CN1201702C - Zirconia-based materials, surgical cutting tools made of zirconia-based materials, tools made of zirconia-based materials - Google Patents

Abstract

A zirconia-based material stabilized with yttria comprises as a stabilizing component an additional metal oxide selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide, scandium oxide and oxides of rare earth elements ranging from europium to lutetium. The proportions of the components are as follows (mol%): yttrium oxide: 0.5-4.5; a stabilizing component: 0.1-4.5; zirconium oxide: and (4) the balance. The surgical cutting tool of the present invention includes a knife having a handle and a blade carrier rigidly securing the handle. The knife is made of a crystal of a zirconium dioxide based material. The crystal has a nanocrystal structure with a domain size of 200 nm but does not have a phase interface. The material is stabilized with yttrium oxide and comprises a further stabilizing component such as a metal oxide selected from calcium oxide, magnesium oxide, strontium oxide, scandium oxide and oxides of rare earth elements from europium to lutetium. The proportions of the components are as follows (mol%): yttrium oxide: 0.5-4.5; a stabilizing component: 0.1-4.5; zirconium oxide: and (4) the balance. The material can also be used for tools used in manufacturing processes such as rolls, dies, flat bearings.

Description

Zirconium dioxide-based materials, surgical cutting tools of zirconium dioxide-based materials, tools of zirconium dioxide-based materials

field of invention

The present invention relates to medical devices, and more particularly to zirconia-based materials, surgical cutting tools made from zirconia-based materials, and tools made from zirconia-based materials.

own technology

A zirconia-based material stabilized with yttria is known (see, for example, Green, DJ, Hannink, RHJ and Swain, MV, Transformation Toughening of Ceramics, CRC Press, Inc. , Boca Ration, Florida, 1989.J), which is a polycrystalline material containing oxides of magnesium, calcium and yttrium as stabilizing additives. The material is characterized by a flexural strength of 430-980 MPa and a failure viscosity (stress intensity coefficient) of 5.8-9.0 MPa·m ^1/2 .

A disadvantage of this material is the presence of grain boundaries in the material, which do not produce high quality, wear-resistant cutting tools with a similar grain size, ie cutting edge sharpness ≤ 1 μm.

A zirconia-based single crystal material stabilized with yttrium oxide is known (see, for example, Savage, JA, "Preparation and Properties of Hard Crystalline Materiais for Optical Applications" Application) - Review, J. Cryst. Growth, 1991, Vol. 113, p. 708), which contains 88 mol % of ZrO ₂ and 12 mol % of Y ₂ O ₃ . The material is characterized by a microhardness of 1100-1400 kg/mm ² and a bending strength of 200-330 MPa.

The disadvantage of this material is its low strength and insufficient wear resistance due to its high brittleness.

Zirconia-based materials stabilized with yttria are known which comprise at least one mixed oxide (see for example British Patent No. 1373888, IPC 04 B35/50, 35/48) which The compound contains 10-20 mole % Y ₂ O ₃ and 0.01-5 weight % colored mixed oxide. The material is characterized by a microhardness of 1200-1300 kg/mm ² .

A disadvantage of this material is that it has insufficient wear resistance due to its high brittleness.

A zirconia-based material stabilized with yttria is known (see, for example, Marscher, GN, Pirouz, P. and Heuer, AN, "Hardness and temperature dependence of yttria-stabilized zirconia single crystals" ( Temperature Dependence of Hardness in Yttria-Stabilized Zirconia Single Crystals), J. Am. Ceram. Soc., 1991, Vol. 74, Page 491), which contains 90.5 mol% _ZrO2 and 9.5 mol% _{Y2O3 .} The material is characterized by a microhardness of 1400-1500 kg/mm ² and a bending and compressive strength of 200-330 MPa.

Disadvantages of this material are the small size of the crystals, low strength and insufficient wear resistance due to their high brittleness.

The closest prior art material to the material of the invention is a zirconia-based material partially stabilized with yttria (see for example GA Gogotsi, EE Lomonova, VG Peichev, "Strength and Fracture Toughness of Zirconia Crystals") of Zirconia Crystals), J. Eur. Ceram. Soc., Vol. 11, pp. 123-132, 1993), which contains 97 mol % ZrO ₂ and 3 mol % Y ₂ O ₃ . The material is characterized by a flexural and compressive strength of 500-800 MPa and a failure viscosity (stress intensity coefficient) of 5-16 MPa ^1/2 .

Disadvantages of this material are insufficient wear resistance due to their low flexural strength and a wide range of damage viscosity values due to the inhomogeneous microstructure and phase composition of the material.

For cutting biological tissue during surgery, a disposable steel knife is usually used, which is provided in a sterile package and is fixed on the handle of the holder just before use.

The term "disposable" has both a formal and a practical meaning for the knives in question, since they dull very quickly and several disposable knives must be used in one operation to perform complex cuts.

The disadvantages of this knife are obvious. First, the stainless steel used for metal knives and scalpels is incompatible with, and is repelled by, the tissue of living organisms. This can form microthrombi, which can cause blockage of tiny blood vessels.

Second, the passivation of steel knives is a physical/chemical process that results in the introduction into the body of fine (or larger) particles of metal and products of chemical reactions between the metal and the corrosive environment in the lymph and blood, causing Various post-processing complexities.

Third, as the knife dulls very quickly and requires a new one, the surgeon's sense of touch will change, resulting in uncontrolled cuts in tissue.

Fourth, the physical structure of stainless steel prevents it from achieving the sub-1-micron cutting edge sharpness required for high-quality cuts. Also, machining techniques give the cutting edge a "serrated" shape. All of these lead to significant deformation and trauma when the tissue is cut. Tissue can be crushed and damaged.

Known a kind of surgical cutting tool (for example referring to Russian patent 2053718), it comprises a knife handle and the blade that is connected with described knife handle, and described blade is to be made by ceramics based on aluminum oxide, and this surgical blade is passed through tight The solid material is firmly connected to the handle, and it is made of polycrystalline ceramics based on α-alumina with an average grain size of 0.1-3.0 μm.

A disadvantage of this tool is that the scalpel edge is sharpened at only one angle, which results in greater friction during the cutting process, greater cutting force, and greater friction in the cut tissue. deformation and trauma. Moreover, it is practically impossible to obtain a wear-resistant cutting edge whose characteristic size is smaller than the maximum grain size of the polycrystalline ceramic from which the scalpel blade is made, ie, 3 μm.

A surgical cutting tool (scalpel) is known which comprises a knife with a handle and a holder for rigidly fixing the knife (see eg Russian patent 2005426). Longitudinal end slots and slits are formed in the bracket. The longitudinal end slots and their corresponding knives are made of trapezoidal cross-section, the knives being made of ceramic.

A disadvantage of this cutting tool is that the removable knife is "compressed" mounted so that significant shearing force is required to be applied to the portion of the knife that is immediately parallel to the cutting edge during installation or removal . This operation, if performed manually, often causes injury to the hands of the operator. Furthermore, the sharp edges and angles of the trapezoidal device can cause damage to the sterile surgical glove into which the operator inserts the scalpel after it has been sterilized. This cutting tool also has disadvantages, since the knife is made of ceramics with a grain structure. For this reason, it is practically impossible to manufacture wear-resistant cutting tools with the required cutting edge sharpness of less than 1 μm and with high-quality operating surfaces.

Overview of the invention

The present invention aims to provide a zirconium dioxide-based material in the form of large-sized crystals having a nanocrystalline structure with a domain size (domain size) of less than 200 nanometers and without phase boundaries, but which has a high Hardness, high flexural strength and large stress intensity coefficient/damage viscosity values as well as high chemical inertness, low thermal conductivity, biocompatibility with living organism tissue and X-ray diffraction spectrum line contrast, while at room temperature It does not interact with electromagnetic fields.

The present invention also aims to provide a surgical cutting tool made of a zirconium dioxide-based material in the form of large-sized crystals having a nanocrystalline structure with domain sizes less than 200 nanometers and having no phase boundaries, but It has high stiffness, high flexural strength and large stress intensity coefficient/damage viscosity values as well as high chemical inertness, low thermal conductivity, biocompatibility with living organism tissue and X-ray diffraction spectrum line contrast , while it does not interact with electromagnetic fields at room temperature, the cutting tool has an ultra-sharp cutting edge sharpened at dual angles, its surface is optically clean, and the tool has high wear resistance .

In addition, the present invention aims to provide a surgical cutting tool made of a zirconium dioxide-based material in the form of large-sized crystals having a nanocrystalline structure with a domain size of less than 200 nanometers and having no phase boundaries, But it has high hardness, high flexural strength and large stress intensity coefficient/damage viscosity values as well as high chemical inertness and low thermal conductivity.

The above objects are achieved by the present invention of a zirconia-based material stabilized with yttria, said material also comprising, as a stabilizing component, a metal oxide selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide , scandium oxide and the oxides of rare earth elements from europium to lutetium, the ratio of each component is as follows (mol%):

Yttrium oxide 0.5-4.5

Stable components 0.1-4.5

Zirconia Balance.

The material should preferably contain a modifying component which may comprise rare earth oxides selected from cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide, titanium oxide, vanadium oxide, manganese oxide, The transition element oxides of iron oxide, nickel oxide and copper oxide, the added amount of the modification component is 0.05-3.0 mole % of the total amount of materials.

The aforementioned objects are also achieved by a surgical cutting tool according to the invention, said cutting tool comprising a knife with a handle and a holder for a rigidly fixed knife, said knife being made of zirconium dioxide-based material, said single crystal has a nanocrystalline structure with a domain size of less than 200 nanometers and has no phase boundaries, said material is stabilized with yttrium oxide, and is also stabilized with a component comprising a metal oxide, said metal The oxide is selected from the oxides of calcium oxide, magnesium oxide, strontium oxide, scandium oxide and rare earth elements from europium to lutetium, and the ratio of each component is as follows (mol %):

Yttrium oxide 0.5-4.5

Stable components 0.1-4.5

Zirconia Balance.

The material of the knife used to manufacture said surgical tool should preferably contain modified components which may comprise rare earth oxides selected from cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide, titanium oxide , transition element oxides of vanadium oxide, manganese oxide, iron oxide, nickel oxide, and copper oxide, and the amount of the modification component added is 0.05-3.0 mole percent of the total amount of materials.

The width of the knife should preferably be in the range of 1 to 15 mm, the thickness of the knife should preferably be in the range of 0.15 to 1 mm, the length of the cutting edge of the knife should preferably be in the range of 1 to 60 mm, and the cutting edge of the knife should be sharpened The radius R of R is preferably in the range of 0.05 μm<R<2 μm.

The knife should preferably be sharpened at two angles, the secondary sharpening angle of the cutting edge is 15-25°, the main sharpening angle is 30-60°, and the operating surface width of the cutting edge with the main sharpening angle should be 30 -500 μm.

It is also preferred that the configuration of the cutting edge of the knife should be selected from straight, round, combined and double-edged configurations.

It is also preferred that the knife should be of various colors selected from the group consisting of cream, pink, lavender, yellow, red, orange, light blue, chartreuse, violet, ivory, wet pitch and black , depending on the type and concentration of the modified component.

In addition, the aforementioned objects are achieved by a tool according to the invention, comprising an operating element fixed in the tool body, said operating element being made of a material based on zirconium dioxide in the form of a single crystal, said single crystal Having a nanocrystalline structure with a domain size of less than 200 nm and no phase boundaries, said material is stabilized with yttrium oxide and is also stabilized with a component comprising a metal oxide selected from the group consisting of calcium oxide, oxide Magnesium, strontium oxide, scandium oxide and rare earth oxides from europium to lutetium, the ratio of each component is as follows (mol%):

Yttrium oxide 0.5-4.5

Stable components 0.1-4.5

Zirconia Balance.

The material should preferably also contain a modifying component which may comprise a rare earth oxide selected from cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and a rare earth oxide selected from cobalt oxide, titanium oxide, vanadium oxide, manganese oxide, oxide The transition element oxides of iron, nickel oxide, and copper oxide, the added amount of the modification component is 0.05-3.0 mole percent of the total amount of materials.

Due to the specific composition of stabilizing and modifying components, the material has high hardness and high strength, which enables the sharpest possible sharpening of the cutting edge.

The surgical cutting tool of the invention is simple and convenient to use, and the operation is effective and reliable. It is clean for human tissue because the material of the knife is biocompatible with living organism tissue.

The surgical cutting tool is a versatile type of tool because, depending on the shape and width of the blade, it can be used in a variety of surgical procedures, including microsurgery and ophthalmic surgery.

The surgical cutting tool actually cuts the tissue during the cutting process, so the two cut parts are "moved apart" with as little deformation and damage to the tissue as possible. This is attributable firstly to the ultra-sharp cutting edge utilized and secondly to the fact that the knife is sharpened at two angles, thereby minimizing interaction between the knife and the cut tissue and deformation of the tissue.

Since the elements and structure of the surgical cutting tool are generally chemically inert and heat resistant, it can withstand any disinfection and sterilization treatments, including dry heat treatment, which makes it applicable in any clinical conditions.

The surgical cutting tool of the present invention is cost-effective because the material of the blade is highly wear-resistant and can be used many times (hundreds or more) while maintaining the same cutting characteristics.

Brief description of the drawings

Below, the present invention will be described in detail in conjunction with some accompanying drawings for illustrating its preferred embodiment,

in:

Figure 1 shows a surgical cutting tool of the present invention;

Fig. 2 shows the cross-section along II-II line in Fig. 1 of the present invention;

Figures 3a to 3g show the profiles of various knives of the present invention;

Figures 4a to 4c show various examples of operative bodies of the present invention.

Description of the preferred implementation

A zirconia-based material stabilized with yttrium oxide is characterized in that it also comprises, as a stabilizing component, a metal oxide selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide, scandium oxide and from europium to lutetium The oxides of rare earth elements, the ratio of each component is as follows (mol%):

Yttrium oxide 0.5-4.5

Stable components 0.1-4.5

Zirconia Balance.

The material also contains a modifying component which may comprise rare earth oxides selected from the group consisting of cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide, titanium oxide, vanadium oxide, manganese oxide, iron oxide, oxide The transition element oxides of nickel and copper oxide, the added amount of the modification component is 0.05-3.0 mole % of the total amount of materials.

The surgical cutting tool comprises a knife 1 (Fig. 1) having a handle 2 and a holder 3 for rigidly holding the knife. Knife 1 is made of a zirconia-based material in the form of a single crystal having a nanocrystalline structure with a domain size of less than 200 nm and no phase boundaries, which material is stabilized with yttrium oxide and also A component comprising metal oxides selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide, scandium oxide and oxides of rare earth elements from europium to lutetium in the following ratios ( mole%):

Yttrium oxide 0.5-4.5

Stable components 0.1-4.5

Zirconia Balance.

The material from which surgical tools are made also contains modified components which may contain rare earth oxides selected from the group consisting of cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide, titanium oxide, vanadium oxide, manganese oxide, oxide The transition element oxides of iron, nickel oxide, and copper oxide, the added amount of the modification component is 0.05-3.0 mole percent of the total amount of materials.

The knife holder 3 includes a knife fixing part 4 , a frame body 5 and a handle 6 .

There are two possible ways to connect the knife 1 to the knife holder 3, namely: a detachable way and a non-detachable way. In a detachable manner, a collet is used as the knife fixing part 4, and in a non-detachable way, the knife 1 is glued in the knife fixing part 4 using a pharmaceutically acceptable adhesive.

The width A of the knife 1 is in the range of 1 to 15 mm, the thickness B of the knife (Fig. 2) is 0.15 to 1 mm, the length L of the cutting edge of the knife is in the range of 1 to 60 mm, and the cutting edge of the knife is sharpened The radius R is in the range of 0.05 μm<R<2 μm.

The knife 1 is sharpened at two angles, the secondary sharpening angle α is 15-25°, the primary sharpening angle β is 30-60°, and the operating surface width C of the cutting edge with the primary sharpening angle is 30-500 μm.

The profile of the cutting edge of the knife 1 ( FIGS. 3 a to 3 g ) is selected from straight, round, combined and double-edged profiles.

Knife 1 is in various colors, depending on the type and concentration of the modified components used, the colors are selected from milky white, pink, lavender, yellow, red, orange, light blue, yellow-green, violet, ivory color, wet asphalt and black.

Other tools according to the invention comprise an operating member 7 fixed to a tool body 8 ( FIGS. 4 a , 4 b , 4 c ). The operating part 7 is made of a zirconia-based material in the form of a single crystal having a nanocrystalline structure with a domain size of less than 200 nanometers and having no phase interface, which material is stabilized with yttrium oxide, and also Stabilized with a component comprising a metal oxide selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide, scandium oxide and oxides of rare earths from europium to lutetium in the following ratios ( mole%):

Yttrium oxide 0.5-4.5

Stable component 0.1-4.5

Zirconia Balance.

The material from which the operating part is made also contains a modified component which may contain rare earth oxides selected from the group consisting of cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide, titanium oxide, vanadium oxide, manganese oxide , transition element oxides of iron oxide, nickel oxide, and copper oxide, and the addition amount of the modification component is 0.05-3.0 mole percent of the total amount of materials.

Figure 4a illustrates an embodiment in which the manipulating components include a die for producing calibrated fine fibers, including those made from chemically aggressive materials.

Figure 4b illustrates such an embodiment, wherein the operating member is a roll for rolling very thin calibrated metal foil.

Figure 4c illustrates such an embodiment, wherein the operating part is a face bearing designed for use in a corrosive environment at various temperatures and high rotational speeds, including operation without lubrication.

Claims (9)

1. A zirconium dioxide-based material stabilized with yttrium oxide, characterized in that said material has a nanocrystalline structure with a domain size of less than 200 nanometers, It also contains, as a stabilizing component, metal oxides selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide, scandium oxide, and oxides of rare earth elements from europium to lutetium, said components in ratios expressed in moles % is expressed as follows: Yttrium oxide 0.5-4.5 Stable components 0.1-4.5 Zirconia Balance, The material also comprises a modifying component comprising a rare earth oxide selected from the group consisting of cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and a compound selected from the group consisting of cobalt oxide, titanium oxide, vanadium oxide, manganese oxide, iron oxide, oxide The transition element oxides of nickel and copper oxide, the added amount of the modification component is 0.05-3.0 mole % of the total amount of materials. 2. A surgical cutting tool comprising a knife with a handle and a holder for rigidly fixing said knife, characterized in that said knife is made of a zirconia-based material in monocrystalline form, The single crystal has a nanocrystalline structure with a domain size of less than 200 nm and no phase boundaries, the material is stabilized with yttria and is also stabilized with a component comprising a metal oxide selected from Calcium oxide, magnesium oxide, strontium oxide, scandium oxide and oxides of rare earth elements from europium to lutetium, the ratio of each component is expressed in mole % as follows: Yttrium oxide 0.5-4.5 The stable component 0.1-4.5 Zirconia Balance. 3. The surgical cutting tool according to claim 2, characterized in that it comprises a modified component comprising rare earth oxides selected from the group consisting of cerium oxide, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide, The transition element oxides of titanium oxide, vanadium oxide, manganese oxide, iron oxide, nickel oxide, and copper oxide, the added amount of the modification component is 0.05-3.0 mole % of the total material. 4. The surgical cutting tool according to claim 2, wherein the width of the knife is in the range of 1 to 15 mm, the thickness of the knife is 0.15 to 1 mm, and the length of the cutting edge of the knife is in the range of 1 to 60 mm , the sharpened radius R of the cutting edge of the knife is within the following range         0.05 μm < R < 2 μm. 5. The surgical cutting tool as claimed in claim 2, wherein the knife is sharpened at two angles, the secondary sharpening angle of the cutting edge is 15-25°, the main sharpening angle is 30-60°, and the main sharpening angle is 30-60°. The operating surface width of the sharpened cutting edge is 30-500 μm. 6. The surgical cutting tool of claim 2, wherein the configuration of the cutting edge of the knife is selected from the group consisting of straight, round and double-edged configurations. 7. The surgical cutting tool as claimed in claim 2, wherein the knife has various colors selected from milky white, pink, lavender, yellow, red, orange, light blue, yellow-green, violet , ivory, wet bitumen and black, depending on the type and concentration of modifying components used. 8. A tool comprising an operating part fixed in the tool body, characterized in that said operating part is made of a zirconium dioxide-based material in the form of a single crystal having a domain size of less than 200 Nano crystalline structure and without phase boundaries, said material is stabilized with yttrium oxide and also stabilized with a component comprising a metal oxide selected from the group consisting of calcium oxide, magnesium oxide, strontium oxide, oxide Oxides of scandium and rare earths from europium to lutetium, the ratios of said components are expressed in mole % as follows: Yttrium oxide 0.5-4.5 The stable component 0.1-4.5 Zirconia Balance. 9. The tool of claim 8, wherein said material further comprises a modifying component comprising rare earth oxides selected from the group consisting of ceria, neodymium oxide, praseodymium oxide, samarium oxide and cobalt oxide , transition element oxides of titanium oxide, vanadium oxide, manganese oxide, iron oxide, nickel oxide, copper oxide, the addition of the modification component is 0.05-3.0 mole % of the total material.

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