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
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
  • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
  • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
  • A61B5/15159—Piercing elements stocked in or on a disc
  • A61B5/15163—Characterized by propelling the piercing element in an axial direction relative to the disc
• • 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
  • A61B5/150374—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
• • 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
  • A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• • 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
  • A61B5/15111—Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• • 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
  • A61B5/15126—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
  • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.

Definitions

• the present invention relates to a lancing device for the removal of body fluids for diagnostic purposes with coupled clamping and release mechanism, wherein the
• Triggering mechanism is mechanically coupled to the clamping mechanism, that upon actuation of the clamping mechanism of the lancing operation is automatically triggered by continuous continuation of the clamping movement and wherein the thus triggered lancing operation is performed by a lancet.
• body fluids in particular human blood
• an analyte contained therein In various diseases it is necessary to study body fluids, in particular human blood, for an analyte contained therein. In many cases, it is sufficient to remove a small amount of the desired body fluid, especially blood in the form of a blood drop, by producing a small puncture wound.
• a particularly important case is diabetes, in which the blood must be tested for glucose levels at regular intervals. Further blood tests can be carried out, for example, on coagulation parameters, triglycerides, HbAlc or lactate. To generate the required puncture wounds are usually
• Blood lancet devices used consisting of a lancing device and adapted thereto replaceable lancets.
• a lancet holder In the housing of the lancing device is a lancet holder, in each of which a lancet can be used interchangeably.
• the lancet holder is quickly moved in a puncture direction by a lancet drive also integrated in the lancing device until the lancet tip emerges from an exit opening provided by the front end of the puncturing device and generates a small puncture wound in the body part against which the front end is pressed.
• the lancets are disposable elements intended for single use. After a single use of a lancet, the lancet is removed after the lancing process or ejected from the device and disposed of.
• lancing devices are also used by laymen in the so-called home monitoring area. This is especially true for the therapy control of diabetics. For example, in the treatment of diabetics, it has been found that serious diabetes related complications, such as blindness, can be significantly reduced if the glucose concentration in the diabetic's blood is determined frequently, up to five times a day, and based on these measurements Insulin injection can be set exactly. In order to realize such frequent measurements, lancing devices are used within the scope of the home monitoring area, so that the diabetic himself can carry out a blood test.
• EP 0 668 049 A1 discloses an automatically exciting lancet device comprising a release button which is acted upon by a release button spring and a drive spring which connects the release button with a plunger. When triggered is the
• Trigger button spring compressed, and as soon as the user releases the release button, the trigger button spring brings the plunger and the release button under the biasing force of the release button spring in the cocked position.
• the disclosed lancet device stretches automatically and is therefore constantly tense and ready to trigger. Clamping and release of the lancet device are therefore carried out in two separate operations to be carried out the release button.
• the US 2008/0195132 AI discloses special lancing devices, each with a clamping and a
• the lancing devices have, in one embodiment, an automatic tensioning and release system, in which the lancing device first by pressing the
• Clamping knob is tensioned and then triggered automatically by releasing the release button, ie by relaxing the tension spring.
• the tense Drive spring By expanding the tense Drive spring, the holding element and the lancet connected thereto is driven in the puncture direction and pulled back by relaxing it in the housing.
• the subject of WO 03/073936 A2 is a device for puncturing the skin of a patient for single use, which has a pressure element with which both a drive spring can be tensioned as after mechanical overuse of internal holding elements a puncture unit for performing a puncture movement can be released.
• the device is placed on the skin area to be punctured and compressed by means of the pressure element. After execution of the puncturing movement, the free-flying puncture unit is retracted by a return spring to a position within the device.
• WO 02/05872 A2 discloses a disposable lancing device that can be both tensioning and triggering by a single, one-way operation of a trigger.
• a lancet is driven by means of a tensioned spring from a sterile environment within the device in the puncture direction and retracted back into the housing after the puncture.
• the device allows neither the individual adaptation of the penetration depth nor the driving force or speed.
• an automatic lancing device which also has a single trigger button both for clamping and for triggering.
• the lancing device further comprises a mechanism in which a guide pin is moved in a guide, wherein the guide has a circumferential part and a longitudinal portion.
• the release button When pressing the release button, the lancing device is tensioned and the guide pin is moved in the guide, wherein upon reaching the longitudinal section of the guide automatically a puncturing movement is triggered.
• One is initially not engaged with the lancet accelerated in the direction of the lancet and carried out by striking the plunger on the lancet puncturing movement.
• EP 1 384 438 A1 discloses a blood collection system for withdrawing blood for
• Diagnostic purposes comprising a housing, a lancet guide and a lancet drive with a drive spring.
• To the lancet drive includes a tensioning device to tension the drive spring, a driven by the drive spring drive rotor and a driven-side coupling mechanism by which the rotational movement of the drive rotor is converted into the puncturing movement. It also mentions the possibility that
• the object has been achieved by providing a system for
• Collection of body fluids for diagnostic purposes comprising a removal device and at least one lancet adapted to the removal device with a lancet body and a lancet tip, a housing with an outlet opening for the lancet tip, a lancet holder movable in the housing along a predetermined insertion path for exchangeable holding of the lancet, a lancet guide for guiding the lancet holder on the lancet holder predetermined lancing path after triggering the puncturing movement, a lancet drive with an elastic drive element, which can be transferred by clamping from an unstressed to a tensioned state and is converted by the relaxation of the tensioned elastic drive element in a puncturing movement after triggering, in which the lancet holder held lancet along the predetermined insertion path is moved in the puncture direction until the lancet tip at least partially exits the outlet opening and by the lancet is returned to a position in which the tip of the lancet is located in the housing, and a combined clamping and triggering
• Tripping device has a locking device, with the
• Actuator and the lancet drive is mechanically coupled such that the lancet drive is initially stretched and then released upon displacement of the actuating element along the actuation path, wherein the triggering of the lancet drive upon reaching a certain point along the
• the inventive system is suitable for the removal of body fluids such as blood or interstitial fluid, preferably for the removal of blood for
• an incision in a previously selected skin area for example on a fingertip or on the earlobe, is usually brought about using the system according to the invention.
• the desired incision is usually brought about by the quickest possible and short puncture of the lancet encompassed by the system according to the invention into the selected area of the skin.
• the desired small amount of the respective body fluid can escape from the selected area of the skin.
• the system of the present invention is a reusable system for withdrawing body fluids, preferably blood, i. such a system, which is not intended for single use only. Consequently, the system according to the invention, or more precisely the removal device comprised by the system, can be used one or more times in succession, preferably after replacement of the respective used lancet by an unused lancet.
• the system according to the invention comprises a removal device and at least one lancet with a lancet body and a lancet tip matched to the removal device.
• the removal device is suitable both for single and multiple use, but preferably for repeated use.
• the system according to the invention can be used several times, optionally with repeated use of an already used lancet or preferably after replacing an already used lancet with a still unused lancet.
• a used lancet is to be understood as one with which one or more punctures have already been performed.
• the lancets encompassed by the system according to the invention have a lancet tip and a lancet body, which can be configured in one piece as well as in several pieces.
• the lancet body and the lancet tip can be made both from the same and preferably from different materials.
• Suitable materials for the lancet tip are metals such as stainless steel or specifically called spring steel.
• the lancets to be used in the context of the system according to the invention are those which comprise a lancet tip made of stainless steel, which are connected to a lancet body, preferably made of a suitable plastic, more preferably of acrylonitrile-butadiene-styrene.
• the lancets to be used in the context of the system according to the invention preferably have a protective body which serves for the purpose of producing the skin incision
• sterile protection protective body Surrounds the lancet tip so that contamination of the lancet tip with impurities or germs can be avoided and the sterility of a still unused lancet can be guaranteed.
• sterile protection protective body are known in the art and described for example in EP 1 263 320 AI. They are usually made of a suitable plastic and can both before use of the lancet or during use, i. during the puncture of the
• the system according to the invention specifically the removal device comprised by the said system, has a housing with an outlet opening for the lancet tip.
• the housing preferably has an elongate shape, which preferably has a main axis (A).
• the said outlet opening for the lancet tip is located at one end of the elongated housing. This end is referred to in the context of the present invention as the proximal end of the housing.
• the system according to the invention further comprises a lancet holder which is movable in the housing along a predetermined, usually straight-line insertion path for exchangeable holding of the lancet.
• the predetermined puncture path is aligned parallel to the direction of the main axis (A) of the housing.
• the lancet holder provided in accordance with the invention serves to receive the lancet and is advantageously designed such that it holds the lancet during the displacement along the puncture path for producing the aforementioned skin incision, i. is located with the lancet in permanent but detachable mechanical coupling.
• interchangeable holder is to be understood as meaning that the lancet holder is linked to the lancet at least in the course of the puncturing procedure, that the mechanical coupling between the lancet, preferably between the lancet body and
• Puncture procedure can be solved or maintained.
• a used lancet can optionally be further used after removal of a puncture or removed and replaced by another, preferably unused lancet.
• the mechanical coupling between the lancet and lancet holder can be realized for example by press fit or by jamming or latching.
• suitable lancet holder is described for example in EP 0 565 970 AI.
• the lancet body may for example be surrounded by the lancet holder in a form-fitting manner.
• a positive coupling between the lancet body and lancet holder is also possible if the lancet holder is designed as a plunger, which has a holding device through which a releasable positive coupling with the
• Holding region of a lancet is produced, as described for example in WO 02/36010 AI, to which reference is made in this regard.
• the latter embodiment of the positive coupling between a designed as a ram lancet holder and a Lancet with a holding area has proved to be particularly advantageous when several lancets in the form of a lancet magazine are to be used in the context of the system according to the invention.
• the removal device of the system according to the invention further comprises a lancet guide for guiding the lancet holder on the predetermined, usually rectilinear
• the puncture path preferably runs along a straight line parallel to the main axis (A) of the housing.
• the lancet guide advantageously makes it possible for the lancet holder, and thus the lancet held or connected thereto, to be in mechanical coupling with the lancet drive at least during the entire puncturing procedure.
• the term puncture procedure in the context of the present invention means the entire cycle of movement of the lancet, in which the lancet is initially moved in the direction of the outlet opening at the proximal end of the housing, at least with a part of the lancet tip, starting from a rest position located in the housing out of the housing, at the point of maximum
• the lancet can advantageously be in permanent contact with other guide elements such as one or more guide rails.
• the mentioned guide elements or guide rails can, for example, on the inside of the housing of the
• a lancet magazine may also be part of a lancet magazine as described in more detail below.
• they may be mounted on the inner surface of a magazine housing.
• Magazine housing itself be designed so that it serves as a guide element.
• the individual stored lancets in individual compartments For example, the individual stored lancets in individual compartments,
• the respective shaft walls can serve as guide elements.
• the piercing movement can be stabilized and, moreover, a permanent contact between the lancet drive and a lancet connected to the lancet holder can be achieved, which is desirable in particular with regard to a low-pain induction of the skin incision.
• the system according to the invention further comprises a lancet drive with an elastic drive element, which can be transferred by clamping from an unstressed to a tensioned state and is converted by the relaxation of the tensioned elastic drive element after the release in a puncturing movement, in which the lancet held by the lancet holder is moved along the predetermined insertion path in the puncture direction until the lancet tip at least partially exits the outlet opening and through which the lancet holder is preferably returned to a position in which the tip of the lancet is located in the housing.
• suitable elastic drive elements may be mentioned in particular springs, which may be made of all, the skilled person appearing elastic materials, in particular plastics and preferably metals such as spring steel 1.4310 and in various configurations, such as spiral or leaf springs, preferably as Spiral springs, can be used.
• the tensioning of said elastic drive elements can take place in various ways, for example by stretching coil springs along their axis of rotation or preferably through
• Twisting of said coil springs about its axis of rotation it is also possible to tension leaf springs by deflection from the rest position.
• the lancet held by the lancet holder runs along the predetermined puncture path moved in the piercing direction until the lancet tip at least partially exits the outlet opening and through which the lancet holder is returned to a position at which the tip of the lancet is in the housing, preferably until the lancet holder or the lancet is again in the initial rest position , It has proven to be advantageous that the lancet holder and thus also a lancet connected thereto preferably during the entire puncture and return movement of a lancet in permanent mechanical coupling with the lancet drive and thereby the lancet drive both the puncture and the return movement of Lancet holder or lancet can drive continuously.
• Such positive-driving drives are known in the art, for example in the form of crank gears, lever gears, gate or cam controls.
• drive has proven such that has a transmission through which a torque introduced on the input side of the transmission is converted into a longitudinal displacement in the direction of the predetermined Einichweges, wherein the output side longitudinal displacement of the transmission to the Lancet holder is transferred.
• Such drives are known, for example, from EP 0 565 970 A1 and EP 1 384 438 A1, to which reference is hereby made.
• the term "gear” is understood in the context of the present invention, as in the cited documents, in the general sense, ie as a kinematic device which serves to couple and transform movements, in the present case, the movement in the relaxation of the elastic drive element , Preferably, the elastic drive spring, is converted into the movement of the lancet holder or the lancet held therein interchangeable.
• the lancet drive has a rotary slide transmission with a rotatable drive rotor, by means of which a torque introduced on the input side of the rotary slide transmission is converted into a longitudinal displacement in the direction of the predetermined insertion travel, the drive rotor of the rotary slide transmission being coupled to the elastic drive element is and the output-side longitudinal displacement of the rotary slide transmission is transmitted to the lancet holder. It is possible that the drive rotor to both a
• predetermined Einichweg parallel axis of rotation and is rotatable about an axis perpendicular to the predetermined Einstichweg axis of rotation.
• the drive rotor be moved one to the predetermined insertion path, i. is preferably rotatable about an axis of rotation parallel to the main axis (A) of the housing.
• the rotary slide transmission has a rotatable with the drive rotor recess into which a matching control pin engages, wherein at least a portion of the piercing and return movement is determined by a relative movement between the control pin and the recess, wherein the control pin formed by the cam cam departs.
• the recess forming the control cam and rotatable together with the drive rotor is designed so that the pin, upon actuation of the operating element in a continuous, i. continuous movement completely or at least partially, but preferably completely leaves.
• the drive rotor is formed as a cylindrical sleeve, within which a piston-shaped part is arranged, which slides in the longitudinal displacement in the direction of the puncture path with a cylindrical outer wall in the sleeve.
• the system according to the invention has a
• Lancet drive with two rotors wherein the first is to be designated as a clamping rotor and the second as a drive rotor.
• the said rotors are in turn preferably linked together by a drive spring as described above and further preferably the same axis of rotation parallel to the main axis of the device (A) of the system according to the invention.
• Clamping and driving rotor have the same direction of rotation in this embodiment and rotate in succession by 360 °. For this reason, this drive is also referred to as "360 ° drive.”
• a detailed description of this drive can be found, for example, in EP 1 034 740 A1.
• the system according to the invention further comprises a combined tensioning and
• Tripping device with an accessible from the outside of the housing
• Actuator having an initial state and an actuated state
• the combined clamping and triggering device comprises a locking device which is mechanically coupled to the actuator and the lancet drive such that the lancet drive upon displacement of the actuating element along the actuating path, preferably in the direction of the proximal End of the system according to the invention, first tensioned and then triggered, the release of the lancet drive is released upon reaching a certain point along the actuation path.
• the combined tension and release device according to the present invention serves both for tensioning and for releasing the one as described above
• Lancet drive It comprises an actuating element which is accessible from the outside of the housing and which can be actuated by actuation, i. Move can be transferred from an initial state to an actuated state. It is within the scope of a preferred
• the actuating element arranged such that it is at least partially introduced by the displacement in the housing. Further preferred is the
• Actuating element is at least partially introduced by the displacement into the end of the housing facing away from the puncture opening, hereinafter referred to as the "distal end" of the housing.
• the actuation element is preferably arranged so that the displacement takes place along a preferably linear actuation path
• This preferably linear actuating path preferably runs parallel to the puncturing movement of the lancet, ie preferably parallel to the main axis (A) of the housing
• the actuating element is a from the rear, facing away from the outlet opening for the lancet tip, ie distal end of the housing outstanding control knob.
• the actuating element preferably the control button as shown above, according to the invention has an initial state and an actuated state and can be transferred by shifting from the initial state to the actuated state.
• the control knob can be inserted or pressed into the housing in the direction of the proximal end of the housing.
• the combined tensioning and releasing device is coupled with the lancet drive in such a way that the elastic drive element of the lancet drive is first transferred from an untensioned to a tensioned state by continuous, unidirectional displacement of the actuating element and then, preferably automatically, triggered.
• a direction is understood to mean a movement of the actuating element which is guided along the actuation path without changing the direction of movement, the actuation path preferably being linear and particularly preferably parallel to the puncturing direction or to the main axis (A) of FIG Housing runs.
• the removal device has a control knob which protrudes from the distal end of the housing and can be displaced completely or at least partially into the housing by being pressed in the direction of the proximal end of the housing.
• Actuator achieved in the course of the shift from the initial state in the actuated state and preferably by construction of the locking device
• Tripping device are freely selected, which share of the shift of the
• Actuator must first be moved almost over the entire actuation path and the triggering is achieved only at or preferably shortly before reaching the maximum possible displacement. Alternatively, it is also possible, for example, that upon reaching half of the maximum actuation travel of the operating element, the triggering of the
• Actuating element for clamping the lancet drive and thus a higher expenditure of force would be connected. It is advantageous that during the operation of the control element is not determined when, ie at what time during the move or Impressing the actuator, a triggering of the puncturing process takes place.
• the system according to the invention may also comprise suitable means for indicating the imminent initiation of the puncture movement.
• suitable means could be, for example, visible or tactile markings on the housing of the sampling system or on the surface of the operating element. Particularly preferred would be said means for indicating the impending initiation of the puncture movement part of
• Operating element particularly preferably a visible or tactile mark on the surface of the control element, for example, a color or distinguishable by the surface texture of the rest of the control element area, preferably at the distal end of the
• the combined clamping and release device according to the invention has a
• Locking device on.
• various technical embodiments of the inventively provided locking device are conceivable in which the mechanical coupling between actuator and lancet drive is configured so that the lancet drive is initially stretched and then released upon displacement of the actuating element along the actuating path, wherein the triggering of the lancet drive upon reaching a certain Point along the Betjansweges, as explained above, is released.
• the system according to the invention comprises a locking device which is designed as a path control comprising as members a control track part and a control cam, wherein the control cam during at least part of the displacement of Actuator along the actuation path makes a relative movement with respect to the control track part, in which he at least partially, preferably completely leaves the control track of the control track part, whereby preferably at least a part of the movement of the lancet drive is controlled.
• a locking device which is designed as a path control comprising as members a control track part and a control cam, wherein the control cam during at least part of the displacement of Actuator along the actuation path makes a relative movement with respect to the control track part, in which he at least partially, preferably completely leaves the control track of the control track part, whereby preferably at least a part of the movement of the lancet drive is controlled.
• control cam is a part of the actuating element or firmly connected to the actuating element.
• control track part is preferably a component of the lancet drive or firmly connected to a component of the lancet drive.
• control path part of the path control is completely or at least partially, but preferably completely, part of the drive rotor or mounted on the drive rotor of a lancet drive as described above. It has proven to be advantageous if the control track is mounted on the outside of the drive rotor, and it may in principle be connected in other ways with this, for example on the inwardly facing surface of an optionally hollow or sleeve-shaped drive rotor.
• the control cam preferably performs a relative movement with respect to the control track part during the entire displacement of the actuating element from the starting position into the actuated position.
• the control cam moves the control track at least partially, but preferably completely.
• the control track can be designed, for example, as a recess in the surface of the respective component of the lancet drive. However, in a preferred manner it is also possible to design the control track in the form of a rail projecting beyond the surface of the respective element, preferably over the surface of the drive rotor, or else in the form of two rails guided essentially parallel to one another. The control cam can then slide along such a rail or in a path formed by two rails.
• control track preferably comprises at least one linear section runs parallel to the axis of rotation of the lancet drive or preferably parallel to the axis of rotation of the drive rotor, provided that it is designed as part of the drive rotor.
• control track portion comprises a first, preferably linear portion and a second, preferably linear portion, wherein the first portion of the control track portion substantially parallel to the axis of rotation of
• preferred rotary transmission i. is preferably parallel to the axis of rotation of the drive rotor and wherein the second portion of the control track portion is substantially perpendicular to the axis of rotation of the rotary slide transmission, i. preferably runs perpendicular to the axis of rotation of the drive rotor.
• substantially parallel or substantially perpendicular means small deviations of up to about 10 °, preferably of up to about 5 ° and particularly preferably up to about 2 ° (in each case in both directions) from the ideal parallel or vertical orientation.
• the first section of the control track part preferably runs parallel in nature, preferably parallel to the axis of rotation of the rotary slide transmission or drive rotor, if fitted thereon, i. preferably parallel to the main axis (A) of the housing.
• the second section of the control track part preferably extends substantially perpendicular, preferably perpendicular to the axis of rotation of the rotary slide transmission or drive rotor, if mounted thereon.
• the two sections i. the essentially parallel and the in the
• Output state is transferred to an actuated state.
• the formed control track has a substantially rectangular course in this embodiment. It will
• the part of the element which runs essentially parallel to the device axis, preferably parallel to the axis of rotation of the rotary sliding gear or drive rotor is preferably preferred Tax tract part of the control cam.
• Control track is mounted on this, during the clamping initially inhibited in its rotation, since the control cam engages in the substantially parallel to the axis of rotation extending portion of the control track portion.
• the rotation of the drive rotor Upon reaching the end of the substantially parallel portion or with reaching the second, substantially perpendicular to the axis of rotation portion then the rotation of the drive rotor is released.
• the inventively provided triggering the puncture movement upon reaching a predetermined point along the displacement path of the actuating element is determined in the context of this embodiment by the end of the first, parallel to the axis of rotation of the drive rotor portion of the drive rotor, or through the point at which the first portion of Control path in the second, perpendicular to the axis of rotation of the drive rotor extending portion of the control path passes.
• perpendicular to the axis of rotation or “perpendicular to the axis of rotation A” also means a section of the control path running along a circular path around the lancet drive or a circular path along the circumference of the drive rotor.
• control track in addition to the above-mentioned first and second sections also comprise further sections, which are not aligned substantially parallel or perpendicular to the axis of rotation of the drive rotor.
• track sections that are neither parallel nor are aligned perpendicular to the axis of rotation of the drive rotor, but with this an angle of up to about 60 °, preferably up to about 40 ° and more preferably include up to about 20 °.
• Such control track sections can for example be provided between the above-mentioned first and second sections of the control track, whereby upon actuation of the actuating element, the imminent release of the drive rotor, ie the upcoming puncture, can be signaled.
• the actuating element is within the scope of a preferred
• Embodiment guided along the actuation path, without changing the direction of movement wherein the actuation path is preferably linear and particularly preferably parallel to the puncture direction or to the main axis (A) of the housing and is particularly preferably guided in the direction of the proximal end of the housing.
• Actuator usually shifted back to its original position, preferably in the direction of the distal end of the sampling device, for example by the action of a suitable return spring, as is familiar to the expert. It moves the
• the system according to the invention comprises a lancet drive with rotary slide transmission, which has a rotatable input-side gear member, through which a torque introduced on the input side of the rotary slide transmission into a longitudinal displacement in the direction of the predetermined
• the lancet drive is mechanically linked to the actuating element such that on the input side of the rotary slide transmission
• Displacement of the actuating element along the actuating path is converted into a rotational movement of the rotatable gear member to tension the rotatable gear member against the force of the elastic drive member.
• the axis of rotation of the rotatable gear member is converted into a rotational movement of the rotatable gear member to tension the rotatable gear member against the force of the elastic drive member.
• Gear element both perpendicular and parallel to the puncture direction or to the main axis (A) be aligned with the housing.
• the axis of rotation of the rotatable gear member of the rotary slide transmission is aligned parallel to the puncturing direction or to the main axis (A) of the housing.
• This can be accomplished, for example, by forming the input side of the rotary sliding gear by means of a helix provided on the rotatable gear member and by means of a clamping cam which is movable along the actuating path and slidable on a sliding surface of the helix by means of a contact surface.
• a clamping cam Such a device is known, for example, from EP 1 034 740 A1, to which reference is hereby made.
• the clamping cam is fixed to the invention provided
• the system according to the invention comprises a removal device and at least one lancet adapted to the removal device.
• the term "at least one lancet” should be understood to mean that the system comprises either a single lancet or a plurality of lancets, whereby a plurality in the context of the present invention is generally an amount of from 2 to about 50, preferably 3 up to about 25, more preferably 4 to 10, most preferably 5 to 8, even more preferably 6 or 7 and most preferably 6 lancets
• the system according to the invention therefore comprises a magazine with a plurality of lancets, which can be coupled successively to the lancet holder.
• magazines often referred to as “lancing units” are known in the art and disclosed, for example, in WO 02/36010 AI, to the expressly referred to in this regard.
• usable magazines or lancing units generally comprise a plurality of lancets, which are usually each individually in separate chambers, which are surrounded by a magazine housing.
• the lancets are in rest position, i. before the puncturing movement and preferably after the puncturing movement preferably within the magazine housing. In this way, unwanted injuries can be avoided, especially with an already used lancet.
• the magazine is advantageously designed so that it can be introduced into the housing of the removal device according to the invention.
• the lancet magazine is designed so that it can be attached to the lancet drive.
• the inventively usable magazine for example, have the form of a cap, which is attached to the lancet drive. Magazines preferably to be used according to the invention generally have a plurality of chambers, in each of which a lancet is located, which are positioned successively relative to the lancet drive or lancet holder, so that the lancet can be coupled to the lancet holder designed as a ram.
• the said chambers can be arranged, for example, in rows next to each other.
• Such magazines also referred to as drum magazines, have chambers arranged parallel to their axis of rotation and are advantageously introduced into the system according to the invention in such a way that their axis of rotation is parallel, particularly preferably coaxial to the main axis (A) of the system housing. Similar to a revolver drum, such a magazine can be mounted on the drive unit automatically or manually repeatable.
• the magazine comprises at least a part of the lancet guide, particularly preferably the entire lancet guide, as disclosed, for example, in the aforementioned WO 02/36010 A1, to which reference is hereby made.
• the lazet storage principle described above often results in the path of the lancet coupled to the lancet drive being considerably longer in comparison with that of a non-lancet in the course of the puncture procedure. As a rule, this also leads to larger, ie less favorable, dimensions of such removal systems in comparison to systems without collated lancets.
• the lancet provided according to the invention or the envisaged lancets are each provided with a sterile protection which ensures the sterility of still unused lancets, at least the respective lancet tips, up to the puncture.
• Suitable sterile protection bodies are, for example, those which are removed from the lancet before use. Particularly preferred are in the context of the present invention, such sterile protection body, which usually consist of an elastomeric material and punctured by the puncture by the lancet tip to be protected or stripped, but preferably are pierced, as are known from EP 1 263 320. In such systems higher drive forces are usually necessary because an additional force entry for stripping or piercing the usually elastic sterile protection is necessary.
• the systems according to the invention for the removal of body fluids make it possible, in particular by the locking device provided according to the invention, to have a significantly more compact design even when using lancets which have been stored in a magazine and are additionally provided with individual sterile protection.
• lancet drive or the drive element is not displaced as in comparable devices of the prior art in use initially by clamping in a tensioned state and permanently or for a freely determinable period remains in this tensioned state until it is triggered in a separate operating step.
• Such latching or locking of the lancet drive in the tensioned state is usually accompanied by the fact that for safe locking of the lock and to release the lock, ie to trigger the standing process an additional energy input by the user is applied.
• the preferred 360 ° drive becomes this extra
• the present invention also allows the use of lower power to achieve the same drive forces or speeds
• Another aspect of the present invention also relates to a sampling device (1) as described above suitable for providing the body fluid sampling system of the invention for diagnostic purposes.
• Such a removal device preferably comprises a housing (10) with an outlet opening for the lancet tip of a lancet tuned to the removal device, a lancet holder (20) movable in the housing (10) along a predetermined insertion path for exchangeably holding the lancet (91), a lancet guide (92) for guiding the lancet holder (20) on the predetermined insertion path after triggering the puncture movement, a lancet drive (30) with a resilient drive element (31), which can be transferred by clamping from an unstressed to a tensioned state and by the after Triggering the relaxation movement of the tensioned elastic drive element (31) is converted into a puncturing movement, in which the lancet holder (20) held lancet (91) along the predetermined insertion path is moved in the piercing direction until the lancet tip at least partially exits the outlet opening, and Durc h the lancet holder (20) is returned to a position in which the tip of the lancet (91) is located in the housing (10
• the combined clamping and triggering device has a locking device (70) which is mechanically coupled to the actuating element (40) and the lancet drive (30) such that the lancet drive (30) when moving the
• Fig. La shows a cross section of a system according to the invention with attached lancet magazine
• Fig. Lb is an enlarged detail of the lancet magazine of the cross section of Fig. La
• Fig. 2 is a perspective cross-section of the system of Fig. La;
• Fig. 3 is a perspective view of a removal device of the system according to the invention without housing
• Fig. 3a separate illustration of the locking device
• Fig. 4 is a side view of the removal system of FIG. 3 before moving the
• Fig. 5 is a side elevational view of the extraction apparatus of Fig. 3 with the actuator in the actuated condition;
• FIG. 6 shows a side view of the removal device from FIG. 3, with the drive rotor already rotated and the lancet holder displaced in the puncturing direction;
• Fig. 7 is a side elevational view of the rear side of the sampling device shown in Fig. 6;
• FIGS. 3 to 7 shows a detailed view of the output-side gear member with lancet holder of the removal device illustrated in FIGS. 3 to 7;
• FIG. 9 simplified representation of the detailed view of the output-side gear member with
• Fig. 10 is a perspective view of the lancet holder shown in Figs. 8 and 9
• Fig. 11 is a perspective view of the removal device shown in Fig. La with attached lancet magazine without housing.
• Figures 1 and 2 show cross-sections along the main axis of rotation or main unit axis (A) of a system according to the invention, which in the illustrated form comprises a removal device (1) and a lancet magazine (90).
• Figures 3 to 11 show details of the sampling device, partly in lateral, partially in perspective view.
• the lancet magazine (90) forms the proximal end (2) of the system and is inserted into the proximal end (11) of the housing (10).
• the actuator (40) forms the distal end (3) of the system and projects out of the distal end (12) of the housing (10).
• the system has a lancet drive (30) in the form of a rotary slide transmission which is connected to a tension spring designed as a torsion spring as an elastic drive element (31) via a drive rotor (50).
• Lancet drive is the output side connected to a designed as a ram lancet holder (20) having at its proximal end a holding device (21) for releasably holding a lancet (91) by positive coupling with the holding portion (93) and a drive sleeve (63, see FIGS. 4 to 10) is connected to the input-side gear member (50).
• the lancet magazine (90) provided in this embodiment comprises a lancet guide (92) through which the lancet holder or the lancet (91) detachably connected thereto are guided on a predetermined puncture parallel to the axis of rotation (A) of the system.
• the lancets stored in the lancet magazine each have a sterile protection (94) which at least tightly surrounds the respective lancet tip. The details are illustrated in the enlarged detail shown in Fig. Lb. In this embodiment, the
• Lancet guide (92) designed as part of a lancet magazine (90).
• the lancet guide can of course be different, for example, as part of the housing, ie, for example, be mounted on the inside of the housing.
• the drive rotor (50) of the rotary sliding gear (output side) is in a fixed
• the clamping bolt (80) has a coil with a contact surface on which a with the
• Actuator connected clamping cam (81) is slidably mounted.
• the clamping cam (81) can also be linked to the actuating element (40) via a clamping sleeve (82) as shown in FIG.
• Embodiment by means of a designed as a ram lancet holder (20). At the lancet (91) facing the end of the plunger (20) is a thickened holding device
• (Coupling geometry) (21) is provided, which is introduced for coupling a lancet (91) in a corresponding holding device in the holding portion (93) of the lancet body (91).
• the holding device of the lancet body (91) is formed so that it
• the puncture direction is moved so that its front end contacts the lancet body and shifts the lancet (91) in the puncture direction.
• the lancet (91) is positively coupled to the lancet drive (30).
• the lancet (91) is "directly guided", ie it is located immediately in a required guide (92) during the Puncture motion forming part of the housing (10) (in the present case, a magazine (90) containing a plurality of lancets).
• the embodiment of the lancet drive (30) according to the invention explained below is particularly suitable for such directly guided stored lancets (91).
• the lancet drive is permanently coupled with a lancet holder into which a new lancet is manually inserted for each blood withdrawal.
• the lancet holder (20) is guided by means of a housing or magazine part (92) serving as a guide and thus indirectly provides the required guidance of the lancet (91) on the puncture path.
• FIG. 3 shows a perspective view of the removal device (1) according to the invention from FIGS. 1 and 2, the housing (10) and the lancet magazine (90) being omitted for better explanation of the mode of operation.
• the removal device (1) shown has a locking device (70) connected to the actuating element (40) and designed as a path control (72, 73).
• the locking device has on its side facing the interior of the device (not visible in Figure 3) control cam (71) which is slidably mounted along a control track (72, 73), wherein the control track or the control track part (72, 73) on the rotatable drive rotor (50) of the rotary slide transmission is mounted.
• control cam (71) when moving the actuating element (40) parallel to the device main axis (A) perform a relative movement with respect to the control track (72, 73), wherein it moves off the respective portion of the control track or slides along it.
• Control track of the control track part has, in the context of this embodiment, two sections (72, 73), the first section (72) being substantially parallel to the main axis of the implement (A), i. parallel to the axis of rotation of the drive rotor (50) of the rotary slide transmission runs.
• the first portion (72) of the control track immediately merges into a second portion (73), this second portion (73) substantially perpendicular to the main axis of the implement (A), i.
• the locking device (70) is shown separately again in Fig. 3a. That's it Actuator (40) shown transparent, so that the drive rotor (50) facing control cam (71) is visible.
• the drive rotor (50) rotatable about the main implement axis (A) is under the action of the elastic drive element (31) designed as a torsion spring (hereinafter referred to as the drive spring).
• the drive spring (31) One end of the drive spring (31) is connected to the drive rotor (50), the other end with the helical clamping bolt
• the drive spring (31) is stretched in the context of this embodiment by a spring force counteracting rotation of the helical clamping bolt (80), wherein the rotation of the helical
• Clamping bolt (80) is effected by a displacement of the actuating element (40) in the direction of the proximal end (2) of the sampling system.
• Figures 4 to 6 illustrate the timing of the operation of the removal device shown in Figures 1 to 3.
• the components shown in connection with the respective preceding figures are characterized as throughout the present disclosure with the same reference numerals and will not be described again.
• the sampling device according to the invention is in the initial state, i. before shifting the
• the tension cam is (not visible) within the clamping sleeve (82).
• the control cam (71) is located at the starting point of the first, parallel to the axis of rotation of the drive rotor extending portion (72) of the control path portion of the path control.
• the actuating element (40) is shown transparent.
• the drive rotor (50) of the rotary sliding gear as well as the lancet holder (20) are in their
• the actuating element (40) is then of the in FIG. 4 shown initial state by displacement in the direction of the proximal end (2) of the sampling system in the actuated state.
• the tensioning cam (81) arranged in the tensioning sleeve (82) and not visible in FIG. 4 slides over the helix of the
• This state in which the actuating element (40) is displaced maximally in the direction of the proximal end (2) of the removal device, is shown in FIG.
• the drive rotor (50) begins to rotate about its axis of rotation (A) by the action of the spring force of the tensioned drive spring (31).
• FIG. 6 shows a temporally subsequent state of the removal device according to the invention, in which the drive rotor (50) has already rotated through approximately 90 ° about its axis of rotation and the curved lancet holder (20) already in a puncturing direction
• Figure 7 illustrates the same state of the sampling device, but viewed from the opposite side. In this case, the output side, designed as a cam control (60) coupling mechanism is visible.
• Output-side coupling mechanism is in the illustrated case of a cam control (60) with a lancing curve or a lancing profile (61) and a lancing curve or the Grooving profile (61) during the puncturing movement departing control pin (62) formed.
• the control cam (61) from one at the periphery of
• Propulsion sleeve (63) formed circumferential recess.
• the control pin (62) is on
• Drive rotor (50) is formed, which is surrounded by the with the lancing curve or the lancing profile (61) provided part of the drive sleeve (63).
• the propulsion sleeve (63) is rotatably guided by a longitudinal groove, not shown, so that they can perform only a translational movement.
• a longitudinal groove not shown
• At its front end of the lancet holder (20) is rigidly fixed.
• the cam control (60) basically works in the same way as the cam controls described in US 5,318,584 and EP 1 034 740 AI.
• An essential difference, however, is that the drive rotor (50) does not have to be turned back during the tensioning of the drive spring (31). Therefore, on the one hand a very simple design of the lancing curve or the lancing profile (61) selected and on the other hand, the entire rotation angle of 360 ° for the implementation of the rotational movement of the drive rotor (50) in a translational movement of the lancet holder (20) and an associated lancet (20). 91).
• the clamping device according to the invention preferably constructed according to the OWADAC principle (One Way Alternating Drive and Cocking), as disclosed in EP 1 384 438 AI, to which reference is made in this regard.
• the end of the drive spring (31) facing away from the drive rotor (50) is braced against an input-side gear element designed as a helical clamping bolt (80), which is used to tension the drive spring (31) in the same direction of rotation when the drive rotor (50) is locked is rotatable, in which the drive rotor (50) during the
• Einstichterrorism rotates. During the puncture movement of the helical clamping bolt (80) is locked against a reverse rotation, so that the drive rotor (50) after release of the its rotation preventing locking device performs the rotational movement, which is converted into the puncturing movement of the lancet (91).
• FIG. 11 shows a perspective view of the removal device (1) shown in FIG. 1a with attached lancet magazine (90) but without housing (10).

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• 2010
  • 2010-04-30 EP EP10004578A patent/EP2382921A1/de not_active Withdrawn
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