TWI654971B - Cartilage repair implant, auxiliary surgical tool kit and cartilage repair system - Google Patents

Cartilage repair implant, auxiliary surgical tool kit and cartilage repair system Download PDF

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TWI654971B
TWI654971B TW106146212A TW106146212A TWI654971B TW I654971 B TWI654971 B TW I654971B TW 106146212 A TW106146212 A TW 106146212A TW 106146212 A TW106146212 A TW 106146212A TW I654971 B TWI654971 B TW I654971B
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positioning
cartilage
sleeve
passage
surgical tool
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TW201929791A (en
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江清泉
張方杰
楊明嘉
林芸含
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財團法人工業技術研究院
國立臺灣大學醫學院附設醫院
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Abstract

一種軟骨修復載體、所搭配的手術用具組與軟骨修復系統。軟骨修復載體包括本體與多個定位柱。本體為多孔性結構且用以承載軟骨修復材料。定位柱固定至本體且用以插入患者的硬骨。手術用具組包括定位套管以及按壓式器械。定位套管具有貫穿通道。貫穿通道的側壁上具有第一定位結構。按壓式器械包括外套管與推桿。外套管的外壁上具有與第一定位結構相互對位的第二定位結構。外套管用以穿過定位套管的貫穿通道。推桿可滑動地設置於外套管內。外套管的一端具有塑形刀,用以在患者的患部上切出待植入區,其中待植入區的形狀對應本體的形狀。A cartilage repairing vehicle, a surgical tool set and a cartilage repairing system. The cartilage repair carrier includes a body and a plurality of positioning posts. The body is a porous structure and is used to carry a cartilage repair material. The positioning post is secured to the body and is used to insert a patient's hard bone. The surgical kit includes a positioning sleeve and a push-on instrument. The positioning sleeve has a through passage. There is a first positioning structure on the side wall of the through passage. The push-type instrument includes an outer sleeve and a push rod. The outer wall of the outer sleeve has a second positioning structure that is aligned with the first positioning structure. The outer sleeve is for passing through the through passage of the positioning sleeve. The push rod is slidably disposed within the outer sleeve. One end of the outer sleeve has a shaping knife for cutting the area to be implanted on the affected part of the patient, wherein the shape of the area to be implanted corresponds to the shape of the body.

Description

軟骨修復載體、所搭配的手術用具組與軟骨修復系統Cartilage repair carrier, surgical tool set and cartilage repair system

本發明是有關於一種載體、用具組與系統,且特別是有關於一種軟骨修復載體、所搭配的手術用具組與軟骨修復系統。The present invention relates to a carrier, a kit and system, and more particularly to a cartilage repair carrier, a surgical kit and a cartilage repair system.

關節軟骨組織位於關節面的硬骨表層,在人體組織中是一個具有多功能且相當特殊的組織,其主要功能在於傳遞關節面上下硬骨的不同方向應力、吸收硬骨層傳送關節面的衝擊力、提供低磨擦係數的潤滑關節面、及配合肌肉韌帶組織,以於關節活動時可產生滑動及滾動的不同方向的運動模式。The articular cartilage tissue is located on the surface of the hard bone of the articular surface. It is a multifunctional and quite special tissue in human tissue. Its main function is to transmit the different direction stress of the lower surface of the articular surface, and absorb the impact of the hard bone layer to transmit the articular surface. The low friction coefficient lubricates the articular surface and cooperates with the muscle ligament tissue to produce a sliding and rolling motion pattern in different directions when the joint is active.

軟骨組織的自我修復和再生能力皆十分的不足,一旦受到損害,往往無法自行復原。據統計,目前美國每年因軟骨深層次傷害,而需進行人工關節置換手術者可達20萬例以上,且案例仍逐年攀升中。然而,置換人工關節需切除患者關節面的大量的軟骨及硬骨組織,傷害及破壞性皆相當大,且材質為金屬的人工關節植入體內後,只能維持十至十五年左右的功能。以年輕患者而言,將面臨再次人工關節置換手術的痛苦,而對老年病患來說,則往往無法承受再次置換人工關節的手術。再者,反覆置換人工關節很可能導致殘疾且不良於行,進而造成社會及家庭沉重的負擔。The self-repairing and regenerative ability of cartilage tissue is very inadequate. Once damaged, it is often unable to recover itself. According to statistics, at present, there are more than 200,000 cases of artificial joint replacement surgery in the United States due to deep-level injury of cartilage, and the case is still rising year by year. However, replacing the artificial joint requires removal of a large amount of cartilage and hard bone tissue on the joint surface of the patient, and the damage and destructiveness are quite large, and the artificial joint made of metal is only able to maintain the function for ten to fifteen years after being implanted into the body. In the case of young patients, it will face the pain of re-artificial replacement surgery, and for elderly patients, it is often impossible to undergo surgery to replace the artificial joint again. Furthermore, repeated replacement of artificial joints is likely to result in disability and poor behavior, which in turn creates a heavy burden on society and the family.

目前醫界對於軟骨受損的治療方法,主要是採用軟骨移植(cartilage transplantation),以修補受損的軟骨區塊。此法為近廿年內所發明的新穎醫療方法,包含自體軟骨移植(ACI, autologous chondrocyte implantation)以及異體骨關節移植(OA, osteoarticular allograft),即採用自體或異體的軟骨移植再生新組織,可避免置換人工關節的永久性破壞,亦不需定期再開刀替換老化的金屬或塑膠組件。上述治療方法中,又以自體軟骨移植較廣為接受,因為其移植物來源為患者本身的組織,不會發生異體或異種移植免疫排斥的問題。At present, the medical treatment of cartilage damage is mainly the use of cartilage transplantation to repair damaged cartilage blocks. This method is a novel medical method invented in the last year, including autologous chondrocyte transplantation (ACI) and autologous bone graft (OA, osteoarticular allograft), that is, autologous or allogeneic cartilage transplantation to regenerate new tissue. It can avoid the permanent damage of the replacement artificial joints, and it is not necessary to periodically replace the aging metal or plastic components. Among the above treatment methods, autologous cartilage transplantation is widely accepted because the graft source is the patient's own tissue, and no problem of allogeneic or xenograft immune rejection occurs.

自體移植的手術方法主流為「馬賽克彌補法(Mosaic plasty procedure)」,此法為匈牙利的外科醫師於1995年所提出,該手術方法將病患關節不受應力的關節面軟骨,以環鋸鑽取一塊含有軟骨及下層接觸的硬骨圓柱狀栓塊,並於受損部位以相同的環鋸鑽出相同直徑的填補凹槽,再將未受損的健康自體軟硬骨栓塊填入。然而,以馬賽克彌補法在修復軟骨創傷時,所植入的軟骨栓塊間的軟骨面有一如磁磚的界面,而此界面間的軟骨細胞由於被包覆在大量的基質中,其分裂能力相當差。因此,軟骨栓塊間事實上並不易形成再生融合;另一方面,軟骨栓塊周邊間隙將產生纖維軟骨組織,造成日後該受創面容易產生退化性關節炎。The main surgical method for autografting is the "Mosaic plasty procedure", which was proposed by a Hungarian surgeon in 1995. The surgical method is to treat the joints of the patient without stress. Drill a piece of hard bone cylindrical plug containing cartilage and lower layer contact, and drill the same diameter of the filling groove with the same ring saw at the damaged part, and then fill the undamaged healthy autologous soft and hard bone block . However, when the cartilage wound is repaired by the mosaic compensation method, the cartilage surface between the implanted cartilage plugs has a tile interface, and the chondrocytes between the interfaces are coated in a large amount of matrix, and their splitting ability. Quite poor. Therefore, it is not easy to form regenerative fusion between the cartilage blocks; on the other hand, the fibrous cartilage tissue will be generated in the peripheral space of the cartilage block, which may cause degenerative arthritis in the wound surface in the future.

目前以組織工程體外培養軟骨組織修復軟骨損傷亦有同樣的困擾,以及,體外所培養的軟骨組織植入軟骨受創面後,新舊軟骨組織間的間隙融合問題仍為目前無法突破的難題。因此,如何克服移植軟骨(implant)與原軟骨組織(host)間的組織再生融合,為目前相當重要且亟待解決的骨科臨床研究課題。At present, the tissue culture in vitro culture of cartilage tissue to repair cartilage damage has the same problem, and after the cartilage tissue cultured in vitro is implanted into the cartilage, the problem of gap fusion between the old and new cartilage tissue is still a difficult problem that cannot be broken. 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 problem in orthopedic clinical research.

本發明提供一種軟骨修復載體、所搭配的手術用具組與軟骨修復系統,可改善現有軟骨修復手術所存在的問題。The invention provides a cartilage repairing carrier, a matched surgical tool set and a cartilage repairing system, which can improve the problems existing in the existing cartilage repairing surgery.

本發明的一實施例的軟骨修復載體包括一本體與多個定位柱。本體為多孔性結構且用以承載軟骨修復材料。各個定位柱的一端固定至本體,且另一端用以插入一患者的硬骨。A cartilage repairing 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 a cartilage repair material. One end of each positioning post is fixed to the body, and the other end is used to insert a patient's hard bone.

本發明的一實施例的手術用具組包括一定位套管以及一按壓式器械。定位套管具有一貫穿通道。貫穿通道的側壁上具有一第一定位結構。按壓式器械包括一外套管與一推桿。外套管的外壁上具有一第二定位結構。外套管用以穿過定位套管的貫穿通道。第二定位結構與第一定位結構相互對位。推桿可滑動地設置於外套管內。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區。A surgical tool set according to an embodiment of the invention includes a positioning sleeve and a push-type instrument. The positioning sleeve has a through passage. A first positioning structure is formed on the sidewall of the through passage. The push-type instrument includes an outer sleeve and a push rod. The outer sleeve of the outer sleeve has a second positioning structure. The outer sleeve is for passing through the through passage of the positioning sleeve. The second positioning structure and the first positioning structure are aligned with each other. The push rod is slidably disposed within the outer sleeve. One end of the outer cannula has a shaping knife for cutting a region to be implanted on the affected part of the patient.

本發明的一實施例的軟骨修復系統包括一軟骨修復載體、一定位套管以及一按壓式器械。軟骨修復載體包括一本體與多個定位柱。本體為多孔性結構且用以承載軟骨修復材料。各個定位柱的一端固定至本體,且另一端用以插入一患者的硬骨。定位套管具有一貫穿通道。貫穿通道的側壁上具有一第一定位結構。按壓式器械包括一外套管與一推桿。外套管的外壁上具有一第二定位結構。外套管用以穿過定位套管的貫穿通道。第二定位結構與第一定位結構相互對位。推桿可滑動地設置於外套管內。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區。待植入區的形狀對應本體的形狀。A cartilage repair system according to an embodiment of the present invention includes a cartilage repair carrier, a positioning sleeve, and a push-type 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 a cartilage repair material. One end of each positioning post is fixed to the body, and the other end is used to insert a patient's hard bone. The positioning sleeve has a through passage. A first positioning structure is formed on the sidewall of the through passage. The push-type instrument includes an outer sleeve and a push rod. The outer sleeve of the outer sleeve has a second positioning structure. The outer sleeve is for passing through the through passage of the positioning sleeve. The second positioning structure and the first positioning structure are aligned with each other. The push rod is slidably disposed within the outer sleeve. One end of the outer cannula has a shaping knife for cutting 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.

基於上述,在本發明的軟骨修復載體、所搭配的手術用具組與軟骨修復系統中,具有多孔性結構的軟骨修復載體有助於新舊軟骨組織間的間隙融合,而手術用具組使得軟骨修復載體可輕鬆植入患者的患部。Based on the above, in the cartilage repairing carrier, the paired surgical tool set and the cartilage repairing system of the present invention, the cartilage repairing carrier having a porous structure contributes to the gap fusion between the old and new cartilage tissues, and the surgical tool set enables the cartilage repair The carrier can be easily implanted into the affected part of the patient.

為讓本發明的上述特徵和優點能更明顯易懂,下文特舉實施例,並配合所附圖式作詳細說明如下。The above described features and advantages of the invention will be apparent from the following description.

本發明的一實施例的手術用具組包括一定位套管以及一按壓式器械。此外,本發明一實施例的軟骨修復系統除了上述的手術用具組之外,還包括一軟骨修復載體。A surgical tool set according to an embodiment of the invention includes a positioning sleeve and a push-type instrument. Further, a cartilage repairing system according to an embodiment of the present invention includes a cartilage repairing carrier in addition to the above-described surgical tool set.

圖1是本發明一實施例的軟骨修復載體的示意圖,圖2是本發明一實施例的軟骨修復載體的實體照片。請同時參照圖1與圖2,在一實施例中,此軟骨修復載體100包括一本體110與多個定位柱120。本體110為多孔性結構,用以承載軟骨修復材料。定位柱120為實心結構,各個定位柱120的一端固定至本體110,另一端於手術過程中將用以插入患者的硬骨,以便將整個軟骨修復載體100固定於患者的硬骨上。選擇性地,本實施例的本體110可更具有一凹槽114,且以凹槽114的空間承載將用以修復軟骨的材料。BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view showing a cartilage repairing carrier according to an embodiment of the present invention, and Fig. 2 is a photograph of a body of a cartilage repairing carrier according to an embodiment of the present invention. Referring to FIG. 1 and FIG. 2 simultaneously, in an embodiment, the cartilage repairing carrier 100 includes a body 110 and a plurality of positioning posts 120. The body 110 is a porous structure for carrying a cartilage repair material. The positioning post 120 is a solid structure, one end of each positioning post 120 is fixed to the body 110, and the other end is used to insert a bone of the patient during the surgery to fix the entire cartilage repairing carrier 100 to the patient's hard bone. Alternatively, the body 110 of the present embodiment may further have a recess 114 and carry the material that will be used to repair the cartilage with the space of the recess 114.

在一實施例中,軟骨修復載體100的本體110由於採用了多孔性結構,可讓鄰近組織或細胞與潤滑液透過孔徑進入本體110的內部或凹槽114的空間中,與軟骨修復材料共同修復患部,進而提升復原的效果。In one embodiment, the body 110 of the cartilage repairing carrier 100 has a porous structure that allows adjacent tissue or cells and lubricating fluid to pass through the aperture into the interior of the body 110 or the space of the recess 114, and repair together with the cartilage repair material. The affected part enhances the healing effect.

在一實施例中,本體110的材料可採用生物可降解材料。因此,在患者的患部修復完成後,軟骨修復載體100可在體內自然分解並代謝,只留下恢復功能的正常軟骨,而不留下任何非人體本身的天然產物在體內。在一實施例中,本體110的材料可使用單一種生物可降解材料,材料組成成分較為單純,可進一步縮短完全降解所需要的時間。在一實施例中,本體110的材料可為單一高分子材料,例如是聚乳酸(Polylactide, PLA)、聚乙醇酸(Polyglycolic Acid, PGA)、聚己內酯(Polycaprolactone, PCL)、聚乙烯醇(Polyvinyl alcohol, PVA)、聚羥基烷酸(polyhydroxy-alkanoates, PHA),但不限於此。在另一實施例中,本體110的材料可為複合高分子材料,例如是至少兩種上述聚合物的共聚物(co-polymer),但不限於此。In an 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 repairing carrier 100 can be naturally decomposed and metabolized in the body, leaving only the normal cartilage that restores function, without leaving any natural products other than the human body itself in the body. In an embodiment, the material of the body 110 can use a single biodegradable material, and the material composition is relatively simple, which can further shorten the time required for complete degradation. In an embodiment, the material of the body 110 may be a single polymer material, such as polylactide (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polyvinyl alcohol. (Polyvinyl alcohol, PVA), polyhydroxy-alkanoates (PHA), but is not limited thereto. In another embodiment, the material of the body 110 may be a composite polymer material, for example, a copolymer of at least two of the above polymers, but is not limited thereto.

在一實施例中,定位柱120的材料可採用生物可降解材料。在一實施例中,定位柱120的材料可使用單一種生物可降解材料,材料組成成分較為單純,可進一步縮短完全降解所需要的時間。在一實施例中,定位柱120的材料可為單一高分子材料,例如是聚乳酸(Polylactide, PLA)、聚乙醇酸(Polyglycolic Acid, PGA)、聚己內酯(Polycaprolactone, PCL)、聚乙烯醇(Polyvinyl alcohol, PVA)、聚羥基烷酸(polyhydroxy-alkanoates, PHA),但不限於此。在另一實施例中,定位柱120的材料可為複合高分子材料,例如是至少兩種上述聚合物的共聚物(co-polymer),但不限於此。本體110的材料與定位柱120的材料可以相同或不同。In an embodiment, the material of the positioning post 120 may be a biodegradable material. In an embodiment, the material of the positioning post 120 can use a single biodegradable material, and the material composition is relatively simple, which can further shorten the time required for complete degradation. In an embodiment, the material of the positioning post 120 may be a single polymer material, such as polylactide (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polyethylene. Polyvinyl alcohol (PVA), polyhydroxy-alkanoates (PHA), but is not limited thereto. In another embodiment, the material of the positioning post 120 may be a composite polymer material, for example, a copolymer of at least two of the above polymers, but is not limited thereto. The material of the body 110 and the material of the positioning post 120 may be the same or different.

在一實施例中,本體110的多孔性結構的孔隙度為50%~90%,例如是50%、55%、60%、65%、70%、75%、80%、85%、90%。此外,多孔性結構的孔徑大小約為50 mm到1,000 mm。在一實施例中,本體110的外觀型態可為圓盤狀或殼蓋狀,但不限於此。在一實施例中,本體110的直徑可為約8 mm到10 mm,可適用於軟骨上不同程度的缺損。本體110的壁厚可為1 mm到1.5 mm,具有足夠強度以抵抗周圍組織的壓縮力,並且不至於壓縮到軟骨修復材料的存放空間。本體110的總高度可為1.8 mm到2.2 mm,與人類膝關節軟骨層的厚度大致相同,以便於操作過程中不至侵害到硬骨層,且於手術後不會突出於膝關節表面,可避免被關節面磨損。在一實施例中,定位柱120的直徑可以是1 mm到2 mm,長度可以是2 mm到3 mm,且可以是實心柱體,以便以一對硬骨而言破壞最小的方式將本體110固定在軟骨受損處。In an 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 porous structure has a pore size of about 50 mm to 1,000 mm. In an embodiment, the appearance of the body 110 may be a disk shape or a shell shape, but is not limited thereto. In one embodiment, the body 110 can have a diameter of between about 8 mm and 10 mm and is suitable for use with varying degrees of defect on the cartilage. The body 110 may have a wall thickness of 1 mm to 1.5 mm, has sufficient strength to resist the compressive forces of the surrounding tissue, and does not compress to the storage space of the cartilage repair material. The total height of the body 110 can be 1.8 mm to 2.2 mm, which is substantially the same as the thickness of the human knee cartilage layer, so as not to invade the hard bone layer during operation, and does not protrude from the knee joint surface after surgery, and can be avoided. Wear by the joint surface. In an embodiment, the positioning post 120 may have a diameter of 1 mm to 2 mm, a length of 2 mm to 3 mm, and may be a solid cylinder to secure the body 110 in a manner that minimizes damage in a pair of hard bones. In the cartilage damage.

在一實施例中,本體110的外圍可具有一定位角112。定位角112可以是約0.5 mm到1 mm的突出的小尖點,例如是外型呈現為三角形的突出,但不限於此。此定位角112可搭配其他手術器械上的定位結構,可於手術過程中輔助定位而將軟骨修復載體100導引至正確的位置。In an embodiment, the periphery of the body 110 can have a positioning angle 112. The locating angle 112 may be a protruding small cusp of about 0.5 mm to 1 mm, such as a protrusion that is triangular in appearance, but is not limited thereto. The locating angle 112 can be used with a positioning structure on other surgical instruments to assist in positioning during the surgical procedure to guide the cartilage repair carrier 100 to the correct position.

圖3是本發明一實施例的手術用具組的定位套管的示意圖。請參照圖3,定位套管200具有一貫穿通道T10。貫穿通道T10的側壁W10上具有一第一定位結構210。圖4A與圖4B分別是本發明一實施例的手術用具組的按壓式器械的外觀示意圖與剖面示意圖。請參照圖4A與圖4B,按壓式器械300包括一外套管310與一推桿320。外套管310的外壁W20上具有一第二定位結構312。外套管310用以穿過圖3的定位套管200的貫穿通道T10。第二定位結構312與圖3的第一定位結構210可相互對位,以確保定位套管200與按壓式器械300於操作過程中可精準定位。推桿320以可滑動形式設置於外套管310內,透過按壓或推動可在外套管310內進行滑動。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區(未繪示)。待植入區的形狀可對應圖1的本體110的形狀。3 is a schematic view of a positioning sleeve of a surgical tool set according to an embodiment of the present invention. Referring to FIG. 3, the positioning sleeve 200 has a through passage T10. A first positioning structure 210 is formed on the side wall W10 of the through-channel T10. 4A and 4B are respectively a schematic view and a cross-sectional view showing a push type device of a surgical tool set according to an embodiment of the present invention. Referring to FIGS. 4A and 4B, the push-type instrument 300 includes an outer sleeve 310 and a push rod 320. The outer wall W20 of the outer sleeve 310 has a second positioning structure 312 thereon. The outer sleeve 310 is used to pass through the through passage T10 of the positioning sleeve 200 of FIG. The second positioning structure 312 and the first positioning structure 210 of FIG. 3 can be aligned with each other to ensure that the positioning sleeve 200 and the push-type instrument 300 can be accurately positioned during operation. The push rod 320 is slidably disposed in the outer sleeve 310 and is slidable within the outer sleeve 310 by pressing or pushing. One end of the outer sleeve 310 has a shaping knife 314 for cutting an area to be implanted (not shown) on the affected part of the patient. The shape of the implanted region may correspond to the shape of the body 110 of FIG.

請參照圖3、圖4A與圖4B,當按壓式器械300的外套管310穿過定位套管200的貫穿通道T10時,由於定位套管200中設置有第一定位結構210而按壓式器械300的外套管310的外壁W20上設置有第二定位結構312,且第二定位結構312必須與第一定位結構210相互對位,如此便可限制按壓式器械300滑動時的方位。此外,設置於外套管310內的可滑動式推桿320於遠離塑形刀314的一端突出於外套管310外。當使用者推動推桿320突出於外套管310外的一端時,就能將推桿320朝向塑形刀314的方向推動。Referring to FIG. 3, FIG. 4A and FIG. 4B, when the outer sleeve 310 of the push-type instrument 300 passes through the through-channel T10 of the positioning sleeve 200, the push-type instrument 300 is provided because the first positioning structure 210 is disposed in the positioning sleeve 200. 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 orientation of the pressing device 300 when sliding can be restricted. In addition, the slidable push rod 320 disposed in the outer sleeve 310 protrudes beyond the outer sleeve 310 at one end away from the shaping knife 314. When the user pushes the push rod 320 to protrude from one end of the outer sleeve 310, the push rod 320 can be pushed toward the shaping blade 314.

在一實施例中,塑形刀314的形狀可配合軟骨修復載體100的本體110的形狀進行設計,意即,將塑形刀314設計為與本體110的輪廓及構型一致,以完整容置本體110而使軟骨修復載體100可完整地安置在塑形刀314所構築的區域內。如此一來,使用者僅需推動推桿320即可將軟骨修復載體100推置入患部目標處。換言之,按壓式器械300除了可以塑形刀314切出待植入區之外,還可以作為將軟骨修復載體100推往待植入區的工具。在另一實施例中,為了方便使用,可在外套管310與推桿320之間設置彈性恢復件330,例如是彈簧,以使推桿320可自動復位。In one embodiment, the shape of the shaping knife 314 can be designed to match the shape of the body 110 of the cartilage repairing carrier 100, that is, the shaping knife 314 is designed to conform to the contour and configuration of the body 110 for complete containment. The body 110 allows the cartilage repair carrier 100 to be completely disposed within 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 repairing carrier 100 into the target of the affected part. In other words, the push-type instrument 300 can be used as a tool for pushing the cartilage repairing carrier 100 to the area to be implanted, in addition to the shaping knife 314 cutting out the area to be implanted. In another embodiment, for ease of use, an elastic return member 330, such as a spring, may be disposed between the outer sleeve 310 and the push rod 320 to allow the push rod 320 to be automatically reset.

請參照圖3,在一實施例中,定位套管200的一端具有多個套管定位柱220,用以插入患者的患部,如此可在手術過程中初步固定定位套管200的位置且初步框定手術部位,以便後續實施精準的手術。套管定位柱220的長度可為8-12 mm,例如為10 mm,而套管定位柱220的外表面與其中心軸線的夾角可為0.5-2度,例如是1度,以使套管定位柱220在打入骨頭進行固定時可減少阻力而較為容易地打入骨頭內。貫穿通道T10的直徑可為12-14 mm,例如為13 mm,可提供後續手術器械操作的空間。此外,貫穿通道T10的側壁W10設置有至少一個排出開口P10,例如是兩個或三個,但不限於此。在一實施例中,可設置有四個排出開口P10。排出開口P10可以為寬度1-5 mm而長度20-30 mm的長形開口,例如是寬度2.5 mm而長度24 mm到25 mm的長條狀開口。在後續使用清創鑽頭進行清創的時候,可以透過排出開口P10將清除出來的組織排出,以留下乾淨的傷口。Referring to FIG. 3, in one embodiment, the positioning sleeve 200 has a plurality of cannula positioning posts 220 at one end for insertion into the affected part of the patient, so that the position of the positioning sleeve 200 can be initially fixed during the operation and initially framed. The surgical site for subsequent precise surgery. The sleeve positioning post 220 can have a length of 8-12 mm, for example 10 mm, and the outer surface of the sleeve positioning post 220 can be at an angle of 0.5-2 degrees to its central axis, for example 1 degree, to position the sleeve. The post 220 can be easily driven into the bone by reducing the resistance when it is driven into the bone for fixation. The through-channel T10 can have a diameter of 12-14 mm, for example 13 mm, providing space for subsequent surgical instrument operation. Further, the side wall W10 penetrating the passage T10 is provided with at least one discharge opening P10, for example, two or three, but is not limited thereto. In an embodiment, four discharge openings P10 may be provided. The discharge opening P10 may be an elongated opening having a width of 1-5 mm and a length of 20-30 mm, for example, an elongated opening having a width of 2.5 mm and a length of 24 mm to 25 mm. In the subsequent debridement using the debridement drill, the cleared tissue can be discharged through the discharge opening P10 to leave a clean wound.

另外,在又一實施例中,上述定位套管200上與套管定位柱220相對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,上述設置於貫穿通道T10側壁W10上的第一定位結構210可為長度約0.5-2 mm的導引通道,例如是1 mm,用以提供其他手術器械對位的功能,以確保上述的軟骨修復載體100的多個定位柱120可順利插入且密合壓入於硬骨上的小洞中。In addition, in another embodiment, the other end of the positioning sleeve 200 opposite to the sleeve positioning post 220 may have a grip 230 for providing a user's grip to improve the convenience of use. Moreover, the first positioning structure 210 disposed on the side wall W10 of the through-channel T10 may be a guiding channel having a length of about 0.5-2 mm, for example, 1 mm, for providing the function of alignment of other surgical instruments to ensure the above. The plurality of positioning posts 120 of the cartilage repairing carrier 100 can be smoothly inserted and tightly pressed into a small hole that is pressed into the hard bone.

請同時參照圖1與圖4A,在一實施例中,塑形刀314上設置有一定位角314A。定位角314A與軟骨修復載體100的定位角112可相互配合進行對位。因此,當軟骨修復載體100安置在塑形刀314所圈起的區域內時,可確保軟骨修復載體100的方位處於後續所欲操作的方位。Referring to FIG. 1 and FIG. 4A simultaneously, in an embodiment, the shaping blade 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 to perform alignment. Therefore, when the cartilage repairing carrier 100 is placed in the area enclosed by the shaping blade 314, it is ensured that the orientation of the cartilage repairing carrier 100 is in the position to be subsequently operated.

圖5是本發明一實施例的手術用具組的清創鑽頭的示意圖。請同時參照圖3與圖5,在一實施例中,清創鑽頭400可穿過定位套管200的貫穿通道T10以清除位於患者的待植入區的軟骨,以便在患者的患部空出可供植入如圖1的軟骨修復載體100的位置。在另一實施例中,清創鑽頭400具有一止擋部410。止擋部410的尺寸大於貫穿通道T10的尺寸。在一實施例中,止擋部410的直徑約為14-16 mm,例如是15 mm。因此,當清創鑽頭400穿過定位套管200的貫穿通道T10時,止擋部410會使得清創鑽頭400無法持續往前,進而限制清創鑽頭400的清創深度。舉例而言,止擋部410使得清創鑽頭400突出定位套管200的部分是2 mm,則清創鑽頭400所切除的軟骨的深度也會是2 mm。換言之,清創鑽頭400所切除的軟骨的深度是配合軟骨修復載體100的本體110的高度。Fig. 5 is a schematic view of a debridement drill of a surgical tool set according to an embodiment of the present invention. Referring to FIG. 3 and FIG. 5 simultaneously, in an embodiment, the debridement bit 400 can pass through the through passage T10 of the positioning sleeve 200 to remove the cartilage located in the patient's implanted area so as to be vacated in the affected part of the patient. The position of the cartilage repair carrier 100 as shown in Fig. 1 is implanted. In another embodiment, the debridement bit 400 has a stop 410. The size of the stopper 410 is larger than the size of the through passage T10. In an embodiment, the stop 410 has a diameter of about 14-16 mm, such as 15 mm. Therefore, when the debridement drill bit 400 passes through the through passage T10 of the positioning sleeve 200, the stopper portion 410 may prevent the debridement bit 400 from continuing forward, thereby limiting the debridement depth of the debridement bit 400. For example, the stop portion 410 causes the portion of the debridement bit 400 to protrude from the positioning cannula 200 to be 2 mm, and the depth of the cartilage excised by the debridement bit 400 is also 2 mm. In other words, the depth of the cartilage excised by the debridement bit 400 is the height of the body 110 of the cartilage repairing carrier 100.

在另一實施例中,清創鑽頭400下方鑽紋部位的直徑約為8到10mm,是配合軟骨修復載體100的本體110的直徑。更詳細言之,清創鑽頭400下方鑽紋部位的直徑幾乎等於軟骨修復載體100的本體110的外圍直徑,以清理出適合容置軟骨修復載體100的空間。由於清創鑽頭400會在貫穿通道T10內轉動,所以清創鑽頭400上並沒有對應貫穿通道T10的第一定位結構210的結構。In another embodiment, the diameter of the drilled portion below the debridement bit 400 is about 8 to 10 mm, which is the diameter of the body 110 of the cartilage repair carrier 100. In more detail, the diameter of the drilled portion below the debridement bit 400 is almost equal to the peripheral diameter of the body 110 of the cartilage repairing carrier 100 to clear out a space suitable for housing the cartilage repairing carrier 100. Since the debridement bit 400 will rotate within the through passage T10, there is no structure of the first positioning structure 210 corresponding to the through passage T10 on the debridement bit 400.

圖6是本發明一實施例的手術用具組的鑽孔器械的示意圖。請同時參照圖3與圖6,本實施例的鑽孔器械500用以穿過定位套管200的貫穿通道T10而在位於患者的待植入區的硬骨上鑽出多個定位孔(未繪示)。舉例來說,鑽孔器械500具有多根定位柱510,定位柱510所鑽出的定位孔的位置可對應圖1的軟骨修復載體100的定位柱120的位置。舉例來說,若定位柱120的數量是三個,三個定位柱120相較於鑽孔器械500的中心軸的方位角為0度、120度與240度,也就是三個定位柱120是以點對稱的方式分部。定位柱120的外表面與其中心軸線的夾角例如是3度到5度,以鑽出具有斜率的定位孔。具體而言,因為定位孔具有斜率,所以軟骨修復載體100的定位柱120越深入定位孔內,定位孔就能越緊迫地抓住定位柱120,以將軟骨修復載體100牢牢固定在患者的患部。Fig. 6 is a schematic view of a drilling apparatus of a surgical tool set according to an embodiment of the present invention. Referring to FIG. 3 and FIG. 6 simultaneously, the drilling tool 500 of the present embodiment is configured to drill a plurality of positioning holes on the hard bone located in the patient's to-be-implanted region through the through-channel T10 of the positioning sleeve 200 (not drawn) Show). For example, the drilling apparatus 500 has a plurality of positioning posts 510, and the position of the positioning holes drilled by the positioning posts 510 may correspond to the position of the positioning posts 120 of the cartilage repair carrier 100 of FIG. For example, if the number of the positioning posts 120 is three, the azimuth angles of the three positioning posts 120 compared to the central axis of the drilling tool 500 are 0 degrees, 120 degrees, and 240 degrees, that is, the three positioning posts 120 are Segmented in a point-symmetric manner. The angle between the outer surface of the positioning post 120 and its central axis is, for example, 3 to 5 degrees to drill a positioning hole having a slope. Specifically, since the positioning hole has a slope, the deeper the positioning post 120 of the cartilage repairing carrier 100 is, the more the positioning hole can firmly grasp the positioning post 120 to firmly fix the cartilage repairing carrier 100 to the patient. The affected part.

此外,在另一實施例中,鑽孔器械500例如具有一第三定位結構520,第三定位結構520與圖3的第一定位結構210相互對位。因此,鑽孔器械500在外套管310內滑動時的方位會受到限制,進而確保鑽孔器械500鑽出的定位孔的位置對應後續植入的軟骨修復載體100的定位柱120的位置。Moreover, in another embodiment, the drilling apparatus 500 has, for example, a third positioning structure 520 that is aligned with the first positioning structure 210 of FIG. Therefore, the orientation of the drilling apparatus 500 when sliding within the outer sleeve 310 is limited, thereby ensuring that the position of the positioning hole drilled by the drilling apparatus 500 corresponds to the position of the positioning post 120 of the subsequently implanted cartilage repairing carrier 100.

圖7A至圖7G是使用本發明一實施例的軟骨修復系統對豬隻進行軟骨修復手術的各階段的照片。請先參照圖7A,選用了一般成豬作為建立膝關節微創手術的對象。實驗過程中記錄了包括豬的編號、大約年齡、體重、性別以及在手術和屍體解剖方面的相關資訊。手術前各豬隻需先禁食24小時,手術所使用的麻醉劑為3% sodium pentobarbital,由後腿部注射,劑量約為1 mL/kg,並視各豬隻的麻醉情況而增減劑量。待確認麻醉後,將豬隻剃毛並用碘酒消毒,且以無菌巾覆蓋手術部位之外的地方,只露出關節位置,以確保手術是在無菌狀態下進行。接著,於外側皮膚切開約3 cm傷口,剝離軟組織後露出欲植入如圖1所示的軟骨修復載體100的位置。7A to 7G are photographs of various stages of a cartilage repair operation of a pig using a cartilage repair system according to an embodiment of the present invention. Referring first to Figure 7A, a general pig is selected as a subject for minimally invasive surgery for the knee. The number of pigs, approximate age, weight, sex, and information on surgery and autopsy were recorded during the experiment. Before the operation, each pig only needs to fast for 24 hours. The anesthetic used in the operation is 3% sodium pentobarbital, which is injected from the hind leg at a dose of about 1 mL/kg, and the dose is increased or decreased depending on the anesthesia of each pig. After the anesthesia is confirmed, the pigs are shaved and sterilized with iodine, and the area outside the surgical site is covered with a sterile towel to expose only the joint position to ensure that the surgery is performed under aseptic conditions. Next, a wound of about 3 cm was cut in the lateral skin, and the soft tissue was peeled off to expose the position where the cartilage repairing carrier 100 as shown in Fig. 1 was to be implanted.

接著請參照圖7B,將如圖3所示的定位套管200放置在患部,然後將定位套管200的兩根套管定位柱220打入並固定在患部。接著請參照圖7C,使用如圖4A所示的按壓式器械300插入定位套管200並以塑形刀在患部切出待植入區A10。接著,使用如圖5所示的清創鑽頭400插入定位套管200而清除位於待植入區A10的軟骨組織。Next, referring to FIG. 7B, the positioning sleeve 200 shown in FIG. 3 is placed on the affected part, and then the two cannula positioning posts 220 of the positioning sleeve 200 are driven into and fixed to the affected part. Next, referring to FIG. 7C, the positioning cannula 200 is inserted using the push-type instrument 300 as shown in FIG. 4A and the area to be implanted A10 is cut out at the affected part with a shaping knife. Next, the cartilage tissue located in the area to be implanted A10 is removed by inserting the positioning cannula 200 using the debridement drill bit 400 as shown in FIG.

接著請參照圖7D,將如圖6所示的鑽孔器械500插入定位套管200,並在位於待植入區A10的硬骨上鑽出如圖7E所示的多個定位孔P20。接著請參照圖7F,將如圖1所示的軟骨修復載體100放置於待植入區A10。為了方便理解,在圖7F中是將軟骨修復載體100放置於待植入區A10旁,但實際手術時是使用如圖4A所示的按壓式器械300將軟骨修復載體100直接推入待植入區A10。由於塑形刀的形狀是對應軟骨修復載體100的形狀,且鑽孔器械500與定位套管200之間也有互相對位的定位結構,因此鑽孔器械500所鑽出的定位孔P20的位置會直接對應軟骨修復載體100的定位柱120,而不需要額外進行對位的步驟,不僅可縮短手術所需的時間,並因精準對位而可提高手術成功機率。圖7G顯示軟骨修復載體100已經置入待植入區A10。Next, referring to FIG. 7D, the drilling tool 500 shown in FIG. 6 is inserted into the positioning sleeve 200, and a plurality of positioning holes P20 as shown in FIG. 7E are drilled on the hard bone located in the area to be implanted A10. Next, referring to FIG. 7F, the cartilage repairing carrier 100 shown in FIG. 1 is placed in the area to be implanted A10. For ease of understanding, in FIG. 7F, the cartilage repairing carrier 100 is placed beside the area to be implanted A10, but in actual operation, the cartilage repairing carrier 100 is directly pushed into the implant to be implanted using the push-type instrument 300 as shown in FIG. 4A. District A10. Since the shape of the shaping knife is corresponding to the shape of the cartilage repairing carrier 100, and the drilling tool 500 and the positioning sleeve 200 also have a positioning structure that is aligned with each other, the position of the positioning hole P20 drilled by the drilling tool 500 will be Directly corresponding to the positioning column 120 of the cartilage repairing carrier 100, without the need for additional alignment steps, not only can shorten the time required for surgery, but also improve the chance of successful surgery due to accurate alignment. Fig. 7G shows that the cartilage repairing carrier 100 has been placed in the area to be implanted A10.

圖8是本發明一實施例的軟骨修復載體的使用方式的示意圖。請參照圖8,軟骨修復材料是取自於患者本身,特別是取自於關節非受應力處的軟骨,例如以刮匙刮取自體軟骨。將上述取出的自體軟骨置於10 cm的培養皿中,以手術刀將軟骨切碎,碎片大小以20孔目到40孔目的篩網控制在560-800 μm之間。切碎的軟骨碎片收集於15 ml的離心管中,加入5 ml的膠原蛋白酶(collagenase),置於37ºC的培養箱中,靜置1小時,使部分軟骨細胞游離出來。膠原蛋白酶是置於磷酸鹽緩衝溶液(phosphate-buffered saline, PBS)中,並調整其比例為2 mg/ml PBS。以膠原蛋白酶分離溶解過後的軟骨骨塊置於離心機中,以轉速1500 r.p.m.離心5分鐘,將膠原蛋白酶與軟骨塊加以分離。離心後的軟骨碎片,經吸除澄清的膠原蛋白酶上清液(supernatant)後,餘留的軟骨碎片及細胞組織再以PBS沖洗兩次,且離心兩次,以除去殘留的膠原蛋白酶而完成軟骨修復材料的製備。Fig. 8 is a schematic view showing the manner of use of a cartilage repairing carrier according to an embodiment of the present invention. Referring to Figure 8, the cartilage repair material is taken from the patient itself, particularly from the unstressed joint of the joint, for example, by scraping the autologous cartilage. The autologous cartilage taken out above was placed in a 10 cm culture dish, and the cartilage was chopped with a scalpel, and the size of the pieces was controlled between 560 and 800 μm in a 20-mesh to 40-mesh screen. The minced cartilage fragments were collected in a 15 ml centrifuge tube, and 5 ml of collagenase was added to the incubator at 37 ° C for 1 hour to allow some of the chondrocytes to be released. Collagenase was placed in phosphate-buffered saline (PBS) and adjusted to a ratio of 2 mg/ml PBS. The cartilage block after separation and dissolution by collagenase was placed in a centrifuge, and centrifuged at 1500 r.p.m. for 5 minutes to separate collagenase from the cartilage block. After centrifugation of the cartilage fragments, after removing the clarified collagenase supernatant (supernatant), the remaining cartilage fragments and cell tissues were washed twice with PBS and centrifuged twice to remove residual collagenase to complete the cartilage. Preparation of repair materials.

接著,將前述製備完成的軟骨修復材料置入1 c.c.注射針筒中,並配合18號針頭(18G)以注射的方式將製備完成軟骨修復材料置於軟骨修復載體100上。之後,軟骨修復載體100是以承載軟骨修復材料的一面朝向患部進行置放,以使軟骨修復材料直接接觸患部。由於軟骨修復材料具備一定的黏稠性,因此並不容易從軟骨修復載體上掉出。Next, the prepared cartilage repairing material was placed in a 1 c.c. syringe, and the prepared cartilage repairing material was placed on the cartilage repairing carrier 100 by injection with an 18 gauge needle (18G). Thereafter, the cartilage repairing carrier 100 is placed toward the affected part with the side carrying the cartilage repairing material so that the cartilage repairing material directly contacts the affected part. Since the cartilage repair material has a certain viscosity, it is not easily dropped from the cartilage repair carrier.

圖9A與圖9B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經復原後的患部照片,手術對象皆為如上述的豬隻。由圖9A可以看出,使用本發明一實施例的手術用具組進行手術後12個月,患部(如箭頭所指處)的軟骨復原良好,幾乎看不到傷口痕跡。反之,以傳統手術用具組進行手術者,12個月後患部(如圖9B箭頭所指處)的軟骨復原狀況較差,傷口痕跡明顯。Fig. 9A and Fig. 9B are respectively an experimental example of surgery performed using the cartilage repairing system according to an embodiment of the present invention, and a photograph of the affected part after restoration using a conventional surgical tool, the surgical subjects being pigs as described above. As can be seen from Fig. 9A, 12 months after the operation using the surgical tool kit of one embodiment of the present invention, the cartilage of the affected part (as indicated by the arrow) is well restored, and no trace of the wound is observed. On the other hand, in the case of the operation of the conventional surgical tool group, the cartilage recovery condition of the affected part (as indicated by the arrow in Fig. 9B) was poor after 12 months, and the wound trace was obvious.

圖10A與圖10B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經6個月復原後的患部X光片,手術對象皆為如上述的豬隻。由圖10A可以看出,使用本發明一實施例的手術用具組進行手術後6個月,患部的軟骨復原迅速,傷口深度僅2.8 mm。反之,以傳統手術用具組進行手術者,6個月後患部的軟骨復原較慢,如圖10B所示,傷口深度達13.4 mm。10A and FIG. 10B are an experimental example of an operation using a cartilage repair system according to an embodiment of the present invention, and an X-ray film of an affected part after a 6-month restoration using a conventional surgical tool, and the surgical objects are as described above. Pig. As can be seen from Fig. 10A, the cartilage of the affected part was quickly recovered and the wound depth was only 2.8 mm 6 months after the operation using the surgical tool set of one embodiment of the present invention. On the other hand, in the case of the operation of the conventional surgical tool group, the cartilage recovery of the affected part was slow after 6 months, as shown in Fig. 10B, the wound depth was 13.4 mm.

圖11A與圖11B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經6個月復原後的患部樣本照片,手術對象皆為如上述的豬隻。由圖11A可以看出,使用本發明一實施例的手術用具組進行手術後6個月,患部(如箭頭所指處)的硬骨復原迅速,僅少許手術殘留物,且軟骨復原良好。反之,以傳統手術用具組進行手術者,6個月後患部(如圖11B箭頭所指處)的硬骨復原速度較慢,有許多手術殘留物。11A and FIG. 11B are photographs of an experimental example of an operation using a cartilage repair system according to an embodiment of the present invention, and a sample of an affected part after a 6-month restoration using a conventional surgical tool, the surgical objects are as described above. Pig. As can be seen from Fig. 11A, 6 months after the operation using the surgical tool set of one embodiment of the present invention, the hard bone of the affected part (as indicated by the arrow) is quickly restored, only a small amount of surgical residue, and the cartilage is well restored. On the other hand, in the case of the operation of the conventional surgical tool group, the hard bone recovery rate of the affected part (as indicated by the arrow in Fig. 11B) is slow after 6 months, and there are many surgical residues.

圖12A與圖12B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經12個月復原後的患部樣本照片,手術對象皆為如上述的豬隻。由圖12A可以看出,使用本發明一實施例的手術用具組進行手術後12個月,患部(如箭頭所指處)的硬骨復原良好,幾乎沒有手術殘留物,且新生硬骨組織已確實長入。反之,以傳統手術用具組進行手術者,12個月後患部(如圖12B箭頭所指處)的硬骨復原狀況較差,仍有不少手術殘留物。12A and FIG. 12B are photographs of an experimental example of an operation using a cartilage repair system according to an embodiment of the present invention, and a sample of an affected part after a 12-month restoration using a conventional surgical tool, the surgical objects are as described above. Pig. As can be seen from Fig. 12A, 12 months after the operation using the surgical tool kit of one embodiment of the present invention, the affected bone (as indicated by the arrow) has good bone recovery, almost no surgical residue, and the new hard bone tissue is indeed long. In. On the other hand, in the case of the operation of the conventional surgical tool group, the hard bone recovery condition of the affected part (as indicated by the arrow in Fig. 12B) is poor after 12 months, and there are still many surgical residues.

圖13A與圖13B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經復原後的患部的染色切片,手術對象皆為如上述的豬隻。圖13A與圖13B是使用番紅(Safranin-O)與固綠(Fast Green FCF)同時進行染色,以進一步檢視軟骨增生狀況及硬骨復原狀況。13A and FIG. 13B are respectively an experimental example of performing surgery using a cartilage repairing system according to an embodiment of the present invention, and a stained section of the affected part after restoration using a conventional surgical tool, the surgical subjects are pigs as described above. . 13A and 13B are stained simultaneously using Safranin-O and Fast Green FCF to further examine the condition of cartilage hyperplasia and the state of hard bone recovery.

請同時參照圖13A與圖13B,由番紅的染色區域可以看出,使用本發明一實施例的手術用具組進行手術後12個月,如圖13A中上方箭頭所指處,軟骨增生狀況良好,而使用傳統手術用具組進行手術者,如圖13B中上方箭頭所指處,軟骨增生狀況普通。另一方面,由固綠的染色區域可以看出,使用本發明一實施例的手術用具組進行手術後12個月,如圖13A中中間箭頭所指處,硬骨復原狀況良好,而使用傳統手術用具組進行手術者,如圖13B中中間箭頭所指處,硬骨幾乎沒有增生。Referring to FIG. 13A and FIG. 13B simultaneously, it can be seen from the stained area of the reddish color that the cartilage hyperplasia is good, 12 months after the operation, using the surgical tool set of one embodiment of the present invention, as indicated by the upper arrow in FIG. 13A. When the operator is operated using the conventional surgical tool set, as indicated by the upper arrow in Fig. 13B, the cartilage hyperplasia is normal. On the other hand, it can be seen from the dyed area of the solid green that, 12 months after the operation using the surgical tool set of one embodiment of the present invention, as indicated by the middle arrow in Fig. 13A, the hard bone is in a good condition, and the conventional surgery is used. The appliance group performs the operation, as indicated by the middle arrow in Fig. 13B, and the hard bone has almost no proliferation.

圖14是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例的傷口寬度的量化圖。請參照圖14,使用本發明一實施例的手術用具組進行手術的實驗例在手術後半年的傷口寬度僅是使用傳統手術用具進行手術的對照例在手術後半年的傷口寬度的60%,且前述實驗例於手術後一年的傷口寬度約為對照例於手術後一年的傷口寬度的50%。Fig. 14 is a quantification diagram of a wound width of an experimental example in which a cartilage repairing system according to an embodiment of the present invention is performed and a comparative example in which surgery is performed using a conventional surgical tool. Referring to FIG. 14, an experimental example in which a surgical tool set according to an embodiment of the present invention is used for surgery is only 60% of the wound width of a comparative example using a conventional surgical tool during the half year after surgery, and The width of the wound in the previous experimental example one year after surgery was about 50% of the wound width of the control one year after surgery.

綜上所述,在本發明的軟骨修復載體、所搭配的手術用具組與軟骨修復系統中,軟骨修復載體採用了多孔性結構,有助於新舊軟骨組織間的間隙融合,而手術用具組使得微創軟骨修復手術成為可能。此外,軟骨修復載體採用生物可降解的材料時,可承載促進軟骨修復的物質,搭配可定位的手術用具組,以微創的方式,精確地將軟骨修復載體定位並植入患者的患部。如此,可在對硬骨破壞較小的情況下協助重建軟骨缺損部位,並且在修復完成後軟骨修復載體可在體內自然分解並代謝。In summary, in the cartilage repairing carrier, the matched surgical tool set and the cartilage repairing system of the present invention, the cartilage repairing carrier adopts a porous structure, which contributes to the gap fusion between the old and new cartilage tissues, and the surgical tool set Minimally invasive cartilage repair surgery is possible. In addition, when the cartilage repair carrier uses a biodegradable material, it can carry a substance that promotes cartilage repair, and with a set of positionable surgical instruments, 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 assisted in the case of 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.

雖然本發明已以實施例揭露如上,然其並非用以限定本發明,任何所屬技術領域中具有通常知識者,在不脫離本發明的精神和範圍內,當可作些許的更動與潤飾,故本發明的保護範圍當視後附的申請專利範圍所界定者為準。Although the present invention has been disclosed in the above embodiments, it is not intended to limit the present invention, and any one of ordinary skill in the art can make some changes and refinements without departing from the spirit and scope of the present invention. The scope of the invention is defined by the scope of the appended claims.

100‧‧‧軟骨修復載體100‧‧‧Cartilage repair carrier

110‧‧‧本體110‧‧‧ body

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 casing

210‧‧‧第一定位結構210‧‧‧First positioning structure

220‧‧‧套管定位柱220‧‧‧ casing positioning column

230‧‧‧握把230‧‧‧ grip

T10‧‧‧貫穿通道T10‧‧‧through passage

W10‧‧‧側壁W10‧‧‧ side wall

P10‧‧‧排出開口P10‧‧‧ discharge opening

300‧‧‧按壓式器械300‧‧‧Pushing instruments

310‧‧‧外套管310‧‧‧Outer casing

312‧‧‧第二定位結構312‧‧‧Second positioning structure

314‧‧‧塑形刀314‧‧‧Shaping knife

314A‧‧‧定位角314A‧‧‧ positioning angle

320‧‧‧推桿320‧‧‧Put

330‧‧‧彈性恢復件330‧‧‧Elastic recovery parts

W20‧‧‧外壁W20‧‧‧ outer wall

400‧‧‧清創鑽頭400‧‧‧Developing drill bits

410‧‧‧止擋部410‧‧‧stop

500‧‧‧鑽孔器械500‧‧‧Drilling equipment

520‧‧‧第三定位結構520‧‧‧ Third positioning structure

A10‧‧‧待植入區A10‧‧‧ to be implanted

P20‧‧‧定位孔P20‧‧‧Positioning hole

圖1是本發明一實施例的軟骨修復載體的示意圖。 圖2是本發明一實施例的軟骨修復載體的實體照片。 圖3是本發明一實施例的手術用具組的定位套管的示意圖。 圖4A與圖4B分別是本發明一實施例的手術用具組的按壓式器械的外觀示意圖與剖面示意圖。 圖5是本發明一實施例的手術用具組的清創鑽頭的示意圖。 圖6是本發明一實施例的手術用具組的鑽孔器械的示意圖。 圖7A至圖7G是使用本發明一實施例的軟骨修復系統進行軟骨修復手術的各階段的照片。 圖8是本發明一實施例的軟骨修復載體的使用方式的示意圖。 圖9A與圖9B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經6個月復原後的患部照片。 圖10A與圖10B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經6個月復原後的患部X光片。 圖11A與圖11B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經6個月復原後的患部樣本照片。 圖12A與圖12B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經12個月復原後的患部樣本照片。 圖13A與圖13B分別是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例經12個月復原後的患部的染色切片。 圖14是使用本發明一實施例的軟骨修復系統進行手術的實驗例以及使用傳統手術用具進行手術的對照例的傷口寬度的量化圖。BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view of a cartilage repairing carrier according to an embodiment of the present invention. 2 is a photograph of a solid of a cartilage repairing carrier according to an embodiment of the present invention. 3 is a schematic view of a positioning sleeve of a surgical tool set according to an embodiment of the present invention. 4A and 4B are respectively a schematic view and a cross-sectional view showing a push type device of a surgical tool set according to an embodiment of the present invention. Fig. 5 is a schematic view of a debridement drill of a surgical tool set according to an embodiment of the present invention. Fig. 6 is a schematic view of a drilling apparatus of a surgical tool set according to an embodiment of the present invention. 7A to 7G are photographs of various stages of a cartilage repair operation using a cartilage repair system according to an embodiment of the present invention. Fig. 8 is a schematic view showing the manner of use of a cartilage repairing carrier according to an embodiment of the present invention. 9A and 9B are photographs of an affected part of a case in which a cartilage repairing system according to an embodiment of the present invention is used for surgery, and a comparative example in which a conventional surgical tool is used for surgery, after 6 months of recovery. 10A and FIG. 10B are an experimental example of surgery performed using the cartilage repair system according to an embodiment of the present invention, and an X-ray film of an affected part after restoration for 6 months in a comparative example of surgery using a conventional surgical tool. Fig. 11A and Fig. 11B are photographs of an experimental example of an operation of a cartilage repair system according to an embodiment of the present invention, and a control sample of a control using a conventional surgical tool, which was restored after 6 months, respectively. Fig. 12A and Fig. 12B are photographs of an experimental example of an operation of a cartilage repair system according to an embodiment of the present invention, and a control sample of a control using a conventional surgical tool, which was restored after 12 months, respectively. Fig. 13A and Fig. 13B are staining sections of an affected part of an experimental example in which a cartilage repairing system according to an embodiment of the present invention is used and a control which is performed using a conventional surgical tool, after 12 months of recovery, respectively. Fig. 14 is a quantification diagram of a wound width of an experimental example in which a cartilage repairing system according to an embodiment of the present invention is performed and a comparative example in which surgery is performed using a conventional surgical tool.

Claims (26)

一種軟骨修復載體,包括:一本體,為多孔性結構,用以承載軟骨修復材料,其中該多孔性結構的孔隙度為50%~90%;以及多個定位柱,各該定位柱的一端固定至該本體,另一端用以插入一患者的硬骨。 A cartilage repairing carrier comprises: a body, a porous structure for carrying a cartilage repairing material, wherein the porous structure has a porosity of 50% to 90%; and a plurality of positioning columns, each of which is fixed at one end of the positioning column To the body, the other end is used to insert a patient's hard bone. 如申請專利範圍第1項所述的軟骨修復載體,其中該本體的材料為生物可降解材料。 The cartilage repairing carrier according to claim 1, wherein the material of the body is a biodegradable material. 如申請專利範圍第1項所述的軟骨修復載體,其中該本體的材料為聚乳酸、聚乙醇酸、聚己內酯、聚乙烯醇、聚羥基烷酸或至少兩種上述聚合物的共聚物。 The cartilage repairing carrier according to claim 1, wherein the material of the body is polylactic acid, polyglycolic acid, polycaprolactone, polyvinyl alcohol, polyhydroxyalkanoic acid or a copolymer of at least two of the above polymers. . 如申請專利範圍第1項所述的軟骨修復載體,其中該本體的外圍具有一定位角。 The cartilage repairing carrier of claim 1, wherein the periphery of the body has a positioning angle. 一種手術用具組,包括:一定位套管,具有一貫穿通道,其中該貫穿通道的側壁上具有一第一定位結構;以及一按壓式器械,包括一外套管與一推桿,其中該外套管的外壁上具有一第二定位結構,該外套管用以穿過該定位套管的該貫穿通道,且該第二定位結構與該第一定位結構相互對位,該推桿可滑動地設置於該外套管內,該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區。 A surgical tool set comprising: a positioning sleeve having a through passage, wherein a side wall of the through passage has a first positioning structure; and a pressing device comprising an outer sleeve and a push rod, wherein the outer sleeve The outer wall has a second positioning structure, the outer sleeve is configured to pass through the through passage of the positioning sleeve, and the second positioning structure is aligned with the first positioning structure, and the push rod is slidably disposed on the Inside the outer cannula, one end of the outer cannula has a shaping knife for cutting a region to be implanted on the affected part of the patient. 如申請專利範圍第5項所述的手術用具組,其中該定位套管的一端具有多個套管定位柱,用以插入該患者的患部。 The surgical tool set of claim 5, wherein the positioning sleeve has a plurality of cannula positioning posts at one end for insertion into the affected part of the patient. 如申請專利範圍第6項所述的手術用具組,其中該定位套管的另一端具有一握把,用以供使用者握持。 The surgical tool set of claim 6, wherein the other end of the positioning sleeve has a grip for the user to hold. 如申請專利範圍第5項所述的手術用具組,其中該貫穿通道的側壁更設置有一排出開口。 The surgical tool set of claim 5, wherein the side wall of the through passage is further provided with a discharge opening. 如申請專利範圍第5項所述的手術用具組,其中該塑形刀具有一定位角。 The surgical tool set of claim 5, wherein the shaping tool has a positioning angle. 如申請專利範圍第5項所述的手術用具組,更包括一清創鑽頭,用以穿過該定位套管的該貫穿通道而清除位於該患者的該待植入區的軟骨。 The surgical tool set of claim 5, further comprising a debridement drill bit for removing the cartilage located in the patient to be implanted region through the through passage of the positioning sleeve. 如申請專利範圍第10項所述的手術用具組,其中該清創鑽頭具有一止擋部,該止擋部的尺寸大於該貫穿通道的尺寸而用以限制該清創鑽頭的清創深度。 The surgical tool set of claim 10, wherein the debridement bit has a stop portion having a size larger than a size of the through passage for limiting a debridement depth of the debridement bit. 如申請專利範圍第5項所述的手術用具組,更包括一鑽孔器械,用以穿過該定位套管的該貫穿通道而在位於該患者的該待植入區的硬骨上鑽出多個定位孔。 The surgical tool set of claim 5, further comprising a drilling device for drilling through the through passage of the positioning sleeve to drill a plurality of hard bones in the patient to be implanted area Positioning holes. 如申請專利範圍第12項所述的手術用具組,其中該鑽孔器械具有一第三定位結構,該第三定位結構與該第一定位結構相互對位。 The surgical tool set of claim 12, wherein the drilling tool has a third positioning structure, and the third positioning structure and the first positioning structure are aligned with each other. 一種軟骨修復系統,包括:一軟骨修復載體,包括一本體與多個定位柱,其中該本體為 多孔性結構且用以承載軟骨修復材料,各該定位柱的一端固定至該本體且各該定位柱的另一端用以插入一患者的硬骨;一定位套管,具有一貫穿通道,其中該貫穿通道的側壁上具有一第一定位結構;以及一按壓式器械,包括一外套管與一推桿,其中該外套管的外壁上具有一第二定位結構,該外套管用以穿過該定位套管的該貫穿通道,且該第二定位結構與該第一定位結構相互對位,該推桿可滑動地設置於該外套管內,該外套管的一端具有一塑形刀,用以在該患者的患部上切出一待植入區,該待植入區的形狀對應該本體的形狀。 A cartilage repairing system comprising: a cartilage repairing carrier comprising a body and a plurality of positioning posts, wherein the body is a porous structure for carrying the cartilage repairing material, one end of each of the positioning posts is fixed to the body and the other end of each of the positioning posts is for inserting a patient's hard bone; a positioning sleeve has a through passage, wherein the through hole The first side of the channel has a first positioning structure; and a pressing device includes an outer sleeve and a push rod, wherein the outer sleeve has a second positioning structure on the outer wall, and the outer sleeve is used to pass through the positioning sleeve The through-channel, and the second positioning structure and the first positioning structure are aligned with each other, the push rod is slidably disposed in the outer sleeve, and one end of the outer sleeve has a shaping knife for the patient An area to be implanted is cut out from the affected part, and the shape of the area to be implanted corresponds to the shape of the body. 如申請專利範圍第14項所述的軟骨修復系統,其中該本體的材料為生物可降解材料。 The cartilage repair system of claim 14, wherein the material of the body is a biodegradable material. 如申請專利範圍第14項所述的軟骨修復系統,其中該本體的材料為聚乳酸、聚乙醇酸、聚己內酯、聚乙烯醇、聚羥基烷酸或至少兩種上述聚合物的共聚物。 The cartilage repairing system according to claim 14, wherein the material of the body is polylactic acid, polyglycolic acid, polycaprolactone, polyvinyl alcohol, polyhydroxyalkanoic acid or a copolymer of at least two of the above polymers. . 如申請專利範圍第14項所述的軟骨修復系統,其中該多孔性結構的孔隙度為50%~90%。 The cartilage repair system of claim 14, wherein the porous structure has a porosity of 50% to 90%. 如申請專利範圍第14項所述的軟骨修復系統,其中該本體的外圍具有一定位角。 The cartilage repair system of claim 14, wherein the periphery of the body has a positioning angle. 如申請專利範圍第14項所述的軟骨修復系統,其中該定位套管的一端具有多個套管定位柱,用以插入該患者的患部。 The cartilage repair system of claim 14, wherein the positioning sleeve has a plurality of cannula positioning posts at one end for insertion into the affected part of the patient. 如申請專利範圍第19項所述的軟骨修復系統,其中該定位套管的另一端具有一握把,用以供使用者握持。 The cartilage repairing system of claim 19, wherein the other end of the positioning sleeve has a grip for the user to hold. 如申請專利範圍第14項所述的軟骨修復系統,其中該貫穿通道的側壁更設置有一排出開口。 The cartilage repairing system of claim 14, wherein the side wall of the through passage is further provided with a discharge opening. 如申請專利範圍第14項所述的軟骨修復系統,其中該塑形刀具有一定位角。 The cartilage repair system of claim 14, wherein the shaping tool has a positioning angle. 如申請專利範圍第14項所述的軟骨修復系統,更包括一清創鑽頭,用以穿過該定位套管的該貫穿通道而清除位於該患者的該待植入區的軟骨。 The cartilage repair system of claim 14, further comprising a debridement drill bit for removing the cartilage located in the patient to be implanted region through the through passage of the positioning sleeve. 如申請專利範圍第23項所述的軟骨修復系統,其中該清創鑽頭具有一止擋部,該止擋部的尺寸大於該貫穿通道的尺寸而用以限制該清創鑽頭的清創深度。 The cartilage repairing system of claim 23, wherein the debridement bit has a stop portion having a size greater than a size of the through passage for limiting a debridement depth of the debridement bit. 如申請專利範圍第14項所述的軟骨修復系統,更包括一鑽孔器械,用以穿過該定位套管的該貫穿通道而在位於該患者的該待植入區的硬骨上鑽出多個定位孔,該些定位孔對應該些定位柱。 The cartilage repair system of claim 14, further comprising a drilling device for drilling through the through passage of the positioning sleeve to drill a plurality of hard bones in the patient to be implanted region Positioning holes corresponding to the positioning posts. 如申請專利範圍第25項所述的軟骨修復系統,其中該鑽孔器械具有一第三定位結構,該第三定位結構與該第一定位結構相互對位。 The cartilage repairing system of claim 25, wherein the drilling tool has a third positioning structure, the third positioning structure and the first positioning structure being aligned with each other.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080167716A1 (en) * 2001-07-16 2008-07-10 Schwartz Hebert E Cartilage repair apparatus and method
CN101332313A (en) * 2008-08-06 2008-12-31 北京大学第三医院 Bracket for regenerating decalcification cortical-bone articular cartilage with vertical drill and preparation method thereof
TW201004599A (en) * 2008-07-23 2010-02-01 Otismed Corp System and method for manufacturing arthroplasty jigs having improved mating accuracy

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080167716A1 (en) * 2001-07-16 2008-07-10 Schwartz Hebert E Cartilage repair apparatus and method
TW201004599A (en) * 2008-07-23 2010-02-01 Otismed Corp System and method for manufacturing arthroplasty jigs having improved mating accuracy
CN101332313A (en) * 2008-08-06 2008-12-31 北京大学第三医院 Bracket for regenerating decalcification cortical-bone articular cartilage with vertical drill and preparation method thereof

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