本新型是有關一種融合裝置，尤其係安裝在脊椎椎體終板間替代椎間盤的融合裝置。The present invention relates to a fusion device, particularly a fusion device installed in the intervertebral disc endplate instead of the intervertebral disc.
脊柱融合術的發展有近百年的歷史，1911年Albee等採用脊柱融合術治療脊柱結核，以達到阻止結核感染播散的目的，同年Hibbs等採用脊柱融合術控制脊柱側凸患者畸形的發展，1959年Boucher等做了第一例椎弓根螺釘腰椎關節固定。自20世紀80年代以來，椎弓根螺釘技術得到廣泛應用，1996~2001年美國脊柱融合人數增加了77%，融合手術費用昂貴，不包括醫生手術費用，全美醫院平均每人年費用不少於34000美元。The development of spinal fusion has a history of nearly 100 years. In 1911, Albee and others used spinal fusion to treat spinal tuberculosis to prevent the spread of tuberculosis infection. In the same year, Hibbs and others used spinal fusion to control the development of deformities in patients with scoliosis, 1959. Boucher et al. Did the first lumbar spine fixation with pedicle screws. Since the 1980s, pedicle screw technology has been widely used. From 1996 to 2001, the number of spine fusions in the United States increased by 77%. The cost of fusion surgery is expensive, excluding doctors' surgery costs, and the average annual cost per hospital in the United States is not less than $ 34,000.
脊柱融合術中外科植入物的使用一直呈比例增加，腰椎融合臨床研究報告顯示1980~1990年內固定放置率幾乎增長了2倍，大多數植入物是椎弓根螺釘，自1996年以來，椎體間融合支架較常用。採用單純骨移植融合和椎弓根螺釘融合進行主觀比較研究，雖然均有良好的融合率，但實驗結果認為只單用椎弓根螺釘並沒有臨床優勢。The use of surgical implants in spinal fusion has been increasing proportionally. Clinical research reports on lumbar spine fusion show that the fixed placement rate has almost doubled between 1980 and 1990. Most implants are pedicle screws. Since 1996, Interbody fusion scaffolds are more commonly used. Subjective comparative study using pure bone graft fusion and pedicle screw fusion, although both are goodThe fusion rate, but the experimental results believe that pedicle screws alone have no clinical advantage.
脊柱融合術通常用於治療由脊椎退化、椎間盤突出等脊柱病而引致的持續背痛、坐骨神經痛或雙腿酸軟無力等病患。現存椎間融合植體於植入骨後有融合效果不佳並且造成滑脫的問題，因此臨床常利用人工骨、聚合物填充塊、金屬填充塊，促進脊椎骨質與植體的融合與暫時支撐能力，但是傳統植入物長骨效率不佳而常造成位移與假關節現象。Spinal fusion is usually used to treat patients with persistent back pain, sciatica, or weakness in the legs caused by spinal diseases such as spinal degeneration and disc herniation. Existing intervertebral fusion implants have a poor fusion effect after implantation in bone and cause problems of slippage. Therefore, artificial bones, polymer filler blocks, and metal filler blocks are often used clinically to promote the fusion and temporary support of spinal bone and implants. Capacity, but traditional implants have poor long bone efficiency and often cause displacement and pseudo-joint phenomena.
有鑑於此，本創作人係改善并解決上述之缺失，潛心研究并配合學理之運用，提出一種設計合理且有效改善上述缺失之創作。In view of this, the author has improved and resolved the above-mentioned shortcomings, and has devoted himself to studying and cooperating with the application of theories to propose a reasonable design and effectively improve the above-mentioned shortcomings.
本新型之主要目的，在於提供一種椎間融合裝置，增加融合裝置的固定穩定力，提高細胞貼附能力，增大血液與植入物的接觸面積，促進骨細胞向植入物內生長，解決融合裝置不牢固的問題。The main purpose of the new model is to provide an intervertebral fusion device, which can increase the fixation and stability of the fusion device, improve the cell attachment ability, increase the contact area between blood and the implant, and promote the growth of bone cells into the implant. Problems with weak fusion devices.
為了達到上述之目的，本新型揭示了一種椎間融合裝置，設置於二脊椎之椎體終板之間，該融合裝置包含一中空本體，該中空本體至少一表面設有一開口，該中空本體更包含：一植入前端，該植入前端之一第一上表面及一第一下表面分別設有一第一限位件；以及一植入後端，該植入後端之一第一上表面及一第一下表面分別設有一第二限位件；以及一填充體，其設置於該中空本體內，該填充體設有複數個孔洞，該些個孔洞相互連通，使得該融合裝置在椎體終板之間有更大的長骨容積，提高長期穩定力。In order to achieve the above-mentioned object, the present invention discloses an intervertebral fusion device disposed between vertebral endplates of two vertebrae. The fusion device includes a hollow body, and at least one surface of the hollow body is provided with an opening. The hollow body is more Including: an implanted front end, a first upper surface and a first lower surface of the implanted front end are respectively provided with a first stopper; and an implanted rear end, a first upper surface of the implanted rear end And a first lower surface respectivelyA second limiting member; and a filling body provided in the hollow body, the filling body is provided with a plurality of holes, and the holes are mutually connected, so that the fusion device has a larger space between the vertebral endplates. Long bone volume, improve long-term stability.
本新型之一實施例中，其亦揭露該融合裝置之一植入前端之一第一厚度小於該中空本體之一第二厚度，並且該植入前端為圓弧結構。In an embodiment of the present invention, it is also disclosed that a first thickness of one of the implanted front ends of the fusion device is smaller than a second thickness of the hollow body, and the implanted front end has a circular arc structure.
本新型之一實施例中，其亦揭露該中空本體為鈦合金。In one embodiment of the present invention, it is also disclosed that the hollow body is a titanium alloy.
本新型之一實施例中，其亦揭露該中空本體表面設有二氧化鈦。In one embodiment of the present invention, it is also disclosed that the surface of the hollow body is provided with titanium dioxide.
本新型之一實施例中，其亦揭露該填充體包含一露出部，該露出部設置在該中空本體外，該露出部為鋸齒結構。In an embodiment of the present invention, it is also disclosed that the filling body includes an exposed portion, the exposed portion is disposed outside the hollow body, and the exposed portion has a sawtooth structure.
本新型之一實施例中，其亦揭露該些個孔洞直徑大小為700微米至900微米之間。In one embodiment of the present invention, it is also disclosed that the diameters of the holes are between 700 micrometers and 900 micrometers.
本新型之一實施例中，其亦揭露該植入後端為實心結構。In one embodiment of the present invention, it is also disclosed that the implanted back end is a solid structure.
本新型之一實施例中，其亦揭露該植入後端之末端設有一凹槽。In one embodiment of the present invention, it is also disclosed that a recess is provided at the end of the implanted rear end.
本新型之一實施例中，其亦揭露該植入後端之該第一上表面及該第一下表面分別設有複數個第二限位件。In one embodiment of the present invention, it is also disclosed that the first upper surface and the first lower surface of the implanted rear end are respectively provided with a plurality of second limiting members.
1‧‧‧融合裝置1‧‧‧ fusion device
10‧‧‧中空本體10‧‧‧ Hollow Ontology
12‧‧‧植入前端12‧‧‧ implanted in the front end
122‧‧‧第一上表面122‧‧‧First upper surface
124‧‧‧第一下表面124‧‧‧First lower surface
126‧‧‧第一限位件126‧‧‧The first limit piece
14‧‧‧植入後端14‧‧‧ implanted in the back end
142‧‧‧第二上表面142‧‧‧second upper surface
144‧‧‧第二下表面144‧‧‧Second lower surface
146‧‧‧第二限位件146‧‧‧Second limit piece
16‧‧‧凹槽16‧‧‧ groove
20‧‧‧填充體20‧‧‧ Filler
22‧‧‧孔洞22‧‧‧ Hole
24‧‧‧露出部24‧‧‧ exposed
30‧‧‧鋸齒結構30‧‧‧Sawtooth structure
第一圖：其係為本新型之一較佳實施例之立體圖；第二圖：其係為本新型之一較佳實施例之俯視圖；第三圖：其係為本新型之一較佳實施例之側視圖；第四A圖：其係為本新型之一較佳實施例之安裝示意圖一；第四B圖：其係為本新型之一較佳實施例之安裝示意圖二；以及第五圖：其係為本新型之另一較佳實施例之安裝示意圖。The first picture: it is a perspective view of a preferred embodiment of the new model; the second picture: it is a top view of a preferred embodiment of the new model; the third picture: it is a preferred implementation of the new model A side view of the example; FIG. 4A is an installation schematic diagram I of a preferred embodiment of the present invention; FIG. 4B is an installation schematic diagram 2 of a preferred embodiment of the present invention; and a fifth Figure: This is a schematic diagram of the installation of another preferred embodiment of the present invention.
為使 貴審查委員對本新型之特徵及所達成之功效有更進一步之瞭解與認識，謹佐以較佳之實施例及配合詳細之說明，說明如後：本新型針對習知技術之椎間融合裝置進行研發，解決了融合裝置不穩定、細胞貼附能力不高、血液與植入物的接觸不充分、骨細胞向植入物內生長緩慢、融合裝置不牢固等問題。In order for your review members to have a better understanding and understanding of the features and achieved effects of the new model, I would like to provide a better embodiment and a detailed description, as described below: This new type of intervertebral fusion device is aimed at the conventional technology The research and development have been carried out to solve the problems of unstable fusion device, low cell attachment ability, insufficient contact between blood and implant, slow growth of bone cells into the implant, and unstable fusion device.
首先，請一併參閱第一圖、第二圖及第三圖，其係為本新型之一較佳實施例之立體圖、俯視圖及側視圖。如圖所示，本新型之椎間融合裝置設置於二脊椎之椎體終板之間，該融合裝置1包含一中空本體10及一填充體20，該中空本體10一般可設為長方體結構，該中空本體10至少包含上表面、下表面、左表面及右表面，與上述之表面中具有至少一表面設有一開口，該中空本體10與該開口形成一個容置空間，另外，該中空本體10更包含一植入前端12，該植入前端12之一第一上表面122及一第一下表面124分別設有一第一限位件126，該第一限位件126在該融合裝置1設置於脊椎之椎體終板時起到支撐脊椎並限位固定的作用，該中空本體10更包含一植入後端14，該植入後端14之一第二上表面142及一第二下表面144分別設有一第二限位件146，該第二限位件146同樣在該融合裝置1設置於脊椎之椎體終板時起到支撐脊椎並限位固定的作用；該填充體20設置於該中空本體10內，該填充體20設有複數個孔洞22，該些個孔洞22相互連通，並且均勻分佈在該填充體20上；其中，該植入前端12之一第一厚度小於該中空本體之一第二厚度，並且該植入前端為圓弧結構。First, please refer to the first figure, the second figure, and the third figure together, which are perspective views, top views, and side views of a preferred embodiment of the present invention. As shown in the figure, the novel intervertebral fusion device is disposed between the vertebral endplates of the two vertebrae. The fusion device 1 includes a hollow body 10 and a filling body 20, and the hollow body 10 can generally be a rectangular parallelepiped structure. The hollow body10 includes at least an upper surface, a lower surface, a left surface, and a right surface, and at least one of the above surfaces is provided with an opening. The hollow body 10 and the opening form an accommodation space. In addition, the hollow body 10 further includes an opening. The front end 12 is implanted, and a first upper surface 122 and a first lower surface 124 of the implanted front end 12 are respectively provided with a first stopper 126, and the first stopper 126 is disposed on the spine of the fusion device 1. The vertebral endplate supports the spine and restricts and fixes it. The hollow body 10 further includes an implanted rear end 14, one of the second upper surface 142 and a second lower surface 144 of the implanted rear end 14, respectively. A second stopper 146 is provided. The second stopper 146 also supports the spine and fixes the position when the fusion device 1 is installed on the vertebral endplate of the spine. The filler 20 is disposed in the hollow. In the body 10, the filling body 20 is provided with a plurality of holes 22, which are communicated with each other and are evenly distributed on the filling body 20. Among them, a first thickness of the implanted front end 12 is smaller than that of the hollow body. A second thickness, and the front end of the implant is a circular arc Structure.
其次，請繼續參閱第一圖、第二圖及第三圖，如圖所示，在本案一較佳實施例中，為了提高該融合裝置1整體的穩定力，需選用合金材料，其中由於鈦合金具備強度高、耐腐蝕性好、彈性模量較低、耐疲勞、生物相容性好等特點，其中生物相容性好這一特點使其與其他金屬相比具有獨特的優勢，因此該中空本體10為鈦合金製作。另外，該中空本體10或該填充體20表面設有二氧化鈦，其分佈可為人體接觸面或全表面，該二氧化鈦所形成的粗糙親水性表面可以促進細胞貼附能力，最大化血液與該融合裝置1的接觸面積。Secondly, please continue to refer to the first, second and third figures. As shown in the figure, in a preferred embodiment of the present case, in order to improve the overall stability of the fusion device 1, an alloy material is required. The alloy has the characteristics of high strength, good corrosion resistance, low elastic modulus, fatigue resistance, and good biocompatibility. Among them, the feature of good biocompatibility makes it have unique advantages compared to other metals. The hollow body 10 is made of a titanium alloy. In addition, the surface of the hollow body 10 or the filling body 20 is provided with titanium dioxide, and its distribution can be the human contact surface or the entire surface. The rough hydrophilic surface formed by the titanium dioxide can promote the cell attachment ability and maximize the blood and theContact area of the fusion device 1.
接著，請繼續參閱第三圖，如圖所示，在本實施例中，該中空本體10之上表面、下表面、左表面及右表面均設有開口，其中，孔隙率達到65~85%；該填充體20包含一露出部24，該露出部24設置在該中空本體10外，也就是說，該露出部24至少於該填充體20之上表面、下表面、左表面及右表面之其中一面或多面之開口露出該中空本體10外，其中，該露出部24為鋸齒狀，在較佳的實施例中，該露出部24或該露出部24與該第一限位件126及該第二限位件146形成結構分佈均勻的一鋸齒結構30，該鋸齒結構30之表面可增加固定穩定力，提高使用可靠性。Next, please continue to refer to the third figure. As shown in the figure, in the embodiment, the upper surface, the lower surface, the left surface, and the right surface of the hollow body 10 are provided with openings, wherein the porosity reaches 65 to 85%. ; The filling body 20 includes an exposed portion 24, which is disposed outside the hollow body 10, that is, the exposed portion 24 is at least less than the upper surface, the lower surface, the left surface, and the right surface of the filling body 20; One or more of the openings are exposed outside the hollow body 10, wherein the exposed portion 24 is jagged. In a preferred embodiment, the exposed portion 24 or the exposed portion 24 and the first stopper 126 and the The second limiting member 146 forms a sawtooth structure 30 with a uniform structure distribution. The surface of the sawtooth structure 30 can increase the fixing and stability force and improve the reliability of use.
接著，請繼續參閱第一圖、第二圖及第三圖，如圖所示，在本實施例中，該填充體20之該些個孔洞22直徑大小為500微米至1500微米之間，由於該些個孔洞22相互連接，其可提高該融合裝置1的穩定性和提供骨細胞自然的向該融合裝置1內生長的條件，同時可以確保不間斷的血液流動，並且在視覺上可穿透輻射線供醫師觀察骨細胞的生長狀況。Next, please continue to refer to the first diagram, the second diagram, and the third diagram. As shown in the figure, in the embodiment, the diameters of the holes 22 of the filler 20 are between 500 μm and 1500 μm. These holes 22 are connected to each other, which can improve the stability of the fusion device 1 and provide conditions for natural growth of bone cells into the fusion device 1, and at the same time can ensure uninterrupted blood flow and can be visually penetrated The radiation is used by the physician to observe the growth of bone cells.
接著，請繼續參閱第一圖及第三圖，如圖所示，在本實施例中，該植入後端14為實心結構，並且該植入後端14之末端設有一凹槽16，其中，該凹槽16可設置在該植入後端14之末端的任意位置，並且形狀可根據具體情況調整，在本實施例中，其設置在該末端的中間位置，並且呈一字型形狀，該形狀使得該融合裝置1進入脊椎椎體終板時可用工具抵住該凹槽16，方便了植入時的操作。Next, please continue to refer to the first and third figures. As shown in the figure, in this embodiment, the implanted rear end 14 is a solid structure, and a groove 16 is provided at the end of the implanted rear end 14, where The groove 16 can be set at any position on the end of the implanted back end 14 and the shape can be adjusted according to specific conditions. In this embodiment, it is set in the middle position of the endThe shape is in the shape of a letter. This shape allows the fusion device 1 to abut the groove 16 with tools when entering the vertebral body endplate, which facilitates the operation during implantation.
另外，請繼續參閱第一圖、第二圖及第三圖，以及第四A圖、第四B圖及第五圖，其中，第四A圖及第四B圖係為本新型之一較佳實施例之安裝示意圖一及安裝示意圖二，第五圖係為本新型之另一較佳實施例之安裝示意圖，如圖所示，當患者腰椎兩節脊椎中的椎間盤出現病變或者以為損壞，需先將椎間盤從兩節脊椎中取出，再將該融合裝置植入兩椎體終板之間，隨著骨生長的趨勢會將上下椎體骨融合起來，在本新型中，該植入前端12之一第一厚度(圖中未標出)小於該中空本體10之一第二厚度(圖中未標出)，並且該植入前端12為圓弧結構。在植入過程中，可選擇多種植入方式，其中之一選擇錘子與鑿子配合進行植入，具體而言，先將該植入前端12卡設於兩椎體終板之間，然後，再將鑿子抵住該植入後端14之該凹槽16槽體，在抵住該凹槽16後，利用錘子逐漸將該融合裝置1植入，此處要說明的是，為了避免該融合裝置1在植入時被工具撞擊而損壞，該植入後端14設為實心結構，以此達到更高的穩定性，抵抗工具的撞擊，提高使用的穩定性。In addition, please continue to refer to the first diagram, the second diagram, and the third diagram, as well as the fourth diagram A, the fourth diagram B, and the fifth diagram. Among them, the fourth diagram A and the fourth diagram B are one of the new models. installation embodiment of a schematic diagram of a two and installation, FIG fifth mounting system of the present embodimentis intended to illustrate another preferred embodiment of the novel, as shown, when the patient two lumbar intervertebral disc disease in the spine or that damage embodiment Jia First, the intervertebral disc needs to be taken out from the two vertebrae, and then the fusion device is implanted between the two vertebral endplates. As the bone grows, the upper and lower vertebral bones are fused. A first thickness (not shown) of one of the front ends 12 is smaller than a second thickness (not shown) of the hollow body 10, and the implanted front end 12 has a circular arc structure. During the implantation process, a variety of implantation methods can be selected. One of them is to use a hammer and a chisel to implant. Specifically, the implant front end 12 is clamped between the two vertebral endplates, and then, The chisel is placed against the groove 16 of the implanted rear end 14 and the hammer is used to gradually implant the fusion device 1 after the groove 16 is inserted. It is to be noted here that in order to avoid the fusion device 1 Damaged by the impact of the tool during implantation. The implanted back end 14 is set as a solid structure to achieve higher stability, resist the impact of the tool, and improve the stability of use.
綜上所述，本新型之該椎間融合裝置，在該融合裝置1之該中空本體10的表面設置開口，在該第一上表面122及該第一下表面124上設置該第一限位件126，在該第二上表面142及該第二下表面144上設置該第二限位件146，使得該填充體20之該露出部24或該露出部24與該第一限位件126及該第二限位件146形成該鋸齒結構30，藉由上述之結構，解決了融合裝置不穩定、細胞貼附能力不高、血液與植入物的接觸不充分、骨細胞向植入物內生長緩慢、融合裝置不牢固等問題。In summary, in the novel intervertebral fusion device of the present invention, an opening is provided on the surface of the hollow body 10 of the fusion device 1, and the first limit position is provided on the first upper surface 122 and the first lower surface 124. Piece 126,The second limiting member 146 is disposed on the second upper surface 142 and the second lower surface 144, so that the exposed portion 24 or the exposed portion 24 of the filling body 20 and the first limiting member 126 and the first The two stoppers 146 form the zigzag structure 30. With the above structure, the unstable fusion device, the low cell attachment ability, the insufficient contact between the blood and the implant, and the slow growth of bone cells into the implant are solved. , The fusion device is not solid and so on.
惟以上所述者，僅為本新型之較佳實施例而已，並非用來限定本新型實施之範圍，舉凡依本新型申請專利範圍所述之形狀、構造、特徵及精神所為之均等變化與修飾，均應包括於本新型之申請專利範圍內。However, the above are only the preferred embodiments of the present invention, and are not intended to limit the scope of implementation of the present invention. For example, all equivalent changes and modifications in accordance with the shape, structure, characteristics, and spirit described in the scope of the patent application for the novel Shall be included in the scope of patent application for this new model.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW108200596UTWM585598U (en) | 2019-01-10 | 2019-01-10 | Intervertebral fusion device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW108200596UTWM585598U (en) | 2019-01-10 | 2019-01-10 | Intervertebral fusion device |
| Publication Number | Publication Date |
|---|---|
| TWM585598Utrue TWM585598U (en) | 2019-11-01 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW108200596UTWM585598U (en) | 2019-01-10 | 2019-01-10 | Intervertebral fusion device |
| Country | Link |
|---|---|
| TW (1) | TWM585598U (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USD1039697S1 (en) | 2022-09-13 | 2024-08-20 | National Taiwan University | Artificial implant |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USD1039697S1 (en) | 2022-09-13 | 2024-08-20 | National Taiwan University | Artificial implant |
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