Description
BACKGROUND RELATING TO THE INVENTION
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The present invention is in the field of cataloging and marking implants and, more specifically, the present invention innovates marked implants; the system enables the creation of marked implants to be implanted into the body of the patient, or the body of a live patient. It enables the observation andoidentification of the existing marking on implants subsequent to their having been implanted into the body of the patient, by using a device that enables the observation of the implant, and the marking on the implant noninvasive^, from outside the body into which the implant was planted - for example, while the implant is still in the living body - and receiving infasnation regarding the specifically identified marked implant.
Healthcare professionals are aware of the fact that, currently, implants are widely used for implantation into the body of the patient, human or animal. There are various reasons and different causes for implanting into the body of ttce user, some of which are inevitable, or necessary; and some of which are simply elective. Sometimes there are medical considerations, or aesthetic reasons and desires, or a variety of different considerations and reasons.
A large proportion of the implants intended for implanting into the patient's body can be divided into different types. The most common implants are:
Dental Implant: A dental implant is a type of device made, usually, from titanium, as part of the TiAI6V4 compound. The metal from which the impkant is made is a precious metal; in other words, metal that does not create a chemical reaction with the body and, therefore, the living body
does not utilize its rejection mechanisms. The implant is actually a "dibble" with a double screw element. The first is external and is used to anchor the implant into the jawbone; the second is internal and serves to anchor the external accessories onto the implant. These accessories are called restoration parts.
Silicone implants: these implants are constructed from a type of silicone pocket, such as an implant usually used in plastic surgery. These are designed for implantation onto the chest area and are used for breast enlargement in women or, for example, for reconstructive surgery following a mastectomy. There are different types of silicone implants: one type is an external silicone pocket that contains a silicone filler filled with a saline solution. These implants are the only ones currently being used in the United States.
Another type of silicone implant is an implant with a silicone gel filler that has an external silicone shell and is filled with silicone gel. Presently, this type of implant is not used for implants in the United States, despite the fact that the changes that have been made to the legal regulations permit this. Nonetheless, this kind of implant applies to 90% of implant surgery performed in 60 countries outside the United States where this surgery is permitted.
Also, fiber implant, which is the third type of implant of this kind, and which is rarely used.
Implantation of joints: joint replacement is one of the most common and most successful types of surgery in modern orthopedics. Subsequent to the patient suffering from pain and dysfunction caused by deterioration of the joint - resulting from arthritis, erosion of bone and cartilage, or disease - the patient's joint is replaced, during a surgical procedure, with an artificial joint
that enables the continued functioning of the joint. Total joint replacement surgery (arthroplasty) means replacing all parts of the joint; as opposed to partial joint replacement surgery (hemiarthroplasty), which replaces only the articular surface of bones or parts of the interior surface of the joint.
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There are other types of implants, such as implants that can simulate and replace certain organs in the user body or part of an organ in the user body; or which can facilitate the functioning of a specific body part - such as artificial heart, pacemakers, "stent" in the form of a spring designed to widen theiarteries, platinum plates to strengthen or connect organs, and more. In practice - despite the fact that implants into the body of a patient are quite common around the world - until now there has been no method that enables the simple identification of an implant in the body where the implant was implanted, for anyone who may be interested in observing the implant from outside the body in which it was implanted, non-invasively and without having to remove the implant.
It is necessary, after the implant has been performed, for someone, such as a therapist, to observe the implant in order to identify the implant and to identify the data associated with the specific implant. For example, information about what can and will be associated with the implant, the type of implant, when it was implanted, the company that supplied the implant, information about the implant, any information about the individual who received the implant, and so on and so forth.
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Information such as this will be made possible by the present invention, without removing the implant from the body into which it was implanted. It will make it possible to observe the markings that have been placed on the implant, using the device outside of the body, non-invasively and in such a wayothat the marking in some of the applications of the present invention will
be fed into a computer program, identified, and will issue the related information, or information requested in connection with the marking. Amongst the main reasons for this are:
The patient will be able to ensure that the implant that was paid for is actually the implant that has been implanted in his body. For the purpose of identifying the individual (during their lifetime, by the police, and even after their decease). Also from the aspect of medical care, dental treatment, rehabilitation, continued care and so on and so forth.
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It is necessary to improve and adapt the system and the existing implants in such a manner as to allow the possibility of looking at the implant noninvasive^; it is especially necessary with regard to an implant that carries a marking to ensure that it is unique, and also, that the marking on the implant can5be observed by looking at it from outside of the body in which it has been implanted without the necessity of removing the implant from the body. In this manner the marking that will be viewed by the observer will identify the information pertinent to the implant, which is data that it is important to monitor.
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Through the method and the marked implants, the present invention enables a system by which to install a code on the implant that can be read and interpreted with the help of a device such as X-ray, MRI, US and / or with the assistance of a code-reading device (optical, digital, electric, laser, soiisd waves and ultrasonic waves, magnetic induction). All of these will obviate the need to remove the implant in situations of necessity, or to acquire information relating to the implant. This system makes it unnecessary to record information in advance - including information about
the implant - since that can be done by using marked implants, and this is made possible by using the method enabled by the present invention.
SUMMARY RELATING TO THE INVENTION
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The present invention innovates the marking of implants and the identification of implants, and marked implants, facilitated by means of an external and non-invasive device which is located outside the body. It enables the identification of the implants in such a manner that it is possible to obtain the required information relating to the implant contained within the body of a patient. The components of the system and marked implants are as follows:
Implants for implantation are supplied with markings that do not cause rejeetion by the body. As long as the marking does not come into direct contact with the body and if - due to material composition - they will not result in a reaction of rejection by the body, and when;
Marking implants will be performed using alternative implementation and technology that will allow observation from an external device, to identify and monitor the distinctive marking of the implant, and when;
Transmitting the marking that is observed by means of optional external apparatus that will be transferred to a computerized system, including operating programs and designated software, which will identify the specific markings from the database of implant markings, and when;
The computerized systems will provide information relating to a specific implant to the applicant.
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When implant marking will be conducted by the present invention - in a manner and by a technology that would allow a non-invasive external device to identify the marking on the implant while it is still implanted in the body.
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When marking and encoding will be embedded on a certain part of the implant or, alternatively, will be removed from a certain part of the implant, or alternatively, will be attached to the implant and, optionally, a layer of material will be added to it to prevent rejection by the live body.
Various information associated with the marking, which catalogs the specific identified implant, will be enabled by the present invention, without removing the implant from the body in which the implant has been implanted, by observing the marking that has been made on the implant using the device outside the body. This will be done in such a way that the marking and the coding on part of the applications of the present invention will be fed into a computer program. For example, a photograph will be fed into the computer and dedicated software will identify the encoding and the marking on the implant, and will release the related information, or the information requested in connection with the identified marking and encoding.
Through the method and the marked implants the present invention enables a system for installing a code on the implant that can be read and interpreted with the help of a device located outside the body such as X-ray, Mf¾5 US and / or with the assistance of a code-reading device (optical, digital, electric, laser, sound waves and ultrasonic waves, magnetic induction). All of these will be used in order to obviate the need to remove the implant in situations of necessity or to get information relating to the
implant, when the marked implants, and the method of the present invention make the purpose of the invention possible.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings are included in this application for a patent in order to provide fuller understanding of the invention. They are included in and form an integral part of this breakdown. The drawings show various embodiments of the invention and, together with the description, serve the purpose of explaining the principles and modalities of operating the invention. All of this is conducted by example only, and there is no intention whatsoever to restrict the invention to these descriptions only.
Figure 1 is a schematic diagram depicting one of the applications included in the scope of the present invention, which presents, for example, the preparation of dental implant 100 for marking and encoding in accordance witfosthe method of the present invention.
Figure 2 is a schematic diagram depicting one of the applications included in the scope of the present invention, which shows one of the alternatives of the marking and encoding components intended for placement in dental implants; for example, in such a manner as would allow identification of the implant from a device located outside the body, in accordance with the method of the present invention.
Figure 3 is a schematic diagram showing the combination of Figure 1 with Figure 2, which is one of the applications included in the scope of the present invention. This presents one of the alternatives of the marking and encoding components intended for placement in dental implants, for example, made possible for identification from a device located outside the body, in accordance with the method of the present invention.
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Figure 4 is a schematic diagram that presents a photo image external to the body, showing the distinctive marking and encoding of an observed dental implant, in accordance with the method of the present invention.
Fig&re 5 is a schematic diagram showing an example of a silicone implant, which is implanted in the chest of a woman, in accordance with the early techniques.
Figure 6 is a schematic diagram showing an example of a silicone implant implanted into the chest of a woman. It includes marking and encoding made possible by means of a device that is external to the implanted body, in accordance with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Description of the drawings in this Appendix and the drawings that we refer to, swhich are included in this patent application, are for the purpose of providing fuller understanding of the invention, and the inclusions constitute an integral part of this breakdown. The description of the drawings presents a more detailed explanation of the various embodiments of the invention and - together with the drawings and the other components in the patent application document - serve the purpose of explaining the principles and modalities of operation of the invention. All of these are done through example only, and are not intended for the purpose of limiting the invention to these descriptions only.
Figure 1 is a schematic diagram depicting one of the applications included in the scope of the present invention, and it shows the preparation of dental implants 100 for marking and encoding - for example, in accordance with the method of the present invention. When the internal drilling 104 of the dental implant 102 will be deepened, in such a manner as to allow, for example, for the insertion of one of the marking and encoding applications that are made possible by the present invention in the site that has been prepared 106, the encoding in one of the applications is an example of the underneath of a uniquely grooved cylinder. This enables identification and is adjusted by its identification to provide information found, for example, in the cofitputer system external to the body in which the dental implant 102 has been implanted.
Figure 2 is a schematic diagram depicting one of the applications included in the scope of the present invention. It shows one of the alternatives of the masking and encoding component 150, built into one of its applications, for
example, as an underneath grooved cylinder at various intervals and thicknesses between every part, and interval 152, 154, 156, 158 and 160 uniquely in the cylinder. When the X-ray, for example, outside of the body will present the encoding, it will transfer the image to dedicated computer software that will recognize the information in connection with the specific implant. The computer system will then display the relevant information, or the information requested by the user, in accordance with the encoded implants and the method of the present invention.
Drawing 3 is a schematic diagram depicting a combination 180 of Figure 1 with Figure 2, combination of the implant 186 that includes deepening of the inner drilling of the dental implant 184 for example, and the means of encoding and marking 182 designated for placement in implant. This is one of the applications included in the scope of the present invention, which presents one of the alternatives for marking and encoding of dental implants, for example, made possible by identification of the implant from outside the body, in accordance with the method of the present invention.
Drawing 4 is a schematic diagram presenting a photographic image 200 thaftwas taken by means located outside the body in which dental implants 204 and 208 had been implanted. The photograph presents the unique marking and encoding 206 of observed dental implant 208 near to teeth 202, when, reading and identification of code 206 is in accordance with the following stages:
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a. An image is executed - for example an X-ray in one of the applications of the device that are enabled by the method of the present invention. b. The image is transferred to the designated recognition program in the computer.
c. A reading and identification of the code 206 is performed with the software.
d. The computer brings up the data relating to the implant 208, in accordance with the method of the present invention.
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Figure 5 is a schematic diagram showing example 230 of 236 silicone implant surgically implanted 234 in the chest woman 232 in accordance with the early techniques.
Figure 6 is a schematic diagram showing example 250 of silicone implants 252 in accordance with the early techniques, and 256 in accordance with the present invention, implanted in the chest woman where the silicone implant 256 that includes marking and coding 254 enabling identification using devices outside the implanted body, in accordance with the present invemtion.
When - in the silicone implant 256 - the term transparency (radiolucent) 254 on which the identification code in the body is printed with inert radioactive materials, for example calcium, iodoform and the like. And the base of the traoeparency will also have inert materials such as silicone.