the twist ends in the transition region to the braid segments, in which the individual filaments of the connecting segments are intertwined crosswise to the actual stent element.
  • two opposing filaments are twisted together again to form the next connecting segment.
  • the method allows the production of braid segments of the desired length and the respective desired diameter, each separately connecting segments of a defined length.
  • the connecting elements are severed in the middle and the removed braid segments are provided with a sleeve in the region of the transition from the braiding segment into the connecting elements of filaments twisted together.
  • the cuffs are positively and non-positively by two arranged opposite each other from the stent emerging filaments, preferably crimped. Following this, the twisted filaments projecting beyond the sleeve are cut off.
  • the cuffs with the filaments therein are terminally remelted, so they are atraumatic.
  • a more radiopaque material can be remotely fused onto the cuff; Tantalum has also proven itself in this case.
  • Other materials include tungsten and platinum metals and their alloys.
  • the atraumatic treatment of the filament ends with the sleeves is made at both ends of the braided stent, unless a different fixation of the filaments is made on one of the stent ends.
  • a fixation can be done for example by the attachment of elements that allows the determination of the stent on a guide mechanism.
  • the invention also relates to an endless braid for the production of a stent of the aforementioned type, as can be seen from the method described above and can be further processed into the individual stents. Since the production of braids from a variety of nitinol wires requires special knowledge, it will be carried out regularly in specialized companies. The final production of the stents then takes place in specialist companies, who then process these endless braids into the corresponding braided stents.
  • FIG. 3 shows the connected filaments from FIG. 2 after the atraumatic deformation and remelting in the end region.
  • FIG. 1 shows a "continuous braid" produced according to the invention and made of braiding segments A, B, C and connecting segments D and E.
  • the connecting segments D are terminal and border only on a braiding segment, the connecting segments E are located between two braiding segments
  • the braiding segments A, B and C. have different lengths, depending on the desired stent length, while the connecting segments D usually have a uniform length.
  • All connecting segments D and E consist of a plurality of mutually twisted filament pairs. These are pairs of filaments which emerge in opposite directions from a braiding segment and are combined by twisting and are broken down again into individual filaments at the transition to the next braiding segment.
  • the co-extending filaments are designated by the reference numeral 2, and the opposing (crossing) filaments by the reference numeral 3.
  • a plurality of filaments 2 and 3 are interlaced to form a stent member 1.
  • Typical stent lengths for peripheral purposes are, for example, 20 to 200 mm, whereby naturally also other stent lengths can be adapted to the individual patient.
  • the filaments running in the same direction have a substantially equal distance from one another, for example in the range from 0.5 to 3 mm, in particular from approximately 1.4 to 1.8 mm.
  • the same goes for the opposing filaments. It is true that with the decrease in the distance of the filament turns to each other, the radial force and stiffness of the stent increases, with expansion the distance corresponding to the radial force decreases and the flexibility increases.
  • a rectified influence has the angle a, which forms between the course (slope) of the filaments and the longitudinal axis of the stent and which preferably lies in the range of 50 to 75 °. The larger the angle, the greater the radial force and rigidity, as the angle decreases a decreasing radial force follows with increasing flexibility.
  • winding distances of approximately 1.6 mm and angles of approximately 65 ° have proven successful.
  • FIG. 1 shows the endless mesh of FIG. 1 which is severed in the middle of the connecting segments E for conversion into a stent according to the invention, so that the twisted connecting elements formed from the filaments 2, 3 are divided between the adjacent braiding segments.
  • the cuffs 4 are arranged, which limit the stent according to the invention.
  • FIG. 2 shows two filaments 2 and 3 which emerge from a stent according to the invention at the end face, which emerge from turns running in opposite directions, are supplied to one another and are combined in a sleeve 4.
  • the cuff 4 has the shape of an eight and summarizes the two filaments 2 and 3 a positive and non-positive.
  • Such a cuff connection is formed for example by crimping a correspondingly shaped round or oval ring with a pair of pliers. After joining the filaments 2 and 3 of the sleeve 4, the filaments 2 and 3 at the front or outer edge 5 of the sleeve 4 are separated.
  • FIG. 3 shows the cuff connection of the filaments 2 and 3 after atraumatic deformation with a cap 6.
  • a cap 6 can be formed from existing material by applying heat to a laser, but also by applied material.
  • the first variant is useful if the cuff 4 consists of a good radiopaque material such as tantalum, the latter variant is appropriate if a good radiopaque material is applied to the cuff.
  • the remelting process results in the formation of an atraumatic end of the filaments and an additional safeguard the connection of the two filaments 2 and 3.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Textile Engineering (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un stent constitué d'une pluralité de filaments (2, 3) tressés ensemble et croisés, un écart prédéfini étant maintenu respectivement entre les filaments (2, 3) parallèles. A au moins une extrémité du stent, des filaments (2, 3) sont reliés par paire à des manchettes (4), lesquelles présentent la forme d'un huit, des filaments (2, 3) se déplaçant en sens contraire étant réunis dans les manchettes (4), les extrémités des filaments s'étendant sensiblement dans le même sens et se terminant sur le bord (5) des manchettes. L'invention concerne en outre un procédé de fabrication d'un tel stent.
PCT/EP2013/072242 2012-10-24 2013-10-24 Stent tressé et procédé de fabrication dudit stent tressé Ceased WO2014064181A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102012020849.9 2012-10-24
DE102012020849.9A DE102012020849B4 (de) 2012-10-24 2012-10-24 Verfahren und Endlosgeflecht zur Herstellung von Stents

Publications (1)

Publication Number Publication Date
WO2014064181A1 true WO2014064181A1 (fr) 2014-05-01

Family

ID=49596240

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2013/072242 Ceased WO2014064181A1 (fr) 2012-10-24 2013-10-24 Stent tressé et procédé de fabrication dudit stent tressé

Country Status (2)

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DE (1) DE102012020849B4 (fr)
WO (1) WO2014064181A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118581636A (zh) * 2024-05-09 2024-09-03 江苏唯德康医疗科技有限公司 一种适应肠道蠕动的消化器官编织支架及其编织方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999025271A1 (fr) * 1997-11-18 1999-05-27 Schneider (Europe) Gmbh Extenseur pour operations d'implantation dans le corps humain, notamment dans des vaisseaux sanguins
US6632241B1 (en) * 2000-03-22 2003-10-14 Endovascular Technologies, Inc. Self-expanding, pseudo-braided intravascular device
DE102008033170A1 (de) * 2008-07-15 2010-01-21 Acandis Gmbh & Co. Kg Implantat mit einer geflochtenen Gitterstruktur und Verfahren zum Herstellen eines derartigen Implantats
DE102008036429A1 (de) * 2008-08-05 2010-02-11 Acandis Gmbh & Co. Kg Medizinisches Implantat
DE102010044746A1 (de) * 2010-09-08 2012-03-08 Phenox Gmbh Implantat zur Beeinflussung des Blutflusses bei arteriovenösen Fehlbildungen

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999025271A1 (fr) * 1997-11-18 1999-05-27 Schneider (Europe) Gmbh Extenseur pour operations d'implantation dans le corps humain, notamment dans des vaisseaux sanguins
US6632241B1 (en) * 2000-03-22 2003-10-14 Endovascular Technologies, Inc. Self-expanding, pseudo-braided intravascular device
DE102008033170A1 (de) * 2008-07-15 2010-01-21 Acandis Gmbh & Co. Kg Implantat mit einer geflochtenen Gitterstruktur und Verfahren zum Herstellen eines derartigen Implantats
DE102008036429A1 (de) * 2008-08-05 2010-02-11 Acandis Gmbh & Co. Kg Medizinisches Implantat
DE102010044746A1 (de) * 2010-09-08 2012-03-08 Phenox Gmbh Implantat zur Beeinflussung des Blutflusses bei arteriovenösen Fehlbildungen

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118581636A (zh) * 2024-05-09 2024-09-03 江苏唯德康医疗科技有限公司 一种适应肠道蠕动的消化器官编织支架及其编织方法

Also Published As

Publication number Publication date
DE102012020849B4 (de) 2023-10-19
DE102012020849A1 (de) 2014-04-24

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