WO2003094731A1 - Painless blood collection method - Google Patents

Painless blood collection method Download PDF

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Publication number
WO2003094731A1
WO2003094731A1 PCT/JP2003/005578 JP0305578W WO03094731A1 WO 2003094731 A1 WO2003094731 A1 WO 2003094731A1 JP 0305578 W JP0305578 W JP 0305578W WO 03094731 A1 WO03094731 A1 WO 03094731A1
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WO
WIPO (PCT)
Prior art keywords
puncture
skin
finger
joint
puncturing
Prior art date
Application number
PCT/JP2003/005578
Other languages
French (fr)
Japanese (ja)
Inventor
Toru Nakayama
Mariko Nakayama
Masafumi Nakayama
Takayuki Nakayama
Original Assignee
Toru Nakayama
Mariko Nakayama
Masafumi Nakayama
Takayuki Nakayama
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from JP2002167855A external-priority patent/JP2003319925A/en
Application filed by Toru Nakayama, Mariko Nakayama, Masafumi Nakayama, Takayuki Nakayama filed Critical Toru Nakayama
Priority to AU2003235830A priority Critical patent/AU2003235830A1/en
Publication of WO2003094731A1 publication Critical patent/WO2003094731A1/en

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Classifications

    • 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
    • A61B5/15—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
    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced

Definitions

  • the present invention relates to a method for puncturing the skin with a puncture needle and bleeding the skin to reduce the pain associated with puncture. It is useful for measuring autoglycemia in patients with urine disease. It is suitable for testing that requires a small amount of blood sample. Disgusting background
  • skin puncture is performed at a depth of from 0.1 awake to 0.5 mm or less including an error so as to awaken the skin puncture force.
  • the thickness of the epidermis of the skin is 0.07 to 0.12 mm.
  • the epidermis of the palms and soles is even thicker, with the palm epidermis as thick as 0.8 mm and the sole epidermis as thick as 1.4 mm.
  • Below the epidermis is the dermis.
  • blood vessels such as the lower vascular network around the season. The nerve endings that control pain are distributed between the epidermis and the dermis.
  • the puncture depth is set to the minimum depth at which the puncture needle penetrates the epidermis and damages the vascular network just below the epidermis. If the puncture is shallow, the puncture will cause less damage to the skin fibers.
  • hand Fingers, forearms, abdomen and earlobes are easy to puncture.
  • fingertip age is recommended on the palm side or side of the fingertip. Puncturing the dorsal side of the finger is not recommended.
  • Figure 1 shows the puncture sound! ⁇ On the back of the finger.
  • the description of the reference numerals in the drawings is described below.
  • the puncture depth of a currently available self-fixating puncture device is 0.4 mm or more. Also, the puncture depth varies widely, ranging from ⁇ 0.2 to 0.3 ⁇ . In order to control the depth of puncture and perform painless puncture with good reversibility, the depth of puncture and the variation in the puncture of the commercially available puncture I intestine are too large.
  • the skin puncture at the depth of the thigh was performed with an accuracy of ( ⁇ 0.075 mm).
  • the depth of the puncture was shallower and the pain at the time of puncture was less.
  • skin puncture including errors, at a depth of at least 0.1 awake and under 0.5 mm.
  • the puncture force of the puncture device or puncture needle with a puncture error of ⁇ 0.2 mm is required to be punctured at 0.3 mm.
  • the body parts that can puncture the skin with the above-mentioned depth without pain and with slight pain are considered to be multiple, but the places that can be easily punctured are the shooting point, forearm, abdomen and earlobe.
  • the depth of the puncture was shallow, so bleeding was not recognized only by puncturing the skin.
  • compression around the puncture site or suction by negative pressure at the puncture site is necessary to obtain a blood sample: ⁇ .
  • the fingertip In finger puncture, the fingertip is often used for puncture. However, since the painful area is located on the palm side of the fingertip, the side and side of the fingertip are appropriate parts for puncture.
  • the back of the fingertip is not listed as a puncture site in the patient manual attached to self-sickle measurement. This time we found a site suitable for »
  • the puncture in the skin on the back side of the skin is the finger joint (IP joint of the thumb, DIP joint of the 2nd to 5th fingers), the part to the posterior nail fold, and the «tree from the nail fold to the side / ⁇ Department.
  • the puncture site is shown in (2) of the drawing. The area near the hairline of the nail causes abundant blood flow, causing bleeding.
  • the posterior nail fold and the tree part from the posterior nail fold to the lateral nail fold are the # 1 puncture site. This is shown in (2a) in the figure. Because the puncture is too shallow even in # 11, it is often not possible to obtain the required amount of blood only by puncturing the skin, such as the finger joint of the punctured finger (IP joint of the thumb, second to fifth Flexion of the DIP joint of the finger), puncture by pressing the central part of the finger rather than the puncture sound ⁇ , or puncturing the finger's palmar side of the pierced finger If the required amount of blood cannot be obtained by the above operation, the punctured finger should be stretched and then repeat the above operation.This 1 ⁇ 2fe does not require suction of ⁇ 3 ⁇ 4fc fluid by negative pressure. Industrial available
  • the painless method of the present invention not only reduces the pain of the patient, but also has medical economics advantages.
  • the present method requires expensive equipment, such as a blood squeezing pump, especially on the side and the side of ⁇ t, and can perform tmfc.
  • a blood squeezing pump especially on the side and the side of ⁇ t, and can perform tmfc.
  • a conventional blood glucose measuring device that is already widely used can be used as it is. Because of this many diabetes The patient can use the painless blood glucose measurement system.
  • the method can also be applied to other tests that can be performed on small blood samples in addition to self-blood glucose measurement.

Abstract

A method of collecting a blood sample in a small amount with no or little pain by puncturing the skin with a needle. Pain at puncturing the skin can be eliminated or relieved by accurately puncturing the skin in a depth of from 0.1 mm to 0.5 mm. This method is usable in many parts of the body including fingers, forearms, abdomen and ear lobules. As novel puncture sites, there have been further developed a back part of a finger from a knuckle joint (the IP joint of a first finger or the DIP joint of one of the second to fifth fingers) to the posterior nail fold and a part from the posterior nail fold to the lateral nail fold. The blood collection method as described above is useful mainly for the blood glucose measurement by a diabetic patient himself/herself. Moreover, it is applicable to other various examinations which can be carried out using a blood sample in a small amount.

Description

無痛她法 鎌分野 Painless sickle field
本発明は穿刺針で皮膚を穿刺し出血させて行う 法にぉレ、て、穿刺に伴う痛みを無く するカ«少させる雄に関するものである。特〖^尿病患者の自己血糖測定時に有用であ る。 そのほ力 用する血液サンプルが少量でよい検査の ^に適する。 背景嫌  TECHNICAL FIELD The present invention relates to a method for puncturing the skin with a puncture needle and bleeding the skin to reduce the pain associated with puncture. It is useful for measuring autoglycemia in patients with urine disease. It is suitable for testing that requires a small amount of blood sample. Disgusting background
従来 自己血糖測定は指頭（掌側、側面） または耳朶等を穿刺針で穿刺し、 出血させて 得られる血液を用いて行われてきた。現在ィ吏用されている自己血膽測定用の »用穿朿 具による穿刺の深さは 0. 4隨以上である。 また穿刺の深さの誤差が ±0. 2〜0. 3 瞧程 度 ¾£する。指尖、 耳朶の皮膚穿刺時の痛みは従来の贿で〖透けられなかった。 で は採血部位を腹部や前腕などにすることによつて »時の痛みを避ける試みが行われて レ、るが無痛とするに至つてレヽなレ、。 発明の開示  Conventionally, self-blood glucose measurement has been performed using blood obtained by puncturing a finger tip (palm side, side surface) or earlobe with a puncture needle and bleeding. The depth of the puncture with the self-analyzing bleeding device currently used by the public officials is more than 0.4. In addition, the error of the puncture depth is about ± 0.2 to 0.3 瞧. Pain during skin puncture of fingertips and earlobes could not be seen through conventional skin. Attempts have been made to avoid pain at times by making the blood collection site the abdomen or forearm, etc. Disclosure of the invention
本発明では皮膚穿刺を 誤差を含めて 0. 1醒以上 0. 5 mm以下の深さで行うことに より皮膚穿刺時の痛みを無くする力 \ 醒させるものである。 手掌及び足底をのぞく 皮膚の表皮の厚さは 0. 07〜0. 12瞧である。 手掌や足底の表皮はさらに厚く、 手掌の 表皮の厚さは 0. 8 mm、足底の表皮の厚さは 1. 4 mmにも る。 表皮の下には真皮が ある。 表皮直下には季頃下血管網などの血管が する。 痛覚をつかさどる神経自由 終末は表皮と真皮の間に分布している。 そのため皮膚穿刺を出来るだけ無痛で行うた めには穿刺の深さを、 穿刺針が表皮を貫通し表皮直下の血管網を傷つける最小の深さ に設定する必要がある。 穿刺が浅いと穿刺が皮膚の繊に与える損害も少なレ、。 手 指、 前腕、 腹部及び耳朶の皮虜が穿刺し易い部位である。 現在、 指先で拠する齢 は指頭の掌側または側面で »すること力 S勧められている。 指の手背側を穿刺するこ とは勧められていない。 本発明では無痛 ¾kが可能な手指の部位として、痛点が 分布する ¥ί旨の掌側を避け、背面側の部分《 ί!の皮膚で、指関節 (母指の IP関節、 第 2〜5指の DIP関節 ) 力 ^後 |5までの手背側部分及 から側爪郭への樹亍 mを開発した。 図面の簡単な説明 In the present invention, skin puncture is performed at a depth of from 0.1 awake to 0.5 mm or less including an error so as to awaken the skin puncture force. Except for the palms and soles The thickness of the epidermis of the skin is 0.07 to 0.12 mm. The epidermis of the palms and soles is even thicker, with the palm epidermis as thick as 0.8 mm and the sole epidermis as thick as 1.4 mm. Below the epidermis is the dermis. Just below the epidermis, there are blood vessels such as the lower vascular network around the season. The nerve endings that control pain are distributed between the epidermis and the dermis. Therefore, in order to perform skin puncture as painlessly as possible, it is necessary to set the puncture depth to the minimum depth at which the puncture needle penetrates the epidermis and damages the vascular network just below the epidermis. If the puncture is shallow, the puncture will cause less damage to the skin fibers. hand Fingers, forearms, abdomen and earlobes are easy to puncture. Currently, fingertip age is recommended on the palm side or side of the fingertip. Puncturing the dorsal side of the finger is not recommended. In the present invention, painless pain is distributed as a part of the finger where painless ¾k is possible, avoiding the palm side of the hand, and using the skin of the back side 《ί!, The knuckle (IP joint of the thumb, second to fifth DIP joint of fingers) Force ^ After | 5, we developed a tree m from the dorsal part of the hand to the lateral nail fold. BRIEF DESCRIPTION OF THE FIGURES
図 1は手指の背側の穿刺音!^を示す。 図面中の引用符号の説明を下記に記す。 Figure 1 shows the puncture sound! ^ On the back of the finger. The description of the reference numerals in the drawings is described below.
( 1 ) 爪 （2) 穿刺咅啦 （2 a ) 穿刺音啦  (1) Nail (2) Puncture (2a) Puncture sound
( 3 ) 指関節 （母指 IPの関節、 2〜5指の DIP関節） 発明を実施するための最良の形態  (3) Finger joints (joint of thumb IP, DIP joint of 2 to 5 fingers) Best mode for carrying out the invention
現在市販されている自己 定用の穿刺器具による穿刺の深さは 0. 4咖以上である。 また穿刺の深さのばらつきも大きく、 ±0. 2〜0. 3瞧 である。 穿刺の深さをコント口 ールして無痛穿刺を翻性よく行うためには、市販の穿束 I腸具の穿刺の深さや、そのばら つきは大きすぎる。 我々は TERUM0社の穿刺器具 ( Medisafe Fine Touch ) を浅く穿刺出 来るように改造したものと、長さの精度が高レヽ穿朿掛をィ細して、 0. 2， 0. 3, 0.4, 0. 5 及 ぴ 0. 6 腿の深さの皮膚穿刺を （±0. 075 mm ) の精度で行った。 その結果 穿刺の深さ が浅レ、ほど 穿刺時の痛みは少なレヽことがわかつた。無痛なレヽし痛みの少なレ、穿刺で血液 を得るには、 誤差も含めて皮膺穿刺を常に 0. 1 醒以上 0. 5 mm以下の深さで行う必要 がある。現在、患者が自ら を行う為の装置のうち、 この深さの皮虜穿刺が常に可能な 市販品の穿刺器具及び穿朿 UfHま被しない。前述の深さの範囲で穿刺するとすれば、 ±0. 2 瞧の穿刺の誤差がある穿刺器具または穿刺針の;^は 0. 3 瞧で穿刺すること力 S必要と なる。 0. 3 ±0. 2■の深さの穿刺しか出来ないのでは 穿刺する皮膚に応じた対応が充 分にはとれない。 そのため穿刺の精度を上げる必要がある。 ±0. 075咖 の穿刺精度の Μ^, 0. 1 mm以上 0. 5 腿以下の穿刺の深さの範囲で 0.2， 0. 3及び 0.4 mmの穿刺が出 来たため、個人によってわずかに異なる顯な穿刺の深さにも対応できた。 The puncture depth of a currently available self-fixating puncture device is 0.4 mm or more. Also, the puncture depth varies widely, ranging from ± 0.2 to 0.3 瞧. In order to control the depth of puncture and perform painless puncture with good reversibility, the depth of puncture and the variation in the puncture of the commercially available puncture I intestine are too large. We have modified the puncture device (Medisafe Fine Touch) of TERUM0 so that the puncture comes out shallowly, and the precision of the length has been reduced to a high level. 0.5 and 0.6 The skin puncture at the depth of the thigh was performed with an accuracy of (± 0.075 mm). As a result, it was found that the depth of the puncture was shallower and the pain at the time of puncture was less. In order to obtain blood by puncture without painful pain and less pain, it is necessary to always perform skin puncture, including errors, at a depth of at least 0.1 awake and under 0.5 mm. At present, of the devices that patients do themselves, they do not cover commercially available puncture devices and drilling UfHs that are always capable of puncturing skin at this depth. If the puncture is performed within the above-mentioned depth range, the puncture force of the puncture device or puncture needle with a puncture error of ± 0.2 mm is required to be punctured at 0.3 mm. If only a puncture at a depth of 0.3 ± 0.2 mm can be performed, it will not be possible to adequately respond to the skin to be punctured. Therefore, it is necessary to increase the accuracy of puncturing. ± 0.075 咖 puncture accuracy Μ ^, 0.1 mm to 0.5 Thigh puncture depth range of 0.2, 0.3, and 0.4 mm punctures, allowing for slightly different apparent puncture depths depending on the individual did it.
前述の深さの皮潸穿刺を無痛なレヽし軽度の痛みで行うことが出来る体の部位は多レヽと 思われるが、容易に穿刺出来る場所は 射旨、前腕、腹部 及び耳朶である。 穿刺の深さ が浅レ、ため皮膚を穿刺したのみでは出血が認められなレ、ことが多レ、。 以外の咅啦の穿 刺では、穿刺部の周囲の圧迫や穿刺部の陰圧による吸引が血液サンプルを得るために必要 な:^がある。  The body parts that can puncture the skin with the above-mentioned depth without pain and with slight pain are considered to be multiple, but the places that can be easily punctured are the shooting point, forearm, abdomen and earlobe. The depth of the puncture was shallow, so bleeding was not recognized only by puncturing the skin. For punctures other than 咅 啦, compression around the puncture site or suction by negative pressure at the puncture site is necessary to obtain a blood sample: ^.
の穿刺では 指頭が穿刺によく用いられるが、指頭の掌側には痛点が多く雜す るので、指頭の側面及ひ 面が穿刺謝 として適当な部分である。指頭の背面は自己鎌 測 附属の患者用マニュアルには穿刺部位として掲載されていない。今回 »に適した 部位を発見したので、 図面を謝し説明する。雜背面側の皮膚での穿刺謝立は、指関節 (母指の IP関節、第 2〜5指の DIP関節 ) 力 後爪郭まで部分、及 ·«爪郭から側/^ への樹亍部である。 爾寸の図面の （2) に穿刺部位を示す。 爪の生え際に近い部分が血流 量豊富で出血させ "レ、。 後爪郭及び後爪郭から側爪郭への樹亍部が ¾1穿刺部位であ る。 図中 （2 a ) にこれを示す。 #11でも穿刺が浅レヽため、皮膚の穿刺のみでは必要量の 血液を得られないことが多い。 このような 、 穿刺した指の指関節 （母指の IP関節、 第 2〜5指の DIP関節 ) の屈曲、穿刺音啦よりも指の中枢側部分の圧迫または 、穿刺 した指の指頭掌側の圧迫等で穿刺咅 M立の充血をはかることにより出血を ί足進することが できる。以上の操作で必要量の血液を得られない は 穿刺した指をいつたんのばした 後、 再ひ 述の操作を繰り返す。 この ½feで〖¾fc液の陰圧による吸引を必要としない。 産業上の利用可能  In finger puncture, the fingertip is often used for puncture. However, since the painful area is located on the palm side of the fingertip, the side and side of the fingertip are appropriate parts for puncture. The back of the fingertip is not listed as a puncture site in the patient manual attached to self-sickle measurement. This time we found a site suitable for » The puncture in the skin on the back side of the skin is the finger joint (IP joint of the thumb, DIP joint of the 2nd to 5th fingers), the part to the posterior nail fold, and the «tree from the nail fold to the side / ^ Department. The puncture site is shown in (2) of the drawing. The area near the hairline of the nail causes abundant blood flow, causing bleeding. ”The posterior nail fold and the tree part from the posterior nail fold to the lateral nail fold are the # 1 puncture site. This is shown in (2a) in the figure. Because the puncture is too shallow even in # 11, it is often not possible to obtain the required amount of blood only by puncturing the skin, such as the finger joint of the punctured finger (IP joint of the thumb, second to fifth Flexion of the DIP joint of the finger), puncture by pressing the central part of the finger rather than the puncture sound 、, or puncturing the finger's palmar side of the pierced finger If the required amount of blood cannot be obtained by the above operation, the punctured finger should be stretched and then repeat the above operation.This ½fe does not require suction of 〖¾fc fluid by negative pressure. Industrial available
本発明の無痛»法は患者の痛みを軽 るのみならず、 医療経済学上の利点も有る。 即ち本法では、特に^ tの側部及ひ 部での拠の 、血謙引ポンプのような高価な 器具を必要とせ tmfcを行うことが出来る。 また自己血糖測定を行う齢には、すでに多 数普及している従来の血糖測定機をそのまま用いることが出来る。このため多くの糖尿病 患者に麵に無痛血糖測定システムを働^ rることが出来る。また本法は自己血糖測定以 外にも少量の血液サンプルで行える他の諸検査にも応用出来る。 The painless method of the present invention not only reduces the pain of the patient, but also has medical economics advantages. In other words, the present method requires expensive equipment, such as a blood squeezing pump, especially on the side and the side of ^ t, and can perform tmfc. At the age of self-monitoring of blood glucose, a conventional blood glucose measuring device that is already widely used can be used as it is. Because of this many diabetes The patient can use the painless blood glucose measurement system. The method can also be applied to other tests that can be performed on small blood samples in addition to self-blood glucose measurement.

Claims

請求の範囲 The scope of the claims
1 . 皮廣の穿刺による で、 »B寺の痛みの軽減や、穿刺針による皮 ϋ«の損害を少 なくする等の目的で、皮膚穿刺を正確に 0. 1 mm以上 0. 5瞧以下の範囲内で行うこと。 穿 刺の深さに誤差があっても穿刺の深さが常にこの範囲を超えないようにすること。 1. Due to skin puncture, skin puncture can be performed accurately from 0.1 mm to 0.5 mm for the purpose of reducing pain at »B temple and reducing skin damage due to puncture needle. Perform within the range. The puncture depth should not exceed this range, even if there is an error in the puncture depth.
2. 皮膚穿刺による を手指背面側の皮膚で、 指関節 （母指の IP関節、 第 2〜5指の MP関節） 力 後爪郭までの部分、及«爪郭から側爪郭への樹于部で行うこと。 2. Skin puncture on the skin on the back side of the finger, finger joint (IP joint of thumb, MP joint of 2nd to 5th finger) Force part to nail claw, tree from nail claw to lateral claw What to do in Ube.
PCT/JP2003/005578 2002-05-07 2003-05-01 Painless blood collection method WO2003094731A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2002167855A JP2003319925A (en) 2002-05-07 2002-05-07 Blood collection method by painless skin puncture
JP2002-167855 2002-05-07
JP2003074592 2003-02-13
JP2003-74592 2003-02-13

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07275223A (en) * 1992-04-13 1995-10-24 Boehringer Mannheim Gmbh Blood lancet device for blood-collection
JPH11253409A (en) * 1998-03-11 1999-09-21 Nec Corp Piercing needle and member for corneal layer of epidermis
JP2000116768A (en) * 1998-10-19 2000-04-25 Terumo Corp Puncture appliance
JP2001524343A (en) * 1997-12-02 2001-12-04 アボット・ラボラトリーズ Method and apparatus for obtaining interstitial fluid for diagnostic tests

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07275223A (en) * 1992-04-13 1995-10-24 Boehringer Mannheim Gmbh Blood lancet device for blood-collection
JP2001524343A (en) * 1997-12-02 2001-12-04 アボット・ラボラトリーズ Method and apparatus for obtaining interstitial fluid for diagnostic tests
JPH11253409A (en) * 1998-03-11 1999-09-21 Nec Corp Piercing needle and member for corneal layer of epidermis
JP2000116768A (en) * 1998-10-19 2000-04-25 Terumo Corp Puncture appliance

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