TWI638634B - Surgery device for osteotomy - Google Patents
Surgery device for osteotomy Download PDFInfo
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- TWI638634B TWI638634B TW106127173A TW106127173A TWI638634B TW I638634 B TWI638634 B TW I638634B TW 106127173 A TW106127173 A TW 106127173A TW 106127173 A TW106127173 A TW 106127173A TW I638634 B TWI638634 B TW I638634B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/14—Surgical saws ; Accessories therefor
- A61B17/15—Guides therefor
- A61B17/154—Guides therefor for preparing bone for knee prosthesis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/14—Surgical saws ; Accessories therefor
- A61B17/15—Guides therefor
- A61B17/151—Guides therefor for corrective osteotomy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/14—Surgical saws ; Accessories therefor
- A61B17/15—Guides therefor
- A61B17/154—Guides therefor for preparing bone for knee prosthesis
- A61B17/157—Cutting tibia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/564—Methods for bone or joint treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
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Abstract
本發明提出一種截骨手術器械，包含：一第一主體部件，具有一側導引邊與一上導引邊，用來形成切割道；一第二主體部件，具有一下導引邊，設置於該上導引邊下方，該上導引邊與該下導引邊之間形成一導引槽導引鋸片進行切鋸；其中該上導引邊具有一第一對位穿孔，該下導引邊具有一第二對位穿孔，該第一對位穿孔之一第一孔洞軸線與該第二對位穿孔之一第二孔洞軸線之間具有一矯正夾角。相較於習知技術，本發明對手術本身的精確性與效率進行了改良。 The present invention provides an osteotomy surgical instrument comprising: a first body member having a side guiding edge and an upper guiding edge for forming a cutting track; and a second body member having a lower guiding edge disposed on the A guiding groove guiding saw blade is formed between the upper guiding edge and the lower guiding edge to perform a sawing saw; wherein the upper guiding edge has a first alignment perforation, the lower guiding The leading edge has a second alignment hole, and a first hole axis of the first alignment hole and a second hole axis of the second alignment hole have a correct angle. Compared with the prior art, the present invention improves the accuracy and efficiency of the surgery itself.
Description
本發明係關於一種截骨手術器械，更明確地說，係關於一種用於執行截骨手術，且為受術者量身訂製的截骨手術器械。 The present invention relates to an osteotomy surgical instrument, and more particularly to an osteotomy surgical instrument for performing an osteotomy procedure and tailored to the subject.
膝蓋是人體中承受力量最大的關節之一，一般人若是膝蓋曾有過運動傷害，或是步入中年階段，都有可能造成關節面的軟骨磨損，產生膝關節疼痛的症狀，導致生活日常功能的活動度受減。這就是退化性關節炎的成因。 The knee is one of the most powerful joints in the human body. If a person has had sports injuries on his knees or enters the middle age stage, it may cause cartilage wear on the articular surface, causing symptoms of knee pain, leading to daily life functions. The activity is reduced. This is the cause of degenerative arthritis.
過去的習知治療方法，係以植入人工關節來替換原有的膝關節。但是為了植入人工關節需要大量切除股骨、脛骨與髕骨等的關節面，來提供金屬與高分子植入物的固定。但由於植入物磨耗的緣故，此類全人工膝關節置換手術的有效使用期，最多為二十年，但常會併發手術後的感染、骨溶解與骨疏鬆問題，因而導致有可能必須再進行二次手術。再者，部分退化性關節炎的初期患者，其實僅內側關節面的軟骨磨損，並非有必要使用全人工關節置換，來將所有膝關節面切除。所以對於初期僅內側退化性關節炎患者，通常會施行高位脛骨截骨手術(HIGH TIBIAL OSTEOTOMY)。 In the past, the conventional treatment method was to replace the original knee joint with an artificial joint. However, in order to implant an artificial joint, it is necessary to remove a large number of articular surfaces such as the femur, the tibia and the tibia to provide fixation of the metal and the polymer implant. However, due to the wear of the implant, the effective use period of this type of total artificial knee replacement surgery is up to 20 years, but often the infection, osteolysis and osteoporosis problems after the operation, which may lead to the need for further Second surgery. Furthermore, in the initial stage of some patients with degenerative arthritis, only the cartilage of the medial articular surface is worn, and it is not necessary to use total artificial joint replacement to remove all knee articular surfaces. Therefore, for patients with only medial degenerative arthritis in the early stage, high-level tibia osteotomy (HIGH TIBIAL OSTEOTOMY) is usually performed.
高位脛骨截骨手術(HIGH TIBIAL OSTEOTOMY)係在患者的脛骨靠近膝蓋的內側上端開一道截口，再把截口撐開填入人造補骨後，同時以骨板與骨釘固定。藉此來矯正患者膝關節內翻的生物力學軸線。由於僅只在脛骨內側近端進行骨頭切開與角度調整，因此不會有任何骨質的大量移除，對於內側關節面軟骨所引起的膝關節疼痛患者，是很好的手術治療方式之一。 HIGH TIBIAL OSTEOTOMY is a kerf in the upper end of the patient's tibia near the knee, and then the ostium is opened and filled into the artificial bone, and the bone plate and the nail are fixed. Thereby to correct the biomechanical axis of the patient's knee varus. Since the bone incision and angle adjustment are only performed at the proximal end of the medial aspect of the humerus, there is no substantial removal of any bone mass, and it is one of the good surgical treatment methods for patients with knee joint pain caused by the medial articular surface cartilage.
不過，因為高位脛骨截骨手術需要將脛骨近端切出一道開口，其切入的位置、角度、深度與撐開高度等程序，皆需要在術前進行審慎評估。目前在進行本手術時，臨床醫師常只能藉由X光機的協助，再加上其個人的判斷，來決定上述截骨撐開的幾何參數。但每位退化性關節炎患者膝關節內翻的生物力學軸線狀況不一，上述的手術參數也是每個患者皆不同。考慮到上述個人膝關節內翻的生物力學軸線的不一狀況，在手術器械的設計上也必須將個人差異一併考量。 However, because the high tibial osteotomy requires cutting the proximal end of the humerus, procedures such as the location, angle, depth, and height of the iliac crest need to be carefully evaluated before surgery. At the time of the operation, clinicians often only rely on the assistance of the X-ray machine, coupled with their personal judgment, to determine the geometric parameters of the osteotomy. However, the biomechanical axis of knee varus varies from patient to degenerative arthritis, and the above surgical parameters are different for each patient. In view of the different conditions of the biomechanical axis of the above-mentioned individual knee varus, individual differences must also be considered in the design of surgical instruments.
因應前述的問題點，本發明提出一種截骨手術器械，得用於導引一鋸片來實施一脛骨之一高位脛骨截骨手術，但並不以此為限，本發明之截骨手術器械亦可用於人體其他部位的骨骼，例如：股骨、腓骨、肱骨、尺骨、橈骨、鎖骨、肩胛骨等，於本發明之較佳實施例中係以脛骨進行說明，其外型設計具有可協助臨床醫師精確決定切入的位置、角度、深度與撐開高度等程序，藉由本發明施術後截骨撐開的脛骨，將具有精確切割的準確度與執行效率，且每個器械皆為患者量身打造的優點。 In view of the foregoing problems, the present invention provides an osteotomy surgical instrument which can be used to guide a saw blade to perform a high tibial osteotomy of a tibia, but not limited thereto, the osteotomy surgical instrument of the present invention It can also be used for bones in other parts of the human body, such as femur, humerus, humerus, ulna, humerus, clavicle, scapula, etc. In the preferred embodiment of the present invention, the tibia is described, and the appearance is designed to assist the clinician. The procedure of accurately determining the position, angle, depth and opening height of the incision, the osteotomy of the osteotomy of the present invention will have accurate cutting accuracy and execution efficiency, and each device is tailor-made for the patient. advantage.
本發明提供一種截骨手術器械，得用於導引一鋸片來實施一脛骨之一高位脛骨截骨手術，但並不以此為限，亦可施行於人體其他部位的骨骼，前述脛骨藉由本發明之截骨手術器械可被定義出一第一切割位置與一第二切割位置，該截骨手術器械包含有：一第一主體部件、一第二主體部件以及複數個固定槽孔。其中第一主體部件設置於第一切割位置的上方，具有一側導引邊、一上導引邊以及一第一對位穿孔，第一對位穿孔得穿設於上導引邊；第二主體部件設置於第一切割位置的下方或上導引邊的下方，具有一下導引邊以及一第二對位穿孔，該下導引邊設置於該上導引邊下方，第二對位穿孔得穿設於下導引邊；複數個固定槽孔設置於第一主體部件與第二主體部件之表面上，用以將截骨手術器械固定於該脛骨的表面上。 The invention provides an osteotomy surgical instrument, which can be used for guiding a saw blade to perform a high tibial osteotomy of a humerus, but not limited thereto, and can also be applied to bones of other parts of the human body. The osteotomy surgical instrument of the present invention can define a first cutting position and a second cutting position. The osteotomy instrument includes a first body member, a second body member and a plurality of fixing slots. The first body member is disposed above the first cutting position, and has a side guiding edge, an upper guiding edge and a first alignment hole. The first alignment hole is pierced through the upper guiding edge; The main body member is disposed below the first cutting position or below the upper guiding edge, and has a lower guiding edge and a second alignment hole, the lower guiding edge is disposed below the upper guiding edge, and the second alignment hole is perforated The plurality of fixing slots are disposed on the surfaces of the first body member and the second body member for fixing the osteotomy surgical instrument on the surface of the tibia.
其中，上導引邊與下導引邊之間形成一導引槽，用以導引鋸片至第一切割位置，側導引邊用以導引鋸片至第二切割位置，該上導引邊、下導 引邊及側導引邊用來形成切割道，鋸片依據第一切割位置與第二切割位置對脛骨進行切鋸，藉以進行高位脛骨截骨手術，第一對位穿孔之第一孔洞軸線與第二對位穿孔之第二孔洞軸線之間具有一矯正夾角，而高位脛骨截骨手術中，截骨缺口具有術前規劃之一矯正角度，當截骨缺口的撐開角度與術前規劃的矯正角度相同時，第一對位穿孔與第二對位穿孔之孔洞軸線也將重合。 Wherein, a guiding groove is formed between the upper guiding edge and the lower guiding edge for guiding the saw blade to the first cutting position, and the side guiding edge is used for guiding the saw blade to the second cutting position, the upper guiding Leading edge The leading edge and the side guiding edge are used to form a cutting path, and the saw blade cuts the tibia according to the first cutting position and the second cutting position, thereby performing high tibial osteotomy, the first hole axis of the first alignment perforation and The second hole of the second hole has a correct angle between the axes of the holes, and in the high tibial osteotomy, the osteotomy notch has a correction angle of the preoperative plan, when the angle of the osteotomy is expanded and the preoperative planning When the correction angle is the same, the axis of the first alignment hole and the second alignment hole will also coincide.
於本發明之另一具體實施例中，第一對位穿孔得以一第一桿件與第一主體部件連接；第二對位穿孔得以一第二桿件與第二主體部件連接。 In another embodiment of the invention, the first alignment aperture is coupled to the first body member by a first member; the second alignment aperture is coupled to the second body member by a second member.
於本發明之另一具體實施例中，截骨手術器械進一步包含一矯正軸導引部件，設置於第二主體部件之表面上，其包含一延伸至第二切割位置或導引槽後方之一第三桿件與一第三矯正穿孔，第三矯正穿孔內設有術前規劃之一矯正軸，用於高位脛骨截骨手術中作為脛骨被撐開時的轉軸。藉由預先將一骨針作為矯正軸，打入脛骨外側術前規劃之轉軸位置，如此在撐開手術缺口的時候，可以確保撐開時的旋轉軸線與術前規劃的相同，當鋸片已到達預先規劃的切割深度時會被該矯正軸上的骨針擋住，確保切鋸的深度，提高手術的精確性，此外預鑽的孔洞能夠分散該處應力，避免撐開缺口時脛骨外側骨頭斷裂。 In another embodiment of the present invention, the osteotomy surgical instrument further includes a corrective shaft guiding member disposed on the surface of the second body member and including one extending to the second cutting position or one of the rear of the guiding groove The third rod and a third corrective perforation are provided with a correction axis in the third correction perforation for the rotation of the humerus in the high tibial osteotomy. By using a bone needle as a correcting axis in advance, the position of the shaft of the preoperative planning of the lateral humerus is driven, so that when the surgical incision is opened, the rotation axis at the time of opening can be ensured to be the same as that of the preoperative planning, when the saw blade has been When reaching the pre-planned cutting depth, it will be blocked by the bone needle on the correcting shaft, ensuring the depth of the cutting saw and improving the accuracy of the operation. In addition, the pre-drilled hole can disperse the stress at the place, avoiding the fracture of the lateral bone of the humerus when the gap is opened. .
本發明另提供一種截骨手術器械，用於導引一鋸片來實施一脛骨之一高位脛骨截骨手術，前述脛骨藉由本發明之截骨手術器械可被定義出一第一切割位置與一第二切割位置，截骨手術器械包含有：一第一主體部件、一第二主體部件以及複數個固定槽孔。其中第一主體部件設置於第一切割位置的上方，具有一側導引邊、一上導引邊與一第一對位穿孔，第一對位穿孔以一第一桿件與第一主體部件連接；第二主體部件設置於第一切割位置或上導引邊的下方，具有一下導引邊與一第二對位穿孔，該下導引邊設置於該上導引邊下方，第二對位穿孔以一第二桿件與第二主體部件連接；複數個固定槽孔設置於第一主體部件與第二主體部件之表面上，用以將截骨手術器械固定於脛骨的表面上。 The present invention further provides an osteotomy surgical instrument for guiding a saw blade to perform a high tibial osteotomy of a tibia. The humerus can be defined by the osteotomy surgical instrument of the present invention. In the second cutting position, the osteotomy surgical instrument comprises: a first body member, a second body member and a plurality of fixing slots. The first body member is disposed above the first cutting position, and has a side guiding edge, an upper guiding edge and a first alignment hole. The first alignment hole is a first bar member and the first body member. The second body member is disposed below the first cutting position or the upper guiding edge, and has a lower guiding edge and a second alignment hole, the lower guiding edge is disposed below the upper guiding edge, and the second pair The positional perforation is coupled to the second body member by a second member; the plurality of fixation slots are disposed on the surface of the first body member and the second body member for securing the osteotomy surgical instrument to the surface of the tibia.
其中，上導引邊與下導引邊之間形成一導引槽，用以導引鋸片至第一切割位置，側導引邊用以導引鋸片至第二切割位置，該上導引邊、下導引邊及側導引邊用來形成切割道，鋸片依據第一切割位置與第二切割位置對脛骨進行切鋸，藉以進行高位脛骨截骨手術，第一對位穿孔之第一孔洞軸線與第二對位穿孔之第二孔洞軸線之間具有一矯正夾角，高位脛骨截骨手術中，截骨缺口具有術前規劃之一矯正角度，當截骨缺口的撐開角度與術前規劃的矯正角度相同時，第一對位穿孔與第二對位穿孔之孔洞軸線也將重合。 Wherein, a guiding groove is formed between the upper guiding edge and the lower guiding edge for guiding the saw blade to the first cutting position, and the side guiding edge is used for guiding the saw blade to the second cutting position, the upper guiding The leading edge, the lower guiding edge and the side guiding edge are used to form a cutting track, and the saw blade cuts the tibia according to the first cutting position and the second cutting position, thereby performing high tibial osteotomy, the first alignment perforation There is a correct angle between the axis of the first hole and the axis of the second hole of the second alignment hole. In the operation of the high tibial osteotomy, the osteotomy notch has a correction angle of the preoperative plan, when the angle of the osteotomy is extended When the correction angle of the preoperative plan is the same, the axis of the first alignment hole and the second alignment hole will also coincide.
於本發明之一具體實施例中，截骨手術器械進一步包含一矯正軸導引部件，設置於第二主體部件之表面上，其包含一延伸至第二切割位置或導引槽後方之一第三矯正穿孔，第三矯正穿孔內設有術前規劃之一矯正軸，用於高位脛骨截骨手術中脛骨被撐開時的轉軸，並可確保切割的深度。 In an embodiment of the present invention, the osteotomy surgical instrument further includes a correcting shaft guiding member disposed on the surface of the second body member, and including a length extending to the second cutting position or the rear of the guiding groove The three corrective perforations are provided with a correction axis in the third correction perforation for the rotation of the humerus when the humerus is distracted in the high tibial osteotomy, and the depth of the cutting is ensured.
相較於習知技術，本發明的截骨手術器械係根據術前所蒐集的患者脛骨影像資料，並評估最佳手術切割位置後以三維列印(three-dimensional printing,3D列印)建成。器械本身能夠完全貼合患者的脛骨，而執刀醫師就可根據器械指定的導引槽，進行第一切割位置的下刀，藉由導引槽可讓執刀醫師準確地下刀之外，亦可提供切割角度與深度的計算參考，側導引邊可提供執刀醫師第二切割位置的下刀基準。本發明除了改良手術本身之外，亦標準化執刀醫師手術的實施。 Compared with the prior art, the osteotomy surgical instrument of the present invention is based on the patient's tibia image data collected before surgery, and is evaluated by three-dimensional printing (3D printing) after evaluating the optimal surgical cutting position. The instrument itself can completely fit the patient's tibia, and the surgeon can perform the lower knife at the first cutting position according to the guiding slot specified by the instrument. The guiding groove can allow the surgeon to accurately provide an underground knife. For the calculation of the cutting angle and depth, the side guiding edge provides the lower knife reference of the second cutting position of the surgeon. In addition to improving the surgery itself, the present invention also standardizes the implementation of the surgeon's surgery.
1、2、3‧‧‧截骨手術器械 1, 2, 3‧‧‧ osteotomy instruments
12、22、32‧‧‧第一主體部件 12, 22, 32‧‧‧ first body parts
121、221‧‧‧側導引邊 121, 221‧‧‧ side guiding edge
122、222、321‧‧‧上導引邊 122, 222, 321 ‧ ‧ upper guiding edge
123、223、322‧‧‧第一對位穿孔 123, 223, 322‧‧‧ first alignment perforation
14、24、34‧‧‧第二主體部件 14, 24, 34‧‧‧ second body parts
141、241、341‧‧‧下導引邊 141, 241, 341‧‧‧ guided edge
142、242、342‧‧‧第二對位穿孔 142, 242, 342‧‧‧ second alignment perforation
16、26、36‧‧‧固定槽孔 16, 26, 36‧‧‧ Fixed slots
18‧‧‧固定部件 18‧‧‧Fixed parts
20‧‧‧對位桿件 20‧‧‧ alignment rod
224、323‧‧‧第一桿件 224, 323‧‧‧ first member
243、343‧‧‧第二桿件 243, 343‧‧‧second pole
28‧‧‧矯正軸導引部件 28‧‧‧Correcting shaft guide
281‧‧‧第三矯正穿孔 281‧‧‧ Third corrective perforation
30‧‧‧矯正軸 30‧‧‧Correct axis
40‧‧‧固定銷及固定骨針 40‧‧‧fixed pin and fixed bone needle
50‧‧‧導引槽 50‧‧‧ guiding slot
A1‧‧‧第一孔洞軸線 A1‧‧‧ first hole axis
A2‧‧‧第二孔洞軸線 A2‧‧‧ second hole axis
B‧‧‧脛骨 B‧‧‧胫骨骨
D‧‧‧股骨 D‧‧‧ femur
C1‧‧‧第一切割位置 C1‧‧‧First cutting position
C2‧‧‧第二切割位置 C2‧‧‧Second cutting position
C3‧‧‧第三切割位置 C3‧‧‧ Third cutting position
E‧‧‧已完成切鋸之切割道 E‧‧‧ has completed the cutting of the saw
L、N‧‧‧矯正夾角 L, N‧‧‧correction angle
M‧‧‧矯正角度 M‧‧‧Correction angle
圖一A繪示了本發明之一具體實施例實施時之前視示意圖。 FIG. 1A is a schematic front view showing an embodiment of the present invention.
圖一B繪示了本發明之一具體實施例實施時之側視示意圖。 Figure 1B is a side elevational view showing the implementation of one embodiment of the present invention.
圖二繪示了實施本發明時於脛骨上所欲切割的位置示意圖。 Figure 2 is a schematic view showing the position to be cut on the tibia when the present invention is practiced.
圖三A繪示了本發明之一具體實施例實施於脛骨時之後視示意圖。 FIG. 3A is a schematic rear view of a specific embodiment of the present invention when it is implemented on a tibia.
圖三B繪示了本發明之一具體實施例實施於脛骨時之側視示意圖。 Figure 3B is a side elevational view of one embodiment of the present invention implemented in the tibia.
圖四A繪示了本發明之一具體實施例實施前之前視示意圖。 FIG. 4A is a schematic front view showing a specific embodiment of the present invention before implementation.
圖四B繪示了本發明之一具體實施例實施前之側視示意圖。 Figure 4B is a side elevational view of a particular embodiment of the present invention prior to implementation.
圖五繪示了本發明之另一具體實施例之示意圖。 Figure 5 is a schematic view of another embodiment of the present invention.
圖六繪示了本發明之另一具體實施例實施時之示意圖。 Figure 6 is a schematic diagram showing another embodiment of the present invention.
圖七繪示了本發明之另一具體實施例實施時之前視示意圖。 Figure 7 is a front elevational view showing another embodiment of the present invention.
圖八A繪示了本發明之再一實施例實施時之側視示意圖。 Figure 8A is a side elevational view showing the implementation of still another embodiment of the present invention.
圖八B繪示了實施本發明時於股骨上所欲切割的位置示意圖。 Figure 8B is a schematic view showing the position to be cut on the femur when the present invention is practiced.
圖九A繪示了本發明之再一實施例實施時之前視示意圖。 FIG. 9A is a schematic front view showing another embodiment of the present invention.
圖九B繪示了本發明之再一實施例實施時之側視示意圖。 FIG. 9B is a schematic side view showing another embodiment of the present invention.
本說明書僅對本發明之必要元件作出陳述，且僅係用於說明本發明其中之可能之實施例，然而說明書之記述應不侷限本發明所主張之技術本質的權利範圍。 This description is only for the purpose of illustrating the essential elements of the invention, and is only intended to illustrate the possible embodiments of the invention, but the description of the specification should not limit the scope of the technical nature of the claimed invention.
亦應瞭解的是，目前所述僅係本發明可能之實施例，在本發明之實施或測試中，可使用與本說明書所述裝置或系統相類似或等效之任何方法、流程、功能或手段。除非有另外定義，否則本說明書所用之所有技術及科 學術語，皆具有與熟習本發明所屬技術領域者通常所瞭解的意義相同之意義。本說明書目前所述者僅係實例方法、流程及其相關資料。然而在本發明之實際使用時，其可使用與本說明書所述方法及材料相類似或等效之任何方法及手段。 It should also be understood that the presently described embodiments are merely possible embodiments of the invention, and that any method, process, function or function similar or equivalent to the device or system described herein may be used in the practice or testing of the present invention. means. All techniques and sections used in this manual unless otherwise defined The terminology has the same meaning as commonly understood by one of ordinary skill in the art. The present description is merely an example method, process, and related materials. However, in the actual use of the present invention, any methods and means similar or equivalent to those described in the specification can be used.
再者，本說明書中所提及之一數目以上或以下，係包含數目本身。且應瞭解的是，本說明書揭示執行所揭示功能之某些方法、流程，存在多種可執行相同功能之與所揭示結構有關之結構，且上述之結構通常可達成相同結果。 Furthermore, one or more of the numbers mentioned in the specification include the number itself. It should be understood that the present disclosure discloses certain methods and processes for performing the disclosed functions. There are many structures related to the disclosed structures that perform the same functions, and the above structures generally achieve the same result.
以下將詳述本發明之較佳具體實施例，藉以充分說明本發明之特徵、精神及優點。 The preferred embodiments of the present invention will be described in detail in the following description.
首先請參閱圖一A、圖一B與圖二，圖一A繪示了本發明之一具體實施例實施時之前視示意圖，圖一B繪示了本發明之一具體實施例實施時之側視示意圖，圖二繪示了實施本發明時於脛骨上所欲切割的位置示意圖。 Referring to FIG. 1A, FIG. 1B and FIG. 2, FIG. 1A is a front view showing a specific embodiment of the present invention, and FIG. 1B is a side view of an embodiment of the present invention. Referring to the schematic view, FIG. 2 is a schematic view showing the position to be cut on the tibia when the present invention is implemented.
本發明提供一種截骨手術器械1，得應用在各種截骨手術、矯正或復位手術，本發明之截骨手術器械1可用於人體各部位的骨骼，例如：脛骨B、股骨D、腓骨、肱骨、尺骨、橈骨、鎖骨、肩胛骨等，但並不以此為限，於本實施例中，係應用於導引一鋸片來實施一脛骨B之一高位脛骨截骨手術，脛骨B藉由本發明之截骨手術器械1可被定義出一第一切割位置C1與一第二切割位置C2，截骨手術器械1包含有：一第一主體部件12、一第二主體部件14以及複數個固定槽孔16。其中第一主體部件12設置於第一切割位置C1的上方，具有一側導引邊121以及一上導引邊122；第二主體部件14設置於第一切割位置C1或上導引邊122的下方，具有一下導引邊141，該下導引邊141設置於該上導引邊122下方；複數個固定槽孔16設置於第一主體部件12與第二主體部件14之表面上，藉由穿設複數個固定銷及固定骨針40於複數個固定槽孔16中，來將截骨手術器械1固定於脛骨B的表面上。 The invention provides an osteotomy surgical instrument 1 which can be applied to various osteotomy operations, correction or reduction operations. The osteotomy surgical instrument 1 of the present invention can be used for bones of various parts of the human body, for example, the humerus B, the femur D, the tibia, the tibia , ulna, humerus, clavicle, scapula, etc., but not limited thereto, in this embodiment, is used to guide a saw blade to perform a high tibial osteotomy of a tibia B, the tibia B by the present invention The osteotomy instrument 1 can be defined as a first cutting position C1 and a second cutting position C2. The osteotomy instrument 1 includes a first body member 12, a second body member 14, and a plurality of fixing slots. Hole 16. The first body member 12 is disposed above the first cutting position C1 and has a side guiding edge 121 and an upper guiding edge 122. The second body member 14 is disposed at the first cutting position C1 or the upper guiding edge 122. In the lower part, there is a lower guiding edge 141 disposed under the upper guiding edge 122; a plurality of fixing slots 16 are disposed on the surfaces of the first body member 12 and the second body member 14 by The plurality of fixation pins and the fixation bone pins 40 are inserted into the plurality of fixation slots 16 to fix the osteotomy instrument 1 to the surface of the tibia B.
其中，上導引邊122與下導引邊141係分別自第一主體部件12與第二主體部件14向外延伸，且上導引邊122與下導引邊141之間形成一導引槽50，用以導引鋸片至第一切割位置C1，側導引邊121用以導引鋸片至第二切割位置C2，該上導引邊122、下導引邊141及側導引邊121用來形成切割道，鋸片依據第一切割位置C1與第二切割位置C2對脛骨B進行切鋸，藉以進行高位脛骨截骨手術。 The upper guiding edge 122 and the lower guiding edge 141 extend outward from the first body member 12 and the second body member 14, respectively, and a guiding slot is formed between the upper guiding edge 122 and the lower guiding edge 141. 50, for guiding the saw blade to the first cutting position C1, the side guiding edge 121 is used for guiding the saw blade to the second cutting position C2, the upper guiding edge 122, the lower guiding edge 141 and the side guiding edge 121 is used to form a cutting track, and the saw blade cuts the tibia B according to the first cutting position C1 and the second cutting position C2, thereby performing high tibial osteotomy.
請參閱圖三A至圖三B，圖三A繪示了本發明之一具體實施例實施於脛骨時之後視示意圖，圖三B繪示了本發明之一具體實施例實施於脛骨時之側視示意圖。於本發明之一具體實施例中，第一主體部件12進一步包含一第一對位穿孔123，第一對位穿孔123穿設於上導引邊122；第二主體部件14進一步包含一第二對位穿孔142，第二對位穿孔142穿設於下導引邊141。於本發明中，第一對位穿孔123與第二對位穿孔142係設計來作為高位脛骨截骨手術中，確認脛骨截口被撐開之角度。為此，第一對位穿孔123之第一孔洞軸線A1與第二對位穿孔142之第二孔洞軸線A2之間具有一矯正夾角L(孔洞軸線A1、A2與矯正夾角繪示於圖五)，而高位脛骨截骨手術中，截骨缺口具有術前規劃之一矯正角度M。當脛骨B被第一主體部件12與第二主體部件14撐開矯正角度M之後，第一對位穿孔123與第二對位穿孔142之孔洞軸線A1、A2便能重合，並得以穿設一對位桿件20於第一對位穿孔123與第二對位穿孔142來確保矯正角度。而前述矯正角度的大小需先根據醫師診斷決定脛骨B於高位脛骨截骨手術中需要撐開的矯正角度M後，再根據所需的矯正角度M來決定第一對位穿孔與第二對位穿孔軸線之夾角並製造之。而對位桿件20也只在脛骨B被第一主體部件12與第二主體部件14撐開至術前規劃的矯正角度時方能被穿設於第一對位穿孔123與第二對位穿孔142之間。 Referring to FIG. 3A to FIG. 3B, FIG. 3A is a rear view showing a specific embodiment of the present invention implemented in the tibia, and FIG. 3B is a side view showing an embodiment of the present invention performed on the side of the humerus. See the schematic. In a specific embodiment of the present invention, the first body member 12 further includes a first alignment hole 123. The first alignment hole 123 is disposed through the upper guiding edge 122. The second body member 14 further includes a second portion. The alignment hole 142 and the second alignment hole 142 are disposed through the lower guide edge 141. In the present invention, the first alignment perforation 123 and the second alignment perforation 142 are designed to be used as a high-level tibial osteotomy to confirm the angle at which the tibial section is distracted. To this end, the first hole axis A1 of the first alignment hole 123 and the second hole axis A2 of the second alignment hole 142 have a correction angle L (the hole axes A1, A2 and the correction angle are shown in FIG. 5). In the high tibial osteotomy, the osteotomy gap has a correction angle M for preoperative planning. After the humerus B is stretched by the first body member 12 and the second body member 14 by the correction angle M, the hole alignment axes A1 and A2 of the first aligning hole 123 and the second aligning hole 142 can be overlapped and can be worn. The alignment bar 20 is in the first alignment perforation 123 and the second alignment perforation 142 to ensure a corrective angle. The size of the aforementioned correction angle needs to be determined according to the diagnosis of the humerus B. After the correction angle M of the patella B in the high tibial osteotomy, the first alignment puncture and the second alignment are determined according to the required correction angle M. The angle between the axes of the perforations is created. The alignment rod 20 can also be inserted through the first alignment hole 123 and the second alignment only when the tibia B is stretched by the first body member 12 and the second body member 14 to the corrected angle of the preoperative planning. Between the perforations 142.
請參閱圖四A至圖四B，圖四A繪示了本發明之一具體實施例實施前之前視示意圖，圖四B繪示了本發明之一具體實施例實施前之側視示意圖。於本發明之一實施例中，第一主體部件12與第二主體部件14得利用3D列印方式製成，並由於第一主體部件12與第二主體部件14需相互搭配才能應用在手術上，故本發明之截骨手術器械1進一步包含一固定部件18，在第一主 體部件12與第二主體部件14未使用前，固定部件18將相互搭配的第一主體部件12與第二主體部件14組合在一起，以確保有足夠面積貼附骨頭表面，而在第一主體部件12與第二主體部件14使用於高位脛骨截骨手術之前，得先將第一主體部件12與第二主體部件14固定於患者的脛骨上，再將固定部件18卸除。然本發明並不以此為限，第一主體部件12與第二主體部件14亦得以一體成形的方式製造，此時上導引邊122與下導引邊141之間有連接部相連，固定部件18則不為必須。實施手術時，執刀醫師可直接以骨鋸切開連接部。 Referring to FIG. 4A to FIG. 4B, FIG. 4A is a front view showing a specific embodiment of the present invention, and FIG. 4B is a side view showing a specific embodiment of the present invention. In an embodiment of the present invention, the first body member 12 and the second body member 14 are formed by a 3D printing method, and since the first body member 12 and the second body member 14 need to be matched with each other, the surgery can be applied to the operation. Therefore, the osteotomy surgical instrument 1 of the present invention further comprises a fixing member 18, in the first main Before the body member 12 and the second body member 14 are not in use, the fixing member 18 combines the first body member 12 and the second body member 14 that are matched with each other to ensure that a sufficient area is attached to the bone surface, and in the first body Before the component 12 and the second body member 14 are used in the high tibial osteotomy, the first body member 12 and the second body member 14 are first fixed to the patient's tibia, and the fixing member 18 is removed. However, the present invention is not limited thereto, and the first body member 12 and the second body member 14 are also integrally formed. In this case, the upper guiding edge 122 and the lower guiding edge 141 are connected with each other and fixed. Component 18 is not required. When performing an operation, the surgeon can directly cut the connection with a bone saw.
接著請參閱圖五至圖六，圖五繪示了本發明之另一具體實施例之示意圖，圖六繪示了本發明之另一具體實施例實施時之示意圖。 Referring to FIG. 5 to FIG. 6 , FIG. 5 is a schematic diagram showing another embodiment of the present invention, and FIG. 6 is a schematic diagram showing another embodiment of the present invention.
本發明另提供一種截骨手術器械2，得應用在各種截骨手術、矯正或復位手術，本發明之截骨手術器械2可用於人體各部位的骨骼，例如：脛骨B、股骨D、腓骨、肱骨、尺骨、橈骨、鎖骨、肩胛骨等，但並不以此為限，於本實施例中，係應用於導引一鋸片來實施一脛骨B之一高位脛骨截骨手術，脛骨B藉由本發明之截骨手術器械2可被定義出一第一切割位置C1與一第二切割位置C2，截骨手術器械2包含有：一第一主體部件22、一第二主體部件24、複數個固定槽孔26以及一矯正軸導引部件28。於此實施例中，第一主體部件22與第二主體部件24之間以一連接部相連，實施手術時，執刀醫師可直接以骨鋸切開連接部，但並不以此為限，亦可不需要該連接部而直接將該第一主體部件22與該第二主體部件24搭配使用，或以其他形式連接該第一主體部件22與該第二主體部件24。 The invention further provides an osteotomy surgical instrument 2, which can be applied to various osteotomy operations, correction or reduction operations, and the osteotomy surgical instrument 2 of the invention can be used for bones of various parts of the human body, for example: tibia B, femur D, tibia, The humerus, ulna, humerus, clavicle, scapula, etc., but not limited thereto, in this embodiment, is used to guide a saw blade to perform a high tibial osteotomy of a tibia B, the tibia B by this The osteotomy surgical instrument 2 of the present invention can be defined as a first cutting position C1 and a second cutting position C2. The osteotomy surgical instrument 2 comprises: a first body member 22, a second body member 24, and a plurality of fixed The slot 26 and a correcting shaft guiding member 28. In this embodiment, the first body member 22 and the second body member 24 are connected by a connecting portion. When performing the operation, the surgeon can directly cut the connecting portion with the bone saw, but not limited thereto, or not The first body member 22 and the second body member 24 are directly used in combination with the connecting portion, or the first body member 22 and the second body member 24 are otherwise connected.
其中第一主體部件22設置於第一切割位置C1的上方，具有一側導引邊221、一上導引邊222與一第一對位穿孔223，第一對位穿孔223以一第一桿件224與第一主體部件22連接；第二主體部件24設置於第一切割位置C1或上導引邊222的下方，具有一下導引邊241與一第二對位穿孔242，該下導引邊241設置於該上導引邊222下方，上導引邊222與下導引邊241之間形成一導引槽50，第二對位穿孔242以一第二桿件243與第二主體部件24連接；複數個固定槽孔26設置於第一主體部件22與第二主體部件24之表面 上，藉由穿設複數個固定銷及固定骨針40於複數個固定槽孔26中，來將截骨手術器械2固定於脛骨B的表面上；矯正軸導引部件28設置於第二主體部件24之表面上，其包含一延伸至第二切割位置C2或導引槽50後方之一第三矯正穿孔281，第三矯正穿孔281內設有術前規劃之一矯正軸30，用於作為高位脛骨截骨手術中脛骨B被撐開時的轉軸，藉由預先將一骨針作為矯正軸30打入脛骨外側術前規劃之轉軸位置，如此在撐開脛骨B的時候，可以確保脛骨B撐開時的旋轉軸線與術前規劃的相同，當鋸片已到達預先規劃的切割深度時會被該矯正軸30上的骨針擋住，確保切鋸的深度，提高手術的精確性，此外預鑽的孔洞能夠分散該處應力，避免撐開缺口時脛骨B外側骨頭斷裂。而矯正軸導引部件28得與第二主體部件24為一體成形或組合式。 The first body member 22 is disposed above the first cutting position C1, and has a side guiding edge 221, an upper guiding edge 222 and a first alignment hole 223, and the first alignment hole 223 is a first rod. The piece 224 is coupled to the first body member 22; the second body member 24 is disposed below the first cutting position C1 or the upper guiding edge 222, and has a lower guiding edge 241 and a second alignment hole 242, the lower guiding The side 241 is disposed under the upper guiding edge 222, and a guiding groove 50 is formed between the upper guiding edge 222 and the lower guiding edge 241. The second alignment hole 242 is a second rod 243 and a second body part. 24 connection; a plurality of fixing slots 26 are provided on the surface of the first body member 22 and the second body member 24. The osteotomy surgical instrument 2 is fixed to the surface of the tibia B by inserting a plurality of fixing pins and fixing bone pins 40 in the plurality of fixing slots 26; the correcting shaft guiding member 28 is disposed on the second body The surface of the component 24 includes a third correcting through hole 281 extending to the second cutting position C2 or the rear of the guiding groove 50. The third correcting through hole 281 is provided with a correction axis 30 for preoperative planning. In the high tibial osteotomy, the humerus B is opened when the humerus B is distracted. By preliminarily using a bone needle as the correcting axis 30, it is placed in the preoperative planning of the lateral humerus, so that the humerus B can be ensured when the humerus B is opened. The rotation axis when distracting is the same as that of the preoperative planning. When the saw blade has reached the pre-planned cutting depth, it will be blocked by the bone needle on the correcting shaft 30, ensuring the depth of the cutting saw and improving the accuracy of the operation. The drilled hole can disperse the stress at this point, avoiding the fracture of the lateral bone of the tibia B when the gap is opened. The correcting shaft guiding member 28 is integrally formed or combined with the second body member 24.
其中，上導引邊222與下導引邊241係分別自第一主體部件22與第二主體部件24向外延伸，且上導引邊222與下導引邊241之間形成導引槽50，使導引槽50得以導引鋸片至第一切割位置C1，而側導引邊221則用以導引鋸片至第二切割位置C2。上述導引邊222、下導引邊241及側導引邊221用來形成切割道，使鋸片得以依據切割道之第一切割位置C1與第二切割位置C2對脛骨B進行切鋸，藉以進行高位脛骨截骨手術。 The upper guiding edge 222 and the lower guiding edge 241 extend outward from the first body member 22 and the second body member 24 respectively, and the guiding groove 50 is formed between the upper guiding edge 222 and the lower guiding edge 241. The guiding groove 50 is guided to the first cutting position C1, and the side guiding edge 221 is used to guide the saw blade to the second cutting position C2. The guiding edge 222, the lower guiding edge 241 and the side guiding edge 221 are used to form a cutting path, so that the saw blade can cut the tibia B according to the first cutting position C1 and the second cutting position C2 of the cutting path, thereby Perform a high tibial osteotomy.
於本發明中，第一對位穿孔223與第二對位穿孔242係設計來做為高位脛骨截骨手術中確認脛骨截口被撐開之角度，為此，第一對位穿孔223之第一孔洞軸線A1與第二對位穿孔242之第二孔洞軸線A2之間具有一矯正夾角L，而高位脛骨截骨手術中，截骨缺口具有術前規劃之一矯正角度。當脛骨B被第一主體部件22與第二主體部件24撐開前述矯正角度之後，第一對位穿孔223與第二對位穿孔242之孔洞軸線A1、A2便能重合，並得以穿設一對位桿件20於第一對位穿孔223與第二對位穿孔242來確保矯正角度。而矯正夾角L的大小需先根據醫師診斷決定脛骨B於高位脛骨截骨手術中需要撐開的矯正角度後，再以前述矯正角度決定矯正夾角L的大小並製造之，而對位桿件20也只在脛骨B被第一主體部件22與第二主體部件24撐開至術前規劃的矯正角度時方能被穿設於第一對位穿孔223與第二對位穿孔242之間。 In the present invention, the first alignment perforation 223 and the second alignment perforation 242 are designed to confirm the angle at which the tibial occlusion is distracted in the high tibial osteotomy. For this purpose, the first puncture 223 is the first A hole axis A1 and a second hole axis A2 of the second alignment hole 242 have a correct angle L. In the high tibial osteotomy, the osteotomy gap has a correction angle of one of the preoperative plans. After the humerus B is stretched by the first body member 22 and the second body member 24, the first alignment hole 223 and the second alignment hole 242 can be aligned with the hole axes A1 and A2, and can be worn. The alignment bar 20 is in the first alignment aperture 223 and the second alignment aperture 242 to ensure a corrective angle. The size of the correction angle L needs to be determined according to the doctor's diagnosis, and then the correction angle of the humerus B in the high tibial osteotomy is required, and then the correction angle is determined by the aforementioned correction angle and manufactured, and the alignment rod 20 is manufactured. Only when the humerus B is stretched by the first body member 22 and the second body member 24 to the corrected angle of the preoperative plan can be inserted between the first alignment hole 223 and the second alignment hole 242.
請同時參閱圖二、圖三A、圖三B與圖七，於此說明如何利用本發明進行高位脛骨截骨手術。在圖二中，截骨手術器械1、2所貼附的脛骨位置，係位於人體小腿與接近膝蓋關節的內側近端，然而其所貼附的範圍並不限於此，亦可貼附於其他骨骼的其他位置。換句話說，閱圖人所見圖二的正面是指向人體內側，而閱圖人所見圖二的左邊是指向人體後側。其中圖三A與圖三B對應至截骨手術器械1，圖七繪示了本發明之另一具體實施例實施時之前視示意圖，且對應至截骨手術器械2。 Please also refer to FIG. 2, FIG. 3A, FIG. 3B and FIG. 7 to illustrate how to perform high tibial osteotomy with the present invention. In Fig. 2, the position of the humerus attached to the osteotomy instruments 1 and 2 is located at the proximal end of the human calf and the proximal knee joint. However, the scope of attachment is not limited thereto, and may be attached to other Other locations of the bones. In other words, the front side of Figure 2 is directed to the inside of the human body, while the left side of Figure 2 is directed to the back side of the human body. FIG. 3A and FIG. 3B correspond to the osteotomy surgical instrument 1, and FIG. 7 is a front view showing another embodiment of the present invention, and corresponds to the osteotomy surgical instrument 2.
本發明的截骨手術器械1、2係根據退化性關節炎患者在術前所提供的脛骨影像資訊，利用電腦軟體建立脛骨B的模型之後，再根據脛骨B模型來決定第一切割位置C1與第二切割位置C2的位置，並量身打造截骨手術器械1、2的整體結構。其中截骨手術器械1與2係設計成能夠完全貼合患者的脛骨B表面，再以三維列印(three-dimensional printing,3D列印)技術建置一體成型或組合式的實體器械。 The osteotomy surgical instruments 1 and 2 of the present invention determine the first cutting position C1 according to the tibia B model according to the sacral bone image information provided by the degenerative arthritis patient before the operation, using the computer software to establish the tibia B model. The position of the second cutting position C2 is tailored to the overall structure of the osteotomy instruments 1, 2. Among them, the osteotomy instruments 1 and 2 are designed to completely conform to the surface of the patient's tibia B, and then a three-dimensional printing (3D printing) technology to construct an integrated or combined physical device.
當截骨手術器械1、2被設置於患者的脛骨表面之後，執刀醫師根據截骨手術器械1、2的上導引邊122、222與下導引邊141、241所導引至的第一切割位置C1，將鋸片伸入並開始切割。執刀醫師可利用上導引邊122、222與下導引邊141、241作為切割深度計算的基準參考，或在鋸片上作一標記，即可利用肉眼目視確認鋸片切入脛骨B的深度是否達到預設深度。 After the osteotomy surgical instruments 1, 2 are placed on the patient's tibia surface, the surgeon is guided by the upper guiding edges 122, 222 and the lower guiding edges 141, 241 of the osteotomy surgical instruments 1, 2 Cut position C1, insert the saw blade and start cutting. The surgeon can use the upper guiding edges 122, 222 and the lower guiding edges 141, 241 as reference references for cutting depth calculation, or mark the saw blade to visually confirm whether the depth of the saw blade into the tibia B is visually recognized by the naked eye. The preset depth is reached.
鋸片切至預定深度後沿著上導引邊122、222與下導引邊141、241往人體的內側切入，並截斷部分的脛骨B後，接著延著側導引邊121、221所導引至的第二切割位置C2切入，以切出一道斜切的切口。切口切完後，於截骨手術器械1、2維持固定於脛骨B的情況下撐開脛骨B的第一切割位置C1至術前規劃的矯正角度M後，將對位桿件20穿入第一對位穿孔123、223與第二對位穿孔142、242，確認脛骨B的手術切口矯正角度，便可繼續後續固定缺口的動作以完成手術。 After the saw blade is cut to a predetermined depth, it is cut into the inner side of the human body along the upper guiding edges 122, 222 and the lower guiding edges 141, 241, and the part of the tibia B is cut off, and then guided by the side guiding edges 121, 221 The second cutting position C2 is cut in to cut a beveled slit. After the incision is cut, after the osteotomy surgical instruments 1 and 2 are fixed to the tibia B, the first cutting position C1 of the humerus B is opened to the corrected angle M of the preoperative planning, and the alignment rod 20 is inserted into the The pair of perforations 123, 223 and the second alignment perforations 142, 242 confirm the surgical incision correction angle of the humerus B, and the subsequent fixation of the incision can be continued to complete the operation.
接著請參閱圖八A、圖八B、圖九A與圖九B，圖八A繪示了 本發明之再一實施例實施時之側視示意圖，圖八B繪示了實施本發明時於股骨D上所欲切割的位置示意圖。圖九A繪示了本發明之再一實施例實施時之前視示意圖，圖九B繪示了本發明之再一實施例實施時之側視示意圖。 Please refer to FIG. 8A, FIG. 8B, FIG. 9A and FIG. 9B, and FIG. 8A shows A side view of a further embodiment of the present invention is implemented, and FIG. 8B is a schematic view showing a position to be cut on the femur D when the present invention is implemented. FIG. 9A is a front view showing another embodiment of the present invention, and FIG. 9B is a side view showing another embodiment of the present invention.
本發明另提供一種截骨手術器械3，得應用在各種截骨手術、矯正或復位手術，本發明之截骨手術器械3可用於人體各部位的骨骼，例如：脛骨B、股骨D、腓骨、肱骨、尺骨、橈骨、鎖骨、肩胛骨等，但並不以此為限，於本實施例中，適於導引一鋸片來實施一股骨D之股骨遠端截骨手術(DISTAL FEMORAL OSTEOTOMY,DFO)。截骨手術器械3包含有：一第一主體部件32、一第二主體部件34以及複數個固定槽孔36。於此實施例中，第一主體部件32與第二主體部件34之間以一連接部相連，實施手術時，執刀醫師可直接以骨鋸切開連接部，但並不以此為限，亦可不需要該連接部而直接將該第一主體部件32與該第二主體部件34搭配使用，或以其他形式連接該第一主體部件32與該第二主體部件34。而圖八A至圖九B中所見的股骨D部分是人體左大腿骨(股骨)靠近膝關節的一端，然而其所適用的範圍並不限於此，亦可用於其他骨骼的其他位置。 The invention further provides an osteotomy surgical instrument 3, which can be applied to various osteotomy operations, correction or reduction operations, and the osteotomy surgical instrument 3 of the invention can be used for bones of various parts of the human body, for example: tibia B, femur D, tibia, The humerus, ulna, humerus, clavicle, scapula, etc., but not limited thereto, in this embodiment, it is suitable for guiding a saw blade to perform a femur D osteotomy of the femur (DISTAL FEMORAL OSTEOTOMY, DFO ). The osteotomy instrument 3 includes a first body member 32, a second body member 34, and a plurality of fixing slots 36. In this embodiment, the first body member 32 and the second body member 34 are connected by a connecting portion. When performing the operation, the surgeon can directly cut the connecting portion with the bone saw, but not limited thereto, or The first body member 32 is directly used in conjunction with the second body member 34 or the first body member 32 and the second body member 34 are otherwise connected. The part D of the femur seen in Fig. 8A to Fig. 9B is the end of the human left thigh bone (femur) close to the knee joint, however, the applicable range is not limited thereto, and can be used for other positions of other bones.
前述股骨D藉由本發明之截骨手術器械3可被定義出一第三切割位置C3，其中第一主體部件32設置於一第三切割位置C3的上方，具有一上導引邊321與一第一對位穿孔322，第一對位穿孔322以一第一桿件323與第一主體部件32連接；第二主體部件34設置於第三切割位置C3或上導引邊321的下方，具有一下導引邊341與一第二對位穿孔342，該下導引邊341設置於該上導引邊321下方，第二對位穿孔342以一第二桿件343與第二主體部件34連接；複數個固定槽孔36設置於第一主體部件32與第二主體部件34之表面上，藉由穿設複數個固定銷及固定骨針40於複數個固定槽孔36中，來將截骨手術器械3固定於股骨D的表面上。 The aforementioned femur D can be defined by the osteotomy surgical instrument 3 of the present invention, wherein the first body member 32 is disposed above a third cutting position C3, having an upper guiding edge 321 and a first a pair of through holes 322, the first alignment holes 322 are connected to the first body member 32 by a first rod member 323; the second body member 34 is disposed below the third cutting position C3 or the upper guiding edge 321, a guiding edge 341 and a second alignment hole 342, the lower guiding edge 341 is disposed below the upper guiding edge 321 , and the second alignment hole 342 is connected to the second body member 34 by a second rod 343 ; A plurality of fixing slots 36 are disposed on the surfaces of the first body member 32 and the second body member 34, and the osteotomy is performed by inserting a plurality of fixing pins and fixing the bone pins 40 into the plurality of fixing slots 36. The instrument 3 is fixed to the surface of the femur D.
其中，上導引邊321與下導引邊341係分別自第一主體部件32與第二主體部件34向外延伸，且上導引邊321與下導引邊341之間形成一導引槽50，用以導引鋸片至第三切割位置C3，該上導引邊321、下導引邊341用 來形成切割道，鋸片依據第三切割位置C3對股骨D進行切鋸，藉以進行股骨遠端截骨手術。 The upper guiding edge 321 and the lower guiding edge 341 extend outward from the first body member 32 and the second body member 34 respectively, and a guiding slot is formed between the upper guiding edge 321 and the lower guiding edge 341. 50, for guiding the saw blade to the third cutting position C3, the upper guiding edge 321 and the lower guiding edge 341 To form a cutting lane, the saw blade is cut according to the third cutting position C3 to perform a distal femur osteotomy.
於本發明中，第一對位穿孔322與第二對位穿孔342係設計來做為股骨遠端截骨手術中確認股骨截口被撐開之角度，為此，第一對位穿孔322之第一孔洞軸線A1與第二對位穿孔342之第二孔洞軸線A2之間具有一矯正夾角N，而股骨遠端截骨手術中，截骨缺口具有術前規劃之一矯正角度。當股骨D被第一主體部件32與第二主體部件34撐開前述矯正角度之後，第一對位穿孔322與第二對位穿孔342之孔洞軸線A1、A2便能重合，並得以穿設一對位桿件20於第一對位穿孔322與第二對位穿孔342來確保矯正角度。而矯正夾角N的大小需先根據醫師診斷決定股骨D於股骨遠端截骨手術中需要撐開的矯正角度後，再以前述矯正角度決定矯正夾角N的大小並製造之，而對位桿件20也只在股骨D被第一主體部件32與第二主體部件34撐開至術前規劃的矯正角度時方能被穿設於第一對位穿孔322與第二對位穿孔342。 In the present invention, the first alignment perforation 322 and the second alignment perforation 342 are designed to confirm the angle at which the femoral kerf is distracted in the distal femur osteotomy. To this end, the first alignment perforation 322 The first hole axis A1 and the second hole axis 342 of the second alignment hole 342 have a correct angle N, and in the distal femur osteotomy, the osteotomy gap has a correction angle of preoperative planning. After the femur D is stretched by the first body member 32 and the second body member 34, the first alignment hole 322 and the second alignment hole 342 can be aligned with the hole axes A1 and A2, and can be worn. The alignment bar 20 is in the first alignment aperture 322 and the second alignment aperture 342 to ensure a corrective angle. The size of the correction angle N needs to be determined according to the diagnosis of the femur. After the correction angle of the femur D in the distal femur osteotomy, the angle of the correction angle N is determined by the aforementioned correction angle, and the alignment rod is manufactured. 20 can also be worn through the first alignment aperture 322 and the second alignment aperture 342 only when the femur D is expanded by the first body member 32 and the second body member 34 to a corrected angle of preoperative planning.
請再參閱圖八A、圖八B、圖九A與圖九B，於此說明如何利用本發明進行股骨遠端截骨手術。在圖八A與圖八B中，截骨手術器械3所貼附的股骨位置，係位於人體左大腿接近膝蓋關節的外側遠端，然而其所適用的範圍並不限於此，亦可用於其他骨骼的其他位置。換句話說，閱圖人所見圖八A與圖八B的正面是指向人體外側，而閱圖人所見圖八A與圖八B的左邊是指向人體前側。 Please refer to FIG. 8A, FIG. 8B, FIG. 9A and FIG. 9B, respectively, how to use the present invention to perform distal femur osteotomy. In FIGS. 8A and 8B, the position of the femur attached to the osteotomy instrument 3 is located at the outer distal end of the left thigh of the human body close to the knee joint. However, the applicable range is not limited thereto, and may be used for other purposes. Other locations of the bones. In other words, the front side of the figure 8A and FIG. 8B is directed to the outside of the human body, and the left side of the figure 8A and FIG. 8B is directed to the front side of the human body.
本發明的截骨手術器械3係根據退化性關節炎患者在術前所提供的股骨影像資訊，利用電腦軟體建立股骨D的模型之後，再根據股骨D模型來決定第三切割位置C3的位置，並量身打造截骨手術器械3的整體結構。其中截骨手術器械3係設計成能夠完全貼合患者的股骨D表面，再以三維列印(three-dimensional printing,3D列印)技術建置一體成型或組合式的實體器械。 The osteotomy surgical instrument 3 of the present invention determines the position of the third cutting position C3 according to the femur D model according to the femur image information provided by the degenerative arthritis patient before the operation, using the computer software to establish the model of the femur D. The overall structure of the osteotomy surgical instrument 3 is tailored. The osteotomy instrument 3 is designed to fully conform to the patient's femur D surface, and then a three-dimensional printing (3D printing) technology to construct an integrated or combined physical device.
請參考圖九A，該圖顯示鋸片於第三切割位置C3上已完成切鋸之切割道E。當截骨手術器械3被設置於患者的股骨表面之後，執刀醫師根 據截骨手術器械3的上導引邊321與下導引邊341所導引至的第三切割位置C3，將鋸片伸入並開始切割。執刀醫師可利用上導引邊321與下導引邊341作為切割深度計算的基準參考，或在鋸片上作一標記，即可利用肉眼目視確認鋸片切入股骨D的深度是否達到預設深度。 Please refer to FIG. 9A, which shows the cutting path E of the sawing saw that has been cut by the saw blade at the third cutting position C3. When the osteotomy instrument 3 is placed on the patient's femur surface, the surgeon is rooted. According to the third cutting position C3 to which the upper guiding edge 321 and the lower guiding edge 341 of the osteotomy instrument 3 are guided, the saw blade is inserted into and starts to be cut. The surgeon can use the upper guiding edge 321 and the lower guiding edge 341 as reference references for cutting depth calculation, or marking the saw blade to visually confirm whether the depth of the saw blade into the femur D reaches a preset depth. .
鋸片切至預定深度後沿著上導引邊321與下導引邊341進行切鋸，並截斷部分的股骨D後，於截骨手術器械3維持固定於股骨D的情況下，撐開股骨D的第三切割位置C3至術前規劃的矯正角度後，將對位桿件20穿入第一對位穿孔322與第二對位穿孔342，確認股骨D的手術切口矯正角度，便可繼續後續固定缺口的動作以完成手術。 After the saw blade is cut to a predetermined depth, the saw is cut along the upper guiding edge 321 and the lower guiding edge 341, and after the femur D is partially cut off, the femur is opened while the osteotomy surgical instrument 3 is fixed to the femur D. After the third cutting position C3 of D reaches the corrected angle of the preoperative planning, the alignment rod 20 is inserted into the first alignment perforation 322 and the second alignment perforation 342 to confirm the correction angle of the surgical incision of the femur D, and then continue Follow the action of fixing the gap to complete the operation.
綜上所述，本發明提供一種截骨手術器械1、2、3，於一實施例中係根據醫師對退化性關節炎患者術前所蒐集的骨骼影像資訊而量身打造而成。於一實施例中，藉由上導引邊122、222與下導引邊141、241指定第一切割位置C1，並作為切割深度參考點，使執刀醫師能簡單控制切割深度，再藉由側導引邊121、221指定第二切割位置C2以進行手術。而於另一實施例中，藉由上導引邊321與下導引邊341指定第三切割位置C3，並作為切割深度參考點，使執刀醫師能簡單控制切割深度以進行手術。本案發明除了在手術中能不傷害韌帶外，亦可切出能抵抗骨骼因行走而產生的旋轉運動，亦根據手術前的矯正規劃來設計本案發明，使得手術過程能夠加以簡化。 In summary, the present invention provides an osteotomy surgical instrument 1, 2, and 3, which in one embodiment is tailored to the bone image information collected by a physician prior to surgery on a patient with degenerative arthritis. In one embodiment, the first cutting position C1 is specified by the upper guiding edges 122, 222 and the lower guiding edges 141, 241, and serves as a cutting depth reference point, so that the surgeon can simply control the cutting depth, and then by the side The guiding edges 121, 221 designate a second cutting position C2 for surgery. In another embodiment, the third cutting position C3 is specified by the upper guiding edge 321 and the lower guiding edge 341, and serves as a cutting depth reference point, so that the surgeon can simply control the cutting depth to perform the operation. In addition to not damaging the ligament during surgery, the invention can also cut out the rotational movement of the bone due to walking, and design the invention according to the pre-operative correction plan, so that the surgical procedure can be simplified.
相較於習知技術，本發明的截骨手術器械1、2、3係根據術前所蒐集的患者骨骼資料，並評估最佳手術切割位置後以三維列印(three-dimensional printing,3D列印)建成。器械本身能夠完全貼合患者的骨骼，而執刀醫師就可根據器械指定的導引槽50，進行第一切割位置C1或第三切割位置C3的下刀，藉由導引槽50可讓執刀醫師準確地下刀之外，亦可提供切割角度與深度的計算參考，側導引邊121、221可提供執刀醫師第二切割位置C2的下刀基準。本發明除了改良手術本身之外，亦標準化執刀醫師手術的實施。 Compared with the prior art, the osteotomy surgical instruments 1, 2, and 3 of the present invention are based on the patient's bone data collected before surgery, and are evaluated in three-dimensional printing after three-dimensional printing (3D column). India) was built. The instrument itself can completely conform to the patient's bone, and the surgeon can perform the lower cutting position of the first cutting position C1 or the third cutting position C3 according to the guiding groove 50 designated by the instrument, and the guiding knife 50 can be used by the surgeon. In addition to the accurate underground knife, a calculation reference for the cutting angle and depth can also be provided, and the side guiding edges 121, 221 can provide the lower knife reference of the second cutting position C2 of the surgeon. In addition to improving the surgery itself, the present invention also standardizes the implementation of the surgeon's surgery.
藉由以上具體實施例之詳述，係希望能更加清楚描述本發明之 特徵與精神，而並非以上述所揭露的較佳具體實施例來對本發明之範疇加以限制。相反地，其目的是希望能涵蓋各種改變及具相等性的安排於本發明所欲申請之專利範圍的範疇內。因此，本發明所申請之專利範圍的範疇應根據上述的說明作最寬廣的解釋，以致使其涵蓋所有可能的改變以及具相等性的安排。 Through the detailed description of the above specific embodiments, it is desirable to more clearly describe the present invention. Features and spirits are not intended to limit the scope of the invention in the preferred embodiments disclosed herein. On the contrary, the intention is to cover various modifications and equivalents within the scope of the invention as claimed. Therefore, the scope of the patented scope of the invention should be construed in the broadest
Claims (14)
Priority Applications (10)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17186473.9A EP3284418B1 (en) | 2016-08-19 | 2017-08-16 | Surgery device for osteotomy |
| EP18177577.6A EP3403600B1 (en) | 2016-08-19 | 2017-08-16 | Surgical device for osteotomy |
| EP18177551.1A EP3400888B1 (en) | 2016-08-19 | 2017-08-16 | Surgical device for osteotomy |
| ES18177551T ES2803952T3 (en) | 2016-08-19 | 2017-08-16 | Surgical device for osteotomies |
| CN201710702574.7A CN107753088B (en) | 2016-08-19 | 2017-08-16 | Osteotomy surgical instrument |
| ES17186473T ES2752654T3 (en) | 2016-08-19 | 2017-08-16 | Osteotomy surgical device |
| ES18177577T ES2803953T3 (en) | 2016-08-19 | 2017-08-16 | Surgical device for osteotomies |
| US15/680,235 US10842505B2 (en) | 2016-08-19 | 2017-08-18 | Surgery device for osteotomy |
| JP2018125791A JP6792595B2 (en) | 2016-08-19 | 2018-07-02 | Osteotomy instrument |
| KR1020180081511A KR20200068004A (en) | 2016-08-19 | 2018-07-13 | Surgical device for osteotomy |
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| TW105126498 | 2016-08-19 | ||
| ??105126498 | 2016-08-19 |
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| JP (1) | JP6792595B2 (en) |
| KR (1) | KR20200068004A (en) |
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| WO2020206674A1 (en) * | 2019-04-12 | 2020-10-15 | Johnson & Johnson Medical (Suzhou) Limited | Osteotomy guide |
| JP7312614B2 (en) * | 2019-06-12 | 2023-07-21 | オリンパステルモバイオマテリアル株式会社 | Osteotomy guide device |
| CN113208689B (en) * | 2019-09-30 | 2022-08-02 | 苏州微创畅行机器人有限公司 | Osteotomy guiding tool |
| CN112971911A (en) * | 2019-12-18 | 2021-06-18 | 上海昕健医疗技术有限公司 | Osteotomy guiding tool and method of use thereof |
| CN219763473U (en) * | 2022-11-09 | 2023-09-29 | 北京纳通医疗科技控股有限公司 | Osteotomy positioning device for tibia high osteotomy |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW201102114A (en) | 2009-07-14 | 2011-01-16 | Chen-Kun Liaw | Joint replacement with magnetism |
| TWM462091U (en) | 2013-05-31 | 2013-09-21 | Shi-jie YANG | Osteotomy guiding apparatus |
| TWM509626U (en) | 2014-10-23 | 2015-10-01 | RIOS Medical AG | Osteotomy implant |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP4736091B2 (en) * | 2006-06-30 | 2011-07-27 | オリンパステルモバイオマテリアル株式会社 | Osteotomy opener |
| US8926618B2 (en) * | 2007-04-19 | 2015-01-06 | Howmedica Osteonics Corp. | Cutting guide with internal distraction |
| GB2525593A (en) * | 2014-04-25 | 2015-11-04 | Fusion Implants Ltd | Combined bone cutting guide and spreader device |
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2017
- 2017-08-10 TW TW106127173A patent/TWI638634B/en active
- 2017-08-16 ES ES17186473T patent/ES2752654T3/en active Active
- 2017-08-16 ES ES18177577T patent/ES2803953T3/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW201102114A (en) | 2009-07-14 | 2011-01-16 | Chen-Kun Liaw | Joint replacement with magnetism |
| TWM462091U (en) | 2013-05-31 | 2013-09-21 | Shi-jie YANG | Osteotomy guiding apparatus |
| TWM509626U (en) | 2014-10-23 | 2015-10-01 | RIOS Medical AG | Osteotomy implant |
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| TW201806558A (en) | 2018-03-01 |
| JP6792595B2 (en) | 2020-11-25 |
| ES2803953T3 (en) | 2021-02-01 |
| ES2803952T3 (en) | 2021-02-01 |
| JP2019034120A (en) | 2019-03-07 |
| KR20200068004A (en) | 2020-06-15 |
| ES2752654T3 (en) | 2020-04-06 |
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