DE202010012426U1 - Titanium wire-sternal closure - Google Patents

Abstract

Titanium wire sternum closure for use in cardiac surgery, which consists of a USP 9 titanium wire and is equipped with a sharp, terminal insertion needle. characterized in that the wire is packaged in a pre-bent version on a holding device with individual needle pockets and the needle opposite end of the wire carries a special bend, which prevents slipping of the required for the implantation clamp.

Description

1. Initial situation

In Heart surgery will provide access to the heart medially via the Sternum of the patient selected. The sternum becomes longitudinal sawed. To After surgery, the sternum must be closed. this happens with different techniques that serve to ensure mechanical stability, until the healing process is complete. The most common form of Sternum closure will over Sternotomy carried out. There are 45 cm long stainless steel wires in the usual Strength USP 5/6 and 7.

through a large-caliber sharp needle, which is unilaterally connected to the wire, will be 4-8 cerclages (Holding / wire loops) laid, whose open ends twisted manually become. With the help of the needle, the wire is usually through the Sternum bone tissue retracted. This procedure may be due to Bone injury can lead to extra bleeding and wound healing disorders. at Patients with osteoperotic bone structure may also experience tears come in the tissue. this leads to for loosening the cerclages and often has to be surgically supplied (resternotomy).

Re-intervention in wound healing disorders of unknown cause through chromium / nickel allergies caused, as often prove a bacterial findings leaves.

The currently in use Titanium wires, To avoid the allergies are only up to a maximum strength of USP 7 available and because of their higher Susceptibility to breakage Chrome / nickel steels with certain risks for the patient (sternum stability with renewed need for surgical intervention).

These new interventions, with a reopening of the thorax (rewiring) are accompanied by a high risk of infection. Furthermore not inconsiderable hospital costs due to long lay time at. The physical and psychological burden on the patient is significant.

For problem patients (Osteoporosis or patients with infections with tissue loss) exist already other elaborate procedures to remedy. There are For example, titanium plate systems screwed to the sternum become. An application is very rare, being extremely expensive and complicated in the application. Other systems consist of braces that extrasternally about ratchets held together. These too are costly and voluminous and at slender patients barely conceal their tissues cosmetically well.

2. Utility model description

• 1. Das System Titan-Draht-Sternum-Verschluss durch Drahtverdrillung besteht aus einem Titandraht in der noch nicht im Markt befindlichen Drahtstärke USP 9 (Metric 11/1,100–1,199 mm Durchmesser), der an einer Seite mit einer scharfen Nadel (Standard.Sternotomienadel, Bogenlänge bis max. 40 mm) verbunden ist. Die Länge des Drahtes beträgt 45 cm. Zeichnungen/Bezugszeichenliste 0.
• 2. Der Titan-Draht wird mit der Sternotomienadel intra- oder extra-sternal angewandt. Bei intrasternaler Anwendung wird die Sternotomienadel mittels eines stabilen Nadelhalters durch das Sternum gestochen und der Titandraht durchgezogen. Dies geschieht auf beiden Seiten des durchtrennten Sternums. Die nach oben stehenden Drahtenden werden nach Abschneiden der Sternotomienadel miteinander verdrillt. Dabei ist darauf zu achten, dass die Verdrillung ein symmetrisches Bild ergibt, um die Überdrehung eines nicht erwünscht innenliegenden Drahtes zu vermeiden (Bruchgefahr). Der neue USP 9 Titan-Draht hat den Vorteil, das er sowohl bei der Handhabung (Verdrillung) als auch später als implantierte Cerclage deutlich stabiler als herkömmliche Titandrähte ist, was sich durch das höhere Kaliber definiert. Die Drahtstärke USP 9 verringert auch das Einschneiden im Sternumgewebe. Bei der extrasternalen/parasternalen Applikation wird der Titan-Draht im ICR (Intercostalraum) eingezogen und anschließend wie oben weiter verfahren. Zeichnung/Bezugzeichenliste 6.
• 3. Der Titan-Draht wird steril in einer speziell entwickelten Verpackung geliefert. Normaldrähte, wie im Markt befindlich, werden in langen Schachteln von einer Länge von mindesten 50 cm verpackt und ausgeliefert. Die langgestreckten Drähte (Länge ohne Nadel 45 cm) werden von der OP-Schwester vorgebogen und die Nadel in dem speziellen Nadelhalter eingespannt. Das andere Ende wird durch Umwickeln am Maulteil an einer gekrümmten Klemme fixiert. Die neuentwickelte Verpackung und Vorbereitung des Titan-Draht-Sternum-Verschlusses besteht aus einer Haltevorrichtung aus Karton mit angesetzten Taschen, die die scharfen Nadeln aufnehmen. Der Draht ist vorgebogen und benötigt damit nur eine Abmessung der Verpackung von maximal 25 mal 20 cm (Länge × Breite). Dies schafft zusätzlich Vorteile bei der Lagerhaltung speziell im räumlich knapp bemessenen OP-Lager. Der vorgebogene Gesamtdraht erspart einen Arbeitsgang, das Biegen des Standard-Langdrahtes am OP-Tisch. Die Verpackungstaschen für die scharfen Nadeln vermindern das Verletzungsrisiko bei der Entnahme. Das vorpräparierte, andere Ende des Drahtes macht ein Umwickeln an einer Klemme überflüssig. Auch damit wird Zeit gespart und auch hier das Verletzungsrisiko durch das freie Drahtende vermindert. Jeder einzelne Draht hat für die Nadel eine eigene Tasche, um ein gegenseitiges Verhaken zu vermeiden. Es können bis zu acht Drähte auf einer Haltevorrichtung verwendet werden, die wiederum in einer sterilen Aufreißverpackung untergebracht ist. Bei sechs bis acht Drähten lassen sich aus praktischen Gründen jeweils drei oder vier Drähte auf jeder Seite der Haltevorrichtung unterbringen, um damit eine übersichtliche Entnahme zu erreichen. Zeichnung/Bezugzeichenliste 3.

The object registered here for utility model is defined as follows:

• 1. The titanium-wire-sternum-closure system by wire twisting consists of a titanium wire in the not yet marketed wire gauge USP 9 (Metric 11 / 1,100-1,199 mm diameter), which on one side with a sharp needle (Standard.Sternotomienadel , Arc length up to 40 mm) is connected. The length of the wire is 45 cm. Drawings / LIST OF REFERENCE NUMERALS 0 ,
• 2. The titanium wire is applied with the sternotomy needle intra- or extra-sternal. In intrasternal application, the sternotomy needle is stung through the sternum using a sturdy needle holder and the titanium wire is pulled through. This happens on both sides of the severed sternum. The upstanding wire ends are twisted together after cutting off the sternotomy needle. It is important to ensure that the twisting results in a symmetrical image in order to avoid the over-rotation of an undesired inner wire (risk of breakage). The advantage of the new USP 9 titanium wire is that it is much more stable in handling (twisting) and later than implanted cerclage than conventional titanium wires, which is defined by the higher caliber. The wire gauge USP 9 also reduces the incision in the sternum tissue. In the case of extrasternal / parasternal application, the titanium wire is drawn into the ICR (intercostal space) and then proceeded as above. Drawing / LIST OF REFERENCE NUMERALS 6 ,
• 3. The titanium wire is delivered sterile in a specially designed package. Standard wires, as in the market, are packed and delivered in long boxes of at least 50 cm in length. The elongated wires (length without needle 45 cm) are pre-bent by the surgical nurse and the needle is clamped in the special needle holder. The other end is fixed by wrapping on the jaw part on a curved clamp. The newly developed packaging and preparation of the titanium-wire-sternum closure consists of a holding device made of cardboard with attached pockets which receive the sharp needles. The wire is pre-bent and thus requires only one dimension of the packaging of a maximum of 25 by 20 cm (length × width). This creates additional advantages in warehousing, especially in the tightly dimensioned surgical bearing. The pre-bent total wire saves one operation, bending the standard long wire on the operating table. Packing bags for sharp needles ver reduce the risk of injury during removal. The pre-prepared, other end of the wire eliminates the need to wrap on a clamp. This also saves time and also reduces the risk of injury from the free end of the wire. Each individual wire has its own pocket for the needle, to avoid mutual entanglement. Up to eight wires can be used on one fixture, which in turn is housed in a sterile tear-open package. For six to eight wires, for practical reasons, three or four wires can be placed on each side of the fixture to provide easy access. Drawing / LIST OF REFERENCE NUMERALS 3 ,

3. advantages and special indications

The Sternum will, as for Sternum wires usual, by means of penetrated a sternum needle or in the extrasternal intercostal space serged. The titanium wire can as a single loop (cerclage) or cross be applied. The wire thickness USP 9 reduces trauma due to bone tear in the sternum tissue. In order to Sternum loosening (Dehizenzen) is avoided surgically need to be re-supplied and a significant physical and psychological burden on the patient to lead.

Especially Patients with bronchial problems (mechanical loading of the closure through Cough), with osteoporosis (high risk of laceration in the weakened tissue), with obesity (high mechanical load of the wire), which is allergic need a titanium wire, benefit from the USP 9 wire gauge of titanium wire.

The Twisting is done as usual and is for the cardiac surgeon a common Method.

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Titanium wire-sternal closure

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surgical, cutting sternotomy needle

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pre-bent wire end

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holder

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holding pocket

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flap

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sternum with application examples

Claims (4)

Titanium wire sternum closure for use in cardiac surgery, which consists of a USP 9 titanium wire and is equipped with a sharp, terminal insertion needle. characterized in that the wire is packaged in a pre-bent version on a holding device with individual needle pockets and the needle opposite end of the wire carries a special bend, which prevents the slipping of the clamp required for the implantation. Wire according to claim 1, characterized in that the pre-bent titanium wire ( 0 ) made of implantable titanium with the grade Medical Grade 1 in the length of about 45 cm and a thickness of USP 9 (Metric 11 / 1,100-1,199 mm diameter). The wire end ( 2 ) has a curvature with a final eyelet. Sternotomy needle according to claim 1, characterized in that the sternotomy needle ( 1 ) consists of surgical stainless steel. The sternotomy needle ( 1 ) has a 3/8 curvature of at least 135 degrees and an arc length of at least 35 mm. The needle point has a ground, cutting shape, which punctures the tissue when used selectively. Holding device according to claim 1, characterized in that the holding device ( 3 ) made of cardboard with holding pocket ( 4 ) for the sternotomy needle ( 1 ) and the pre-bent wire end ( 2 ) and at the top of a tab ( 5 ) for fixing the arch wire. The cardboard holding device contains up to 8 separate holding pockets.