Blood sampling system

0001The invention relates to a blood collection system for evulsing blood for diagnostic purposes.

0002In order for analytical and diagnostic purposes, a small amount Blood from a body part (usually a finger or the refer earlobe), lancets are used, required to produce a wound in the corresponding body part are engraved. Unless this is done manually, specially trained personnel required. Still the puncture is associated with considerable pain.

0003Already blood sampling systems have long been used, consisting of a lancing device and associated, for the respective Apparatus specially adapted lancet exist. In a housing of the lancing device is a lancet drive, by a lancet mechanically in the Skin is pierced. As a drive element for the puncturing movement is a spring. At the beginning of the development were very simple constructions in use, in which the lancet directly at one end of in an elongated housing arranged compression spring was attached (Eg US Patent 4,469,110).

0004Such blood sampling systems, however, were the high Requirements do justice, to be complied with when regular monitoring of certain analytic is blood values ​​required. This applies in particular for diabetics who control their blood sugar levels frequently should order through adjustment of insulin injections to the needs (depending on the food intake, physical activity varies greatly etc.) their glucose levels continuously possible within certain Set limits to keep. through scientific Studies, it was shown that by means of an intensive therapy with at least four blood analyzes per day dramatic decrease severe late complications of diabetes mellitus (eg retinopathy with resulting Blindness of the patient) can be achieved.

0005This intensive therapy requires that the blood is connected with the least possible pain. With the aim in this respect to achieve an improvement, were numerous different blood collection systems developed.

0006requires the blood by means of a blood collection system two basic functions:<ul><li>First, the lancing device must by tensioning the drive spring placed in the puncture-ready state will. This is known as "Span" phase.</li><li>Thereafter, the triggering of the lancet drive is, the relaxation movement of the drive spring to Puncture the lancet drives. This is called "forward phase" designated.</li></ul>

0007In previous blood systems presented the puncture phase the kinematic reversal represents the tensioning phase. With In other words: The tensioning of the drive was made easy characterized in that the lancet in the puncture after successful Starting position has been pushed back, in the tensioned spring was.

0008Better results, in particular with regard to a possible slight pain, with simple operation, be achieved with blood collection systems whose lancet drive is designed so that the two functions decoupled are:<ul><li>In a tightening phase, the movement of an actuator a tensioning device on an input side Coupling mechanism such on the transmitted power spring that this is tensioned.</li><li>In a forward phase is the relaxation movement the drive spring by means of an output-side coupling mechanism transfer such to the lancet, that such the puncturing motion at high speed performs.</li></ul>

0009The two coupling mechanisms are usually made at least partially different elements. Anyway, the movement sequences in both phases are different (Not only a kinematic reversal of the other phase).

0010Such blood sampling systems are, for example, from following publications known:<sl><li>(1) US Patent 4,442,836</li><li>(2) US Patent 5,318,584</li><li>(3) US Patent 6,409,740</li><li>(4) US Patent 6,419,661</li><li>(5) EP 1254632 A1</li></sl>

0011Despite the extensive development work that the described in these documents and numerous other have resulted in structures, there is great interest at a blood collection system that the difficult and partially contradictory requirements (minimal Pain, easy operation, compact, possible slim design and easy, cost-effective design) simultaneously as far as possible fulfilled.

0012To fulfill this requirement, according to a first Main aspect of the invention provides a blood collection system, comprising a housing having an outlet opening for the Tip of a lancet in the housing along a predetermined piercing path is movable, and a lancet drive with a drive spring and a tensioning device proposed, wherein the clamping means comprises a Actuator includes the input side via a Coupling mechanism such with the drive spring is coupled to receive a tensioning phase of the movement the lancet drive during movement of the clamping element is tensioned and the drive spring by a output-side coupling mechanism such with the Lancet is coupled to the lancet in a forward phase the movement of the lancet drive during the relaxation movement of the drive spring at high speed on the predetermined puncture in the puncture direction is moved until its tip to produce a wound from the outlet orifice emerges. It is is characterized in that the actuating element the clamping device with a web control, as Members of train control, a control track part and a comprises control cam, is coupled, wherein the control cams during at least part of the clamping phase, a Relative movement with respect to the control track part makes in he leaves the control path of the control track part and characterized at least a part of the movement of the lancet take-off is controlled.

0013According to the invention - in addition to the coupling mechanisms, on the transfer of force from the tensioning element the drive spring (clamping phase) or by the drive spring on the lancet (forward phase) cause - a path control mechanism provided. This additional Path control mechanism with the actuating element coupled to the clamping device and controls at least Parts of the movement of the lancet drive. He has two Parts, referred to as the links of the path control be, namely a control track part and a control cam. The control action based on the fact that during the movement of the lancet drive train, the control part and the control cam in such a way to cooperate with the lancet drive, that a relative movement of the control cam with respect to the control path takes place, in which the control cams follows the control path, ie it "leaves" and characterized a control function of the lancet drive into the Tensioning phase and / or is effected in the injection phase.

0014The required management of the control cam along the Control path can through different constructive measures be achieved. The control path can of a groove are formed in the control track part whose width so is matched to the dimensions of the control cam, that this is precisely guided in the control path. The controlling Effect can also be achieved in that the Control path is designed as a sliding surface, which against the Control cam is pressed under spring action. In each Case, one of the members with the actuating element of the Tensioning device coupled in the sense that it with this move together synchronously. The coupling can be rigid or flexible, and in the case of a mobile Coupling conventional coupling elements, such as Lever for connection of the actuating element of the Clamping device with the ( "input side") of the member be continuous path control, with which it is coupled used can. Preferably, this input-side member is the Control path portion while the output-side member of the Train control (which is coupled to the lancet drive so is that the controlling effect of the path control transmits on these), preferably by the control cams is formed.

0015The relative movement of the control cam with respect to the control track portion can be obtained by different combinations of realized movement of the two members of the Rail Control will. For example, on a Part the relative movement of the control track part to be moved, while the control cam - in relation to the housing of the Lancing device - is stationary. In other sections can the shutdown of the control track on a motion of Control cam based in stationary control track part. Finally, both members of the Rail Control be moved simultaneously. Details are each of the Individual case depends. Preferably, the control track part at least during at least part of the desired control action moved in translation, during the movement of the control cam preferably at least partially runs on a circular path.

0016The actuating element of the clamping device is in the Usually implemented as a tension knob, the rear of the (The piercing opening opposite) end of an elongated Housing projects and normally Press with the thumb is pressed. The invention is However, also for use with other operating elements the tensioning device suitable, for example a along the housing wall movable slide or a by pulling movable actuator which, for example, are formed by the rear housing part can. Subsequently, without loss of generality by way of example reference is made to a tension knob.

0017The path control, of the tensioning of the lancet drive (Ie for power transmission between the tension knob and the lancet drive) necessary mechanical isolated elements, but with the clamping knob of the lancet drive is coupled, allows the realization of advantageous features:<ul><li>Characterized in that the path control of a hand, with the coupled tension knob of the lancet drive, on the other hand but by the power transmission is independent, it is possible the tightening knob (next to the tensioning of the Lancet drive) additional functions, such as triggering the propulsion phase (puncturing movement) or the removal of a used lancet allocate from the lancing device. Thus a "One-button operation" possible.</li><li>The web control can be used to defined to implement intermediate positions the tension knob, which intermediates of the handling of the blood lancet system characterize and thus provides users with clear Notes on the state (for example, "relaxed" "Tense" give).</li><li>It is possible by means of a provided in the control path "Reversal section" a pushbutton-like to realize operation of a tension knob, as is explained further below in more detail.</li><li>explained with the help of also in more detail below Disposable portions of the control path, it is possible ensure that these only in a direction is run through and thus a certain sequence of without unwanted repetitions to achieve steps. An important example is a "Spannwiederholsperre" by a multiple tensioning of the drive is prevented.</li></ul>

0018According to a second main aspect, the compound preferably in is used with the first main aspect, however, also has independent significance, the invention is directed a blood collection system with the above-explained general characteristics, the Lanzettenauswerfmechanismus a includes a release element, which is mounted in the housing so that it is between a Passive position and an active position is adjustable, wherein in the active position of the activation element of Lanzettenauswerfmechanismus is activated so that by Operation of an operation knob of Lanzettenauswerfmechanismus a used lancet from the housing is removed, and in the passive position of the activation element the Lanzettenauswerfmechanismus is passivated, so that actuation of the operation knob not to Ejecting a lancet leads that in the puncture direction front end of the housing to the piercing opening of a cap is formed for use for removing Lancet is removable, the mounted state Kappe.im such cooperates with the release element, that it is in the passive position and the release element when the cap is removed in the active position is adjusted.

0019The term "ejection" is common to to refer to a combination of mechanical elements, by the total removal of the lancet from the Lancing device possible by moving an actuating button is, without having to touch it. "Eject" in this Sense does not mean that the lancet in removing is accelerated from the device. Rather, it is in the Generally considered to be advantageous if only one in the puncturing device known lancet holder by the Ejection is opened, so that the lancet falls by gravity.

0020Through the second main aspect of the invention is achieved, that the ejection mechanism is inoperative, as long as the cap at the front end of the housing of Lancing device is attached. Characterized in that it only at the Removal of the cap is activated, possible incorrect operation prevented. It is also possible, the tension knob of the lancet drive simultaneously as to use operating knob of the ejector mechanism, without its other functions, for example by a limitation of the possible movement path impaired will. Again, this is more detail below explained.

0021Both aspects of the invention are preferably lancet systems used whose lancet drive a driven by the drive spring to a rotatable axis Drive rotor includes, in the forward phase of the lancet drive, the drive rotor, by the driven drive spring, performs a rotational movement, by means of the output-side coupling mechanism into the Puncturing motion is implemented. Such rotor drive is used for example in the lancet systems, in the documents cited above (2), (3) and (4) are described.

0022Particularly preferably the present invention is in Conjunction with a special rotor drive used, of the non-prepublished EP 1384438 A1 (and the equivalent patent applications US 10 / 445.606 and JP 149780/2003) will be described. In this earlier application Referring in the sense that their content in full made peripheral to the content of the present application becomes.

0023The rotor drive described therein underlying the facing away from the drive rotor end of the drive spring against a rotating movable clamping element from which to Tensioning of the drive spring with inhibited rotation of the drive rotor is rotatable in the same direction, in the the drive rotor rotates during the forward phase. The clamping element is compared during the forward phase a reverse rotation is locked, so that the drive rotor after release of the locking rotational movement carried out, in means of the output-side coupling mechanism the puncturing movement of the lancet is implemented. Thereby resulting in a drive in which the said elements whilst the clamping phase and during the forward phase alternating are rotated in the same direction. This Principle is called "<u>O</u>ne <u>W</u>ay <u>A</u>lternating <u>D</u>rive <u>A</u>nd <u>C</u>ocking, Soon OWADAC designated ".

0024The invention is described based on the figures in Embodiments illustrated explained in detail. The illustrated and described specific features can be used singly or in combination to preferred Embodiments of the invention to provide. Show it:<dl tsize="7"><dt>Fig. 1</dt><dd>a partially cutaway perspective Representation of a blood collection system of the invention; </dd><dt>FIG. 2</dt><dd>a perspective view of a drive module of in the blood system Lancet drive used shown in FIG. 1;</dd><dt>Fig. 3</dt><dd>an exploded perspective view of Components of the module of Fig. 2;</dd><dt>Fig. 4</dt><dd>a perspective view of a module FIG. 2 in a partly assembled State;</dd><dt>Fig. 5</dt><dd>a perspective view of a lancet holder the blood collection system in accordance with Figure 1;</dd><dt>Fig. 6</dt><dd>a perspective view of a Drive module according to FIG. 2 and a lancet holder FIG. 5 existing subunit Blood lancet system according to Figure 1;</dd><dt>Fig. 7</dt><dd>a perspective view of a portion of the blood collection system shown in Fig. 1 from the other side ( "control side") ago;</dd><dt>Fig. 8</dt><dd>a control track part and a drive rotor Cam in a perspective-exploded representation;</dd><dt>Fig. 9</dt><dd>a side view of parts of an ejector with a release element in Passive position;</dd><dt>Fig. 10</dt><dd>a side view of parts of an ejector with a release element in active position</dd></dl>

0025The blood collection system 1 shown in the figures consists of a puncturing device 2 and lancets 3. The holder and guide a lancet 3 in the lancing device 2 is shown in FIG. 7 A lancet holder 4 embraces with retaining tongues 4a to a lancet body 5 designated the rear of the lancet. From the lancet body 5 projects a lancet tip 6 forward out.

0026During the lancing process the lancet holder 4 means of serving as a guide (not shown) Housing part out and thus ensures indirectly for required guidance of the lancet on a predetermined Puncturing (here along the main axis A of the lancing device 2). In this case, the lancet is indirectly out by means of the lancet holder. 4

0027However, the invention is also applicable to lancing devices, in which the lancet "done directly", that is to directly in the required leadership during the puncturing movement forming part of the housing (for example, a magazine comprising a plurality of lancets contains) is. Here, too, can more information EP 384 438 A1 are taken 1.

0028In the housing 8 of the lancing device 2 is a located Lancet drive 9, which serves a lancet with high speed in the puncture direction (arrow 10) move until its tip from a discharge port 11 exits while the piercing device 2 with the outlet opening 11 surrounding contact surface 12 against a not shown body part is pressed. Thereby is a wound in the body part for the withdrawal of blood generated. The housing 8 of the lancing device has an elongated Form. The end at which the outlet opening 11 is located, is defined herein as front end, the opposite End called rear end. The front End of the housing 8 is of a removable cap 7 formed.

0029Figures 1 to 6 illustrate the features of construction the lancet drive 12 for the power transmission during the tensioning phase and during the forward phase required are. During the clamping phase the applied to a tension knob 14 by means of a force total with 13 designated clamping device to a (Here integrated in a drive module 15) drive spring 16 transferred to tighten these. During the Forward phase relaxes the drive spring 16 and thereby driving a drive rotor 17, the rotational movement turn in the translational puncturing motion the lancet holder 4 is reacted. This power transmission is true in the present invention with the EP 1384438 A1 match.

0030Components of the drive module 15, the drive rotor 17 and a clamping element 19, about a common axis C are rotatable, which is perpendicular to the puncturing direction 10 and extends to the longitudinal axis A of the lancing device. 2

0031For tensioning of the lancet drive 9, the translatory movable clamping knob 14 and with him a power transmission part 20 pressed in the puncturing direction 10th A Rack 21 is part of the power transmission part 20 and drives a coaxial with the clamping element 19 pinion 22 at. The pinion 22 is connected to the clamping element 19 via a free wheel 23 in such a manner that both parts during the clamping movement (movement of the force transmitting member 20 coupled together in the puncturing direction), however, at the return of the power transmission member 20 and the cocking button 14 under the action of a return spring 14a decoupled. In the illustrated embodiment the freewheel 23 means of two elastic Tongues 24 realized, which is connected to the pinion 22 are. The tongues 24 are located in one of the drive rotor 17 facing away from the recess 25 of the clamping element 19 with stops 27, at which the ends of the tongues 24 in the coupling direction (in Figure 2 in a clockwise direction) bear, while in the reverse direction the pinion 22 rotate relative to the clamping element 19 free can.

0032By the rotation of the clamping element 19, the drive spring 16 excited, the form of a helical spring is facing and in a the drive rotor 17 recess 28 of the clamping element is mounted 19th The power transmission part 20 with the rack 21, the pinion 22, the freewheel 23 and the clamping element 19 together form an input-side coupling mechanism 29, through the in the tension phase, the force exerted on the tension knob 14 Power is transmitted to the drive spring 16th

0033The output-side coupling mechanism 30, through the the force of the spring 16 in the forward phase to the lancet is transferred 3, includes a cam 31 a, which is formed by a circumferential groove 32nd The Cam 31 has in the illustrated case the shape of an eccentric to the axis C circuit. It is during the rotation of the drive rotor 17 by a control pin 33 worn, the part of the lancet holder 4. For fixation of a lancet, the lancet holder 4 resilient arms 35 and a stop member 36 whose shape as the corresponding shaping the lancet body 5 is tuned so that the lancet 3 in an exactly reproducible longitudinal position is held in the lancet holder. 4

0034The rear end of the lancet holder 4 with the control pin 33 engages in a peripheral slot of the drive module 15 a such that the rotational movements of the Components of the module 15 are not hindered. Around ensure this, in the illustrated embodiment a blade 37 made of metal, the on a plateau 38 of the drive rotor 17 such bears, that between it and the radially outward from the Cam 31 lying parts of the rotor 17, a circumferential Nip with the required width for the lancet holder 4 remains. In the illustrated embodiment the lancet drive 9 run its movement phases OWADAC according to the principle as follows:<ul><li>During the clamping phase rotates the rotatable Clamping element 19, driven by the tightening knob 14 via the power transmission member 20 by the rack 21 and the pinion 22 in a predetermined Direction (in Figures 1 and 2 in the clockwise direction), the drive spring 16 is tensioned, while the Rotation of the drive rotor 17 (by means of the following further explained trigger mechanism) inhibited is.</li><li>In the forward phase, the drive spring 16 drives the Drive rotor 17 (after releasing the inhibition), while simultaneously the clamping element 19 (for example by means a in a recess of the clamping element 19 engaging not shown elastic jack) is locked against reverse rotation.</li></ul>

0035Figures 7 to 9 show the essential design features the path control 40 and the ejector 41, which, based on the drive rotor 17 located on the side of the piercing device 2, in the Figure 1 recognizable drive side 42 opposite and called control side 43rd

0036The members of the path control 40 are a control track part 45 and a control cam 46 which is shown in Embodiment as to the drive rotor 17 fixed Pin is formed. Characterized in that the control cams on the drive rotor is fixed 17, he can only refer to move a circular path around the axis C. The drive spring 16 exerts a (in proportion to its state of stress different strong, but always rectified) torque to the drive rotor 17 and thus on the control cam 46 (in the figures clockwise) out.

0037In the assembled state, the drive rotor 17 sits such at the control path portion 45, that the control cam 46 in a control track 47 of the control track part 45 is (in Figure 8 is such a control position of Control cam 46 indicated by dashed lines). A relative movement the control cam 46 with respect to the control track part 45 resulted in part when the control track part 45 moved parallel to the longitudinal axis A of the lancing device 2 is, on the other hand by the movement of the control cam 46 on a circular path around the axis C. The translational motion the control track part 45 results from that is coupled to the tension knob 14th In the illustrated preferred embodiment, the control path portion 45 and the force transmission member 20 with the rack 21 produced in one piece and bent approximately in a U-shape, so that in the installed position, the two legs of the U extend on the two sides of the drive module 15, Namely, the power transmitting member 20 on the drive side 42 and the control track part 45 on the control side 43. The rear end of the interconnected Components 20, 45 is mounted such on the clamping knob 14, that both parts upon actuation of the cocking button 14 are uniformly moved in translation.

0038As a result of the actuation of the cocking button 14, and the tension effect the drive spring (with resultant rotational movement the drive rotor 17) drives the control cam 46 broken lines drawn in Figure 8 control path 47 from that impressed by in the control track part 45 Control profiles 49, 50, 51 defined. The most important Functional positions of the control path in Figure 8 with in letters, to which the following Explanation relates:<sl><li>a) This is the starting position in which the cam 46 is when the lancet drive is unstrung and the tension knob 14 furthest from the housing 8 protrudes. is the axis C of the drive rotor 17 thereby a1 in the position.</li><li>b) Here is the control cam 46 in a pocket 52 of the control profile 50, which is adapted that the control cam 46 in only one direction (in moved out continuation of the previous movement) back can be. The defined by the pocket 52 Section of the cam track 47 is a disposable portion 53 denotes, because the control cam when it is inserted into the disposable portion 53, only in one direction can be moved out again, so that a relative movement of the control cam 46 with respect to the control track part 45 via the one-way section 53 addition, only in a path direction of the control path 47 is possible. This is a security feature realized because a multiple tensioning of the lancet drive, which could lead to damage, is prevented.</li><li>c) Upon further pressing the tension knob 14 (and resulting forward movement of the control track part 45) reaches the control cam 46 under the action the spring force of the drive spring in this position before a formed by the control profile 51 barrier wall, the another pressing the tension knob prevented.</li><li>d) By releasing the tension knob 14 and a resulting Movement of the control track part 45 rearward passes the control cam in this position, the a represents stable intermediate position in which the Lancet drive for triggering, ie the start of the Forward phase, is ready. The tension knob located thereby in a position from the starting position (Corresponding to the control track position a) differs significantly and in addition (for example, by a colored mark on the shaft of the tension knob 14) can be marked. This the user sees clearly that the device is in the tensioned and user-ready state. The portion of the control path between the positions c and e represents a reversal section 54th through the U-shaped sections of this chapter, the Control cam 46 only after prior to the movement counter-rotating relative movement with respect to the Control part 45 moved out of the reversing section 54 will. This allows a pushbutton-like Actuating the tension knob with a stable Intermediate position. </li><li>e) By again depressing the cocking button 14 passes the control cam 46 in this position, in which the contact between the cam 46 and the Control track part 45 is interrupted. Control cam is free, so that the drive rotor 17 fast can perform rotational movement about the rotor axis C, which is located at this time in the position e1. The tension knob 14 fulfills therefore a Dual function for tensioning and triggering.</li><li>f) The rotational movement is terminated when the control cam 46 in this position again in contact with the Control track part 45 (here the control profile 49) comes.</li><li>g) 14a under the action of the return spring of the Winding knob 14 and with it the control track part 45 again moves backward, the control cam via this position will get back to the starting position. The position g again marks a disposable portion 55, in which the control cam in a Pocket 56 is located, through which a movement sequence counter to the predetermined direction of the control path 47 is prevented.</li></sl>

0039In the figures 8 to 10 are the total of the central parts to detect with 41 designated ejection, the embodiment of the illustrated in the Tightening knob 14, the control track part 45 and a release element 61 there. These components are shown in Puncturing direction 10 (and thus in direction of the axis A the device) mounted translationally and form a power transmission chain, indicated by the arrow 70 and is symbolized by the movement of a Operating knob of Lanzettenauswerfmechanismus on is the lancet holder 4 transmitted such that the Lancet 3 is released and by gravity from the Holder 4 may fall out. In the illustrated embodiment is the operating knob of Lanzettenauswerfmechanismus simultaneously the actuator of Tensioning device, ie the tension knob 14. While this is not essential, but especially preferred. A total of is thus a triple function of a single Operating knob (prime, trigger, eject) possible.

0040The release of the lancet is in the illustrated embodiment achieved in that on the activation element 61 trained sliding tongues 62 between the elastic Tongues 4a of the lancet holder 4 and an obliquely outwardly extending abutment 63 of the lancet holder are pressed. 4 Thereby, the holding tongues 4a forced apart and release the lancet. 3

0041As long as the removable cap 7, which of the front end Housing 8 forms, is placed, is the Lanzettenauswerfmechanismus 41 passivated, ie the operation of the Tension knob 14 does not lead to eject the lancet. When removing the cap 7 of Lanzettenauswerfmechanismus goes 41 over to the active state.

0042Switching between active and passive state achieved by a change in position of the activation element, which is illustrated in Figures 9 and 10. FIG. In Figure 9 is the enabling element in the passive position, in the power transmission chain 70 between the Tension knob and the lancet is interrupted: The cap 7 contains a phantom shown in Figure 9 abutment 64, against the front end of a to the release element 61 trained actuating piece 65 suppressed as long as the cap is fitted. This a pressure piece 68 of the activation element against a fixed device in Figure 9 only schematically indicated inclined surface 69 pressed. The release element is in the in Figure 9 Horizontal position shown held. A Displacement of the front end of the control path portion 45 according to arrow 66 is not on the enabling element 61 transferred because both parties do not engage with each other come.

0043Conversely, when the cap is removed 7, eliminates the Pressure of the re-bearing 64 on the actuating piece 65 and the release element 61 is under the action of a Leaf spring 67 to the position shown in Figure 10 brought. In this position, the rear End of the activation element 61 in the sliding path of the Control track member 45 so that its forward motion (at Actuating the tension knob 14) to the safety disconnection element 61 and is thus transmitted to the lancet.