TW202008968A - Vertebral implant and method for manufacturing the same - Google Patents
Vertebral implant and method for manufacturing the same Download PDFInfo
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- 239000007943 implant Substances 0.000 title claims abstract description 78
- 238000004519 manufacturing process Methods 0.000 title claims description 10
- 238000000034 method Methods 0.000 title claims description 8
- 210000000988 bone and bone Anatomy 0.000 claims description 23
- 230000007246 mechanism Effects 0.000 claims description 2
- 230000002265 prevention Effects 0.000 claims 1
- 238000007373 indentation Methods 0.000 abstract 2
- 239000004696 Poly ether ether ketone Substances 0.000 description 9
- 230000004927 fusion Effects 0.000 description 9
- 239000000463 material Substances 0.000 description 9
- 239000002184 metal Substances 0.000 description 9
- 229910052751 metal Inorganic materials 0.000 description 9
- 229920002530 polyetherether ketone Polymers 0.000 description 9
- 239000007769 metal material Substances 0.000 description 8
- 238000006073 displacement reaction Methods 0.000 description 4
- 239000002861 polymer material Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 210000002449 bone cell Anatomy 0.000 description 2
- 230000008468 bone growth Effects 0.000 description 2
- 210000005036 nerve Anatomy 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 239000011295 pitch Substances 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 229910001200 Ferrotitanium Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000012227 artificial bone substitute Substances 0.000 description 1
- 239000000316 bone substitute Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- -1 for example Substances 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000004705 lumbosacral region Anatomy 0.000 description 1
- 239000012567 medical material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000944 nerve tissue Anatomy 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
- A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/4435—Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
Abstract
Description
本發明是有關於一種脊椎植入物及其製造方法,且特別是有關於一種具有固定元件之脊椎植入物及其製造方法。The invention relates to a spinal implant and a method for manufacturing the same, and particularly relates to a spinal implant with a fixing element and a method for manufacturing the same.
脊椎在人體中扮演重要的角色,能夠支撐及保護重要的神經組織。其中,脊椎包括椎骨(vertebral body)與椎間盤(intervertebral disc),椎間盤位於上下兩個椎骨之間,可以吸收來自椎骨的壓力,緩衝脊柱的受力與衝擊。然而,當椎間盤受到長期的局部應力的壓迫時,往往容易退化或脫出而壓迫到神經,引起劇烈疼痛,且不易緩解。The spine plays an important role in the human body and can support and protect important nerve tissue. Among them, the spine includes a vertebral body and an intervertebral disc. The intervertebral disc is located between the upper and lower vertebrae. It can absorb the pressure from the vertebrae and cushion the force and impact of the spine. However, when the intervertebral disc is compressed by long-term local stress, it is often easy to degenerate or protrude and compress the nerve, causing severe pain and not easy to relieve.
近來,常見的治療方法為脊椎融合術(spinal fusion surgery),或稱椎間融合術,其係以外科手術來進行移除壓迫神經或脊髓的椎間盤,並將脊椎植入物置入椎間盤切除後所形成的空洞中,不僅暫時性的維持相鄰二個椎體之間的高度,還可協助日後達成骨融合(例如可搭配植入自體骨),恢復脊椎的穩定性。Recently, a common treatment method is spinal fusion surgery, or intervertebral fusion, which is a surgical operation to remove the disc that compresses the nerve or spinal cord, and the spinal implant is placed after the disc is removed. The formed cavity not only temporarily maintains the height between the two adjacent vertebral bodies, but also helps to achieve bone fusion in the future (for example, it can be combined with autologous bone) to restore the stability of the spine.
然而脊椎的活動量相當大,尤其是頸椎部分,脖子轉動或俯仰時會造成上下椎體相對位移,從而搖晃植入物造成滑脫。後有醫材製造商開發出搭配螺釘的植入物,以螺釘直接將植入物鎖在上下椎體。但植入物主要的材料為高分子材料聚醚醚酮(poly etherether ketone,簡稱PEEK),此材料雖兼具剛性與彈性,但是剛性強度仍低於金屬的螺釘,所以當螺釘反覆被晃動後,就會逐漸向後退出而失去鎖固之功用。However, the amount of activity of the spine is quite large, especially the cervical spine. When the neck rotates or pitches, it causes relative displacement of the upper and lower vertebral bodies, which shakes the implant and causes slippage. Later, some medical material manufacturers developed implants with screws to directly lock the implants to the upper and lower vertebral bodies. However, the main material of the implant is the polymer material polyetherether ketone (PEEK). Although this material has both rigidity and elasticity, the rigidity is still lower than that of metal screws, so when the screws are shaken repeatedly , Will gradually withdraw backwards and lose the function of locking.
改良式的脊椎植入物會在前端組裝硬度較大之金屬材料,以替換剛性略低的聚醚醚酮供螺釘鎖固。因為兩者同為金屬(較佳為相同的金屬材料),所以螺紋之間配合緊密,螺釘能夠穩定地鎖固在脊椎植入物上。然而,以金屬塊組裝在植入物前端取代原本聚醚醚酮材料的方式也有其重大缺點。首先,因為金屬材料過硬,所以會造成椎體在接觸面上發生局部受壓而凹陷的情況。再者,因為金屬材料不適合骨細胞生長於其上,且利用組合金屬塊的方式還會影響植骨空間(即可容置自體骨或人工骨替代物等骨修補材料的空間)之大小,嚴重影響骨融合速度與效果。另外,金屬材料增加會影響手術醫師在術中對移動式X光機C-arm拍攝結果的判斷。The modified spinal implant will assemble a harder metal material at the front end to replace the slightly lower rigid polyetheretherketone for screw locking. Because the two are the same metal (preferably the same metal material), the thread fits tightly, and the screw can be stably locked on the spinal implant. However, the way in which the metal block is assembled at the front of the implant to replace the original polyetheretherketone material also has its major disadvantages. First of all, because the metal material is too hard, it will cause local compression of the vertebral body on the contact surface and depression. Furthermore, because the metal material is not suitable for bone cells to grow on it, and the method of combining metal blocks will also affect the size of the bone graft space (that is, the space where bone repair materials such as autologous bone or artificial bone substitutes are accommodated), Seriously affect the speed and effect of bone fusion. In addition, the increase in metal materials will affect the surgeon's judgment on the shooting results of the mobile X-ray machine C-arm during the operation.
因此,目前仍亟需改良脊椎植入物,尤其是防止螺釘退出的同時還要減少對患者之骨融合效果的影響。Therefore, there is still an urgent need to improve spinal implants, especially to prevent screw withdrawal while reducing the impact on the patient's bone fusion effect.
本發明係有關於一種脊椎植入物及其製造方法。本發明的植入物具有防止螺釘退出,且減少對患者骨融合影響的優勢。The invention relates to a spinal implant and a manufacturing method thereof. The implant of the present invention has the advantages of preventing screw withdrawal and reducing the impact on the patient's bone fusion.
根據本發明之第一方面,提出一種脊椎植入物。脊椎植入物包括一本體、至少一固定元件以及至少一螺釘。本體具有相互連通的至少一凹槽及至少一通孔。固定元件內嵌於凹槽中。固定元件具有至少一第一螺紋,第一螺紋對應通孔。螺釘穿過通孔而與本體結合,其中螺釘具有與第一螺紋對應之至少一第二螺紋,以鎖於第一螺紋並固定於本體上。According to a first aspect of the invention, a spinal implant is proposed. The spinal implant includes a body, at least one fixing element, and at least one screw. The body has at least one groove and at least one through hole communicating with each other. The fixing element is embedded in the groove. The fixing element has at least one first thread, and the first thread corresponds to the through hole. The screw passes through the through hole and is combined with the body, wherein the screw has at least one second thread corresponding to the first thread to lock on the first thread and be fixed on the body.
根據本發明之第二方面,提出一種脊椎植入物的製造方法。方法包括下列步驟。首先,提供脊椎植入物之一本體。本體上形成至少一凹槽及至少一通孔。接著,形成至少一固定元件,固定元件具有至少一第一螺紋。嵌入固定元件於凹槽中,並使第一螺紋對應通孔。形成至少一螺釘,螺釘具有與第一螺紋對應之至少一第二螺紋,螺釘穿過通孔而與本體結合,且以第二螺紋鎖於第一螺紋以固定於本體上。According to the second aspect of the present invention, a method for manufacturing a spinal implant is proposed. The method includes the following steps. First, one body of the spinal implant is provided. At least one groove and at least one through hole are formed on the body. Next, at least one fixing element is formed, and the fixing element has at least one first thread. The fixing element is embedded in the groove, and the first thread corresponds to the through hole. At least one screw is formed, the screw has at least one second thread corresponding to the first thread, the screw passes through the through hole and is combined with the body, and the second thread is locked to the first thread to be fixed on the body.
為了對本發明之上述及其他方面有更佳的瞭解,下文特舉實施例,並配合所附圖式詳細說明如下:In order to have a better understanding of the above and other aspects of the present invention, the following examples are specifically described in conjunction with the accompanying drawings as follows:
第1A圖繪示依據本發明一實施例之脊椎植入物100的爆炸圖。第1B圖繪示依據本發明一實施例之脊椎植入物100的上視圖。第1C圖繪示第1B圖之脊椎植入物100的沿著A-A’連線的剖面圖。FIG. 1A shows an exploded view of a
請同時參照第1A圖及1B圖,脊椎植入物100包括本體110、相互連通的凹槽112及通孔114、固定元件120以及螺釘140。本體110具有上表面110a及相對於上表面110a之下表面110b。本體110之上表面110a與下表面110b可具有齒狀結構或是多個凹凸結構,以增加脊椎植入物100與椎體接觸面的摩擦力,減少相對位移。Please refer to FIGS. 1A and 1B at the same time. The
在本實施例中,凹槽112的數量為二個(凹槽112a、112b),通孔114的數量為二個(通孔114a、114b),固定元件120的數量為二個(固定元件120a、120b),螺釘140的數量為二個(螺釘140a、140b)。通孔114可由本體110的前端AS往後端PS的延伸,通孔114a的延伸方向可不同於通孔114b的延伸方向。例如,通孔114a可由前端AS往上表面110a的方向朝後端PS延伸。通孔114b可由前端AS往下表面110b的方向朝後端PS延伸。凹槽112a的開口在上表面110a,並可由本體110的上表面110a往下表面110b延伸,但是不會貫穿本體110,也就是凹槽112a在下表面110b沒有開口;至於凹槽112b的開口在上表面110b,並可由下表面110b往上表面110a延伸,但是不會貫穿本體110,也就是凹槽112a在上表面110a沒有開口。凹槽112a與通孔114a相互連通,凹槽112b與通孔114b相互連通。在本實施例中,通孔114a在其延伸方向上由凹槽112a的前側貫通凹槽112a的後側,而通孔114b在其延伸方向上由凹槽112b的前側貫通凹槽112b的後側。In this embodiment, the number of
固定元件120a、120b分別內嵌於凹槽112a、112b之中。在本實施例中,是將固定元件120a由上表面110a的開口插入,而固定元件120b由下表面110b的開口插入。固定元件120a具有對應於通孔114a的第一螺紋124a。在本實施例中,所稱之對應是例如固定元件120a插入凹槽112a後,可使第一螺紋124a環繞於通孔114a貫穿固定元件120a之處的周圍,例如固定元件120a、120b可分別具有開口122a、122b,其分別為通孔114a、114b貫穿固定元件120a、120b的周圍,而第一螺紋124a、124b可分別形成於開口122a、122b的內緣。The
螺釘140a及螺釘140b可分別用於穿過通孔114a、114b而與本體110結合。在本實施例中,所稱之結合是指二個以上的零部件以穩定的方式組合或連結在一起。螺釘140a、140b可分別穿過固定元件120a、120b上的開口122a、122b。螺釘140a、140b可分別具有與第一螺紋124a、124b對應的第二螺紋142a、142b。螺釘140a、140b以第二螺紋142a、142b鎖於凹槽112a中的第一螺紋124a及凹槽112b中的第一螺紋124b的方式固定於本體110上。第二螺紋142a、142b與螺釘140a、140b鎖在椎骨上的螺紋可有不同,例如第二螺紋142a、142b可以設置於螺釘140的頭部SF或延伸部SB的上端(與鎖於椎骨之螺紋不同的態樣),或者可以由頭部SF連續延伸至延伸部SB(與鎖於椎骨之螺紋相同的態樣)。在手術時,可以先將脊椎植入物100設置於兩個椎體間,其後以器械持取螺釘140a、140b並由通孔114a、114b進入,以第一螺紋124a、124b與第二螺紋142a、142b配對的方式,將螺釘140a、140b與本體110結合,同時也分別向上及向下鎖入相鄰的椎骨中。第一螺紋124及第二螺紋142的形狀並沒有限定,只要兩者之間可以至少部分互相配合即可。在本實施例中,螺釘140a、140b的直徑可以為約3至4毫米,長度可以為約15毫米。The
依據上述的結構設計,由於固定元件120與螺釘140的進入與退出方向之間形成一個大的角度(角度數據請參考以下說明),所以兩者分別對於對方的後退或退出造成牽制,更進一步穩定螺釘140,穩定脊椎植入物100不易發生晃動或位移。According to the above structural design, since a large angle is formed between the entry and exit directions of the fixing
固定元件120可為板狀物或片狀物,固定元件120之厚度t是介於0.5毫米至10毫米,較佳是介於0.8毫米至3毫米,可以依據患部是頸、胸、腰椎的不同而調整。在本實施例中,固定元件的厚度t為約1至2毫米,長度為約5至5.5毫米,而寬度為約5至6毫米。然而,固定元件的尺寸可因為以下因素而調整:第一,主體110本身的尺寸規格;第二,螺釘140的直徑大小。固定元件120可為矩形、圓形、不規則形等任意形狀。在一實施例中,固定元件120是圓形或可能會在凹槽112中發生轉動的形狀時,固定元件120可具有一卡合部126,凹槽112具有一限位部112p,固定元件120透過卡合部126與限位部112卡合而固定於凹槽112中,可以避免固定元件120受外力而原處自轉,造成螺釘140a、140b鎖入的困難。卡合部126與限位部112p的形狀並不特別限定,只要兩者能夠互相固定即可。然而,本發明並不限於此,在一些實施例中,固定元件120並不具有卡合部,凹槽112亦不具有限位部。The fixing
本體110的前端AS在沿著X軸的延伸方向上具有第一寬度W1
,後端PS在沿著X軸的延伸方向上具有一第二寬度W2
,第一寬度W1
大於第二寬度W2
。本體110的尺寸規格會隨著是應用於頸、胸、腰椎的不同而變化,在本實施例中,本體110的長度為12毫米、寬度為約15至16毫米,而厚度為5毫米本體110還包括一植骨空間116。植骨空間116的形狀為梯形,上底長為約7至7.5毫米,下底長為約9毫米,高(厚度)為5毫米,植骨空間可以容置或填充骨修補材料,是為協助骨生長的空間,在本實施例中,因為固定元件120是以嵌入凹槽112的方式設置,所以可以盡量維持本體110的聚醚醚酮使用量,降低對骨生長不利的條件。凹槽112形成於本體110之前端AS與本體110之植骨空間116之間。當然,在其他實施例中,凹槽112可以開設於後端PS或側邊與植骨空間116之間。The front end AS of the
比較以上實施例所列的本體110與固定元件120尺寸可知,固定元件120相對於本體110的大小比例遠較於習知使用金屬塊替代並組合於聚醚醚酮本體前端的固定手段要來得小,所以可以降低對骨融合以及X光攝影結果的影響。Comparing the sizes of the
本體110可為一體成形的結構。本體110之材料可例如是包括高生物相容性的高分子材料,高生物相容性的高分子材料例如是聚醚醚酮。固定元件120以及螺釘140的材料可例如是金屬,金屬可例如是鈦或不鏽鋼,或其他醫療等級的金屬材料。The
在一實施例中,固定元件120可另外增設各種形式的額外防退機構,例如是孔形對鎖螺紋、孔型防退片等,以進一步防止螺絲140退出。In an embodiment, the fixing
在其他實施例中,固定元件120的數量可以為一個或大於等於二個,螺釘140的數量可以為一個或大於等於二個,凹槽112的數量可為一個或大於等於二個,通孔114的數量可以為一個或大於等於二個。固定元件120之開口122的數量對應於需要鎖固之螺釘140之數量即可。In other embodiments, the number of the fixing
請參照第1C圖,凹槽112的深度可小於本體110之厚度。然本揭露不以此為限,凹槽112的深度亦可等於本體110之厚度,亦即是可形成貫穿孔,只要能夠提供固定元件120內嵌於本體110中即可。在本實施例中,本體110具有六個表面,上表面110a及下表面110b之間具有對應於前端AS的側表面110s。在Y軸的延伸方向上,固定元件120是與側表面110s之間之具有一間距D1
。間距D1為約0毫米至2毫米。固定元件120置入於凹槽112之中後,在Z軸的延伸方向上,固定元件120之上表面120s與本體110的上表面110a之間具有一段差高度H1
。段差高度H1
為約0.5毫米至1.5毫米本體110於Y軸的延伸方向(例如是水平方向上)具有一中心線c,中心線c與固定元件120的延伸方向之間具有一夾角θ,夾角θ的範圍是十度至八十度之間,較佳為二十度至七十度之間,更佳可以是三十度至六十度之間。中心線c與螺釘140的延伸方向之間具有一夾角α。在本實施例中,夾角α的範圍可以是十度至八十度之間,較佳可以是三十度至六十度之間。。利用斜向開設的凹槽112以及斜向設置的螺釘140,可以使固定元件120以較薄的厚度設置較多的螺紋圈數。Referring to FIG. 1C, the depth of the
在一實施例中,脊椎植入物100可用於頸椎的植入治療。即使頸椎的活動較其他脊椎部位為多,脊椎植入物100透過固定元件之第一螺紋與螺釘之第二螺紋間的鎖合,仍可穩定螺釘避免退出,使脊椎植入物100可以更為穩固地固定在頸椎骨之間。本發明並不限於此,脊椎植入物亦可應用於其他部位的脊椎骨之治療。In one embodiment, the
第1D至1G圖繪示固定元件的放大圖。第1D圖繪示依照本發明一實施例之固定元件120的上視圖。第1E圖繪視依照本發明又一實施例之固定元件220a的上視圖。第1F圖繪視依照本發明又一實施例之固定元件220b的上視圖。第1G圖繪視依照本發明一實施例的固定元件320的剖面圖。Figures 1D to 1G show enlarged views of the fixing element. FIG. 1D is a top view of the fixing
請參照第1D圖,在固定元件120中,第一螺紋124可完全環繞開口122,亦即是螺釘140與固定元件120結合之後,第一螺紋124可完全環繞螺釘140。Please refer to FIG. 1D. In the fixing
請參照第1E圖,在固定元件220a中,第一螺紋224a可部分環繞開口122a,亦即是螺釘140a與固定元件220a結合之後,第一螺紋224a可部分環繞螺釘140a。例如,第一螺紋224a可環繞開口122a之內緣的一半。Referring to FIG. 1E, in the fixing
請參照第1F圖,固定元件220b類似於固定元件220a,其不同之處在於,固定元件220b並未形成封閉式的開口,而是形成開放式之開口222b。固定元件220b的體積例如是固定元件220a的一半。在螺釘140a與固定元件220b結合之後,第一螺紋224b可部分環繞螺釘140a。Referring to FIG. 1F, the fixing
請參照第1G圖,其繪示固定元件320的剖面圖,由類似於第1E圖中B-B’連線所形成的剖面觀之,在固定元件320的厚度t的方向上,可沿著內緣分部有多個第一螺紋324,例如是第一螺紋324a與324b。Please refer to FIG. 1G, which shows a cross-sectional view of the fixing
第2圖繪示依照本發明又一實施例之脊椎植入物400的爆炸圖。脊椎植入物400是類似於脊椎植入物100,其不同之處在於,凹槽412a與412b皆由本體410的同一表面延伸。FIG. 2 shows an exploded view of a
請參照第2圖,凹槽412a與412b皆由本體410的上表面410a往下表面410b延伸。上表面410a相對於下表面410b。在一實施例中,凹槽412a與412b的傾斜方向可不相同,例如,凹槽412a可朝向後端PS傾斜,凹槽412b可朝向前端AS傾斜。然本發明不以此為限,凹槽412a與412b可皆未傾斜,或者朝相同的方向傾斜。凹槽412a與412b分別與通孔414a與414b相互連通,固定元件420a與420b分別嵌入於凹槽412a與412b之中,螺釘140a與140b分別穿過通孔414a與414b而與本體410結合。Please refer to FIG. 2, the
第3圖繪示依照本發明又一實施例之脊椎植入物500的爆炸圖。脊椎植入物500是類似於脊椎植入物400,其不同之處在於,凹槽512及固定元件520的數量為一個。FIG. 3 shows an exploded view of a
請參照第3圖,凹槽512由本體510的上表面510a往下表面510b延伸。上表面510a相對於下表面510b。凹槽512可不傾斜,或朝向後端PS或前端AS傾斜。凹槽512與通孔514a、514b相互連通。固定元件520具有開口522a、522b,固定元件520之對應於開口522a、522b的內緣可具有至少一第一螺紋。固定元件520嵌入於凹槽512之中,螺釘140a、140b分別穿過通孔514a、514b而與本體510結合。Referring to FIG. 3, the
第4圖繪示依照本發明又一實施例之脊椎植入物600的爆炸圖。脊椎植入物600是類似於脊椎植入物100,其不同之處在於凹槽612的位置。FIG. 4 shows an exploded view of a
請參照第4圖,本體610具有上表面610a、相對於上表面610a的下表面610b及連接於上表面610a與下表面610b的側表面,其中,側表面610c、610d為由前端AS延伸至後端PS的側表面,側表面610c相對於側表面610d。凹槽612可由本體610的側表面610c往側表面610d延伸。在一實施例中,另一凹槽(未繪示)可由本體610的側表面610d往側表面610c延伸。凹槽612可不傾斜,或朝向後端PS或前端AS傾斜。凹槽612與通孔614a相互連通。固定元件620具有開口622,固定元件620之對應於開口622的內緣可具有至少一第一螺紋。固定元件620嵌入於凹槽612之中,螺釘140a、140b分別穿過通孔614a、614b而與本體610結合。Referring to FIG. 4, the body 610 has an
第5A至5C圖繪示依據本發明一實施例之脊椎植入物700的製造及使用方法的流程圖。5A to 5C are flowcharts illustrating a method of manufacturing and using a
請參照第5A圖,其繪示病患的上方椎骨10a及下方椎骨10b。椎骨10a與椎骨10b之間的椎間盤有所損傷,需要進行將椎骨10a與椎骨10b融合之治療。Please refer to FIG. 5A, which shows the
請參照第5B圖,將依照本發明一實施例的脊椎植入物700放置於脊椎骨10a及脊椎骨10b之間。脊椎植入物700的製造方法是先提供脊椎植入物700之一本體710。可藉高分子材料(例如是PEEK)射出成型之後,將成型之成品於表面加工形成齒狀溝槽(例如是多個凹凸結構)以形成本體710。接著,在本體710上形成凹槽712a、712b及通孔714a、714b。凹槽712a、712b分別與通孔714a、714b互相連通。之後,形成金屬材料之固定元件720a、720b,固定元件720a、720b可分別具有至少一第一螺紋724a、724b。將固定元件720a、720b分別嵌入於凹槽712a、712b中,使第一螺紋724a、724b分別對應通孔714a、714b。Referring to FIG. 5B, a
請參照第5C圖,形成螺釘740a、740b,螺釘740a、740b可分別具有至少一第二螺紋(未繪示),螺釘740a、740b分別穿過通孔714a、714b及固定元件720a、720b而與本體710結合,並分別鎖入椎骨10a、10b。其中,螺釘740a、740b是分別以第二螺紋(未繪示)鎖於第一螺紋724a、724b而固定於本體710上。在一實施例中,由於脊椎植入物700的第一螺紋724a、724b與第二螺紋(未繪示)可互相配合,施術者可用器械將螺釘740a、740b分別與固定元件720a、720b咬合,並繼續朝向椎體轉動,使螺釘740a、740b能確實鎖入椎骨10a、10b,完成脊椎植入物700的固定。Referring to FIG. 5C, screws 740a and 740b are formed. The
本發明的脊椎植入物是透過固定元件之第一螺紋與螺釘之第二螺紋互相配合,由於固定元件與螺釘皆為硬度類似的金屬材料,螺紋之間可配合緊密,螺釘能夠穩定地鎖固在脊椎植入物上,即使經由長時間的椎體相對位移,螺釘仍能維持在適當的鎖固位置而不易滑脫,讓脊椎植入物受到良好的固定。由於本發明的脊椎植入物具有內嵌於凹槽內之固定元件,相較於以金屬塊組裝在植入物前端取代原本聚醚醚酮材料的方式的脊椎植入物之比較例而言,在製程上更加便利,內嵌式之固定元件較不會接觸於椎體,可避免椎體與金屬之接觸面之間的凹陷的情況,且本發明之脊椎植入物的本體可完全使用適合骨細胞生長的材料所形成,不需要另外組合金屬塊,故可擴大植骨空間,提供較優良之骨融合的環境。因此,本發明的脊椎植入物不但具有防止螺釘退出的功能,還具有效降低對患者骨融合影響的優勢。The spinal implant of the present invention cooperates with each other through the first thread of the fixing element and the second thread of the screw. Since both the fixing element and the screw are metal materials with similar hardness, the threads can be tightly matched, and the screw can be stably locked On spinal implants, even after a long period of relative displacement of the vertebral body, the screw can still be maintained in a proper locking position and not easy to slip off, allowing the spinal implant to be well fixed. Since the spinal implant of the present invention has a fixing element embedded in the groove, compared to a comparative example of a spinal implant in which a metal block is assembled at the front end of the implant to replace the original polyetheretherketone material , It is more convenient in the manufacturing process, the embedded fixing element is less likely to contact the vertebral body, which can avoid the depression between the contact surface of the vertebral body and the metal, and the body of the spinal implant of the present invention can be fully used It is formed of materials suitable for the growth of bone cells and does not require additional metal blocks, so it can expand the bone graft space and provide a better environment for bone fusion. Therefore, the spinal implant of the present invention not only has the function of preventing the screw from withdrawing, but also has the advantage of effectively reducing the impact on the patient's bone fusion.
綜上所述,雖然本發明已以實施例揭露如上,然其並非用以限定本發明。本發明所屬技術領域中具有通常知識者,在不脫離本發明之精神和範圍內,當可作各種之更動與潤飾。因此,本發明之保護範圍當視後附之申請專利範圍所界定者為準。In summary, although the present invention has been disclosed as above with examples, it is not intended to limit the present invention. Those with ordinary knowledge in the technical field to which the present invention belongs can make various modifications and retouching without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be deemed as defined by the scope of the attached patent application.
10a、10b‧‧‧脊椎骨100、400、500、600、700‧‧‧脊椎植入物110、410、510、710‧‧‧本體110a、120s、410a、510a、610a‧‧‧上表面110b、410b、510b、610b‧‧‧下表面110s、610c、610d‧‧‧側表面112、112a、112b、412a、412b、512、612、712a、712b‧‧‧凹槽112p‧‧‧限位部114、114a、114b、414、414a、414b、514a、514b、614a、614b、714a、714b‧‧‧通孔116‧‧‧植骨空間120、120a、120b、220a、220b、320、420a、420b、520、620、720a、720b‧‧‧固定元件122、122a、122b、222a、222b、422a、422b、522a、522b、622‧‧‧開口124a、124b、224a、224b、324a、324b、724a、724b‧‧‧第一螺紋126‧‧‧卡合部140、140a、140b、740a、740b‧‧‧螺釘142a、142b‧‧‧第二螺紋A、A’、B、B’‧‧‧剖面線端點C‧‧‧中心線D1‧‧‧間距H1‧‧‧高度AS‧‧‧前端PS‧‧‧後端SF‧‧‧頭部SB‧‧‧延伸部t‧‧‧厚度W1、W2‧‧‧寬度α、θ‧‧‧夾角10a, 10b ‧ spine 100, 400, 500, 600, 700 ‧ ‧ spine implants 110, 410, 510, 710 ‧ ‧‧ body 110a, 120s, 410a, 510a, 610a ‧ ‧ ‧ upper surface 110b, 410b, 510b, 610b ‧‧‧ lower surface 110s, 610c, 610d ‧‧‧ side surfaces 112, 112a, 112b, 412a, 412b, 512, 612, 712a, 712b ‧‧‧ groove 112p‧‧‧ limit part 114 , 114a, 114b, 414, 414a, 414b, 514a, 514b, 614a, 614b, 714a, 714b ‧‧‧ through hole 116 ‧‧‧ bone graft space 120, 120a, 120b, 220a, 220b, 320, 420a, 420b, 520, 620, 720a, 720b ‧‧‧ Fixing elements 122, 122a, 122b, 222a, 222b, 422a, 422b, 522a, 522b, 622 ‧‧‧ First thread 126‧‧‧ Engagement part 140, 140a, 140b, 740a, 740b ‧‧‧ Screw 142a, 142b ‧‧‧ Second thread A, A', B, B'‧‧‧ Point C‧‧‧Centerline D 1 ‧‧‧Pitch H 1 ‧‧‧ Height AS‧‧‧Front end PS‧‧‧ Rear end SF‧‧‧Head SB‧‧‧Extension t‧‧‧Thickness W 1 , W 2 ‧‧‧Width α, θ‧‧‧ included angle
第1A圖繪示依據本發明一實施例之脊椎植入物的爆炸圖。 第1B圖繪示依據本發明一實施例之脊椎植入物的上視圖。 第1C圖繪示第1B圖之脊椎植入物100的沿著A-A’連線的剖面圖。 第1D圖繪示依照本發明一實施例之固定元件的上視圖。 第1E圖繪視依照本發明又一實施例之固定元件的上視圖。 第1F圖繪視依照本發明又一實施例之固定元件的上視圖。 第1G圖繪視依照本發明一實施例的固定元件的剖面圖。 第2圖繪示依照本發明又一實施例之脊椎植入物的爆炸圖。 第3圖繪示依照本發明又一實施例之脊椎植入物的爆炸圖。 第4圖繪示依照本發明又一實施例之脊椎植入物的爆炸圖。 第5A至5C圖繪示依據本發明一實施例之脊椎植入物的製造及使用方法的流程圖。FIG. 1A shows an exploded view of a spinal implant according to an embodiment of the invention. FIG. 1B shows a top view of a spinal implant according to an embodiment of the invention. FIG. 1C shows a cross-sectional view of the
100‧‧‧脊椎植入物 100‧‧‧Spine implant
110‧‧‧本體 110‧‧‧Body
110a‧‧‧上表面 110a‧‧‧upper surface
110b‧‧‧下表面 110b‧‧‧Lower surface
112、112a、112b‧‧‧凹槽 112, 112a, 112b ‧‧‧ groove
112p‧‧‧限位部 112p‧‧‧Limiting Department
114、114a、114b‧‧‧通孔 114, 114a, 114b ‧‧‧ through hole
116‧‧‧植骨空間 116‧‧‧Bone grafting space
120、120a、120b‧‧‧固定元件 120, 120a, 120b‧‧‧Fixed components
122、122a、122b‧‧‧開口 122, 122a, 122b ‧‧‧ opening
124a、124b‧‧‧第一螺紋 124a, 124b ‧‧‧ first thread
126‧‧‧卡合部 126‧‧‧Joint Department
140、140a、140b‧‧‧螺釘 140, 140a, 140b ‧‧‧ screws
142a、142b‧‧‧第二螺紋 142a, 142b ‧‧‧ second thread
AS‧‧‧前端 AS‧‧‧Front end
PS‧‧‧後端 PS‧‧‧Back
SF‧‧‧頭部 SF‧‧‧Head
SB‧‧‧延伸部 SB‧‧‧Extension
t‧‧‧厚度 t‧‧‧thickness
Claims (14)
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|---|---|---|---|
| TW107129511A TW202008968A (en) | 2018-08-23 | 2018-08-23 | Vertebral implant and method for manufacturing the same |
| CN201910483490.8A CN110856674A (en) | 2018-08-23 | 2019-06-04 | Spinal implant and method of making same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW107129511A TW202008968A (en) | 2018-08-23 | 2018-08-23 | Vertebral implant and method for manufacturing the same |
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| Publication Number | Publication Date |
|---|---|
| TW202008968A true TW202008968A (en) | 2020-03-01 |
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|---|---|---|---|
| TW107129511A TW202008968A (en) | 2018-08-23 | 2018-08-23 | Vertebral implant and method for manufacturing the same |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN110856674A (en) |
| TW (1) | TW202008968A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI813158B (en) * | 2021-02-09 | 2023-08-21 | 尚品醫療器材股份有限公司 | Spinal fixation device |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111419483B (en) * | 2020-04-17 | 2025-03-25 | 常州集硕医疗器械有限公司 | Self-stabilizing anti-regression intervertebral fusion device |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8182518B2 (en) * | 2003-12-22 | 2012-05-22 | Life Spine, Inc. | Static and dynamic cervical plates and cervical plate constructs |
| EP3219293B1 (en) * | 2008-11-07 | 2020-02-19 | Synthes GmbH | Vertebral interbody spacer and coupled plate assembly |
| CN202619827U (en) * | 2012-05-03 | 2012-12-26 | 常州市康辉医疗器械有限公司 | Anterior cervical dynamic universal locking steel plate |
| CN203458453U (en) * | 2013-07-10 | 2014-03-05 | 浙江科惠医疗器械有限公司 | Anterior cervical plate system with clasp automatic fixing structure |
-
2018
- 2018-08-23 TW TW107129511A patent/TW202008968A/en unknown
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- 2019-06-04 CN CN201910483490.8A patent/CN110856674A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI813158B (en) * | 2021-02-09 | 2023-08-21 | 尚品醫療器材股份有限公司 | Spinal fixation device |
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| Publication number | Publication date |
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| CN110856674A (en) | 2020-03-03 |
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