DE20306636U1 - Surgical suture material comprises a mono- or multifilament thread of synthetic material with a biocompatible metal-containing coating - Google Patents
Surgical suture material comprises a mono- or multifilament thread of synthetic material with a biocompatible metal-containing coatingInfo
- Publication number
- DE20306636U1 DE20306636U1 DE20306636U DE20306636U DE20306636U1 DE 20306636 U1 DE20306636 U1 DE 20306636U1 DE 20306636 U DE20306636 U DE 20306636U DE 20306636 U DE20306636 U DE 20306636U DE 20306636 U1 DE20306636 U1 DE 20306636U1
- Authority
- DE
- Germany
- Prior art keywords
- thread
- surgical suture
- coating
- suture material
- containing coating
- 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
Links
- 238000000576 coating method Methods 0.000 title claims abstract description 18
- 239000011248 coating agent Substances 0.000 title claims abstract description 16
- 239000003356 suture material Substances 0.000 title claims abstract description 11
- 229910052751 metal Inorganic materials 0.000 title claims abstract description 9
- 239000002184 metal Substances 0.000 title claims abstract description 9
- 229920002994 synthetic fiber Polymers 0.000 title abstract 2
- 239000000463 material Substances 0.000 claims description 11
- 239000004033 plastic Substances 0.000 claims description 9
- 229920003023 plastic Polymers 0.000 claims description 9
- 239000010936 titanium Substances 0.000 claims description 8
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 6
- 229910052719 titanium Inorganic materials 0.000 claims description 6
- 150000001875 compounds Chemical class 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 3
- -1 polypropylene Polymers 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 238000009954 braiding Methods 0.000 claims description 2
- 238000005229 chemical vapour deposition Methods 0.000 claims description 2
- 239000004014 plasticizer Substances 0.000 description 6
- 238000005538 encapsulation Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- 208000002847 Surgical Wound Diseases 0.000 description 1
- 229910001069 Ti alloy Inorganic materials 0.000 description 1
- QCWXUUIWCKQGHC-UHFFFAOYSA-N Zirconium Chemical compound [Zr] QCWXUUIWCKQGHC-UHFFFAOYSA-N 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229910052796 boron Inorganic materials 0.000 description 1
- 230000000711 cancerogenic effect Effects 0.000 description 1
- 231100000315 carcinogenic Toxicity 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 229910052735 hafnium Inorganic materials 0.000 description 1
- VBJZVLUMGGDVMO-UHFFFAOYSA-N hafnium atom Chemical compound [Hf] VBJZVLUMGGDVMO-UHFFFAOYSA-N 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 229910052758 niobium Inorganic materials 0.000 description 1
- 239000010955 niobium Substances 0.000 description 1
- GUCVJGMIXFAOAE-UHFFFAOYSA-N niobium atom Chemical compound [Nb] GUCVJGMIXFAOAE-UHFFFAOYSA-N 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 229910052709 silver Inorganic materials 0.000 description 1
- 239000004332 silver Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 229910052715 tantalum Inorganic materials 0.000 description 1
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 1
- 229910052726 zirconium Inorganic materials 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/14—Post-treatment to improve physical properties
- A61L17/145—Coating
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Materials Engineering (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
• ··
Chirurgisches Nahtmaterial in Form eines mono- oder multifilen Fadens aus KunststoffmaterialSurgical suture material in the form of a monofilament or multifilament thread made of plastic material
Die Erfindung betrifft ein chirurgisches Nahtmaterial in Form eines mono- oder multifilen Fadens aus Kunststoffmaterial, insbesondere aus Polypropylen. The invention relates to a surgical suture material in the form of a monofilament or multifilament thread made of plastic material, in particular polypropylene.
Derartige Nahtfäden sind - anders als Fäden aus bioresorbierbarem Material - zum dauerhaften Verbleib im Körper bestimmt, insbesondere, wenn eine Naht im Körperinneren anzulegen und zur dauerhaften Verbindung oder Stabilisierung chirurgischer Schnitte bestimmt ist. Bei diesem Einsatz ergibt sich bei den bekannten Fäden aufgrund des dafür verwendeten Kunststoffmaterials das Problem, dass der Faden vom Körper als Fremdkörper wahrgenommen wird. Als Abstoßungsreaktion scheidet der Körper an der Grenzfläche zum Faden Collagen ab, was zu einer unerwünschten Versteifung des Nahtbereiches führt. Dies kann bei einer Verformungsbeanspruchung des Nahtbereiches zu einem Bruch der Naht fuhren. Neben dieser Verkapselung treten durch den inkorporierten Faden bisweilen auch entzündliche Reaktionen auf.Such suture threads - unlike threads made of bioresorbable material - are intended to remain in the body permanently, especially when a suture is to be placed inside the body and is intended to permanently connect or stabilize surgical incisions. When used in this way, the problem with the known threads is that the thread is perceived by the body as a foreign body due to the plastic material used. As a rejection reaction, the body secretes collagen at the interface with the thread, which leads to an undesirable stiffening of the suture area. This can lead to the suture breaking if the suture area is subjected to deformation stress. In addition to this encapsulation, inflammatory reactions sometimes also occur due to the incorporated thread.
Ein weiteres Problem bei chirurgischem Nahtmaterial aus Kunststoffmaterial besteht darin, dass die regelmäßig im Kunststoffmaterial enthaltenen Weichmacher mit der Zeit aus dem Material diffundieren, was zwei nachteilige Folgen mit sich bringt. Zum einen stehen Weichmacher gemäß jüngeren medizinischen Untersuchungen in dem Verdacht, krebserregend zu sein. Zum anderen tritt beim Faden durch das Herausdiffundieren der Weichmacher eine Versprödung ein, die wiederum bei Deformationsbeanspruchung des Nahtbereiches zu einem Bruch des Fadens führen kann.Another problem with surgical sutures made of plastic is that the plasticizers that are regularly contained in the plastic diffuse out of the material over time, which has two negative consequences. Firstly, according to recent medical studies, plasticizers are suspected of being carcinogenic. Secondly, the thread becomes brittle as the plasticizer diffuses out, which in turn can lead to the thread breaking if the suture area is subjected to deformation.
&igr; · &Ogr;&Igr;&Egr; ChtrurgiidKi Nahtmaterial&igr; · &Ogr;&Igr;&Egr; ChtrurgiidKi suture material
Ausgehend von diesen Problemen des Standes der Technik liegt der Erfindung die Aufgabe zugrunde, chirurgisches Nahtmaterial der eingangs genannten Art so zu verbessern, dass einerseits ein dauerhafter Verbleib des Fadens ohne Verkapselung und Freisetzung von Weichmachern ermöglicht wird und andererseits das Handling des Fadens beim Legen der Naht verbessert wird.Based on these problems of the prior art, the invention is based on the object of improving surgical suture material of the type mentioned at the outset in such a way that, on the one hand, the thread can remain permanently in place without encapsulation and release of plasticizers and, on the other hand, the handling of the thread when laying the suture is improved.
Diese Aufgabe wird durch die im Kennzeichnungsteil des Anspruches 1 angegebene metallhaltige, körperverträgliche, durchgehende Beschichtung auf der Außenseite des Fadens gelöst.This object is achieved by the metal-containing, body-compatible, continuous coating on the outside of the thread as specified in the characterizing part of claim 1.
Diese Beschichtung, die vorzugsweise auf der Basis Titan-haltiger Verbindungen mit einer Dicke von < 2 &mgr;&eegr;&igr;, vorzugsweise von 5 bis 700 nm hergestellt ist, erfüllt im Sinne der erfindungsgemäßen Aufgabe eine Vielzahl von Funktionen. So erfolgt durch ihre Durchgängigkeit kein direkter Kontakt des Basis-Kunststoffmaterials - also der Seele - des Fadens mit Körpergewebe mehr, so dass der Faden vom Körper durchgängig als aus einem vorzugsweise Titan-haltigen Material bestehend wahrgenommen wird. Dadurch wird die eingangs geschilderte Abstoßungsreaktion in Form einer Verkapselung des Fadens nicht in Gang gesetzt. Ferner stellt nachweisbar die metallhaltige Beschichtung eine Diffussionssperre für die Weichmachermoleküle im Kunststoffmaterial des Fadens dar, so dass ein Herausdiffundieren der Weichmacher unterbunden wird. Damit wird die ebenfalls geschilderte Versprödung des Fadens minimiert. Schließlich beeinflusst die Beschichtung positiv das Durchzugsverhalten und die Knotenbildung des Fadens, was dessen Handling erleichtert.This coating, which is preferably made on the basis of titanium-containing compounds with a thickness of < 2 μηλ, preferably from 5 to 700 nm, fulfils a number of functions in the sense of the inventive task. For example, due to its permeability, there is no longer any direct contact between the base plastic material - i.e. the core - of the thread and body tissue, so that the thread is consistently perceived by the body as consisting of a material that preferably contains titanium. This means that the rejection reaction described at the beginning in the form of encapsulation of the thread is not set in motion. Furthermore, the metal-containing coating verifiably represents a diffusion barrier for the plasticizer molecules in the plastic material of the thread, so that the plasticizer is prevented from diffusing out. This minimizes the embrittlement of the thread, which has also been described. Finally, the coating has a positive effect on the thread's pulling behavior and knot formation, which makes it easier to handle.
Die metallhaltige Beschichtung besteht bevorzugt aus einer Verbindung der Formel TiaObCc, wobei giltThe metal-containing coating preferably consists of a compound of the formula Ti a O b C c , where
-3--3-
a = 0,025 bis 0,9,
b = 0,025 bis 0,7 und
c = 0,2 bis 0,9.a = 0.025 to 0.9,
b = 0.025 to 0.7 and
c = 0.2 to 0.9.
Ggf. können im Austausch zu den Titan-Anteilen auch Tantal, Niob, Silber, Zirkon und Hafnium eingesetzt werden. Als weitere Elemente in der Verbindung können ferner Stickstoff und Bor beinhaltet sein.Tantalum, niobium, silver, zirconium and hafnium can also be used in place of the titanium components. Nitrogen and boron can also be included as additional elements in the compound.
Gemäß einer weiteren bevorzugten Ausführungsform ist bei Auslegung des chirurgischen Nahtmaterials als multifiler Faden jedes einzelne Filament durchgehend mit einer metallhaltigen, körperverträglichen Beschichtung versehen. Dies kann durch Flechten der Filamente und anschließendes Aufbringen der metallhaltigen Beschichtung durch chemische Gasphasenabscheidung erfolgen.
15According to a further preferred embodiment, when the surgical suture material is designed as a multifilament thread, each individual filament is provided with a metal-containing, biocompatible coating throughout. This can be done by braiding the filaments and then applying the metal-containing coating by chemical vapor deposition.
15
Ein Ausführungsbeispiel der Erfindung wird anhand der beigefügten Zeichnung näher erläutert. Die einzige Figur zeigt einen vergrößerten, schematischen Längsaxialschnitt durch einen monofilen Nahtfaden.An embodiment of the invention is explained in more detail with reference to the accompanying drawing. The single figure shows an enlarged, schematic longitudinal axial section through a monofilament suture thread.
Der in der Figur gezeigte monofile Faden weist eine Seele 1 aus Polypropylen auf. Deren Durchmesser D beträgt beispielsweise 0,5 mm. Die Außenfläche 2 der Seele 1 weist eine in Längs- und Umfangsrichtung durchgehende, körperverträgliche Beschichtung 3 aus einem Titan-haltigen Material der Formel TiaObCc auf.The monofilament thread shown in the figure has a core 1 made of polypropylene. Its diameter D is, for example, 0.5 mm. The outer surface 2 of the core 1 has a body-compatible coating 3 made of a titanium-containing material of the formula Ti a ObC c that runs along the longitudinal and circumferential directions.
Die Anteilsbereiche a, b und c entsprechen denen in der Beschreibungseinleitung. Eine derartige Beschichtung hat sich als absolut körperverträglich herausgestellt. Durch ihre Durchgängigkeit wird die gesamte Seele des Fa-The proportions a, b and c correspond to those in the description introduction. Such a coating has proven to be absolutely compatible with the body. Due to its permeability, the entire core of the fabric is
-4--4-
dens 1 mit ihrem Kunststoffmaterial nicht mehr als solches vom Körper wahrgenommen. Die Körperverträglichkeit ist somit mit komplett aus einer Titanlegierung gefertigten Implantaten vergleichbar, die in der Medizintechnik breite Akzeptanz finden.
5dens 1 with its plastic material is no longer perceived as such by the body. The body compatibility is therefore comparable to implants made entirely of a titanium alloy, which are widely accepted in medical technology.
5
Bevorzugte Dicken d der Beschichtungen 9, 10 liegen im Bereich von 5 bis 700 nm, wobei Schichtdicken von etwa 50 nm sich als einerseits besonders haft- und reibfest, andererseits aber auch genügend flexibel und duktil herausgestellt haben, um alle Dehnungen und Verformungen des Fadens schadlos mit zu vollführen.Preferred thicknesses d of the coatings 9, 10 are in the range from 5 to 700 nm, with layer thicknesses of about 50 nm having proven to be particularly adhesive and abrasion-resistant on the one hand, but also sufficiently flexible and ductile on the other hand to accommodate all stretching and deformations of the thread without damage.
Derartige Titan-haltige Beschichtungen und die Technik zum Aufbringen auf flexible Kunststoffsubstrate sind im Übrigen aus dem Stand der Technik grundsätzlich bekannt.
15Such titanium-containing coatings and the technology for applying them to flexible plastic substrates are, moreover, basically known from the state of the art.
15
Uo &ogr;,::=:=Uo γ,::=:=
Claims (4)
TiaObCc
aufweist, wobei gilt a = 0,025 bis 0,9
b = 0,025 bis 0,7 und
c = 0,2 bis 0,9. 3. Surgical suture material according to claim 2, characterized in that the coating ( 9 ) is a compound of the formula
T i a O b C c
where a = 0.025 to 0.9
b = 0.025 to 0.7 and
c = 0.2 to 0.9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE20306636U DE20306636U1 (en) | 2003-04-28 | 2003-04-28 | Surgical suture material comprises a mono- or multifilament thread of synthetic material with a biocompatible metal-containing coating |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE20306636U DE20306636U1 (en) | 2003-04-28 | 2003-04-28 | Surgical suture material comprises a mono- or multifilament thread of synthetic material with a biocompatible metal-containing coating |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE20306636U1 true DE20306636U1 (en) | 2003-06-26 |
Family
ID=7981667
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE20306636U Expired - Lifetime DE20306636U1 (en) | 2003-04-28 | 2003-04-28 | Surgical suture material comprises a mono- or multifilament thread of synthetic material with a biocompatible metal-containing coating |
Country Status (1)
| Country | Link |
|---|---|
| DE (1) | DE20306636U1 (en) |
-
2003
- 2003-04-28 DE DE20306636U patent/DE20306636U1/en not_active Expired - Lifetime
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| R207 | Utility model specification |
Effective date: 20030731 |
|
| R150 | Utility model maintained after payment of first maintenance fee after three years |
Effective date: 20060522 |
|
| R151 | Utility model maintained after payment of second maintenance fee after six years |
Effective date: 20090706 |
|
| R081 | Change of applicant/patentee |
Owner name: PFM MEDICAL TITANIUM GMBH, DE Free format text: FORMER OWNER: GFE MEDIZINTECHNIK GMBH, 90431 NUERNBERG, DE Effective date: 20100813 |
|
| R152 | Utility model maintained after payment of third maintenance fee after eight years | ||
| R152 | Utility model maintained after payment of third maintenance fee after eight years |
Effective date: 20110711 |
|
| R071 | Expiry of right | ||
| R071 | Expiry of right |