Embroidery pattern for making a mesh pocket to support an implant and method for making a mesh pocket

Abstract

The invention relates to an embroidery pattern for producing a mesh pocket to support an implant, specifically a breast implant, and / or tissue, specifically breast tissue, comprising a two-dimensional ring structure (1) with several spaced-apart concentric rings (1.1 - 1.13), each adjacent concentric ring (1.1 - 1.13) having several connections (2.1 - 2.12), wherein the connection length of the connections (2.1 - 2.12) formed between adjacent concentric rings, extending from one of the inner concentric rings (1.1 - 1.12) to the outer concentric ring (1.13), increases, at least in certain areas, relative to the distance between the respective adjacent concentric rings (1.1 - 1.13). The invention further relates to a method for producing the mesh pocket, wherein the embroidery pattern is stitched onto a substrate and the substrate is subsequently removed.The net pocket is finally formed by concentric twisting of the concentric rings (1.1 - 1.13).

Description

[0001] The invention relates to an embroidery pattern for producing a mesh pocket to support an implant, in particular a breast implant, and / or tissue. The invention further relates to a method for producing such a mesh pocket and its use.

[0002] A breast implant is a medical device consisting of a shell and a filling of silicone gel or saline solution. Breast implants are used to enlarge the breasts (augmentation) or to replace breast tissue that has been removed due to cancer or trauma. They are also used for breast reconstruction, for example, in cases of severe breast anomalies where the breast tissue has not developed properly. Both breast reconstruction and augmentation require surgery to restore or alter the appearance and shape of one or both breasts. Various surgical techniques and implants are used in these procedures.Several thousand breast reconstruction and augmentation surgeries are performed annually, with over 70% of patients opting for implants. The choice of method depends on various factors, including the individual needs of the patient and their medical history. Due to concerns about implant displacement caused by slippage or rotation of the implant body and the risk of capsular contracture, implant placement without the support of a mesh or acellular matrix is ​​increasingly discouraged. The preferred alternative method for implant reconstruction therefore utilizes mesh or acellular dermal matrices (ADM) to support the implant, with several placement options available. One possibility is subpectoral / retropectoral placement.Alternatively, the implant can be positioned above the pectoral muscle (prepectoral / epipectoral). Prepectoral implant placement has proven to be particularly patient-friendly. This is due to less postoperative pain and fewer limitations in shoulder and arm mobility, as the pectoralis major muscle does not need to be detached for prepectoral placement, unlike subpectoral placement. Consequently, prepectoral breast reconstruction is the gentler procedure. Furthermore, it prevents the side effect of the jumping breast phenomenon (the formation of wrinkles or puckering of the remaining breast tissue after a mastectomy due to contraction of the pectoral muscle) and reduces the operating time, drainage duration, and hospital stay.

[0003] To ensure safe and easy implant placement, pocket-shaped mesh implants are used for prepectoral breast reconstruction. The implant is held in place within a pocket-shaped mesh, which is attached to the pectoral muscle. The use of mesh pockets effectively prevents implant displacement. Further advantages include a shorter operating time and more satisfactory aesthetic results.

[0004] Such a mesh pocket for supporting a breast implant is known from EP 2 830 533 B1. The textile mesh structure of the pocket has a bulge in the central section to form a recess for the breast implant. The pocket thus formed consists of two-dimensional textile pieces, which are folded into the desired pocket shape and then fixed by sewing. Both the seams and the overlapping areas of the textile pieces lead to local material compaction or thickening with altered material properties. These are undesirable for applications as an implant in the body, as they can lead to inflammation and consequently to fibrosis or rejection reactions. Furthermore, the shape of such a folded pocket does not correspond to the shape of the implant (teardrop shape, hemispherical shape), or this shape can only be achieved with a very large number of seams.Therefore, a support structure is required that does without overlaps and sutures, thus contributing to improved biocompatibility of the implant.

[0005] The invention therefore aims to propose a method for manufacturing a mesh pocket to support an implant, specifically a breast implant, which can overcome the known problems. Furthermore, it aims to provide a suitable mesh pocket that meets the requirements for use as an implant.

[0006] The problem is solved by an embroidery pattern for the production of an implant, specifically a breast implant, and / or a tissue, specifically breast tissue, with the features according to claim 1 and a method with the features according to claim 10. Embodiments of the embroidery pattern and embodiment variants of the method are specified in the dependent claims.

[0007] The core of the invention is the production of a mesh pocket for supporting an implant, specifically a breast implant, and / or tissue, specifically breast tissue, by means of embroidery. A two-dimensional embroidery pattern serves as a template for producing the three-dimensional mesh pocket. The resulting mesh pocket is intended, in principle, to support and hold implants and / or tissue within a human or animal body.

[0008] The embroidery pattern for creating a mesh pocket to support an implant, specifically a breast implant, and / or tissue, specifically breast tissue, features a ring structure with several spaced-apart concentric rings. The ring structure thus comprises an outer concentric ring and several inner concentric rings. Each adjacent concentric ring has multiple connections, with the ratio of the connection length formed between adjacent concentric rings to the distance between each adjacent concentric ring increasing from one of the inner concentric rings to the outer concentric ring. In other words, the connection length between adjacent concentric rings increases outward from one of the inner concentric rings.Inwards, that is, towards the center of the ring structure, the connection lengths between adjacent concentric rings, starting from one of the inner concentric rings, can correspond to the distance between the respective adjacent concentric rings. The ratio of the connection length of the connections between adjacent concentric rings to the distance between the respective adjacent concentric rings, starting from one of the inner concentric rings, is 1. Thus, some of the concentric rings of the ring structure, towards the outer concentric ring, have connections with progressively longer thread lengths, while another part of the concentric rings, towards the center of the ring structure, has connections whose thread length between the respective adjacent concentric rings corresponds to the distance between the respective concentric rings.

[0009] Starting from one of the inner concentric rings, the connections between two adjacent concentric rings are therefore, at least in some sections, longer than the length of the line segment between the respective adjacent concentric rings.

[0010] From the inside out, a first half of the number of inner concentric rings of the ring structure can have connections between adjacent concentric rings whose connection length corresponds to the distance between the respective adjacent concentric rings, wherein a number of the second half of the concentric rings have connections between adjacent concentric rings whose connection lengths increase up to the outer concentric ring, so that the ratio is also greater than 1 and increases towards the outside.

[0011] Furthermore, it can be provided that the connections between adjacent concentric rings are formed with connecting threads which have a meandering thread path.

[0012] According to one embodiment, the embroidery pattern has a holding structure which is formed section by section on the outer concentric ring of the ring structure, wherein the holding structure has a filling of holding thread.

[0013] According to a further embodiment, which can be a further development of the ring structure with a holding structure, the embroidery pattern has a support structure which has a pull thread attached at both ends in different positions on the outer concentric ring, wherein a filling of support thread is formed between the pull thread and the outer ring.

[0014] The support thread(s) may have a zigzag pattern.

[0015] The filling of the holding structure can have a mesh size that is smaller than the mesh size of the support structure.

[0016] According to a particularly preferred embodiment of the embroidery pattern, the holding structure and the support structure are located opposite each other on the ring structure.

[0017] The concentric rings can have a circular or an elliptical shape.

[0018] The ring structure can be configured with concentric rings. In this configuration, the length of the connections formed by the connecting threads of the ring structure between adjacent concentric rings, which are arranged between the center of the ring structure and half a radius of the ring structure, corresponds to the distance between the adjacent concentric rings. The ratio of the length of the connections to the distance between adjacent concentric rings is 1 for these concentric rings. Towards the outside, that is, in the radial direction, the ratio of the length of the connections to the distance between adjacent concentric rings increases.

[0019] The advantages arising from the embroidery pattern according to the invention are explained in more detail below in connection with the inventive method for producing a mesh pocket to support an implant, in particular a breast implant, and / or tissue, in particular breast tissue.

[0020] The inventive method for manufacturing the mesh bag comprises the following steps. The first step concerns providing a substrate for applying an embroidery pattern. To avoid subsequent distortion of an embroidered structure, the embroidery surface should be kept as tension-free as possible, although certain slight tensions for holding the substrate cannot be ruled out due to the nature of the process and should therefore be taken into account when planning the embroidery pattern. The substrate should be as easy to remove as possible.

[0021] The second step of the process involves embroidering a two-dimensional pattern, which in its simplest form is a two-dimensional ring structure. In this process, a two-dimensional ring structure is first stitched onto the substrate, with one or more threads being joined to form several spaced concentric rings. Adjacent concentric rings are then connected without tension using a connecting thread to create stitches. Thus, the concentric rings and the connections between adjacent concentric rings are stitched.

[0022] Advantageously, the two-dimensional embroidery pattern is stitched in one go, so that the production of the net bag can be done advantageously without additional seams or overlaps of the textile.

[0023] The two-dimensional ring structure comprises an outer concentric ring and several inner concentric rings, with adjacent concentric rings being connected by a connecting thread to form loops. Thus, multiple connections are stitched between each pair of adjacent concentric rings using the respective connecting threads, with the connections preferably being evenly spaced along the adjacent concentric rings. The number of connections between the multiple adjacent concentric rings can vary. Preferably, the concentric rings and the connections between adjacent concentric rings are stitched from the same thread.According to one design variant, it can be provided that the concentric rings and the connections are embroidered from different threads, i.e. monofilament thread or multifilament thread, and / or different thread materials.

[0024] In embroidery, a top thread and a bobbin thread, which is guided under the substrate, are preferably interlocked. Thus, embroidering the pattern results in the top thread becoming entangled with the bobbin thread.

[0025] According to the invention, the connecting threads are stitched such that the stitched connection length of the connections between adjacent concentric rings increases, at least in certain areas, relative to the distance between the respective adjacent concentric rings, starting from one of the inner concentric rings and extending towards the outer concentric ring. Each adjacent concentric ring has several connections, with the ratio of the connection length formed between adjacent concentric rings to the distance between the respective adjacent concentric rings, starting from one of the inner concentric rings and extending to the outer concentric ring, increasing.The increase in the length of the connections means that the stitched thread length of the connections gradually increases from one of the inner concentric rings of the ring structure towards the outer concentric ring, so that the stitched connection length is greatest between the outermost concentric ring (which, starting from the center of the ring structure, is the last concentric ring) and the penultimate concentric ring, compared to the more closely located adjacent concentric rings. Furthermore, "increase" means that the length of the connections from one of the inner concentric rings outwards becomes greater than the distance between the respective adjacent concentric rings.Starting from one of the inner concentric rings, the connections between two adjacent concentric rings are thus, at least in some areas, stitched longer than the length of the distance between the respective adjacent concentric rings.

[0026] The concentric rings can be stitched in a circular or elliptical shape, so that the two-dimensional ring structure can have concentric circular rings or concentric ellipses.

[0027] In one variation where the concentric rings are stitched in a circular shape, the connections between the circular concentric rings can be stitched obliquely relative to an imaginary radial line radiating from the center of the ring structure. The angle of the oblique line relative to this imaginary radial line increases from one of the inner concentric rings to the outermost concentric ring. Towards the center of the ring structure, the connecting threads can be stitched such that the length of the connections between the respective adjacent concentric circular rings corresponds to the distance between those rings. In this case, the connections of the connecting threads between two adjacent circular concentric rings are oriented along an imaginary radial line of the ring structure.The connections of the connecting threads of each adjacent concentric rings, which are arranged between the center of the ring structure and half a radius of the ring structure, can be stitched in such a way that their connection length corresponds to the distance between the respective adjacent concentric rings.

[0028] In the third step of the process, the substrate is removed, revealing the embroidered ring structure.

[0029] Finally, a three-dimensional mesh pocket is formed by concentrically rotating the concentric rings of the ring structure. Due to this concentric rotation around its center, the concentric rings are shifted relative to each other in the z-direction from a two-dimensional xy-plane, as the oblique connections between adjacent concentric rings are established. The distances between the concentric rings in the xy-plane remain constant. After forming, the inner concentric rings are higher than the outer concentric rings because the shifts in the z-direction are cumulative. This creates a hemispherical or dome shape, which forms the mesh pocket for holding and supporting an implant, specifically a breast implant, and / or tissue, specifically breast tissue.Alternatively, the two-dimensional ring structure, freed from the substrate, can also be formed directly on or with the implant.

[0030] The geometric design of the dome or hemisphere shape can be influenced by the length of the connections between adjacent concentric rings. It is possible to vary the length of these connections in certain areas. Specifically, the connections made of the respective connecting threads between adjacent concentric rings are stitched longer along a section of the adjacent rings, resulting in a more pronounced shape of the resulting net pocket in those areas. This regional extension of the connecting threads can extend from one of the inner concentric rings towards the outer concentric ring.

[0031] The connecting threads can be stitched with a meandering thread pattern between adjacent concentric rings.

[0032] To create a support structure for attaching the mesh pocket, for example to a muscle, an additional step of embroidering a support structure with one or more threads can be included, whereby the support structure is embroidered at least partially onto the outer concentric ring of the ring structure. The support structure is thus attached to a ring segment of the outer concentric ring of the ring structure. The embroidery of the support structure and the ring structure is carried out in a single process step, that is, in one pass while embroidering the two-dimensional ring structure. The support structure comprises a filling of embroidered support threads, whereby the multiple support threads can be stitched in a crisscrossing pattern.

[0033] For the specific application of prepectoral breast reconstruction, a semi-closed mesh pocket is required. For this purpose, the method can include stitching an additional support structure, wherein one or more threads are joined to form a tension thread attached at different positions on the outer concentric ring at both ends, and a filling of support thread is stitched between the tension thread and the outer ring. The filling is preferably stitched such that the support threads connect the tension thread and the outer ring. The support threads thus form connections between the outer ring of the support structure and the tension thread. The support structure is therefore attached to a ring segment of the outer concentric ring of the ring structure.

[0034] After removing the substrate, the additional two-dimensional support structure is preferably folded over at the outer concentric ring after the mesh pocket has been formed. By folding over at the outer concentric ring, the filling of the support structure forms a supporting back wall of the mesh pocket, thus securing an implant and / or tissue against slippage at one end. The stitch pattern of the two-dimensional support structure interacts with the two-dimensional ring structure to form a semi-open mesh pocket.

[0035] The tension thread of the additional two-dimensional support structure can be embedded unpaired, forming a tunnel. By tensioning the tension thread, the two-dimensional support structure can be gathered, thereby adapting the shape of the filling to support the forming of the mesh pocket. The process can thus include tensioning the tension thread to support the forming of the three-dimensional shape of a mesh pocket.

[0036] Furthermore, the drawstring can be knotted after the semi-open mesh pocket has been formed to fix the resulting shape. The process can therefore also include the step of knotting the drawstring to fix the formed shape of the mesh pocket.

[0037] Preferably, the holding structure and the support structure are embroidered such that they are opposite each other on the ring structure. In the two-dimensional embroidery pattern, the two-dimensional holding structure is thus located on the top side of the outer circumference of the ring structure, while the support structure is located on the underside of the outer circumference of the ring structure.

[0038] A water-soluble substrate, preferably made of polyvinyl alcohol, can be used as the substrate, allowing it to be removed with water. Advantageously, a polyvinyl alcohol fleece or film is used as the substrate. In the case of a polyvinyl alcohol substrate, removal is achieved with water.

[0039] For embroidery, a plastic thread material is preferred, with a thread diameter of 90 µm proving advantageous. It may be provided that one or more threads made of a material or combination of materials selected from the group containing polypropylene (PP), TiO2-coated PP, polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), silk, cotton, polycaprolactone (PCL), polycaprolactam P(LA-CL), polyglycolic acid (PGA), polylactide (PLA), bioactive glass, cellulose, chitosan, alginate, collagen, zein, polyhydroxyalkanoates, polydioxanone, polyester, poly(lactide-co-caprolactone), poly(L-lactide-co-glycolide), poly(L-lactide-co-PEG), and poly(lactide-co-trimethylenecarbonate) are used for embroidery.For embroidery, one or more threads can be used, which consist of polypropylene (PP), TiO2-coated PP, polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), silk, cellulose, chitosan, alginate, collagen, zein, polydioxanone and various polyesters such as polyethylene terephthalate (PET), the group of polyhydroxyalkanoates, polycaprolactone (PCL), polycaprolactam P(LA-CL), polyglycolic acid (PGA), polylactide (PLA), poly(lactide-co-caprolactone), poly(L-lactide-co-glycolide), poly(L-lactide-co-PEG), poly(lactide-co-trimethylene carbonate), polypropylene carbonate (PPC) (PPF), polybutylene succinate (PBS), polypropylene fumarate or long-chain aliphatic polyesters formed from polycondensation of long-chain dicarboxylic acids and polyols. Furthermore, at least one thread can be used which consists of a combination of at least two of the aforementioned materials.

[0040] The threads used for embroidery can be monofilament or multifilament. A combination of monofilament and multifilament threads is also possible for stitching the design. The thread thickness is preferably in the range of 15 µm to 200 µm. The use of multifilament yarns made of materials such as ceramic, bioactive glass, metal, or metal alloys is also conceivable, provided they meet biocompatibility requirements.

[0041] It is possible to use threads that differ in material and / or composition for embroidering the concentric rings and the connecting threads. For example, the connecting threads for creating the joints can be made of a different material than the threads used to embroider the concentric rings. Regarding composition, monofilament or multifilament threads can be used.

[0042] A two-dimensional embroidery pattern underlying the shape of the net bag can advantageously be provided using a computer program. The creation of the two-dimensional embroidery pattern from which the net bag results can be considered the zeroth process step.

[0043] The invention further relates to the use of a mesh pocket produced according to the method for supporting an implant, specifically a breast implant, and / or tissue, specifically breast tissue. In particular, its use is intended for supporting an implant and / or tissue in prepectoral breast reconstruction.

[0044] The mesh bag features an embroidered two-dimensional ring structure in which one or more threads are connected to form several spaced-apart concentric rings. Adjacent concentric rings are connected without tension by connecting threads, creating spaced connections. Thus, the ring structure comprises an outer concentric ring and several inner concentric rings, with the connecting threads forming the connections between the concentric rings, creating a mesh structure. Furthermore, according to the invention, the connections between adjacent concentric rings, starting from one of the inner concentric rings and extending to the outer concentric ring, are embroidered such that their length increases, at least in certain areas, relative to the distance between the respective adjacent concentric rings.This makes it possible for the embroidered two-dimensional ring structure to be formed into a three-dimensional mesh bag by concentric rotation of the concentric rings.

[0045] According to one embodiment, the embroidered two-dimensional ring structure has thirteen concentric rings. The two-dimensional ring structure is configured such that, starting from the center of the ring structure, the first six concentric rings each have connections linking adjacent concentric rings, the length of which corresponds to the distance between the respective adjacent concentric rings. From the sixth concentric ring to the thirteenth concentric ring, which corresponds to the outermost concentric ring, the length of the connections between the adjacent concentric rings increases according to the invention. In this embodiment, the resulting mesh pocket is less pronounced towards the center of the ring structure, with the shape flattening towards the center and thus promoting the formation of a hemispherical shape.

[0046] Because the connection length of the connections between each adjacent concentric rings increases at least in some areas in relation to the distance between the respective adjacent concentric rings, a concentric rotation of the concentric rings of the two-dimensional ring structure can create a three-dimensional shape in the net pocket.

[0047] It can be designed so that the extension of the connections, relative to the distance between adjacent concentric rings, is only formed in certain sections along a segment of the respective adjacent concentric rings. This allows for the realization of various three-dimensional shapes of the resulting mesh pocket.

[0048] According to an advantageous embodiment of the mesh pocket, a retaining structure is provided, which is formed at least partially on an outer contour of the ring structure. Since the outer contour of the ring structure is formed by the outer concentric ring, the ring structure transitions into the retaining structure at a ring segment of the outer concentric ring. This embodiment of the mesh pocket with a retaining structure is particularly advantageous in prepectoral breast reconstruction, where the retaining structure is attached to a pectoral muscle to support a breast implant held in the mesh pocket.

[0049] The thread(s) of the embroidered two-dimensional ring structure can be selected from one or a combination of materials from a group of materials including polypropylene (PP), TiO2-coated PP, polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), silk, cellulose, chitosan, alginate, collagen, zein, polydioxanone, and various polyesters such as polyethylene terephthalate (PET), the polyhydroxyalkanoates group, polycaprolactone (PCL), polycaprolactam P(LA-CL), polyglycolic acid (PGA), polylactide (PLA), poly(lactide-co-caprolactone), poly(L-lactide-co-glycolide), poly(L-lactide-co-PEG), poly(lactide-co-trimethylene carbonate), polypropylene carbonate (PPC) (PPF), polybutylene succinate (PBS), polypropylene fumarate, or long-chain aliphatic polyesters formed from the polycondensation of long-chain dicarboxylic acids and polyols. The threads can be monofilament or multifilament and each has a coating.

[0050] The thread(s) can have a diameter ranging from 15 µm to 200 µm.

[0051] Due to the embroidered two-dimensional ring shape, three-dimensional mesh pockets can be provided without the need for additional seams or material overlaps. The invention thus enables particularly biocompatible support for an implant. The dimensions of the mesh pocket can be adapted to different implant sizes and shapes. Therefore, the number of concentric rings, the number of connections between the concentric rings, and the lengths of the connections can be varied, at least in certain areas.

[0052] Further details, features, and advantages of embodiments of the invention will become apparent from the following description of exemplary embodiments with reference to the accompanying drawings. These show: Fig. 1: Two schematic representations a) and b) to further explain an embodiment of the method according to the invention, specifically the embroidery step, Fig. 2: a schematic representation of an embroidered embodiment of an embroidered two-dimensional ring structure, Fig. 3: a schematic representation of a further embodiment of the embroidered two-dimensional ring structure with a holding structure and a support structure, and Fig. 4: a schematic representation of an embroidery pattern with a ring structure with elliptical concentric rings.

[0053] Recurring features are marked with the same reference symbols in the figures.

[0054] The Fig. Figure 1 shows two schematic diagrams a) and b) to further explain an embodiment of the method according to the invention, specifically the embroidery step. In the method for producing a mesh pocket to support a breast implant, a polyvinyl alcohol fleece is first provided as a water-soluble substrate for embroidering a predetermined embroidery pattern. For the sake of simplicity, the substrate is shown in Figures a) and b). Fig. 1 not shown. To avoid subsequent distortions of the embroidery pattern to be applied, the polyvinyl alcohol fleece is kept as free of tension as possible, whereby process-related tensions can be taken into account when planning the embroidery pattern.

[0055] In the second step of the process, a predetermined embroidery pattern is stitched onto the polyvinyl alcohol fleece. The embroidery can be done with an industrial embroidery machine, whereby an upper thread and a lower thread are interlocked. Figures a) and b) are purely schematic and serve only to further illustrate the process, without having any limiting effect. Thus, the embroidery is variable, particularly with regard to the thread guidance and the sequence of individual structures to be stitched.

[0056] As in the Fig. As shown in Figure a), a two-dimensional ring structure 1 is embroidered onto the polyvinyl alcohol nonwoven fabric, whereby one or more polypropylene monofilament threads are joined to form thirteen spaced-apart concentric rings 1.1–1.13. The largest outer concentric ring bears the reference numeral 1.13 and the smallest concentric ring the reference numeral 1.1. In the example shown, the ring structure 1 of the two-dimensional embroidery pattern thus has thirteen concentric rings 1.1–1.13, which, due to their circular shape, can also be referred to as circular rings. Between each adjacent concentric ring 1.1 and 1.2; 1.2 and 1.3; 1.3 and 1.4; 1.4 and 1.5; 1.5 and 1.6; 1.6 and 1.7; 1.7 and 1.8; 1.8 and 1.9; 1.9 and 1.10; 1.10 and 1.11; 1.11 and 1.12; as well as 1.12 and 1.13, are stitched with connecting thread 7 (see figure b) several connections 2.1 to 2.12, where in figure a) the Fig. 1 For better illustration, only one connection 2.1 to 2.12 is shown between two adjacent concentric rings 1.1 to 1.13. With the multiple connections 2.1 to 2.12 thus stitched, adjacent concentric rings 1.1 to 1.13 of the two-dimensional ring structure 1 are connected to each other without tension. The connections 2.1 to 2.12 are stitched with the connecting thread 7 in one go, together with the concentric rings 1.1 to 1.13, as shown in Figure b). Fig. 1 is shown.

[0057] According to the invention, the connections 2.6 to 2.12 between the respective adjacent concentric rings 1.6 to 1.13 are stitched such that the stitched connection length of the connections 2.6 to 2.12, which are formed with the respective connecting threads 7, increases from the inner concentric ring 1.6 towards the outer concentric ring 1.13 in proportion to the distance between the respective adjacent concentric rings 1.6 to 1.13. The ratio of the connection lengths of the connections 2.6 to 2.12 to the radial distances between the respective adjacent concentric rings 1.6 to 1.13 is thus 1 and increases further towards the outside.

[0058] The increase in the length of connections 2.6 to 2.12 results in a gradual increase in the stitched thread length of connections 2.6 to 2.12, starting from the sixth inner concentric ring 1.6 of the two-dimensional ring structure 1 and moving towards the thirteenth concentric ring 1.13 of the two-dimensional ring structure 1. Consequently, the stitched length of connections 2.12 is greatest between the outer concentric ring 1.13 and the penultimate concentric ring 1.12, relative to the distance between these two concentric rings. Due to the gradual lengthening of connections 2.6 to 2.12, they are stitched obliquely in the two-dimensional ring structure 1 with respect to an imaginary radial of the two-dimensional ring structure 1 radiating from the center of ring 6, forming an angle between connections 2.6 and 2.12.Figure 12 is enlarged in relation to the imaginary radial extending from the inner concentric ring 1.6 outwards towards the outer concentric ring 1.13. An overall view of the concentric rings 1.1 to 1.6 with the connections 2.1 to 2.12 is shown in the figure. Fig. 2 shown.

[0059] The remaining connections 2.1 to 2.5 of the ring structure 1 are stitched according to the example such that the stitched connection length of connections 2.1 to 2.5 between the respective adjacent concentric rings 1.1 to 1.6, starting from the innermost first concentric ring 1.1 in the direction of the sixth inner concentric ring 1.6, corresponds to the distance between the respective adjacent concentric rings 1.1 to 1.6. The ratio of the connection length of connections 2.1 to 2.5 to the lengths of the radial distances between respective adjacent concentric rings 1.1 to 1.6 is therefore always 1. Connections 2.1 to 2.5 thus lie on the imaginary radial of the two-dimensional ring structure 1.

[0060] The distances between the respective concentric rings 1.1 to 1.13 can be the same or vary. In the case shown in Figure a), Fig. In the example shown, the distances between the concentric rings 1.8 to 1.13 are smaller than the distances between the concentric rings 1.1 to 1.8.

[0061] To further illustrate the exemplary embodiment of the method for manufacturing a mesh pocket to support a breast implant, see figure b) of the Fig. Figure 1 shows only the thirteenth outermost concentric ring 1.13 and the adjacent twelfth concentric ring 1.12. As can be seen in Figure b), in the stitching process step, a connecting thread 7 is stitched in a meandering pattern around the concentric rings 1.12 and 1.13, so that several evenly spaced connections 2.12 are formed between the concentric rings 1.12 and 1.13. The lengths of the connections 2.12 between the concentric rings 1.12 and 1.13 are each greater than the length of the direct radial distance between the concentric rings 1.12 and 1.13.

[0062] After embroidery, the substrate is removed with water, for example in a water bath, thereby exposing the two-dimensional ring structure 1. An example of the resulting two-dimensional embroidery pattern of the two-dimensional ring structure 1 is shown in the Fig. 2 shown. As the example of the Fig. As can be seen from Figure 2, the connecting threads 7 for forming the connections 2.1 to 2.12 are each stitched in a meandering pattern around adjacent concentric rings 1.1 to 1.13, so that several gaps 3.1 to 3.12 are formed between each pair of adjacent concentric rings 1.1 to 1.13. In the example shown, the gaps 3.1 to 3.12 are evenly distributed. According to one embodiment, the connections 2.1 to 2.12 can be stitched closer together in certain sections. In the area of ​​more closely stitched connections 2.1 to 2.12, the gaps 3.1 to 3.12 are smaller, so that a resulting mesh pocket has increased stability in that area.

[0063] To shape the two-dimensional ring structure 1 into the desired three-dimensional mesh pocket, the concentric rings 1.1 to 1.13 can be twisted concentrically relative to each other, provided that the two-dimensional ring structure 1 does not shape itself into the desired three-dimensional mesh pocket solely by the effect of gravity. In the case of the Fig. In the example shown, a concentric rotation of the two-dimensional ring structure 1 in a clockwise direction leads to the concentric rings 1.1 to 1.13 being raised into a three-dimensional dome shape, which forms the net pocket. During the concentric rotation, the initially inclined connections 2.6 to 2.12 are erected, whereby the concentric rings 1.1 to 1.13 are moved from the two-dimensional xy-plane of the ring structure 1 into a z-direction.

[0064] The Fig. Figure 3 shows a schematic representation of a further embodiment of the embroidered two-dimensional ring structure 1 with a two-dimensional retaining structure 5 and a support structure 8 for forming a semi-open mesh pocket, which is particularly suitable for prepectoral breast reconstruction. The two-dimensional ring structure 1 corresponds to the one shown in Fig. Figure 2 shows a two-dimensional ring structure 1 with concentric rings, in which a two-dimensional retaining structure 5 and a support structure 8 are additionally stitched. The retaining structure 5 arises directly from a section of the outer concentric ring 1.13 without the need for a separate connecting seam. Unlike the ring structure 1, the two-dimensional retaining structure 5 does not form a three-dimensional shape after the substrate is removed, but remains as a two-dimensional planar structure. The two-dimensional retaining structure 5 serves to attach the resulting mesh pocket to a muscle surface.

[0065] The filling of the two-dimensional support structure 5, enclosed by an outer contour of the two-dimensional support structure 5, has vertically, horizontally and diagonally embroidered support threads 5.1.

[0066] To embroider the support structure 8, several threads are joined to form a draw thread 4, which is attached at both ends to the outer concentric ring 1.13 at different positions. The draw thread 4 is positioned with its ends on opposite sides of the outer concentric ring 1.13 such that the support structure 8 and the two-dimensional retaining structure 5 are opposite each other on the two-dimensional ring structure 1. In the example shown, the two-dimensional retaining structure 5 is formed on an upper half of the concentric ring 1.13, while the support structure 8 is formed on the lower half of the concentric ring 1.13. The draw thread 4 forms an outer contour, and a filling of support thread 8.1 is embroidered between the draw thread 4 and the outer ring 1.13. The zigzag-stitched support threads 8.1 form stitches whose stitch size is larger than that formed by the retaining threads 5.1.

[0067] After removal of the substrate, the support structure 8 is folded over by 180° at the outer ring 1.13. This tensions the drawstring 4, causing the support threads 8.1 of the filling to gather together. This results in the formation of an expanded shape of the mesh pocket, becoming a semi-open mesh pocket with a stabilizing back wall. The resulting shape of the semi-open mesh pocket can be fixed by knotting the drawstring 4.

[0068] Tensioning the free draw thread 4 supports the shaping into the form of the semi-open mesh pocket.

[0069] The Fig. Figure 4 shows a schematic representation of an embroidery pattern with a two-dimensional ring structure 1 with elliptical concentric rings 1.1 to 1.13. In contrast to the ones shown in the Fig. The two-dimensional ring structure 1 exhibits the configurations described in 1 to 3 according to the Fig. Four elliptical concentric rings 1.1 to 1.13 are arranged. Ten ellipses 1.1 to 1.13 are arranged concentrically around the center of the ring 6. As in the previously described configurations, connecting threads 7 are stitched between adjacent concentric elliptical rings 1.1 to 1.13, forming several connections 2.1 to 2.12. The thread path of the connecting threads 7 is as in the Fig. 1 to 3 are described as meandering. Unlike the two-dimensional ring structure 1 with concentric circular rings, it must be noted in this embodiment that the lengths of the connections 2.1 to 2.12 from ellipse to ellipse are naturally not the same length around the circumference. Connections 2.1 to 2.12 between adjacent concentric elliptical rings 1.1 to 1.13 are longer near a minor semi-axis 10 than connections 2.1 to 2.12 near a major semi-axis 9. This must be taken into account in the embodiment of the connection lengths of the connections 2.1 to 2.12 according to the invention. If the ratio of the minor semi-axis 10 to the major semi-axis 9 is, for example, 0.75:1, the ratio of the connections 2.1 to 2.12 near the minor semi-axis 10 and the connections 2.1 to 2.12 near the major semi-axis 9 is approximately 1.2:1. These ratios must be observed when embroidering the connection lengths of connections 2.1 to 2.12 between the concentric elliptical rings 1.1 to 1.13 are included to achieve a shaping of the two-dimensional ring structure 1 with concentric elliptical rings 1.1 to 1.13 according to the invention into a three-dimensional mesh pocket.

[0070] In the illustrated embodiment, the ends of the tension thread 4 of the support structure 8 emerge from the opposite ends of the major semi-axis 9 on the outer concentric elliptical ring 1.13. Furthermore, the two-dimensional embroidery pattern features a retention structure 5, which emerges from the upper half of the outer concentric elliptical ring 1.13 of the two-dimensional ring structure 1. The two-dimensional retention structure 5 is filled with retention thread 5.1.

[0071] The two-dimensional embroidery pattern of the in Fig.The design shown in Figure 4 is embroidered onto a substrate. The substrate is then removed, revealing the two-dimensional embroidery pattern with the concentric elliptical rings 1.1 to 1.13. Finally, the net pocket is formed by concentrically twisting the concentric elliptical rings 1.1 to 1.13. Reference symbol list 1 two-dimensional ring structure 1.1 - 1.13 concentric rings 2.1-2.12 Connections 3.1-3.12 Gaps 4 pull threads 5 two-dimensional support structure 5.1 Holding thread 6 Center / Ring Center 7 Connecting thread 8 Support structure 8.1 Support thread 9 major semi-axis 10 minor semi-axis QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] EP 2 830 533 B1

[0004]

Claims

[1] Embroidery pattern for producing a mesh pocket to support an implant, specifically a breast implant, and / or tissue, specifically breast tissue, comprising a two-dimensional ring structure (1) with several spaced-apart concentric rings (1.1 - 1.13), each of which adjacent concentric rings (1.1 - 1.13) have several connections (2.1 - 2.12), wherein the ratio of a connection length of connections (2.1 - 2.12) formed between adjacent concentric rings and a distance between the respective adjacent concentric rings (1.1-1.13) increases from one of the inner concentric rings (1.1 - 1.12) to the outer concentric ring (1.13). [2] Embroidery pattern according to claim 1, characterized by, that the connections (2.1 - 2.12) between adjacent concentric rings (1.1 - 1.13) are formed with connecting thread (7) which has a meandering thread path. [3] Embroidery pattern according to claim 1 or 2, further comprising a two-dimensional retaining structure (5) which is formed section by section on the outer concentric ring (1.13) of the ring structure (1), wherein the two-dimensional retaining structure (5) has a filling of retaining thread (5.1). [4] Embroidery pattern according to one of claims 1 to 3, further comprising a support structure (8) which has a draw thread (4) attached at both ends at different positions on the outer concentric ring (1.13), wherein a filling of support thread (8.1) is formed between the draw thread (4) and the outer ring (1.13). [5] Embroidery pattern according to claim 4 characterized by , that the support thread (8.1) has a zigzag-shaped thread path. [6] Embroidery pattern according to claim 4 or 5, characterized by , that the filling of the two-dimensional holding structure (5) has a mesh size which is smaller than a mesh size of the support structure (8). [7] Embroidery patterns according to claims 4 to 6, characterized by , that the two-dimensional holding structure (5) and the support structure (8) are opposite each other on the two-dimensional ring structure (1). [8] Embroidery patterns according to claims 1 to 7, characterized by , that the concentric rings (1.1 - 1.13) have a circular or elliptical shape. [9] Method for producing a mesh pocket to support an implant, specifically a breast implant, and / or tissue, specifically breast tissue, comprising the steps - Providing a substrate, - Embroidery of a two-dimensional ring structure (1) onto the substrate, wherein one or more threads are joined to form several spaced-apart concentric rings (1.1 - 1.13), of which adjacent concentric rings (1.1 - 1.13) are connected without tension with connecting thread (7) forming several connections (2.1 - 2.12), wherein - the stitched connection length of the connections (2.1 - 2.12) stitched with the connecting thread (7) between each adjacent concentric rings (1.1 - 1.13) starting from one of the inner concentric rings (1.1 - 1.12) in the direction of the outer concentric ring (1.13) increases at least in some areas in relation to the distance between the respective adjacent concentric rings (1.1 - 1.13), - Removal of the substrate, and - Forming a three-dimensional mesh pocket by concentric twisting of the concentric rings (1.1 - 1.13). [10] Method according to claim 9, further comprising the step of embroidering a two-dimensional support structure (5) on the substrate with the one or more threads, wherein the support structure (5) is embroidered at least partially on the outer concentric ring (1.13) of the two-dimensional ring structure (1). [11] Method according to claim 9 or 10, further comprising embroidering a support structure (8), wherein the one or more threads are joined to form a draw thread (4) which is attached at different positions at both ends to the outer concentric ring (1.13), wherein a filling of support thread (8.1) is embroidered between the draw thread (4) and the outer concentric ring (1.13). [12] Method according to one of claims 10 or 11, characterized by , that the two-dimensional holding structure (5) and the support structure (8) are stitched in such a way that they are opposite each other on the two-dimensional ring structure (1). [13] Method according to claim 11 or 12, further comprising tensioning the draw thread (4) to assist in forming the shape of a net bag. [14] Method according to any one of claims 11 to 13, further comprising knotting the drawstring (4) to fix the transferred shape of the net bag. [15] Method according to any one of claims 9 to 14, characterized by , that the connecting thread (7) is embroidered with a meandering thread pattern between adjacent concentric rings (1.1 - 1.13). [16] Method according to any one of claims 9 to 15, characterized by , that a water-soluble substrate, preferably made of polyvinyl alcohol, is used to remove the substrate with water. [17] Method according to any one of claims 9 to 16, characterized by, that for embroidery one or more threads made of a material or a combination of materials selected from a group of materials containing polypropylene (PP), TiO2-coated PP, polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), silk, cellulose, chitosan, alginate, collagen, zein, polydioxanone and various polyesters such as polyethylene terephthalate (PET), the group of polyhydroxyalkanoates, polycaprolactone (PCL), polycaprolactam P(LA-CL), polyglycolic acid (PGA), polylactide (PLA), poly(lactide-co-caprolactone), poly(L-lactide-co-glycolide), poly(L-lactide-co-PEG), poly(lactide-co-trimethylene carbonate), polypropylene carbonate (PPC) (PPF), polybutylene succinate (PBS), polypropylene fumarate or long-chain aliphatic polyesters formed from the polycondensation of long-chain dicarboxylic acids and polyols and bioactive glass is / are used. [18] Method according to any one of claims 9 to 17, characterized by, that for embroidery thread with a thread thickness in the range of 15 µm to 200 µm is used. [19] Method according to any one of claims 9 to 18, characterized by , that for embroidering the concentric rings (1.1 - 1.13) and the connections (2.1 - 2.12) threads are used which differ in material and / or composition. [20] Mesh pocket, manufactured by a method according to claims 9 to 19, for supporting an implant and / or tissue in prepectoral breast reconstruction.

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