Prosthetic implants

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis

Reexamination Certificate

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Details

C623S901000

Reexamination Certificate

active

06254639

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an improved method of making prosthetic implants, methods of treatment incorporating the use of such implants, and to the prosthetic implants themselves.
The invention is of particular usefulness in relation to maxillofacial surgery and will be particularly described with reference to that field, but may also be utilised in the treatment of disease or damage in other parts of the body.
2. Prior Art
Maxillofacial surgery may be necessary to deal with congenital defect, accidental damage, or malignant tumours. Such surgery presents particular difficulties since the aim is to achieve a result which is not only functional in dealing with the particular problem addressed, but also ensures that a patient is left with a good level of ability to breath, eat and speak, while at the same time achieving a satisfactory aesthetic appearance.
Techniques are known in which diseased or damaged bone is excised and replaced. The replacement may be by way of grafting bone taken from other parts of the patient's body. More recently replacement bone has been achieved by attaching a titanium armature to sound bone to act as a support for grafted bone cells derived from bone in other parts of the patient's body. In either case, it is then necessary to attempt to reform the adjacent soft tissue over the resulting implant.
Another known technique is the use of microvascular free transfer osseofasciocutaneous flaps, in which a flap of bone and skin, for example from the forearm and optionally with attached muscle, is transferred to the mouth, with the blood vessels of the flap being connected to those of the head by microscopic surgery. A functional result may be achieved, but is non-anatomical.
Such techniques are extremely time consuming and difficult. A typical maxillofacial repair may require a surgical procedure lasting up to about 15 hours, and the procedure will involve opening a second surgical site (typically in the region of the iliac crest) to obtain bone or bone cells for grafting.
OBJECTS OF THE INVENTION
An object of the present invention is to enable reconstructive surgery of this nature to be carried out much more rapidly, thus markedly reducing the stress on the patient caused by the surgery, while reducing the load on the surgical team and also markedly reducing the costs of the surgery.
BRIEF SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, a method of making a prosthetic implant comprises the steps of obtaining a set of data defining the body parts of interest in three dimensions, using said set of data to create a three dimensional model of at least part of the body parts of interest, and using the three dimensional model to develop and fit to size a prosthetic implant which entirely replaces body parts which are missing or are to be excised from the patient.
The invention also provides a prosthesis made by the foregoing method.
From another aspect, the invention provides a method of treating damaged, diseased or missing body parts which comprises excising damaged and/or diseased body parts and selected adjacent parts, and replacing excised and/or missing parts entirely by a prosthetic implant secured to the sound adjacent bone structures. In the preferred form of the method, both bone and soft tissue are replaced by a single prosthetic implant made of a material onto the surface of which soft tissue is capable of growing in a manner to prevent the incursion of infection; such a material will typically be titanium.
The foregoing method in preferably carried out by obtaining a set of data defining the body parts of interest in three dimensions, using said set of data to create a three dimensional model of at least part of the body parts of interest, and using the model to develop and fit to size the prosthetic implant prior to surgery.
In preferred forms of the invention the prosthesis extends through a body surface such as skin or mucous membrane, for example in the palate or nasal cavity.
The prosthetic implant may be provided with mechanical attachment means for the releasable attachment of further prosthetic devices such as dentures.
The set of data defining the body parts of interest is preferably reduced by CAT scanning. The data resulting from the CAT scanning may be manipulated by computer, for example to derive from a CAT head scan a set of data defining three dimensionally only the bony structures of the skull.
The three dimensional model may conveniently be produced by stereolithography in a manner known per se by laser irradiation of a photoreactive polymer.
A further aspect of the invention provides a connector block comprising a body and a post extending from the body, the post being shaped for selective attachment to dental prostheses, and the body being formed with passages for rivets for attachment to a surgical plate.
Preferably, the body is rectangular, and the connector block is formed integrally from titanium.


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