Element for providing ingrowth and growth of bone tissue and/or connective tissue and a method of manufacturing such element

 

The invention relates to medicine, namely to the prosthetic bone. The invention provides an increase in the rate of growth of bone tissue and a greater amount of bone mass, which greatly improves the adhesion and strength of the bone tissue on the biologically compatible material. Element, such as grain, is designed for providing ingrowth and growth of bone tissue and/or connective tissue that consists of plastic or slightly elastic biocompatible material, preferably metal or metal alloy. The element is porous and has the following characteristics porosity: (a) the porosity is continuous and (b) the internal dimensions of the cavity (cavities) of the pockets and channels that connect them to each other, have a width which is over about 50 μm for bone and more than approximately 10 microns for connective tissue. In accordance with the method of manufacturing such an element was obtained by blowing gas through the molten metal with automatic separation of the grains or granules that do not meet the requirements of porosity, the internal dimensions of the cavity (cavities) of the pockets and channels/passages, coedine means for attaching the elongated prosthesis, such as the stem of the prosthesis to the femur, the living tissue that forms the cavity in which the area of the prosthesis comes with a clearance with respect to the boundary of the cavity. Essentially the entire gap is filled loose, but tightly linked grains biologically compatible material, the grains are closed. As an example, the bulk material mentioned titanium and argues that the grains have an irregular shape, are essentially inelastic and preferably porous, it is specified that the latter property enables linking the growth of bone tissue, which has grown from the bone wall. Porosity was achieved by blowing gas through a melt of the bulk material.

In U.S. patent US-A-5217496 disclosed implant suitable for use in living bone tissue and contains the supporting element is made of titanium, having a porous outer surface and an attached layer of a mixture of chopped living bone and titanium powder. The mixture was fed together with a nutritious substance that causes the crushed bone tissue to grow and form the tissue that connects the crushed bone and titanium powder with each other and with the control element.

The Pat is amany bone moreover indicated that these elements form osteopathy or osteoinductive matrix (basis) in the cavity of the bone. Material items can be a Titan, and indicates that the elements are preferably microporous to ensure the ingrowth of natural bone.

All the documents mentioned above, as a biologically compatible material, in addition to titanium, mentioned, among other things, hydroxylapatite, bioceramics, biostable.

Thus, in the above-mentioned documents is emphasized that the porosity of biologically compatible materials, to some extent, is a favorable factor for joining the bone.

In accordance with the invention it has been unexpectedly found that pre-specified degree of porosity of biologically compatible material is indeed a decisive factor in terms of the rate of growth of bone tissue. It was found that, apart from the fact that the porosity of the surface undoubtedly enables splicing of bone tissue, is achieved speed is considerably increased bone growth and a greater amount of bone mass and thereby greatly improved traction and durability bone the material is entirely porous, - pore volume element has a minimum limit value.

An additional advantage of the invention is achieved due to the fact that the strength of the porous granules together with ingrown bone tissue has a higher value compared to the situation in which would not be possible ingrowth of bone. Due to the ingrowth of bone strength is mainly provided with the bone tissue, which is favorable from the point of view of biomechanics.

The term "all porous" here implies porosity, which allows germination of bone tissue through the porous body, such as grain biologically compatible material. In accordance with this invention the porosity leads to the formation of cavities in the body element, which are connected to each other by channels, passages, so that the growth of bone tissue in part of the outer surface of the element provides the opportunity to continue growth with growth through the element body and out through the other part of the outer surface of the element. Under the cavity defined grooves, holes, pockets of arbitrary shape, channels, passages connecting these cavities with each other, can have arbitrary shape and form part of the cavities. is th.

Under the minimum limit value in this case refers to the internal dimension of the holes, recesses, pockets and the dimensions of the channel having a width of more than about 50 μm. Smaller holes restricts or impairs bone growth, possibly due to the fact that hampered the supply of nutrients and creates an obstacle to the formation of normal bone structure with elements that are included in it. Indeed, there is no upper limit for the porosity of the element. Rather, the upper limit is determined by the strength properties of the body element.

In accordance with the invention can be provided with the possibility of the formation of the surface of the pores in the elements, which are located next to each other and have open pores in the surface so that the surface of the pores in a single element form a cavity or channel/aisle together with surface pores in another element.

In accordance with the invention it was also found that fragile biologically compatible material such as hydroxylapatite, is not optimal for achieving the objectives of the invention, when such material is used for recovery, strengthening and replacement of the EU is proishodit, for example, when a person's body or part of a human body, which is biologically compatible with the item, such as grain, is subjected to a load, for example, when the movement of the limbs. Decayed parts of an item of biologically compatible material cause adverse inflammatory reaction, which leads to inhibition of bone formation and which often causes bone resorption.

Thus, in accordance with the invention, the selected metal material or non-fragile composite materials, with natural material such as hydroxylapatite, bio, etc. may be included as a component in the material of the porous body element and another component, such as plastic, provides flexibility. The material of the body element according to the invention should really be plastic or slightly elastic. Excessive elasticity leads to pressure on the bone, causing its destruction.

As the metal material is preferably selected titanium (titanium dioxide). The porosity of the body of titanium element preferably is achieved by blowing gas through the melt titanium. This provides the possibility of polycaste, as described above, is not done automatically by blowing gas through the molten metal. Therefore, in accordance with the invention checks the porosity of the body element/grain/grains, thus obtained, to make sure that it/they meet/satisfy this requirement. Verification may be performed, for example, using fluoroscopy, with a corresponding wavelength and a television receiver and can be carried out automatically Department (for example, with a conveyor belt) grains that do not meet the above requirement.

Above the limit value of more than approximately 50 microns, refers to bone tissue. If it is desirable ingrowth of connective tissue instead of, or due to bone tissue, the limit value is more than approximately 10 microns instead referred to 50 μm.

A porous element, such as grain, in accordance with the invention can be implanted in a living organism such as the human body, in order to fill the cavity of the bone as a replacement after the growth of bone tissue in a living organism, the thin bone of the leg (rheumatism) or for the fixation of the prosthesis according to the publication Sweden SE-B-air traffic management of bone tissue in vitro or can be filled with a nutrient solution, containing, among other things, the growth factors in vitro for subsequent implantation in living tissue. In the case of filling a bone cavity preferably, the element body was grainy and had an irregular shape and have a size of less than 10 mm, so that the many/many of the grains optimally fills the cavity of the bone.

The porous element body can be filled degrade the material, for example a so-called matrix (base) made of natural material. Examples of such natural matrices are gels of collagen, fibrin, starch and hyaluronic acid. In accordance with the invention, this matrix is decomposed with its replacement of ingrown bone. Can be made more stimulating the ingrowth of bone tissue, if material, are able to decompose will be added substances that stimulate growth, particularly growth factors such as TGF beta (factor beta transforming growth - Transforming Growth Factor beta) or BGF (growth factor bone - Bone Growth Factor). The pores in the body element according to the invention can be modified gel-like material, for example, by suction before the material will turn into a gel.

The smaller elements, namely grain according Isobe invention can be enclosed in a rigid tube with the together with the tube to form a spinal implant, see, for example, the tubular element in U.S. patent US-A-5015247. Other possibilities wrapping disclosed in the publication Sweden SE 9803078-6. The shell has openings to allow ingrowth and growth of biological cellular material in grains and beans through the shell. Grain according to the invention can be mixed with decayed biological tissue.

Embodiments of the invention illustrated in the accompanying figures, which represent the images obtained using the electron microscope and of which Fig.1 shows a porous structure according to the invention and Fig. 2 shows another porous structure according to the invention, constituting the porous structure of the outer surface of the grain titanium. Fig.3 is an image of a thin section grain titanium with porosity according to the invention. All images were made for grain or pellets of irregular shape, which (who) was (were) removed from the femur of a human body after implantation, using the vibration method, which is described in more detail in the publication Sweden SE-B-462638.

In Fig. 1 shows the structure of the titanium and perform this quality control. Both images show a whitish-gray film of live material at the stage of preliminary formation of bone tissue that covers the outer surface of the grain and into the cavities and gaps in the pores of the grain titanium. In Fig.1 also shows the growth of bone-forming cells bridges through cavity/cavities in the structure.

In Fig.3 illustrates the bone tissue, which crossed penetrated into the grain according to the invention.

Clinical tests showed that the bone in the grains in Fig.1-3 had the following composition: bone - 95-98%, bone marrow (2%) and connective tissue - 0-3%, which mainly corresponds to the composition of the bone on the outside of the grains in the immediate vicinity.

Claims

1. Element, such as grain, is designed for providing ingrowth and growth of bone tissue and/or connective tissue, and the specified element is made of plastic or slightly elastic biocompatible material, preferably metal or metal alloy, characterized in that it is porous and has the following characteristics porosity: porosity is continuous; internal dimensions of the cavities/recesses/pocket the bone and more than approximately 10 microns for the connective tissue.

2. Item under item 1, characterized in that it is made of titanium.

3. Item under item 1 or 2, characterized in that its cavity is filled with material that can decompose, for example a matrix of natural material, such as a gel of collagen, fibrin, starch, hyaluronic acid.

4. Item under item 3, characterized in that the material is able to decompose, contains growth stimulating substances.

5. Element according to any one of paragraphs.1-4, characterized in that it has a structure of coral.

6. Element according to any one of paragraphs.1-5, characterized in that the size thereof is less than 10 mm

7. Element according to any one of paragraphs.1-6, characterized in that it consists of a single element together similar elements.

8. Element according to any one of paragraphs.1-7, characterized in that it is a grain or pellets of irregular shape.

9. Item under item 7, characterized in that it is enclosed in a shell with holes/pores.

10. Item under item 9, characterized in that the shell is a rigid cylindrical tubular element for receiving the spinal implant.

11. A method of manufacturing an element according to any one of paragraphs.1-8, characterized in that the element consisting of a metal, such as titanium, obtained by blowing g is Yasemin to porosity, the internal dimensions of the cavities/holes/pockets and channels/passages connecting them, have a width of less than 50 microns.

Priorities for items:

28.04.1999 on PP.1-8;

28.04.2000 on PP.9 and 10.

 

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