背景技术Background technique
本发明涉及分类和标记植入物的领域，更具体地，本发明创新标记的植入物；该系统能够产生将要植入到患者的身体或者有生命的患者的身体中的标记的植入物。其能够在植入物已植入到患者的身体中之后，通过使用能够从其中植入了植入物的身体(例如，在植入物仍在活体中时)的外部非侵入性地观察植入物以及植入物上的标记的装置，和接收关于具体鉴别的带标记的植入物的信息，观察和鉴别在植入物上已存在的标记。The present invention relates to the field of classifying and marking implants, and more particularly, the invention innovates marked implants; the system is capable of producing marked implants to be implanted in a patient's body or in a living patient's body . It enables the implant to be non-invasively observed after the implant has been implanted in the patient's body by using an external view of the body from which the implant has been implanted (for example, while the implant is still in vivo). and means for receiving markings on implants and implants, and receiving information regarding specific identification of marked implants, viewing and identifying markings already present on the implants.
健康护理专业人员知道这样的事实：目前，植入物广泛用于在患者，人或动物，的身体中的植入。关于在使用者的身体中植入，存在各种原因和不同的起因，其中一些是不可避免的或必要的；而其中一些是只是可选的。有时存在医疗考虑，或审美原因和期望，或者多种不同的考虑和原因。Healthcare professionals are aware of the fact that implants are currently widely used for implantation in the body of a patient, human or animal. There are various reasons and different causes for implantation in the user's body, some of which are unavoidable or necessary; and some of which are merely optional. Sometimes there are medical considerations, or aesthetic reasons and desires, or a combination of different considerations and reasons.
大部分旨在植入患者身体的植入物可分为不同的种类。最常见的植入物为：Most implants intended to be placed in a patient's body fall into different categories. The most common implants are:
牙齿植入物：牙齿植入物为通常由钛(作为TiAl6V4化合物的一部分)制备的装置类型。制备植入物的金属为贵金属；换言之，不与身体产生化学反应的金属，因此，活体不运用其排异机制。植入物实际上是具有双螺杆要素的"挖洞器(dibble)"。第一个是外部的并且用于使植入物在颌部内锚接；第二个是内部的并且用于在植入物上锚接外部附件。这些附件称为恢复部分。Dental Implants : Dental implants are a type of device usually made of titanium (as part of the TiAl6V4 compound). The metals from which the implants are made are noble metals; in other words, metals that do not chemically react with the body, so that the living body does not employ its rejection mechanisms. The implant is actually a "dibble" with a twin screw element. The first is external and is used to anchor the implant in the jaw; the second is internal and is used to anchor the external attachment on the implant. These attachments are called recovery parts.
硅酮植入物：这些植入物由一种硅酮袋构成，例如通常用于整形手术的植入物。这些设计用于在胸部区域上植入，并且用于妇女的乳房扩大，或者例如用于在乳房切除术后的再构造手术。存在不同类型的硅酮植入物：一种类型是含有填充有盐水溶液的硅酮填料的外部硅酮袋。这些植入物为目前在美国使用的仅有的植入物。Silicone implants : These implants consist of a silicone pocket, such as those commonly used in plastic surgery. These are designed for implantation on the breast area and for breast augmentation in women, or eg for reconstruction surgery after a mastectomy. There are different types of silicone implants: one type is an external silicone bag that contains a silicone filler filled with a saline solution. These implants are the only implants currently used in the United States.
另一种类型的硅酮植入物为带有硅酮凝胶填料的植入物，其具有外部硅酮壳并且填充有硅酮凝胶。目前，这种类型的植入物在美国不用于植入物，尽管事实上法律规章已经做出的改变允许这种情况。然而，这种植入物适用于美国以外的许可该手术的60个国家中实施的植入物手术中的90％。Another type of silicone implant is a silicone gel-filled implant, which has an outer silicone shell and is filled with silicone gel. Currently, this type of implant is not used for implants in the United States, despite the fact that changes have been made to the law and regulations to allow this. However, the implant is suitable for 90% of implant procedures performed in the 60 countries outside the United States that license the procedure.
另外，纤维植入物，为这种植入物的第三种类型，其很少使用。Additionally, fibrous implants, a third type of such implants, are rarely used.
关节植入：关节置换为现代矫形术中最常见和最成功的手术类型之一。在患者遭受由于关节劣化(由关节炎、骨和软骨腐蚀或疾病导致)引起的痛苦和机能障碍之后，在手术操作期间，用能够使关节继续工作的人造关节置换患者的关节。全关节置换手术(关节成形术)指置换关节的全部；与之相对的是部分关节置换手术(半关节成形术)，其仅置换骨关节表面或关节内表面的部分。Joint Implants : Joint replacement is one of the most common and successful types of surgery in modern orthopedics. After a patient has suffered pain and dysfunction due to joint deterioration (caused by arthritis, bone and cartilage erosion, or disease), the patient's joint is replaced with an artificial joint that enables the joint to continue to function during a surgical procedure. Total joint replacement surgery (arthroplasty) refers to the replacement of all of the joint; as opposed to partial joint replacement surgery (hemiarthroplasty), which replaces only part of the articular surface of the bone or the inner surface of the joint.
存在其他类型的植入物，例如可模拟和置换使用者身体的某些器官或使用者身体的器官的部分的植入物；或者可促进具体的身体部分的工作的植入物，例如人造心脏、起搏器、设计用于加宽动脉的弹簧形式的"支架"、用于加强或连接器官的铂板等。在实践中，尽管事实上在患者的身体中的植入物在全世界相当常见，但迄今为止，还不存在对于可能意图从其中植入了植入物的身体的外部观察植入物的任何人而言，能够非侵入性地并且在不移除植入物的情况下简单鉴别在植入了植入物的身体中的植入物的方法。Other types of implants exist, such as implants that mimic and replace certain organs of the user's body or parts of organs of the user's body; or implants that facilitate the functioning of specific body parts, such as artificial hearts , pacemakers, "stents" in the form of springs designed to widen arteries, platinum plates to strengthen or connect organs, and more. In practice, despite the fact that implants in patients' bodies are quite common all over the world, so far there has not been any system for viewing implants from the outside of the body in which they may be intended to be implanted. A method that enables simple identification of an implant in a body in which it is implanted, non-invasively and without removal of the implant.
在已实施植入物后，某些人，例如治疗师，需要观察植入物以鉴别植入物和鉴别与具体的植入物相关的数据，例如，关于在植入物被植入时什么能够并且将与植入物、植入物的类型相关的信息、供应植入物的公司、关于植入物的信息、关于接受植入物的个体的任何信息等等。After the implant has been implemented, someone, such as a therapist, needs to observe the implant to identify the implant and to identify data related to the specific implant, for example, about what Information related to the implant, the type of implant, the company supplying the implant, information about the implant, any information about the individual receiving the implant, etc. can be and will be.
在不从其中植入了植入物的身体中移除植入物的情况下，通过本发明使得诸如这样的信息成为可能。使得使用在身体外部的装置非侵入地并且以如下方式观察已置于植入物上的标记成为可能：本发明其中一些应用中的标记将被提供给计算机程序，被鉴别，以及将发布相关的信息或者与标记关联的请求的信息。其中主要的原因在于：Information such as this is made possible by the present invention without removing the implant from the body in which it is implanted. Make it possible to use a device external to the body to observe markers that have been placed on implants non-invasively and in such a way that markers in some applications of the invention will be provided to a computer program, be identified, and related information or requested information associated with the tag. The main reasons are:
患者能够确保支付的植入物正是已在其身体中植入的植入物。以鉴别个体为目的(在他们的寿命期间、被警察识别，甚至在他们死亡后)。而且从医疗护理、牙齿治疗、康复、继续护理等等的方面。Patients can be assured that the implants they pay for are the ones that have already been placed in their body. For the purpose of identifying individuals (during their lifetime, being identified by the police, and even after their death). But also from medical care, dental treatment, rehabilitation, continuing care and so on.
需要以如下方式改进和适应系统和现有的植入物：能够非侵入地查看植入物；关于携带标记的植入物，尤其需要确保该标记是唯一的，而且可通过从其中已植入了植入物的身体的外部查看来观察植入物上的标记，而无需从身体移除植入物。以这种方式，观察者看到的标记将鉴别与植入物相关的信息，这是对于监测来说重要的数据。There is a need to improve and adapt the system and existing implants in such a way that the implant can be viewed non-invasively; in particular with regard to implants carrying a marker, it is necessary to ensure that the marker is unique and can be accessed through the External inspection of the body with the implant to observe the markings on the implant without removing the implant from the body. In this way, the markers seen by the observer will identify information related to the implant, which is important data for monitoring.
通过所述方法和标记的植入物，本发明能够提供这样的系统：通过该系统在植入物上安装编码，其可借助例如X-射线、MRI、US的装置和/或借助编码读取装置(光学的、数字的、电的、激光、声波和超声波、磁感应)被读取和解释。所有这些将在必要情况下避免移除植入物的需要，或者获得与植入物相关的信息。这种系统使得不必提前记录信息，包括关于植入物的信息，因为这可通过使用带标记的植入物来进行，并且这通过使用本发明实现的方法成为可能。By means of the described method and marked implants, the present invention is able to provide a system by which a code is mounted on the implant, which can be read by means of devices such as X-ray, MRI, US and/or by means of the code Devices (optical, digital, electrical, laser, sound and ultrasound, magnetic induction) are read and interpreted. All of this will avoid the need to remove the implant if necessary, or obtain information related to the implant. Such a system makes it unnecessary to record information in advance, including information about implants, as this can be done using tagged implants, and this is made possible by using the method implemented by the present invention.
发明内容Contents of the invention
本发明创新植入物的标记和植入物的鉴别以及带标记的植入物——借助于位于身体之外的外部和非侵入性装置。其以如下方式能够识别植入物：可以得到与包含在患者身体内的与植入物相关的所需信息，。系统的构件和带标记的植入物如下：The present invention innovates marking of implants and identification of implants and implants with markings - by means of external and non-invasive means located outside the body. It enables the identification of the implant in such a way that the required information related to the implant contained in the patient's body is available. The components of the system and the labeled implants are as follows:
用于植入的植入物被提供以不引起身体排异的标记。只要标记不与身体直接接触，并且如果由于材料组合物它们不会导致身体的排异反应，并且其中；Implants for implantation are provided with markings that do not cause rejection by the body. provided that the markings do not come into direct contact with the body and if they do not cause rejection by the body due to the composition of the material, and in which;
使用允许从外部装置观察的备选的器具和技术，实施标记植入物，以鉴别和监测植入物的区别性标记，并且其中；Marking the implant using alternative implements and techniques that allow viewing from an external device to identify and monitor the implant's distinctive markings, and wherein;
传输借助任选的外部设备观察到的标记，其将被转移至计算机化系统，包括操作程序和指定的软件，该计算机化系统将从植入物标记数据库鉴别具体的标记，并且其中；transmitting the markers observed by means of the optional external device, which will be transferred to a computerized system, including an operating program and designated software, which will identify specific markers from a database of implant markers, and wherein;
计算机化系统将为申请者提供与具体的植入物相关的信息。The computerized system will provide the applicant with information related to the specific implant.
其中通过本发明以如下方式并且通过如下技术进行植入物标记：允许非侵入性外部装置来鉴别仍植入在身体中的植入物上的标记。Wherein implant marking is performed by the present invention in such a way and by a technique that allows a non-invasive external device to identify the marking on the implant still implanted in the body.
其中标记和编码将被嵌入植入物的某部分上，或者可选地，将从植入物的某部分被除去，或者可选地，将被附加到植入物上，并且任选地，向其中加入材料层，以防止活体排异。wherein the marking and coding are to be embedded in some part of the implant, or alternatively are to be removed from some part of the implant, or alternatively are to be affixed to the implant, and optionally, Layers of material are added to it to prevent rejection by living organisms.
通过本发明将能够获得这样的与标记相关的各种信息：在不从其中已植入了植入物的身体移除植入物的情况下，通过用在身体外部的装置观察已在植入物上制成的标记，将具体的被识别的植入物分类。这将通过如下方式进行：将在本发明应用的部分上的标记和编码提供给计算机程序。例如，将照片提供给计算机，并且专用的软件将鉴别植入物上的编码和标记，并且将释放相关的信息、或者与被识别的标记和编码相关的请求的信息。By means of the present invention it will be possible to obtain various information related to markers that have been implanted by observing them with a device external to the body without removing the implant from the body in which it has been implanted. Markings made on the implant classify the specific implant being identified. This will be done by providing the computer program with the marking and coding on the part of the application of the invention. For example, a photograph is provided to a computer, and specialized software will identify the codes and markings on the implant, and will release the relevant information, or requested information related to the identified markings and codes.
通过所述方法和带标记的植入物，本发明能够提供这样的系统：用于在植入物上安装编码，该编码可借助位于身体外部的装置(例如X-射线、MRI、US)和/或借助编码读取装置(光学的、数字的、电的、激光、声波和超声波、磁感应)来读取和解释。这些全部将用于避免在必要情况下移除植入物的需要，或者得到与植入物相关的信息，此时带标记的植入物和本发明的方法使得本发明的目的成为可能。By means of the method and the implant with markers, the present invention can provide a system for installing a code on an implant that can be detected by means of devices located outside the body (e.g. X-ray, MRI, US) and /or read and interpret by means of coded reading devices (optical, digital, electrical, laser, acoustic and ultrasonic, magnetic induction). These will all be used to avoid the need to remove the implant if necessary, or to obtain information related to the implant, at which point the marked implant and the method of the invention make possible the objects of the invention.
附图说明Description of drawings
本专利申请中包括附图，以提供对本发明的更充分的理解。这些附图包括在这种分类细目的整体部分中，并且形成这种分类的整体部分。附图显示本发明的各种实施方式，连同说明书，用于解释操作本发明的原理和特征的目的。仅通过举例的方式进行所有这些，并且无论怎样没有使本发明仅局限于这些描述的意图。The accompanying drawings are included in this patent application to provide a fuller understanding of the invention. These drawings are included in and form an integral part of this classification. The drawings illustrate various embodiments of the invention, and together with the description, serve the purpose of explaining the principles and features of operating the invention. All of this is done by way of example only, and there is no intention in any way to limit the invention to these descriptions only.
图1为描述包括在本发明的范围内的应用中的一种的示意图，其呈现例如牙齿植入物100的制备，用于根据本发明的方法标记和编码。Figure 1 is a schematic diagram describing one of the applications included within the scope of the invention, which presents, for example, the preparation of a dental implant 100 for marking and coding according to the method of the invention.
图2为描述包括在本发明的范围内的应用中的一种的示意图，其显示旨在布置在牙齿植入物中的标记和编码构件的备选中的一种；例如，方式如下：根据本发明的方法，允许从位于身体外部的装置鉴别植入物。Figure 2 is a schematic diagram describing one of the applications included within the scope of the present invention, showing one of the alternatives for marking and coding means intended to be placed in dental implants; for example, in the following manner: according to The method of the present invention allows the identification of implants from devices located outside the body.
图3为显示图1与图2的组合的示意图，其是包括在本发明的范围内的应用中的一种。其呈现旨在布置在牙齿植入物中的标记和编码构件的备选中的一种，例如，使得可以根据本发明的方法从位于身体外部的装置进行识别。Figure 3 is a schematic diagram showing the combination of Figures 1 and 2, which is one of the applications included within the scope of the present invention. It presents one of the alternatives for marking and coding means intended to be arranged in dental implants, eg to enable identification according to the method of the invention from devices located outside the body.
图4为在身体外部呈现照片图像的示意图，显示根据本发明的方法观察到的牙齿植入物的区别性标记和编码。Figure 4 is a schematic representation of a photographic image presented outside the body showing the distinctive marking and coding of a dental implant observed according to the method of the present invention.
图5为显示根据早期技术，在妇女的胸中植入的硅酮植入物的实例的示意图。Fig. 5 is a schematic diagram showing an example of a silicone implant implanted in a woman's chest according to earlier techniques.
图6为显示在妇女的胸中植入的硅酮植入物的实例的示意图。其包括根据本发明可以借助在被植入的身体的外部的装置进行的标记和编码。Fig. 6 is a schematic diagram showing an example of a silicone implant implanted in a woman's breast. It includes marking and coding which can be carried out according to the invention by means of means external to the implanted body.
具体实施方式Detailed ways
对本专利申请包括的、此附录中的附图和被参考的附图的描述的目的是提供对本发明的更充分理解，并且包含物组成分类细目的整体部分。附图的描述呈现对本发明的各种实施方式的更详细的解释，连同附图和专利申请文件中的其他部分，用于解释本发明操作的原理和特征的目的。这些全部仅通过举例的方式进行，并且并非意图使本发明仅局限于这些描述。The description of the drawings and referenced drawings in this appendix included in this patent application is for the purpose of providing a fuller understanding of the invention and the inclusions form an integral part of the taxonomy. The description of the drawings presents a more detailed explanation of various embodiments of the invention which, together with the drawings and the rest of the patent application document, serve the purpose of explaining the principles and features of the invention's operation. All of this is done by way of example only, and it is not intended that the invention be limited to these descriptions only.
图1为描述包括在本发明的范围内的应用中的一种的示意图，并且其显示用于标记和编码的牙齿植入物100的制备，例如，根据本发明的方法。当以允许例如在已准备的部位106插入通过本发明可以进行的标记和编码应用中的一种的方式将牙齿植入物102的内部钻孔104加深时，该应用其中一种中的编码为在具有独特沟槽的圆柱体下部的一个实例。这能够进行鉴别，并且通过其鉴别而被调节，以提供例如在其中已植入牙齿植入物102的身体的外部的计算机系统中发现的信息。Fig. 1 is a schematic diagram describing one of the applications included within the scope of the present invention, and which shows the preparation of a dental implant 100 for marking and coding, for example, according to the method of the present invention. When the internal bore 104 of the dental implant 102 is deepened in a manner that allows insertion, for example, at the prepared site 106, of one of the marking and coding applications possible with the present invention, the coding in one of the applications is An example on the lower part of a cylinder with unique grooves. This can be authenticated, and through its authentication, adjusted to provide information such as found in a computer system external to the body in which the dental implant 102 has been implanted.
图2为描述包括在本发明的范围内的应用中的一种的示意图。其显示标记和编码构件150的备选中的一种，建立其应用中的一种，例如，作为处于各部分之间不同间隔和厚度的下部有槽圆柱体，以及圆柱体中独特的间隔152、154、156、158和160。当X-射线(例如在身体的外部)将呈现编码时，其将图像转移至识别与具体的植入物关联的信息的专用计算机软件。计算机系统然后根据本发明的编码的植入物和方法显示相关的信息或者使用者请求的信息。Figure 2 is a schematic diagram illustrating one of the applications included within the scope of the present invention. It shows one of the alternatives for the marking and coding member 150, establishing one of its applications, for example, as a lower grooved cylinder at various spacing and thickness between parts, and the unique spacing 152 in the cylinder , 154, 156, 158 and 160. When an X-ray (eg, outside of the body) will present a code, it transfers the image to specialized computer software that identifies information associated with a specific implant. The computer system then displays relevant information or information requested by the user according to the encoded implant and method of the present invention.
图3为描述图1与图2的组合180的示意图，例如包括加深牙齿植入物的内部钻孔184的植入物186的组合，以及指定用于布置在植入物中的编码和标记的器件182。这是包括在本发明的范围内的应用中的一种，其呈现用于标记和编码牙齿植入物的备选中的一种，例如，根据本发明的方法，可以通过从身体的外部鉴别植入物进行。FIG. 3 is a schematic diagram depicting a combination 180 of FIGS. 1 and 2, such as a combination of an implant 186 including a deepened internal bore 184 of a dental implant, and designation for coding and marking placed in the implant. Device 182. This is one of the applications included within the scope of the present invention, which presents one of the alternatives for marking and coding dental implants, for example, according to the method of the present invention, by identifying Implants are performed.
图4为呈现通过位于其中已植入牙齿植入物204和208的身体的外部的装置所拍摄的照片图像200的示意图。照片呈现了在接近牙齿202处在根据以下阶段读取和识别编码206时观察到的牙齿植入物208的独特标记和编码206：FIG. 4 is a schematic diagram presenting a photographic image 200 taken by a device located outside the body in which dental implants 204 and 208 have been implanted. The photograph presents the unique marking and code 206 of the dental implant 208 as observed close to the tooth 202 when the code 206 is read and recognized according to the following stages:
a.执行图像——例如，在本发明的方法允许的装置的应用中的一种中的X-射线。a. Performing images - eg X-rays in one of the applications of the device enabled by the method of the present invention.
b.将图像转移至计算机中的指定识别程序。b. Transfer the image to a designated recognition program in the computer.
c.使用软件实施读取和鉴别编码206。c. Reading and authenticating the code 206 is implemented using software.
d.根据本发明的方法，计算机提取与植入物208相关的数据。d. The computer extracts data related to the implant 208 according to the method of the present invention.
图5为显示根据早期技术在妇女胸232中通过手术植入234的硅酮植入物236的实例230的示意图。5 is a schematic diagram showing an example 230 of a silicone implant 236 surgically implanted 234 in a woman's breast 232 according to earlier techniques.
图6为显示在妇女胸中植入的根据早期技术的硅酮植入物252以及根据本发明的硅酮植入物256的实例250的示意图，其中硅酮植入物256包括根据本发明能够使用在被植入的身体的外部的装置来鉴别的标记和编码254。FIG. 6 is a schematic diagram showing an example 250 of a silicone implant 252 according to earlier technology and a silicone implant 256 according to the present invention implanted in a woman's breast, wherein the silicone implant 256 includes Marking and coding 254 for identification of devices external to the implanted body.
其中，在硅酮植入物256中，术语透明物(射线可透过)254——其上用惰性放射性材料例如钙、碘仿等印刷有身体中的鉴别编码。并且透明物的基体也具有惰性材料，例如硅酮。Therein, in the silicone implant 256, the term transparent (radiolucent) 254 - on which is printed an identification code in the body with an inert radioactive material such as calcium, iodoform, etc. And the matrix of the transparency also has an inert material, such as silicone.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IL22129412 | 2012-08-05 | ||
| IL221294 | 2012-08-05 | ||
| PCT/IL2013/000063WO2014024179A1 (en) | 2012-08-05 | 2013-08-04 | Method of marking and identifying implants, and marked implants, enabling data registration and identification of implants using a non-invasive device |
| Publication Number | Publication Date |
|---|---|
| CN104540468Atrue CN104540468A (en) | 2015-04-22 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380041201.XAPendingCN104540468A (en) | 2012-08-05 | 2013-08-04 | Method of marking and authenticating implants and marked implants capable of implant data registration and identification using non-invasive means |
| Country | Link |
|---|---|
| EP (1) | EP2879612A4 (en) |
| KR (1) | KR20150041059A (en) |
| CN (1) | CN104540468A (en) |
| RU (1) | RU2015102050A (en) |
| WO (1) | WO2014024179A1 (en) |
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| PB01 | Publication | ||
| EXSB | Decision made by sipo to initiate substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | Application publication date:20150422 | |
| RJ01 | Rejection of invention patent application after publication |