Puncture instrument

p0001The invention relates to a lancing device having the features specified in the preamble of claim 1.

p0002To remove for analytic-diagnostic purposes, a small amount of body fluid, such as blood and / or interstitial fluid from a body part, such as a finger, lancets are used, which are engraved to generate a puncture wound with a lancing device in the corresponding body part.

p0003To enable efficient and painless as possible for collecting samples, usually can be adjusted the lancing depth and thus adapted to the individual requirements of a user in the lancing devices. The penetration depth should the one hand, be large enough to provide a sufficiently large amount of body fluid, on the other hand be as low as possible to avoid unnecessary pain.

p0004From the <patcit id="pcit0001" dnum="EP1427327B1"><text>EP 427 327 B1 1</text></patcit> is a puncturing device, in which the position of a stop inside the device can be adjusted, the clocking a pricking movement and so limits the stroke occurring during a pricking movement to what is necessary for a desired penetration depth. This has the disadvantage that when stopping a lancet vibrations can be caused by a stroke, leading to painful transverse movements of the lancet.

p0005From the <patcit id="pcit0002" dnum="US6022366A"><text>US 6022366</text></patcit> is a puncturing device, in which can be customized to adjust the penetration depth, the length of the lancet holder. For this, however, where a cap has to be removed, which is troublesome for many users. In addition, there is a danger that violate a user of a lancet in the device.

p0006From the <patcit id="pcit0003" dnum="US20070055298A1"><text>US 2007/0055298 A1</text></patcit> a puncturing device is known in which a screwed end cap is used for lancing depth adjustment. This end cap forms a support member having an opening for application to a body part in which a puncture wound is to be generated. By rotating the cap screwed it moves in the puncture direction relative to the puncturing drive of the device, so that a desired penetration depth can be adjusted. A disadvantage here, however, is that a gap forms between the cap and the device housing when the cap to reduce the penetration depth by a screw in the puncture direction is moved away from the housing. Such a gap is difficult to clean. In addition, it collects easily on dirt.

p0007Object of the present invention is to show a way of how to realize an adjustment of the lancing depth in a lancing device without the aforementioned disadvantages.

p0008This object is achieved by a puncturing device with the features specified in claim. 1 Advantageous developments of the invention are subject of the dependent claims.

p0009In a lancing device according to the invention an adjustment of the penetration depth is achieved by changing the position of the support member relative to the puncturing drive. Advantageously, therefore, be carried out independently of the required penetration depth at each lancet puncture the same stroke. A premature stopping of a lancet, which could cause painful vibrations, thus can be avoided.

p0010The support element of a lancing device according to the invention is secured by a thread rotation and stitch direction movable to an intermediate piece which is rotatably movable relative to the housing. Therefore, a setting of a desired lancing depth can be even for users whose manual mobility is restricted by age or illness, make easy by the intermediate member is rotated relative to the support element. This rotation causes a movement of the support element in the puncturing direction relative to the puncturing drive. As a result of this movement, the distance of the support element of the lancing drive and thus the set puncturing depth. Preferably, the rotary motion simultaneously causes a change in the distance of the support element of the housing. However, in principle it is also possible to mount the lancing drive movable in the housing, so that need not change during the rotational movement, the distance of the support element of the housing.

p0011By the spacer according to the invention can be avoided advantageous that a difficult created between the support element and the housing to clean gap in which dirt can accumulate.

p0012A rotational movement of the bearing element relative to the housing is prevented by a guide. By a rotary movement of the bearing element is prevented relative to the housing of the lancing device, the support element and in particular the opening of which always maintains the same orientation with respect to the lancing drive of the lancing device. This is for lancing devices, the drum magazine containing a plurality of lancets work important, because each time the opening of the support element has to be positioned in alignment with the coupled respectively to the lancet drive lancet of the drum magazine for a stitch.

p0013The guide can be for example an exhibit in the puncturing direction extending guide element which is arranged between two stops against which it is movable in the piercing direction. The guide member may be formed for example as a lug or spring on the support element. It is also possible that the stops are formed on the support element and a rigidly mounted to the housing guide member protrudes between these stops.

p0014A lancing device with a receiving compartment for a drum magazine is known for example from <patcit id="pcit0004" dnum="EP1669028A1"><text>EP 1669028 A1</text></patcit> known that is made in this respect by reference to the present application, in particular with respect to possible configurations of a drum magazine and a co-operating with him lancing drive. Preferably, the receiving compartment is arranged in a lancing depth adjustment device formed by the support element and the intermediate piece.

p0015The thread by means of which the support element is rotatably attached to the intermediate piece may be provided on the support element and / or on the intermediate piece. It is sufficient to provide at one of these two parts a groove or notch, forming a thread. As a counter-thread is sufficient in itself, a single projection which engages in this thread. However, in order to prevent tilting and terminals is advantageous more such projections, in particular, provide three projections, for example, engage the threaded cam in the thread.

p0016Preferably, the support element is seated at least in part in the intermediate part, which can be configured for example as a sleeve. The smaller the set puncturing depth, the further protrudes the support element of the intermediate piece. By the support element is surrounded by the intermediate piece, the lancing device can be better cleaned. is preferred here that the support element is situated on a major part of its length at setting a minimum penetration depth of the intermediate piece.

p0017Preferably, the lancing device, a rail for attaching to a measuring instrument on, as from the <patcit id="pcit0005" dnum="EP1032307B1"><text>EP 032 307 B1 1</text></patcit> is known. A gauge with an infected piercing device forms a system with which a user can obtain a body fluid sample and evaluate. Such a system can advantageously be operated with one hand, to win by one stitch a sample and then evaluate, for example, for measuring the glucose concentration.

p0018Further details and advantages of the invention will be explained on an exemplary embodiment with reference to the accompanying drawings. Show it:<dl id="dl0001"><dt>Figure 1a:</dt><dd>an embodiment of a lancing device according to the invention</dd><dt>Figure 1b:</dt><dd>an embodiment of an associated measuring device;</dd><dt>Figure 1c:</dt><dd>a schematic sectional view of the <figref idrefs="f0001">figure 1a</figref> shown lancing device with an attached meter;</dd><dt>Figure 1d:</dt><dd>an exploded view to <figref idrefs="f0001">figure 1a</figref>;</dd><dt>Figure 2:</dt><dd>a the piercing depth adjusting device of the lancing device;</dd><dt>Figure 3:</dt><dd>a sectional view to <figref idrefs="f0003">figure 2</figref>;</dd><dt>Figure 4:</dt><dd>a side view to <figref idrefs="f0003">figure 2</figref>;</dd><dt>Figure 5:</dt><dd>a sectional view of the piercing depth adjusting device with retracted support element;</dd><dt>Figure 6:</dt><dd>a side view to <figref idrefs="f0003">figure 5</figref>;</dd><dt>Figure 7:</dt><dd>the piercing depth adjusting device in an exploded view; and</dd><dt>Figure 8:</dt><dd>a sectional view to <figref idrefs="f0003">figure 7</figref>,</dd></dl>

p0019The <figref idrefs="f0001">1a</figref> and <figref idrefs="f0002">1d</figref> show an embodiment of a puncturing device 1 with an associated drum magazine 2, in which a plurality of lancets are included. 4 The puncturing device 1 has a housing 3, which in a<figref idrefs="f0001 f0002">figure 1</figref> a puncturing drive 5 shown surrounding. Suitable piercing drives, which can be lancet in a pricking movement move are well known in the art and therefore require at this point no further explanation. Particularly advantageously, in particular rotor drives can be used, is where tensioned by rotating a clamping element 5 a drive spring 5b which a drive rotor 5c is added at a stitch in rotation, having a cam 5d, 5e via a coupling mechanism, a feed motion of a lancet holder 5f causes of a lancet 4 of the drum cartridge 2 so that a puncture wound is produced in a voltage applied to the opening 12 of the device body portion advances and then retracts.

p0020The puncturing device 1 further includes an indexing mechanism 6, with an inserted drum magazine 2 can be rotated stepwise, can be such that the annular array in him lancet 4 successively aligned with the opening 12 and used for a stitch.

p0021The puncturing device 1 has on one side a rail 7 at which it at an in <figref idrefs="f0001">figure 1b</figref> shown gauge 8 can be attached. <figref idrefs="f0001">1c</figref> shows a schematic sectional view of the measuring device 8 with attached lancing device 1. As seen in <figref idrefs="f0001">1c</figref> see, the puncturing device 1 is inserted for attachment to the gauge 8, so that the rail 7 engages in a matching recess of the measuring device eighth

p0022The gauge 8 has a display device 9 for displaying measurement results and controls 22 for operating. The meter 8 may be formed in other such commercially available devices for measuring the glucose concentration of a blood sample and, for example, working with test elements that allow a photometric or electrochemical concentration determination. By the pricking device 1 is attached to the measuring device 8, created a system that can be operated with one hand to perform a trick for collecting samples and then take a sample obtained by a measurement.

p0023The peculiarity of the puncturing device 1 illustrated in the <figref idrefs="f0003">Figures 2-8</figref> Piercing depth adjusting device shown 10 to the piercing depth adjusting device 10 includes a support member 11 with an opening 12 for application to a body part, in which a puncture wound is to be formed, and an intermediate piece 13, on which the supporting element 11 by means of an in <figref idrefs="f0003">figure 7</figref> Thread represented 14 is attached rotatably movable and in the puncture direction. Advantageously can be in this way, the penetration depth also conveniently set when the lancing device is attached to the 1 meter. 8

p0024In the illustrated embodiment, the intermediate piece 13 is fastened to a carrier 15, which is detachable from the appliance housing the third However, in principle it is also possible to integrate the carrier 15 in the housing 3 and to attach the intermediate piece 13 directly on the housing 3rd

p0025A rotational movement of the intermediate piece 13 relative to the supporting element 11 causes because of the forces acting between these two parts thread 14 that the support element 11 is moved in the puncturing direction. Since the puncturing drive produces the same lancet with each stitch movement, resulting in an increased distance of the rest element 11 of the housing 3 and the support 15 a reduced penetration depth. on the other hand the distance between the supporting element 11 and the housing 3 and the carrier 15 therefore, the supporting element 11 is reduced, screwed deeper into the intermediate piece 13, results in an increased penetration depth. In the<figref idrefs="f0003">Figures 2 to 4 </figref>is the piercing depth adjusting device 10 in a setting for a low penetration depth, in the <figref idrefs="f0003">Figures 5 and 6</figref> shown in a setting for a high penetration depth.

p0026In the illustrated embodiment, comprises between the support member 11 and the intermediate piece 13 operating threads 14 a groove in the support element 11. In this groove, engage projections 16 on the inner side of the intermediate piece 15 a. However, in principle it would also be possible to provide corresponding projections 16 on the supporting element 11 and to provide the intermediate piece 15 with a complete thread.

p0027The piercing depth adjusting device 10 has, 17b, the rotational movement of the support member 11 prevents a linear guide 17a relative to the carrier 15 and hence also relative to the housing 3rd This guide 17a, 17b is formed by a stitch extending in the direction of guide element 17a which is aged in the manner of a tongue-and-groove joint between two stops 17b, against which it is movable in the piercing direction. In the illustrated embodiment, the guide member 17a is formed as a nose which engages in a matching recess of the support 15th

p0028The guide 17a, 17b causes the eccentrically arranged opening 12 of the support element 11 always maintains the puncturing drive contained therein regardless of the set puncturing depth their orientation with respect to the housing 3 and thus with respect and consequently the particular intended for use lancet of a set drum magazine is aligned to the opening 12th

p0029The trained as a sleeve adapter 13 is locked to the ring-shaped support 15th This latching is done in the illustrated embodiment by engagement of one or more projections 18 of the carrier 15 into an annular groove 19 of the intermediate piece 13. Thus the intermediate piece 13 relative to the carrier 15 is rotatable and simultaneously fixed in the axial direction. It is also possible to connect the Zwischenstück13 means of a further thread rotatably to the housing. Preferably, in this case, the thread, by means of which the support element 11 is rotatably attached to the intermediate piece 13, is opposite to the second thread, by means of which the intermediate piece 13 rotatably connected to the housing 3, is, for example, via the carrier 15, respectively.

p0030The carrier 15 is removable from the housing 3 of the puncturing device 1 to replace a drum magazine 2 in a dedicated storage compartment of the puncturing device. 1 In the illustrated embodiment, the drum cartridge 2 is arranged in the piercing depth adjusting device formed by the carrier 15, the intermediate part 13 and the support element 11th

p0031In the embodiment shown, the carrier 15 is latched to the housing 3 and has for this purpose corresponding locking elements 20, which are formed in the illustrated embodiment as recesses into the appropriate locking elements of the housing 3rd On its underside the housing 3 facing the carrier has an indentation 15 to 21, into which a fixing element of the housing 3 to 15 to hold the carrier against rotation in a predetermined position on the housing 3rd

<u>numerals</u>

p0032<dl id="dl0002" compact="compact"><dt>1</dt><dd>puncturing device</dd><dt>2</dt><dd>drum magazine</dd><dt>3</dt><dd>housing</dd><dt>4</dt><dd>lancet</dd><dt>5</dt><dd>lancing drive</dd><dt>5a</dt><dd>clamping element</dd><dt>5b</dt><dd>driving spring</dd><dt>5c</dt><dd>drive rotor</dd><dt>5d</dt><dd>Steuerkurve</dd><dt>5e</dt><dd>coupling mechanism</dd><dt>5f</dt><dd>Lancet holder</dd><dt>6</dt><dd>Indexing mechanism</dd><dt>7</dt><dd>rail</dd><dt>8th</dt><dd>gauge</dd><dt>9</dt><dd>display</dd><dt>10</dt><dd>Piercing depth adjusting device</dd><dt>11</dt><dd>supporting element</dd><dt>12</dt><dd>opening</dd><dt>13</dt><dd>connecting piece</dd><dt>14</dt><dd>thread</dd><dt>15</dt><dd>carrier</dd><dt>16</dt><dd>head Start</dd><dt>17a</dt><dd>guide</dd><dt>17b</dt><dd>guide</dd><dt>18</dt><dd>projections</dd><dt>19</dt><dd>groove</dd><dt>20</dt><dd>locking element</dd><dt>21</dt><dd>indentation</dd><dt>22</dt><dd>controls</dd></dl>