WO2023010909A1

WO2023010909A1 - Cartilage stabilizer and fully-degradable cartilage stabalization system

Info

Publication number: WO2023010909A1
Application number: PCT/CN2022/089876
Authority: WO
Inventors: 张晓芳; 谢勇; 储成生; 宋保组; 逄永刚
Original assignee: 合肥启灏医疗科技有限公司
Priority date: 2021-07-31
Filing date: 2022-04-28
Publication date: 2023-02-09

Abstract

A cartilage stabilizer, comprising an implantation system, a driving system, and an ejection system. The implantation system comprises a first implantation mechanism (2) and a second implantation mechanism (3). The driving mechanism comprises a braking mechanism, a clamping driving mechanism, and a staple-discharge driving mechanism. The braking mechanism drives the clamping driving mechanism so as to drive the second implantation mechanism (3) to move towards or away from the first implantation mechanism (2). The braking mechanism drives the staple-discharge driving mechanism to discharge a stitching staple from the first implantation mechanism (2), so as to implement quick stitching. One end of the ejection system abuts against a stitching staple set. After a stitching staple is discharged from the first implantation mechanism (2), the ejection system drives the stitching staple set to move towards the staple discharge end of the first implantation mechanism, so that the implantation direction of the next stitching staple can be adjusted by adjusting the positions of the first implantation mechanism (2) and the second implantation mechanism (3), and the purpose of accurately implanting stitching staples is achieved. A fully-degradable cartilage stabilization system.

Description

Cartilage Fixator and Fully Degradable Cartilage Fixation System

cross reference

This application claims priority to Chinese patent applications filed on July 31, 2021 with application numbers 202110876783.X and 202110878032.1. The content of the above application is incorporated herein by reference.

technical field

The invention relates to the technical field of medical devices, in particular to a cartilage fixer and a fully degradable cartilage fixation system.

technical background

The septal cartilage is usually 2-4 mm thick and is covered on both sides with a layer of mucous membrane called periosteum. Imagine a piece of sausage sandwiched between two slices of thin bread. The big sausage is the septal cartilage and the bread is the mucous membrane. Septoplasty is the third most common surgical procedure performed by otolaryngologists. The goal of septal surgery is to carefully lift the mucous dura on both sides from the septum, remove any deviations, and then remove all Things clip together. This surgery is done to relieve nasal congestion, which is often caused by bending of the tissue in the middle of the nose. Current techniques for accomplishing septoplasty include bilateral lifting of the subperichondrial flap and resection of cartilage and/or bone offset. Over time, techniques have evolved to prevent septal hematomas by removing the underlying dead space after chondrectomy. Petroleum gauze is generally used to fill the nose in traditional surgery, and the use of sutures to stitch the mucosa back together has become the preferred method. Nasal septal cartilage suture can be sutured with a common intestinal straight needle or absorbable suture such as Vicryl.5, but these two suture methods have certain limitations, especially in a narrow nose, The time required for stitching may be as little as 4 minutes or as many as 20 minutes, and if the inferior turbinate is close, the turbinate is often torn due to the tight constraints of taking the thread; the procedure requires removal of the suture segment to start over , the suture may break, resulting in a scar zone of cartilage; in the worst case, the needle may break and be lost, requiring radiology to help localize the remnant. In general, the technique of septal chondroplasty involves the placement of simple splints and sutures during surgery to suture the septal cartilage flap, however, suturing within the confines of the narrow and deep nasal passages is difficult for even the most experienced surgeon. A difficult and time-consuming task.

The commonly used surgical stapler is easy to operate, requires less professional knowledge, and saves time, but the commonly used surgical stapler triggers the braking device once, and all the staples are implanted together, and there are implants that cannot adjust the staples. Insertion direction, the problem of inaccurate placement of sutures.

Publication No. US7438208B2 discloses a spacer suturing device comprising an instrument body with a proximal portion and a distal portion, a handle at the distal portion enables the user to hold and manipulate the instrument body, a pair of spaced apart arms from The handle extends and includes a nail arm and a tension arm, the body includes a trigger movable between a rest position and a firing position, an actuator link moves between a first and a second position, and the actuator link passes through The trigger moves, wherein the actuator linkage includes a staple moving member attached to a staple arm having a staple set comprising a plurality of staples, the trigger, the actuator linkage, the staple The group and staple moving members are configured to move the staples to the staple position when the trigger is pulled, the staple arm and tensioning arm moving together when the trigger is pulled. However, the structure of this patent cannot determine the number of staples in the nail box; and the fixing method of the nail box may cause the risk of the nail box falling, and it is not easy to replace. At present, the country strongly advocates the reduction of disposable medical devices to reduce the cost of surgery, and the aseptic requirements of fixed nail boxes make the staplers that do not need to be used disposable become disposable products, wasting resources and increasing pollution.

Therefore, it is necessary to provide a novel cartilage fixator and fully degradable cartilage fixation system to solve the above-mentioned problems in the prior art.

Summary of the invention

The purpose of the present invention is to provide a cartilage fixator and a fully degradable cartilage fixation system, so as to quickly suture and connect the internal tissue and the soft tissue on both sides during cartilage surgery, and after a single implant nail is implanted, the The position of the first implanting mechanism and the second implanting mechanism is used to adjust the implanting direction of the next staple, so as to achieve the purpose of precise implantation of the staple.

To achieve the above object, the cartilage fixator of the present invention includes an implant system, a drive system and an ejection system;

The implant system includes a first implant mechanism and a second implant mechanism, the first implant mechanism is opposite to the second implant mechanism, and the first implant mechanism and the second implant mechanism The body divider is configured to receive the patient's cartilage;

The driving mechanism includes a braking mechanism, a clamping driving mechanism and a nail ejection driving mechanism, the braking mechanism is respectively connected with the clamping driving mechanism and the nail ejection driving mechanism, and the clamping driving mechanism is connected with the nail ejection driving mechanism. The second implanting mechanism is connected, the brake mechanism drives the clamping driving mechanism to drive the second implanting mechanism to move toward or away from the first implanting mechanism, and the nail ejection driving mechanism is connected to the first implanting mechanism. an implantation mechanism coupled, the brake mechanism actuating the staple ejection drive mechanism to eject staples from the first implantation mechanism;

One end of the ejection system abuts a set of staples, and the ejection system drives the set of staples toward an ejection end of the first implantation mechanism after ejection of staples in the first implantation mechanism.

The beneficial effect of the cartilage fixator of the present invention is that: the implant system includes a first implant mechanism and a second implant mechanism, the first implant mechanism is opposite to the second implant mechanism and The first implant mechanism is spaced from the second implant mechanism to receive the patient's cartilage, the drive mechanism includes a brake mechanism, a clamp drive mechanism and a nail ejection drive mechanism, and the brake mechanism is respectively connected to the The clamping driving mechanism is connected with the nail ejection driving mechanism, the clamping driving mechanism is connected with the second implanting mechanism, and the braking mechanism drives the clamping driving mechanism to drive the second implanting mechanism. the mechanism moves toward or away from the first implantation mechanism, the staple ejection drive mechanism is connected to the first implantation mechanism, and the braking mechanism drives the staple ejection drive mechanism to extract the staple ejection mechanism from the first implantation mechanism Middle ejection staples, that is, the first implant mechanism and the second implant mechanism can be inserted from the left and right nasal cavities respectively, and then point-fixed by ejecting staples, so that the internal tissues can be quickly sutured and connected in cartilage surgery Compared with the soft tissues on both sides, it saves time and reduces edema, and compared with sutures, staples are more tightly fixed, so that the postoperative wound can heal naturally without additional splints or fillers, improving the patient's postoperative Comfort, as well as reducing postoperative complications, is beneficial to help healing, the implant system can operate on the edge of the cartilage flap, and repair the tear; through one end of the ejection system against the staple group, the first said ejection system drives said staple set towards the staple ejection end of said first implant mechanism after ejection of staples in an implant mechanism, a single staple trigger mechanism so that the cartilage does not tear during closure, and After a single implant is implanted, the implantation direction of the next staple can be adjusted by adjusting the positions of the first implant mechanism and the second implant mechanism, so as to realize the precise implantation of the staple Purpose, can re-approximate the suturing of the cartilage mucous membrane tear, and have additional benefits for the repair of cartilage perforation, resulting in a more uniform closure.

Optionally, the ejection system includes a ejector rod, a spring and a ejector block, one end of the spring abuts against the fixing member, the other end of the spring abuts against one end of the ejector rod, and one end of the ejector block abuts against The other end of the ejector bar is connected to the other end of the ejector block against the staple set. Its beneficial effect is: so that one of the staples is ejected, the elastic force of the spring can be used to push the push rod and the push block to automatically push the set of staples toward the side of the first implanting mechanism. The movement of the staple outlet is fully automatic controlled, which is simple and convenient, and is beneficial to ensure the smoothness of the staple discharge.

Optionally, the ejection system further includes a pointer structure and a digital indicating part, and the digital indicating part includes a pointer moving accommodating window that passes through the main casing of the stapler and is arranged on the main casing of the stapler The number marks on the outer wall of the body, the pointer structure and the ejector rod are vertically arranged, the pointer structure passes through the pointer movement accommodation window, and the pointer structure moves on the pointer with the movement of the ejector rod Move the containment window to move and point to the number marker. The beneficial effect is that the number of staples discharged is represented by the numbers on the main housing, which is simple and clear, and can easily and clearly know the implanted quantity of staples during the operation and the remaining quantity of staples in the staple box. To facilitate timely replacement of the nail box.

Optionally, the brake mechanism includes a brake assembly and a brake lever, the brake assembly is fixedly connected to the brake lever, the clamping drive mechanism includes a driven lever, and the brake lever is connected to the brake lever. The brake part of the driven rod overlaps, and one end of the driven rod is connected and fixed to the second implant mechanism, and the brake rod is driven to press or release the brake rod by the rotation of the brake assembly. and the brake part of the driven rod, so that the other end of the driven rod drives the second implant mechanism to move toward or away from the first implant mechanism. The beneficial effect is that the second implanting mechanism is clamped or separated from the first implanting mechanism.

Optionally, the brake mechanism includes a brake assembly, the nail ejection drive mechanism includes a brake gear assembly, a traction assembly and a nail ejector assembly, the brake assembly is connected to the brake gear assembly, and the traction The components are respectively connected with the brake gear assembly and the nail row assembly, and the brake gear assembly is driven to move by the rotation of the brake assembly, so that the brake gear assembly drives the nail row assembly through the traction assembly. The staple assembly is moved to expel the staples from the first implantation mechanism. The beneficial effect is: to realize the ejection of staples from the first implanting mechanism.

Optionally, the cartilage fixator further includes a nail box and a nail box replacement assembly, the nail box is arranged on the first implant mechanism to hold the staples, and the nail box replacement assembly includes a push handle to move the receiving window and Nail box push rod, the moving storage window of the push handle runs through the main housing of the nail fixer, one end of the nail box push rod is vertically provided with a push handle, and the other end of the nail box push rod is connected to the nail The box is connected, and the push handle passes through the push handle moving accommodating window and moves in the pushing handle moving accommodating window. Its beneficial effect is: that is, by pushing the push handle to make it move in the push handle moving accommodation window, thereby driving the nail cartridge push rod to move toward the direction of the first implanting mechanism, so as to move the nail cartridge from the The above-mentioned first implant mechanism is released, thereby realizing the replacement of the nail box.

Optionally, the traction assembly includes a traction wire and a traction wire fixing assembly, both ends of the traction wire are respectively fixed to the brake gear assembly, and the traction wire is fixed by the traction wire fixing assembly to form a ring structure . The beneficial effect is that: the staple ejector assembly can be repeatedly driven to move repeatedly in multiple cycles to eject the staples from the first implanting mechanism.

Optionally, the nail stripping assembly is arranged on the first implant mechanism, the nail stripping assembly includes a push plate, a track, a nail box bracket, and a track top plate, and the track is set on the top of the nail box bracket, The track top plate is connected with the nail box bracket to form a guide rail communicating with the track, the push plate is fixedly connected with the traction wire, and the traction wire drives the push plate to move in the track and the guide rail so that the push plate is pressed against the head of the staple to expel the staple from the first implanting mechanism. The beneficial effect is that: each time the brake mechanism is triggered, the pulling wire drives the push plate to move to push out a staple and implant the wound.

Optionally, the thickness of the push plate is less than or equal to the width of the head of the staple. Its beneficial effect is that: every time the braking device is triggered, only one staple will be implanted into the wound, and the next staple in the staple box will be pushed by the ejection system to the first implantation. The nail-out end of the mechanism; when more staples are needed for suturing, the braking mechanism is triggered again, and the next implanted staple is implanted, and multiple individual staples are implanted in sequence, so that the cartilage closure process does not torn.

Optionally, the brake gear assembly includes a brake gear, a first gear row assembly and a second gear row assembly, the brake gear is connected to the brake assembly, the first gear row assembly and the The second gear row assembly is arranged opposite to the symmetrical end of the brake gear, one end of the pulling wire is connected and fixed to the first gear row assembly, and the other end of the pulling wire is connected to the second gear row assembly fixed. The beneficial effect is that the traction assembly is driven to move by the braking gear assembly, so as to drive the staple ejection assembly to move and eject the staples from the first implanting mechanism.

Optionally, the connecting end of the nail box push rod connected to the nail box is provided with an external thread, and the inner wall of the nail box is provided with an internal thread adapted to the external thread, and the nail box and the The connecting end of the nail box push rod is connected and fixed by threading. The beneficial effect is that the fixing of the nail box is more firm and stable, the nail box can be effectively prevented from falling, and the nail box and the nail box push rod are detachably connected through threaded connection, and the nail box can be easily replaced. box.

Optionally, the track top plate is arranged at an open end of the nail box support, and the track top plate is detachably connected to the nail box support. The beneficial effect is that the replacement of the nail box is convenient.

Optionally, the drawing wire fixing assembly includes a drawing wire fixing plate and a plurality of drawing wire pulleys, the drawing wire fixing plate and the nail box bracket are connected and fixed and arranged in the first implant mechanism, the drawing wire fixing plate A symmetrical end surface of the wire fixing plate and the nail box bracket is provided with a drawing wire installation groove, and the drawing wire pulley is arranged on the inner wall of the main housing of the nail fixer, and the drawing wire passes through several of the drawing wires. The pulley, the pulling wire fixing plate and the nail box support are fixed to form a ring structure.

Optionally, the first implant mechanism includes an implant bracket, the implant bracket, the pulling wire fixing plate and the nail box bracket are all cavity structures, the pulling wire fixing plate and the nail The cartridge bracket is fixedly arranged in the cavity structure of the implant bracket, and the nail box bracket is detachably fixedly connected to the nail box. The beneficial effect is that it is beneficial to structural integration, making the overall structure of the nail fixer compact, and reducing the overall volume of the first implanting mechanism.

Optionally, the nail box push rod is movably arranged on the main housing of the nail fixer, the side wall of the nail box push rod is provided with a chute, and a push rod is movably arranged in the chute. The beneficial effect is that it is beneficial to the structural integration, so that the overall structure of the nail fixer is compact, and the overall volume of the main shell of the nail fixer is reduced.

Optionally, the main housing of the nail fixer includes a first through hole structure and a second through hole structure, the driven rod in the clamping drive mechanism is movably arranged in the main housing of the nail fixer and Through the second through hole structure, the first implant mechanism is fixedly connected to the main housing of the nail fixer, and the opening end of the first implant mechanism is docked with the first through hole structure In communication, the nail cartridge push rod and the ejector rod pass through the first through hole structure and extend into the first implantation mechanism.

Optionally, the staple box includes a staple box receiving chamber and a staple chute for the staples to slide. The beneficial effect is that: the staples are stored in the staple box to perform nasal septal cartilage surgery, which can effectively prevent the accidental displacement of the nail head.

Optionally, the present invention also provides a fully degradable cartilage fixation system, including a suture nail and the cartilage fixer, and the suture nail is arranged in the first implantation mechanism of the cartilage fixer.

The beneficial effect of the fully degradable cartilage fixation system of the present invention is that: by including a staple and the cartilage fixer, the staple is set in the first implantation mechanism of the cartilage fixer, so that the cartilage fixation The device can nail the staples into the double layer of mucous membrane that runs through the cartilage, or further penetrate the cartilage between the mucous membrane layers, so that the suture nails can pull the mucous membrane layer at a close distance, prevent the formation of hematoma, and realize fast suturing in nasal septal cartilage surgery It connects internal tissues and soft tissues on both sides. Compared with sutures, using the fully degradable cartilage fixation system for suturing can save time and reduce edema, and it is more tightly fixed than sutures, so that postoperative wounds can heal naturally. Additional splints or fillers can improve patient comfort and reduce postoperative complications, helping to aid healing.

Optionally, the staples are made of absorbable and degradable materials. The beneficial effect is that the degradation products of the staple implant can be digested through normal physiological ways, and a uniform closure is provided.

Optionally, the staple includes a nail body, and a driving part and a nail cap part respectively arranged at two ends of the nail body, and the nail cap part is vertically arranged to the nail body. Its beneficial effects are: the nail-in part can be easily passed through and implanted into cartilage and other tissues, and the cartilage and other tissues can be stably fixed through the nail cap part, so that the suture nail can be implanted through the cartilage fixer into the double-sided cartilage penetrating the nasal septum. Mucous membrane, or further penetrate the cartilage between the mucous membrane layers, so that the suture nails can pull the mucous membrane layer at a close distance, prevent the formation of hematoma, and realize the rapid suturing of the internal tissue and the soft tissue on both sides during nasal septum surgery. In comparison, the cartilage fixator combined with suture nails saves time and reduces edema, and is more tightly fixed than sutures, so that the postoperative wound can heal naturally without additional splints or fillers, improving postoperative comfort for patients, and Reduce postoperative complications and help to heal.

Optionally, grooves are provided on the end surface of the nut portion abutting against the push plate. The beneficial effect is that: when the push plate pushes the staples to move, the push plate can push against the groove, which has a force point and is easier to push.

Optionally, the nut portion is any one of an I-shaped structure, a circular structure and a cross-shaped structure. The beneficial effect is that the nail cap can stably fix tissues such as cartilage.

Optionally, the nail-in portion is any one of a hook-shaped structure and a tapered structure. The beneficial effect is that the nailing part can easily pass through implanted tissues such as cartilage.

Further optionally, the nail-in portion of the hook-shaped structure is provided with at least one hook body, and one end of the hook body is fixedly arranged on the working end of the nail-in portion.

Optionally, the total axial length of the staple is 2-5 mm, the axial length of the nail body is 1.5-3.5 mm, the radial length of the nail body is 0.3-0.8 mm, and the nail cap The maximum length of the radially acting surface of the nut part is 1.2-3mm, and the maximum width of the radially acting surface of the nut part is 0.4-1mm. The beneficial effect is that the nail-in part can be easily passed through implanted cartilage and other tissues, and cartilage and other tissues can be stably fixed through the nail cap part, and has better mechanical properties.

Optionally, the biodegradable material includes a polyester biodegradable material and an active ingredient, and the active ingredient includes at least one of a surfactant and a bioactive glass;

Based on the total mass percentage of the polyester biodegradable material, the content of the active ingredient is less than or equal to 40%, and the content of the surfactant is less than or equal to 15%;

The polyester-based biodegradable material includes a blending modification component, and the blending modification component includes at least one of polyglycolic acid, glycolide, caprolactone, lactide, and polyethylene glycol. Its beneficial effects are: the degradation products of the bioactive glass can promote the generation of growth factors, promote the reproduction of cells, enhance the gene expression of osteoblasts and the growth of bone tissue, so that the biocompatibility is good, the tissue reaction is small, and at the same time It can improve the mechanical strength and toughness of biodegradable materials, and itself has better biocompatibility and degradability. The mechanical properties of materials and the controllability of degradation are increased through surfactants, so that the biodegradable The degradable material also has good mechanical properties while possessing degradability; by accounting for the total mass percentage of the polyester biodegradable material, the content of the active ingredient is less than or equal to 40%, and the content of the surfactant Less than or equal to 15%, it is beneficial to improve the bioactivity, biocompatibility, mechanical properties and degradation controllability of the biodegradable material.

Optionally, the equivalent particle size of the bioactive glass is less than 45 microns. The beneficial effect is that the bioactive glass is easily fused into the polyester biodegradable material.

Optionally, based on the total mass percentage of the polyester biodegradable material, the content of the blending modification component is 5-95%. The beneficial effect is that it is beneficial to improve the controllability of the degradable performance of the biodegradable material.

Optionally, the polyester biodegradable material further includes any one of polylactic acid, polyglycolide, polycaprolactone, polydioxanone and polytrimethylene carbonate. The beneficial effect is that: the biodegradable material has good degradability, and the degradation product has good biocompatibility.

Optionally, the bioactive glass includes any one of silicate glass, glass ceramics and borate-based glass. The beneficial effect is that it helps to promote the production of growth factors, promote the multiplication of cells, enhance the gene expression of osteoblasts and the growth of bone tissue, so that the biocompatibility is good and the tissue reaction is small.

Optionally, the surfactant is polyoxyethylene polyoxypropylene ether tri-block copolymer. The beneficial effect is that it has good compatibility with skin, increases skin permeability, and can promote the absorption of external medicines.

Optionally, the polyoxyethylene polyoxypropylene ether triblock copolymer is any one of F127, L61, L64, F68, P85, P94, P104, P105, P123, L121 and L122. The beneficial effect is that it has good compatibility with skin, increases skin permeability, and can promote the absorption of external medicines.

Optionally, the weight average molecular weight of the polyester biodegradable material is 5000-80000 Daltons. The beneficial effect is to provide the required mechanical properties and degradation time.

Description of drawings

Fig. 1 is the structural diagram of the cartilage fixator of the embodiment of the present invention;

Fig. 2 is a structural schematic diagram formed after decomposing part of the structure of the cartilage fixator shown in Fig. 1;

Fig. 3 is the exploded view of the cartilage fixator of the embodiment of the present invention;

Fig. 4 is a schematic right view of the internal structure of the cartilage fixator according to the embodiment of the present invention;

5 is a schematic left view of the internal structure of the cartilage fixator according to the embodiment of the present invention;

Fig. 6 is a schematic right view of the assembly of the driving mechanism in the cartilage fixator according to the embodiment of the present invention;

Fig. 7 is a schematic left view of the assembly of the driving mechanism in the cartilage fixator according to the embodiment of the present invention;

Fig. 8 is an assembly schematic diagram of the internal structure of the first implant mechanism in the cartilage fixator according to the embodiment of the present invention;

9 is an exploded view of the internal structure of the first implant mechanism in the cartilage fixator according to the embodiment of the present invention;

Fig. 10 is a schematic diagram of partial structural assembly of the cartilage fixator according to the embodiment of the present invention;

Fig. 11 is a schematic structural view of the staple in the first embodiment of the present invention;

Fig. 12 is a schematic structural view of a staple in a second embodiment of the present invention;

Fig. 13 is a schematic structural view of a staple in a third embodiment of the present invention;

Fig. 14 is a schematic structural view of a staple in a fourth embodiment of the present invention;

Fig. 15 is a schematic structural view of a staple in a fifth embodiment of the present invention;

Figure 16 is a front view of the staple shown in Figure 11;

Figure 17 is a right side view of the staple shown in Figure 11;

Fig. 18 is a schematic diagram of the change curve of the tensile elastic modulus over time of the staples prepared according to the ratio of Example 1 of the present invention;

Fig. 19 is a schematic diagram of the change curve of the tensile elastic modulus over time of the staples prepared according to the ratio of Example 2 of the present invention;

Fig. 20 is a schematic diagram of the change curve of the tensile modulus of elasticity over time of the staples prepared according to the ratio of Example 3 of the present invention;

Fig. 21 is a schematic diagram of the change curve of the tensile elastic modulus over time of the suture staple prepared according to the ratio of Example 4 of the present invention;

Fig. 22 is a schematic diagram of the change curve of the tensile modulus of elasticity over time of the staples prepared according to the ratio of Example 5 of the present invention;

Fig. 23 is a schematic diagram of the change curve of the tensile elastic modulus with time of the staple prepared according to the ratio of Example 6 of the present invention.

Contents of the invention

In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, not all of them. the embodiment. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by those skilled in the art to which the present invention belongs. As used herein, "comprising" and similar words mean that the elements or items appearing before the word include the elements or items listed after the word and their equivalents, without excluding other elements or items.

In order to overcome the problems existing in the prior art, the embodiment of the present invention provides a cartilage fixator, including an implant system, a drive system and an ejection system;

The working mechanism of the cartilage fixator is that every time the braking mechanism is triggered, only one staple will be implanted into the wound, and the next staple in the nail box will be pushed to the outlet of the first implanting mechanism. Nail end; When more implant nails are needed, the braking mechanism is triggered again to implant the next staple.

In some embodiments of the present invention, the cartilage is nasal septal cartilage.

Fig. 1 is a structural diagram of a cartilage fixator according to an embodiment of the present invention; Fig. 2 is a schematic structural diagram formed after partial structure decomposition of the cartilage fixator shown in Fig. 1; Fig. 3 is an exploded view of a cartilage fixator according to an embodiment of the present invention .

In some embodiments of the present invention, referring to FIG. 1 , FIG. 2 and FIG. 3 , the stapler includes a main housing 1, a first implant mechanism 2 and a second implant mechanism 3, and the main housing 1 includes a second implant mechanism. A casing 11 and a second casing 12, the first casing 11 and the second casing 12 are fixedly connected. In some specific embodiments of the present invention, the main casing 1 is in the shape of a pistol.

In some specific embodiments of the present invention, referring to FIG. 3 , the first housing 11 and the second housing 12 are fixedly connected by screws 13 .

In other specific embodiments of the present invention, the first housing 11 and the second housing 12 are fixedly connected by clamping or riveting.

In some embodiments of the present invention, referring to FIG. 1 and FIG. 2, the main housing 1 includes a first through hole structure 14 and a second through hole structure 15, and the first implant mechanism 2 and the nail fixer The main housing 1 is fixedly connected, and the open end of the first implant mechanism 2 is connected to the first through-hole structure 14 . In some specific embodiments of the present invention, the first through-hole structure 14 and the second through-hole structure 15 are separated to avoid Parts collide with each other and affect the use.

Fig. 4 is a schematic right view of the internal structure of the cartilage fixator according to the embodiment of the present invention; Fig. 5 is a schematic left view of the internal structure of the cartilage fixator according to the embodiment of the present invention; Fig. 6 is a driving mechanism in the cartilage fixator according to the embodiment of the present invention Fig. 7 is a schematic left view of the assembly of the driving mechanism in the cartilage fixator according to the embodiment of the present invention; Fig. 8 is a schematic diagram of the assembly of the internal structure of the first implant mechanism in the cartilage fixator according to the embodiment of the present invention ; FIG. 9 is an exploded view of the internal structure of the first implant mechanism in the cartilage fixator according to the embodiment of the present invention.

In some embodiments of the present invention, with reference to FIGS. 3-9 , the ejector rod 111, the spring 112 and the ejector block 113 constitute the ejection system, and one end of the spring 112 abuts against a fixing member (not shown in the figures), so The other end of the spring 112 abuts against one end of the push rod 111, one end of the top block 113 abuts against the other end of the push rod 111, and the other end of the top block 113 passes through the first through hole structure 14 and extend into the first implanting mechanism 2 to resist the staple set 4, so that the staple set 4 discharges a staple, and the elastic force of the spring 112 can be used to push the top The rod 111 and the ejector block 113 automatically push the staple set 4 to move toward the staple output end of the first implanting mechanism 2, fully automatic control, simple and convenient, and help to ensure smooth discharge of the staples. In some specific embodiments of the present invention, the fixing member includes a spring chamber 114, the spring 112 is movably arranged in the spring chamber 114, and one end is abutted against the bottom of the spring chamber 114, so that the spring 112 can realize shrinkage and extension between the bottom of the spring chamber 114 and the push rod 111 .

In some embodiments of the present invention, referring to FIG. 3 , FIG. 5 , and FIGS. 6-8 , the pointer structure 115 and the digital indicating part constitute the ejection system, and the digital indicating part includes a pointer movement through the main housing 1 The storage window 116 and a number of numerals 117 arranged on the outer wall of the main housing 1, the pointer structure 115 is arranged perpendicular to the push rod 111, the pointer structure 115 passes through the pointer to move the storage window 116, and The pointer structure 115 moves in the pointer moving accommodation window 116 with the movement of the ejector rod 111 and points to the number mark 117, that is, the number mark 117 provided on the main housing is used to indicate the number of staples discharged, It is simple and clear, and can easily and clearly know the number of staples implanted in the operation. In some specific embodiments of the present invention, the pointer movement accommodating window 116 and the number marks 117 are arranged on the first housing 11 .

Specifically, the numerals are arranged in ascending order from the direction away from the first implant mechanism to the direction close to the first implant mechanism in the order of Arabic numerals such as 1, 2, 3, and 4, and the first implant mechanism A staple is ejected from the mechanism, and the pointer structure moves forward one grid in the pointer moving accommodation window with the movement of the ejector rod, and the number indicated by the pointer structure changes accordingly. For example: the number indicated by the original pointer structure is 2, a staple is ejected from the first implanting mechanism, and the pointer structure moves forward in the pointer moving accommodation window with the movement of the ejector rod One grid, the number indicated by the pointer structure changes to 3, to indicate that 3 staples have been discharged.

In some embodiments of the present invention, the cartilage fixator further includes a nail box and a nail box replacement assembly. Referring to FIGS. 4. The nail box replacement assembly includes a push handle moving storage window and a nail box push rod 121, the push handle moving storage window runs through the main housing 1 of the stapler, and one end of the nail box push rod 121 is vertical A push handle 122 is provided, and the other end of the nail box push rod 121 passes through the first through hole structure 14 and extends into the first implant mechanism 2 to connect with the nail box 5 , the push handle 122 passes through the moving storage window of the push handle and can move in the moving storage window of the push handle; that is, by pushing the push handle 122, it moves in the moving storage window of the push handle, thereby driving the nail box push rod 121 moves toward the direction of the first implanting mechanism 2 to push the nail cartridge 5 out of the first implanting mechanism 2 , so as to realize the replacement of the nail cartridge 5 .

In some specific embodiments of the present invention, the moving receiving window of the push handle is arranged on the second casing.

In some embodiments of the present invention, with reference to Fig. 3, Fig. 7 and Fig. 8, the connecting end 123 of the nail box push rod 121 connected with the nail box 5 is provided with an external thread, and the inner wall of the nail box 5 is provided with a The internal thread adapted to the external thread, the connecting end 123 of the nail box 5 and the nail box push rod 121 is connected by thread, so that the nail box is fixed more firmly and stably, which can effectively prevent the nail box from falling, and easy to replace.

In some embodiments of the present invention, referring to Fig. 2-8, the nail box push rod 121 is movably arranged on the main housing 1 of the nail fixer, and the side wall of the nail box push rod 121 is provided with a chute, so The ejector rod 111 is movable in the chute, and the nail box push rod 121 and the ejector rod 111 pass through the first through hole structure 14 and extend into the first implantation mechanism, which is beneficial to the structure The integration makes the overall structure of the nail fixer compact and reduces the overall volume of the main shell of the nail fixer.

In some embodiments of the present invention, the brake mechanism includes a brake assembly and a brake lever. Referring to FIGS. 3-8 , the brake assembly includes a trigger 131 and a connecting shaft 132. Through-hole structure, the connecting shaft 132 is fixedly passed through the through-hole structure, the trigger 131 is fixedly connected with the brake lever 134, the trigger 131 is movably installed on the main body shell 1, and the user can pass through the The trigger 131 is pulled or released like a pistol to effect ejection of the staples. In some specific embodiments of the present invention, the trigger 131 and the brake lever 134 are integrally structured.

In some embodiments of the present invention, referring to FIGS. 3-8 , the clamping drive mechanism includes a driven rod 141 , the driven rod 141 is movably arranged in the main housing 1 , and one end of the driven rod 141 part is the brake part 142, the brake rod 134 overlaps with the brake part 142 of the driven rod 141, and the other end of the driven rod 141 passes through the second through hole structure 15 and is connected to the second through hole structure 15. The second implant mechanism 3 is connected and fixed, and the brake lever 134 is driven to press or release the brake part 142 of the driven lever 141 through the rotation of the brake assembly, so that the slave The other end of the moving rod 141 drives the second implant mechanism 3 to move toward or away from the first implant mechanism 2, so that the second implant mechanism 3 and the first implant mechanism 2 are clamped. tight or separated. Specifically, by artificially pulling the trigger 131, while allowing it to rotate through the rotating fulcrum, that is, the connecting shaft 132, the braking lever 134 is in contact with the braking portion 142 in the driven lever 141, so that The other end of the driven rod 141 drives the second implant mechanism 3 to move toward the first implant mechanism 2, so as to achieve the purpose of clamping the cartilage and its soft tissue mucous membrane; , while allowing it to reversely rotate through the fulcrum of rotation, that is, the connecting shaft 132, the braking lever 134 is not in contact with the braking portion 142 in the driven lever 141, so that the other end of the driven lever 141 Drive the second implant mechanism 3 to move away from the first implant mechanism 2, so as to achieve the purpose of releasing the cartilage and its soft tissue mucosa. In this embodiment, the overlap means that the brake lever 134 and the driven lever 141 overlap each other to a certain extent.

In some embodiments of the present invention, the nail ejection drive mechanism includes a braking gear assembly, a traction assembly and a nail ejection assembly, the braking assembly is connected to the braking gear assembly, and the traction assembly is connected to the braking assembly respectively. The gear assembly is connected with the nail row assembly, and the brake gear assembly is driven to move by the rotation of the brake assembly, so that the brake gear assembly drives the nail row assembly to move through the traction assembly to move the Staples are ejected from the first implantation mechanism to effect ejection of staples from the first implantation mechanism.

In some embodiments of the present invention, the traction assembly includes a traction wire and a traction wire fixing assembly, both ends of the traction wire are respectively fixed to the brake gear assembly, and the traction wire is fixed by the traction wire fixing assembly An annular structure is formed so as to drive the staple row assembly repeatedly in multiple cycles to discharge the staples from the first implanting mechanism.

Fig. 10 is a schematic diagram of partial structural assembly of the cartilage fixator according to the embodiment of the present invention.

In some embodiments of the present invention, the nail stripping assembly is arranged on the first implant mechanism. Referring to FIGS. Described track 152 is arranged on the top of described nail box support 153, and described track top plate 154 is connected with described nail box support 153 and forms the guide rail that communicates with described track 152, and described push plate 151 is fixedly connected with pulling wire 171, The traction wire 171 drives the push plate 151 to move in the track 152 and the guide rail, so that the push plate 151 is pressed against the head of the staple and the staple is moved from the first planting nail. The push plate 151 is driven to move by the traction wire 171 every time the brake mechanism is triggered to push out a staple to be implanted into the wound.

In some embodiments of the present invention, referring to FIGS. 7-9 , the track top plate 154 is arranged on an open end of the nail box bracket 153, and the track top plate 154 is detachably connected to the nail box bracket 153, so as to Easy to change the nail box.

In some embodiments of the present invention, the thickness of the push plate is less than or equal to the width of the head of the staple, so that each time the braking device is triggered, only one staple will be implanted into the wound, The next staple will be pushed by the ejection system to the nail-out end of the first implant mechanism; when more staples are needed for suturing, the braking mechanism will be triggered again, and the next implant will be implanted. Multiple individual staples are inserted sequentially so that the cartilage does not tear during closure. In the embodiment of the present invention, the width of the head of the staple is the maximum length of the head of the staple in a direction perpendicular to the direction in which the push plate abuts against the head of the staple.

In some embodiments of the present invention, the brake gear assembly includes a brake gear, a first gear row assembly and a second gear row assembly, the brake gear is connected to the brake assembly, and the first gear row assembly The second tooth row assembly is opposite to the symmetrical end of the brake gear, one end of the pulling wire is connected and fixed to the first tooth row assembly, and the other end of the pulling wire is connected to the second tooth row assembly. The row assembly is connected and fixed, so that the traction assembly is driven to move by the braking gear assembly, so as to drive the staple row assembly to move to discharge the staples from the first implanting mechanism.

Specifically, referring to FIGS. 3-7 , the braking gear 161 is passed through and fixed to the engaging slot 133 through the connecting shaft 132 , and rotates with the rotation of the trigger 131 . The first tooth row assembly includes a first tooth row 162 and a first tooth row fixing bracket 163, the second tooth row assembly includes a second tooth row 164 and a second tooth row fixing bracket 165, and the first tooth row The fixing bracket 163 and the second row of teeth fixing bracket 165 are fixedly arranged in the main housing 1, the first row of teeth 162 is fixedly connected with the fixing bracket 163 of the first row of teeth, and the second row of teeth 164 is fixedly connected with the second gear row fixing bracket 165, and the gear part of the first gear row 162 is opposite to the gear part of the second gear row 164 and is symmetrical to that of the braking gear 161. One end of the pulling wire 171 is connected and fixed to the first row of teeth 162 , and the other end of the pulling wire 171 is connected and fixed to the second row of teeth 164 . In some specific embodiments of the present invention, the first row of teeth fixing bracket 163 and the second row of teeth fixing bracket 165 are respectively connected to the inner walls of the first housing 11 and the second housing 12 by buckling. Fixed connection. Specifically, the trigger 131 is connected to the braking gear 161 through the action of the locking slot 133, and the braking gear 161 rotates with the movement of the trigger 131 by manually pulling the trigger 131. Thereby driving the first row of teeth 162 and the second row of teeth 164 to move, so as to drive the pulling wire 171 and the push plate 151 on the pulling wire 171 to move between the track 152 and the track 152. The guide rail moves according to a fixed trajectory, so that the active end of the push plate 151 abuts one of the staples and pushes the staple into a predetermined position in the nasal cavity of the human body.

In some embodiments of the present invention, referring to FIGS. 3-10 , the drawing wire fixing assembly includes a drawing wire fixing plate 172 and a plurality of drawing wire pulleys 173, the drawing wire fixing plate 172 and the nail box bracket 153 are connected and fixed and set In the first implant mechanism 2, a symmetrical end surface of the drawing wire fixing plate 172 and the nail box bracket 153 is provided with a drawing wire installation groove 174, and the drawing wire pulley 173 is arranged on the fixed nail The inner wall of the main housing 1 of the device, the drawing wire 171 is fixed by several drawing wire pulleys 173, the drawing wire fixing plate 172 and the nail box bracket 153 to form an annular structure, specifically, the drawing wire 171 moves around several said drawing wire pulleys 173, the drawing wire installation groove 174 on one end surface of said drawing wire fixing plate 172, the drawing wire installation groove 174 on one end surface of said nail box bracket 153, the said nail box The drawing wire installation groove 174 on the other symmetrical end surface of the bracket 153 , the drawing wire installation groove 174 on the other symmetrical end surface of the drawing wire fixing plate 172 , and several drawing wire pulleys 173 form an annular structure.

In some embodiments of the present invention, referring to FIG. 8 and FIG. 9 , the first implant mechanism 2 includes an implant bracket 21, and the implant bracket 21, the pulling wire fixing plate 172 and the nail box bracket 153 are all It is a cavity structure, the pulling wire fixing plate 172 and the nail box bracket 153 are fixedly arranged in the cavity structure of the implant bracket 21, and the nail box bracket 153 is detachably fixedly connected to the nail box 5, That is, the nail box 5 is arranged in the cavity structure of the nail box bracket 153, which is beneficial to structural integration, makes the overall structure of the nail fixer compact, and reduces the overall volume of the first implanting mechanism. Specifically, the nail box push rod 121 passes through the drawing wire fixing plate 172 and is connected to the nail box 5, the ejector rod 111 is arranged in the chute of the nail box push rod 121, and passes through in turn. Pass through the drawing wire fixing plate 172 and the nail box 5 to resist against the top block 113 slidably arranged in the nail box 5 .

In some specific embodiments of the present invention, referring to FIG. 10 , the drawing wire fixing plate 172 and the nail box bracket 153 are fixedly connected by a buckle.

In some embodiments of the present invention, referring to FIG. 9 , the staple cartridge 5 includes a staple cartridge accommodating chamber and a staple chute 51 for the staples to slide. Specifically, referring to FIG. 7 and FIG. 8 , the staple set 4 and the top block 113 are arranged in the nail box storage cavity, and the ejector rod 111 pushes the staple set 4 through the top block 113 Move in the staple chute 51 . The staples are stored in the staple box to perform nasal septal cartilage surgery, which can effectively prevent accidental displacement of nail heads.

In some embodiments of the present invention, a fully degradable cartilage fixation system is also provided, including a suture nail and the cartilage fixer, and the suture nail is set in the first implantation mechanism of the cartilage fixer.

In some embodiments of the present invention, the staples are made of absorbable and degradable materials. Specifically, the absorbable and degradable material includes polyglycolic acid (PGA) or polylactide (PLA), or is made of polyglycolic acid (PGA) and polylactide (PLA) as components of a copolymer. In order to increase the degradation rate of polylactide (PLA), adding polylactide (PLA) to polyglycolic acid (PGA) to form a copolymer material can accelerate the liquid absorption of staples, thereby accelerating the degradation time of staples.

In some embodiments of the present invention, the biodegradable material includes a polyester biodegradable material and an active ingredient, and the active ingredient includes at least one of a surfactant and a bioactive glass,

The polyester-based biodegradable material includes a blending modification component, and the blending modification component includes at least one of polyglycolic acid, glycolide, caprolactone, lactide, and polyethylene glycol.

Specifically, using the principle of bioactive glass degradation, the cations released by the bioactive glass will form a layer of bone carbonate hydroxyapatite on the surface of the biodegradable material during degradation, which can protect the surface of the material body in a short-term Increase the mechanical properties of the composite material of bioactive glass and polyester biodegradable materials in a short period of time, so that it can maintain more than 50% of the initial tensile strength within a week, so as to meet the clinical needs of continuous mechanical properties of the material; The surfactant can enhance the hydrophilicity of the biodegradable material, promote the entry of nutrients, so as to promote the regeneration of the tissue sutured with the biodegradable material.

In some embodiments of the present invention, the active ingredient is composed of at least one of surfactant and bioactive glass.

In some specific embodiments of the present invention, the active ingredient is a surfactant, and the content of the surfactant is less than or equal to 15% based on the total mass percentage of the polyester biodegradable material.

In other specific embodiments of the present invention, the active ingredient is bioactive glass, and the content of the bioactive glass is less than or equal to 40% based on the total mass percentage of the polyester biodegradable material.

In still some specific embodiments of the present invention, the active ingredient is composed of a surfactant and bioactive glass. In terms of the total mass percentage of the polyester biodegradable material, the content of the surfactant and the bioactive glass The sum of the contents of the active glass is less than or equal to 40%, and the content of the surfactant is less than or equal to 15%.

In some embodiments of the present invention, the active ingredient is a surfactant, or the active ingredient is composed of a surfactant and bioactive glass, in terms of the total mass percentage of the polyester biodegradable material, the surface The content of the active agent is less than or equal to 5%.

In some embodiments of the present invention, the equivalent particle size of the bioactive glass is less than 45 microns, so that the bioactive glass is easily fused into polyester biodegradable materials.

In some embodiments of the present invention, based on the total mass percentage of the polyester biodegradable material, the content of the blended modification component is 5-95%, which is conducive to improving the degradability of the biodegradable material. Controllability.

In some embodiments of the present invention, the polyester biodegradable material also includes any one of polylactic acid, polyglycolide, polycaprolactone, polydioxanone and polytrimethylene carbonate . Specifically, the polylactic acid includes any one of L-polylactic acid, racemic polylactic acid, L-polylactic acid and D-polylactic acid.

Polyglycolic acid (PGA), also known as polyglycolic acid, is derived from the alpha-hydroxy acid, glycolic acid. Glycolic acid is produced by the normal human body during metabolism. Polyglycolic acid is a synthetic polymer material with good biodegradability and biocompatibility. Unlike traditional polymer materials with stable performance, such as plastics and rubber, polyglycolic acid is used as a material after a certain period of time. Gradually degrade and eventually turn into water and carbon dioxide that are harmless to human body, animals, plants and natural environment. The application of polyglycolic acid is mainly manifested in two aspects of biomedicine and ecology. The biomedical applications of polyglycolic acid are mainly manifested in medical sutures, drug controlled release carriers, fracture fixation materials, tissue engineering scaffolds, and suture reinforcement materials.

Polylactic acid, also known as polylactide (PLA), belongs to the polyester family. Polylactic acid is a polymer obtained by polymerization of lactic acid as the main raw material. The source of raw materials is sufficient and can be regenerated. It mainly uses corn and cassava as raw materials. Polylactic acid has good biodegradability. After use, it can be completely degraded by microorganisms in nature under specific conditions, and finally produces carbon dioxide and water without polluting the environment. This is very beneficial to protecting the environment and is recognized as an environmentally friendly material.

Polycaprolactone (Polycaprolactone, PCL, CAS No.: 24980-41-4), also known as polyε-caprolactone, is formed by ring-opening polymerization of ε-caprolactone monomer under the catalysis of metal anion complex catalyst High-molecular organic polymers can obtain different molecular weights by controlling the polymerization conditions. Its appearance is white solid powder, non-toxic, insoluble in water, soluble in many polar organic solvents. PCL has good biocompatibility, good organic polymer compatibility, and good biodegradability. It can be used as a cell growth support material and is compatible with a variety of conventional plastics. 6-12 in the natural environment Months can be completely degraded.

Specifically, based on the total mass percentage of the polyester-based biodegradable material, the content of the blended modification component is 5-95%, and the balance of the polyester-based biodegradable material is the polylactic acid , the content of any one of the polyethylene lactide, the polycaprolactone, the polydioxanone and the polytrimethylene carbonate, that is, the polyester biodegradable 5-95% of the total mass percentage of the material is the blending modification component, and the remaining content is the polylactic acid, the polyglycolide, the polycaprolactone, the polydioxane Any one content in hexanone and described polytrimethylene carbonate.

In some embodiments of the present invention, the surfactant is a polyoxyethylene polyoxypropylene ether triblock copolymer, which has good compatibility with the skin, increases skin permeability, and can promote the absorption of externally applied agents.

Specifically, the general formula of the polyoxyethylene polyoxypropylene ether triblock copolymer is HO(C ₂ H ₄ O)a(C ₃ H ₆ O)b(C ₂ H ₄ O)cH. Where a and c are 2-130, b is 15-67. The content of polyoxyethylene is 81.8±1.9%. Soluble in water or ethanol, soluble in absolute ethanol, ethyl acetate, chloroform, almost insoluble in ether or petroleum ether, with certain foaming properties. The pH value of 2.5% aqueous solution is between 5.0 and 7.5, and the pH value for injection is between 6.0 and 7.0. The aqueous solution is relatively stable in the air, and the pH value will drop when exposed to light. This product is stable to acid-base aqueous solution and metal ions.

In some embodiments of the present invention, the polyoxyethylene polyoxypropylene ether triblock copolymer is any one of F127, L61, L64, F68, P85, P94, P104, P105, P123, L121 and L122. Theoretically, there can be countless kinds of compounds with such basic structures. The NF standard stipulates that their molecular weights range from 1,000 to 7,000 or more. An appropriate amount of polyoxypropylene and an appropriate amount of polyoxyethylene are copolymerized into compounds with different lipophilic and water balance values.

In some embodiments of the present invention, the bioactive glass includes any one of silicate glass, glass ceramics and borate-based glass, which helps to promote the production of growth factors, promote the reproduction of cells, and enhance the Gene expression and growth of bone tissue, resulting in good biocompatibility and minimal tissue response.

In some specific embodiments of the present invention, the silicate glass includes 45S5 bioactive glass, the glass ceramics includes S53P4 bioactive glass, and the borate-based glass includes 19-93B3 bioactive glass. 45S5 bioactive glass, composed of 24.5wt% _Na2O , 24.5wt% CaO, _6.0wt % _P2O5 and 45wt% _SiO2 , 45S means 45% mass fraction of _SiO2 , 5 means Ca The molar ratio of P and P is 5:1.

In some embodiments of the present invention, the weight average molecular weight of the polyester biodegradable material is 5000-80000 Daltons.

In some embodiments of the present invention, the staple includes a nail body, and a nail-in portion and a nail cap portion respectively arranged at both ends of the nail body, and the nail cap portion is arranged perpendicular to the nail body so that the The entry part can easily pass through implanted cartilage and other tissues, and the nail cap can stably fix cartilage and other tissues.

In some embodiments of the present invention, the staple is integrally formed.

In some embodiments of the present invention, a groove is provided on the end surface of the nail cap part against the push plate, so that when the push plate pushes the staple to move, the push plate can hold against the groove Pushing, with a strong point, it is easier to push.

In some embodiments of the present invention, the nut part is any one of an I-shaped structure, a circular structure and a cross-shaped structure, that is, the upper surface of the nut part is an I-shaped structure, a circular structure or a cross-shaped structure. any of the structures. The nail cap of the circular structure and the nail cap of the cross-shaped structure have a large area of action surface, so that the fixation area between the nail cap and cartilage and other tissues is larger, and the fixation is firmer. The I-shaped structure is a cuboid structure or a cylindrical structure.

In some embodiments of the present invention, the nail-in portion is any one of a hook-shaped structure and a tapered structure. The nailing part of the hook-shaped structure is suitable for tissues such as cartilage of different thicknesses, and has greater versatility; the nailing part of the tapered structure is suitable for scenarios where the area of remaining cartilage and other tissues is small, and when the area of cartilage and other tissues is small Effective fixation can also be achieved.

In some embodiments of the present invention, the nail-in portion of the hook-shaped structure is provided with at least one hook body, and one end of the hook body is fixedly arranged at the working end of the nail-in portion.

In some embodiments of the present invention, the total axial length of the staple is 2-5 mm, the axial length of the nail body is 1.5-3.5 mm, and the radial length of the nail body is 0.3-0.8 mm, so The maximum length of the radially acting surface of the nut part is 1.2-3mm, and the maximum width of the radially acting surface of the nut part is 0.4-1mm.

In the embodiment of the present invention, the axial length is the length along the direction in which the nail body extends, the radial length is the length in the direction perpendicular to the direction in which the nail body extends, and the diameter of the nail cap The acting surface is the upper surface of the nut portion in a direction perpendicular to the direction in which the nail body extends.

Fig. 11 is a schematic structural view of the staple according to the first embodiment of the present invention.

In some specific embodiments of the present invention, referring to FIG. 8 and FIG. 11 , the first staple 100 includes a first I-shaped nail cap portion 101, a hook-shaped nailing portion 102 and a first nail body 103, and the first I-shaped staple The nail cap portion 101 and the hook-shaped nailing portion 102 are arranged at both ends of the first nail body 103, and the upper surface of the first I-shaped nail cap portion 101 is provided with a groove 104, and the groove 104 and The push plate 151 is adapted so that the push plate 151 can resist the groove 104 and push the first staple 100 to move. Specifically, the first I-shaped nail cap portion 101 has a rectangular parallelepiped structure.

Fig. 12 is a schematic structural view of the staple in the second embodiment of the present invention.

In some specific embodiments of the present invention, referring to FIG. 12 , the second staple 200 includes a second I-shaped nail cap portion 201, a first tapered nail-in portion 202 and a second nail body 203, and the second I-shaped staple The cap portion 201 and the first conical nailing portion 202 are disposed at both ends of the second nail body 203 , specifically, the second I-shaped nail cap portion 201 is in a cylindrical structure.

Fig. 13 is a schematic structural view of a staple in a third embodiment of the present invention.

In some specific embodiments of the present invention, referring to FIG. 13 , the third staple 300 includes a circular nail cap portion 301, a second tapered nail penetration portion 302 and a third nail body 303, and the circular nail cap portion 301 and The second tapered nailing portion 302 is disposed on two ends of the third nail body 303 .

Fig. 14 is a schematic structural view of a staple in a fourth embodiment of the present invention.

In some specific embodiments of the present invention, referring to FIG. 14 , the fourth staple 400 includes a first cross-shaped nail cap portion 401 , a single hook-shaped nail-in portion 402 and a fourth nail body 403 , and the first cross-shaped nail cap The part 401 and the single hook-shaped nailing part 402 are arranged at both ends of the fourth nail body 403 .

Fig. 15 is a schematic structural view of a staple in a fifth embodiment of the present invention.

In some specific embodiments of the present invention, with reference to FIG. 15 , the fifth staple 500 includes a second cross-shaped nail cap portion 501, a four-hook nail-in portion 502 and a fifth nail body 503, and the second cross-shaped nail cap part 501 and the four-hook-shaped nailing part 502 are arranged at both ends of the fifth nail body 503, the four-hook-shaped nailing part 502 includes four hook bodies, and one end of the four hook bodies is fixedly arranged on The working end of the four-hook-shaped nailing part 502 .

Fig. 16 is a front view of the staple shown in Fig. 11; Fig. 17 is a right view of the staple shown in Fig. 11 .

In some specific embodiments of the present invention, referring to Fig. 16 and Fig. 17, the total axial length L1 of the first staple 100 is 2-5mm, and the axial length L2 of the first staple body 103 is 1.5-3.5mm , the radial length W1 of the first nail body 103 is 0.3-0.8 mm, the maximum length W2 of the radial action surface of the first I-shaped nail cap portion 101 is 1.2-3 mm, and the first I-shaped nail The maximum width W3 of the radially acting surface of the cap portion 101 is 0.4-1 mm.

In Example 1-6 of the present invention, the polyester biodegradable material in the biodegradable material is composed of polyglycolic acid (PGA) and polylactic acid (PLA), and the polyglycolic acid (PGA) is added to the polyglycolic acid (PGA). In lactic acid (PLA), it is possible to control the liquid absorption of the biodegradable material, thereby controlling the degradation time of the staple; the active ingredient includes at least one of a surfactant and a bioactive glass, wherein the surface The active agent is F127 surfactant, and the bioactive glass is 45S5 bioactive glass; the active ingredient and the polyester biodegradable material are prepared into the biodegradable material by melt blending, and then the The biodegradable material is prepared into the staple by methods such as extrusion, compression or injection molding.

Specifically, please refer to Table 1 for the content wt% of each component in the proportions of Examples 1-6 of the present invention based on the total mass percentage of the polyester biodegradable material.

Table 1

In Examples 1-6 of the present invention, taking Example 1 as an example, the weight of the polyester biodegradable material in the biodegradable material is 100g, that is, the polyglycolic acid (PGA) and the polylactic acid The total weight of (PLA) is 100g, wherein the polyglycolic acid (PGA) accounts for 95wt% of the total mass percentage of the polyester biodegradable material, then the weight of the polyglycolic acid (PGA) is 95g, and the polyglycolic acid (PGA) Lactic acid (PLA) accounts for 5wt% of the total mass percentage of the polyester biodegradable material, then the weight of the polyglycolic acid (PGA) is 5g, and the F127 surfactant accounts for the total mass of the polyester biodegradable material Percentage of 5wt%, then the weight of the F127 surfactant is 5g, and the 45S5 bioactive glass accounts for 5wt% of the total mass percentage of the polyester biodegradable material, then the weight of the 45S5 bioactive glass is 5g.

In Examples 1-6 of the present invention, the staples prepared according to the ratio in Table 1 were prepared in the following manner:

Each staple sample prepared is weighed, wherein, the total axial length of the staple is 5 mm, and the maximum length of the radially acting surface of the cap part is 3 mm, and is recorded as Wo, and then the sample is Soak in 1mL tissue culture water (Sigma Aldrich, China) for 1 day, 3 days, 7 days, 14 days and 21 days (n=9) respectively. According to the requirements of GB/T16886-Part 12, each sample was stored in a 10mL polypropylene tube, kept in a shaking water bath at 37°C (electric constant temperature water bath, Shanghai Boxun), and stirred at 2HZ (longitudinal movement). After each incubation period, the non-degraded part of the staples was gently removed with sterile forceps, and the leached single extract solution was filtered using a 0.2 micron sterile filter (Thermo Fisher Scientific, China). Then, 0.5ml of each filtrate was diluted with tissue culture water to obtain 5ml extract, and stored at 4°C for future in vitro evaluation.

In the embodiment of the present invention 1-6, the sample that makes is carried out mass loss test:

After each incubation period, the cement was blotted dry, and the weight of each sample was recorded as Wt (n=3). Then the staple samples were collected in a 48-well plate, dried at 37°C for 24 hours, and the mass of the staple sample was measured as Wd, and the mass loss (m) of the staple was determined with the culture time by using the following formula:

m(%)=[(Wo-Wd)/Wo]×100%

Among them: Wo is the initial mass of the sample, Wd is the mass of the degraded sample after drying at 37 °C for 24 h; m is the mass loss of the sample, assuming that there is no mass loss during the drying process.

Specifically, please refer to Table 2 for the mass loss (m) of the staples in Examples 1-6 of the present invention as a function of culture days.

Table 2 shows the mass loss measurements for the staple samples of Examples 1-6 over the 3-day, 7-day, 14-day and 21-day incubation periods. As can be seen from Table 2, the mass loss of the staples of Examples 1-6 during the 1-21 day culture period is between 3.15%-46.9%; And the mass loss of Example 6 even only has more than 30%, it can be seen that adding at least one of the F127 surfactant and the 45S5 bioactive glass in the polyglycolic acid (PGA) and the polylactic acid (PLA) The suturing nails made in this way can fully support the suturing nails until the operation site is fully healed and then degrade, and the F127 surfactant is added to the polyglycolic acid (PGA) and the polylactic acid (PLA) at the same time Agent and the 45S5 bioactive glass, or adding more of the 45S5 bioactive glass, makes the staple degrade within 4 to 8 weeks, which is beneficial to the closure of the wound at the surgical site.

Table 2

In the embodiment of the present invention 1-6, the sample that makes is carried out mechanical performance test:

During sample preparation for extracts, after each incubation period, unincubated staple samples and freshly removed wet staples (n = 3) were tested on a universal testing machine, uniaxial tensile In the grip on the machine (2710-100 series screw side-moving grip), use a 10N sensor; measure the length of the staple, which is recorded as L1, and the width of the contact surface is marked as W2 and W3; the cross traction speed is 10mm/ min, Young's modulus is calculated from the stress-strain curve generated during the test.

Fig. 18 is a schematic diagram of the tensile elastic modulus of the staples prepared according to the ratio of Example 1 according to the present invention. The schematic diagram of the change curve of elastic modulus with time; Fig. 20 is a schematic diagram of the change curve of tensile elastic modulus with time of the suture nail prepared according to the ratio of Example 3; Fig. 21 is a schematic diagram of the change curve of the staple according to Example 4 A schematic diagram of the change curve of the tensile elastic modulus over time of the suture staple prepared by proportioning; FIG. 22 is a schematic diagram of the change curve of the tensile elastic modulus over time of the suture staple prepared according to the proportion of Example 5 in the present invention; Fig. 23 is a schematic diagram of the change curve of the tensile elastic modulus with time of the staple prepared according to the ratio of Example 6 of the present invention.

Referring to Figures 18-23, the staples prepared in Examples 1-3, Example 5 and Example 6 all have a Young's modulus greater than 20 MPa after 21 days of cultivation, and can maintain 50 MPa in one week. % of the initial tensile strength, which greatly meets the clinical needs of continuous mechanical properties of the material.

In the embodiment of the present invention 1-6, carry out cytotoxicity evaluation according to standard ISO 10993-5, specifically include:

(1) The staple finger prepared in Examples 1-6 was dissected and the extract was incubated to incubate L929 cells: L929 cells passaged 7 times were used for MTT detection. Cell count and viability were detected by trypan blue staining and hemocytometer. The positive control of cells is cells plus culture medium and the experimental wells of the 24-well plate are inoculated with a cell density of 1×10 ⁴ /ml. The culture medium was only used as a negative control. The dishes were then incubated in a cell culture incubator at 37°C (5% CO ₂ /95% air atmosphere) for 24 hours. After 24 hours, 100 μl of sterile tissue culture water was added to the control wells. 100 μl of relevant experimental extracts (n=3) (extracts prepared according to the sample preparation steps) were added to corresponding wells for detection. The dishes were then incubated again for 24 hours in a cell culture incubator at 37°C (5% CO ₂ /95% air atmosphere).

(2) Carry out MTT assay: after culturing for 24 hours, each well was incubated with 10% MTT of medium volume (100 μl). The dish was then returned to the incubator for 3 hours. After incubation, add MTT booster solution to each well in a volume equal to the volume of the original culture medium (1ml). To enhance dissolution of crystals, each well was titrated with a pipette, and then the absorbance of each well was measured spectrophotometrically at a wavelength of 570 nm (TriStar LB 941, Berthold Technologies, USA). Assuming 100% metabolic activity of the cells in the control wells, the percent metabolic activity of the cells exposed to the experimental extracts was calculated from this. The results were analyzed by T contrast method, and there was a significant difference at p<0.05.

table 3

Table 3 shows the MTT assay cell activity of the staple samples of Examples 1-6 during the 1-day, 3-day, 7-day, 14-day and 21-day culture periods. As can be seen from Table 3, the staples of Examples 1-6 can all meet the requirements of GB/T16886 on the cytotoxicity of medical devices. It can be seen that the biodegradable material of the present invention and the biodegradable material made of the biodegradable material of the present invention The obtained staple has good biocompatibility and little tissue reaction.

The septal cartilage is usually 2-4 mm thick and is covered on both sides with a layer of mucous membrane called periosteum. Imagine a piece of sausage sandwiched between two thin slices of bread. The sausage is the cartilage and the bread is the mucous membrane. The purpose of septal cartilage surgery is to carefully lift the mucous membrane dura on both sides from the septum, remove the deviated part, and then clip everything together. The current treatment process of septal cartilage surgery is as follows:

Step S1: Perform a half incision on the mucosal inner layer on the side of the cartilage;

Step S2: Lift the mucous dura from the septal cartilage on one side using a Cato or Freer lifter;

Step S3: Immediately cut the septum in front of the deviation with a manual instrument, and peel off the mucosal lining of the septum from the cartilage of the septum on the other side;

Step S4: Physically remove the deflected part of the cartilage, the maxillary crest can be removed with a chisel;

Step S5: granulating (e.g., hammering to remove "memory") time-lapsed cartilage and replacing;

Step S6: The mucoperiosteum is reapproximated to the midline using sutures or nasal packing.

If the fully degradable cartilage fixation system of the present invention is used for treatment in the case of rhinoplasty surgery (NRS) and endoscopic sinus surgery (ESS), usually NRS is followed by ESS. A treatment method using a fully degradable cartilage fixation system, comprising the steps of:

Step S11: Place the disposable nail box containing the staples in the nail box bracket of the cartilage fixer, and connect the nail box with the nail box push rod, so as to prevent the nail caps of the staples from moving accidentally bit;

Step S12: inserting the first implanting mechanism and the second implanting mechanism of the cartilage fixator into the two nostrils of the patient respectively so that the first implanting mechanism and the second implanting mechanism receive and hold the cartilage , adjusting the position of the nail outlet end of the first implantation mechanism according to the position required for suturing, so as to ensure that the cartilage fixator is correctly placed for effective suturing;

Step S13: before the staples are officially ejected for suturing, gently pull the trigger to make the first implanting mechanism and the second implanting mechanism of the cartilage fixer flush with the spacer;

Step S14: Pull the trigger and release it immediately, neither too fast nor too slow, imagine the best effect of using a common stapler on a stack of papers;

Step S15: After a single implant nail is implanted, the implantation direction of the next staple is adjusted by adjusting the positions of the first implant mechanism and the second implant mechanism, and after the cartilage fixator is deployed, the Make sure the cartilage fixator head has been loosened before moving;

Wherein, in order to ensure proper placement, each staple must pass through at least two of the three tissue layers, including the right mucosa, septal cartilage and left mucosa.

Although the embodiments of the present invention have been described in detail above, it will be apparent to those skilled in the art that various modifications and changes can be made to the embodiments. However, it should be understood that such modifications and changes are within the scope and spirit of the present invention described in the claims. Furthermore, the invention described herein is capable of other embodiments and of being practiced or carried out in various ways.

Claims

A cartilage fixator, characterized in that it includes an implant system, a drive system and an ejection system;

The implant system includes a first implant mechanism and a second implant mechanism, the first implant mechanism is opposite to the second implant mechanism, and the first implant mechanism and the second implant mechanism The body divider is configured to receive the patient's cartilage;

The driving mechanism includes a braking mechanism, a clamping driving mechanism and a nail ejection driving mechanism, the braking mechanism is respectively connected with the clamping driving mechanism and the nail ejection driving mechanism, and the clamping driving mechanism is connected with the nail ejection driving mechanism. The second implanting mechanism is connected, the brake mechanism drives the clamping driving mechanism to drive the second implanting mechanism to move toward or away from the first implanting mechanism, and the nail ejection driving mechanism is connected to the first implanting mechanism. an implantation mechanism coupled, the brake mechanism actuating the staple ejection drive mechanism to eject staples from the first implantation mechanism;

One end of the ejection system abuts a set of staples, and the ejection system drives the set of staples toward an ejection end of the first implantation mechanism after ejection of staples in the first implantation mechanism.
The cartilage fixator according to claim 1, wherein the ejection system comprises a push rod, a spring and a push block, one end of the spring abuts against the fixing member, and the other end of the spring abuts against the push One end of the rod, one end of the top block abuts against the other end of the push rod, and the other end of the top block abuts against the staple set.
The cartilage fixator according to claim 2, wherein the ejection system further comprises a pointer structure and a digital indicating part, and the digital indicating part includes a moving receiving window for the pointer passing through the main shell of the nail fixer and a number of numerals arranged on the outer wall of the main shell of the nail fixer, the pointer structure is vertically arranged with the ejector rod, the pointer structure passes through the pointer movement accommodation window, and the pointer structure follows The movement of the ejector rod moves in the moving accommodation window of the pointer and points to the digital mark.
The cartilage fixator according to claim 1, wherein the brake mechanism includes a brake assembly and a brake lever, the brake assembly and the brake lever are fixedly connected, and the clamping drive mechanism includes The driven rod, the braking rod is overlapped with the braking part of the driven rod, the other end of the driven rod is connected and fixed with the second implant mechanism, and the brake assembly is rotated to driving the braking lever to press or release the braking part of the driven lever, so that the other end of the driven lever drives the second implant mechanism toward or away from the first implant Into the institutional movement.
The cartilage fixator according to claim 1, wherein the brake mechanism includes a brake assembly, the nail ejection drive mechanism includes a brake gear assembly, a traction assembly and a nail ejector assembly, and the brake assembly is compatible with The brake gear assembly is connected, the traction assembly is respectively connected with the brake gear assembly and the nail row assembly, and the brake gear assembly is driven to move by the rotation of the brake assembly, so that the brake The gear assembly drives the staple ejection assembly to move through the traction assembly to eject the staples from the first implanting mechanism.
The cartilage fixator according to claim 1, further comprising a nail box and a nail box replacement assembly, the nail box is arranged on the first implant mechanism to contain staples, and the nail box replacement assembly includes The push handle moves the storage window and the nail box push rod. The push handle moves the storage window through the main housing of the nail fixer. One end of the nail box push rod is vertically provided with a push handle. The other end is connected with the nail box, and the push handle passes through the push handle moving accommodation window and moves in the push handle moving accommodation window.
The cartilage fixator according to claim 5, wherein the traction assembly includes a traction wire and a traction wire fixing assembly, both ends of the traction wire are respectively fixed to the braking gear assembly, and the traction wire The ring structure is formed by fixing the drawing wire fixing assembly.
The cartilage fixator according to claim 7, wherein the nail row assembly is arranged on the first implant mechanism, the nail row assembly includes a push plate, a track, a nail box bracket, and a track top plate, and the The track is arranged on the top of the nail box support, the track top plate is connected with the nail box support to form a guide rail communicating with the track, the push plate is fixedly connected with the traction wire, and the traction wire drives the The push plate moves in the track and the guide rail, so that the push plate abuts against the head of the staple to expel the staple from the first implanting mechanism.
The cartilage fixator according to claim 8, wherein the thickness of the push plate is less than or equal to the thickness of the head of the staple.
The cartilage fixator according to claim 7, wherein the brake gear assembly comprises a brake gear, a first rack assembly and a second rack assembly, and the brake gear is connected to the brake assembly , the first gear row assembly and the second gear row assembly are arranged opposite to the symmetrical end of the brake gear, one end of the pulling wire is connected and fixed to the first gear row assembly, and the pulling wire The other end is connected and fixed with the second rack assembly.
The cartilage fixator according to claim 6, wherein the connecting end of the nail box push rod connected to the nail box is provided with an external thread, and the inner wall of the nail box is provided with a thread that is adapted to the external thread. The internal thread of the nail box and the connecting end of the nail box push rod are connected and fixed by thread.
The cartilage fixator according to claim 8, wherein the track top plate is arranged at an open end of the nail box bracket, and the track top plate is detachably connected to the nail box bracket.
The cartilage fixator according to claim 8, wherein the pulling wire fixing assembly includes a pulling wire fixing plate and a plurality of pulling wire pulleys, the pulling wire fixing plate is connected and fixed to the nail box bracket and is arranged on the In the first implantation mechanism, a symmetrical end surface of the drawing wire fixing plate and the nail box bracket is provided with a drawing wire installation groove, and the drawing wire pulley is arranged on the inner wall of the main housing of the nail fixer , the drawing wire is fixed by several drawing wire pulleys, the drawing wire fixing plate and the nail box bracket to form an annular structure.
The cartilage fixator according to claim 13, wherein the first implant mechanism comprises an implant bracket, and the implant bracket, the traction wire fixing plate and the nail box bracket are all cavity structures The pulling wire fixing plate and the nail box bracket are fixedly arranged in the cavity structure of the implant bracket, and the nail box bracket is detachably fixedly connected to the nail box.
The cartilage fixator according to claim 6, wherein the nail box push rod is movably arranged on the main housing of the nail fixer, and the side wall of the nail box push rod is provided with a chute, the The ejector rod is movable in the chute.
The cartilage fixator according to claim 15, wherein the main housing of the nail fixer includes a first through-hole structure and a second through-hole structure, and the driven rod in the clamping drive mechanism is set movably In the main casing of the stapler and through the second through hole structure, the first implanting mechanism is fixedly connected to the main casing of the stapler, and the first implanting mechanism The open end is butt-connected with the first through-hole structure, and the nail cartridge push rod and the ejector rod pass through the first through-hole structure and extend into the first implantation mechanism.
The cartilage fixator according to claim 6, wherein the nail box comprises a nail box storage chamber and a staple chute for sliding the staples.
A fully degradable cartilage fixation system, characterized in that it comprises a suture nail and the cartilage fixator according to any one of claims 1-17, the suture nail is arranged in the first implantation mechanism of the cartilage fixator .
The fully degradable cartilage fixation system according to claim 18, wherein the staples are made of absorbable and degradable materials.
The fully degradable cartilage fixation system according to claim 18, characterized in that, the staple includes a nail body, and a nail-in portion and a nail cap portion respectively arranged at two ends of the nail body, and the nail cap portion is connected to the nail cap portion. The nail body is set vertically.
The fully degradable cartilage fixation system according to claim 20, characterized in that a groove is provided on the end surface of the nail cap part against the push plate.
The fully degradable cartilage fixation system according to claim 20, characterized in that, the cap portion is any one of an I-shaped structure, a circular structure and a cross-shaped structure.
The fully degradable cartilage fixation system according to claim 20, wherein the nail-in portion is any one of a hook-shaped structure and a tapered structure.
The fully degradable cartilage fixation system according to claim 23, wherein the nail-in portion of the hook-shaped structure is provided with at least one hook body, and one end of the hook body is fixedly arranged on the working end of the nail-in portion .
The fully degradable cartilage fixation system according to claim 20, wherein the total axial length of the staple is 2-5 mm, the axial length of the nail body is 1.5-3.5 mm, and the axial length of the nail body is 1.5-3.5 mm. The radial length is 0.3-0.8mm, the maximum length of the radially acting surface of the nut part is 1.2-3mm, and the maximum width of the radially acting surface of the nut part is 0.4-1mm.
The fully degradable cartilage fixation system according to claim 19, wherein the biodegradable material comprises a polyester biodegradable material and an active component, and the active component comprises at least one of a surfactant and a bioactive glass kind;

Based on the total mass percentage of the polyester biodegradable material, the content of the active ingredient is less than or equal to 40%, and the content of the surfactant is less than or equal to 15%;

The polyester-based biodegradable material includes a blending modification component, and the blending modification component includes at least one of polyglycolic acid, glycolide, caprolactone, lactide, and polyethylene glycol.
The fully degradable cartilage fixation system according to claim 26, wherein the equivalent particle diameter of the bioactive glass is less than 45 microns.
The fully degradable cartilage fixation system according to claim 26, characterized in that, based on the total mass percentage of the polyester biodegradable material, the content of the blended modification component is 5-95%.
The fully degradable cartilage fixation system according to claim 26, wherein the polyester biodegradable material also includes polylactic acid, polyglycolide, polycaprolactone, polydioxanone and poly Any of the trimethylene carbonates.
The fully degradable cartilage fixation system according to claim 26, wherein the bioactive glass comprises any one of silicate glass, glass ceramics and borate-based glass.
The fully degradable cartilage fixation system according to claim 26, wherein the surfactant is polyoxyethylene polyoxypropylene ether triblock copolymer.
The fully degradable cartilage fixation system according to claim 31, wherein the polyoxyethylene polyoxypropylene ether triblock copolymer is F127, L61, L64, F68, P85, P94, P104, P105, P123, Either of L121 and L122.
The fully degradable cartilage fixation system according to claim 26, wherein the weight average molecular weight of the polyester biodegradable material is 5000-80000 Daltons.