WO2023010909A1 - 软骨固定器及全降解软骨固定*** - Google Patents
软骨固定器及全降解软骨固定*** Download PDFInfo
- Publication number
- WO2023010909A1 WO2023010909A1 PCT/CN2022/089876 CN2022089876W WO2023010909A1 WO 2023010909 A1 WO2023010909 A1 WO 2023010909A1 CN 2022089876 W CN2022089876 W CN 2022089876W WO 2023010909 A1 WO2023010909 A1 WO 2023010909A1
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- Prior art keywords
- nail
- cartilage
- assembly
- staple
- implant
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/06—At least partially resorbable materials
- A61L17/10—At least partially resorbable materials containing macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/06—At least partially resorbable materials
- A61L17/10—At least partially resorbable materials containing macromolecular materials
- A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
Definitions
- the invention relates to the technical field of medical devices, in particular to a cartilage fixer and a fully degradable cartilage fixation system.
- the septal cartilage is usually 2-4 mm thick and is covered on both sides with a layer of mucous membrane called periosteum.
- periosteum a layer of 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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
- 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
- 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.
- 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.
- the ejection system further includes a pointer structure and a digital indicating part
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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.
- 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.
- 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
- 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 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.
- 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.
- the connecting end of the nail box push rod connected to the nail box is provided with an external thread
- the inner wall of the nail box is provided with an internal thread adapted to the external thread
- the nail box and the The connecting end of the nail box push rod is connected and fixed by threading.
- 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.
- 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.
- 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 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 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
- the nail cartridge push rod and the ejector rod pass through the first through hole structure and extend into the first implantation mechanism.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- the nail cap The maximum length of the radially acting surface of the nut part is 1.2-3mm
- the maximum width of the radially acting surface of the nut part is 0.4-1mm.
- 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 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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FIG. 5 is a schematic left view of the internal structure of 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. 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. 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.
- the embodiment of the present invention provides a cartilage fixator, including 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 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.
- 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 .
- 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.
- the main casing 1 is in the shape of a pistol.
- the first housing 11 and the second housing 12 are fixedly connected by screws 13 .
- first housing 11 and the second housing 12 are fixedly connected by clamping or riveting.
- 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 .
- 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.
- 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.
- 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 .
- 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 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
- 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.
- the pointer movement accommodating window 116 and the number marks 117 are arranged on the first housing 11 .
- 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.
- 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
- the cartilage fixator further includes a nail box and a nail box replacement assembly.
- 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 .
- the moving receiving window of the push handle is arranged on the second casing.
- the connecting end 123 of the nail box push rod 121 connected with the nail box 5 is provided with an external thread
- 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.
- 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.
- the brake mechanism includes a brake assembly and a brake lever.
- 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.
- the trigger 131 and the brake lever 134 are integrally structured.
- 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.
- 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.
- the overlap means that the brake lever 134 and the driven lever 141 overlap each other to a certain extent.
- 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.
- 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.
- the nail stripping assembly is arranged on the first implant mechanism.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 .
- 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.
- 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.
- 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.
- 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 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.
- 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 .
- the drawing wire fixing plate 172 and the nail box bracket 153 are fixedly connected by a buckle.
- the staple cartridge 5 includes a staple cartridge accommodating chamber and a staple chute 51 for the staples to slide.
- 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.
- a fully degradable cartilage fixation system including a suture nail and the cartilage fixer, and the suture nail is set in the first implantation mechanism of the cartilage fixer.
- the staples are made of absorbable and degradable materials.
- 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.
- PGA polyglycolic acid
- PLA polyglycolic acid
- PLA polyglycolic acid
- PLA polylactide
- 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 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 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.
- the active ingredient is composed of at least one of surfactant and bioactive glass.
- the active ingredient is a surfactant
- the content of the surfactant is less than or equal to 15% based on the total mass percentage of the polyester biodegradable material.
- the active ingredient is bioactive glass
- the content of the bioactive glass is less than or equal to 40% based on the total mass percentage of the polyester biodegradable material.
- the active ingredient is composed of a surfactant and bioactive glass.
- 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%.
- 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%.
- 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.
- the content of the blended modification component is 5-95%, which is conducive to improving the degradability of the biodegradable material. Controllability.
- the polyester biodegradable material also includes any one of polylactic acid, polyglycolide, polycaprolactone, polydioxanone and polytrimethylene carbonate .
- the polylactic acid includes any one of L-polylactic acid, racemic polylactic acid, L-polylactic acid and D-polylactic acid.
- Polyglycolic acid 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 poly ⁇ -caprolactone, is formed by ring-opening polymerization of ⁇ -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.
- 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.
- 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.
- the polyoxyethylene polyoxypropylene ether triblock copolymer is any one of F127, L61, L64, F68, P85, P94, P104, P105, P123, L121 and L122.
- 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.
- 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.
- the silicate glass includes 45S5 bioactive glass
- the glass ceramics includes S53P4 bioactive glass
- 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.
- the weight average molecular weight of the polyester biodegradable material is 5000-80000 Daltons.
- 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.
- the staple is integrally formed.
- 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.
- 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.
- 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.
- 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.
- 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
- the maximum length of the radially acting surface of the nut part is 1.2-3mm
- the maximum width of the radially acting surface of the nut part is 0.4-1mm.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 .
- 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.
- 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).
- the active ingredient includes at least one of a surfactant and a bioactive glass, wherein the surface
- the active agent is F127 surfactant
- 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.
- 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
- tissue culture water Sigma Aldrich, China
- 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).
- 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.
- 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.
- the mass loss of the staples of Examples 1-6 during the 1-21 day culture period is between 3.15%-46.9%;
- 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.
- 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.
- 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
- 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.
- 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.
- cytotoxicity evaluation according to standard ISO 10993-5 specifically include:
- 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 ⁇ l of sterile tissue culture water was added to the control wells.
- 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.
- 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.
- septal cartilage is usually 2-4 mm thick and is covered on both sides with a layer of mucous membrane called periosteum.
- periosteum a layer of 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.
- 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;
- each staple 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.
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Abstract
一种软骨固定器,包括植入***、驱动***和顶出***,植入***包括第一植入机构(2)和第二植入机构(3),驱动机构包括制动机构,夹紧驱动机构和钉排出驱动机构,制动机构驱动夹紧驱动机构以带动第二植入机构(3)朝向或远离第一植入机构(2)运动,制动机构驱动钉排出驱动机构已从第一植入机构(2)中排出缝合钉,以实现快速缝合;顶出***的一端抵持缝合钉组,第一植入机构(2)中排出缝合钉之后顶出***驱使缝合钉组朝向第一植入机构的出钉端运动,使得能通过调整第一植入机构(2)和第二植入机构(3)的位置而调整下一颗缝合钉的植入方向,达到缝合钉精准植入的目的。一种全降解软骨固定***也被提及。
Description
交叉引用
本申请要求2021年7月31日提交的申请号为202110876783.X和202110878032.1的中国专利申请的优先权。上述申请的内容以引用方式被包含于此。
本发明涉及医疗器械技术领域,尤其涉及一种软骨固定器及全降解软骨固定***。
鼻中隔软骨通常有2-4毫米厚,两侧覆盖着一层叫做粘周骨膜的粘膜,想象两片薄面包之间夹着一片腊肠,大腊肠是鼻中隔软骨,面包是粘膜。鼻中隔软骨成形术是耳鼻喉科医生进行的第三种最常见的外科手术,鼻中隔手术的目的是小心地将两边的黏液膜硬膜从隔膜上抬高,移除偏离的部分,然后把所有的东西夹在一起。这种手术是为了缓解鼻塞,鼻塞通常是由于鼻子中间的组织弯曲造成的。目前完成鼻中隔成形术的技术包括双侧提起软骨膜下皮瓣,切除软骨和/或骨头的偏移部分。随着时间的推移,通过移除软骨切除术后潜在的死腔来防止室间隔血肿的技术已经发展。传统手术中一般采用石油纱布填充鼻子,目前使用缝合线将粘膜重新缝合在一起已经成为首选的方法。鼻中隔软骨缝合可以使用一个普通的肠道直针缝合,也可以使用可吸收缝合线,例如采用Vicryl.5进行缝合,但是这两种缝合方式具有一定的局限性,特别是在一个狭窄的鼻子,针迹缝合所需的时间可能少至4分钟,或多至20分钟,如果下鼻甲距离较近,由于取线的约束太紧,常导致鼻甲撕裂;过程中需要移除缝合片段以重新开始,缝合线可能会断裂,导致软骨形成疤痕带;在最坏的情况下,针可能会断裂和丢失,需要放射学来帮助残余定位。总的来说,鼻中隔软骨成形术 技术包括在手术中放置简单的夹板和缝合线来缝合鼻中隔软骨皮瓣,然而,即使是最有经验的外科医生,在狭窄而深的鼻道范围内缝合也是一项艰巨而费时的任务。
通常用的外科吻合器操作简单,需要较少的专业知识,节省时间,但是通常用的外科吻合器,触发制动装置一次,所有的缝合钉是一起被植入,存在不能调整缝合钉的植入方向,缝合钉植入不精准的问题。
公开号为US7438208B2的美国专利公开了一种间隔缝合装置,包括具有近端部分和远端部分的器械主体,远端部分处的手柄使用户能够保持和操纵器械主体,一对间隔开的臂从手柄延伸并且包括钉臂和张紧臂,主体包括一个触发器,可以在静止位置和射击位置之间移动,致动器连杆在第一和第二位置之间移动,致动器连杆通过触发器移动,其中致动器连杆包括附接到钉臂的钉移动构件,订书钉臂具有包括多个订书钉的订书钉组,触发器、致动器连杆、订书钉组和订书钉移动构件被配置成当触发器被拉动时将订书钉移动到订书钉位置,扣动扳机时,订书钉臂和张紧臂一起移动。但该专利的结构无法判断出钉盒中的缝合钉的数量;而且钉盒的固定方法可能会有钉盒掉落的风险,且不易更换。而目前,国家大力提倡减少一次性使用医疗器械来减少手术费用,固定钉盒的无菌需求,使得不需要一次性使用的定钉器也成为一次性产品,浪费资源增加污染。
因此,有必要提供一种新型的软骨固定器及全降解软骨固定***以解决现有技术中存在的上述问题。
发明概要
本发明的目的在于提供一种软骨固定器及全降解软骨固定***,以实现在软骨手术中能快速缝合连接内部组织和两侧的软组织,以及在单颗植入钉植入之后,通过调整所述第一植入机构和所述第二植入机构的位置而调整下一颗缝合钉的植入方向,达到缝合钉精准植入的目的。
为实现上述目的,本发明的所述软骨固定器,包括植入***、驱动***和顶出***;
所述植入***包括第一植入机构和第二植入机构,所述第一植入机构与所述第二植入机构相对设置且所述第一植入机构与所述第二植入机构分隔设置以接纳患者的软骨;
所述驱动机构包括制动机构、夹紧驱动机构和钉排出驱动机构,所述制动机构分别与所述夹紧驱动机构和所述钉排出驱动机构连接,所述夹紧驱动机构与所述第二植入机构连接,所述制动机构驱动所述夹紧驱动机构以带动所述第二植入机构朝向或远离所述第一植入机构运动,所述钉排出驱动机构与所述第一植入机构连接,所述制动机构驱动所述钉排出驱动机构以从所述第一植入机构中排出缝合钉;
所述顶出***的一端抵持缝合钉组,所述第一植入机构中排出缝合钉之后所述顶出***驱使所述缝合钉组朝向所述第一植入机构的出钉端运动。
本发明的所述软骨固定器的有益效果在于:通过所述植入***包括第一植入机构和第二植入机构,所述第一植入机构与所述第二植入机构相对设置且所述第一植入机构与所述第二植入机构分隔设置以接纳患者的软骨,所述驱动机构包括制动机构、夹紧驱动机构和钉排出驱动机构,所述制动机构分别与所述夹紧驱动机构和所述钉排出驱动机构连接,所述夹紧驱动机构与所述第二植入机构连接,所述制动机构驱动所述夹紧驱动机构以带动所述第二植入机构朝向或远离所述第一植入机构运动,所述钉排出驱动机构与所述第一植入机构连接,所述制动机构驱动所述钉排出驱动机构以从所述第一植入机构中排出缝合钉,即所述第一植入机构和所述第二植入机构可以分别从左右鼻腔***,再通过排出缝合钉进行点固定,使得实现了在软骨手术中能快速缝合连接内部组织和两侧的软组织,与缝合线比较,节省时间,减少水肿,而且相对缝合线,缝合钉缝合固定更紧密,使得术后创口能自然愈合,不需要额外的夹板或填充物,提 高患者术后舒适度,以及减少术后并发症,有利于帮助愈合,所述植入***能够在软骨皮瓣边缘操作,并修复撕裂;通过所述顶出***的一端抵住缝合钉组,所述第一植入机构中排出缝合钉之后所述顶出***驱使所述缝合钉组朝向所述第一植入机构的出钉端运动,单钉触发机制,使得软骨闭合过程中不会撕裂,而且可以在单颗植入钉植入之后,通过调整所述第一植入机构和所述第二植入机构的位置而调整下一颗缝合钉的植入方向,达到实现缝合钉精准植入的目的,可以使软骨粘膜的撕裂重新接近缝合,并对软骨穿孔的修复有额外的好处,从而得到更均匀的闭合。
可选的,所述顶出***包括顶杆、弹簧和顶块,所述弹簧的一端抵接固定件,所述弹簧的另一端抵接所述顶杆的一端,所述顶块的一端抵接所述顶杆的另一端,所述顶块的另一端抵持所述缝合钉组。其有益效果在于:以使得所述缝合钉排出一个,便可利用所述弹簧的弹力通过推动所述顶杆和所述顶块而自动推动所述缝合钉组朝向所述第一植入机构的出钉端运动,全自动控制,简单方便,有利于保证缝合钉排出的顺畅性。
可选的,所述顶出***还包括指针结构和数字指示部,所述数字指示部包括贯穿所述定钉器的主壳体的指针移动收容窗和设置于所述定钉器的主壳体的外壁的若干数字标号,所述指针结构与所述顶杆垂直设置,所述指针结构穿过所述指针移动收容窗,且所述指针结构随所述顶杆的运动而在所述指针移动收容窗中移动并指向所述数字标号。其有益效果在于:即利用主壳体上设置的数字标号来表示缝合钉的排出数量,简单明了,能轻松明确的知道手术中缝合钉的植入数量以及钉盒中的缝合钉剩余的数量,以方便及时更换钉盒。
可选的,所述制动机构包括制动组件和制动杆,所述制动组件和所述制动杆固定连接,所述夹紧驱动机构包括从动杆,所述制动杆与所述从动杆的制动部搭接,所述从动杆的一端部与所述第二植入机构连接固定,通过所述制动组件转动而带动所述制动杆压住或放开所述从动杆的所述制动部,从而使所述从动杆的另一端部带动所述第二植入机构朝向或远离所述第一植入机构运动。其 有益效果在于:以使所述第二植入机构与所述第一植入机构实现夹紧或分隔。
可选的,所述制动机构包括制动组件,所述钉排出驱动机构包括制动齿轮组件、牵引组件和排钉组件,所述制动组件与所述制动齿轮组件连接,所述牵引组件分别与所述制动齿轮组件和所述排钉组件连接,通过所述制动组件转动而带动所述制动齿轮组件运动,使所述制动齿轮组件通过所述牵引组件带动所述排钉组件运动以将所述缝合钉从所述第一植入机构中排出。其有益效果在于:以实现从所述第一植入机构中排出缝合钉。
可选的,所述软骨固定器还包括钉盒和钉盒替换组件,所述钉盒设置于所述第一植入机构以盛装缝合钉,所述钉盒替换组件包括推柄移动收容窗和钉盒推杆,所述推柄移动收容窗贯穿所述定钉器的主壳体,所述钉盒推杆的一端垂直设置有推柄,所述钉盒推杆的另一端与所述钉盒连接,所述推柄穿过所述推柄移动收容窗且在所述推柄移动收容窗中移动。其有益效果在于:即通过推动推柄使其在所述推柄移动收容窗中移动,从而带动所述钉盒推杆朝向所述第一植入机构的方向运动,以将所述钉盒从所述第一植入机构中推出,从而实现钉盒的替换。
可选的,所述牵引组件包括牵引丝和牵引丝固定组件,所述牵引丝的两端分别与所述制动齿轮组件固定,且所述牵引丝通过所述牵引丝固定组件固定形成环形结构。其有益效果在于:以实现能多次循环重复带动所述排钉组件运动而将所述缝合钉从所述第一植入机构中排出。
可选的,所述排钉组件设置于所述第一植入机构,所述排钉组件包括推板、轨道、钉盒支架、轨道顶板,所述轨道设置于所述钉盒支架的顶部,所述轨道顶板与所述钉盒支架连接形成与所述轨道相通的导轨,所述推板与所述牵引丝固定连接,所述牵引丝带动所述推板于所述轨道和所述导轨中移动,以使所述推板抵持所述缝合钉的头部而使所述缝合钉从所述第一植入机构中排出。其有益效果在于:使得每一次触发制动机构时,通过所述牵引丝带动所述推板运动 以推出一颗缝合钉植入创口。
可选的,所述推板的厚度小于或等于所述缝合钉的头部的宽度。其有益效果在于:使得每一次触发制动装置时,只一颗缝合钉会被植入创口,而在钉盒中的下一个缝合钉会被所述顶出***推送到所述第一植入机构的出钉端;当需要更多的缝合钉缝合时,就再次触发制动机构,植入下一颗植入缝合钉,多个单独的缝合钉依次植入,使得软骨闭合过程中不会撕裂。
可选的,所述制动齿轮组件包括制动齿轮、第一齿排组件和第二齿排组件,所述制动齿轮与所述制动组件连接,所述第一齿排组件和所述第二齿排组件相对设置于所述制动齿轮的对称端,所述牵引丝的一端与所述第一齿排组件连接固定,所述牵引丝的另一端与所述第二齿排组件连接固定。其有益效果在于:使得通过所述制动齿轮组件驱动所述牵引组件运动,以实现带动所述排钉组件运动以将所述缝合钉从所述第一植入机构中排出。
可选的,所述钉盒推杆与所述钉盒连接的连接端设有外螺纹,所述钉盒的内壁设有与所述外螺纹适配的内螺纹,所述钉盒和所述钉盒推杆的连接端通过螺纹方式连接固定。其有益效果在于:使得钉盒固定更为牢固稳定,能有效防止钉盒掉落,且通过螺纹方式连接使得所述钉盒和所述钉盒推杆实现了可拆卸连接,容易更换所述钉盒。
可选的,所述轨道顶板设置于所述钉盒支架的一开口端,且所述轨道顶板与所述钉盒支架为可拆卸连接。其有益效果在于:方便更换钉盒。
可选的,所述牵引丝固定组件包括牵引丝固定板和若干牵引丝滑轮,所述牵引丝固定板和所述钉盒支架连接固定且设置于所述第一植入机构内,所述牵引丝固定板和所述钉盒支架的一对称端面均设置有牵引丝安装槽,所述牵引丝滑轮设置于所述定钉器的主壳体的内壁,所述牵引丝通过若干所述牵引丝滑轮、所述牵引丝固定板和所述钉盒支架固定以形成环形结构。
可选的,所述第一植入机构包括植入支架,所述植入支架、所述牵引丝固 定板和所述钉盒支架均为腔体结构,所述牵引丝固定板和所述钉盒支架固定设置于所述植入支架的所述腔体结构中,所述钉盒支架可拆卸固定连接钉盒。其有益效果在于:有利于结构集成,使得该定钉器整体结构紧凑,减小了所述第一植入机构的整体体积。
可选的,所述钉盒推杆活动设置于所述定钉器的主壳体,所述钉盒推杆的侧壁设置有滑槽,所述滑槽内活动设置顶杆。有益效果在于:有利于结构集成,使得该定钉器整体结构紧凑,减小了所述定钉器的主壳体的整体体积。
可选的,所述定钉器的主壳体包括第一贯穿孔结构和第二贯穿孔结构,所述夹紧驱动机构中的从动杆活动设置于所述定钉器的主壳体内且穿过所述第二贯穿孔结构,所述第一植入机构与所述定钉器的主壳体固定连接,且所述第一植入机构的开口端与所述第一贯穿孔结构对接连通,所述钉盒推杆和所述顶杆穿过所述第一贯穿孔结构并伸入所述第一植入机构中。
可选的,所述钉盒包括钉盒收纳腔和供所述缝合钉滑行的缝合钉滑槽。有益效果在于:所述缝合钉收纳于所述钉盒中以进行鼻中隔软骨手术,能有效防止钉头意外移位。
可选的,本发明还提供一种全降解软骨固定***,包括缝合钉和所述的软骨固定器,所述缝合钉设置于所述软骨固定器的第一植入机构中。
本发明的所述全降解软骨固定***的有益效果在于:通过包括缝合钉和所述的软骨固定器,所述缝合钉设置于所述软骨固定器的第一植入机构中,使得通过软骨固定器可以将缝合钉钉入贯穿软骨的粘膜双层,或者进一步贯穿在粘膜层之间的软骨,使得缝合钉能近距离拉动粘膜层,防止血肿的形成,实现了在鼻中隔软骨手术中能快速缝合连接内部组织和两侧的软组织,与缝合线比较,采用所述全降解软骨固定***进行缝合能节省时间,减少水肿,而且相对缝合线缝合固定更紧密,使得术后创口能自然愈合,不需要额外的夹板或填充物,提高患者术后舒适度,以及减少术后并发症,有利于帮助愈合。
可选的,所述缝合钉采用可吸收降解材料制作而成。其有益效果在于:使得缝合钉植入物的降解产物可以通过正常生理途径消化,提供一个均匀的闭合。
可选的,所述缝合钉包括钉身、以及分别设置在所述钉身两端的钉入部和钉帽部,所述钉帽部与所述钉身垂直设置。其有益效果在于:使得通过所述钉入部可以轻松的穿过植入软骨等组织,通过钉帽部能稳定地固定软骨等组织,使得可以通过软骨固定器将缝合钉植入贯穿鼻中隔软骨的双层粘膜,或者进一步贯穿在粘膜层之间的软骨,使得缝合钉能近距离拉动粘膜层,防止血肿的形成,实现了在鼻中隔手术中能快速缝合连接内部组织和两侧的软组织,与缝合线比较,软骨固定器配合缝合钉进行缝合节省时间,减少水肿,而且相对缝合线缝合固定更紧密,使得术后创口能自然愈合,不需要额外的夹板或填充物,提高患者术后舒适度,以及减少术后并发症,有利于帮助愈合。
可选的,所述钉帽部与推板抵持的端面设有凹槽。其有益效果在于:使得所述推板在推动所述缝合钉运动时,所述推板能抵持着所述凹槽推动,有着力点,更容易推动。
可选的,所述钉帽部为I形结构、圆形结构和十字形结构中的任意一种。其有益效果在于:使得所述钉帽部能稳定地固定软骨等组织。
可选的,所述钉入部为钩形结构和锥形结构中的任意一种。其有益效果在于:使得通过所述钉入部可以轻松的穿过植入软骨等组织。
进一步可选的,所述钩形结构的钉入部设有至少1个钩体,且所述钩体的一端固定设置于所述钉入部的作用端。
可选的,所述缝合钉的总轴向长度为2-5mm,所述钉身的轴向长度为1.5-3.5mm,所述钉身的径向长度为0.3-0.8mm,所述钉帽部的径向作用面的最大长度为1.2-3mm,所述钉帽部的径向作用面的最大宽度为0.4-1mm。其有益效果在于:使得通过所述钉入部可以轻松的穿过植入软骨等组织,通过钉帽部能稳定地固定软骨等组织等,且具有较好的机械性能。
可选的,所述生物可降解材料包括聚酯类生物降解材料和活性成分,所述活性成分包括表面活性剂和生物活性玻璃中的至少一种;
以占所述聚酯类生物降解材料的总质量百分比计,所述活性成分的含量小于等于40%,所述表面活性剂的含量小于等于15%;
所述聚酯类生物降解材料包括共混改性成分,所述共混改性成分包括聚羟基乙酸、乙交酯、己内酯、丙交酯、聚乙二醇中的至少一种。其有益效果在于:使得通过生物活性玻璃的降解产物能够促进生长因子的生成、促进细胞的繁衍、增强成骨细胞的基因表达和骨组织的生长,使得生物相容性好,组织反应小,同时可以提高生物可降解材料的机械强度和韧性,且其本身具有较好的生物相容性和可降解性,通过表面活性剂增加了材料的机械性能和降解的可控性,使得所述生物可降解材料在具备降解性能的同时还具有良好的机械性能;通过以占所述聚酯类生物降解材料的总质量百分比计,所述活性成分的含量小于等于40%,所述表面活性剂的含量小于等于15%,有利于提升所述生物可降解材料的生物活性,生物相容性,机械性能和降解的可控性。
可选的,所述生物活性玻璃的等效粒径小于45微米。其有益效果在于:使得所述生物活性玻璃易于融合在聚酯类生物降解材料中。
可选的,以占所述聚酯类生物降解材料的总质量百分比计,所述共混改性成分的含量为5-95%。其有益效果在于:有利于提升生物可降解材料的可降解性能的可控性。
可选的,所述聚酯类生物降解材料还包括聚乳酸、聚乙丙交酯、聚己内酯、聚对二氧环己酮和聚三亚甲基碳酸酯中的任意一种。其有益效果在于:使得所述生物可降解材料的可降解性能好,且降解产物的生物相容性好。
可选的,所述生物活性玻璃包括硅酸盐玻璃、玻璃陶瓷和硼酸盐基玻璃中的任意一种。其有益效果在于:有助于促进生长因子的生成、促进细胞的繁衍、增强成骨细胞的基因表达和骨组织的生长,使得生物相容性好,组织反应小。
可选的,所述表面活性剂为聚氧乙烯聚氧丙烯醚三嵌段共聚物。其有益效果在于:与皮肤相溶性佳,增加皮肤通透性,可促进外用药剂的吸收。
可选的,所述聚氧乙烯聚氧丙烯醚三嵌段共聚物为F127、L61、L64、F68、P85、P94、P104、P105、P123、L121和L122中的任意一种。其有益效果在于:与皮肤相溶性佳,增加皮肤通透性,可促进外用药剂的吸收。
可选的,所述聚酯类生物降解材料的重均分子量为5000-80000道尔顿。其有益效果在于:提供所需的机械性能和降解时间。
图1为本发明实施例的软骨固定器的结构图;
图2为对图1所示的软骨固定器的部分结构分解后形成的结构示意图;
图3为本发明实施例的软骨固定器的***图;
图4为本发明实施例的软骨固定器的内部结构右视示意图;
图5为本发明实施例的软骨固定器的内部结构左视示意图;
图6为本发明实施例的软骨固定器中驱动机构的装配右视示意图;
图7为本发明实施例的软骨固定器中驱动机构的装配左视示意图;
图8为本发明实施例的软骨固定器中的第一植入机构的内部结构的装配示意图;
图9为本发明实施例的软骨固定器中的第一植入机构的内部结构的***图;
图10为本发明实施例的软骨固定器的部分结构装配示意图;
图11为本发明第一种实施例的缝合钉的结构示意图;
图12为本发明第二种实施例的缝合钉的结构示意图;
图13为本发明第三种实施例的缝合钉的结构示意图;
图14为本发明第四种实施例的缝合钉的结构示意图;
图15为本发明第五种实施例的缝合钉的结构示意图;
图16为图11所示的缝合钉的主视图;
图17为图11所示的缝合钉的右视图;
图18为本发明按实施例1的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;
图19为本发明按实施例2的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;
图20为本发明按实施例3的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;
图21为本发明按实施例4的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;
图22为本发明按实施例5的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;
图23为本发明按实施例6的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图。
发明内容
为使本发明实施例的目的、技术方案和优点更加清楚,下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。除非另外定义,此处使用的技术术语或者科学术语应当为本发明所属领域内具有一般技能的人士所理解的通常意义。本文中使用的“包括”等类似的词语意指出现该词前面的元件或者物件涵盖出现在该词后面列举的元件或者物件及其等同,而不排除其他元件或者物件。
为克服现有技术中存在的问题,本发明实施例提供了软骨固定器,包括植入***、驱动***和顶出***;
所述植入***包括第一植入机构和第二植入机构,所述第一植入机构与所述第二植入机构相对设置且所述第一植入机构与所述第二植入机构分隔设置以接纳患者的软骨;
所述驱动机构包括制动机构、夹紧驱动机构和钉排出驱动机构,所述制动机构分别与所述夹紧驱动机构和所述钉排出驱动机构连接,所述夹紧驱动机构与所述第二植入机构连接,所述制动机构驱动所述夹紧驱动机构以带动所述第二植入机构朝向或远离所述第一植入机构运动,所述钉排出驱动机构与所述第一植入机构连接,所述制动机构驱动所述钉排出驱动机构以从所述第一植入机构中排出缝合钉;
所述顶出***的一端抵持缝合钉组,所述第一植入机构中排出缝合钉之后所述顶出***驱使所述缝合钉组朝向所述第一植入机构的出钉端运动。
软骨固定器的工作机制是当每一次触发制动机构时,只一颗缝合钉会被植入创口,而在钉盒中的下一个缝合钉会被推送到所述第一植入机构的出钉端;当需要更多的植入钉时,就再次触发制动机构,植入下一颗缝合钉。
本发明一些实施例中,所述软骨为鼻中隔软骨。
图1为本发明实施例的软骨固定器的结构图;图2为对图1所示的软骨固定器部分结构分解后形成的结构示意图;图3为本发明实施例的软骨固定器的***图。
本发明一些实施例中,参考图1、图2和图3,所述定钉器包括主壳体1、第一植入机构2和第二植入机构3,所述主壳体1包括第一壳体11和第二壳体12,所述第一壳体11和所述第二壳体12固定连接。本发明一些具体实施例中,所述主壳体1呈***形结构。
本发明一些具体实施例中,参考图3,所述第一壳体11和所述第二壳体12通过螺钉13固定连接。
本发明另一些具体实施例中,所述第一壳体11和所述第二壳体12通过卡 接方式或铆接方式等固定连接。
本发明一些实施例中,参考图1和图2,所述主壳体1包括第一贯穿孔结构14和第二贯穿孔结构15,所述第一植入机构2与所述定钉器的主壳体1固定连接,且所述第一植入机构2的开口端与所述第一贯穿孔结构14对接连通。本发明一些具体实施例中,所述第一贯穿孔结构14和所述第二贯穿孔结构15分隔设置,以避免穿过所述第一贯穿孔结构14和所述第二贯穿孔结构15的部件相互碰撞摩擦而影响使用。
图4为本发明实施例的软骨固定器的内部结构右视示意图;图5为本发明实施例的软骨固定器的内部结构左视示意图;图6为本发明实施例的软骨固定器中驱动机构的装配右视示意图;图7为本发明实施例的软骨固定器中驱动机构的装配左视示意图;图8为本发明实施例的软骨固定器中的第一植入机构的内部结构的装配示意图;图9为本发明实施例的软骨固定器中的第一植入机构的内部结构的***图。
本发明一些实施例中,参考图3-9,顶杆111、弹簧112和顶块113构成了所述顶出***,所述弹簧112的一端抵接固定件(图中未示出),所述弹簧112的另一端抵接所述顶杆111的一端,所述顶块113的一端抵接所述顶杆111的另一端,所述顶块113的另一端穿过所述第一贯穿孔结构14并伸入所述第一植入机构2中抵持所述缝合钉组4,以使得所述缝合钉组4排出一个缝合钉,便可利用所述弹簧112的弹力通过推动所述顶杆111和所述顶块113而自动推动所述缝合钉组4朝向所述第一植入机构2的出钉端运动,全自动控制,简单方便,有利于保证缝合钉排出的顺畅性。本发明的一些具体实施例中,所述固定件包括弹簧腔114,所述弹簧112活动设置于所述弹簧腔114内,且一端与所述弹簧腔114的底部抵持,以使所述弹簧112能在所述弹簧腔114的底部和所述顶杆111之间实现收缩和伸长。
本发明一些实施例中,参考图3、图5、图6-8,指针结构115和数字指示 部构成了所述顶出***,所述数字指示部包括贯穿所述主壳体1的指针移动收容窗116和设置于所述主壳体1的外壁的若干数字标号117,所述指针结构115与所述顶杆111垂直设置,所述指针结构115穿过所述指针移动收容窗116,且所述指针结构115随所述顶杆111的运动而在所述指针移动收容窗116中移动并指向所述数字标号117,即利用主壳体上设置的数字标号117来表示缝合钉的排出数量,简单明了,能轻松明确的知道手术中缝合钉的植入数量。本发明一些具体实施例中,所述指针移动收容窗116和所述若干数字标号117设置于所述第一壳体11。
具体的,所述数字标号按1、2、3、4等***数字的顺序从远离所述第一植入机构到靠近所述第一植入机构的方向依次递增排列,所述第一植入机构中排出一个缝合钉,所述指针结构随所述顶杆的运动而在所述指针移动收容窗中向前移动一格,所述指针结构指示的数字标号随之变化。比如:原所述指针结构指示的数字标号为2,所述第一植入机构中排出一个缝合钉,所述指针结构随所述顶杆的运动而在所述指针移动收容窗中向前移动一格,所述指针结构指示的数字标号变为3,以表示已排出3个缝合钉。
本发明一些实施例中,所述软骨固定器还包括钉盒和钉盒替换组件,参考图3-9,所述钉盒5设置于所述第一植入机构2以盛装所述缝合钉组4,所述钉盒替换组件包括推柄移动收容窗和钉盒推杆121,所述推柄移动收容窗贯穿所述定钉器的主壳体1,所述钉盒推杆121的一端垂直设置有推柄122,所述钉盒推杆121的另一端穿过所述第一贯穿孔结构14并伸入所述第一植入机构2中与所述钉盒5连接,所述推柄122穿过所述推柄移动收容窗且可在所述推柄移动收容窗中移动;即通过推动所述推柄122使其在所述推柄移动收容窗中移动,从而带动所述钉盒推杆121朝向所述第一植入机构2的方向运动,以将所述钉盒5从所述第一植入机构2中推出,从而实现钉盒5的替换。
本发明一些具体实施例中,所述推柄移动收容窗设置于所述第二壳体。
本发明一些实施例中,参考图3、图7和图8,所述钉盒推杆121与所述钉盒5连接的连接端123设有外螺纹,所述钉盒5的内壁设有与所述外螺纹适配的内螺纹,所述钉盒5和所述钉盒推杆121的连接端123通过螺纹方式连接,使得钉盒固定更为牢固稳定,能有效防止钉盒掉落,且容易更换。
本发明一些实施例中,参考图2-8,所述钉盒推杆121活动设置于所述定钉器的主壳体1,所述钉盒推杆121的侧壁设置有滑槽,所述滑槽内活动设置所述顶杆111,所述钉盒推杆121和所述顶杆111穿过所述第一贯穿孔结构14并伸入所述第一植入机构中,有利于结构集成,使得该定钉器整体结构紧凑,减小了所述定钉器的主壳体的整体体积。
本发明一些实施例中,所述制动机构包括制动组件和制动杆,参考图3-8,所述制动组件包括扳机131和连接轴132,所述扳机131设有卡槽133和通孔结构,所述连接轴132固定穿设于所述通孔结构,所述扳机131与所述制动杆134固定连接,所述扳机131活动安装于所述主体壳1,使用者可通过像使用***一样扳动或松开所述扳机131以实现缝合钉的排出。本发明一些具体实施例中,所述扳机131与所述制动杆134为一体式结构。
本发明一些实施例中,参考图3-8,所述夹紧驱动机构包括从动杆141,所述从动杆141活动设置于所述主壳体1内,所述从动杆141的一端部为制动部142,所述制动杆134与所述从动杆141的制动部142搭接,所述从动杆141的另一端部穿过所述第二贯穿孔结构15且与所述第二植入机构3连接固定,通过所述制动组件转动而带动所述制动杆134压住或放开所述从动杆141的所述制动部142,从而使所述从动杆141的另一端部带动所述第二植入机构3朝向或远离所述第一植入机构2运动,以使所述第二植入机构3与所述第一植入机构2实现夹紧或分隔。具体的,通过人为扳动所述扳机131,让其通过转动支点即连接轴132进行转动的同时,所述制动杆134与所述从动杆141中的所述制动部142接触,使所述从动杆141的另一端部带动所述第二植入机构3朝向所述第一植入机构2运动,从而达到夹紧软骨及其软组织黏膜的目的;通过人为放松压 制所述扳机131,让其通过转动支点即连接轴132进行反向转动的同时,所述制动杆134与从动杆141中的所述制动部142不接触,使所述从动杆141的另一端部带动所述第二植入机构3远离所述第一植入机构2运动,从而达到放开软骨及其软组织黏膜的目的。本实施例中所述搭接为所述制动杆134与所述从动杆141相互有一定的重叠处。
本发明一些实施例中,所述钉排出驱动机构包括制动齿轮组件、牵引组件和排钉组件,所述制动组件与所述制动齿轮组件连接,所述牵引组件分别与所述制动齿轮组件和所述排钉组件连接,通过所述制动组件转动而带动所述制动齿轮组件运动,使所述制动齿轮组件通过所述牵引组件带动所述排钉组件运动以将所述缝合钉从所述第一植入机构中排出,以实现从所述第一植入机构中排出缝合钉。
本发明一些实施例中,所述牵引组件包括牵引丝和牵引丝固定组件,所述牵引丝的两端分别与所述制动齿轮组件固定,且所述牵引丝通过所述牵引丝固定组件固定形成环形结构,以实现能多次循环重复带动所述排钉组件运动而将所述缝合钉从所述第一植入机构中排出。
图10为本发明实施例的软骨固定器的部分结构装配示意图。
本发明一些实施例中,所述排钉组件设置于所述第一植入机构,参考图7-10,所述排钉组件包括推板151、轨道152、钉盒支架153、轨道顶板154,所述轨道152设置于所述钉盒支架153的顶部,所述轨道顶板154与所述钉盒支架153连接形成与所述轨道152相通的导轨,所述推板151与牵引丝171固定连接,所述牵引丝171带动所述推板151于所述轨道152和所述导轨中移动,以使所述推板151抵持所述缝合钉的头部而使所述缝合钉从所述第一植入机构中排出,使得每一次触发制动机构时,通过所述牵引丝171带动所述推板151运动以推出一颗缝合钉植入创口。
本发明一些实施例中,参考图7-9,所述轨道顶板154设置于所述钉盒支架 153的一开口端,且所述轨道顶板154与所述钉盒支架153为可拆卸连接,以方便更换钉盒。
本发明一些实施例中,所述推板的厚度小于或等于所述缝合钉的头部的宽度,使得每一次触发制动装置时,只一颗缝合钉会被植入创口,而在钉盒中的下一个缝合钉会被所述顶出***推送到所述第一植入机构的出钉端;当需要更多的缝合钉缝合时,就再次触发制动机构,植入下一颗植入缝合钉,多个单独的缝合钉依次植入,使得软骨闭合过程中不会撕裂。本发明实施例中,所述缝合钉的头部的宽度为所述缝合钉的头部在与所述推板抵持所述缝合钉的头部的方向相垂直的方向的最大长度。
本发明一些实施例中,所述制动齿轮组件包括制动齿轮、第一齿排组件和第二齿排组件,所述制动齿轮与所述制动组件连接,所述第一齿排组件和所述第二齿排组件相对设置于所述制动齿轮的对称端,所述牵引丝的一端与所述第一齿排组件连接固定,所述牵引丝的另一端与所述第二齿排组件连接固定,使得通过所述制动齿轮组件驱动所述牵引组件运动,以实现带动所述排钉组件运动以将所述缝合钉从所述第一植入机构中排出。
具体的,参考图3-7,所述制动齿轮161通过所述连接轴132穿设固定于所述卡槽133,并随所述扳机131的转动而旋转。所述第一齿排组件包括第一齿排162和第一齿排固定支架163,所述第二齿排组件包括第二齿排164和第二齿排固定支架165,所述第一齿排固定支架163和所述第二齿排固定支架165固定设置于所述主壳体1内,所述第一齿排162与所述第一齿排固定支架163固定连接,所述第二齿排164与所述第二齿排固定支架165固定连接,且所述第一齿排162的排齿部和所述第二齿排164的排齿部相对设置且与所述制动齿轮161的对称端分别抵持设置,所述牵引丝171的一端与所述第一齿排162连接固定,所述牵引丝171的另一端与所述第二齿排164连接固定。本发明一些具体实施例中,所述第一齿排固定支架163和所述第二齿排固定支架165通过卡扣方式分别与所述第一壳体11和所述第二壳体12的内壁固定连接。具体的,所述扳 机131通过所述卡槽133的作用,与所述制动齿轮161相连,通过人为扳动所述扳机131,所述制动齿轮161随所述扳机131的运动而转动,从而带动所述第一齿排162和所述第二齿排1***,以带动牵引丝171及所述牵引丝171上的所述推板151在所述轨道152和与所述轨道152相通的导轨中按照固定轨迹运动,使得所述推板151的作用端抵持一个所述缝合钉并将所述缝合钉推入人体鼻腔的预定位置。
本发明一些实施例中,参考图3-10,所述牵引丝固定组件包括牵引丝固定板172和若干牵引丝滑轮173,所述牵引丝固定板172和所述钉盒支架153连接固定且设置于所述第一植入机构2内,所述牵引丝固定板172和所述钉盒支架153的一对称端面均设置有牵引丝安装槽174,所述牵引丝滑轮173设置于所述定钉器的主壳体1的内壁,所述牵引丝171通过若干所述牵引丝滑轮173、所述牵引丝固定板172和所述钉盒支架153固定以形成环形结构,具体的,所述牵引丝171通过依次活动绕设于若干所述牵引丝滑轮173、所述牵引丝固定板172一端面的牵引丝安装槽174、所述钉盒支架153一端面的牵引丝安装槽174、所述钉盒支架153另一对称端面的牵引丝安装槽174、所述牵引丝固定板172另一对称端面的牵引丝安装槽174、若干所述牵引丝滑轮173以形成环形结构。
本发明一些实施例中,参考图8和图9,所述第一植入机构2包括植入支架21,所述植入支架21、所述牵引丝固定板172和所述钉盒支架153均为腔体结构,所述牵引丝固定板172和所述钉盒支架153固定设置于所述植入支架21的所述腔体结构中,所述钉盒支架153可拆卸固定连接钉盒5,即所述钉盒5设置于所述钉盒支架153的腔体结构中,有利于结构集成,使得该定钉器整体结构紧凑,减小了所述第一植入机构的整体体积。具体的,所述钉盒推杆121穿过所述牵引丝固定板172而与所述钉盒5连接,所述顶杆111设置于所述钉盒推杆121的滑槽中,并依次穿过所述牵引丝固定板172和所述钉盒5而与滑动设置于所述钉盒5中的顶块113抵持。
本发明一些具体实施例中,参考图10,所述牵引丝固定板172和所述钉盒 支架153通过卡扣方式固定连接。
本发明一些实施例中,参考图9,所述钉盒5包括钉盒收纳腔和供所述缝合钉滑行的缝合钉滑槽51。具体的,参考图7和图8,所述缝合钉组4和所述顶块113设置于所述钉盒收纳腔中,所述顶杆111通过所述顶块113推动所述缝合钉组4在所述缝合钉滑槽51中移动。所述缝合钉收纳于所述钉盒中以进行鼻中隔软骨手术,能有效防止钉头意外移位。
本发明一些实施例中,还提供一种全降解软骨固定***,包括缝合钉和所述的软骨固定器,所述缝合钉设置于所述软骨固定器的第一植入机构中。
本发明一些实施例中,所述缝合钉采用可吸收降解材料制作而成。具体的,所述可吸收降解材料包括聚乙二醇酸(PGA)或聚丙交酯(PLA),或由聚乙醇酸(PGA)和聚丙交酯(PLA)作为共聚物的组份制成。为了提高聚丙交酯(PLA)的降解速度,在聚乙醇酸(PGA)加入聚丙交酯(PLA)以形成共聚物材料可以加快缝合钉的液体吸收,从而加快缝合钉的降解时间。
本发明一些实施例中,所述生物可降解材料包括聚酯类生物降解材料和活性成分,所述活性成分包括表面活性剂和生物活性玻璃中的至少一种,
以占所述聚酯类生物降解材料的总质量百分比计,所述活性成分的含量小于等于40%,所述表面活性剂的含量小于等于15%;
所述聚酯类生物降解材料包括共混改性成分,所述共混改性成分包括聚羟基乙酸、乙交酯、己内酯、丙交酯、聚乙二醇中的至少一种。
具体的,运用生物活性玻璃降解原理,在降解时所述生物活性玻璃释放的阳离子在所述生物可降解材料表面会形成一层骨碳酸羟基磷灰石,对材料本体表面进行短期保护,可以短期时间内增加生物活性玻璃与聚酯类生物降解材料的复合型材料的机械性能,使其在一周内都能保持50%以上的初始抗拉强度,以满足临床需要持续材料的机械性能;而所述表面活性剂可以增强所述生物可 降解材料的亲水性,促进营养物质的进入,以促进使用所述生物可降解材料进行缝合的组织的再生。
本发明一些实施例中,所述活性成分由表面活性剂和生物活性玻璃中的至少一种组成。
本发明一些具体实施例中,所述活性成分为表面活性剂,以占所述聚酯类生物降解材料的总质量百分比计,所述表面活性剂的含量小于等于15%。
本发明另一些具体实施例中,所述活性成分为生物活性玻璃,以占所述聚酯类生物降解材料的总质量百分比计,所述生物活性玻璃的含量小于等于40%。
本发明又一些具体实施例中,所述活性成分由表面活性剂和生物活性玻璃组成,以占所述聚酯类生物降解材料的总质量百分比计,所述表面活性剂的含量和所述生物活性玻璃的含量之和小于等于40%,且所述表面活性剂的含量小于等于15%。
本发明一些实施例中,所述活性成分为表面活性剂,或所述活性成分由表面活性剂和生物活性玻璃组成,以占所述聚酯类生物降解材料的总质量百分比计,所述表面活性剂的含量小于等于5%。
本发明一些实施例中,所述生物活性玻璃的等效粒径小于45微米,使得所述生物活性玻璃易于融合在聚酯类生物降解材料中。
本发明一些实施例中,以占所述聚酯类生物降解材料的总质量百分比计,所述共混改性成分的含量为5-95%,有利于提升生物可降解材料的可降解性能的可控性。
本发明一些实施例中,所述聚酯类生物降解材料还包括聚乳酸、聚乙丙交酯、聚己内酯、聚对二氧环己酮和聚三亚甲基碳酸酯中的任意一种。具体的,所述聚乳酸包括L-聚乳酸、外消旋聚乳酸、左旋聚乳酸和右旋聚乳酸中的任意一种。
聚羟基乙酸(PGA),又称聚乙醇酸,它来源于α一羟基酸,即乙醇酸。乙醇酸由正常人体在新陈代谢过程中产生。聚乙醇酸是一种具有良好生物降解性和生物相容性的合成高分子材料,与传统的性能稳定的高分子材料,例如塑料、橡胶等不同,聚乙醇酸作为材料在使用到一定时间后逐渐降解,并最终变成对人体、动植物和自然环境无害的水和二氧化碳。聚乙醇酸的应用主要表现在生物医学和生态学两个方面。聚乙醇酸的生物医学应用主要表现在医用缝合线、药物控释载体、骨折固定材料、组织工程支架、缝合补强材料。
聚乳酸也称为聚丙交酯(polylactide,PLA),属于聚酯家族。聚乳酸是以乳酸为主要原料聚合得到的聚合物,原料来源充分而且可以再生,主要以玉米、木薯等为原料。聚乳酸具有良好的生物可降解性,使用后能被自然界中微生物在特定条件下完全降解,最终生成二氧化碳和水,不污染环境,这对保护环境非常有利,是公认的环境友好材料。
聚己内酯(Polycaprolactone,PCL,CAS号:24980-41-4)又称聚ε-己内酯,是通过ε-己内酯单体在金属阴离子络合催化剂催化下开环聚合而成的高分子有机聚合物,通过控制聚合条件,可以获得不同的分子量。其外观为白色固体粉末,无毒,不溶于水,易溶于多种极性有机溶剂。PCL具有良好的生物相容性、良好的有机高聚物相容性,以及良好的生物降解性,可用作细胞生长支持材料,可与多种常规塑料互相兼容,自然环境下6-12个月即可完全降解。
具体的,以占所述聚酯类生物降解材料的总质量百分比计,所述共混改性成分的含量为5-95%,所述聚酯类生物降解材料的余量为所述聚乳酸、所述聚乙丙交酯、所述聚己内酯、所述聚对二氧环己酮和所述聚三亚甲基碳酸酯中的任意一种的含量,即所述聚酯类生物降解材料的总质量百分比的5-95%为所述共混改性成分,剩余的含量为所述聚乳酸、所述聚乙丙交酯、所述聚己内酯、所述聚对二氧环己酮和所述聚三亚甲基碳酸酯中的任意一种的含量。
本发明一些实施例中,所述表面活性剂为聚氧乙烯聚氧丙烯醚三嵌段共聚 物,与皮肤相溶性佳,增加皮肤通透性,可促进外用药剂的吸收。
具体的,所述聚氧乙烯聚氧丙烯醚三嵌段共聚物的通式为HO(C
2H
4O)a(C
3H
6O)b(C
2H
4O)cH。其中a和c为2-130,b为15-67。含聚氧乙烯为81.8±1.9%。在水或乙醇中易溶,在无水乙醇、乙酸乙酯、氯仿中溶解,在***或石油醚中几乎不溶,具有一定的起泡性。2.5%水溶液的pH值在5.0~7.5之间,注射用者pH值在6.0~7.0。水溶液在空气中较稳定,遇光则使pH值下降。本品对酸碱水溶液和金属离子稳定。
本发明一些实施例中,所述聚氧乙烯聚氧丙烯醚三嵌段共聚物为F127、L61、L64、F68、P85、P94、P104、P105、P123、L121和L122中的任意一种。理论上,此类基本结构的化合物可以有无数种,NF标准规定其分子量从1000到7000以上不等,由适当量的聚氧丙烯与适当量的聚氧乙烯共聚成亲油水平衡值不同的化合物。
本发明一些实施例中,所述生物活性玻璃包括硅酸盐玻璃、玻璃陶瓷和硼酸盐基玻璃中的任意一种,有助于促进生长因子的生成、促进细胞的繁衍、增强成骨细胞的基因表达和骨组织的生长,使得生物相容性好,组织反应小。
本发明一些具体实施例中,所述硅酸盐玻璃包括45S5生物活性玻璃,所述玻璃陶瓷包括S53P4生物活性玻璃,所述硼酸盐基玻璃包括19-93B3生物活性玻璃。45S5生物活性玻璃,组成为24.5wt%的Na
2O、24.5wt%的CaO、6.0wt%的P
2O
5和45wt%的SiO
2,45S是指45%质量分数的SiO
2,5表示Ca和P的摩尔比为5:1。
本发明一些实施例中,所述聚酯类生物降解材料的重均分子量为5000-80000道尔顿。
本发明一些实施例中,所述缝合钉包括钉身、以及分别设置在所述钉身两端的钉入部和钉帽部,所述钉帽部与所述钉身垂直设置,使得通过所述钉入部 可以轻松的穿过植入软骨等组织,通过钉帽部能稳定地固定软骨等组织等。
本发明一些实施例中,所述缝合钉为一体成型结构。
本发明一些实施例中,所述钉帽部与推板抵持的端面设有凹槽,使得所述推板在推动所述缝合钉运动时,所述推板能抵持着所述凹槽推动,有着力点,更容易推动。
本发明一些实施例中,所述钉帽部为I形结构、圆形结构和十字形结构中的任意一种,即所述钉帽部的上表面为I形结构、圆形结构和十字形结构中的任意一种。圆形结构的钉帽部和十字形结构的钉帽部的作用面面积大,使得钉帽部与软骨等组织的固定面积更大,固定更牢固。所述I形结构为长方体形结构或圆柱形结构。
本发明一些实施例中,所述钉入部为钩形结构和锥形结构中的任意一种。所述钩形结构的钉入部适用于不同厚度的软骨等组织,通用性更大;所述锥形结构的钉入部适用于剩余的软骨等组织面积较小的场景,在软骨等组织面积较小时也能实现有效固定。
本发明一些实施例中,所述钩形结构的钉入部设有至少1个钩体,且所述钩体的一端固定设置于所述钉入部的作用端。
本发明一些实施例中,所述缝合钉的总轴向长度为2-5mm,所述钉身的轴向长度为1.5-3.5mm,所述钉身的径向长度为0.3-0.8mm,所述钉帽部的径向作用面的最大长度为1.2-3mm,所述钉帽部的径向作用面的最大宽度为0.4-1mm。
本发明实施例中,所述轴向长度为沿所述钉身延伸的方向的长度,所述径向长度为与所述钉身延伸的方向垂直的方向的长度,所述钉帽部的径向作用面为所述钉帽部在与所述钉身延伸的方向垂直的方向的上表面。
图11为本发明第一种实施例的缝合钉的结构示意图。
本发明一些具体实施例中,参考图8和图11,所述第一缝合钉100包括第 一I形钉帽部101、钩形钉入部102和第一钉身103,所述第一I形钉帽部101和所述钩形钉入部102设置于所述第一钉身103的两端,所述第一I形钉帽部101的上表面设有凹槽104,所述凹槽104与所述推板151相适配,使得所述推板151能抵持着所述凹槽104推动所述第一缝合钉100运动,具体的,第一I形钉帽部101呈长方体形结构。
图12为本发明第二种实施例的缝合钉的结构示意图。
本发明一些具体实施例中,参考图12,所述第二缝合钉200包括第二I形钉帽部201、第一锥形钉入部202和第二钉身203,所述第二I形钉帽部201和所述第一锥形钉入部202设置于所述第二钉身203的两端,具体的,所述第二I形钉帽部201呈圆柱形结构。
图13为本发明第三种实施例的缝合钉的结构示意图。
本发明一些具体实施例中,参考图13,所述第三缝合钉300包括圆形钉帽部301、第二锥形钉入部302和第三钉身303,所述圆形钉帽部301和所述第二锥形钉入部302设置于所述第三钉身303的两端。
图14为本发明第四种实施例的缝合钉的结构示意图。
本发明一些具体实施例中,参考图14,所述第四缝合钉400包括第一十字形钉帽部401、单钩形钉入部402和第四钉身403,所述第一十字形钉帽部401和所述单钩形钉入部402设置于所述第四钉身403的两端。
图15为本发明第五种实施例的缝合钉的结构示意图。
本发明一些具体实施例中,参考图15,所述第五缝合钉500包括第二十字形钉帽部501、四钩形钉入部502和第五钉身503,所述第二十字形钉帽部501和所述四钩形钉入部502设置于所述第五钉身503的两端,所述四钩形钉入部502包括四个钩体,且所述四个钩体的一端固定设置于所述四钩形钉入部502的作用端。
图16为图11所示的缝合钉的主视图;图17为图11所示的缝合钉的右视图。
本发明一些具体实施例中,参考图16和图17,所述第一缝合钉100的总轴向长度L1为2-5mm,所述第一钉身103的轴向长度L2为1.5-3.5mm,所述第一钉身103的径向长度W1为0.3-0.8mm,所述第一I形钉帽部101的径向作用面的最大长度W2为1.2-3mm,所述第一I形钉帽部101的径向作用面的最大宽度W3为0.4-1mm。
本发明实施例1-6中,所述生物可降解材料中的聚酯类生物降解材料由聚羟基乙酸(PGA)和聚乳酸(PLA)组成,所述聚羟基乙酸(PGA)加入所述聚乳酸(PLA)中,使得可以控制所述生物可降解材料的液体吸收,从而控制缝合钉的降解时间;所述活性成分包括表面活性剂和生物活性玻璃中的至少一种,其中,所述表面活性剂为F127表面活性剂,所述生物活性玻璃为45S5生物活性玻璃;将所述活性成分和所述聚酯类生物降解材料通过熔融共混方式制备成所述生物可降解材料,再将所述生物可降解材料通过挤压、压缩或注射成型等方法制备成所述缝合钉。
具体的,以占所述聚酯类生物降解材料的总质量百分比计,本发明实施例1-6的配比中各成分的含量wt%请参见表1。
表1
本发明实施例1-6中,以实施例1为例,所述生物可降解材料中所述聚酯类生物降解材料的重量为100g,即所述聚羟基乙酸(PGA)和所述聚乳酸(PLA) 的总重量为100g,其中所述聚羟基乙酸(PGA)占所述聚酯类生物降解材料总质量百分比的95wt%,则所述聚羟基乙酸(PGA)重量为95g,所述聚乳酸(PLA)占所述聚酯类生物降解材料总质量百分比的5wt%,则所述聚羟基乙酸(PGA)重量为5g,所述F127表面活性剂占所述聚酯类生物降解材料总质量百分比的5wt%,则所述F127表面活性剂重量为5g,所述45S5生物活性玻璃占所述聚酯类生物降解材料总质量百分比的5wt%,则所述45S5生物活性玻璃重量为5g。
本发明实施例1-6中,将按表1中的配比制得的所述缝合钉分别按以下方式进行样品制备:
将制备的每个缝合钉样品称重,其中,所述缝合钉的总轴向长度为5mm,所述钉帽部的径向作用面的最大长度为3mm,并记录为Wo,然后将样品在1mL组织培养水(Sigma Aldrich,中国)中分别浸泡1天、3天、7天、14天和21天(n=9)时间。根据GB/T16886-第12部分要求,每个样品保存在10mL聚丙烯管中,在摇晃的水浴中保持37℃(电热恒温水浴锅,上海***),以2HZ(纵向运动)搅拌。每个培养期结束后,用无菌镊子轻轻的取出未降解部分的缝合钉,再使用0.2micron无菌过滤器(Thermo Fisher Scientific,中国)过滤浸提过的单个提取物溶液。然后,将每种滤液0.5ml用组织培养水稀释成5ml提取液,4℃保存,以备日后体外评价。
本发明实施例1-6中,将制得的样品进行质量损失测试:
在每一培养期结束后,将水泥吸干,记录每个样品的重量为Wt(n=3)。然后将缝合钉样品收集在48孔板中,在37℃环境温度环境中干燥24h,测量缝合钉样品的质量为Wd,用以下公式确定随着培养时间变化,缝合钉的质量损失(m):
m(%)=[(Wo-Wd)/Wo]×100%
其中:Wo为样品的初始质量,Wd为37℃干燥24h后的降解样品的质量;m为样品的质量损失,假设干燥过程中没有质量损失。
具体的,本发明实施例1-6的缝合钉的质量损失(m)随培养天数的变化请参见表2。
表2显示了实施例1-6的缝合钉样品在3天、7天、14天和21天培养期的质量损失测量值。从表2可知,实施例1-6的缝合钉在1-21天培养期间的大量损失在3.15%-46.9%之间;培养21天后,实施例2的质量损失接近50%,而实施例1和实施例6的质量损失甚至只有30%多,可见在所述聚羟基乙酸(PGA)和所述聚乳酸(PLA)中添加所述F127表面活性剂和所述45S5生物活性玻璃中的至少一种制得的缝合钉都能使所述缝合钉充分支撑到手术部位完全痊愈后再降解,而且在所述聚羟基乙酸(PGA)和所述聚乳酸(PLA)中同时添加所述F127表面活性剂和所述45S5生物活性玻璃,或添加较多的所述45S5生物活性玻璃时,使得所述缝合钉在4到8周内完成降解,这有利于手术部位创口的闭合。
表2
本发明实施例1-6中,将制得的样品进行机械性能测试:
在样品制备浸提液的过程中,在每个培养期结束后,用万能材料试验机对未培养的缝合钉样品和刚取出的湿的缝合钉(n=3)进行测试,单轴拉伸机上的 握把(2710-100系列螺钉侧动握把)中,使用10N传感器;测量所述缝合钉的长度,记为L1,接触面的宽度标记为W2和W3;以十字牵引速度为10mm/min,杨氏模数是由试验过程中产生的应力-应变曲线计算得到。
图18为本发明按实施例1的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;图19为本发明按实施例2的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;图20为本发明按实施例3的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;图21为本发明按实施例4的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;图22为本发明按实施例5的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图;图23为本发明按实施例6的配比制得的缝合钉的拉伸弹性模量随时间的变化曲线示意图。
参考图18-23,按实施例1-3、实施例5和实施例6制得的所述缝合钉在培养21天后,都有大于20MPa的杨氏模数,而且在一周内都能保持50%以上的初始抗拉强度,极大满足了临床需要持续材料的机械性能。
本发明实施例1-6中,按标准ISO 10993-5进行细胞毒性评价,具体的包括:
(1)将实施例1-6制得的所述缝合钉指解剖那个提取物孵化L929细胞:用细胞传代7代的L929细胞进行MTT检测。采用台盼蓝染色和血细胞计数法检测细胞计数和活力。细胞阳性对照为细胞加培养基和24孔板的实验孔接种1×10
4/ml细胞密度。培养基仅作为阴性对照。然后将培养皿在37℃(5%CO
2/95%空气气氛)的细胞培养箱中培养24小时。24h后,在对照孔中加入100μl无菌组织培养水。将相关实验提取液(n=3)(按样品制备步骤制得的提取液)的100μl添加到相应的孔中进行检测。然后将培养皿在37℃(5%CO
2/95%空气气氛)的细胞培养箱中再次孵育24小时。
(2)进行MTT试验:培养24小时后,每孔以培养基体积(100μl)的10%的MTT孵育。然后将培养皿放回培养箱中3小时。孵育后,在每孔中加入MTT增 溶液,其体积等于原培养基体积(1ml)。为了增强晶体的溶解,每个孔都用移液管滴定,然后在波长为570nm的波长下,用分光光度法测量每个孔的吸光度(TriStar LB 941,Berthold Technologies,美国)。假设细胞对照孔的代谢活性为100%,并以此计算暴露于实验提取物中的细胞的代谢活性百分比。结果采用T对比法进行分析,p<0.05显著性差异。
表3
表3显示了实施例1-6的缝合钉样品在1天、3天、7天、14天和21天培养期的MTT检测细胞活性。从表3可知,实施例1-6的缝合钉都能满足GB/T16886对医疗器械细胞毒性的要求,可见,本发明的所述生物可降解材料及采用本发明的所述生物可降解材料制得的缝合钉的生物相容性好,组织反应小。
鼻中隔软骨通常有2-4毫米厚,两侧覆盖着一层叫做粘周骨膜的粘膜,想象两片薄面包之间夹着一片腊肠,大腊肠是软骨,面包是粘膜。鼻中隔软骨手术的目的是小心地将两边的黏液膜硬膜从隔膜上抬高,移除偏离的部分,然后把所有的东西夹在一起,现有鼻中隔软骨手术的治疗过程如下:
步骤S1:在软骨一侧的粘膜内层进行半切开;
步骤S2:使用卡托或弗利尔提升器,将黏液膜硬膜从一侧的隔软骨处提起;
步骤S3:立即在偏斜前方用人工器械切开隔片,将隔片的粘膜衬里从另一侧的隔片软骨剥离;
步骤S4:将软骨的偏曲部分物理移除,可以用凿子取下上颌嵴;
步骤S5:将时隔软骨颗粒化(如锤击以去除“记忆”)并替换;
步骤S6:使用缝合线或鼻腔填塞将粘囊骨膜重新接近中线。
如果在鼻整形手术(rhinoplasty Surgery,NRS)和内窥镜鼻窦手术(Endoscopic Sinus Surgery,ESS)情况下使用本发明的全降解软骨固定***进行治疗,通常是NRS在ESS之后。一种采用全降解软骨固定***的治疗方法,包括以下步骤:
步骤S11:将装有缝合钉的一次性钉盒,置于所述软骨固定器的钉盒支架中,并使所述钉盒与钉盒推杆连接,以防止缝合钉的钉帽部意外移位;
步骤S12:将所述软骨固定器的第一植入机构和第二植入机构分别***患者的两个鼻孔中以使所述第一植入机构和所述第二植入机构接纳夹持软骨,根据需要缝合的位置调整所述第一植入机构出钉端的位置,确保软骨固定器正确放置能进行有效缝合;
步骤S13:在正式排出所述缝合钉进行缝合前,轻轻扳动扳机使软骨固定器的所述第一植入机构和所述第二植入机构与隔片齐平;
步骤S14:扳动所述扳机然后立即释放,不要太快,也不要太慢,想象一下在一叠纸上使用普通订书器的最佳效果;
步骤S15:单颗植入钉植入之后,通过调整所述第一植入机构和所述第二植入机构的位置而调整下一颗缝合钉的植入方向,软骨固定器展开后,在移动前确保软骨固定器头已经松开;
其中,为了确保合适的放置,每颗缝合钉必须穿过三个组织层中的至少两层,所述三个组织层包括右黏膜、隔软骨和左黏膜。
虽然在上文中详细说明了本发明的实施方式,但是对于本领域的技术人员来说显而易见的是,能够对这些实施方式进行各种修改和变化。但是,应理解, 这种修改和变化都属于权利要求书中所述的本发明的范围和精神之内。而且,在此说明的本发明可有其它的实施方式,并且可通过多种方式实施或实现。
Claims (33)
- 一种软骨固定器,其特征在于,包括植入***、驱动***和顶出***;所述植入***包括第一植入机构和第二植入机构,所述第一植入机构与所述第二植入机构相对设置且所述第一植入机构与所述第二植入机构分隔设置以接纳患者的软骨;所述驱动机构包括制动机构、夹紧驱动机构和钉排出驱动机构,所述制动机构分别与所述夹紧驱动机构和所述钉排出驱动机构连接,所述夹紧驱动机构与所述第二植入机构连接,所述制动机构驱动所述夹紧驱动机构以带动所述第二植入机构朝向或远离所述第一植入机构运动,所述钉排出驱动机构与所述第一植入机构连接,所述制动机构驱动所述钉排出驱动机构以从所述第一植入机构中排出缝合钉;所述顶出***的一端抵持缝合钉组,所述第一植入机构中排出缝合钉之后所述顶出***驱使所述缝合钉组朝向所述第一植入机构的出钉端运动。
- 根据权利要求1所述的软骨固定器,其特征在于,所述顶出***包括顶杆、弹簧和顶块,所述弹簧的一端抵接固定件,所述弹簧的另一端抵接所述顶杆的一端,所述顶块的一端抵接所述顶杆的另一端,所述顶块的另一端抵持所述缝合钉组。
- 根据权利要求2所述的软骨固定器,其特征在于,所述顶出***还包括指针结构和数字指示部,所述数字指示部包括贯穿所述定钉器的主壳体的指针移动收容窗和设置于所述定钉器的主壳体的外壁的若干数字标号,所述指针结构与所述顶杆垂直设置,所述指针结构穿过所述指针移动收容窗,且所述指针结构随所述顶杆的运动而在所述指针移动收容窗中移动并指向所述数字标号。
- 根据权利要求1所述的软骨固定器,其特征在于,所述制动机构包括制动组件和制动杆,所述制动组件和所述制动杆固定连接,所述夹紧驱动机构包括 从动杆,所述制动杆与所述从动杆的制动部搭接,所述从动杆的另一端部与所述第二植入机构连接固定,通过所述制动组件转动而带动所述制动杆压住或放开所述从动杆的所述制动部,从而使所述从动杆的另一端部带动所述第二植入机构朝向或远离所述第一植入机构运动。
- 根据权利要求1所述的软骨固定器,其特征在于,所述制动机构包括制动组件,所述钉排出驱动机构包括制动齿轮组件、牵引组件和排钉组件,所述制动组件与所述制动齿轮组件连接,所述牵引组件分别与所述制动齿轮组件和所述排钉组件连接,通过所述制动组件转动而带动所述制动齿轮组件运动,使所述制动齿轮组件通过所述牵引组件带动所述排钉组件运动以将所述缝合钉从所述第一植入机构中排出。
- 根据权利要求1所述的软骨固定器,其特征在于,还包括钉盒和钉盒替换组件,所述钉盒设置于所述第一植入机构以盛装缝合钉,所述钉盒替换组件包括推柄移动收容窗和钉盒推杆,所述推柄移动收容窗贯穿所述定钉器的主壳体,所述钉盒推杆的一端垂直设置有推柄,所述钉盒推杆的另一端与所述钉盒连接,所述推柄穿过所述推柄移动收容窗且在所述推柄移动收容窗中移动。
- 根据权利要求5所述的软骨固定器,其特征在于,所述牵引组件包括牵引丝和牵引丝固定组件,所述牵引丝的两端分别与所述制动齿轮组件固定,且所述牵引丝通过所述牵引丝固定组件固定形成环形结构。
- 根据权利要求7所述的软骨固定器,其特征在于,所述排钉组件设置于所述第一植入机构,所述排钉组件包括推板、轨道、钉盒支架、轨道顶板,所述轨道设置于所述钉盒支架的顶部,所述轨道顶板与所述钉盒支架连接形成与所述轨道相通的导轨,所述推板与所述牵引丝固定连接,所述牵引丝带动所述推板于所述轨道和所述导轨中移动,以使所述推板抵持所述缝合钉的头部而使所述缝合钉从所述第一植入机构中排出。
- 根据权利要求8所述的软骨固定器,其特征在于,所述推板的厚度小于或等于所述缝合钉的头部的厚度。
- 根据权利要求7所述的软骨固定器,其特征在于,所述制动齿轮组件包括制动齿轮、第一齿排组件和第二齿排组件,所述制动齿轮与所述制动组件连接,所述第一齿排组件和所述第二齿排组件相对设置于所述制动齿轮的对称端,所述牵引丝的一端与所述第一齿排组件连接固定,所述牵引丝的另一端与所述第二齿排组件连接固定。
- 根据权利要求6所述的软骨固定器,其特征在于,所述钉盒推杆与所述钉盒连接的连接端设有外螺纹,所述钉盒的内壁设有与所述外螺纹适配的内螺纹,所述钉盒和所述钉盒推杆的连接端通过螺纹方式连接固定。
- 根据权利要求8所述的软骨固定器,其特征在于,所述轨道顶板设置于所述钉盒支架的一开口端,且所述轨道顶板与所述钉盒支架为可拆卸连接。
- 根据权利要求8所述的软骨固定器,其特征在于,所述牵引丝固定组件包括牵引丝固定板和若干牵引丝滑轮,所述牵引丝固定板和所述钉盒支架连接固定且设置于所述第一植入机构内,所述牵引丝固定板和所述钉盒支架的一对称端面均设置有牵引丝安装槽,所述牵引丝滑轮设置于所述定钉器的主壳体的内壁,所述牵引丝通过若干所述牵引丝滑轮、所述牵引丝固定板和所述钉盒支架固定以形成环形结构。
- 根据权利要求13所述的软骨固定器,其特征在于,所述第一植入机构包括植入支架,所述植入支架、所述牵引丝固定板和所述钉盒支架均为腔体结构,所述牵引丝固定板和所述钉盒支架固定设置于所述植入支架的所述腔体结构中,所述钉盒支架可拆卸固定连接钉盒。
- 根据权利要求6所述的软骨固定器,其特征在于,所述钉盒推杆活动设置于所述定钉器的主壳体,所述钉盒推杆的侧壁设置有滑槽,所述滑槽内活动设置顶杆。
- 根据权利要求15所述的软骨固定器,其特征在于,所述定钉器的主壳体包括第一贯穿孔结构和第二贯穿孔结构,所述夹紧驱动机构中的从动杆活动设置于所述定钉器的主壳体内且穿过所述第二贯穿孔结构,所述第一植入机构与所述定钉器的主壳体固定连接,且所述第一植入机构的开口端与所述第一贯穿孔结构对接连通,所述钉盒推杆和所述顶杆穿过所述第一贯穿孔结构并伸入所述第一植入机构中。
- 根据权利要求6所述的软骨固定器,其特征在于,所述钉盒包括钉盒收纳腔和供所述缝合钉滑行的缝合钉滑槽。
- 一种全降解软骨固定***,其特征在于,包括缝合钉和如权利要求1-17任意一项所述的软骨固定器,所述缝合钉设置于所述软骨固定器的第一植入机构中。
- 根据权利要求18所述的全降解软骨固定***,其特征在于,所述缝合钉采用可吸收降解材料制作而成。
- 根据权利要求18所述的全降解软骨固定***,其特征在于,所述缝合钉包括钉身、以及分别设置在所述钉身两端的钉入部和钉帽部,所述钉帽部与所述钉身垂直设置。
- 根据权利要求20所述的全降解软骨固定***,其特征在于,所述钉帽部与推板抵持的端面设有凹槽。
- 根据权利要求20所述的全降解软骨固定***,其特征在于,所述钉帽部为I形结构、圆形结构和十字形结构中的任意一种。
- 根据权利要求20所述的全降解软骨固定***,其特征在于,所述钉入部为钩形结构和锥形结构中的任意一种。
- 根据权利要求23所述的全降解软骨固定***,其特征在于,所述钩形结构的钉入部设有至少1个钩体,且所述钩体的一端固定设置于所述钉入部的作用端。
- 根据权利要求20所述的全降解软骨固定***,其特征在于,所述缝合钉的总轴向长度为2-5mm,所述钉身的轴向长度为1.5-3.5mm,所述钉身的径向长度为0.3-0.8mm,所述钉帽部的径向作用面的最大长度为1.2-3mm,所述钉帽部的径向作用面的最大宽度为0.4-1mm。
- 根据权利要求19所述的全降解软骨固定***,其特征在于,所述生物可降解材料包括聚酯类生物降解材料和活性成分,所述活性成分包括表面活性剂和生物活性玻璃中的至少一种;以占所述聚酯类生物降解材料的总质量百分比计,所述活性成分的含量小于等于40%,所述表面活性剂的含量小于等于15%;所述聚酯类生物降解材料包括共混改性成分,所述共混改性成分包括聚羟基乙酸、乙交酯、己内酯、丙交酯、聚乙二醇中的至少一种。
- 根据权利要求26所述的全降解软骨固定***,其特征在于,所述生物活性玻璃的等效粒径小于45微米。
- 根据权利要求26所述的全降解软骨固定***,其特征在于,以占所述聚酯类生物降解材料的总质量百分比计,所述共混改性成分的含量为5-95%。
- 根据权利要求26所述的全降解软骨固定***,其特征在于,所述聚酯类生物降解材料还包括聚乳酸、聚乙丙交酯、聚己内酯、聚对二氧环己酮和聚三亚甲基碳酸酯中的任意一种。
- 根据权利要求26所述的全降解软骨固定***,其特征在于,所述生物活性玻璃包括硅酸盐玻璃、玻璃陶瓷和硼酸盐基玻璃中的任意一种。
- 根据权利要求26所述的全降解软骨固定***,其特征在于,所述表面活性剂为聚氧乙烯聚氧丙烯醚三嵌段共聚物。
- 根据权利要求31所述的全降解软骨固定***,其特征在于,所述聚氧乙烯聚氧丙烯醚三嵌段共聚物为F127、L61、L64、F68、P85、P94、P104、P105、P123、L121和L122中的任意一种。
- 根据权利要求26所述的全降解软骨固定***,其特征在于,所述聚酯类生物降解材料的重均分子量为5000-80000道尔顿。
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