阅读说明：本技术 一种新型的医用空心钉 (Novel medical hollow nail ) 是由 范存义 钱运 王旭 刘珅 欧阳元明 王伟 陈帅 于 2021-10-13 设计创作，主要内容包括：本发明公开了一种新型的医用空心钉,由中部具有通孔的钉体组成,钉体包括头部和尾部,尾部从内到外包括多层,相邻层之间设有连接梁,尾部设有孔道连通外壁面与通孔；头部下端与尾部上端固定连接；头部的上端设有沉孔,尾部的下端为齿状钉尖,钉体的外侧壁设有螺纹部,螺纹部设有凹槽。本发明针对临床中具体问题,对于需要长期存在或者二次取出的空心钉,采用不可降解的材料,可在骨愈合阶段提供更强的固定支撑作用；不需要长期存在或者二次取出的情况,采用可降解材料,可在骨愈合阶段提供一定的固定支撑作用,愈合后完全降解,避免二次取出,减轻患者经济负担与疼痛。具有更多选择和明显优势,具有显著的临床价值。(The invention discloses a novel medical hollow nail, which consists of a nail body with a through hole in the middle, wherein the nail body comprises a head part and a tail part, the tail part comprises a plurality of layers from inside to outside, a connecting beam is arranged between adjacent layers, and the tail part is provided with a pore passage for communicating the outer wall surface with the through hole; the lower end of the head part is fixedly connected with the upper end of the tail part; the upper end of the head is provided with a counter bore, the lower end of the tail is a toothed nail tip, the outer side wall of the nail body is provided with a threaded portion, and the threaded portion is provided with a groove. Aiming at the specific problems in clinic, the invention adopts non-degradable materials for the hollow nail which needs to exist for a long time or be taken out for the second time, and can provide stronger fixing and supporting functions in the bone healing stage; the condition that need not exist for a long time or take out for the second time adopts degradable material, can provide certain fixed support effect at the bone healing stage, and the back is degraded completely after healing, avoids the secondary to take out, alleviates patient's economic burden and pain. Has more choices and obvious advantages and has obvious clinical value.)

1. A novel medical hollow nail comprises a nail body (1) with a through hole (14) in the middle, and is characterized in that the nail body (1) comprises a head part (11) and a tail part (12), the tail part (12) comprises a plurality of layers from inside to outside, a connecting beam is arranged between adjacent layers, and the tail part (12) is provided with a pore passage for communicating the outer wall surface with the through hole (14); the lower end of the head part (11) is fixedly connected with the upper end of the tail part (12); a counter bore (111) is formed in the upper end of the head (11), a toothed nail tip (121) is arranged at the lower end of the tail (12), a threaded portion (13) is formed in the outer side wall of the nail body (1), and a groove (131) is formed in the threaded portion (13);

the hollow nail material is a non-degradable material or a degradable material; the non-degradable material is one or more of stainless steel, cobalt alloy, titanium alloy, shape memory alloy, noble metal, pure metal tantalum, pure metal niobium and pure metal zirconium;

the non-degradable material is one or more of PCL, PLA, PHA, PLCL, PLGA, magnesium alloy, iron alloy and zinc alloy.

2. The novel medical hollow nail as claimed in claim 1, wherein N grooves (131) are parallel to the nail body (1) and are centrosymmetric relative to the central axis of the nail body (1), and N is 1-4.

3. The new medical hollow nail according to claim 1, characterized in that the head (11) and the tail (12) of the nail body (1) are formed in one piece.

4. The new medical hollow nail according to claim 1, characterized in that the shape of said counter bore (111) is one of quincunx, straight, internal hexagonal.

5. The new medical hollow nail according to claim 1, characterized in that the cross section of the groove (131) is one of circular, rectangular or triangular.

6. The new medical hollow nail according to claim 1, characterized in that the toothed spike (121) is centrosymmetric with respect to the central axis of the nail body (1).

7. The new hollow medical nail according to claim 1, characterized in that the thread formed on the outer wall of the nail body (1) near the lower end forms the thread portion (13).

8. The new medical hollow nail according to claim 7, characterized in that the external diameter of the threaded portion (13) is greater than the diameter of the upper end surface of the head (11).

9. The new medical hollow nail according to claim 1, characterized in that the thread formed on the outer wall of the tail (12) near the lower end and the thread formed on the outer wall of the head (11) near the upper end form the threaded portion (13).

10. The new hollow medical nail according to claim 1, characterized in that the threads provided on the entire outer wall of the nail body (1) form said threaded portion (13).

Technical Field

The invention relates to the field of medical instruments, in particular to a novel medical hollow nail.

Background

After fracture, different internal fixing objects are selected according to different fracture parts, and the hollow nail is an important internal fixing instrument. The hollow nail is mainly applied to the femoral neck fracture and other parts, and the hollow nail has very small damage mainly due to special fixing and pressurizing functions and does not need a steel plate.

For example, patent No. cn201922417528.x provides a hollow nail, which includes a nail body having a through hole in the middle, the upper end of the nail body is a nail cap, the lower end of the nail body is a nail head, the outer side wall of the lower end of the nail body is provided with a threaded portion, and the lower end face of the nail cap is a plane perpendicular to the axis of the nail body.

At present, most hollow nails are nondegradable metal hollow nails, for example, the hollow nails are made of nondegradable medical titanium alloy. The biological inert material is used as a foreign body to be remained in a body for a long time after being implanted, and can stimulate peripheral body tissues to different degrees and generate tissue reactions to different degrees. However, from a clinical point of view, most implants, except for those requiring permanent support for joints and the like, do not need to be present for a long time after the healing of the body tissue. For patients who do not need to exist for a long time, if the non-degradable metal hollow nail is adopted, the non-degradable metal hollow nail needs to be taken out by a secondary operation, so that the pain and the economic burden of the patients are increased.

Therefore, the novel medical hollow nail is provided, and the hollow nail which needs to exist for a long time or be taken out for the second time is made of non-degradable materials such as stainless steel, cobalt alloy, titanium alloy, shape memory alloy, precious metal and pure metals such as tantalum, niobium and zirconium, so that a stronger fixing and supporting effect can be provided in the bone healing stage; for hollow nails which do not need to exist for a long time, the hollow nails can meet the requirements of clinical mechanical properties and can be degraded in a human body by adopting PCL, PLA, PHA, PLCL, PLGA and the like and degradable materials such as degradable magnesium alloy, iron alloy, zinc alloy and the like, and the hollow nails have important significance for repairing hard tissues, and cannot cause adverse reaction to the human body in the degradation process.

Disclosure of Invention

In order to achieve the purpose, the invention provides a novel medical hollow nail which is made of non-degradable materials and degradable materials, can meet the mechanical property requirement required by hard tissue repair, can be safely degraded in vivo, avoids secondary taking out, and reduces the economic burden and pain of patients.

A novel medical hollow nail comprises a nail body with a through hole in the middle, wherein the nail body comprises a head part and a tail part, the tail part comprises a plurality of layers from inside to outside, a connecting beam is arranged between adjacent layers, and the tail part is provided with a pore passage for communicating the outer wall surface with the through hole; the lower end of the head part is fixedly connected with the upper end of the tail part; the upper end of the head part is provided with a counter bore, the lower end of the tail part is a toothed nail tip, the outer side wall of the nail body is provided with a threaded part, and the threaded part is provided with a groove;

the hollow nail material is a non-degradable material or a degradable material; the non-degradable material is one or more of stainless steel, cobalt alloy, titanium alloy, shape memory alloy, noble metal, pure metal tantalum, pure metal niobium and pure metal zirconium;

the non-degradable material is one or more of PCL, PLA, PHA, PLCL, PLGA, magnesium alloy, iron alloy and zinc alloy.

Preferably, the two grooves are parallel to the nail body and are centrosymmetric relative to the central axis of the nail body.

Preferably, the head and the tail of the nail body are integrally formed.

Preferably, the shape of the counter bore is one of a quincunx shape, a straight line shape and an internal hexagon shape.

Preferably, the cross-section of the groove is one of circular, rectangular or triangular.

Preferably, the tooth-shaped nail tip is centrosymmetric relative to the central axis of the nail body.

Preferably, the screw thread formed on the outer wall surface of the nail body near the lower end forms the screw thread part.

Further, the outer diameter of the threaded portion is larger than the diameter of the upper end face of the head portion.

Preferably, the thread portion is formed by a thread provided on an outer wall surface of the tail portion near the lower end and a thread provided on an outer wall surface of the head portion near the upper end.

Preferably, the screw thread formed on the entire outer wall surface of the nail body forms the screw thread part.

Compared with the prior art, the invention has the following technical effects:

(1) aiming at the hollow nail which does not need to exist for a long time in clinic, the degradable magnesium alloy material is adopted, the fixing and supporting effect can be provided in the bone healing stage, the hollow nail is completely degraded after healing, secondary taking out is avoided, the economic burden and pain of a patient are relieved, and compared with the non-degradable metal hollow nail, the hollow nail has obvious advantages and obvious clinical value.

(2) Through the arrangement of the layered structure of the nail body, liquid in the body can enter between adjacent layers and in the through hole through the pore channel, so that the degradation rate is greatly increased.

(3) The screw thread portion of the hollow nail is provided with the centrosymmetric grooves, so that looseness of the nail body can be effectively avoided, and the blood supply effect is improved.

(4) The tooth-shaped nail tip is designed in a central symmetry mode relative to the central axis of the nail body, adapts to material characteristics and facilitates nailing.

(5) The distribution of the screw threads on the outer wall surface of the nail body can be designed and selected according to actual requirements.

(6) The counter bore for adapting the screwdriver can be in one of a quincunx shape, a straight line shape and an inner hexagon shape, and is adapted to various types of screwdrivers.

(6) The invention adopts the design of the countersunk head without the nail cap, thereby avoiding exposure and avoiding secondary operation.

Drawings

FIG. 1 is a schematic structural view of a novel medical hollow nail according to the present invention;

FIG. 2 is a schematic structural view of a second novel medical hollow nail according to the present invention;

FIG. 3 is a schematic structural view of a third novel medical hollow nail according to the present invention;

FIG. 4 is a sectional view of the nail A shown in FIG. 3;

FIG. 5 is a sectional view of the nail body B shown in FIG. 3;

fig. 6 is a schematic distribution diagram of the grooves in the present invention, wherein the left one shows one groove, the left two shows two grooves, and the left three shows three grooves; the left four shows four grooves;

FIGS. 7a-c are schematic views of the cross-section of the groove of the present invention, with FIG. 7a showing a circular groove, FIG. 7b showing a circular groove, and FIG. 7c showing a triangular groove;

the symbols in the drawings indicate the description:

1-nail body, 11-head, 111-counter bore, 12-tail, 121-dentate nail tip, 13-thread part, 131-groove and 14-through hole.

Detailed Description

The materials used for the clinical orthopaedics internal fixation hollow nail have different forms, but have specific properties meeting the requirements of endophyte. The hollow nail material has far composition difference with human tissue, different tolerance degrees of different tissues of human body and different requirements of mechanical properties of hollow nails at different implantation parts, so the hollow nails used at different parts of human body need to be screened according to application requirements. Therefore, the novel medical hollow nail is provided, and for the hollow nail which needs to exist for a long time or be taken out for the second time, non-degradable materials are adopted, including but not limited to 316L stainless steel, cobalt-based alloy, titanium alloy and the like, and the novel medical hollow nail has better comprehensive mechanical properties (strength, toughness and fatigue resistance) and excellent processing and forming capabilities, and can provide stronger fixing and supporting functions in the bone healing stage; for hollow nails which do not need to exist for a long time, degradable materials are adopted, including but not limited to magnesium base, zinc base, iron base and other alloys, polylactic acid resin, hydroxyapatite, tricalcium phosphate, externally-rotated polylactic acid (PDLLA), polylactic acid (PLA), poly (lactic-co-glycolic acid) (PLGA) and other polymer/polymer composite materials, polymer/inorganic composite materials and the like. Can meet the requirements of clinical mechanical properties, can be degraded in a human body, does not cause adverse reaction to the human body in the degradation process, and has important significance for hard tissue repair.

In conclusion, the invention provides a novel medical hollow nail, as shown in fig. 1, the medical hollow nail is made of non-degradable and degradable materials and comprises a nail body 1, a through hole 14 penetrating through the nail body 1 from top to bottom is formed in the nail body 1, a thread part 13 is partially or completely arranged on the outer side wall of the nail body 1, a counter bore 111 is formed in the upper end of the nail body 1, and a toothed nail tip 121 is formed in the lower end of the nail body.

The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.

Example 1

Referring to fig. 1, the present embodiment is shown to provide a novel medical hollow nail, which is composed of a nail body 1 with a through hole 14 in the middle, the nail body 1 includes a head portion 11 and a tail portion 12 which are integrally formed, the tail portion 12 includes multiple layers from inside to outside, and adjacent layers are connected and fixed through a connecting beam, as shown in fig. 4; the tail part 12 is provided with one or more pore channels to communicate the outer wall surface with the through hole 14, as shown in fig. 5, the pore channels and the connecting beam are arranged in a staggered way, and after the tail part is implanted into a human body, liquid in the body can enter between adjacent layers and in the through hole through the pore channels, so that the degradation rate is greatly increased.

Because the materials are screened according to the application requirements of different implantation parts and are made of non-degradable and degradable materials, the design of the countersunk head without the nail cap can be adopted according to specific conditions and parts, the exposure is avoided, and the stimulation to peripheral body tissues is reduced.

In a specific embodiment, the diameter is larger the farther the head 11 is from the upper end of the tail 12.

In this embodiment, the upper end of the head 11 is provided with a counter bore 111, and the lower bottom surface of the counter bore 111 is communicated with the through hole 14, as shown in fig. 2, the counter bore 111 is one of a quincunx shape, a straight shape and an internal hexagon shape, and is adapted to a multi-type screwdriver.

In this embodiment, the screw thread formed on the outer wall surface of the nail body 1 near the lower end forms a screw thread portion 13, and the screw thread portion 13 is provided with N grooves 131. Specifically, as shown in fig. 6, the grooves 131 may be provided with 1 to 4 strips, parallel to the nail body 1, and in central symmetry with respect to the central axis of the nail body 1.

Can effectively avoid the not hard up of nail body through the design of recess 131, promote blood supply effect simultaneously.

Further, the cross-section of the groove 131 may be one of circular, rectangular or triangular, as shown in fig. 7a-7 c.

In a preferred embodiment, the shape of the counterbore 111 is a straight line, and when there are two grooves 131, the connecting line of the upper ends of the two grooves 131 is perpendicular to the counterbore 111, as shown in fig. 7a-7 c.

In this embodiment, the lower end of the tail 12 is a tooth-shaped spike 121, and there may be a plurality of teeth of the tooth-shaped spike 121; furthermore, the teeth of the tooth-shaped nail tip 121 are centrosymmetric relative to the central axis of the nail body 1, so that the nail is suitable for material characteristics and convenient to nail.

In this embodiment, as shown in fig. 1, the outer diameter D2 of the threaded portion 13 is larger than the diameter D1 of the upper end surface of the head 11.

Example 2

Referring to fig. 2, the present embodiment is based on embodiment 1, and the difference from embodiment 1 is that: the screw thread 13 is formed by the screw thread arranged on the whole outer wall surface of the nail body 1, and the screw thread 13 is provided with N grooves 131.

Specifically, as shown in fig. 6, the grooves 131 may be provided with 1 to 4 strips, parallel to the nail body 1, and in central symmetry with respect to the central axis of the nail body 1. The cross-section of the groove 131 may be one of circular, rectangular or triangular, as shown in fig. 7a-7 c.

In one embodiment, the thread of the outer wall of the head portion 11 has a pitch that is less than the pitch of the thread of the outer wall of the tail portion 12.

Example 3

Referring to fig. 3, the present embodiment is based on embodiment 1, and the difference from embodiment 1 is that: the thread arranged on the outer wall surface of the tail part 12 close to the lower end and the thread arranged on the outer wall surface of the head part 11 close to the upper end form a thread part 13, and the thread part 13 is provided with N grooves 131.

Specifically, as shown in fig. 6, the grooves 131 may be provided with 1 to 4 strips, parallel to the nail body 1, and in central symmetry with respect to the central axis of the nail body 1. The cross-section of the groove 131 may be one of circular, rectangular or triangular, as shown in fig. 7a-7 c.

In one embodiment, the thread of the outer wall of the head portion 11 has a pitch that is less than the pitch of the thread of the outer wall of the tail portion 12.

The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.