HK1131953B - Actuation means, packaging system and a cartridge containing the packaging system - Google Patents

Description

Packaging system, packaging box with same and actuator

Technical Field

The present invention relates to a packaging system containing disposable medical devices and a packaging strip having a plurality of storage compartments containing disposable medical devices. The present invention is also directed to actuators and packages for use in packaging systems.

Background

Disposable medical devices such as lancets, test strips and the like used for sampling fluids such as blood for quantitative chemical analysis of blood samples need to be packaged to avoid damage to the disposable medical parts before use and to maintain their sterility. In addition, single-use disposable medical devices require inexpensive and disposable medical device packaging.

Packaging strips meeting these requirements can be found in us patent 4,328,184. Packaging strips are known which comprise a plurality of storage compartments with mutually placed tops and containing disposable medical devices. The strip comprises a continuous base sheet and a continuous cover sheet, both sheets being transparent polyethylene film sheets. The base sheet and the cover sheet overlap each other with the plurality of disposable test elements sandwiched at equal intervals therebetween. The base sheet and the cover sheet around each test element are joined by heat sealing to form a storage chamber for mounting the test elements.

One disadvantage of the known packaging strip is that it is very difficult and cumbersome to use the disposable medical elements for decapsulation. To unpack the disposable medical components, a section of the packaging strip containing the storage compartment for the disposable medical components is torn, and the cover layer is peeled or torn away from the base layer. This is particularly difficult for those who suffer from impaired hand dexterity, as well as those who are diabetic and/or older and therefore use disposable medical elements such as lancets, test elements, etc. several times a day.

In addition, when using packaging strips in integrated devices, such as lancing devices or analytical devices, the process of detaching the disposable medical elements in known packaging strips from their packaging is rather complicated. The disposable medical elements of such robots are usually stored in a disc or drum magazine which is inserted into the robot and contains the disposable medical elements. In operation, such a hand-held device automatically removes a disposable medical element, such as a lancet, a test element, etc., from the cartridge and punctures with the disposable medical element, such as with a lancet, or analyzes a body fluid, such as blood, with the test element.

Several prior art methods for storing and automatically using lancets and test elements in medical test devices, such as for testing the glucose content of a body fluid, are known. The lancet is typically placed in a cartridge assembly and the test element is placed in a tape or pack. Both assemblies are inserted into a medical analysis device to form a relatively integrated, integrated system.

In addition, the lancet can be placed on the tape like a test element. However, in order to achieve a smaller radius of curvature and a smaller package volume, the needles are fixed to the web in a direction perpendicular to the longitudinal direction of the web. If the lancet is fixed at one end to the tape, the tape must be moved in a direction perpendicular to the longitudinal direction of the tape while pricking the skin with the lancet when the lancet needs to be transported and handled after use. This can crease the tape, reducing the reliability of the system.

Disclosure of Invention

It is therefore an object of the present invention to provide an inexpensive method for packaging disposable medical devices. In addition, the disposable medical device should be easily removable from the packaging system of the invention.

These and other objects of the present invention are achieved by a packaging system and a packaging strip: the packaging system houses disposable medical devices and the packaging strip has a plurality of reservoirs containing the disposable medical devices and is folded along transverse fold lines to form a series of loops, each loop having opposed sections, at least some of the opposed sections of the loops being sealed to one another to form the reservoirs between the sections.

These objects are also achieved by a package comprising such a packaging system, wherein the package has a slot-shaped opening for pulling out one end of the packaging strip.

The packaging strip according to the invention can easily be made of a thin paper sheet or a thin plastic sheet. The packaging strip according to the invention is less expensive to manufacture than the packaging strip described in us 4,328,148, since it does not require base and lid sheets. According to the invention, the bottom and the top of the storage chamber for the disposable medical elements can be formed by a single sheet.

The loop of the packaging strip according to the invention is preferably arranged and sealed as follows: pulling on one end of the strap opens the loop and in turn opens the storage compartment. Preferably, the opposed sections of the loop are sealed to each other by an adhesive, particularly an adhesive that opens the storage compartment by unrolling the strip and tearing the sealed section. Suitable adhesives may be used for the adhesive labels which are easily removable from release paper or other smooth surfaces.

Drawings

The invention will be elucidated on the basis of an illustrative embodiment. The features may be used alone or in combination to give priority to the invention. In the figure:

FIG. 1 shows a packaging system assembly according to the present invention;

fig. 2 shows a packaging strip closing compartment according to fig. 1;

FIG. 3 shows the process of FIG. 2 in which the storage compartment is torn open;

FIG. 4 shows the reservoir of FIG. 1 with a disposable medical insert;

FIG. 5 shows the embodiment of FIG. 1 with the adhesive shelf;

FIG. 6 shows a package containing a wrapping strip according to the present invention;

FIG. 7 shows another embodiment of a packaging strip according to the invention;

FIG. 8 shows the package of FIG. 6 before the disposable medical item is pulled out;

FIG. 9 shows the package of FIG. 8 after the disposable medical item has been pulled out;

FIG. 10 shows the package of FIG. 8 with another embodiment of the disposable strip, wherein the disposable medical elements have not been pulled out;

FIG. 11 shows the package of FIG. 10 after the disposable medical item has been pulled out;

figure 12 shows the first step when the strip is pulled out of the pack and the step of unrolling the loop and opening the storage compartment;

FIG. 13 shows a second step after the step in FIG. 12;

FIG. 14 shows an alternative detail of FIGS. 6, 12 and 13 in a closed position;

FIG. 15 shows an alternative portion of FIG. 14 in an open position;

FIG. 16 shows a first step according to FIGS. 12 and 13;

FIG. 17 shows a second step according to FIGS. 12 and 13;

fig. 18 shows a third step according to fig. 12 and 13;

FIG. 19 shows a fourth step according to FIGS. 12 and 13;

fig. 20 shows a fifth step according to fig. 12 and 13;

fig. 21 shows a sixth step according to fig. 12 and 13;

fig. 22 shows a seventh step according to fig. 12 and 13;

fig. 23 shows an eighth step according to fig. 12 and 13;

fig. 24 shows a ninth step according to fig. 12 and 13;

fig. 25 shows a tenth step according to fig. 12 and 13;

FIG. 26 shows the first actuator in a first position;

FIG. 27 shows the actuator of FIG. 26 in a second position;

FIG. 28 shows a packaging system having three components;

fig. 29 shows the winding device according to fig. 28;

FIG. 30 shows another winding apparatus;

fig. 31 shows yet another winding device.

Detailed Description

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the illustrated embodiments and specific language will be used to describe the same. It is not intended to limit the scope of the invention. Any alterations and further modifications in the described embodiments are contemplated as would normally occur to one skilled in the art to which the invention relates, and such further applications of the principles of the invention as described herein are contemplated. For the sake of brevity, certain features not pertinent to the present invention that are readily apparent to those skilled in the art have been omitted herein, but one embodiment of the invention has been illustrated in greater detail.

Fig. 1 shows a schematic view of a packaging strip 1 comprising a plurality of storage compartments 2. The base material of the strip may be paper, plastic or a suitable synthetic material. The strip 1 is folded along the transverse fold line 5 to form a loop. Each loop is made up of opposed segments 3 and 4. To form the reservoir 2, the opposing sections 3, 4 of the loop are sealed to one another. A disposable medical device (not shown) such as a lancet or a chemical test element for body fluid analysis is placed in the reservoir 2, and preferably a desiccant is placed to keep the disposable medical device dry. The packaging strip 1 may also be adapted for use in an integrated disposable medical device comprising a lancet and an instrument, such as a test element, for taking a sample of body fluid from the puncture of the lancet to be used for analysis.

The adhesive 6 serves to seal the opposed sections 3, 4 of the loop to one another, thereby forming the reservoir 2. The adhesive 6 allows the storage compartment 2 to be opened by unrolling the strip 1, thereby tearing the opposing segments 3, 4 apart as shown in fig. 2 and 3. Suitable adhesives may be adhesive labels and release papers to which the labels have been affixed prior to use. The adhesive 6 forms a frame which constitutes the side walls of the storage compartment 2, i.e. three side walls 12, 13, 14. The fourth side wall of the storage compartment 2 is formed by a fold line 5.

Depending on the disposable medical elements stored in the storage chamber 2, the thickness of the frame should be between 0.5 and 3.0 mm, preferably between 0.8 mm and 1.5 mm. The frame, which may be formed with a short-curing adhesive as the adhesive to form the appropriate frame 6 forming the side wall of the reservoir 2, may be used as a separate piece which is in turn sealed to the opposed sections 3, 4 of the loop by a suitable adhesive. Such a frame may be made of plastic, paper or cardboard.

Fig. 2 is a schematic view of a packaging strip 1 closing a compartment 2. Fig. 3 shows the reservoir 2 of fig. 2 opened by tearing the opposing segments 3, 4 apart. This can be done by stretching the strip 1 in the direction of arrow F. The method of setting and sealing the loop of the strip 1 is as follows: when the strap 1 is subjected to a pulling force, such as securing one end of the strap and pulling the other end, the pulling force causes the loop to unfold and the storage compartments 2 to open in sequence. Generally, the following tension forces may be applied to strap 1, or forces may be present simultaneously: (i) the rear end, i.e. the beginning of the folding, of the strip 1 is fixed, while its front end is stretched forward, i.e. towards the end of the used and opened storage compartment; (ii) the front end is fixed, and the rear end is pulled backwards; and/or (iii) both front and rear ends are fixed and the strip moves in a direction perpendicular to the longitudinal direction of the strip. In all cases, the tension created by the stretching or movement of the strap 1 will open the storage compartment 2.

Fig. 4 shows the storage chamber 2 of fig. 1 with a disposable medical insert, i.e. a spike 21. The adhesive frame 6 is U-shaped and includes side walls 12, 13 and 14. The fourth, open side of the U-shaped frame is closed and sealed by the fold line 5 so that the storage compartment 2 is completely sealed.

Fig. 5 shows the storage compartment 2 of fig. 1 with an alternative rectangular adhesive frame 6, the fourth side wall 43 of which is closed and parallel to the fold line 5. In such an embodiment the accuracy of the manufacture of the strip 1 is less important than the accuracy of the fold line 5.

Figure 6 is a cross-sectional view of a package 10 containing the packaging strip 1 shown in figures 1-3. The package 10 has a slot-shaped opening 11, out of which one end of the packaging strip 1 protrudes. The strip 1 is pulled out of the package 10, which automatically opens the storage compartment 2, as shown in fig. 3.

In principle, opposite sections of each loop can be sealed back so that one section of the strip 1 acts as both the bottom of a first reservoir 2 and the top of an adjacent reservoir 2. But preferably only opposing segments of some loops, preferably every second loop, are sealed as shown in figure 6. The length of strip 1 thus forming the bottom of a reservoir is above the length of strip forming the top of an adjacent reservoir. In the example, a length of strap 1 can constitute either the bottom or the top of the storage compartment. So that the disposable unit 8 is always on the same side of the strip as the strip 1 is pulled from the package 10.

The disposable medical element is preferably secured to the bottom of the reservoir within the reservoir 2, i.e. to the front surface of the strip 1, by means of a releasable adhesive. In this way, after opening the storage chamber 2, the disposable medical device can always be accessed exactly at the same location. This facilitates the use of the packaging strip 1 in an automatic device which automatically removes medical devices, in particular disposable medical pieces such as lancets or test elements, and uses them for their intended purpose. Such handheld devices are used by people for analyzing body fluids such as blood or for lancing purposes, for example, diabetics may be used to detect their blood glucose levels.

But it is also possible to permanently fix the disposable medical element to the bottom of the reservoir, i.e. to the front surface of the strip, in the reservoir 2. Only a portion of the disposable medical elements may be secured, for example, only the rear end of the lancet 21 may be secured to the tape 1 to pierce the skin, so that the lancet 21 can both pierce the skin and be attached to the tape 1. This allows for the simultaneous operation and use of disposable medical elements such as needles 21 and associated tape 1, wherein tape 1 can be used as a manipulator to manipulate the disposable medical elements secured to tape 1. The disposable medical elements can be secured to the strip 1 in any suitable manner, for example, with a securing glue, a spray glue or an adhesive tape; clamping the disposable medical member in the tape layer; riveting disposable medical devices to thin strips, and the like. If necessary, sealing should be ensured.

As shown in fig. 1, the loops forming adjacent reservoirs 2 are secured to each other by a releasable adhesive, preferably with an adhesive patch 7 placed between the section 4 forming the bottom of the first reservoir and the section 9 forming the top of the second reservoir. This way, the packaging strip 1 is not accidentally unfolded and a secondary loop (closed loop) 15 is formed between the subsequent storage compartments 2. The loop stack may be supported by a compression spring 16 so that the top end can be lifted to close the package opening 11.

Fig. 7 shows another embodiment in which the storage compartments 2 of the packaging strips 1 do not overlap each other on top but are offset from each other so that they only partially overlap (see the lower part of fig. 7) or do not overlap (see the rest of fig. 7). In these embodiments, however, the strip 1 is also folded along the transverse fold line 5 to form a series of loops, and the opposed sections of the strip form the storage compartments 2 therebetween.

To meet sterility, humidity and other environmental requirements, while also enabling the storage and removal of disposable medical items such as test elements, lancets and the like, there are two main possibilities for the tape 1. The first possibility is to use a waterproof material or a finishing material for the strip 1. In this case, the package 10 does not necessarily need to be waterproof. Another possibility is to use a non-waterproof sheet for the strip 1. In this case, the waterproof package 10 is preferably used for storing the strip 1 with the unused disposable medical elements 8.

It has to be noted that in some embodiments of the invention, it is not preferred to place the disposable medical elements 8 in sequence at very close intervals, seen in the longitudinal direction of the unrolled strip 1, but rather a considerable distance between successive disposable medical elements 8 on the strip 1 is left, i.e. a sufficient length of the strip 1 is left between successive disposable medical elements 8. It is advantageous if the actuator 20 simultaneously moves the tape 1 and the disposable medical element 8, such as the lancet 21. The free portion of the strip 1 between successive disposable components 8 is available for movement of one of the disposable components 8 without interfering with another of the disposable components 8 in the immediate vicinity. In a practical embodiment, the distance between successive disposable medical elements 8 on the strip 1, i.e. the distance between adjacent reservoirs 2 on the unfolded strip 1, as seen in the longitudinal direction of the unfolded strip 1, may be in the range of 3-20 cm, preferably 5-10 cm.

Of course, the adhesive patch 7 can also be used to overlap the free portion of the strip 1 between successive disposable medical components 8 into a secondary loop, thereby resulting in a compact stack that occupies only a minimal amount of space in the package 10. In a preferred embodiment, the tape 1 can have alternating reservoirs 2 along its longitudinal direction containing two types of medical devices, for example, in one reservoir 2 an alternating reservoir 2 contains a lancet 21 and in the subsequent reservoir 2 a test element 44. Such an embodiment may be preferred for use in a glucose meter wherein the user is presented with alternating lancet needles 21 to make a puncture, and test element 44 is used to make a glucose measurement of blood previously taken with lancet needles 21.

The preferential manufacturing process of the packaging strip 1 according to the invention may comprise the following steps:

1. the disposable 8, i.e. the lancet 21, is placed on the longitudinal tape 1. Optionally, an adhesive may be used to secure it.

2. Tape 1 is folded to form reservoir 2 containing needles 21.

3. The folded strip 1 is sterilized, for example by applying gamma radiation.

4. The test element 44 is placed on the strip 1 and can be selectively fixed. Test elements, such as chemical test elements, are generally sensitive to gamma radiation and cannot be subjected to gamma radiation. In this way, the test elements are positioned after the strip 1 has been sterilized.

5. If desired, the test element may also be contained within the storage compartment 2 by folding the strip 1. This step is carried out if the test element needs to be contained in the storage chamber 2 due to moisture protection. If the strip 1 is stacked in a moisture-proof package, it is not necessary to fold the strip 1 to bring the test element into the storage compartment 1.

6. The strip 1 is cut into sections and the sections are packed into suitable packages.

Fig. 8 shows a packaging system according to the invention, in which the strip 1 comprises a secondary loop 15 formed between successive reservoirs 2, so as to ensure that the medical devices in the reservoirs 2 are located on the same side of the strip 1 and thus ensure that the actuators 34 remove the medical devices. Or the actuators 34 are easier to handle the medical device than when the medical device is located on different sides, e.g. alternating sides, of the strip 1.

Fig. 9 shows the situation in which strip 1 of fig. 8 is pulled out of packet 10, wherein, thanks to the presence of secondary ring 15, it is not necessary to turn the storage compartment of packet 10 over. Because of this feature, the package 10 may require less space. In addition, as can be seen from fig. 9, although the tension of the strap 1 is easily maintained after the storage compartment 2 is pulled out, it is easier to loosen the strap 1 remaining in the package 10 and the strap 1 in the package 10 becomes tangled.

Fig. 10, 11 correspond to fig. 8, 9, wherein the strap 1 does not have the secondary loop 15. It can be seen that the storage compartment 2 within the package 10 needs to be turned over when the strip 1 is pulled out of the package 10, and therefore the space required for packaging in the corresponding device is greater. As can also be seen in fig. 11, the strips 1 of the package 10 are easier to mix in this case.

Figures 12 and 13 show successive steps of drawing strip 1 out of package 10 shown in figure 6. The package opening 11 includes a movable door 35, and the movable door 35 presses the thin strip 1 to fix its position when closed, and allows the thin strip 1 to move when the movable door 35 is opened. The movable door 35 provides a gripping means for gripping the strap 1 in the direction opposite to the stretching direction to assist in opening the storage compartment for the strap 1. The strip 1 is pulled by the winding device 36, while the winding device 36 is also used for taking and handling the used strip 1 containing the used medical device. In fig. 12, one of the compartments 2 has been completely pulled out of the package 10, the flap 35 has been closed and the strip has been pulled out a little bit by the winding device 36. So that during the tearing off by pulling the thin strip 1 straight, the reservoir 2 has been opened from the right side to its half-stretched state, in which the adhesive patch 7 has been torn.

When the winding device with the movable door 35 in the closed state further stretches the web 1, the storage chamber 2 will continue to open until the storage chamber 2 is fully open as shown in fig. 13, so that the medical device, e.g. a needle 21, is released from the storage chamber 2 and lays flat on top of the web 1 ready for use. The strip 1, the fold line 5 and the reservoir 2 are preferably configured such that all medical devices lie flat on top of the strip 1 after the reservoir 2 is opened during the tearing off process. From this position, it is available for grasping the medical device or preferentially grasping the medical device with an automated actuator.

In the embodiment of figures 14 and 15, a strap retaining mechanism is provided adjacent the package opening 11, instead of the moveable door 35. This embodiment is preferably used in the following situations: the strip 1 used is already sealed, so that the package 10 itself and its opening 11 do not have to be closed in such a way that the flap 35 exerts a seal. It comprises a circular roller 41 and an eccentric 42, wherein the eccentric 42 can be driven by a transmission motor or by a spring, wherein the spring can be released by an actuator made of a shape memory metal actuator, such as nitinol. In fig. 14, the mechanism is in the closed position, wherein the stretching action on the strap 1 increases the clamping force. In fig. 15, the mechanism is in the open position, in which the strip 1 can be pulled out of the package 10.

Braking of the strap 1 can be carried out in two ways. The first option is that package 10 does not have a flap 35 and the strap 1 is braked using an additional external brake. Another possibility is to use a movable door 35, shown in fig. 12 and 13, which serves both to close the packet 10 and as a brake for braking the strip 1.

Fig. 16-25 show the sequence of pulling the first reservoir 2 of fig. 6 containing spike 21 out of the package for use as actuator 20 to perform the actuation step on spike 21 to obtain a blood sample from finger 45, to pull the second reservoir 2 containing test element 44 out of storage container 10, and to press test element 44 against the skin of finger 45 to collect blood. In figures 16-25, strip 1 in package 10 is wound on roller 46. The package 10 includes a movable door 35.

Fig. 16 shows the starting position. At which time the flap 35 is closed and the strap 1 is tensioned by the winding device 36.

In fig. 17, storage compartment 2 with lancet 21 has been pulled out of package 10 by the winding device with open shutter 35.

In fig. 18, reservoir 2 has been opened so that lancet 21 is deployed outside reservoir 2. To this end, the movable door 35 is closed and prevents further removal of strip 1 from the package 10. The winding device 36 continues to rotate, wherein the storage chamber 2 containing the lancet 21 is opened. Needles 21 lie flat on tape 1 and are secured to tape 1 at their rear ends by adhesive 47.

In fig. 19, the actuator 20 with the roller 28 lifts the needles 21 upwards by about 90 degrees from a direction parallel to the longitudinal direction of the tape 1. In the process, the flexibility of the tape 1 serves to lift the needles 21, wherein the needles 21 are fixed to one end of the tape 1 by adhesive. To take up sufficient slack in tape 1 to turn needles 21, winding device 36 can be reversed. The actuator 20 and roller 28 function in detail as shown in fig. 26 and 28. Which includes a linkage to move roller 28 to fold tape 1 back into loop 48 to move needles 21. Other actuators may be suitably used.

In fig. 20, the locating surface 49 is located under the finger. To do this, the entire actuator 20 or linkage is moved into the direction of the device opening 50, where the finger 45 will be placed or punctured. Actuator 20 is moved fully toward the skin to be pricked before the pricking step is performed with needle 21. At this point, the strip 1 is known to move until it contacts the skin. It is advantageous for both sterilization and for transporting the material for subsequent testing.

The positioning surface 49 against which the skin is pressed by means of the strip 1 has the following advantages: the length of the penetration of the needle 21 when pricking the skin is equal to the depth of penetration of the needle 21 into the skin. For this purpose, the skin is pressed against the positioning face 49.

In fig. 21, a finger 45 is pressed against the opening 50.

In fig. 22, lancet 21 is inserted into a finger 45 for skin pricking. In order to prick while still maintaining the pull of the strap 1, the roller is moved under the elastic force of the spring 51.

In FIG. 23, the squeezing is performed to express blood 52 from the punctured skin, and actuator 20 and the lancet have been retracted from finger 45.

In FIG. 24, the chemical test element 44 is accessed by opening the moveable door 35 and pulling the test element 44 out of the package 10 by the winding action of the winder 36, similar to the process shown in FIG. 17. If the test element 44 is positioned in the storage compartment 2 of the strip 1, the storage compartment 2 can be opened by a procedure similar to that shown in fig. 18, i.e. a procedure of closing the movable door 35 and winding the strip 1 with the winding device 36. Finally, test element 44 is positioned at a location below blood 52 to be tested.

In fig. 25, the chemical test element 44 is in contact with blood 52 expressed from a finger 45. To do this, the actuator 20 is moved into the direction of the finger 45. Thereafter, the test element 44 can be pushed forward by the strip 1 to an analysis device, such as an optical glucose measuring device. The entire process can then be performed starting with fig. 16 for the next lancet 21 and test element 44 of tape 1.

Fig. 26 shows an actuator 20 with a linkage for lifting the medical device from the storage compartment 2 of the opened strip 1. The actuator is applied to a needle 21 on the tape 1 which has been pulled out of the package 10. The needles 21 contained in the storage chamber 2 are oriented in the longitudinal direction of the tape, i.e. perpendicular to the transverse fold line 5. This is advantageous for further operation of the lancet 21 and the thin strip 1 shown in fig. 27, because the actuator 20 does not necessarily need to move the thin strip in a direction perpendicular to the longitudinal direction of the thin strip 1 when taking a blood sample with the lancet 21. The lancet 21 is preferably fixed at its rear end to the tape 1 and at its front end for piercing the skin. However, if the actuator 20 is adapted, the spike 21 can also be arranged in a direction perpendicular to the longitudinal direction of the strip 1.

Tape 1 carries needles 21 to a predetermined position. Which lies flat on a first link 22, wherein the first link 22 is connected to a second link 24 by a short coupling rod 23. The movements of the two links 22 and 24 are synchronized by means of the two sector gears 25 and 26. The link 22 has a longitudinal slot over approximately its entire length.

The first link 22 is slightly bent at its end and is connected to the third link 27 by a pin. The third link 27 is supported on a roller 28 slidable in the vertical direction. Furthermore, the third link 27 is connected to a rocker 29, and the rocker 29 is rotatably supported in a housing 30 of the actuator 20. The first link 22 or rocker 29 is engaged with a rotary drive (not shown) of the device. When the rotary drive is activated, the linkage is folded. In the folding movement, the first link 22, the rocker 29, the coupling rod 23 and the housing 30 together form a four-bar linkage. The meshing action of the sector gears 25 and 26 initiates movement of the second link 24. The right end of the second link 24 can also be guided by a groove in the case, in which there must be sufficient clearance so that no sticking occurs. During this folding process, the strip guide wheels 28 ensure that the strip 1 is drawn downwards.

Finally, the lancets with the slots are spun onto the cam 31, wherein the sharp grinding of the cam cuts the matrix material and embeds the slots of the lancets 21. The thin strip 1, together with the ends of the first link 22 and the second link 24, form a contact surface which serves as a reference surface for stabilizing the skin for the prick by the lancet 21. To do this, the entire mechanism is driven forward by a driver (not shown) until the reference surface 32 of the skin is compressed as necessary.

Referring now to fig. 27, cam 31 pushes lancet 21 into the skin and moves it back, i.e., the linkage of actuator 20 is used to perform the lancing motion of lancet 21, wherein the linkage is designed to rotate the medical device 90 degrees relative to its starting position shown in fig. 26 and tape 1. While cam 31 is driving lancet 21, roller 28 will swing to position 33 and back, thereby ensuring that the lancing motion is not impeded. In addition, the pulling force on the thin strip 1 to support the lancet 21 can keep the lancet 21 properly adjusted. During lancing, only a small thin strip section of skin pressure between lancet 21 and the fixed articulation of first link 22 will sag, and therefore sufficient space must be found for it to function properly without affecting the process.

Lancet 21 has a longitudinal slot 53 for its guidance on cam 31. Due to the tension of the tape 1, a straight guidance of the lancet 21 is obtained without the need for an additional guide at the front end of the lancet 21. Spike 21 can be of any suitable shape, such as flat or circular.

Two modes of operation of the actuator 20 are possible. In the first mode, lancet 21 only penetrates the skin for a short period of time, and the entire mechanism is then immediately withdrawn from the skin. The mechanism is then opened again to retrieve the test element from another storage compartment in stock, such as the packaging strip 1, and the folding mechanism is opened to deliver the test element to the skin for blood collection.

According to the second mode of operation, the test element already resides between the second link 24 and the third link 27, but still below the bottleneck between the first link 22 and the second link 24. In this condition, the prick motion looks slightly different. Spike 21 pierces and is withdrawn upwardly to a position of 0.5 mm. The entire mechanism is then slowly moved away from the skin, with lancet 21 collecting blood with the capillary tube open on the right.

The driver of thin strip 1 then pulls the test element slightly upward out of its resting position, fully closing the folding mechanism with a certain force, wherein the chemical layer is pressed against the capillary open side at the tip of lancet 21. This transfers blood from lance 21 to the test element. The folding mechanism is then opened and the test object is transported to the measurement optics.

One advantage of this mechanism is that: in the open state, all components above the web transport plane are sufficiently far from the pricking movement axis to transport the web 1 to a position directly below the extraction cone.

In another embodiment, no test element is engaged and actuator 20 can be used to perform only the lancing motion of lancet 21 without delivering blood to the test element.

While the actuator 20 shown in fig. 26 and 27 is preferably used in a packaging system according to the present invention, it may be used in a medical apparatus for manipulating a strip-carried medical device.

Overall, the actuator shown in fig. 16-27 has the following advantages: actuator 20 comprises a linkage mechanism for driving a disposable medical device longitudinally extending the packaging strip 1, wherein the medical device is placed on the packaging strip 1 in a direction parallel to the direction of extension of the strip 1 before being manipulated by the actuator 20, in particular for the actuator 20 described in the present application for use in a packaging system for folding the strip 1, characterized in that: the medical device is secured at one end to the packaging strip 1, for example by adhesive, the linkage being configured to move the medical device and the section of strip 1 secured thereby, the actuator 20 folding the strip 1 back into a loop 48 to move the medical device.

According to another preferred embodiment, the medical device is a lancet 21 and the linkage is designed to perform a pricking movement of the lancet 21.

According to yet another preferred embodiment, the linkage mechanism is designed to turn the medical device about 90 degrees into the unflexed position of the strap 1. For this purpose, the linkage is preferably provided with rollers 28, over which rollers 28 the strip 1 is guided with a certain tension in the longitudinal direction of the strip 1 in order to change the orientation of the medical device without tearing loads being applied to the strip or the medical device being fixed to the strip without bending the medical device. There is also an advantage that: actuator 20 comprises an elastic reservoir 54 for releasing packaging strip 1 with a certain tensile force in the longitudinal direction of packaging strip 1, so that the medical device can be turned without having to reverse the reel 55 of the winding device 36 on which the strip 1 is wound.

As shown in the figures, the linkage preferably includes a locating surface 49, the locating surface 49 providing the reference surface 32 for positioning the actuator 20 at a predetermined distance from the skin to be pricked by the actuator 20. In this embodiment, the strip 1 is preferably placed between the locating surface 49 and the skin to be pricked by the actuator 20.

According to another preferred embodiment of actuator 20, actuator 20 comprises a movement mechanism by means of which actuator 20 is moved towards the skin to be pricked by needles 21 of packaging strip 1 until packaging strip 1 is applied against the skin to be pricked before needles 21 perform the pricking.

The packaging system shown in fig. 28 comprises a packaging 37, which packaging 37 contains a fresh component 38, which fresh component 38 contains unused medical devices on the packaging strip 1, which packaging may be, for example, the packaging 10 shown in fig. 6, the actuating component 39 comprises an actuator for pulling the medical devices out of the fresh component, which actuator may be, for example, the actuator 34 shown in fig. 26-27, the reject component 40 is intended to contain used medical devices and the corresponding strip portions, and the reject component 40 further comprises a winding device 36 for facilitating the transfer of the strip 1 from the fresh component 38 to the reject component 40 by means of the actuating component 39. For example, a one-way clutch may be used to ensure that the winding device 36 does not reverse.

The package 37 can be easily inserted into a corresponding analyzing apparatus, for example, a blood glucose meter for pricking skin and measuring blood glucose. The desired medical device, such as spike 21 and/or an analytical instrument for receiving a blood sample, is received in strip storage chamber 2 in fresh assembly 38. They are fed one by one to the actuating element 39 for use by the analysis apparatus and are discarded in the reject element 40. The overall length of the strip 1 may be 5 cm. When all the medical devices in the storage chamber 2 have been used up, the entire package 37 is removed from the analysis apparatus and discarded.

FIG. 29 shows the winding device 36 equipped with a reel 55 for winding the tape 1 with used lancets 21 or used test elements 44. However, the winding device 36, i.e., the winding drum 55, does not necessarily have to be circular, but may be polygonal. Figure 30 shows a polygonal mandrel 55 embodiment. Of course, new, unused disposable medical items need not be stacked within the package 10 of fig. 6 or wrapped around the roller 46 of fig. 16, but may be wrapped around a polygonal roller. In the embodiment in which the roller is circular, the diameter of the roller is preferably greater than the needles 21 placed longitudinally of the tape 1 so as not to excessively bend on the roller. In the polygonal embodiment, the diameter of the mandrel 55 must be adjusted to accommodate the spacing of the disposable on the strip 1.

Fig. 31 shows another embodiment of the winding device 36. The elastic reservoir 54 longitudinally stretches and releases the packaging strip 1 to divert the medical device on the strip 1 without having to reverse the spool 55 of the winding device 36 around which the strip 1 is wound. For this purpose, a roller 56 is mounted on a link 57 of the elastic belt store 54, which is supported in tension by a spring 58. The device 54 can pull the strip 1 a little from the winding device 36 without reversing the reel 55. Such an embodiment is advantageous from a hygienic point of view, since the used lancet 21 is still wound on the reel 55. A corresponding elastic reservoir may also be mounted on the unused side of the strap 1.

The invention has been described in detail with reference to the drawings and text, which are intended to be illustrative of the invention and not to be limiting, it being understood that only the preferred embodiments have been shown and described and that all changes, equivalents and modifications that come within the spirit of the invention as defined by the following claims are desired to be protected. All publications, patent documents, and patent applications cited herein are incorporated by reference as if each individual publication, patent document, or patent application were individually set forth.

List of reference numerals

1-packaging strip; 2-a storage chamber; 3-section; 4-section; 5-folding line; 6-bonding frame; 7-adhesive patch; 8-minor medical parts; 9-section; 10-packaging box; 11-package opening; 12-side wall; 13-side wall; 14-side wall; 15-the auxiliary ring; 16-compression spring; 20-an actuator; 21-a needle; 22-first link; 23-a coupling rod; 24-a second link; 25-sector gear; 26-sector gear; 27-third link; 28-roller (thin belt guide wheel); 29-swing link; 30-a housing; 31-cam; 32-reference plane; 33-position; 34-actuator; 35-a movable door; 36-a winding device; 37-packaging box; 38-new component; 39-an actuating element; 40-waste component; 41-circular wheel; 42-eccentric wheel; 43-side wall; 44-test element; 45-finger; 46-roller; 47-viscose; 48-loop back; 49-positioning surface; 50-opening; 51-a spring; 52-blood; 53-groove; 54-elastic accumulator; 55-a reel; 56-roller; 57-connecting rod; 58-spring.

Claims (34)

1. A packaging system comprising a disposable medical device and a packaging tape comprising a plurality of storage compartments containing said disposable medical device configured as a lancet or a test element for analysis of body fluids;

the strip being folded along transverse fold lines into a series of loops, each loop comprising opposed sections;

at least part of the opposing sections of the loop are sealed to each other, thereby forming a reservoir between the opposing sections,

the disposable medical device is secured to the packaging strip.

2. The packaging system of claim 1, wherein the sections of the strip are sealed by an adhesive.

3. The packaging system of claim 2, wherein the adhesive allows the storage compartment to be opened by tearing the opposed segments.

4. The packaging system of claim 1, wherein the strip is made of release paper.

5. The packaging system of claim 1, wherein the section of the strip forming the bottom of a storage chamber is located on top of the section of the strip forming the top of an adjacent storage chamber.

6. The packaging system of claim 5, wherein a peelable adhesive is placed between the section forming the bottom of the first storage compartment and the section forming the top of the second storage compartment to secure the loops forming adjacent storage compartments of the strip to each other.

7. The packaging system of claim 1 wherein the strip storage compartment comprises a frame defining the side walls of the storage compartment.

8. The packaging system of claim 1, wherein the strip storage compartments are positioned on top of each other.

9. The packaging system of claim 1 wherein the loop of the strip is disposed and sealed by the following method: when the strap is subjected to a pulling force, it will unfold back and in turn open the storage compartment.

10. A packaging system according to claim 9, comprising a gripper for gripping the strip in a direction opposite to the direction of stretching, thereby facilitating opening of the strip storage compartment.

11. The packaging system of claim 1, wherein the strip includes a secondary loop formed between successive reservoirs to ensure that the medical devices in the reservoirs are all on the same side of the strip.

12. The packaging system according to claim 1, wherein the space between the adjacent strip storage compartments in the strip-unfolded state is in the range of 3 to 20 cm.

13. Packaging system according to claim 1, wherein the strip has in its longitudinal direction alternating reservoirs containing two medical devices, one of the reservoirs of the alternating reservoirs containing the lancet and the next containing the test element.

14. The packaging system of claim 1, wherein the strip storage compartment contains not only the disposable medical device but also a desiccant.

15. The packaging system of claim 1, wherein the lancet housed within the storage chamber is oriented in a longitudinal direction of the tape.

16. The packaging system of claim 1 wherein a rear end of the lancet, opposite a front end of the lancet for lancing the skin, is secured to the tape.

17. The packaging system of claim 1, wherein the medical device is configured as an integrated device comprising the lancet and an instrument for collecting a sample of the bodily fluid from a puncture of the lancet.

18. The packaging system of claim 6, wherein the releasable adhesive is an adhesive patch.

19. The packaging system of claim 1 wherein the strip loop seating and sealing method comprises: when one end of the strap is secured and the other end is stretched, it will unfold back and open the storage compartment in turn.

20. The packaging system according to claim 1, wherein the space between the adjacent strip storage compartments in the strip-unfolded state is in the range of 5 to 10 cm.

21. A package containing a packaging system according to claim 1, the package having a slot-shaped opening for pulling out one end of the strip.

22. A package according to claim 21, wherein the strap ends project through the opening.

23. A package according to claim 21, comprising a gripper for gripping the strip in the direction opposite to the stretching direction to facilitate opening of the strip storage compartment.

24. A package according to claim 23, wherein the slot-shaped opening is configured as a flap and is provided with a holding device according to claim 18.

25. A packaging system according to claim 1, comprising an actuator with a linkage for actuating the medical device with the strip open storage compartment.

26. Actuator with a linkage for operating a disposable medical device of the system according to claim 1, the packaging strip extending longitudinally, wherein the medical device is placed on the packaging strip parallel to the direction of extension of the strip before being operated by the actuator,

wherein:

one end of the medical device is fixed on the packaging strip;

the linkage mechanism is configured to move the medical device and the strip section secured thereby by moving the strip; and

the strip is folded into a loop by an actuator to move the medical device.

27. Actuator according to claim 26, wherein the medical device is a needle and the linkage is designed for performing a needle pricking movement.

28. Actuator according to claim 26, wherein the linkage is designed to turn the medical device 90 degrees into the bending-resistant strip position.

29. Actuator according to claim 28, wherein the linkage comprises a roller over which the strip is guided under longitudinal tension, thereby enabling the direction change of the medical device without a tearing load being applied to the strip or to the fixation of the medical device to the strip and without bending the medical device.

30. Actuator according to claim 28, comprising an elastic reservoir for releasing the packaging strip under longitudinal tension, thereby enabling rotation of the medical device without reversing the winding device reel on which the strip is wound.

31. Actuator according to claim 26, wherein the linkage comprises a positioning surface providing a reference surface for positioning the actuator at a predetermined distance with respect to the skin to be pricked by the actuator.

32. Actuator according to claim 31, wherein the strip is arranged between the positioning surface and the skin to be pricked by the actuator.

33. Actuator according to claim 26, wherein the actuator comprises a movement means by means of which the actuator can be moved towards the skin to be pricked by the packaging strip puncturing needle until the packaging strip is applied against the skin to be pricked before the puncturing needle performs the puncturing.

34. A packaging system according to claim 1, comprising a package containing a fresh component containing unused medical devices in a packaging strip according to claim 1, an actuating component containing an actuating means according to claim 25 or 26, and a waste component for containing used medical devices and corresponding parts of the strip.