TW201620463A - Manufacturing method of mineralized scaffold and device therefor - Google Patents

Manufacturing method of mineralized scaffold and device therefor Download PDF

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TW201620463A
TW201620463A TW103141858A TW103141858A TW201620463A TW 201620463 A TW201620463 A TW 201620463A TW 103141858 A TW103141858 A TW 103141858A TW 103141858 A TW103141858 A TW 103141858A TW 201620463 A TW201620463 A TW 201620463A
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mineralized
carrier
chamber
stent
manufacturing
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TW103141858A
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TWI562769B (en
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qi-chang Lin
Yi-Kuan Yang
ye-song Gu
Shu-Juan Fu
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Univ Tunghai
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Abstract

A manufacturing method of mineralized scaffold and a device therefor are disclosed. The disclosed mineralized scaffold manufacturing device includes a bioscaffold having a pre-determined shape, an imaginary baseline extending from one end of the bioscaffold to the other thereof, a chamber having a space accommodating the bioscaffold and formed a corresponding sub-chamber space at two sides of the bioscaffold along the baseline. The disclosed is characterized by having the baseline as an axis, and the radial inner diameter of each sub-chamber space is gradually increased or decreased in sequence.

Description

礦化支架之製造方法及其裝置 Method and device for manufacturing mineralized stent

本發明係與組織工程有關,特別是關於一種礦化支架之製造方法及其裝置。 The present invention relates to tissue engineering, and more particularly to a method of manufacturing a mineralized stent and apparatus therefor.

按,組織工程者係指於一仿生之生物支架中植入細胞,使細胞於該生物支架上生長成為新的組織與器官,而供人體缺損組織之修復者,於習知技術中,常被作為生物支架之材料者,則有如天然之膠原蛋白、幾丁聚醣、透明質酸、褐藻膠、明膠等,以及人造之聚乳酸、聚乙醇酸、聚乳酸-甘醇酸、聚己內酯等各種不同之高分子材料。 According to the tissue engineer, the cells are implanted in a biomimetic scaffold, so that the cells grow into new tissues and organs on the bioscaffold, and the repairers for the human defect tissue are often used in the prior art. As a material for biological scaffolds, there are natural collagen, chitosan, hyaluronic acid, alginate, gelatin, etc., as well as artificial polylactic acid, polyglycolic acid, polylactic acid-glycolic acid, polycaprolactone. And a variety of different polymer materials.

而其中,人造之高分子材料,於細胞辨識性上固然不及天然高分子材料,但相較於天然高分子材料取得來源之有限性與較差之機械強度而言,人造之高分子材料,則可經由合成而大量生產,並可控制其尺寸與結構強度,相較之下,人造之高分子材料係更適於被廣泛應用於組織工程之產業領域中。 Among them, the artificial polymer material is not as good as the natural polymer material in cell identification, but compared with the limited source and poor mechanical strength of the natural polymer material, the artificial polymer material can be It is mass-produced through synthesis and can control its size and structural strength. In contrast, artificial polymer materials are more suitable for use in the industrial field of tissue engineering.

囿於人造高分子材料有於細胞辨識性上不及天然高分子材料之事實存在者,例如聚乳酸-甘醇酸雖不失為一良好之生物支架材料,但由於其表面疏水性強、細胞之親和力較差,造成其於產業應用上受到若干之侷限,而為改善是項缺失,於習知技術中乃有以礦化之技術手段對其表面進行改質,使生物支架之表面形成礦化層,從而提高其生物相容性與細 胞之親和性,習知技術中並有指出:於生物支架上形成類骨磷灰石層者乃係於生物支架上直接成骨之先決條件(Kokubo T.Novel biomedical materials based on glasses[J].Materials Science Forum.1999,293:65-82.)。 The fact that artificial polymer materials are inferior to natural polymer materials in cell identification, such as polylactic acid-glycolic acid, is a good biological scaffold material, but its surface is hydrophobic and the affinity of cells is poor. As a result of its limitations in industrial applications, and in order to improve the lack of it, in the conventional technology, the surface of the bio-scaffold is modified to form a mineralized layer. Improve its biocompatibility and fineness Affinity of cells, it is pointed out in the prior art that the formation of bone-like apatite layers on biological scaffolds is a prerequisite for direct bone formation on biological scaffolds (Kokubo T.Novel biomedical materials based on glasses[J] .Materials Science Forum. 1999, 293: 65-82.).

習知用以使生物支架表面形成礦化層之具體技術內容,大抵上乃係將所擬礦化之生物支架置入特定組成成分之過飽和溶液中,使溶液中之成分成核生長於支架之表面,從而於生物支架之表面形成礦化層者,是等之習知技術,固得達成使生物支架表面形成礦化層,惟因其欠缺對該礦化層形成之控制,因此,習知技術於實施後所獲得者僅係為單一型態結晶與密度之礦化層,雖仍得以達成對生物支架材料表面改質之目的,但未能增加該等生物支架於組織工程產業領域中之應用性。 Conventionally, the specific technical content for forming a mineralized layer on the surface of a biological stent is basically to place the biological stent to be mineralized into a supersaturated solution of a specific composition, so that the components in the solution are nucleated and grown on the stent. The surface, thus forming a mineralized layer on the surface of the biological scaffold, is a conventional technique that is solidified to form a mineralized layer on the surface of the bioscaffold, but because of its lack of control over the formation of the mineralized layer, therefore, The technology obtained after the implementation is only a single type of crystallized and dense mineralized layer, although the purpose of modifying the surface of the biological scaffold material is still achieved, but the bioscaffold is not increased in the field of tissue engineering industry. Application.

因此,本發明之主要目的即係在提供一種礦化支架之製造方法及其裝置,其主要之技術特徵乃藉由使製造生物支架之裝置內部腔室空間之變化,形成具有濃度梯度之環境,據以於該生物支架之表面上形成不同密度與擴散範圍之礦化層,俾以令所製成之生物支架各部位之表面上具有不等程度之沉積礦物,使其更適於組織工程之利用。 Accordingly, the main object of the present invention is to provide a method and apparatus for manufacturing a mineralized stent, the main technical feature of which is to form an environment having a concentration gradient by changing a space in a chamber of a device for manufacturing a biological stent. According to the formation of a mineralized layer of different density and diffusion range on the surface of the biological scaffold, the surface of the biological scaffold made by the various parts of the bio-scaffold has an unequal amount of deposited minerals, making it more suitable for tissue engineering. use.

緣是,為達成上述之目的,本發明所提供礦化支架之製造裝置乃係包含有一預定形狀之生物支架:一假想之基準線,係自該生物支架之一端延伸至另一端;一腔室部,係以空間容納該生物支架,並沿該基準線於該生物支架之兩側分別形成一對應之子室空間;而其特徵則係在於,以該基準線為軸,各該子室空間之徑向內徑係呈依序漸次增加或減少者。 In order to achieve the above object, the apparatus for manufacturing a mineralized stent provided by the present invention comprises a biological stent having a predetermined shape: an imaginary reference line extending from one end of the biological stent to the other end; a chamber a space for accommodating the biological support, and respectively forming a corresponding sub-chamber space on both sides of the biological support along the reference line; and the feature is that the reference line is an axis, and each of the sub-chamber spaces The radial inner diameter is gradually increasing or decreasing in sequence.

具體而言,係得以該基準線為軸,令各該子室空間於同一方向之內徑變化,一者係為漸減,另一者則為漸增。 Specifically, the reference line is the axis, and the inner diameter of each of the sub-chamber spaces is changed in the same direction, one is gradually decreasing, and the other is increasing.

其中,為便於改變各該子室空間之內徑尺寸,該礦化支架之製造裝置乃係更包含了有一中空之主體,係以中空之內部空間形成該腔室部,具有一中空之身部,二端部,係分設於該身部之兩端,二進流道,係分設於各該端部上,並各自與該身部之中空內部連通,且於對應端部之一端形成進流口;一載件,亙陳於該身部中,介於各該端部之間,用以載設該生物支架。 In order to facilitate changing the inner diameter of each of the sub-chamber spaces, the manufacturing device of the mineralized stent further comprises a hollow body, which is formed by a hollow inner space, and has a hollow body. The two ends are respectively disposed at two ends of the body, and the two inlet passages are respectively disposed on the respective ends, and each communicates with the hollow interior of the body portion, and is formed at one end of the corresponding end portion. Inflow port; a carrier member, in the body, between each of the ends for carrying the biological support.

其中,該載件係呈板狀,容納於該身部中,並橋接於該身部內側之相向室壁上。 Wherein, the carrier is in the shape of a plate, is accommodated in the body, and is bridged on the opposite chamber wall on the inner side of the body.

其中,該載件係更包含有一板狀載體,二樞軸係彼此同軸地分設於該載體之兩側,且樞接於該身部之對應室壁上,據以使該載體得以之為轉軸而於該主體內部空間轉動。 Wherein, the carrier further comprises a plate-shaped carrier, and the two pivoting systems are disposed coaxially on the two sides of the carrier and pivotally connected to the corresponding chamber wall of the body, so that the carrier can be The shaft rotates in the interior space of the body.

其中,該生物支架係呈薄片狀,並設於該載體上。 Wherein, the biological scaffold is in the form of a sheet and is disposed on the carrier.

其中,該載件係更包含有一磁鐵或感磁體,係設於該載體遠離該轉軸之一端上。 Wherein, the carrier further comprises a magnet or a magnet, disposed on the carrier away from one end of the rotating shaft.

其中,各該端部係分別呈中空,並以中空之內部空間分別形成各該子室空間。 Each of the end portions is hollow, and each of the sub-chamber spaces is formed by a hollow inner space.

另外,為使本發明所提供礦化支架之製造裝置於產業之應用上更為靈活,則使其具體之構造係包含了有一中空之主體,具有一預定形狀之中空身部,二端部,係分設於該中空身部之兩端,二進流道,係分設於各該端部中,並與該身部之中空內部連通,且個別地於對應端部之一端 形成進流口;一腔室部,係由該主體中空內部之空間所形成者;一載件,設於該腔室部內,具有一載體,介於各該端部之間且亙陳於該身部內,並以兩端與該身部之內側對應室壁樞接,據以使該載體得以之為轉軸而於該腔室部之空間中轉動。 In addition, in order to make the manufacturing device of the mineralized stent provided by the present invention more flexible in industrial application, the specific structure includes a hollow body having a hollow body with a predetermined shape and two ends. The system is disposed at two ends of the hollow body, and the two inlet channels are respectively disposed in each end portion and communicate with the hollow interior of the body portion, and are individually at one end of the corresponding end portion Forming an inflow port; a chamber portion formed by a space inside the hollow interior of the main body; a carrier member disposed in the chamber portion and having a carrier interposed between the end portions The body is pivotally connected to the inner wall of the body at both ends, so that the carrier can be rotated as a shaft and rotate in the space of the chamber portion.

俾得使該載體於該腔室部中之傾斜狀態得以獲的調整,乃至於得以使該載體呈水平狀態,而令位於該載體兩側之子室空間之內徑尺寸分別呈單一者。 The slanting state of the carrier in the chamber portion is adjusted so that the carrier is horizontal, and the inner diameters of the sub-chamber spaces on both sides of the carrier are respectively single.

其中,該載件係更包含有二樞軸,係彼此同軸地分設於該載體之兩端上,而與該身部內側之對應室壁樞接。 The carrier further includes two pivots which are coaxially disposed on both ends of the carrier and are pivotally connected to the corresponding chamber walls on the inner side of the body.

其中,該身部之兩端係呈透空並分別受各該端部所封閉。 Wherein, the two ends of the body are emptied and are respectively closed by the ends.

其中,該載件係更包含有一磁體或感磁體,係設於該載體遠離該轉軸之一端上。 Wherein, the carrier further comprises a magnet or a magnet, disposed on the carrier away from one end of the rotating shaft.

另外,前述礦化支架之製造裝置係得以應用於礦化支架之製造方法中,該製造方法具體而言者,乃係將生物支架容設於一封閉腔室空間中,並將用以形成礦化層之溶液注入該腔室空間內,據以使無機物得以於該生物支架之表面成核生長為礦化層;而其特徵則係在於以該生物支架為基準,該腔室空間位於該生物支架兩側之部分空間之內徑係分別呈依序漸次增加或減少者。 In addition, the manufacturing device of the mineralized stent is applied to a method for manufacturing a mineralized stent, and the manufacturing method specifically includes housing the biological stent in a closed chamber space and is used to form a mine. a solution of the layer is injected into the chamber space, so that the inorganic substance can be nucleated to form a mineralized layer on the surface of the biological scaffold; and the feature is that the chamber space is located on the organism based on the biological scaffold The inner diameters of the partial spaces on both sides of the stent are gradually increasing or decreasing in sequence.

其中,該腔室空間位於該生物支架兩側之各該部分空間之內徑變化係彼此相反。 Wherein, the inner diameter of each of the chamber spaces on the two sides of the biological support is opposite to each other.

(10)(10’)‧‧‧礦化支架之製造裝置 (10) (10') ‧ ‧ Manufacture of mineralized stents

(20)‧‧‧主體 (20) ‧‧‧ Subject

(21)‧‧‧身部 (21)‧‧‧ Body

(22)(22’)‧‧‧端部 (22) (22’) ‧ ‧ end

(221’)‧‧‧殼體 (221’) ‧‧‧shell

(222’)‧‧‧開口 (222’) ‧ ‧ openings

(23)‧‧‧進流道 (23) ‧‧‧ Inflow

(231)‧‧‧進流口 (231)‧‧‧ Inlet

(30)(30’)‧‧‧腔室部 (30) (30') ‧ ‧ Chambers

(31)(32)‧‧‧子室空間 (31) (32) ‧ ‧ sub-room space

(40)(40’)‧‧‧載件 (40) (40’) ‧‧‧Send

(41)‧‧‧載體 (41) ‧ ‧ carrier

(42)‧‧‧樞軸 (42) ‧‧‧ pivot

(43)‧‧‧感磁體 (43)‧‧‧Magnetic magnets

(44)‧‧‧固定片 (44) ‧‧‧Fixed tablets

(45)(45’)‧‧‧墊片 (45) (45') ‧ ‧ shims

(46)(46’)‧‧‧穿孔 (46) (46’) ‧ ‧ perforation

(50)(50’)‧‧‧生物支架 (50) (50’) ‧ ‧ biological stent

(d)‧‧‧基準線 (d) ‧ ‧ baseline

第一圖係本發明一較佳實施例之分解立體圖。 The first figure is an exploded perspective view of a preferred embodiment of the present invention.

第二圖係本發明一較佳實施例之組合立體圖。 The second drawing is a combined perspective view of a preferred embodiment of the present invention.

第三圖係本發明一較佳實施例沿第二圖a-a割線之剖視圖。 Figure 3 is a cross-sectional view of a preferred embodiment of the present invention taken along the line a-a of Figure 2;

第四圖係本發明一較佳實施例對第三圖之簡化示意圖。 The fourth figure is a simplified schematic diagram of a third embodiment of a preferred embodiment of the present invention.

第五圖係本發明一較佳實施例沿第二圖a-a割線之剖視圖。 Figure 5 is a cross-sectional view of a preferred embodiment of the present invention taken along the line a-a of Figure 2;

第六圖係本發明一較佳實施例對第五圖之簡化示意圖。 Figure 6 is a simplified schematic view of a fifth embodiment of a preferred embodiment of the present invention.

第七圖係本發明另一較佳實施例之分解立體圖。 Figure 7 is an exploded perspective view of another preferred embodiment of the present invention.

第七圖係本發明另一較佳實施例之組合立體圖。 Figure 7 is a perspective view of a combination of another preferred embodiment of the present invention.

第九圖係本發明另一較佳實施例沿第八圖9-9割線之剖視圖。 Figure 9 is a cross-sectional view of another preferred embodiment of the present invention taken along the line sec of Figure 9-9.

首先,請參閱第一圖至第六圖所示,在本發明一較佳實施例中所提供礦化支架之製造裝置(10)者,其主要乃係包含了有一主體(20)、一腔室部(30)、一載件(40)以及多數之生物支架(50)。 First, referring to the first to sixth figures, in the manufacturing apparatus (10) of the mineralized stent provided in a preferred embodiment of the present invention, the main body comprises a main body (20) and a cavity. The chamber portion (30), a carrier member (40), and a plurality of biological stents (50).

該主體(20)係呈中空,具有一身部(21),係呈兩端透空之中空殼體,二端部(22)係分設於該身部(21)之兩端開口上,用以將該身部(21)之兩端開口予以封閉,二進流道(23),係分設於各該端部(22)上,而與該身部(21)之中空內部空間連通,且各自於對應之端部(22)之一端形成進流口(231)。 The main body (20) is hollow and has a body portion (21), which is a hollow shell with two ends permeable, and the two end portions (22) are respectively disposed on the openings at both ends of the body portion (21). The two ends of the body (21) are closed, and the two inlet channels (23) are respectively disposed on the end portions (22) to communicate with the hollow inner space of the body portion (21). And each of them forms an inlet port (231) at one end of the corresponding end portion (22).

該腔室部(30)係為由該主體(20)中空內部之空間所形成之容納空間。 The chamber portion (30) is an accommodation space formed by a space inside the hollow portion of the main body (20).

該載件(40)係概呈板狀,容納於該腔室部(30)中,以兩側相背板端樞接於該身部(21)之內側對應室壁上,並介於各該端部(22)之間,俾 使該載件(40)得以其與該身部(21)樞接之軸為轉軸而於該腔室部(30)之空間中轉動。 The carrier member (40) is substantially plate-shaped and is received in the chamber portion (30), and is pivotally connected to the inner wall of the body portion (21) on both sides of the body portion (21), and is interposed therebetween. Between the ends (22), 俾 The carrier (40) is rotated in the space of the chamber portion (30) by the shaft pivotally connected to the body portion (21).

各該生物支架(50)係為由合成高分子材料所製成之薄膜片狀體,分別設於該載件(40)上,而可隨該載件(40)之轉動而於該腔室部(30)中異動其位置。 Each of the biological scaffolds (50) is a film sheet body made of a synthetic polymer material, which is respectively disposed on the carrier member (40), and is rotatable with the carrier member (40) in the chamber. The position of the part (30) is changed.

據此,該礦化支架之製造裝置(10)係得以應用於礦化支架之製造方法者,亦即係以習知礦化作用之方法,將兩相異組成溶液分別經由各該端部(22)上之進流口(231),各自注入該腔室部(30)中,俾以於各該生物支架(50)之表面進行成核生長之礦化作用,從而達到對該生物支架(50)表面改質之目的及功效者。 Accordingly, the manufacturing device (10) of the mineralized stent is applied to a method for manufacturing a mineralized stent, that is, by a method of mineralization, a two-phase different composition solution is respectively passed through each end portion ( 22) The upper inflow port (231) is injected into the chamber portion (30), and the mineralization of the nucleation growth is performed on the surface of each of the biological scaffolds (50), thereby achieving the biological scaffold ( 50) The purpose and function of surface modification.

同時,為達到使各該生物支架(50)表面各部位之礦化程度有別之目的及效果,係以各該生物支架(50)所在之平面為一假想之基準線(d),而使該腔室部(30)沿該基準線(d)於各該生物支架(50)兩側分別形成一對應之子室空間(31)(32),並以該基準線(d)為軸,使各該子室空間(31)(32)之徑向內徑分別呈依序遞減或遞增者,從而於各該生物支架(50)各個部位之兩側,由該腔室部(30)分別形成不同容積之空間,據以於各該生物支架(50)之不同部位提供不同總量之溶質,達到使各該生物支架(50)之各部位具有不同礦化程度之目的及效果者。 At the same time, in order to achieve the purpose and effect of the degree of mineralization of each part of the surface of each biological scaffold (50), the plane in which each bioscaffold (50) is located is an imaginary reference line (d). The chamber portion (30) forms a corresponding sub-chamber space (31) (32) on each side of each of the biological supports (50) along the reference line (d), and the reference line (d) is used as an axis. The radial inner diameters of the sub-chamber spaces (31) (32) are sequentially decreased or increased, respectively, so as to be formed by the chamber portions (30) on both sides of each part of the biological stent (50). Different volumes of space provide different amounts of solutes in different parts of the biological scaffold (50), so as to achieve the purpose and effect of different mineralization levels of each part of the bioscaffold (50).

為達到使各該子室空間(31)(32)之內徑產生變化,係可使該載件(40)於該腔室部(30)中轉動,以偏轉該基準線,從而達到使各該子室空間(31)(32)之內徑一呈遞減、另一則呈遞增之變化者。 In order to change the inner diameter of each of the sub-chamber spaces (31) (32), the carrier (40) can be rotated in the chamber portion (30) to deflect the reference line, thereby achieving The inner diameter of the sub-chamber space (31) (32) is decreasing, and the other is increasing in increments.

而具體地,該載件(40)乃係具有了一中空之板狀載體(41), 係亙陳於該腔室部(30)中,二樞軸(42)係彼此同軸地分別突設於該載體(41)之兩側相背板端,而與該身部(21)內側室壁對應樞接,用以構成該轉軸,使該載體(41)得以之為軸而為轉動。 Specifically, the carrier (40) has a hollow plate-shaped carrier (41). The system is in the chamber portion (30), and the two pivots (42) are respectively coaxially disposed on the opposite sides of the carrier (41), and the inner chamber of the body (21) The wall is pivotally connected to form the rotating shaft, so that the carrier (41) can be rotated as an axis.

而為使位於呈封閉狀之該腔室部(30)內部之該載件(40)得以受控制地進行轉動,係可於該載件(40)遠離該轉軸之一端設置適當之磁鐵或感磁體(43),俾得於該主體(20)之外部,經由外部之感磁體或外部之磁鐵(圖上未示)與該磁鐵或感磁體(43)間之磁力作用,據以使該載件(40)進行對之轉動者。 To enable the carrier (40) located inside the closed chamber portion (30) to be controlled to rotate, a suitable magnet or sense can be placed on the carrier (40) away from one end of the shaft. a magnet (43), which is external to the main body (20), acts on the magnetic force between the external magnet or an external magnet (not shown) and the magnet or the magnet (43), so that the load The piece (40) is turned on.

而為使呈薄膜片狀之各該生物支架(50)適當地結合於該載件(40)上,於本實施例中,係使該載件(40)更包含了有一對彼此平行之固定片(44),係插設於該載件(40)中,一對彼此平行之墊片(45),係夾置於各該固定片(44)之間,多數之穿孔(46)係分別貫穿各該固定片(44)與各該墊片(45),孔徑並分別小於各該生物支架(50)之外徑,俾使各該生物支架(50)得以受夾於各該墊片(45)間且經由對應之穿孔(46)而顯露,得以與該腔室部(30)之空間接觸。 In order to properly bond each of the biological stents (50) in the form of a film sheet to the carrier member (40), in the embodiment, the carrier member (40) further comprises a pair of parallel fixings. The sheet (44) is inserted into the carrier (40), and a pair of spacers (45) parallel to each other are sandwiched between the fixing pieces (44), and the plurality of perforations (46) are respectively Through the respective fixing pieces (44) and each of the spacers (45), the apertures are smaller than the outer diameters of the respective biological brackets (50), so that the biological brackets (50) are clamped to the respective spacers ( 45) is exposed through the corresponding perforation (46) to be in contact with the space of the chamber portion (30).

於此所應再進一步說明者係,於上開實施例所提供之該礦化支架之製造裝置(10)中,藉由其可轉動之該載件(40)以承載各該生物支架(50)之具體構造,係可控制該載件(40)之轉動角度,以調整各該子室空間(31)(32)內徑之變化,俾以因應實際產業上之需求者,因此,倘產業上有具體之需求時,亦得以使該礦化支架之製造裝置(10)於使用上不排除使各該子室空間(31)(32)之內徑分別呈單一之狀態者,此即有如第五圖與第六圖所示者。 In the manufacturing device (10) of the mineralized stent provided in the above embodiment, the carrier (40) is rotatable to carry each of the biological stents (50). The specific configuration is to control the rotation angle of the carrier (40) to adjust the variation of the inner diameter of each of the sub-chamber spaces (31) (32), so as to meet the actual industrial needs, therefore, if the industry When there is a specific need, the manufacturing device (10) of the mineralized stent can also be used in a state in which the inner diameters of the sub-chamber spaces (31) and (32) are respectively in a single state. The figures shown in the fifth and sixth figures.

另外,用以使生物支架兩側空間之內徑產生變化之具體技術內容並非僅侷限於前述實施例所具體揭露者,其亦得以如第七圖至第九圖所示本發明另一較佳實施例中揭之礦化支架之製造裝置(10’)般,在構件上更為精簡。 In addition, the specific technical content for changing the inner diameter of the space on both sides of the biological support is not limited to the specific disclosure of the foregoing embodiment, and it is also another preferred embodiment of the present invention as shown in the seventh to ninth embodiments. In the same manner as the manufacturing device (10') of the mineralized stent disclosed in the embodiment, the member is more compact.

具體而言,本實施例中所揭之該礦化支架之製造裝置(10’)乃係具有二端部(22’)、一腔室部(30’)、一載件(40’)以及多數之生物支架(50’)者,其中:各該端部(22’)係分別具有一中空之楔形殼體(221’),一開口(222’)係開設於該殼體(221’)之一側並彼此同軸相向對應者。 Specifically, the manufacturing device (10') of the mineralized stent disclosed in the embodiment has a two-end portion (22'), a chamber portion (30'), a carrier member (40'), and In most biological stents (50'), each of the ends (22') has a hollow wedge-shaped casing (221'), and an opening (222') is opened in the casing (221'). One side and the other side facing each other coaxially.

該載件(40’)係受夾於各該端部(22’)之間,具有彼此平行之二墊片(45’),多數之穿孔(46’)係分別貫設於各該墊片(45’)上,內徑並略小於各該生物支架(50’)之外徑,並與各該開口(222’)連通。 The carrier (40') is sandwiched between the ends (22') and has two spacers (45') parallel to each other, and a plurality of perforations (46') are respectively disposed on the spacers. (45'), the inner diameter is slightly smaller than the outer diameter of each of the biological stents (50'), and is in communication with each of the openings (222').

各該生物支架(50’)係分別為薄膜片狀體,各自受夾於各該墊片(45’)之間,且經由對應之穿孔(46’)而顯露於各該開口(222’)空間範圍內。 Each of the bio-scaffolds (50') is a film sheet-like body, each of which is sandwiched between each of the spacers (45'), and is exposed to each of the openings (222') via a corresponding perforation (46'). Within the space.

該腔室部(30’)實質上係由各該殼體(221’)之內部空間以及經由各該開口(222’)而彼此連通之各該穿孔(46’)所形成者,並藉由個該殼體(221’)之三角形內部空間,而於各該生物支架(50’)之兩側形成內徑具有變化之子室空間(31’)(32’),從而達到與前述實施例藉由轉動載件所達成使子室空間內徑產生變化之相同功效者。 The chamber portion (30') is substantially formed by an inner space of each of the housings (221') and each of the perforations (46') communicating with each other via the openings (222'), and by a triangular inner space of the casing (221'), and a sub-chamber space (31') (32') having a different inner diameter is formed on both sides of each of the biological supports (50'), thereby achieving the borrowing from the foregoing embodiment. The same effect is achieved by rotating the carrier to change the inner diameter of the sub-chamber space.

換言之,該礦化支架之製造裝置(10’)於支架之礦化作用實施之應用上,亦得藉由以各該生物支架(50’)所在之平面為基準線,並以該基準線為軸,令位於各該生物支架(50’)兩側之各該子室空間(31’)(32’)之徑向 內徑,一呈遞增變化,另一則呈遞減變化者,從而達到與前述實施例般,令所形成之礦化層在不同部位具有不同之沉積狀態者。 In other words, the manufacturing device (10') of the mineralized stent is applied to the mineralization of the stent, and the plane in which the biological stent (50') is located is used as a reference line, and the reference line is a shaft, the radial direction of each of the sub-chamber spaces (31') (32') located on either side of each of the biological supports (50') The inner diameter, one is incrementally changed, and the other is a decreasing one, so that the formed mineralized layer has different deposition states at different locations as in the previous embodiment.

(10)‧‧‧礦化支架之製造裝置 (10) ‧ ‧ manufacturing device for mineralized stent

(20)‧‧‧主體 (20) ‧‧‧ Subject

(21)‧‧‧身部 (21)‧‧‧ Body

(22)‧‧‧端部 (22) ‧ ‧ end

(23)‧‧‧進流道 (23) ‧‧‧ Inflow

(231)‧‧‧進流口 (231)‧‧‧ Inlet

(40)‧‧‧載件 (40) ‧‧‧Ship

(41)‧‧‧載體 (41) ‧ ‧ carrier

(42)‧‧‧樞軸 (42) ‧‧‧ pivot

(43)‧‧‧感磁體 (43)‧‧‧Magnetic magnets

(44)‧‧‧固定片 (44) ‧‧‧Fixed tablets

(45)‧‧‧墊片 (45) ‧‧‧shims

(46)‧‧‧穿孔 (46) ‧‧‧Perforation

(50)‧‧‧生物支架 (50) ‧ ‧ biological stent

Claims (14)

一種礦化支架之製造裝置,包含有:一預定形狀之生物支架:一假想之基準線,係自該生物支架之一端延伸至另一端;一腔室部,係以空間容納該生物支架,並沿該基準線於該生物支架之兩側分別形成一對應之子室空間;其特徵在於:以該基準線為軸,各該子室空間之徑向內徑係呈依序漸次增加或減少者。 A manufacturing device for mineralized stents, comprising: a biological stent of a predetermined shape: an imaginary reference line extending from one end of the biological stent to the other end; a chamber portion accommodating the biological stent in a space, and A corresponding sub-chamber space is formed on each side of the biological support along the reference line; and the radial inner diameter of each of the sub-chamber spaces is gradually increased or decreased in sequence according to the reference line. 依據申請專利範圍第1項所述礦化支架之製造裝置,其中,以該基準線為軸,各該子室空間沿同一方向之內徑變化,一者係為漸減,另一者則為漸增。 According to the manufacturing apparatus of the mineralized stent according to the first aspect of the invention, wherein the reference line is the axis, the inner diameter of each of the sub-chamber spaces changes in the same direction, one is gradually decreasing, and the other is gradually decreasing. increase. 依據申請專利範圍第1或2項所述礦化支架之製造裝置,其更包含有:一中空之主體,係以中空之內部空間形成該腔室部,具有一中空之身部,二端部,係分設於該身部之兩端,二進流道,係分設於各該端部上,並各自與該身部之中空內部連通,且於對應端部之一端形成進流口;一載件,亙陳於該身部中,介於各該端部之間,用以載設該生物支架。 The manufacturing device for mineralized stent according to claim 1 or 2, further comprising: a hollow body formed by a hollow inner space having a hollow body and two ends The system is disposed at two ends of the body, and the two inlet channels are respectively disposed on each end portion, and each of them communicates with the hollow interior of the body portion, and an inflow port is formed at one end of the corresponding end portion; A carrier member is disposed in the body between the ends to carry the biological support. 依據申請專利範圍第3項所述礦化支架之製造裝置,其中,該載件係呈板狀,容納於該身部中,並橋接於該身部內側之相向室壁上。 The apparatus for manufacturing a mineralized stent according to claim 3, wherein the carrier is in the form of a plate, is received in the body, and is bridged to the opposing chamber wall on the inner side of the body. 依據申請專利範圍第4項所述礦化支架之製造裝置,其中,該載件係更包含有一板狀載體,二樞軸係彼此同軸地分設於該載體之兩側,且樞接 於該身部之對應室壁上,據以使該載體得以之為轉軸而於該主體內部空間轉動。 The apparatus for manufacturing a mineralized stent according to claim 4, wherein the carrier further comprises a plate-shaped carrier, and the two pivotal systems are coaxially disposed on opposite sides of the carrier, and are pivotally connected. On the corresponding chamber wall of the body, the carrier is rotated as a shaft to be rotated in the interior space of the body. 依據申請專利範圍第5項所述礦化支架之製造裝置,其中,該生物支架係呈薄片狀,並設於該載體上。 The apparatus for manufacturing a mineralized stent according to claim 5, wherein the biological stent is in the form of a sheet and is disposed on the carrier. 依據申請專利範圍第4項所述礦化支架之製造裝置,其中,該載件係更包含有一磁鐵或感磁體,係設於該載體遠離該轉軸之一端上。 The apparatus for manufacturing a mineralized stent according to the fourth aspect of the invention, wherein the carrier further comprises a magnet or a magnet, disposed on the carrier away from one end of the rotating shaft. 依據申請專利範圍第3項所述礦化支架之製造裝置,其中,各該端部係分別呈中空,並以中空之內部空間分別形成各該子室空間。 The apparatus for manufacturing a mineralized stent according to claim 3, wherein each of the end portions is hollow, and each of the sub-chamber spaces is formed by a hollow internal space. 一種礦化支架之製造裝置,包含有:一中空之主體,具有一預定形狀之中空身部,二端部,係分設於該中空身部之兩端,二進流道,係分設於各該端部中,並與該身部之中空內部連通,且個別地於對應端部之一端形成進流口;一腔室部,係由該主體中空內部之空間所形成者;一載件,設於該腔室部內,具有一載體,介於各該端部之間且亙陳於該身部內,並以兩端與該身部之內側對應室壁樞接,據以使該載體得以之為轉軸而於該腔室部之空間中轉動。 A manufacturing device for a mineralized stent comprises: a hollow body having a hollow body of a predetermined shape, two ends, which are respectively disposed at two ends of the hollow body, and two flow paths are respectively arranged in Each of the end portions is in communication with the hollow interior of the body portion, and an inlet port is formed at one end of the corresponding end portion; a chamber portion is formed by a space inside the hollow portion of the body; a carrier member Provided in the chamber portion, having a carrier interposed between the end portions and being in the body portion, and pivoting the two ends to the corresponding inner wall of the body portion, thereby enabling the carrier to It rotates in the space of the chamber portion as a rotating shaft. 依據申請專利範圍第9項所述礦化支架之製造裝置,其中,該載件係更包含有二樞軸,係彼此同軸地分設於該載體之兩端上,而與該身部內側之對應室壁樞接。 The apparatus for manufacturing a mineralized stent according to claim 9, wherein the carrier further comprises two pivots disposed coaxially with each other on both ends of the carrier, and the inner side of the body Corresponding to the wall of the chamber. 依據申請專利範圍第10項所述礦化支架之製造裝置,其中,該身部之兩端係呈透空並分別受各該端部所封閉。 The apparatus for manufacturing a mineralized stent according to claim 10, wherein both ends of the body are permeable and are respectively closed by the ends. 依據申請專利範圍第9項所述礦化支架之製造裝置,其中,該載件 係更包含有一磁體或感磁體,係設於該載體遠離該轉軸之一端上。 A manufacturing device for mineralized stent according to claim 9 of the patent application, wherein the carrier The system further includes a magnet or a magnet, disposed on the carrier away from one end of the rotating shaft. 一種礦化支架之製造方法,係將生物支架容設於一封閉腔室空間中,並將用以形成礦化層之溶液注入該腔室空間內,據以使無機物得以於該生物支架之表面成核生長為礦化層;其特徵係在於:以該生物支架為基準,該腔室空間位於該生物支架兩側之部分空間之內徑係分別呈依序漸次增加或減少者。 A method for manufacturing a mineralized stent, wherein a biological stent is accommodated in a closed chamber space, and a solution for forming a mineralized layer is injected into the chamber space, so that inorganic substances can be allowed on the surface of the biological stent. The nucleation grows into a mineralized layer; the characteristic is that the inner diameter of the space of the chamber on both sides of the biological support is gradually increasing or decreasing in sequence according to the biological support. 依據申請專利範圍第13項所述礦化支架之製造方法,其中,該腔室空間位於該生物支架兩側之各該部分空間之內徑變化係彼此相反。 The method for manufacturing a mineralized stent according to claim 13 , wherein the inner diameter of each of the chamber spaces on the two sides of the biological stent is opposite to each other.
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CN111449804A (en) * 2020-03-18 2020-07-28 中南大学湘雅医院 Tissue engineering scaffold mineralization device and method

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US6783793B1 (en) * 2000-10-26 2004-08-31 Advanced Cardiovascular Systems, Inc. Selective coating of medical devices
US20040013792A1 (en) * 2002-07-19 2004-01-22 Samuel Epstein Stent coating holders
US8337937B2 (en) * 2002-09-30 2012-12-25 Abbott Cardiovascular Systems Inc. Stent spin coating method
US20070286941A1 (en) * 2006-06-13 2007-12-13 Bin Huang Surface treatment of a polymeric stent

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CN111449804A (en) * 2020-03-18 2020-07-28 中南大学湘雅医院 Tissue engineering scaffold mineralization device and method
CN111449804B (en) * 2020-03-18 2022-12-20 中南大学湘雅医院 Tissue engineering scaffold mineralization method

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