EP1357837A1 - Appareil et procede pour la determination de la taille admissible d'une aiguille a injection - Google Patents

Appareil et procede pour la determination de la taille admissible d'une aiguille a injection

Info

Publication number
EP1357837A1
EP1357837A1 EP02709986A EP02709986A EP1357837A1 EP 1357837 A1 EP1357837 A1 EP 1357837A1 EP 02709986 A EP02709986 A EP 02709986A EP 02709986 A EP02709986 A EP 02709986A EP 1357837 A1 EP1357837 A1 EP 1357837A1
Authority
EP
European Patent Office
Prior art keywords
needle
injection
human body
recommended
penetration length
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP02709986A
Other languages
German (de)
English (en)
Inventor
Carsten Gerner Larsen
Jörgen K. SMEDEGAARD
Jan Solvig
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
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
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of EP1357837A1 publication Critical patent/EP1357837A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0858—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving measuring tissue layers, e.g. skin, interfaces

Definitions

  • the invention relates to an apparatus for non-invasive determination of the possible allowable penetration length of an injection needle for injecting a liquid drug into a human body in order to avoid penetration of a specific target located inside the human body.
  • the invention furthermore relates to a method of non-invasive determination of the possible allowable penetration length of an injection needle for injecting a liquid drug into a human body avoiding intracutaneous or intramuscular injection.
  • Hypodermic injections where a liquid drug is expelled into the human body are usually performed either as intramuscular injections i.e. injections into the muscle tissue, or as subcutaneous injections i.e. injections into the subcutaneous tissue lying between the cutis and a muscle membrane which cover the underlying muscle tissue.
  • Some drugs have to be injected subcutaneously in order to obtain the desired pharmacoki- netic properties. If insulin aimed for subcutaneous administration is injected accidentally into the muscle tissue, the insulin will be absorbed more rapidly than from the subcutaneous tissue and this is potentially dangerous as it may cause low levels of blood glucose (hypogly- caemia). In order to prevent this people suffering from diabetes are often advised to inject into a lifted skin fold.
  • new data suggest that in some cases the diabetic person will still inject into the muscle by hazard if they use an injection needle which is to long, it is therefore becoming more and more preferred to inject directly at an angle of 90° without the skin fold using an injection needle having a short and limited injection length.
  • an injecting needle having a short and well-defined length of the injection part of the needle cannula the frequency of accidental muscular injections can be reduced to almost zero. It is however quit difficult for the individual person to determine which needle length to use at the different injection sites.
  • US 5.944.700 discloses an injection needle provided with an adjustable extender limiting the available injection length of the needle cannula, such that the muscle tissue is not penetrated when such an injection needle is used. Prior to injecting a medicament using one of these injection needles the adjustable extender has to be set in a way leaving the injecting part of the needle cannula with a length short enough to prevent intramuscular injection.
  • injection needles where the part of the needle cannula inserted into the human body has a standard length has been developed.
  • the standard length of the injection part of these commercial available injection needles for insulin delivery systems is usually 6, 8, 10 and 12 mm.
  • the individual person suffering from diabetes then chooses an injection needle adequate for his or hers body structure. It is however quite difficult to choose the right needle size since it is impossible for the single user to determined the actual depth an injection needle can be inserted into the body without penetrating a specific target inside the body such as the muscle membrane covering the muscular tissue. Moreover, the distance from the surface of the skin to the muscle membrane may be different in places only a few centimetres apart.
  • EP 278.993 discloses an ultrasound apparatus for guiding a biopsy needle inside a human body. This known apparatus is rather complicated; it is not portable and it is not suitable for use by not trained personnel away from a hospital setting.
  • a needle-free injection syringe which forces the medicament into the human body using high pressure, is known from JP A 2000-233021.
  • This complex needle-free injection syringe is equipped with an ultrasonic measuring device, which measures the thickness of the subcutaneous fat layer and determines the property of the skin. These measurements are used for setting the pressure by which the medicament is injected into the body.
  • the target is preferably the muscle membrane covering the muscular tissue. It is fur- ther an object to provide such a portable handheld apparatus, which presents a proper readout of a recommended needle size and which are both simple to use and cheap to manufacture.
  • an apparatus By mounting both the ultrasonic measuring head, the electronic circuit and the display in one manually-gripable housing, a very user-friendly design can be obtained.
  • the ready to use apparatus fits into one hand when in use, and into e.g. the pocket of a shirt when not in use. It is therefore easy to carry the apparatus from one patient to another e.g. in a hospital, and the simple design of the apparatus makes it very easy to use, even for untrained personnel.
  • the compact design which resembles somewhat of an injection device for insulin, also makes the apparatus very attractable for people who are used to performing daily self- injections e.g. people suffering from diabetes.
  • the target is the muscle membrane separating the muscular tissue from the subcutis tissue, it is ensured that the possible allowable penetration length of the injection needle displayed will be a needle length short enough to prevent intramuscular injection.
  • the possible allowable penetration length is displayed by displaying the allowable standard needle sizes recommended for that particular anatomical injection site.
  • the correct needle sizes for a particular injection site is directly shown in the display, it is very easy for the user to select the correct needle size. The user just has to use one of the injection needle sizes presented in the display.
  • the algorithm used for recommending an injection needle is according to yet another embodiment of the apparatus according to the invention, that a 6 mm needle is recommended if the total distance from the outside surface of the skin to the muscle membrane is larger than 6 mm, an 8 mm needle is recommended if the distance is larger than 8 mm, and a 12 mm needle is recommended if the distance is larger than 12 mm.
  • the emission of liquid from the injection needle usually takes place in a distance of 0,4 to 1 ,2 millimetres from the point of the needle due to the oblique cut of the end of the needle.
  • the algorithm will therefore secure that the standard injection needle recommended does in fact deliver the drug above the muscle membrane.
  • a message indicating that the chosen injection site is unsuitable for injections are displayed if the possible allowable penetration length is shorter than a predetermined length e.g. 6 mm. In that way injections are always performed in location where the thickness of the cutis and the subcutis is larger than a predetermined length.
  • the predetermined length is set to 6 mm since this is the smallest standard size of the commercial injection needle available today.
  • the message could be followed by an acoustic signal warning the user against injecting at the particular injection site.
  • the housing is a pen-style elongated housing, it is ensured that the familiarity with the known injection devices for self-injection of insulin is obvious for the user.
  • the housing further comprises power means, such as batter- ies, the portability of the apparatus is enhanced.
  • the batteries could be of the rechargeable type if wanted.
  • the claimed apparatus for carrying out the described method, which method includes pressing the ultrasonic measuring head against the human body on the site where the injection is intended to be performed, the user can easily determine which standard needle size to use on a specific injection site in order to avoid intramuscular injections.
  • injection means expelling a liquid into a human body through a hollow injection needle or another hollow conduit, which is temporarily inserted in the human body.
  • injection length or "injection part of the needle cannula” is taken to mean the part of the needle cannula entering the human body during injection, which also is the part extending in the proximal direction from its fastenings point in the needle hub.
  • needle size usually means the length of the needle cannula extending beyond the needle hub, this part is normally between 6 to 12 mm
  • the term "subcutaneously” refers to the subcutaneous tissue of the human body, which are the tissue located between the cutis and a muscle membrane covering the muscular tissue, while the term “intramuscular” refers to the muscular tissue.
  • the average depth of the muscle membrane is 9,5 mm for males and 13,8 mm for females, measured from the outside of the human skin.
  • the minimum length of the part of the needle cannula penetrating the subcutaneous tissue must be longer than the thickness of the cutis, which is approximately 1 to 4 mm.
  • pen-style elongated housing merely refers to a housing having an oblong or elongated shape and fits into one hand, somewhat like an ordinary pen for writing. Although such pens usually have a tubular cross-section, modern writing pens often have a different cross-section such as triangular, rectangular or square. A pen shaped housing can in a similar way have a large variety of different cross-sections.
  • the housing is also referred to as being a "Manually-gripable housing", which means that the housing is gripable by the human hand, and can be manually manipulated Brief Description of the Drawings:
  • Figure 1 Shows a front view of the apparatus according to the present invention.
  • Figure 2 Shows a top view of the apparatus according to the present inven- tion.
  • Figure 3 shows a sectional view of the distal end of the apparatus according to the present invention.
  • Figure 4 shows a graph of the ultrasound signal and of the bounced off echoes.
  • distal end of the apparatus is meant to refer to the end, which is pressed against the human skin when operating the apparatus, whereas the term “proximal end” is meant to refer to the opposite end of the apparatus which in use points away from the human body.
  • Figure 1 shows an apparatus for non-invasive determination the possible allowable penetration length according to the invention.
  • the apparatus comprises an elongated housing 1 having a distal end 2 and a proximal end 3.
  • the housing 1 has the shape of an ordinary pen for writing, and is at the proximal end 3 equipped with a clip 4 for clipping the apparatus on to a pocket of a shirt or the like.
  • the power of the apparatus is switch on by pressing the on/off button 5 located at the proximal end.
  • the distal end is then pressed against the skin 8 of the user, and the ultrasonic measuring head is activated, as later explained, by pressing the start button 6 located in the distal half of the housing 1.
  • the result of the measurement will be presented in the display 7.
  • the biological structure of a human being is shown in figure 3.
  • the outer skin 8 covers the cutis layer 9, which is usually between 1 to 4 millimetres thick.
  • the underside 10 of the cutis layer 9 faces the subcutis layer 11 , which again is separated from the muscle tissue 13 by the muscle membrane 12.
  • Cutis (9) 1 ,1 3,6 1 ,7 1 ,2 4,1 2,3
  • the overall distance from the outside surface of the outer skin 8 to the muscle membrane is somewhere between 3,5 to 34,4 millimetres.
  • the ultrasonic measuring head is located at the proximal end of the apparatus, as shown in figure 2.
  • the ultrasonic measuring head comprises a piezoelectric body 14, which produces an ultrasonic signal 19 when a voltage is applied to the piezoelectric body 14.
  • the voltage is supplied from the electronic circuit 16 through wires 15.
  • a bounced off echo is re- fleeted onto the piezoelectric body 14, an electric voltage is generated and lead back to the electronic circuit also through one of the wires 15.
  • the electronic circuit 16 and the display 7 are powered through wires 17 connecting the electronic circuit 16 to a not shown electric transformer or a not shown battery.
  • a somewhat soft protective pad 18 working as an impedance matching layer is therefore provided between the piezoelectric body 14 and the outside surface of the skin 8 of the user.
  • a jellylike acoustic impedance oil is often applied to the outside of the skin 8 prior to placing the ultrasonic measuring head of the apparatus against the skin 8.
  • the piezoelectric body 14 When activating the start button 6 an electric voltage is applied to the piezoelectric body 14 causing it to transmit an ultrasonic signal at time TO. A short time thereafter, at time T1 , the first echo 20 bouncing off from the interface 10 between the cutis layer 9 and the subcutis layer 11 is received by the piezoelectric body 14. Sometime later, at time T2, the piezoelectric body 14 receives the bounced off second echo 21 from the muscle membrane 12.
  • a timer timing the time passing form TO to T2 is also activated when the ultrasonic signal is transmitted.
  • the distance from the outside surface of the skin of the user to the muscle membrane can be calculated as a result of the time passing from TO to T2, e.g. by multiplying the time passing with the speed of sound.
  • the speed of sound in the cutis layer 9 and in the subcutis layer 11 might differ from the sound of speed in air, and might be stored in the electric circuit 16 as an empiric value. From the ultrasound signal 19 is initiated and to the bounced off second echo 21 is received at the piezoelectric body 14, the signal has travelled twice the distance from the surface of the skin 8 of the user to the muscle membrane 12.
  • the distance can either be calculated on the basis of a single ultrasonic signal and a single bounced off echo, or the electric circuit 16 and the piezoelectric body 14 can be made to transmit a number of ultrasonic signals into the body of the user and to calculate an average distance on basis of the bounced off echoes 21.
  • the possible allowable standard sizes of injection needles recommended for that particular anatomical injection site is automatically determined using the following table, which is electronically stored in the electronic circuit 16.
  • the result originating from the right column of the table is displayed in the display 7. It is however possible to alter the apparatus such that only the maximum allowable standard needle size recommended for that particular anatomical injection site is shown in the display 7.
  • the lower limit for when the result: "Unsuitable for injection” is displayed could be set to accommodate an even shorter injection needle if so wanted.
  • the electronic circuit 16 which could be a microprocessor, is designed such that the accuracy of the measurement is within half a millimetre.
  • the accuracy could however be chosen differently, and the table indicating which needle sizes is recommended for a specific measurement could also be altered.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un appareil manipulé à une seule main, facile à utiliser, permettant la détermination non invasive de la longueur de pénétration admissible d'une aiguille à injection, pour les injections dans le tissu sous-cutané du corps humain. L'appareil en question comporte une enveloppe allongée équipée d'une tête de mesure ultrasonique qui transmet un signal ultrasonore dans le corps humain et qui reçoit un signal réfléchi depuis la membrane musculaire séparant le tissu musculaire du tissu sous-cutané. L'appareil comprend un circuit électronique permettant d'analyser les signaux ultrasonores et de calculer la longueur de pénétration admissible d'une aiguille à injection, afin d'éviter toute pénétration dans la membrane musculaire. Cette longueur s'affiche instantanément sur un écran intégré à l'enveloppe, selon les tailles classiques admissibles, au format recommandé pour le site anatomique d'injection considéré.
EP02709986A 2001-01-31 2002-01-30 Appareil et procede pour la determination de la taille admissible d'une aiguille a injection Withdrawn EP1357837A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DKPA200100156 2001-01-31
DK200100156 2001-01-31
US26674301P 2001-02-06 2001-02-06
US266743P 2001-02-06
PCT/DK2002/000067 WO2002060325A1 (fr) 2001-01-31 2002-01-30 Appareil et procede pour la determination de la taille admissible d'une aiguille a injection

Publications (1)

Publication Number Publication Date
EP1357837A1 true EP1357837A1 (fr) 2003-11-05

Family

ID=26068958

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02709986A Withdrawn EP1357837A1 (fr) 2001-01-31 2002-01-30 Appareil et procede pour la determination de la taille admissible d'une aiguille a injection

Country Status (3)

Country Link
EP (1) EP1357837A1 (fr)
JP (1) JP2004534564A (fr)
WO (1) WO2002060325A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160047518A (ko) * 2013-08-27 2016-05-02 레프로-메드 시스템즈, 인코포레이티드 피하 치료를 위한 바늘을 선택하는 방법

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2004052A2 (fr) * 2006-03-31 2008-12-24 Koninklijke Philips Electronics N.V. Méthode et appareil pour la détermination de niveaux d'hydratation
JP5234545B2 (ja) * 2008-11-13 2013-07-10 学校法人日本大学 物質の硬さ分布表示システム及び物質の硬さ分布表示方法
US9993226B2 (en) * 2014-12-09 2018-06-12 Mylan Inc. Device and method for detecting skin to muscle depth by simultaneous detection of ultrasonic depth sensor and force sensor

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SU891036A1 (ru) * 1979-05-16 1981-12-23 Тартуский Ордена Трудового Красного Знамени Государственный Университет Устройство дл измерени толщины жировой прослойки
EP0278993A1 (fr) * 1987-02-16 1988-08-24 Dymax Corporation Sonde de biopsie concentrique
WO1989004635A1 (fr) * 1987-11-20 1989-06-01 Estonskaya Selskokhozyaistvennaya Akademia Testeur d'echos-impulsions
CA2126088C (fr) * 1991-12-19 1999-05-11 Royden James William Lake Instrument de mesure de la profondeur du tissu adipeux
JPH10234734A (ja) * 1996-12-27 1998-09-08 Nohmi Bosai Ltd 超音波プローブ
US5872314A (en) * 1997-07-25 1999-02-16 Clinton; Robert P. Method and apparatus for measuring characteristics of meat
JP4152517B2 (ja) * 1999-02-12 2008-09-17 株式会社島津製作所 皮下注射可否判定装置及びその機能を備えた針無注射器
JP2001252258A (ja) * 2000-03-09 2001-09-18 Casio Comput Co Ltd 体脂肪表示制御装置及び身長表示制御装置

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO02060325A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160047518A (ko) * 2013-08-27 2016-05-02 레프로-메드 시스템즈, 인코포레이티드 피하 치료를 위한 바늘을 선택하는 방법

Also Published As

Publication number Publication date
JP2004534564A (ja) 2004-11-18
WO2002060325A1 (fr) 2002-08-08

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