Skull plug

Abstract

The utility model provides a skull plug which comprises a plug body and a plug cap, the plug body is cylindrical, the plug cap is connected with the plug body, the cross section of the plug cap along the center line of the plug cap is arc-shaped, and the diameter of the plug cap is larger than that of the plug body. When the skull plug is plugged into a skull defect position, the plug body is plugged into the defect position so as to be matched with other skull. On one hand, the plug cap covers the whole plug body and makes contact with bone tissue at other positions, the plug body can be prevented from entering the human body skull under the action of external force, and on the other hand, the shape of the plug cap is similar to that of the skull, so that the applicability of the skull plug is improved.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical instruments of neurosurgery skull defect repair, especially relates to a skull plug. BACKGROUND

[0002] In the current medical field, for the skull small hole type defect caused by disease or accident, generally do not recommend repair operation. However, if the defect is located in the frontal, temporal and other thin scalp or near the important brain function area (such as motor area, language area), even slight external force can cause compression or damage to brain tissue. In addition, even if the skull defect is small, it may also cause local head depression, asymmetry, which may cause patients to have inferiority, anxiety and other psychological problems, thereby affecting their social, work and life quality. Normal skull is a barrier to protect the brain from external damage, and defect may cause various risks. Therefore, for the skull small hole type bone defect, repair operation is necessary in some cases.

[0003] As a skull defect repair medical device, the applicability of the skull plug has always been a subject of research in the field of medical devices. UTILITY MODEL CONTENT

[0004] The technical purpose of the utility model is to provide a skull plug, which aims to improve the applicability of the skull plug.

[0005] To solve the above technical problems, the utility model provides a skull plug, which comprises:

[0006] A plug body, which is cylindrical;

[0007] A plug cap connected to the plug body, and the cross section of the plug cap along the center line of the plug cap is arc-shaped, and the diameter of the plug cap is larger than that of the plug body.

[0008] Further, the plug body comprises a first plug body and at least one second plug body surrounding the periphery of the first plug body, the first plug body is cylindrical, each layer of the second plug body comprises a plurality of columnar petals uniformly arranged around the first plug body, and the cross section of the columnar petal is arc-shaped.

[0009] Further, a gap is provided between two adjacent columnar petals, and the second plug body has multiple layers, and the gaps of two adjacent layers of the second plug body are arranged in a staggered manner.

[0010] Further, along the radial direction of the first plug body, the thickness of the columnar petal is 1mm-2mm.

[0011] Further, along the axial direction of the first plug body, the height of the first plug body is 3mm-10mm, and the height of the second plug body is 3mm-10mm.

[0012] Further, the first plug body has a diameter of 3-6mm.

[0013] Further, the second plug body has multiple layers, and the distance between two adjacent layers of the second plug body is 1-2mm.

[0014] Further, the central axis of the plug cap coincides with the central axis of the plug body.

[0015] Further, the thickness of the plug cap at the central position is 1-5mm.

[0016] Further, the plug body and the plug cap are both provided with apertures, and the porosity of the skull plug is 50-90%.

[0017] Further, the plug cap is circular, the outer surface of the plug cap is spherical, and the diameter of the plug cap is 10-50mm.

[0018] Further, the cross section of the plug cap along the central line of the plug cap is arc-shaped, and the arc angle of the arc shape is 20-45°.

[0019] Further, the thickness of the plug cap at the central position is greater than the thickness of the plug cap at other positions.

[0020] Further, along the radial direction of the plug cap, the thickness of the plug cap gradually decreases from the central position of the plug cap to the edge of the plug cap.

[0021] The utility model relates to a skull plug, and the skull plug comprises a plug body and a plug cap, the plug body is cylindrical, the plug cap is connected with the plug body, the cross section of the plug cap along the central line of the plug cap is arc-shaped, and the diameter of the plug cap is greater than the diameter of the plug body. When the skull plug is inserted into the skull defect, the plug body is inserted into the defect to cooperate with other skull bones. The plug cap covers the whole plug body and contacts with other bone tissues, so that the plug body can be prevented from entering the human skull under the action of external force, and the shape of the plug cap is similar to the shape of the skull, so that the applicability of the skull plug is improved. ACCURATE DRAWINGS

[0022] Figure 1 It is the whole structure schematic view of the skull plug in the utility model embodiment;

[0023] Figure 2 It is the schematic view of the cross section of the plug cap along the central line of the plug cap in the utility model embodiment;

[0024] Figure 3 It is the whole structure schematic view of the skull plug from another angle in the utility model embodiment;

[0025] Figure 4 It is the bottom view of the skull plug in the utility model embodiment.

[0026] In the drawings, the reference signs represent: 1, plug body; 11, first plug body; 12, second plug body; 121, columnar petal; 2, plug cap. DETAILED DESCRIPTION

[0027] The embodiments of the present application are described in detail below, examples of which are shown in the drawings, wherein the same or similar reference signs represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by reference to the drawings are exemplary and are intended to explain the present application, and cannot be understood as a limitation of the present application, and all other embodiments obtained by those skilled in the art without creative labor on the basis of the embodiments in the present application belong to the scope of protection of the present application.

[0028] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "circumferential", "radial" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements indicated must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation of the present application.

[0029] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "multiple" is two or more, unless otherwise specifically limited.

[0030] A normal skull is a barrier that protects the brain from external damage, and defects can lead to a variety of risks. Therefore, for small hole type skull defects, repair surgery is necessary in some cases. As a medical device for repairing skull defects, the applicability of skull plugs has always been a subject of research in the field of medical devices.

[0031] In view of the above technical problems, the present application provides a skull plug to improve the applicability of the skull plug.

[0032] As shown in the accompanying Figure 1 Fig. 1 is a schematic diagram of the overall structure of the skull plug in the embodiment of the present application; and Figure 2The image shown is a schematic diagram of a cross-section of the cap 2 along its center line in an embodiment of this utility model. (From the attached image...) Figure 1 and attached Figure 2 It can be seen that the skull plug includes a plug body 1 and a plug cap 2.

[0033] The plug 1 is cylindrical, and its cross-sectional shape can be adjusted according to the shape of the missing skull. The cap 2 is connected to the plug 1. When the skull plug is inserted into the skull defect, the plug 1 is inserted into the defect to fit with other skull fragments. The cap 2 has an arc-shaped cross-section along its center line, and its shape is similar to that of the skull, thus improving the applicability of the skull plug. The diameter of the cap 2 is larger than that of the plug 1, allowing it to completely cover the plug 1 while maintaining contact with other bone tissue, preventing the plug 1 from entering the skull under external force.

[0034] As can be seen from the above embodiments, when the skull plug of this utility model is inserted into a skull defect, the plug body 1 is inserted into the defect to cooperate with other skull bones. The plug cap 2 covers the entire plug body 1 and is in contact with other bone tissues, which can prevent the plug body 1 from entering the human skull under external force. On the other hand, the shape of the plug cap 2 is similar to the shape of the skull, thus improving the applicability of the skull plug.

[0035] As attached Figure 3 -Appendix Figure 4 As shown, in some embodiments, the plug 1 includes a first plug 11 and at least one layer of second plugs 12 surrounding the first plug 11. The first plug 11 is cylindrical, and each layer of the second plug 12 includes a plurality of columnar petals 121 evenly arranged around the first plug 11. The cross-section of the columnar petals 121 is arc-shaped. The second plug 12 can be adjusted according to the size of the skull defect. There is a certain distance between each layer of columnar petals 121, which can be manually adjusted according to the size of the skull defect. For example, the outer columnar petals 121 can be deformed inward, thereby tilting the columnar petals 121 inward, thus changing the size of the plug 1 to adapt to the size of the skull defect location.

[0036] In some embodiments, a gap is provided between two adjacent columnar flaps 121, and the second plug 12 has multiple layers, with the gaps between adjacent layers of the second plug 12 being staggered. With this configuration, when the second plug 12 is deformable, each location of the skull defect is supported and filled by columnar flaps 121 when the plug 1 is inserted into the skull defect, preventing the formation of another skull defect location.

[0037] In some embodiments, the thickness of the columnar petals 121 is 1mm-2mm in the radial direction of the first plug body 11, i.e. the thickness direction of the columnar petals 121 is parallel to the radial direction of the first plug body 11. In this way, the structure of the columnar petals 121 has a certain stability, can fill the skull defect, and provide a little support force at the skull defect. Exemplarily, the thickness of the columnar petals 121 can be 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm. The thickness of the columnar petals 121 can also be a value between any two adjacent values in the above examples.

[0038] In some embodiments, the height of the first plug body 11 is 3mm-10mm, and the height of the second plug body 12 is parallel to the axial direction of the first plug body 11. The height of the first plug body 11 is 3mm-10mm, and the height of the second plug body 12 is 3mm-10mm. In this way, the overall height of the plug 1 is 3mm-10mm, which is close to the thickness of the human skull, and the simulation of the skull plug is higher. Exemplarily, the height of the first plug body 11 is 3mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm...9.8mm, 9.9mm, 10mm. The height of the first plug body 11 can also be a value between any two adjacent values in the above examples. Exemplarily, the height of the second plug body 12 is 3mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm...9.8mm, 9.9mm, 10mm. The height of the second plug body 12 can also be a value between any two adjacent values in the above examples. Exemplarily, the overall height of the skull plug is 5mm-15mm.

[0039] In some embodiments, the diameter of the first plug body 11 is 3mm-6mm, so that the first plug body 11 has sufficient strength to support the surrounding human skull and the surrounding second plug body 12. Exemplarily, the diameter of the first plug body 11 is 3mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm...5.8mm, 5.9mm, 6mm. The diameter of the first plug body 11 can also be a value between any two adjacent values in the above examples.

[0040] In some embodiments, the second plug body 12 has multiple layers, and the distance between two adjacent layers of the second plug body 12 is 1-2 mm. In this way, the different layers of the second plug body 12 can be deformed with a certain space, and the space between the two adjacent layers of the second plug body 12 is not too large. After being inserted into the skull defect position, it can support the surrounding human skull and cooperate with the surrounding human skull to protect the brain tissue. For example, the distance between two adjacent layers of the second plug body 12 is 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2 mm. The distance between two adjacent layers of the second plug body 12 can also be a value between any two adjacent values in the above examples.

[0041] In some embodiments, the central axis of the plug cap 2 coincides with the central axis of the plug body 1. In this way, the plug cap 2 can cover the plug body 1 and the skull defect position repaired by the plug body 1, thereby protecting the plug body 1 and the skull defect position.

[0042] In some embodiments, the thickness of the central position of the plug cap 2 is 1-5 mm. In this way, the plug cap 2 can have sufficient structural stability to protect the skull defect position and the skull plug. The central position of the plug cap 2 can be the position of the center point, or the position within a preset distance from the center point. For example, the position within a radius of 2 mm. For example, the thickness of the central position of the plug cap 2 is 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 4.8 mm, 4.9 mm, or 5 mm. The thickness of the central position of the plug cap 2 can also be a value between any two adjacent values in the above examples.

[0043] In some embodiments, the plug body 1 and the plug cap 2 are both provided with pores, and the porosity of the skull plug is 50-90%. In this way, the pores of the skull plug can help the diffusion of liquid and the growth of cell tissue, disperse a small amount of subcutaneous hydrops and be absorbed by cell tissue, avoid the formation of a false membrane between the skull implant and the cell tissue, and thus reduce the incidence of subcutaneous hydrops. The porosity of the skull plug can be 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 88%, 89%, or 90%. The porosity of the skull plug can also be a value between any two adjacent values in the above examples.

[0044] In some embodiments, the plug cap 2 is circular, and the outer surface of the plug cap 2 is spherical. In this way, the shape of the plug cap 2 is close to the shape of the human skull, which can improve the simulation of the skull plug. The diameter of the plug cap 2 is 10-50 mm. The diameter of the plug cap 2 in this numerical range can completely cover the skull defect to be repaired. For example, the diameter of the plug cap 2 is 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, 50 mm. The diameter of the plug cap 2 can also be a value between any two adjacent values in the above examples.

[0045] In some embodiments, the cross section of the plug cap 2 along the center line of the plug cap 2 is arc-shaped, and the arc angle of the arc-shaped is 20-45°. In this way, the shape of the plug cap 2 is close to the shape of the skull, which can increase the applicability of the skull plug and reduce the foreign body sensation after the skull plug is inserted into the skull defect position. The arc angle of the arc-shaped of the plug cap 2 is 20°, 21°, 22°, 23°, 24°, 25°, 26°, 27°, 28°, 29°, 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°. The arc angle of the arc-shaped of the plug cap 2 can also be a value between any two adjacent values in the above examples.

[0046] In some embodiments, the thickness of the plug cap 2 at the center position is greater than the thickness of the plug cap 2 at other positions. Since the edge of the plug cap 2 needs to abut against the human bone tissue, if the edge of the plug cap 2 is too thick, it is easy to make the patient feel foreign body sensation, and the structural strength of the edge of the plug cap 2 can be lower than that of the center position of the plug cap 2. The center position of the plug cap 2 has no bone tissue to support, and the center position of the plug cap 2 needs to protect the brain tissue and the plug body 1, so the center position of the plug cap 2 needs strong structural stability. Therefore, the structural stability of the plug cap 2 set in this way meets the actual needs.

[0047] In some embodiments, the thickness of the plug cap 2 gradually decreases radially from the center of the plug cap 2 to the edge of the plug cap 2. Similarly, since the edge of the plug cap 2 needs to abut against the human bone tissue, if the edge of the plug cap 2 is too thick, it is easy to make the patient feel foreign, and the structural strength of the edge of the plug cap 2 can be lower than that of the center of the plug cap 2. The center of the plug cap 2 has no bone tissue to support, and the center of the plug cap 2 needs to protect the brain tissue and the plug body 1, so the center of the plug cap 2 needs strong structural stability, and therefore, the structural stability of the plug cap 2 thus arranged meets the actual needs.

[0048] In some embodiments, the material of the skull plug is a polyether ether ketone (PEEK) and BCP composite material, wherein the PEEK component is about 60-80%, and the BCP component is about 20-40%. In terms of process, the integrated molding is realized by a fused deposition forming additive manufacturing technology, the core of which is to heat the PEEK and BCP filaments to a molten state, and then extrude through a nozzle, and deposit layer by layer on the building platform according to the pre-set path.

[0049] The PEEK and BCP composite material has no artifacts, excellent bone integration ability to promote bone fusion, better bioactivity, and better hydrophilicity. The PEEK and BCP composite material, wherein the BCP is a "dual-phase composite" material of HA and β-TCP, realizes the synergistic optimization of degradation rate, mechanical strength and bioactivity. This makes the skull plug not only serve as a "temporary scaffold" in bone tissue engineering and clinical repair, but also has the dual function of "bone inductive factor". Finally, the skull plug is closely fused with the new bone itself to form an integrally formed overall structure.

[0050] The skull plug adopts a melting extrusion process to realize multiple porosities of one product, and the plug cap 2 and the plug body 1 can exhibit different pore structures. The part contacting the skull is designed to promote bone growth, and the part contacting the soft tissue is beneficial to the adhesion of the soft tissue. The pores of the skull plug are connected, and the liquid flow rate is increased.

[0051] Exemplarily, after the neurosurgeon completes the intracranial surgical operation, according to the actual size of the skull defect, the corresponding size of the skull plug is selected, and after the bone margin is fully hemostatic, the plug body 1 of the skull plug is embedded into the defect to directly realize the repair function of the small range of skull defects. The top end of the plug cap 2 is designed as a circular arc shape, which maximally simulates the natural arc, and the incision of the edge of the plug cap 2 is low, which effectively reduces the postoperative skin friction. During the operation of the patient, the diameter of the plug body 1 can be manually adjusted according to the specific size of the skull defect, which is simple and convenient to operate, significantly shortens the operation time and reduces the operation difficulty.

[0052] The above merely describes preferred embodiments of the present application and is not intended to limit the present application, and any modification, equivalent replacement, and improvement within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A skull plug, characterized in that The skull plug comprises: a plug body, which is cylindrical; a plug cap connected to the plug body, and the cross section of the plug cap along the center line of the plug cap is arc-shaped, and the diameter of the plug cap is larger than the diameter of the plug body; the plug body comprises a first plug body and at least one second plug body surrounding the first plug body, the first plug body is cylindrical, and each second plug body comprises a plurality of columnar petals uniformly arranged around the first plug body, and the cross section of the columnar petal is arc-shaped; a gap is provided between two adjacent columnar petals, and the second plug body has multiple layers, and the gaps of two adjacent layers of the second plug body are arranged in a staggered manner.

2. The skull plug of claim 1, wherein, In the radial direction of the first plug body, the thickness of the columnar petal is 1mm-2mm.

3. The skull plug of claim 1, wherein, In the axial direction of the first plug body, the height of the first plug body is 3mm-10mm, and the height of the second plug body is 3mm-10mm; and / or the diameter of the first plug body is 3mm-6mm.

4. The skull plug of claim 1, wherein, The second plug body has multiple layers, and the distance between two adjacent layers of the second plug body is 1mm-2mm.

5. The skull plug of claim 1, wherein, The center axis of the plug cap coincides with the center axis of the plug body; and / or the thickness of the center position of the plug cap is 1mm-5mm.

6. The skull plug of claim 1, wherein, The plug body and the plug cap are both provided with apertures, and the porosity of the skull plug is 50%-90%.

7. The skull plug of claim 1, wherein, The plug cap is circular, the outer surface of the plug cap is spherical, and the diameter of the plug cap is 10mm-50mm.

8. The skull plug of claim 1, wherein, The cross section of the plug cap along the center line of the plug cap is arc-shaped, and the arc angle of the arc shape is 20°-45°.

9. The skull plug of claim 1, wherein, The thickness of the center position of the plug cap is greater than the thickness of other positions of the plug cap.

10. The skull plug of claim 1, wherein, In the radial direction of the plug cap, from the center position of the plug cap to the edge of the plug cap, the thickness of the plug cap gradually decreases.

Images