Facial midsection defect filling implant

Abstract

The utility model discloses a kind of face middle part defect filling implants, the face middle part defect filling implant includes: first implant, is provided with first inner abdomen, first flaps, first concave-convex structure and first slot hole, the first flaps are set in the side of the first implant, the first concave-convex structure is set in the surface of the first implant, the first slot hole is through the first implant;Second implant, is provided with second inner abdomen, second flaps, second concave-convex structure and second slot hole, the second flaps are set in the side of the second implant, the second concave-convex structure is set in the surface of the second implant, the second slot hole is through the second implant;Connecting structure is set between the first implant and the second implant, the first implant and the second implant are connected together in the utility model, with mechanical stability, the advantage that operation is simple, and can be applicable to most patients.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and further to an implant for filling midface defects. Background Technology

[0002] Some patients develop a sunken nasal base due to congenital facial developmental deficiencies or trauma. This not only affects overall appearance but can also make a person look older, tired, or have stiff, unnatural facial expressions. Treatment typically involves injecting hyaluronic acid or autologous fat, or implanting prostheses to correct the sunken nasal base. However, injectable fillers are technically sensitive, have a high risk of vascular embolism, and the injected material can easily form clumps or fibrosis, thus disrupting normal facial structures. Furthermore, the injected material is easily absorbed, requiring multiple injections over a long period to maintain the effect.

[0003] The materials used for implanted nasal prostheses are typically expanded polytetrafluoroethylene (ePTFE) or PEEK. After ePTFE implantation, factors such as gravity, external kneading, and improper sleeping posture (such as sleeping on one's stomach) can cause implant displacement, leading to nasal asymmetry or abnormal shape. PEEK implants usually require screw fixation; without screws, the implant will shift, affecting appearance. However, screw fixation requires strict adherence to screw placement; otherwise, it can cause persistent pain, pressure, and unnatural facial expressions. Therefore, while PEEK implants offer stable results, they carry significant risks and have limited indications, making them unsuitable for most patients.

[0004] Therefore, it is necessary to design a midface defect filling implant to solve the above problems. Utility Model Content

[0005] To address the aforementioned technical problems, the purpose of this utility model is to provide a midface defect filling implant that has the advantages of mechanical stability, simple surgical operation, and applicability to most patients.

[0006] To achieve the above objectives, this utility model provides a midface defect filling implant, comprising: The first implant has a first inner abdomen, a first wing, a first concave-convex structure and a first slot. The first inner abdomen is used to fit and conform to the human bone surface. The first wing is located on the side of the first implant. The first concave-convex structure is located on the surface of the first implant. The first slot penetrates the first implant and is used to induce bone growth. The second implant has a second inner abdomen, a second wing, a second concave-convex structure, and a second slot. The second inner abdomen is used to adapt and fit the human bone surface. The second wing is located on the side of the second implant. The second concave-convex structure is located on the surface of the second implant. The second slot penetrates the second implant and is used to induce bone growth. A connecting structure is disposed between the first implant and the second implant, the connecting structure connecting the first implant and the second implant together.

[0007] In some embodiments, the first flap is set at a preset angle to the first implant and extends toward the piriform foramen of the human body; And / or, the second flap is set at a preset angle to the second implant and extends toward the piriform aperture of the human body.

[0008] In some embodiments, the first uneven structure includes at least one of regular stripe patterns, regular fish scale patterns, regular polygonal grid patterns, irregular rock-like surface depressions, and irregular volcano-like surface depressions. The second uneven structure includes at least one of the following: regular stripe pattern, regular fish scale pattern, regular polygonal grid pattern, irregular rock-like surface depression, and irregular volcano-like surface depression.

[0009] In some embodiments, the height range of the first uneven structure is 0.001mm-2mm; And / or, the height range of the undulations in the second concave-convex structure is 0.001mm-2mm.

[0010] In some embodiments, the first slot includes a plurality of spaced first through holes, the first through holes penetrating the first implant, the first through holes including at least one of rectangular holes, rhomboid holes, polygonal holes, circular holes, elliptical holes, and irregular holes, the distance between two adjacent first through holes is 0.2mm-15mm, and the distance between the outermost first through hole and the side edge of the first implant is 0.5mm-30mm. And / or, the second slot includes a plurality of spaced second through holes, the second through holes penetrating the second implant, the second through holes including at least one of rectangular holes, rhomboid holes, polygonal holes, circular holes, elliptical holes, and irregular holes, the distance between two adjacent second through holes is 0.2mm-15mm, and the distance between the outermost second through hole and the side edge of the second implant is 0.5mm-30mm.

[0011] In some embodiments, the first slot includes a plurality of spaced first through slots that penetrate the first implant and the opening of the first through slot faces the side of the first implant. The first through slot includes at least one of a straight elongated slot, a chamfered slot, and an irregularly shaped slot. The distance between the first through slot and the side edge of the first implant is 0.5mm-30mm, and the width of the first through slot is 0.2mm-15mm. And / or, the second slot includes a plurality of spaced second through slots, the second through slots penetrating the second implant, and the opening of the second through slot facing the side of the second implant. The second through slot includes at least one of a straight elongated slot, a chamfered slot, and an irregularly shaped slot. The distance between the second through slot and the side edge of the second implant is 0.5mm-30mm, and the width of the second through slot is 0.2mm-15mm.

[0012] In some embodiments, the periphery of the first implant has a first ventral surface, the first ventral surface has a gradient structure, and the first ventral surface is in contact with the human bone surface, the thickness of the connecting surface is 0.1mm-2mm; And / or, the second implant has a second ventral surface on its periphery, the second ventral surface having a gradient structure, and the second ventral surface fitting against the human bone surface, the thickness of the connecting surface being 0.1mm-2mm.

[0013] In some embodiments, the connection structure is a hinge structure, through which the first implant is connected to the second implant; Alternatively, the connection structure is a mortise and tenon structure, through which the first implant is connected to the second implant.

[0014] In some embodiments, the first implant is made of one of pure polyetheretherketone, composite hydroxyapatite material, composite calcium phosphate material, or composite bone morphogenetic protein. And / or, the second implant is made of one of pure polyetheretherketone, composite hydroxyapatite material, composite calcium phosphate material, or composite bone morphogenetic protein.

[0015] In some embodiments, the surface of the first implant is provided with a first coating, which is hydroxyapatite or calcium phosphate. And / or, the surface of the second implant is provided with a second coating, the second coating being hydroxyapatite or calcium phosphate.

[0016] Compared with the prior art, the midface defect filling implant provided by this utility model has at least one of the following beneficial effects: In this invention, the first and second implants are shaped according to the defects of the human maxillofacial region. The inner surfaces of the first and second implants fit and conform to the surface of the human jawbone, and the transition between the first and second implants and the surface of the human jawbone is smooth. By setting the implants separately and connecting them through a connecting structure, it can adapt to complex bone contours, facilitate surgical installation, and reduce surgical difficulty. The implant is fixed by setting folded wings. The bent wings utilize the natural shape of the bone to form a "clamping" effect, which can stabilize the implant without additional screws, further simplifying the surgical operation, reducing the learning curve for doctors, and avoiding screw-related complications (such as intractable pain), so that more patients (such as those whose bone conditions are not suitable for screws) can receive treatment. By setting concave and convex structures on the surface of the implant, the contact area with muscles and bones is increased and the hydrophilicity is improved, which facilitates cell adhesion and proliferation. By setting slots, space is provided for muscles to directly adhere to the bone. Attached Figure Description

[0017] The preferred embodiments will be described below in a clear and easy-to-understand manner, in conjunction with the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages and implementation methods of this utility model.

[0018] Figure 1 This is a schematic diagram of the structure of a preferred embodiment of the implant for filling defects in the mid-surface of this utility model; Figure 2 This is a top view of the structure of the second implant in a preferred embodiment of this utility model; Figure 3 This is a front view of the structure of the second implant according to a preferred embodiment of the present invention; Figure 4 This is a partial structural schematic diagram of the first implant of a preferred embodiment of the present invention; Figure 5 This is a partial structural schematic diagram of the second implant according to a preferred embodiment of the present invention; Figure 6 This is a schematic diagram of the structure of the implant for filling defects in the center of the face, a preferred embodiment of the present invention, in use.

[0019] Explanation of icon numbers: First implant 1, first slot 11, first concave-convex structure 12, second implant 2, second slot 21, second concave-convex structure 22, second wing 23, second inner abdomen 24, connecting structure 3, human body 4, piriform orifice 41. Detailed Implementation

[0020] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the specific implementation methods of this utility model will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of this utility model. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0021] To keep the drawings concise, each figure only schematically shows the parts relevant to the utility model, and these do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of the components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0022] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0023] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0024] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0025] In one embodiment, refer to the appendix to the specification. Figures 1 to 6The present invention provides a midface defect filling implant, comprising: a first implant 1, a second implant 2, and a connecting structure 3. The first implant 1 is provided with a first inner abdomen, a first wing, a first concave-convex structure 12, and a first slot 11. The first inner abdomen is used to adapt and fit with the human bone surface. The first wing is provided on the side of the first implant 1. The first concave-convex structure 12 is provided on the surface of the first implant 1. The first slot 11 penetrates the first implant 1 and is used to induce bone growth. The second implant 2 is provided with a second inner abdomen 24, a second wing 23, a second concave-convex structure 22, and a second slot 21. The second inner abdomen 24 is used to adapt and fit with the human bone surface. The second wing 23 is provided on the side of the second implant 2. The second concave-convex structure 22 is provided on the surface of the second implant 2. The second slot 21 penetrates the second implant 2 and is used to induce bone growth. The connecting structure 3 is provided between the first implant 1 and the second implant 2, and the connecting structure 3 connects the first implant 1 and the second implant 2 together.

[0026] In this embodiment, the shapes of the first implant 1 and the second implant 2 are made according to the human maxillofacial defects. The inner abdomens of the first implant 1 and the second implant 2 are adapted to fit the surface of the human jawbone, and the transition between the first implant 1 and the second implant 2 and the surface of the human jawbone is smooth. By setting the implants separately and connecting them through the connecting structure 3, it can adapt to complex bone contours, facilitate surgical installation, and reduce surgical difficulty. The implant is fixed by setting folded wings. The bent wings use the natural shape of the bone to form a "clamping" effect, which can stabilize the implant without additional screws, further simplifying the surgical operation, reducing the learning curve for doctors, and avoiding screw-related complications (such as intractable pain), so that more patients (such as those whose bone conditions are not suitable for screws) can receive treatment. By setting concave and convex structures on the surface of the implant, the contact area with muscles and bones is increased and the hydrophilicity is improved, which facilitates cell adhesion and proliferation. By setting slots, space is provided for muscles to directly adhere to the bones.

[0027] In one embodiment, refer to the appendix to the specification. Figure 2 The first flap is set at a preset angle to the first implant 1 and extends toward the piriform aperture of the human body; the second flap 23 is set at a preset angle to the second implant 2 and extends toward the piriform aperture of the human body.

[0028] The piriform foramen is a bony opening at the front of the maxilla (an inverted triangular opening in the anterior part of the nasal cavity). The "wings" (lateral extensions) of the implant bend in this direction, indicating that the design conforms to the anatomical structure of the nasal base and maxilla. The specific bending angle is adjusted according to the individual skeletal morphology of the patient to ensure that the implant fits naturally with the maxillofacial bones and avoids compression or displacement due to improper angle.

[0029] Traditional PEEK implants rely on screw fixation, requiring highly skilled surgeons (precise positioning is essential to avoid nerve / vascular damage). This design, however, achieves mechanical stability through anatomically adapted flexible wings, simplifying the surgical procedure and reducing the learning curve for surgeons. The flexible wings conform closely to the bone in the piriform foramen area, resisting the effects of gravity, external forces, or sleeping posture, reducing displacement issues common with traditional expanded polytetrafluoroethylene (ePTFE) or unfixed PEEK implants. It also avoids screw-related complications (such as intractable pain), making the treatment accessible to more patients (e.g., those with bone conditions unsuitable for screw placement).

[0030] In one embodiment, refer to the appendix to the specification. Figure 4 , Figure 5 The first uneven structure 12 includes at least one of the following: regular stripes, regular fish scales, regular polygonal grids, irregular rock-like surface depressions, and irregular volcano-like surface depressions; the second uneven structure 22 includes at least one of the following: regular stripes, regular fish scales, regular polygonal grids, irregular rock-like surface depressions, and irregular volcano-like surface depressions. By setting uneven structures on the surface of the implant, the contact area and hydrophilicity with muscles and bones are increased, facilitating cell adhesion and proliferation. Of course, the uneven structure can also be set to other structures according to actual needs, as long as the above functions can be achieved.

[0031] The height range of the first concave-convex structure 12 is 0.001mm-2mm; the height range of the second concave-convex structure 22 is also 0.001mm-2mm. The height of the concave-convex structure can be set to any value within this range according to actual needs.

[0032] Furthermore, the first implant 1 has a first ventral surface on its periphery, which has a gradient structure and conforms to the human bone surface. The thickness of this connecting surface is 0.1mm-2mm, ensuring a smooth transition between the first implant 1 and the bone surface. The second implant 2 has a second ventral surface on its periphery, which also has a gradient structure and conforms to the human bone surface. The thickness of this connecting surface is 0.1mm-2mm, ensuring a smooth transition between the second implant 2 and the bone surface.

[0033] In one embodiment, refer to the appendix to the specification. Figures 1 to 3The first slot 11 includes several spaced-apart first through holes, which penetrate the first implant 1. The first through holes include at least one of the following: rectangular, rhomboid, polygonal, circular, elliptical, and irregularly shaped holes. The distance between two adjacent first through holes is 0.2mm-15mm, and the distance between the outermost first through hole and the side edge of the first implant 1 is 0.5mm-30mm. The second slot 21 includes several spaced-apart second through holes, which penetrate the second implant 2. The second through holes include at least one of the following: rectangular, rhomboid, polygonal, circular, elliptical, and irregularly shaped holes. The distance between two adjacent second through holes is 0.2mm-15mm, and the distance between the outermost second through hole and the side edge of the second implant 2 is 0.5mm-30mm. In practical applications, the distance between two adjacent through holes and the distance between the outermost through hole and the side edge of the implant can be set to any value within this range according to actual needs.

[0034] In another embodiment, the first slot 11 includes a plurality of spaced-apart first through slots that penetrate the first implant 1, with the opening of the first through slot facing the side of the first implant 1. The first through slot includes at least one of a straight elongated slot, a chamfered slot, or an irregularly shaped slot. The distance between the first through slot and the side edge of the first implant 1 is 0.5mm-30mm, and the width of the first through slot is 0.2mm-15mm. The second slot 21 includes a plurality of spaced-apart second through slots that penetrate the second implant 2, with the opening of the second through slot facing the side of the second implant 2. The second through slot includes at least one of a straight elongated slot, a chamfered slot, or an irregularly shaped slot. The distance between the second through slot and the side edge of the second implant 2 is 0.5mm-30mm, and the width of the second through slot is 0.2mm-15mm. The specific distance between the through slot and the side edge of the implant, and the specific width of the through slot, can be set to any value within this range according to actual needs.

[0035] In this embodiment, by setting different structures of slots on the first implant 1 and the second implant 2 according to different needs, the muscles can pass through the slots and directly contact the bones, providing space for the muscles to directly adhere to the bones and also providing space for the bones to grow into the implants, thus avoiding problems such as implant displacement, facial stiffness, and unnatural expressions after midface surgery.

[0036] In one embodiment, refer to the appendix to the specification. Figure 1The connecting structure 3 is a hinge structure, through which the first implant 1 is connected to the second implant 2. The nasal base region moves slightly during speaking, chewing, or facial expressions. The hinge structure allows the implant to adaptively adjust to these slight bone movements, reducing mechanical stress on surrounding tissues and avoiding the displacement or pressure pain caused by traditional rigid implants due to external forces. Surgeons do not need to precisely sculpt the curvature of every part of the implant; the hinge can automatically adjust local angles, reducing the demands on surgical manipulation. Furthermore, if subjected to external impact (such as rubbing the nose), the hinge can cushion the energy through micro-movements, reducing the risk of implant breakage or displacement.

[0037] Alternatively, the connecting structure 3 can be a mortise and tenon structure, with the first implant 1 connected to the second implant 2 via the mortise and tenon structure. The mortise and tenon structure achieves self-locking through physical snap-fit, avoiding the use of screws or sutures and reducing the risk of foreign body reaction and infection; the tight fit of the mortise and tenon can resist slippage caused by gravity or external forces, which is especially suitable for positions such as the nasal base that need to maintain their shape for a long time; in addition, if the mortise and tenon contact surface adopts a porous structure, bone tissue may grow into the gap, further strengthening the fixation.

[0038] In this embodiment, the dual implant design, which is connected by hinges or tenons, achieves the dual goals of biomechanical adaptation and surgical simplification, representing a significant advancement in nasal base repair technology.

[0039] In one embodiment, refer to the appendix to the specification. Figure 1 The first implant 1 and the second implant 2 are made of polyetheretherketone (PEEK) and composite bone growth induction materials, which are medical implantable materials. For example, the first implant 1 is made of one of pure polyetheretherketone, composite hydroxyapatite, composite calcium phosphate, and composite bone morphogenetic protein; the second implant 2 is made of one of pure polyetheretherketone, composite hydroxyapatite, composite calcium phosphate, and composite bone morphogenetic protein.

[0040] Furthermore, the surface of the first implant 1 can be coated with a first coating, which is hydroxyapatite or calcium phosphate; the surface of the second implant 2 can be coated with a second coating, which is also hydroxyapatite or calcium phosphate. By uniformly distributing hydroxyapatite or calcium phosphate on the surface of the implant, new bone will form at the contact point between the defective maxillofacial region and the implant, filling the entire gap between the defective maxillofacial region and the implant, and growing on the hydroxyapatite; callus is likely to form at the defective maxillofacial region covered by the implant, ultimately integrating the implant with human tissue, greatly reducing the chance of postoperative infection.

[0041] Furthermore, the first implant 1 and the second implant 2 can be manufactured using traditional subtractive processing methods such as machining, or additive manufacturing methods such as 3D printing. The uneven surface structure of the first implant 1 and the second implant 2 can be formed by machining, spraying, shot peening, or 3D printing. Jawbone data acquisition and reconstruction of three-dimensional images of the jawbone can be performed using methods known in the art. For example, jawbone data acquisition can be performed using CT / MRI and other means; the acquired data can be imported into medical image processing software to perform three-dimensional reconstruction of the jawbone model. The first implant 1 and the second implant 2 can be designed using reverse modeling based on CT scan data, ensuring that the ventral surface of the implant fits perfectly with the bone surface, guaranteeing a smooth transition between the implant and the surface of the human jawbone.

[0042] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0043] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this utility model. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this utility model, and these improvements and modifications should also be considered within the protection scope of this utility model.

Claims

1. A midface defect filling implant, characterized in that, include: The first implant has a first inner abdomen, a first wing, a first concave-convex structure and a first slot. The first inner abdomen is used to fit and conform to the human bone surface. The first wing is located on the side of the first implant. The first concave-convex structure is located on the surface of the first implant. The first slot penetrates the first implant and is used to induce bone growth. The second implant has a second inner abdomen, a second wing, a second concave-convex structure, and a second slot. The second inner abdomen is used to adapt and fit the human bone surface. The second wing is located on the side of the second implant. The second concave-convex structure is located on the surface of the second implant. The second slot penetrates the second implant and is used to induce bone growth. A connecting structure is disposed between the first implant and the second implant, the connecting structure connecting the first implant and the second implant together.

2. The midface defect filling implant according to claim 1, characterized in that, The first flap is set at a preset angle to the first implant and extends toward the piriform foramen of the human body; And / or, the second flap is set at a preset angle to the second implant and extends toward the piriform aperture of the human body.

3. The midface defect filling implant according to claim 1, characterized in that, The first concave-convex structure includes at least one of regular stripe patterns, regular fish scale patterns, and regular polygonal grid patterns; The second concave-convex structure includes at least one of regular stripe patterns, regular fish scale patterns, and regular polygonal grid patterns.

4. The midface defect filling implant according to claim 3, characterized in that, The height range of the first uneven structure is 0.001mm-2mm; And / or, the height range of the undulations in the second concave-convex structure is 0.001mm-2mm.

5. The midface defect filling implant according to claim 1, characterized in that, The first slot includes a plurality of spaced first through holes, which penetrate the first implant. The first through holes include at least one of rectangular holes, rhomboid holes, circular holes, and elliptical holes. The distance between two adjacent first through holes is 0.2mm-15mm, and the distance between the outermost first through hole and the side edge of the first implant is 0.5mm-30mm. And / or, the second slot includes a plurality of spaced second through holes, the second through holes penetrating the second implant, the second through holes including at least one of rectangular holes, rhomboid holes, circular holes, and elliptical holes, the distance between two adjacent second through holes is 0.2mm-15mm, and the distance between the outermost second through hole and the side edge of the second implant is 0.5mm-30mm.

6. The midface defect filling implant according to claim 1, characterized in that, The first slot includes a plurality of spaced first through slots, the first through slots penetrate the first implant, and the opening of the first through slot faces the side of the first implant. The first through slot includes at least one of a straight elongated slot and a slot with a chamfer. The distance between the first through slot and the side edge of the first implant is 0.5mm-30mm, and the width of the first through slot is 0.2mm-15mm. And / or, the second slot includes a plurality of spaced second through slots, the second through slots penetrating the second implant, and the opening of the second through slots facing the side of the second implant, the second through slots including at least one of straight elongated slots and chamfered slots, the distance between the second through slots and the side edge of the second implant is 0.5mm-30mm, and the width of the second through slots is 0.2mm-15mm.

7. The midface defect filling implant according to claim 1, characterized in that, The first implant has a first ventral surface on its periphery. The first ventral surface has a gradient structure and is in contact with the human bone surface. The thickness of the interface between the first ventral surface and the human bone surface is 0.1mm-2mm. And / or, the second implant has a second ventral surface on its periphery, the second ventral surface has a gradient structure, and the second ventral surface is in contact with the human bone surface, the thickness of the interface between the second ventral surface and the human bone surface is 0.1mm-2mm.

8. The midface defect filling implant according to claim 1, characterized in that, The connection structure is a hinge structure, and the first implant is connected to the second implant through the hinge structure; Alternatively, the connection structure is a mortise and tenon structure, through which the first implant is connected to the second implant.

9. The midface defect filling implant according to claim 1, characterized in that, The first implant is made of one of the following: pure polyetheretherketone, composite hydroxyapatite material, composite calcium phosphate material, and composite bone morphogenetic protein. And / or, the second implant is made of one of pure polyetheretherketone, composite hydroxyapatite material, composite calcium phosphate material, or composite bone morphogenetic protein.

10. The midface defect filling implant according to claim 1, characterized in that, The surface of the first implant is provided with a first coating, which is hydroxyapatite or calcium phosphate; And / or, the surface of the second implant is provided with a second coating, the second coating being hydroxyapatite or calcium phosphate.

Images