CN109966029A - Cartilage repair carrier, matched surgical instrument set and cartilage repair system - Google Patents
Cartilage repair carrier, matched surgical instrument set and cartilage repair system Download PDFInfo
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- A61B17/00—Surgical instruments, devices or methods
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Dentistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Prostheses (AREA)
Abstract
Description
技术领域technical field
本发明涉及一种载体、用具组与系统,且特别是涉及一种软骨修复载体、所搭配的手术用具组与软骨修复系统。The present invention relates to a carrier, an appliance set and a system, and in particular to a cartilage repair carrier, a matched surgical appliance set and a cartilage repair system.
背景技术Background technique
节软骨组织位于关节面的硬骨表层,在人体组织中是一个具有多功能且相当特殊的组织,其主要功能在于传递关节面上下硬骨的不同方向应力、吸收硬骨层传送关节面的冲击力、提供低磨擦系数的润滑关节面、及配合肌肉韧带组织,以于关节活动时可产生滑动及滚动的不同方向的运动模式。The articular cartilage tissue is located on the hard bone surface of the articular surface. It is a multi-functional and quite special tissue in human tissue. Its main function is to transmit the stress in different directions on the upper and lower hard bones on the articular surface, absorb the impact force of the hard bone layer to transmit the articular surface, and provide The lubricated joint surfaces with low friction coefficient and the coordination of muscle and ligament tissue can produce different motion patterns of sliding and rolling during joint activities.
软骨组织的自我修复和再生能力都十分的不足,一旦受到损害,往往无法自行复原。据统计,目前美国每年因软骨深层次伤害,而需进行人工关节置换手术者可达20万例以上,且案例仍逐年攀升中。然而,置换人工关节需切除患者关节面的大量的软骨及硬骨组织,伤害及破坏性都相当大,且材质为金属的人工关节植入体内后,只能维持十至十五年左右的功能。以年轻患者而言,将面临再次人工关节置换手术的痛苦,而对老年病患来说,则往往无法承受再次置换人工关节的手术。再者,反复置换人工关节很可能导致残疾且不良于行,进而造成社会及家庭沉重的负担。The self-repair and regeneration ability of cartilage tissue is very insufficient, and once damaged, it often cannot recover on its own. According to statistics, more than 200,000 cases of artificial joint replacement surgery are required in the United States every year due to deep cartilage damage, and the number of cases is still increasing year by year. However, the replacement of an artificial joint requires the removal of a large amount of cartilage and hard bone tissue on the articular surface of the patient, which is quite damaging and destructive. After the artificial joint made of metal is implanted into the body, it can only maintain its function for about ten to fifteen years. For young patients, they will face the pain of re-artificial joint replacement surgery, while for elderly patients, they are often unable to bear the surgery of re-artificial joint replacement. Furthermore, repeated replacement of artificial joints is likely to lead to disability and poor mobility, which in turn creates a heavy burden on society and families.
目前医界对于软骨受损的治疗方法,主要是采用软骨移植(cartilagetransplantation),以修补受损的软骨区块。此法为近廿年内所发明的新颖医疗方法,包含自体软骨移植(ACI,autologous chondrocyte implantation)以及异体骨关节移植(OA,osteoarticular allograft),即采用自体或异体的软骨移植再生新组织,可避免置换人工关节的永久性破坏,也不需定期再开刀替换老化的金属或塑胶组件。上述治疗方法中,又以自体软骨移植较广为接受,因为其移植物来源为患者本身的组织,不会发生异体或异种移植免疫排斥的问题。The current medical treatment for damaged cartilage mainly adopts cartilage transplantation to repair the damaged cartilage. This method is a novel medical method invented in the past two decades, including autologous cartilage transplantation (ACI, autologous chondrocyte implantation) and osteoarticular allograft (OA, osteoarticular allograft). Replace the permanent damage of the artificial joint, and also do not need to periodically re-operate to replace the aging metal or plastic components. Among the above treatment methods, autologous cartilage transplantation is widely accepted, because the source of the graft is the patient's own tissue, and the problem of immune rejection of allograft or xenograft will not occur.
自体移植的手术方法主流为「马赛克弥补法(Mosaic plasty procedure)」,此法为匈牙利的外科医师于1995年所提出,该手术方法将病患关节不受应力的关节面软骨,以环锯钻取一块含有软骨及下层接触的硬骨圆柱状栓块,并于受损部位以相同的环锯钻出相同直径的填补凹槽,再将未受损的健康自体软硬骨栓块填入。然而,以马赛克弥补法在修复软骨创伤时,所植入的软骨栓块间的软骨面有一如磁砖的界面,而此界面间的软骨细胞由于被包覆在大量的基质中,其分裂能力相当差。因此,软骨栓块间事实上并不易形成再生融合;另一方面,软骨栓块周边间隙将产生纤维软骨组织,造成日后该受创面容易产生退化性关节炎。The mainstream surgical method of autologous transplantation is the "Mosaic plasty procedure", which was proposed by a Hungarian surgeon in 1995. A cylindrical plug of hard bone with cartilage and underlying contact was taken, and a filling groove of the same diameter was drilled with the same trephine at the damaged site, and then the undamaged healthy autologous soft and hard bone plug was filled. However, when repairing cartilage wounds by the mosaic method, the cartilage surface between the implanted cartilage plugs has a tile-like interface, and the chondrocytes between the interfaces are covered in a large amount of matrix, and their ability to divide is limited. Pretty bad. Therefore, in fact, it is not easy to form regenerative fusion between cartilage plugs; on the other hand, fibrocartilage tissue will be formed in the surrounding space of cartilage plugs, which makes the wounded surface prone to degenerative arthritis in the future.
目前以组织工程体外培养软骨组织修复软骨损伤也有同样的困扰,以及,体外所培养的软骨组织植入软骨受创面后,新旧软骨组织间的间隙融合问题仍为目前无法突破的难题。因此,如何克服移植软骨(implant)与原软骨组织(host)间的组织再生融合,为目前相当重要且亟待解决的骨科临床研究课题。At present, the repair of cartilage damage by tissue engineering in vitro culture of cartilage tissue also has the same problem, and after the cartilage tissue cultured in vitro is implanted into the cartilage wound, the problem of gap fusion between old and new cartilage tissue is still a difficult problem that cannot be broken through. Therefore, how to overcome the tissue regeneration and fusion between the transplanted cartilage (implant) and the original cartilage tissue (host) is a very important and urgent clinical research topic in orthopaedics.
发明内容SUMMARY OF THE INVENTION
本发明提供一种软骨修复载体、所搭配的手术用具组与软骨修复系统,可改善现有软骨修复手术所存在的问题。The present invention provides a cartilage repair carrier, a matched surgical tool set and a cartilage repair system, which can improve the problems existing in the existing cartilage repair operation.
本发明的一实施例的软骨修复载体包括一本体与多个定位柱。本体为多孔性结构且用以承载软骨修复材料。各个定位柱的一端固定至本体,且另一端用以插入一患者的硬骨。A cartilage repair carrier according to an embodiment of the present invention includes a body and a plurality of positioning posts. The body is a porous structure and is used to carry the cartilage repair material. One end of each positioning post is fixed to the body, and the other end is used for insertion into a patient's hard bone.
本发明的一实施例的手术用具组包括一定位套管以及一按压式器械。定位套管具有一贯穿通道。贯穿通道的侧壁上具有一第一定位结构。按压式器械包括一外套管与一推杆。外套管的外壁上具有一第二定位结构。外套管用以穿过定位套管的贯穿通道。第二定位结构与第一定位结构相互对位。推杆可滑动地设置于外套管内。外套管的一端具有一塑形刀,用以在一患者的患部上切出一待植入区。A surgical tool set according to an embodiment of the present invention includes a positioning sleeve and a pressing tool. The positioning sleeve has a through channel. A first positioning structure is provided on the side wall of the through channel. The pressing device includes an outer sleeve and a push rod. The outer wall of the outer sleeve has a second positioning structure. The outer sleeve is used to pass through the through channel of the positioning sleeve. The second positioning structure is aligned with the first positioning structure. The push rod is slidably arranged in the outer sleeve. One end of the outer sleeve is provided with a shaping knife, which is used to cut out an area to be implanted on the affected part of a patient.
本发明的一实施例的软骨修复系统包括一软骨修复载体、一定位套管以及一按压式器械。软骨修复载体包括一本体与多个定位柱。本体为多孔性结构且用以承载软骨修复材料。各个定位柱的一端固定至本体,且另一端用以插入一患者的硬骨。定位套管具有一贯穿通道。贯穿通道的侧壁上具有一第一定位结构。按压式器械包括一外套管与一推杆。外套管的外壁上具有一第二定位结构。外套管用以穿过定位套管的贯穿通道。第二定位结构与第一定位结构相互对位。推杆可滑动地设置于外套管内。外套管的一端具有一塑形刀,用以在患者的患部上切出一待植入区。待植入区的形状对应本体的形状。A cartilage repair system according to an embodiment of the present invention includes a cartilage repair carrier, a positioning sleeve and a pressing instrument. The cartilage repair carrier includes a body and a plurality of positioning posts. The body is a porous structure and is used to carry the cartilage repair material. One end of each positioning post is fixed to the body, and the other end is used for insertion into a patient's hard bone. The positioning sleeve has a through channel. A first positioning structure is provided on the side wall of the through channel. The pressing device includes an outer sleeve and a push rod. The outer wall of the outer sleeve has a second positioning structure. The outer sleeve is used to pass through the through channel of the positioning sleeve. The second positioning structure is aligned with the first positioning structure. The push rod is slidably arranged in the outer sleeve. One end of the outer sleeve is provided with a shaping knife, which is used to cut out an area to be implanted on the affected part of the patient. The shape of the area to be implanted corresponds to the shape of the body.
基于上述,在本发明的软骨修复载体、所搭配的手术用具组与软骨修复系统中,具有多孔性结构的软骨修复载体有助于新旧软骨组织间的间隙融合,而手术用具组使得软骨修复载体可轻松植入患者的患部。Based on the above, in the cartilage repair carrier, the matched surgical tool set and the cartilage repair system of the present invention, the cartilage repair carrier with a porous structure facilitates the gap fusion between new and old cartilage tissues, and the surgical tool set makes the cartilage repair carrier Can be easily implanted into the patient's affected area.
为让本发明的上述特征和优点能更明显易懂,下文特举实施例,并配合所附的附图作详细说明如下。In order to make the above-mentioned features and advantages of the present invention more obvious and easy to understand, the following embodiments are given and described in detail with the accompanying drawings as follows.
附图说明Description of drawings
图1是本发明一实施例的软骨修复载体的示意图;1 is a schematic diagram of a cartilage repair carrier according to an embodiment of the present invention;
图2是本发明一实施例的软骨修复载体的实体照片图;2 is a solid photograph of a cartilage repair carrier according to an embodiment of the present invention;
图3是本发明一实施例的手术用具组的定位套管的示意图;3 is a schematic diagram of a positioning sleeve of a surgical tool set according to an embodiment of the present invention;
图4A与图4B分别是本发明一实施例的手术用具组的按压式器械的外观示意图与剖面示意图;FIG. 4A and FIG. 4B are a schematic external view and a schematic cross-sectional view of a pressing device of a surgical tool set according to an embodiment of the present invention, respectively;
图5是本发明一实施例的手术用具组的清创钻头的示意图;5 is a schematic diagram of a debridement drill of a surgical tool set according to an embodiment of the present invention;
图6是本发明一实施例的手术用具组的钻孔器械的示意图;6 is a schematic diagram of a drilling instrument of a surgical instrument set according to an embodiment of the present invention;
图7A至图7G是使用本发明一实施例的软骨修复系统进行软骨修复手术的各阶段的照片图;7A to 7G are photographic views of various stages of cartilage repair surgery using the cartilage repair system according to an embodiment of the present invention;
图8是本发明一实施例的软骨修复载体的使用方式的示意图;FIG. 8 is a schematic diagram of the usage mode of the cartilage repair carrier according to an embodiment of the present invention;
图9A与图9B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经6个月复原后的患部照片图;9A and FIG. 9B are photographs of the affected part after 6 months of recovery of an experimental example using the cartilage repair system according to an embodiment of the present invention for surgery and a control example for surgery using traditional surgical instruments;
图10A与图10B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经6个月复原后的患部X光片图;10A and FIG. 10B are respectively the X-ray pictures of the affected part after 6 months of recovery for an experimental example using the cartilage repair system according to an embodiment of the present invention for surgery and a control example for using traditional surgical instruments for surgery;
图11A与图11B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经6个月复原后的患部样本照片图;11A and FIG. 11B are respectively photographs of the affected part samples after 6 months of recovery from an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical instruments for surgery;
图12A与图12B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经12个月复原后的患部样本照片图;12A and FIG. 12B are respectively a photo of an affected part sample after 12 months of recovery of an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical instruments for surgery;
图13A与图13B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经12个月复原后的患部的染色切片图;13A and FIG. 13B are respectively the stained section views of the affected part after 12 months of recovery in an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical instruments for surgery;
图14是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例的伤口宽度的量化图。FIG. 14 is a quantification diagram of the wound width of an experimental example performed using the cartilage repair system according to an embodiment of the present invention and a control example performed using a conventional surgical tool.
符号说明Symbol Description
100:软骨修复载体100: Cartilage Repair Carrier
110:本体110: Ontology
112:定位角112: Positioning angle
114:凹槽114: Groove
120、510:定位柱120, 510: positioning column
200:定位套管200: Positioning sleeve
210:第一定位结构210: First positioning structure
220:套管定位柱220: casing positioning column
230:握把230: Grip
T10:贯穿通道T10: Through the channel
W10:侧壁W10: Sidewall
P10:排出开口P10: Discharge opening
300:按压式器械300: Press-type instruments
310:外套管310: Outer casing
312:第二定位结构312: Second positioning structure
314:塑形刀314: Shaper Knife
314A:定位角314A: Positioning Angle
320:推杆320: Putter
330:弹性恢复件330: Elastic recovery piece
W20:外壁W20: outer wall
400:清创钻头400: Debridement Drill
410:止挡部410: Stopper
500:钻孔器械500: Drilling Instruments
520:第三定位结构520: Third positioning structure
A10:待植入区A10: Area to be implanted
P20:定位孔P20: Positioning hole
具体实施方式Detailed ways
本发明的一实施例的手术用具组包括一定位套管以及一按压式器械。此外,本发明一实施例的软骨修复系统除了上述的手术用具组之外,还包括一软骨修复载体。A surgical tool set according to an embodiment of the present invention includes a positioning sleeve and a pressing tool. In addition, the cartilage repair system according to an embodiment of the present invention further includes a cartilage repair carrier in addition to the above-mentioned surgical tool set.
图1是本发明一实施例的软骨修复载体的示意图,图2是本发明一实施例的软骨修复载体的实体照片。请同时参照图1与图2,在一实施例中,此软骨修复载体100包括一本体110与多个定位柱120。本体110为多孔性结构,用以承载软骨修复材料。定位柱120为实心结构,各个定位柱120的一端固定至本体110,另一端于手术过程中将用以插入患者的硬骨,以便将整个软骨修复载体100固定于患者的硬骨上。选择性地,本实施例的本体110可更具有一凹槽114,且以凹槽114的空间承载将用以修复软骨的材料。FIG. 1 is a schematic diagram of a cartilage repair carrier according to an embodiment of the present invention, and FIG. 2 is a solid photo of the cartilage repair carrier according to an embodiment of the present invention. Please refer to FIG. 1 and FIG. 2 simultaneously. In one embodiment, the cartilage repair carrier 100 includes a body 110 and a plurality of positioning posts 120 . The body 110 is a porous structure for carrying the cartilage repair material. The positioning posts 120 are solid structures. One end of each positioning post 120 is fixed to the body 110 , and the other end is used to insert into the patient's hard bone during the operation, so as to fix the entire cartilage repair carrier 100 on the patient's hard bone. Optionally, the body 110 of this embodiment may further have a groove 114 , and the space of the groove 114 is used to carry the material to be used for cartilage repair.
在一实施例中,软骨修复载体100的本体110由于采用了多孔性结构,可让邻近组织或细胞与润滑液通过孔径进入本体110的内部或凹槽114的空间中,与软骨修复材料共同修复患部,进而提升复原的效果。In one embodiment, the body 110 of the cartilage repair carrier 100 adopts a porous structure, so that adjacent tissues or cells and lubricating fluid can enter the interior of the body 110 or the space of the groove 114 through the aperture, and repair together with the cartilage repair material. The affected area, thereby enhancing the recovery effect.
在一实施例中,本体110的材料可采用生物可降解材料。因此,在患者的患部修复完成后,软骨修复载体100可在体内自然分解并代谢,只留下恢复功能的正常软骨,而不留下任何非人体本身的天然产物在体内。在一实施例中,本体110的材料可使用单一种生物可降解材料,材料组成成分较为单纯,可进一步缩短完全降解所需要的时间。在一实施例中,本体110的材料可为单一高分子材料,例如是聚乳酸(Polylactide,PLA)、聚乙醇酸(Polyglycolic Acid,PGA)、聚己内酯(Polycaprolactone,PCL)、聚乙烯醇(Polyvinylalcohol,PVA)、聚羟基烷酸(polyhydroxy-alkanoates,PHA),但不限于此。在另一实施例中,本体110的材料可为复合高分子材料,例如是至少两种上述聚合物的共聚物(co-polymer),但不限于此。In one embodiment, the material of the body 110 may be a biodegradable material. Therefore, after the repair of the affected part of the patient is completed, the cartilage repair carrier 100 can be naturally decomposed and metabolized in the body, leaving only the normal cartilage with restored function, without leaving any non-human body natural products in the body. In one embodiment, a single biodegradable material can be used as the material of the body 110 , and the composition of the material is relatively simple, which can further shorten the time required for complete degradation. In one embodiment, the material of the body 110 can be a single polymer material, such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polyvinyl alcohol (Polyvinylalcohol, PVA), polyhydroxy-alkanoates (polyhydroxy-alkanoates, PHA), but not limited thereto. In another embodiment, the material of the body 110 may be a composite polymer material, such as a co-polymer of at least two of the above polymers, but not limited thereto.
在一实施例中,定位柱120的材料可采用生物可降解材料。在一实施例中,定位柱120的材料可使用单一种生物可降解材料,材料组成成分较为单纯,可进一步缩短完全降解所需要的时间。在一实施例中,定位柱120的材料可为单一高分子材料,例如是聚乳酸(Polylactide,PLA)、聚乙醇酸(Polyglycolic Acid,PGA)、聚己内酯(Polycaprolactone,PCL)、聚乙烯醇(Polyvinyl alcohol,PVA)、聚羟基烷酸(polyhydroxy-alkanoates,PHA),但不限于此。在另一实施例中,定位柱120的材料可为复合高分子材料,例如是至少两种上述聚合物的共聚物(co-polymer),但不限于此。本体110的材料与定位柱120的材料可以相同或不同。In one embodiment, the material of the positioning post 120 can be a biodegradable material. In one embodiment, a single biodegradable material can be used as the material of the positioning post 120 , and the composition of the material is relatively simple, which can further shorten the time required for complete degradation. In one embodiment, the material of the positioning column 120 can be a single polymer material, such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polyethylene Alcohol (Polyvinyl alcohol, PVA), polyhydroxy-alkanoates (polyhydroxy-alkanoates, PHA), but not limited thereto. In another embodiment, the material of the positioning post 120 may be a composite polymer material, such as a co-polymer of at least two of the above polymers, but not limited thereto. The material of the body 110 and the material of the positioning post 120 may be the same or different.
在一实施例中,本体110的多孔性结构的孔隙度为50%~90%,例如是50%、55%、60%、65%、70%、75%、80%、85%、90%。此外,多孔性结构的孔径大小约为50μm到1,000μm。在一实施例中,本体110的外观型态可为圆盘状或壳盖状,但不限于此。在一实施例中,本体110的直径可为约8mm到10mm,可适用于软骨上不同程度的缺损。本体110的壁厚可为1mm到1.5mm,具有足够强度以抵抗周围组织的压缩力,并且不至于压缩到软骨修复材料的存放空间。本体110的总高度可为1.8mm到2.2mm,与人类膝关节软骨层的厚度大致相同,以便于操作过程中不至侵害到硬骨层,且于手术后不会突出于膝关节表面,可避免被关节面磨损。在一实施例中,定位柱120的直径可以是1mm到2mm,长度可以是2mm到3mm,且可以是实心柱体,以便以一对硬骨而言破坏最小的方式将本体110固定在软骨受损处。In one embodiment, the porosity of the porous structure of the body 110 is 50% to 90%, for example, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% . In addition, the pore size of the porous structure is about 50 μm to 1,000 μm. In one embodiment, the appearance of the main body 110 may be a disc shape or a cover shape, but is not limited thereto. In one embodiment, the diameter of the body 110 may be about 8 mm to 10 mm, which may be suitable for different degrees of cartilage defects. The wall thickness of the body 110 may be 1 mm to 1.5 mm, with sufficient strength to resist the compressive force of the surrounding tissue, and not to be compressed into the storage space of the cartilage repair material. The total height of the body 110 can be 1.8mm to 2.2mm, which is approximately the same as the thickness of the cartilage layer of the human knee joint, so that the hard bone layer will not be violated during the operation, and will not protrude from the surface of the knee joint after the operation, which can avoid Worn by articular surfaces. In one embodiment, the positioning post 120 may be 1 mm to 2 mm in diameter, 2 mm to 3 mm in length, and may be a solid post in order to secure the body 110 to the damaged cartilage with minimal disruption to a pair of hard bones. place.
在一实施例中,本体110的外围可具有一定位角112。定位角112可以是约0.5mm到1mm的突出的小尖点,例如是外型呈现为三角形的突出,但不限于此。此定位角112可搭配其他手术器械上的定位结构,可于手术过程中辅助定位而将软骨修复载体100导引至正确的位置。In one embodiment, the periphery of the body 110 may have a positioning angle 112 . The positioning angle 112 may be a protruding small point of about 0.5 mm to 1 mm, such as a protruding triangular shape, but not limited thereto. The positioning angle 112 can be matched with positioning structures on other surgical instruments to assist positioning during the operation and guide the cartilage repair carrier 100 to the correct position.
图3是本发明一实施例的手术用具组的定位套管的示意图。请参照图3,定位套管200具有一贯穿通道T10。贯穿通道T10的侧壁W10上具有一第一定位结构210。图4A与图4B分别是本发明一实施例的手术用具组的按压式器械的外观示意图与剖面示意图。请参照图4A与图4B,按压式器械300包括一外套管310与一推杆320。外套管310的外壁W20上具有一第二定位结构312。外套管310用以穿过图3的定位套管200的贯穿通道T10。第二定位结构312与图3的第一定位结构210可相互对位,以确保定位套管200与按压式器械300于操作过程中可精准定位。推杆320以可滑动形式设置于外套管310内,通过按压或推动可在外套管310内进行滑动。外套管310的一端具有一塑形刀314,用以在患者的患部上切出一待植入区(未绘示)。待植入区的形状可对应图1的本体110的形状。3 is a schematic diagram of a positioning sleeve of a surgical tool set according to an embodiment of the present invention. Please refer to FIG. 3 , the positioning sleeve 200 has a through channel T10 . A first positioning structure 210 is formed on the side wall W10 of the through channel T10. 4A and FIG. 4B are a schematic external view and a schematic cross-sectional view of a push-type instrument of a surgical instrument set according to an embodiment of the present invention, respectively. Referring to FIGS. 4A and 4B , the pressing device 300 includes an outer sleeve 310 and a push rod 320 . A second positioning structure 312 is formed on the outer wall W20 of the outer sleeve 310 . The outer sleeve 310 is used to pass through the through channel T10 of the positioning sleeve 200 of FIG. 3 . The second positioning structure 312 and the first positioning structure 210 in FIG. 3 can be aligned with each other, so as to ensure that the positioning sleeve 200 and the pressing device 300 can be accurately positioned during the operation. The push rod 320 is disposed in the outer sleeve 310 in a slidable form, and can slide in the outer sleeve 310 by pressing or pushing. One end of the outer sleeve 310 has a shaping knife 314 for cutting out an area to be implanted (not shown) on the affected part of the patient. The shape of the area to be implanted may correspond to the shape of the body 110 of FIG. 1 .
请参照图3、图4A与图4B,当按压式器械300的外套管310穿过定位套管200的贯穿通道T10时,由于定位套管200中设置有第一定位结构210而按压式器械300的外套管310的外壁W20上设置有第二定位结构312,且第二定位结构312必须与第一定位结构210相互对位,如此便可限制按压式器械300滑动时的方位。此外,设置于外套管310内的可滑动式推杆320于远离塑形刀314的一端突出于外套管310外。当使用者推动推杆320突出于外套管310外的一端时,就能将推杆320朝向塑形刀314的方向推动。Referring to FIGS. 3 , 4A and 4B , when the outer sleeve 310 of the pressing device 300 passes through the through channel T10 of the positioning sleeve 200 , because the positioning sleeve 200 is provided with the first positioning structure 210 , the pressing device 300 The outer wall W20 of the outer sleeve 310 is provided with a second positioning structure 312, and the second positioning structure 312 must be aligned with the first positioning structure 210, so that the sliding position of the pressing device 300 can be restricted. In addition, the slidable push rod 320 disposed in the outer sleeve 310 protrudes out of the outer sleeve 310 at one end away from the shaping knife 314 . When the user pushes the end of the push rod 320 protruding from the outer sleeve 310 , the push rod 320 can be pushed toward the direction of the shaping knife 314 .
在一实施例中,塑形刀314的形状可配合软骨修复载体100的本体110的形状进行设计,意即,将塑形刀314设计为与本体110的轮廓及构型一致,以完整容置本体110而使软骨修复载体100可完整地安置在塑形刀314所构筑的区域内。如此一来,使用者仅需推动推杆320即可将软骨修复载体100推置入患部目标处。换言之,按压式器械300除了可以塑形刀314切出待植入区之外,还可以作为将软骨修复载体100推往待植入区的工具。在另一实施例中,为了方便使用,可在外套管310与推杆320之间设置弹性恢复件330,例如是弹簧,以使推杆320可自动复位。In one embodiment, the shape of the shaping blade 314 can be designed to match the shape of the body 110 of the cartilage repair carrier 100 , that is, the shaping blade 314 is designed to be consistent with the contour and configuration of the body 110 so as to be completely accommodated. The body 110 allows the cartilage repair carrier 100 to be completely placed in the area constructed by the shaping knife 314 . In this way, the user only needs to push the push rod 320 to push the cartilage repair carrier 100 into the target of the affected part. In other words, the pressing instrument 300 can be used as a tool for pushing the cartilage repair carrier 100 to the to-be-implanted area in addition to the shaping knife 314 to cut out the to-be-implanted area. In another embodiment, for the convenience of use, an elastic restoring member 330, such as a spring, can be arranged between the outer sleeve 310 and the push rod 320, so that the push rod 320 can be automatically reset.
请参照图3,在一实施例中,定位套管200的一端具有多个套管定位柱220,用以插入患者的患部,如此可在手术过程中初步固定定位套管200的位置且初步框定手术部位,以便后续实施精准的手术。套管定位柱220的长度可为8~12mm,例如为10mm,而套管定位柱220的外表面与其中心轴线的夹角可为0.5~2度,例如是1度,以使套管定位柱220在打入骨头进行固定时可减少阻力而较为容易地打入骨头内。贯穿通道T10的直径可为12~14mm,例如为13mm,可提供后续手术器械操作的空间。此外,贯穿通道T10的侧壁W10设置有至少一个排出开口P10,例如是两个或三个,但不限于此。在一实施例中,可设置有四个排出开口P10。排出开口P10可以为宽度1~5mm而长度20~30mm的长形开口,例如是宽度2.5mm而长度24mm到25mm的长条状开口。在后续使用清创钻头进行清创的时候,可以通过排出开口P10将清除出来的组织排出,以留下干净的伤口。Referring to FIG. 3 , in one embodiment, one end of the positioning sleeve 200 has a plurality of sleeve positioning posts 220 for inserting into the affected part of the patient, so that the position of the positioning sleeve 200 can be preliminarily fixed and framed during the operation. Surgical site for subsequent precise surgery. The length of the casing positioning column 220 may be 8-12 mm, for example, 10 mm, and the angle between the outer surface of the casing positioning column 220 and its central axis may be 0.5-2 degrees, such as 1 degree, so that the casing positioning column When the 220 is driven into the bone for fixation, the resistance can be reduced and it can be more easily driven into the bone. The diameter of the through channel T10 may be 12-14 mm, for example, 13 mm, which may provide space for subsequent operation of surgical instruments. In addition, at least one discharge opening P10 is provided through the side wall W10 of the passage T10, for example, two or three, but not limited thereto. In one embodiment, four discharge openings P10 may be provided. The discharge opening P10 may be an elongated opening with a width of 1 to 5 mm and a length of 20 to 30 mm, for example, an elongated opening with a width of 2.5 mm and a length of 24 to 25 mm. When the debridement drill is used for subsequent debridement, the removed tissue can be discharged through the discharge opening P10 to leave a clean wound.
另外,在又一实施例中,上述定位套管200上与套管定位柱220相对的另一端可具有一握把230,用以提供使用者握持,以提升使用的便利性。以及,上述设置于贯穿通道T10侧壁W10上的第一定位结构210可为长度约0.5~2mm的导引通道,例如是1mm,用以提供其他手术器械对位的功能,以确保上述的软骨修复载体100的多个定位柱120可顺利插入且密合压入于硬骨上的小洞中。In addition, in yet another embodiment, the other end of the positioning sleeve 200 opposite to the sleeve positioning post 220 may have a handle 230 to provide a user to hold, so as to improve the convenience of use. And, the above-mentioned first positioning structure 210 disposed on the side wall W10 of the through channel T10 can be a guide channel with a length of about 0.5-2 mm, for example, 1 mm, to provide the function of positioning other surgical instruments to ensure the above-mentioned cartilage The plurality of positioning posts 120 of the repair carrier 100 can be smoothly inserted and tightly pressed into the small holes on the hard bone.
请同时参照图1与图4A,在一实施例中,塑形刀314上设置有一定位角314A。定位角314A与软骨修复载体100的定位角112可相互配合进行对位。因此,当软骨修复载体100安置在塑形刀314所圈起的区域内时,可确保软骨修复载体100的方位处于后续所欲操作的方位。Please refer to FIG. 1 and FIG. 4A at the same time, in one embodiment, the shaping knife 314 is provided with a positioning angle 314A. The positioning angle 314A and the positioning angle 112 of the cartilage repair carrier 100 can cooperate with each other to perform alignment. Therefore, when the cartilage repair carrier 100 is placed in the area encircled by the shaping knife 314, it can be ensured that the orientation of the cartilage repair carrier 100 is in the orientation desired for subsequent operations.
图5是本发明一实施例的手术用具组的清创钻头的示意图。请同时参照图3与图5,在一实施例中,清创钻头400可穿过定位套管200的贯穿通道T10以清除位于患者的待植入区的软骨,以便在患者的患部空出可供植入如图1的软骨修复载体100的位置。在另一实施例中,清创钻头400具有一止挡部410。止挡部410的尺寸大于贯穿通道T10的尺寸。在一实施例中,止挡部410的直径约为14~16mm,例如是15mm。因此,当清创钻头400穿过定位套管200的贯穿通道T10时,止挡部410会使得清创钻头400无法持续往前,进而限制清创钻头400的清创深度。举例而言,止挡部410使得清创钻头400突出定位套管200的部分是2mm,则清创钻头400所切除的软骨的深度也会是2mm。换言之,清创钻头400所切除的软骨的深度是配合软骨修复载体100的本体110的高度。5 is a schematic diagram of a debridement drill of a surgical tool set according to an embodiment of the present invention. Please refer to FIG. 3 and FIG. 5 at the same time. In one embodiment, the debridement drill bit 400 can pass through the through channel T10 of the positioning sleeve 200 to remove the cartilage in the patient's area to be implanted, so as to vacate the patient's affected area. For implantation in the position of the cartilage repair carrier 100 as shown in FIG. 1 . In another embodiment, the debridement drill bit 400 has a stop portion 410 . The size of the stopper portion 410 is larger than that of the through passage T10. In one embodiment, the diameter of the stopper portion 410 is about 14-16 mm, for example, 15 mm. Therefore, when the debridement bit 400 passes through the through channel T10 of the positioning sleeve 200 , the stopper 410 prevents the debridement bit 400 from moving forward continuously, thereby limiting the debridement depth of the debridement bit 400 . For example, if the stop portion 410 makes the portion of the debridement drill 400 protruding from the positioning sleeve 200 by 2 mm, the depth of the cartilage cut by the debridement drill 400 will also be 2 mm. In other words, the depth of the cartilage excised by the debridement drill 400 is matched to the height of the body 110 of the cartilage repair carrier 100 .
在另一实施例中,清创钻头400下方钻纹部位的直径约为8到10mm,是配合软骨修复载体100的本体110的直径。更详细言之,清创钻头400下方钻纹部位的直径几乎等于软骨修复载体100的本体110的外围直径,以清理出适合容置软骨修复载体100的空间。由于清创钻头400会在贯穿通道T10内转动,所以清创钻头400上并没有对应贯穿通道T10的第一定位结构210的结构。In another embodiment, the diameter of the drilled portion under the debridement drill bit 400 is about 8 to 10 mm, which is matched with the diameter of the body 110 of the cartilage repair carrier 100 . In more detail, the diameter of the drilled portion under the debridement drill 400 is almost equal to the outer diameter of the body 110 of the cartilage repair carrier 100 , so as to clear a space suitable for accommodating the cartilage repair carrier 100 . Since the debridement drill bit 400 rotates in the through channel T10, the debridement drill bit 400 does not have a structure corresponding to the first positioning structure 210 of the through channel T10.
图6是本发明一实施例的手术用具组的钻孔器械的示意图。请同时参照图3与图6,本实施例的钻孔器械500用以穿过定位套管200的贯穿通道T10而在位于患者的待植入区的硬骨上钻出多个定位孔(未绘示)。举例来说,钻孔器械500具有多根定位柱510,定位柱510所钻出的定位孔的位置可对应图1的软骨修复载体100的定位柱120的位置。举例来说,若定位柱120的数量是三个,三个定位柱120相较于钻孔器械500的中心轴的方位角为0度、120度与240度,也就是三个定位柱120是以点对称的方式分部。定位柱120的外表面与其中心轴线的夹角例如是3度到5度,以钻出具有斜率的定位孔。具体而言,因为定位孔具有斜率,所以软骨修复载体100的定位柱120越深入定位孔内,定位孔就能越紧迫地抓住定位柱120,以将软骨修复载体100牢牢固定在患者的患部。6 is a schematic diagram of a drilling instrument of a surgical instrument set according to an embodiment of the present invention. 3 and 6 at the same time, the drilling instrument 500 of this embodiment is used to drill a plurality of positioning holes (not shown) in the hard bone of the patient to be implanted through the through channel T10 of the positioning sleeve 200 Show). For example, the drilling instrument 500 has a plurality of positioning posts 510 , and the positions of the positioning holes drilled by the positioning posts 510 may correspond to the positions of the positioning posts 120 of the cartilage repair carrier 100 in FIG. 1 . For example, if the number of the positioning columns 120 is three, the azimuth angles of the three positioning columns 120 relative to the central axis of the drilling instrument 500 are 0 degrees, 120 degrees and 240 degrees, that is, the three positioning columns 120 are Divide in a point-symmetric fashion. The included angle between the outer surface of the positioning post 120 and its central axis is, for example, 3 degrees to 5 degrees, so as to drill a positioning hole with a slope. Specifically, because the positioning hole has a slope, the deeper the positioning post 120 of the cartilage repair carrier 100 is in the positioning hole, the more tightly the positioning hole can grasp the positioning post 120 to firmly fix the cartilage repair carrier 100 on the patient's body. affected part.
此外,在另一实施例中,钻孔器械500例如具有一第三定位结构520,第三定位结构520与图3的第一定位结构210相互对位。因此,钻孔器械500在外套管310内滑动时的方位会受到限制,进而确保钻孔器械500钻出的定位孔的位置对应后续植入的软骨修复载体100的定位柱120的位置。In addition, in another embodiment, the drilling instrument 500 has, for example, a third positioning structure 520, and the third positioning structure 520 is aligned with the first positioning structure 210 in FIG. 3 . Therefore, the orientation of the drilling instrument 500 when sliding in the outer sleeve 310 is limited, thereby ensuring that the position of the positioning hole drilled by the drilling instrument 500 corresponds to the position of the positioning post 120 of the subsequently implanted cartilage repair carrier 100 .
图7A至图7G是使用本发明一实施例的软骨修复系统对猪只进行软骨修复手术的各阶段的照片。请先参照图7A,选用了一般成猪作为建立膝关节微创手术的对象。实验过程中记录了包括猪的编号、大约年龄、体重、性别以及在手术和尸体解剖方面的相关信息。手术前各猪只需先禁食24小时,手术所使用的麻醉剂为3%sodium pentobarbital,由后腿部注射,剂量约为1mL/kg,并视各猪只的麻醉情况而增减剂量。待确认麻醉后,将猪只剃毛并用碘酒消毒,且以无菌巾覆盖手术部位之外的地方,只露出关节位置,以确保手术是在无菌状态下进行。接着,于外侧皮肤切开约3cm伤口,剥离软组织后露出欲植入如图1所示的软骨修复载体100的位置。7A to 7G are photographs of various stages of cartilage repair surgery performed on pigs using the cartilage repair system according to an embodiment of the present invention. Please refer to FIG. 7A first, a general adult pig is selected as the object for establishing minimally invasive knee joint surgery. The number of pigs, approximate age, body weight, sex, and relevant information on surgery and autopsy were recorded during the experiment. Before the operation, the pigs only needed to fast for 24 hours. The anesthetic used in the operation was 3% sodium pentobarbital, which was injected from the hind leg at a dose of about 1 mL/kg, and the dose was increased or decreased according to the anesthesia of each pig. After confirming anesthesia, the pigs were shaved and disinfected with iodine, and a sterile towel was used to cover the area outside the surgical site, and only the joints were exposed to ensure that the operation was performed in a sterile state. Next, a wound of about 3 cm is incised on the outer skin, and the soft tissue is peeled off to expose the position where the cartilage repair carrier 100 as shown in FIG. 1 is to be implanted.
接着请参照图7B,将如图3所示的定位套管200放置在患部,然后将定位套管200的两根套管定位柱220打入并固定在患部。接着请参照图7C,使用如图4A所示的按压式器械300插入定位套管200并以塑形刀在患部切出待植入区A10。接着,使用如图5所示的清创钻头400插入定位套管200而清除位于待植入区A10的软骨组织。Next, please refer to FIG. 7B , place the positioning sleeve 200 shown in FIG. 3 on the affected part, and then drive the two sleeve positioning posts 220 of the positioning sleeve 200 into the affected part and fix it. Next, referring to FIG. 7C , use the pressing device 300 shown in FIG. 4A to insert the positioning sleeve 200 and use a shaping knife to cut out the area A10 to be implanted in the affected part. Next, the debridement drill 400 shown in FIG. 5 is used to insert the positioning sleeve 200 to remove the cartilage tissue in the area A10 to be implanted.
接着请参照图7D,将如图6所示的钻孔器械500插入定位套管200,并在位于待植入区A10的硬骨上钻出如图7E所示的多个定位孔P20。接着请参照图7F,将如图1所示的软骨修复载体100放置于待植入区A10。为了方便理解,在图7F中是将软骨修复载体100放置于待植入区A10旁,但实际手术时是使用如图4A所示的按压式器械300将软骨修复载体100直接推入待植入区A10。由于塑形刀的形状是对应软骨修复载体100的形状,且钻孔器械500与定位套管200之间也有互相对位的定位结构,因此钻孔器械500所钻出的定位孔P20的位置会直接对应软骨修复载体100的定位柱120,而不需要额外进行对位的步骤,不仅可缩短手术所需的时间,并因精准对位而可提高手术成功机率。图7G显示软骨修复载体100已经置入待植入区A10。7D, insert the drilling instrument 500 shown in FIG. 6 into the positioning sleeve 200, and drill a plurality of positioning holes P20 shown in FIG. 7E in the hard bone in the area A10 to be implanted. Next, referring to FIG. 7F , the cartilage repair carrier 100 shown in FIG. 1 is placed in the area A10 to be implanted. For the convenience of understanding, in FIG. 7F , the cartilage repair carrier 100 is placed beside the area A10 to be implanted, but in actual operation, the pressing instrument 300 as shown in FIG. 4A is used to directly push the cartilage repair carrier 100 into the area to be implanted District A10. Since the shape of the shaping knife corresponds to the shape of the cartilage repair carrier 100 , and the drilling instrument 500 and the positioning sleeve 200 also have positioning structures that are aligned with each other, the position of the positioning hole P20 drilled by the drilling instrument 500 will be different. Directly corresponding to the positioning column 120 of the cartilage repair carrier 100 , no additional alignment step is required, which not only shortens the time required for the operation, but also improves the success rate of the operation due to the precise alignment. FIG. 7G shows that the cartilage repair carrier 100 has been placed in the area A10 to be implanted.
图8是本发明一实施例的软骨修复载体的使用方式的示意图。请参照图8,软骨修复材料是取自于患者本身,特别是取自于关节非受应力处的软骨,例如以刮匙刮取自体软骨。将上述取出的自体软骨置于10cm的培养皿中,以手术刀将软骨切碎,碎片大小以20孔目到40孔目的筛网控制在560-800μm之间。切碎的软骨碎片收集于15ml的离心管中,加入5ml的胶原蛋白酶(collagenase),置于37℃的培养箱中,静置1小时,使部分软骨细胞游离出来。胶原蛋白酶是置于磷酸盐缓冲溶液(phosphate-buffered saline,PBS)中,并调整其比例为2mg/ml PBS。以胶原蛋白酶分离溶解过后的软骨骨块置于离心机中,以转速1500r.p.m.离心5分钟,将胶原蛋白酶与软骨块加以分离。离心后的软骨碎片,经吸除澄清的胶原蛋白酶上清液(supernatant)后,余留的软骨碎片及细胞组织再以PBS冲洗两次,且离心两次,以除去残留的胶原蛋白酶而完成软骨修复材料的制备。FIG. 8 is a schematic diagram of the usage of the cartilage repair carrier according to an embodiment of the present invention. Please refer to FIG. 8 , the cartilage repair material is obtained from the patient itself, especially from the cartilage at the unstressed joint of the joint, for example, the autologous cartilage is scraped with a curette. The autologous cartilage taken out above was placed in a 10 cm petri dish, and the cartilage was minced with a scalpel. The size of the fragments was controlled between 560-800 μm with a 20-hole to 40-hole mesh screen. The minced cartilage fragments were collected in a 15 ml centrifuge tube, 5 ml of collagenase was added, and placed in a 37° C. incubator for 1 hour to free some chondrocytes. Collagenase was placed in phosphate-buffered saline (PBS), and its ratio was adjusted to 2 mg/ml PBS. The dissolved cartilage block was separated with collagenase, placed in a centrifuge, and centrifuged at 1500 r.p.m. for 5 minutes to separate collagenase from the cartilage block. The cartilage fragments after centrifugation, after suctioning off the clarified collagenase supernatant (supernatant), the remaining cartilage fragments and cell tissue were washed twice with PBS and centrifuged twice to remove the residual collagenase to complete the cartilage. Preparation of restorative materials.
接着,将前述制备完成的软骨修复材料置入1c.c.注射针筒中,并配合18号针头(18G)以注射的方式将制备完成软骨修复材料置于软骨修复载体100上。之后,软骨修复载体100是以承载软骨修复材料的一面朝向患部进行置放,以使软骨修复材料直接接触患部。由于软骨修复材料具备一定的粘稠性,因此并不容易从软骨修复载体上掉出。Next, the above-prepared cartilage repair material is placed into a 1c.c. injection syringe, and an 18-gauge needle (18G) is used to inject the prepared cartilage repair material onto the cartilage repair carrier 100 . After that, the cartilage repair carrier 100 is placed with the side bearing the cartilage repair material facing the affected part, so that the cartilage repair material directly contacts the affected part. Since the cartilage repair material has a certain viscosity, it is not easy to fall off the cartilage repair carrier.
图9A与图9B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经复原后的患部照片,手术对象都为如上述的猪只。由图9A可以看出,使用本发明一实施例的手术用具组进行手术后12个月,患部(如箭头所指处)的软骨复原良好,几乎看不到伤口痕迹。反之,以传统手术用具组进行手术者,12个月后患部(如图9B箭头所指处)的软骨复原状况较差,伤口痕迹明显。9A and 9B are respectively pictures of the restored affected part of an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical tools for surgery. As can be seen from FIG. 9A , 12 months after the operation using the surgical tool set of an embodiment of the present invention, the cartilage of the affected part (as indicated by the arrow) recovered well, and almost no wound traces were seen. On the contrary, for those who underwent surgery with the traditional surgical instrument group, the cartilage in the affected part (indicated by the arrow in Figure 9B) after 12 months was in a poor state of recovery, and the wound marks were obvious.
图10A与图10B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经6个月复原后的患部X光片,手术对象都为如上述的猪只。由图10A可以看出,使用本发明一实施例的手术用具组进行手术后6个月,患部的软骨复原迅速,伤口深度仅2.8mm。反之,以传统手术用具组进行手术者,6个月后患部的软骨复原较慢,如图10B所示,伤口深度达13.4mm。FIG. 10A and FIG. 10B are respectively the X-ray films of the affected part after six months of recovery of an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical tools for surgery. pigs. As can be seen from FIG. 10A , 6 months after the operation using the surgical instrument set according to an embodiment of the present invention, the cartilage in the affected part recovered rapidly, and the wound depth was only 2.8 mm. On the contrary, in those who performed the operation with the traditional surgical instrument group, the recovery of the cartilage in the affected part was slow after 6 months, as shown in Fig. 10B , and the depth of the wound was 13.4 mm.
图11A与图11B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经6个月复原后的患部样本照片,手术对象都为如上述的猪只。由图11A可以看出,使用本发明一实施例的手术用具组进行手术后6个月,患部(如箭头所指处)的硬骨复原迅速,仅少许手术残留物,且软骨复原良好。反之,以传统手术用具组进行手术者,6个月后患部(如图11B箭头所指处)的硬骨复原速度较慢,有许多手术残留物。11A and FIG. 11B are respectively pictures of the affected part samples after 6 months of recovery from an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical tools for surgery. pig. It can be seen from FIG. 11A , 6 months after the operation using the surgical tool set of an embodiment of the present invention, the hard bone of the affected part (as indicated by the arrow) recovered rapidly, with only a few surgical residues, and the cartilage recovered well. On the contrary, for those who performed surgery with the traditional surgical instrument group, the recovery of the hard bone in the affected part (indicated by the arrow in Figure 11B ) was slow after 6 months, and there were many surgical residues.
图12A与图12B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经12个月复原后的患部样本照片,手术对象都为如上述的猪只。由图12A可以看出,使用本发明一实施例的手术用具组进行手术后12个月,患部(如箭头所指处)的硬骨复原良好,几乎没有手术残留物,且新生硬骨组织已确实长入。反之,以传统手术用具组进行手术者,12个月后患部(如图12B箭头所指处)的硬骨复原状况较差,仍有不少手术残留物。12A and FIG. 12B are respectively photos of the affected part samples after 12 months of recovery from an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical tools for surgery. The surgical objects are all as described above. pig. As can be seen from FIG. 12A , 12 months after the operation using the surgical instrument set of an embodiment of the present invention, the hard bone of the affected part (as indicated by the arrow) recovered well, with almost no surgical residue, and the new hard bone tissue has indeed grown. enter. On the contrary, for those who operated with the traditional surgical instrument group, the recovery of the hard bone in the affected part (indicated by the arrow in Fig. 12B ) was poor after 12 months, and there were still many surgical residues.
图13A与图13B分别是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例经复原后的患部的染色切片,手术对象都为如上述的猪只。图13A与图13B是使用番红(Safranin-O)与固绿(Fast Green FCF)同时进行染色,以进一步检视软骨增生状况及硬骨复原状况。13A and FIG. 13B are respectively the restored stained sections of the affected part of an experimental example using the cartilage repair system according to an embodiment of the present invention and a control example using traditional surgical tools for surgery, and the surgical objects are all pigs as described above. . Fig. 13A and Fig. 13B are stained with Safranin-O and Fast Green FCF at the same time to further examine the condition of cartilage hyperplasia and the condition of hard bone recovery.
请同时参照图13A与图13B,由番红的染色区域可以看出,使用本发明一实施例的手术用具组进行手术后12个月,如图13A中上方箭头所指处,软骨增生状况良好,而使用传统手术用具组进行手术者,如图13B中上方箭头所指处,软骨增生状况普通。另一方面,由固绿的染色区域可以看出,使用本发明一实施例的手术用具组进行手术后12个月,如图13A中中间箭头所指处,硬骨复原状况良好,而使用传统手术用具组进行手术者,如图13B中中间箭头所指处,硬骨几乎没有增生。Please refer to FIG. 13A and FIG. 13B at the same time. It can be seen from the stained area of safranin that 12 months after the operation using the surgical tool set according to an embodiment of the present invention, as indicated by the upper arrow in FIG. 13A , the cartilage hyperplasia is in good condition. , while those who performed surgery using the traditional surgical tool set, as indicated by the upper arrow in Figure 13B, had normal cartilage hyperplasia. On the other hand, it can be seen from the stained area of fast green that 12 months after the operation using the surgical tool set according to an embodiment of the present invention, as indicated by the middle arrow in FIG. For those who underwent surgery in the appliance group, as indicated by the middle arrow in Fig. 13B, there was almost no hyperplasia of hard bone.
图14是使用本发明一实施例的软骨修复系统进行手术的实验例以及使用传统手术用具进行手术的对照例的伤口宽度的量化图。请参照图14,使用本发明一实施例的手术用具组进行手术的实验例在手术后半年的伤口宽度仅是使用传统手术用具进行手术的对照例在手术后半年的伤口宽度的60%,且前述实验例于手术后一年的伤口宽度约为对照例于手术后一年的伤口宽度的50%。FIG. 14 is a quantification diagram of the wound width of an experimental example performed using the cartilage repair system according to an embodiment of the present invention and a control example performed using a conventional surgical tool. Referring to FIG. 14 , the wound width of the experimental example using the surgical instrument set according to an embodiment of the present invention in the second half of the operation is only 60% of the wound width of the control example using the traditional surgical instrument in the second half of the operation, and The wound width of the experimental example at one year after the operation was about 50% of the wound width of the control example at one year after the operation.
综上所述,在本发明的软骨修复载体、所搭配的手术用具组与软骨修复系统中,软骨修复载体采用了多孔性结构,有助于新旧软骨组织间的间隙融合,而手术用具组使得微创软骨修复手术成为可能。此外,软骨修复载体采用生物可降解的材料时,可承载促进软骨修复的物质,搭配可定位的手术用具组,以微创的方式,精确地将软骨修复载体定位并植入患者的患部。如此,可在对硬骨破坏较小的情况下协助重建软骨缺损部位,并且在修复完成后软骨修复载体可在体内自然分解并代谢。To sum up, in the cartilage repair carrier, the matched surgical tool set and the cartilage repair system of the present invention, the cartilage repair carrier adopts a porous structure, which is helpful for the gap fusion between new and old cartilage tissues, and the surgical tool set makes Minimally invasive cartilage repair surgery possible. In addition, when the cartilage repair carrier is made of biodegradable materials, it can carry substances that promote cartilage repair. With a positionable surgical tool set, the cartilage repair carrier can be accurately positioned and implanted into the affected part of the patient in a minimally invasive manner. In this way, the cartilage defect site can be reconstructed with less damage to the hard bone, and the cartilage repair carrier can be naturally decomposed and metabolized in the body after the repair is completed.
虽然结合以上实施例公开了本发明,然而其并非用以限定本发明,任何所属技术领域中具有通常知识者,在不脱离本发明的精神和范围内,可作些许的更动与润饰,故本发明的保护范围应当以附上的权利要求所界定的为准。Although the present invention is disclosed in conjunction with the above embodiments, it is not intended to limit the present invention. Anyone with ordinary knowledge in the technical field can make some changes and modifications without departing from the spirit and scope of the present invention. Therefore, The scope of protection of the present invention should be defined by the appended claims.
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