WO2001022881A1 - System for transdermally obtaining body fluids - Google Patents
System for transdermally obtaining body fluids Download PDFInfo
- Publication number
- WO2001022881A1 WO2001022881A1 PCT/EP2000/009175 EP0009175W WO0122881A1 WO 2001022881 A1 WO2001022881 A1 WO 2001022881A1 EP 0009175 W EP0009175 W EP 0009175W WO 0122881 A1 WO0122881 A1 WO 0122881A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- particle
- particles
- body fluid
- skin
- blood
- Prior art date
Links
Classifications
-
- 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
- A61B5/14507—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 specially adapted for measuring characteristics of body fluids other than blood
- A61B5/1451—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
- A61B5/14514—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
-
- 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
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B2010/008—Interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—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
- A61B5/1486—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 using enzyme electrodes, e.g. with immobilised oxidase
-
- 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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
Definitions
- the present invention relates to a system for obtaining body fluid through the skin surface in order to determine one or more analytes in the body fluid thus obtained.
- a skin area is bombarded with particles so that they penetrate into the epidermis or the dermis.
- the particles used in the system according to the invention preferably contain no fraction of the analytes to be determined. to avoid falsifying the analysis.
- the particles are preferably such that they can be resorbed by the epidermis or dermis.
- the present invention is in the field of systems and devices for removing body fluids from living beings. Such an extraction is carried out millions of times around the world today to enable medical diagnoses.
- This area of technology is essentially divided into two. In the first area, amounts of fluid in the range of a few milliliters are withdrawn with the aid of syringes or so-called vacutainers in order to be able to carry out a large number of examinations with the body fluid sample. In a second area, however, liquids in the range of approximately 2 to 20 ⁇ l are removed in order to be able to carry out so-called rapid tests. This type of rapid test has become particularly popular in the area of blood sugar measurement. In addition, the rapid tests also cholesterol. Blood lipids.
- Drugs and other analytical parameters are determined. In terms of numbers, however, the blood glucose determination outweighs the rest of the evidence by a multiple. The reason for this is the relatively high proportion of diabetics in the population, the need for frequent measurements of blood sugar levels and the great medical benefit from knowledge of blood sugar levels. Regular monitoring allows the diabetic to recognize when their blood sugar level is outside the normal range and can take appropriate measures to bring the blood sugar level back into the normal range. Frequently exceeding the blood sugar level results in blindness and makes amputations of extremities necessary. The number of blindness and amputations has increased in recent years due to greater control of blood Sugar levels can already be significantly reduced with the help of cutting tests. For a short time, fatally high blood sugar levels are even more fatal than high blood sugar levels, which can lead to a so-called hypoglycemic shock in which the diabetic becomes unconscious and dies, unless he receives help from third parties.
- a system for the transdermal extraction of body fluids which includes a device with which at least one particle is accelerated to a speed which allows the particle to penetrate the skin into the epidermis or dermis.
- the at least one particle should be free of the analyte to be determined in order to avoid interference with the analysis and the particle is still resorbed by the body.
- Preferred embodiments of the system according to the invention relate to devices which support the leakage of body fluid and means for determining an analyte. that are integrated into the system.
- the present invention is based on the observation that penetration of particles into an area of the skin can be associated with the escape of blood or interstitial fluid through the resulting skin opening. This observation is by no means new. which makes sense in terms of firearms. However, it is also directly apparent that direct use of firearms or the like is impossible for the purpose of the present invention, since the projectiles used are much too large, penetrate too deep into the body and cause too large, often life-threatening injuries. Furthermore, the projectiles used in the area of firearms are not absorbed by the body, which makes them unsuitable for the purpose according to the invention.
- a system in the sense of the present invention is used to obtain small amounts of body fluids.
- the amounts of body fluid that are obtained are typically in the range of about 0.1-2 ⁇ l.
- Body fluids in the sense of the invention are to be understood in particular as blood and interstitial fluid (ISF).
- ISF interstitial fluid
- Blood can be obtained by injuring the capillary network in the boundary layer between the dermis and epidermis or in the dermis.
- the penetration depth for this is approximately 500 ⁇ m.
- penetration depth is understood to mean the distance between the skin surface and the center of gravity of the respective particle.
- capillary blood The preferred collection point for capillary blood is the fingertips, since the skin openings made here do not close again immediately, so that sufficient blood can escape to the outside.
- the removal of blood from the so-called plate skin, as is present on the forearm is less painful.
- additional measures will usually be required to keep a channel created in the skin surface open in order to allow enough blood to escape.
- No capillaries have to be injured to remove interstitial fluid.
- interstitial fluid is an ultrafiltrate of capillary blood, in which blood sugar can be detected using the same methods as in capillary blood.
- a system according to the present invention includes a device for the transdermal application of particles. To do this, the particles must be accelerated to a speed sufficient to allow them to penetrate into the epidermis or dermis.
- Suitable accelerators can be based on different principles. For example, it is possible to detachably attach the particles to a carrier which is accelerated and which remains within the acceleration device while the particles detach and penetrate into the body.
- a device for this purpose which is based on an electromagnetic principle, is described in WO 99/04838, to which reference is hereby made in full.
- Another way to accelerate the particles to the necessary speeds is to apply them to a membrane that is accelerated by a pressure surge. Suitable devices are described for example in US 5,204,253 and US 5,630,796.
- a device for the transdermal application of particles can in principle be designed in accordance with the device shown in US Pat. No. 5,630,796, in which a tube is provided. which is placed with its open end on a skin area and which creates a defined distance between a reservoir for the particles and the skin surface.
- the particles according to the present invention can also be arranged in a reservoir which surrounds the particles without contamination and which opens when the acceleration device is actuated.
- the particles that are administered transdermally should be essentially free of constituents that interfere with a subsequent analysis.
- the particles should be free of the analyte or analytes that are determined.
- admixtures of the analyte can be tolerated if their concentration is so low that a subsequent analysis is not significantly falsified.
- proportions of the analyte in the particles can be tolerated under certain circumstances.
- Another criterion for the particles is that they should be essentially completely absorbed by the body. Gelatine has proven to be suitable. Sugar. Proteins. Ice and mixtures of the substances mentioned have been proven.
- sugars such as e.g. Sucrose.
- Fructose and mannose can be used. It has proven to be advantageous in order to obtain an essentially painless extraction of body fluid.
- the particles can be in the form of spheres, for example. Have ellipsoids or discs.
- the system according to the following invention is particularly suitable for the collection of capillary blood and interstitial fluid. It turned out. that different parameters regarding particle size and speed are advantageous for these two types of body fluids.
- capillary blood It is favorable for obtaining capillary blood.
- particles with a diameter in the range between 100 and 500 ⁇ m since there is a sufficient probability in this size range to hit a capillary with just one or a few particles.
- the depth of penetration of the particles into the skin for the collection of capillary blood should be between 0.5 and 1.3 mm. It has been shown that such a penetration depth can be achieved with a particle speed in the range from 500 to 1500 m / sec for particles between 100 and 500 ⁇ m diameter and a density of approximately 1 g / cm 3 .
- Particles of this size can convey a sufficient amount of interstitial fluid, it is preferred to use 100-10,000 particles simultaneously.
- a system according to the invention can be used in the form described above. to deliver body fluid to the body surface, from where it is applied to a test element or the like to perform an analytical test.
- This corresponds to the use of blood collection devices customary in the market today, in which a wound is produced by a lancet and leaked blood is applied by patients to a test strip.
- a system according to the invention can also be equipped with means that absorb the body fluid that is being conveyed, such as, for example, capillaries or capillary-active (absorbent) materials.
- These means for absorbing body fluid are preferably directly Nem test element connected to carry out an analytical test, so that the absorbed body fluid is supplied to the test element.
- test element advantageously has a region with which it can be brought up to the body fluid located on the body surface and which contains no reagent or a test chemical. This can prevent chemical substances from getting into the body opening.
- the glucose oxidase used in many tests can lead to irritation.
- a system according to the invention can also include means for determining an analyte.
- an agent can be, for example, a test element that changes color when it is moistened with the analyte. Such a color change can then be evaluated visually or colorimetrically with a photometer in order to enable a quantitative determination of the analyte. Since such test elements and photometers are well known to the state of the art for their evaluation, this will not be discussed in more detail here.
- an analyte can be determined with the aid of a measuring cell, such as an electrochemical measuring cell. For a glucose determination, for example, measuring cells are used in which glucose oxidase is applied to an electrode and an uncoated metal electrode is used as the counter electrode.
- the measured change in potential is based on the formation of hydrogen peroxide on the electrode coated with glucose oxidase.
- Electrochemical test elements are also known in the prior art, as are described, for example, in EP-B-0505475, in which the so-called Kottrell current is measured.
- This description of devices for determining analytes is merely exemplary in nature. Of course, a multitude of further devices for analyte determination are known to the person skilled in the art which can be used in the context of the present invention.
- the means for determining an analyte can be integrated into a system according to the invention, for example, by coupling the means for determining the analyte to the means for absorbing body fluid, so that when the means for absorbing body fluid is brought up to the leaked body fluid, a the agent for analysis is supplied directly with analyte.
- the means for determining the analyte can also be integrated into the system according to the invention in such a way that it is either so close to the point of exit of body fluid that it is supplied directly with body fluid or the means for analysis can be brought up to the body fluid, for example, by a movable arrangement of the means for analyte determination in the system.
- 3,626,929 also describes a method and a device in which a wound is created on the tip of the finger and the proximal part of the finger is pressed periodically in order to promote blood leakage.
- means for supporting an escape of body fluid are to comprise devices which exert pressure on a skin area which has penetrated the skin area into which the at least one particle has penetrated. is adjacent.
- Means are also to be included which include an ultrasound device, as described, for example, in WO 94-08655 and US Pat. No. 5,458,140.
- means are also to be included which, in order to support the exit, have a device for applying a negative pressure to the area of the skin, into which the at least one particle has penetrated.
- Figure 1 Penetration of a particle in a skin area and leakage of blood
- Figure 5 Cross-sectional packaging shown in Figure 4
- FIG. 1 shows in representations A to C the penetration of a particle and the escape of blood.
- FIG. 1A shows the movement of the particle (10) onto the body surface.
- the skin layers epidermis and dermis can also be seen from the figure.
- Blood-carrying capillary loops (20) are present in the dermis.
- Representation B shows a state in which the particle has penetrated the epidermis and is in the dermis.
- the capillary loops shown were partially damaged so that blood can escape from them.
- FIG. 1C shows how blood exits the capillary loops from the skin through the opening caused by the particle and how a drop of blood (30) forms on the surface of the body.
- FIGS. 2 to 6 show systems for accelerating particles which are taken from international application WO 99/04838.
- FIG. 2 shows an electromagnetic system for accelerating the particles (10).
- a thin metal band (101) is arranged in such a way that regions of the band which lie opposite one another result. If a current pulse is applied to the metal strip at its ends, the opposite parts of the metal strip collide due to the electromagnetic waves generated Fields. The lower part of the metal strip is in contact with a replacement bearing (102). so that he cannot dodge down. Accordingly, the upper part of the metal strip is thrown upwards by the electromagnetic repulsion, as shown in FIG. 2B.
- the particles (10) are located in a reservoir which is closed by a plastic skin (103).
- the plastic skin has a predetermined breaking point (104). which tears open when the upper part of the metal strip is thrown away. As a result, the particles (10) are released and fly towards a body surface at a speed which is essentially determined by the speed of the metal strip. to penetrate the skin there.
- FIG. 1 An alternative fastening of the particles is shown in FIG. This consists in that the particles are detachably connected to a surface (1 10).
- the surface (1 10) can be a double-sided adhesive tape, which in turn is attached to a plate (1 1 1).
- the plate (1 1 1) can be accelerated in the direction of the particles, and when the plate is braked, the particles detach from the surface (1 10) due to their inertia and fly towards the surface of the skin.
- the plate (1 1 1) can be accelerated mechanically, for example, by a spring arranged on the side opposite the particles, by a pressure surge, or else using the electromagnetic principle shown in FIG. 2.
- Another possibility is to use a plate which has a depression in the region shown in FIG. 3A and the remaining region of the plate is planar. When the plate is bent at two opposite ends in the direction of the depression, the depression suddenly bulges out due to mechanical tension. as shown in Figure 3, and accelerates the particles.
- FIG. 4 shows a further possibility of a reservoir for particles, as can be used for example in connection with the device shown in FIG. 2.
- the particles are in a plastic container, which is folded at its ends and in which
- FIG. 6 shows an exchangeable module with a reservoir for particles.
- the arrangement is based on the electromagnetic drive principle, as has already been described in connection with FIG. 2.
- the particles (10) are located in the recess (101 a) of an electrically conductive capable band (101), which is arranged M-shaped in the example shown. If a current pulse is applied to the contacts (105), the opposite arms of the electrically conductive tape repel one another and the outer regions are pressed against the walls (106) of the housing (108). By moving the arms apart, the U-shaped part of the band in which the particle (10) is located is stretched and the particle (10) is thrown upwards out of the housing.
- the module shown in FIG. 6 also has a sealing film (109) with which the space in which the particles are located is sealed off from the outside space. This can ensure sterility of the particles entering the body. Before the module shown is used to introduce the particles into the body, the sealing film (109) is removed.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Pathology (AREA)
- Hematology (AREA)
- Optics & Photonics (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Anesthesiology (AREA)
- Emergency Medicine (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP00964207A EP1220641A1 (en) | 1999-09-25 | 2000-09-20 | System for transdermally obtaining body fluids |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE1999146059 DE19946059A1 (en) | 1999-09-25 | 1999-09-25 | System for the transdermal production of body fluid |
DE19946059.0 | 1999-09-25 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2001022881A1 true WO2001022881A1 (en) | 2001-04-05 |
WO2001022881A8 WO2001022881A8 (en) | 2002-05-30 |
Family
ID=7923327
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2000/009175 WO2001022881A1 (en) | 1999-09-25 | 2000-09-20 | System for transdermally obtaining body fluids |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP1220641A1 (en) |
DE (1) | DE19946059A1 (en) |
WO (1) | WO2001022881A1 (en) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5204253A (en) * | 1990-05-29 | 1993-04-20 | E. I. Du Pont De Nemours And Company | Method and apparatus for introducing biological substances into living cells |
US5458140A (en) * | 1993-11-15 | 1995-10-17 | Non-Invasive Monitoring Company (Nimco) | Enhancement of transdermal monitoring applications with ultrasound and chemical enhancers |
US5630796A (en) * | 1993-04-08 | 1997-05-20 | Oxford Biosciences Limited | Method of delivering powder transdermally with needless injector |
WO1998055033A1 (en) * | 1997-06-04 | 1998-12-10 | Spectrx, Inc. | Fluid jet blood sampling device and methods |
WO1999004838A1 (en) * | 1997-07-21 | 1999-02-04 | Roche Diagnostics Gmbh | Electromagnetic transdermal injection device and methods related thereto |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US35803A (en) * | 1862-07-01 | Improvement in sash-fasteners | ||
CH500707A (en) * | 1968-07-26 | 1970-12-31 | Micromedic Systems Inc | Device for performing percutaneous and digital blood sampling |
US4326524A (en) * | 1980-09-30 | 1982-04-27 | Minnesota Mining And Manufacturing Company | Solid dose ballistic projectile |
US4627445A (en) * | 1985-04-08 | 1986-12-09 | Garid, Inc. | Glucose medical monitoring system |
US5243516A (en) * | 1989-12-15 | 1993-09-07 | Boehringer Mannheim Corporation | Biosensing instrument and method |
US5421816A (en) * | 1992-10-14 | 1995-06-06 | Endodermic Medical Technologies Company | Ultrasonic transdermal drug delivery system |
US5582184A (en) * | 1993-10-13 | 1996-12-10 | Integ Incorporated | Interstitial fluid collection and constituent measurement |
AU3207197A (en) * | 1996-05-17 | 1997-12-05 | Mercury Diagnostics Inc. | Body fluid sampling device and methods of use |
US5951492A (en) * | 1996-05-17 | 1999-09-14 | Mercury Diagnostics, Inc. | Methods and apparatus for sampling and analyzing body fluid |
JP2828064B2 (en) * | 1996-09-20 | 1998-11-25 | 日本電気株式会社 | Suction leachate collection method and device |
-
1999
- 1999-09-25 DE DE1999146059 patent/DE19946059A1/en not_active Withdrawn
-
2000
- 2000-09-20 EP EP00964207A patent/EP1220641A1/en not_active Withdrawn
- 2000-09-20 WO PCT/EP2000/009175 patent/WO2001022881A1/en not_active Application Discontinuation
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5204253A (en) * | 1990-05-29 | 1993-04-20 | E. I. Du Pont De Nemours And Company | Method and apparatus for introducing biological substances into living cells |
US5630796A (en) * | 1993-04-08 | 1997-05-20 | Oxford Biosciences Limited | Method of delivering powder transdermally with needless injector |
US5458140A (en) * | 1993-11-15 | 1995-10-17 | Non-Invasive Monitoring Company (Nimco) | Enhancement of transdermal monitoring applications with ultrasound and chemical enhancers |
WO1998055033A1 (en) * | 1997-06-04 | 1998-12-10 | Spectrx, Inc. | Fluid jet blood sampling device and methods |
WO1999004838A1 (en) * | 1997-07-21 | 1999-02-04 | Roche Diagnostics Gmbh | Electromagnetic transdermal injection device and methods related thereto |
Also Published As
Publication number | Publication date |
---|---|
WO2001022881A8 (en) | 2002-05-30 |
EP1220641A1 (en) | 2002-07-10 |
DE19946059A1 (en) | 2001-03-29 |
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