WO2022038235A1

WO2022038235A1 - Method for providing an implant, implant, and use of the implant for reconstruction of a body part

Info

Publication number: WO2022038235A1
Application number: PCT/EP2021/073067
Authority: WO
Inventors: Dirk Hellekes; Lukas PORAK
Original assignee: Dirk Hellekes
Priority date: 2020-08-19
Filing date: 2021-08-19
Publication date: 2022-02-24
Also published as: DE102020121761B3

Abstract

The present invention relates to a method for providing an implant (1) for a patient, in particular an implant (1) with vital cartilage, tissue or bone, having a three-dimensional digital model of a container (2) with a lumen (15) which is surrounded by a wall (10) and with a closable opening (20), said method being characterised by: forming the closable container (2) from a biodegradable material in an additive process, the wall (10) being formed at least in some sections so as to be suitable for diffusion; filling the container (2), in particular with vital cartilage, vital bone and/or vital tissue; and closing the opening (20) of the container (2). The present invention additionally relates to an implant (1) and to the use of the implant (1) for reconstruction of a body part of a patient.

Description

Method for providing an implant, implant and use of the implant for body part reconstruction

The present invention relates to a method for providing an implant for a patient, in particular an implant with vital cartilage, tissue and/or bone, with the features of patent claim 1, an implant for a patient with the features of patent claim 20 and the use of the implant for the reconstruction of a body part, in particular a human ear or a nasal septum, with the features of patent claim 30.

Methods for providing an implant and implants are already known from the prior art in different configurations. Trauma or tumor diseases can lead to a loss of a patient's tissue structures that contain cartilage structures that provide the shape. Such structures can also be absent due to the nature of the system. Ears and nose, for example, are parts of the body that are formed by cartilage structures that give shape. A loss or absence of these body parts can lead to a significant impairment of the patient, which is why there is an effort, particularly in head and neck surgery, to replace the loss or the hereditary absence of these body parts with reconstructions.

In the prior art, the missing tissue can be replaced by various measures, the tissue being brought into a permanent, required form which can correspond to the lost tissue. For example, such cartilage-supported and skin-covered areas are reached by a skin covering of the transplanted cartilage and parts of the body parts, especially noses and ears, up to a complete reconstruction.

One method known in the art involves harvesting a block of tissue, for example by harvesting costal cartilage. The block of tissue is formed into a suitable cartilage implant by “carving”, with the implant formed in this way having an inherent stability and, if necessary, being reinforced and joined by thread material or supporting structures.

A disadvantage of this method known from the prior art has been shown to be that the shaping of the implant requires a great deal of time and that the implant produced has a low degree of precision and therefore does not meet the individual needs of the patient. In particular, the enormous amount of time required to shape the implant lengthens the surgical intervention and entails corresponding health risks. The "carving" procedure, which can also be understood as a subtractive procedure, has also shown that the success of an intervention depends to a large extent on the practice of the staff and significant amounts of potential donor material accumulate as waste.

Another approach is known from the prior art, in which the patient's own cartilage is chopped up into fine pieces using a knife and the fine pieces are formed into a cartilage-fibrin implant using fibrin glue and a negative mold. For example, injection syringes cut in half are used as a negative mold, with the pieces of cartilage and the fibrin glue in the negative mold to form the cartilage-fibrin implant. This approach is also referred to as "diced catilage" or "Turkish delight" in nose surgery.

During the implantation of the cartilage-fibrin implant, no pressure forces must act on the cartilage-fibrin implant, otherwise unintentional changes in shape and injuries may occur. The cartilage-fibrin implant also has the disadvantage of only having a low support function, which is why there is an increased risk of injury and the goal pursued with the surgical intervention is missed.

This is where the present invention comes in.

It is the object of the present invention a method for providing an implant or. to provide a method for the reconstruction of a body part that improves the methods known from the prior art in an expedient manner and eliminates their disadvantages. The method should enable precise shaping of the body part to be reconstructed, enable a reduction in the duration of the operation and increase process reliability. A temporary support function of the cartilage reconstruction should also be realized in order to ensure the continued success of the surgical intervention.

These objects are achieved by a method having the features of patent claim 1 , an implant having the features of patent claim 20 and using the implant to reconstruct a human body part , in particular an auricle or a nasal septum having the features of patent claim 30 . Advantageous developments of the invention are specified in the dependent claims.

The inventive method for providing an implant tates for a patient, in particular an implant with vital cartilage, tissue and / or bone, with the features of claim 1 is characterized in that a three-dimensional digital model of a container with a lumen enclosed by a wall and a closable opening is generated. The digital model of the container can be a CAD model known from the prior art, which can be stored on a digital storage medium based on data. After the three-dimensional digital model of the container has been created, the closable container is formed from a biodegradable material in an additive process, with the wall of the container being diffusible at least in sections.

The term “diffusible” is used below to mean a property of the wall that either forces an exchange of liquid, substance and/or gas through the wall or allows it due to Brownian molecular movement. The term “biodegradable material” includes all materials that are biologically degradable in the human body and can be broken down by biological processes in the human body.

A patient in connection with this invention can be a human being or another living being, in particular a horse, dog or the like.

After physically creating the sealable container from the biodegradable material, also known as a "scaf- fold" or "scaffold", the lumen in the container is filled, in particular with vital tissue, vital cartilage and/or vital bone, and in a further process step the opening is closed by a closure or a lid so that the filling of the Lumens loss-proof enclosed in the lumen. The diffusible wall is preferably configured in such a way that the filling cannot escape from the lumen through the wall.

The present invention is based on the idea of providing an implant for a patient, which can be designed to be individually adapted to the patient and his/her anatomy and, in addition, a container can be prefabricated in advance of a surgical intervention to reconstruct a part of the patient's body. The prefabrication of the container saves time, since the filling of the container, in particular the vital tissue, cartilage and/or bone, does not have to be shaped in a complex manner. This can shorten the duration of the operation. A temporary support function of the implant is also ensured by the method according to the invention, as a result of which high precision is ensured and the reconstructed body part is less sensitive to the effects of force during the healing process. The proposed method also offers the advantage that the quality of the formed reconstruction or implant is less dependent on the practice of the staff and, moreover, the removal of material for filling can be designed more precisely and efficiently.

The body part in the context of this invention can be a complete body part or a partial area of a body part, in particular a cartilaginous partial area or a cartilaginous Be part of . For example, the body part can be an ear or an outer ear, an auricle or components thereof such as helix, antihelix auriculae, tragus, antitragus, triangular fossa, scapha, etc. or parts thereof. The body part can also be the nose or parts of the nose, e.g. B. septum, alar or triangular cartilage or the like. However, this list of examples is not exhaustive. Rather, a body part can be understood to mean any partial area of a body that can be reconstructed using an implant according to the invention.

A preferred development of the method provides that the three-dimensional digital model is generated using parameter input and/or a 3D scan. In particular, it is possible to provide the three-dimensional digital model according to the individual requirements of the patient, with a reconstruction of the body part, for example a septum of a nose, i.e. a so-called neoseptum, aesthetic aspects and ideas of the patient in addition to the anatomical requirements when designing the reconstruction can be included. Either the digital model can be created generatively or be generated algorithmically or using CAD models. Such a parameter input can be understood as parametric modeling, which includes the logical connection of geometric elements. It can also be possible to record the shape of the body part to be reconstructed by means of a scan or 3D scan or a simulation. For example, in paired body parts z. B. the ears the opposite ear of the patient be the basis for the digital model of the container. Using the example of a reconstruction of an ear, parts of the container can also be rithms are generated. The diffusible constituents or sections can be created by an appropriate algorithmic manipulation of an originally closed surface.

The digital model can also be generated by free CAD drawing, for example the model can be created using images from an imaging process, e.g. B. an MRI , can be generated . For this purpose, a corresponding image from the MRT can be used for the construct when creating the model digitally. A corresponding data processing or data manipulation can use the data of the digital model for the body part to be reconstructed or convert ear .

In addition, it has proven to be advantageous if the three-dimensional model is scaled, as a result of which, for example, the resorption of the biodegradable material used is taken into account. Due to the resorption of the biodegradable material used, the implant "shrinks" over time until the container is completely absorbed. It can therefore be advantageous to take the resorption into account when generating the three-dimensional model, which is exactly reproduced in the additive process to achieve the best possible aesthetic result .

A further development of the method according to the invention provides that when the sealable container is produced, the wall is produced with an opening section surrounding the opening and a wall section, the wall section being configured to permit diffusion through the wall by means of a perforation. The opening section can be diffusion-tight. According to a development of the present method, the perforation is formed by a lattice structure, a network structure and/or a hole structure, each with a plurality of perforation openings, the wall having an open area of 10% to 90% and/or a width of each perforation opening is < 5 mm. The open area is preferably approx. 25% - 75% and even more preferably approx. 50% ± 10%, the open area describing the ratio between the area blocked by the wall and the area of the perforation openings. With an open area of 0%, the wall is completely closed. When choosing the open area, it is important to remember that the open area should be as large as possible to ensure maximum diffusion and nutrient supply while maintaining mechanical integrity.

In accordance with a preferred development of the method, the opening section forms a reinforcement surrounding the opening. The stiffening of the opening section is characterized in that the stiffness of the stiffening is greater than a corresponding segment of the wall, with the stiffness preferably being at least twice as great as the stiffness of a corresponding segment of the wall. Here and below, a strapping reinforcement is understood to mean a reinforcement which preferably completely surrounds the opening. Further reinforcements can be provided in order to specifically improve the support function of the implant.

Furthermore, it has proven to be advantageous if the opening section is designed during manufacture of the container in such a way that two wall sections are arranged at a distance from one another on opposite sides of the container. The opening section or The stiffening in the opening section can set a constant distance between the two opposite wall sections in a circumferential direction or specify a variable distance.

A further advantageous implementation of the method provides that the container is cleaned and/or sterilized before filling. In particular, it can be advantageous if the container is made available and sterilized before the operation. The container is preferably made available before the operation and sterilized by gas sterilization, preferably using ethylene oxide, with the sterilization lasting between 6-12 hours in order to achieve hygienic conditions. The container can, for example, be reserved for the OP in a sterile environment, in particular in a packaging container, but it is also possible to provide and sterilize the container ad hoc during the OP due to necessary changes using the additive method. Even in the event of unforeseeable complications, a container for the implant that is individually adapted to the patient can be provided in order to be able to carry out the reconstruction of the body part. It can also be advantageous if several containers with different parameters or Sizes are provided in particular before the surgical intervention. If changes are required, a suitable container can be used without significant delay.

A preferred development of the method provides that the container is formed from two half-shells and that the two half-shells can be connected. The two half-shells can be easily filled with the filling, in particular with the vital cartilage, the vital Bone and / or the vital tissue, stocked or. be filled . The two half-shells can be connected at the respective opening section, with the opening section preferably being arranged in a sectional plane of the container which has the largest area. The two half-shells can be connected frictionally, non-positively, materially and/or positively, with the two half-shells preferably being able to be plugged together. Accordingly, one of the two half-shells forms a cover or closure for the opening of the other. Also, individual half-shells with different parameters or Sizes are provided in order to have a choice during the surgical procedure, whereby a suitable container can be assembled without significant delays.

Furthermore, it has proven to be advantageous if the two half-shells can be connected by a seam, in particular a surgical seam made of a more preferred biodegradable suture material.

In accordance with an advantageous embodiment of the present invention, the two half-shells can be produced in the connected state. Alternatively, the two half-shells can be manufactured separately from one another, with production-related advantages being associated in particular with the creation of the two half-shells in the connected state.

A development of the present method provides that vital cartilage tissue, vital tissue or vital bone is removed from the patient before the container is filled. The vital cartilage tissue, the vital tissue and/or the vital bone can, for example, come from the inside of the nose, the opposite ear or from the rib region, but is this list is not complete and exhaustive. Rather, tissue, cartilage, bones, but also individual cells or stem cells can be removed from the patient's body and filled into the container. For example, a bone can be reconstructed using a container filled with bone, which bone can be obtained from the traumatized bone, or from any other bone in the patient. Also, and this should be noted at this point, it is not absolutely necessary that the vital tissue, the vital cartilage or the bone come from one and the same patient. The tissue, the cartilage and/or the bone can also be removed from a donor, corresponding to an allotransplantation.

It can be advantageous if, before filling the container, the filling, in particular the cartilage, bone or tissue, is comminuted, with the comminuted pieces preferably being larger than the perforations in the wall in order to prevent the filling from being accidentally lost from the container .

Fibrin glue may be applied to the cartilage, tissue and/or bone to improve the internal adherence of the pieces of cartilage, tissue and/or bone.

After the container has been filled and closed, the implant is ready for implantation in the patient and can be implanted in the patient. The implant can preferably be fixed in a body cavity or body opening in the region of the patient's body part to be reconstructed, biodegradable thread material preferably being used for the fixation. The fixation can be done either with a surgical suture through the perforated tion breakthroughs in the wall, or fastening means can be provided on the container, which enable such a fixation. The fastening means can, for example, comprise eyelets, loops or the like, which protrude from the wall of the container and are formed integrally with the container in the additive manufacturing process.

According to a further advantageous implementation of the method, a biodegradable polymer, a biodegradable plastic, a biodegradable tissue or a curable cell suspension is used to form the container. For example, a polylactide (PLA) or Polylactic acid are used, which is a biodegradable polyester and can be obtained from polymerized monomer lactic acid. PLA can also be used as PLA mixtures, also in connection with other materials or material mixtures. Polyhydroxy fatty acids (PHF) can also be used. The best-known representatives are polyhydroxybutyrate (PHB) and polyhydroxyvalerate (PHV). In addition, poly-p-dioxanone or for the formation of the container. PDS , PPDX or PPDO can be used .

Furthermore, it has proven to be advantageous if a material mixture or several components are used to form the container. In particular, it can be advantageous if materials with different degradation times through to permanence are used, with at least one component being biodegradable. For example, a biodegradable material can be combined with metal or other materials, as a result of which different degrees of dimensional stability or partial absorbability of the container or parts thereof can be achieved. In particular, according to a further preferred embodiment of the method according to the invention, provision is made for inclusions to be provided within the wall during the production of the container. An agent can be enclosed in the respective inclusion, the agent containing an active substance, for example. By arranging the at least one inclusion in the wall, the active substance can be released in a targeted manner at a point in time, whereby wound healing can be improved, for example, or a rejection reaction by the patient's body can be prevented.

Another aspect of the present invention is the use of the method described above and its advantageous developments for the reconstruction of a body part of a patient, preferably human body parts, in particular an auricle or a nasal septum or other cartilaginous parts or partial areas of the nose (e.g. nostrils or triangular cartilage , tip of the nose and/or parts thereof) or the ear or the auricle .

Another aspect of the present invention relates to an implant for the reconstruction of a body part of a patient, in particular a human body part, in particular an auricle or a nasal septum, in particular for carrying out the method described above and its advantageous developments, having a container with a wall enclosed Lumen and a closable opening, wherein the container is made of a biodegradable material in an additive process, and the wall is at least partially diffusible. Thanks to the additive process, the container of the implant are built up in layers, creating a surface precision which, after the implantation of the implant, due to an enlarged surface, promotes resorption of the biodegradable material by the human body.

According to a further advantageous embodiment of the implant, the wall can have an opening section surrounding the opening and a wall section, the wall section having a perforation with at least one, preferably with a plurality of perforation openings. The perforation openings enable gas and/or substance exchange through the perforation openings in the wall, as a result of which the implant filled with vital tissue, vital cartilage and/or vital bone is supplied by the patient's body after implantation.

It has proven to be advantageous if the perforation is formed by a lattice structure, a net structure and/or a hole structure and has an open area of 10% to 90%. An open area of 0% corresponds to a completely closed area. In order to prevent a loss of the vital tissue, vital cartilage and/or vital bone arranged in the lumen, the width of a perforation opening should be less than 5 mm or be smaller than the inserted pieces of vital cartilage, vital tissue and/or vital bone.

In addition, it has proven to be advantageous if the opening section has two wall sections spaced apart on two opposite sides of the container. The opening section can surround the two wall sections in one keep running direction at a constant distance or the distance can specify any desired distance between the two wall sections arranged on opposite sides in the direction of circulation.

According to a further development of the present invention, the container can be formed from two half-shells, the two half-shells each having a wall section and an opening section, and being connectable at the respective opening section. The two half-shells together enclose a lumen, whereby the two half-shells can be easily filled with a filling. The filling can also be provided with fibrin glue, for example, in the two half-shells that form the lumen.

The two half-shells forming the container can preferably be connected to one another in a frictional, form-fitting, non-positive and/or material-locking manner, with the two half-shells preferably being able to be plugged together. The opening of the container is closed by the friction, positive, non-positive and/or material connection between the two half-shells. When the two half-shells are plugged together, the two half-shells can wedge and thus form a resilient connection.

Furthermore, it has proven to be advantageous if a reinforcement surrounding the opening is provided. The stiffness of the reinforcement is preferably greater than a corresponding segment of the wall or. of the wall section, the rigidity preferably being at least twice as great as the rigidity of a corresponding segment of the wall. The stiffening can in particular form corresponding plug-in areas that can engage in one another. Furthermore, it has proven to be advantageous if the container is polygonal, in particular triangular, circular, oval or shell-shaped. In a preferred embodiment, the container is triangular and the circumferential end faces form the opening section or. the stiffening with the plug-in area, while the opposite main surfaces form the diffusible wall. The polygonal shape can be modeled on the shape of a nose, with the outer circumference being designed according to patient-specific parameters. The stiffening or the opening sections form a supporting frame, which is modeled, for example, on the shape of the bridge of the nose, a tip of the nose and a bridge of the nose of the patient in a reconstruction.

A development of the present invention provides that the container is designed in the shape of a torus. The two half-shells of the toroidal container can be shell-shaped. An opening in the toroidal container can form the auditory canal, for example, in the case of an implant for the reconstruction of an ear.

According to a further advantageous embodiment of the present implant, at least one inclusion can be provided in the wall of the container. The at least one inclusion in the container can be arranged at a predetermined distance from an outside and/or an inside of the wall, as a result of which the at least one inclusion in the container is uncovered after implantation during biodegradation at a specified point in time. A plurality of inclusions can preferably be provided, which are distributed on the one hand over the wall of the container can, and can also be arranged at different distances from the inside and/or the outside.

An agent, in particular a drug, which can contain an active substance, can be provided in the at least one inclusion. The agent can, for example, promote wound healing or prevent a rejection reaction of the patient's body. The rejection reaction of the patient's body can thus be prevented until the foreign body, namely the container made of a biodegradable material, has decomposed. An implant designed in this way combines a support function with a (medicinal) agent delivery system.

A preferred development of the present invention provides that the container produced in the additive process is made from a biodegradable plastic, tissue and/or from a cell suspension. In particular, it is preferred if the material used for the container is completely resorbed or absorbed by the human body. can be degraded, whereby no residues of the container of the implant remain on the body part of the patient after complete biodegradation.

A further aspect of the present invention relates to the use of the implant described above and its preferred developments for the reconstruction of a human body part and/or a cartilage-supported structure, in particular an auricle or a nasal septum.

Two exemplary embodiments of the method according to the invention are described below with reference to the accompanying drawing. rens and an implant according to the invention are described in detail. Show it :

FIG. 1 shows a schematic and perspective representation of a container of an implant for the reconstruction of a septum,

FIG. 2 shows a side view of the container according to FIG. 1,

FIG. 3 shows a sectional view of the container along the section line A-A according to FIG. 2, with a lumen in the container being filled with a filling,

FIG. 4 shows an exploded view of the container according to FIGS. 1-3, with a lumen in the container being filled with a filling,

FIG. 5 shows a schematic and greatly simplified illustration of a container, which is designed in the shape of a torus, for an implant for the reconstruction of an ear and

FIG. 6 shows a schematic and highly simplified representation of the method for providing an implant, in particular an implant with vital cartilage, tissue and/or bone, for a patient.

Identical or functionally identical components are identified below with the same reference symbols. For the sake of clarity, not all identical or functionally identical parts are provided with a reference number in the individual figures. The perspective representation according to FIG. 1 shows a container 2 of an implant 1, which can be used for the reconstruction of a part of a patient's body, in particular a septum.

The container 2 according to FIGS. 1-5 is produced in an additive process, for example by means of 3D printing, and can be produced layer by layer during the additive manufacturing process. The container 2 is made from a biodegradable material, which can be degraded in the patient by biological processes, preferably completely and without residues. In a preferred embodiment, the container 2 can be made of poly-p-dioxanone, for example, with this material being characterized in that it can be produced in an additive manufacturing process, such as free-jet binder application, material application with directed energy input, material extrusion, free-jet material application, powder-bed-based Melting, layer lamination and bath-based photopolymerization is processable. The device used to produce the container 2 can produce the container 2 from a digital model, preferably from a three-dimensional model, CNC (Computerized Numerical Control) with high precision.

The container 2 comprises a wall 10 which encloses a lumen 15 . In addition, the container 2 has a closable opening 20 through which a filling can be introduced into the container 2 . The opening 20 can be closed by a closure or cover.

The wall 10 of the container 2 is at least partially formed diffusible, whereby a substance f exchange - like will be described later in detail - can take place between the lumen 15 and an area surrounding the container 2 through the wall 10 .

The wall 10 can be divided into an opening section 12 and a wall section 14, with the opening section 12 being arranged around the opening 20 and being non-diffusible and the wall section 14 being diffusible.

The opening section 12 can be designed as a reinforcement 13 which is characterized in that the rigidity of the reinforcement 13 is greater than a corresponding segment of the wall section 14 . The reinforcement 13 encircles the opening 20 and on the one hand forms a stable support structure for the container 2 and enables the opening 20 of the container 2 to be securely closed. Additional stiffeners 13 can be formed at any point on the container 2 .

The wall section 14 has a perforation 40 which is formed from a plurality of perforation openings 45 . The perforation 40 can be formed by perforation openings 45 of any configuration, with the perforation 40 being formed by a lattice structure according to the exemplary embodiment shown. Alternatively, the perforation 40 can also have a network structure and/or a hole structure.

The perforation openings 45 can be arranged in such a way that the wall section 14 has a relative open area A _o of A _o *50%. However, the open area A _o can be made arbitrarily large or small as long as a width of the perforation openings 45 does not exceed a value that would allow the filling in the lumen 15 to exit the lumen 15 through the perforation openings 45 . In a preferred embodiment of the present invention, the width of the perforation openings 45 is at most 5 mm.

As can be seen in particular from the sectional representation according to FIG. 3 and the representation according to FIG. Each of the two half-shells 21 , 22 has a wall section 14 and an opening section 12 , the two half-shells 21 , 22 being able to be fitted together in the opening sections 12 . One of the two half-shells 21, 22 forms a cover for the opening 20 of the respective other half-shell 21, 22.

For this purpose, the opening sections 12--as can be seen in particular from FIG. In the assembled state of the two half-shells 21, 22, the opening sections 12 or the mutually corresponding plug-in areas 16 wedge, whereby the two half-shells 21, 22 can be connected to each other. In addition or as an alternative, the two half-shells 21, 22 can be connected to one another by means of a positive, non-positive and/or material connection. It is also conceivable to connect the two half-shells 21, 22 by means of a snap-in closure and/or by means of an adhesive connection.

The shape of the container 2 can be designed as desired. In the first embodiment shown in Figures 1-4, the Container 2 can be approximately triangular in shape and thus be modeled on the shape of a patient's nose. The exact shape of the container 2 can be patient-specific, with the digital model of the container 2 being formed either by entering a large number of values or parameters or by measuring the patient. The model can be manipulated at will in order to take account of the patient's individual wishes or ideas. In particular, simulations can be used to generate the model of the container 2 in order to illustrate the desired reconstruction result and to be able to make adjustments.

While the side surfaces of the container 2 are formed by the circumferential opening section 12 with the stiffening 13, the main surfaces of the wall 10 are designed as a wall section 14 capable of diffusion. After the container 2 has been implanted in the patient, the reinforcement 13 provides support and contributes significantly to the shape of the reconstructed nose.

FIG. 5 shows a first half shell 21 of a container 2 for the reconstruction of a human ear. The shape of the half-shell 21 of the container 2 can be approximately described as shell-shaped, with the container 2 having a toroidal opening which is later to form an auditory canal for the patient. Otherwise, the container 2 according to FIG. 5 can be designed analogously to the container 2 according to FIGS. 1-4 and the lumen 15 in the container 2 can be closed by connecting the two shell-shaped half-shells 21 , 22 . It should be noted at this point that the wall sections 14 of the two half-shells 21, 22 can have different shapes in order to be able to reproduce the body part to be reconstructed in detail. A method sequence for providing an implant 1 for the reconstruction of a body part, in particular a nose, or a nasal septum or an ear , with a container 2 . The container can be designed according to an exemplary embodiment described above and have a wall 10 which is designed to be diffusible at least in sections and which encloses a closable lumen 15 .

In a first method step 110 a digital model of the container 2 is generated. As already described above, the digital model can be generated in any way. For example, various parameters can be used for a reconstruction of a septum, a so-called neoseptum, in order to describe the shape of the bridge of the nose, the tip of the nose and the bridge of the nose. The properties, in particular for the functional wall, of the container can be generated generically, it also being possible to use parameters for the generic generation, in order to specify, for example, the open area and the maximum width of an opening. For example, the opposite ear of the patient can serve as a model for an implant 1 for the reconstruction of an ear. The digital model for the container 2 of the implant 1 can be derived, for example, from a 3D scan, with the data being converted, transformed and/or scaled by appropriate data manipulation or data processing in order to create a digital model suitable for the reconstruction of the respective body part provide a container 2 .

After the first step 110, in a second

Method step 120 of the container 2 using a biodegradable material are produced in an additive process. The two half-shells 21 , 22 of the container 2 can be manufactured in the detachable and connected state or separately, in which case manufacturing in the detachable and connected state can offer manufacturing advantages. For example, with powder-based melting, a smaller powder pool can be used and/or the manufacturing process takes less time.

At least one inclusion (not shown) can be formed in the wall 10 of the container 2 during the additive manufacturing of the container 2 . The inclusion can be arranged in the wall 10 of the container 2 precisely at predetermined positions between an inside facing the lumen 15 and an outside facing away from the lumen 15, whereby the inclusion is exposed at a predetermined point in time during subsequent biodegradation in the patient. For example, an active substance which promotes wound healing or prevents a rejection reaction of the patient's body can be arranged in the inclusion. It goes without saying that a large number of inclusions can be arranged at different positions in the wall 10 of the container 2, as a result of which one or more active substances can be released in a targeted manner over a period of time.

After the container 2 has been produced in method step 120, the container 2 can be cleaned and/or sterilized. Method steps 110 and 120 can be carried out in advance of an operation. suitable for surgery or The container 2 can be provided sterile for the OP, resulting in a time saving in the OP due to this prefabrication. In a subsequent method step 130 , the lumen 15 of the container 2 is filled, with the container 2 preferably being able to be filled with vital tissue, vital cartilage and/or vital bone, as shown in FIG. 4 . At least one of the half-shells 21, 22 can be filled.

The vital tissue, vital cartilage and/or vital bone can be removed from the patient (autotransplantation) or from a suitable donor (allotransplantation), with the cartilage tissue, for example, being taken from uninjured areas of the patient's body, in particular from the inside of the nose, the opposite ear or from can be taken from the rib region.

The vital tissue, the vital cartilage and / or the vital bone can, respectively. can be crushed either mechanically or manually, the pieces formed during crushing should not be smaller than the width of the perforation openings 45 . This ensures that the reduced pieces cannot escape from the lumen 15 of the container 2 through the perforation openings 45 .

In a subsequent step 140, the container 2 or. the lumen 15 is filled with the vital tissue, vital cartilage and/or the vital bone, it being possible for the vital tissue, the vital cartilage and/or the vital bone to be provided with a fibrin glue both before and after the filling of the container 2 , to check the inner adherence of the particles resp. to improve cartilage bits . When using a container 2 made of two half-shells 21, 22, either the two half-shells 21, 22 can each be filled, or only one of the two half-shells 21, 22. After the container 2 has been filled in method step 140, the opening 20 of the container 2 is closed. When using two half-shells 21, 22—as described in the exemplary embodiments with reference to FIGS. 1-5—the two half-shells 21, 22 can be plugged together. Alternatively, a cover of any design can be placed on the opening in order to close the opening.

The two half-shells 21, 22 can also be connected to one another by means of a material connection, in which case fibrin glue can be used, for example, in order to bring about a material connection between the two half-shells 21, 22. Also, the lid with the container 2 or the two half-shells 21, 22 are connected to one another by a seam, in which case a biodegradable suture material should be used.

After the opening 20 of the container 2 has been closed, the implant 1 thus formed can be implanted in the patient's body. FIG. 5 shows a sectional representation of a closed container 2 filled with pieces of cartilage.

The container 2 or the implant 1 according to FIG. 1-5 for the reconstruction of a nose forms a neoseptum, which can be positioned in the patient between divided bands of mucous membrane of the nose. In order to keep the implant 1 in position, the implant 1 can be fixed by means of sutures, which can also be made of biodegradable suture material.

The lumen 15 in the container 2 provides passive support for the vital tissue 15, the vital cartilage and/or the vital

bones, with the circumferential stiffening providing a supporting function tion in the body part of the patient provides . Thus, the implant 1 according to FIGS. 1-4 can offer a protective function for the nose vertically and horizontally and at the same time keep the filling of the lumen 15 in a protected position until the body part or the neoseptum is ingrown.

Due to the diffusible wall 10 of the container 2 , the vital tissue, the vital cartilage and/or the vital bone can be nourished early by diffusion and the later ingrowth of blood vessels is possible.

reference character list

1 implant

2 containers

10 wall

12 opening section

13 stiffener

14 wall section

15 lumens

16 mating area

20 opening

21 half shell

22 half shell

40 perforation

45 perforation breakthrough

Claims

patent claims

1. A method for providing an implant for a patient, in particular an implant with vital cartilage, tissue or bone, having the following method steps:

- Generating a three-dimensional digital model of a container (2) with a wall (10) enclosed lumen (15) and a closable opening (20),

- Production of the lockable container (2) from biodegradable material in an additive process, the wall (10) being designed to be diffusible at least in sections,

- filling the container (2), in particular with vital cartilage, vital bone and/or vital tissue,

- Closing the opening (20) of the container (2).

2. The method according to claim 1, d a d a d u r c h g e k e n n z e i c h n e t that the three-dimensional digital model is generated using a parameter input and / or a 3D scan.

3. The method according to claim 1 or 2, d a d u r c h g e k e n n z e i c h n e t that the three-dimensional model is scaled.

4. The method according to any one of the preceding claims, characterized in that the wall (10) has an opening section (12) surrounding the opening (20) and a wall section (14) has, and that the wall section (14) is diffusible and has a perforation (40). Method according to one of the preceding claims, characterized in that the perforation (40) is formed by a lattice structure, a network structure and/or a hole structure with perforation openings (45) and has an open area (A _o ) of 10% to 90%, and /or that the width of the perforation opening (45) is between 0.05 and 5 mm. Method according to one of Claims 4 or 5, characterized in that the opening section (12) forms a reinforcement (13) surrounding the opening (20). Method according to one of Claims 4 to 6, characterized in that two wall sections (14) are arranged spaced apart on opposite sides through the opening section (12). Method according to one of the preceding claims, characterized in that the container (2) is cleaned and/or sterilized before filling. Method according to one of the preceding claims, characterized in that the container (2) is formed from two half-shells (21, 22) and that the two half-shells (21, 22) can be connected are .

10. The method according to claim 9, d a d u r c h g e k e n n z e i c h n e t that the two half-shells (21, 22) can be plugged together and are held frictionally and/or positively in the plugged together state.

11. The method according to claim 9 or 10, d a d u r c h g e k e n n z e i c h n e t that the two half-shells (21, 22) can be connected by a seam.

12. The method according to any one of claims 9 to 11, d a d u r c h g e k e n n z e i c h n e t that the two half-shells (21, 22) are manufactured in the connected state, or that the two half-shells are manufactured separately from one another.

13. The method according to any one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the cartilage tissue is removed from the patient and in the container (2) through the opening (20) is arranged.

14. The method according to any one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the cartilage tissue is crushed before filling into the container (2).

15. The method according to any one of the preceding claims, characterized in that the cartilage and / or the crushed cartilage tissue is provided with fibrin glue. Method according to one of the preceding claims, characterized in that the implant (1) is implanted in the patient. Method according to one of the preceding claims, characterized in that the implant (1) is fixed in a patient, in particular by means of biodegradable thread material. Method according to one of the preceding claims, characterized in that a biodegradable polymer, biodegradable plastic, biodegradable tissue or a curable cell suspension is used to form the container (2). Method according to one of the preceding claims for use in the reconstruction of human body parts, in particular an auricle or a nasal septum. Implant (1) for the reconstruction of a human body part, in particular an auricle or a nasal septum, having:

- a container (2) with a wall (10) enclosed lumen (15) and a closable opening (20),

- wherein the container (2) is made of a biodegradable material, and the wall (10) being diffusible in sections.

21. Implant (1) according to claim 20, characterized in that the wall (10) has an opening section (12) surrounding the opening (20) and a wall section (14), and that the wall section (14) has a perforation (40 ) having.

22. Implant (1) according to claim 21, characterized in that the perforation (40) is formed by a lattice structure, mesh structure or a hole structure and an open area (A _o ) of 10% <A _o

90%, preferably A _o «50, and wherein a width of a perforation opening (45) is between 0.05 mm and 5 mm.

23. The implant according to claim 21 or 22, d a d u r c h g e k e n n z e i c h n e t that the opening section (12) holds two wall sections (14) spaced apart on opposite sides.

24. Implant according to one of claims 20 to 23, characterized in that the container (2) is formed from two half-shells (21, 22) and that the two half-shells (21, 22) can be plugged together at a respective opening section (12). .

25. Implant according to one of claims 20 to 24, characterized in that the wall (10) has at least one reinforcement (13).

26. Implant according to one of claims 20 to 25, d a d u r c h g e k e n n z e i c h n e t that the container (2) is polygonal, circular, oval or shell-shaped.

27. Implant according to one of claims 20 to 26, d a d u r c h g e k e n n z e i c h n e t that the container (2) is toroidal.

28. Implant according to one of claims 20 to 27, d a d u r c h g e k e n n z e i c h n e t that the two half-shells (21, 22) are held frictionally and/or positively in the assembled state.

29. Implant according to one of claims 20 to 28, d a d u r c h g e k e n n z e i c h n e t that the container (2) is formed by an additive process, in particular from a biodegradable polymer, plastic, tissue or a curable cell suspension.

30. Use of the implant (1) according to any one of claims 20 to 29 for the reconstruction of a human body part, in particular an auricle or a nasal septum.