Implant

Abstract

An implant (1), in particular a bone screw, for use in the animal or human body is provided. The implant (1) comprises a head (2) with a first side (3) and a second side (4), and a shaft (5) extending along a longitudinal axis (A), wherein the head (2) has at least one fluid path (6) configured to bring the first side (3) into fluid communication with the second side (4). Furthermore, a transport system (10) for the implant (1) and a method for manufacturing the implant (1) are provided.

Description

[0001] The present disclosure relates to an implant, in particular a bone screw, for attachment to a bone, a transport system and a manufacturing process for producing the implant.

[0002] Implants, such as bone screws, can indirectly promote the formation of new bone by stabilizing bone tissue and supporting healing. However, they do not have a direct osteogenic (i.e., bone-building) effect, but rather create favorable biomechanical conditions for bone healing. Furthermore, bone graft implants are known to replace missing or damaged bone tissue and promote natural bone regeneration. Such bone screws or implants are often used in orthopedics, dentistry, or surgery when bone mass has been lost, for example, after fractures, tumors, infections, or due to osteoporosis. Autologous bone, which is bone tissue taken from the patient's own body, is used as a bone replacement material. In this procedure, the bone tissue is harvested from one patient and transplanted to another site.The transported bone tissue can be fixed or held in place by an implant or a bone screw in order to fix it in a desired location.

[0003] However, with known implants, it is a disadvantage that the implant hinders or delays the healing process.

[0004] Therefore, it is an objective of the present disclosure to provide an implant for use in the animal or human body that does not hinder bone formation and preferably promotes it.

[0005] This problem is solved with a device having the features of claim 1, as well as with a transport system having the features of claim 9, and with a method for manufacturing an implant having the features of claim 10.

[0006] According to one aspect of the present invention, an implant is provided for use in the animal or human body. The implant can comprise a head with a first side and a second side. The implant can comprise a shaft extending along a longitudinal axis. The head can have at least one fluid path configured to bring the first side into fluid communication with the second side.

[0007] Compared to the prior art, the subject matter of the present disclosure offers the advantage that the implant, and in particular its head, presents a reduced obstacle to a fluid (e.g., blood), allowing the fluid to flow freely between the first and second sides of the head. This improves blood flow to the tissue and / or bone on either side. In other words, the obstacle to a fluid that can be created by the head of an implant can be reduced by at least one fluid pathway. This can increase the healing rate and support the healing process. Furthermore, it can ensure uniform bone formation.

[0008] The implant can be a bone screw. Furthermore, the bone screw can be designed as a tenting screw. A tenting screw can be a specialized type of bone screw. In particular, a tenting screw can be a specific type of bone screw used in reconstructive surgery, especially for treating bone defects and supporting bone regeneration. The term "tenting" refers to the screw's primary function: to hold up or stabilize the surrounding tissue—especially the periosteum, the membrane covering the bone—to promote healing. A membrane can also be held up by the implant or tenting screw, with the periosteum or other soft tissue in contact with the membrane. The membrane can be designed to be fluid-permeable.Thus, the periosteum, soft tissue, or other substances surrounding the first side of the head do not need to come into direct contact with the first side of the head. The membrane can be placed over the head. A cavity can be created through the head and / or the membrane. In cases of larger bone defects or after bone loss, the periosteum is often pulled over the affected area, which can create a "cavity." The tenting screw can be used here to lift the periosteum from the underlying defect area, thus creating space for new bone growth. Furthermore, the bone screw can prevent soft tissue ingrowth by supporting the periosteum and thus preventing soft tissue (e.g., muscle or connective tissue) from invading and filling the bone defect. This keeps the cavity clear for the ingrowth of new bone material.Furthermore, bone regeneration can be supported by creating a space beneath the periosteum, allowing for the insertion of bone substitute material or autologous bone tissue. The stabilized periosteum then acts as a natural layer, supporting and promoting bone healing. Additionally, bone structure can be restored by stabilizing the defect area with the tenting screw, helping to maintain the bone's natural shape and structure during the healing phase. This enables the restoration of the original bone shape and function. The implant can be used in trauma surgery, particularly for significant bone loss following accidents; in reconstructive surgery, especially in surgical procedures where bone has been removed (e.g., tumor resection); and in orthopedic surgery, particularly for building up and stabilizing bone defects.Tenting screws are used in complex fractures and / or in oral surgery, particularly to support bone augmentation for dental implants. A tenting screw is a bone screw that provides support by bracing the periosteum and / or the periosteum, thereby promoting the growth and regeneration of bone tissue in the defect area. In other words, the implant can be screwed into existing bone. For example, the implant can be screwed into bone in such a way that it can hold bone material, such as that taken from the patient's own body, in the required position (i.e., it can be fixed there). The head can hold the transplanted bone material in place. The shaft can have a cylindrical shape. In other words, the shaft can have a constant cross-section in the longitudinal direction.The shaft can be designed to position the head in a specific way relative to the bone. In other words, the implant can be attached to healthy bone in such a way that a space is formed between the head and the healthy bone. Bone graft material or other bone-building material can be placed in this space. This implanted material can be held in place by the head. In other words, the head prevents the bone graft material from slipping or shifting. The first and second sides can be arranged opposite each other, thus representing two sides of the head. At least one fluid pathway ensures communication between the first and second sides of the head.On the second side of the head, for example, bone material can be arranged. This bone material can refer to the bone to be augmented. On the opposite, first side of the head, tissue or the like can be arranged. In other words, the implant head can form a boundary between the bone to be augmented and the soft tissue. In another embodiment, the head can also be completely integrated into the bone to be augmented. Thus, bone substance can be provided on both the first and second sides of the head. Regardless of how the implant is used, the fluid pathway is designed to provide communication between the first and second sides. Communication here can mean that a fluid can move back and forth between the first and second sides. The fluid pathway can, for example, be a recess in the head.Furthermore, the fluid path can be a through-hole or bore extending through the head. The fluid path can extend along the longitudinal axis. Thus, fluid such as blood or other bodily fluids can flow back and forth between the first and second sides. This minimizes resistance to fluid exchange facilitated by the head. The shaft can extend along the longitudinal axis. The head can extend substantially perpendicular to the longitudinal axis. In other words, the head and shaft can be oriented at an angle of substantially 90° to each other. The implant of the present disclosure provides the advantageous effect of improved blood supply beneath the head.

[0009] Optionally, at least one fluid path can have a constant flow cross-section. The flow cross-section is the cross-section available to a flowing fluid as it passes through the fluid path. The fluid can flow from an upstream point through the fluid path to a downstream point. Thus, a constant flow cross-section can be provided between the upstream and downstream points of the fluid path. In other words, the walls of the fluid path can be essentially parallel. This ensures that the flow capacity is independent of the flow direction (i.e., from the first side to the second side or from the second side to the first). Optionally, the fluid path can have only an inlet and an outlet.In other words, the fluid path cannot have any branches or other openings. This ensures a uniform flow within the fluid path.

[0010] Optionally, at least one fluid path has a variable cross-sectional area. In this embodiment, the fluid path can therefore have a non-constant cross-sectional area, so that the fluid path either narrows or widens from the upstream side to the downstream side. This ensures advantageous fluid flow when the flow direction is known. This is advantageous, for example, when a well-vascularized area is located on a known side of the head (i.e., on the first and second sides), and bone material is to be built up on the opposite side. Thus, the flow of blood to the desired side can be forced.

[0011] Optionally, at least one fluid path extends along the longitudinal axis. This fluid path can be inclined relative to the longitudinal axis. Furthermore, the fluid path can also be helical around the longitudinal axis. This lengthens the fluid path, thereby creating a suction effect. The suction effect can be achieved by a lower pressure on the first or second side relative to the other side. It is also conceivable that an overpressure forces fluid through the fluid path. This prevents pressure peaks on one side of the head. Especially in conjunction with variable flow cross-sections, this can facilitate fluid exchange between the first and second sides. Furthermore, at least one fluid path can be designed as a Venturi nozzle, at least in sections (for example, by a local constriction within the fluid path).A Venturi nozzle offers a reliable way to control flow and generate a desired pressure differential. The Venturi nozzle is characterized by its simple and robust design, which requires no moving parts and enables high efficiency. This allows a desired pressure to be set on one side, which can accelerate the healing process.

[0012] Optionally, at least one fluid path is inclined relative to the longitudinal axis. This allows the fluid path to be positioned within the implant head in such a way that other structures on the head are not affected. For example, an intervention structure can be provided that interacts with a tool to handle the implant. By angling the fluid path relative to the longitudinal axis, mutual interference between the intervention structure and the fluid path can be prevented, while still ensuring fluid exchange between the first and second sides.

[0013] Optionally, the fluid path runs parallel to the longitudinal axis. In this case, the fluid path can run straight through the head. This can simplify the manufacturing of the implant.

[0014] Optionally, the cross-sectional area of ​​at least one fluid path can be essentially round or elliptical. The at least one fluid path can also be designed as an elongated slot. This offers the advantage of preventing flow shadows or fluid turbulence within the fluid path. As a result, the flow capacity through a fluid path can be kept constant.

[0015] Optionally, the fluid path is at least partially enclosed by the head. The fluid path can therefore also be a recess at the edge of the head. In such a case, the fluid path may only be partially enclosed by the head. In another embodiment, the fluid path is completely enclosed by the head. In other words, the fluid path can be a through-hole. This allows for the use of very small heads or small implants that still provide improved fluid exchange between the first and second sides. With such small heads, it is often difficult to create through-holes. Therefore, the advantageous effect of the subject matter of the present disclosure can also be achieved with very small implants.

[0016] Optionally, the head has a flat section and a rounded section surrounding it. The flat section may have a surface that is substantially perpendicular to the longitudinal axis. The rounded section may extend at least partially around one circumference of the flat section. This allows soft tissue that is positioned over the head on the first side of the implant to be guided in such a way as to prevent excessive tension on and within the soft tissue. The flat section can ensure a flat contact surface for the soft tissue. The rounded section, on the other hand, can serve to adapt to bone shapes or external tissue contours.

[0017] Optionally, at least one fluid pathway runs at least partially through both the flat and the rounded sections. In other words, the at least one fluid pathway can be arranged so that it is located in both the flat and the rounded sections. This ensures sufficient fluid circulation even at the transition zone. Furthermore, by having an opening (e.g., an inlet) on the first side in the region of the rounded section, the fluid pathway can have a larger inlet area there than on the second side. This allows more fluid to be absorbed from the first side and transported through the fluid pathway to the second side. This, in turn, allows for an advantageous blood supply to the tissue being built up on the second side of the head.

[0018] Optionally, the head features an engagement feature designed to allow insertion of a tool. This engagement feature can be a point of insertion that interacts with a tool. For example, the engagement feature could be a cross-slot pattern, an internal square drive, a Torx drive, or the like. This allows the implant to be conveniently handled with common tools.

[0019] Optionally, the engagement structure is arranged in the flat section of the head. This ensures good force transmission.

[0020] Optionally, a central axis of the at least one fluid path is arranged radially within an outer circumference of the intervention structure. In other words, the intervention structure can form a circumferential contour that is essentially circular. The central axis can be the central axis of the at least one fluid path. By arranging the central axis of the at least one fluid path within this outer contour of the intervention structure, a relative position of the intervention structure relative to the at least one fluid path can be defined. It has been shown that by arranging the intervention structure relative to the at least one fluid path, advantageous stiffness can be achieved in the implant head.

[0021] Optionally, the intervention structure has a cross-like shape in a top view. The outer contour of the intervention structure can therefore be defined by connecting the outer ends of the respective straight lines with a circular arc. The central axis of at least one fluid path can lie within this contour.

[0022] Optionally, the engagement structure has a rounded cross-section along its longitudinal axis. This allows a tool to penetrate deeply into the engagement structure at a central position without excessively weakening the head.

[0023] Optionally, the ratio of the diameter of at least one fluid path to the diameter of the head can be in the range of 0.1 to 0.2. This has been shown to provide an optimal balance between the head's ability to retain bone and its permeability to fluid. Optionally, a ratio of 0.15 to 0.17 is also possible. Surprisingly, the greatest strength (i.e., the force the implant can withstand without failure) was achieved in this range. The fluid path can have a round outer shape. The head can also have a round outer shape.

[0024] Optionally, the head can have multiple fluid pathways. In other words, the head can have two, three, four, five, six, or more fluid pathways. Optionally, the fluid pathways can be evenly distributed across the head. In other words, the fluid pathways can all be the same distance apart (for example, center to center). This can ensure a uniform blood supply to the bone tissue. Optionally, the multiple fluid pathways can be arranged in a circular path on the head. Arranging the fluid pathways in a circular path or shape can ensure uniform fluid communication between the first and second sides.

[0025] Optionally, at least two fluid paths are arranged such that their central axes and the longitudinal axis lie on the same line perpendicular to these axes. In other words, at least two fluid paths can be arranged opposite each other relative to the longitudinal axis on the head such that all three axes lie on a virtual straight line. This can increase the head's rigidity, which improves its durability, particularly during implant handling. The central axis can be the midpoint of a fluid path.

[0026] Optionally, the head is designed to hold or fix bone material in a desired location. In other words, the head can serve as a kind of retention element to position bone material at a desired location in the human body, for example, against a healthy bone. For this purpose, the head can have a plate-like shape. It can be round or angular. The head can also feature a collar element that runs along its outer circumference to further improve bone retention. Therefore, bone material can be fixed or held in a desired position by the implant. Bone material can also be referred to as bone substance.

[0027] Optionally, the head can have a substantially round outer contour when viewed from above. In other words, the head can be circular in shape. This offers the advantage that if soft tissue is present on the first side of the head, the soft tissue will not be damaged by any existing edges or the like.

[0028] Optionally, the head can taper to a point on its outer circumference. This allows for the provision of a rounded section. This offers the further advantage that soft tissue placed over the first side of the head contacts the implant head with less tension. This helps prevent damage to the soft tissue. Furthermore, it allows for a more favorable definition of the bone contour.

[0029] Optionally, the head can have a variable extent along one direction of the longitudinal axis. In other words, the head can have its thickest point along the longitudinal axis at its center. Since the stem connects to the head at this point, this can provide improved overall stability of the implant.

[0030] Optionally, the shaft can taper along its longitudinal axis. This can facilitate removal. In other words, the shaft can have a conical shape.

[0031] Optionally, the stem can have a threadless section, at least in part. This threadless section can be located adjacent to the head along the stem. This allows the area where bone material used to build new bone to be concentrated precisely where the threadless section is located, thus enabling the formation of more new bone material.

[0032] Optionally, the ratio of the length of the unthreaded section to the length of the threaded section along the longitudinal direction can be in the range of 0.2 to 0.9. Since the threaded section 51 can be the section that secures the implant in the desired position, it is indicative of the implant's potential retention force. The unthreaded section, on the other hand, defines the receiving space for bone material. In the aforementioned ratio, it has been shown that the implant possesses the necessary retention force to hold the bone material in the desired position. Optionally, the ratio is in the range of 0.4 to 0.7. This range has surprisingly proven advantageous when soft tissue is present on the first side of the abutment. The threaded section can have a thread with a diameter of 1.2 mm.

[0033] Optionally, the shaft thread can be designed as a self-tapping thread. This allows the implant to be inserted into healthy bone without prior drilling (depending on bone quality). Optionally, a cutting edge with a radius of approximately 2.5 mm can be provided at the outer end of the shaft.

[0034] Optionally, the shaft has a proximal end, where it connects to the head, and a distal end. The distal end can also be referred to as the outer end of the shaft. The proximal end can be the point of contact between the shaft and the head.

[0035] Optionally, the distal end can be pointed, ground, or rounded. This allows the implant to be adapted to a specific application site, depending on where the implant is to be inserted.

[0036] Optionally, the thread can have at least one thread pitch, preferably two or more. The thread pitch can specify the distance between the thread turns. Providing a single pitch ensures a homogeneous arrangement of the implant in healthy bone. Using different pitches allows for specific consideration of the implant's intended location, thereby increasing its range of applications.

[0037] The implant can be made of metal, steel, titanium, plastic, or resorbable materials. Furthermore, the implant can be a combination of these materials. This allows for the development of an implant that can be easily inserted into a human or animal body.

[0038] According to a further aspect of the present invention, a transport system for an implant is provided. The transported implant can be one of the implants described above. The transport system can comprise a container. The transport system can include a lid element that can form a receiving space with the container. The transport system can include at least one receptacle for receiving an implant, wherein the receiving space can be formed in the lid element. The transport system can include at least one implant according to one of the preceding embodiments. The at least one implant can be arranged in the at least one receptacle of the lid element such that the stem projects into the receiving space. In other words, the implant can be held by its head against the lid element. This allows the implant to be handled directly from the transport system with a tool.The transport system can be provided in a sterile or non-sterile condition.

[0039] Furthermore, the transport system can include a packaging element positioned on the container to form an interior space, within which the lid element is located. The packaging element can exhibit high tear resistance, durability, breathability, and clean peelability. It can also provide a microbial barrier to maintain the sterility of the implant located within the interior and the receiving chamber throughout its life cycle. The packaging element can be designed to be compatible with all common sterilization methods, particularly ethylene oxide (EO), radiation (gamma and electron beam), steam under controlled conditions, and low-temperature oxidative sterilization. The packaging element can be made of HDPE and is therefore recyclable.

[0040] Optionally, the receiving chamber is hermetically sealed from the environment. The environment can refer to the surroundings of the transport system. This allows the implant to be packaged in a sterile environment, ensuring that the stem, which is located within the receiving chamber, remains sterile during transport.

[0041] Optionally, the container can be designed so that the cross-section of the receiving chamber tapers. In other words, the container can be designed so that the lid element provides secure contact with the container wall, allowing the receiving chamber to be hermetically sealed. This allows for manufacturing tolerances that make production more efficient.

[0042] Optionally, the lid element can be detachably attached to the container. This allows the lid element to be replaced and adapted to different implant sizes.

[0043] Optionally, the transport system can include an identification section designed to hold an information carrier. This carrier can provide information about the type of implant being transported. For example, the carrier could be a sticker indicating which implants are being transported. Alternatively, the carrier could be an RFID chip or similar device containing information about the implants being transported. This would enable contactless information transfer.

[0044] According to another aspect of the present disclosure, a method for building up new bone using an implant according to one of the embodiments described above is provided. The implant is fixed to a bone such that a receiving space is formed between the bone and the second side of the head. Bone material is inserted into the receiving space. The bone material is held in place between the bone and the head by the head itself. The second side of the head is in contact with the bone material. Soft tissue and / or the membrane is then stretched over the first side of the head. The first side of the implant head is in direct contact with the soft tissue.

[0045] According to a further aspect of the present invention, a method for manufacturing an implant according to one of the above embodiments is provided. The method may include providing a blank. The method may include creating a head by forming, in particular by cold forming, the blank. The method may include creating a stem, in particular by forming.

[0046] Individual embodiments and features can be combined with other embodiments or features to form new embodiments. Features and advantages mentioned in connection with the features mentioned under the embodiment also apply analogously to the new embodiments. Advantages and features mentioned in connection with the device also apply analogously to the method, and vice versa.

[0047] The following describes embodiments of the present invention in detail with reference to the accompanying figures: Fig. Figure 1 is a schematic and perspective view of an implant according to an embodiment of the present invention. Fig. Figure 2 is a schematic and perspective view of an implant according to an embodiment of the present invention. Fig. Figure 3 is a schematic side view of an implant according to an embodiment of the present invention. Fig. Figure 4 is a schematic top view of an implant according to an embodiment of the present invention. Fig. Figure 5 is a schematic and perspective view of a transport system according to an embodiment of the present invention.

[0048] Fig. Figure 1 is a schematic and perspective view of an implant 1 according to an embodiment of the present invention. In the present embodiment, the implant is implemented as a bone screw or so-called tenting screw. The implant 1 has a head 2 and a shaft 5. The head is connected to the shaft 5. The shaft 5 extends along a longitudinal axis A. In other words, the shaft has its greatest extent along the longitudinal axis A. The head 2 has a plurality of fluid channels 6.

[0049] In the present embodiment, the head 2 has four fluid paths 6. Furthermore, the head 2 has an engagement structure 7 designed to interact with a tool. The shank 5 has a threadless section 51 and a threaded section 52. In the present embodiment, the threaded section 52 has a length of 5 mm along the longitudinal axis A. The threadless section 51 also has a length of 5 mm along the longitudinal axis A. In another embodiment, the length of the threaded section 52 remains constant, but the length of the threadless section 51 is 7 mm. In a further embodiment, the length of the threaded section 52 remains constant, but the length of the threadless section 51 is 3 mm. The head 2 can have a length of 0.9 mm along the longitudinal axis A. The head 2 can have a diameter of 6 mm.In another embodiment, the head 2 can have a diameter of 5 mm. The diameter of a fluid path can be 1 mm.

[0050] In Fig. 2 is the implant made of Fig. 1. Shown from a bottom view. In Fig. Figure 2 shows the implant 1 such that the second side 4 is visible. The second side 4 of the head 2, unlike the first side 3, is flat. The shaft 5 is connected to the head 2 at a ridge 11. The connection between the shaft 5 and the head 2 can have a radius of 1.4 m.

[0051] Fig. Figure 3 is a schematic side view of the implant 1. In the side view, the flat section 8 and the rounded section 9, which surrounds the flat section 8, are visible on the first side 3 of the head 2. The rounded section 9 surrounds the flat section 8 in a circular fashion.

[0052] embodiment of the present invention. In the Fig. In the embodiment shown in Figure 4, the four fluid paths 6 have a constant cross-section along the longitudinal axis. The engagement structure 7 has a recess in the center.

[0053] Fig.Figure 5 is a schematic and perspective view of a transport system according to an embodiment of the present invention. The transport system comprises a container 12 and a lid element 13. The lid element 13 is arranged on the container 12. In the present embodiment, the lid element 13 has three receiving spaces 15 for receiving an implant 1. Thus, in the present embodiment, three implants can be held by one lid element 13. The lid element 13, together with the container, forms a receiving space 15. The transport system has an identification section 16 to which an information carrier can be attached. Furthermore, the transport system can have a packaging element (not shown in the figures) which is attached or can be attached to the container in such a way as to create an interior space in which the heads of the implants are arranged. Reference symbol list: 1 implant 2 heads 3 first page 4 second page 5 shaft 6 Fluid path 7 Intervention structure 8 level section 9 rounded section 10 Transport system 11 bulge 12 containers 13 Cover element 15 Recording room 16 Identification section A Longitudinal axis

Claims

Implant (1), in particular bone screw, for use in the animal or human body, comprising: a head (2) with a first side (3) and a second side (4), a shaft (5) extending along a longitudinal axis (A), wherein the head (2) has at least one fluid path (6) designed to bring the first side (3) into fluid communication with the second side (4). Implant (1) according to claim 1, wherein the at least one fluid path (6) has a constant cross-sectional area. Implant (1) according to claim 1 or 2, wherein the head (2) has a flat section (8) and a rounded section (9) surrounding the flat section (8). Implant (1) according to claim 3, wherein the at least one fluid path (6) runs at least partially through the flat section (8) and the rounded section (9). Implant (1) according to one of the preceding claims, wherein a plurality of fluid paths (6) are provided. Implant (1) according to claim 5, wherein at least two fluid paths (6) have different flow cross-sections. Implant (1) according to one of the preceding claims, wherein the head (2) tapers to a point towards its outer circumference. Implant (1) according to one of the preceding claims, wherein the head (2) has the greatest extent at its center along the longitudinal axis (A). Transport system (10) for the implant (1) according to one of the preceding claims, comprising a container (12), a lid element (13) which forms a receiving space (15) with the container (12), at least one receiving space (15) for receiving an implant (1), wherein the receiving space (15) is formed in the lid element (13), at least one implant (1) according to one of the preceding claims, wherein the at least one implant (1) is arranged in the at least one receptacle of the lid element (13) such that the shaft (5) projects into the receiving space (15). Method for manufacturing an implant (1), in particular a bone screw, according to any one of claims 1 to 8, comprising: providing a blank, creating a head (2) by forming, in particular by cold forming, the blank, creating a shaft (5), in particular by forming.

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