M273326 八、新型說明： 【新型所屬之技術領域】 本創作是一種用於脊椎兩鄰近椎體間之融合手術植入物， 用於’口療因退化性脊椎病變或受外力創傷所造成的脊椎不穩定 才關疾病k供手術後良好的穩定能力。此外，此植入物能稱 開兩椎體之間南度解除神經壓迫的問題，能有效減輕頸部與背 部疼痛的問題。 【先前技術】 脊椎融合術的技術首先是導源於1911年11化以提出的臨床方 法，其目的是植入補骨於脊椎不穩定的位置，使補骨與原來骨 組織融合而成穩定結構，而補骨來源不外乎來自腓骨(_的、 胳骨(lllium)、腸骨(iiiac crest)、肋骨(rib)、捐贈的異體移植骨 (allograft)或疋取自其他生物的異種植骨(狀啊恤)。採用異體與 難移植骨常有生長緩慢與人體排斥的問題，且補骨強度低， 吊韦在手術植入位置未生長穩定即塌陷或是人體自行吸收消失 ㈣sorbed)。此外’採用自體移植骨則會使病患本身有兩處傷 口，不但增加了手_間、住院天數、也提高了手術後發生感 染的機率。 基於此，1985年首先在美國專利號懂269提出將 I狀生物可相谷ϋ金屬圓柱體放置在兩鄰近關節面，並在金屬 監中放入補骨進彳讀椎或關節的融合手術方法，許多學者即針 對此脊椎融合植入物進行改良以獲得較佳的治療效果。其中最 5 M273326 =要=改良參數即維持手術後初期的穩定程度，使骨頭能在穩 疋的％境巾生長。針對此手術方式，有許多專獅此金屬植入 物進仃改良與設計。美國專利號4834757提出將植入物上下及 左右表面佈滿_尖點使植人物不㈣動，穩定度佳，但是其 表面H點谷易在手術時傷及周圍神經與組織(圖―）。美國專 & 25772與5443514提出鄰近椎體接觸表面無孔洞的植入 物’使植入物能有較好的表面支撐能力，但是卻阻擒了骨頭生 長祕徑卻使得融合速度變慢。而美國專利號6麵3為了增 加穩定度增加-倾核狀敎結構，但是㈣致手術器^ 構複雜與料手鱗缺·_二)。美賴,遞6娜75為了增加M273326 8. Explanation of the new type: [Technical field to which the new type belongs] This creation is a fusion surgical implant used between two adjacent vertebral bodies of the spine, used for 'oral treatment of the spine caused by degenerative spinal disease or external force trauma Instability is only a concern for disease stability after surgery. In addition, this implant can be used to relieve the problem of nerve compression between the two vertebrae, which can effectively alleviate the problem of neck and back pain. [Prior technology] The technique of spinal fusion is firstly derived from the clinical method proposed in November 11, 1911, and its purpose is to implant psora in the unstable position of the spine, so that the psora is fused with the original bone tissue to form a stable structure. The source of psoralen is nothing more than fibula (_, lllium, iiiac crest, rib), donated allograft bone (allograft) or xenograft bone taken from other organisms ( (Using ah shirts). The use of allogeneic and difficult-to-transplant bones often has problems of slow growth and human rejection, and low bone strength. Dangwei collapses when the surgical implantation site does not grow stably, or the human body absorbs itself and disappears (sorbed). In addition, the use of autologous bone grafting will cause the patient to have two wounds, which not only increases the number of hands and hospital stays, but also increases the chance of infection after surgery. Based on this, in 1985, a fusion surgery method was first proposed in U.S. Patent No. 269 to place a I-shaped biocompatible gluten metal cylinder on two adjacent articular surfaces, and put a psora bone into the vertebra or joint for reading in a metal monitor. Many scholars have improved this spinal fusion implant to obtain better treatment results. The most 5 M273326 = to = to improve the parameters that maintain the initial stability after surgery, so that bones can grow in a stable% environment. For this surgical method, many special lion implants have been improved and designed. U.S. Patent No. 4,834,757 proposes to cover the implant with up and down and left and right surfaces. The sharp points make the implanted person not to move, and the stability is good, but the H-point valley on the surface is easy to damage the peripheral nerves and tissues during the operation (Figure ―). The US patents & 25772 and 5443514 proposed that implants without holes near the contact surface of the vertebral body make the implants have a better surface support ability, but they hinder the growth of the bones and slow the fusion speed. The U.S. Patent No. 6 and 3 are added to increase the stability of the nucleus-like structure, but the structure of the surgical device is complicated and the scale is lacking. Mei Lai, pass 6 Na 75 in order to increase
^师π口、枉狀本體内部空間、 本體表面軸向分佈的螺紋、至少 捏向分佈壁面孔洞所組成。 間、伸長柱狀本體表面、隨著長軸 至少一個徑向分佈壁面開口、多個 ，入物的穩定能力，將植人物職改成雙螺紋型式，以增加固 疋力’但此設計並沒有考_人體的生理特性。 伸長柱狀植人__反_㈣直面具有—個前方壁面 6 M273326 與-個後方壁面，前方壁面為—平滑· 個手術器械操作口。伸長錄本趙内 === 艘表面嶋健棒繼 洞。隨者本體軸向分佈的螺紋由外因直徑 : :後::::直徑尺寸會大於椎間盤高度，_二： ml二 人體曰常動作中，前f動作的運動 祀圍取大’在此情形下前方椎體所支撐的力量也最大，容易發 螺紋之間的空間變大，可以抓住較多骨頭，穩定度增加。本創 作優點在鱗考人魅鱗性，、_職設収骨融合植入物 生植入物_進人椎_併發症，#前方敎_直徑較大 寺植物強度車乂大。相反的，由於脊椎後方有小面關節(facet joint)支樓，且後彎的運動範圍較前彎小，因此，後方椎體的受 力較小，本創新中’越往後方，植入物螺紋内圓直徑越小，兩 在不增加機構複雜度的情形下增加穩定程度，減少移位 (disbdgemem)的併發症狀發生’此外，本設計沒有鋒利刃口， 不至於傷害神經與軟組織。 【實施方式】 參考第四圖，本創作係提供一種脊椎融合手術植入物，此 植入物為一個伸長柱狀本體(1)，該本體的兩相反側軸向垂直面 方疋鈿方壁面(20)另一方是後方壁面(30)，伸長柱狀本體(1)上 的伸長柱狀本體表面(40)包覆成一個中空内部空間(50)，隨著伸 7 M273326 長柱狀本體表面(40)軸向分佈著螺紋(60)，柱狀本體表面(4〇)徑 向有壁面開口(70)與數量不等的壁面孔洞(8〇)。 在第三圖中、伸長柱狀本體(1)的兩相反側軸向垂直面—方 是前方壁面(20)另一方是後方壁面(3〇)。前方壁面(2〇)為一平滑 曲面，如橢圓曲面，可使植入物易於放入脊椎關節之間，且平 滑面不易傷害神經與軟組織。此伸長柱狀本體⑴由生物可相容 性(biocompatible)材質製成，例如鈦合金、銘鉻鉬合金、不鏽鋼、 碳纖維聚合物、PEEK(p〇lyether ether ketone)高分子材料與骨頭 強度接近的材料或陶莞材料等。此伸長柱狀本體⑴上的伸長柱 狀本體表面(40)塗佈-層氫氧基麟灰石(hydr〇xylapatite)或其他 生物可適性材料，提供骨頭生長良好環境，使骨頭易於長入。 伸長柱狀本體⑴的内部空間(5〇)可以放入生物可相容性補骨材 料，如自體骨補骨、異體補骨與具有生物可相容性骨誘導 (osteoinductive)或骨傳導(〇ste_duc㈣ BMP，使關節融合。 在第四圖中’後方壁面(30)具有一個手術器械操作口(3〇1)， 可以使手術ϋ械放人並進行手術程序，此菱形孔操作口縱向長 度(3〇2)與菱形孔操作口橫向長度_長度不同，可對齊伸長柱 狀本體⑴的壁面開口 (70)作為定位之用，使手術操作者易於了解 植入物開口的位置。壁面開口 (70)與數量不等壁面孔洞(80)可使 上方椎華〇與下方椎體(9晴細胞易於透過壁面開口⑽盥 壁面孔洞(8〇)長入伸長柱狀本體⑴之内部空間⑽，與補骨生長 在一起，將兩鄰賴節面融合⑼），其巾f融合植人物固定鄰近 8 M273326 兩端骨區域(904)由前方往後方逐漸變大，在手術後可增加植入 物穩定度。如第五圖所示。 在第六圖中，為本創作之侧視圖，其中伸長柱狀本體表面(4〇) 上方具有隨著軸向分佈的螺紋(6〇)，螺紋由外圓直徑(6〇丨)與内圓 直徑(602)組合喊，其巾相錄_)尺核於錄椎間盤高 度，以提供退化椎間盤回復原始脊椎生理高度；而内圓直徑(6〇2) 由前往後逐漸變小。這是因為在人體動作巾，前f動作的運動 範圍較大’在此動作下前方椎斷支撐的力量也最大，在受到 強大外力下’植人物容紐生沉陷進人椎體的併發症。因此本 設計中’前方内圓直徑(602)尺寸較大，.提供較大強度；相反的， 脊椎後方有小面關節支樓，在後彎動作下，力量會由小面關節 $ ’且運動範圍也較前彎動作小。此外，後方脊椎融合手術 a採用内固定器固定，故後方椎體所承受的力量較前方 低。因此，越往後方’本創作之内圓直徑(6〇2)越往後方直徑越 兩累、、文之間的空間變大，'可以抓住較多骨頭，穩定度增加。 另三種不同螺紋形式實施例是螺紋採用V型螺紋(圖七)、兩 1 有傾斜角度方螺紋(圖八)與具有倒在句的螺紋(圖九）。如圖 七所不，㈣v獅紋設計使植场有祕旋人雜的優點， 此V螺紋外圓直郷⑼會大於椎隨高度，而V螺肋圓直徑 (_)會由前往後逐漸變小；如圖八所示，具有傾斜角度之方螺 紋外__5)會大娜間盤高度，邮有傾斜航之方螺紋 /内囫直師06)會由前往後逐漸變小，兩鄰近外圓直徑與内圓直 徑之相連㈣呈現—傾斜纽C(6G7)，此設狀外圓直徑具有 9 M273326 外圓直徑軸向寬度A(608)，而内圓直徑具有内圓直徑軸向寬度 B(609);倒鉤設計可以再次增加植入物穩定能力，如圖九所示， 此裝置倒鉤型螺紋外圓直徑(61〇)會大於椎間盤高度，而倒鉤型 螺紋内圓直徑(611)會由前往後逐漸變小。 在方螺紋或具有傾斜角度之方螺紋其外圓直徑軸向寬度 A(108)與内圓直徑軸向寬度B(6〇9)有三種實施例，其一為外圓 直徑軸向寬度A(608)與内圓直徑軸向寬度B(6〇9)等寬，表示為 A-B，其一為外圓直徑軸向寬度A(608)較内圓直徑軸向寬度 B(609)小，將孔洞分佈在内圓直徑表面，經由較大孔洞促進補骨 長出，表示為A<B ;其三為外圓直徑軸向寬度A(6〇8)較内圓直 &軸向見度B_)大’經由增加A使植人物與㈣細表面增 加’減少接觸面壓力，使植入物減少沉陷發生，表示為A>B。 【圖式簡單說明】 第一圖係習知脊椎融合植入物 第二圖係習知脊椎融合植入物 第三圖係本創作之斜視立體圖 第四圖係本創作之後視圖 第五圖係本創作與_結合之示意圖 第六圖係本創作之側視圖 第七圖係本創作之另-實施例(V型螺紋） ★圖係本創作之另一實施例（兩侧面具有傾斜角度方螺紋） 第九圖係本創作之另—實施例㈣釣型螺紋） M273326 【主要元件符號說明】 [習知] 苐圖22側面粗链尖齒，23上表面粗糖尖齒 第二圖11板；19後方螺旋；21螺帽 [本創作] 1伸長柱狀本體 30後方壁面 302菱形操作口縱向長度 40本體表面 60螺紋 602方螺紋内圓直徑 604 V螺紋内圓直徑 20前方壁面 301，手術器械操作口 303菱形操作口橫向長度 50内部空間 601方螺紋外圓直徑 603 V螺紋外圓直徑 605具有傾斜角度之方螺紋外圓直徑 606具有傾斜角度之方螺紋内圓直徑 607 —個傾斜角度 609内圓直徑之軸向寬度 611倒鉤型螺紋内圓直徑 80壁面孔洞 901上方椎體 903小面關節 608外圓直徑之軸向寬度 610倒鉤型螺紋外圓直徑 70壁面開口 90骨融合示意圖 902下方椎體 904植入物固定鄰近兩端骨區域 11It consists of the mouth of the teacher, the internal space of the 枉 -shaped body, the threads distributed axially on the surface of the body, and at least the holes facing the distribution wall. The elongated cylindrical body surface, along with at least one radial distribution of the wall openings on the long axis, and multiple, stabilizing capabilities of the object, will change the character of the planting plant into a double-threaded type to increase the retention force. But this design does not have Test _ physiological characteristics of the human body. The elongated columnar implant __anti_㈣ has a front wall 6 M273326 and a rear wall, and the front wall is-smooth · a surgical instrument operation port. Extending the record Zhao Nei === The surface of the ship is a healthy rod following a hole. The axially distributed threads of the body are formed by the external diameter :: posterior ::::: the diameter dimension will be greater than the height of the intervertebral disc. The anterior vertebral body also supports the largest force, and the space between threads is likely to become larger, which can hold more bones and increase stability. The advantages of this creation are in the scale test of human charm, _ post osteosynthesis fusion implants, biological implants _ into the human vertebra _ complications, # 前 敎 _ large diameter temple plant strength car large. In contrast, because there is a facet joint at the back of the spine, and the range of motion of the posterior curve is smaller than that of the anterior curve, the force of the posterior vertebra is less. In this innovation, 'the more backward, the implant The smaller the inner diameter of the thread, the more the two will increase the stability without increasing the complexity of the mechanism and reduce the complications of disbdgemem. In addition, the design does not have sharp edges, which will not hurt nerves and soft tissues. [Embodiment] Referring to the fourth figure, the present invention provides a spinal fusion surgical implant. The implant is an elongated columnar body (1), and two opposite sides of the body are axially perpendicular to the square wall. (20) The other side is the rear wall surface (30). The surface of the elongated columnar body (40) on the elongated columnar body (1) is wrapped into a hollow interior space (50). (40) Threads (60) are distributed in the axial direction, and the surface of the cylindrical body (40) is provided with wall openings (70) and wall holes (80) of varying numbers in the radial direction. In the third figure, two opposite sides of the elongated columnar body (1) are axially perpendicular planes-one is a front wall surface (20) and the other is a rear wall surface (30). The front wall surface (20) is a smooth curved surface, such as an elliptical curved surface, which allows the implant to be easily placed between the spinal joints, and the smooth surface is not easy to hurt nerves and soft tissues. The elongated cylindrical body ⑴ is made of biocompatible materials, such as titanium alloy, chrome molybdenum alloy, stainless steel, carbon fiber polymer, PEEK (polyether ether ketone) polymer material, which is close to bone strength. Materials or ceramic materials. The surface of the elongated columnar body (40) on the elongated columnar body is coated with a layer of hydroxylapatite or other biocompatible materials to provide a good environment for bone growth and make bones easy to grow in. The internal space (50) of the elongated columnar body can be filled with biocompatible bone filling materials, such as autologous bone filling, allogeneic bone filling, and biocompatible osteoinductive or bone conduction ( 〇ste_duc㈣ BMP to make the joints fused. In the fourth figure, 'the rear wall (30) has a surgical instrument operation port (301), which can put the surgical instrument and perform a surgical procedure, the longitudinal length of this diamond hole operation port (30) Different from the lateral length_length of the diamond-shaped hole operation port, the wall surface opening (70) of the elongated cylindrical body can be aligned for positioning, so that the operator can easily understand the position of the implant opening. The wall surface opening ( 70) and the number of wall face holes (80) can make the upper vertebra and the lower vertebral body (9 clear cells easily pass through the wall opening (wash wall face hole (80)) into the inner space of the elongated columnar body ⑴, and The bones are grown together, and the two adjacent joints are fused together), the towel f fusion is implanted and the character is fixed adjacent to 8 M273326. The bone area (904) at both ends gradually increases from the front to the rear, which can increase the stability of the implant after surgery. Degrees. As shown in the fifth figure. In the sixth In the figure, this work is a side view of the creation. Above the surface of the elongated cylindrical body (40), there are threads (60) distributed along the axial direction. The threads consist of an outer diameter (60) and an inner diameter (602). ) The group shouted, its towel was recorded _) The ulnar core was recorded at the height of the intervertebral disc to provide the degenerated intervertebral disc to restore the original physiological height of the spine; and the inner circle diameter (602) gradually became smaller after going. This is because in the human action towel, the range of motion of the front f motion is large. 'Under this motion, the force of the frontal vertebral fracture support is also the largest, and under the strong external force, the complication of the implanted character Rong Niusheng sinking into the human vertebral body. Therefore, in this design, the diameter of the front inner circle (602) is larger and provides greater strength. On the contrary, there is a facet joint pedestal behind the spine. In the backward bending action, the force will be moved by the facet joint $ 'and move. The range is also smaller than the forward bend. In addition, the posterior spinal fusion surgery a is fixed with an internal fixator, so the force on the posterior vertebral body is lower than that on the front. Therefore, the “inner circle diameter (602)” of this creation becomes more and more exhausting, and the space between the text becomes larger. “You can grab more bones and increase the stability. The other three examples of different thread forms are a V-shaped thread (Figure 7), two square threads with an inclined angle (Figure 8), and a thread with an inverted sentence (Figure 9). As shown in Figure 7, the ㈣v lion design makes the plantation have the advantages of secret rotation. This V-threaded outer circle will be larger than the height of the vertebra, and the diameter of the V-spiral circle (_) will gradually change from the front to the back. Small; as shown in Figure 8, the square thread with an oblique angle __5) will increase the height of the disc, and the square thread with an oblique flight / inner straight straight 06) will gradually become smaller after going, two adjacent to the outside The connection between the diameter of the circle and the diameter of the inner circle is presented-a slanted button C (6G7). This design has an outer diameter of 9 M273326 and an outer diameter of the axial width A (608), and the inner diameter of the inner diameter has the inner diameter of the axial width B. (609); The barb design can increase the stability of the implant again. As shown in Figure 9, the diameter of the outer circle of the barb thread (61) of this device will be greater than the height of the disc, and the diameter of the inner circle of the barb thread (611 ) Will gradually become smaller after going. There are three embodiments of the external diameter of the external diameter of the square thread or the square thread with an oblique angle A (108) and the internal diameter of the axial width B (609), one of which is the external diameter of the axial width A ( 608) is the same width as the axial width B (609) of the inner circle diameter, and is expressed as AB. One is that the axial width A (608) of the outer circle diameter is smaller than the axial width B (609) of the inner circle diameter. It is distributed on the surface of the inner circle diameter and promotes the growth of psoralens through larger holes, which is expressed as A <B; the third is the outer diameter of the outer circle. The axial width A (6〇8) is straighter than the inner circle & axial visibility B_) The large 'increased the number of the implanted person and the thin surface by increasing A' reduces the contact surface pressure and reduces the occurrence of subsidence of the implant, which is expressed as A > B. [Schematic description] The first picture is a conventional spine fusion implant. The second picture is a conventional spine fusion implant. The third picture is an oblique perspective view of the author. The fourth picture is a view after the creation. The fifth picture is a view. The illustration of the combination of creation and _ The sixth figure is a side view of this creation. The seventh figure is another embodiment of this creation (V-shaped thread). ★ The picture is another embodiment of this creation (both sides have oblique square threads). The ninth picture is another one of this creation—an embodiment of a fishing thread.) M273326 [Description of the main component symbols] [Knowledge] 苐 Figure 22 side coarse chain tines, 23 upper surface coarse sugar tines, second plate 11; 19 rear Spiral; 21 nuts [this creation] 1 elongated cylindrical body 30 rear wall surface 302 diamond-shaped operation port longitudinal length 40 body surface 60 thread 602 square thread inner circle diameter 604 V thread inner circle diameter 20 front wall surface 301, surgical instrument operation port 303 Diamond-shaped operating port transverse length 50 internal space 601 square thread outer circle diameter 603 V thread outer circle diameter 605 square thread outer circle diameter with inclined angle square thread inner circle diameter with inclined angle 607-within an inclined angle 609 Axial width of circle diameter 611 barb thread inner circle diameter 80 wall face hole 901 above vertebra 903 facet joint 608 outer diameter axial width 610 barb thread outer circle diameter 70 wall surface opening 90 bone fusion diagram below 902 Vertebral body 904 implants fix adjacent bone regions 11