Classifications

• • 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
  • A61B5/15—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
  • A61B5/150175—Adjustment of penetration depth
  • A61B5/150198—Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• • 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
  • A61B5/150358—Strips for collecting blood, e.g. absorbent
• • 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
  • A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing 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
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150503—Single-ended needles
• • 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
  • A61B5/150748—Having means for aiding positioning of the piercing device at a location where the body is to be pierced
• • 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
• • 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
• • 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
• • 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
  • A61B5/151—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
  • A61B5/15123—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 magnets or solenoids
• • 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
  • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
  • A61B5/15128—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads
• • 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
  • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
  • A61B5/15188—Constructional features of reusable driving devices
  • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
• • 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
  • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
  • A61B5/15188—Constructional features of reusable driving devices
  • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
  • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Definitions

• the invention relates to a device for removing the body fluid with a pierceable into the skin of a body part piercing element having a (in particular effective as a capillary) receiving structure for body tissue obtained in the skin puncture, and a lancing drive for a forward and backward movement of the lancing element, the duration of the retraction movement (preferably many times) is longer than the duration of the forward motion.
• the invention further relates to a corresponding method for the removal of body fluid.
• the object of the invention is to further improve the systems and methods proposed in the prior art and to ensure reliable sample collection with limited constructional effort and, at the same time, to reduce the painfulness of the procedure.
• the combination of features specified in the independent claims is proposed.
• Advantageous embodiments and modifications of the invention will become apparent from the dependent claims.
• the invention is based on the idea to place the collection start on an intermediate position under the skin, which can be approached at very high speed, and which is a fixed pull-back distance behind the selected deepest puncture position. It is intended to move the piercing element in a first retraction phase of the retraction movement with a maximum retraction speed of more than 0.02 m / s.
• the maximum puncture depth can be selected according to the individual skin properties so that enough blood capillaries are opened by the puncture, while this particularly pain-intensive phase is reduced by the fast first return movement to a minimum.
• the collecting process then takes place, which is determined by the fact that body fluid flows into the receiving structure.
• the skin puncture should take a sufficiently long time in order to be able to take up the required amount of sample. Surprisingly, however, it has been shown that a too slow movement of the lancing element hinders blood uptake. Furthermore, the collection phase should be completed within a defined time interval in order to meet the boundary conditions at the puncture depth. Accordingly, it is proposed according to the invention that the piercing drive is designed to retract the piercing element from the skin during a second retraction phase subsequent to the first retraction phase for collecting body fluid in the receiving structure such that the retraction speed is between 0.6 and 2 mm / s is and / or the collection period is in the range between 0.3 and 0.8 s.
• the piercing element is retracted by a defined first partial section, preferably of up to 0.5 mm, from the deepest piercing position into an intermediate position lying below the skin surface.
• the skin surface can be determined on the device side by a corresponding reference position, for example via a positioning for the body part or a skin detector or a predetermined piercing depth.
• a technically complex motion control can be dispensed with by the constant first retraction path, whereby a harmonic movement sequence in the area of the direction reversal of the needle without vibration-critical stop structures becomes possible.
• the return movement of the puncturing element takes place in such a way that the receiving structure can be filled at least predominantly with body fluid within the collection time, while the puncturing element still projects into the skin. It should be noted that only after the first rapid retraction phase is a significant intake of released in the puncture wound body fluid.
• the duration of the forward movement and the first retraction phase is between 0.3 to 3 ms, preferably 0.3 to 0.7 ms, so that a harmonic movement sequence is made possible for the initial lancing process.
• the collection duration for receiving body fluid in the receiving structure should be between 0.4 and 0.5 s.
• the average retraction speed of the piercing element during the second retraction phase in the range of 1 to 1, 5 mm / s.
• the maximum penetration depth should be adjustable between 1 and 2.5 mm.
• the speed profile during the return movement of the puncturing element in accordance with a variable puncture depth adapted so that the piercing element remains stabbed for a predetermined residence time in the skin.
• the speed profile during the return movement of the piercing element is predetermined independently of the piercing depth.
• a further improvement in sample recovery is achieved in that the speed of the piercing element is substantially constant in the second retraction phase.
• test element which can be acted upon by body fluid from the receiving structure.
• the total duration from the beginning of the retraction movement of the lancing element to the application of the body fluid to the test element should be less than 5 s, preferably less than 1 to 2 s.
• test element designed to detect an analyte in the body fluid is arranged such that the transfer time for transferring the body fluid from the receiving structure to the test element (20) is less than 1.5 s, preferably less than 1 s and preferably less than 0.5 s. Surprisingly, it has been found that compliance with this time window is particularly important for the test quality.
• the test element can be arranged directly on the puncturing element and optionally fluidly connected to the receiving structure via a flow path. It is also possible to arrange the test element separately, in particular physically separate from the receiving structure, and to transfer the liquid by means of a suitable actuation, for example under structural deformation.
• WO 2005/084530 and WO 2007/025713 By way of example, reference is made here to WO 2005/084530 and WO 2007/025713.
• the lancing element has a sharp piercing member, in particular a single needle point, which penetrates the skin with little pain when penetrating the skin.
• the position of the skin surface can be detected by a skin detector and / or determined by means of a positioning unit for the body part.
• a puncture-inducing, in particular channel-shaped or slit-shaped, channel structure can be brought into the puncturing element, which can be brought into contact with the bodily fluid, at least at a distal end section during skin puncture.
• a further advantageous aspect of the invention lies in the fact that the drive mechanism controls the forward movement and retraction movement during a first retraction phase of the piercing element, while the drive motor retracts the piercing element out of the skin in a second retraction phase of the retraction movement.
• the drive mechanism can be effectively designed for fast movement be made, and designed for the slow residual movement engine can be designed to be compact and energy-saving.
• the drive motor supplies the drive mechanism for automatic motion control with mechanical energy.
• a further improvement is achieved in that the drive motor retracts the drive mechanism together with the lancing element as a composite in the second retraction phase.
• a structurally particularly advantageous embodiment provides that the drive mechanism has a cam control driven by a spring.
• the subject matter of the invention is also a method for removing bodily fluid in which a lancing drive controls a forward and backward movement of a piercing element in such a way that the piercing element is moved back in a first retraction phase of the retraction movement with a maximum retraction speed of more than 0.02 m / s ., And in which the lancing element during a second retraction phase subsequent to the first retraction phase for collecting body fluid in the receiving structure is withdrawn from the skin so that the collection time is in the range between 0.2 and 0.8 s and / or the retraction speed between 0.8 and 1.5 mm / s.
• 1 shows a device for blood sugar tests with a multi-stage lancing drive in a simplified sectional view
• 2 shows a lancing profile when using the device according to FIG. 1.
• the device shown in FIG. 1 serves for the self-withdrawal of a blood sample by a user for analysis purposes, in particular for blood sugar monitoring.
• the device comprises a hand-held device 10 with a lancing drive 12 for the automatic handling of a lancing element 14 used as a disposable article for drawing blood.
• the piercing element 14 is provided as a so-called "microsampler” for obtaining a small amount of blood from a body part 17, in particular a fingertip. It may consist of a thin stainless steel sheet as a monolithic one-piece molding and have a distally formed tip 16 as a lancing member for producing a puncture wound. A groove-shaped or slot-shaped capillary channel 18 extending with its distal end section into the region of the tip 16 makes it possible to absorb body fluid (blood and / or tissue fluid) from the puncture wound.
• body fluid blood and / or tissue fluid
• a test element 20 provided with a test chemistry can be used, which after the skin puncture can be acted upon from the receiving structure 18 by producing a suitable fluid connection with body fluid.
• the detection of blood glucose especially by means of non-contact optical methods is known per se in the prior art and is therefore not explained in detail here.
• the lancing drive 12 allows a controlled forward and backward movement of the lancing element 14 along a lancing axis 22, wherein the lancing depth is suitably selectable in the range between 1 and 2.5 mm to adapt to different skin types by means of a setting unit 24 by the user.
• the position of the skin surface can be predetermined by means of a positioning unit 26 for the body part 17.
• the lancing drive 12 comprises an electrically operating lift motor 28 and a purely mechanically driven drive mechanism 30 biased therewith.
• the drive mechanism 30 controls the fast forward movement and a first fast phase of return movement while the drive motor 28 controls the lancing element 14 via the drive mechanism 30 slowly withdraws from the skin in a second retraction phase. In this way, the collection process can be optimized and made very user-friendly.
• the mechanical drive mechanism 30 includes a tension rotor 32 and a drive rotor 34, the rotors being interconnected via a biased torsion spring 36. Furthermore, the drive mechanism 30 comprises a cam drive 38, which converts the rotational movement of the drive rotor 34 via a control cam 40 into a translational or piercing movement of the coupled lancing element 14. For this purpose, a protruding on the drive rotor 34 control arm 42 engages at its free end via a cam rider 44 in the circumferential cam 40 a. Upon rotation of the drive rotor 34, a stroke is generated according to the curve slope, wherein the cam drive 38 is guided via a linear guide 46 in the device housing 48.
• the relative rotation of the two rotors 32, 34 can be mutually limited by stop elements 50, 52 in order to receive the bias of the spring 36 and to stop the drive rotor 34 in a desired angular position.
• the drive rotor 34 is locked against rotation relative to the housing 48, so that the spring 36 can be tensioned via the tensioning rotor 32 by rotation of the motor 28 until the starting position of the stop elements 50, 52 is established.
• the locking of the drive rotor 34 is performed in a given angular position.
• the drive motor 28 is coupled on the output side with the tensioning rotor 32 in order to supply the mechanism 30 with mechanical energy in a preliminary tensioning phase.
• Another essential function of the drive motor 28 is the controlled slow return movement of the piercing element 14 during the second retraction phase.
• the stop elements 50, 52 are held by the remaining spring tension in the end position described above.
• the drive mechanism 30 can be further rotated as a unit in order to drive off the remaining section of the control cam 40, the lancing element 14 being retracted at a defined retraction speed. In this phase, the lancing member 16, which is still under the skin 16, can absorb sufficient blood via the collecting structure 18 from the partially released puncture wound.
• the absorbed blood is transferred to the test element 20 in a transfer step by a suitable actuation in preferably less than 0.5 s.
• the test element 20 is arranged sufficiently close to the receiving structure, so that the liquid transport takes place in consideration of the achievable transport speed in the given time.
• the lancing profile shown in FIG. 2 is particularly advantageous.
• the term "lancing profile" is to be understood here as the time course of the puncturing movement, as represented as a function of puncture depth over time.
• This depth must be individually optimized to reach the dermis containing the blood capillaries through the epidermis.
• the duration of the forward movement is preferably between 0.3 to 0.7 ms.
• the tip 16 is retracted by a predetermined distance ⁇ d of approximately 0.5 mm to an intermediate position which lies below the surface of the skin.
• this retraction position is located in the stratum corneum of the epidermis.
• This first retraction R1 should take place as quickly as possible because the lancing element 14, which was excited into oscillations by the sharp reversal of direction, should as far as possible not carry out too many vibration periods in the perfused and innervated dermis.
• the maximum retraction speed reached shortly after the reversal of motion should therefore be more than 0.02 m / s. Accordingly, the duration of the first retraction phase is limited in the range between 0.3 and 3 ms.
• a uniform harmonic motion sequence in the phases v and R1 is achieved by means of the drive mechanism 30.
• the withdrawal of the piercing element 14 is significantly slowed down, so that the collecting process can take place during the subsequent second retraction phase R2.
• the retraction speed should not fall below a minimum value and should still be sufficiently high in order for the skin tissue to Willingly releases fluid.
• the collection time must be long enough for the receiving structure or capillary 18 to be able to absorb the liquid, which can take up to 500 ms taking into account production tolerances and aging effects. It should also be taken into account that too long a residence time of the piercing element in the inserted state in the skin is perceived as annoying by the user.
• the speed of the piercing element in the second retraction phase should be substantially constant, with a value between 1 and 1, 5 mm / s is favorable.
• Such a comparatively slow retreat can be achieved by energizing a compact drive motor 28 with a voltage kept constant by simple means.
• the lancing profile can be fixed independently of the puncturing depth. In a deeper puncture, the curve shown in Fig. 2 is then moved unchanged as it is up. Alternatively, it may be advantageous to adjust the speed curve as a function of an optionally changed puncturing depth so that a defined dwell time is achieved in the inserted state.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Hematology (AREA)
• Physics & Mathematics (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Vascular Medicine (AREA)
• Dermatology (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• External Artificial Organs (AREA)

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• 2008
  • 2008-02-11 EP EP08151294A patent/EP2087840A1/de not_active Withdrawn
• 2009
  • 2009-02-11 PL PL09710235T patent/PL2242424T3/pl unknown
  • 2009-02-11 CN CN200980104803.9A patent/CN101951833B/zh not_active Expired - Fee Related
  • 2009-02-11 CN CN201310420563.1A patent/CN103462616B/zh not_active Expired - Fee Related
  • 2009-02-11 JP JP2010545505A patent/JP5683275B2/ja not_active Expired - Fee Related
  • 2009-02-11 ES ES09710235T patent/ES2809496T3/es active Active
  • 2009-02-11 EP EP09710235.4A patent/EP2242424B1/de not_active Not-in-force
  • 2009-02-11 CA CA2711595A patent/CA2711595C/en not_active Expired - Fee Related
  • 2009-02-11 WO PCT/EP2009/051581 patent/WO2009101112A1/de not_active Ceased
  • 2009-02-11 KR KR1020107017753A patent/KR101178742B1/ko not_active Expired - Fee Related
• 2010
  • 2010-08-11 US US12/854,665 patent/US9028426B2/en not_active Expired - Fee Related
• 2014
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