TWM537881U - Surgical implant structure - Google Patents

Surgical implant structure Download PDF

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Publication number
TWM537881U
TWM537881U TW105218993U TW105218993U TWM537881U TW M537881 U TWM537881 U TW M537881U TW 105218993 U TW105218993 U TW 105218993U TW 105218993 U TW105218993 U TW 105218993U TW M537881 U TWM537881 U TW M537881U
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surgical implant
pulse
substrate
implant structure
ranges
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TW105218993U
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Chinese (zh)
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Xi-Kai Zou
zhu-liang He
Qi-Ren Zhong
xian-de Chen
Yi-Ru Yang
bing-yan Xie
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Xi-Kai Zou
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Priority to TW105218993U priority Critical patent/TWM537881U/en
Publication of TWM537881U publication Critical patent/TWM537881U/en
Priority to JP2017002173U priority patent/JP3211656U/en
Priority to DE202017103016.4U priority patent/DE202017103016U1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Inorganic Chemistry (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Physical Vapour Deposition (AREA)

Description

外科手術植入物結構Surgical implant structure

本創作為一種植入物結構，尤指一種利用高功率脈衝磁控濺鍍技術所製造，且具有高生物相容性的外科手術植入物結構。The present invention is an implant structure, especially a surgical implant structure that is manufactured using high power pulsed magnetron sputtering technology and has high biocompatibility.

聚醚醚酮（Polyetheretherketone；PEEK）由於具有低彈性係數、高拉抗強度、高抗疲勞強度、及高機械耐久性等優勢，因而相當適合作為醫療植入物的材料。然而，此種材料的生物相容性卻不佳，因此如何製作出具有高生物相容性的外塗層即為本技術領域相當重要的一項課題。Polyetheretherketone (PEEK) is quite suitable as a material for medical implants due to its low modulus of elasticity, high tensile strength, high fatigue strength, and high mechanical durability. However, the biocompatibility of such materials is not good, so how to make an outer coating with high biocompatibility is a very important topic in the technical field.

1999年高功率脈衝磁控濺鍍（High Power Impulse Magnetron Sputtering；HIPIMS）技術首度由Vladimir Kousnetzov等人於美國發明專利號US6,296,472提出。接著，2009年Glen West等人使用直流磁控濺鍍（Direct Current Magnetron Sputtering；DCMS）、直流脈衝濺鍍（Pulsed Direct Current Sputtering；Pulsed DC）及HIPIMS於相同平均功率下比較這些技術對高分子基材的受熱影響。結果顯示，HIPIMS對基材的熱影響較小，且能獲得較佳的薄膜品質。2011年Kusiak-Nejman等人使用HIPIMS製備銅薄膜於聚酯纖維布上，並以固定薄膜厚度下探討不同峰值電流對於所製備抗菌薄膜對大腸桿菌的鈍化情形。2012年Oualid Baghriche等學者比較HIPIMS及DCMS鍍銀薄膜於聚酯纖維布上對大腸桿菌的抗菌研究。結果顯示，HIPIMS所製備的薄膜擁有較高的抗菌活性表現。同年Peter Kelly等學者使用Pulsed DC及HIPIMS於相同條件下施鍍氧化鈦於高分子基材上。結果顯示，以Pulsed DC施鍍的高分子基材發生融化變形現象，而HIPIMS所施鍍者不僅未變形，甚至獲得較佳的結晶性鍍膜。The High Power Impulse Magnetron Sputtering (HIPIMS) technology was first proposed by Vladimir Kousnetzov et al. in U.S. Patent No. 6,296,472. Then, in 2009, Glen West et al. used Direct Current Magnetron Sputtering (DCMS), Pulsed Direct Current Sputtering (Pulsed DC) and HIPIMS to compare these technologies to polymer bases at the same average power. The material is affected by heat. The results show that HIPIMS has less thermal impact on the substrate and can achieve better film quality. In 2011, Kusiak-Nejman et al. used HIPIMS to prepare copper film on polyester fiber cloth, and investigated the passivation of Escherichia coli on the prepared antibacterial film with different peak currents at a fixed film thickness. In 2012, Oualid Baghriche and other scholars compared the antibacterial research of HIPIMS and DCMS silver-plated film on E. coli on polyester fiber cloth. The results show that the film prepared by HIPIMS has higher antibacterial activity. In the same year, Peter Kelly and other scholars used Pulsed DC and HIPIMS to apply titanium oxide on polymer substrates under the same conditions. The results show that the polymer substrate plated with Pulsed DC is melted and deformed, and the HIPIMS plater is not only undeformed, but even obtains a better crystalline coating.

由以上說明可以清楚得知，HIPIMS技術由於其優異的特性，自從問世以來在過去的十多年間引起了相當大的關注。然而，PEEK用於醫療植入物時，要如何提高植入物整體的生物相容性以避免對人體產生不良反應，即為本領域中研究人員首要研究解決的課題。It can be clearly seen from the above description that HIPIMS technology has attracted considerable attention in the past ten years since its inception due to its excellent characteristics. However, when PEEK is used in medical implants, how to improve the biocompatibility of the implant as a whole to avoid adverse reactions to the human body is the subject of research and research by researchers in the field.

是以，要如何解決上述習用之問題與缺失，即為本創作之創作人與從事此行業之相關廠商所亟欲研究改善的方向所在者。Therefore, how to solve the above problems and lack of use, that is, the creators of the creation and the relevant manufacturers engaged in this industry are eager to study the direction of improvement.

故，本創作之創作人有鑑於上述缺失，乃搜集相關資料，經由多方評估及考量，並以從事於此行業累積之多年經驗，經由不斷試作及修改，始設計出此種新型專利者。Therefore, in view of the above-mentioned shortcomings, the creators of this creation have collected relevant information, and have designed and developed such new patents through continuous evaluation and modification through multi-party evaluation and consideration, and through years of experience in the industry.

本創作之目的在於提供一種利用高功率脈衝磁控濺鍍技術所製造，且具有高度生物相容性的外科手術植入物結構。The purpose of this creation is to provide a surgical implant structure that is manufactured using high power pulsed magnetron sputtering techniques and that is highly biocompatible.

為了達到上述或其他目的，本創作一種外科手術植入物結構，用於植入於人體內，該植入物包括：一聚醚醚酮（Polyetheretherketone；PEEK）基材；一鈦（Ti）層，係以高功率脈衝磁控濺鍍（High Power Impulse Magnetron Sputtering；HIPIMS）技術產生複數單極性脈衝（Unipolar Pulse）形成於該聚醚醚酮基材外表面；以及一二氧化鈦（TiO 2）層，係以高功率脈衝磁控濺鍍技術產生複數單極性脈衝形成於該鈦層外表面；其中，該每一單極性脈衝的重複頻率範圍為600Hz至1,000Hz之間，脈衝開啟（pulse on）時間範圍為100μs至200μs之間，脈衝關閉（pulse off）時間範圍為1,050μs至1,150μs之間，平均功率範圍為5,000W至7,000W之間。 In order to achieve the above or other objects, a surgical implant structure is created for implantation in a human body, the implant comprising: a polyetheretherketone (PEEK) substrate; a titanium (Ti) layer a high power Impulse Magnetron Sputtering (HIPIMS) technique for generating a plurality of unipolar pulses formed on the outer surface of the polyetheretherketone substrate; and a titanium dioxide (TiO 2 ) layer, Forming a plurality of unipolar pulses on the outer surface of the titanium layer by high-power pulsed magnetron sputtering; wherein the repetition frequency of each unipolar pulse ranges from 600 Hz to 1,000 Hz, pulse on time The range is between 100 μs and 200 μs, the pulse off time range is between 1,050 μs and 1,150 μs, and the average power range is between 5,000 W and 7,000 W.

在一較佳實施例中，該鈦層的總操作脈衝時間範圍為15分鐘至45分鐘之間。In a preferred embodiment, the titanium layer has a total operating pulse time ranging from 15 minutes to 45 minutes.

在一較佳實施例中，該二氧化鈦層的總操作脈衝時間範圍為1小時至3小時之間。In a preferred embodiment, the total operating pulse time of the titanium dioxide layer ranges from 1 hour to 3 hours.

在一較佳實施例中，該每一單極性脈衝包括複數微脈衝（micro pulse）。In a preferred embodiment, each unipolar pulse comprises a plurality of micro pulses.

在一較佳實施例中，該每一微脈衝的脈衝開啟時間範圍為100μs至200μs之間，脈衝關閉的時間範圍為1,050μs至1,150μs之間，脈衝週期範圍為1,000μs至1,667μs之間。In a preferred embodiment, the pulse on time of each micropulse ranges from 100 μs to 200 μs, the pulse off time ranges from 1,050 μs to 1,150 μs, and the pulse period ranges from 1,000 μs to 1,667 μs. .

在一較佳實施例中，該植入物可以為脊椎固定器、顱骨網、骨錨、或人工關節。In a preferred embodiment, the implant can be a spinal fixator, a skull mesh, a bone anchor, or an artificial joint.

在一較佳實施例中，該聚醚醚酮基材為一聚芳醚酮類（Polyaryletherketone）高分子基材。In a preferred embodiment, the polyetheretherketone substrate is a polyaryletherketone polymer substrate.

在一較佳實施例中，該聚芳醚酮類高分子基材為一聚醚酮（Polyetherketone）、聚醚酮酮（Polyetherketoneketone）、聚醚酮醚酮酮（Polyetherketoneetherketoneketone）、或其任意組合的基材。In a preferred embodiment, the polyaryletherketone polymer substrate is a polyetherketone, a polyetherketoneketone, a polyetherketoneetherketoneketone, or any combination thereof. Substrate.

在一較佳實施例中，該聚醚醚酮基材為一纖維複合強化聚芳醚酮類（Fiber reinforced polyaryletherketone）高分子基材。In a preferred embodiment, the polyetheretherketone substrate is a fiber reinforced polyaryletherketone polymer substrate.

在一較佳實施例中，該纖維複合強化聚芳醚酮類高分子基材為一纖維複合強化聚醚醚酮（Fiber reinforced polyetheretherketone）、纖維複合強化聚醚酮（Fiber reinforced polyetherketone）、纖維複合強化聚醚酮酮（Fiber reinforced polyetherketoneketone）、纖維複合強化聚醚酮醚酮酮（Fiber reinforced polyetherketoneetherketoneketone）、或其任意組合的基材。In a preferred embodiment, the fiber composite reinforced poly(aryl ether ketone) polymer substrate is a fiber reinforced polyetheretherketone, a fiber reinforced polyetherketone, and a fiber composite. A substrate reinforced with a reinforced polyetherketoneketone, a fiber reinforced polyetherketoneetherketone, or any combination thereof.

為達成上述目的及功效，本創作所採用之技術手段及構造，茲繪圖就本創作較佳實施例詳加說明其特徵與功能如下，俾利完全了解。In order to achieve the above objectives and effects, the technical means and structure adopted by the present invention are described in detail in the preferred embodiment of the present creation, and the features and functions are as follows.

請參閱圖1a所示，係為依據本創作外科手術植入物較佳實施例之立體圖。由圖中可清楚看出，本創作一種外科手術植入物結構，用於植入於人體內，本文所謂的「植入物」乙詞係可以為脊椎固定器、顱骨網、骨錨、或人工關節等等可供植入於人體的物體，但並不限於此。本創作利用高功率脈衝磁控濺鍍技術所製造之植入物具有高度生物相容性之優勢。請再參閱圖1b，該植入物包括：一聚醚醚酮（Polyetheretherketone；PEEK）基材1、一鈦（Ti）層2、及一二氧化鈦（TiO 2）層3。 Please refer to FIG. 1a, which is a perspective view of a preferred embodiment of the surgical implant according to the present invention. As can be clearly seen from the figure, a surgical implant structure is created for implantation in a human body. The so-called "implant" can be a spinal fixator, a skull mesh, a bone anchor, or Artificial joints and the like can be implanted in the human body, but are not limited thereto. The implants made with high power pulsed magnetron sputtering technology have the advantage of high biocompatibility. Referring again to FIG. 1b, the implant comprises: a polyetheretherketone (PEEK) substrate 1, a titanium (Ti) layer 2, and a titanium dioxide (TiO 2 ) layer 3.

該聚醚醚酮基材1例如可為一聚芳醚酮類（Polyaryletherketone）高分子基材或一纖維複合強化聚芳醚酮類（Fiber reinforced polyaryletherketone）高分子基材等相關族群，但不限於此。其中，該聚芳醚酮類高分子基材為一聚醚酮（Polyetherketone）、聚醚酮酮（Polyetherketoneketone）、聚醚酮醚酮酮（Polyetherketoneetherketoneketone）、或上述材料任意組合的基材，但不限於此。該纖維複合強化聚芳醚酮類高分子基材為一纖維複合強化聚醚醚酮（Fiber reinforced polyetheretherketone）、纖維複合強化聚醚酮（Fiber reinforced polyetherketone）、纖維複合強化聚醚酮酮（Fiber reinforced polyetherketoneketone）、纖維複合強化聚醚酮醚酮酮（Fiber reinforced polyetherketoneetherketoneketone）、或上述材料任意組合的基材，但不限於此。The polyetheretherketone substrate 1 may be, for example, a polyaryletherketone polymer substrate or a fiber reinforced polyaryletherketone polymer substrate, but is not limited thereto. this. Wherein, the polyaryletherketone polymer substrate is a polyetherketone, a polyetherketoneketone, a polyetherketoneetherketoneketone, or a substrate of any combination of the above materials, but not Limited to this. The fiber composite reinforced poly(aryl ether ketone) polymer substrate is a fiber reinforced polyetheretherketone, a fiber reinforced polyetherketone, and a fiber reinforced polyetherketoneketone (Fiber reinforced polyetherketone). A polyetherketoneketone), a fiber reinforced polyetherketoneetherketoneketone, or a substrate of any combination of the above materials, but is not limited thereto.

該鈦層2係以高功率脈衝磁控濺鍍技術產生複數單極性脈衝形成於該聚醚醚酮基材1外表面。進一步說明，所謂「形成」乙詞係沉積（deposite）該鈦層2於該聚醚醚酮基材1外表面。並且，該鈦層2的總操作脈衝時間範圍為15分鐘至45分鐘之間。The titanium layer 2 is formed on the outer surface of the polyetheretherketone substrate 1 by a high power pulsed magnetron sputtering technique to generate a plurality of unipolar pulses. Further, the term "formation" is used to deposit the titanium layer 2 on the outer surface of the polyetheretherketone substrate 1. Also, the total operating pulse time of the titanium layer 2 ranges from 15 minutes to 45 minutes.

該二氧化鈦層3係以高功率脈衝磁控濺鍍技術產生複數單極性脈衝形成於該鈦層2外表面。進一步說明，所謂的「形成」乙詞係沉積該二氧化鈦層3於該鈦層2外表面。並且，該二氧化鈦層3的總操作脈衝時間範圍為1小時至3小時之間。The titanium dioxide layer 3 is formed on the outer surface of the titanium layer 2 by a high power pulsed magnetron sputtering technique to generate a plurality of unipolar pulses. Further, the so-called "formation" is to deposit the titanium dioxide layer 3 on the outer surface of the titanium layer 2. Also, the total operating pulse time of the titanium dioxide layer 3 ranges from 1 hour to 3 hours.

其中，上述每一高功率脈衝磁控濺鍍技術係產生複數單極性脈衝，而該每一複數單極性脈衝之重複頻率範圍為600Hz至1,000Hz之間，脈衝開啟（pulse on）時間範圍為100μs至200μs之間，脈衝關閉（pulse off）時間範圍為1,050μs至1,150μs之間，平均功率範圍為5,000W至7,000W之間。而該每一單極性脈衝可包括複數微脈衝（micro pulse）。所謂微脈衝開啟的時間範圍為100μs至200μs之間，該微脈衝關閉的時間範圍為1,050μs至1,150μs之間，該微脈衝的週期範圍為1,000μs至1,667μs之間。Wherein each of the high-power pulsed magnetron sputtering techniques generates a plurality of unipolar pulses, and the repetition frequency of each of the plurality of unipolar pulses ranges from 600 Hz to 1,000 Hz, and the pulse on time range is 100 μs. Between 200 μs, the pulse off time range is between 1,050 μs and 1,150 μs, and the average power range is between 5,000 W and 7,000 W. Each of the unipolar pulses can include a plurality of micro pulses. The micropulse is turned on for a time ranging from 100 μs to 200 μs, and the micropulse is turned off for a time ranging from 1,050 μs to 1,150 μs, and the period of the micropulse ranges from 1,000 μs to 1,667 μs.

進一步說明，為了驗證本創作外科手術植入物之結構確實為TiO 2/Ti層堆疊結構於該聚醚醚酮基材1表面，請同時參閱圖2所示，係為依據本創作外科手術植入物結構較佳實施例之掃描式電子顯微鏡（Scanning Electron Microscopy；SEM）照片圖。由圖中可清楚看出，以高功率脈衝磁控濺鍍技術沉積之該鈦層2可緊密貼附於該聚醚醚酮基材1表面；接續以高功率脈衝磁控濺鍍技術所沉積之該二氧化鈦層3亦可與該鈦層2緊密貼附。其中，該鈦層2及二氧化鈦層3之厚度並無特別限制，其可由製程時間所調整。 Further, in order to verify that the structure of the present surgical implant is indeed a TiO 2 /Ti layer stack structure on the surface of the polyetheretherketone substrate 1, please also refer to FIG. 2, which is based on the present surgical implant. A scanning electron microscope (SEM) photograph of a preferred embodiment of the substrate structure. As is clear from the figure, the titanium layer 2 deposited by the high-power pulsed magnetron sputtering technique can be closely attached to the surface of the polyetheretherketone substrate 1; subsequently deposited by high-power pulsed magnetron sputtering technology. The titanium dioxide layer 3 can also be closely attached to the titanium layer 2. The thickness of the titanium layer 2 and the titanium dioxide layer 3 is not particularly limited and may be adjusted by the process time.

為了驗證本創作外科手術植入物之表面疊層結構確實為鈦層2及二氧化鈦層3於聚醚醚酮基材1表面。請同時參閱圖3a及3b所示，係為依據本創作外科手術植入物結構晶體結構之X光繞射圖以及拉曼（Raman）光譜圖。由圖3a所示的X光繞射圖可知，可偵測到鈦層2之Ti (010)、Ti (002)、Ti (011)及Ti (012)訊號及二氧化鈦層3之R-TiO 2(110)訊號。接著，圖3b的拉曼光譜圖再次檢驗二氧化鈦層3，可證實其乃金紅石相二氧化鈦（Rutile Phase-TiO 2；R-TiO 2）。 In order to verify that the surface laminate structure of the present surgical implant is indeed the surface of the titanium layer 2 and the titanium dioxide layer 3 on the polyetheretherketone substrate 1. Please also refer to FIGS. 3a and 3b, which are X-ray diffraction patterns and Raman spectra of the crystal structure of the surgical implant structure according to the present invention. It can be seen from the X-ray diffraction pattern shown in FIG. 3a that the Ti (010), Ti (002), Ti (011) and Ti (012) signals of the titanium layer 2 and the R-TiO 2 of the titanium dioxide layer 3 can be detected. (110) Signal. Next, the Raman spectrum of Fig. 3b was again examined for the titanium dioxide layer 3, which was confirmed to be rutile phase titanium dioxide (Rutile Phase-TiO 2 ; R-TiO 2 ).

為驗證本創作外科手術植入物結構確實具有良好之生物相容性，本創作將TiO 2/Ti/PEEK層堆疊結構進行生物相容性試驗，並將其與純聚醚醚酮基材進行比較。請參閱圖4a以及4b，此等為測試本創作外科手術植入物結構及純聚醚醚酮基材於生物相容性試驗之骨母細胞（Osteoblast）貼附狀態圖以及骨母細胞增生試驗圖。結果顯示，本創作外科手術植入物結構可提供骨母細胞優異之生長環境，故骨母細胞可完整服貼於二氧化鈦層表面，且其細胞增生試驗亦具有較佳之表現。綜上，本創作確實具有良好之生物相容性。 To verify that the surgical implant structure does have good biocompatibility, this work performed a biocompatibility test on the TiO 2 /Ti/PEEK layer stack structure and performed it with a pure polyetheretherketone substrate. Comparison. Referring to Figures 4a and 4b, these are the Osteoblast attachment state diagrams and the osteoblast proliferation test for testing the biosynthesis test of the surgical implant structure and the pure polyetheretherketone substrate. Figure. The results show that the surgical implant structure can provide an excellent growth environment for the osteoblasts, so the osteoblast can be completely applied to the surface of the titanium dioxide layer, and the cell proliferation test also has better performance. In summary, this creation does have good biocompatibility.

藉由上述之結構、組成設計，茲就本創作之使用作動情形說明如下： 本創作利用高功率脈衝磁控濺鍍技術來進行鍍膜，而具有良好附著性、無缺陷（Defect-free）、超緻密、良好繞鍍性、對於複雜基材有良好覆蓋性、及相對低溫生長結晶結構等優異特性。而本創作利用二氧化鈦層/鈦層/聚醚醚酮基材之三明治結構來做為外科手術植入物，更可以達到良好生物相容性。With the above structure and composition design, the following is the use of this creation: The creation uses high-power pulsed magnetron sputtering technology for coating, and has good adhesion, defect-free (Defect-free), super Excellent properties such as compactness, good winding properties, good coverage for complex substrates, and relatively low temperature growth crystal structure. The creation of the titanium dioxide layer / titanium layer / polyether ether ketone substrate sandwich structure as a surgical implant, can achieve good biocompatibility.

故，請參閱全部附圖所示，本創作使用時，與習用技術相較，著實存在下列優點：本創作外科手術植入物結構係利用高功率脈衝磁控濺鍍技術所製造，其具有高度生物相容性之優勢。Therefore, please refer to all the drawings. When using this design, compared with the conventional technology, the following advantages exist: the surgical implant structure is manufactured by high-power pulsed magnetron sputtering technology, and has a height. The advantage of biocompatibility.

惟，以上所述僅為本創作之較佳實施例而已，非因此即拘限本創作之專利範圍，故舉凡運用本創作說明書及圖式內容所為之簡易修飾及等效結構變化，均應同理包含於本創作之專利範圍內，合予陳明。However, the above description is only for the preferred embodiment of the present invention, and thus the scope of the patent is not limited thereby, so the simple modification and equivalent structural changes of the present specification and the drawings are the same. It is included in the scope of this patent and is given to Chen Ming.

1‧‧‧聚醚醚酮基材
2‧‧‧鈦層
3‧‧‧二氧化鈦層1‧‧‧Polyetheretherketone substrate
2‧‧‧Titanium layer
3‧‧‧ Titanium dioxide layer

〔圖1a〕係為依據本創作外科手術植入物結構較佳實施例之立體圖。 〔圖1b〕係為依據本創作外科手術植入物結構較佳實施例之圖1a中的AA線剖面圖。 〔圖2〕係為依據本創作外科手術植入物結構較佳實施例之掃描式電子顯微鏡（Scanning Electron Microscopy；SEM）照片圖。 〔圖3a〕係為依據本創作外科手術植入物結構晶體結構之X光繞射圖。 〔圖3b〕係為依據本創作外科手術植入物結構晶體結構之拉曼（Raman）光譜圖。 〔圖4a〕係為測試本創作外科手術植入物結構及純聚醚醚酮基材於生物相容性試驗之骨母細胞（Osteoblast）貼附狀態圖。 〔圖4b〕係為測試本創作外科手術植入物結構及純聚醚醚酮基材於生物相容性試驗之骨母細胞增生試驗圖。[Fig. 1a] is a perspective view of a preferred embodiment of a surgical implant structure in accordance with the present invention. [Fig. 1b] is a cross-sectional view taken along line AA of Fig. 1a in accordance with a preferred embodiment of the present surgical implant structure. [Fig. 2] is a scanning electron microscope (SEM) photograph of a preferred embodiment of the surgical implant structure according to the present invention. [Fig. 3a] is an X-ray diffraction pattern of the crystal structure of the surgical implant according to the present invention. [Fig. 3b] is a Raman spectrum of the crystal structure of the surgical implant according to the present invention. [Fig. 4a] is a state diagram of the Osteoblast attachment test for testing the structure of the surgical implant and the pure polyetheretherketone substrate in the biocompatibility test. [Fig. 4b] is a test for the osteoblast proliferation test of the biosynthesis test of the present surgical implant structure and the pure polyetheretherketone substrate.

1‧‧‧聚醚醚酮基材 1‧‧‧Polyetheretherketone substrate

2‧‧‧鈦層 2‧‧‧Titanium layer

3‧‧‧二氧化鈦層 3‧‧‧ Titanium dioxide layer

Claims (10)

一種外科手術植入物結構，用於植入於人體內，該植入物包括： 一聚醚醚酮（Polyetheretherketone；PEEK）基材； 一鈦（Ti）層，係以高功率脈衝磁控濺鍍技術（High Power Impulse Magnetron Sputtering；HIPIMS）產生複數單極性脈衝（Unipolar Pulse）形成於該聚醚醚酮基材外表面；以及 一二氧化鈦（TiO 2）層，係以高功率脈衝磁控濺鍍技術產生複數單極性脈衝形成於該鈦層外表面； 其中，該每一單極性脈衝之重複頻率範圍為600Hz至1,000Hz之間，脈衝開啟（pulse on）時間範圍為100μs至200μs之間，脈衝關閉（pulse off）時間範圍為1,050μs至1,150μs之間，平均功率範圍為5,000W至7,000W之間。 A surgical implant structure for implantation in a human body, the implant comprising: a polyetheretherketone (PEEK) substrate; a titanium (Ti) layer, which is pulsed with high power pulsed magnetron High Power Impulse Magnetron Sputtering (HIPIMS) produces a complex unipolar pulse formed on the outer surface of the polyetheretherketone substrate; and a titanium dioxide (TiO 2 ) layer with high power pulsed magnetron sputtering The technique generates a plurality of unipolar pulses formed on the outer surface of the titanium layer; wherein the repetition frequency of each unipolar pulse ranges from 600 Hz to 1,000 Hz, and the pulse on time ranges from 100 μs to 200 μs, and the pulse The pulse off time range is from 1,050 μs to 1,150 μs and the average power range is between 5,000 W and 7,000 W. 如申請專利範圍第1項所述之外科手術植入物結構，其中該鈦層的總操作脈衝時間範圍為15分鐘至45分鐘之間。The surgical implant structure of claim 1 wherein the total operating pulse time of the titanium layer ranges from 15 minutes to 45 minutes. 如申請專利範圍第1項所述之外科手術植入物結構，其中該二氧化鈦層的總操作脈衝時間範圍為1小時至3小時之間。The surgical implant structure of claim 2, wherein the total operating pulse time of the titanium dioxide layer ranges from 1 hour to 3 hours. 如申請專利範圍第1項所述之外科手術植入物結構，其中該各單極性脈衝包括複數微脈衝（micro pulse）。The surgical implant structure of claim 1, wherein the unipolar pulses comprise a plurality of micro pulses. 如申請專利範圍第4項所述之外科手術植入物結構，其中該每一微脈衝的脈衝開啟時間範圍為100μs至200μs之間，脈衝關閉的時間範圍為1,050μs至1,150μs之間，脈衝週期範圍為1,000μs至1,667μs之間。The surgical implant structure as described in claim 4, wherein the pulse on time of each micropulse ranges from 100 μs to 200 μs, and the pulse off time ranges from 1,050 μs to 1,150 μs, pulse The period ranges from 1,000 μs to 1,667 μs. 如申請專利範圍第1項所述之外科手術植入物結構，其中該植入物為脊椎固定器、顱骨網、骨錨、或人工關節。The surgical implant structure as described in claim 1, wherein the implant is a spinal fixator, a skull mesh, a bone anchor, or an artificial joint. 如申請專利範圍第1項所述之外科手術植入物結構，其中該聚醚醚酮基材為一聚芳醚酮類（Polyaryletherketone）高分子基材。The surgical implant structure according to claim 1, wherein the polyetheretherketone substrate is a polyaryletherketone polymer substrate. 如申請專利範圍第7項所述之外科手術植入物結構，其中該聚芳醚酮類高分子基材為一聚醚酮（Polyetherketone）、聚醚酮酮（Polyetherketoneketone）、聚醚酮醚酮酮（Polyetherketoneetherketoneketone）或其任意組合的基材。The surgical implant structure according to claim 7, wherein the polyaryletherketone polymer substrate is a polyetherketone, a polyetherketoneketone, a polyetherketone ether ketone. A substrate of a ketone (Polyetherketoneetherketoneketone) or any combination thereof. 如申請專利範圍第1項所述之外科手術植入物結構，其中該聚醚醚酮基材為一纖維複合強化聚芳醚酮類（Fiber reinforced polyaryletherketone）高分子基材。The surgical implant structure according to claim 1, wherein the polyetheretherketone substrate is a fiber reinforced polyaryletherketone polymer substrate. 如申請專利範圍第9項所述之外科手術植入物結構，其中該纖維複合強化聚芳醚酮類高分子基材為一纖維複合強化聚醚醚酮（Fiber reinforced polyetheretherketone）、纖維複合強化聚醚酮（Fiber reinforced polyetherketone）、纖維複合強化聚醚酮酮（Fiber reinforced polyetherketoneketone）、纖維複合強化聚醚酮醚酮酮（Fiber reinforced polyetherketoneetherketoneketone）、或其任意組合的基材。The surgical implant structure according to claim 9 , wherein the fiber composite reinforced poly(aryl ether ketone) polymer substrate is a fiber reinforced polyetheretherketone or a fiber composite reinforced polypolymer. A substrate of a fiber reinforced polyetherketone, a fiber reinforced polyetherketoneketone, a fiber reinforced polyetherketoneetherketone, or any combination thereof.
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