TWI677327B - Spinal implant and method of manufacture thereof - Google Patents

Spinal implant and method of manufacture thereof Download PDF

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Publication number
TWI677327B
TWI677327B TW107135640A TW107135640A TWI677327B TW I677327 B TWI677327 B TW I677327B TW 107135640 A TW107135640 A TW 107135640A TW 107135640 A TW107135640 A TW 107135640A TW I677327 B TWI677327 B TW I677327B
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Taiwan
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intervertebral implant
exit hole
hole
rear end
item
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TW107135640A
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Chinese (zh)
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TW202014164A (en
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戴宏穎
Hung-Yin Tai
曾鼎翔
Ting-Hsiang Tsang
梁晃千
Huang-Chien Liang
蘇義鈞
Yi-Chun Su
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台灣微創醫療器材股份有限公司
Wiltrom Co., Ltd.
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Priority to TW107135640A priority Critical patent/TWI677327B/en
Priority to CN201910837180.1A priority patent/CN111012552B/en
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Publication of TW202014164A publication Critical patent/TW202014164A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30622Implant for fusing a joint or bone material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本發明揭露一種椎間植入物,其包括一前端、一後端以及二側壁。前端與後端是相對於椎間植入物的一被植入方向。後端具有一注入孔。至少該二側壁的其中之一具有一斜出孔,斜出孔的開設方向是由後端朝向前端並向外斜的方向開設於側壁上。斜出孔與注入孔連通。本發明另外揭露一種椎間植入物之製造方法。The invention discloses an intervertebral implant, which includes a front end, a rear end, and two side walls. The front end and the rear end are relative to an implantation direction of the intervertebral implant. The rear end has an injection hole. At least one of the two side walls has an oblique exit hole, and the opening direction of the oblique exit hole is opened on the side wall from the rear end toward the front end and inclined outward. The oblique exit hole communicates with the injection hole. The invention further discloses a method for manufacturing an intervertebral implant.

Description

椎間植入物及其製造方法Intervertebral implant and manufacturing method thereof

本發明係關於一種椎間植入物及其製造方法。The invention relates to an intervertebral implant and a manufacturing method thereof.

脊椎係為決定人體活動能力最重要的部位之一,當脊椎發生病變時,往往會對患者產生相當大的影響,包括引起疼痛、麻木感、無力感,甚至是大小便失禁或困難等症狀。脊椎病變發生的原因大多是椎間盤(Intervertebral disc)周圍韌帶受損或弱化導致髓核由韌帶間突出,或椎骨(或稱椎體,Vertebral body)因老化、骨折等原因而塌陷或受損,兩者都可能導致神經或脊髓受到壓迫,使患者感到劇烈疼痛或下肢運動功能受到影響。The spine is one of the most important parts in determining human mobility. When a spinal disease occurs, it often has a considerable impact on patients, including causing pain, numbness, weakness, and even symptoms of incontinence or difficulty. Spondylopathy occurs mostly because the ligaments around the intervertebral disc are damaged or weakened, causing the nucleus pulposus to protrude from between the ligaments, or the vertebrae (or vertebral body) is collapsed or damaged due to aging and fractures. Both may cause nerves or spinal cords to be oppressed, causing patients to experience severe pain or impaired motor function of the lower limbs.

椎間盤是連接相鄰二個椎骨的纖維軟骨盤,位置就位於二個椎骨之間,可作為椎骨間的緩衝區域,降低外力對脊椎骨的衝擊以及增加脊椎的運動幅度。椎間盤是由兩個部分所組成,包括位於中心部分的髓核(nucleus pulposus)以及位於周圍部分的纖維環(anulus fibrosis)。髓核的成分是多醣體和水分,用以緩衝脊柱的受力及衝擊。纖維環是由數十層環狀及放射狀的膠原纖維及彈性纖維交織而成的緻密組織,可保護髓核,並將相鄰的椎骨緊密地連接成一體。An intervertebral disc is a fibrocartilage disc that connects two adjacent vertebrae, and is located between the two vertebrae. It can be used as a buffer area between vertebrae, reducing the impact of external forces on the vertebrae and increasing the spinal motion. The intervertebral disc is composed of two parts, including the nucleus pulposus in the central part and anulus fibrosis in the peripheral part. The components of the nucleus pulposus are polysaccharides and water, which are used to cushion the stress and impact of the spine. A fibrous ring is a dense tissue composed of dozens of layers of annular and radial collagen fibers and elastic fibers, which can protect the nucleus pulposus and tightly connect adjacent vertebrae into one body.

若椎間盤退化,髓核會逐漸失去吸收水份的能力而變成脫水狀態。此時髓核的厚度會增加,同時也會發生纖維化而失去吸收衝擊的能力,結果造成壓力會直接作用在脊椎的骨頭結構上,進而產生椎骨相互磨損、骨刺生成、椎間韌帶鬆弛以及神經根壓迫等問題。另外,椎間盤退化或是脊椎不正常受力會造成纖維環變形,甚至纖維環結構破裂,導致髓核膨出或破出而壓迫後方的脊椎神經根,產生背痛等惱人的症狀。If the disc degenerates, the nucleus pulposus will gradually lose its ability to absorb water and become dehydrated. At this time, the thickness of the nucleus pulposus will increase, and at the same time, fibrosis will occur, and the ability to absorb shocks will be lost. As a result, the pressure will directly act on the bone structure of the spine, resulting in vertebra wear and tear, spur formation, intervertebral ligament relaxation, and nerve Root pressure and other issues. In addition, degeneration of the intervertebral disc or abnormal stress on the spine can cause deformation of the fibrous ring and even rupture of the fibrous ring structure.

椎間盤退化除了可能會發展成為椎間盤突出症外,其他可能引發的包括脊椎滑脫症、脊椎管狹窄症或其他神經壓迫症狀等。目前治療嚴重椎間盤退化的手術方式是以脊椎融合手術(Spinal fusion surgery)為主,其是先由施術者以器械破壞外層纖維環進入內層髓核,以清理出可供植體植入的路徑,或者以椎間盤切除術(Discectomy)直接移除整個椎間盤。接著,對患者施以椎間融合術(Intervertebral Cage Fusion)。施術者於相鄰兩個椎骨之間植入椎間植入物(Spinal implant)及充填植骨材料,使相鄰的椎骨融合在一起。其中,椎間植入物例如是椎間融合器(Spinal interbody fusion cage或Intervertebral cage),此植入物的主要功能是將椎骨之間的高度回復至正常或合適的高度。植骨材料包括植骨(Bone graft),植骨例如是自體骨、異體骨或人工骨替代物(Bone graft substitutes),並可能搭配骨生長因子一同使用,可促進植骨生長,以與椎骨融合。In addition to intervertebral disc degeneration that may develop into disc herniation, other possible causes include spondylolisthesis, spinal canal stenosis or other nerve compression symptoms. The current surgical method for treating severe degenerative discs is spinal fusion surgery, which is performed by the operator first using a device to destroy the outer fiber ring into the inner nucleus pulposus to clear the path for implantation. , Or remove the entire disc directly with Discectomy. The patient was then treated with Intervertebral Cage Fusion. The operator implants a spinal implant between the two adjacent vertebrae and fills them with bone grafting material to fuse the adjacent vertebrae together. The intervertebral implant is, for example, a spinal interbody fusion cage or an intervertebral cage. The main function of the implant is to restore the height between the vertebrae to a normal or suitable height. Bone graft materials include bone grafts. Bone grafts are, for example, autogenous bones, allogeneic bones, or artificial bone substitutes. They may be used with bone growth factors to promote the growth of bone grafts. Integration.

習知的手術在植入椎間植入物及充填植骨材料的搭配上僅有兩種方式可選擇,但效果均有限。第一種方式是先在植入空間預先充填植骨材料,再植入椎間植入物。然而,後植入的椎間植入物會壓迫已充填的植骨材料,使植骨材料向二側與前端擠壓。除了可能產生額外的風險以外,也會因植入空間已充填植骨材料,造成椎間植入物難以到達預定的位置。There are only two options for the conventional surgery to match the implantation of intervertebral implants and filling bone graft materials, but the effects are limited. The first method is to pre-fill the bone graft material in the implant space, and then implant the intervertebral implant. However, post-implantation intervertebral implants will compress the filled bone graft material, causing the bone graft material to squeeze to the two sides and the front end. In addition to the possible risks, it may also be difficult for the intervertebral implant to reach the intended location because the implant space has been filled with bone graft material.

第二種方式是先植入椎間植入物再充填植骨材料。然而,植入空間在椎間植入物植入後所剩餘的空間有限,故能夠填充的植骨材料相當有限,影響融合的效果與速度。The second method is to implant the intervertebral implant and then fill the bone graft material. However, the implantation space is limited after the intervertebral implant is implanted, so the bone graft material that can be filled is quite limited, affecting the effect and speed of fusion.

為解決上述問題,市面上出現一種椎間植入物9,如圖1所示,圖1為習知的椎間植入物的示意圖。此類型的椎間植入物9的一端具有注入孔91,內部具有一注入空間92,注入孔91與注入空間92相互連通。又,椎間植入物9的上、下表面具有出孔93,而側壁具有側出孔94。出孔93及側出孔94皆與注入空間92相互連通。施術者可以先利用椎間植入物持取裝置(Holder)持取椎間植入物9,並將其植入患部,再搭配植骨材料輸送組件自椎間植入物9的注入孔91注入植骨材料至注入空間92。接著,注入的植骨材料可再從出孔93及側出孔94溢出而與周遭的骨組織接觸,加速椎骨間的融合。In order to solve the above problems, an intervertebral implant 9 appears on the market, as shown in FIG. 1, which is a schematic diagram of a conventional intervertebral implant. This type of intervertebral implant 9 has an injection hole 91 at one end and an injection space 92 inside, and the injection hole 91 and the injection space 92 communicate with each other. In addition, the intervertebral implant 9 has exit holes 93 on the upper and lower surfaces, and side exit holes 94 on the side wall. Both the exit hole 93 and the side exit hole 94 communicate with the injection space 92. The surgeon can first use the intervertebral implant holding device (Holder) to hold the intervertebral implant 9 and implant it into the affected area, and then use the bone graft material delivery component to remove the intervertebral implant 9 from the injection hole 91. The bone graft material is injected into the injection space 92. Then, the injected bone graft material can overflow from the exit hole 93 and the side exit hole 94 to contact the surrounding bone tissue, thereby accelerating the fusion between the vertebrae.

然而,由於上述設計的側出孔94是垂直於椎間植入物9之長軸方向的貫孔,實際使用時會發生溢出的植骨材料堆積在側出孔94的出口周邊,而椎間植入物9的前端周圍反而沒有充填足夠量的植骨材料,導致植入的椎間植入物9容易發生鬆動及融合效果不佳的問題。另外,自側出孔94溢出的植骨材料也有可能被向後推擠而從植入路徑的開口中滲漏出去,傷害周圍組織。However, since the side exit hole 94 of the above design is a through hole perpendicular to the long axis direction of the intervertebral implant 9, the bone graft material overflowing in actual use is accumulated around the exit of the side exit hole 94, and the intervertebral Instead of filling the bone graft material around the front end of the implant 9, a sufficient amount of loosening and poor fusion results are caused in the implanted intervertebral implant 9. In addition, the bone graft material overflowing from the side exit hole 94 may be pushed backward and leak out from the opening of the implantation path, thereby damaging surrounding tissues.

因此,如何提供一種椎間植入物,其結構設計可以引導注入之植骨材料至適當的位置,避免植骨材料堆積在部分區域或由植入路徑向後滲漏,已成為相關領域中亟欲突破之重點。Therefore, how to provide an intervertebral implant with a structural design that can guide the injected bone grafting material to an appropriate position to prevent the bone grafting material from accumulating in some areas or leaking backward from the implantation path has become an urgent desire in related fields Breakthrough points.

有鑑於上述課題,本發明之主要目的係在提供一種椎間植入物及其製造方法,藉由開設一個斜出孔於側壁上,且斜出口是由後端朝向前端並向外斜的方向開設於側壁上,以解決習知椎間植入物無法將植骨材料分散,導致堆積在出口周圍、無法輸送到植入物前端或由植入路徑向後滲漏的問題。In view of the above-mentioned problems, the main object of the present invention is to provide an intervertebral implant and a method for manufacturing the same, by opening an oblique exit hole in the side wall, and the oblique exit is inclined from the rear end toward the front end and outward. It is opened on the side wall to solve the problem that the conventional intervertebral implant cannot disperse the bone grafting material, which leads to the accumulation around the outlet, the inability to transport to the front of the implant, or the backward leakage from the implant path.

為達成上述之目的,本發明提供一種椎間植入物,其包括一前端、一後端以及二側壁。前端與後端是相對於椎間植入物的一被植入方向。後端具有一注入孔。至少該二側壁的其中之一具有一斜出孔,斜出孔是由後端向前端並向外斜的方向開設於側壁上,且斜出孔與注入孔連通。To achieve the above object, the present invention provides an intervertebral implant including a front end, a rear end, and two side walls. The front end and the rear end are relative to an implantation direction of the intervertebral implant. The rear end has an injection hole. At least one of the two side walls has an oblique exit hole, the oblique exit hole is opened on the side wall from the rear end to the front end and obliquely outward, and the oblique exit hole is in communication with the injection hole.

根據本發明之一實施例,椎間植入物更包括一注入空間,其形成於椎間植入物的內部,並與注入孔連通。According to an embodiment of the present invention, the intervertebral implant further includes an injection space, which is formed inside the intervertebral implant and communicates with the injection hole.

根據本發明之一實施例,斜出孔係透過與注入空間連通,而連通注入孔。According to an embodiment of the present invention, the oblique exit hole communicates with the injection space through the injection hole.

根據本發明之一實施例,斜出孔靠近前端之一側為一導引壁。According to an embodiment of the present invention, one side of the oblique exit hole near the front end is a guide wall.

根據本發明之一實施例,導引壁與被植入方向之間具有一預定角度,預定角度大於90度。According to an embodiment of the present invention, the guide wall and the implantation direction have a predetermined angle, and the predetermined angle is greater than 90 degrees.

根據本發明之一實施例,椎間植入物包括二斜出孔、二導引壁以及一分流壁,分流壁位於二導引壁交界處。According to an embodiment of the present invention, the intervertebral implant includes two oblique exit holes, two guide walls, and a shunt wall, and the shunt wall is located at the junction of the two guide walls.

根據本發明之一實施例,椎間植入物更包括一容置空間,其形成於椎間植入物的內部,且靠近前端。According to an embodiment of the present invention, the intervertebral implant further includes a receiving space formed inside the intervertebral implant and close to the front end.

根據本發明之一實施例,至少該二側壁的其中之一具有一側出孔,其係與容置空間連通。According to an embodiment of the present invention, at least one of the two side walls has a side exit hole, which is communicated with the accommodation space.

根據本發明之一實施例,椎間植入物更包括一上表面以及一下表面。上表面具有一上出孔,下表面具有一下出孔,上出孔與下出孔相互連通。According to an embodiment of the present invention, the intervertebral implant further includes an upper surface and a lower surface. The upper surface has an upper exit hole, the lower surface has a lower exit hole, and the upper exit hole and the lower exit hole communicate with each other.

為達成上述之目的,本發明另提供一種椎間植入物,包括一前端、一後端以及二側壁。前端與後端是相對於椎間植入物的一被植入方向,後端具有一注入孔。至少該二側壁的其中之一具有一斜出孔。斜出孔是由後端向前端並向外斜的方向開設於側壁上,並斜出孔與注入孔連通。斜出孔靠近該前端之一側為一導引壁,導引壁與被植入方向之間具有一預定角度,預定角度大於90度。To achieve the above object, the present invention further provides an intervertebral implant including a front end, a rear end, and two side walls. The front end and the rear end are relative to an implantation direction of the intervertebral implant, and the rear end has an injection hole. At least one of the two sidewalls has an oblique exit hole. The oblique exit hole is opened on the side wall from the rear end to the front and obliquely outward, and the oblique exit hole communicates with the injection hole. One side of the oblique exit hole near the front end is a guide wall, and the guide wall and the implanted direction have a predetermined angle, and the predetermined angle is greater than 90 degrees.

根據本發明之一實施例,椎間植入物更包括一注入空間以及二該斜出孔。注入空間形成於椎間植入物的內部,並與注入孔連通。二斜出孔位於注入空間的相對二側。According to an embodiment of the present invention, the intervertebral implant further includes an injection space and two oblique exit holes. The injection space is formed inside the intervertebral implant and communicates with the injection hole. Two oblique exit holes are located on two opposite sides of the injection space.

根據本發明之一實施例,椎間植入物更包括一容置空間以及一上表面。容置空間形成於椎間植入物的內部,且靠近前端。上表面具有一上出孔,上出孔的孔徑大於或等於容置空間的孔徑。According to an embodiment of the present invention, the intervertebral implant further includes a receiving space and an upper surface. The accommodation space is formed inside the intervertebral implant and is close to the front end. The upper surface has an upper exit hole, and the hole diameter of the upper exit hole is greater than or equal to the hole diameter of the accommodation space.

為達成上述之目的,本發明又提供一種椎間植入物,其包括一前端、一後端、二側壁以及一分流壁。前端與後端是相對於椎間植入物的一被植入方向。後端具有一注入孔。二側壁分別具有一斜出孔。斜出孔是由後端向前端並向外斜的方向開設於側壁上,且斜出孔與注入孔連通。斜出孔靠近前端之一側為一導引壁。分流壁位於該二側壁之導引壁交界處。To achieve the above object, the present invention further provides an intervertebral implant, which includes a front end, a rear end, two side walls, and a shunt wall. The front end and the rear end are relative to an implantation direction of the intervertebral implant. The rear end has an injection hole. The two side walls each have an oblique exit hole. The oblique exit hole is opened on the side wall from the rear end to the front and obliquely outward, and the oblique exit hole is in communication with the injection hole. One side of the oblique exit hole near the front end is a guide wall. The shunt wall is located at the junction of the guide walls of the two side walls.

根據本發明之一實施例,導引壁與被植入方向之間具有一預定角度,預定角度大於90度。According to an embodiment of the present invention, the guide wall and the implantation direction have a predetermined angle, and the predetermined angle is greater than 90 degrees.

根據本發明之一實施例,椎間植入物更包括一容置空間以及一上表面。容置空間形成於椎間植入物的內部,且靠近前端。上表面具有一上出孔,上出孔的孔徑小於容置空間的孔徑。According to an embodiment of the present invention, the intervertebral implant further includes a receiving space and an upper surface. The accommodation space is formed inside the intervertebral implant and is close to the front end. The upper surface has an upper exit hole, and the hole diameter of the upper exit hole is smaller than that of the accommodation space.

為達成上述之目的,本發明又提供一種椎間植入物之製造方法,包括下列步驟:提供一椎間植入物,其包括一前端、一後端及二側壁;提供一治具,固定椎間植入物;提供一刀具,刀具與椎間植入物的一被植入方向之間具有一預定角度,預定角度大於90度;以及刀具於該二側壁的其中之一進行加工,以形成由後端向前端並向外斜的方向延伸的斜出孔。In order to achieve the above object, the present invention further provides a method for manufacturing an intervertebral implant, including the following steps: providing an intervertebral implant including a front end, a rear end, and two side walls; providing a jig and fixing Intervertebral implant; providing a tool having a predetermined angle between the tool and an implanted direction of the intervertebral implant, the predetermined angle is greater than 90 degrees; and the tool is processed on one of the two side walls to An oblique exit hole is formed extending from the rear end to the front end and obliquely outward.

根據本發明之一實施例,斜出孔靠近前端之一側為一導引壁,且導引壁與被植入方向之間具有預定角度。According to an embodiment of the present invention, one side of the oblique exit hole near the front end is a guide wall, and the guide wall and the implanted direction have a predetermined angle.

根據本發明之一實施例,研磨刀以類橢圓形的一旋轉軌跡於該二側壁的其中之一進行研磨。According to an embodiment of the present invention, the grinding knife performs grinding on one of the two side walls with an ellipse-like rotation track.

根據本發明之一實施例,研磨刀為圓柱形或水滴形。According to an embodiment of the present invention, the grinding knife is cylindrical or water droplet-shaped.

承上所述,依據本發明之椎間植入物及其製造方法,其後端具有注入孔,至少一側壁具有斜出孔。斜出孔是由後端向前端並向外斜的方向開設於側壁上,且斜出孔與該注入孔連通。植骨材料可自後端的注入孔注入,並藉由斜出孔的構型被導引往椎間植入物的外側及前端方向移動,使植骨材料在植入空間內的分散及充填效果更好,以避免過度堆積在部分區域。According to the above description, according to the intervertebral implant of the present invention and the manufacturing method thereof, the rear end has an injection hole, and at least one side wall has an oblique exit hole. The oblique exit hole is opened on the side wall from the rear end to the front and obliquely outward, and the oblique exit hole is in communication with the injection hole. The bone graft material can be injected from the injection hole at the rear end, and is guided to move outward and forward of the intervertebral implant through the configuration of the oblique exit hole, so that the bone graft material is dispersed and filled in the implantation space. Better to avoid excessive accumulation in some areas.

為能讓 貴審查委員能更瞭解本發明之技術內容,特舉較佳具體實施例說明如下。In order to make your reviewing committee better understand the technical content of the present invention, specific preferred embodiments are described below.

圖2為本發明之椎間植入物之第一實施例的示意圖,圖3A為圖2所示之椎間植入物的部分剖面示意圖,圖3B為圖3A所示之椎間植入物之另一視角的部分剖面示意圖,請先同時參考圖2及圖3A所示。首先,本實施例之椎間植入物1是以椎間融合器(或稱為椎籠)為例說明。椎間植入物1包括一前端11、一後端12以及二側壁13。其中,前端11與後端12是相對於椎間植入物1的一被植入方向P,被植入方向P即為椎間植入物1植入患部時的移動方向(請先參見圖6A)。當椎間植入物1植入患部(例如二個椎骨之間受損或退化的椎間盤80內,或原本受損或退化的椎間盤80被移除後的位置,可先參考圖6A所示),先靠近於患部的該端於本實施例稱為前端11;反之,稱為後端12。換言之,前端11與後端12分別位於椎間植入物1的相對二端,且前端11與後端12的連線平行於椎間植入物1的被植入方向P。在本實施例中,被植入方向P與椎間植入物1的長軸相互平行。FIG. 2 is a schematic view of a first embodiment of the intervertebral implant of the present invention, FIG. 3A is a partial cross-sectional schematic view of the intervertebral implant shown in FIG. 2, and FIG. 3B is an intervertebral implant shown in FIG. 3A For a partial cross-sectional view from another perspective, please refer to FIG. 2 and FIG. 3A simultaneously. First, the intervertebral implant 1 of this embodiment is described using an intervertebral cage (or a cage) as an example. The intervertebral implant 1 includes a front end 11, a rear end 12, and two side walls 13. The front end 11 and the rear end 12 are an implantation direction P relative to the intervertebral implant 1, and the implantation direction P is the moving direction of the intervertebral implant 1 when it is implanted in the affected part (see the figure first). 6A). When the intervertebral implant 1 is implanted in the affected part (for example, the damaged or degenerated intervertebral disc 80 between the two vertebrae, or the position of the originally damaged or degenerated intervertebral disc 80 is removed, refer to FIG. 6A). The end close to the affected part is called the front end 11 in this embodiment; otherwise, it is called the back end 12. In other words, the front end 11 and the rear end 12 are respectively located at opposite ends of the intervertebral implant 1, and the line connecting the front end 11 and the rear end 12 is parallel to the implantation direction P of the intervertebral implant 1. In this embodiment, the implantation direction P and the long axis of the intervertebral implant 1 are parallel to each other.

一般而言,施術者可利用椎間植入物持取裝置(Holder)連結椎間植入物1的後端12,藉此固定並持取椎間植入物1。本實施例之後端12具有一注入孔121,且注入孔121的內側具有內螺紋,其係與持取裝置前端的外螺紋配合,以透過螺鎖的方式將持取裝置與椎間植入物1固定在一起,供施術者操作持取裝置將椎間植入物1植入患部。在本實施例中,椎間植入物1更包括一注入空間14,其形成於椎間植入物1的內部,並與注入孔121連通。持取裝置不僅扮演移動椎間植入物1的角色,另外還可與輸送植骨材料的送料組件組合,以供施術者自注入孔121將植骨材料充填至注入空間14再分散至植入空間中。當然,在本發明其他實施例中,椎間植入物1可以用注入孔121直接與輸送植骨材料的送料組件組合,本發明在此不限。注入的植骨材料可例如但不限於自體骨、異體骨或人工骨替代物(Bone graft substitutes)。Generally, the surgeon can use the intervertebral implant holding device (Holder) to connect the rear end 12 of the intervertebral implant 1, thereby fixing and holding the intervertebral implant 1. The rear end 12 of this embodiment has an injection hole 121, and the inside of the injection hole 121 has an internal thread, which cooperates with the external thread at the front end of the holding device, and connects the holding device and the intervertebral implant by means of a screw lock. 1 is fixed together for the operator to operate the holding device to implant the intervertebral implant 1 into the affected part. In this embodiment, the intervertebral implant 1 further includes an injection space 14 which is formed inside the intervertebral implant 1 and communicates with the injection hole 121. The holding device not only plays the role of moving the intervertebral implant 1, but also can be combined with a feeding component for transporting the bone graft material for the operator to fill the bone graft material into the injection space 14 from the injection hole 121 and then disperse it to the implant. In space. Of course, in other embodiments of the present invention, the intervertebral implant 1 may be directly combined with a feeding component for transporting bone graft material by using the injection hole 121, and the present invention is not limited thereto. The implanted bone graft material may be, for example, but not limited to, autogenous bone, allogeneic bone, or bone graft substitutes.

請同時參考圖2及圖3B所示,二側壁13分別具有一斜出孔131,且二斜出孔131分別位於注入空間14的相對二側。又,斜出孔131是由後端12向前端11並向外斜的方向開設於側壁13上。詳細而言,斜出孔131是設置於側壁13,並貫穿側壁13的開孔,故於側壁13的內側(即椎間植入物1內部)及外側皆具有開口。其中,斜出孔131位於側壁13內側的開口較靠近於後端12,而斜出孔131位於側壁13外側的開口則靠近於前端11,以形成自後端12向前端11並向外斜的方向延伸的開孔(斜出孔131)。斜出孔131與位於椎間植入物1內部的注入空間14連通,進而連通注入孔121。植骨材料可自注入孔121充填至注入空間14,當注入的量增多後,部分的植骨材料會被推擠朝向注入空間14的周圍移動,然後進入連通注入空間14與外部的開口,包括斜出孔131。Please refer to FIG. 2 and FIG. 3B at the same time. The two side walls 13 each have an oblique exit hole 131, and the two oblique exit holes 131 are respectively located on two opposite sides of the injection space 14. The oblique exit hole 131 is formed in the side wall 13 from the rear end 12 to the front end 11 and obliquely outward. In detail, the oblique exit hole 131 is an opening provided in the side wall 13 and penetrating through the side wall 13, so there are openings on the inner side of the side wall 13 (that is, the inside of the intervertebral implant 1) and the outer side. Among them, the opening of the oblique exit hole 131 on the inner side of the side wall 13 is closer to the rear end 12, and the opening of the oblique exit hole 131 on the outer side of the side wall 13 is closer to the front end 11 to form an oblique outward from the rear end 12 to the front end 11 and outward. An opening (inclined exit hole 131) extending in the direction. The oblique exit hole 131 communicates with the injection space 14 located inside the intervertebral implant 1, and further communicates with the injection hole 121. The bone grafting material can be filled into the injection space 14 from the injection hole 121. When the amount of injection increases, part of the bone grafting material will be pushed to move around the injection space 14 and then enter the opening connecting the injection space 14 and the outside, including斜 出 孔 131.

進入斜出孔131的植骨材料移動方向受到侷限,只能被沿著斜出孔131向外推出,例如植骨材料被斜出孔131本身開設的方向導引至側壁13的外側。是以,斜出孔131向前端11並向外斜的方向延伸的設計,使植骨材料被導引可以優先往前端11的方向輸出,進而從前端11附近的植入空間開始充填植骨材料,再慢慢往後堆積。相較來說,習知椎間植入物9在側壁上只有開設垂直貫通的側出孔94,植骨材料沿側出孔94被推擠出去後,很容易滯留在出口附近,當溢出側出孔94的植骨材料持續被擠壓後,就會變得緊實而難以再移動,導致椎間植入物9前端的植入空間所被充填的植骨材料不足,過度集中在部分區域(側出孔94的外側)的情形。The movement direction of the bone graft material entering the oblique exit hole 131 is limited and can only be pushed outward along the oblique exit hole 131. For example, the bone graft material is guided to the outside of the side wall 13 by the direction in which the oblique exit hole 131 itself is opened. Therefore, the oblique exit hole 131 extends toward the front end 11 and obliquely outwards, so that the bone graft material can be guided to output in the direction of the front end 11 preferentially, and then the bone implantation can be filled from the implantation space near the front end 11 Material, and then slowly pile up. Comparatively speaking, the conventional intervertebral implant 9 only has a vertical through-hole side exit hole 94 on the side wall. After the bone graft material is pushed out along the side exit hole 94, it is easy to stay near the exit. After the bone grafting material of the side exit hole 94 is continuously squeezed, it will become compact and difficult to move, resulting in insufficient bone grafting material filled in the implantation space at the front end of the intervertebral implant 9 and being excessively concentrated in part. Area (outside of the side exit hole 94).

圖4為圖3A所示之椎間植入物的俯視圖,請同時參考圖3A、圖3B及圖4所示。由於斜出孔131是向前端11且向外斜的方向延伸的開孔,故於斜出孔131靠近前端11之一側為一導引壁132,且導引壁132為弧形側壁,有助於加強植骨材料沿斜出孔131的流動。具體而言,導引壁132與被植入方向P之間具有一預定角度q1,且預定角度q1大於90度。本實施例之斜出孔131可以為類圓形、或類橢圓形的通道,較佳可以為類橢圓形通道,如圖2所示,以增加導引植骨材料的空間、維持植骨材料的流動性以及避免加工難度過高。FIG. 4 is a top view of the intervertebral implant shown in FIG. 3A. Please refer to FIG. 3A, FIG. 3B and FIG. 4 at the same time. Since the oblique exit hole 131 is an opening extending toward the front end 11 and obliquely outward, one side of the oblique exit hole 131 near the front end 11 is a guide wall 132, and the guide wall 132 is an arc-shaped side wall. Helps strengthen the flow of bone graft material along the oblique exit hole 131. Specifically, there is a predetermined angle q1 between the guide wall 132 and the implantation direction P, and the predetermined angle q1 is greater than 90 degrees. The oblique exit hole 131 in this embodiment may be a circular or oval channel, preferably an oval channel, as shown in FIG. 2 to increase the space for guiding the bone graft material and maintain the bone graft material. Fluidity and avoiding excessive processing difficulties.

在本實施例中,斜出孔131及其導引壁132可透過刀具加工製成,例如透過刀具研磨方式製成。圖5A為圖2所示之椎間植入物的製造方法的步驟流程圖,圖5B為圖5A所示之步驟S30的示意圖,圖5C為圖5A所示之步驟S40的示意圖,請同時參考圖5A、圖5B及圖5C所示。本實施例之椎間植入物1的製造方法,其包括下列步驟:提供一椎間植入物1a,椎間植入物1a包括一前端11a、一後端12a及二側壁13a(步驟S10);提供一治具,固定椎間植入物1a(步驟S20);提供一刀具2,刀具2與椎間植入物1a的一被植入方向P之間具有一預定角度q2,預定角度q2大於90度(步驟S30);以及刀具2於該二側壁13a的其中之一進行加工,以形成由後端12a向前端11a並向外斜的方向延伸的斜出孔131a(步驟S40)。In this embodiment, the oblique exit hole 131 and the guide wall 132 thereof can be manufactured by using a tool, for example, by using a tool grinding method. FIG. 5A is a flowchart of the steps of the method for manufacturing the intervertebral implant shown in FIG. 2, FIG. 5B is a schematic diagram of step S30 shown in FIG. 5A, and FIG. 5C is a schematic diagram of step S40 shown in FIG. 5A. 5A, 5B and 5C. The manufacturing method of the intervertebral implant 1 of this embodiment includes the following steps: providing an intervertebral implant 1a, the intervertebral implant 1a includes a front end 11a, a rear end 12a, and two side walls 13a (step S10) ); Provide a jig to fix the intervertebral implant 1a (step S20); provide a tool 2, the tool 2 and a implanted direction P of the intervertebral implant 1a have a predetermined angle q2, a predetermined angle q2 is greater than 90 degrees (step S30); and the tool 2 is processed on one of the two side walls 13a to form an inclined exit hole 131a extending from the rear end 12a to the front end 11a and outwardly obliquely (step S40).

於步驟S20中,先提供一治具,以固定椎間植入物1a,需說明的是,此時的椎間植入物1a為半成品,其具有前端11a、後端12a及二側壁13a,且椎間植入物1a的內部可以預先加工形成注入空間14a,但側壁13a仍為封閉而尚未開設斜出孔131a。較佳的,椎間植入物1a可利用具生物相容性或的可高溫高濕滅菌的高分子材料製成,例如聚醚醚酮(polyetheretherketone,PEEK)。椎間植入物1a先加工形成貫通的上出孔151與下出孔161(可參考圖2),然後使用圓柱形的治具由水平方向貫通椎間植入物1a的上出孔151與下出孔161,以固定椎間植入物1a並使椎間植入物1a的側壁13a朝上,準備以刀具2進行加工。In step S20, a jig is first provided to fix the intervertebral implant 1a. It should be noted that the intervertebral implant 1a at this time is a semi-finished product, which has a front end 11a, a rear end 12a, and two side walls 13a. Moreover, the interior of the intervertebral implant 1a can be processed in advance to form an injection space 14a, but the side wall 13a is still closed and the oblique exit hole 131a has not been opened yet. Preferably, the intervertebral implant 1a may be made of a polymer material that is biocompatible or sterilizable at high temperature and high humidity, such as polyetheretherketone (PEEK). The intervertebral implant 1a is first processed to form a penetrating upper exit hole 151 and a lower exit hole 161 (refer to FIG. 2), and then a cylindrical jig is used to penetrate the upper exit hole 151 and the intervertebral implant 1a horizontally from the horizontal direction. The exit hole 161 is lowered to fix the intervertebral implant 1 a with the side wall 13 a of the intervertebral implant 1 a facing upward, and is intended to be processed by the tool 2.

利用治具固定半成品的椎間植入物1a後,再將刀具2相對於二側壁13a的其中之一傾斜設置(步驟S30)。如圖5B及圖5C所示,刀具2與椎間植入物1a的被植入方向P之間具有一預定角度q2,且預定角度q2大於90度,較佳可介於110度至130度之間,本實施例之預定角度q2是120度。需說明的是,本實施例所述之預定角度q2是指刀具2與側壁13a之間的夾角角度,且為靠近後端12a之側壁13a與刀具2之間的夾角。After the semi-finished intervertebral implant 1a is fixed with a jig, the cutter 2 is tilted relative to one of the two side walls 13a (step S30). As shown in FIG. 5B and FIG. 5C, there is a predetermined angle q2 between the tool 2 and the implantation direction P of the intervertebral implant 1a, and the predetermined angle q2 is greater than 90 degrees, preferably between 110 degrees and 130 degrees. In between, the predetermined angle q2 of this embodiment is 120 degrees. It should be noted that the predetermined angle q2 described in this embodiment refers to an included angle between the tool 2 and the side wall 13a, and is an included angle between the side wall 13a and the tool 2 near the rear end 12a.

接著,刀具2於其中一側壁13a上開始研磨(步驟S40),刀具2係自側壁13a的外表面往椎間植入物1a的內部移動,如圖5B及圖5C所示,刀具2的移動方向M與被植入方向P之間同樣是夾有預定角度q2。藉由預定角度q2的設計,以形成自後端12a向前端11a並向外斜的方向延伸的斜出孔131a,且斜出孔131a與注入空間14a連通。又,斜出孔131a靠近前端11a之一側為導引壁132a,且導引壁132a與被植入方向P之間所具有的預定角度q1(請參考圖4所示)其度數是與刀具2與側壁13a之間的預定角度q2相同。本實施例之預定角度q1及預定角度q2皆是120度。在本實施例中,刀具2亦可以為圓柱形或水滴形,並以類橢圓形的旋轉軌跡於側壁13a進行研磨,同樣可形成類橢圓形的斜出孔131a。Next, the tool 2 starts grinding on one of the side walls 13a (step S40). The tool 2 moves from the outer surface of the side wall 13a to the inside of the intervertebral implant 1a, as shown in FIGS. 5B and 5C. There is also a predetermined angle q2 between the direction M and the implanted direction P. With the design of the predetermined angle q2, an oblique exit hole 131a extending from the rear end 12a to the front end 11a and outwardly obliquely is formed, and the oblique exit hole 131a communicates with the injection space 14a. In addition, one side of the oblique exit hole 131a near the front end 11a is a guide wall 132a, and the predetermined angle q1 (refer to FIG. 4) between the guide wall 132a and the implantation direction P is the same as that of the tool The predetermined angle q2 between 2 and the side wall 13a is the same. The predetermined angle q1 and the predetermined angle q2 in this embodiment are both 120 degrees. In this embodiment, the cutter 2 may also be cylindrical or drop-shaped, and is polished on the side wall 13a with an ellipse-like rotation track, and an ellipse-like oblique exit hole 131a may also be formed.

接著,再於另一側壁13a重複步驟S30及步驟S40,以形成如圖4所示之椎間植入物1。另需說明的是,本發明不限制斜出孔131的數量,亦可僅有一個斜出孔131,即至少二側壁13的其中之一具有一斜出孔131。另外,亦可於同一個側壁13上具有一個以上的斜出孔131。Then, steps S30 and S40 are repeated on the other side wall 13a to form the intervertebral implant 1 as shown in FIG. 4. It should also be noted that the present invention does not limit the number of the inclined exit holes 131, and there may be only one inclined exit hole 131, that is, one of the at least two side walls 13 has an inclined exit hole 131. In addition, there may be more than one inclined exit hole 131 in the same sidewall 13.

請同時參考圖2、圖3A及圖3B所示,椎間植入物1亦包括一上表面15及一下表面16,且上表面15具有一上出孔151,下表面16具有一下出孔161。其中,上出孔151及下出孔161分別與注入空間14連通,使上出孔151與下出孔161可透過注入空間14相互連通。換言之,注入空間14的後側與注入孔121連通、左右二側與斜出孔131連通、及上下二側分別與上出孔151及下出孔161連通。Please refer to FIG. 2, FIG. 3A and FIG. 3B together. The intervertebral implant 1 also includes an upper surface 15 and a lower surface 16. The upper surface 15 has an upper exit hole 151 and the lower surface 16 has an lower exit hole 161. . The upper exit hole 151 and the lower exit hole 161 communicate with the injection space 14 respectively, so that the upper exit hole 151 and the lower exit hole 161 can communicate with each other through the injection space 14. In other words, the rear side of the injection space 14 communicates with the injection hole 121, the left and right sides communicate with the oblique exit hole 131, and the upper and lower sides communicate with the upper exit hole 151 and the lower exit hole 161, respectively.

較佳的,椎間植入物1更包括一容置空間17,其形成於椎間植入物1的內部,且相對於注入空間14更靠近前端11。在本實施例中,容置空間17為靠近於前端11的貫孔,故於上表面15及下表面16上分別形成出孔171。又,至少二側壁13的其中之一具有一側出孔172,其係與容置空間17連通。如圖4所示,側出孔172垂直於被植入方向P,換言之,側出孔172與被植入方向P之間的夾角角度實質上為90度。容置空間17用以容置植骨材料,可例如但不限於自體骨、異體骨或人工骨替代物,但較佳為自體骨。將椎間植入物1植入患部之前,可先將植骨材料置入容置空間17內,且部分植骨材料自出孔171及側出孔172露出於椎間植入物1的外側。Preferably, the intervertebral implant 1 further includes a receiving space 17 formed inside the intervertebral implant 1 and closer to the front end 11 than the injection space 14. In this embodiment, the accommodating space 17 is a through hole close to the front end 11, so holes 171 are respectively formed on the upper surface 15 and the lower surface 16. In addition, at least one of the two side walls 13 has a side exit hole 172, which is in communication with the accommodation space 17. As shown in FIG. 4, the side exit hole 172 is perpendicular to the implantation direction P, in other words, the angle between the side exit hole 172 and the implantation direction P is substantially 90 degrees. The accommodating space 17 is used for accommodating bone graft material, and may be, for example, but not limited to, autogenous bone, allogeneic bone, or artificial bone substitute, but is preferably autologous bone. Before the intervertebral implant 1 is implanted in the affected part, the bone graft material can be placed in the accommodation space 17 and part of the bone graft material can be exposed from the exit hole 171 and the side exit hole 172 outside the intervertebral implant 1 .

請搭配參考圖6A及圖6B所示,圖6A為圖2所示之椎間植入物植入椎間盤的側視圖,圖6B為圖6A所示之椎間植入物植入椎間盤的俯視圖。當椎間植入物1植入患者的椎間盤80後,預先置於容置空間17的自體骨會自出孔171露出,並與相鄰二椎骨81、82接觸。接著,將人工骨替代物自後端12的注入孔121注入,並充填注入空間14。當人工骨替代物被推擠進入斜出孔131後,可以順著前側的導引壁132被導引往椎間植入物1的外側及前端11的方向移動,如圖6B所示,使人工骨替代物可優先充填在前端11附近的植入空間中,有利完整填充椎間植入物1以外的空間,尤其是椎間植入物1兩側的空間,協助誘導上下椎骨81、82在椎間植入物1兩側的融合生長。又人工骨替代物可由上出孔151或下出孔161溢出,以接觸上下椎骨81、82,同樣可以提供誘導上下椎骨81、82融合生長的功效,以形成自上方的椎骨81貫穿上出孔151、容置空間17以及下出孔161至下方的椎骨82的融合骨結構。Please refer to FIG. 6A and FIG. 6B. FIG. 6A is a side view of the intervertebral implant implanted into the intervertebral disc shown in FIG. 2, and FIG. 6B is a top view of the intervertebral implant implanted into the intervertebral disc shown in FIG. 6A. After the intervertebral implant 1 is implanted into the intervertebral disc 80 of the patient, the autogenous bone previously placed in the accommodating space 17 will be exposed from the exit hole 171 and contact the adjacent two vertebrae 81 and 82. Next, the artificial bone substitute is injected from the injection hole 121 of the rear end 12 and fills the injection space 14. After the artificial bone substitute is pushed into the oblique exit hole 131, it can be guided along the anterior guide wall 132 toward the outside of the intervertebral implant 1 and the front end 11 as shown in FIG. 6B, so that The artificial bone substitute can be preferentially filled in the implant space near the front end 11, which is beneficial to completely fill the space other than the intervertebral implant 1, especially the space on both sides of the intervertebral implant 1, to help induce the upper and lower vertebrae 81, 82 Fusion growth on both sides of the intervertebral implant 1. The artificial bone substitute can overflow from the upper exit hole 151 or the lower exit hole 161 to contact the upper and lower vertebrae 81 and 82. It can also provide the effect of inducing the fusion of the upper and lower vertebrae 81 and 82 to form the upper vertebrae 81 through the upper exit hole. 151. The fused bone structure of the accommodation space 17 and the lower exit hole 161 to the lower vertebra 82.

在第一實施例中,注入空間14與容置空間17的比例大致相同,或注入空間14略大於容置空間17。換言之,上出孔151的孔徑R1大於或等於容置空間17的孔徑R2,如圖4所示。此類型的椎間植入物1可應用在自體骨的需求量或可用量較少的患部。較佳的,本實施例之斜出孔131的孔徑R3可大於椎間植入物1之總長度L的1/4。由於注入孔121與導引壁132的距離較長,且斜出孔131的孔徑R3較大,使得注入的骨粉可順利地被導引至斜出孔131的通道內,進而可溢出椎間植入物1的外側,避免堆積於注入空間14。In the first embodiment, the ratio of the injection space 14 and the accommodation space 17 is substantially the same, or the injection space 14 is slightly larger than the accommodation space 17. In other words, the aperture R1 of the upper exit hole 151 is greater than or equal to the aperture R2 of the accommodation space 17, as shown in FIG. 4. This type of intervertebral implant 1 can be applied to the affected part where the required or available amount of autologous bone is less. Preferably, the diameter R3 of the oblique exit hole 131 in this embodiment may be larger than 1/4 of the total length L of the intervertebral implant 1. Because the distance between the injection hole 121 and the guide wall 132 is long, and the diameter R3 of the oblique exit hole 131 is relatively large, the injected bone meal can be smoothly guided into the channel of the oblique exit hole 131, which can overflow the intervertebral implant. The outside of the inlet 1 is prevented from accumulating in the injection space 14.

在其他實施例中,容置空間17b亦可大於注入空間14b,以下第二實施例之椎間植入物1b進一步說明之。圖7為本發明之椎間植入物之第二實施例的示意圖,圖8A為圖2所示之椎間植入物的部分剖面示意圖,圖8B為圖8A所示之椎間植入物之另一視角的部分剖面示意圖,請先同時參考圖7及圖8A所示。本實施例之椎間植入物1b同樣包括前端11b、後端12b及二側壁13b。後端12b具有注入孔121b,二側壁13b則分別具有一斜出孔131b。斜出孔131b同樣以後端12b向外斜及向前端11b的方向開設於側壁13b上,且斜出孔131b靠近前端11b的一側為導引壁132b。椎間植入物1b的上表面15b具有上出孔151b,且下表面16b具有下出孔161b。注入孔121b、斜出孔131b、上出孔151b及下出孔161b皆與椎間植入物1b內部注入空間14b連通。In other embodiments, the accommodating space 17b may be larger than the injection space 14b. The intervertebral implant 1b of the second embodiment is further described below. FIG. 7 is a schematic view of a second embodiment of the intervertebral implant of the present invention, FIG. 8A is a partial cross-sectional schematic view of the intervertebral implant shown in FIG. 2, and FIG. 8B is an intervertebral implant shown in FIG. 8A For a partial cross-sectional view from another perspective, please refer to FIG. 7 and FIG. 8A simultaneously. The intervertebral implant 1b in this embodiment also includes a front end 11b, a rear end 12b, and two side walls 13b. The rear end 12b has an injection hole 121b, and the two side walls 13b each have an oblique exit hole 131b. The oblique exit hole 131b is also opened on the side wall 13b in the direction of the rear end 12b oblique outward and toward the front end 11b, and the side of the oblique exit hole 131b near the front end 11b is a guide wall 132b. The upper surface 15b of the intervertebral implant 1b has an upper exit hole 151b, and the lower surface 16b has a lower exit hole 161b. The injection hole 121b, the oblique exit hole 131b, the upper exit hole 151b, and the lower exit hole 161b are all in communication with the injection space 14b inside the intervertebral implant 1b.

圖9為圖8A所示之椎間植入物的俯視圖,請搭配參考圖9所示。本實施例之椎間植入物1b亦具有容置空間17b,並靠近於前端11b。與第一實施例之椎間植入物1的差異之一為容置空間17b與注入空間14b的比例關係。在本實施例中,注入空間14b小於容置空間17b,進而使上出孔151b的孔徑R1亦小於容置空間17b的孔徑R2。容置空間17b用以容置自體骨,故本實施例之椎間植入物1b可應用在自體骨使用需求量較大的患部。FIG. 9 is a top view of the intervertebral implant shown in FIG. 8A. Please refer to FIG. 9 for reference. The intervertebral implant 1b of this embodiment also has a receiving space 17b and is close to the front end 11b. One of the differences from the intervertebral implant 1 of the first embodiment is the proportional relationship between the accommodation space 17b and the injection space 14b. In this embodiment, the injection space 14b is smaller than the accommodating space 17b, so that the aperture R1 of the upper exit hole 151b is also smaller than the aperture R2 of the accommodating space 17b. The accommodating space 17b is used for accommodating the autogenous bone, so the intervertebral implant 1b of this embodiment can be applied to the affected part where autogenous bone is used in a large amount.

相較於第一實施例之椎間植入物1,在本實施例中,椎間植入物1b更包括一分流壁18b,且分流壁18b位於二導引壁132b之間。亦即,分流壁18b位於二側壁13b之導引壁132b的交界處。自注入孔121b注入的人工骨替代物在注入空間14b中會逐漸被推擠向前,當與分流壁18b接觸時,分流壁18b類似稜台或是錐台的構型將有助於人工骨替代物向兩側分散,並分別順著導引壁132b而進入斜出孔131b,從而被導引壁132b侷限流向而沿著導引壁132b向椎間植入物1b的外側及前端11b移動。本實施例之椎間植入物1b藉由分流壁18b的設計,使注入注入空間14b的植骨材料不會因為被推擠向前而在二斜出孔131b的交界處堆積,也就是不會被推擠而在注入孔121b直線方向的前方位置上堆積,有助於注入椎間植入物1b的植骨材料充填至植入空間內。Compared to the intervertebral implant 1 of the first embodiment, in this embodiment, the intervertebral implant 1b further includes a shunt wall 18b, and the shunt wall 18b is located between the two guide walls 132b. That is, the dividing wall 18b is located at the boundary of the guide wall 132b of the two side walls 13b. The artificial bone substitute injected from the injection hole 121b will be gradually pushed forward in the injection space 14b. When it comes into contact with the split wall 18b, the configuration of the split wall 18b similar to a pyramid or a truncated cone will help the artificial bone. The substitutes are dispersed to both sides and enter the oblique exit holes 131b respectively along the guide wall 132b, so that the guide wall 132b restricts the flow direction and moves along the guide wall 132b to the outer side of the intervertebral implant 1b and the front end 11b. . The design of the intervertebral implant 1b of this embodiment prevents the bone graft material injected into the injection space 14b from being stacked at the junction of the two oblique exit holes 131b because it is pushed forward, that is, it does not It will be pushed to accumulate at the front position in the straight direction of the injection hole 121b, which will help the bone graft material injected into the intervertebral implant 1b to fill the implantation space.

綜上所述,依據本發明之椎間植入物及其製造方法,其後端具有注入孔,至少一側壁具有斜出孔。斜出孔是由後端向前端並向外斜的方向開設於側壁上,且斜出孔與注入孔連通。植骨材料可自後端的注入孔注入,並藉由斜出孔的構型被導引往椎間植入物的外側及前端方向移動,使植骨材料在植入空間內的分散及充填效果更好,以避免過度堆積在部分區域。To sum up, according to the intervertebral implant of the present invention and the manufacturing method thereof, the rear end has an injection hole, and at least one side wall has an oblique exit hole. The oblique exit hole is opened on the side wall from the rear end to the front and obliquely outward, and the oblique exit hole is in communication with the injection hole. The bone graft material can be injected from the injection hole at the rear end, and is guided to move outward and forward of the intervertebral implant through the configuration of the oblique exit hole, so that the bone graft material is dispersed and filled in the implantation space. Better to avoid excessive accumulation in some areas.

應注意的是,上述諸多實施例係為了便於說明而舉例,本發明所主張之權利範圍自應以申請專利範圍所述為準,而非僅限於上述實施例。It should be noted that the above-mentioned many embodiments are examples for convenience of explanation, and the scope of the claimed rights of the present invention shall be based on the scope of the patent application, rather than being limited to the above-mentioned embodiments.

1、1a、1b、9‧‧‧椎間植入物1, 1a, 1b, 9‧‧‧ intervertebral implants

11、11a、11b‧‧‧前端11, 11a, 11b ‧‧‧ Front

12、12a、12b‧‧‧後端12, 12a, 12b ‧‧‧ back end

121、121b、91‧‧‧注入孔121, 121b, 91‧‧‧ injection holes

13、13a、13b‧‧‧側壁13, 13a, 13b‧‧‧ sidewall

131、131a、131b‧‧‧斜出孔131, 131a, 131b‧‧‧ oblique exit hole

132、132a、132b‧‧‧導引壁132, 132a, 132b‧‧‧Guide wall

14、14a、14b、92‧‧‧注入空間14, 14a, 14b, 92‧‧‧ into space

15、15b‧‧‧上表面15, 15b‧‧‧ Top surface

151、151b‧‧‧上出孔151, 151b‧‧‧

16、16b‧‧‧下表面16, 16b‧‧‧ lower surface

161、161b‧‧‧下出孔161, 161b

17、17b‧‧‧容置空間17, 17b‧‧‧ accommodation space

171、172b、93‧‧‧出孔171, 172b, 93‧‧‧ outlets

172、172b、94‧‧‧側出孔172, 172b, 94‧‧‧ side exit

18b‧‧‧分流壁18b‧‧‧ split wall

2‧‧‧刀具2‧‧‧ cutter

80‧‧‧椎間盤80‧‧‧Intervertebral Disc

81、82‧‧‧椎骨81, 82‧‧‧ vertebra

L‧‧‧長度L‧‧‧ length

M‧‧‧移動方向M‧‧‧ direction of movement

P‧‧‧被植入方向P‧‧‧ implantation direction

R1、R2、R3‧‧‧孔徑R1, R2, R3 ‧‧‧ Aperture

S20~S40‧‧‧步驟S20 ~ S40‧‧‧‧Steps

q1、q2‧‧‧預定角度q1, q2‧‧‧ predetermined angle

圖1為習知椎間植入物的外觀示意圖。 圖2為本發明之椎間植入物之第一實施例的示意圖。 圖3A為圖2所示之椎間植入物的部分剖面示意圖。 圖3B為圖3A所示之椎間植入物之另一視角的部分剖面示意圖。 圖4為圖3A所示之椎間植入物的俯視圖。 圖5A為圖2所示之椎間植入物的製造方法的步驟流程圖。 圖5B為圖5A所示之步驟S30的示意圖。 圖5C為圖5A所示之步驟S40的示意圖。 圖6A為圖2所示之椎間植入物植入椎間盤的側視圖。 圖6B為圖6A所示之椎間植入物植入椎間盤的俯視圖。 圖7為本發明之椎間植入物之第二實施例的示意圖。 圖8A為圖2所示之椎間植入物的部分剖面示意圖。 圖8B為圖8A所示之椎間植入物之另一視角的部分剖面示意圖。 圖9為圖8A所示之椎間植入物的俯視圖。FIG. 1 is a schematic view of a conventional intervertebral implant. FIG. 2 is a schematic diagram of a first embodiment of the intervertebral implant of the present invention. 3A is a schematic partial cross-sectional view of the intervertebral implant shown in FIG. 2. 3B is a schematic partial cross-sectional view of the intervertebral implant shown in FIG. 3A from another perspective. FIG. 4 is a top view of the intervertebral implant shown in FIG. 3A. FIG. 5A is a flowchart of steps in a method of manufacturing the intervertebral implant shown in FIG. 2. FIG. 5B is a schematic diagram of step S30 shown in FIG. 5A. FIG. 5C is a schematic diagram of step S40 shown in FIG. 5A. FIG. 6A is a side view of the intervertebral implant implanted into the intervertebral disc shown in FIG. 2. FIG. 6B is a top view of the intervertebral implant implanted into the intervertebral disc shown in FIG. 6A. FIG. 7 is a schematic diagram of a second embodiment of the intervertebral implant of the present invention. FIG. 8A is a schematic partial cross-sectional view of the intervertebral implant shown in FIG. 2. 8B is a schematic partial cross-sectional view of the intervertebral implant shown in FIG. 8A from another perspective. FIG. 9 is a top view of the intervertebral implant shown in FIG. 8A.

Claims (19)

一種椎間植入物,包括:一前端;一後端,該前端與該後端是相對於該椎間植入物的一被植入方向,該後端具有一注入孔;以及二側壁,至少該二側壁的其中之一具有一斜出孔,該斜出孔是由該後端朝向該前端並向外斜的方向開設於該側壁上,且該斜出孔與該注入孔連通。An intervertebral implant includes: a front end; a rear end, the front end and the rear end being an implanted direction relative to the intervertebral implant, the rear end having an injection hole; and two side walls, At least one of the two side walls has an oblique exit hole, the oblique exit hole is opened on the side wall from the rear end toward the front end and inclined outward, and the oblique exit hole is in communication with the injection hole. 如申請專利範圍第1項所述之椎間植入物,更包括:一注入空間,其形成於該椎間植入物的內部,並與該注入孔連通。The intervertebral implant according to item 1 of the patent application scope further includes: an injection space formed in the interior of the intervertebral implant and communicating with the injection hole. 如申請專利範圍第2項所述之椎間植入物,其中該斜出孔係透過與該注入空間連通,而連通該注入孔。The intervertebral implant according to item 2 of the scope of patent application, wherein the oblique exit hole communicates with the injection hole by communicating with the injection space. 如申請專利範圍第1項所述之椎間植入物,其中該斜出孔靠近該前端之一側為一導引壁。The intervertebral implant according to item 1 of the patent application scope, wherein one side of the oblique exit hole near the front end is a guide wall. 如申請專利範圍第4項所述之椎間植入物,其中該導引壁與該被植入方向之間具有一預定角度,該預定角度大於90度。The intervertebral implant according to item 4 of the scope of patent application, wherein the guide wall and the implanted direction have a predetermined angle, and the predetermined angle is greater than 90 degrees. 如申請專利範圍第4項所述之椎間植入物,其中該椎間植入物包括二該斜出孔、二該導引壁以及一分流壁,該分流壁位於二該導引壁交界處。The intervertebral implant according to item 4 of the scope of patent application, wherein the intervertebral implant includes two oblique exit holes, two guide walls, and a shunt wall, and the shunt wall is located at the junction of the two guide walls. Office. 如申請專利範圍第1項所述之椎間植入物,更包括:一容置空間,其形成於該椎間植入物的內部,且靠近該前端。The intervertebral implant according to item 1 of the patent application scope further includes: an accommodation space formed inside the intervertebral implant and close to the front end. 如申請專利範圍第7項所述之椎間植入物,其中至少該二側壁的其中之一具有一側出孔,其係與該容置空間連通。The intervertebral implant according to item 7 of the scope of patent application, wherein at least one of the two side walls has a side exit hole, which is in communication with the accommodation space. 如申請專利範圍第1項所述之椎間植入物,更包括:一上表面,其具有一上出孔;以及一下表面,其具有一下出孔,該上出孔與該下出孔相互連通。The intervertebral implant according to item 1 of the scope of patent application, further comprising: an upper surface having an upper exit hole; and a lower surface having a lower exit hole, and the upper exit hole and the lower exit hole are mutually Connected. 一種椎間植入物,包括:一前端;一後端,該前端與該後端是相對於該椎間植入物的一被植入方向,該後端具有一注入孔;以及二側壁,至少該二側壁的其中之一具有一斜出孔,該斜出孔是由該後端向該前端並向外斜的方向開設於該側壁上,並與該注入孔連通,且該斜出孔靠近該前端之一側為一導引壁,該導引壁與該被植入方向之間具有一預定角度,該預定角度大於90度。An intervertebral implant includes: a front end; a rear end, the front end and the rear end being an implanted direction relative to the intervertebral implant, the rear end having an injection hole; and two side walls, At least one of the two side walls has an oblique exit hole, the oblique exit hole is opened on the side wall from the rear end to the front end and obliquely outward, and communicates with the injection hole, and the oblique exit hole A side near the front end is a guide wall, and the guide wall and the implanted direction have a predetermined angle, and the predetermined angle is greater than 90 degrees. 如申請專利範圍第10項所述之椎間植入物,更包括:一注入空間,其形成於該椎間植入物的內部,並與該注入孔連通;以及二該斜出孔,二該斜出孔位於該注入空間的相對二側。The intervertebral implant according to item 10 of the scope of patent application, further comprising: an injection space formed inside the intervertebral implant and communicating with the injection hole; and two the oblique exit hole, two The oblique exit holes are located on opposite sides of the injection space. 如申請專利範圍第10項所述之椎間植入物,更包括:一容置空間,其形成於該椎間植入物的內部,且靠近該前端;以及一上表面,具有一上出孔,該上出孔的孔徑大於或等於該容置空間的孔徑。The intervertebral implant according to item 10 of the patent application scope further includes: an accommodation space formed inside the intervertebral implant and close to the front end; and an upper surface having an upper exit The hole has a diameter larger than or equal to the diameter of the accommodating space. 一種椎間植入物,包括:一前端;一後端,該前端與該後端是相對於該椎間植入物的一被植入方向,該後端具有一注入孔;二側壁,分別具有一斜出孔,該斜出孔是由該後端向該前端並向外斜的方向開設於該側壁上,並與該注入孔連通,且該斜出孔靠近該前端之一側為一導引壁;以及一分流壁,位於該二側壁之該導引壁交界處。An intervertebral implant includes: a front end; a rear end, the front end and the rear end being an implanted direction relative to the intervertebral implant, the rear end having an injection hole; two side walls, respectively The oblique exit hole is opened on the side wall from the rear end to the front end and obliquely outwards, and communicates with the injection hole, and the oblique exit hole is close to one side of the front end. A guide wall; and a diverting wall at the junction of the guide walls of the two side walls. 如申請專利範圍第13項所述之椎間植入物,其中該導引壁與該被植入方向之間具有一預定角度,該預定角度大於90度。The intervertebral implant according to item 13 of the patent application, wherein the guide wall and the implantation direction have a predetermined angle, and the predetermined angle is greater than 90 degrees. 如申請專利範圍第13項所述之椎間植入物,更包括:一容置空間,其形成於該椎間植入物的內部,且靠近該前端;以及一上表面,具有一上出孔,該上出孔的孔徑小於該容置空間的孔徑。The intervertebral implant according to item 13 of the scope of patent application, further comprising: an accommodation space formed inside the intervertebral implant and close to the front end; and an upper surface having an upper exit The hole has a diameter smaller than that of the accommodating space. 一種椎間植入物之製造方法,包括下列步驟:提供一椎間植入物,該椎間植入物包括一前端、一後端及二側壁;提供一治具,固定該椎間植入物;提供一刀具,該刀具與該椎間植入物的一被植入方向之間具有一預定角度,該預定角度大於90度;以及該刀具於該二側壁的其中之一進行加工,以形成由該後端向該前端並向外斜的方向延伸的該斜出孔。A method for manufacturing an intervertebral implant includes the following steps: providing an intervertebral implant including a front end, a rear end, and two side walls; providing a jig to fix the intervertebral implant Providing a tool having a predetermined angle between the tool and an implanted direction of the intervertebral implant, the predetermined angle being greater than 90 degrees; and processing the tool on one of the two side walls to The oblique exit hole extending from the rear end toward the front end and obliquely outward is formed. 如申請專利範圍第16項所述之椎間植入物之製造方法,其中該斜出孔靠近該前端之一側為一導引壁,且該導引壁與該被植入方向之間具有該預定角度。The method for manufacturing an intervertebral implant according to item 16 of the application, wherein a side of the oblique exit hole near the front end is a guide wall, and the guide wall and the implantation direction have a The predetermined angle. 如申請專利範圍第16項所述之椎間植入物之製造方法,其中該研磨刀以類橢圓形的一旋轉軌跡於該二側壁的其中之一進行研磨。According to the method for manufacturing an intervertebral implant according to item 16 of the scope of the patent application, wherein the grinding knife grinds one of the two side walls with an ellipse-like rotation track. 如申請專利範圍第16項所述之椎間植入物之製造方法,其中該研磨刀為圓柱形或水滴形。The method for manufacturing an intervertebral implant according to item 16 of the patent application, wherein the grinding knife is cylindrical or water drop-shaped.
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