Oral cavity guided bone regeneration barrier membrane fixing nail

Abstract

The utility model discloses an oral cavity guided bone regeneration barrier membrane fixing nail which structurally comprises a top part, a rod part and a self-tapping part from top to bottom, the top part is of a cylinder-like structure, and the bottom surface of the top part is connected with the top end of the rod part; the rod part is of an inverted circular truncated cone structure, and the bottom end of the rod part is connected with the top end of the self-tapping part; the self-tapping part is formed by splicing an inverted circular truncated cone and an inverted cone, and self-tapping threads are arranged on the side face of the self-tapping part. The structure of the fixing nail has self-tapping performance, stress uniformization can be achieved during fixing, and the situation that the guided bone regeneration membrane is impacted and cracks are generated in the fixing process can be effectively prevented.

Description

Technical Field

[0001] This utility model belongs to the field of medical devices, specifically relating to an oral cavity guided bone regeneration barrier membrane fixation nail. Background Technology

[0002] Dental implants have become a standardized treatment for tooth defects. Before implantation, it is essential to ensure sufficient bone volume in the implantation area. However, tooth defects are often accompanied by insufficient alveolar bone volume, necessitating guided bone regeneration (GBR). During this process, a guiding bone regeneration membrane (GBR membrane) is used to separate the upper soft tissue from the lower bone repair zone, maintaining space for bone repair.

[0003] To ensure proper adhesion to bone tissue, the GBR membrane itself often possesses a degree of flexibility, requiring auxiliary fixation with guide bone regeneration barrier membrane fixation pins to prevent membrane displacement during bone regeneration and ensure optimal restoration results. Existing fixation pins have poor self-tapping properties and are often fixed using a hammering method, generating significant impact during fixation. This impacts the accuracy of GBR membrane positioning and, for metal GBR membranes such as titanium mesh and titanium films, even carries the risk of membrane tearing and restoration failure. Furthermore, existing fixation pins generally have low strength, making them prone to bending or breakage during use. Given the limited space in alveolar bone restoration, solutions that achieve mechanical reinforcement by adjusting pin dimensions are difficult to implement. Therefore, a new fixation pin design is needed to address the issues of insufficient strength and inadequate positioning and installation stability of existing fixation pins. Utility Model Content

[0004] The purpose of this invention is to overcome the shortcomings of the existing technology and provide an oral cavity guided bone regeneration barrier membrane fixation nail with good positioning and installation stability and high strength.

[0005] The objective of this utility model is achieved through the following technical solution:

[0006] An oral cavity guided bone regeneration barrier membrane fixation nail, the structure of which includes, from top to bottom: a top 1, a rod 2, and a self-tapping part 3; the top 1 is a cylindrical structure, the bottom surface of the top is connected to the top of the rod; the rod 2 is an inverted frustum structure, the bottom end of the rod is connected to the top of the self-tapping part; the self-tapping part 3 is formed by splicing an inverted frustum and an inverted cone, and has self-tapping threads on the side.

[0007] Preferably, the maximum diameter (horizontal cross-section at the center) of the cylindrical structure at the top of the fixing nail ranges from 2 to 5 mm, the minimum diameter (upper end face / lower end face) ranges from 2 to 4 mm, the difference between the maximum diameter and the minimum diameter is not greater than 20% of the minimum diameter, and the height of the top ranges from 0.8 to 1.5 mm.

[0008] Preferably, the top surface of the fixing nail has a cross groove 11 at its center for self-tapping screwing, which can be used to fit a standard screwdriver in the planting system.

[0009] Preferably, the minimum (lower end face) diameter of the inverted frustum structure of the fixing nail rod is in the range of 0.9-1.5 mm, the maximum (upper end face) diameter is in the range of 1-1.8 mm, the height of the rod is in the range of 1-3 mm, the taper of the inverted frustum structure is in the range of 0.05-0.15, and the upper end fillet radius (R) is in the range of 0.1-0.5 mm.

[0010] Preferably, the self-tapping part of the fixing screw includes a frustum end 31, a tip 32, and a thread 33; the taper of the frustum end is in the range of 0.2-0.4 mm, the height is in the range of 1-2 mm, the diameter of the upper end face of the frustum end is equal to the diameter of the lower end face of the rod, and the diameter of the lower end face of the frustum end is in the range of 0.6-1.2 mm; the height of the tip is in the range of 0.6-1.2 mm, the diameter of the upper end face of the tip is equal to the diameter of the lower end face of the frustum end, and the taper of the tip is in the range of 0.5-1 mm.

[0011] Preferably, the threads of the self-tapping part of the fixing screw are distributed on the inverted frustum end, the pitch range is 0.1-0.4 mm, and the thread height is not greater than 40% of the minimum diameter of the inverted frustum end.

[0012] Preferably, the fixing pin is made of ultrafine-grained pure titanium, with an average grain size of less than 700 nm and more than 95% of the grains having a size of less than 1 μm.

[0013] Compared with the prior art, this utility model has the following advantages and effects:

[0014] (1) The structure of the fixation nail is self-tapping, which can achieve uniform force distribution during fixation and effectively prevent the bone regeneration membrane from cracking due to impact during fixation.

[0015] (2) The top surface of the fixing nail is provided with a cross groove for the screwdriver to be screwed in, which is conducive to the screwdriver being clamped and fixed.

[0016] (3) The material used for the fixing nail is ultrafine-grained pure titanium, which is prepared by equal channel angular extrusion technology. Compared with pure titanium, ultrafine-grained pure titanium has higher tensile strength and elongation, and is more suitable for the use of fixing nails. Attached Figure Description

[0017] Figure 1 This is a front view schematic diagram of the fixing screw, where: 1-top, 2-rod, 3-self-tapping part, 11-cross groove, 31-frustum end of the self-tapping part, 32-tip of the self-tapping part, 33-thread of the self-tapping part.

[0018] Figure 2 This is a top view of the fixing pin.

[0019] Figure 3 This is a schematic diagram of the use of fixation pins in the process of guiding bone regeneration, where: 4-fixation pin, 5-lateral soft tissue, 6-GBR membrane, 7-filling bone powder, 8-alveolar bone.

[0020] Figure 4 This is a microscopic morphology diagram of ultrafine-grained pure titanium material.

[0021] Figure 5 This is a tensile curve of ultrafine-grained pure titanium material. Detailed Implementation

[0022] To facilitate understanding of this utility model, specific embodiments will be described in detail below. The following embodiments will help those skilled in the art to further understand this utility model; however, they are not intended to limit this utility model in any way. It should be noted that those skilled in the art can make various modifications and improvements to this utility model without departing from its concept, and these modifications and improvements all fall within the protection scope of this utility model.

[0023] Example 1

[0024] like Figure 1 and Figure 2 As shown, the oral cavity guided bone regeneration barrier membrane fixation nail of this utility model has the following structure from top to bottom: top 1, rod 2, and self-tapping part 3; top 1 is a cylindrical structure, and the bottom surface of the top is connected to the top of the rod; rod 2 is an inverted frustum structure, and the bottom end of the rod is connected to the top of the self-tapping part; self-tapping part 3 is formed by splicing an inverted frustum and an inverted cone, and has self-tapping threads on the side.

[0025] Combination Figure 3 As shown, the top 1 has a cylindrical structure to limit the position of the fixation pin 4 on the alveolar bone 8 and prevent the bar 2 and self-tapping part 3 from penetrating excessively into the alveolar bone 8. The sides of the top are rounded to prevent the bottom edge from cutting the GBR membrane 6 after fixation or irritating the lateral soft tissue 5 after suturing. A cross groove 11 is opened in the center of the upper end face of the top. For fixation positions with a large operating space nearby, a standard Phillips screwdriver can be used to screw it in directly for fixation. For positions with a small operating space, a pin holder can be used to assist by matching the internal cross protrusion with the cross groove 11 before screwing it in for fixation.

[0026] The rod 2 has an inverted frustum structure, which fits against the side wall of the hole drilled on the alveolar bone 8 during the fixing process. This part has a certain taper to increase the side contact area and enhance the fixing effect. The overall diameter of the rod 2 should be slightly larger than the major diameter of the self-tapping thread 33 so that it is subjected to a certain side wall pressure, increasing friction and improving stability. The joint between the upper end of the rod 2 and the top 1 is designed with a rounded corner to avoid the nail body from breaking or bending due to excessive stress.

[0027] The self-tapping part 3 includes a frustum-shaped end 31 and a tip 32. The frustum-shaped end 31 has a thread 33. The tip 32 is used to pierce the GBR membrane 6 and perform initial positioning and drilling on the alveolar bone 8. Thanks to the cross groove 11, the force in the above process is transformed from impact force to continuous uniform force, reducing the risk of cracking of the GBR membrane 6 and bending / poor positioning of the fixation pin 4. Subsequently, the thread 33 is screwed into and cuts into the alveolar bone 8 until the rod 2 and the self-tapping part 3 enter the interior of the alveolar bone 8, achieving fixation. The thread 33 also increases the contact surface between the fixation pin 4 and the alveolar bone 8, strengthening the fixation effect.

[0028] The fixing pin 4 is made of ultrafine-grained pure titanium, such as Figure 4 As shown, its average grain size should be less than 700 nm, preferably less than 500 nm. Ultrafine-grained pure titanium has higher tensile strength and elongation; for example... Figure 5 As shown, the tensile strength of ultrafine-grained pure titanium is 1100 MPa and the elongation is 15%, which far exceeds that of conventional pure titanium, thus preventing the failure of the fixing nail 4 during use.

[0029] During pre-implantation bone repair surgery, the use of fixation nail 4 in conjunction with GBR membrane 6 is as follows: Figure 3 As shown. The surgeon first incises the lateral soft tissue 5 and places bone filler 7 into the bone defect area. Then, a GBR membrane 6 is placed over the bone filler 7, ensuring that the tail end of the GBR membrane 6 covers the adjacent alveolar bone 8 for easy fixation. The screw holder / screwdriver is inserted into the fixation screw 4 through the cross-shaped groove 11 and screwed in at the preset positioning point until the shaft 2 and self-tapping part 3 are completely submerged in the alveolar bone 8 and the bottom surface of the top 1 is in close contact with the GBR membrane 6, thus completing the fixation. When the bone repair is complete and the GBR membrane 6 and fixation screw 4 need to be removed, the fixation screw 4 is simply unscrewed in the reverse direction using the cross-shaped groove 11.

Claims

1. An oral cavity guided bone regeneration barrier membrane fixation nail, characterized in that: Its structure, from top to bottom, includes: a top, a rod, and a self-tapping part; the top is a cylindrical structure, with the bottom surface of the top connected to the top of the rod; the rod is an inverted frustum structure, with the bottom end of the rod connected to the top of the self-tapping part; the self-tapping part is formed by splicing an inverted frustum and an inverted cone, and has self-tapping threads on the side.

2. The oral cavity guided bone regeneration barrier membrane fixation nail according to claim 1, characterized in that: The maximum diameter of the cylindrical structure at the top of the fixing nail ranges from 2 to 5 mm, the minimum diameter ranges from 2 to 4 mm, the difference between the maximum and minimum diameters is no more than 20% of the minimum diameter, and the height of the top ranges from 0.8 to 1.5 mm.

3. The oral cavity guided bone regeneration barrier membrane fixation nail according to claim 1, characterized in that: The top surface of the fixing pin has a cross groove at its center for self-tapping screwing.

4. The oral cavity guided bone regeneration barrier membrane fixation nail according to claim 1, characterized in that: The minimum diameter of the inverted frustum structure of the fixed nail rod ranges from 0.9 to 1.5 mm, the maximum diameter ranges from 1 to 1.8 mm, the height of the rod ranges from 1 to 3 mm, the taper of the inverted frustum structure ranges from 0.05 to 0.15, and the upper fillet radius (R) ranges from 0.1 to 0.5 mm.

5. The oral cavity guided bone regeneration barrier membrane fixation nail according to claim 1, characterized in that: The self-tapping part of the fixing screw includes a truncated cone end, a tip, and a thread; the taper of the truncated cone end ranges from 0.2 to 0.4 mm, the height ranges from 1 to 2 mm, the diameter of the upper end face of the truncated cone end is equal to the diameter of the lower end face of the rod, and the diameter of the lower end face of the truncated cone end ranges from 0.6 to 1.2 mm; the height of the tip ranges from 0.6 to 1.2 mm, the diameter of the upper end face of the tip is equal to the diameter of the lower end face of the truncated cone end, and the taper of the tip ranges from 0.5 to 1 mm.

6. The oral cavity guided bone regeneration barrier membrane fixation nail according to claim 1, characterized in that: The threads of the self-tapping part of the fixing screw are distributed on the chamfered end, with a pitch range of 0.1-0.4 mm and a thread height not greater than 40% of the minimum diameter of the chamfered end.

7. The oral cavity guided bone regeneration barrier membrane fixation nail according to claim 1, characterized in that: The fixing pin is made of ultrafine-grained pure titanium, with an average grain size of less than 700 nm and more than 95% of the grains having a size of less than 1 μm.

Images