JP7315777B2 - 連続血糖測定装置用挿入ガイドニードル製作方法 - Google Patents
連続血糖測定装置用挿入ガイドニードル製作方法 Download PDFInfo
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- JP7315777B2 JP7315777B2 JP2022503989A JP2022503989A JP7315777B2 JP 7315777 B2 JP7315777 B2 JP 7315777B2 JP 2022503989 A JP2022503989 A JP 2022503989A JP 2022503989 A JP2022503989 A JP 2022503989A JP 7315777 B2 JP7315777 B2 JP 7315777B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
- A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
- A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150167—Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
- A61B5/150396—Specific tip design, e.g. for improved penetration characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
- A61B5/15045—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin comprising means for capillary action
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements 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
- A61B5/6847—Arrangements 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
Description
Claims (5)
- 連続血糖測定装置用のセンサー部材の身体挿入をガイドするために前記センサー部材と共に身体に挿入される挿入ガイドニードルを製作する方法であって、
(a)身体挿入方向に沿って長く形成される金属材質のニードル円板を準備する段階と、
(b)前記挿入ガイドニードルが身体に挿入されることによって身体の肌を拡張切開することができる拡張切開部が形成され、前記拡張切開部の前方末端が身体の肌と点接触する形態のドット先端を成すように前記ニードル円板の前方末端部位を切断する段階と、
(c)前記(b)段階を通じて切断したニードル円板に対して幅方向両側端部を折曲する段階と、
を含み、
前記(b)段階は、
前記ニードル円板の上面を経つ長さ方向中心軸と交差する方向に第1傾斜面が形成されるように切断刃により前記ニードル円板を1次切断する段階と、前記ニードル円板の長さ方向中心軸を基準で前記第1傾斜面と対称になるように第2傾斜面が形成されるように前記ニードル円板を切断刃により2次切断する段階を含み、
前記第1傾斜面及び第2傾斜面は下端に行くほど前記ニードル円板の長さ方向中心軸と前記ドット先端を含む仮想の平面から遠くなる方向に傾くように形成される
連続血糖測定装置用挿入ガイドニードル製作方法。 - 前記第1傾斜面及び第2傾斜面と前記ニードル円板の長さ方向中心軸が相互交差する一つの交差支点は前記ニードル円板の前方末端から一定距離離隔された位置に位置することを特徴とする請求項1に記載の連続血糖測定装置用挿入ガイドニードル製作方法。
- 前記(b)段階は、
前記第1傾斜面と第2傾斜面が前記ニードル円板の長さ方向中心軸を中心にお互いに対称になるように交差し、交差するラインに沿って先端エッジラインが形成され、前記先端エッジラインの前方末端に前記ドット先端が形成されるように遂行されることを特徴とする請求項2に記載の連続血糖測定装置用挿入ガイドニードル製作方法。 - 前記(c)段階はプレス成形加工を通じて行われることを特徴とする請求項1から3のいずれか一つに記載の連続血糖測定装置用挿入ガイドニードル製作方法。
- 前記(c)段階は前記拡張切開部に前方末端から後方側に先端部、変曲部及び連結部が順次に形成されるように遂行され、前記先端部は前記ドット先端から後方に行くほど前記ニードル円板の幅方向に拡張されて身体挿入過程で身体の肌を該当方向に拡張切開するように形成され、前記変曲部は後方に行くほど前記ニードル円板の幅方向に拡張しながら厚さ方向に拡張する形態で変化されて身体挿入過程で身体の肌を該当方向に拡張切開するように形成され、
前記連結部は後方に行くほど前記ニードル円板の厚さ方向に拡張されて身体挿入過程で身体の肌を該当方向に拡張切開するように形成されることを特徴とする請求項4に記載の連続血糖測定装置用挿入ガイドニードル製作方法。
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KR10-2019-0095973 | 2019-08-07 | ||
KR1020190095973A KR102238432B1 (ko) | 2019-08-07 | 2019-08-07 | 연속 혈당 측정 장치용 삽입 가이드 니들 제작 방법 |
PCT/KR2020/003703 WO2021025257A1 (ko) | 2019-08-07 | 2020-03-18 | 연속 혈당 측정 장치용 삽입 가이드 니들 제작 방법 |
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JP7315777B2 true JP7315777B2 (ja) | 2023-07-26 |
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EP (1) | EP3991652A4 (ja) |
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KR102321265B1 (ko) | 2021-04-30 | 2021-11-03 | 주식회사 두원필터 | 식모기 바늘 가공방법 |
KR102592776B1 (ko) * | 2021-06-29 | 2023-10-25 | 주식회사 아이센스 | 경피성 센서를 삽입하기 위한 니들 및 니들 어셈블리 |
Citations (5)
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JP2003260042A (ja) | 2002-03-07 | 2003-09-16 | Univ Toyama | 微量の生体試料の採取・保持方法 |
JP2016128031A (ja) | 2010-03-24 | 2016-07-14 | アボット ダイアベティス ケア インコーポレイテッドAbbott Diabetes Care Inc. | 挿入器を検体モニタ装置に係合するシステムおよび挿入器を検体モニタ装置に係合する方法 |
JP2017525516A (ja) | 2014-09-03 | 2017-09-07 | ノヴァ バイオメディカル コーポレイション | 皮下センサインサータ及び方法 |
WO2018222009A1 (ko) | 2017-06-02 | 2018-12-06 | 주식회사 아이센스 | 연속 혈당 측정기용 센서 어플리케이터 조립체 |
WO2019045503A1 (ko) | 2017-09-01 | 2019-03-07 | 최규동 | 탄소 나노 튜브 구조의 혈당측정센서 일체형 삽입 가이드 바늘 |
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WO2015128263A1 (en) * | 2014-02-26 | 2015-09-03 | Roche Diagnostics Gmbh | An implant needle and method for production |
ES2899901T3 (es) * | 2016-01-25 | 2022-03-15 | Hoffmann La Roche | Dispositivo médico y procedimiento para su fabricación |
KR102164782B1 (ko) | 2017-06-02 | 2020-10-15 | 주식회사 아이센스 | 연속 혈당 측정기용 센서 어플리케이터 조립체 |
KR102238431B1 (ko) * | 2019-08-07 | 2021-04-12 | 주식회사 아이센스 | 연속 혈당 측정 장치용 삽입 가이드 니들 |
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- 2019-08-07 KR KR1020190095973A patent/KR102238432B1/ko active IP Right Grant
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- 2020-03-18 EP EP20849455.9A patent/EP3991652A4/en active Pending
- 2020-03-18 US US17/631,012 patent/US20220240815A1/en active Pending
- 2020-03-18 JP JP2022503989A patent/JP7315777B2/ja active Active
- 2020-03-18 WO PCT/KR2020/003703 patent/WO2021025257A1/ko unknown
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Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2003260042A (ja) | 2002-03-07 | 2003-09-16 | Univ Toyama | 微量の生体試料の採取・保持方法 |
JP2016128031A (ja) | 2010-03-24 | 2016-07-14 | アボット ダイアベティス ケア インコーポレイテッドAbbott Diabetes Care Inc. | 挿入器を検体モニタ装置に係合するシステムおよび挿入器を検体モニタ装置に係合する方法 |
JP2017525516A (ja) | 2014-09-03 | 2017-09-07 | ノヴァ バイオメディカル コーポレイション | 皮下センサインサータ及び方法 |
WO2018222009A1 (ko) | 2017-06-02 | 2018-12-06 | 주식회사 아이센스 | 연속 혈당 측정기용 센서 어플리케이터 조립체 |
WO2019045503A1 (ko) | 2017-09-01 | 2019-03-07 | 최규동 | 탄소 나노 튜브 구조의 혈당측정센서 일체형 삽입 가이드 바늘 |
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JP2022542353A (ja) | 2022-10-03 |
EP3991652A1 (en) | 2022-05-04 |
WO2021025257A1 (ko) | 2021-02-11 |
EP3991652A4 (en) | 2023-07-19 |
KR20210018631A (ko) | 2021-02-18 |
AU2020326035A1 (en) | 2022-02-17 |
US20220240815A1 (en) | 2022-08-04 |
KR102238432B1 (ko) | 2021-04-12 |
AU2020326035B2 (en) | 2024-01-25 |
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