JP2010531196A - カニューレ挿入用デバイス - Google Patents
カニューレ挿入用デバイス Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
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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
- A61B5/68—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
- A61B5/6848—Needles
- A61B5/6849—Needles in combination with a needle set
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
- A61M5/422—Desensitising skin
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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
- A61B5/145—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/1426—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with means for preventing access to the needle after use
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1581—Right-angle needle-type devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1585—Needle inserters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
- A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
- A61M2205/362—General characteristics of the apparatus related to heating or cooling by gas flow
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
- A61M2205/3673—General characteristics of the apparatus related to heating or cooling thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/1413—Modular systems comprising interconnecting elements
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Abstract
Description
本出願は、「Protector for Cannula and Penetrating Member Insertable in the Body of a Patient」という表題の米国仮特許出願第60/937,155号、「Insertion Device for Inserting a Cannula into a Body」という表題の米国仮特許出願第60/937,214号、「Devices and Methods for Pain Reduction」という表題の米国仮特許出願第60/937,163号の優先権を主張するものであり、それらはすべて2007年6月25日に出願され、それらの開示は参照により本明細書に組み込まれている。
1.以下のものを備える調剤パッチユニット。
a.駆動機構、プリント基板(「PCB」)、および電子装置を収納する再利用可能部。
b.貯蔵槽、送達チューブ、および接続ルーメンを備える出口を収納する使い捨て部。
2.調剤パッチユニットを患者の身体に接続し、また再接続するためのクレードルユニット。クレードルユニットは、カニューレが皮膚を貫通できるようにする通路(つまり、「ウェル」として設計されている)を備え、また身体に装着できるように下側の面の下に接着剤層を備える。
3.カニューレ、貫通部材、およびプロテクタを備えるカニューレカートリッジ。カニューレハブは、調剤パッチユニットの使い捨て部に備えられている接続ルーメンで繰り返し穿刺可能である自己封止可能なゴム製隔壁を収納する。
1.貯蔵槽の充填。
2.調剤パッチユニットが2つの部分(使い捨て部と再利用可能部)から組み立てられる。
3.クレードルユニットの接着(いくつかの実施形態では、このステップは、挿入器をクレードルユニットに接続した後に実行される)。
4.カニューレの挿入。
a.カニューレカートリッジユニットが挿入器内に装填される(いくつかの実施形態では、このステップは、挿入器がクレードルユニットに接続された後に実行される)。
b.挿入器をクレードルユニットに接続する。
c.カニューレが身体に向けて自動的にまたは手動でクレードルユニットに通され、皮膚を穿刺し、貫通して、皮下区画内に置かれたままとなる。
d.貫通部材が、身体から自動的にまたは手動で引き出されてプロテクタ内に入り、カニューレが、クレードルユニットに剛性的に固定される。
5.調剤パッチユニットは、接続ルーメンが使い捨て部の出口から現れ出て、カニューレハブのゴム製隔壁を穿刺し、貯蔵槽、送達チューブ、カニューレ、および皮下組織の間の流体的連通を維持するようにクレードルユニットに接続される。
6.流体送達は、遠隔制御ユニットによってプログラムされる。
・皮膚プリックが行いやすくなるようにカニューレを貫通部材と結合できる。
・カニューレおよび貫通部材は、意図しないプリックが行われないようにするために保護ハウジング(「プロテクタ」)によって隠蔽し、覆うことができる。カニューレ、貫通部材、およびプロテクタは、まとめて、「カニューレカートリッジユニット」と称される。
・カニューレカートリッジユニットは、自動挿入手段(「挿入器」)内に装填可能なものとすることができる。
・カニューレおよび貫通部材は、挿入器によって体内に一緒に発射させることができる。
・貫通部材は、引き込み可能でありプロテクタ内に戻すことができ、そうしてから一緒に処分される。
・挿入器および調剤パッチユニット10の接続および分離のため接着剤層が皮膚5に面する方にあり、固定手段302,304がその上側にある平坦なシートとして構成されうるクレードル基部300。図4a乃至図4bは、挿入器と調剤パッチユニットを示していない。
・クレードルユニット20と挿入器(図に示されていない)、さらにはクレードルユニット20と調剤パッチユニット10の位置合わせおよび適切な接続が可能なようにクレードル基部300から上方へ出てくるチューブ状突起部として構成されうるウェル310。いくつかの実施形態では、ウェルは、調剤パッチユニットによって体内に送達される流体が通るチューブ状通路を構成する。
Claims (25)
- 治療液を患者の体内に送達するための、および/または体内検体を感知するためのデバイスとともに用いられる装置であって、少なくとも1つの皮下挿入可能要素と前記患者の前記皮膚を貫通するための少なくとも1つの貫通部材とを収容するように適合された、装置において、
細長い本体を有する保護部材であって、前記患者の前記皮膚を貫通するために前記皮下挿入可能要素および前記貫通部材が前記細長い本体から突き出され、前記貫通の後に前記貫通部材が前記細長い本体内に引っ込められることにより、前記皮下挿入可能要素が前記患者の前記体内に保持される、保護部材、を備えた装置。 - 請求項1に記載の装置において、
前記保護部材は、少なくとも1つの異なるサイズおよび形状の皮下挿入可能要素を収容するように構成された装置。 - 請求項1に記載の装置において、
前記保護部材は、さらに、把持ハンドルを備えた装置。 - 請求項1に記載の装置において、
前記保護部材と、
前記皮下挿入可能要素、および前記患者の前記皮膚を貫通するための前記貫通部材を有する貫通カートリッジとを有する使い捨てカニューレカートリッジユニットをさらに備え、
前記保護部材の前記細長い本体は、前記貫通カートリッジを収納する装置。 - 請求項4に記載の装置において、
前記保護部材の前記細長い本体は、下側開口端を備え、
前記貫通カートリッジは、前記下側開口端を通して突き出て前記患者の前記皮膚を貫通する装置。 - 請求項5に記載の装置において、
前記貫通部材は、前記下側開口端を通して前記保護部材内に引っ込められることができる装置。 - 請求項5に記載の装置において、
前記保護部材の前記細長い本体は、さらに、前記貫通カートリッジを前記患者の前記身体に向けて突き出させるために前記貫通カートリッジに接近できるようにする少なくとも1つの窓を備え、
前記少なくとも1つの窓は、前記保護部材内に配置された上側開口端および長手方向スリットからなる群から選択される装置。 - 請求項5に記載の装置において、
流体送達および/または検体感知用の前記デバイスは、皮膚接着可能であり、
前記デバイスは、前記カニューレカートリッジユニットが通って前記デバイスに結合される開口を備え、前記皮下挿入可能要素は、前記開口を通して突き出される装置。 - 請求項5に記載の装置において、
流体送達および/または検体感知用の前記デバイスは、輸液セットを備え、
前記輸液セットは、
前記患者の前記皮膚に接着可能な輸液セットハブを有し、前記輸液セットハブは、前記カニューレカートリッジユニットが通って前記輸液セットに結合される輸液セットハブ開口を有し、
前記皮下挿入可能要素は、前記ハブ内の前記開口を通して突き出される装置。 - 請求項5に記載の装置において、
流体送達および/または検体感知用の前記デバイスは、前記患者の前記皮膚に接着可能なクレードルユニットを備え、
前記クレードルユニットは開口を有するウェル部分を有し、
前記カニューレカートリッジユニットは、前記ウェル部分に結合され、前記皮下挿入可能要素は、前記ウェル部分内の前記開口を通して突き出される装置。 - 請求項4に記載の装置において、
前記皮下挿入可能要素は、カニューレであり、前記カニューレカートリッジユニットは、さらに、カニューレハブを備え、
前記カニューレハブは、前記貫通部材を引っ込めた後に前記カニューレを封止するための隔壁を備える装置。 - 請求項11に記載の装置において、
前記カニューレは、治療液を前記患者の前記身体に送達するように適合されている装置。 - 請求項12に記載の装置において、
前記カニューレは、さらに、体内検体を感知するための感知手段を備えた装置。 - 請求項4に記載の装置において、
前記皮下挿入可能要素は、体内検体を感知するためのセンサである装置。 - 請求項4に記載の装置において、
治療液は、インスリンであり、体内検体は、グルコースである装置。 - 請求項4に記載の装置において、
さらに、前記皮下挿入可能要素および前記貫通部材を前記患者の身体に向かって突き出して前記患者の前記皮膚に貫通させるために、前記患者の前記身体に向かって前記貫通カートリッジを手動で押すための手段を備えた装置。 - 請求項4に記載の装置において、
前記カニューレカートリッジユニットは、挿入デバイスとともに用いられるように構成された装置。 - 請求項17に記載の装置において、
前記保護部材の前記細長い本体は、さらに、前記挿入デバイスが前記貫通カートリッジに接近できるようにする少なくとも1つの窓を備え、
前記少なくとも1つの窓は、前記保護部材内に配置されている上側開口端および長手方向スリットからなる群から選択される装置。 - 請求項18に記載の装置において、
前記挿入デバイスは、前記少なくとも1つの窓を通して前記貫通カートリッジに接近できるように適合されている変位機構を備え、
前記変位機構は、前記患者の前記身体に向かって前記貫通カートリッジの強制的変位を行わせるための荷重付与可能なバネを有する装置。 - 請求項19に記載の装置において、
前記変位機構は、前記貫通カートリッジを前記患者の前記身体に向けて変位させて、前記患者の前記皮膚をさまざまな角度で貫通させるように適合された装置。 - 請求項10に記載の装置において、
前記保護部材の前記細長い本体の前記下側開口端は、前記クレードルユニットの前記ウェル部分に固定可能である装置。 - 治療液を患者の体内に送達するための、および/または体内検体を感知するためのデバイスとともに用いる装置を用いて患者の体内に皮下挿入可能要素を挿入する方法において、
前記装置は、少なくとも1つの皮下挿入可能要素と前記患者の前記皮膚を貫通するための少なくとも1つの貫通部材とを収容する保護部材を備え、
前記皮下挿入可能要素および前記貫通部材を前記保護部材から突き出させるステップと、
前記皮下挿入可能要素および前記貫通部材を前記患者の前記体内に挿入するステップと、
前記貫通部材を前記患者の前記身体から引っ込めるステップと、
前記皮下挿入可能要素を前記患者の前記体内に保持するステップとを含む方法。 - 請求項22に記載の方法において、
治療液を送達するための、および/または体内検体を感知するための前記デバイスは、前記患者の前記皮膚に接着可能で、ウェル部分を有するクレードルユニットを備え、
前記カニューレカートリッジユニットを前記クレードルユニットの前記ウェル部分に結合するステップをさらに含む方法。 - 請求項22に記載の方法において、
さらに、手動で実行される、前記突き出すステップおよび/または引っ込めるステップを含む方法。 - 請求項22に記載の方法において、
さらに、自動で実行される、前記突き出すステップおよび/または引っ込めるステップを含む方法。
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US20080319416A1 (en) | 2008-12-25 |
AU2008269310A1 (en) | 2008-12-31 |
US9808574B2 (en) | 2017-11-07 |
JP2010531197A (ja) | 2010-09-24 |
US8715232B2 (en) | 2014-05-06 |
AU2008269311A1 (en) | 2008-12-31 |
EP2170439A1 (en) | 2010-04-07 |
PL2185223T3 (pl) | 2017-10-31 |
US20080319414A1 (en) | 2008-12-25 |
US8002752B2 (en) | 2011-08-23 |
DK2185223T3 (en) | 2017-08-28 |
CN101815550A (zh) | 2010-08-25 |
WO2009001347A1 (en) | 2008-12-31 |
US8628500B2 (en) | 2014-01-14 |
DK2170439T3 (en) | 2017-08-28 |
CN101784296A (zh) | 2010-07-21 |
WO2009001345A1 (en) | 2008-12-31 |
EP2185223A1 (en) | 2010-05-19 |
US20100106088A1 (en) | 2010-04-29 |
JP5385901B2 (ja) | 2014-01-08 |
US20110288390A1 (en) | 2011-11-24 |
JP2014128710A (ja) | 2014-07-10 |
WO2009001346A1 (en) | 2008-12-31 |
JP5820008B2 (ja) | 2015-11-24 |
EP2185223B1 (en) | 2017-07-19 |
EP2167174A1 (en) | 2010-03-31 |
EP2170439B1 (en) | 2017-07-19 |
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