Intramedullary nail

Abstract

The present invention provides an intramedullary nail, comprising a sleeve, a driving assembly, a transmission assembly and a supporting nail, wherein the driving assembly and the transmission assembly are arranged at the upper part of the sleeve, and the supporting nail is arranged at the lower part of the sleeve, and the transmission assembly comprises a rotating rod and a rotating ring, and a limiting groove is arranged in the sleeve, and the limiting groove is used to limit the axial position of the rotating rod in the sleeve, an external thread is arranged on the outer circular wall of the rotating rod, and an internal thread matching the external thread is arranged on the inner circular wall of the rotating ring, and the rotating ring is arranged above the supporting nail, and the driving assembly can drive the rotating rod to rotate around its axis from the side or top, and the rotating ring can drive the supporting nail to synchronously make axial movement; through the above structure, the intramedullary nail can flexibly adjust the extension speed and strength according to the patient's condition, the extension process is stable, the extension result is accurate, the operation is convenient, the incision is small, the processing method cost is low, and the efficiency is high.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intramedullary nail. Background Art

[0002] Intramedullary nails, also known as intramedullary needles, are long, thin metal nails that are specially used to insert into the medullary cavity of long bones to provide stable support for the fracture site, thereby promoting the healing process of the fracture. Among them, extendable intramedullary nails have been widely used due to their adjustable length.

[0003] Traditional intramedullary nail extension methods mostly rely on the tail drive mechanism, among which the most prominent defects are the difficulty in monitoring and the difficulty in ensuring the elongation accuracy. During the tail drive process, due to the limited operating space and complex operation process, it is often difficult for doctors to monitor the elongation of the intramedullary nail in real time and accurately. As a result, in actual operation, the elongation is often difficult to control accurately, and it is easy to over or under elongate. Excessive elongation may cause unnecessary pain to the patient, and even cause serious complications such as fractures and joint dislocations; while insufficient elongation may not meet the treatment needs and affect the surgical effect.

[0004] In addition, the tail drive method has certain risks. Since it is necessary to perform deep operations from the tail end of the intramedullary nail, it increases the difficulty of the operation and the pain of the patient. At the same time, if the operation is improper or the equipment fails, it may also cause damage to the surrounding nerves, blood vessels and other tissues, further increasing the risk of the operation and the pain of the patient.

[0005] After the intramedullary nail is placed in the body, rejection may occur, and bone growth also requires more nutrients. The current method of drug administration is to apply the drug on the surface of the intramedullary nail, which is easy to fall off and the degree of drug release is uncontrollable. In addition, some toxic reagents are used in the production process, which increases the complexity of the process and the safety of the intramedullary nail.

[0006] In view of these problems, the industry has been seeking more accurate and reliable methods for lengthening intramedullary nails. Summary of the invention

[0007] The object of the present invention is to provide an intramedullary nail to solve the above problems.

[0008] The technical solution adopted by the present invention is:

[0009] An intramedullary nail comprises a sleeve, a drive assembly, a transmission assembly and a supporting nail, wherein the drive assembly and the transmission assembly are arranged at the upper part of the sleeve, and the supporting nail is arranged at the lower part of the sleeve. The transmission assembly comprises a rotating rod and a rotating ring. A limiting groove is arranged in the sleeve, and the limiting groove is used to limit the axial position of the rotating rod in the sleeve. An external thread is arranged on the outer circular wall of the rotating rod, and an internal thread matching the external thread is arranged on the inner circular wall of the rotating ring. The rotating ring is arranged above the supporting nail. The drive assembly can drive the rotating rod to rotate around its axis from the side or top, and the rotating ring can drive the supporting nail to make axial movement synchronously.

[0010] As a further improved technical solution of the present invention, the rotating rod includes a head and a rod, the diameter of the head is larger than the diameter of the rod, the head is arranged in a limiting groove, and the driving assembly can drive the head to rotate around the axis of the rod from the side or top.

[0011] As a further improved technical solution of the present invention, there are a plurality of rotating rings, and check members are provided between adjacent rotating rings.

[0012] As a further improved technical solution of the present invention, the driving assembly includes a supporting rotary block and a rotary needle, the rotary needle crosses the sleeve, and spiral teeth are arranged on the rotary needle. The surface of the supporting rotary block facing the rotary needle is a tooth surface that can engage with the spiral teeth of the rotary needle, and the surface of the rotating rod facing the rotary needle is a tooth surface that can engage with the spiral teeth of the rotary needle.

[0013] As a further improved technical solution of the present invention, the rotary needle includes a front part, a tooth part and a tail part which are arranged in sequence, the spiral teeth of the rotary needle are arranged on the tooth part, and the diameter d1 of the tooth root circle of the tooth part ≥ the diameter d2 of the tail part>the diameter d3 of the front part.

[0014] As a further improved technical solution of the present invention, the driving assembly includes a motor, a coupling and a wireless power supply module. The motor is arranged in a sleeve, the coupling is arranged between the output shaft of the motor and the rotating rod, the coupling is used to transmit the driving force of the motor to the rotating rod, and the wireless power supply module is used to power the motor.

[0015] As a further improved technical solution of the present invention, a plurality of convex ribs are arranged on the outer circular wall of the support pin, the convex ribs are parallel to the axis of the support pin, and a plurality of grooves matching with the convex ribs are arranged on the inner circular wall of the sleeve, and the convex ribs can slide axially in the grooves.

[0016] As a further improved technical solution of the present invention, there is a gap between the inner circular wall of the sleeve and the outer circular wall of the supporting pin, and the gap is filled with a drug-loaded hydrogel.

[0017] As a further improved technical solution of the present invention, the hydrogel is a mesh hydrogel, the drug is in liquid state and is arranged in the mesh hydrogel, the diameter of the drug is smaller than the gaps in the mesh hydrogel, the mesh hydrogel is attached to the surface of the supporting pin, the rotating ring squeezes the hydrogel when moving axially, and the drug in the hydrogel is released according to the degree of squeezing.

[0018] As a further improved technical solution of the present invention, a plurality of hollow structures are provided on the supporting nails, and the hollow structures can allow drugs to pass through.

[0019] As a further improved technical solution of the present invention, a plurality of staggered textures are arranged on the outer circular wall of the sleeve, and the textures are groove-shaped.

[0020] As a further improved technical solution of the present invention, the texture includes a first section, a bending section, a second section and a water drop section connected in sequence, the first section and the second section are parallel, the end of the first section away from the bending section is in an arc shape, the bending section connects the first section and the second section, the bending section and the first section are inclined and have an arc transition, the bending section and the second section are inclined and have an arc transition, the width of the bending section is greater than the width of the first section, the width of the bending section is greater than the width of the second section, the water drop section is in a water drop shape, and the width of the second section and the water drop section gradually increases in the direction extending from the second section to the water drop section.

[0021] As a further improved technical solution of the present invention, the method for manufacturing the texture comprises the following steps:

[0022] S1. A plurality of protrusions having the same texture shape are formed in advance on the stamping area of ​​the two stamping plates by mechanical cutting;

[0023] S2. The sleeve is heated at 450 ° C ~ 600 ° C for 15 ~ 30S;

[0024] S3. The sleeve is fixed to the inner fixed shaft of the stamping fixed platform, and the sleeve is stamped using upper and lower stamping plates to form a texture on the outer surface of the sleeve;

[0025] S4. After the stamping is completed, the sleeve is cooled;

[0026] S5. Use a grinding tool to grind the surface of the sleeve in the order of first mesh, second mesh, and third mesh particle sizes to remove the oxide film and impurities on the surface of the sleeve, wherein the first mesh, second mesh, and third mesh particle sizes increase in sequence.

[0027] As a further improved technical solution of the present invention, there is a step S6 after step S5, and step S6 is:

[0028] A porous structure is manufactured on the surface of the sleeve using a strong alkaline solution. After the manufacturing is completed, the sleeve is cleaned with an acidic solution, and then the sleeve is ultrasonically cleaned for more than 10 minutes. After the cleaning is completed, the sleeve is dried and then plasma cleaned.

[0029] The beneficial effects of the present invention are:

[0030] Through the above structure, the intramedullary nail can flexibly adjust the extension speed and strength according to the patient's condition, the extension process is stable, the extension result is accurate, the operation is convenient, the wound is small, the processing method cost is low, and the efficiency is high. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of the structure of a mechanically driven intramedullary nail;

[0032] Figure 2 is a cross-sectional view of a mechanically driven intramedullary nail;

[0033] Figure 3 It is an exploded view of a mechanically driven intramedullary nail;

[0034] Figure 4 is a partial cross-sectional view of a mechanically driven intramedullary nail;

[0035] Figure 5 is a cross-sectional view of an electrically driven intramedullary nail;

[0036] Figure 6 yes Figure 5 Enlarged view of point A in the middle;

[0037] Figure 7 It is a structural diagram of the wireless power supply module;

[0038] Figure 8 is a schematic diagram of the sleeve surface texture;

[0039] Fig. 9 It is a schematic diagram of the texture.

[0040] Among them: 1-sleeve, 101-second positioning groove, 103-texture, 1031-first section, 1032-bending section, 1033-second section, 1034-water drop section; 2-support nail, 201-mounting hole, 202-convex rib; 3-column top plug, 301-first positioning groove; 4-rotating rod, 401-head, 402-rod; 5-rotating ring; 6-check piece; 7-supporting rotary block; 8- -spin needle, 801-front part, 802-tooth part, 803-tail part; 9-handle, 901-grip part, 902-transmission part, 903-connecting end; 10-spin needle protective cover, 1001-buckle; 11-motor; 12-coupling; 13-wireless power supply module, 1301-external fixing cover, 1302-flexible PCB board, 1303-lead wire; 14-hydrogel; 15-screw. DETAILED DESCRIPTION

[0041] The present invention will be described in detail below in conjunction with the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and any structural, methodological, or functional changes made by a person skilled in the art based on these embodiments are all within the scope of protection of the present invention.

[0042] If the invention involves directions (e.g., up, down, left, right, front, back, outside, inside, etc.) when describing, it is necessary to define the directions involved, such as "In order to clearly express the positions and directions described in the invention, the end close to the operator is the proximal end, and the end away from the operator is the distal end." Or define it with the paper as a reference. Of course, if the positional relationship between the two is defined by mutual reference in the subsequent description, it does not need to be defined here.

[0043] An intramedullary nail, such as Figures 1 to 5 As shown, the intramedullary nail comprises a sleeve 1, a driving assembly, a transmission assembly and a support nail 2, wherein the driving assembly and the transmission assembly are arranged at the upper part of the sleeve 1, and the support nail 2 is arranged at the lower part of the sleeve 1. The driving assembly is used to drive the transmission assembly, and after being driven, the transmission assembly can drive the support nail 2 to move so that the support nail 2 extends out of the sleeve 1. The support nail 2 is coaxially arranged with the sleeve 1.

[0044] The transmission assembly includes a rotating rod 4 and a rotating ring 5. A limiting groove is provided in the sleeve 1. The limiting groove is used to limit the axial position of the rotating rod 4 in the sleeve 1. An external thread is provided on the outer circular wall of the rotating rod 4, and an internal thread matching the external thread of the rotating rod 4 is provided on the inner circular wall of the rotating ring 5. The rotating ring 5 is sleeved on the rotating rod 4. The rotating rod 4 and the rotating ring 5 are threadedly matched. The rotating ring 5 is arranged above the supporting nail 2. The driving assembly can drive the rotating rod 4 to rotate around the axis of the rotating rod 4 from the side or top. The rotating ring 5 can move axially on the rotating rod 4, so that the rotating ring 5 can drive the supporting nail 2 to make axial movement synchronously.

[0045] As an embodiment of the present invention, the rotating rod 4 includes a head 401 and a rod 402, the diameter of the head 401 is larger than the diameter of the rod 402, the head 401 is arranged in a limiting groove, the limiting groove can prevent the head 401 from moving toward the lower part of the sleeve 1, and the driving assembly can drive the head 401 to rotate around the axis of the rod 402 from the side or top. Preferably, the head 401 and the rod 402 are coaxially arranged, and the rotating rod 4 and the rotating ring 5 are coaxially arranged.

[0046] The driving assembly can drive the rotating rod 4 to rotate. When the rotating rod 4 rotates, due to the blocking effect of the limiting groove, the rotating rod 4 rotates around its axis, and the rotating ring 5 performs linear motion along the axis of the rotating rod 4, that is, performs linear motion close to the supporting pin 2. The supporting pin 2 is pushed by the rotating ring 5 to move close to the bottom of the sleeve 1, that is, the supporting pin 2 extends out of the sleeve 1. The supporting pin 2 can abut against the rotating ring 5, so that the rotating ring 5 pushes the supporting pin 2, or the supporting pin 2 can be fixedly connected to the rotating ring 5.

[0047] As an embodiment of the present invention, there are several rotating rings 5, and a check member 6 is provided between adjacent rotating rings 5, and the check member 6 is used to prevent the support pin 2 from retracting into the sleeve 1 under the action of external force. Preferably, the check member 6 can be a gasket. Preferably, the check member 6 can be made of PDMS (polydimethylsiloxane), which has good biocompatibility and high strength.

[0048] A column top plug 3 is arranged on the top of the sleeve 1, and the column top plug 3 is connected to the sleeve 1 by threads. A first positioning groove 301 is opened on the top surface of the column top plug 3, and a second positioning groove 101 is opened on the top surface of the sleeve 1. The column top plug 3 is placed after all parts are installed. When the first positioning groove 301 and the second positioning groove 101 coincide with each other, the column top plug 3 and the sleeve 1 reach a specified installation state, and then the screw 15 is implanted for fixing.

[0049] Traditional intramedullary nail extension techniques mostly rely on the tail drive mechanism, that is, from the tail end axial direction, a long adjustment rod is inserted into the patient's wound for adjustment. However, this adjustment method has obvious limitations: the operating area is small, the adjustment process is complicated and risky, and it is easy to aggravate the patient's pain. In addition, intramedullary nail implantation itself will cause significant pain in the wound area. If frequent adjustments are made through the wound at the nail placement site, it will not only increase the patient's pain, but may also delay the healing process of the wound. Considering that the use cycle of intramedullary nails is usually as long as 1 to 2 months, patients have to endure this discomfort and pain for a long time, which has a serious impact on postoperative recovery and quality of life.

[0050] In view of the above problems, the driving mode of the driving assembly provided by the present invention may include mechanical driving and electric driving. Figures 1 to 4 As shown in the figure, as an embodiment of the mechanical drive of the present invention, the driving assembly of the mechanical drive includes a supporting rotary block 7 and a rotary needle 8, the rotary needle 8 crosses the sleeve 1, and a circumferential spiral tooth is arranged on the rotary needle 8. The surface of the supporting rotary block 7 facing the rotary needle 8 is a tooth surface that can mesh with the spiral teeth of the rotary needle 8, and the surface of the rotating rod 4 facing the rotary needle 8 is a tooth surface that can mesh with the spiral teeth of the rotary needle 8. When the rotary needle 8 rotates around its axis, the supporting rotary block 7 can rotate around the axis of the supporting rotary block 7, and the rotating rod 4 can rotate around the axis of the rotating rod 4. The rotation direction of the supporting rotary block 7 is opposite to that of the rotating rod 4. The supporting rotary block 7 cooperates with the rotating rod 4 to fix and support the rotary needle 8 together to prevent the rotary needle 8 from affecting the top area of ​​the sleeve 1 when rotating. Preferably, the support rotary block 7 is coaxially arranged with the head 401 of the rotating rod 4, and the surface of the head 401 of the rotating rod 4 facing the rotating needle 8 is a tooth surface that can mesh with the spiral teeth of the rotating needle 8. A through hole for rotational insertion is arranged in the sleeve 1.

[0051] The rotary needle 8 includes a front portion 801, a tooth portion 802 and a tail portion 803 which are arranged in sequence. The spiral teeth are arranged on the tooth portion 802. The diameter d1 of the tooth root circle of the tooth portion 802 is ≥ the diameter d2 of the tail portion 803> the diameter d3 of the front portion 801. The diameter d1 of the tooth portion 802 is increased to achieve rotation, avoid collision and increase strength; the diameter d3 of the front portion 801 is reduced to facilitate insertion into the sleeve 1. In addition, the end of the front portion 801 away from the tail portion 803 can be chamfered to facilitate insertion into the sleeve 1. For easy adjustment, the length of the tail portion 803 can be set to be longer.

[0052] The rotary needle 8 is inserted into the sleeve 1 from the side, and the tooth portion 802 of the rotary needle 8 is directly meshed with the support rotary block 7 and the head portion 401 of the rotating rod 4. When the rotary needle 8 rotates, the tooth portion 802 of the rotary needle 8 drives the head portion 401 of the rotating rod 4 and the support rotary block 7 to rotate. The rotation of the rotating rod 4 drives the rotating ring 5 to rotate together, and the rotating ring 5 gradually moves axially downward, thereby squeezing the supporting nail 2 to move downward, and the portion of the supporting nail 2 extending out of the sleeve 1 will also become longer and longer, thereby achieving the extension effect of the entire device. This transmission method reduces the volume of the intramedullary nail and is suitable for situations where the space inside the intramedullary nail is limited.

[0053] As an embodiment of the present invention, in order to facilitate adjustment, a handle 9 is also connected to the tail 803 of the rotary needle 8, and the rotary needle 8 can be rotated by rotating the handle 9. Specifically, the handle 9 includes a grip 901 and a transmission part 902, and a connecting end 903 is provided at the end of the transmission part 902 away from the grip 901, and a straight thread groove is provided at the tail 803 of the rotary needle 8. The connecting end 903 can be inserted into the straight thread groove to realize the connection between the handle 9 and the rotary needle 8, so as to transmit the driving force of the handle 9 to the rotary needle 8.

[0054] A rotary needle protection sleeve 10 is provided in the radial direction of the sleeve 1, the rotary needle 8 is provided in the rotary needle protection sleeve 10, a plurality of circumferentially evenly distributed buckles 1001 are provided at one end of the rotary needle protection sleeve 10, a buckle hole for connecting the rotary needle protection sleeve 10 is provided on the sleeve 1, the rotary needle protection sleeve 10 is connected to the sleeve 1 through the buckle 1001, and can be quickly installed on the sleeve 1. The surface of the rotary needle protection sleeve 10 is a smooth structure, which can reduce skin irritation and improve patient comfort.

[0055] As an embodiment of the electric drive of the present invention, Figure 5 , Figure 7 As shown, the electric drive component includes a motor 11, a coupling 12 and a wireless power supply module 13. The motor 11 is arranged in the sleeve 1, and the coupling 12 is arranged between the output shaft of the motor 11 and the rotating rod 4. The coupling 12 is used to transmit the driving force of the motor 11 to the rotating rod 4, and the wireless power supply module 13 is used to supply power to the motor 11.

[0056] As an embodiment of the present invention, the wireless power supply module 13 includes an annular outer fixing sleeve 1301 and an annular flexible PCB board 1302, the outer fixing sleeve 1301 wraps the flexible PCB board 1302, and the lead wire 1303 of the flexible PCB board 1302 is connected to the motor 11. The outer fixing sleeve 1301 is made of stainless steel.

[0057] The mechanically driven drive assembly provided by the present invention can drive the transmission assembly from the side to extend the support nail, and the electrically driven drive assembly provided by the present invention can drive the transmission assembly from the top to extend the support nail. These two methods are more convenient to operate than the tail-driven intramedullary nail structure, and do not require in-depth adjustment inside the wound; they significantly reduce the surgical wound and reduce secondary damage to the patient's tissue; there is no need to change the original cylindrical shape of the intramedullary nail, ensuring the overall structural integrity and functionality of the intramedullary nail. This improvement not only improves the safety and efficiency of the operation, but also greatly reduces the pain burden of the patient and promotes postoperative recovery.

[0058] The intramedullary nail structure is divided into a non-drug-containing intramedullary nail and a drug-containing intramedullary nail. In the intramedullary nail provided by the present invention, when the inner diameter of the sleeve 1 is consistent with the outer diameter of the support nail 2, that is, there is no gap between the inner wall of the sleeve 1 and the support nail 2, and there is no space for drug storage. The outer diameter of the rotating ring 5 is consistent with the inner diameter of the sleeve 1. This intramedullary nail is a standard non-drug-containing intramedullary nail. At this time, the rotating ring 5, the support nail 2 and the sleeve 1 are tightly combined, there is no cavity, and it has a stronger supporting effect in mechanics.

[0059] like Figure 6 As shown, when the inner diameter of the sleeve 1 is larger than the outer diameter of the supporting nail 2, that is, there is a gap between the inner wall of the sleeve 1 and the supporting nail 2, and the gap is filled with a drug-loaded hydrogel 14. This intramedullary nail is a drug-delivery intramedullary nail, which is suitable for patients with larger body weight and can deliver drugs in the marrow while maintaining antibacterial properties.

[0060] As an embodiment of the present invention, the hydrogel 14 is a mesh hydrogel, the mesh hydrogel is a drug-carrying substrate, the drug is arranged in the mesh hydrogel in a liquid state, the diameter of the drug is smaller than the gap of the mesh hydrogel, and the mesh hydrogel is applied to the surface of the support pin 2. The mesh hydrogel is similar to a sponge, which can absorb drugs and be stored inside the sleeve 1 without external force. Since the present invention adopts the adjustment method of the rotating ring 5, during the adjustment process, the rotating ring 5 will squeeze the hydrogel 14 when it moves axially, and the drug in the hydrogel 14 will be gradually released according to the degree of squeezing of the hydrogel 14. Therefore, the drug can be quantitatively released on demand, that is, according to the amount of drug to be released, the rotating ring 5 is adjusted to rotate to a corresponding degree, and the hydrogel 14 is squeezed, thereby releasing a corresponding amount of drug to meet the medication needs, avoiding the situation where the drug release amount is small and the expected effect cannot be achieved, or the drug release amount is large and causes waste. In addition, the hydrogel coating also has a certain supporting effect, which can prevent the support pin 2 from falling off in a natural state.

[0061] As an embodiment of the present invention, the hydrogel 14 may be methacryloyl gelatin (GelMA) and dextran hydrogel 14. The drug may be selected according to the specific conditions of the patient, and may be an anti-inflammatory drug, or may be a vitamin, protein or other drug.

[0062] When filling the drug-loaded hydrogel 14, the liquid hydrogel 14 is first applied to the inner wall of the sleeve 1 by spin coating, and then a smooth glass rod with the same diameter as the supporting pin 2 is placed to perform regional shaping, so that the required circular area is left after the hydrogel 14 solidifies, and then the hydrogel 14 is irradiated with an ultraviolet lamp with a wavelength of 365nm to solidify the hydrogel 14. The present invention adopts a purely physical method to make and set the drug-loaded hydrogel 14, which is simple and fast, does not use other chemical drugs, and is safer.

[0063] As an embodiment of the present invention, a mounting hole 201 is provided on the support nail 2, and the mounting hole 201 extends from the top to the bottom of the support nail 2 and does not penetrate the bottom of the support nail 2. The rod portion 402 of the rotating rod 4 partially extends into the mounting hole 201, and the rod portion 402 of the rotating rod 4 transitionally fits with the mounting hole 201, thereby improving the adjustable range of the support nail 2 that can be extended, and playing a certain supporting and fixing role on the support nail 2.

[0064] As an embodiment of the present invention, Figure 3 As shown, a plurality of convex ribs 202 are arranged on the outer circumferential wall of the support pin 2, and the convex ribs 202 are parallel to the axis of the support pin 2. A plurality of grooves matching the convex ribs 202 are arranged on the inner circumferential wall of the sleeve 1. During the insertion of the support pin 2 into the sleeve 1, the convex ribs 202 can slide axially in the grooves but will not slide out of the grooves, and play a role of anti-torsion and anti-rotation while performing axial positioning. The positions of the convex ribs 202 and the grooves correspond one-to-one, and the numbers of the convex ribs 202 and the grooves correspond one-to-one. The convex ribs 202 are uniformly distributed circumferentially relative to the support pin 2, and the grooves are uniformly distributed circumferentially relative to the sleeve 1. As a preferred embodiment of the present invention, there are four convex ribs 202 and four grooves. As a preferred embodiment of the present invention, the length of the groove accounts for one-third of the total length of the inner part of the sleeve 1. Such a configuration facilitates the installation of the rotary needle protective sleeve 10 and can avoid obstruction to the rotation of the rotating rod 4 and the supporting rotary block 7.

[0065] In order to reduce the weight of the intramedullary nail, a number of hollow structures are provided on the support nail 2. Such hollow structures can be designed by topologically optimizing the support nail 2, and the specific structure is customized according to the patient's weight and other conditions. Such hollow structures also help to release drugs from the inside of the support nail 2 through the hollow structures.

[0066] As an embodiment of the present invention, Figure 8 As shown, a plurality of staggered textures 103 are arranged on the outer circumferential wall of the sleeve 1, and the textures 103 are groove-shaped. The textures 103 are used to reduce the friction force when the sleeve 1 is inserted into the medullary cavity, and at the same time, the textures 103 can also store drugs.

[0067] As an embodiment of the present invention, Fig. 9 As shown, the texture 103 is in the shape of a meandering river. Specifically, the texture 103 includes a first section 1031, a bending section 1032, a second section 1033 and a water drop section 1034 that are connected in sequence. The first section 1031 and the second section 1033 are relatively straight as a whole. The end of the first section 1031 away from the bending section 1032 is in an arc shape, and the width of the middle part of the first section 1031 is slightly smaller than the width of the upper and lower parts, which reduces the contact distance between two adjacent textures 103, increases the number of textures 103 on the sleeve 1, and thus improves the drug loading capacity of the sleeve 1. The bending section 1032 connects the first section 1031 and the second section 1033. The bending section 1032 is inclined with the first section 1031, and the bending section 1032 is inclined with the second section 1033. The first section 1031 and the second section 1033 are parallel, which reduces The resistance encountered by the sleeve 1 during the placement process is reduced, the strength of the texture 103 is improved, and the bending section 1032 transitions to the first section 1031 in an arc, and the bending section 1032 transitions to the second section 1033 in an arc, the width of the bending section 1032 is greater than the width of the first section 1031, the width of the bending section 1032 is greater than the width of the second section 1033, and in the direction extending from the second section 1033 to the water drop section 1034, the widths of the second section 1033 and the water drop section 1034 gradually increase, the width of the second section 1033 increases slowly from the bending section 1032 to the water drop section 1034, and the width of the water drop section 1034 increases rapidly from the second section 1033, the water drop section 1034 is in the shape of a water drop, and the end of the water drop section 1034 away from the second section 1033 is in the shape of an arc, thereby reducing the resistance of the sleeve 1 during movement.

[0068] In the existing design, the texture 103 is mostly processed one by one by laser processing or mechanical cutting, but this processing method takes a long time. Therefore, as an embodiment of the present invention, the manufacturing method of the texture 103 includes the following steps:

[0069] S1. A plurality of projections having the same shape as the texture 103 are formed in advance by mechanical cutting on the stamping area of ​​the two stamping plates;

[0070] S2. The sleeve 1 is heated at 450 ° C ~ 600 ° C for 15 ~ 30S;

[0071] S3. The sleeve 1 is fixed to the inner fixed shaft of the stamping fixed platform, and the sleeve 1 is stamped using upper and lower stamping plates to form a texture 103 on the outer surface of the sleeve 1;

[0072] S4. After the stamping is completed, the sleeve 1 is cooled;

[0073] S5. Use a grinding tool to grind the surface of the sleeve 1 in the order of first mesh, second mesh, and third mesh to remove the oxide film and other impurities on the surface of the sleeve 1, wherein the particle sizes of the first mesh, second mesh, and third mesh increase in sequence.

[0074] Specifically, in step S1 , the stamping area is the area where the stamping plate contacts the sleeve 1 .

[0075] In step S2, the sleeve 1 can be heated in a heating furnace. As a preferred embodiment of the present invention, the sleeve 1 can be heated at 450°C for 30S.

[0076] In step S3, since the sleeve 1 is a hollow structure, the internal fixed shaft is used not only to fix the sleeve 1, but also to prevent the sleeve 1 from deforming during the stamping process. After stamping, the strength of the sleeve 1 will be further improved.

[0077] In step S4, the sleeve 1 may be placed in cold water for cooling.

[0078] In step S5, as a preferred embodiment of the present invention, the grinding tool can be made of materials such as boron carbide or silicon carbide. The first purpose particle size range is 180 mesh to 200 mesh, and the surface of the sleeve 1 is initially ground to remove the more obvious impurities and part of the oxide film on the surface of the sleeve 1, wherein the first mesh is preferably 180 mesh; the second purpose particle size range is 300 mesh to 350 mesh, and the surface of the sleeve 1 is further finely ground to effectively remove the impurities and oxide film remaining in the previous stage, thereby improving the flatness of the surface of the sleeve 1, wherein the second mesh is preferably 320 mesh. The third purpose particle size range is 1000 mesh and above, and the surface of the sleeve 1 is finely ground to ensure that the oxide film and other fine impurities remaining on the surface of the sleeve 1 are completely removed, wherein the third mesh is preferably 1000 mesh. After grinding, microscopic rough marks are formed on the surface of the sleeve 1, which can increase the surface area for drug attachment, provide more drug binding sites, and increase physical adsorption forces such as van der Waals forces, which, in conjunction with the texture 103, can greatly increase the drug adsorption capacity.

[0079] It should be noted that the drug here needs to be in oily form, such as vitamin A oil, diclofenac diethylamine emulsion, etc., because the molecules of oily drugs have a certain viscosity, and the rough surface of the sleeve 1 can provide more physical adsorption sites, coupled with the adsorption effect of the van der Waals force and capillary force of the channels between the textures 103, more drugs can be stored for a long time, and it can be ensured that the drugs will not fall off after being installed in the marrow. This method of storing drugs does not require the treatment of other organic solvents, reducing the occurrence of uncertain factors.

[0080] As an embodiment of the present invention, there is a step S6 after step S5, and step S6 is:

[0081] A porous structure is manufactured on the surface of the sleeve 1 using a strong alkaline solution. After the manufacturing is completed, the sleeve 1 is cleaned with an acidic solution, and then the sleeve 1 is ultrasonically cleaned for at least 10 minutes. After the cleaning is completed, the sleeve 1 is dried and plasma cleaned.

[0082] As a preferred embodiment of the present invention, the strong alkaline solution can be a 5 mol / L to 10 mol / L sodium hydroxide solution, and the acidic solution can be a 1 mol / L glacial acetic acid solution.

[0083] The sleeve 1 is ultrasonically cleaned with a deionized water solution. The cleaning completion standard is: the sleeve 1 is placed in a new deionized water solution, and the acidity and alkalinity of the new deionized water solution are tested. If the new deionized water solution is neutral, the cleaning is completed, otherwise the cleaning is not completed.

[0084] Preferably, the time for plasma cleaning the sleeve is 30 seconds.

[0085] The porous structure on the surface of the sleeve 1 improves the drug storage capacity of the sleeve 1. After cleaning, the hydrophilicity of the surface of the sleeve 1 is enhanced, thereby enhancing the ability to adsorb drugs.

[0086] Due to the deep depth of the medullary cavity, it is difficult for doctors to completely and evenly apply anti-inflammatory drugs on each side wall of the medullary cavity, and due to the influence of gravity, the drugs will accumulate at the bottom. Therefore, the above-mentioned sleeve 1 texture 103 structure can be used to solve this problem. Before the intramedullary nail is inserted into the medullary cavity, antibacterial drugs can be sprayed on the surface of the sleeve 1, and the drugs will adhere to the surface of the sleeve 1 due to capillary force. When the intramedullary nail is placed in the body, the antibacterial drugs can be slowly released, and the internal tissues of the medullary cavity can contact with the drugs, thereby providing continuous antibacterial protection for the surgical site and reducing the rejection reaction in the early stage of placement.

[0087] The intramedullary nail provided by the present invention integrates the functions of extension, antibacterial and drug delivery, meets the demand for lightweight, can flexibly adjust the extension speed and strength according to the patient's condition, the extension process is stable, and the extension result is accurate. Among them, the mechanical drive method can be driven and adjusted from the side, which is convenient to operate and has a small wound; combined with the structure of the transmission component, the mesh hydrogel drug carrier can release the drug quantitatively on demand, and at the same time support the support nail 2; adding a texture 103 on the surface of the sleeve 1 reduces the friction during installation and plays a role in antibacterial protection. The processing method has low cost and high efficiency.

[0088] It should be understood that although this specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each implementation mode may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

[0089] The series of detailed descriptions listed above are only specific descriptions of feasible implementation methods of the present invention. They are not intended to limit the scope of protection of the present invention. All equivalent implementation methods or changes that do not deviate from the technical spirit of the present invention should be included in the scope of protection of the present invention.

Claims

1. An intramedullary nail, characterized in that: The invention comprises a sleeve (1), a driving assembly, a transmission assembly and a supporting nail (2), wherein the driving assembly and the transmission assembly are arranged at the upper part of the sleeve (1), and the supporting nail (2) is arranged at the lower part of the sleeve (1); the transmission assembly comprises a rotating rod (4) and a rotating ring (5); a limiting groove is arranged in the sleeve (1), and the limiting groove is used to limit the axial position of the rotating rod (4) in the sleeve; an external thread is arranged on the outer circular wall of the rotating rod (4), and an internal thread matching the external thread is arranged on the inner circular wall of the rotating ring (5); the rotating ring (5) is arranged above the supporting nail (2); the driving assembly can drive the rotating rod (4) to rotate around its axis from the side or the top, and the rotating ring (5) can drive the supporting nail (2) to synchronously make axial movement; There is a gap between the inner circular wall of the sleeve (1) and the outer circular wall of the support pin (2), and a drug-loaded hydrogel (14) is filled in the gap. The hydrogel (14) is a mesh hydrogel, and the drug is arranged in a liquid state in the mesh hydrogel. The diameter of the drug is smaller than the gap of the mesh hydrogel. The mesh hydrogel is attached to the surface of the support pin (2). The rotating ring (5) squeezes the hydrogel (14) when moving axially, and the drug in the hydrogel (14) is released according to the degree of squeezing. A plurality of staggered textures (103) are arranged on the outer circular wall of the sleeve (1), and the texture (103) is groove-shaped. The texture (103) includes a first section (1031), a bending section (1032), a second section (1033) and a water drop section (1034) which are connected in sequence. The first section (1031) is connected to the outer circular wall of the sleeve (1). The first section (1031) and the second section (1033) are parallel to each other, one end of the first section (1031) away from the bending section (1032) is in an arc shape, the bending section (1032) connects the first section (1031) and the second section (1033), the bending section (1032) and the first section (1031) are arranged obliquely and have an arc transition, the bending section (1032) and the second section (1033) are arranged obliquely and have an arc transition, the width of the bending section (1032) is greater than the width of the first section (1031), the width of the bending section (1032) is greater than the width of the second section (1033), the water drop section (1034) is in a water drop shape, and in the direction extending from the second section (1033) to the water drop section (1034), the widths of the second section (1033) and the water drop section (1034) gradually increase.

2. The intramedullary nail according to claim 1, characterized in that: The rotating rod (4) comprises a head (401) and a rod (402); the diameter of the head (401) is larger than the diameter of the rod (402); the head (401) is arranged in a limiting groove; and the driving assembly can drive the head (401) to rotate around the axis of the rod (402) from the side or top.

3. The intramedullary nail according to claim 1, characterized in that: There are a plurality of rotating rings (5), and a check piece (6) is provided between adjacent rotating rings (5).

4. The intramedullary nail according to claim 1, characterized in that: The driving assembly comprises a supporting rotary block (7) and a rotary needle (8), wherein the rotary needle (8) crosses the sleeve (1), and a spiral tooth is arranged on the rotary needle (8), and the surface of the supporting rotary block (7) facing the rotary needle (8) is a tooth surface that can mesh with the spiral tooth of the rotary needle (8), and the surface of the rotating rod (4) facing the rotary needle (8) is a tooth surface that can mesh with the spiral tooth of the rotary needle (8).

5. The intramedullary nail according to claim 4, characterized in that: The rotary needle (8) comprises a front portion (801), a tooth portion (802) and a tail portion (803) which are arranged in sequence, the spiral teeth of the rotary needle (8) being arranged on the tooth portion (802), and the diameter d1 of the tooth root circle of the tooth portion (802) being ≥ the diameter d2 of the tail portion (803)> the diameter d3 of the front portion (801).

6. The intramedullary nail according to claim 1, characterized in that: The driving assembly comprises a motor (11), a coupling (12) and a wireless power supply module (13); the motor (11) is arranged in a sleeve (1); the coupling (12) is arranged between an output shaft of the motor (11) and a rotating rod (4); the coupling (12) is used to transmit a driving force of the motor (11) to the rotating rod (4); and the wireless power supply module (13) is used to supply power to the motor (11).

7. The intramedullary nail according to claim 1, characterized in that: A plurality of convex ribs (202) are arranged on the outer circular wall of the support pin (2), the convex ribs (202) are parallel to the axis of the support pin (2), and a plurality of grooves matching the convex ribs (202) are arranged on the inner circular wall of the sleeve (1), the convex ribs (202) can slide axially in the grooves.

8. The intramedullary nail according to claim 1, characterized in that: A plurality of hollow structures are provided on the supporting pin (2), and the hollow structures allow drugs to pass through.

9. The intramedullary nail according to claim 1, characterized in that: The method for manufacturing the texture (103) comprises the following steps: S1. Preliminary mechanical cutting is performed on the stamping areas of the two stamping plates to form a plurality of protrusions having a shape consistent with the texture (103); S2. The sleeve (1) is heated at 450°C to 600°C for 15 to 30S; S3. Fixing the sleeve (1) on the inner fixed shaft of the stamping fixed platform, and stamping the sleeve (1) using upper and lower stamping plates to form a texture (103) on the outer surface of the sleeve (1); S4. After the stamping is completed, the sleeve (1) is cooled; S5. Use a grinding tool to grind the surface of the sleeve (1) in the order of first mesh, second mesh, and third mesh to remove the oxide film and impurities on the surface of the sleeve (1), wherein the particle sizes of the first mesh, second mesh, and third mesh increase in sequence.

10. The intramedullary nail according to claim 9, characterized in that: There is a step S6 after step S5, and step S6 is: A porous structure is manufactured on the surface of the sleeve (1) using a strong alkaline solution. After the manufacturing is completed, the sleeve (1) is cleaned with an acidic solution, and then the sleeve (1) is ultrasonically cleaned for more than 10 minutes. After the cleaning is completed, the sleeve (1) is dried and then plasma cleaned.

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