TWM509626U - Osteotomy implant - Google Patents
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本創作是關於用於執行膝蓋之開放楔狀物截骨術(opening wedge osteotomy)及閉合楔狀物截骨術(closing wedge osteotomy)的手術裝置。This creation relates to a surgical device for performing an open wedge osteotomy and a closing wedge osteotomy of the knee.
膝蓋截骨術為用以重新對準下肢之大關節(即,髖部、膝蓋及足踝)之米古力茲氏線(Mikulicz-line)的手術方法。在肢之正常軸向對準的情況下,髖部之中心、脛骨平台之髁間隆起及足踝關節之中心處於一條線,其為下肢之機械軸線。Knee osteotomy is a surgical procedure used to realign the Mikulicz-line of the large joints of the lower extremities (ie, hips, knees, and ankles). In the case of normal axial alignment of the limb, the center of the hip, the intercondylar ridge of the tibial plateau, and the center of the ankle joint are in a line that is the mechanical axis of the lower extremity.
由於(例如)膝蓋之一個側上的關節炎損害、先天錯位或創傷性損傷,此對準可受到干擾,且造成被稱作膝蓋關節病(knee-arthroses)的膝蓋軟骨之過度磨損。This alignment can be disturbed by, for example, arthritic damage, congenital dislocation, or traumatic injury on one side of the knee, and causes excessive wear of knee cartilage known as knee-arthroses.
膝蓋截骨術手術技術之目的是在早期階段中使膝蓋中之力遠離受損害區域而重新劃分至膝蓋之相對較健康側。源於患者之體重的力及肌肉反作用力遍及膝蓋關節較好地散佈。The purpose of the knee osteotomy technique is to re-divide the force in the knee away from the damaged area to the relatively healthy side of the knee in the early stages. The force and muscle reaction originating from the patient's weight are better spread throughout the knee joint.
兩種技術在臨床實踐中是常見的,即,開放楔狀物截骨術及閉合楔狀物截骨術。兩種技術皆旨在部分地或完全地重新建立前述米古力茲氏線。Two techniques are common in clinical practice, namely open wedge osteotomy and closed wedge osteotomy. Both techniques are intended to partially or completely re-establish the aforementioned Miguriz line.
當執行閉合楔狀物技術時,移除在脛骨平台下方之骨 頭楔狀物。下拉脛骨平台以閉合間隙,且運用創傷學板及螺絲進行固定。Remove the bone below the tibial plateau when performing the closed wedge technique Head wedge. The tibial plate is pulled down to close the gap and secured with a traumatic plate and screws.
當執行開放楔狀物技術時,在脛骨平台下方遍及表面積之約80%而產生水平骨頭切口。插入楔狀物形隔片。在一個側上使脛骨平台強制向上以校正腿部軸線。楔狀物形隔片可由天然骨頭、人造骨頭或其他生物相容或骨綜合(osteointegrative)材料製成。When the open wedge technique is performed, a horizontal bone incision is made throughout the tibial plateau over approximately 80% of the surface area. Insert a wedge-shaped spacer. The tibial plateau is forced upward on one side to correct the leg axis. The wedge-shaped septum can be made of natural bone, artificial bone or other biocompatible or osteointegrative material.
為了使隔片保持於適當位置,通常運用創傷性板及螺絲來固定隔片。In order to hold the septum in place, the septum is usually secured with a traumatic plate and screws.
膝蓋截骨術手術技術向患者提供重要益處,此是因為膝蓋截骨術手術技術可將患者需要進行總體膝蓋替換之時刻延遲高達10年。Knee osteotomy surgical techniques provide important benefits to patients because knee osteotomy techniques can delay the time a patient needs to perform an overall knee replacement for up to 10 years.
儘管存在此等優點,但併發症常常與此技術相關聯,此技術常常造成患者在恢復期間不舒適。疼痛之較重要原因中的一者為位於骨頭頂部上之板及螺絲的隆凸,從而造成軟組織刺激。Despite these advantages, complications are often associated with this technique, which often causes the patient to be uncomfortable during recovery. One of the more important causes of pain is the protrusion of the plate and the screw on the top of the bone, causing soft tissue irritation.
US 8,137,406 B2(Arthrex Inc.)揭示一種用於執行膝蓋之開放楔狀物高脛骨截骨術的裝置。該裝置包含截骨術板,該截骨術板包括具有前側及背側之本體、自本體之背側延伸以用於裝設於骨頭之類楔狀物開口中的突起物,以及用於收納固定螺絲之複數個安裝孔洞。安裝孔洞經形成為使得當突起物定位於類楔狀物開口中時,固定螺絲在類楔狀物開口之任一側上被引導至骨頭中。US 8,137,406 B2 (Arthrex Inc.) discloses a device for performing an open wedge high tibial osteotomy of the knee. The device includes an osteotomy plate including a body having a front side and a back side, a protrusion extending from a back side of the body for mounting in a wedge opening such as a bone, and for receiving A plurality of mounting holes for fixing screws. The mounting holes are formed such that when the protrusions are positioned in the wedge-like opening, the set screws are guided into the bone on either side of the wedge-like opening.
如US 8,137,406 B2所揭示之裝置的一個主要缺陷為:截骨術板跨越骨頭之類楔狀物開口的大區段,藉此防止遍及此大區段之骨頭向內生長。另外,骨頭板具有遵循患者之骨頭在類楔狀物開口之邊緣處之輪廓的形狀,藉此在骨頭板之形狀並不與開口 之外部輪廓確切地匹配的狀況下引起骨頭板遍及開口之邊緣的隆凸。A major drawback of the device disclosed in U.S. Patent No. 8,137,406 B2 is that the osteotomy plate spans a large section of a wedge opening such as a bone, thereby preventing bone ingrowth throughout the large segment. In addition, the bone plate has a shape that follows the contour of the patient's bone at the edge of the wedge-like opening, whereby the shape of the bone plate does not open The protuberance of the bone plate over the edge of the opening is caused by the exact alignment of the outer contour.
本創作之目的是產生一種關於最初提及之技術領域的截骨術植體,該截骨術植體僅微不足道地干擾截骨術開口中之骨頭向內生長,且縮減任何植體部分之隆凸的發生。The purpose of this creation is to create an osteotomy implant in the first-mentioned technical field that only insignificantly interferes with bone ingrowth in the osteotomy opening and reduces the bulge of any implant portion. The occurrence of convexity.
本創作之解決方案是由申請專利範圍第1項之特徵指定。根據本創作,一種以一實質上埋頭方式在一目標骨頭中橋接一開口之截骨術植體包含:一近端部,其具有用於收納至少一個骨頭固定元件之至少一個孔隙;及一遠端部,其具有用於收納至少一個骨頭固定元件之至少一個孔隙。另外,該截骨術植體包括連接該近端部與該遠端部之至少一個中間支柱部。該至少一個中間支柱部具有等於或小於該至少一個中間支柱部之一厚度的一寬度。The solution for this creation is specified by the characteristics of item 1 of the scope of the patent application. According to the present invention, an osteotomy implant bridging an opening in a target bone in a substantially countersunk manner comprises: a proximal end having at least one aperture for receiving at least one bone fixation element; and a distal end An end having at least one aperture for receiving at least one bone fixation element. Additionally, the osteotomy implant includes at least one intermediate post connecting the proximal portion and the distal portion. The at least one intermediate post portion has a width equal to or less than a thickness of one of the at least one intermediate post portion.
具有所描述之寬度對厚度比率的至少一個中間支柱部之提供具有如下優點:由該至少一個中間支柱部提供遍及該截骨術開口之足夠支撐,同時減少由於該至少一個支柱部之隆凸的軟組織刺激。此情形主要是由於該至少一個中間支柱部被埋頭至該目標骨頭中的事實。另外,因為該至少一個中間支柱部之寬度可保持相對小;至開放楔狀物中之骨頭向內生長受到僅微不足道地擾亂。另外,該截骨術開口之邊緣的僅一小部分由該截骨術植體佔據,因此允許該邊緣之較大部分由(例如)骨頭替換材料佔據或保持開放。骨頭替換材料將逐漸地由天然骨頭吸收及替換。若使該截骨術開口保持開放,則天然骨頭將逐漸地生長至該開口中且閉合間隙。Providing the at least one intermediate strut portion having the width-to-thickness ratio described has the advantage of providing sufficient support throughout the osteotomy opening by the at least one intermediate strut portion while reducing the protuberance due to the at least one strut portion Soft tissue stimulation. This situation is primarily due to the fact that the at least one intermediate strut is buried in the target bone. In addition, because the width of the at least one intermediate strut portion can be kept relatively small; the ingrowth of the bone into the open wedge is only negligibly disturbed. Additionally, only a small portion of the edge of the osteotomy opening is occupied by the osteotomy implant, thus allowing a larger portion of the edge to be occupied or remain open by, for example, bone replacement material. The bone replacement material will gradually be absorbed and replaced by natural bone. If the osteotomy opening is left open, the natural bone will gradually grow into the opening and close the gap.
在本申請案中,術語「埋頭」意謂該截骨術植體之各別部分完全地置放至該目標骨頭中,該截骨術植體之表面與該目標骨頭之表面齊平。In the present application, the term "buried head" means that the respective portions of the osteotomy implant are completely placed into the target bone, the surface of the osteotomy implant being flush with the surface of the target bone.
另外,該至少一個中間支柱部之寬度是由在與該骨頭之長度軸線實質上成直角之方向上實質上平行於該截骨術開口之邊緣而置放之表面的尺寸所界定。Additionally, the width of the at least one intermediate post portion is defined by the size of the surface that is placed substantially parallel to the edge of the osteotomy opening in a direction substantially perpendicular to the longitudinal axis of the bone.
對應地,該至少一個中間支柱部之厚度為該至少一個中間支柱部的與該寬度成直角且意欲延伸至松質骨頭中之尺寸。Correspondingly, the thickness of the at least one intermediate strut portion is a dimension of the at least one intermediate strut portion that is at right angles to the width and is intended to extend into the cancellous bone.
該待橋接開口較佳地為一楔狀物形開口。該等孔隙較佳地經組態為可包含一有螺紋內部圓周之螺絲孔洞。在替代性較佳實施例中,該等孔隙可經組態以收容任何類型之骨頭扣件,例如,銷釘或葉片,或任何其他合適類型之骨頭扣件。The to-be-bridged opening is preferably a wedge-shaped opening. The apertures are preferably configured to include a screwed hole with a threaded inner circumference. In an alternative preferred embodiment, the apertures can be configured to receive any type of bone fastener, such as a pin or blade, or any other suitable type of bone fastener.
根據本創作之截骨術植體較佳地包含一個中間支柱部。然而,在另外較佳實施例中,該截骨術植體可包含一個以上中間支柱部,諸如,兩個中間支柱部、三個中間支柱部,或更多中間支柱部。The osteotomy implant according to the present invention preferably comprises an intermediate strut. However, in further preferred embodiments, the osteotomy implant can include more than one intermediate strut portion, such as two intermediate strut portions, three intermediate strut portions, or more intermediate strut portions.
該截骨術植體較佳地是由諸如以下各者之生物相容材料製成:不鏽鋼、鈦、諸如聚醚醚酮(PEEK)之生物相容聚合物,或生物相容金屬合金。The osteotomy implant is preferably made of a biocompatible material such as stainless steel, titanium, a biocompatible polymer such as polyetheretherketone (PEEK), or a biocompatible metal alloy.
在本申請案之上下文中,術語「近端」及「遠端」用以界定該截骨術植體之特定部分相對於肢之附接點的位置,該截骨術植體待自身體植入至該附接點中。亦即,為「遠端」之元件相較於為「近端」之元件進一步遠離肢至身體之附接點。In the context of this application, the terms "proximal" and "distal" are used to define the position of a particular portion of the osteotomy implant relative to the attachment point of the extremity. Go to the attachment point. That is, the component that is "remote" is further away from the limb-to-body attachment point than the component that is "proximal".
較佳地,該至少一個中間支柱部具有大於該至少一個中間支柱部之該寬度的高度。該至少一個中間支柱部之長度被理解 為該至少一個中間支柱部的自該遠端部跨越至該近端部之距離。提供大於寬度之高度允許跨越較大開口,同時仍不由該截骨術植體阻擋該開口之邊緣的大延伸。Preferably, the at least one intermediate pillar portion has a height greater than the width of the at least one intermediate pillar portion. The length of the at least one intermediate strut is understood a distance from the distal end portion of the at least one intermediate strut portion to the proximal end portion. Providing a height greater than the width allows for a large opening to be spanned while still not blocking the large extension of the edge of the opening by the osteotomy implant.
較佳地,該至少一個中間支柱部之寬度與厚度之間的比率為至少1:1,較佳地大於1:2.5。此等比率已展現對該開口之極強支撐,同時由該植體僅微不足道地阻擋該開口之邊緣。Preferably, the ratio of the width to the thickness of the at least one intermediate post portion is at least 1:1, preferably greater than 1:2.5. These ratios have shown a very strong support for the opening while the implant is only insignificantly blocking the edge of the opening.
該至少一個中間支柱部較佳地具有為矩形之橫截面。此情形向該至少一個中間支柱部提供抵禦遍及該目標骨頭中之開口而施加之彎曲力的良好回彈性。The at least one intermediate post portion preferably has a rectangular cross section. This condition provides the at least one intermediate strut with good resilience against the bending forces applied throughout the opening in the target bone.
另外較佳地,該至少一個中間支柱部具有一長方體形狀,亦即,該至少一個中間支柱部之所有表面皆彼此成直角而配置。長方體形狀允許提供高度穩定之中間支柱部,尤其是抵禦壓縮力及彎曲力,同時使大小保持至最小值。Further preferably, the at least one intermediate post portion has a rectangular parallelepiped shape, that is, all surfaces of the at least one intermediate post portion are disposed at right angles to each other. The cuboid shape allows for a highly stable intermediate strut, especially against compression and bending forces, while keeping the size to a minimum.
較佳地,該近端部及/或該遠端部包含兩個或兩個以上圓柱形本體,該等圓柱形本體彼此鏈接且具有實質上平行中心軸線,其中此等圓柱形本體中之每一者包含用於收納一骨頭固定元件之一個孔隙。Preferably, the proximal portion and/or the distal portion comprises two or more cylindrical bodies that are linked to each other and have substantially parallel central axes, wherein each of the cylindrical bodies One includes an aperture for receiving a bone fixation element.
在用於收納一骨頭固定元件之該等孔隙周圍提供一圓柱形本體增加該截骨術植體之穩定性,此是因為由該等骨頭固定元件施加於該等孔隙上之任何力可被可靠地轉移至該至少一個中間支柱部,而該截骨術植體無任何斷裂風險。Providing a cylindrical body around the apertures for receiving a bone fixation element increases the stability of the osteotomy implant because any force exerted by the bone fixation elements on the apertures can be reliably Transfer to the at least one intermediate strut without any risk of breakage.
較佳地,該兩個或兩個以上圓柱形本體朝向意欲插入於該骨頭內之末端成錐形。提供錐形圓柱形本體有助於將該截骨術植體插入至骨頭中。Preferably, the two or more cylindrical bodies are tapered toward the end intended to be inserted into the bone. Providing a tapered cylindrical body facilitates insertion of the osteotomy implant into the bone.
較佳地,至少一個孔隙具有相對於各別圓柱形本體之中心軸線成一銳角而定向的軸線。此情形允許將本創作之截骨術植體錨定於該骨頭中之較大支撐區域中。Preferably, the at least one aperture has an axis oriented at an acute angle relative to a central axis of the respective cylindrical body. This situation allows the osteotomy implant of the present creation to be anchored in a larger support area in the bone.
較佳地,該近端部及該遠端部兩者皆包含兩個圓柱形本體,其中該近端部及該遠端部中之每一孔隙具有自其各別圓柱形本體之中心軸線分岔成在彼此相對之方向上銳角指向的軸線。該等軸線藉此更佳地配置於與該至少一個中間支柱部之長度軸線成直角的平面中,亦即,該等軸線在該平面內彼此分岔。此情形允許使該骨頭內之支撐區域最大化,此是因為插入於該等孔隙中之兩個骨頭錨將遠離彼此而指向。Preferably, the proximal end portion and the distal end portion both comprise two cylindrical bodies, wherein each of the proximal end portion and the distal end portion has a central axis from its respective cylindrical body An axis that is pointed at an acute angle in opposite directions to each other. The axes are thereby preferably arranged in a plane at right angles to the longitudinal axis of the at least one intermediate strut, that is, the axes are spaced apart from each other in the plane. This situation allows the support area within the bone to be maximized because the two bone anchors inserted in the apertures will point away from each other.
較佳地,該近端部之兩個孔隙的軸線及/或該遠端部之兩個孔隙的軸線相對於彼此成至少2°之角度,更佳地為至少8°之角度,最佳地為11°至30°之角度。Preferably, the axis of the two apertures of the proximal portion and/or the axes of the two apertures of the distal portion are at an angle of at least 2° with respect to each other, more preferably at least 8°, optimally It is an angle of 11° to 30°.
藉此,該等軸線較佳地位於與該至少一個中間支柱部之長度軸線成直角的平面中。已發現,在該等較佳角度的情況下,可達成該近端部及/或該遠端部在一骨頭內之最佳錨定。Thereby, the axes are preferably located in a plane at right angles to the longitudinal axis of the at least one intermediate post portion. It has been found that, at such preferred angles, optimal anchoring of the proximal portion and/or the distal portion within a bone can be achieved.
較佳地,該等軸線之間的角度相對於該至少一個中間支柱部之長度軸線對稱地配置,亦即,每一軸線圍封其自身與該至少一個中間支柱部之長度軸線之間的角度之一半。舉例而言,若該等軸線之間的角度為15°,則每一軸線將與該長度軸線成7.5°之角度。該等軸線之對稱配置具有該截骨術植體可用於左脛骨及右脛骨中之截骨術的優點。若該等軸線相對於該至少一個中間支柱部之長度軸線並未以對稱方式配置,則將必須提供用於左脛骨及右脛骨中之截骨術的不同截骨術植體。Preferably, the angle between the axes is symmetrically arranged with respect to the length axis of the at least one intermediate strut portion, that is, the angle between each axis enclosing itself and the length axis of the at least one intermediate strut portion Half of it. For example, if the angle between the axes is 15°, then each axis will be at an angle of 7.5° to the length axis. The symmetric configuration of the axes has the advantage that the osteotomy implant can be used for osteotomy in the left and right tibia. If the axes are not symmetrically arranged with respect to the longitudinal axis of the at least one intermediate strut, it will be necessary to provide different osteotomy implants for osteotomy in the left and right tibia.
替代地,該等軸線之間的角度相對於該至少一個中間支柱部之長度軸線不對稱地配置。因此,可提供適應於左脛骨骨頭及右脛骨骨頭之不同截骨術植體。提供用於左脛骨及右脛骨之截骨術植體的優點為:該截骨術植體之外部輪廓(尤其是該至少一個中間支柱部之外部輪廓)經特定地塑形以符合該脛骨之皮質的外部形狀,因此減少該截骨術植體之隆凸且因此減少軟組織刺激之風險。Alternatively, the angle between the axes is asymmetrically arranged with respect to the length axis of the at least one intermediate post portion. Thus, different osteotomy implants adapted to the left tibia bone and the right tibia bone can be provided. An advantage of providing an osteotomy implant for the left tibia and the right tibia is that the outer contour of the osteotomy implant (especially the outer contour of the at least one intermediate strut) is specifically shaped to conform to the tibia The outer shape of the cortex thus reduces the protrusion of the osteotomy implant and thus reduces the risk of soft tissue irritation.
通常,該等軸線之間的角度愈小,則可使用之骨頭固定元件愈長,而沒有該等骨頭固定元件在該骨頭外(例如,在該骨頭之與該截骨術植體之部位相對的側上)之任何突出風險。Generally, the smaller the angle between the axes, the longer the bone fixation element can be used without the bone fixation elements being outside the bone (e.g., at the location of the bone relative to the osteotomy implant) Any of the outstanding risks of the side.
另外較佳地,該等軸線可經配置成使得一旦將該截骨術植體植入至一骨頭中,該等軸線就朝向尾側或顱側方向傾斜。本質上,該遠端部及/或該近端部之孔隙的軸線配置於一平面中,該平面相對於由各別圓柱形本體之中心軸線跨越的平面成一傾斜角而配置。該傾斜角較佳地為1°至15°,更佳地為3°至6°。最佳地,一旦將該截骨術植體植入至一骨頭中,該近端部之孔隙的軸線就經配置為以便在尾側方向上定向,且該遠端部之孔隙的軸線經配置為以便在顱側方向上定向。Further preferably, the axes may be configured such that once the osteotomy implant is implanted into a bone, the axes are inclined toward the caudal or cranial side. Essentially, the axis of the distal portion and/or the aperture of the proximal portion is disposed in a plane that is disposed at an oblique angle relative to a plane spanned by a central axis of the respective cylindrical body. The angle of inclination is preferably from 1 to 15 and more preferably from 3 to 6. Optimally, once the osteotomy implant is implanted into a bone, the axis of the proximal end aperture is configured to be oriented in the caudal direction and the axis of the distal end aperture is configured In order to be oriented in the direction of the cranial side.
替代地,該近端部之兩個孔隙的軸線相對於彼此成大於30°之角度,較佳地為65°至75°之角度。Alternatively, the axes of the two apertures of the proximal portion are at an angle greater than 30° with respect to each other, preferably from 65° to 75°.
另外較佳地,該遠端部之兩個孔隙的軸線同樣地相對於彼此成大於30°之角度,較佳地為65°至75°之角度。Further preferably, the axes of the two apertures of the distal portion are likewise at an angle greater than 30° with respect to each other, preferably from 65° to 75°.
較佳地,該近端部及/或該遠端部包含兩個圓柱形本體,該兩個圓柱形本體彼此鏈接且各自包含具有一軸線之一孔隙,該等孔隙之軸線彼此平行。Preferably, the proximal portion and/or the distal portion includes two cylindrical bodies that are linked to each other and each include an aperture having an axis that is parallel to each other.
在一替代性較佳實施例中,該近端部及/或該遠端部包含兩個圓柱形本體,該兩個圓柱形本體彼此鏈接且各自包含具有一軸線之一孔隙,其中該等孔隙之軸線經配置為以便較佳地在該目標骨頭內之一位置彼此相交。In an alternative preferred embodiment, the proximal portion and/or the distal portion comprises two cylindrical bodies that are linked to each other and each comprise an aperture having an axis, wherein the apertures The axes are configured to preferably intersect one another at a location within the target bone.
該截骨術植體較佳地包含可與該至少一個中間支柱部進行組裝之一楔狀物形骨頭移植物或楔狀物形人造骨頭。此情形允許在骨頭中最佳地橋接截骨術間隙,此是因為該骨頭移植物或人造骨頭提供骨頭向內生長以便橋接該截骨術間隙,同時該截骨術植體傳輸施加於該截骨術間隙上之任何負載。該楔狀物形骨頭移植物或楔狀物形人造骨頭之總成較佳地屬於湊配形類型(form-fit type)。The osteotomy implant preferably includes a wedge shaped bone graft or a wedge shaped artificial bone that can be assembled with the at least one intermediate post. This situation allows for optimal bridging of the osteotomy gap in the bone because the bone graft or artificial bone provides bone ingrowth to bridge the osteotomy gap while the osteotomy implant transmission is applied to the cut Any load on the osteosynthesis gap. The assembly of the wedge shaped bone graft or the wedge shaped artificial bone preferably belongs to a form-fit type.
本申請案進一步是有關於一種套組,其包含根據本創作之一截骨術植體、至少一個楔狀物形試驗隔片元件,及一骨層製備導引器。The application further relates to a kit comprising an osteotomy implant according to the present invention, at least one wedge-shaped test septum element, and a bone layer preparation guide.
該楔狀物形試驗隔片用以過渡地填充一楔狀物形截骨術間隙且使該楔狀物形截骨術間隙保持開放,同時使用該骨頭製備導引器。該骨頭製備導引器包含鑽孔及鋸切導引器,以便允許外科醫生產生必要孔及切除切口以插入根據本創作之截骨術植體。The wedge shaped test septum is used to transiently fill a wedge shaped osteotomy gap and to keep the wedge shaped osteotomy gap open while using the bone to prepare the introducer. The bone preparation introducer includes a drilling and sawing guide to allow the surgeon to create the necessary holes and to remove the incision for insertion of the osteotomy implant according to the present invention.
其他有利實施例及特徵組合來自以下詳細描述及總體申請專利範圍。Other advantageous embodiments and combinations of features are derived from the following detailed description and the general patent claims.
1‧‧‧截骨術植體總成1‧‧‧ osteotomy implant assembly
10、10.1、10.2、10.3、10.4‧‧‧截骨術植體10, 10.1, 10.2, 10.3, 10.4‧‧‧ osteotomy implants
11‧‧‧近端部11‧‧‧ Near end
12‧‧‧第一圓柱形本體12‧‧‧First cylindrical body
13‧‧‧第二圓柱形本體13‧‧‧Second cylindrical body
14‧‧‧第一孔隙14‧‧‧First pore
15‧‧‧第二孔隙15‧‧‧second pore
20‧‧‧遠端部20‧‧‧ distal end
21‧‧‧第三圓柱形本體21‧‧‧ Third cylindrical body
22‧‧‧第四圓柱形本體22‧‧‧Four cylindrical body
23‧‧‧第三孔隙23‧‧‧ third aperture
24‧‧‧第四孔隙24‧‧‧fourth pore
30‧‧‧中間支柱部30‧‧‧ Middle pillar
31‧‧‧前部31‧‧‧ front
40‧‧‧脛骨骨頭40‧‧‧Sacral bones
41‧‧‧截骨術開口41‧‧‧ osteotomy opening
42‧‧‧脛骨之近端部42‧‧‧ proximal end of the humerus
43‧‧‧骨層43‧‧‧Bone layer
44‧‧‧第一孔44‧‧‧ first hole
45‧‧‧第二孔45‧‧‧second hole
46‧‧‧第三孔46‧‧‧ third hole
47‧‧‧第四孔47‧‧‧ fourth hole
48‧‧‧溝槽48‧‧‧ trench
50a至50d‧‧‧骨頭螺絲50a to 50d‧‧‧ bone screws
51a至51d‧‧‧K導線51a to 51d‧‧‧K wire
55‧‧‧楔狀物形骨頭移植物55‧‧‧Wedge-shaped bone graft
60、110‧‧‧骨層製備器具60,110‧‧‧Bone preparation equipment
61a至61d、111a至111d‧‧‧平行孔61a to 61d, 111a to 111d‧‧‧ parallel holes
62、112‧‧‧鋸切銑削狹槽62, 112‧‧‧ saw cutting and milling slots
63、123‧‧‧銑削工具63, 123‧‧‧ milling tools
64‧‧‧插管式鑽頭64‧‧‧Intubation drill
65、122‧‧‧擋止件65, 122‧‧ ‧ stop
70‧‧‧第五孔隙70‧‧‧ fifth pore
71‧‧‧壓縮螺絲71‧‧‧Compression screws
72‧‧‧中心軸線72‧‧‧ center axis
100‧‧‧試驗隔片器具100‧‧‧Test septum appliances
101‧‧‧楔狀物形本體101‧‧‧Wedge shaped body
102‧‧‧第一圓柱形突起物102‧‧‧First cylindrical protrusion
103‧‧‧第二圓柱形突起物103‧‧‧Second cylindrical protrusion
104‧‧‧凹入104‧‧‧ recessed
105‧‧‧手柄105‧‧‧handle
106‧‧‧固定孔106‧‧‧Fixed holes
113‧‧‧導引孔113‧‧‧ Guide hole
114‧‧‧導引凹入114‧‧‧ guiding recess
120‧‧‧K導線120‧‧‧K wire
121‧‧‧鑽頭121‧‧‧ drill bit
130‧‧‧楔狀物形移植物130‧‧‧Wedge-shaped graft
A‧‧‧支撐區域A‧‧‧Support area
H、H1、H2、H3、H4‧‧‧高度H, H1, H2, H3, H4‧‧‧ height
T‧‧‧深度或厚度T‧‧‧depth or thickness
W‧‧‧寬度W‧‧‧Width
W1‧‧‧第一寬度W1‧‧‧ first width
W2‧‧‧第二寬度W2‧‧‧ second width
X1、X2、X3、X4‧‧‧中心軸線X1, X2, X3, X4‧‧‧ central axis
Y1、Y2、Y3、Y4‧‧‧軸線Y1, Y2, Y3, Y4‧‧‧ axis
用以解釋實施例之圖式展示:圖1a及圖1b為具有根據本創作之截骨術植體的截骨術植體總成;圖2a及圖2b為根據圖1之具有四個骨頭螺絲的截骨術植體總成;圖3a至圖3g為使用根據本創作之截骨術植體之開放楔狀物截 骨術的不同植入步驟;圖4a及圖4b為用於植入根據本創作之截骨術植體之較佳手術技術的器具;圖5a至圖5i為使用試驗隔片器具及骨層製備器具以植入根據本創作之截骨術植體的較佳手術步驟;圖6為根據本創作之具有不同長度的多個截骨術植體;圖7a至圖7c為根據本創作之截骨術植體的第二實施例;圖8a及圖8b為根據本創作之截骨術植體的第三實施例。A schematic representation of an embodiment is illustrated: Figures 1a and 1b are osteotomy implant assemblies having an osteotomy implant according to the present invention; Figures 2a and 2b are four bone screws according to Figure 1 Osteotomy implant assembly; Figures 3a to 3g are open wedge cuts using an osteotomy implant according to the present invention Different implantation steps of orthopedics; Figures 4a and 4b are instruments for implanting a preferred surgical technique for an osteotomy implant according to the present invention; Figures 5a to 5i are for the use of a test spacer device and bone layer preparation The device is preferably a surgical procedure for implanting an osteotomy implant according to the present invention; FIG. 6 is a plurality of osteotomy implants having different lengths according to the present invention; FIGS. 7a to 7c are osteotomy according to the present invention. A second embodiment of a surgical implant; Figures 8a and 8b are a third embodiment of an osteotomy implant according to the present invention.
在該等圖中,相同組件被給出相同元件符號。In the figures, the same components are given the same component symbols.
圖1a及圖1b展示用於以實質上埋頭方式在目標骨頭中橋接截骨術開口或切除部之截骨術植體總成1。截骨術植體10包含具有兩個一致或鏈接圓柱形本體12、13之近端部11,圓柱形本體12、13具有實質上平行中心軸線X1、X2。第一圓柱形本體12及第二圓柱形本體13各自包含用於收納骨頭固定元件之孔隙14、15。在一較佳實施例中,孔隙14、15傾斜地定向,從而引起其各別軸線Y1、Y2之分岔定向。1a and 1b show an osteotomy implant assembly 1 for bridging an osteotomy opening or resection in a target bone in a substantially countersunk manner. The osteotomy implant 10 comprises a proximal end 11 having two uniform or linked cylindrical bodies 12, 13 having substantially parallel central axes X1, X2. The first cylindrical body 12 and the second cylindrical body 13 each comprise apertures 14, 15 for receiving bone fixation elements. In a preferred embodiment, the apertures 14, 15 are oriented obliquely, causing their respective axes Y1, Y2 to be oriented.
此外,截骨術植體10包含具有兩個一致或鏈接圓柱形本體21、22之遠端部20,圓柱形本體21、22具有實質上平行中心軸線X3、X4。第三圓柱形本體21及第四圓柱形本體22各自亦包含用於收納骨頭固定元件之孔隙23、24。在一較佳實施例中,遠端部20之兩個孔隙23、24傾斜地定向,從而引起其各別軸線Y3、Y4之分岔定向。Furthermore, the osteotomy implant 10 comprises a distal end portion 20 having two uniform or linked cylindrical bodies 21, 22 having substantially parallel central axes X3, X4. The third cylindrical body 21 and the fourth cylindrical body 22 each also include apertures 23, 24 for receiving bone fixation elements. In a preferred embodiment, the two apertures 23, 24 of the distal portion 20 are oriented obliquely, thereby causing the orientation of their respective axes Y3, Y4.
藉由具有四邊形橫截面之中間支柱部30來連接近端 部11及遠端部20,其中中間支柱部30之寬度W等於或小於中間支柱部30之深度或厚度T。在一較佳實施例中,連接中間支柱部30具有至少1:1之寬度W對厚度T比率,較佳地為大於1:2.5之寬度W對厚度T比率。Connecting the proximal end by a middle pillar portion 30 having a quadrangular cross section The portion 11 and the distal end portion 20, wherein the width W of the intermediate post portion 30 is equal to or smaller than the depth or thickness T of the intermediate post portion 30. In a preferred embodiment, the connecting intermediate post portion 30 has a width W to thickness T ratio of at least 1:1, preferably a width W to thickness T ratio greater than 1:2.5.
與目前先前技術之骨頭板相反,未使厚度T保持小以防止軟組織刺激,但由於預期埋頭置放,中間支柱部30之厚度T與軟組織刺激無關。連接中間支柱部30之前部31經解剖學上塑形以遵循目標骨頭之外部輪廓。在一替代性實施例中,藉由多個中間支柱部(未圖示)來連接近端部11及遠端部20。In contrast to the prior art bone plates, the thickness T is not kept small to prevent soft tissue irritation, but the thickness T of the middle strut portion 30 is independent of soft tissue stimulation due to the expected placement of the head. The front portion 31 of the connecting intermediate pillar portion 30 is anatomically shaped to follow the outer contour of the target bone. In an alternative embodiment, the proximal portion 11 and the distal portion 20 are joined by a plurality of intermediate post portions (not shown).
在一替代性實施例中,截骨術植體10可包含不等量之近端圓柱形本體12、13及遠端圓柱形本體21、22,近端圓柱形本體12、13及遠端圓柱形本體21、22具有用於收納骨頭螺絲50a至50d之孔隙14、15、23、24。舉例而言,近端部11可由於骨頭朝向其近端之較大橫截面而包含三個圓柱形本體,且遠端部20僅包含兩個圓柱形本體。In an alternative embodiment, the osteotomy implant 10 can comprise unequal amounts of proximal cylindrical bodies 12, 13 and distal cylindrical bodies 21, 22, proximal cylindrical bodies 12, 13 and distal cylinders The shaped bodies 21, 22 have apertures 14, 15, 23, 24 for receiving bone screws 50a to 50d. For example, the proximal portion 11 can comprise three cylindrical bodies due to the larger cross section of the bone toward its proximal end, and the distal portion 20 comprises only two cylindrical bodies.
圖1b說明截骨術植體10內之四個孔隙14、15、23、24之軸線Y1、Y2、Y3、Y4的定向,其自近端部11朝向遠端部20予以展示。第一圓柱形本體12及第二圓柱形本體13各自具有彼此實質上平行之中心軸線X1、X2。相同情形分別適用於第三圓柱形本體21及第四圓柱形本體22,其各自具有中心軸線X3、X4。兩個軸線X3、X4亦實質上平行於該第一圓柱形本體12及該第二圓柱形本體13之中心軸線X1、X2。1b illustrates the orientation of the axes Y1, Y2, Y3, Y4 of the four apertures 14, 15, 23, 24 within the osteotomy implant 10, which are shown from the proximal end portion 11 toward the distal end portion 20. The first cylindrical body 12 and the second cylindrical body 13 each have a central axis X1, X2 that is substantially parallel to each other. The same applies to the third cylindrical body 21 and the fourth cylindrical body 22, respectively, each having a central axis X3, X4. The two axes X3, X4 are also substantially parallel to the central axes X1, X2 of the first cylindrical body 12 and the second cylindrical body 13.
另外,第一孔隙14具有與第一圓柱形本體12之中心軸線X1成一角度而配置的軸線Y1。相同情形適用於另外三個孔隙 15、23、24,其各自具有與其各別圓柱形本體13、21、22之中心軸線X2、X3、X4成一角度而配置的軸線Y2、Y3、Y4。第二孔隙15之軸線Y2分岔至第一孔隙14之軸線Y1的相對方向上。相同情形適用於第三孔隙23及第四孔隙24之軸線Y3、Y4。In addition, the first aperture 14 has an axis Y1 disposed at an angle to the central axis X1 of the first cylindrical body 12. The same situation applies to the other three pores 15, 23, 24 each having an axis Y2, Y3, Y4 disposed at an angle to the central axes X2, X3, X4 of their respective cylindrical bodies 13, 21, 22. The axis Y2 of the second aperture 15 branches into the opposite direction of the axis Y1 of the first aperture 14. The same applies to the axes Y3, Y4 of the third aperture 23 and the fourth aperture 24.
圖2a及圖2b展示具有根據圖1a之截骨術植體10以及四個骨頭螺絲50a至50d的截骨術植體總成1。一個骨頭螺絲插入至截骨術植體10之四個孔隙14、15、23、24中的每一者中。該第一孔隙14及該第二孔隙15之分岔軸線Y1、Y2導致各別骨頭螺絲50a、50b之分岔。由於分岔骨頭螺絲50a、50b之緣故,獲得相較於平行置放之骨頭螺絲50a、50b較寬的支撐區域A,其中植體10保持具有小的總寬度。2a and 2b show an osteotomy implant assembly 1 having an osteotomy implant 10 and four bone screws 50a to 50d according to Fig. 1a. A bone screw is inserted into each of the four apertures 14, 15, 23, 24 of the osteotomy implant 10. The bifurcation axes Y1, Y2 of the first aperture 14 and the second aperture 15 result in the division of the respective bone screws 50a, 50b. Due to the bifurcation of the bone screws 50a, 50b, a wider support area A is obtained than the bone screws 50a, 50b placed in parallel, wherein the implant 10 maintains a small overall width.
圖2b以與圖1b相同之觀點展示截骨術植體總成1,然而,其中四個骨頭螺絲50a至50d插入至該等孔隙14、15、23、24中。Figure 2b shows the osteotomy implant assembly 1 in the same view as Figure 1b, however, four bone screws 50a to 50d are inserted into the apertures 14, 15, 23, 24.
圖3a至圖3g展示使用根據本創作的本創作之截骨術植體10之開放楔狀物截骨術的不同植入步驟。Figures 3a through 3g show different implantation steps of an open wedge osteotomy using the present osteotomy implant 10 according to the present teachings.
圖3a展示楔狀物形骨頭移植物55,或替代地展示插入於脛骨骨頭40中之截骨術開口41中的人造植體。楔狀物形骨頭移植物55提高脛骨之近端部42且校正腿部軸線。Figure 3a shows a wedge shaped bone graft 55, or alternatively an artificial implant inserted into the osteotomy opening 41 in the humeral bone 40. The wedge shaped bone graft 55 raises the proximal end 42 of the tibia and corrects the leg axis.
圖3b展示與脛骨骨頭40抵靠地定位且運用K導線51a至51d進行固定之骨層製備器具60。骨層製備器具60包含用於收納K導線51a至51d之多個實質上平行孔61a至61d,以及鋸切或銑削狹槽62。骨層製備器具60經定位為以便橋接截骨術開口41,其中第一平行孔61a及第二平行孔61b配置於截骨術開口41 之近端側上,而第三平行孔61c及第四平行孔61d配置於截骨術開口41之遠端側上。Figure 3b shows a bone layer preparation device 60 positioned in abutment with the tibia bone 40 and secured using K-wires 51a to 51d. The bone layer preparation device 60 includes a plurality of substantially parallel holes 61a to 61d for accommodating the K wires 51a to 51d, and a sawing or milling slot 62. The bone layer preparation device 60 is positioned to bridge the osteotomy opening 41, wherein the first parallel hole 61a and the second parallel hole 61b are disposed in the osteotomy opening 41 On the proximal side, the third parallel hole 61c and the fourth parallel hole 61d are disposed on the distal end side of the osteotomy opening 41.
藉由通過如圖3c所示之銑削狹槽62進行鋸切或銑削(例如,運用銑削工具63),將溝槽48切割至脛骨骨頭40及楔狀物形骨頭移植物55中。該溝槽48自截骨術開口41近端之骨頭延伸至截骨術開口41遠端之骨頭。在後繼步驟中,移除器具。現在,在使用具有擋止件65之插管式鑽頭64的情況下,將K導線51a至51d各自過度鑽孔至經預界定深度,如圖3d所示。The groove 48 is cut into the tibia bone 40 and the wedge-shaped bone graft 55 by sawing or milling (e.g., using the milling tool 63) by milling the slot 62 as shown in Figure 3c. The groove 48 extends from the bone at the proximal end of the osteotomy opening 41 to the bone at the distal end of the osteotomy opening 41. In a subsequent step, the appliance is removed. Now, in the case where the cannulated drill bit 64 having the stopper 65 is used, the K wires 51a to 51d are each excessively drilled to a predetermined depth as shown in Fig. 3d.
圖3e展示脛骨骨頭40中在截骨術開口41周圍之經製備骨層43。骨層43包含位於截骨術開口41之近端側上的第一孔44及第二孔45,該兩個孔44、45鏈接在一起且彼此實質上平行地對準。另外,第三孔46及第四孔47位於截骨術開口41之遠端側上,該兩個孔鏈接在一起且彼此實質上平行地配置。溝槽48藉此自近端孔44、45跨越至遠端孔46、47。3e shows the prepared bone layer 43 in the humeral bone 40 around the osteotomy opening 41. The bone layer 43 includes a first aperture 44 and a second aperture 45 located on the proximal side of the osteotomy opening 41, the two apertures 44, 45 being linked together and aligned substantially parallel to one another. Additionally, the third aperture 46 and the fourth aperture 47 are located on the distal side of the osteotomy opening 41, which are linked together and disposed substantially parallel to one another. The grooves 48 thereby span from the proximal holes 44, 45 to the distal holes 46, 47.
圖3f展示與骨層43對準之截骨術植體10。截骨術植體10之實質上平行近端圓柱形本體13、14及遠端圓柱形本體21、22與骨層43之實質上平行孔44、45、46、47對準,而中間支柱部30與溝槽48對準。Figure 3f shows an osteotomy implant 10 aligned with the bone layer 43. The substantially parallel proximal cylindrical bodies 13, 14 and the distal cylindrical bodies 21, 22 of the osteotomy implant 10 are aligned with the substantially parallel holes 44, 45, 46, 47 of the bone layer 43, and the intermediate post portion 30 is aligned with the groove 48.
接著將截骨術植體10插入於骨層43中,且將骨頭螺絲50a至50d插入至四個孔隙14、15、23、24中。圖3g展示埋頭植入於脛骨40中之截骨術植體總成1。截骨術植體總成1橋接截骨術開口41,且經由楔狀物55及截骨術植體10之負載分擔構造將近端脛骨42上之體重轉移至遠端脛骨。The osteotomy implant 10 is then inserted into the bone layer 43 and the bone screws 50a to 50d are inserted into the four apertures 14, 15, 23, 24. Figure 3g shows an osteotomy implant assembly 1 implanted in the tibia 40. The osteotomy implant assembly 1 bridges the osteotomy opening 41 and transfers the weight on the proximal tibia 42 to the distal tibia via the wedge 55 and the load sharing configuration of the osteotomy implant 10.
根據上述技術之植體總成亦適合於使閉合楔狀物截 骨術穩定化。在此狀況下,忽略楔狀物形骨頭移植物55至截骨術開口41中之插入。The implant assembly according to the above technique is also suitable for cutting the closed wedge Osteosynthesis is stabilized. In this case, the insertion of the wedge-shaped bone graft 55 into the osteotomy opening 41 is ignored.
在另一替代性實施例中,將插入器具(未圖示)附接至截骨術植體10以允許在製備平行孔61a至61d及銑削狹槽62之後插入截骨術植體10。插入器具包含額外開口集合,該等開口與近端部11中之孔隙14、15及遠端部20中之孔隙23、24的軸線對應。可通過此等開口而在骨頭中對孔洞進行預鑽孔,該等孔洞將在後繼步驟中收納骨頭螺絲。替代地,可將包含內部鑽頭導引通道的具有圓錐形外螺紋之鑽頭套筒鎖定至每一孔隙14、15、23、24中。藉由通過此等套筒進行鑽孔,可將孔洞鑽孔至骨頭中。In another alternative embodiment, an insertion instrument (not shown) is attached to the osteotomy implant 10 to allow insertion of the osteotomy implant 10 after preparation of the parallel holes 61a-61d and the milling slot 62. The insertion device includes an additional set of openings that correspond to the axes of the apertures 14, 15 in the proximal portion 11, and the apertures 23, 24 in the distal portion 20. The holes can be pre-drilled in the bone through the openings, which will receive the bone screws in subsequent steps. Alternatively, a drill sleeve having a conical external thread including an internal drill guide passage can be locked into each of the apertures 14, 15, 23, 24. Holes can be drilled into the bone by drilling through the sleeves.
參看圖4a及圖4b,展示用於植入截骨術植體10之較佳手術技術的器具。圖4a展示包含楔狀物形本體101之試驗隔片器具100,楔狀物形本體101具有兩個圓柱形突起物102及103。突起物103以彎曲形狀而結束,且連接至手柄105。此外,楔狀物形本體101包含位於圓柱形突起物102與圓柱形突起物103之間的凹入104處。固定孔106另外配置於該楔狀物形本體101中。Referring to Figures 4a and 4b, an instrument for a preferred surgical technique for implanting an osteotomy implant 10 is shown. Figure 4a shows a test spacer device 100 comprising a wedge-shaped body 101 having two cylindrical protrusions 102 and 103. The protrusion 103 ends in a curved shape and is connected to the handle 105. Furthermore, the wedge-shaped body 101 comprises a recess 104 between the cylindrical protrusion 102 and the cylindrical protrusion 103. The fixing hole 106 is additionally disposed in the wedge-shaped body 101.
此外,展示骨層製備器具110。圖4b中更詳細地展示該骨層製備器具。骨層製備器具110包含用於導引具有擋止件之鑽頭的多個第二平行孔111a至111d。另外,骨層製備器具110包括第二鋸切或銑削狹槽112。此外,骨層製備器具110包含用於將該器具組裝至試驗隔片器具100上之導引孔113及導引凹入114。In addition, a bone layer preparation device 110 is shown. The bone layer preparation device is shown in more detail in Figure 4b. The bone layer preparation implement 110 includes a plurality of second parallel holes 111a to 111d for guiding a drill having a stopper. Additionally, the bone layer preparation appliance 110 includes a second sawing or milling slot 112. In addition, the bone layer preparation device 110 includes a guide hole 113 and a guide recess 114 for assembling the device to the test spacer device 100.
圖5a至圖5i展示使用試驗隔片器具100及骨層製備器具110以植入截骨術植體10之較佳手術步驟。Figures 5a through 5i illustrate a preferred surgical procedure for implanting the osteotomy implant 10 using the trial septum device 100 and the bone layer preparation device 110.
圖5a展示具有部分截骨術開口41之脛骨骨頭40。將 試驗隔片器具100之楔狀物形本體101插入於截骨術開口41中,其提升近端脛骨42。如圖5b所示,將近端脛骨42提升達角度α。角度α對應於楔狀物形本體101之楔角。因此,用於截骨術之套組較佳地包含具有楔狀物形本體101之多個試驗隔片器具100,楔狀物形本體101具有不同角度以便個別地設定校正角α。Figure 5a shows a humeral bone 40 having a partial osteotomy opening 41. will The wedge-shaped body 101 of the test septum device 100 is inserted into the osteotomy opening 41, which lifts the proximal tibia 42. As shown in Figure 5b, the proximal tibia 42 is raised by an angle a. The angle α corresponds to the wedge angle of the wedge-shaped body 101. Accordingly, the kit for osteotomy preferably includes a plurality of trial spacers 100 having a wedge-shaped body 101 having different angles to individually set the correction angle a.
接著,如圖5c所示,將骨層製備器具110組裝至試驗隔片器具100上以便與脛骨骨頭40之外部皮質嚙合。藉此,將骨層製備導引器110可滑動地組裝至試驗隔片器具100上,其中導引孔113及導引凹入114正與試驗隔片器具100之兩個圓柱形突起物102、103配合。骨層製備器具110之鋸切或銑削狹槽112藉此與楔狀物形本體101之凹入104對準,其中該凹入104有助於銑削或鋸切工具之通過,如稍後更詳細地解釋。Next, as shown in Figure 5c, the bone layer preparation device 110 is assembled to the test septum device 100 for engagement with the outer cortex of the humerus bone 40. Thereby, the bone layer preparation guide 110 is slidably assembled to the test spacer device 100, wherein the guide hole 113 and the guiding recess 114 are being combined with the two cylindrical protrusions 102 of the test spacer device 100, 103 cooperation. The sawing or milling slot 112 of the bone layer preparation appliance 110 is thereby aligned with the recess 104 of the wedge-shaped body 101, wherein the recess 104 facilitates the passage of milling or sawing tools, as will be more detailed later Explain.
視情況,使用K導線120將試驗隔片器具100與骨層製備導引器110之總成固定至骨頭,K導線120插入至固定孔106中,如圖5d所示。Optionally, the K-wire 120 is used to secure the assembly of the test septum device 100 and the bone layer preparation guide 110 to the bone, and the K-wire 120 is inserted into the fixation hole 106 as shown in Figure 5d.
圖5e展示第一骨層製備步驟。在使用具有擋止件122之鑽頭121的情況下,將四個孔洞鑽孔至脛骨40骨頭中以用於收納截骨術植體10,其中該鑽頭藉由骨層製備器具110之第二平行孔111a至111d導引。替代地,鑽頭不藉由第二平行孔111a至111d直接地導引,但借助於置放至該等第二平行孔111a至111d中之中間元件(諸如,鑽頭導引器或鑽頭套筒)導引。使用中間元件之優點為:鑽頭之切割邊緣可由該中間元件完全地環繞,因此避免該等切割邊緣抵靠著第二平行孔111a至111d與狹槽112相交的區域而被擋住及堵塞。Figure 5e shows a first bone layer preparation step. Where a drill bit 121 having a stop 122 is used, four holes are drilled into the bone of the tibia 40 for receiving the osteotomy implant 10, wherein the drill bit is second parallel by the bone preparation device 110 The holes 111a to 111d are guided. Alternatively, the drill bit is not directly guided by the second parallel holes 111a to 111d, but by means of an intermediate member (such as a drill guide or a drill sleeve) placed in the second parallel holes 111a to 111d guide. An advantage of using the intermediate member is that the cutting edge of the drill bit can be completely surrounded by the intermediate member, thereby preventing the cutting edges from being blocked and blocked against the area where the second parallel holes 111a to 111d intersect the slot 112.
在下一步驟中,如圖5f所示,藉由通過狹槽112進行鋸切或銑削,將溝槽48切割至骨頭中,溝槽48自截骨術開口41近端之骨頭延伸至截骨術開口41遠端之骨頭。使用銑削工具123而執行鋸切或銑削。替代地,狹槽112可由導引擺鋸之兩個實質上平行狹槽取代。此等狹槽亦可經組態以朝向彼此會合。In the next step, as shown in Figure 5f, the groove 48 is cut into the bone by sawing or milling through the slot 112, the groove 48 extending from the proximal end of the osteotomy opening 41 to the osteotomy The bone at the distal end of the opening 41. Sawing or milling is performed using the milling tool 123. Alternatively, the slot 112 can be replaced by two substantially parallel slots that guide the pendulum saw. These slots can also be configured to meet toward each other.
圖5g展示在移除器具之後的脛骨骨頭40中在截骨術開口41周圍之經製備骨層43。該骨層包含位於截骨術開口41近端之兩個鏈接孔44、45,以及位於截骨術開口41遠端之兩個鏈接孔46、47。此外,骨層43包括一個溝槽48,溝槽48在截骨術開口41近端之兩個孔44、45至截骨術開口41遠端之兩個孔46、47之間延伸。Figure 5g shows the prepared bone layer 43 around the osteotomy opening 41 in the humeral bone 40 after removal of the instrument. The bone layer includes two link holes 44, 45 located at the proximal end of the osteotomy opening 41, and two link holes 46, 47 located at the distal end of the osteotomy opening 41. In addition, the bone layer 43 includes a groove 48 extending between the two holes 44, 45 at the proximal end of the osteotomy opening 41 and the two holes 46, 47 distal to the osteotomy opening 41.
在下一步驟中,如圖5h所示,將經附接有骨頭移植物楔狀物130之截骨術植體10插入至截骨術開口41及骨層43中。骨頭移植物楔狀物130較佳地是由骨頭移植物製成,但亦可由塑膠(例如,聚醚醚酮(PEEK))或金屬(例如,多孔鈦)或人造骨頭取代物或其組合製成。替代地,未將骨頭移植物材料插入至截骨術開口41中。取而代之,使截骨術開口41保持開放,使得天然骨頭可生長至截骨術開口41中且逐漸地密封截骨術開口41。In the next step, as shown in Figure 5h, the osteotomy implant 10 to which the bone graft wedge 130 is attached is inserted into the osteotomy opening 41 and the bone layer 43. The bone graft wedge 130 is preferably made of a bone graft, but may also be made of plastic (eg, polyetheretherketone (PEEK)) or metal (eg, porous titanium) or artificial bone substitutes or combinations thereof. to make. Alternatively, the bone graft material is not inserted into the osteotomy opening 41. Instead, the osteotomy opening 41 remains open so that natural bone can grow into the osteotomy opening 41 and gradually seal the osteotomy opening 41.
圖5i展示截骨術植體10使用骨頭螺絲50a至50d之最終固定。在一替代性實施例中,骨頭螺絲50a至50d可為自鑽孔骨頭螺絲,且結果,用於置放骨頭螺絲50a至50d之預鑽孔將不為必要的。在另一替代性實施例中,可應用銷釘或葉片作為骨頭固定元件或其組合,其中孔隙14、15、23、24可為呈圓形孔洞、間隙、狹縫或狹槽之形狀的開口。Figure 5i shows the final fixation of the osteotomy implant 10 using the bone screws 50a to 50d. In an alternative embodiment, the bone screws 50a through 50d can be self-drilling bone screws, and as a result, pre-drilling for placing the bone screws 50a through 50d would not be necessary. In another alternative embodiment, a pin or blade may be applied as the bone fixation element or combination thereof, wherein the apertures 14, 15, 23, 24 may be openings in the shape of circular holes, gaps, slits or slots.
圖6展示多個截骨術植體10.1、10.2、10.3、10.4,其各自具有中間支柱部30之不同高度H1、H2、H3、H4以與患者之個體解剖學匹配。Figure 6 shows a plurality of osteotomy implants 10.1, 10.2, 10.3, 10.4 each having a different height H1, H2, H3, H4 of the intermediate strut portion 30 to match the individual anatomy of the patient.
圖7a至圖7c展示根據本創作之截骨術植體10的第二實施例。中間支柱部30在其兩個側上具有不同寬度W1、W2。中間支柱部30的意欲配置於骨頭內之側具有小於前部31上之第一寬度W1的第二寬度W2,前部31意欲平行於骨頭之皮質而配置。此特徵可藉由比較自前部31展示截骨術植體10的圖7a與自意欲配置於骨頭內之側展示截骨術植體10的圖7b予以辨識。Figures 7a through 7c show a second embodiment of an osteotomy implant 10 in accordance with the present teachings. The middle pillar portion 30 has different widths W1, W2 on both sides thereof. The side of the intermediate pillar portion 30 intended to be disposed within the bone has a second width W2 that is smaller than the first width W1 of the front portion 31, and the front portion 31 is intended to be disposed parallel to the cortex of the bone. This feature can be identified by comparing Figure 7a showing the osteotomy implant 10 from the anterior portion 31 and Figure 7b showing the osteotomy implant 10 from the side intended to be placed within the bone.
另外,四個圓柱形本體12、13、21、22朝向其意欲插入於骨頭內之末端成錐形,從而向四個圓柱形本體12、13、21、22提供輕微圓錐形形狀,如藉由如圖7c所示之截骨術植體10的側視圖可看出。使用錐形圓柱形本體12、13、21、22有助於將截骨術植體10插入至骨頭中。如熟習此項技術者所理解,骨頭內的經預鑽孔之孔洞將較佳地具有同等錐形形狀。In addition, the four cylindrical bodies 12, 13, 21, 22 are tapered toward their ends intended to be inserted into the bone, thereby providing a slight conical shape to the four cylindrical bodies 12, 13, 21, 22, such as by A side view of the osteotomy implant 10 as shown in Figure 7c can be seen. The use of tapered cylindrical bodies 12, 13, 21, 22 facilitates insertion of the osteotomy implant 10 into the bone. As will be appreciated by those skilled in the art, the pre-drilled holes in the bone will preferably have an equally conical shape.
圖8a及圖8b展示根據本創作之截骨術植體10的第三實施例。此實施例很大程度上對應於如圖2所示之實施例。然而,如圖8a所示,額外第五孔隙70配置於中間支柱部30中。第五孔隙70具有中心軸線72,中心軸線72包括與中間支柱部30之前部31所成的銳角。如在圖8b中所看出,第五孔隙70可收納壓縮螺絲71。壓縮螺絲71有助於遍及截骨術開口41建立壓縮力,該壓縮力有助於植體之初級穩定性及次級穩定性。Figures 8a and 8b show a third embodiment of an osteotomy implant 10 in accordance with the present teachings. This embodiment largely corresponds to the embodiment shown in FIG. 2. However, as shown in FIG. 8a, an additional fifth aperture 70 is disposed in the intermediate post portion 30. The fifth aperture 70 has a central axis 72 that includes an acute angle with the front portion 31 of the intermediate post portion 30. As seen in Figure 8b, the fifth aperture 70 can receive a compression screw 71. The compression screw 71 facilitates the creation of a compressive force throughout the osteotomy opening 41 that contributes to the primary stability and secondary stability of the implant.
在另一替代性實施例,用於植入之器具及截骨術植體為單使用套組之部分。不同大小之植體將需要與植體之形狀對應的 不同骨頭製備裝置。例示性單使用套組包含以下組件之組合:In another alternative embodiment, the instrument for implantation and the osteotomy implant are part of a single use kit. Different sizes of implants will need to correspond to the shape of the implant Different bone preparation devices. An exemplary single use kit contains a combination of the following components:
●截骨術植體10;Osteotomy implant 10;
●具有不同長度之骨頭螺絲50a至50d;● bone screws 50a to 50d having different lengths;
●經預製造之骨頭移植物楔狀物130;a pre-manufactured bone graft wedge 130;
●至少一個試驗隔片器具100;At least one test spacer device 100;
●骨層製備器具110;● bone layer preparation device 110;
●鑽頭121;● drill bit 121;
●銑削工具123;● milling tool 123;
●用於固定骨層製備器具100之K導線51;a K-wire 51 for fixing the bone layer preparation device 100;
●用以在插入骨頭螺絲50a至50d之前進行預鑽孔的鑽頭(未圖示)a drill bit (not shown) for pre-drilling before inserting the bone screws 50a to 50d
●插入器具(未圖示);● Inserting device (not shown);
●螺絲刀(未圖示)。● Screwdriver (not shown).
詳細描述集中於開放楔狀物截骨術,然而,截骨術植體亦可用於閉合楔狀物截骨術。此外,截骨術植體10以及各種器具可經調適以應用於其他解剖學區域,例如,應用於遠端股骨、近端股骨、橈骨、脊椎等等。The detailed description focuses on open wedge osteotomy, however, osteotomy implants can also be used to close wedge osteotomy. In addition, the osteotomy implant 10 and various instruments can be adapted for application to other anatomical regions, for example, to the distal femur, proximal femur, tibia, spine, and the like.
10‧‧‧截骨術植體10‧‧‧ osteotomy implants
11‧‧‧近端部11‧‧‧ Near end
12‧‧‧第一圓柱形本體12‧‧‧First cylindrical body
13‧‧‧第二圓柱形本體13‧‧‧Second cylindrical body
14‧‧‧第一孔隙14‧‧‧First pore
15‧‧‧第二孔隙15‧‧‧second pore
20‧‧‧遠端部20‧‧‧ distal end
21‧‧‧第三圓柱形本體21‧‧‧ Third cylindrical body
22‧‧‧第四圓柱形本體22‧‧‧Four cylindrical body
23‧‧‧第三孔隙23‧‧‧ third aperture
24‧‧‧第四孔隙24‧‧‧fourth pore
30‧‧‧中間支柱部30‧‧‧ Middle pillar
H‧‧‧高度H‧‧‧ Height
T‧‧‧深度或厚度T‧‧‧depth or thickness
W‧‧‧寬度W‧‧‧Width
Claims (13)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
TW103218804U TWM509626U (en) | 2014-10-23 | 2014-10-23 | Osteotomy implant |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
TW103218804U TWM509626U (en) | 2014-10-23 | 2014-10-23 | Osteotomy implant |
Publications (1)
Publication Number | Publication Date |
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TWM509626U true TWM509626U (en) | 2015-10-01 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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TW103218804U TWM509626U (en) | 2014-10-23 | 2014-10-23 | Osteotomy implant |
Country Status (1)
Country | Link |
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TW (1) | TWM509626U (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI638634B (en) | 2016-08-19 | 2018-10-21 | 愛派司生技股份有限公司 | Surgery device for osteotomy |
-
2014
- 2014-10-23 TW TW103218804U patent/TWM509626U/en not_active IP Right Cessation
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI638634B (en) | 2016-08-19 | 2018-10-21 | 愛派司生技股份有限公司 | Surgery device for osteotomy |
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MM4K | Annulment or lapse of a utility model due to non-payment of fees |