Implant for restoring the passability and functionality of the uterine tube in reproduction processes

Abstract

The invention relates to an implant (3) for restoring the passability and functionality of the uterine tube in reproduction processes. The implant (3) has a support element (17) having a tubular outer wall (18) which at least partially delimits an inner volume (20) of the support element (17) and has an at least approximately circular cross section, wherein openings (19) are provided in the outer wall (18) which are designed such that at least for a time after implantation of the support element (17), at least in some regions, folds of a mucosa of the uterine tube grow through and / or penetrate through the openings (19) into the inner volume (20).

Description

[0001] Implant to restore the patency and functionality of the fallopian tube in reproductive processes

[0002] The invention describes an implant for restoring the patency and functionality of the fallopian tube during reproductive processes. The described implant has a support element with a tubular outer wall that at least partially defines an inner volume of the support element and has an at least approximately circular cross-section. Openings are provided in the outer wall and are designed such that, at least temporarily after implantation of the support element in a fallopian tube, folds of a mucous membrane of the fallopian tube grow and / or carry the material through the openings into the inner volume, at least in some areas. The implant according to the invention specifically improves the permeability or permanently guarantees the permeability of sperm and / or fertilized eggs through the fallopian tube into the uterus.

[0003] Up to 15% of couples of reproductive age suffer from an unfulfilled desire to have children. If couples are unable to have children, adhesions in the woman's fallopian tubes are often one of the possible causes. Eggs and sperm then have difficulty moving through the fallopian tubes, and pregnancy often fails to occur.

[0004] In most cases, sperm cannot reach the fertilization site because the blockage is located in the proximal region. If fertilization does occur, an ectopic pregnancy can occur because the fertilized cell cannot pass through the constriction.

[0005] The fallopian tubes are 10 to approximately 12 cm long, muscular tubes that connect the ovary to the uterus. Their function is fundamental for fertilization, as the gametes are transported through the fallopian tubes before fertilization: the egg cells are transported from the ovary toward the uterus, and the sperm cells are transported from the uterus upward toward the ovary. Therefore, the fallopian tubes must not be blocked. Furthermore, the fallopian tubes must be mobile in order to receive the egg after ovulation and move it toward the sperm cells through muscular contractions.

[0006] The human fallopian tubes are paired, muscular hollow organs located in the lesser pelvis (pelvis minor) of the female body and are surrounded by the peritoneum. The proximal region of the fallopian tube, the isthmus, extends over a length of approximately 3 to 4 cm and, in addition to a small vessel lumen diameter of 0.1 to 1 mm, has a well-developed, 2 to 3 mm thick wall musculature. In addition, the so-called tubal mucosa forms a multitude of longitudinal, secondary, and tertiary folds and is composed primarily of glandular cells and ciliated cells, the kinocilia. The ciliated beat of the kinocilia supports the transport of egg cells and generates a secretion stream directed towards the uterus, which carries the sperm.

[0007] Fallopian tube blockage is one of the main causes of female infertility, as the duct connecting the ovary and uterus is disrupted. The causes of tubal blockage vary.

[0008] To treat such a fallopian tube blockage or narrowing, surgery or catheterization are often performed, if at all possible. However, it has now been shown that these procedures to restore tubal patency are not only risky, but also only moderately successful in terms of pregnancy rates. Furthermore, postoperative complications, pain, and impaired function can occur due to the shortening of the fallopian tube and the formation of scar tissue. In contrast, catheterization of narrowed areas is characterized by satisfactory pregnancy success rates in the first few months after treatment. However, the reocclusion rates in the subsequent period are comparatively high.

[0009] For these reasons, assisted reproduction methods such as in vitro fertilization (IVF) are often recommended for those diagnosed with tubal blockage. However, these procedures also have disadvantages, as they involve the administration of significant doses of hormones and the associated side effects, as well as poor pregnancy success rates after one cycle. Furthermore, ethical and religious considerations often play a key role in IVF. Last but not least, IVF is associated with considerable financial expenditure.

[0010] In addition to the previously described procedures for treating blocked or narrowed fallopian tubes, support elements are also known, some of which are used in the treatment of fallopian tube injuries or diseases. For example, DE 60222 565 T2 describes a spiral stent made of biocompatible metal that is generally said to be suitable for keeping body cavities open. However, the use of such a stent in the area of ​​a fallopian tube carries the risk of chronic inflammation in the proximal region of the fallopian tube, thus posing the risk of blockage of the fallopian tube and resulting sterility.

[0011] Furthermore, implants such as those described in CN 113017948 A are known which are used as a drug depot in the area of ​​the fallopian tube before or after an operation.

[0012] However, none of the technical solutions described above guarantees the permanent opening of a fallopian tube or the removal of a constriction in the fallopian tube, so that a channel in the fallopian tube can be created without complications that is passable for sperm and / or fertilized eggs in the long term.

[0013] Based on the technical solutions known from the prior art and the previously described problems that can arise from a narrowing or blockage of a fallopian tube, the object of the invention is to ensure the permeability of a previously closed or at least partially narrowed fallopian tube using comparatively simple means. The key aspect here is that only a minor intervention should be required to enable the permeability of a fallopian tube for sperm and / or fertilized eggs, thus enabling a natural pregnancy, even over a comparatively long period of time such as several weeks, months, or even years. The technical solution to be specified should not involve any side effects or risks for the patient and should be simple and intuitive to implement for the practitioner.Furthermore, the invention should be easily applicable to patients with different anatomies and sizes, especially those with differently shaped fallopian tubes, or should be easily adaptable. Furthermore, the natural function of the fallopian tube should be unimpaired or only minimally impaired. It is particularly important that the functionality of the fallopian tube as a hormonal valve and the tubal mucosa of the fallopian tube is ensured even after implantation of the implant according to the invention, thus ensuring the most complication-free movement of sperm and / or fertilized eggs through a fallopian tube.

[0014] The above-mentioned object is achieved by means of an implant according to claim 1. Advantageous embodiments of the invention are specified in the dependent claims and are explained in more detail in the following description with partial reference to figures. The invention relates to an implant for restoring the patency and functionality of the fallopian tube during reproductive processes, wherein the implant has a support element with a tubular outer wall that at least partially delimits an inner volume of the support element and has an at least approximately circular cross-section. Openings are provided in the outer wall and are designed such that, at least temporarily after implantation of the support element, folds of a mucous membrane of the fallopian tube grow through and / or protrude at least partially through the openings into the inner volume that is at least partially delimited by the outer wall.Thus, an implant is provided with a tubular support element that has inlets and outlets at its two longitudinally opposite ends and has an open-pore outer wall. The implant according to the invention is characterized in that the support element can be anchored in the isthmus of the fallopian tube due to its radial rigidity, and in that the outer wall, with the openings provided therein, is designed in such a way that the support element adapts to the course of the fallopian tube.

[0015] According to the invention, the implant, in particular the support element, is designed such that the fallopian tube can be permanently dilated or kept open without impairing the valve function of the fallopian tube. This is advantageously achieved in that the implant can be at least partially compressed in cross-section upon muscle contraction, in particular to its minimum or minimal extent, and automatically expands back to its standard size upon subsequent relaxation. With the aid of the implant according to the invention, the fallopian tube, in particular a constriction of the fallopian tube, can be dilated and / or kept open in order to restore or safely enable passage for sperm and / or fertilized eggs. In this way, the transport function of the fallopian tube is maintained and natural fertilization is enabled.

[0016] A further aspect of the invention is that the implant, in particular the tubular support element, adapts to the course of the fallopian tube due to the specific design of the outer wall with its openings or pores and does not simply straighten it. Rather, the support element with its outer wall nestles against the fallopian tube wall after implantation. The implant according to the invention for keeping the fallopian tube open, with its open-pore support element, thus adapts to the individually shaped fallopian tube wall as needed, and on the other hand, it keeps the required hollow canal within the fallopian tube open. Furthermore, after implantation of the support element, the folds of the tubal mucosa grow or protrude through the openings in the outer wall into the interior volume, which particularly promotes the transport of a fertilized egg.

[0017] When designing the implant, determining its strength, and selecting the material, the invention takes into account that the channel to be kept open, i.e., the fallopian tube, must be capable of transporting not only a fluid, as is the case with stents used in the bloodstream, but also an expanded body in the form of an egg cell. The design of the implant according to the invention is therefore specifically for use in a fallopian tube.

[0018] Preferably, the support element has a length of 10 to 20 mm and / or the outer wall preferably has a thickness or wall thickness of 50 to 100 pm.

[0019] According to a specific development of the invention, the stiffness of the support element varies in the longitudinal direction of the support element. This specific embodiment of the implant according to the invention is thus based on the idea that the support element, which has a plurality of openings in the outer wall, has a varying stiffness in the longitudinal direction. Such a design results in the stiffness in the region of a first end of the support element being greater than the average stiffness of the support element, and in the region of the opposite, second end, the stiffness being lower than the average stiffness.

[0020] Advantageously, the support element comprises individual elements, segments, or struts in the longitudinal direction, which are configured and interconnected in such a way that the individual elements are movable relative to one another in the region of the connection points. The support element thus preferably comprises a plurality of individual elements in the longitudinal direction, which are interconnected and simultaneously configured such that they form the outer wall of the support element with their openings and can be moved relative to one another in the manner of chain links, so that the shape of the implant can be adapted to the shape of a fallopian tube in a comparatively simple manner as required.

[0021] In a further specific embodiment of the invention, the stiffness of the support element changes continuously in the longitudinal direction of the support element such that the stiffness decreases in the distal direction of the fallopian tube when implanted. According to this embodiment, the stiffness of the support element can be adapted to the contour of the fallopian tube. A key aspect of the invention is that the implant, in particular the tubular support element, adapts to the course of the fallopian tube due to the specific design of the outer wall with its openings or pores and does not simply straighten it. Rather, the support element with its outer wall conforms to the fallopian tube wall after implantation.The implant according to the invention for keeping the fallopian tube open, with its open-pore support element, thus adapts to the individually shaped fallopian tube wall as needed, while also keeping the required hollow canal open within the fallopian tube. Furthermore, after implantation of the support element, the folds of the tubal mucosa grow or protrude through the openings in the outer wall into the inner volume, which particularly favors the transport of a fertilized egg.

[0022] Preferably, the support element has a length of 10 to 20 mm and / or the outer wall preferably has a thickness or wall thickness of 50 to 100 pm.

[0023] Furthermore, it is advantageous if the outer wall of the support element comprises a tissue-compatible, biocompatible, and / or degradable material. The use of a support element made of such a tissue-compatible, biocompatible, and / or degradable material, which, due to its radial rigidity, ensures that the support element is anchored in the isthmus in such a way that the isthmus is dilated permanently or for a desired period of time, ensures that the implanted implant is well tolerated, in particular that it is not rejected by the patient's body. Tissue compatibility is essential for the selection of a suitable material. According to a particular embodiment, the support element comprises a poly(L-lactide).

[0024] The use of a degradable, particularly biodegradable, material also ensures that there is no permanent intervention in the body of the person being treated, but rather the implant decomposes after a desired period of time and is ultimately no longer present in the body.

[0025] In this context, it is advantageously conceivable for the implant, in particular its support element, to remain in the body after a predetermined period of time, which may be a few months or one to two years, particularly preferably a period during which there is a desire to have children, and then to dissolve independently, for example through the material decomposing hydrolytically, being absorbed by the body or finally excreted again, without any further intervention being necessary. However, it is also conceivable for the implant, in particular the support element, to comprise a metal, preferably magnesium, titanium and / or a nickel-titanium alloy. Titanium or a nickel-titanium alloy offers the advantage that it is well tolerated by the body and, moreover, an implant can be realized that can also absorb comparatively high radial forces that may occur in the fallopian tube.

[0026] In a particular embodiment of the invention, the surfaces of the openings in the outer wall of the support element account for 70 to 80%, in particular 72 to 77%, and particularly preferably 75% of the outer surface of the outer wall. Such an open-pore design or an outer wall with a plurality of openings ensures that the functionality of the fallopian tube is maintained and that the support element exhibits particular flexibility and adapts precisely to the shape of the fallopian tube.Because, due to this particular embodiment, the implant only covers a surface of 20 to 30%, in particular 28 to 23%, and particularly preferably 25% of the surface of the fallopian tube in the region in which the implant is arranged with its support element, the functionality of the fallopian tube, in particular the functionality of the tubal mucosa, which can grow through and / or protrude through the openings in the outer wall, is only slightly or not at all restricted. Furthermore, it is conceivable that by additionally structuring the surface of the outer wall of the support element, in particular the surface of the outer wall facing the inner volume, the surface can be optimized for cell colonization. In this way, kinocilia in particular can differentiate on the surface of the outer wall in areas facing the inner volume of the support element, and inflammation can be advantageously avoided.In this way, kinocilia can be achieved to overgrow the surface of the outer wall facing the inner volume of the support element and thus to cover this area of ​​the outer wall at least partially, preferably completely.

[0027] It is particularly advantageous if the outer wall, particularly the surface facing the inner volume, is structured or microstructured in such a way that the outer wall has depressions and / or recesses, thereby supporting the regeneration of ciliated epithelial cells and the cell colonization of the implant, thus supporting the transport function of the fallopian tube. In a particular development, the recesses and / or depressions in the surface of the outer wall facing the inner volume run either linearly or spirally, particularly with respect to a longitudinal axis of the support element.

[0028] A further specific development of the invention provides that opposite ends of the outer wall, which delimit the outer wall in the longitudinal direction of the support element, are rounded at least in some regions. These are the opposite ends of the outer wall of the support element. The support element according to the invention has a hollow channel inside and is open at its two opposite ends, so that these each form an inlet and outlet. Preferably, the edges of the openings provided at the opposite ends of the outer wall, which each form an inlet or outlet, are surface-treated in such a way that no sharp edges are present in these regions. Preferably, the edges of the two openings are finely polished and rounded.

[0029] Furthermore, according to a further embodiment of the invention, it is conceivable for the wall thickness of the outer wall to change, preferably change continuously, in the longitudinal direction of the support element. In such an embodiment of the invention, it is thus provided that the wall thickness of the outer wall changes in the longitudinal direction of the support element, wherein the inner diameter of the internal volume enclosed by the outer wall preferably changes in the longitudinal direction, in particular such that after implantation of the support element, the average inner diameter in the distal direction of the fallopian tube becomes smaller. According to a very special embodiment, in this context, it is provided that the wall thickness at one end of the outer wall (18) assumes a value that is 1.1 to 2 times, in particular 1.5 to 2 times greater than the wall thickness at the opposite end in the longitudinal direction of the support element (17).

[0030] According to a further embodiment, a cross-section of the internal volume of the support element changes in the longitudinal direction of the support element. In this case, generally different changes to the cross-section of the internal volume are conceivable, each adapted to the anatomy of a patient and / or the shape, size, and contour of a fallopian tube. It is particularly advantageous if the internal volume of the support element is funnel-shaped, for example in the form of a straight or at least partially curved truncated cone or pyramid. The correspondingly designed support element can advantageously be implanted such that the region with the smaller cross-section of the internal volume is arranged in the distal region of the fallopian tube. A further embodiment of the invention provides that the outer wall, on the side facing and / or facing away from the internal volume, is at least partially coated with a medium that promotes cell growth.Preferably, the coating is designed in such a way that this coating promotes the colonization of the coated surface with kinocilia. Alternatively or additionally, it is conceivable that the outer wall, on the side facing and / or away from the interior volume, at least in sections has a surface structure that promotes cell growth. In this context, it is conceivable that at least selected surface areas are processed using a suitable mechanical method, for example polishing or grinding, in order to impart a particularly suitable structure to the surface. Here, too, a main objective is to promote the colonization of the correspondingly structured surface with kinocilia after the implant has been implanted in a patient's fallopian tube.

[0031] A special development of the invention provides that, as an alternative or in addition to a groove running straight or spirally in the longitudinal direction of the support element, the cross-sectional shapes of the inner lumen also vary in the longitudinal direction of the support element or are designed differently. A special embodiment provides for periodically recurring increases or decreases in the wall thickness, so that the cross-section of the channel held open by the implant also varies. It is conceivable to provide increases and / or decreases in the wall thickness so that the cross-section of the channel held open has a polygonal shape at least in sections, preferably a polygonal shape with n = 3 corner points. By means of at least sectionally orBy locally minimizing the wall thickness of the support element of the implant according to the invention, the probabilities of rapid epithelialization and unhindered passage of an egg cell are increased in the corresponding areas.

[0032] A further special embodiment of the invention provides a surface structuring inside the support element or on its inner wall, which delimits the canal to be kept open, which has a trapezoidal cross-sectional shape. In this case, it is advantageous if the individual trapezoidal elements or struts protruding into the interior of the support element are designed such that the elements are wider on the outward-facing side than on the side facing inwards towards the interior of the support element. This embodiment of the elements creates a type of ramp on the inward-facing side. These ramps, which are directed towards the distal fallopian tube after implantation of the implant, are intended to reduce the risk of egg cells passing through the fallopian tube from distal to proximal becoming caught in the elements or struts.According to a very special embodiment of the invention, ramp angles in the range of 90° to 150°, in particular in the range of 112° to 142°, and particularly preferably 135°, are realized. The microstructuring is preferably implemented in the manufacturing process using laser structuring. In a special refinement, the desired design on the inner surface of the implant is realized by tilting the laser head as needed during the laser cutting process.

[0033] In general, it is conceivable that the previously described trapezoidal-shaped elements or struts of the support element, which are arranged in a successive and interconnected manner in the longitudinal direction of the support element, could be implemented on one or both sides (distal, proximal, and distal and proximal) of the outer wall of the support element. A ramp oriented toward the proximal fallopian tube after implantation advantageously improves sperm passage. The same angles within the aforementioned range can be used for the distal and proximal ramps, but it is also conceivable to use angle combinations.

[0034] Another special embodiment of a surface structuring provides that the opposite ends of the outer wall, which limit the outer wall in the longitudinal direction of the support element, are rounded in some areas.

[0035] Furthermore, it is particularly conceivable that surface structuring could be achieved by at least partially enlarging the surface of the inner wall of the support element, which faces the inner lumen of the implant. This would maximize the area covered by the fallopian tube epithelium after implantation, thus exerting a positive influence on the oocyte transport function of the fallopian tube and optimizing sperm capacitation.

[0036] A further specific embodiment of the invention is characterized in that the outer wall of the support element is coated and / or impregnated with a hormone, an enzyme, a vitamin, and / or a protein, at least in sections, specifically on a side facing or remote from the interior volume. According to this embodiment, the outer wall is provided with a corresponding substance either by coating the surface or by impregnating the material forming the outer wall. Alternatively or additionally, the outer wall of the support element is coated and / or impregnated with a growth-promoting, anti-infective, antimycotic, spermatozoal antibody, antibiotic, antimicrobial, anticanceroid, cytostatic, and / or other pharmacological active ingredient, which can be selected as needed and applied into or onto the outer wall.

[0037] According to a very special embodiment, the outer wall is provided with a drug-eluting coating that prevents inflammatory reactions via antibiotic agents (e.g., through the incorporation of macrolides, β-lactam antibiotics, cephalosporins, lincosamines) or mediates anti-inflammatory properties through coupled cytokines (e.g., interleukin-4, interleukin-10). Furthermore, it is conceivable to use such a drug-eluting coating to inhibit the proliferation of fibroblasts and smooth muscle cells of the myometrium by inhibiting specific signaling cascades (e.g., the TGFβ cascade), thus preventing sclerotic processes. Furthermore, the modulation of signaling cascades (e.g. EGF or WNT cascade) via inhibitors or by cytokines is suitable to accelerate colonization of the surface of the outer wall, especially on a surface of the outer wall facing the inner volume, with epithelial cells.The release of hormones incorporated into the implant, such as estrogen or progesterone or their derivatives, also offers the advantage of promoting faster epithelial regeneration in the endometrium or, via differentiation or transcription factors coupled to the implant, increased cilia growth with physiological properties in the ciliated epithelial cells of the endometrium. Substances generally suitable for coating the outer wall and selectable according to needs include geminin, multicilin, and / or forkhead box protein J1 (FOXJ1).

[0038] The support element according to the invention can thus be used for different indications as needed. For example, it is conceivable for the outer wall of the support element to be provided with at least one pharmacologically active ingredient that is suitable for treating an inflammation and / or a disease and / or that has health-promoting properties. It is also conceivable for the support element to be designed in such a way that it also serves as a contraceptive, for example by coating and / or impregnating it with an antispermatozoal medium, in particular with spermatozoal antibodies. A particularly preferred embodiment provides in this context for the support element to have a depot that, after implantation, releases at least one substance, in particular one of the aforementioned substances or active ingredients, into an environment over an extended period.In this context, it is conceivable that the corresponding substance is released from the depot over a longer period of time, in particular several weeks or months, so that an active ingredient can act over a longer period of time in a target horizon intended for this purpose.

[0039] A particularly specific embodiment of the invention provides that the support element has a membrane that closes a channel formed by the internal volume in the longitudinal direction of the support element at a location or in a region. Such a membrane is preferably a foldable diaphragm.

[0040] In this context, it is conceivable that an implant designed according to this embodiment, with the membrane arranged in the inner volume, could be implanted into a woman's fallopian tube. At a later point in time, when this is medically possible and / or desired, the membrane could be removed and / or destroyed, thus re-opening the channel formed by the inner volume in the longitudinal direction of the support element. The channel is preferably opened using a suitable catheter system inserted into the fallopian tube. Opening the channel by an external stimulus, e.g., ultrasound, or a targeted local increase in temperature, is also conceivable.

[0041] Alternatively, it is conceivable to manufacture the membrane entirely or partially from a bioresorbable material, so that after a certain point in time, it automatically loses its occlusive function and opens the inner lumen of the fallopian tube. The bioresorbable material used is preferably the same as for the rest of the implant, especially the support element, most preferably polylactide, especially poly-L-lactide (PLLA).

[0042] Alternatively, the use of significantly more rapidly degradable biocompatible polymers, e.g., polydioxanone, is also conceivable. A very special embodiment involves producing the membrane from the bioresorbable material in sections along defined predetermined breaking points, which run approximately circularly around the membrane and can be combined with one or more radially extending cutting surfaces. A support element containing the previously described membrane within its interior volume allows for temporary closure of the fallopian tube and targeted opening at a desired time. In this context, it is conceivable that temporary closure using the membrane may be necessary for medical reasons, for example, to ensure reliable healing of the fallopian tube after an illness, inflammation, or medical intervention and / or to ensure sufficient cell ingrowth into the interior volume of the support element.Alternatively or in addition, it is conceivable that a support element with such a membrane serves as contraception for a certain period of time.

[0043] In the following, the invention is explained in more detail, without limiting the general inventive concept, using exemplary embodiments with reference to the figures. In the figures:

[0044] Fig. 1 : Schematic overview of a uterine tract with a

[0045] Catheter and an implant arranged in the fallopian tube, designed according to the invention;

[0046] Fig. 2: schematic representation of different variants of the shape for an implant designed according to the invention:

[0047] Fig. 3: Top view and sectional view of an inventively designed

[0048] implant;

[0049] Fig. 4: Detailed view of the implant shown in Fig. 3;

[0050] Fig. 5: enlarged view of a section of the section shown in Fig. 4

[0051] Detailed representation;

[0052] Fig. 6: schematic representation of an implant placed in the fallopian tube with

[0053] Support element

[0054] Fig. 7: schematic representation of the transport process of an egg cell with different designs of the implant according to the invention;

[0055] Fig. 8: Representation of several method steps for implanting the implant according to the invention into a fallopian tube;

[0056] Fig. 9: different variants of cross sections of an implant designed according to the invention;

[0057] Fig. 10: Illustration of special design options for

[0058] Surface structuring on the inside of an implant according to the invention and

[0059] Fig. 11: Illustration of a very specific form of surface structuring on the inside of an implant according to the invention. Fig. 1 shows a schematic representation of the female genital tract, whereby the view chosen here shows only the parts relevant to the invention, in particular the uterus 2 and the fallopian tube 1. Furthermore, a possible positioning of an implant 3 with a support element 17 and an application system 4 suitable for implantation are shown schematically.

[0060] In addition, Fig. 2 shows different variants of a design of an implant 3 according to the invention with a support element 17, wherein Fig. 2a) shows a first variant, Fig. 2b) a second variant and Fig. 2c) a third variant of a possible shape of the support element 17 with its outer wall 18.

[0061] The implant 3 according to the invention has a flexible, tubular, for example cylindrical support element 17, which has an outer wall 18 which circumferentially surrounds an inner volume 19 of the support element 17. The support element 17 is thus hollow and has a first end 5, which is arranged proximally in the fallopian tube after implantation, and a second end 6, which is arranged distally in the fallopian tube after implantation. While the outer wall 18 according to the first variant shown in Fig. 2a) has a constant wall thickness in the longitudinal direction of the support element 17 and is cylindrically shaped, Fig. 2b) shows a second variant of the implant according to the invention, in which the outer wall 18 of the support element 17 has a constant wall thickness and the support element 17 is not cylindrically shaped. Furthermore, Fig.2c) shows a third embodiment of the implant 3 according to the invention, in which the support element 17 is not cylindrically shaped and the wall thickness of the outer wall 18 is not constant in the longitudinal direction of the support element 17, i.e. changes in the longitudinal direction of the support element 17.

[0062] Fig. 3 shows a first embodiment of the implant 3 according to the invention, wherein Fig. 3a) shows a plan view of the implant 3 and Fig. 3b) shows a representation of the section AA through the implant 3. The implant has a support element 17 which has an outer wall 18 with a plurality of openings 19. According to the embodiment shown in Fig. 3, the outer wall 18 has a net-like shape. This net-like outer wall 18 is formed by individual struts 7 which, according to the embodiment shown in Fig. 3, are meander-shaped. Furthermore, the surface of the outer wall facing the inner volume is structured or microstructured in such a way that the struts have grooves 8 which, after implantation, support the transport of egg cells and the colonization with kinocilia 10.

[0063] In addition to Fig. 3, Fig. 4 shows a three-dimensional detailed view of an embodiment of the implant according to the invention. This view particularly shows the design of the outer wall 18 of the support element 17, which, according to the embodiment shown, is mesh-like, with the openings 19 accounting for a particularly large surface area. Furthermore, Fig. 5 shows a further detailed view of an even more enlarged section of the outer wall 18, clearly showing the surface structure in the form of grooves 8.

[0064] Fig. 6 also shows a schematic representation of an implant 3 after implantation into a fallopian tube 1. The implant is located within the fallopian tube 1, and the outer surface of the outer wall 18 lies tightly against the fallopian tube wall 9. Due to the large number of openings 19 in the outer wall and the special design of the outer wall 18, it is now possible for folds of the mucous membrane of the fallopian tube 1 to grow through the openings 19 into the inner volume 20.

[0065] In addition to the schematic representation in Fig. 6, Figures 7a) and 7b) show detailed representations of area C at the distal end of the implant, specifically in a state in which an egg cell 11 is located in the fallopian tube. The edges 21 at this first end 5 of the support element are rounded and finely polished, so that a transition angle of less than 90° is realized at the transition between the tissue area of ​​the fallopian tube held open by the implant and the tissue area of ​​the fallopian tube in which the implant is not located.

[0066] The implant 1 shown in Fig. 7a) has a support element 17 with an outer wall 18, the openings 19 of which are arranged between struts 7. According to the embodiment shown in Fig. 7a), no structure in the form of grooves 8 is provided on the surface of the struts 7 opposite the fallopian tube wall 9. As in Fig. 7a), the egg cell 11 becomes trapped on the strut 7 without any surface structuring, since the kinocilia 10 are only differentiated on the fallopian tube wall 9.

[0067] In contrast, Fig. 7b) shows the successful transport of an egg cell 11 through the fallopian tube held open by an implant according to the invention. Due to the structuring of the surface of the struts 7 facing the inner volume, which form the outer wall 18 of the support element 17, with a groove 8, the settlement of kinocilia is promoted, which can differentiate on the surface of the struts 7 after a comparatively short time after implantation.

[0068] Furthermore, Fig. 8 shows the sequence of a suitable minimally invasive implantation procedure to illustrate a possible use of the implant 3 according to the invention. In this context, Figures 8a), 8b) and 8c) schematically show the various process steps carried out during implantation. Fig. 8a) shows the application system 4 loaded with an implant 3, which has a guide wire 12, an outer shaft 13 and a hollow punch 14. Fig. 8b) shows a process step in which the partially still crimped implant 15, which is in a compressed state within the outer shaft 13, is slowly and in a controlled manner by retracting the outer shaft 13, so that the implant 3, in its unfolded state, rests against the fallopian tube wall 9. During this process step, the hollow punch 14 fixes the implant 3, 15 at the implantation site. Finally, Fig.8c) shows the implant 3 completely released in the fallopian tube 3.

[0069] In Fig. 9, partial views A to E show various variants of cross-sections of an implant designed according to the invention, wherein suitable surface structuring is provided at least partially on an inner side of the support element wall facing the inner lumen. Preferably, such surface structuring of the inner lumen is introduced into a semi-finished product by laser cutting prior to the implant manufacturing process, which is then shaped into the desired form.

[0070] Partial view A shows an implant with a circular cross-section without surface structuring. Partial views B to E each show surface structuring in the form of grooves with a rectangular cross-sectional profile, as in partial view B, or with a cross-sectional profile with varying degrees of rounding, as in partial views C to E. Special designs are characterized by polygonal cross-sectional shapes, as shown in partial view D with n = 3 corner points and in partial view E with n = 4 corner points.

[0071] Fig. 10 shows a special possibility for designing surface structuring on the inside of an implant according to the invention, wherein two different embodiments are shown in partial views A and B. The surface structuring uses elements or struts which are arranged in the longitudinal direction of the support element and have a trapezoidal cross-sectional shape. In the detailed view “X”, two elements according to the embodiment as shown in partial view A are shown. It is important that the cross-section of the element decreases in the direction of the inner lumen of the support element, so that a type of ramp is created. Such a ramp can be arranged on both sides, as shown in partial view A, i.e. distally and proximally after implantation, or, as shown in partial view B, on one side, proximally after implantation of the stent. The ramp improves the transport of the egg cell orof the sperm, as shown schematically in the detailed view “X”.

[0072] Finally, Fig. 11 shows a very special form of surface structuring. According to the illustrated embodiment, different surface structurings are combined. As shown in Fig. 11, in this case, grooves with a rounded cross-section are combined with elements or struts that have a trapezoidal cross-sectional shape. The resulting increase in the surface area of ​​the inner lumen or the inner wall of the support element maximizes the area that can be covered by the fallopian tube epithelium, which in turn has a positive influence on the egg transport function of the fallopian tube and also optimizes sperm capacitation, i.e., the biochemical maturation process of the sperm cells in the fallopian tube.

[0073] List of reference symbols

[0074] 1 fallopian tube

[0075] 2 uterus

[0076] 3 Implant

[0077] 4 Application system

[0078] 5 first end

[0079] 6 second end

[0080] 7 Strut

[0081] 8 grooves

[0082] 9 Fallopian tube wall

[0083] 10 cinemas

[0084] 11 egg cell

[0085] 12 Guide wire

[0086] 13 outer shaft

[0087] 14 hollow punches

[0088] 15 Crimped stent

[0089] 16 Expanded stent

[0090] 17 Support element

[0091] 18 Exterior wall

[0092] 19 openings

[0093] 20 internal volume

[0094] 21 end edges of the support element

Claims

Patent claims 1. Implant (3) for restoring the patency and functionality of a fallopian tube (1) during reproduction in the longitudinal direction of the fallopian tube (1), which has a support element (17) with a tubular outer wall (18) which at least partially delimits an inner volume (20) of the support element (17) and has an at least approximately circular cross-section, wherein openings (19) are provided in the outer wall (18) and are designed such that, at least temporarily after implantation of the support element (17), folds of a mucous membrane of the fallopian tube (1) grow through and / or protrude at least partially through the openings (19) into the inner volume (20), characterized in that the support element (17) can be anchored in the isthmus of the fallopian tube due to its radial rigidity and the outer wall (18) with the openings provided therein is designed such that the support element adapts to the course of the fallopian tube.

2. Implant according to claim 1, characterized in that a stiffness of the support element (17) varies in the longitudinal direction of the support element.

3. Implant according to claim 2, characterized in that the stiffness of the support element (17) changes continuously in the longitudinal direction of the support element (17) in such a way that the stiffness in the implanted state of the support element (17) decreases in the distal direction of the fallopian tube (1).

4. Implant according to one of the preceding claims, characterized in that the support element (17) has a length of 10 to 20 mm in the longitudinal direction.

5. Implant according to one of the preceding claims, characterized in that the outer wall (18) of the support element (17) has an outer diameter of 0.8 to 2.5 mm and / or comprises a tissue-compatible and / or biodegradable material.

6. Implant according to one of the preceding claims, characterized in that surfaces of the openings (19) have a proportion of 70 to 80%, in particular of 72 to 77% and particularly preferably of 75% of an outer surface of the outer wall (18).

7. Implant according to one of the preceding claims, characterized in that the outer wall (18) of the support element (17) has a wall thickness of 50 to 100 pm and / or ends of the outer wall (18) which delimit the outer wall (18) in the longitudinal direction are rounded at least in regions.

8. Implant according to one of the preceding claims, characterized in that a wall thickness of the outer wall (18) changes in the longitudinal direction.

9. Implant according to claim 7, characterized in that the wall thickness at one end of the outer wall (18) assumes a value of 1.1 to 2 times, in particular 1.5 to 2 times, compared to the wall thickness at the opposite end in the longitudinal direction of the support element (17).

10. Implant according to one of the preceding claims, characterized in that the outer wall (18) on the side facing and / or facing away from the inner volume (20) is coated at least in sections with a medium that promotes cell growth.

11. Implant according to one of the preceding claims, characterized in that the outer wall (18) on the side facing and / or facing away from the inner volume has, at least in sections, a surface structure, in particular at least one groove (8), which promotes cell growth.

12. Implant according to claim 10, characterized in that the at least one groove (8) is arranged parallel and / or spirally to the longitudinal center axis of the inner volume (20) of the support element (17).

13. Implant according to one of the preceding claims, characterized in that the outer wall (18) of the support element (17) comprises a metal and / or a poly-L-lactide.

14. Implant according to one of the preceding claims, characterized in that a cross-section of the internal volume (20) of the support element (17) changes in the longitudinal direction.

15. Implant according to one of the preceding claims, characterized in that the inner volume (20) of the support element (17) is funnel-shaped and / or in the form of a straight or at least partially curved truncated cone or truncated pyramid.

16. Implant according to one of the preceding claims, characterized in that the outer wall (18) of the support element (17) is at least partially coated and / or impregnated with a hormone, an enzyme, a vitamin and / or a protein.

17. Implant according to one of the preceding claims, characterized in that the outer wall (18) of the support element (17) is coated and / or impregnated at least in sections with a growth-promoting, anti-infective, antimycotic, antispermatozoid, antibiotic, antimicrobial, anticanceroid and / or other pharmacological active ingredient.

18. Implant according to one of the preceding claims, characterized in that the support element (17) has a depot which, after implantation, releases at least one substance into an environment over a longer period of time.

19. Implant according to one of the preceding claims, characterized in that the support element (17) has a membrane which closes the internal volume over its cross-section and can be opened once.

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