EP1361834B1 - Tension-free elastic tape - Google Patents

Tension-free elastic tape Download PDF

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Publication number
EP1361834B1
EP1361834B1 EP02718107A EP02718107A EP1361834B1 EP 1361834 B1 EP1361834 B1 EP 1361834B1 EP 02718107 A EP02718107 A EP 02718107A EP 02718107 A EP02718107 A EP 02718107A EP 1361834 B1 EP1361834 B1 EP 1361834B1
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EP
European Patent Office
Prior art keywords
tape
tape according
threads
band
tissue
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
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EP02718107A
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German (de)
French (fr)
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EP1361834A1 (en
Inventor
Martin Dauner
Erhard Müller
Heinrich Planck
Hans-Gerd Schmees
Diethelm Wallwiener
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Deutsche Institute fuer Textil und Faserforschung Stuttgart
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Deutsche Institute fuer Textil und Faserforschung Stuttgart
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Publication of EP1361834A1 publication Critical patent/EP1361834A1/en
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    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/20—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes specially adapted for knitting articles of particular configuration
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/14—Fabrics characterised by the incorporation by knitting, in one or more thread, fleece, or fabric layers, of reinforcing, binding, or decorative threads; Fabrics incorporating small auxiliary elements, e.g. for decorative purposes
    • 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
    • D10B2509/08—Hernia repair mesh

Definitions

  • the invention relates to a tensile elastic band for the operative treatment of urinary incontinence of the woman according to the preamble of claim 1.
  • This known band has a relatively high rigidity on, which can complicate the feeding of the tape.
  • the Tape is cut as a strip of textile sheet material. This results in the longitudinal edges of the band free monofilament ends. When feeding the band favor These free ends provide a primary anchoring of the band in the fabric.
  • the cutting of the textile sheet material leads in the production of the tapes to a disintegration of the stitches at the wall edges, so that at the edge during the Insertion and also postoperatively peel off particles. Either the protruding monofilament ends as well as severed, in particular sharp-edged monofilament particles can be permanent Cause inflammation.
  • the separation of the edge stitch is reduced
  • the strength of the band resulting in an increased Material use must be compensated.
  • the invention is based on the object, a band available to provide, which eliminates the problems mentioned or reduced and in particular a good primary anchorage with a minimal tissue irritation combined.
  • That for the operative treatment of urinary incontinence of the woman suitable band is dimensioned so that its length is essential bigger than its width, for example more than that Twenty times the width.
  • a band for example, a length of 450mm and a width of 10mm exhibit.
  • the essential idea of the invention is that of the Longitudinal edges of the strip to provide edge threads, on the one hand sticking out of the textile composite of the band to get a good To ensure primary anchoring of the band, and that themselves On the other hand, it does not come loose from the textile structure of the band.
  • the selvage threads thereby form loops which have a relatively large opening, so that the fabric can penetrate directly into the openings of these loops and a fast and good primary anchoring is effected.
  • the permanent stabilization of the band in the tissue can be favored by these loops.
  • the opening of the loops preferably has a size of more than 0.01 mm 2 , preferably from 0.02 to 1 mm 2 .
  • the loops are integrated into the textile composite of the band so that they can not be detached from the band. Since the loops have no free ends, they cause no irritation of the tissue, which could lead to permanent inflammation.
  • a fabric is used whose width is several times the width of the single band corresponds and that in the individual bands is divided. It is advantageous, compared to the for the bands provided composite deviating indentations by remaining free Lochnadeln provide, in the area of this sheet to be separated into the individual bands. Thereby is a simple separation, especially a machine Disconnect possible.
  • the separation can be different Way done, z. B. by chemical or physical action. It can be a cutting process by means of a mechanical Cutting edge, by means of a thermal cutting wire or by means of an ultrasonic cutting device are performed.
  • the Thermal cutting and ultrasonic cutting in particular the advantage that the severed threads that the Edge threads of the bands form, with suitable process control have no sharp-edged separation points.
  • edged filaments are to be severed Edged threads made from a resorbable filament.
  • the band must have sufficient tensile stability to be able to move in streamlined condition to support the urethra. Likewise, that must Band have sufficient elasticity to the anatomical Give way to tissue movements and be able to follow.
  • the textile composite of the band is preferably designed as a knitted fabric, z. B. as in jersey, cloth and velvet binding. The mesh size is chosen so that a good ingrowth connective tissue into the textile structure is possible.
  • the knit terry toweling executed so that both the Primärverhakung as also the ingrowth of tissue is favored.
  • the band can be mainly or exclusively monofilament or be formed of multifilaments. It can for the entire Band will use the same filament material. Consists the band of a non-absorbable material, so the band remains permanently as a supporting matrix in the tissue. If adequate connective tissue proliferation is to be expected, so also a resorbable material can be used. The band then dissolves and is reabsorbed if that Connective tissue has again achieved sufficient stability.
  • the mechanical properties of the tape become.
  • the edge threads can consist of a resorbable material. These border threads serve primarily for the primary anchoring of the tape during and after the operation. Once the tape is sprouted connective tissue is permanently anchored, the edge threads be absorbed. This causes a tissue irritation the edge threads permanently excluded.
  • the band may have a low Have mesh size made up of the resorbable and gives the non-absorbable filaments. This is one high stabilization effect of the tape ensured.
  • the subsequent absorption of resorbable filaments remains then tape with the larger stick width of the remaining ones non-absorbable filaments, allowing a good ingrowth connective tissue in the band is favored.
  • a rough surface e.g. terry toweling or the augmented Scarring due to absorbable sutures may be in the range of Bubble be undesirable.
  • This is preferred by a change the bond over the implant length solved. For example, becomes the anchoring area is formed by a terry tie, while in the area of the bladder e.g. a tricot tie or a Fleet is executed.
  • all thread-forming biocompatible polymers be used. These are from the group of non-absorbable Polymers namely polyethylene PE, polypropylene PP, polyester (e.g., polyethylene terephthalate PET and polybutylene terephthalate PBT), polyvinylidene fluoride PVDF, polytetrafluoroethylene PTFE and other fluorine-containing polymers as well Polyurethanes PUR, polyether ketones and polyphenylene sulfide.
  • the absorbable polymers are preferably selected from the group of alpha and beta hydroxycarboxylic acids chosen.
  • suitable Short-term resorbable polymers such as polyglycolic acid PGA.
  • Slow-absorbing polymers such as polylactides can also be used.
  • the implant sterilized by ionizing radiation shall be.
  • copolymers and terpolymers are mutually exclusive and with elastifying components such as caprolactone and trimethylene carbonate suitable.
  • polyesteramides or other resorbable biocompatible thread-forming Polymer materials are also suitable. The absorption time of these materials can with the well-known methods of ionizing Radiation are affected, at the same time a sterilization of the band to be implanted.
  • the primary anchorage serving looped or hooked Outstanding edge threads would be in the operation hampering the passage of the tape through the tissue and to cause additional traumatization of the tissue. Therefore is the tape for insertion into the tissue, preferably with a enclosed tubular casing after placing of the band can be easily removed, as is itself already known from US 5,899,909.
  • the hose may consist of any biocompatible material for a short time, for example, from one used for the manufacture of catheters Material (e.g., polyamide, polypropylene, polyethylene, Polyvinyl chloride).
  • the Cover removed lengthwise from the tape.
  • the Sheath preferably in the central region of its longitudinal extent be provided with a predetermined breaking perforation or can as open decision to be placed around the band.
  • the band is preferably transmitted by atraumatic needles pulled the tissue.
  • Particularly preferred are reusable Needles.
  • the adapter mechanism Can be screwed, Luerlock, bayonet lock or snap connection. He insists from a biocompatible solid material, preferably from a polymeric Construction material, such as Polyamide, polyoxymethylene, Polyether ketone, polypropylene, polyethylene or polyester.
  • the tape and possibly the case are with the adapter by welding, gluing, clamping or a shrink tube connected. In a particularly preferred embodiment are the adapters directly to the tape and possibly the Cover molded.
  • the band of basic threads 1 is knitted in a modified tricot binding.
  • the knit is supplemented in the edge region by another bond so that each edge threads 2 form at the two longitudinal edges of the band loops that protrude laterally beyond the edge of the tape.
  • the loops of the edge threads 2 have an opening area of about 0.02 to 1.0 mm 2 . Since the edge yarns 2 are included in the knit of the ground yarns 1, they are firmly connected to the band. Since the edge threads 2 have no open ends, they do not cause injury or irritation of the tissue. However, the large loops of the edge threads 2 'cause a secure primary anchoring of the tape when pulled into the fabric. The large openings of the loops of the edge threads 2 also favor the ingrowth of the tissue into the structure of the band and thus a permanent anchoring of the band in the tissue.
  • the ground threads 1 are as fringes formed, forfeited by part weft threads 3 to ribbons are.
  • These bands are by connecting threads 4 connected to each other to the sheet.
  • the connecting threads 4 between the individual bands severed along dividing lines 5.
  • the severing of the connecting threads 4 is preferably carried out by ultrasonic cutting or by thermal cutting, whereby the cut edges of the then remaining free ends of the connecting threads 4 rounded become.
  • the connecting threads 4 After severing the connecting threads 4 and thus the Separating the bands, the connecting threads 4 form the Edging threads of the band.
  • the severed free ends of this Edging threads protrude from the composite of the tapes and form Hooks effective for the primary anchoring of the band.
  • the rounding of the cut ends reduces the irritation the tissue through this protruding edge threads.
  • Prefers the connecting threads 4 are made of soluble or absorbable Filaments formed.
  • the connecting threads 4 are each over a few courses knitted into the composite of the ribbon before moving to the edge of the ribbon subsequent band are performed. This causes the connecting threads 4 by setting in several courses in the Knitted fabric of the tapes, so that they also after the Not cutting without a significant mechanical action from the fabric of the tape solve.
  • the Basic threads 1 a knitted fabric.
  • Edged threads 6 are in this knit integrated and projecting to large over the longitudinal edges of the tape Loops formed.
  • the loops of the edged threads 6 also ensure a secure primary anchorage here, without causing irritation of the tissue.
  • To a binding technology to get clean edge are the edged threads 6 additionally secured by a float 7.

Abstract

A tension-free elastic tape is used for the surgical treatment of female urinary incontinence. The tape has a textile structure that allows ingrowth of the tape into the connective tissue. On its longitudinal edges, the tape has edge threads (2, 4, 6, 8) that project from the textile structure of the tape and that especially facilitate a good primary anchoring of the tape in the tissue. The edge threads are firmly incorporated in the structure of the tape.

Description

Die Erfindung betrifft ein zugstabiles elastisches Band für die operative Behandlung der Harninkontinenz der Frau gemäß dem Oberbegriff des Anspruchs 1.The invention relates to a tensile elastic band for the operative treatment of urinary incontinence of the woman according to the preamble of claim 1.

Die Harninkontinenz der Frau entsteht häufig durch Bindegewebsschwäche. Zur Therapie wird daher u. a. eine Operationstechnik eingesetzt, bei welcher ein zugstabiles elastisches Band eingezogen wird, welches die Urethra abstützt, das Bindegewebe festigt und als Matrix für das Einwachsen von neugebildetem Bindegewebe dient. Diese Operationstechnik ist beispielsweise in der US 5,899,909 beschrieben, in welcher auch ein für diese Operationstechnik geeignetes gattungsgemäßes Band angegeben ist.Female urinary incontinence is often caused by connective tissue weakness. For therapy is therefore u. a. a surgical technique used, in which a tensile elastic Band which supports the urethra, the connective tissue solidifies and as a matrix for the ingrowth of newly formed Connective tissue is used. This surgical technique is for example in US 5,899,909, in which also a suitable for this surgical technique generic Band is specified.

Dieses bekannte Band weist eine verhältnismäßig hohe Steifigkeit auf, die das Einziehen des Bandes erschweren kann. Das Band wird als Streifen aus einem textilen Flächenmaterial geschnitten. Dadurch ergeben sich an den Längskanten des Bandes freie Monofil-Enden. Beim Einziehen des Bandes begünstigen diese freien Enden eine Primärverankerung des Bandes im Gewebe. Jedoch führt das Durchtrennen des textilen Flächenmaterials bei der Herstellung der Bänder zu einem Auflösen der Maschen an den Wandkanten, so dass sich an der Kante während des Einsetzens und auch postoperativ Partikel ablösen können. Sowohl die abstehenden Monofil-Enden als auch abgetrennte, insbesondere scharfkantige Monofil-Partikel können dauerhafte Entzündungen verursachen. Das Auftrennen der Randmasche reduziert zudem die Festigkeit des Bandes, was durch einen erhöhten Materialeinsatz kompensiert werden muß.This known band has a relatively high rigidity on, which can complicate the feeding of the tape. The Tape is cut as a strip of textile sheet material. This results in the longitudinal edges of the band free monofilament ends. When feeding the band favor These free ends provide a primary anchoring of the band in the fabric. However, the cutting of the textile sheet material leads in the production of the tapes to a disintegration of the stitches at the wall edges, so that at the edge during the Insertion and also postoperatively peel off particles. Either the protruding monofilament ends as well as severed, in particular sharp-edged monofilament particles can be permanent Cause inflammation. The separation of the edge stitch is reduced In addition, the strength of the band, resulting in an increased Material use must be compensated.

Der Erfindung liegt die Aufgabe zu Grunde, ein Band zur Verfügung zu stellen, welches die genannten Probleme beseitigt oder reduziert und insbesondere eine gute Primärverankerung mit einer minimalen Gewebsirritation vereinigt. The invention is based on the object, a band available to provide, which eliminates the problems mentioned or reduced and in particular a good primary anchorage with a minimal tissue irritation combined.

Diese Aufgabe wird erfindungsgemäß gelöst durch ein Band mit den Merkmalen des Anspruchs 1.This object is achieved by a band with the features of claim 1.

Vorteilhafte Ausführungen und Weiterbildungen der Erfindung sind in den Unteransprüchen angegeben.Advantageous embodiments and developments of the invention are given in the subclaims.

Das für die operative Behandlung der Harninkontinenz der Frau geeignete Band ist so dimensioniert, dass seine Länge wesentlich größer als seine Breite ist, zum Beispiel mehr als das Zwanzigfache der Breite. Typischerweise kann ein solches Band beispielsweise eine Länge von 450mm und eine Breite von 10mm aufweisen.That for the operative treatment of urinary incontinence of the woman suitable band is dimensioned so that its length is essential bigger than its width, for example more than that Twenty times the width. Typically, such a band for example, a length of 450mm and a width of 10mm exhibit.

Der, wesentliche Gedanke der Erfindung besteht darin, an den Längskanten des Bandes Kantenfäden vorzusehen, die einerseits aus dem textilen Verbund des Bandes herausragen, um eine gute Primärverankerung des Bandes zu gewährleisten, und die sich andererseits nicht aus der textilen Struktur des Bandes lösen.The essential idea of the invention is that of the Longitudinal edges of the strip to provide edge threads, on the one hand sticking out of the textile composite of the band to get a good To ensure primary anchoring of the band, and that themselves On the other hand, it does not come loose from the textile structure of the band.

In einer Ausführungsform bilden die Kantenfäden dabei Schlaufen, die eine relativ große Öffnung aufweisen, so dass das Gewebe unmittelbar in die Öffnungen dieser Schlaufen eindringen kann und eine schnelle und gute Primärverankerung bewirkt wird. Auch die dauerhafte Stabilisierung des Bandes in dem Gewebe kann durch diese Schlaufen begünstigt werden. Die Öffnung der Schlaufen weist vorzugsweise eine Größe von mehr als 0,01mm2, vorzugsweise von 0,02 bis 1mm2 auf. Die Schlaufen sind dabei in den textilen Verbund des Bandes eingebunden, so dass sie sich nicht von dem Band lösen können. Da die Schlaufen keine freien Enden aufweisen, bewirken sie keine Reizung des Gewebes, die zu dauerhaften Entzündungen führen könnte.In one embodiment, the selvage threads thereby form loops which have a relatively large opening, so that the fabric can penetrate directly into the openings of these loops and a fast and good primary anchoring is effected. Also, the permanent stabilization of the band in the tissue can be favored by these loops. The opening of the loops preferably has a size of more than 0.01 mm 2 , preferably from 0.02 to 1 mm 2 . The loops are integrated into the textile composite of the band so that they can not be detached from the band. Since the loops have no free ends, they cause no irritation of the tissue, which could lead to permanent inflammation.

In einer anderen Ausführung wird ein textiles Flächengebilde hergestellt, dessen Breite einem Mehrfachen der Breite des einzelnen Bandes entspricht und das in die einzelnen Bänder unterteilt wird. Dabei ist es vorteilhaft, gegenüber dem für die Bänder vorgesehen Verbund abweichende Einzüge durch freibleibende Lochnadeln vorzusehen, in deren Bereich dieses Flächengebilde in die einzelnen Bänder getrennt werden soll. Dadurch ist ein einfaches Trennen, insbesondere auch ein maschinelles Trennen möglich. Das Trennen kann auf unterschiedliche Weise erfolgen, z. B. durch chemische oder physikalischen Einwirkung. Es kann ein Schneidvorgang mittels einer mechanischen Schneide, mittels eines Thermoschneiddrahtes oder auch mittels einer Ultraschall-Schneideinrichtung durchgeführt werden. Das Thermoschneiden und das Ultraschallschneiden haben dabei insbesondere den Vorteil, dass die durchtrennten Fäden, die die Kantenfäden der Bänder bilden, die bei geeigneter Prozessführung keine scharfkantigen Trennstellen aufweisen. Dauerhafte Entzündungsreize werden daher durch die Kantenfäden nicht verursacht. Um zu vermeiden, dass die durchtrennten Kantenfäden sich aus dem Verbund des abgetrennten Bandes lösen; werden diese Kantenfäden mit einer langen Unterlegung in dem textilen Verbund und Abbindung in mehreren Maschenreihen ausgeführt. In einer besonders bevorzugten Ausführung bestehen die zu durchtrennenden Kantenfäden aus einem resorbierbaren Filament.In another embodiment, a fabric is used whose width is several times the width of the single band corresponds and that in the individual bands is divided. It is advantageous, compared to the for the bands provided composite deviating indentations by remaining free Lochnadeln provide, in the area of this sheet to be separated into the individual bands. Thereby is a simple separation, especially a machine Disconnect possible. The separation can be different Way done, z. B. by chemical or physical action. It can be a cutting process by means of a mechanical Cutting edge, by means of a thermal cutting wire or by means of an ultrasonic cutting device are performed. The Thermal cutting and ultrasonic cutting in particular the advantage that the severed threads that the Edge threads of the bands form, with suitable process control have no sharp-edged separation points. durable Inflammatory stimuli are therefore not caused by the edged filaments. To avoid the severed edge threads detach from the composite of the severed band; become these edge threads with a long underlay in the textile Bonding and setting executed in several courses. In In a particularly preferred embodiment, they are to be severed Edged threads made from a resorbable filament.

Das Band muß eine ausreichende Zugstabilität aufweisen, um in gestrafftem Zustand die Urethra zu stützen. Ebenso muß das Band eine ausreichende Elastizität aufweisen, um den anatomischen Gewebebewegungen nachgeben und folgen zu können. Um die erforderliche Zugstabilität und Elastizität zu erhalten, ist der textile Verbund des Bandes vorzugsweise als Gewirk ausgeführt, z. B. als in Trikot-, Tuch- und Samtbindung. Die Maschenweite wird dabei so gewählt, dass ein gutes Einwachsen des Bindegewebes in die textile Struktur möglich ist. In einer besonders bevorzugten Ausführung wird das Gewirk in Frottierbindung so ausgeführt, dass sowohl die Primärverhakung als auch das Einwachsen von Gewebe begünstigt wird.The band must have sufficient tensile stability to be able to move in streamlined condition to support the urethra. Likewise, that must Band have sufficient elasticity to the anatomical Give way to tissue movements and be able to follow. To the to obtain the required draft stability and elasticity is the textile composite of the band is preferably designed as a knitted fabric, z. B. as in jersey, cloth and velvet binding. The mesh size is chosen so that a good ingrowth connective tissue into the textile structure is possible. In a particularly preferred embodiment, the knit terry toweling executed so that both the Primärverhakung as also the ingrowth of tissue is favored.

Das Band kann vorwiegend oder ausschließlich aus Monofilen oder auch aus Multifilen gebildet sein. Dabei kann für das gesamte Band das gleiche Filamentmaterial verwenden werden. Besteht das Band aus einem nicht resorbierbaren Material, so verbleibt das Band dauerhaft als stützende Matrix in dem Gewebe. Ist eine ausreichende Bindegewebsproliferation zu erwarten, so kann auch ein resorbierbares Material verwendet werden. Das Band löst sich dann auf und wird resorbiert, wenn das Bindegewebe wieder eine ausreichende Stabilität erlangt hat.The band can be mainly or exclusively monofilament or be formed of multifilaments. It can for the entire Band will use the same filament material. Consists the band of a non-absorbable material, so the band remains permanently as a supporting matrix in the tissue. If adequate connective tissue proliferation is to be expected, so also a resorbable material can be used. The band then dissolves and is reabsorbed if that Connective tissue has again achieved sufficient stability.

Vorzugsweise wird das Band aus zwei oder gegebenenfalls mehr unterschiedlichen Filamentmaterialien hergestellt. Dadurch können die mechanischen Eigenschaften des Bandes optimiert werden. Insbesondere ist es von Vorteil, das Band aus einem resorbierbaren und einem nicht resorbierbaren Filamentmaterial herzustellen. Durch Resorption eines Materials wird die Narbenbildung und damit die dauerhafte Verankerung gefördert. Dies kann durch resorbierbare Filamente oder durch resorbierbare Beschichtung eines nicht oder langsam resorbierbaren Filaments gelöst werden. Insbesondere können dabei die Randfäden aus einem resorbierbaren Material bestehen. Diese Randfäden dienen in erster Linie zur Primärverankerung des Bandes während und nach der Operation. Sobald das Band durch Einsprossen des Bindegewebes dauerhaft verankert ist, können die Kantenfäden resorbiert werden. Dadurch ist eine Gewebsreizung durch die Kantenfäden auf Dauer ausgeschlossen. Weiter kann auch der gesamte textile Verbund des Bandes durch eine Kombination von resorbierbaren und nicht resorbierbaren Filamenten hergestellt werden. Beim operativen Einsetzen kann das Band eine geringe Maschenweite aufweisen, die sich aus den resorbierbaren und den nicht resorbierbaren Filamenten ergibt. Dadurch ist eine hohe Stabilisierungswirkung des Bandes sichergestellt. Durch. das spätere Resorbieren der resorbierbaren Filamente verbleibt das Band dann mit der größeren Stäbchenweite der noch verbleibenden nicht resorbierbaren Filamente, so dass ein gutes Einwachsen des Bindegewebes in das Band begünstigt wird. Eine rauhe Oberfläche z.B. der Frottierbindung oder die vermehrte Narbenbildung durch resorbierbare Fäden kann im Bereich der Blase unerwünscht sein. Dies wird bevorzugt durch eine Veränderung der Bindung über der Implantatlänge gelöst. Z.B. wird der Verankerungbereich durch eine Frottierbindung gebildet, während im Bereich der Blase z.B. eine Trikotbindung oder eine Flottung ausgeführt ist.Preferably, the band of two or more, if necessary produced different filament materials. Thereby can optimize the mechanical properties of the tape become. In particular, it is advantageous to make the tape from a resorbable and a non-absorbable filament material manufacture. Resorption of a material causes scarring and thus promote the permanent anchorage. This can be caused by resorbable filaments or by resorbable Coating of a non or slowly resorbable filament be solved. In particular, the edge threads can consist of a resorbable material. These border threads serve primarily for the primary anchoring of the tape during and after the operation. Once the tape is sprouted connective tissue is permanently anchored, the edge threads be absorbed. This causes a tissue irritation the edge threads permanently excluded. Next can also be the entire textile composite of the band by a combination of absorbable and non-absorbable filaments become. During operative insertion, the band may have a low Have mesh size made up of the resorbable and gives the non-absorbable filaments. This is one high stabilization effect of the tape ensured. By. the subsequent absorption of resorbable filaments remains then tape with the larger stick width of the remaining ones non-absorbable filaments, allowing a good ingrowth connective tissue in the band is favored. A rough surface e.g. terry toweling or the augmented Scarring due to absorbable sutures may be in the range of Bubble be undesirable. This is preferred by a change the bond over the implant length solved. For example, becomes the anchoring area is formed by a terry tie, while in the area of the bladder e.g. a tricot tie or a Fleet is executed.

Grundsätzlich können alle fadenbildenden biokompatiblen Polymere verwendet werden. Dies sind aus der Gruppe der nicht resorbierbaren Polymere namentlich Polyethylen PE, Polypropylen PP, Polyester (z.B. Polyethylenterephthalat PET und Polybutylenterephthalat PBT), Polyvinylidenefluorid PVDF, Polytetrafluorethylen PTFE und andere fluorhaltige Polymere sowie Polyurethane PUR, Polyetherketone und Polyphenylensulfid. Die resorbierbaren Polymere werden bevorzugt aus der Gruppe der alpha- und beta-Hydroxycarbonsäuren gewählt. Vorzugsweise eignen sich kurzzeitig resorbierbare Polymere, wie Polyglykolsäure PGA. Langsam resorbierende Polymere wie Polylactide können ebenfalls eingesetzt werden. Hier ergibt sich ein besonderer Vorteil, wenn das Implantat durch ionisierende Strahlung sterilisiert werden soll. Ebenso sind Co- und Terpolymere untereinander und mit elastifizierenden Komponenten wie Caprolakton und Trimethylencarbonat geeignet. Schließlich eignen sich auch Polyesteramide oder andere resorbierbare biokompatible fadenbildende Polymerwerkstoffe. Die Resorptionszeit dieser Materialen kann mit den bekannten Methoden der ionisierenden Strahlung beeinflußt werden, wobei gleichzeitig eine Sterilisation des zu implantierenden Bandes erfolgt.In principle, all thread-forming biocompatible polymers be used. These are from the group of non-absorbable Polymers namely polyethylene PE, polypropylene PP, polyester (e.g., polyethylene terephthalate PET and polybutylene terephthalate PBT), polyvinylidene fluoride PVDF, polytetrafluoroethylene PTFE and other fluorine-containing polymers as well Polyurethanes PUR, polyether ketones and polyphenylene sulfide. The absorbable polymers are preferably selected from the group of alpha and beta hydroxycarboxylic acids chosen. Preferably suitable Short-term resorbable polymers, such as polyglycolic acid PGA. Slow-absorbing polymers such as polylactides can also be used. Here's a special one Advantage, if the implant sterilized by ionizing radiation shall be. Likewise, copolymers and terpolymers are mutually exclusive and with elastifying components such as caprolactone and trimethylene carbonate suitable. Finally, are also suitable Polyesteramides or other resorbable biocompatible thread-forming Polymer materials. The absorption time of these materials can with the well-known methods of ionizing Radiation are affected, at the same time a sterilization of the band to be implanted.

Die zur Primärverankerung dienenden schlaufenförmig oder hakenförmig herausragenden Kantenfäden würden bei der Operation das Durchziehen des Bandes durch das Gewebe behindern und zu einer zusätzlichen Traumatisierung des Gewebes führen. Daher wird das Band zum Einziehen in das Gewebe vorzugsweise mit einer schlauchförmigen Hülle umschlossen, die nach Platzieren des Bandes leicht entfernt werden kann, wie dies an sich ebenfalls bereits aus der US 5,899,909 bekannt ist. Der Schlauch kann aus jedem kurzzeitig biokompatiblen Material bestehen, zum Beispiel aus einem für die Herstellung von Kathetern verwendeten Material (z.B. Polyamid, Polypropylen, Polyethylen, Polyvinylchlorid). Nach dem Platzieren des Bandes wird die Hülle der Länge nach von dem Band abgezogen. Hierzu kann die Hülle vorzugsweise in dem Mittelbereich ihrer Längserstreckung mit einer Sollbruch-Perforierung versehen sein oder kann als offene Einscheidung um das Band gelegt sein.The primary anchorage serving looped or hooked Outstanding edge threads would be in the operation hampering the passage of the tape through the tissue and to cause additional traumatization of the tissue. Therefore is the tape for insertion into the tissue, preferably with a enclosed tubular casing after placing of the band can be easily removed, as is itself already known from US 5,899,909. The hose may consist of any biocompatible material for a short time, for example, from one used for the manufacture of catheters Material (e.g., polyamide, polypropylene, polyethylene, Polyvinyl chloride). After placing the tape, the Cover removed lengthwise from the tape. For this purpose, the Sheath preferably in the central region of its longitudinal extent be provided with a predetermined breaking perforation or can as open decision to be placed around the band.

Das Band wird vorzugsweise mittels atraumatischer Nadeln durch das Gewebe gezogen. Besonders bevorzugt sind hierbei wiederverwendbare Nadeln. Zur sicheren, ablösbaren und auch intraoperativ handhabbaren Konnektierung des Bandes und der Hülle an den Nadeln sind diese vorzugsweise an den beiden Enden jeweils mit einem Adapter versehen, der mit einem entsprechenden Adapter der Nadeln gekuppelt werden kann. Der Adaptermechanismus kann als Schraubverbindung, Luerlock, Bajonettverriegelung oder Schnappverbindung ausgeführt sein. Er besteht aus einem biokompatiblen Festmaterial, bevorzugt aus einem polymeren Konstruktionswerkstoff, wie z.B. Polyamid, Polyoxymethylen, Polyetherketon, Polypropylen, Polyethylen oder Polyester. Das Band und gegebenenfalls die Hülle sind mit dem Adapter durch Schweißung, Klebung, Klemmung oder einen Schrumpfschlauch verbunden. In einer besonders bevorzugten Ausführung sind die Adapter direkt an das Band und gegebenenfalls die Hülle angespritzt.The band is preferably transmitted by atraumatic needles pulled the tissue. Particularly preferred are reusable Needles. For safe, detachable and also intraoperative manageable connection of the band and the case at the needles these are preferably at the two ends each provided with an adapter with a corresponding Adapter of the needles can be coupled. The adapter mechanism Can be screwed, Luerlock, bayonet lock or snap connection. He insists from a biocompatible solid material, preferably from a polymeric Construction material, such as Polyamide, polyoxymethylene, Polyether ketone, polypropylene, polyethylene or polyester. The tape and possibly the case are with the adapter by welding, gluing, clamping or a shrink tube connected. In a particularly preferred embodiment are the adapters directly to the tape and possibly the Cover molded.

Im Folgenden wird die Erfindung anhand von in der Zeichnung dargestellten Ausführungsbeispielen näher erläutert. Es zeigen

Figur 1
eine erste Ausführung des Bandes,
Figur 2
eine zweite Ausführung des Bandes,
Figur 3
eine dritte Ausführung des Bandes,
Figur 4
eine vierte Ausführung des Bandes und
Figur 5
eine fünfte Ausführung des Bandes.
In the following the invention will be explained in more detail with reference to embodiments shown in the drawing. Show it
FIG. 1
a first version of the tape,
FIG. 2
a second embodiment of the tape,
FIG. 3
a third embodiment of the tape,
FIG. 4
a fourth version of the band and
FIG. 5
a fifth version of the volume.

In dem ersten Ausführungsbeispiel der Figur 1 ist das Band aus Grundfäden 1 in einer modifizierten Trikotbindung gewirkt. Das Gewirk wird im Randbereich durch eine weitere Bindung so ergänzt, dass jeweils Kantenfäden 2 an den beiden Längskanten des Bandes Schlaufen bilden, die seitlich über die Kante des Bandes hinausragen. Die Schlaufen der Kantenfäden 2 weisen eine Öffnungsfläche von etwa 0,02 bis 1,0mm2 auf. Da die Kantenfäden 2 in den Wirkverbund der Grundfäden 1 einbezogen sind, sind sie fest mit dem Band verbunden. Da die Kantenfäden 2 keine offenen Enden aufweisen, verursachen sie keine Verletzungen oder Reizungen des Gewebes. Die großen Schlaufen der Kantenfäden 2'bewirken jedoch eine sichere Primärverankerung des Bandes beim Einziehen in das Gewebe. Die großen Öffnungen der Schlaufen der Kantenfäden 2 begünstigen darüber hinaus das Einwachsen des Gewebes in die Struktur des Bandes und damit eine dauerhafte Verankerung des Bandes im Gewebe.In the first embodiment of FIG. 1, the band of basic threads 1 is knitted in a modified tricot binding. The knit is supplemented in the edge region by another bond so that each edge threads 2 form at the two longitudinal edges of the band loops that protrude laterally beyond the edge of the tape. The loops of the edge threads 2 have an opening area of about 0.02 to 1.0 mm 2 . Since the edge yarns 2 are included in the knit of the ground yarns 1, they are firmly connected to the band. Since the edge threads 2 have no open ends, they do not cause injury or irritation of the tissue. However, the large loops of the edge threads 2 'cause a secure primary anchoring of the tape when pulled into the fabric. The large openings of the loops of the edge threads 2 also favor the ingrowth of the tissue into the structure of the band and thus a permanent anchoring of the band in the tissue.

In der in Figur 2 dargestellten zweiten Ausführung wird ein textiles Flächengebilde erzeugt, welches dann in einzelne Bänder unterteilt wird. In der Figur 2 sind nur zwei der Bänder zur Erläuterung dargestellt und die weiteren Bänder ergeben sich durch eine periodische Wiederholung der dargestellten Struktur.In the second embodiment shown in Figure 2 is a textile fabric produced, which then in individual bands is divided. In Figure 2, only two of the bands for explanation and the other bands arise by a periodic repetition of the illustrated Structure.

In der zweiten Ausführung sind die Grundfäden 1 als Fransen ausgebildet, die durch Teilschussfäden 3 zu Bändern verwirkt sind. Auf diese Weise werden eine Vielzahl von parallel verlaufenden Bändern erzeugt. Diese Bänder sind dabei durch Verbindungsfäden 4 miteinander zu dem Flächengebilde verbunden. Um die einzelnen Bänder aus diesem Flächengebilde zu trennen, werden die Verbindungsfäden 4 zwischen den einzelnen Bändern längs Trennlinien 5 durchtrennt. Das Durchtrennen der Verbindungsfäden 4 erfolgt vorzugsweise durch Ultraschallschneiden oder durch Thermoschneiden, wodurch die Schnittkanten der dann verbleibenden freien Enden der Verbindungsfäden 4 abgerundet werden.In the second embodiment, the ground threads 1 are as fringes formed, forfeited by part weft threads 3 to ribbons are. In this way, a large number of parallel Created bands. These bands are by connecting threads 4 connected to each other to the sheet. To separate the individual ribbons from this fabric, the connecting threads 4 between the individual bands severed along dividing lines 5. The severing of the connecting threads 4 is preferably carried out by ultrasonic cutting or by thermal cutting, whereby the cut edges of the then remaining free ends of the connecting threads 4 rounded become.

Nach dem Durchtrennen der Verbindungsfäden 4 und damit dem Heraustrennen der Bänder, bilden die Verbindungsfäden 4 die Kantenfäden des Bandes. Die durchtrennten freien Enden dieser Kantenfäden ragen aus dem Verbund der Bänder heraus und bilden Haken, die für die Primärverankerung des Bandes wirksam sind. Die Abrundung der geschnittenen Enden verringert die Reizung des Gewebes durch diese abstehenden Kantenfäden. Bevorzugt werden die Verbindungsfäden 4 aus löslichen oder resorbierbaren Filamenten gebildet.After severing the connecting threads 4 and thus the Separating the bands, the connecting threads 4 form the Edging threads of the band. The severed free ends of this Edging threads protrude from the composite of the tapes and form Hooks effective for the primary anchoring of the band. The rounding of the cut ends reduces the irritation the tissue through this protruding edge threads. Prefers the connecting threads 4 are made of soluble or absorbable Filaments formed.

Die Verbindungsfäden 4 sind jeweils über einige Maschenreihen in den Verbund des Bandes gewirkt, bevor sie zu der Kante des anschließenden Bandes geführt sind. Dadurch sind die Verbindungsfäden 4 durch Abbindung in mehreren Maschenreihen in dem Gewirk der Bänder gesichert, so dass sie sich auch nach dem Durchtrennen nicht ohne eine wesentliche mechanische Einwirkung aus dem Gewirk des Bandes lösen.The connecting threads 4 are each over a few courses knitted into the composite of the ribbon before moving to the edge of the ribbon subsequent band are performed. This causes the connecting threads 4 by setting in several courses in the Knitted fabric of the tapes, so that they also after the Not cutting without a significant mechanical action from the fabric of the tape solve.

In der in Figur 3 gezeigten dritten Ausführung bilden die Grundfäden 1 ein Gewirk. Kantenfäden 6 sind in dieses Gewirk eingebunden und zu großen über die Längskanten des Bandes hinausragenden Schlaufen ausgeformt. Die Schlaufen der Kantenfäden 6 gewährleisten auch hier eine sichere Primärverankerung, ohne eine Reizung des Gewebes zu verursachen. Um einen bindungstechnisch sauberen Rand zu erhalten, sind die Kantenfäden 6 zusätzlich noch durch eine Flottung 7 gesichert.In the third embodiment shown in Figure 3 form the Basic threads 1 a knitted fabric. Edged threads 6 are in this knit integrated and projecting to large over the longitudinal edges of the tape Loops formed. The loops of the edged threads 6 also ensure a secure primary anchorage here, without causing irritation of the tissue. To a binding technology to get clean edge are the edged threads 6 additionally secured by a float 7.

In der in Figur 4 dargestellten vierten Ausführung sind die Grundfäden 1 in Fileteinzug zu einem wabenförmigen Band verwirkt. Die jeweils an den Längskanten des Bandes verlaufenden äussersten Grundfäden bilden Kantenfäden 2, die über den Rand des Bandes hinausragende Schlaufen mit einer großen rautenförmigen Öffnung 8 bilden. Diese Schlaufen bewirken eine Primärverankerung des Bandes im Gewebe und begünstigen das Einwachsen des Gewebes zur dauerhaften Stabilisierung des Bandes.In the fourth embodiment shown in Figure 4 are the Grundfäden 1 in Fileteinzug forfeited to a honeycomb band. Each extending at the longitudinal edges of the band outermost staple threads form selvage 2, which over the edge the band protruding loops with a large diamond-shaped Form opening 8. These loops cause a primary anchorage of the band in the tissue and promote ingrowth of the fabric for permanent stabilization of the band.

In der in Figur 5 dargestellten fünften Ausführung sind die Grundfäden 1 als Fransen ausgebildet. Eine Kombination bestehend aus Fäden 9 Masch und Schuß wird auf zwischennadeln gelegt, so dass über die gesamte Breite des Bandes Schlaufen gebildet werden, die sowohl die Primärverankerung als auch das dauerhafte Einwachsen des Gewebes begünstigen.In the fifth embodiment shown in Figure 5 are the Basic threads 1 designed as fringes. A combination exists from threads 9 Masch and shot is placed on intermediate needles, so that formed over the entire width of the strap loops which are both the primary anchorage and the promote permanent tissue ingrowth.

Claims (19)

  1. A tension-free, elastic tape for the surgical treatment of urinary incontinence in women, the textile structure of which makes the ingrowth of connective tissue possible,
    characterised in that at its longitudinal edges the tape comprises selvedge threads (2, 4, 6, 8), which for primary anchoring of the tape in the tissue protrude from the fibrous web of the tape and which are securely tied into the structure of the tape.
  2. A tape according to Claim 1,
    characterised in that the fibrous web of the tape is designed as a knitted fabric.
  3. A tape according to Claim 2,
    characterised in that the knitted fabric is designed in towel weave.
  4. A tape according to one of Claims 1 to 3,
    characterised in that the tape is predominantly or exclusively made from monofilaments.
  5. A tape according to one of Claims 1 to 3,
    characterised in that the tape is predominantly formed of multifilaments.
  6. A tape according to one of Claims 1 to 5,
    characterised in that the tape is manufactured from non-absorbable material.
  7. A tape according to one of Claims 1 to 5,
    characterised in that the tape is produced from at least two different filament materials.
  8. A tape according to Claim 7,
    characterised in that at least one of the filament materials is absorbable.
  9. A tape according to Claim 8,
    characterised in that the selvedge threads (2, 4, 6, 8) are made from absorbable filament material.
  10. A tape according to one of Claims 1 to 9,
    characterised in that the selvedge threads (2, 6, 8) take the form of loops, which are tied into the textile structure of the tape.
  11. A tape according to one of Claims 1 to 9,
    characterised in that the selvedge threads (4) protrude by their free ends from the composite tape and are tied or anchored into the structure of the tape.
  12. A tape according to Claim 11,
    characterised in that several mutually parallel tapes are produced as textile fabric,
    in that the tapes in this textile fabric are connected to each other by connecting threads (4)
    and in that the connecting threads (4) are cut through to separate the tapes and after being cut through protrude as selvedge threads from the composite tape.
  13. A tape according to Claim 12,
    characterised in that the free ends of the connection threads (4) are rounded off during the cutting-through process.
  14. A tape according to one of the preceding Claims,
    characterised in that the selvedge threads (6) are secured by a float stitch (7).
  15. A tape according to one of the preceding Claims,
    characterised in that the tape is surrounded by an easily removable casing for surgical retraction into the tissue.
  16. A tape according to Claim 15,
    characterised in that the tape and possibly the casing are provided at both ends with adapters, which make possible an easily releasable connection with a preferably reusable introducer.
  17. A tape according to Claim 16,
    characterised in that the external diameter of the adapter corresponds to the external diameter of the introducer at the connection site.
  18. A tape according to Claim 16 or 17,
    characterised in that the tape and possibly the casing are fixed to the adapters by welding, gluing, clamping and/or by means of a heat-shrinkable tube or are sprayed onto them.
  19. A tape according to Claim 16,
    characterised in that the adapter can be connected to the introducer by means of a screw connection, Luer lock, bayonet catch or snap connection.
EP02718107A 2001-02-17 2002-02-08 Tension-free elastic tape Expired - Lifetime EP1361834B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10107521 2001-02-17
DE10107521A DE10107521A1 (en) 2001-02-17 2001-02-17 Tensile elastic band
PCT/EP2002/001295 WO2002065944A1 (en) 2001-02-17 2002-02-08 Tension-free elastic tape

Publications (2)

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EP1361834A1 EP1361834A1 (en) 2003-11-19
EP1361834B1 true EP1361834B1 (en) 2005-04-27

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US (2) US7901415B2 (en)
EP (1) EP1361834B1 (en)
AT (1) ATE293933T1 (en)
CA (1) CA2438556C (en)
DE (2) DE10107521A1 (en)
DK (1) DK1361834T3 (en)
ES (1) ES2242007T3 (en)
WO (1) WO2002065944A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2340769A2 (en) 2009-12-31 2011-07-06 Aesculap AG Implant, in particular for treating urinary incontinence, method for producing same and surgical set
DE102009060802A1 (en) 2009-12-31 2011-07-07 Aesculap AG, 78532 Implant, in particular for the treatment of urinary incontinence, process for its preparation and surgical set
CN108625034A (en) * 2018-05-01 2018-10-09 章进通 A kind of PE cladding fabric and preparation method thereof

Also Published As

Publication number Publication date
US8152857B2 (en) 2012-04-10
US7901415B2 (en) 2011-03-08
DK1361834T3 (en) 2005-08-29
US20110130623A1 (en) 2011-06-02
DE50202911D1 (en) 2005-06-02
EP1361834A1 (en) 2003-11-19
CA2438556A1 (en) 2002-08-29
CA2438556C (en) 2010-04-13
ES2242007T3 (en) 2005-11-01
WO2002065944A1 (en) 2002-08-29
ATE293933T1 (en) 2005-05-15
DE10107521A1 (en) 2002-09-05
US20040144394A1 (en) 2004-07-29

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