Package making – Methods – Sterilizing complete package
Reexamination Certificate
1998-07-10
2002-01-22
Gerrity, Stephen F. (Department: 3721)
Package making
Methods
Sterilizing complete package
C053S432000, C427S002270, C623S016110
Reexamination Certificate
active
06339913
ABSTRACT:
This invention provides a series of treatments on osseous fixing implant surfaces, such that the implant subject to the treatment improves substantially its osteointegration properties with respect to the bone with which the implant will be in contact. These treatments comprise a cleaning and passivation process, the application of a Ca—P—H—O—C system coating (i.e., a compound of formula Ca
U
P
V
H
X
O
Y
C
Z
where subscripts u, v, x, y, and z are natural numbers including zero) by means of a laser ablation technique, and sterilization by an irradiation process.
When the replacement of a defective member of a human body is required, the best solution would be the use of compatible tissue or organ provided by a human donor, since natural tissues and organs contain the right proportions of materials needed to satisfy the body functions. However, because of increasing demand for transplants, there are not enough human donors to satisfy the need for living implants. On the other hand, when natural implants are used, frequently rejection problems appear in the receiving body.
A solution to meet the increasing demand for transplants is the use of manmade tissues and organs. Since 1950 continuous research has been performed on biomaterials and non-pharmacological products that are adequate to improve or substitute for the functions of human organs and tissues.
Present biomaterials are useful for many applications, ranging from substitution of intraocular lenses to the manufacture of artificial hearts. Generally, a biomaterial can be defined as a mechanically and biologically compatible material, i.e., it must stand the mechanical stresses derived from its function, and be non-toxic, controllable, and predictable in its interaction with the human body.
In particular, a set of specifications can be defined, which the biomaterials should meet (see, for example: S. F. Hulbert “Use of Ceramics in Surgical Implants”, ed. By S. F. Hulbert and F. A. Young, Gordon and Breach Science Publishers, New York (1969)).
The biomaterials should have the following characteristics: a) resistance to the action of body fluids; b) an ability to withstand the mechanical stresses inherent in the required functions; c) an ability to adapt to the required shape; d) an absence of resulting toxic or allergenic reactions; e) no impact on natural defense mechanisms of the body; and f) no impact on the formation of blood platelets, or on the coagulation or denaturalization of plasma proteins.
In other words, the material needs to be compatible from two points of view. The effects of the human body on the implant, as well as the effects of the implant (or substances produced due to corrosion or wear) on the human body must be considered.
The most popular odontological and orthopedic implants are those made of pure titanium or those made with titanium alloys (Ti-6A1-4V) (D. F. Williams, J. Med. Eng. Technol. I (1977) 266-270). Such implants enjoy a high resistance to mechanical stresses together with a resistance to corrosion; this property results from the high affinity of the implants for oxygen, which generates a fine protective oxide coating at ambient temperature. However, this affinity for oxygen makes the cleaning of the implants particularly difficult.
Titanium and titanium alloy implants are bioinert implants. If an interface displacement occurs during the recovery period, the fibrous tissue capsule may be too thick, thus causing a quick loosening of the implant and, finally, causing the implant or the adjacent bone to break (L. L. Hench & J. Wilson, “An Introduction to Bioceramics”, ed. By L. L. Hench & J. Wilson, Advance Series in Ceramics-Vol. 1. World Scientific Publishing, Singapore, (1933) 1-24). Furthermore, the metal implants differ significantly, in their mechanical features as well as in their composition, from the osseous tissues where they are to be inserted.
With the purpose of avoiding the disadvantages of metal implants, tests have been conducted on non-metallic materials such as ceramics, polymers, and hybrid materials.
Since the bone mineral phase is made of calcium phosphate, research has been conducted on biocompatible ceramics, and in particular on different types of calcium phosphates (CaP) such as hydroxyapatite, tricalcium phosphate, carbonated hydroxyapatite, apatite, pyrophosphate, and tetracalcium phosphate. The advantage of calcium phosphates is based on their direct coupling to the bone with no fibrous tissue in the interface. This type of material has a high bioactivity (S. Best “Seminar in Bio-Active Materials in Orthopedics” Sep. 27, 1994, Cambridge, UK).
Among these calcium phosphates, the hydroxylapatite (HA), having the formula Ca
10
(PO
4
)
6
(OH)
2
has generated great interest since for a long time it was believed that it had the same composition as the calcium phosphate of bone. At present it is widely accepted that bone develops a strong coupling with implants made with sintered hydroxylapatite (K. DeGroot, R. Geesink, C.P.A. T. Klein and P. Serekian, Journal of Biomedical Materials Research, Vol. 21, (1987) 1375-1381). Thus, hydroxylapatite has a very high bioactivity.
The main disadvantage in the use of implants made of calcium phosphates is their low resistance to mechanical stresses due to their poor mechanical properties. For this reason the application of calcium phosphate coatings over metal substrates or other materials subject to stress is becoming very common for odontological and orthopedic implants.
The CaP coatings more frequently applied on odontological and orthopedic implants are those made of HA. If the HA coating is pure and thick, i.e., with low porosity, it will not be reabsorbed and the coupling between bone and HA will take place in a 3 to 6 week period. The HA density will depend on the morphology as well as the physical and chemical properties of the HA powder used. The coupling between bone and HA has been proved by tests conducted on animals as well as on humans (R. G. T. Geesink, Ph.D. Thesis, Marquette University, 1974). Furthermore, HA is considered to be an osteoconductive material, meaning that it would force the bone growth in accordance with its own crystal structure.
However, it has been found recently that the CaP composition, forming the bone mineral phase, is not exactly the same as that of HA, for the CaP composition contains carbon in carbonate groups to constitute a carbonated hydroxylapatite (HAC). Also, it has been found that the interface between implants made of different calcium phosphates and the bone is made of the carbonated hydroxylapatite (HAC). The crystal structure of this HAC coincides in practice with that of HA. For this reason, it is thought that this HAC can be a much more bioactive ceramic than HA and possibly, have a higher osteoconductivity. In fact, HAC powders are being produced and sintered for use in implants.
The methods commonly used to produce such coatings are electrophoresis deposition (P. Ducheyne, W. V. Raemdonck, J. C. Heughebaert & M. Heughebaert, Biomaterials 7 (1986) 97), plasma spraying (S. D. Cook, J. F. Kay, K. A. Thomas, R. C. Anderson, M. C. Reynolds & J. Jarcho, J. Dental Res. 65(1986) 222) and cathodic spraying by radio frequency (E. Ruckenstein, S. Gourisanker & R. E. Baier, J. Colloid and Interface Sci. 63 (1983) 245). The method most commonly used to produce such HA coatings is the plasma spraying method, which creates 50-200 &mgr;m thick coatings with a HA content of 90% in case that the initiation material is 100% HA. The minimum thickness obtained by industrial processes is 50-60 &mgr;m and it is the result of a compromise between minimum thickness and homogeneity, due to the fact that this technique produces very high porosity coatings and, thus, it becomes necessary to deposit successive coatings of approximately 10 &mgr;m in thickness to obtain a uniform granular coating. However, such coatings present the following inconveniences: a) at present it is not possible to get continuous coatings of less than 20 &mgr;m thickness; b) the coatings have a granular morphology, i.e., they h
Arias Otero Jorge Luis
Garcia Sanz Francisco Jose
Gonzalez Fernandez Pio Manuel
Leon Fong Betty Mireya
Mayor Leiros Mercedes Belen
Baker & Botts LLP
Gerrity Stephen F.
Universidad de Vigo
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