WO2009112683A2 - Surgical thread for reconstruction in the field of cosmetic surgery and medicine - Google Patents

Surgical thread for reconstruction in the field of cosmetic surgery and medicine Download PDF

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Publication number
WO2009112683A2
WO2009112683A2 PCT/FR2009/000065 FR2009000065W WO2009112683A2 WO 2009112683 A2 WO2009112683 A2 WO 2009112683A2 FR 2009000065 W FR2009000065 W FR 2009000065W WO 2009112683 A2 WO2009112683 A2 WO 2009112683A2
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WO
WIPO (PCT)
Prior art keywords
elongation
surgical
wire
elastic product
surgical thread
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PCT/FR2009/000065
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French (fr)
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WO2009112683A3 (en
Inventor
Jean Frismand
Original Assignee
1St Surgiconcept
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Publication of WO2009112683A2 publication Critical patent/WO2009112683A2/en
Publication of WO2009112683A3 publication Critical patent/WO2009112683A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00792Plastic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00796Breast surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • A61B2017/06176Sutures with protrusions, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • A61B2017/0618Sutures elastic, e.g. stretchable

Definitions

  • TITLE Surgical wire for reconstruction in the field of surgery and aesthetic medicine.
  • the invention relates to a surgical wire for reconstruction in the field of surgery and aesthetic medicine.
  • the man consists of a hard frame made up of bones and joints and soft tissues including ligaments that connect the bones at the joints, muscles and tendons that provide mobility and other organs, tissues, skins , viscera, etc.
  • the anterior cruciate ligament of the knee presents an exponential tensile curve: it extends about 10% in the low loads of everyday life, between 10 and 20 daN, and has a reserve of elongation of 15 to 25% in case of excessive tension, ie a total elongation of 25 to 35%, for a breaking load of the order of 150 daN.
  • the superficial tissues of the body, or the subcutaneous tissues also possess important elasticity properties that allow them to follow the movements of the body without excessive crease.
  • a rupture of the anterior cruciate ligament can, depending on the case, be treated by the suture of the natural tissues, or if this action turns out to be impossible, by its replacement.
  • the replacement can be done by an autologous tissue, that is to say a sample of a piece of tissue on the same patient, for example part of his patellar tendon or by placing a synthetic ligament prosthesis.
  • An autologous transplant can also be reinforced with a synthetic ligament prosthesis to withstand mechanical stress while waiting for autologous transplant healing. Many attempts were made in the 1980s and later to implant artificial ligaments. Success was limited for several reasons.
  • the product used usually a polyethylene terephthalate (polyester) braid, does have an elongation of 20 to 30%, but this elongation does not correspond to the curve of a natural ligament.
  • These artificial ligaments thus have an almost linear elongation from the origin until rupture which occurs at 300 daN according to an example. Also, the artificial ligament can not be put in low tension, there is either an excessive tightening of the joint, or on the contrary the presence of a game harmful.
  • This rehabitation can have two possible consequences, namely the crushing of the cells of the body by the threads of the helix if the tensions are strong, at the origin of the necrosis of the cells, of an inflammatory reaction or of the intolerance of the product, either to cause the blocking of the operation of the propeller if it is less strong than the resistance exerted by the invasion of the tissues.
  • Document WO-01/12073 discloses an isoelastic suture for the repair of blood vessels.
  • the suture has a low modulus of elasticity base and an inner core of a more rigid fiber or a group of fibers having a helicoidal orientation.
  • the object of the invention is to overcome the aforementioned drawbacks by proposing a surgical thread allowing a significant elongation in the small displacements, under the action of weak stresses, and to limit the elongation in a controlled manner, if the constraints continue to increase and are excessive.
  • Another object of the invention is to provide a surgical thread easily tolerated tissue, thus limiting the risk of inflammatory reaction.
  • Another object of the invention is to provide a surgical wire finding an application in the reconstruction of the face, breasts, or arms.
  • the invention relates to a surgical wire for reconstruction in the field of surgery and / or aesthetic medicine, said wire being at least in the form of an elastic product, in particular a rod.
  • the surgical thread has attachment means for the tissues in the form of barbs or spikes, further comprising an elasticity modulus elongation limiting member
  • the properties of total and reversible elasticity of a low modulus elasticity elastomer for example silicone or polyurethane, and the resistance properties are combined.
  • mechanics of another polymer with a higher modulus of elasticity, hence with a smaller but more resistant elongation for example polyester, polyamide, polypropylene or polyetheretherketone.
  • FIGS. 1 and 2 illustrate a surgical wire, according to the invention, respectively at rest and under stress
  • FIGS. 3 and 4 illustrate a surgical wire, according to the invention, according to a second embodiment, respectively at rest and under stress
  • FIG. 5 illustrates a surgical thread, according to the invention, in particular provided with hooking pins for the tissues,
  • FIGS. 6 and 7 illustrate a surgical wire, according to the invention, according to a third embodiment, respectively at rest and under stress
  • FIG. 8 illustrates a surgical wire, according to the invention, according to a fourth embodiment
  • FIG. 9 is a sectional view of the wire as illustrated in FIG. 8.
  • the invention relates to a surgical wire 1 for reconstruction in the field of surgery, the implant being at least in the form of an elastic product 2, in particular a rod.
  • the yarn has attachment means 8 for the tissues in the form of barbs or spikes.
  • the barbs or pins are preferably made of the same material as said elastic product 2, obtained during the molding of said product 2.
  • the wire further comprises a member 3 limiting elongation of elastic modulus material E 2 , greater than the modulus of elasticity Ei of the material of said elastic ring.
  • the elongation limiter element 3 is arranged intimately along the length of said elastic product so that said surgical wire has a on the other hand, a first stiffness ki for tensile forces lower than a limit force Fo for which the surgical thread lengthens as a percentage of a value P 0 , and secondly, a second stiffness K 2 greater than ki, for tensile forces greater than said limit force F 0 .
  • the elongation limiting element is in a chosen form, loose at rest, so that the filament or filaments constituting it do not work in elasticity for any elongation of the surgical wire less than said percentage P 0 . From this value P 0 , the filaments of the elongation limiting element undergo the constraints of elongation and are made to work elastically, thus limiting in a controlled manner the elongation of the wire. From P 0 , the filament is thus set in straightness and limit of elongation except to play on the elasticity of this "reinforcement" filament.
  • the elongation limiting element is in the form of a helical filament 4 embedded in said product by overmolding techniques.
  • a helix is made by winding a polyester thread 0.2 to 0.3 mm in diameter around a metal axis of 0.2 mm, in particular at a winding pitch of 1 mm.
  • the assembly namely the polyester wire wound on its metal axis is placed in a mold for manufacturing a silicone rod. More particularly, this assembly is placed on a half-shell of the mold previously loaded with silicone. The mold is then closed by adding the other half-shell, itself loaded with silicone. After cooking, the wire is removed and leaves a channel of 0.2 mm which presents no inconvenience. The channel will also be reduced by the compression of the silicone, in particular due to the pulling forces exerted on the rod.
  • the tensioning of the elongation limiter element namely the polyester thread, takes place only in the case of the near straightness of said polyester thread corresponding to the value extension Po.
  • the simple helical wire of the previous example can be replaced by a double helix, in order to increase the resistance of the soul and to improve the attachment of the silicone on the soul in particular. In particular, a double helix helped to avoid the "sock effect".
  • the elongation-limiting element may take the form of a knit chain 5 embedded in the elastic product. At the resting state of the surgical wire, it is found that two successive links of the chain have a clearance allowing an elongation of the surgical wire without tensioning the chain and up to the extension of value P 0 for which the chain is stretched.
  • the elongation limiting element is in the form of a textured yarn embedded in the elastic product, that is to say a yarn having a crimp.
  • the tensioning of the element 3 thus takes place only in the case of the straightness of the textured yarn, corresponding to the value elongation Po.
  • the length-limiting element may take the form of a knit, in particular of tubular shape, constituting a sheath for the elastic ring 2.
  • the knit may advantageously be made with a textured yarn which itself has a good elasticity.
  • the fabric works in elasticity from the P 0 value elongation.
  • the association between the two components, namely the elastic product and elongation limiter element 3 can thus be achieved in the case where the element 3 is in the form of a knit or a tubular braid surrounding the product 2, especially the ring, or by intimate embedding of the two components, such as for example by overmolding a propeller including polyester (element 3) with silicone (product 2).
  • surgical wire may be of circular section, of flat section, or even of tubular section.
  • the surgical wire in accordance with the invention can find a particular application, in particular for the treatment of the aging of the cutaneous and subcutaneous tissues in medicine and plastic surgery, for example for the facial suspension, for the fight against the ptosis of the breasts, arms.
  • the surgical wire 1 may have attachment means 8 for human tissues, in particular constituted by barbs or pins.
  • an elastic silicone bead of 0.5 mm in diameter is produced having overthickness studs (overmolded) and having a 0.5 mm diameter helix produced with a polyester multifilament having a diameter of 0.2 mm.
  • an elongation of 10 to 20% is obtained for charges of between 10 and 20 g.
  • the propeller limits the additional elongation of the wire and also gives it a resistance to pass in force in traction during the operation of setting up the wire.
  • the passage in traction force of the wire also leads to the possibility of extending it to its maximum elastic (percentage extension P 0 ), or 20% for example, and therefore to place the wire with a known and controlled claim.
  • Another example of a suitable application may concern the fight against breast ptosis. To do this, we put in place a U-shaped wire passing through the bottom of the mammary gland.
  • a surgical wire about 40 cm long and about 1 mm in diameter will have a smooth central portion of 15 to 20 cm in length and two end portions with snap pins.
  • the central part is reinforced by a tubular knitted fabric or tubular braid or a helical filament allowing an elongation of 50% (P 0 ) in order to allow the movements of the breast, while the extremities are reinforced by a textile which limits the elongation of these parts by 10 to 20% (Po) in order to be iso elastic tissues in which spikes are fixed and therefore offer better resistance to anchoring.
  • Said central portion of 15 to 20 cm length lengthening 50% can allow a descent of the breast of 5 cm.
  • the silicone wire can withstand an elongation of 50% without degradation especially if it is subjected before use this elongation (preconditioning). This allows movements of great physiological amplitude of the breast with a return of it to its desired raised position.
  • the invention thus relates to a surgical wire having a smooth central portion and two end portions provided with hooking means with the human tissues and in which the central portion is provided with a first elongation limiter element so that is between 30% and 60% on the central part and the end parts have a second elongation limiter so that Po is between 5% and 25% on the end portions.

Abstract

The invention relates to a surgical thread (1) for reconstruction in the field of cosmetic surgery and medicine, said thread being at least in the form of an elastic product (2), especially a filament. According to the invention, the surgical thread additionally comprises a material elongation limiting element (3) with a modulus of elasticity E2, greater than the modulus of elasticity E1 of the material of said elastic product, and arranged intimately along the length of said elastic product such that said surgical thread has, on the one hand, a first stiffness k1 for traction forces below a limit force F0 for which the surgical thread lengthens in percentage by a value Po, and, on the other hand, a second stiffness k2, greater than k-ι, for traction forces greater than said limit force Fo.

Description

TITRE : Fil chirurgical pour la reconstruction dans le domaine de la chirurgie et de la médecine esthétique. TITLE: Surgical wire for reconstruction in the field of surgery and aesthetic medicine.
L'invention est relative à un fil chirurgical pour la reconstruction dans le domaine de la chirurgie et de la médecine esthétique. L'homme est constitué d'une charpente dure constituée par les os et les articulations et de tissus mous dont les ligaments qui relient les os au niveau des articulations, les muscles et tendons qui assurent la mobilité et d'autres organes, tissus, peaux, viscères, etc..The invention relates to a surgical wire for reconstruction in the field of surgery and aesthetic medicine. The man consists of a hard frame made up of bones and joints and soft tissues including ligaments that connect the bones at the joints, muscles and tendons that provide mobility and other organs, tissues, skins , viscera, etc.
Une caractéristique mécanique importante des tissus mous est de posséder une certaine élasticité qui leur permet de s'allonger sous une contrainte puis de revenir à leur état initial si la contrainte n'a pas dépassé les capacités de résistance du tissu.An important mechanical feature of soft tissues is to have some elasticity that allows them to stretch under stress and then return to their original state if the stress has not exceeded the strength capabilities of the fabric.
Cette propriété se trouve particulièrement dans les ligaments qui s'allongent en cas de mouvements entre deux os. Par exemple, le ligament croisé antérieur du genou présente une courbe de traction de type exponentiel : il s'allonge de 10 % environ dans les faibles charges de la vie courante, comprises entre 10 et 20 daN, et possède une réserve d'allongement de 15 à 25 % en cas de traction excessive, soit un allongement total de 25 à 35 %, pour une charge de rupture de l'ordre de 150 daN. Dans un autre domaine, les tissus superficiels du corps, ou les tissus sous cutanés possèdent également des propriétés d'élasticité importantes qui leur permettent de suivre les mouvements du corps sans pli excessif.This property is particularly found in ligaments that lengthen when moving between two bones. For example, the anterior cruciate ligament of the knee presents an exponential tensile curve: it extends about 10% in the low loads of everyday life, between 10 and 20 daN, and has a reserve of elongation of 15 to 25% in case of excessive tension, ie a total elongation of 25 to 35%, for a breaking load of the order of 150 daN. In another area, the superficial tissues of the body, or the subcutaneous tissues also possess important elasticity properties that allow them to follow the movements of the body without excessive crease.
En cas de dégât de ces tissus, rupture d'un ligament lors d'un traumatisme ou vieillissement cutané et sous-cutané, les chirurgiens sont amenés à intervenir.In the event of damage to these tissues, rupture of a ligament during trauma or skin and subcutaneous aging, surgeons are called upon to intervene.
Une rupture du ligament croisé antérieur peut, en fonction des cas, être traitée par la suture des tissus naturels, ou si cette action se révèle impossible, par son remplacement. Le remplacement peut se faire par un tissu autologue, c'est-à- dire un prélèvement d'un morceau de tissu sur le même patient, par exemple une partie de son tendon rotulien ou par la pose d'une prothèse ligamentaire synthétique. La greffe d'un transplant autologue peut également être renforcée par une prothèse ligamentaire synthétique afin de supporter les contraintes mécaniques en attendant la cicatrisation du transplant autologue. De nombreux essais ont été faits dans les années 1980 et suivantes pour implanter des ligaments artificiels. Le succès a été limité pour plusieurs raisons. Le produit utilisé, en général une tresse de polyéthylène téréphtalate (polyester), présente bien un allongement de 20 à 30 %, mais cet allongement ne correspond pas à la courbe d'un ligament naturel. Ces ligaments artificiels présentent ainsi un allongement quasi linéaire depuis l'origine jusqu'à la rupture qui survient à 300 daN selon un exemple. Aussi, le ligament artificiel ne pouvant être mis en faible tension, on constate soit un serrage excessif de l'articulation, soit au contraire la présence d'un jeu néfaste.A rupture of the anterior cruciate ligament can, depending on the case, be treated by the suture of the natural tissues, or if this action turns out to be impossible, by its replacement. The replacement can be done by an autologous tissue, that is to say a sample of a piece of tissue on the same patient, for example part of his patellar tendon or by placing a synthetic ligament prosthesis. An autologous transplant can also be reinforced with a synthetic ligament prosthesis to withstand mechanical stress while waiting for autologous transplant healing. Many attempts were made in the 1980s and later to implant artificial ligaments. Success was limited for several reasons. The product used, usually a polyethylene terephthalate (polyester) braid, does have an elongation of 20 to 30%, but this elongation does not correspond to the curve of a natural ligament. These artificial ligaments thus have an almost linear elongation from the origin until rupture which occurs at 300 daN according to an example. Also, the artificial ligament can not be put in low tension, there is either an excessive tightening of the joint, or on the contrary the presence of a game harmful.
Concernant le traitement du vieillissement cutané et sous- cutané, bien souvent, le chirurgien utilise des fils munis de crans pour lutter contre la pesanteur qui entraîne une ptôse ou « chute » des tissus. Cette technique est utilisée sur les seins, les bras, les jambes ou encore la face. La plupart des fils sont peu ou pas élastiques et le traitement est donc imparfait. Pour ces fils de faible élasticité, on constate un aspect figé de rigidité des tissus et une perte de correction dans le temps par décrochage des crans.Regarding the treatment of cutaneous and subcutaneous aging, the surgeon often uses son with notches to fight against the gravity that causes ptosis or "fall" of tissues. This technique is used on breasts, arms, legs or face. Most of the threads are weak or not elastic and the treatment is imperfect. For these son of low elasticity, there is a fixed aspect of stiffness of the tissues and a loss of correction over time by stalling notches.
Au cours de ses travaux, le présent inventeur a mis au point l'utilisation de fils de silicone élastiques pour traiter en particulier le vieillissement des tissus cutanés et sous-cutanés en médecine et chirurgie esthétique. Ces fils, après traitement, présentent des caractéristiques d'élasticité nécessaires pour pouvoir s'allonger de quelques pour cent, à savoir entre 5 et 20 %, en cas de faible charge de l'ordre de 5 à 20 g puis de revenir à leur longueur initiale.In the course of his work, the present inventor has developed the use of elastic silicone threads for treating in particular the aging of cutaneous and subcutaneous tissues in medicine and cosmetic surgery. These son, after treatment, have elastic characteristics necessary to be able to stretch a few percent, namely between 5 and 20%, in case of low load on the order of 5 to 20 g and then back to their initial length.
Cependant, ces fils de silicone peuvent s'allonger de façon très importante, c'est-à-dire de plusieurs dizaines ou centaines de pour cent, pour des charges croissantes. Cette caractéristique élastique quasi linéaire n'est pas un inconvénient si les déplacements maximum sont faibles de par la structure anatomique, notamment dans Ie cas de traitements par concentration des tissus sur une pommette avachie.However, these silicone yarns can extend very significantly, i.e., by tens or hundreds of percent, for increasing loads. This quasi-linear elastic characteristic is not a disadvantage if the maximum displacements are small because of the anatomical structure, especially in the case of treatment by concentration of tissue on a slumped cheekbone.
En revanche, dans le cas d'un déplacement important tel que l'on peut le rencontrer dans le cas d'un repositionnement d'un sein ptosé, cette caractéristique s'avère un problème.On the other hand, in the case of a major displacement such as can be encountered in the case of a repositioning of a ptose breast, this characteristic is a problem.
On connaît également du document EP-1.726.317 l'utilisation d'un fil ressort. Ce fil est constitué d'un polymère ou d'un métal mis en hélice pour lui procurer son élasticité ressort. Ce produit présente une élasticité linéaire jusqu'à la mise en tension excessive du ressort, puis présentera ensuite un risque de dénaturation. D'autre part, la construction ouverte du ressort autorise sa réhabitation par les cellules de l'organisme.Document EP-1,726,317 also discloses the use of a spring wire. This wire is made of a polymer or a metal put in a helix to give it spring elasticity. This product has a linear elasticity until the excessive tension of the spring, then present a risk of denaturation. On the other hand, the open construction of the spring allows its rehabitation by the cells of the body.
Cette réhabitation peut avoir deux conséquences possibles, soit l'écrasement des cellules de l'organisme par les fils de l'hélice si les tensions sont fortes, à l'origine de la nécrose des cellules, d'une réaction inflammatoire ou encore de l'intolérance du produit, soit provoquer le blocage du fonctionnement de l'hélice si celle-ci est moins forte que la résistance exercée par l'envahissement des tissus.This rehabitation can have two possible consequences, namely the crushing of the cells of the body by the threads of the helix if the tensions are strong, at the origin of the necrosis of the cells, of an inflammatory reaction or of the intolerance of the product, either to cause the blocking of the operation of the propeller if it is less strong than the resistance exerted by the invasion of the tissues.
On connaît du document WO-01/12073 une suture isoélastique pour la réparation de vaisseaux sanguins. Selon une variante, le fil de suture présente une base à faible module d'élasticité et une âme intérieure, constituée d'un fibre plus rigide, ou d'un groupe de fibres, présentant une orientation en hélicoïde.Document WO-01/12073 discloses an isoelastic suture for the repair of blood vessels. Alternatively, the suture has a low modulus of elasticity base and an inner core of a more rigid fiber or a group of fibers having a helicoidal orientation.
On connaît des documents US-4.610.688, US-5.217.495 et US-4.662.886 des prothèses bi-matériaux pour le remplacement de tendons ou ligaments.US-4,610,688, US-5,217,495 and US-4,662,886 are known from bi-material prostheses for the replacement of tendons or ligaments.
On connaît du document WO-2004/066.847 un fil chirurgical trouvant une application particulière en chirurgie esthétique. Ce fil comprend un noyau élastique et une gaine non élastique, constituée de fils biocompatibles non élastiques, enroulés autour dudit noyau. Selon ce document, lorsque le fil est introduit de manière permanente dans les tissus, la gaine non élastique, extérieure, est colonisée par les tissus humains de telle façon à permettre l'accrochage des tissus sur la longueur du fil chirurgical.Document WO-2004 / 066,847 discloses a surgical thread having a particular application in cosmetic surgery. This wire comprises an elastic core and a non-elastic sheath, consisting of non-elastic biocompatible son, wrapped around said core. According to this document, when the yarn is permanently introduced into the tissues, the non-elastic outer sheath is colonized by the human tissues so as to allow the attachment of the tissues along the length of the surgical thread.
Le but de l'invention est de pallier les inconvénients précités en proposant un fil chirurgical autorisant un allongement important dans les faibles déplacements, sous l'action de contraintes faibles, et de limiter l'allongement de façon contrôlée, si les contraintes continuent à augmenter et sont excessives.The object of the invention is to overcome the aforementioned drawbacks by proposing a surgical thread allowing a significant elongation in the small displacements, under the action of weak stresses, and to limit the elongation in a controlled manner, if the constraints continue to increase and are excessive.
Un autre but de l'invention est de proposer un fil chirurgical toléré facilement des tissus, limitant ainsi les risques de réaction inflammatoire. Un autre but de l'invention est de proposer un fil chirurgical trouvant une application dans la reconstruction de la face, des seins, ou encore des bras.Another object of the invention is to provide a surgical thread easily tolerated tissue, thus limiting the risk of inflammatory reaction. Another object of the invention is to provide a surgical wire finding an application in the reconstruction of the face, breasts, or arms.
D'autres buts et avantages de la présente invention apparaîtront au cours de la description qui va suivre, qui n'est donnée qu'à titre indicatif et qui n'a pas pour but de la limiter.Other objects and advantages of the present invention will become apparent from the description which follows, which is given for information only and which is not intended to limit it.
L'invention concerne un fil chirurgical pour la reconstruction dans le domaine de la chirurgie et/ou de la médecine esthétique, ledit fil se présentant au moins sous la forme d'un produit élastique, notamment d'un jonc. Selon l'invention, le fil chirurgical présente des moyens d'accrochage pour les tissus sous la forme de barbes ou picots, comprenant, en outre, un élément limiteur d'allongement de matériau de module d'élasticitéThe invention relates to a surgical wire for reconstruction in the field of surgery and / or aesthetic medicine, said wire being at least in the form of an elastic product, in particular a rod. According to the invention, the surgical thread has attachment means for the tissues in the form of barbs or spikes, further comprising an elasticity modulus elongation limiting member
E2, supérieur au module d'élasticité Ei du matériau dudit produit élastique, et agencé intimement sur la longueur dudit produit élastique afin que ledit fil chirurgical présente, d'une part, une première raideur 1^1 pour des efforts de traction inférieurs à un effort limite Fo pour lequel le fil chirurgical s'allonge en pourcentage d'une valeur P0 et d'autre part, une deuxième raideur k2, supérieure à k-i, pour des efforts de traction supérieures audit effort limite Fo-E 2 , greater than the modulus of elasticity Ei of the material of said elastic product, and arranged intimately along the length of said elastic product so that said surgical wire has, on the one hand, a first stiffness 1 ^ 1 for tensile stresses lower than a limit force Fo for which the surgical wire lengthens as a percentage of a value P 0 and secondly, a second stiffness k2, greater than ki, for tensile forces greater than said limit force F0
Selon un mode de réalisation, on associe les propriétés d'élasticité totale et réversible d'un élastomère à module d'élasticité bas, par exemple la silicone ou le polyuréthane, et les propriétés de résistance mécanique d'un autre polymère à module d'élasticité plus élevée, donc à allongement plus faible, mais plus résistant, par exemple le polyester, le polyamide, le polypropylène ou le polyetheretherketone.According to one embodiment, the properties of total and reversible elasticity of a low modulus elasticity elastomer, for example silicone or polyurethane, and the resistance properties are combined. mechanics of another polymer with a higher modulus of elasticity, hence with a smaller but more resistant elongation, for example polyester, polyamide, polypropylene or polyetheretherketone.
L'invention sera mieux comprise à la lecture de la description suivante accompagnée des dessins en annexe parmi lesquels :The invention will be better understood on reading the following description accompanied by the appended drawings among which:
- les figures 1 et 2 illustrent un fil chirurgical, conforme à l'invention, respectivement au repos et sous contrainte,FIGS. 1 and 2 illustrate a surgical wire, according to the invention, respectively at rest and under stress,
- les figures 3 et 4 illustrent un fil chirurgical, conforme à l'invention, selon un second mode de réalisation, respectivement au repos et sous contrainte,FIGS. 3 and 4 illustrate a surgical wire, according to the invention, according to a second embodiment, respectively at rest and under stress,
- la figure 5 illustre un fil chirurgical, conforme à l'invention, notamment muni de picots d'accrochage pour les tissus,FIG. 5 illustrates a surgical thread, according to the invention, in particular provided with hooking pins for the tissues,
- les figures 6 et 7 illustrent un fil chirurgical, conforme à l'invention, selon un troisième mode de réalisation, respectivement au repos et sous contrainte,FIGS. 6 and 7 illustrate a surgical wire, according to the invention, according to a third embodiment, respectively at rest and under stress,
- la figure 8 illustre un fil chirurgical, conforme à l'invention, selon un quatrième mode de réalisation,FIG. 8 illustrates a surgical wire, according to the invention, according to a fourth embodiment,
- la figure 9 est une vue de coupe du fil tel qu'illustré à la figure 8. L'invention concerne un fil chirurgical 1 pour la reconstruction dans le domaine de la chirurgie, l'implant se présentant au moins sous la forme d'un produit élastique 2, notamment d'un jonc.FIG. 9 is a sectional view of the wire as illustrated in FIG. 8. The invention relates to a surgical wire 1 for reconstruction in the field of surgery, the implant being at least in the form of an elastic product 2, in particular a rod.
Selon l'invention, le fil présente des moyens d'accrochage 8 pour les tissus sous la forme de barbes ou picots. Les barbes ou picots sont de préférence constitués du même matériau que ledit produit élastique 2, obtenus lors du moulage dudit produit 2.According to the invention, the yarn has attachment means 8 for the tissues in the form of barbs or spikes. The barbs or pins are preferably made of the same material as said elastic product 2, obtained during the molding of said product 2.
Selon l'invention, le fil comprend, en outre, un élément 3 limiteur d'allongement de matériau de module d'élasticité E2 , supérieur au module d'élasticité Ei du matériau dudit jonc élastique. L'élément 3 limiteur d'allongement est agencé intimement sur la longueur dudit produit élastique afin que ledit fil chirurgical présente, d'une part, une première raideur ki pour des efforts de traction inférieurs à un effort limite Fo pour lequel le fil chirurgical s'allonge en pourcentage d'une valeur P0, et d'autre part, une deuxième raideur K2 supérieure à ki, pour des efforts de traction supérieure audit effort limite F0. L'élément limiteur d'allongement se présente sous une forme choisie, lâche au repos, pour que le ou les filaments qui le constituent ne travaillent pas en élasticité pour tout allongement du fil chirurgical inférieur audit pourcentage P0. A partir de cette valeur P0, les filaments de l'élément limiteur d'allongement subissent les contraintes de l'allongement et sont amenés à travailler en élasticité, limitant ainsi de manière contrôlée l'allongement du fil. A partir de P0, le filament est ainsi mis en rectitude et limite d'allongement sauf à jouer sur l'élasticité de ce filament de « renfort ».According to the invention, the wire further comprises a member 3 limiting elongation of elastic modulus material E 2 , greater than the modulus of elasticity Ei of the material of said elastic ring. The elongation limiter element 3 is arranged intimately along the length of said elastic product so that said surgical wire has a on the other hand, a first stiffness ki for tensile forces lower than a limit force Fo for which the surgical thread lengthens as a percentage of a value P 0 , and secondly, a second stiffness K 2 greater than ki, for tensile forces greater than said limit force F 0 . The elongation limiting element is in a chosen form, loose at rest, so that the filament or filaments constituting it do not work in elasticity for any elongation of the surgical wire less than said percentage P 0 . From this value P 0 , the filaments of the elongation limiting element undergo the constraints of elongation and are made to work elastically, thus limiting in a controlled manner the elongation of the wire. From P 0 , the filament is thus set in straightness and limit of elongation except to play on the elasticity of this "reinforcement" filament.
Selon l'exemple des figures 1 et 2, l'élément limiteur d'allongement se présente sous la forme d'un filament 4 en hélice noyé dans ledit produit par les techniques de surmoulage. A titre d'exemple de réalisation, une hélice est réalisée en enroulent un fil de polyester de 0,2 à 0,3 mm de diamètre autour d'un axe métallique de 0,2 mm, notamment selon un pas d'enroulement de 1 mm.According to the example of Figures 1 and 2, the elongation limiting element is in the form of a helical filament 4 embedded in said product by overmolding techniques. As an exemplary embodiment, a helix is made by winding a polyester thread 0.2 to 0.3 mm in diameter around a metal axis of 0.2 mm, in particular at a winding pitch of 1 mm.
L'ensemble, à savoir le fil polyester enroulé sur son axe métallique est placé dans un moule de fabrication d'un jonc en silicone. Plus particulièrement, cet ensemble est posé sur une demi-coque du moule préalablement chargée de silicone. Le moule est alors fermé en ajoutant l'autre demi-coque, elle-même chargée de silicone. Après cuisson, le fil métallique est retiré et laisse un canal de 0,2 mm qui ne présent aucun inconvénient. Le canal va d'ailleurs se réduire par la compression de la silicone, en particulier du fait des efforts de tractions exercés sur le jonc. La mise en tension de l'élément limiteur d'allongement, à savoir le fil polyester n'a lieu que dans le cas de la quasi rectitude dudit fil polyester correspondant à l'allongement de valeur Po. Le simple fil en hélice de l'exemple précédent peut être remplacé par une double hélice, afin d'augmenter la résistance de l'âme et d'améliorer l'accrochage de la silicone sur l'âme notamment. Une double hélice a notamment permis d'éviter « l'effet chaussette ».The assembly, namely the polyester wire wound on its metal axis is placed in a mold for manufacturing a silicone rod. More particularly, this assembly is placed on a half-shell of the mold previously loaded with silicone. The mold is then closed by adding the other half-shell, itself loaded with silicone. After cooking, the wire is removed and leaves a channel of 0.2 mm which presents no inconvenience. The channel will also be reduced by the compression of the silicone, in particular due to the pulling forces exerted on the rod. The tensioning of the elongation limiter element, namely the polyester thread, takes place only in the case of the near straightness of said polyester thread corresponding to the value extension Po. The simple helical wire of the previous example can be replaced by a double helix, in order to increase the resistance of the soul and to improve the attachment of the silicone on the soul in particular. In particular, a double helix helped to avoid the "sock effect".
Selon l'exemple des figures 3 et 4, l'élément limiteur d'allongement peut prendre la forme d'une chaînette de tricot 5 noyée dans le produit élastique. A l'état de repos du fil chirurgical, on constate que deux maillons successifs de la chaînette présentent un jeu autorisant un allongement du fil chirurgical sans mise en tension de la chaînette et ce jusqu'à l'allongement de valeur P0 pour lequel la chaînette se tend.According to the example of FIGS. 3 and 4, the elongation-limiting element may take the form of a knit chain 5 embedded in the elastic product. At the resting state of the surgical wire, it is found that two successive links of the chain have a clearance allowing an elongation of the surgical wire without tensioning the chain and up to the extension of value P 0 for which the chain is stretched.
Selon l'exemple des figures 6 et 7, l'élément limiteur d'allongement se présente sous la forme d'un fil texture noyé dans le produit élastique, c'est-à-dire d'un fil présentant une frisure. La mise en tension de l'élément 3 n'a ainsi lieu que dans le cas de la quasi rectitude du fil texture, correspondant à l'allongement de valeur Po.According to the example of Figures 6 and 7, the elongation limiting element is in the form of a textured yarn embedded in the elastic product, that is to say a yarn having a crimp. The tensioning of the element 3 thus takes place only in the case of the straightness of the textured yarn, corresponding to the value elongation Po.
Enfin, selon un autre mode de réalisation, illustré aux figures 8 et 9, l'élément limiteur d'allongement peut prendre la forme d'un tricot notamment de forme tubulaire, constituant un fourreau pour le jonc élastique 2.Finally, according to another embodiment, illustrated in FIGS. 8 and 9, the length-limiting element may take the form of a knit, in particular of tubular shape, constituting a sheath for the elastic ring 2.
Le tricot peut être avantageusement réalisé avec un fil texture qui présente lui-même une bonne élasticité. Le tissu travaille en élasticité à partir de l'allongement de valeur P0. L'association entre les deux composants, à savoir du produit élastique et élément 3 limiteur d'allongement peut ainsi être réalisée dans le cas où l'élément 3 se présente sous la forme d'un tricot ou d'une tresse tubulaire en entourant le produit 2, notamment le jonc, ou encore en noyant de façon intime les deux composants, tels que par exemple par surmoulage d'une hélice notamment en polyester (élément 3) avec de la silicone (produit 2).The knit may advantageously be made with a textured yarn which itself has a good elasticity. The fabric works in elasticity from the P 0 value elongation. The association between the two components, namely the elastic product and elongation limiter element 3 can thus be achieved in the case where the element 3 is in the form of a knit or a tubular braid surrounding the product 2, especially the ring, or by intimate embedding of the two components, such as for example by overmolding a propeller including polyester (element 3) with silicone (product 2).
Il est à noter que le fil chirurgical peut être de section circulaire, de section plate, voire même de section tubulaire.It should be noted that the surgical wire may be of circular section, of flat section, or even of tubular section.
On notera toutefois que l'association des deux composants, à savoir produit élastique 2 et élément limiteur d'allongement 3 est intime, le fil chirurgical présentant un aspect lisse ou quasi lisse, interdisant la réhabitation et l'enchevêtrement des cellules de l'organisme avec le fil chirurgical, prévenant ainsi les risques d'inflammation, voir de rejet.It should be noted, however, that the combination of the two components, namely elastic product 2 and elongation limiter element 3 is intimate, the surgical thread having a smooth or almost smooth appearance, preventing the rehabitation and entanglement of the cells of the body. with the surgical wire, thus preventing the risk of ignition, see rejection.
Le fil chirurgical conforme à l'invention peut trouver une application particulière en particulier pour le traitement du vieillissement des tissus cutanés et sous-cutanés en médecine et chirurgie esthétique, par exemple pour la suspension faciale, pour la lutte contre la ptôse des seins, des bras. A cet effet, le fil chirurgical 1 peut présenter des moyens 8 d'accrochage pour les tissus humains, notamment constitués par des barbes ou picots.The surgical wire in accordance with the invention can find a particular application, in particular for the treatment of the aging of the cutaneous and subcutaneous tissues in medicine and plastic surgery, for example for the facial suspension, for the fight against the ptosis of the breasts, arms. For this purpose, the surgical wire 1 may have attachment means 8 for human tissues, in particular constituted by barbs or pins.
Selon un exemple d'application pour la suspension faciale, on réalise un jonc élastique en silicone de 0,5 mm de diamètre possédant des picots d'accrochage en surépaisseur (surmoulés) et présentant une hélice de diamètre de 0,5 mm réalisée avec un multifilament de polyester présentant un diamètre de 0,2 mm. En fonction du pas de l'hélice, on obtient un allongement de 10 à 20 % pour des charges comprises entre 10 et 20 g.According to an example of application for the facial suspension, an elastic silicone bead of 0.5 mm in diameter is produced having overthickness studs (overmolded) and having a 0.5 mm diameter helix produced with a polyester multifilament having a diameter of 0.2 mm. Depending on the pitch of the helix, an elongation of 10 to 20% is obtained for charges of between 10 and 20 g.
L'hélice limite l'allongement supplémentaire du fil et lui donne également une résistance permettant de le passer en force en traction lors de l'opération de mise en place du fil. Le passage en force de traction du fil entraîne aussi la possibilité de l'allonger à son maximum élastique (allongement de pourcentage P0), soit 20 % par exemple, et donc de placer le fil avec une prétention connue et contrôlée. Un autre exemple d'application adapté peut concerner la lutte contre la ptôse des seins. Pour ce faire, on met en place un fil en U passant par le bas de la glande mammaire. Un fil chirurgical de 40 cm environ de long et de 1 mm de diamètre environ va présenter une partie centrale lisse de 15 à 20 cm de longueur et deux parties extrêmes avec des picots d'accrochage. La partie centrale est renforcée par un textile tricoté tubulaire ou tresse tubulaire ou un filament en hélice permettant un allongement de 50 % (P0) afin d'autoriser les mouvements du sein, tandis que les parties extrêmes sont renforcées par un textile qui limite l'allongement de ces parties de 10 à 20 % (Po) afin d'être iso élastique des tissus dans lesquels des picots se fixent et donc offrent une meilleure résistance à l'ancrage.The propeller limits the additional elongation of the wire and also gives it a resistance to pass in force in traction during the operation of setting up the wire. The passage in traction force of the wire also leads to the possibility of extending it to its maximum elastic (percentage extension P 0 ), or 20% for example, and therefore to place the wire with a known and controlled claim. Another example of a suitable application may concern the fight against breast ptosis. To do this, we put in place a U-shaped wire passing through the bottom of the mammary gland. A surgical wire about 40 cm long and about 1 mm in diameter will have a smooth central portion of 15 to 20 cm in length and two end portions with snap pins. The central part is reinforced by a tubular knitted fabric or tubular braid or a helical filament allowing an elongation of 50% (P 0 ) in order to allow the movements of the breast, while the extremities are reinforced by a textile which limits the elongation of these parts by 10 to 20% (Po) in order to be iso elastic tissues in which spikes are fixed and therefore offer better resistance to anchoring.
Ladite partie centrale de 15 à 20 cm de longueur s'allongeant de 50 % peut permettre une descente du sein de 5 cm. Le fil en silicone peut supporter un allongement de 50 % sans dégradation surtout si on lui fait subir avant utilisation cet allongement (préconditionnement). Ceci autorise des mouvements de grande amplitude physiologique du sein avec un retour de celui-ci à sa position relevée souhaitée.Said central portion of 15 to 20 cm length lengthening 50% can allow a descent of the breast of 5 cm. The silicone wire can withstand an elongation of 50% without degradation especially if it is subjected before use this elongation (preconditioning). This allows movements of great physiological amplitude of the breast with a return of it to its desired raised position.
L'invention concerne donc ainsi un fil chirurgical présentant une partie centrale lisse et de deux parties extrêmes munies de moyens d'accrochage avec les tissus humains et dans lesquels la partie centrale est pourvue d'un premier élément limiteur d'allongement de façon que Po est compris entre 30 % et 60 % sur la partie centrale et les parties extrêmes présentent un deuxième limiteur d'allongement de telle façon que Po est compris entre 5 % et 25 % sur les parties extrêmes.The invention thus relates to a surgical wire having a smooth central portion and two end portions provided with hooking means with the human tissues and in which the central portion is provided with a first elongation limiter element so that is between 30% and 60% on the central part and the end parts have a second elongation limiter so that Po is between 5% and 25% on the end portions.
Naturellement, d'autres modes de réalisation auraient pu être envisagés sans pour autant sortir du cadre de l'invention définie par les revendications ci-après. Naturally, other embodiments could have been envisaged without departing from the scope of the invention defined by the claims below.

Claims

REVENDICATIONS
1. Fil chirurgical (1) pour la reconstruction dans le domaine de la chirurgie, et/ou de la médecine esthétique, ledit fil se présentant au moins sous la forme d'un produit élastique (2), caractérisé en ce qu'il présente des moyens d'accrochage (8) pour les tissus sous la forme de barbes ou picots, ledit fil comprenant en outre, un élément (3) limiteur d'allongement en un matériau de module d'élasticité E2, supérieur au module d'élasticité Ei du matériau dudit produit élastique, et agencé intimement sur la longueur dudit produit élastique (2) afin que ledit fil chirurgical présente, d'une part, une première raideur ki pour des efforts de traction inférieurs à un effort limite F0 pour lequel le fil chirurgical s'allonge en pourcentage d'une valeur Po, et d'autre part une deuxième raideur k2, supérieure à ki, pour des efforts de traction supérieure audit effort limite Fo.Surgical wire (1) for reconstruction in the field of surgery, and / or aesthetic medicine, said wire being at least in the form of an elastic product (2), characterized in that it presents fastening means (8) for the tissues in the form of barbs or pins, said wire further comprising an elongation-limiting element (3) of a modulus of elasticity material E 2 , greater than the modulus of elasticity; elasticity Ei of the material of said elastic product, and arranged intimately along the length of said elastic product (2) so that said surgical wire has, on the one hand, a first stiffness ki for tensile forces lower than a limit force F 0 for which the surgical thread lengthens as a percentage of a value Po, and secondly a second stiffness k 2 , greater than ki, for tensile forces greater than said limit force Fo.
2. Fil chirurgical (1) selon la revendication 1 , dans lequel le produit élastique (2) est en silicone ou en polyuréthane et l'élément limiteur d'allongement (3) est choisi parmi le groupe de matériaux suivants : polyester, polyamide, polypropylène ou polyetheretherketone.2. surgical yarn (1) according to claim 1, wherein the elastic product (2) is silicone or polyurethane and the elongation limiting element (3) is selected from the group of materials: polyester, polyamide, polypropylene or polyetheretherketone.
3. Fil chirurgical (1) selon la revendication 1 ou 2, se présentant sous la forme d'un jonc, dans lequel l'élément (3) limiteur d'allongement est un filament (4) en hélice noyé dans ledit jonc.3. surgical wire (1) according to claim 1 or 2, being in the form of a rod, wherein the element (3) elongation limiter is a filament (4) helically embedded in said rod.
4. Fil chirurgical selon la revendication 1 ou 2, dans lequel l'élément (3) limiteur d'allongement prend la forme d'une chaînette (5) de tricot, d'un tricot (6), d'une tresse ou encore d'un fil texture (7).4. Surgical thread according to claim 1 or 2, wherein the element (3) elongation limiter takes the form of a chain (5) knit, a knit (6), a braid or a texture thread (7).
5. Fil chirurgical selon l'une des revendications 1 à 4, dans lequel l'élément limiteur d'allongement est noyé dans ledit produit élastique par les techniques de surmoulage.5. surgical thread according to one of claims 1 to 4, wherein the elongation limiting element is embedded in said elastic product by overmolding techniques.
6. Fil chirurgical selon l'une des revendications 1 à 5 convenant pour le traitement du vieillissement des tissus cutanés et sous- cutanés, plus particulièrement pour la suspension faciale, la lutte contre la ptôse des seins ou des bras.6. Surgical thread according to one of claims 1 to 5 suitable for the treatment of aging of the skin and subcutaneous tissues, more particularly for the facial suspension, the fight against the ptosis of the breasts or arms.
7. Fil chirurgical selon la revendication 6, particulièrement destiné pour la suspension faciale présentant un allongement en pourcentage de valeur Po compris entre 10% et 20% pour une charge comprise entre 10 g et 20 g.Surgical thread according to claim 6, particularly intended for the facial suspension having a percentage elongation of value Po of between 10% and 20% for a load of between 10 g and 20 g.
8. Fil chirurgical selon la revendication 6, notamment destiné à lutter contre la ptôse des seins, présentant une partie centrale lisse et deux parties extrêmes munies desdits moyens (8) d'accrochage avec les tissus humains et dans lequel la partie centrale est pourvue d'un premier élément limiteur d'allongement de telle façon que P0 est compris entre 30% et 60% sur ladite partie centrale et les parties extrêmes présentent un deuxième limiteur d'allongement de telle façon à ce que P0 est compris entre 5 % et 25% sur les parties extrêmes.8. Surgical thread according to claim 6, in particular for controlling the ptosis of the breasts, having a smooth central portion and two end portions provided with said means (8) for attachment with the human tissues and wherein the central portion is provided with a first elongation limiter element such that P 0 is between 30% and 60% on said central portion and the end portions have a second elongation limiter so that P 0 is between 5% and 25% on the extreme parts.
9. Fil selon l'une des revendications 1 à 8, dans lequel les moyens d'accrochage (8) sont prévus en surépaisseur du produit élastique (2).9. Thread according to one of claims 1 to 8, wherein the attachment means (8) are provided in excess of the elastic product (2).
10. Fil selon la revendication 5, dans lequel l'élément limiteur d'allongement est constitué par une double hélice noyée dans ledit produit élastique. 10. The yarn of claim 5, wherein the elongation limiting element is constituted by a double helix embedded in said elastic product.
PCT/FR2009/000065 2008-01-21 2009-01-21 Surgical thread for reconstruction in the field of cosmetic surgery and medicine WO2009112683A2 (en)

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FR0800297A FR2926452B1 (en) 2008-01-21 2008-01-21 SURGICAL WIRE FOR RECONSTRUCTION IN THE FIELD OF SURGERY AND AESTHETIC MEDICINE
FR08/00.297 2008-01-21

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ES2488406T3 (en) 2007-09-27 2014-08-27 Ethicon Llc Self-retaining sutures that include tissue retention elements with enhanced strength
US20130226234A1 (en) * 2009-11-16 2013-08-29 Angiotech Pharmaceuticals, Inc. Braided self-retaining sutures and methods
DE202016107015U1 (en) * 2016-12-15 2018-03-28 Johannes Reinmüller implant

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