Coating processes – Medical or dental purpose product; parts; subcombinations;... – Implantable permanent prosthesis
Reexamination Certificate
1999-11-02
2001-04-10
Beck, Shrive (Department: 1762)
Coating processes
Medical or dental purpose product; parts; subcombinations;...
Implantable permanent prosthesis
C427S002180, C427S002250, C427S002280, C427S002300, C427S242000, C118S056000
Reexamination Certificate
active
06214407
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a method of coating the surfaces of medical implants with living cells deposited from a nutritive physiological liquid, wherein the implants are placed into a receiving container which is filled with the liquid containing the cells and which is then rotated around at least one axis.
BACKGROUND INFORMATION
It is widely known to implant medical implants, which include natural biological implants such as transplanted organs or parts thereof as well as artificial prostheses, into the bodies of recipient patients. The medical implants used in this context can therefore consist of living tissue that has been harvested from living or recently deceased bodies, such as animal bodies, or of non-living, biologically inert materials. However, a medical implant that does not originate from the tissues or cells of the respective recipient patient himself or from his identical twin, will often be recognized by the recipient organism as a foreign body and will therefore be attacked and combatted by so-called immunocompetent or immunoactive cells of the immune system of the recipient patient.
In order to prevent such an immune reaction in a patient who is to receive a medical implant, it is known in the art to cover the surfaces of the implant that would otherwise be recognized as a foreign body, with a coating layer of cells taken from the patient's own body or cells of an identical character, before the implant is implanted into the patient's body. Due to the surface coating of cells that are recognized as autologous (or at least not recognized as foreign) by the recipient patient's immune system, the coated implant will not be attacked by the immune system of the patient. In other words, the coating of cells applied onto the surface of the medical implant masks the foreign characteristics of the implant material.
In the conventional coating process, the coating cells are typically applied in the manner of a cell suspension onto the implant, whether it be a natural organ, a part of an organ, or an artificial prosthesis, before the operation by which this implant is to be implanted into the recipient patient. In this context, it is the goal to ensure that as many living cells as possible are deposited out of the cell suspension onto the surface to be coated, and that these living cells remain adherently fixed on the intended surface and then grow securely in place on this surface.
The PCT International Patent Publication WO 93/01843 discloses a method of the type generally described above, which serves to coat the surfaces of cylindrical medical implants. In this known method, the tubular implants that are to be coated are inserted into a horizontally arranged cylindrical chamber, which is filled with the respective cell suspension. The chamber is then rotated about its lengthwise axis, either in a continuous rotation or in a step-wise partial rotation manner. The partial stepwise rotation involves rotating the chamber about its lengthwise axis through a prescribed rotational angle, and then holding the chamber fixed for a predetermined period of time in the particular angular position that was reached by the partial rotation, and thereafter rotating the chamber through another rotational angle and again holding the chamber fixed in the new angular position for a predetermined period of time.
SUMMARY OF THE INVENTION
In view of the above, it is an object of the invention to provide a method of applying a surface coating onto a surface of a medical implant in such a manner that the selected surfaces or all surfaces of an implant having any desired configuration can be surfacially completely and uniformly covered and populated by a coating of cells that originate from the body of the recipient patient himself or cells that are genetically identical thereto, whereby the implant may be a natural biological implant such as an organ or an artificial implant such as a synthetic prosthesis. The invention further aims to avoid or overcome the disadvantages of the prior art, and to achieve additional advantages, as apparent from the present specification.
The above objects have been achieved in a method of coating the surface of a medical implant with living cells, according to the invention, comprising the following steps: placing, or particularly inserting and fixing, the implant into a chamber of a receiving container; filling at least a portion of the chamber of the receiving container with a nutritive liquid containing living cells; and rotating the receiving container independently about two rotation axes that are preferably substantially perpendicular to each other. The rotation can be carried out simultaneously or successively about the two axes. The particular pattern or manner of rotation about each of the two rotation axes can be carried out according to a prescribed motion program or sequence.
The living cells that are used in the method according to the invention can either be cells of the recipient body, such as cells recovered from a blood vessel, part of an organ, or other tissue sample of the patient, or may be genetically altered omnipotent donor cells. The living cells are seeded into a nutritive physiological liquid or solution, and are then deposited from this liquid medium to form a coating on the medical implant that is intended to be implanted into the patient in a subsequent implantation operation. More particularly, the cells are deposited out of the liquid medium onto the respective surface or surfaces of the implant as the receiving container (together with the implant and liquid medium therein) is rotated about the two rotation axes. Due to the rotation of the receiving container about the two rotation axes, the cells are deposited onto the surface or surfaces of the implant under the influence of gravity and/or a centrifugal force generated by the rotation.
Preferably, the respective rotation is carried out simultaneously and independently about the two axes, and the two axes are substantially perpendicular to each other. Throughout this specification, unless otherwise defined, the term “substantially” means that the indicated parameter is within the customary range of accuracy and precision that is used in the present art for specifying and/or carrying out a physical embodiment of such a parameter. Due to the rotation about two distinct axes, the depositing of the cells onto the surface of the implant is especially uniform and complete, and can be controlled or targeted as desired.
An apparatus that is suitable for carrying out the method according to the invention comprises a set of different modular receiving containers, i.e. receiving containers that are assembled as needed from different modular container components, whereby the respective size of the interior chamber of the receiving container is respectively optimally adapted to the size and configuration of the implant that is to be coated. The apparatus further includes a motion unit or particularly a so-called coating rotator for rotating the receiving container. The coating rotator is embodied in such a manner that it can receive and carry a receiving container and rotate this container together with the implant contained therein, either simultaneously or separately in any desired steps or succession and with any desired rotational speeds respectively about two rotation axes that are preferably substantially perpendicular to each other. In this manner, the apparatus ensures that an absolutely uniform distribution of the cells is achieved over the surfaces of the implant, so that the resulting coating on the surfaces is complete and uniform.
The use of the inventive method contributes to a substantial improvement of the success rate of implantation operations, for example heart valve operations, because of the improved coating results. Namely, the high quality of the “masking” cell coating applied onto the implant according to the inventive method essentially eliminates or substantially reduces the risk of damage being caused to the implant by an imm
Laube Horst
Matthaeus Martin
Nickel Erika
Willenbockel Helmut
Beck Shrive
co.don AG
Fasse W. F.
Fasse W. G.
Kolb Jennifer
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