M4.11225 五、新型說明： 【新型所屬之技術領域】 ^本創作係涉及一種棘間隙固定器，尤指一種可利用 微創手術植入兩相鄰棘間以固定棘間隙 f先前技術】M4.11225 V. New description: [New technical field] ^This creation relates to a ratchet spacer, especially a microinvasive surgery to implant two adjacent spines to fix the interphalangeal space.
脊椎疾病大都是由長期姿勢不正確、運動傷害或是 隨著年齡老化等因素所造成的，許多脊椎病變，:椎管 狹窄或椎間盤突出#，當病發時經t會伴隨著嚴重的坐 骨神經痛、跛行或神經病變等症狀，特別是，當一個椎 間盤之後部毁損時，脊椎的伸展會使兩個脊椎骨由該盤 分離f不JE常地互相靠攏，這結果會使神經根被陷住2 產生嚴重的疼痛感覺，導致病人在行動上產生困擾。通 常這類脊椎病變是無法使用藥物治癒的，經過驗證的有 效方式是以手術治療，在故障的相鄰棘間植入固定物以Spinal diseases are mostly caused by long-term posture errors, sports injuries or ageing. Many spinal lesions, spinal canal stenosis or intervertebral disc herniation, are accompanied by severe sciatica when the disease occurs. Symptoms such as limp, or neuropathy, especially when a posterior disc is damaged, the extension of the spine causes the two vertebrae to separate from the disc, and the JE is often close to each other, which results in the nerve root being trapped 2 Severe pain sensation causes the patient to be troubled by the action. Often such spinal lesions are not curable with drugs, and a proven and effective way is surgical treatment to implant a fixture between adjacent adjacent spines.
限制脊椎骨之延伸向彼此靠攏，避免病人在行動時產生 疼痛等不利特徵；而傳統的手術方式是從病人背部的正 中線切開筋膜及棘上韋刃帶，並將脊椎旁之肌肉沿著骨膜 撥離以及將附著於脊椎上的肌腱切斷，然後將固定物植 設於脊椎的棘突之間，此類開刀手術極具侵犯性，操作 過程複雜、手術時間長，且傷口大、復原期較長，特別 是，手術過程中患者的部分椎骨韌帶及肌肉、肌腱受到 破壞，因此手術後即使肌肉縫合，但肌肉及肌腱無法完 全回復到原來的效能，而遭到切除的棘上韌帶、椎棘及 棘間韌帶，易造成術後脊柱的不穩定。 【新型内容】 器，it:此/本創作乃提供-種改良的棘間隙固定 二二α微創手術施作，將該固定器以側面螺入方 式植：在：障的相鄰棘間，以固定棘突之間隙 神經組織，增】;同時可保護人體脊椎附近的 諸多缺點/ 全性，並—舉改善傳統手術存有 把:據本創作’該棘間隙固定器主要包含：在固定琴 ^體上設—^位環槽，於較位環槽-側設有-子彈型 對向的另一側則具-止檔板，且在該鑽頭上 二 > -螺旋導槽’由該鑽頭前端緣延伸至該定位環 又於該讀㈣側面設有樞接結構，可與-安裝 =具^以將該固^器螺人兩相鄰棘間，利用該定位環 &的上棘突和下棘突之間，以達穩定棘間 丨糸之目的。 根據本創作，朗旋導槽的㈣規格係呈由大到小 其可防止該螺旋導槽於旋入兩相鄰棘間的固定位 後，容易因外力影響而退出該固定位置。 根據本創作，該棘間隙固^器係使用複合材料或合 =料以：體成型方式加工製成者，其中，該複合材料 自於碳素纖維、聚醚賴(PEEK，pQ|y etherether ef〇ne)等，而該合金材料是選自於鈦合金、|E合金、不 ，鋼等仁實把範圍不以前述材料為限，各類適合植設 人體内使用的具有良好機械強度和抗化學性的生物 相容性材料均適用。 根據本創作，該定位環槽具有不同大小的尺寸規 。，以適應不同位置的患部，且其截面可為任意形狀’ M4.11225 如圓形、橢圓形或多邊形等。 又根據本創作，該樞接結構包含一螺孔及至少一定 位插孔，亦可以理解的述樞接結構亦可設為二： 不同形式安裝工具的孔形或槽狀的樞接構造，以便因應 手術操作上的實際需求，使該固定器可結合適宜的安g 工具’便利操作地將該固定器旋轉進入兩相鄰棘間，： 安裝至所需的固定位置。Limiting the extension of the vertebrae to each other, avoiding the unfavorable features of the patient's pain during the operation; the traditional surgical method is to cut the fascia and the supraspinal blade from the median line of the patient's back, and the muscles along the vertebrae along the periosteum Disengaged and cut the tendon attached to the spine, and then implant the fixture between the spinous processes of the spine. Such surgery is extremely aggressive, complicated in operation, long in operation time, and large in wound and recovery period. Longer, in particular, part of the patient's vertebral ligaments and muscles and tendons are destroyed during the operation. Therefore, even if the muscles are sutured after the operation, the muscles and tendons cannot completely return to the original efficacy, and the removed supraspinous ligament and vertebrae are removed. Spinal and interspinous ligaments are prone to postoperative instability of the spine. [New content] device, it: This / this creation is to provide an improved treatment of the interstitial fixation of the two-two alpha minimally invasive surgery, the stent is planted sideways: in the adjacent spines of the barrier, In order to fix the interstitial nerve tissue, increase; at the same time, it can protect many shortcomings/fullness in the vicinity of the human spine, and improve the traditional surgery. According to the creation, the ratchet spacer mainly includes: ^ The body is provided with a ring groove, which is provided on the side of the position ring groove - the other side of the bullet type opposite has a stop plate, and on the drill bit, the second > - the spiral guide groove The front end edge of the drill bit extends to the positioning ring and is provided with a pivoting structure on the side of the read (four), and can be mounted between the two adjacent thorns, and the upper thorn of the positioning ring & Between the sudden and the lower spinous processes, to achieve the purpose of stabilizing the spine. According to the present invention, the (four) specification of the slewing guide groove is from large to small, which prevents the spiral guide groove from being withdrawn from the fixed position after being screwed into the fixed position between the two adjacent thorns. According to the present invention, the ratcheting device is manufactured by using a composite material or a composite material by a body molding method, wherein the composite material is derived from carbon fiber, polyether lye (PEEK, pQ|y etherether ef) 〇ne), etc., and the alloy material is selected from titanium alloy, |E alloy, no, steel, etc. The range is not limited to the above materials, and various types are suitable for planting in human body with good mechanical strength and resistance. Chemically biocompatible materials are suitable. According to the present creation, the positioning ring groove has different size gauges. To adapt to the affected part of different positions, and the cross section can be any shape ' M4.11225 such as a circle, an ellipse or a polygon. According to the present invention, the pivoting structure includes a screw hole and at least one positioning socket. It can also be understood that the pivoting structure can also be set as two: a hole-shaped or groove-shaped pivoting structure of different forms of the mounting tool, so that Depending on the actual needs of the surgical procedure, the holder can be conveniently operated to rotate the holder into two adjacent spines in conjunction with a suitable gage tool: Mount to the desired fixed position.
此將於下文中加以說明本創作其他的目的，優點 =著的特徵’熟習本技術者熟讀文中的說明後實現本創 【實施方式】 。。如第一至二圖所示之本創作實施例，該棘間隙固定 器之本體略呈子彈狀構型，其係由聚㈣㉞酮材料一體成 型製作而成，具有良好機械強度和抗化學性，因此 適合植設在人體内使用；該固定器本體之前端部位 造型渾81流暢的子彈型鑽頭1 ’在中段部位設有定位環 槽2 ’且有-職導槽3由該鑽頭彳前緣延伸到該定位 :槽2上，而該螺旋導槽3的具有由大漸小的溝槽規 ，’·另於該mu本體之末端部位設有—止檔板4，並 在該止檔板的外側端面上設有一螺孔41 孔42。 』〜’儿伯 如前述結構特徵的棘間隙固定器，當使用微創手術 (或稱為内視鏡手術）安裝時係以—小直徑之套筒（―般 勺為2 cm左右）穿過肌肉由側面到達脊椎故障部位的相 鄰棘間隙附近，再於該套筒内穿設—微型攝影機，進而 5 M411225 將，野傳達投射至顯示器螢幕上，並進行手術部位的準 確定位（以上未顯示於圖面），然後，以一旋把5前端的 ，動螺栓51及定位掣子52(如第四圖所示）搭配框接於 该棘間隙固^器後端面的螺孔41及^位插孔42上，藉 。亥旋把5樞接該棘間隙固定器並通過前述套筒抵達脊椎 故障部位，再利用該旋把6旋轉推進以及該固定器上的 螺旋導槽3之導引’使該棘間隙固定器的子彈型鑽頭， 在不截斷棘上勒帶61的情況下旋鑽通過二相鄰棘突間 隙中的生理組織，並使該棘間隙固定器的定位環槽2恰 停留在^棘突62和下棘突63之間（如第五及六圖戶^ 不），而藉由在脊椎故障部位的相鄰棘間隙植入本創作之 口疋器，即可達到穩定棘間隙之目的，以避免相鄰棘間 隙不，常壓迫限縮所引致的各種不利特徵。 棘 綜上所述可知，本創作之棘間隙固定器可使用微創 手術由脊椎側面植入故障部位的棘突間隙中，手術操作 簡便快速，傷口微小復原迅速，而且植入手術過程不需 f斷韌帶、肌腱或是破壞病人脊突間的解剖結構，可減 少對病人的傷害，並確保脊椎結構在手術裔後可完全恢 復原有的活動效能；另，本創作固定器具有渾圓的子彈 型鑽頭1，當其旋鑽通過相鄰棘間隙時，可避免有銳部 十周邊，’且織&成削刮破壞，從而大幅降低損傷神經組織 的風險，又，該固定器採用聚醚醚酮（PEEK)材料製成， ，生物相容性材料的性質非常接近人體脊椎強度，可減 ;沉降作用以及對脊椎的磨損傷害。 以上所舉實施例，僅用為方便說明本創作並非加以 限制，在不離本創作精神範疇，熟悉此一行業技藝人士 ml 1225 依本創作申請專利範圍 形與修飾，均仍瘅含括於 說明所作之各種簡易變 【圓式簡單·】3括^申請專利範圍中。 第一圖為本創作實施例之立體圖； , 第二圖為本創作實施例之部分剖示的側視圖； 弟三圖為本創作實施例之另一角度的立體圖； 第四圖為本創作之固定器與旋把組合的示意圖； ：·This will be explained below for the other purposes of the present invention, the advantages of the features = the familiarity of the skilled artisan to read the description of the text to achieve the original [Embodiment]. . As shown in the first and second embodiments, the body of the ratchet spacer has a slightly bullet-like configuration, which is integrally formed from poly(tetra)34 ketone material, and has good mechanical strength and chemical resistance. Therefore, it is suitable for planting in the human body; the front end of the holder body is shaped 浑 81 smooth bullet type drill bit 1 'with a positioning ring groove 2 ' at the middle portion and the --position guide groove 3 is extended by the front edge of the drill bit To the positioning: the groove 2, and the spiral guide groove 3 has a groove gauge which is gradually smaller, and the end portion of the mu body is provided with a stop plate 4, and is at the stop plate A screw hole 41 is provided in the outer end surface. 』~'Children's asbestos gap fixator with the above-mentioned structural features, when used in minimally invasive surgery (or called endoscopic surgery), is a small-diameter sleeve ("2" is about 2 cm) The muscles reach the vicinity of the adjacent ratchet space of the spinal failure site from the side, and then the micro-camera is placed in the sleeve, and then the 5 M411225, the wild communication is projected onto the display screen, and the precise location of the surgical site is performed (not shown above) In the figure), then, with the front end of the knob 5, the moving bolt 51 and the positioning tweezers 52 (as shown in the fourth figure) are matched with the screw holes 41 and the position of the rear end surface of the ratchet gap fixing device. On the jack 42, borrow. The spinner 5 pivotally connects the spine gap holder and reaches the spinal failure site through the sleeve, and then uses the rotation of the knob 6 and the guidance of the spiral guide groove 3 on the holder to make the spine gap holder The bullet-type drill bit is drilled through the physiological tissue in the adjacent adjacent spinous process gap without cutting the spine-like strip 61, and the positioning ring groove 2 of the ratchet spacer is just stopped at the spinous process 62 and under Between the spinous processes 63 (such as the fifth and sixth figures), and by implanting the mouthpiece of the creation in the adjacent interspinous space of the spinal failure site, the purpose of stabilizing the interstitial space can be achieved to avoid the phase. The adjacent interphalangeal gap is not, and various unfavorable features caused by constant compression and contraction. As can be seen from the above, the artificial interspinous space fixator can be implanted into the spinous process space of the fault site by the side of the spine using minimally invasive surgery, the operation is simple and rapid, the wound is small and the recovery is rapid, and the implantation process does not need f Broken ligaments, tendons or anatomical structures that disrupt the spine of the patient can reduce the damage to the patient and ensure that the spine structure can fully restore the original activity after the surgery. In addition, the creation fixture has a round bullet type. The drill bit 1 can avoid the sharp periphery of the sharp portion when it is drilled through the adjacent ratchet gap, and the damage is reduced, thereby greatly reducing the risk of damage to the nerve tissue. Moreover, the holder uses polyether ether. Made of ketone (PEEK) material, the properties of biocompatible materials are very close to the strength of the human spine, which can be reduced; sedimentation and wear damage to the spine. The above embodiments are used for convenience only to illustrate the creation of the present invention, and are not limited to the scope of the creative spirit. Those skilled in the art, ml 1225, apply for the scope and modification of the patent application, and are still included in the description. Various kinds of simple changes [round simple] 3 brackets ^ in the scope of patent application. The first figure is a perspective view of a part of the present invention; the second figure is a side view of a part of the creation embodiment; the third figure is a perspective view of another angle of the creation embodiment; Schematic diagram of the combination of the holder and the knob;
第五圖為本創作之固定器被安裝在相鄰棘間隙的 平面示意圖；以及 第六圖為本創作之固定器被安裝在相鄰棘間隙的 側面示意圖。 【主要元件符號說明】 鑽頭1 定位環槽2 螺旋導槽3 止檔板4 螺孔41 定位插孔42 旋把5 活動螺栓51 定位掣子52 棘上韌帶61 上棘突62 下棘突63 7The fifth figure is a plan view showing the fixture of the present invention installed in the adjacent ratchet gap; and the sixth figure is a schematic side view of the fixture in which the creation is mounted on the adjacent ratchet gap. [Description of main components] Drill bit 1 Positioning ring groove 2 Spiral guide groove 3 Stop plate 4 Screw hole 41 Positioning socket 42 Rotary handle 5 Movable bolt 51 Positioning tweezers 52 Spinal ligament 61 Upper spinous process 62 Lower spinous process 63 7