WO2022002468A1

WO2022002468A1 - Kit comprising a custom implant and at least one other element

Info

Publication number: WO2022002468A1
Application number: PCT/EP2021/062535
Authority: WO
Inventors: Mark KOENE; Klaus Roeser; Steffen Kuhn; Mike KOENE
Original assignee: R3Volution D Ag
Priority date: 2020-06-29
Filing date: 2021-05-11
Publication date: 2022-01-06

Abstract

The invention relates to a kit, consisting of an implant and at least one additional element selected from the group consisting of an adapter, anvil, tool and countersink, wherein the implant has a substantially cylindrical shape and comprises, in the longitudinal direction, three subregions each having variable geometric dimensions: a) a threaded region, b) a thread-free application region having an axial channel with radial through-openings, c) a head region as a tool attachment point for the insertion of the implant, the head region being provided with a point of access to the axial channel for the supplying of active substances and discharge via the radial through-openings, and the at least one additional element being specifically designed to cooperate with the custom implant and/or with one of the additional elements.

Description

Kit consisting of a tailor-made implant and at least one additional element

The invention relates to a kit comprising a tailor-made implant and at least one further element according to claim 1.

The surgical treatment of bone cysts, septic bone inflammation, metastases, in patients, especially humans and animals in general, often requires the use of implants, e.g. B. in the form of compression screws that are surgically inserted into the body part concerned.

However, conventional compression screws are made of stainless steel and are only available in specified sizes. In addition, stainless steel implants are not completely inert and create a biofilm so that such implants do not grow in. Therefore, these almost always have to be removed in a second operation.

Such implants also generate artifacts in conventional imaging processes.

In contrast, the object of the present invention is to provide a kit which overcomes these disadvantages.

This object is achieved by the kit reproduced in claim 1. Advantageous refinements result from the subclaims and the description.

The kit according to the invention makes it possible to avoid the above disadvantages, since the implants and the other parts of the kit are now made to measure to match one another, in particular by additive manufacturing (3D printing).

These are preferably implants in standard sizes or custom-made implants.

In other words, individually adaptable implants can preferably be produced on the basis of the patient data in the 3D printing process, in particular made of titanium or ceramic.

An optimal treatment without storage is thus possible. The other parts of the kit are then specifically adapted to the tailor-made implant. The use of 3D printable titanium and / or biocompatible ceramics means that a second operation is not necessary, as this is biocompatible and grows in or, in the case of ceramics, is resorbed.

The kit or the implants are suitable for both veterinary and human medicine.

The implant according to the invention, also independently, is in one piece and essentially cylindrical and elongated and has three in the longitudinal direction

Subareas each with variable (from the adaptation process described) geometric dimensions: a) a threaded area, b) a thread-free application area with an axial channel with radial passage openings, c) a head area as a tool attachment for inserting the implant, which has an access to the axial channel to the Supply of active ingredients and delivery via the radial passage openings is provided.

The implant is preferably made of titanium, in particular Ti64, and has a rough surface and optionally a density that can be variably adjusted by means of a sponge-like jacket structure. These features allow good compatibility and improved ingrowth with low weight.

Alternatively, the implant can be made from biocompatible ceramic. A ceramic made of silicon nitride is particularly suitable as a biocompatible ceramic. This material has the same density as human bone and its surface has a bactericidal and osteoinductive effect.

The (hole-free) thread area at the tip is used for insertion in the manner of a screw and preferably has a thread with a low notch effect. The thread area is particularly preferred especially for screwing into

Bone structures have been developed so as not to unnecessarily damage the bone.

The (thread-free) application area has a varying number and geometries of the passage openings in terms of their size and shape, in particular elongated holes, and is used to introduce treatment agents (pastes, liquids, etc.). These are the radial passage openings connected to the axial channel or open into this.

Depending on which medium the attending physician would like to use, the geometries of the passage openings vary in their size and shape, and possibly also the diameter of the axial channel. The use of so-called elongated holes, for example, has proven to be sensible for the dosing of low-viscosity medication with a high degree of screw-in resistance (hard bone substance) of the implant.

The passage openings can therefore be varied with regard to number and size and, if necessary, orientation during configuration. So could z. B. a helical arrangement of the longitudinal extension can be specified for elongated holes.

The head area is used to plant the tool for introduction, z. B. Screw in. It also serves as a counter area through the mechanical tensioning of the implant in the bone or for permanent fixation of the implant (interfragmentary compression) by means of an average enlargement.

In other words, the implant comprises three parts: head, porous shaft, self-tapping thread.

In the tailor-made variant, the dimensions (length and diameter) of the three sub-areas can be adapted to the specific conditions and vary from patient to patient and from application to application. Each implant is then unique. Each implant is based on a patient's individual digital data.

In the variant of the standard sizes, the three sub-areas can be designed in such a way that the majority of the conditions that usually occur can be treated with them.

The implant consists of three separate functional areas:

1. Tip with self-tapping thread with low notch effect (thread only in this area)

2. Application area with axial channel with variable and radial openings (free of thread) 3. Head / cone as a tool attachment and with access to the central channel for the supply of active ingredients and delivery via the variable and radial openings.

Due to the possible ready-made production based on patient data in the additive process (3D printing) from titanium, the dimensions / shape of the three areas can be made patient-specifically and there is also a rough surface and a density that is variable depending on the parametric data due to a spongy shell structure.

The product of the manufacturing unit is accordingly a function-integrated implant made of titanium, preferably Ti64 (Ti-6AI-4V), which is particularly preferably produced by selective beam melting or laser melting, e.g. B. is manufactured in the so-called DMLS process (Direct Metal Laser Sintering) and its dimensions may be based on the individual data of a "patient".

Ti64 (Ti-6AI-4V) is a high-strength titanium alloy and consists of titanium, 6 percent by mass aluminum and 4 percent by mass vanadium.

In addition, other materials can also be used, such as bioresorbable polymers, metals, composites and biocompatible ceramics (silicon nitride).

At the same time, applicators can be fixed to the implant in the head area via the adapter. The adapter can fix e.g. B. of medication hoses (leads) to the implant to allow z. B. to enable continuation of the medication through the implant into the bone after the surgical procedure. This adapter is then used intraoperatively either for a single application of regenerative drugs (biologics) or connected via a hose connector system to a drug pump for a longer permanent drug application at the target location in the bone.

The adapter is preferably - similar to the tool - adapted to the head area, so that it engages in this tool-like manner and couples a supply line with the axial channel in order to establish a fluid connection with the axial channel and thus in turn in connection with to enter the passage openings. The adapter can have a widened upper edge on the one hand, as a contact surface, and on the other hand an engagement tip which has a geometry adapted to the head of the implant with a torx-like hexagon socket and an inner cylindrical recess that extends through the entire adapter to accommodate a supply line . At the same time, the essentially cylindrical adapter can have a gap which allows the supply line to be clamped in the manner of a snap ring. After the surgical intervention, the medication can be continued through the implant into the bone via such a feed line.

To fasten the adapter, the kit can have the appropriate anvil, which enables the adapter to be pressed against the head area. The anvil is preferably designed in such a way that it does not interfere with a supply line (hose) attached to the adapter. For this purpose, the anvil is preferably designed with a slot-shaped recess in the area of interaction with the adapter, which allows it to be placed on the adapter despite the supply line. On the one hand, the anvil can have a widened upper striking surface and, on the other hand, a pressure tip which has a geometry adapted to the edge of the adapter. A gap can be provided in its cylindrical lateral surface, which allows the anvil to be used on the adapter without interaction with a fixed supply line, for which purpose the gap is open laterally (radially) and also axially downwards towards the pressure tip.

In order to improve the functionality of the implant, a tool specially developed for this purpose can be used as part of the kit, which is also individually manufactured using the additive process and engages the head area for insertion. For this purpose, the system is preferably set up to produce the tool that matches the implant by means of the production unit, likewise by means of additive production. This is preferably done in the same pass.

The tool, which is also manufactured individually to match the implant using the additive process, grips the implant to insert (screw in) Head area or its z. B. torx-shaped inside. To this end, it can on the one hand have a bit-like outer side in order to be received in a corresponding tool holder so that it cannot rotate, and on the other hand it can have an engagement tip which has a geometry adapted to the head with z. B. has torx-like hexalobular and inner cylindrical recess that extends through the entire tool.

The head area thickened to the application area or the complementary tool is inside or outside z. B. designed torx-like and has a through-channel on the axial channel. The geometry is designed similar to a screw head with a Torx Plus security feature, with the difference that the pin has the through channel on the axial channel.

Both the tool and the adapter have the right geometry with a Torx-like hexagon socket and an inner cylindrical recess or axial channel.

The kit optionally also includes a head space milling cutter that matches the head area of the implant. This can also be produced by the production unit by means of additive production, adapted to the individual implant (in particular its head area). The head space milling cutter enables a pretreatment of the insertion point of the implant or the entry opening, so that the thickened head area is sunk after the complete insertion of the implant. It therefore does not protrude and can remain or grow in.

The headspace milling cutter is also produced by the production unit using additive manufacturing, adapted to the individual implant.

For this purpose, it can on the one hand have a bit-like outer side in order to be received in a corresponding tool holder so as to be secure against rotation, and on the other hand it can have a milling cutter tip. A widening, which defines the milling depth as a stop, can be arranged between the milling cutter tip and the bit-like outer side. To simplify the positioning of the head space milling cutter on the pre-drilled implant insertion hole, the milling cutter tip can have a rounded axial guide nose at the end.

For the production of the kit or customized implants and the other parts or elements of the kit, a system comprising at least one input unit, a determination unit, a calculation unit and a production unit as system components can be used.

The input unit is used to feed the system with imaging patient data of the body part of the respective patient to be treated with the implant. The imaging patient data or digital data can be in Dicom (medical format for the transmission of data) and z. B. can be generated either from multiple X-ray, CT or MRT images / data in order to create a 3-dimensional data model.

These patient imaging data can e.g. B. can be read into the system via a website form.

The determination unit can now calculate optimized geometric dimensions of the implant on the basis of the fed-in patient data for the treatment of the part of the body to be treated and enable a control.

With the help of the doctor, the determination unit can generate an optimized geometry of the implant in a fully automated, partially automated or completely manual manner, which is incorporated into the calculation unit.

By means of a visualization of the affected part of the body, e.g. B. of the bone section, the doctor can digitally check the dimensions or, alternatively, determine or change them himself and thus indirectly define the manufacturing data for the 3D printing.

The system can therefore have a visualization and control unit for the simultaneous visualization of the imaging patient data and an implant image based on the optimized geometric dimensions of the implant for visual control by a doctor.

The calculation unit can then calculate production data from the optimized geometric dimensions of the implant and the system can pass these on to the production unit. So the calculation unit from the Create an optimized 3D model of the implant so-called STL files for additive manufacturing.

The determination unit and the calculation unit are designed accordingly in order to implement the variability of the passage openings.

The manufacturing unit is then used to manufacture the implant using the manufacturing data by additive manufacturing.

Production data for the individual implant are calculated from the individually generated data and accordingly processed to form a 3-dimensional image, and this is then produced using the additive method.

The system can comprise a correspondingly configured computer, such as one or more servers, which is / are programmed to provide the input unit, the determination unit and the calculation unit and to connect them via a suitable interface to the production unit for the transmission of the production data.

So z. B. the input unit receive data directly from the imaging devices or the system of the respective doctor. The input unit could also be used as a user interface in the form of an input mask, such as B. a website form, in which the data is selected and released for uploading.

The use of artificial intelligence is also conceivable. For this purpose, the digital data are continuously evaluated and identified via a deep convolutional neural network (cnn) based medical image classifier, on the one hand to identify the anatomical region but also to make a diagnosis of the disease.

A self-trained deep convolutional neural network is used, which continuously learns from the supply of Dicom data (X-ray, CT and MRT data), in which the result can be validated by the attending physician. This model consists of a classification branch and an attention branch. The classification branch acts as a unified feature extraction classification network and the classification branch uses the Correlation between class names and the areas of pathological irregularities and allows the model to focus on the pathologically abnormal regions.

As part of the system, not only the kit or implant and tool, adapter, anvil or headspace reamer can be individually produced, but also the affected anatomical body area (e.g. part of the affected bone) with its findings (e.g. B. the edema or the cyst) can be produced in any 3D printable materials, so that the doctor can perform a simulation on the individual exercise image (exercise body part) produced in this way in advance of the actual operation to avoid manual errors during the subsequent surgical procedure. Accordingly, realistic training can also take place on the exercise image for training purposes.

The system can accordingly be set up to also generate production data for the production of an exercise image of the body part to be treated by means of the calculation unit and to produce this by means of a production unit by means of additive manufacturing.

The system according to the invention allows a completely digital method (process chain) to be carried out for the production of the individualized implants.

In such a procedure, the following steps can be performed:

1. Generation of the imaging patient data by the attending physician.

2. Feeding or uploading of the corresponding X-ray, CT, or MRT data into the system in the input unit; the data can be scaled or scaled, if z. B. a measurement line was stored in the X-ray image data by measuring the pixels of the X-ray image.

3. Dimensioning of the geometric dimensions of the three sub-areas of the implant by the determination unit (e.g. neural network) and control or adjustment based on the experience of the doctor. Alternatively, not only is the doctor checked, but also the actual dimensioning. 4. Using suitable algorithms, the system can optionally check the specified dimensioning for plausibility.

5. As part of a visualization, there is at least one control of a scaled visual representation of the optimized implant with its dimensions and dimensions on a screen. Optionally, this can also be done via augmented reality.

6. The attending physician must then approve the data.

7. The production data are calculated on the basis of the data released in this way, and the production process is thus started after it has been transmitted to the production unit.

8. Depending on availability, the production on a 3D printer can be decentralized or locally closer to the order.

The individual implants of the kit produced by means of the system according to the invention can also cause fissures, fractures, bone infections,

Osteomyelitis, osteoporosis, metastases in the bone or vertebral body are treated. Retrograde antibiotic therapies can be administered via the bone marrow. The use of growth factors (regenerative biologics) in the case of badly healing bone fractures is made easier. A proactive additive prophylactic use of AO plates against infections as access is also possible.

In addition, the implants made of titanium or biocompatible ceramic enable all subsequent procedures that require advanced imaging procedures (MRT, CT), in which steel screws cannot be used due to the artefacts that arise.

Further details of the invention emerge from the following description of exemplary embodiments with reference to the drawing, in which FIG. 1 shows a schematic view of the system;

2 shows an exemplary implant with accessories, in each case in a side view and according to the American projection method with a view from above and from below; 3 shows the implant from FIG. 2 in different views; 4 shows the Torx bit from FIG. 2 in different views; 5 shows the adapter from FIG. 2 in different views; FIG. 6 shows the anvil in FIG. 2 in different views and FIG. 7 shows the head space milling machine from FIG. 2 in different views as well

FIG. 8 shows a flow chart of a digital process chain for producing the implant from FIG. 2.

FIG. 1 shows a schematic view of the system, designated as a whole by 1, for producing a kit from a tailor-made implant and at least one additional element selected from the group consisting of an adapter, anvil, tool and milling cutter.

The system 1 comprises an input unit 2 for feeding the system with imaging patient data of the body part of a patient to be treated with the implant. In the present case, this is an X-ray device 3 with which several X-ray recordings are generated from a patient in the area of the bone area to be treated. B. website on the Internet, can be uploaded to a suitably programmed server 5.

An automated determination unit is set up on the server 5 to determine the optimized geometric dimensions of the implant on the basis of the fed-in x-ray recordings and to check the implant on the basis of the adapted implant for treating the body part to be treated.

All three partial areas of the implant 100, the thread area, the application area and the head area, including the axial channel and the passage openings, are optimized. For this purpose, the imported x-ray data are first measured in the determination unit 6 and the geometric dimensions of the Implant optimized 7.

The doctor can use a scaled visualization 8 z. B. check the optimized geometric dimensions of the implant on the basis of the X-ray image on the corresponding website on his terminal device, adapt and release if necessary 9. This also applies to the sub-areas.

A calculation unit 10 connected to the server 5 via the Internet 12 is used to calculate production data from the optimized geometric dimensions of the implant.

These manufacturing data are then sent to a 3D printer 11 as a manufacturing unit, which works according to the DLMS method, and are used to control it in order to ultimately manufacture the implant 100 from Ti64 with the optimized geometric dimensions by additive manufacturing.

As part of the system 1, not only the implant 100, but also a tool 200 for inserting the implant, an adapter 300 for connecting medication feed lines to the implant, an anvil 400 for pressing the adapter and a head space milling cutter 500 for countersinking the Implant can be produced individually.

The implant 100 itself is in one piece and essentially cylindrical and elongated and has three partial areas in the longitudinal direction, a threaded area 101 arranged at one end, an application area 102 adjoining it in the longitudinal direction and a head area 103 at the other end, each with variable (from the described adaptation process ) geometric dimensions. The (hole-free) thread area 101 at the tip of the implant 100 is used for

Insertion in the manner of a screw and has a thread with a low notch effect. The thread area 101 is specially optimized for screwing into bone structures and for this purpose has a self-tapping thread 104 with a low notch effect in order not to unnecessarily damage the bone. The adjoining (thread-free) application area 102 has a multiplicity of radial passage openings 105, the size and shape and arrangement of which can be varied in the optimization process. The radial passage openings 105 are connected to an axial channel 106 starting from the head region 103 (and opened there) or open into this.

Depending on which medium the attending physician would like to use, the geometries of the passage openings 105 vary in their size and shape, and possibly also the diameter of the axial channel 106.

In the present case, the passage openings 105 are elongated holes, which has proven to be particularly suitable for the dosing of low-viscosity medication, with a nonetheless high screw-in resistance (hard bone substance) of the implant. The elongated holes 105 are arranged helically; H. arranged helically in the direction of the longitudinal extension in the outer jacket and aligned with its longitudinal extension in the direction of the helical line.

In the transition between the application area 102 and the head area 103 there is a non-perforated, smoother area 107.

The terminal head area 103 is enlarged in diameter compared to the rest of the implant and serves on the one hand as a tool attachment for inserting the implant and on the other hand as a counter area for mechanical bracing of the implant in the bone due to the average enlargement.

The thickened head region 103 has a head 108, which is designed in a torx-like manner on the inside and has a through-channel 109 on the axial channel 106. The geometry is designed similar to a screw head with Torx Plus Security. In addition to the torx-shaped inner side, it has an axially upright pin 110 which, in contrast to Torx Plus Security, has the through-channel 109 on the axial channel 106.

The implant 100 consists as a whole of Ti64 (from the DLMS process) and has a rough surface and a density that can be variably adjusted by means of a sponge-like jacket structure. These features allow a good one with a small weight Compatibility and improved waxing.

Due to the ready-made production based on patient data in the additive process (3D printing) from titanium, the dimensions / shape of the three areas can be made patient-specifically.

The tool 200, which is also individually manufactured using the additive method, engages the head region 103 or its torx-shaped inside 110 to insert (screw in) the implant 100. For this purpose, it has on the one hand a bit-like outside 201 in order to be received in a corresponding tool holder in a rotationally secure manner, and on the other hand an engagement tip 202 which has a geometry adapted to the head area 103 with a Torx-like hexagon and an inner cylindrical recess 203 which extends through the whole tool.

The adapter 300 is - similar to the tool 200 - adapted to the head area 103 so that it engages in this tool-like manner and couples a supply line to the axial channel 106 in order to establish a fluid connection with the axial channel, in turn to come into connection with the passage openings 105.

For this purpose, it has on the one hand a widened upper edge 301, as a contact surface, and on the other hand an engagement point 302, which has a geometry adapted to the head 108 with a Torx-like hexagon socket and an inner cylindrical recess 303 which extends through the entire adapter 300 take up a lead. At the same time, the essentially cylindrical adapter 300 has a gap 304 which allows the supply line to be clamped (indicated by dashed lines as 305) in the manner of a snap ring.

After the surgical intervention, the medication can be continued through the implant into the bone via such a supply line 305.

In order to press the adapter 200 into the head 108, the system 1 comprises a suitable anvil 400.

For this purpose it has, on the one hand, a widened upper striking surface 401 and, on the other hand, a pressure tip 403 which is adapted to the edge 301 Owns geometry. A gap 404 is provided in the cylindrical lateral surface 402, which allows the anvil 400 to be used on the adapter 300 without interaction with the attached supply line 305, for which the gap 404 is open laterally (radially) and also axially downwards towards the pressure tip 403.

The system also includes a head space milling cutter 500 that matches the head region 103 of the implant 100. This is also produced by the production unit using additive production to be adapted to the individual implant.

The head space milling cutter 500 enables a pretreatment of the insertion point of the implant or the entry opening, so that the thickened head region 103 is sunk after the complete insertion of the implant.

To this end, it has a bit-like outer side 501 on the one hand, so that it can be held in a corresponding tool holder so that it cannot rotate, and, on the other hand, a milling tip 502. Between the milling tip 502 and the bit-like outer side 501, a widening 503 is arranged which shows the milling depth as a stop. To simplify the positioning of the head space milling cutter 500 on the pre-drilled implant insertion hole, the milling cutter tip 502 has a rounded axial guide nose 504 at the end.

FIG. 8 shows a schematic flow diagram of a digital process chain for producing an implant 100.

In the first step I, the imaging patient data of the body parts to be treated are generated in the X-ray device 3 by the attending physician.

The X-ray data are then uploaded digitally to the server 5 in the DICOM format in the system 1 via the website (step II).

Then there is a visualized and scaled representation of the body part and the dimensioning of the geometric dimensions of the three partial areas of the implant 100 by the determination unit and control or adjustment based on the experience of the doctor (step III).

In the fourth step IV, the system uses suitable algorithms to check the specified dimensioning for plausibility. Thereafter, within the framework of the visualization 8, there is a control of the scaled visual representation of the optimized implant with its dimensions and dimensions on a screen (step V) and then the attending physician must release the data (step VI).

Using the data released in this way, the production data are calculated in step VII and finally the production process is started after it has been transmitted to the 3D printer 11 (step VIII).

Claims

1. Kit consisting of an implant and at least one additional element selected from the group consisting of an adapter, anvil, tool and head space milling cutter, the implant having an essentially cylindrical shape and three partial areas in the longitudinal direction, each with variable geometric dimensions: a) one Threaded area, b) a thread-free application area with an axial channel with radial passage openings, c) a head area as a tool attachment for inserting the implant, which is provided with an access to the axial channel for the supply of active substances and delivery via the radial passage openings, and at least one additional Element is specifically designed to interact with the customized implant and / or with one of the additional elements.

2. Kit according to claim 1, characterized in that the implant consists of titanium, in particular Ti64, or a biocompatible ceramic and has a rough surface and optionally a variably adjustable density through a sponge-like jacket structure.

3. Kit according to one of claims 1 or 2, characterized in that the thread area of the implant has a thread with a low notch effect.

4. Kit according to one of claims 1 to 3, characterized in that the application area of the implant has a varying number and varying

Has geometries of the passage openings in their size and shape, in particular elongated holes.

5. Kit according to one of the preceding claims, characterized in that the adapter is designed to be on the head region of the implant

Adapters to allow the applicators to be fixed to the implant.

6. Kit according to one of the preceding claims, characterized in that the anvil is designed to interact with the adapter in order to enable the adapter to be pressed against the head area.

7. Kit according to one of the preceding claims, characterized in that the tool is designed to match the head region of the implant.

8. Kit according to one of the preceding claims, characterized in that the head space milling cutter is designed to match the pretreatment of the location of the implant to the head region of the implant.

9. Kit according to one of the preceding claims, characterized in that all parts of the kit are produced by means of 3D printing.