TWM618379U - Translaminar pedicle anchor suspension system and its anchor and related component-set - Google Patents
Translaminar pedicle anchor suspension system and its anchor and related component-set Download PDFInfo
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本創作是關於一種經椎板椎弓根錨釘懸吊系統,尤指一種藉由懸吊線及錨釘來將脊柱之下節椎骨懸吊於上節椎骨下方的經椎板椎弓根錨釘懸吊系統及其錨釘與零件組。 This creation is about a trans-laminar pedicle anchor suspension system, especially a trans-laminar pedicle anchor that suspends the lower vertebrae of the spine under the upper vertebra through suspension wires and anchors Suspension system and its anchors and parts group.
人類的脊柱(Columna Vertebralis)是由24塊脊椎椎骨(頸椎7塊、胸椎12塊、腰椎5塊)、1塊骶骨(sacrum,又稱薦椎)和1塊尾骨(coccyx,又稱尾椎)藉由韌帶、關節及椎間盤連接而成。當其中之一椎骨因疾病或創傷而移位、滑脫、變形、退化或受損時,可能導致脊柱機械傷害或病變;除產生疼痛之外、並會對脊柱的其他部分造成進一步損害。而當椎骨移位、滑脫、變形、退化或受損症狀嚴重,無法以保守的藥物或物理方式治療時,則需施以手術治療。常見的手術治療方式包括了:減壓術、椎間盤切除術、椎板切除術、骨融合術和椎骨固定等。 The human spine (Columna Vertebralis) is composed of 24 vertebrae (7 cervical vertebrae, 12 thoracic vertebrae, and 5 lumbar vertebrae), 1 sacrum (also known as sacrum) and 1 coccyx (also known as coccyx) It is connected by ligaments, joints and intervertebral discs. When one of the vertebrae is displaced, slipped, deformed, degenerated or damaged due to disease or trauma, it may cause mechanical injury or pathology of the spine; in addition to pain, it will cause further damage to other parts of the spine. When the symptoms of vertebrae displacement, spondylolisthesis, deformation, degeneration, or damage are severe and cannot be treated with conservative drugs or physical methods, surgical treatment is required. Common surgical treatment methods include: decompression, discectomy, laminectomy, bone fusion, and vertebral fixation.
脊椎手術常需使用脊椎固定器來固定與支撐手術部位的椎骨。目前習知的脊椎固定器,都是在相鄰的上、下層兩椎骨上分別各鎖入兩隻骨釘,並藉由上下延伸的連結桿來連結分別位於上、下層椎骨的兩骨釘,來達到將相鄰的上、下層兩椎骨加以支撐、固定的效果。然而,目前習知的脊椎固定器,都同樣有以下缺點: Spinal surgery often requires the use of spinal fixators to fix and support the vertebrae at the surgical site. Currently, the conventional spinal fixator is to lock two bone nails on the adjacent upper and lower vertebrae respectively, and connect the two bone nails on the upper and lower vertebrae respectively by connecting rods extending up and down. To achieve the effect of supporting and fixing the adjacent upper and lower vertebrae. However, the currently known spinal fixators also have the following shortcomings:
1.需使用至少四隻以上的骨釘。由於上、下層兩椎骨各需鎖入兩隻骨釘,所以在病人脊椎上需要鎖入至少四根骨釘。所需骨釘越多,不僅手術時間越長、風險越高,且病人的不適感也越嚴重,術後復原所需 時間也越長。 1. At least four bone screws must be used. Since the upper and lower vertebrae need to be locked into two bone screws, at least four bone screws need to be locked in the patient's spine. The more bone nails needed, not only the longer the operation time and the higher the risk, but also the more serious the patient’s discomfort, which requires postoperative recovery. The longer it takes.
2.藉由連結桿來連結上、下層骨釘導致脊椎術後活動能力降低。由於現今脊椎固定器都是以硬質的連結桿來連結上、下層骨釘,把上、下層椎骨兩者藉由連結桿與骨釘加以「固定」及「支撐」;所以,手術後裝置有脊椎固定器的脊椎部位幾乎無法彎曲,病人活動能力大幅降低,甚至造成病人慢性背痛、僵硬。 2. Connecting the upper and lower bone nails by connecting rods leads to reduced mobility after spinal surgery. Since today’s spinal fixators use rigid connecting rods to connect the upper and lower bone nails, the upper and lower vertebrae are "fixed" and "supported" by the connecting rods and bone nails; therefore, the device has a spine after surgery. The spine of the fixator can hardly bend, the patient's mobility is greatly reduced, and even cause chronic back pain and stiffness.
3.脊椎固定器有許多部件會突出於脊椎椎骨外部,造成病人不適與長期疼痛。為了能讓連結桿組合於骨釘的頂部,習知脊椎固定器的骨釘頂部都會包含一個突出於椎骨外部5-10mm的結合部,以供直徑達2-5mm的連結桿能夠安裝、固定於該骨釘頂部。很明顯地,這些突出於椎骨外部的骨釘頂部與連結桿一定會讓病人長期感到不適與異物感,甚至造成病人慢性背痛與僵硬。 3. There are many components of the spinal fixator that protrude outside the vertebrae, causing discomfort and long-term pain for the patient. In order to allow the connecting rod to be combined on the top of the bone nail, the top of the bone nail of the conventional spinal fixator will include a joint part protruding 5-10mm outside the vertebra, so that the connecting rod with a diameter of 2-5mm can be installed and fixed on The top of the bone nail. Obviously, these bone nail tops and connecting rods protruding outside the vertebrae will definitely cause long-term discomfort and foreign body sensation to the patient, and even cause chronic back pain and stiffness.
緣此,本創作揭露了一種經椎板椎弓根錨釘懸吊系統,可解決前述習知脊椎固定器的種種缺失。 For this reason, this creation discloses a translaminar pedicle anchor suspension system, which can solve the various deficiencies of the aforementioned conventional spinal fixators.
本創作之主要目的是在於提供一種經椎板椎弓根錨釘懸吊系統,把人工韌帶所構成的懸吊線的一端藉由錨釘固定於下節椎骨的椎弓根處、而懸吊線的另一端則是藉由墊片卡合在上節椎骨的椎板處,藉此可將上節椎骨與下節椎骨兩者經由懸吊線來懸吊,不僅可穩定脊柱的結構強度,且更能減少手術所需骨釘數量、縮短手術時間、降低神經傷害風險、減少出血量、維持術後椎骨活動度、避免因內固定及融合所造成臨近節的加速退化、降低病人術後的異物、不適、疼痛與僵硬感、以及加速病人術後復原的時程。 The main purpose of this creation is to provide a trans-laminar pedicle anchor suspension system, which fixes one end of the suspension line formed by the artificial ligament to the pedicle of the lower vertebra through the anchor, and the suspension line The other end is clamped to the lamina of the upper vertebra by a spacer, so that both the upper vertebra and the lower vertebra can be suspended by the suspension wire, which not only stabilizes the structural strength of the spine, but also more effectively Reduce the number of bone screws required for the operation, shorten the operation time, reduce the risk of nerve injury, reduce the amount of bleeding, maintain the vertebral mobility after the operation, avoid the accelerated degeneration of the adjacent joints caused by internal fixation and fusion, and reduce the foreign body and discomfort of the patient after the operation , Pain and stiffness, and speed up the time course of the patient's postoperative recovery.
本創作之另一目的是提供一種適用於經椎板椎弓根錨釘懸吊系統的錨釘,其具有獨創的斜向貫穿孔結構。該錨釘不僅可將懸吊線的一端固定於下節椎骨的椎弓根處,且藉由斜向貫穿孔的設計,可利用把錨釘旋轉鎖入椎弓根的操作中來拉扯並調整懸吊線的張力。此外,在手術完成後,錨釘的頂部僅會微微突出、甚至齊平於椎弓根的表面,可讓病人的 異物感與不適感降到最低。 Another purpose of this creation is to provide an anchor suitable for the translaminar pedicle anchor suspension system, which has an original oblique through hole structure. The anchor can not only fix one end of the suspension wire to the pedicle of the inferior vertebra, but also, through the design of the oblique through hole, the anchor can be rotated and locked in the operation of the pedicle to pull and adjust the suspension. The tension of the suspension wire. In addition, after the operation is completed, the top of the anchor will only slightly protrude, even flush with the surface of the pedicle, allowing the patient’s Foreign body sensation and discomfort are minimized.
本創作之再一目的是提供一種適用於經椎板椎弓根錨釘懸吊系統的零件組,其包括了醫師執行本創作的經椎板椎弓根錨釘懸吊系統的手術時所需使用到的工具與預先半組裝完成的零件,以便利與加速醫師執行手術的過程。 Another purpose of this creation is to provide a set of parts suitable for the translaminar pedicle anchor suspension system, which includes what the doctor needs when performing the operation of the translaminar pedicle anchor suspension system. The tools and pre-assembled parts are used to facilitate and speed up the surgeon’s operation.
為達上述之目的,本創作揭露了一種經椎板椎弓根錨釘懸吊系統(Translaminar Pedicle Anchor Suspension System;簡稱T-PAS系統),可供設置於至少包括有一上節椎骨(Upper Vertebral Body)及一下節椎骨(Lower Vertebral Body)的一脊柱(Spine)上;該T-PAS系統包括有:至少一錨釘(Anchor)、至少一墊片(Washer)、以及至少一懸吊線(Suspension Wire)。錨釘是固定於該下節椎骨的一椎弓根(Pedicle)處。墊片是位於該上節椎骨的一椎板(Lamina)處。懸吊線是連結於該錨釘與該墊片之間,並藉由該錨釘與該墊片而分別固定於該下節椎骨的該椎弓根與該上節椎骨的該椎板;並且,該懸吊線具有一預定張力,可將該下節椎骨藉由該懸吊線懸吊於該上節椎骨。 To achieve the above-mentioned purpose, this creation discloses a translaminar pedicle anchor suspension system (Translaminar Pedicle Anchor Suspension System; T-PAS system for short), which can be installed in at least one upper vertebra (Upper Vertebral Body). ) And a spine of the Lower Vertebral Body; the T-PAS system includes: at least one anchor (Anchor), at least one gasket (Washer), and at least one suspension wire (Suspension Wire) ). The anchor is fixed at a pedicle of the inferior vertebra. The spacer is located at a lamina (Lamina) of the superior vertebra. The suspension wire is connected between the anchor and the washer, and is respectively fixed to the pedicle of the lower vertebra and the lamina of the upper vertebra by the anchor and the washer; and, The suspension wire has a predetermined tension, and the lower vertebra can be suspended from the upper vertebra through the suspension wire.
於一實施例中,該上節椎骨及該下節椎骨分別各包括有:該椎板、以及兩該椎弓根其分別位於該椎板的左、右側;於該上節椎骨的該椎板設有貫穿於該椎板的左、右兩側表面的一通孔(tunnel)。 In one embodiment, the upper vertebra and the lower vertebra each include: the vertebral plate and two pedicles which are respectively located on the left and right sides of the vertebral plate; and the vertebral plate of the upper vertebra A through hole (tunnel) penetrating through the left and right sides of the vertebral plate is provided.
於一實施例中,該至少一錨釘的數量為兩個,分別設置於該下節椎骨的兩個該椎弓根處;該至少一墊片的數量為兩個,分別位於該上節椎骨的該椎板的該通孔的左、右兩端處;該至少一懸吊線的數量為兩條;其中之一該懸吊線的一端是固定於位在左側的該椎弓根上的該錨釘、另一端是由該上節椎骨的該椎板左側先向右穿過該通孔後再結合於位在該通孔右端的該墊片上;另一該懸吊線的一端是固定於位在右側的該椎弓根上的該錨釘、另一端是由該上節椎骨的該椎板右側先向左穿過該通孔後再結合於位在該通孔左端的該墊片上。 In one embodiment, the number of the at least one anchor is two, which are respectively disposed at the two pedicles of the inferior vertebra; the number of the at least one spacer is two, which are respectively located on the upper vertebra At the left and right ends of the through hole of the vertebral plate; the number of the at least one suspension wire is two; one end of the suspension wire is the anchor fixed on the pedicle on the left side , The other end is from the left side of the vertebral plate of the superior vertebrae first through the through hole to the right and then combined with the spacer located at the right end of the through hole; the other end of the suspension wire is fixed at the The anchor on the pedicle on the right side and the other end of the vertebral plate of the superior vertebra pass through the through hole from the right side to the left before being combined with the washer at the left end of the through hole.
於一實施例中,該T-PAS系統更包括一鉚套塞置於該通孔內。 In one embodiment, the T-PAS system further includes a riveting plug placed in the through hole.
於一實施例中,該懸吊線是人工韌帶(Artificial Ligament);該錨釘是一具外螺紋的螺釘(Screw);該墊片的一長度是大於該通孔的孔徑。 In one embodiment, the suspension wire is an artificial ligament; the anchor is a screw with an external thread; and a length of the spacer is greater than the aperture of the through hole.
於一實施例中,該錨釘具有沿一中心軸延伸的一狹長柱體、設置於該柱體外表面的一外螺紋、設置於該柱體的一頂端處的一套合結構、以及貫穿該柱體的一斜向貫穿孔;其中,該斜向貫穿孔穿過該中心軸、且該貫穿孔的兩端孔口分別稱為上孔口及下孔口,該上孔口與該柱體的該頂端之間的距離小於該下孔口與該柱體的該頂端之間的距離;該斜向貫穿孔可供該懸吊線穿過,使該錨釘被套掛於該懸吊線上;該套合結構可供與一螺絲起子結合,並藉由操作該螺絲起子來帶動該錨釘以該中心軸為軸進行旋轉,進而把該錨釘鎖入固定於該椎弓根處。 In one embodiment, the anchor has a long and narrow cylinder extending along a central axis, an external thread provided on the outer surface of the cylinder, a fitting structure provided at a top end of the cylinder, and passing through the An oblique through hole of the cylinder; wherein the oblique through hole passes through the central axis, and the two ends of the through hole are respectively called the upper orifice and the lower orifice, the upper orifice and the cylinder The distance between the top ends of the column is smaller than the distance between the lower opening and the top end of the column; the oblique through hole allows the suspension wire to pass through, so that the anchor is hung on the suspension wire; the The sleeved structure can be combined with a screwdriver, and by operating the screwdriver, the anchor is driven to rotate around the central axis, and the anchor is locked and fixed at the pedicle.
於一實施例中,設置於該錨釘的該柱體外表面的該外螺紋包括有一較小間距螺牙部以及一較大間距螺牙部;該較小間距螺牙部是設置於較鄰近該柱體的該頂端處、而該較大間距螺牙部則是設置於較遠離該柱體的該頂端處。 In one embodiment, the external thread provided on the outer surface of the cylinder of the anchor includes a threaded portion with a smaller pitch and a threaded portion with a larger pitch; the threaded portion with a smaller pitch is arranged closer to the The top end of the column and the larger-spaced screw part are arranged at the top end farther from the column.
於一實施例中,該懸吊線是對折成一雙線併排結構並具有位於該對折處的一頭部封閉端以及遠離該對折處的一尾部開放端;把該懸吊線穿過該斜向貫穿孔的方式,是把該懸吊線的該頭部封閉端由該上孔口穿入該斜向貫穿孔中後、再把該懸吊線的該頭部封閉端由該下孔口拉出該斜向貫穿孔外,同時,該懸吊線的該尾部開放端依然保持暴露於該上孔口的外面。 In one embodiment, the suspension wire is folded into a double-line side-by-side structure and has a closed head end at the double fold and an open tail end away from the double fold; the suspension wire is passed through the oblique through hole The method is to pass the closed end of the head of the suspension wire through the upper orifice into the oblique through hole, and then pull the closed end of the head of the suspension wire out of the oblique through hole from the lower opening. Outside the through hole, at the same time, the open end of the tail of the suspension wire remains exposed to the outside of the upper hole.
於一實施例中,將該懸吊線結合於該墊片的方式,是把該懸吊線的該頭部封閉端由該錨釘的該下孔口拉出該斜向貫穿孔外後、先把該懸吊線的該頭部封閉端穿過該上節椎骨的該椎板的該通孔後、再把該懸吊線的該頭部封閉端套置於該墊片的一桿部;之後,從該懸吊線的該尾部開放端施加一拉扯力,可以讓該墊片抵頂住該該上節椎骨的該椎板的該通孔外部,達到把該懸吊線的該頭部封閉端結合並固定於該上節椎骨的該椎板的功效。 In one embodiment, the method of connecting the suspension wire to the gasket is to pull the closed end of the head of the suspension wire out of the oblique through hole from the lower hole of the anchor, and then first After the closed end of the head of the suspension wire passes through the through hole of the lamina of the superior vertebra, the closed end of the head of the suspension wire is placed on a rod of the washer; A pulling force is applied to the open end of the tail of the suspension wire, so that the washer can press against the outside of the through hole of the vertebral plate of the superior vertebra, so as to combine and fix the closed end of the head of the suspension wire The effect of the lamina on the upper vertebra.
於一實施例中,將該錨釘固定於該下節椎骨的該椎弓根的方式,是把該懸吊線的該頭部封閉端由該錨釘的該下孔口拉出該斜向貫穿孔外後,先把該錨釘一部份鎖入該下節椎骨的該椎弓根,使得該錨釘的該下孔口貼近但還暴露在該下節椎骨的該椎弓根外部表面;此時,先從該懸吊線的該尾部開放端施加一拉扯力使得該懸吊線暫時具有一相對較小的第一 張力;然後,將該錨釘繼續鎖入該下節椎骨的該椎弓根,使得該錨釘的該下孔口埋入該下節椎骨的該椎弓根內部,同時並把該懸吊線纏繞於該錨釘外表面且夾置於該錨釘外表面與該下節椎骨的該椎弓根內部;除了可把該懸吊線結合並固定於該下節椎骨的該椎弓根處之外、更可以進一步拉扯該懸吊線並使得該懸吊線達到並保持在一相對較大的第二張力;該第二張力就是該預定張力、且是大於該第一張力。 In one embodiment, the method of fixing the anchor to the pedicle of the inferior vertebra is to pull the closed end of the head of the suspension wire out of the lower hole of the anchor to penetrate the obliquely After the hole is outside, first lock a part of the anchor into the pedicle of the inferior vertebra, so that the inferior orifice of the anchor is close to but still exposed on the outer surface of the pedicle of the inferior vertebra; At this time, first apply a pulling force from the open end of the tail of the suspension wire so that the suspension wire temporarily has a relatively small first Tension; Then, continue to lock the anchor into the pedicle of the inferior vertebra, so that the inferior orifice of the anchor is buried in the pedicle of the inferior vertebra, and the suspension wire is wound at the same time On the outer surface of the anchor and clamped between the outer surface of the anchor and the inside of the pedicle of the lower vertebra; except that the suspension wire can be combined and fixed at the pedicle of the lower vertebra, It is further possible to further pull the suspension wire and make the suspension wire reach and maintain a relatively large second tension; the second tension is the predetermined tension and is greater than the first tension.
為達上述之目的,本創作還揭露了一T-PAS系統的零件組,其包括:至少一錨釘、至少一墊片、至少一懸吊線、一螺絲起子以及一張力計。錨釘可被固定於該下節椎骨的一椎弓根處。墊片可被設置於該上節椎骨的一椎板處。懸吊線可用於連結該錨釘與該墊片,並藉由該錨釘與該墊片而將該懸吊線分別固定於該下節椎骨的該椎弓根與該上節椎骨的該椎板;並且,該懸吊線已預先組合於該錨釘上。螺絲起子可供結合於該錨釘,並藉由操作該螺絲起子來把該錨釘鎖入固定於該椎弓根處。張力計用於量測該懸吊線的張力。 To achieve the above-mentioned purpose, this creation also discloses a T-PAS system component set, which includes: at least one anchor, at least one washer, at least one suspension wire, a screwdriver, and a force gauge. The anchor can be fixed at a pedicle of the inferior vertebra. The spacer can be arranged at a lamina of the superior vertebra. The suspension wire can be used to connect the anchor and the washer, and the suspension wire is respectively fixed to the pedicle of the lower vertebra and the lamina of the upper vertebra by the anchor and the washer; In addition, the suspension wire has been assembled on the anchor nail in advance. A screwdriver can be combined with the anchor, and the anchor can be locked and fixed at the pedicle by operating the screwdriver. Tensiometer is used to measure the tension of the suspension wire.
10:脊柱 10: Spine
11:上節椎骨 11: Upper vertebra
12:下節椎骨 12: Lower vertebra
111、121:椎板 111, 121: lamina
112、113、122、123:椎弓根 112, 113, 122, 123: pedicle
114:通孔 114: Through hole
20:T-PAS系統 20: T-PAS system
21、41、42、43、44、45:錨釘 21, 41, 42, 43, 44, 45: anchor
211、421、431:柱體 211, 421, 431: cylinder
212、432:螺紋 212, 432: Thread
2121、2122:螺牙部 2121, 2122: Thread part
213、430:頂端 213, 430: Top
214:套合結構 214: fit structure
215、411、434、435、443、453:貫穿孔 215, 411, 434, 435, 443, 453: through holes
2151、2152、4431、4432:孔口 2151, 2152, 4431, 4432: Orifice
22、31、32:墊片 22, 31, 32: Gasket
221、321:桿部 221, 321: pole
23:懸吊線 23: Suspended wire
231:封閉端 231: closed end
231a、231b、231b’:懸吊線的部分 231a, 231b, 231b’: the part of the suspension wire
2311、2312:線段 2311, 2312: line segment
2319:貼靠點 2319: Snap Point
232、232a、232b:開放端 232, 232a, 232b: open end
239:繩結 239: Knot
24:鉚套 24: riveting sleeve
311:貫穿孔 311: Through hole
312:末端 312: end
322:槽孔 322: Slot
422、433:沈孔 422, 433: Counterbore
423:塞蓋 423: plug cover
441、451:連桿固定架 441, 451: connecting rod fixing frame
442、452:容置座 442, 452: accommodating seat
50:習知脊椎固定器 50: Known spinal fixator
51:錨釘 51: Anchor
52:連結桿 52: connecting rod
90:中心軸 90: central axis
91:鑽孔工具 91: Drilling tool
92:螺絲起子 92: screwdriver
921:握把部 921: Grip
922:長桿部 922: long pole
923:起子頭端 923: Screwdriver Tip
924:上掛架 924: upper pylon
925:下掛架 925: lower rack
93:張力器 93: Tensioner
94:勾子 94: hook
95:剪刀 95: Scissors
96:手指推銼器 96: Finger Push Filer
961:握把部 961: Grip
962:長桿部 962: long pole
963:椎狀銼頭 963: Cone-shaped file head
9631:尖椎端 9631: Pointed Vertebral End
9632:受壓端 9632: Compressed end
圖一A及圖一B分別為本創作經椎板椎弓根錨釘懸吊系統裝置於脊柱之相鄰兩椎體上的一實施例的第一視角立體示意圖及第二視角立體示意圖。 Figures 1A and 1B are respectively a first perspective schematic diagram and a second perspective perspective schematic diagram of an embodiment of the creation of a translaminar pedicle anchor suspension system on two adjacent vertebral bodies of the spine.
圖二A及圖二B分別為本創作經椎板椎弓根錨釘懸吊系統裝置於脊柱之相鄰兩椎體上的一實施例的頂視示意圖及左側視示意圖。 Figures 2A and 2B are respectively a schematic top view and a schematic left side view of an embodiment of the creation of a translaminar pedicle anchor suspension system on two adjacent vertebral bodies of the spine.
圖三A至圖三E分別為將本創作經椎板椎弓根錨釘懸吊系統設置於相鄰兩椎體上的一實施例過程的數個步驟的示意圖。 Figures 3A to 3E are schematic diagrams of several steps of an embodiment of the process of installing the translaminar pedicle anchor suspension system on two adjacent vertebral bodies.
圖四A及圖四B分別為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的一實施例的立體示意圖及A-A剖面示意圖。 Figures 4A and 4B are respectively a three-dimensional schematic diagram and a schematic cross-sectional view of A-A of an embodiment of the anchor in the creation of a translaminar pedicle anchor suspension system.
圖五為本創作經椎板椎弓根錨釘懸吊系統中,將懸吊線結合於錨釘的方式的一實施例示意圖。 Figure 5 is a schematic diagram of an embodiment of the method of creating a translaminar pedicle anchor suspension system in which the suspension wire is combined with the anchor.
圖六A及圖六B分別為本創作經椎板椎弓根錨釘懸吊系統中,將 懸吊線結合於墊片的方式的一實施例兩個步驟示意圖。 Figure 6A and Figure 6B are respectively in the creation of the translaminar pedicle anchor suspension system. A schematic diagram of two steps of an embodiment of how the suspension wire is bonded to the gasket.
圖七A及圖七B分別為本創作經椎板椎弓根錨釘懸吊系統中,將錨釘固定於下節椎骨的椎弓根的方式的一實施例兩個步驟示意圖。 Fig. 7A and Fig. 7B are schematic diagrams showing two steps of an embodiment of the method of fixing the anchor to the pedicle of the lower vertebra in the creation of the translaminar pedicle anchor suspension system.
圖八為本創作經椎板椎弓根錨釘懸吊系統中的墊片的另一實施例立體示意圖。 Figure 8 is a three-dimensional schematic diagram of another embodiment of the spacer in the creation of the translaminar pedicle anchor suspension system.
圖九A及圖九B分別為將懸吊線結合於如圖八所示的墊片的方式的兩個步驟示意圖。 Fig. 9A and Fig. 9B are schematic diagrams of two steps of the method of bonding the suspension wire to the spacer as shown in Fig. 8 respectively.
圖十為本創作經椎板椎弓根錨釘懸吊系統中的墊片的再一實施例立體示意圖。 Figure 10 is a three-dimensional schematic diagram of another embodiment of the spacer in the creation of the translaminar pedicle anchor suspension system.
圖十一A為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的另一實施例剖面示意圖。 Figure 11A is a schematic cross-sectional view of another embodiment of the anchor in the creation of a translaminar pedicle anchor suspension system.
圖十一B為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的再一實施例剖面示意圖。 Figure 11B is a schematic cross-sectional view of another embodiment of the anchor in the creation of a translaminar pedicle anchor suspension system.
圖十一C為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的更一實施例剖面示意圖。 Fig. 11C is a schematic cross-sectional view of another embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system.
圖十一D為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的又另一實施例剖面示意圖。 Figure 11D is a schematic cross-sectional view of yet another embodiment of the anchor in the creation of a translaminar pedicle anchor suspension system.
圖十一E為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的再更一實施例剖面示意圖。 Figure 11E is a schematic cross-sectional view of yet another embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system.
圖十二A及圖十二B分別為本創作經椎板椎弓根錨釘懸吊系統中,將錨釘固定於下節椎骨的椎弓根的方式的另一實施例兩個步驟示意圖。 Figures 12A and 12B are respectively two schematic diagrams of another embodiment of the method of fixing the anchor to the pedicle of the lower vertebra in the creation of the translaminar pedicle anchor suspension system.
圖十三A及圖十三B分別為本創作的經椎板椎弓根錨釘懸吊系統搭配習知脊椎固定器使用的兩種實施例的示意圖。 Figure 13A and Figure 13B are schematic diagrams of two embodiments of the created translaminar pedicle anchor suspension system used in conjunction with the conventional spinal fixator.
圖十四為本創作的經椎板椎弓根錨釘懸吊系統的零件組中的螺絲起子的一實施例示意圖。 Figure 14 is a schematic diagram of an embodiment of the screwdriver in the component set of the translaminar pedicle anchor suspension system created.
圖十五為本創作的經椎板椎弓根錨釘懸吊系統的零件組中的手指推銼器的一實施例示意圖。 Figure 15 is a schematic diagram of an embodiment of the finger pusher in the component set of the translaminar pedicle anchor suspension system created.
本創作關於一種經椎板椎弓根錨釘懸吊系統(Translaminar Pedicle Anchor Suspension System;簡稱T-PAS系統),可供應用於椎骨手術。該T-PAS系統使用的零件包括:至少一錨釘,固定於一下節椎骨(Lower Vertebral Segment)的椎弓根(Pedicle);以及至少一人工靭帶(Suspension Ligament),做為懸吊線使用,其一端固定於該錨釘處,另一端是藉由一固定手段固定於該上節椎骨的一椎板(Lamina)處;並且,該懸吊線具有一預定張力,可將該上節椎骨與該下節椎骨兩者藉由該懸吊線予以懸吊。藉此人工韌帶經椎板鑽孔來懸吊上節椎骨,不僅可動態式的穩定(Dynamic Stabilization)脊椎,更可以避免使用傳統骨釘的固定及骨融合(Instrumented fusion)。此一創新的T-PAS系統可以:1、縮短手術時間;2、降低神經傷害之風險;3、減少出血;4、維持椎骨的活動度;5、術後腰部感覺自然;及6、理論上可以避免因內固定及融合所造成臨近節的加速退化(Acclerated Degeneration of Adjacent Segments),而造成短期內需要再度接受手術。本創作T-PAS系統的適應症與適用範圍包括了(但不侷限於):單節或多節關節狹窄症、腰椎狹窄症、腰椎滑脫等等。本創作T-PAS系統可以應用於病人的首次手術,預防交界處狹窄,也可以是交界狹窄處的再次手術。 This creation is about a translaminar pedicle anchor suspension system (Translaminar Pedicle Anchor Suspension System; T-PAS system for short), which can be used in vertebral surgery. The parts used in the T-PAS system include: at least one anchor, a pedicle fixed to the lower vertebrae (Lower Vertebral Segment); and at least one artificial ligament (Suspension Ligament), used as a suspension wire, which One end is fixed to the anchor, and the other end is fixed to a lamina (Lamina) of the superior vertebra by a fixing means; and the suspension wire has a predetermined tension, which can connect the superior vertebra and the inferior vertebra. Both segment vertebrae are suspended by the suspension wire. The artificial ligament is drilled through the lamina to suspend the upper vertebrae, which not only dynamically stabilizes the spine, but also avoids the use of traditional bone nail fixation and bone fusion (Instrumented fusion). This innovative T-PAS system can: 1. shorten the operation time; 2. reduce the risk of nerve damage; 3. reduce bleeding; 4. maintain the mobility of the vertebrae; 5. feel natural in the waist after the operation; and 6. theoretically It can avoid the accelerated degeneration of adjacent segments (Acclerated Degeneration of Adjacent Segments) caused by internal fixation and fusion, which will cause the need to undergo surgery again in the short term. The indications and scope of application of the T-PAS system of this creation include (but are not limited to): single or multi-segment joint stenosis, lumbar spine stenosis, lumbar spondylolisthesis, etc. The T-PAS system of this invention can be applied to the patient's first operation to prevent stenosis of the junction, and it can also be used for the second operation of the stenosis of the junction.
為了能更清楚地描述本創作所提出之經椎板椎弓根錨釘懸吊系統及其錨釘與零件組,以下將配合圖式詳細說明之。 In order to more clearly describe the translaminar pedicle anchor suspension system and its anchors and parts set proposed in this creation, the following will be described in detail with the drawings.
請參閱圖一A、圖一B、圖二A及圖二B,分別為本創作經椎板椎弓根錨釘懸吊系統裝置於脊柱之相鄰兩椎體上的一實施例的第一視角立體示意圖、第二視角立體示意圖、頂視示意圖及左側視示意圖。 Please refer to Figure 1A, Figure 1B, Figure 2A and Figure 2B, respectively, which are the first of an embodiment of the creation of a translaminar pedicle anchor suspension system on two adjacent vertebral bodies of the spine Perspective three-dimensional schematic diagram, second perspective three-dimensional schematic diagram, top-view schematic diagram, and left-side schematic diagram.
本創作的經椎板椎弓根錨釘懸吊系統(Translaminar Pedicle Anchor Suspension System;簡稱T-PAS系統),可供設置於至少包括有一上節椎骨11(Upper Vertebral Body)及一下節椎骨12(Lower Vertebral Body)的一脊柱10(Spine)上。該上節椎骨11及該下節椎骨12分別各包括有:該椎板111、121、以及兩該椎弓根112、113、122、123其分別位於其椎板111、121的左、右側。於本實施例中,T-PAS系統20是以設置於脊柱10的腰椎(Lumbar Spine)第L4與L5節椎骨(Vertebra)上為例來進行說明,但也可以是設置於不同位置的椎骨,或是用於連結、懸吊更多數量(例如三層或更多層)的椎骨。
The Translaminar Pedicle Anchor Suspension System (T-PAS system for short) created by this creation can be installed at least including an Upper Vertebral Body 11 (Upper Vertebral Body) and a lower vertebra 12 ( On a spine 10 (Spine) of Lower Vertebral Body). The
如圖一A、圖一B、圖二A及圖二B所示,本創作的經椎板椎
弓根錨釘懸吊系統(T-PAS系統)20包括有:至少一錨釘21(Anchor)、至少一墊片22(Washer)、以及至少一懸吊線23(Suspension Wire)。該錨釘21是固定於該下節椎骨12的一椎弓根122(Pedicle)處。該墊片22是位於該上節椎骨11的一椎板111(Lamina)處,通常是固定於椎板111具有最大強度或厚度的位置處。本創作所述將懸吊線23一端固定於該上節椎骨的一椎板(Lamina)處的固定手段的一實施例是藉由該墊片22來達成。該懸吊線23是連結於該錨釘21與該墊片22之間,並藉由該錨釘21與該墊片22而分別固定於該下節椎骨12的該椎弓根122與該上節椎骨11的該椎板111;並且,該懸吊線23具有一預定張力,可將該下節椎骨12藉由該懸吊線23懸吊於該上節椎骨11下方。
As shown in Figure 1A, Figure 1B, Figure 2A, and Figure 2B, the translaminar vertebra of this creation
The pedestal anchor suspension system (T-PAS system) 20 includes at least one anchor 21 (Anchor), at least one washer 22 (Washer), and at least one suspension wire 23 (Suspension Wire). The
於本實施例中,於該上節椎骨11的該椎板111設有貫穿於該椎板111的左、右兩側表面的一通孔114(tunnel)。該至少一錨釘21的數量為兩個,分別設置於該下節椎骨12的兩個該椎弓根122、123處。該至少一墊片22的數量為兩個,分別位於該上節椎骨11的該椎板111的該通孔114的左、右兩端處。該至少一懸吊線23的數量為兩條;其中之一該懸吊線23的一端是固定於位在左側的該椎弓根122上的該錨釘21、另一端是由該上節椎骨11的該椎板111左側先向右穿過該通孔114後再結合於位在該通孔114右端的該墊片22上;另一該懸吊線23的一端是固定於位在右側的該椎弓根123上的該錨釘21、另一端是由該上節椎骨11的該椎板111右側先向左穿過該通孔114後再結合於位在該通孔114左端的該墊片22上。
In this embodiment, the
於一實施例中,本創作的T-PAS系統20更包括一中空的鉚套24塞置於該通孔114內,並使懸吊線23穿過該鉚套24。或者,也可以不設置鉚套24,而是使用一挫刀或本創作獨創的手指推銼器來將椎板111上的通孔114的內表面及兩端邊緣加以圓滑化,以避免椎板111通孔114的銳利邊緣或表面割傷懸吊線23、或是因為懸吊線23的高張力導致通孔114邊緣碎裂。
In one embodiment, the T-
於本實施例中,該懸吊線23是人工韌帶(Artificial Ligament);該錨釘21是一具外螺紋的螺釘(Screw;或稱骨釘);該墊片22的一長度是大於該通孔114的孔徑,因此可抵頂在椎板111通孔114的外表面,不會因為懸吊線23的張力而掉入通孔114內。錨釘21與墊片22的材質可以是鈦合金、或陶瓷、或其他不會造成人體過敏或排斥的材質所製成。
In this embodiment, the
請參閱圖三A至圖三E,分別為將本創作經椎板椎弓根錨釘 懸吊系統設置於相鄰兩椎體上的一實施例過程的數個步驟的示意圖。 Please refer to Figure 3A to Figure 3E, respectively for the creation of translaminar pedicle anchors A schematic diagram of several steps of an embodiment process in which the suspension system is installed on two adjacent vertebral bodies.
如圖三A所示,當欲將本創作T-PAS系統20設置於相鄰兩椎體11、12上時,首先使用一鑽孔工具91在下節椎骨12的左側椎弓根122鑽一預定深度的細孔。接著,將已預先連結、組裝了懸吊線23的錨釘21藉由一螺絲起子92來把該錨釘21鎖入並固定於該椎弓根122處。此時,連結於錨釘21上的該懸吊線23尚未具有張力而是處於鬆弛狀態。之後,如圖三B所示,將懸吊線23較遠離錨釘21的一端,從上節椎骨11的椎板111左側面向右穿過位於該上節椎骨11的椎板111的該通孔114(或鉚套24)並伸出該上節椎骨11的椎板111的右側面後、組裝於該墊片22上。此時,墊片22尚未抵靠於椎板111表面,且連結於錨釘21與墊片22之間的該懸吊線23仍處於鬆弛狀態。再來,如圖三C所示,藉由自椎板111左側向左拉扯懸吊線23使得墊片22抵靠於上節椎骨11的椎板111的右側面,並以一張力器93量測懸吊線23的張力達到一預定張力值後,將懸吊線23末端固定並去除多餘的懸吊線23。然後,重複前述圖三A至圖三C的相同方式,如圖三C、圖三D、圖三E所示,在下節椎骨12的右側椎弓根123也鎖入一已預先穿設了懸吊線23的錨釘21(如圖三C),並將懸吊線23自右向左穿過該上節椎骨11的椎板111的該通孔114(或鉚套24)後結合於位在椎板111左側的另一墊片22(如圖三D),並在拉扯懸吊線23使其達到該預定張力值後將懸吊線23末端固定並去除多餘的懸吊線23(如圖三E)。藉此,便可完成將下節椎骨12經由懸吊線23來懸吊於上節椎骨11下方的本創作T-PAS系統20的設置。本創作T-PAS系統20,可將下節椎骨經由懸吊線來懸吊於上節椎骨下方,不僅可穩定脊柱的結構強度,且更能減少手術所需骨釘數量、縮短手術時間、降低手術風險、維持術後各椎體應有之活動力、降低病人術後的異物、不適、疼痛與僵硬感、以及加速病人術後復原的時程。
As shown in Figure 3A, when the T-
於上述的實施例中,是先完成一側(左側)之錨釘21與懸吊線23的裝置後、再開始另一側(右側)錨釘21與懸吊線23的裝置。但是,於本創作的另一實施例中,兩側的錨釘21與懸吊線23也可以同步進行設置。具體來說,位於下節椎骨12的左、右兩側椎弓根122、123的兩隻錨釘21也可以一起在圖三A的步驟中就先都依序鎖入固定左、右兩側椎弓根122、123;之後,連結於兩錨釘21上的兩懸吊線23在圖三B的步驟中都依序
被穿過位於該上節椎骨11的椎板111的該通孔114(或鉚套24)並伸出該上節椎骨11的椎板111的另一側面後、組裝於相對應的墊片22上;之後,藉由分別拉扯兩懸吊線23使得兩墊片22分別抵靠於上節椎骨11的椎板111的兩相對側面,並以張力器93量測兩懸吊線23的張力達到一預定張力值後,再將兩懸吊線23末端固定並去除多餘的懸吊線23;同樣可完成將下節椎骨12經由懸吊線23來懸吊於上節椎骨11下方的本創作T-PAS系統20的設置。
In the above-mentioned embodiment, the installation of the
請參閱圖四A及圖四B所示,分別為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的一實施例的立體示意圖及A-A剖面示意圖。於一實施例中,該錨釘21具有沿一中心軸90延伸的一狹長柱體211、設置於該柱體211外表面的一外螺紋212、設置於該柱體211的一頂端213處的一套合結構214、以及貫穿該柱體211的一斜向貫穿孔215。其中,該斜向貫穿孔215穿過該中心軸90、且該貫穿孔215的兩端孔口分別稱為上孔口2151及下孔口2152,該上孔口2151與該柱體211的該頂端213之間的距離hb小於該下孔口2152與該柱體211的該頂端213之間的距離(ha+hb),換言之,兩端孔口2151、2152於該中心軸90方向上的間距為ha。該斜向貫穿孔215可供該懸吊線23穿過,使該錨釘21被套掛於該懸吊線23上。該套合結構214可供與螺絲起子92的前端結合,並藉由操作該螺絲起子92來帶動該錨釘21以該中心軸90為軸進行旋轉,進而把該錨釘21鎖入固定於該椎弓根122處。於本實施例中,該套合結構214是一個內六角凹座,其輪廓與尺寸是對應於螺絲起子92前端的六角凸塊。設置於該錨釘21的該柱體211外表面的該外螺紋212包括有一較小間距螺牙部2121以及一較大間距螺牙部2122。該較小間距螺牙部2121是設置於較鄰近該柱體211的該頂端213處,且具有相對較低的螺牙高度及較小的螺牙間距;而該較大間距螺牙部2122則是設置於較遠離該柱體211的該頂端213處且具有相對較高的螺牙高度及較大的螺牙間距。並且,該上孔口2151及下孔口2152兩者都是位於較鄰近該柱體211的該頂端213處,所以兩孔口2151、2152都是位於該較小間距螺牙部2121處。於本創作中,可預先生產數種不同尺寸、規格的錨釘21,以適應不同病人的不同脊柱尺寸或結構。一般來說,本創作T-PAS系統20所使用的錨釘21,如圖四B所示,其柱體211的外徑(直徑)d1是介於3.5mm-6.5mm之間、總長度H是介於20mm-35mm之間。於本實施例中,該上孔口2151與該柱體211的該頂端213
之間的距離hb可介於3mm-7mm之間,兩孔口2151、2152於該中心軸90方向上的間距為ha可介於2mm-4mm之間;較小間距螺牙部2121的高度h1可介於5mm-11mm之間,而較大間距螺牙部2122的高度h2則可介於14mm-30mm之間。
Please refer to Figure 4A and Figure 4B, which are respectively a three-dimensional schematic diagram and A-A cross-sectional schematic diagram of an embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system. In one embodiment, the
於圖四A及圖四B所示的實施例中,該錨釘21的外螺紋212之所以要設計成鄰近該柱體211的該頂端213的較小間距螺牙部2121以及遠離頂端213的較大間距螺牙部2122,主要原因有二:(1)椎弓根122處的骨骼離表面處硬度與密度相對較高、而深入內部處的骨骼硬度與密度則相對較低;(2)自錨釘21的下孔口2152以上的區域(也就是下孔口2152與頂端213之間的區域),在鎖入時將會把懸吊線23纏繞於錨釘21外表面並一起鎖入椎弓根122的骨骼中。所以,在錨釘21柱體211的近頂端213處使用具有較小螺牙高度的較小間距螺牙部2121,不僅可降低錨釘21螺牙破壞椎弓根122表面的機率、提高鎖合緊密度、更大幅減少錨釘21螺牙刮傷或破壞懸吊線23的風險。然而,在另一實施例中,該錨釘21的外螺紋212也可以設計成:無論是在鄰近頂端213或是遠離頂端213處,其螺牙高度與間距都保持相同。而在又另一實施例中,該錨釘21的外螺紋212也可以設計成:鄰近頂端213處的螺牙高度相對較低、但間距(pitch)保持相同;相對地,在遠離頂端213處的螺牙高度則相對較高、但間距仍保持相同,這樣的設計同樣可具有降低錨釘21螺牙破壞椎弓根122表面的機率、提高鎖合緊密度、及大幅減少錨釘21螺牙刮傷或破壞懸吊線23風險的功效。
In the embodiment shown in FIG. 4A and FIG. 4B, the reason why the
請參閱圖五,為本創作經椎板椎弓根錨釘懸吊系統中,將懸吊線結合於錨釘的方式的一實施例示意圖。於本創作的其中之一實施例中,該懸吊線23的一中間區段是被對折成一雙線併排結構並具有位於該對折處的一頭部封閉端231以及遠離該對折處的一尾部開放端232。把該懸吊線23穿過該斜向貫穿孔215的方式,是把該懸吊線23的該頭部封閉端231由該上孔口2151穿入該斜向貫穿孔215中後、再把該懸吊線23的該頭部封閉端231由該下孔口2152拉出該斜向貫穿孔215外,同時,該懸吊線23的該尾部開放端232依然保持暴露於該上孔口2151的外面。
Please refer to Figure 5, which is a schematic diagram of an embodiment of the method of combining the suspension wire with the anchor in the creation of the translaminar pedicle anchor suspension system. In one of the embodiments of this creation, a middle section of the
請參閱圖六A及圖六B,分別為本創作經椎板椎弓根錨釘懸吊系統中,將懸吊線結合於墊片的方式的一實施例兩個步驟示意圖。於本
創作的其中之一實施例中,將該懸吊線23結合於該墊片22的方式,是先把該懸吊線23的中間區段的該頭部封閉端231由該錨釘21的該下孔口2152拉出該斜向貫穿孔外。之後,藉由一細長的勾子94由右向左穿過上節椎骨11的椎板111的通孔214、並在椎板111左側鉤住懸吊線23的頭部封閉端231後,再把細長的勾子94連同懸吊線23的頭部封閉端231一起向右拉出椎板111的通孔114,因而把該懸吊線23的該頭部封閉端231拉穿過該上節椎骨11的該椎板111的該通孔114(如圖六A)。接著,再把該懸吊線23的該頭部封閉端231套置於該墊片22的一桿部221。套置的方式,是把懸吊線23的該頭部封閉端231的左右兩線段2311、2312分別由墊片22左、右兩側的開口222、223套入墊片22,使得懸吊線23的該頭部封閉端231可以套住該墊片22中間的桿部221。之後,從位於椎板111左側的該懸吊線23的該尾部開放端(本圖未示)施加一拉扯力,可以讓該墊片22抵頂住該上節椎骨11的該椎板111的該通孔214右端口外部表面,達到把該懸吊線23的該頭部封閉端231結合並固定於該上節椎骨11的該椎板111的功效(如圖六B)。於本實施例中,該墊片22的外型類似一”H”字結構,其長度L1及寬度W1都大於椎板111通孔214的孔徑Dh,所以可以卡在通孔214外部不會掉入通孔214中。椎板111通孔214的孔徑Dh可介於1.5mm-5mm之間,墊片22的長度L1可介於6mm-10mm之間、寬度W1可介於6mm-8mm之間、而厚度T則介於0.5mm-2mm之間。於本實施例中,懸吊線23是採用扁平條狀的人工韌帶,其寬度dw可介於1.5mm-4mm之間為較佳。
Please refer to Figure 6A and Figure 6B, which are schematic diagrams of one embodiment of the method of combining the suspension wire with the spacer in the creation of the translaminar pedicle anchor suspension system. Yu Ben
In one of the created embodiments, the method of combining the
請參閱圖七A及圖七B,分別為本創作經椎板椎弓根錨釘懸吊系統中,將錨釘固定於下節椎骨的椎弓根的方式的一實施例示意圖。於本創作的其中之一實施例中,將該錨釘21固定於該下節椎骨12的該椎弓根122的方式,是把該懸吊線23的中間區段的該頭部封閉端231由該錨釘21的該下孔口2152拉出該斜向貫穿孔215外後,先把該錨釘21柱體211一部份(例如較大間距螺牙部)鎖入該下節椎骨12的該椎弓根122,使得該錨釘21的該下孔口2152貼近但還暴露在該下節椎骨12的該椎弓根122外部表面(如圖七A)。此時,先從該懸吊線23左端的該尾部開放端232施加一拉扯力使得該懸吊線23暫時具有一相對較小的第一張力。此第一張力必須小於本創作T-PAS系統完成裝置時的懸吊線23所需的該預定張力。懸吊線23的張力值可藉由
在鎖入錨釘21的過程中操作張力計93來進行量測。然後,當操作螺絲起子92將該錨釘21繼續鎖入該下節椎骨12的該椎弓根122,使得該錨釘21的該下孔口2152逐漸被埋入該下節椎骨12的該椎弓根122內部,同時並把該懸吊線23纏繞於該錨釘21外表面且夾置於該錨釘21外表面與該下節椎骨12的該椎弓根122內部(如圖七B),使得懸吊線23的一端被卡緊、固定於錨釘21與椎弓根122之間;同時,懸吊線23的另一端則是被墊片22固定於上節椎骨11的椎板111的另一側。藉此,除了可把該懸吊線23的一端結合並固定於該下節椎骨12的該椎弓根122處之外、更可以進一步拉扯該懸吊線23並使得該懸吊線23達到並保持在一相對較大的第二張力;該第二張力就是該預定張力、且是大於該第一張力。當張力計93量測到懸吊線23的張力值已達到預定張力時,則可以使用剪刀95或手術刀具把依然暴露於椎弓根122外部的多餘的懸吊線23(尾部開放端232)切斷。同理,位於另一側的錨釘也是以相同的方式與步驟鎖入椎弓根123以及提供預定張力給懸吊線。當完成把錨釘21鎖入椎弓根122操作後,錨釘21的頂端213僅會稍微突出、甚至齊平於椎弓根122表面。本創作T-PAS系統20裝置完成後,只需鎖入兩隻錨釘21在椎弓根122處,且一般來說,錨釘21的頂端213突出於椎弓根122表面之外的高度不會高於5mm,墊片22也是薄片結構且緊貼於椎板表面,不會讓病人感到不適或異物感;此外,由人工韌帶構成的懸吊線23並不會造成病人不舒服或疼痛,確實改善了習知技術的種種缺失。
Please refer to FIG. 7A and FIG. 7B, which are schematic diagrams of an embodiment of the method of fixing the anchor to the pedicle of the lower vertebra in the creation of the translaminar pedicle anchor suspension system. In one of the embodiments of the present creation, the method of fixing the
前述的實施例僅為本創作經椎板椎弓根錨釘懸吊系統的較佳實施例,並非唯一可行的實施例。於本創作中,所述的錨釘與墊片的結構也不侷限於前述各實施例所揭露的結構,而是有其他的可實施結構。 The foregoing embodiment is only a preferred embodiment of the translaminar pedicle anchor suspension system of the present invention, and is not the only feasible embodiment. In this creation, the structure of the anchor and the spacer is not limited to the structure disclosed in the foregoing embodiments, but there are other implementable structures.
例如,請參閱圖八、圖九A及圖九B:其中,圖八為本創作經椎板椎弓根錨釘懸吊系統中的墊片的另一實施例立體示意圖;圖九A及圖九B分別為將懸吊線結合於如圖八所示的墊片的方式的兩個步驟示意圖。於本實施例中,墊片31可以是一細長薄板結構,其具有相對較小的寬度W2及相對較長的長度L2;該寬度W2小於椎板111的通孔114的孔徑Dh(W2<Dh),墊片31的厚度也小於通孔的孔徑Dh,且該長度L2大於椎板111的通孔114的孔徑Dh(L2>Dh)。於墊片31上設置兩個或更多個貫穿孔311,可把懸吊線23依序穿過這些貫穿孔311,達到把懸吊線23結合在墊片31上的
目的。接著,如圖九A所示,將連結有懸吊線23的該墊片31以其細長方向上的末端312對準椎板111的通孔114,利用墊片31的寬度W2與厚度都小於通孔114的孔徑Dh的特性,可將墊片31連同懸吊線23一起穿過椎板111的通孔114至椎板另一側。之後,如圖九B所示,將墊片31轉個角度、並自椎板111左側拉扯懸吊線23,便可以讓墊片31的具有L2長度的細長邊抵靠在椎板111的右側表面上,達到把懸吊線23一端藉由墊片31定位在椎板111的通孔114的右側端的目的。
For example, please refer to Figure 8, Figure 9A and Figure 9B: Figure 8 is a three-dimensional schematic diagram of another embodiment of the spacer in the creation of a translaminar pedicle anchor suspension system; Figure 9A and Figure 9 9B is a schematic diagram of two steps of the method of connecting the suspension wire to the spacer as shown in FIG. 8 respectively. In this embodiment, the
請參閱圖十,為本創作經椎板椎弓根錨釘懸吊系統中的墊片的再一實施例立體示意圖。於本實施例中所示墊片的結構大體上和圖六A所示之墊片幾乎相同、使用方法也類似,其兩者唯一的不同點在於,圖十所示之墊片32上有設置兩個桿部321,並在兩桿部321中間額外形成一槽孔322。此種結構可以讓懸吊線來回穿過該槽孔322並纏繞於兩個桿部321的方式來結合於墊片32,提供更穩固且不易滑移的結合效果。
Please refer to Figure 10, which is a three-dimensional schematic diagram of another embodiment of the spacer in the translaminar pedicle anchor suspension system. The structure of the gasket shown in this embodiment is almost the same as that of the gasket shown in FIG. 6A, and the method of use is similar. The only difference between the two is that the
請參閱圖十一A,為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的另一實施例剖面示意圖。於本實施例中所示錨釘41的結構大體上和圖四A及圖四B所示之錨釘21幾乎相同、使用方法也類似,其兩者唯一的不同點在於,圖十一A所示之錨釘41的貫穿孔411是水平方向的貫穿孔411,其貫穿孔411兩端孔口的高度相同;而非如圖四A及圖四B所示之錨釘21的斜向貫穿孔215是斜向的其兩端孔口2151、2152的高度不同。
Please refer to Figure 11A, which is a schematic cross-sectional view of another embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system. The structure of the
請參閱圖十一B,為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的再一實施例剖面示意圖。於本實施例中,錨釘42的柱體421設有自其頂端沿中心軸方向延伸的一沈孔422,於該沈孔422鄰近頂端處設有內螺牙。懸吊線23的頭部封閉端可以由柱體421頂端穿入此沈孔422,然後,藉由將一具有外螺牙的塞蓋423自柱體421頂端旋轉鎖入該沈孔422,可以把懸吊線23的頭部封閉端夾置並固定於塞蓋423與柱體421頂端沈孔422之間,達到把懸吊線23結合並固定於錨釘42的目的。於本實施例中,由於懸吊線23是以其尾部開放端穿過椎板111之通孔114,所以,將懸吊線23結合於墊片22的方式,是把懸吊線23綁在墊片22的桿部、且至少需打5個繩結239,以確保連結的穩固性。
Please refer to Figure 11B, which is a schematic cross-sectional view of another embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system. In this embodiment, the
請參閱圖十一C,為本創作經椎板椎弓根錨釘懸吊系統中的
錨釘的更一實施例剖面示意圖。於本實施例中,錨釘43同樣具有柱體431以及自柱體431頂端430沿中心軸向下延伸的沈孔433。於柱體431上設置兩個或更多個橫向貫穿孔434、435其貫通於該沈孔433。當把懸吊線由柱體431頂端430穿入此沈孔433後,可以把位於沈孔433內的懸吊線先從其中之一貫穿孔434拉出柱體431外後再由另一貫穿孔435穿入沈孔433,可以讓懸吊線更穩固地結合在錨釘上。此外,設置於柱體431外表面的外螺紋432其螺牙高度與間距保持一致,並無所謂較小間距螺牙部或較大間距螺牙部的差異。
Please refer to Figure 11C, which is part of the translaminar pedicle anchor suspension system in this creation
A schematic cross-sectional view of a further embodiment of the anchor. In this embodiment, the
請參閱圖十一D,為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的又另一實施例剖面示意圖。於本實施例中所示錨釘44的結構大體上和圖四A及圖四B所示之錨釘21幾乎相同、使用方法也類似。於圖十一D所示的實施例中,錨釘44同樣具有沿一中心軸延伸的一狹長柱體、設置於柱體外表面的外螺紋、設置於柱體頂端的一套合結構、以及貫穿該柱體的一斜向貫穿孔443,且該斜向貫穿孔443兩端同樣具有高低落差的上孔口4431與下孔口4432。圖十一D與圖四A所示兩實施例的唯一不同點在於,圖十一D所示之錨釘44的柱體頂端更增設有一U型的連桿固定架441。該連桿固定架441具有一容置座442以供容納一連結桿(圖中未示),使本創作的T-PAS系統可以搭配習知的脊椎固定器來使用。
Please refer to Figure 11D, which is a schematic cross-sectional view of yet another embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system. The structure of the
請參閱圖十一E,為本創作經椎板椎弓根錨釘懸吊系統中的錨釘的再更一實施例剖面示意圖。於本實施例中所示錨釘45的結構大體上和圖十一D所示之錨釘44幾乎相同、使用方法也類似,也同樣具有位在錨釘45的柱體頂端的U型的連桿固定架451及容置座452,其兩者唯一的不同點在於,圖十一E所示之錨釘45的貫穿孔453是水平方向的貫穿孔453,其貫穿孔453兩端孔口的高度相同;而非如圖四A、圖四B或圖十一D所示之錨釘21、44的斜向貫穿孔215、443是斜向的其兩端孔口2151、2152、4431、4432的高度不同。
Please refer to Figure 11E, which is a schematic cross-sectional view of yet another embodiment of the anchor in the creation of the translaminar pedicle anchor suspension system. The structure of the
本創作的T-PAS系統於製造或銷售時,可以把需使用到、且已預先消毒過的工具與預先半組裝完成的零件包裝成零件組來使用,以方便醫師執行手術。於一實施例中,本創作的T-PAS系統的零件組可以包括:數個錨釘、數個墊片、數個懸吊線、一螺絲起子、以及一張力計。錨釘是用於被固定於下節椎骨的椎弓根處。墊片是被設置於上節椎骨的椎板通孔 處。懸吊線是用於連結該錨釘與該墊片,並藉由該錨釘與該墊片而將該懸吊線分別固定於該下節椎骨的該椎弓根與該上節椎骨的該椎板;並且,於此零件組中,該懸吊線已預先組合於該錨釘上。螺絲起子是供結合於該錨釘,並藉由操作該螺絲起子來把該錨釘鎖入固定於下節椎骨的椎弓根處。張力計則用於量測該懸吊線的張力。藉此零件組,可便利與加速醫師執行手術的過程,進而降低手術風險。 The T-PAS system created by this invention can be used and pre-sterilized tools and pre-semi-assembled parts can be packaged into a part group for use when manufacturing or selling, so as to facilitate the surgeon to perform the operation. In one embodiment, the component set of the T-PAS system of the present creation may include: several anchors, several washers, several suspension wires, a screwdriver, and a force gauge. The anchor is used to be fixed to the pedicle of the lower vertebra. The spacer is the through hole of the lamina that is set in the upper vertebra Place. The suspension wire is used to connect the anchor and the spacer, and fix the suspension wire to the pedicle of the inferior vertebra and the lamina of the superior vertebra by the anchor and the spacer, respectively ; And, in this component group, the suspension wire has been pre-assembled on the anchor. A screwdriver is used to be combined with the anchor, and the anchor is locked into the pedicle of the lower vertebrae by operating the screwdriver. Tensiometer is used to measure the tension of the suspension wire. This component set can facilitate and speed up the process of surgeons performing surgery, thereby reducing the risk of surgery.
請參閱圖十二A及圖十二B,分別為本創作經椎板椎弓根錨釘懸吊系統中,將錨釘固定於下節椎骨的椎弓根的方式的另一實施例示意圖。於本創作T-PAS系統中,將錨釘固定於下節椎骨的椎弓根的方式除了如圖七A與圖七B及其相關文字描述所揭露的實施例之外,還可以使用如圖十二A及圖十二B所示的另一實施例來操作。於圖十二A及圖十二B所示的實施例中,把該懸吊線23穿過錨釘21的斜向貫穿孔215的方式,是把該懸吊線23一端由該下孔口2152穿入該斜向貫穿孔215並由該上孔口2151拉出該斜向貫穿孔215外,使該懸吊線23的兩端232a、232b(開放端)分別伸出該下孔口2152與該上孔口2151之外。其中,該懸吊線23的中間區段以及該頭部封閉端231都是位於從該上孔口2151拉出的該懸吊線23的部分。如圖十二A所示,將該錨釘21固定於該下節椎骨的該椎弓根122的方式,是使用螺絲起子92先把該錨釘21一部份鎖入該下節椎骨的該椎弓根122,使得該錨釘的該下孔口2152連同從該下孔口2152延伸出的該懸吊線23的該尾部開放端232a一起被鎖入並夾置於該錨釘21外表面與該下節椎骨的該椎弓根122內部之間,但是,此時該錨釘21的該上孔口2151以及自該上孔口2151延伸出的該懸吊線23的部分231a、231b都還暴露在該下節椎骨的該椎弓根122外部。接著,把該懸吊線23還暴露在外部的另一該尾部開放端232b自該上孔口2151處先從下方鑽過自該上孔口2151延伸出的該懸吊線23的部分231a後,再對還暴露在外部的該另一尾部開放端232b施加一拉扯力使得該懸吊線暫時具有一相對較小的第一張力。亦即,如圖十二A右下區域B所顯示的是上孔口2151處的部分放大圖所示,讓該懸吊線23的兩部分231a、231b的貼靠點2319恰好卡在該上孔口2151和該椎弓根122表面的交會處、且懸吊線23的部分231a是接觸且壓迫在懸吊線23的另一部份231b的上面。然後,如圖十二B所示,以螺絲起子92將該錨釘21繼續鎖入該下節椎骨的該椎弓根122,使得該
錨釘21的該上孔口2151埋入該下節椎骨的該椎弓根122內部,同時並把自該上孔口2151延伸出的該懸吊線23的部分231a連同還暴露在外部的該另一尾部開放端232b所連結的另一部份231b’都一起纏繞於該錨釘21外表面且夾置於該錨釘21外表面與該下節椎骨的該椎弓根122內部,直到由張力計93所量測到懸吊線23的兩部分231a、231b的張力達到一相對較大的第二張力值為止。除了可把該懸吊線23的兩尾部開放端232a、232b都結合並固定於該下節椎骨的該椎弓根122處之外、更可以進一步拉扯該懸吊線23並使得該懸吊線23達到並保持在相對較大的第二張力。該第二張力就是該預定張力、且是大於該第一張力。之後,再使用剪刀95或其他手術刀具從懸吊線23的兩個尾部開放端232a、232b處把多餘的懸吊線剪斷移除。於一實施例中,當把懸吊線23的另一部份231b自該上孔口2151處從下方鑽過該懸吊線23部分231a時,還可以再額外把懸吊線23的另一部份231b纏繞在錨釘21的外表面一圈,以確保之後以螺絲起子92將該錨釘21繼續鎖入該下節椎骨的該椎弓根122時也會把該另一部份231b’都一起纏繞並夾置於該錨釘21外表面與該下節椎骨的該椎弓根122內部。
Please refer to Figure 12A and Figure 12B, which are schematic diagrams of another embodiment of the method of fixing the anchor to the pedicle of the lower vertebra in the creation of the translaminar pedicle anchor suspension system. In the T-PAS system of this creation, the method of fixing the anchor to the pedicle of the inferior vertebra can be used in addition to the embodiments disclosed in Figure 7A and Figure 7B and related text descriptions. Another embodiment shown in Twelve A and Figure Twelve B operates. In the embodiment shown in FIGS. 12A and 12B, the way to pass the
請參閱圖十三A及圖十三B,分別為本創作的經椎板椎弓根錨釘懸吊系統搭配習知脊椎固定器使用的兩種實施例的示意圖。就算欲進行手術的病人先前即已曾開過刀並安裝過習知的脊椎固定器,但現在又有再次進行脊椎手術的需求時,仍可以在後續的手術中設置本創作的T-PAS系統來和舊有的脊椎固定器配合使用。如圖十三A所示,一般來說,典型的習知脊椎固定器50會包含至少四隻錨釘51以及兩根連結桿52,其中,於上節椎骨與下節椎骨的兩側椎弓根處分別釘入一個錨釘51,且在上、下節椎骨同側的兩錨釘51之間以一連結桿52加以連接。有時,還會在這兩根連結桿52或這四根錨釘51上增設一固定板(圖中未示)來強化固定效果。於圖十三A所示的實施例中,本創作的T-PAS系統可以選用尺寸較小的兩根本創作的錨釘21分別鎖固在安裝了習知脊椎固定器50位於上節椎骨之椎弓根的錨釘51的一旁鄰近處。並且,在更上一節椎骨的椎板的通孔兩端分別設置本創作T-PAS系統的墊片22,且分別以具有預定張力的懸吊線23經由椎板上的通孔來連接一側錨釘21與位於另一側的墊片22,達到在不影響現存習知脊椎固定器50的功能的前提下,在上節椎骨與更上節椎骨設置本創作T-PAS系
統將其兩者懸吊的功效。
Please refer to Figure 13A and Figure 13B, which are schematic diagrams of two embodiments of the created translaminar pedicle anchor suspension system used in conjunction with the conventional spinal fixator. Even if the patient who wants to undergo surgery has previously had surgery and installed the conventional spinal fixator, but now there is a need for another spinal surgery, the T-PAS system of this creation can still be set up in the subsequent surgery Comes to work with the old spinal fixator. As shown in Figure 13A, generally speaking, a typical conventional
如圖十三B所示,將本創作T-PAS系統搭配習知脊椎固定器50使用的另一種方式,是把習知脊椎固定器50中位於上節椎骨的左右兩根習知錨釘都拆下、並換裝為如圖十一D(或圖十一E)所示的頂端具有U型的連桿固定架441(或451)與容置座442(或452)的錨釘44(或45)。並且,在更上一節椎骨的椎板的通孔兩端分別設置本創作T-PAS系統的墊片22,且分別以具有預定張力的懸吊線23經由椎板上的通孔來連接一側錨釘44(或45)與位於另一側的墊片22。由於位於上節椎骨的本創作的錨釘44(或45)也具有連桿固定架441(或451)與容置座442(或452),所以,原本已裝置的習知脊椎固定器50的連結桿52可以直接結合並固定於本創作的錨釘44(或45)上。因此,可在不影響現存習知脊椎固定器50的功能的前提下,在上節椎骨與更上節椎骨設置本創作T-PAS系統來進行懸吊。
As shown in Figure 13B, another way of using the T-PAS system of this creation with the
請參閱圖十四,為本創作的經椎板椎弓根錨釘懸吊系統的零件組中的螺絲起子的一實施例示意圖。由於本創作T-PAS系統會使用到細長且柔軟堅韌的人工韌帶來做為懸吊線,為了避免在手術過程中懸吊線會在鎖合錨釘時不小心互相纏繞、或纏繞於螺絲起子上,所以,本創作更獨創了一種創新的螺絲起子92來克服前述問題。如圖十四所示,該螺絲起子92包括有:一握把部921、一長桿部922、一起子頭端923、一上掛架924及一下掛架925。該長桿部922是自該握把部921的一端沿著一軸心延伸一預定長度。該起子頭端923是位於該長桿部922較遠離該握把部921的一末端。該起子頭端923的結構是和本創作的錨釘21的套合結構214相互對應,可供結合於該錨釘21的該套合結構214,使得當握把部921旋轉時,該起子頭端923也會帶動該錨釘21旋轉。該上掛架924及該下掛架925都是設於該長桿部922。其中,下掛架925是設在該長桿部922且隔著該軸心和該上掛架924相對應的位置;並且,該上掛架924與該起子頭端923的距離大於該下掛架925與該起子頭端923的距離。換言之,該上、下掛架924、925是位於該長桿部922的相對兩側面且是呈現一高一低的配置。此外,當該起子頭端923結合於該錨釘21的該套合結構214上時,該上掛架924的位置恰好是對應於該錨釘21的該上孔口2151的位置,且該下掛架925的位置恰好是對應於該錨釘21的該下孔口2152的位置。所以,當進行手術時,醫師只需觀看該上、下掛架924、
925的位置或旋轉角度,就會知道正在被該螺絲起子92鎖合的錨釘21上的上、下孔口2151、2152的當時位置或旋轉角度。此外,該上掛架924與該下掛架925分別都各具有一細長薄片,其藉由數支凸柱結合於長桿部,且薄片的上、下兩端於該軸心方向上都是略突出於下方凸柱,此外,薄片的上端還設置了一下凹部。該上、下掛架的結構設計,可供自該錨釘的該斜向貫穿孔的上、下孔口延伸出的該懸吊線23的兩端所分別纏繞及收掛於該上、下掛架924、925的凸柱上並把懸吊線23尾端塞入薄片上端的凹部,進而避免當操作螺絲起子92來鎖合錨釘21時發生懸吊線23互相纏繞、或纏繞於螺絲起子92上的情況。
Please refer to Figure 14, which is a schematic diagram of an embodiment of the screwdriver in the component set of the translaminar pedicle anchor suspension system created. Since the T-PAS system in this creation uses a slender, soft and tough artificial ligament as the suspension wire, in order to avoid the suspension wire accidentally entangled with each other or entangled on the screwdriver when the anchor is locked during the operation, Therefore, this creation has created an
請參閱圖十五,為本創作的經椎板椎弓根錨釘懸吊系統的零件組中的手指推銼器的一實施例示意圖。於本創作中,於上節椎骨的椎板上會以手動鑽孔器鑽出一通孔。由於剛鑽出來的通口的孔口邊緣常有銳利邊或裂縫,容易刮傷懸吊線、或是因懸吊線的張力而崩裂;因此,本創作開發出一個獨創的手指推銼器96工具,用於把通孔的內部表面及孔口邊緣圓滑化。該手指推銼器96包括:一握把部961、一長桿部962、以及一椎狀銼頭963。該長桿部962是自該握把部961的一端沿著一軸心延伸一預定長度。該椎狀銼頭963是位於該長桿部962較遠離該握把部961的一末端。該椎狀銼頭963是呈圓椎狀結構且其的突伸方向和該軸心方向兩者接近垂直。該椎狀銼頭963的表面為粗糙面以提供銼刀的功能、且具有一尖椎端9631以及一受壓端9632。尖椎端9631的最前端尺寸小於該通孔的孔徑。受壓端9632是位於該椎狀銼頭963的尾端也就是和長桿部962連接的位置;該受壓端9632於遠離該尖椎端9631的表面(尾端面)是設計成一微凹面,以方便讓操作者的手指按壓該受壓端9632的尾端面的方式來對椎狀銼頭963施加壓力、同時擺動握把部961促使握把部961以該椎狀銼頭963為樞軸進行擺動,進而讓椎狀銼頭963的粗糙面可以摩擦通孔的邊緣與內部表面,達到將孔的內部表面及孔口邊緣圓滑化的功效。於本實施例中,該長桿部962還具有一彎折段及一平行段,使得該長桿部962的前半段與後半段兩者雖平行但卻偏移一距離,可以讓操作者在使用手指推銼器96時長桿部962的前半段較不會碰到或擋住上節椎骨的椎板。
Please refer to Figure 15, which is a schematic diagram of an embodiment of the finger pusher in the component set of the translaminar pedicle anchor suspension system created. In this creation, a manual drill will be used to drill a through hole in the vertebral plate of the upper vertebra. Because the edge of the newly drilled port often has sharp edges or cracks, it is easy to scratch the suspension wire or crack due to the tension of the suspension wire; therefore, this creation has developed an
唯以上所述之實施例不應用於限制本創作之可應用範圍,本 創作之保護範圍應以本創作之申請專利範圍內容所界定技術精神及其均等變化所含括之範圍為主者。即大凡依本創作申請專利範圍所做之均等變化及修飾,仍將不失本創作之要義所在,亦不脫離本創作之精神和範圍,故都應視為本創作的進一步實施狀況。 However, the above-mentioned embodiments should not be used to limit the applicable scope of this creation. The scope of protection of the creation shall be based on the technical spirit defined by the content of the patent application for this creation and the scope included in its equivalent changes. That is to say, all equal changes and modifications made in accordance with the scope of patent application for this creation will still not lose the essence of this creation, nor will it deviate from the spirit and scope of this creation, so it should be regarded as the further implementation status of this creation.
10:脊柱 10: Spine
11:上節椎骨 11: Upper vertebra
12:下節椎骨 12: Lower vertebra
111、121:椎板 111, 121: lamina
112、113、122、123:椎弓根 112, 113, 122, 123: pedicle
114:通孔 114: Through hole
20:T-PAS系統 20: T-PAS system
21:錨釘 21: Anchor
22:墊片 22: Gasket
23:懸吊線 23: Suspended wire
Claims (20)
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