TWI666034B - Transdermal microneedle array patch - Google Patents

Transdermal microneedle array patch Download PDF

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Publication number
TWI666034B
TWI666034B TW107107686A TW107107686A TWI666034B TW I666034 B TWI666034 B TW I666034B TW 107107686 A TW107107686 A TW 107107686A TW 107107686 A TW107107686 A TW 107107686A TW I666034 B TWI666034 B TW I666034B
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TW
Taiwan
Prior art keywords
probe
perforation
sheet
lower cover
upper cover
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TW107107686A
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Chinese (zh)
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TW201836659A (en
Inventor
黃榮堂
李冠廷
大宏 錢
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全康科技股份有限公司
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Priority to EP18275046.3A priority Critical patent/EP3381370B1/en
Priority to US15/939,772 priority patent/US11278217B2/en
Publication of TW201836659A publication Critical patent/TW201836659A/en
Application granted granted Critical
Publication of TWI666034B publication Critical patent/TWI666034B/en
Priority to US17/665,269 priority patent/US20220361777A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685Microneedles

Abstract

一種經皮微針陣列貼布,包括:下蓋;上蓋;基板,設於該上蓋內部;以及第一探針及第二探針,設於該下蓋及該上蓋之間且電性連接該基板,其中,該第一探針及該第二探針之間為斷路;其中,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該第一探針及該第二探針之間形成通路。 A percutaneous microneedle array patch includes: a lower cover; an upper cover; a substrate provided inside the upper cover; and a first probe and a second probe provided between the lower cover and the upper cover and electrically connected to the A substrate, wherein the first probe and the second probe are disconnected; wherein, when the lower cover is combined with the upper cover to form the percutaneous microneedle array patch, the first probe and the second probe A path is formed between the needles.

Description

經皮微針陣列貼布    Percutaneous microneedle array patch   

本發明涉及一種經皮微針陣列貼布,尤指一種拋棄式經皮微針陣列貼布。 The invention relates to a percutaneous microneedle array patch, in particular to a disposable percutaneous microneedle array patch.

人體之組織液主要流動於皮下組織。由於組織液含有豐富的胺基酸、脂肪酸、糖、鹽、激素、輔酶以及細胞所產生之廢物等,因此透過分析組織液中各成份濃度的方式,可有效判斷人體生理狀況。 The tissue fluid of the human body mainly flows in the subcutaneous tissue. Because tissue fluids are rich in amino acids, fatty acids, sugars, salts, hormones, coenzymes, and wastes produced by cells, etc., by analyzing the concentrations of various components in tissue fluids, the physiological condition of the human body can be effectively judged.

又例如在服用或施打藥物時,藥物亦會在組織液中長時間且緩慢的釋放,而有濃度的變化,故分析組織液中藥物濃度,亦可有效監控藥物之效力。 For another example, when taking or administering a drug, the drug will also be released in the tissue fluid for a long time and slowly, and there is a change in concentration. Therefore, analyzing the concentration of the drug in the tissue fluid can also effectively monitor the effectiveness of the drug.

現有之生理檢測器材多以扎針穿破角質層來抽取組織液之方式來進行分析檢測,例如經皮感測器等等,此經皮感測器之低侵入性穿刺可有效減輕使用者之痛感,且同時可採集組織液。 Most of the existing physiological detection devices use puncture to cut through the stratum corneum to extract tissue fluid for analysis and detection, such as a percutaneous sensor. The low-invasive puncture of this percutaneous sensor can effectively reduce the pain of the user. And can collect tissue fluid at the same time.

然而,現有之生理檢測器材並非可長時間使用,例如經皮感測器多只能單次檢測,如須重新檢測時必須更換一個新的經皮感測器,而檢測到的資料皆會直接傳出至讀取器或是手機,經皮感測器本身並不會保存資料。又,現有 之生理檢測器材在連續檢測一段時間時,並無法中途中斷檢測,存有浪費系統電力之缺陷,且頻繁更換經皮感測器亦有浪費資源之問題。 However, the existing physiological detection equipment can not be used for a long time. For example, transdermal sensors can only be used for a single test. If a new transdermal sensor is required to be re-tested, the detected data will be directly Transmitted to a reader or mobile phone, the transcutaneous sensor itself does not save data. In addition, the existing physiological detection equipment cannot interrupt the detection midway during continuous detection for a period of time, there is a defect of wasting system power, and frequent replacement of transdermal sensors also has a problem of wasting resources.

本發明之主要目的在於提供一種經皮微針陣列貼布,包括:下蓋;上蓋;基板,設於該上蓋內部;以及第一探針及第二探針,設於該下蓋及該上蓋之間且電性連接該基板,其中,該第一探針及該第二探針之間為斷路;其中,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該第一探針及該第二探針之間形成通路。 The main object of the present invention is to provide a percutaneous microneedle array patch, including: a lower cover; an upper cover; a substrate provided inside the upper cover; and a first probe and a second probe provided on the lower cover and the upper cover The substrate is electrically connected between the first probe and the second probe, and the first probe and the second probe are disconnected. When the lower cover is combined with the upper cover to form the percutaneous microneedle array patch, the first A path is formed between the probe and the second probe.

藉由本發明之經皮微針陣列貼布之下蓋及上蓋分離及拆卸式之設計,可分別將微針組集合設於下蓋、訊號處理單元及電源單元設於上蓋,在下蓋及上蓋組合後使二探針之間形成通路,而可使訊號處理單元啟動,進而令微針組集合獲得適當的電壓使皮下組織液中的待測物可以與微針組集合上的酵素進行電化學反應,而反應之電訊號可由訊號處理單元進行讀取與截取。使用者可輕易更換包含微針組集合之下蓋部份,而不必替換包含有訊號處理單元及電源單元之上蓋部份,以因應長時間監測,並可在中途中斷檢測,且可避免因替換上蓋部份中的訊號處理單元而導致資料流失之情形,亦可依據使用需求調整使用時間而具備節省系統電力之功效。 With the separate and detachable design of the lower cover and the upper cover of the percutaneous microneedle array patch of the present invention, the microneedle set can be assembled on the lower cover, the signal processing unit, and the power supply unit respectively on the upper cover, and the lower cover and the upper cover can be combined. Then, a path is formed between the two probes, so that the signal processing unit can be started, so that the microneedle set can obtain an appropriate voltage so that the test object in the subcutaneous tissue fluid can electrochemically react with the enzyme on the microneedle set. The response electric signal can be read and intercepted by the signal processing unit. The user can easily replace the lower cover part containing the microneedle set without having to replace the upper cover part containing the signal processing unit and the power supply unit, in order to respond to long-term monitoring, and can interrupt the detection midway, and can avoid the replacement. In the case of data loss caused by the signal processing unit in the cover part, the use time can also be adjusted according to the use needs to have the effect of saving system power.

1‧‧‧經皮微針陣列貼布 1‧‧‧ percutaneous microneedle array patch

11‧‧‧下蓋 11‧‧‧ lower cover

111‧‧‧第一表面 111‧‧‧first surface

112‧‧‧第二表面 112‧‧‧Second surface

113‧‧‧金屬片 113‧‧‧metal sheet

12‧‧‧上蓋 12‧‧‧ Upper cover

121‧‧‧內表面 121‧‧‧Inner surface

122‧‧‧訊號處理單元 122‧‧‧Signal Processing Unit

123‧‧‧電源單元 123‧‧‧Power supply unit

13‧‧‧探針 13‧‧‧ Probe

14‧‧‧基板 14‧‧‧ substrate

141‧‧‧介電層 141‧‧‧Dielectric layer

142‧‧‧線路層 142‧‧‧Line layer

143‧‧‧絕緣層 143‧‧‧Insulation

144‧‧‧開口 144‧‧‧ opening

15‧‧‧電流路徑 15‧‧‧ current path

16‧‧‧微針組集合 16‧‧‧ Micro Needle Set Collection

17‧‧‧皮膚 17‧‧‧Skin

18‧‧‧電接點 18‧‧‧ electric contact

19‧‧‧導電柱 19‧‧‧ conductive post

20‧‧‧可撓性墊片 20‧‧‧ Flexible gasket

21‧‧‧開口 21‧‧‧ opening

31‧‧‧第一微針組 31‧‧‧The first microneedle set

311‧‧‧第一薄片 311‧‧‧First sheet

3111‧‧‧第一穿孔 3111‧‧‧first perforation

3112‧‧‧第一突刺 3112‧‧‧The first spike

312‧‧‧第二薄片 312‧‧‧Second sheet

3121‧‧‧第二穿孔 3121‧‧‧second perforation

3122‧‧‧第二突刺 3122‧‧‧Second Strike

3123‧‧‧倒鉤 3123‧‧‧Barb

3124‧‧‧導柄 3124‧‧‧Guide

313‧‧‧第三薄片 313‧‧‧ Third sheet

3131‧‧‧第三穿孔 3131‧‧‧ third perforation

3132‧‧‧第三突刺 3132‧‧‧Third Strike

314‧‧‧第四薄片 314‧‧‧ Fourth sheet

3141‧‧‧第四穿孔 3141‧‧‧ fourth perforation

3142‧‧‧第四突刺 3142‧‧‧The fourth spike

32‧‧‧第二微針組 32‧‧‧Second Micro Needle Set

321‧‧‧薄片 321‧‧‧sheet

3211‧‧‧穿孔 3211‧‧‧perforation

3212‧‧‧突刺 3212‧‧‧ Spike

3213‧‧‧倒鉤 3213‧‧‧Barb

3214‧‧‧導柄 3214‧‧‧Guide

33‧‧‧第三微針組 33‧‧‧The third microneedle set

331‧‧‧薄片 331‧‧‧sheet

3311‧‧‧穿孔 3311‧‧‧perforation

3312‧‧‧突刺 3312‧‧‧Spike

3313‧‧‧倒鉤 3313‧‧‧Barb

3314‧‧‧導柄 3314‧‧‧Guide

第1圖係為本發明之經皮微針陣列貼布之組合示意 圖;第2圖係為本發明之經皮微針陣列貼布之剖面示意圖;第3圖係為第1圖中X-X線段中基板之剖面示意圖;第4圖係為本發明之經皮微針陣列貼布之另一實施例之組合示意前視圖;第5圖係為本發明之經皮微針陣列貼布之另一實施例之組合示意後視圖;第6圖係為本發明之經皮微針陣列貼布中微針組集合之一實施例之示意圖;第7圖係為本發明之經皮微針陣列貼布中微針組集合之另一實施例之示意圖;第8圖係為本發明之經皮微針陣列貼布之另一實施例之剖面示意圖;以及第9圖係為第8圖中基板之剖面示意圖。 Fig. 1 is a schematic diagram of the combination of the percutaneous microneedle array patch of the present invention; Fig. 2 is a schematic sectional view of the percutaneous microneedle array patch of the present invention; and Fig. 3 is the XX line segment in Fig. 1 A schematic cross-sectional view of a substrate; FIG. 4 is a schematic front view of a combination of another embodiment of the percutaneous microneedle array patch of the present invention; and FIG. 5 is another implementation of the percutaneous microneedle array patch of the present invention The combination of the examples is a schematic rear view; FIG. 6 is a schematic diagram of an embodiment of a microneedle group set in the percutaneous microneedle array patch of the present invention; and FIG. 7 is a percutaneous microneedle array patch of the present invention. A schematic view of another embodiment of the microneedle set collection; FIG. 8 is a schematic sectional view of another embodiment of the percutaneous microneedle array patch of the present invention; and FIG. 9 is a schematic sectional view of the substrate in FIG. 8 .

以下藉由特定之具體實施例加以說明本發明之實施方式,而熟悉此技術之人士可由本說明書所揭示之內容輕易地瞭解本發明之其他優點和功效,亦可藉由其他不同的具體實施例加以施行或應用。 The following describes the implementation of the present invention through specific specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification, and can also use other different specific embodiments. To implement or apply.

請參閱第1、2及3圖,本發明之經皮微針陣列貼布1包括下蓋11及上蓋12。下蓋11具有第一表面111及相對於第一表面111之第二表面112,且第一表面111設有一金屬片113。上蓋12內部設有基板14,基板14具有外露 於上蓋12之內表面121之二探針13,其中,二探針13彼此之間呈現斷路狀態。 Please refer to FIGS. 1, 2 and 3. The percutaneous microneedle array patch 1 of the present invention includes a lower cover 11 and an upper cover 12. The lower cover 11 has a first surface 111 and a second surface 112 opposite to the first surface 111, and the first surface 111 is provided with a metal sheet 113. A substrate 14 is provided inside the upper cover 12, and the substrate 14 has two probes 13 exposed on the inner surface 121 of the upper cover 12, wherein the two probes 13 are in an open state with each other.

於一實施例中,二探針13可不同時設在基板14上,而是設於下蓋11及上蓋12之間且電性連接該基板14,例如一探針13可設於基板14上,且另一探針13可設於金屬片113上,本發明並不以此為限。 In an embodiment, the two probes 13 may not be disposed on the substrate 14 at the same time, but may be disposed between the lower cover 11 and the upper cover 12 and electrically connected to the substrate 14. For example, a probe 13 may be disposed on the substrate 14. In addition, another probe 13 may be disposed on the metal sheet 113, which is not limited in the present invention.

於一實施例中,如第3圖所示,基板14包括介電層141,以及形成於介電層141上之線路層142。介電層141具有貫通其二表面之開口144,使得二探針13能設於該開口144中。換言之,二探針13係貫通介電層141而設於其中,此時,貫通介電層141之二探針13之外露於介電層141之一表面之一端與線路層142電性連接,而貫通介電層141之二探針13之外露於介電層141之另一表面之另一端則外露於上蓋12之內表面121。基板14更包括絕緣層143,絕緣層143係設於線路層142上,且設於未設有線路層142之介電層141上。 In an embodiment, as shown in FIG. 3, the substrate 14 includes a dielectric layer 141 and a circuit layer 142 formed on the dielectric layer 141. The dielectric layer 141 has an opening 144 penetrating through two surfaces thereof, so that the two probes 13 can be disposed in the opening 144. In other words, the two probes 13 are disposed through the dielectric layer 141, and at this time, one end of the two probes 13 penetrating the dielectric layer 141 exposed on one surface of the dielectric layer 141 is electrically connected to the wiring layer 142. The other end of the probe 13 that penetrates through the dielectric layer 141 and is exposed on the other surface of the dielectric layer 141 is exposed on the inner surface 121 of the upper cover 12. The substrate 14 further includes an insulating layer 143. The insulating layer 143 is disposed on the circuit layer 142 and is disposed on the dielectric layer 141 on which the circuit layer 142 is not provided.

本發明之經皮微針陣列貼布1更包括微針組集合16,係設於下蓋11之第二表面112上。微針組集合16可讓使用者貼覆於皮膚17上。 The percutaneous microneedle array patch 1 of the present invention further includes a microneedle set 16, which is arranged on the second surface 112 of the lower cover 11. The microneedle set 16 allows the user to attach the skin 17.

上蓋12內部還設有訊號處理單元122及電源單元123。訊號處理單元122透過線路層142而與二探針13電性連接,電源單元123則用以供應工作電源予訊號處理單元122。 The upper cover 12 further includes a signal processing unit 122 and a power supply unit 123. The signal processing unit 122 is electrically connected to the two probes 13 through the circuit layer 142, and the power supply unit 123 is used to supply working power to the signal processing unit 122.

當下蓋11組合上蓋12形成經皮微針陣列貼布1時, 下蓋11之金屬片113接觸外露於上蓋12之內表面121之二探針13時,二探針13之間形成通路,即形成電流路徑15,而啟動訊號處理單元122。此時,微針組集合16之電訊號能有效透過導電柱19而與訊號處理單元122之電接點18電性連接,而獲得合適的電化學反應電壓,以與組織液中待測物進行反應後產生電流/電壓訊號,該電流/電壓訊號會傳遞到訊號處理單元122,訊號處理單元122即可據此產生感測訊號以進行截取與分析體內待測物濃度。此感測訊號可儲存在上蓋12內的儲存單元(未圖示)中。 When the lower cover 11 is combined with the upper cover 12 to form a percutaneous microneedle array patch 1, when the metal piece 113 of the lower cover 11 contacts the two probes 13 exposed on the inner surface 121 of the upper cover 12, a path is formed between the two probes 13, that is, A current path 15 is formed, and the signal processing unit 122 is activated. At this time, the electrical signal of the microneedle set 16 can be effectively connected to the electrical contact 18 of the signal processing unit 122 through the conductive column 19 to obtain a suitable electrochemical reaction voltage to react with the test object in the tissue fluid. A current / voltage signal is generated, and the current / voltage signal is passed to the signal processing unit 122. The signal processing unit 122 can generate a sensing signal for interception and analysis of the concentration of the analyte in the body. The sensing signal can be stored in a storage unit (not shown) in the upper cover 12.

於一實施例中,二探針13亦可不藉由金屬片113來形成通路,例如二探針13可在受下蓋11擠壓時,二探針13彼此靠近而相接成通路。 In an embodiment, the two probes 13 may not form a path through the metal sheet 113. For example, when the two probes 13 are pressed by the lower cover 11, the two probes 13 are close to each other to form a path.

在使用本發明之經皮微針陣列貼布1時,使用者可將設有微針組集合16之下蓋11先貼覆於皮膚17上,接著將上蓋12組合至下蓋11,通過金屬片113導通二探針13,進而啟動訊號處理單元122,以量測皮下組織之組織液中各成份濃度。由於下蓋11及上蓋12之間為可拆卸式,在需要替換微針組集合16時,使用者可先卸除上蓋12,替換包含微針組集合16之下蓋11,即將一新的包含微針組集合16之下蓋11重新貼覆於皮膚17上,此時即可將同一上蓋12再組合至新的下蓋11上,故使用者不須替換包含有訊號處理單元122之上蓋12。所述的可拆卸式,可如第1圖所示,下蓋11與上蓋12可透過環形凹槽及對應之環形凸槽之結構來輕易組合在一起,並可透過卡榫來進行固 定,而此類結構亦可反向讓使用者輕易分離下蓋11與上蓋12,本發明並不以此為限。換言之,由於本發明之微針組集合16與上蓋12內的電路可分開,而具有可拋棄式特性及省電特性,使用者可僅單純更換微針組集合16後即可方便使用,不須將整個電路都拋棄。本發明可因應長時間監測,且使用不同下蓋11時所偵測到生理訊號可同時儲存在同一上蓋12中,可有效避免資料流失之情形。此外,由於不需要替換上蓋12,亦具有節省資源之功效。 When using the transdermal microneedle array patch 1 of the present invention, the user can apply the lower cover 11 provided with the microneedle set 16 to the skin 17 first, and then combine the upper cover 12 to the lower cover 11 through metal. The chip 113 turns on the two probes 13 and then activates the signal processing unit 122 to measure the concentration of each component in the tissue fluid of the subcutaneous tissue. Because the lower cover 11 and the upper cover 12 are detachable, when the microneedle set 16 needs to be replaced, the user can first remove the upper cover 12 and replace the lower cover 11 containing the microneedle set 16, which is about to include a new one. The lower cover 11 of the microneedle set 16 is reattached to the skin 17, and at this time, the same upper cover 12 can be reassembled to the new lower cover 11, so the user does not need to replace the upper cover 12 including the signal processing unit 122. . The detachable type can be easily combined as shown in Figure 1. The lower cover 11 and the upper cover 12 can be easily combined through the structure of the annular groove and the corresponding annular convex groove, and can be fixed by the tenon. Such a structure can also allow the user to easily separate the lower cover 11 and the upper cover 12 in reverse, which is not limited in the present invention. In other words, since the microneedle set 16 of the present invention can be separated from the circuit in the upper cover 12 and has disposable characteristics and power saving characteristics, the user can simply use the microneedle set 16 simply after replacing the microneedle set 16 without having to Discard the entire circuit. The invention can respond to long-term monitoring, and the physiological signals detected when different lower covers 11 are used can be stored in the same upper cover 12 at the same time, which can effectively avoid the situation of data loss. In addition, since the upper cover 12 does not need to be replaced, it also has the effect of saving resources.

請參閱第4及5圖,本發明之經皮微針陣列貼布1所包括的微針組集合16,係透過導電柱19而與基板14上訊號處理單元122之電接點18電性連接,在本實施例中,訊號處理單元122及電源單元123可設於基板14之同一表面上,而電接點18則可設於基板14之另一表面上。在微針組集合16與基板14之間,更可設置一可撓性墊片20。可撓性墊片20具有一開口21以供微針組集合16之導電柱19通過。由於本發明之經皮微針陣列貼布1包含有可撓性墊片20,操作時可與使用者之肌肉輪廓共形而緊密接觸。 Please refer to FIGS. 4 and 5. The microneedle set 16 included in the percutaneous microneedle array patch 1 of the present invention is electrically connected to the electrical contact 18 of the signal processing unit 122 on the substrate 14 through the conductive pillar 19. In this embodiment, the signal processing unit 122 and the power supply unit 123 may be disposed on the same surface of the substrate 14, and the electrical contact 18 may be disposed on the other surface of the substrate 14. Between the microneedle set 16 and the substrate 14, a flexible spacer 20 may be further provided. The flexible gasket 20 has an opening 21 for the conductive posts 19 of the microneedle set 16 to pass through. Since the percutaneous microneedle array patch 1 of the present invention includes a flexible gasket 20, it can conform to the user's muscle contour and come into close contact during operation.

在本實施例中,微針組集合16更包括第一微針組31、第二微針組32及第三微針組33,其中,第一微針組31係作為工作電極,第二微針組32係作為參考電極,而第三微針組33係作為反電極。請進一步參閱第6圖,以更詳細了解微針組集合16的詳細結構。 In this embodiment, the microneedle group set 16 further includes a first microneedle group 31, a second microneedle group 32, and a third microneedle group 33. The first microneedle group 31 serves as a working electrode, and the second microneedle group 31 serves as a working electrode. The needle group 32 serves as a reference electrode, and the third microneedle group 33 serves as a counter electrode. Please refer to FIG. 6 to understand the detailed structure of the microneedle set 16 in more detail.

於本實施例中,第一微針組31可由第一薄片311、第二薄片312及第三薄片313所疊置而成。第一薄片311上設置有至少一第一穿孔3111以及位於第一穿孔3111之邊緣的至少一第一突刺3112。第二薄片312上設置有至少一第二穿孔3121及位於第二穿孔3121之邊緣的至少一第二突刺3122。第三薄片313上設置有至少一第三穿孔3131及位於第三穿孔3131之邊緣之至少一第三突刺3132。其中,第三薄片313設於第一薄片311及第二薄片312之間,而第一薄片311、第二薄片312及第三薄片313疊置在一起時,以第二薄片312之第二突刺3122穿過第三薄片313上相對位置之第三穿孔3131及第一薄片311上相對位置之第一穿孔3111、第三薄片313之第三突刺3132穿過第一薄片311上相對位置之第一穿孔3111之方式疊置而成,使得第一突刺3112、第二突刺3122及第三突刺3132在疊置後呈三角錐形。 In this embodiment, the first microneedle group 31 may be formed by stacking a first sheet 311, a second sheet 312, and a third sheet 313. The first sheet 311 is provided with at least one first perforation 3111 and at least one first spike 3112 located at an edge of the first perforation 3111. The second sheet 312 is provided with at least one second perforation 3121 and at least one second spike 3122 located at an edge of the second perforation 3121. The third sheet 313 is provided with at least one third perforation 3131 and at least one third thorn 3132 located at an edge of the third perforation 3131. Wherein, the third sheet 313 is disposed between the first sheet 311 and the second sheet 312, and when the first sheet 311, the second sheet 312, and the third sheet 313 are stacked together, the second sheet 312 is punctured 3122 penetrates the third perforation 3131 of the relative position on the third sheet 313 and the first perforation 3111 of the relative position on the first sheet 311 and the third spike 3132 of the third sheet 313 passes through the first relative position on the first sheet 311 The perforations 3111 are stacked in such a manner that the first thorn 3112, the second thorn 3122, and the third thorn 3132 have a triangular pyramid shape after being stacked.

此外,第二薄片312的邊緣上可設置倒鉤3123而與一電路板上的孔穴卡合。在一實施例中,第二薄片312的邊緣上可設置導柄3124而插在該電路板上且與導電柱19電性連接。 In addition, a barb 3123 may be provided on the edge of the second sheet 312 to engage with a hole on a circuit board. In an embodiment, a guide handle 3124 may be disposed on an edge of the second sheet 312 and inserted into the circuit board and electrically connected to the conductive pillar 19.

同理,第二微針組32具有薄片321,薄片321上設置有至少一穿孔3211,穿孔3211之邊緣設置有突刺3212,而薄片321的邊緣上可設置倒鉤3213而與該電路板上的孔穴卡合,且薄片321的邊緣上可設置導柄3214而插在該電路板上且與導電柱19電性連接。 Similarly, the second microneedle set 32 has a sheet 321, at least one perforation 3211 is provided on the sheet 321, a spike 3212 is provided on the edge of the perforation 3211, and a barb 3213 can be provided on the edge of the sheet 321 to communicate with the circuit board. The holes are engaged, and a guide handle 3214 can be provided on the edge of the sheet 321 to be inserted on the circuit board and electrically connected to the conductive pillar 19.

同理,第三微針組33具有薄片331,薄片331上設置有至少一穿孔3311,穿孔3311之邊緣設置有突刺3312,而薄片331的邊緣上可設置倒鉤3313而與該電路板上的孔穴卡合,且薄片331的邊緣上可設置導柄3314而插在該電路板上且與導電柱19電性連接。 Similarly, the third microneedle group 33 has a sheet 331. At least one perforation 3311 is provided on the sheet 331. A spike 3312 is provided on the edge of the perforation 3311. A barb 3313 can be provided on the edge of the sheet 331 to communicate with the circuit board. The holes are engaged, and a guide handle 3314 can be provided on the edge of the sheet 331 to be inserted on the circuit board and electrically connected to the conductive pillar 19.

在一實施例中,第一穿孔3111、第二穿孔3121及第三穿孔3131之各自數量係彼此對應且為複數個,且複數個第一穿孔3111、第二穿孔3121及第三穿孔3131可形成陣列形式,如第6圖中所示,穿孔數量為12個且形成3x4的陣列形式,但本發明並不限制穿孔數量及所形成之陣列形式。另第一突刺3112、第二突刺3122及第三突刺3132之數量係分別對應於第一穿孔3111、第二穿孔3121及第三穿孔3131。 In an embodiment, the respective numbers of the first through holes 3111, the second through holes 3121, and the third through holes 3131 correspond to each other and are plural, and a plurality of the first through holes 3111, the second through holes 3121, and the third through holes 3131 may be formed. The array form, as shown in FIG. 6, has a number of perforations of 12 and forms a 3x4 array form, but the present invention does not limit the number of perforations and the array form formed. In addition, the numbers of the first thorn 3112, the second thorn 3122, and the third thorn 3132 correspond to the first perforation 3111, the second perforation 3121, and the third perforation 3131, respectively.

於一實施例中,第一微針組31、第二微針組32及第三微針組33之每一突刺可通過沖壓或蝕刻製程而形成,而這些突刺之材料可選自不鏽鋼、鎳、鎳合金、鈦、鈦合金、奈米碳管、矽材料或樹脂,且其表面沉積具有生物兼容性之金屬,例如金、鈀等。樹脂可例如為聚碳酸酯、聚甲基丙烯酸共聚物、乙烯/醋酸乙烯酯共聚物、鐵弗龍(聚四氟乙烯)或聚酯類。突刺高度可為300-600微米、基底寬度可為150-450微米、該些突刺之尖端部彼此之間的間隔可為500-3000微米。 In an embodiment, each of the thorns of the first microneedle group 31, the second microneedle group 32, and the third microneedle group 33 may be formed by a stamping or etching process, and the materials of these thorns may be selected from stainless steel and nickel. , Nickel alloy, titanium, titanium alloy, nano carbon tube, silicon material or resin, and biocompatible metals such as gold and palladium are deposited on the surface. The resin may be, for example, polycarbonate, polymethacrylic acid copolymer, ethylene / vinyl acetate copolymer, Teflon (polytetrafluoroethylene) or polyester. The height of the spikes may be 300-600 microns, the width of the substrate may be 150-450 microns, and the distance between the tips of the spikes may be 500-3000 microns.

圖7為本發明中微針組集合16之另一實施例,本實施例中所描述的技術內容部份相同於前述實施例中,於此不再贅述。於本實施例中,第一微針組31可由第一薄片311、第二薄片312、第三薄片313及第四薄片314所疊置 而成。第一薄片311上設置有至少一第一穿孔3111以及位於第一穿孔3111之邊緣的至少一第一突刺3112。第二薄片312上設置有至少一第二穿孔3121及位於第二穿孔3121之邊緣的至少一第二突刺3122。第三薄片313上設置有至少一第三穿孔3131及位於第三穿孔3131之邊緣之至少一第三突刺3132。第四薄片314上設置有至少一第四穿孔3141及位於第四穿孔3141之邊緣之至少一第四突刺3142。其中,第三薄片313及第四薄片314設於第一薄片311及第二薄片312之間,而第一薄片311、第二薄片312、第三薄片313及第四薄片314疊置在一起時,以第二薄片312之第二突刺3122穿過第四薄片314上相對位置之第四穿孔3141、第三薄片313上相對位置之第三穿孔3131及第一薄片311上相對位置之第一穿孔3111、第四薄片314之第四突刺3142穿過第三薄片313上相對位置之第三穿孔3131及第一薄片311上相對位置之第一穿孔3111、第三薄片313之第三突刺3132穿過第一薄片311上相對位置之第一穿孔3111之方式疊置而成,使得第一突刺3112、第二突刺3122、第三突刺3132及第四突刺3142在疊置後呈四角錐形。 FIG. 7 is another embodiment of the microneedle set 16 in the present invention. The technical content described in this embodiment is the same as that in the previous embodiment, and details are not described herein again. In this embodiment, the first microneedle group 31 may be formed by stacking a first sheet 311, a second sheet 312, a third sheet 313, and a fourth sheet 314. The first sheet 311 is provided with at least one first perforation 3111 and at least one first spike 3112 located at an edge of the first perforation 3111. The second sheet 312 is provided with at least one second perforation 3121 and at least one second spike 3122 located at an edge of the second perforation 3121. The third sheet 313 is provided with at least one third perforation 3131 and at least one third thorn 3132 located at an edge of the third perforation 3131. The fourth sheet 314 is provided with at least one fourth perforation 3141 and at least one fourth spike 3142 located on an edge of the fourth perforation 3141. Wherein, the third sheet 313 and the fourth sheet 314 are disposed between the first sheet 311 and the second sheet 312, and when the first sheet 311, the second sheet 312, the third sheet 313, and the fourth sheet 314 are stacked together The second puncture 3122 of the second sheet 312 passes through the fourth perforation 3141 of the fourth sheet 314 at a relative position, the third perforation 3131 of the third sheet 313 at a relative position, and the first perforation of the first sheet 311 at a relative position. 3111, the fourth spur 3142 of the fourth sheet 314 passes through the third perforation 3131 of the third sheet 313 at a relative position, and the first perforation 3111 of the third sheet 311, the third perforation of the third sheet 313 is passed through The first perforations 3111 on the first sheet 311 are stacked in a relative manner, so that the first thorn 3112, the second thorn 3122, the third thorn 3132, and the fourth thorn 3142 have a quadrangular pyramid shape after being stacked.

在一實施例中,第一穿孔3111、第二穿孔3121、第三穿孔3131及第四穿孔3141之各自數量係彼此對應且為複數個,且複數個第一穿孔3111、第二穿孔3121、第三穿孔3131及第四穿孔3141可形成陣列形式,如第7圖中所示,穿孔數量為12個且形成3x4的陣列形式,但本發明並不限 制穿孔數量及所形成之陣列形式。另第一突刺3112、第二突刺3122、第三突刺3132及第四突刺3142之數量係分別對應於第一穿孔3111、第二穿孔3121、第三穿孔3131及第四穿孔3141。 In an embodiment, the respective numbers of the first perforations 3111, the second perforations 3121, the third perforations 3131, and the fourth perforations 3141 correspond to each other and are plural, and the plurality of first perforations 3111, second perforations 3121, first The three perforations 3131 and the fourth perforations 3141 may form an array form. As shown in FIG. 7, the number of perforations is 12 and a 3 × 4 array form is formed, but the present invention does not limit the number of perforations and the formed array form. In addition, the numbers of the first thorns 3112, the second thorns 3122, the third thorns 3132, and the fourth thorns 3142 correspond to the first perforations 3111, the second perforations 3121, the third perforations 3131, and the fourth perforations 3141, respectively.

本發明中微針組集合16之再一實施例,第一微針組31可僅由第一薄片311及第二薄片312所疊置而成,本發明並不限制第一微針組31中薄片數量。在本實施例中第一薄片311及第二薄片312的詳細技術內容相同於前述實施例,於此不再贅述。 In another embodiment of the microneedle group set 16 in the present invention, the first microneedle group 31 may be formed only by stacking the first sheet 311 and the second sheet 312, and the present invention does not limit the Number of slices. In this embodiment, the detailed technical content of the first sheet 311 and the second sheet 312 is the same as the foregoing embodiment, and details are not described herein again.

上述實施例中,第一微針組31之每一突刺3112、3122、3132、3142可包括一尖端部及一基部,其中一薄片上的穿孔經其餘的薄片上相對位置的穿孔邊緣的突刺穿過後,各該尖端部不在同一高度。可依照薄片疊置的次序預先設計其突刺的高度,使得其中一薄片上的穿孔經其餘的薄片上相對位置的穿孔邊緣的突刺穿過後,各該尖端部在同一高度。 In the above embodiment, each of the spikes 3112, 3122, 3132, and 3142 of the first microneedle group 31 may include a tip portion and a base portion, and the perforations on one sheet are punctured by the protruding edges of the perforated edges on the other sheets. After that, the respective tip portions are not at the same height. The height of the spikes can be pre-designed in accordance with the stacking order of the slices, so that the perforations on one of the slices are at the same height after passing through the spikes of the perforated edges on the other slices.

本發明之經皮微針陣列貼布中微針組集合16之每一突刺表面可依照目標分子進行改質,其中,目標分子可以是生物分子,例如血糖、皮質醇、脂肪酸等。目標分子亦可以是藥物分子,如抗生素。因此,微針組集合16之第一微針組31之每一突刺之內表面上可塗有感測高分子,感測高分子可例如為抗體、適體、重組單體、醣類、葡萄糖氧化酶或羥基丁酸脫氧酶。而每一突刺之外表面上塗有抗皮膚過敏的藥物。例如,量測血糖時,可通過固定葡萄糖氧 化酶於每一突刺之內表面上。而一般抗體或適體的連接方式是對作為工作電極之第一微針組31的每一突刺之金表層,施加自組裝單層(self-assemble monolayer,SAM)之後接合抗體或適體,接著再施加阻隔分子,填補未接上抗體或適體的自組裝單層,以確保其專一性,如要增加靈敏度,可進一步於金表層中混合奈米碳管。 The surface of each spike of the microneedle set 16 in the percutaneous microneedle array patch of the present invention can be modified according to the target molecule, wherein the target molecule can be a biomolecule, such as blood glucose, cortisol, and fatty acids. The target molecule can also be a drug molecule, such as an antibiotic. Therefore, the inner surface of each spur of the first microneedle group 31 of the microneedle set 16 may be coated with a sensing polymer. The sensing polymer may be, for example, an antibody, an aptamer, a recombinant monomer, a saccharide, or glucose. Oxidase or hydroxybutyrate deoxygenase. The surface of each spike is coated with anti-allergic drugs. For example, blood glucose can be measured by immobilizing glucose oxidase on the inner surface of each spike. The general antibody or aptamer connection method is to apply a self-assemble monolayer (SAM) to the gold surface layer of each of the spikes of the first microneedle group 31 as a working electrode, and then join the antibody or aptamer, and then Blocking molecules are then applied to fill the self-assembled monolayer without antibodies or aptamers to ensure its specificity. If you want to increase the sensitivity, you can further mix the nano carbon tube in the gold surface layer.

請參閱第8及9圖,其為本發明之經皮微針陣列貼布之另一實施例。與上述實施例相較,僅探針13之設置位置不同,其餘技術內容均相同,於此不再贅述。以下僅陳述不同之處。 Please refer to FIGS. 8 and 9, which are another embodiment of the percutaneous microneedle array patch of the present invention. Compared with the above embodiment, only the setting position of the probe 13 is different, and the remaining technical contents are the same, and details are not described herein again. Only the differences are stated below.

在本實施例中,二探針13係設於金屬片113上,而非設於基板14上。設於上蓋12內部之基板14則包括有介電層141及形成於介電層141上的線路層142,其中,線路層142呈現斷路狀態。 In this embodiment, the two probes 13 are disposed on the metal sheet 113 instead of the substrate 14. The substrate 14 provided inside the upper cover 12 includes a dielectric layer 141 and a circuit layer 142 formed on the dielectric layer 141, wherein the circuit layer 142 is in a disconnected state.

於一實施例中,二探針13可不同時設於金屬片113上,而是同時設於線路層142上,或是一探針13設於線路層142上而另一探針13設於金屬片113。當二探針13同時設於線路層142上時,可受下蓋11擠壓而彼此靠近相接成通路,故不需要金屬片113,但本發明並不以此為限。 In one embodiment, the two probes 13 may not be provided on the metal sheet 113 at the same time, but may be provided on the circuit layer 142 at the same time, or one probe 13 is provided on the circuit layer 142 and the other probe 13 is provided on the metal. Tablet 113. When the two probes 13 are provided on the circuit layer 142 at the same time, they can be squeezed by the lower cover 11 and contact each other to form a path, so the metal sheet 113 is not required, but the invention is not limited thereto.

當下蓋11組合上蓋12形成經皮微針陣列貼布1時,二探針13接觸線路層142,此時線路層142將會通過二探針13與金屬片113而呈現通路,即形成電流路徑15,以啟動訊號處理單元122。 When the lower cover 11 is combined with the upper cover 12 to form a percutaneous microneedle array patch 1, the two probes 13 contact the circuit layer 142, and the circuit layer 142 will present a path through the two probes 13 and the metal sheet 113, that is, a current path is formed. 15. To activate the signal processing unit 122.

上述實施形態僅為例示性說明本發明之技術原理、特 點及其功效,並非用以限制本發明之可實施範疇,任何熟習此技術之人士均可在不違背本發明之精神與範疇下,對上述實施形態進行修飾與改變。然任何運用本發明所教示內容而完成之等效修飾及改變,均仍應為下述之申請專利範圍所涵蓋。而本發明之權利保護範圍,應如下述之申請專利範圍所列。 The above-mentioned embodiments are only for illustrative purposes to explain the technical principles, features, and effects of the present invention, and are not intended to limit the implementable scope of the present invention. Any person familiar with this technology can make changes to the invention without departing from the spirit and scope of the present invention. The above embodiments are modified and changed. However, any equivalent modifications and changes made using the teachings of the present invention should still be covered by the scope of patent application described below. The scope of protection of the rights of the present invention should be as listed in the following patent application scope.

Claims (13)

一種經皮微針陣列貼布,包括:下蓋;上蓋;基板,設於該上蓋內部,包括:介電層;線路層,形成於該介電層上;及絕緣層,設於該線路層及未設有線路層之該介電層上;以及第一探針及第二探針,設於該下蓋及該上蓋之間且電性連接該基板,其中,該第一探針及該第二探針之間為斷路,且其中,該第一探針及該第二探針係貫通該介電層,該第一探針及該第二探針之一端與該線路層電性連接,且該第一探針及該第二探針之另一端外露於該上蓋之內表面;其中,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該第一探針及該第二探針之間形成通路。A percutaneous microneedle array patch includes: a lower cover; an upper cover; a substrate provided inside the upper cover, including: a dielectric layer; a circuit layer formed on the dielectric layer; and an insulating layer provided on the circuit layer And the dielectric layer without a circuit layer; and a first probe and a second probe, which are disposed between the lower cover and the upper cover and are electrically connected to the substrate, wherein the first probe and the There is an open circuit between the second probes, and the first probe and the second probe are penetrating the dielectric layer, and one end of the first probe and the second probe is electrically connected to the circuit layer. And the other ends of the first probe and the second probe are exposed on the inner surface of the upper cover; wherein, when the lower cover is combined with the upper cover to form the percutaneous microneedle array patch, the first probe and A path is formed between the second probes. 如申請專利範圍第1項所述之經皮微針陣列貼布,其中,該下蓋具有第一表面及相對於該第一表面之第二表面,該下蓋之該第一表面設有一金屬片,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該下蓋之該金屬片接觸該第一探針及該第二探針,使該第一探針及該第二探針之間形成通路,且其中,該下蓋與該上蓋之間的組合為可拆卸式。The percutaneous microneedle array patch according to item 1 of the patent application scope, wherein the lower cover has a first surface and a second surface opposite to the first surface, and the first surface of the lower cover is provided with a metal Sheet, when the lower cover is combined with the upper cover to form the percutaneous microneedle array patch, the metal piece of the lower cover contacts the first probe and the second probe, so that the first probe and the second probe A path is formed between the probes, and the combination between the lower cover and the upper cover is detachable. 如申請專利範圍第2項所述之經皮微針陣列貼布,其中,該第一探針及該第二探針係同時設於該基板上且外露於該上蓋之表面,或該第一探針及該第二探針之其中一者係設於該基板上且外露於該上蓋之表面,且該第一探針及該第二探針之另一者係設於該下蓋之該金屬片上。The percutaneous microneedle array patch according to item 2 of the scope of the patent application, wherein the first probe and the second probe are both provided on the substrate and exposed on the surface of the upper cover, or the first One of the probe and the second probe is provided on the substrate and exposed on the surface of the upper cover, and the other of the first probe and the second probe is provided on the lower cover. On a metal plate. 如申請專利範圍第1項所述之經皮微針陣列貼布,其中,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該第一探針及該第二探針受該下蓋擠壓而彼此靠近相接成通路。The percutaneous microneedle array patch according to item 1 of the patent application scope, wherein when the lower cover is combined with the upper cover to form the percutaneous microneedle array patch, the first probe and the second probe are subjected The lower covers are squeezed to be close to each other to form a passage. 如申請專利範圍第1項所述之經皮微針陣列貼布,更包括微針組集合、訊號處理單元及電源單元,該微針組集合設於該下蓋上並電性連接該基板,該訊號處理單元設於該上蓋內部,用以在該第一探針及該第二探針之間或該線路層形成通路時,啟動該訊號處理單元以產生感測訊號,該電源單元設於該上蓋內部,用以供應工作電源予該訊號處理單元。The percutaneous microneedle array patch according to item 1 of the scope of patent application, further comprising a microneedle set assembly, a signal processing unit, and a power supply unit. The microneedle set assembly is disposed on the lower cover and is electrically connected to the substrate. The signal processing unit is disposed inside the upper cover, and is used to start the signal processing unit to generate a sensing signal when a path is formed between the first probe and the second probe or the circuit layer. The power unit is provided at The upper cover is used to supply working power to the signal processing unit. 如申請專利範圍第5項所述之經皮微針陣列貼布,其中,該微針組集合更包括第一微針組、第二微針組及第三微針組,且其中,該第一微針組係作為工作電極,該第二微針組係作為參考電極,該第三微針組係作為反電極。The percutaneous microneedle array patch according to item 5 of the scope of patent application, wherein the microneedle group set further includes a first microneedle group, a second microneedle group, and a third microneedle group, and wherein the first One microneedle group is used as a working electrode, the second microneedle group is used as a reference electrode, and the third microneedle group is used as a counter electrode. 如申請專利範圍第6項所述之經皮微針陣列貼布,其中,該第一微針組由至少二薄片所疊置而成,各該至少二薄片上分別設置有至少一穿孔及位於該穿孔之邊緣之至少一突刺,且其中,該至少二薄片之一者之突刺穿過該至少二薄片之另一者上相對位置之該穿孔而與該至少二薄片之另一者之突刺相對,且其中,各該至少二薄片之突刺之各自數量係彼此對應且為複數個,且其中,各該至少二薄片之穿孔係形成為陣列形式。The percutaneous microneedle array patch according to item 6 of the scope of patent application, wherein the first microneedle group is formed by stacking at least two sheets, and each of the at least two sheets is provided with at least one perforation and is located at At least one spike of the edge of the perforation, and wherein the spike of one of the at least two sheets passes through the perforation at a relative position on the other of the at least two sheets to oppose the spike of the other of the at least two sheets And, the respective numbers of the spurs of each of the at least two sheets are corresponding to each other and are plural, and wherein the perforations of each of the at least two sheets are formed in an array form. 如申請專利範圍第7項所述之經皮微針陣列貼布,其中,該至少二薄片包括第一薄片、第二薄片及第三薄片,該第一薄片上設置有至少一第一穿孔及位於該第一穿孔之邊緣之至少一第一突刺,該第二薄片上設置有至少一第二穿孔及位於該第二穿孔之邊緣之至少一第二突刺,以及該第三薄片上設置有至少一第三穿孔及位於該第三穿孔之邊緣之至少一第三突刺,且其中,該第二突刺及該第三突刺穿過該第一薄片上相對位置之該第一穿孔而與該第一突刺呈三角錐形,且其中,該第一穿孔、該第二穿孔及該第三穿孔之各自數量係彼此對應且為複數個,且其中,複數個之該第一穿孔、該第二穿孔或該第三穿孔係形成為陣列形式。The percutaneous microneedle array patch according to item 7 of the patent application scope, wherein the at least two sheets include a first sheet, a second sheet, and a third sheet, and the first sheet is provided with at least one first perforation and At least one first spike located at the edge of the first perforation, at least one second hole located at the edge of the second perforation and at least one second spike located at the edge of the second perforation, and at least one third protrusion located on the third sheet. A third perforation and at least one third burr located at an edge of the third perforation, and wherein the second burr and the third burr pass through the first perforation at a relative position on the first sheet and communicate with the first perforation The spikes have a triangular pyramid shape, and the respective numbers of the first, second, and third perforations correspond to each other and are plural, and wherein the plurality of the first, second, or The third perforation is formed in an array. 如申請專利範圍第7項所述之經皮微針陣列貼布,其中,該至少二薄片包括第一薄片、第二薄片、第三薄片及第四薄片,該第一薄片上設置有至少一第一穿孔及位於該第一穿孔之邊緣之至少一第一突刺,該第二薄片上設置有至少一第二穿孔及位於該第二穿孔之邊緣之至少一第二突刺,該第三薄片上設置有至少一第三穿孔及位於該第三穿孔之邊緣之至少一第三突刺,以及該第四薄片上設置有至少一第四穿孔及位於該第四穿孔之邊緣之至少一第四突刺,且其中,該第二突刺、該第三突刺及該第四突刺穿過該第一薄片上相對位置之該第一穿孔而與該第一突刺呈四角錐形,且其中,該第一穿孔、該第二穿孔、該第三穿孔及該第四穿孔之各自數量係彼此對應且為複數個,且其中,複數個之該第一穿孔、該第二穿孔、該第三穿孔或該第四穿孔係形成為陣列形式。The percutaneous microneedle array patch according to item 7 of the scope of patent application, wherein the at least two sheets include a first sheet, a second sheet, a third sheet, and a fourth sheet, and at least one A first perforation and at least a first burr located at an edge of the first perforation, at least a second perforation and at least a second burr located at an edge of the second perforation, on the third sheet; At least one third perforation and at least one third burr located at an edge of the third perforation, and at least one fourth perforation and at least one fourth burr located at an edge of the fourth perforation, And, the second spur, the third spur, and the fourth stab pass through the first perforation at a relative position on the first sheet to form a quadrangular pyramid with the first spur, and wherein the first perforation, The respective numbers of the second perforation, the third perforation, and the fourth perforation are corresponding to each other and are plural, and wherein the first perforation, the second perforation, the third perforation, or the fourth perforation are plural. The lines are formed in an array. 如申請專利範圍第7項所述之經皮微針陣列貼布,其中,該第一微針組之每一突刺包括一尖端部及一基部,其中一薄片上的穿孔經其餘的薄片上相對位置的穿孔邊緣的突刺穿過後,各該尖端部不在同一高度或在同一高度。The percutaneous microneedle array patch according to item 7 of the scope of the patent application, wherein each spur of the first microneedle group includes a tip portion and a base portion, and the perforations on one sheet are opposed to each other on the other sheets. After the puncture at the perforated edge of the position passes through, the tip portions are not at the same height or at the same height. 一種經皮微針陣列貼布,包括:下蓋,具有第一表面及相對於該第一表面之第二表面;上蓋;金屬片,設於該下蓋之該第一表面;基板,設於該上蓋內部,包括一介電層以及形成於該介電層上之線路層,其中,該線路層為斷路;以及第一探針及第二探針,設於該下蓋及該上蓋之間,其中,該第一探針及該第二探針之間為斷路;其中,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該下蓋之該金屬片接觸該第一探針及該第二探針且該第一探針及該第二探針接觸該線路層,使該線路層形成通路。A percutaneous microneedle array patch includes: a lower cover having a first surface and a second surface opposite to the first surface; an upper cover; a metal sheet provided on the first surface of the lower cover; and a substrate provided on The inside of the upper cover includes a dielectric layer and a circuit layer formed on the dielectric layer, wherein the circuit layer is an open circuit; and a first probe and a second probe are provided between the lower cover and the upper cover. Wherein the first probe and the second probe are disconnected; wherein, when the lower cover is combined with the upper cover to form the percutaneous microneedle array patch, the metal piece of the lower cover contacts the first The probe and the second probe and the first probe and the second probe contact the circuit layer, so that the circuit layer forms a via. 如申請專利範圍第11項所述之經皮微針陣列貼布,其中,該第一探針及該第二探針係同時設於該基板之該線路層上,或同時設於該下蓋之該金屬片上,或一者設於該基板之該線路層上而另一者設於該下蓋之該金屬片上。The percutaneous microneedle array patch according to item 11 of the scope of patent application, wherein the first probe and the second probe are provided on the circuit layer of the substrate or on the lower cover at the same time. On the metal sheet, or one on the circuit layer of the substrate and the other on the metal sheet of the lower cover. 一種經皮微針陣列貼布,包括:下蓋;上蓋;基板,設於該上蓋內部,包括一介電層以及形成於該介電層上之線路層,其中,該線路層為斷路;以及第一探針及第二探針,設於該下蓋及該上蓋之間,其中,該第一探針及該第二探針之間為斷路;其中,當該下蓋組合該上蓋形成該經皮微針陣列貼布時,該第一探針及該第二探針受該下蓋擠壓而彼此靠近相接成通路,並使該線路層形成通路。A percutaneous microneedle array patch includes: a lower cover; an upper cover; a substrate disposed inside the upper cover, including a dielectric layer and a circuit layer formed on the dielectric layer, wherein the circuit layer is open; and The first probe and the second probe are disposed between the lower cover and the upper cover, wherein the first probe and the second probe are disconnected; wherein when the lower cover is combined with the upper cover to form the When the percutaneous microneedle array is applied, the first probe and the second probe are squeezed by the lower cover to be close to each other to form a path, and the circuit layer forms a path.
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