Port body for the administration of drugs

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S175000, C604S533000

Reexamination Certificate

active

06270475

ABSTRACT:

PRIORITY CLAIM
This application claims priority of Swiss patent application 1997 0729/97, filed Mar. 26, 1997, which is hereby fully incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention refers to an implantable cylindrical device for connecting a hose outside of the human or animal body to a hose arranged inside the said body, wherein an anchoring plate falling away peripherally from the skin surface is arranged around the cylindrical device.
2. Description of the Related Art
U.S. Pat. No. 5,306,255 describes a subcutaneous implantable port body. A subcutaneous port body is covered completely by skin and normally remains inside the human body for several months or even years. The port body contains the port chamber. The port chamber, fully located inside the human or animal body, is sealed by a puncturable plastic membrane on the skin side, while a catheter leading to the drug release site is fixed on the side facing the interior of the body. In order to administer the drugs, the skin and membrane are punctured with a needle of an infusion set. The creates a continuous drug channel from the infusion set to the release site.
European Patent EP-B-0 302 076 describes a cylindrical, percutaneous implantable port body. In contrast to the subcutaneous port body, the percutaneous port body is not fully implanted in the human body but is fixed in the tissue in such a way that at least a certain area of the port body is not covered by skin. The center of this area contains a first aperture. A second aperture of the port body is located opposite the first aperture in the section of the port body completely surrounded by tissue. A catheter whose end is located at the site inside the body to which the drug is to be transported is connected to this aperture. The port body consists of two metal parts which are screwed together. The inside of the port body, the port chamber, contains a puncturable membrane, separating the two apertures. The external casing of the port body contains several radial grooves for laterally anchoring the port in the subcutaneous skin tissue, with the outermost groove being located directly under the surface of the skin. The port chamber is also anchored with a base plate in the tissue.
The disadvantages of the subcutaneous port are that the catheter can neither be changed nor mechanically cleaned without explanting the port. A further disadvantage is that the skin is always punctured in the same place. In the short term this is painful and in the long term this causes a perforation of the skin and membrane.
The disadvantages of the described percutaneous port are that it is very heavy and has a large visible external surface. The metal port body is furthermore easily noticeable because of its color. Installed port bodies contain a gap between the base plate and the port body which is difficult to clean and sterilize. This represents an infection hazard. The radial grooves are arranged and dimensioned in such a way that sharp edges and corners are created. In these areas an effective growing-in of the tissue cells and adequate cleaning of the surface is not possible. Due to a lack of a geometrical separating line between the skin surface and the uppermost groove, external body perspiration or dirt may directly enter the grooves. In extreme cases this may cause an infection and require the port to be explanted. A further disadvantage is that the components of the described port must be machined from solid material. The manufacturing costs are consequently high with any weight reduction measures incurring additional costs. Prior art anchorings also present the hazard that parts of the anchoring may project from the skin due to the effect of a tilting moment.
SUMMARY OF THE INVENTION
The invention aims to remedy this situation. It is the aim of the invention to develop a low-cost port whose housing is adapted to the body-shape and contains an interconnected casing surface and continuous transitional areas. The port should preferably be produced by injection molding and be biocompatible. The skin should be able to grow tightly around the port wall. The growing-in depths of the skin should be as even as possible and should be controllable from the port. The shape of the anchoring must be designed in such a way that no edges or other parts of the anchoring protrude from the patient's body in case of a tilting moment.
The invention solves the set task by providing an implantable cylindrical device for connecting a hose outside of the human or animal body to a hose arranged inside the said body, wherein an anchoring plate falling away peripherally from the skin surface is arranged around the cylindrical device.
The invention offers the principle advantages of producing a cheaper port body which can be cleaned better when in use, is retained better by the body due to the design of its external surface and rolls the skin over the anchoring areas in case of a tilting moment. The selected material, shape and surface structure of the port body facilitate a longer implantation period.


REFERENCES:
patent: 3783868 (1974-01-01), Bokros
patent: 4092983 (1978-06-01), Slivenko
patent: 4183357 (1980-01-01), Bentley et al.
patent: 4321914 (1982-03-01), Begovac et al.
patent: 4578063 (1986-03-01), Inman et al.
patent: 4955861 (1990-09-01), Enegren et al.
patent: 5098397 (1992-03-01), Svensson et al.
patent: 5242415 (1993-09-01), Kantrowitz et al.
patent: 5306255 (1994-04-01), Haindl
patent: 5741234 (1998-04-01), Aboul-Hosn
patent: 3742263 (1987-12-01), None
patent: 0302076 (1992-12-01), None

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