KR101104658B1 - Piercing system - Google Patents

Abstract

The present invention relates to a puncture system for obtaining a bodily fluid sample, comprising: at least one magazine (1) having a lancet carrier (4) carrying a plurality of lancets (5), and a compartment for such a magazine (1), Incremental forward mechanism for sequentially moving the lancet 5 contained in the magazine 1 inserted into the compartment to the puncture position, and a puncturing drive for accelerating the lancet 5 positioned at the puncture position for puncture movement. It relates to a puncture system comprising a puncture device having (11). According to the invention, the magazine 1 has a coupling arrangement 7 with a receptacle 8 movable with respect to the magazine housing 11 for the lancet carrier 4, which is carried by the lancet carrier 4. The lancet 5 can be moved relative to the receptacle 8 by actuating the incremental forward mechanism, which, in operation, transmits the driving force generated by the puncture drive 11 during the puncture in the puncture position. For delivery to the lancet 5, the puncture drive 11 is connected to a lancet 5 located in the puncture position.

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Description

Puncture system {PIERCING SYSTEM}

The present invention relates to a puncture system for obtaining a blood sample having the configuration described in the preamble of claim 1.

This type of puncture system, for example, requires checking its own blood sugar level several times a day and for this requires samples of body fluids, typically blood or interstitial fluid, obtained through puncturing wounds formed by the puncture system. It can be used by diabetics.

This type of puncture system includes a magazine having a lancet carrier carrying a plurality of lancets, and a compartment for this kind of magazine, an incremental advance for sequentially moving the lancet of the magazine inserted into the compartment to the puncture position. And a puncture device having a puncture drive for accelerating the lancet positioned at the puncture position for puncture movement.

In this type of puncture system, the transfer of force from the puncture drive to the lancet located at the puncture position must be made by an appropriate connection. Known coupling means are complex, require a lot of physical effort and require the manufacture of small tolerances, and therefore are expensive.

It is therefore an object of the present invention to invent a method by which a puncture system of the above kind can be produced which is cost effective.

This object is achieved by a puncture system having the features described in claim 1. Another advantageous aspect of the invention is the subject of the dependent claims.

In the puncture system according to the present invention, the puncture drive device is not directly connected to the lancet. Instead, the puncture drive is connected by the magazine's coupling facility to the lancet located in the puncture position, which, in operation, connects the puncture drive to the lancet located in the puncture position. By this measure, the physical effort associated with connecting the lancet drive to the lancet to be used for puncture can be reduced.

For example, the coupling arrangement of the magazine may already be connected to the puncture drive upon insertion of the magazine into the magazine compartment of the puncture drive. Correct positioning of the coupling arrangement with respect to the lancet or lancet carrier positioned in the puncture position can already be achieved during the manufacture of the magazine, so that the coupling arrangement of the magazine can be connected to the lancet without any contribution of the user. Particularly in the case of ribbon lancet carriers, it is possible to reliably connect the puncture drive with very little effort, thus accelerating the lancet for puncture movement.

The coupling arrangement is preferably connected to the lancet carrier such that the lancet carrier is moved with the lancet carrier during the puncturing movement. The transmission of the driving force generated by the lancet drive to the lancet located at the puncture position from the coupling arrangement is made very easily via the lancet carrier. This is because the lancet carrier can maintain a defined position relative to the coupling arrangement even during operation of the incremental advance mechanism used to transfer the lancet to the puncture position prior to use of the lancet carrier. Therefore, the coupling arrangement can be connected to the lancet carrier for another puncture with relatively little effort after each operation of the incremental forward mechanism, or even permanently connected to the lancet carrier, even during operation of the incremental forward mechanism, ie connected to the lancet carrier. Can be. Similarly, a reliable connection between the coupling mechanism of the magazine and the puncture drive can also be realized with little effort, since the movement of the lancet carrier by the incremental forward mechanism is coupled to the puncture drive and the magazine couple. This can be done without affecting the ring installation. This means that the part involved in the connection of the puncture drive must be repositioned with a great deal of effort after each puncture or that the correct positioning and connection must be ensured by complex and costly measures after each actuation of the incremental advance mechanism. It is advantageous in that it does not require.

Other details and advantages of the present invention will be described based on exemplary embodiments and with reference to the accompanying drawings. The features described herein can be the subject of the claims, alone or in combination. In the same or equivalent parts of the various exemplary embodiments, the same reference numerals are used in the drawings.

1 is a schematic plan view of one exemplary embodiment of a magazine comprising a ribbon lancet carrier having a plurality of lancets.

2 shows one exemplary embodiment of a lancet carrier having a lancet and a test field.

3 is a side view of the magazine of FIG. 1 in a pre-puncture state.

FIG. 4 is a view according to FIG. 2 being punctured. FIG.

FIG. 5 is a schematic detail view related to FIG. 3.

6 is a cross-sectional view of details of another exemplary embodiment of a magazine.

FIG. 7 is a schematic detail of another exemplary embodiment of a magazine coupling arrangement having a ribbon lancet carrier. FIG.

FIG. 8 is a detailed view according to FIG. 7 being punctured. FIG.

9 is a perspective view according to FIG. 7.

10 shows one exemplary embodiment of a puncture device.

* Explanation of Codes *

1 magazine

2, 3 rollers

4 lancet carrier

5 lancet

6 test field

7 Coupling Equipment

8 Receptacle for lancet carrier

9 Coupling Element / Bristle

10 sled

11 puncture drive

12 pressurized elements

13 pivot points

14 spring elements

15 connection member

16 coupling surface

17 opener

20 puncture device

21 device opening

22 operating elements

23 Display Fixtures

1 shows a magazine 1 comprising two rollers 2, 3, on which the ribbon-shaped lancet carrier 4 schematically shown in FIG. 2 is unwound. In this relation, the first roller 2 carries a section of the lancet carrier 4 with the lancet 5 before use, and the second roller 3 moves the area after the use of the lancet carrier 4. To carry. When the illustrated magazine 1 is inserted into the magazine compartment of the puncture device (not shown), the use of the lancet carrier 4 to sequentially transfer the lancet 5 included in the magazine 1 to the puncture position. The second roller 3 on which the later zone is wound is driven by the incremental forward mechanism of the puncturing device. In the puncture position, once puncture movement is initiated by the puncture drive of the puncture device, the lancet is positioned to form a puncture wound on the part of the user's body that is pressed against the lancet 5, and the diagnosis is made through the puncture wound. A bodily fluid sample can be obtained for the purpose. By operating the incremental advance mechanism (not shown), the driven roller 3 of the magazine 1 can be rotated to the extent that the lancet 5 reaches the puncture position for puncture before use of the lancet carrier 4. have.

According to FIG. 2, the lancet 5 is arranged on the ribbon lancet carrier so as to be transverse to the longitudinal direction of the carrier. There is one test field 6 between two lancets 5, each test field for testing a bodily fluid sample obtained through a puncture wound. For photometric determinatino of analyte concentration, the test field 6 may contain test chemicals that change color with concentration. However, it is also possible to set up a test field 6 for electrochemical or spectroscopic testing of body fluid samples.

As shown in the top view of FIG. 1 and the side view of FIGS. 3 and 4, the magazine 1 has a coupling arrangement 7, and the lancet 5 carried by the lancet carrier 4 is adapted to the operation of the incremental forward mechanism. It is movable with respect to a coupling installation by this. In operation, the coupling arrangement 7 connects the puncture drive of the puncture device to the lancet 5 located in the puncture position. In this way, the coupling arrangement can transmit the driving force generated during the puncture by the puncture drive 11 to the lancet 5 located at the puncture position. In the embodiment shown, the coupling arrangement 7 connects the puncture drive of the puncture device to the lancet carrier 4 so that during the puncture, the lancet carrier 4 is moved together with the lancet 5 in the puncture position. .

The coupling arrangement 7 has a receptacle 8 for the lancet carrier 4. In the embodiment shown, the receptacle has the form of a slit. The receptacle 8 is part of a sled that can be driven in the direction of puncture with respect to the magazine housing. Via the receptacle 8, the coupling arrangement 7 is permanently connected to the lancet carrier 4. Therefore, it is advantageous that the coupling arrangement 7 remains connected to the puncture drive even during operation of the incremental advance mechanism, so that mechanical adjustment of the incremental advance mechanism is not required.

During the puncture, the coupling arrangement 7 is driven by the lancet driving device from the position shown in FIG. 3 in the puncturing direction to the position shown in FIG. 4 in the advanced state, and then returned to the position shown in FIG. 3 in the return movement. For connection to the puncture drive, the coupling arrangement 7 has a coupling element 9 in the form of a peg in the exemplary embodiment shown, which coupling element is a corresponding coupling element of the puncture drive. And positive fit.

The driving force generated during the puncture by the connected puncture drive results in a movement in the puncture direction of the coupling arrangement 7 comprising the tape section of the lancet carrier 4 located in the slit 8. A bending arrangement (not shown), which can optionally be placed in a magazine or puncture device, results in the bending of the lancet carrier tape 4, as shown in FIG. 4. Thus, the tip of the lancet 5 positioned at the puncture position is lifted from the surface of the ribbon lancet carrier 4 and the body of the user contacted against this tip without interference by the ribbon lancet carrier 4. You can puncture some. The bending arrangement can be provided, for example, in the form of two fork prongs standing obliquely with respect to the puncture direction, between which the lancets protrude during the puncture, so that the fork prongs can lift the lancet carrier ribbon on both sides next to the lancet. Restrain and bend.

After puncture, the incremental advance mechanism of the puncture device can be operated to position the test element 6 of the ribbon lancet carrier 4 in the slit 8 of the coupling arrangement 7. By reactivating the puncture drive, the test field 6 can be moved towards the puncture wound created by the previous puncture, and the test field 6 can take a bodily fluid sample.

5 schematically shows the details of the coupling arrangement 7 of the embodiment described above. As is apparent from FIG. 5, the wall of the receptacle 8 in the form of a slit is covered with obliquely standing fibers, for example bristles 9. The bristles are arranged so that their free ends are oriented at an angle with respect to the return direction. Thereby, the lancet carrier 4 can be better retracted together with the coupling device 7 by a puncture drive connected to the lancet carrier and held by the bristle 9 during the return movement of the coupling device 7. . Thus, in the exemplary embodiment shown, the coupling arrangement 7 is provided with a lancet carrier (through a structured coupling surface having a resistance as a function of the direction of relative movement with respect to the relative movement of the lancet carrier 4 with respect to the coupling surface). 4) Contact with

Since the structured surface only results in increased friction in the direction of the return movement, this kind of coupling surface hardly or obstructs the transport of the lancet carrier 4 caused by the incremental forward mechanism. However, during the return movement, in the exemplary embodiment shown, the coupling surface of the receptacle 8, ie the structured surface of the opposing side wall of the slit 8, provides for improved adhesion of the lancet carrier 4 within the receptacle 8. Cause. Therefore, the lancet carrier 4 can be retracted quickly, together with the coupling arrangement 7, and the lancet 5 carried by the lancet carrier 4 can be withdrawn from the puncture wound just created.

The structured surface with such advantageous properties is not only by the fibers 9 shown in FIG. 4, but also by other projections, ridges or recesses of the coupling surface of the receptacle 8 in contact with the surface of the lancet carrier 4. Can also be obtained.

The structured surface according to FIG. 5 can be obtained, for example, by coating of staple fibers oriented in parallel. The fibers 9 are fixed to the fixed layer. The fibers are oriented at an angle of 30 ° to 90 °, preferably 45 ° to 75 ° with respect to the coupling surface of the receptacle 8. In this relationship, the fiber is inclined toward the bottom of the slit, i.e. in the direction of the return movement, and therefore inclined in the direction in which a force is applied to the lancet carrier 4 by the coupling surface 8 as shown in FIG. have.

The transport of the lancet carrier 4 between the two coupling surfaces with this kind of structure advantageously proceeds with less friction. In addition, the insertion of the ribbon lancet carrier 4 into the receptacle 8 causes only minimal friction. However, if the lancet carrier 4 is to be moved against the oblique direction of the fiber 9, these fibers are even stuck in the smallest uneven position, thus suppressing the lancet carrier 4. For example, a flock fiber film can be used as a structured coupling surface with inclined fibers 9 and applied to the coupling installation, in particular to the coupling installation by means of an adhesive.

Suitable flock fiber films can be produced, for example, as follows. Polyester films, such as polyester films consisting of Hostaphan RN50 from Mitsubishi Polyester Film of Wiesbaden, are coated with a conductive adhesive such as Mecoflock D453 / 5-09 from Kissel + Wolf GmbH of Wiesloch, Germany. The adhesive layer is then flocked to 1.7 dtex and 0.5 mm in length polyamide floc using an Ero-Mini flocking device from Maag Flockmaschinen GmbH of Gommeringen, Germany. Flocks of this kind are available from Swissflock, Stuttgart, Germany. Immediately after flocking, the film is pulled through, for example, a calender whose roll gap is set to 360 μm. As a result, the fibers have an oblique orientation. After drying, the floc layer is cleaned by vacuuming loose fibers. The fibers then have an angle of about 45 ° with respect to the polyester film in the rolling direction. The fibers are averaged and in particular oriented perpendicular to the rolling direction.

Another option for the manufacture of a suitable flock fiber film is to alternately bend the plastic film up and down alternately, for example at a distance of 10 mm, such that each kink has an angle of 100 ° to 140 °, for example 120 °. (parallel-bend). The floc is then applied to the film similar to that described above, but the film is not subsequently transported through the roll gap. This is because, due to the inclination of the film zone, the fibers shoot in an oblique orientation to the adhesive, so that they are positioned at an angle of about 60 ° to 70 ° relative to the film.

The groove of the coupling arrangement 7 shown in FIG. 5 can have a width of, for example, 0.8 mm. The flock fiber film can be adhered to the wall of the slit, for example using an epoxy adhesive, with the fiber 9 facing the bottom of the slit according to FIG. 5.

6 shows another exemplary embodiment of a magazine 1 with a coupling arrangement 7. Similar to the magazine 1 shown in FIG. 1, the magazine 1 shown in FIG. 6 includes a ribbon lancet carrier 4 in which a plurality of lancets 5 according to FIG. 2 are arranged. This magazine 1 is essentially different from the previous embodiment described above only in the design of the coupling arrangement 7, which, in operation, punctures the driving force generated by the puncture drive during the puncture. For delivery to the lancet 5 located in position, the puncture drive of the puncture device is connected to the lancet carrier 4.

The coupling arrangement 7 comprises a sled 10 formed to be movable relative to the magazine housing 11. The sled 10 has a coupling element for connecting the recess 9, which is coupled with the puncture drive 11 by a peg, to the puncture drive of the puncture device, so that the sled 10 is puncture drive. It can be moved in the puncture direction by the driving force generated by the device 11.

For connection to the lancet carrier 4, the coupling arrangement 7 shown has a receptacle 8, through which the lancet carrier 4 is guided. The receptacle 8 is a coupling surface 16 fixedly disposed on the sled 10, and is movable relative to the coupling surface 16 and clamps the lancet carrier 4 in the receptacle during puncture and puncture and return movement. After this is completed, it is formed by the pressing element 12 which releases the lancet carrier.

The pressing element 12 is formed on the sled 10 so as to be rotatable about the pivot point 13. The spring member 14 presses the rear end of the pressing element 12 against the connecting member 15 formed integrally with the magazine housing 11 in the illustrated embodiment. Moving the sled 10 in the puncturing direction causes the rear end of the pressing element 12 to move along the connecting member 15, thereby causing the pressing element to rotate so that its front end is coupled to the couple of the sled 10. A closing movement can be made to press against the ring surface 16, as a result of which the lancet carrier 4 is clamped between the coupling surface 16 and the front end of the pressing element 12. Thus, the coupling arrangement 7 of the illustrated exemplary embodiment is held in such a way as to clamp the lancet carrier 4 during the puncture and release the lancet carrier after the puncture and return movement is completed. When the lancet carrier 4 is clamped in the receptacle 8, it is possible to quickly and reliably retract the lancet carrier 4 during the return movement, so that the lancet carried by the lancet carrier can be quickly pulled out of the produced puncture wound. This is important for punctures with as little pain as possible.

In the embodiment shown, the clamping force for clamping the lancet carrier 4 is achieved by a spring element 14 which presses the rear end of the pressing element 12 against the connecting member 15, the connecting member being punctured. It defines the closing movement of the pressing element 12 during the movement.

7 to 9 show another embodiment of a coupling arrangement 7 which can be used instead of the coupling arrangement 7 described and shown above, for example in the case of the magazine 1 according to FIGS. 1 to 6. Similar to the coupling arrangement 7 shown in FIG. 6, the coupling arrangement 7 shown in FIGS. 7 to 9 holds the lancet carrier 4 in a clamping manner during puncture, and after the puncture and return movement is completed, the lancet Release the carrier. Thus, FIG. 7 shows the coupling arrangement 7 in the pre-puncture state in which the lancet carrier 4 is released. In FIG. 8, the lancet carrier 4 is clamped by the coupling arrangement 7, ie it is shown according to the obvious situation during puncture. 9 is a perspective view of a part of the coupling device 7 shown in FIGS. 7 and 8.

Similar to the embodiment shown in FIG. 6, the coupling arrangement 7 of the embodiment shown in FIGS. 7 to 9 includes a sled 10 which can be driven in the puncture direction and which carries the receptacle 8. The lancet carrier 4 is supplied through the receptacle. The puncture direction is indicated by the dotted arrow in FIG. 8. The receptacle 8 for the lancet carrier 4 can be formed, for example, in the form of a slot.

The receptacle 8 interacts with the pressing element 12, which presses the lancet carrier 4 against the coupling surface of the receptacle 8 during the puncture and thereby clamps the lancet carrier. The clamping force for clamping the lancet carrier 4 is achieved by a spring element 14, which is formed of the same part as the pressing element 12 in the exemplary embodiment shown. The spring element 14 interacts with the opener 17, which is arranged in a fixed position relative to the magazine housing (not shown) in the illustrated embodiment, and may be formed in the form of a protrusion of the magazine housing, for example.

If the sled 10 is in the starting position shown in FIG. 7 before puncture, the opener 17 is pressed against the spring element 14, thereby opening the receptacle 8. The lancet carrier 4 can then be moved into the receptacle 8 perpendicular to the puncture direction by actuating the incremental advance mechanism (not shown). Moving the sled 10 in the puncturing direction causes the spring element 14 to move away from the opener 17, causing the spring element to clamp the lancet carrier 4 within the receptacle 8. Thereby, the spring force exerted by the spring element 14 presses the lancet carrier 4 against the coupling surface of the receptacle 8.

The spring element 14 can be made of plastic material at low cost. However, it is also possible to manufacture the spring element 14 from metal.

10 shows an embodiment of a puncture device for taking a bodily fluid sample. The puncture device 20 has an opening 21 in which a body part is pressed against this opening to form a puncture wound. The puncturing device 20 also includes an actuating element 22 in the form of a key and a display arrangement 23 in the form of a liquid crystal display for displaying the test results. The puncture device 20 has a part (not shown) for accommodating the magazine 1, which includes a lancet carrier 4 which carries a plurality of lancets 5. An exemplary embodiment of a magazine 1 of this kind is shown above through FIGS. 1 to 9. The compartment of the illustrated puncture device 20 has an opening that can be closed and is located on the rear side of the illustrated puncture device 20.

A measurement and analysis facility (not shown) may be integrated into the puncture device 20 shown and used to determine the analyte concentration of the bodily fluid sample. For this purpose, a body fluid sample is taken after the puncture wound is formed by the test field 6 (see FIG. 2) of the lancet carrier ribbon 4 included in the inserted magazine 1. Sampling is performed by operating the incremental forward mechanism to position the test field 6 of the lancet carrier ribbon 4 under the device opening 21. When the puncture drive is actuated again, the lancet carrier 4 can be moved in the puncture direction together with the test field 6, so that the test field 6 is opposed to the device opening 21 to collect a body fluid sample. And against the puncture window of the pressurized body part.

The puncture device 20 shown in FIG. 10 and the magazine 1 described with reference to FIGS. 1 to 9 together form a puncture system.

Claims (14)

As a puncture system for obtaining a bodily fluid sample, At least one magazine 1 having a lancet carrier 4 carrying a plurality of lancets 5, and A compartment for such a magazine (1), an incremental forward mechanism for sequentially moving the lancet (5) contained in the magazine (1) inserted into the compartment to a puncture position, and a puncture position for puncture movement In the puncture system comprising a puncture device having a puncture drive device (11) for accelerating the lancet (5), The magazine 1 has a coupling arrangement 7 with a receptacle 8 for the lancet carrier 4, the receptacle 8 being movable with respect to the magazine housing 11, and on the lancet carrier 4. The lancet 5 carried by it can be moved relative to the receptacle 8 by actuating the incremental forward mechanism, which, in operation, acts upon the puncturing position generated by the puncturing drive 11 during puncture. Connect the puncture drive 11 to the lancet 5 located at the puncture position, for delivery to the lancet 5 located at The pierce system characterized in that the lancet (5) is oriented transverse to the longitudinal direction of the lancet carrier (4). The puncture system according to claim 1, wherein the lancet carrier (4) is ribbon-shaped. The lancet carrier (4) according to claim 1, characterized in that the lancet carrier (4) carries a test field (6) for testing a body fluid sample obtained from a puncture wound, said test field being arranged between the lancets (5). Puncture system. 4. The coupling arrangement (7) according to any one of the preceding claims, wherein the coupling arrangement (7) is connected to the lancet carrier (4) and moves the lancet carrier together with the lancet (5) located in the puncture position during the puncture. Puncture system, characterized in that. The puncture system as claimed in claim 4, characterized in that the coupling arrangement (7) remains connected to the lancet carrier (4) during the operation of the incremental forward mechanism. 4. The puncture system according to claim 1, wherein the coupling arrangement (7) remains connected to the puncture drive (11) during the operation of the incremental advance mechanism. 5. 4. The coupling device (7) according to any one of claims 1 to 3, characterized in that the coupling device (7) grasps the lancet carrier (4) during the puncture and releases the lancet carrier again after the puncture and return movement is completed. Puncture system. The puncture system as claimed in claim 7, characterized in that the coupling arrangement (7) comprises a spring element (14) which achieves a clamping force for clamping the lancet carrier (4). 4. The puncture system according to claim 1, wherein the coupling arrangement (7) is in contact with the lancet carrier (4) via a structured contact surface (16). 5. 4. The coupling arrangement (7) according to any one of claims 1 to 3, wherein the coupling arrangement (7) is made of fibers (9) which are inclined obliquely in the direction of the return movement performed by the lancet (5) after the advance step during the puncturing. A puncture system, characterized in that it is in contact with the lancet carrier (4) via the conveying contact surface (16). 10. The structure of claim 9 wherein the structured contact surface 16 resists relative movement of the lancet carrier 4 and the coupling surface 16 with respect to each other, the resistance being dependent on the direction of relative movement. Puncture system. A magazine for puncture device for obtaining a bodily fluid sample, comprising a lancet carrier (4) for carrying a plurality of lancets (5), and a puncture drive (11) for accelerating the lancet (5) contained in the magazine for puncture movement. In a magazine (1) for a puncture device, which can be inserted into a puncture device having a), the magazine (1) has a coupling arrangement (7) for connecting the lancet carrier (4) to the puncture drive (11) of the puncture device. And the coupling arrangement 7 has a receptacle 8 for the lancet carrier 4, the receptacle 8 being movable relative to the magazine housing 11, the receptacle 8 exerting a driving force in the puncture position. The driving force is generated by a puncture drive 11 connected to the receptacle 8 during the puncture, the lancet 5 transverse to the longitudinal direction of the lancet carrier 4. Puncture, characterized in that Magazine for the device. A puncture device for obtaining a bodily fluid sample, comprising: a compartment for a magazine (1) having a lancet carrier (4) carrying a plurality of lancets (5), a lancet (5) contained in a magazine (1) inserted into the compartment; In the puncturing device including an incremental forward mechanism for sequentially moving to the puncture position, and a puncturing drive 11 for accelerating the lancet 5 positioned at the puncture position, the puncturing drive 11 is a puncturing device. The lancet carrier 4 via the coupling arrangement 7 of the inserted magazine 1 so as to accelerate the lancet 5 positioned in the puncture position and oriented transversely with respect to the longitudinal direction of the lancet carrier 4. The puncture device, characterized in that the installation is connected to. 11. The contact surface (16) according to claim 10, characterized in that the contact surface (16) resists relative movement of the lancet carrier (4) and the coupling surface (16) with respect to each other, the resistance being dependent on the direction of the relative movement. Puncture system.

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