Source: http://www.freshpatents.com/-dt20110414ptan20110087196.php
Timestamp: 2013-05-25 10:51:19
Document Index: 292598997

Matched Legal Cases: ['art 13', 'art 13', 'art 13', 'art 34', 'art 34', 'art 34', 'art 34', 'art 34', 'art 34']

Infusion Set 3 views for this patent on FreshPatents.comupdated 05/24/13
Patents sorted by company.	04/14/11 | Class 604 Monitor | RSS | Browse: Prev - Next Infusion set Abstract: A device for inserting a cannula into tissue, including a cannula, a protective element which can accommodate said cannula, an operating element for moving the cannula out of the protective element, and a holder fixedly connected to the cannula. The invention encompasses a system for connecting a liquid supply to the cannula. ...
Inventors: Marcel Hunn, Jürg Liniger, Patrik Denoth, Marc Oesch, Markus Bütikofer, Rudolf Zihlmann, Simon ScheurerUSPTO Applicaton #: #20110087196 - Class: 604533 (USPTO) - 04/14/11 - Class 604 The Patent Description & Claims data below is from USPTO Patent Application 20110087196, Infusion set.
FIG. 1 shows an infusion set including a cannula inserting device 3-8, fixedly pre-assembled to the base body 1, 2. The base body 1, 2 consists of a foundation body 1 and a plaster 2 which exhibits an adhesive lower surface in order to be able to adhere the base body over an injection point. The foundation body 1 is arranged, e.g., adhered, on the upper side of the plaster 2 and is fixedly connected to the cannula inserting device 3-8 by the bracket 6a. The cannula inserting device comprises a guiding needle 8 which is guided through the cannula 3 and using which the cannula 3 can be inserted into a tissue from the underside of the foundation body 1. On the upper side of the cannula 3, i.e., the side of the cannula 3 facing away from the tip of the guiding needle 8, a holder 5 is fixedly connected to the cannula 3, wherein a sealing element or septum 4 is provided in the holder 5, as shown in FIG. 3. The guiding needle 8 and the cannula 3 are surrounded by the guiding element 6 which serves as a protective element, such that on one hand there is no danger of injury to a user since the tip of the guiding needle 8 does not protrude out of the arrangement shown and is still arranged within the foundation body 1 or guiding element 6, and, on the other hand, the arrangement shown in FIG. 1 largely prevents the guiding needle 8 and the cannula 3 from being contaminated before the cannula 3 is inserted into tissue. The later advantage is provided since direct contact between the cannula 3 and the guiding needle 8 and the environment is prevented by the guiding element 6 and the foundation body 1. The guiding needle 8 is fixedly connected to the operating element 7, as shown in FIG. 2, and can be expelled from the foundation body 1 by pressing downwards on the operating element 7, in order to insert the cannula 3 into a tissue.
FIG. 2 shows the arrangement of FIG. 1, after the cannula 3 has been inserted and the connection between the cannula inserting device and the base body has been released. By pressing the operating element 7 downwards, the guiding needle 8 has been shifted downwardly together with the cannula 3 and the cannula 3 has been inserted into a tissue (not shown) below the plaster 2. This has inserted the holder 5 connected fixedly to the cannula 3, together with the sealing element 4 within it, into the foundation body 1 until an annular protrusion 1d of the foundation body 1 engages with a channel 5a running around the holder 5 and thus latches the holder 5 into the foundation body 1. Once the holder 5 has been latched in the foundation body 1, the guiding needle 8 can be removed from the cannula 3 by moving the operating element 7 upwards, without an excessively large force acting on the inserted cannula 3 during this process of removing the guiding needle 8 from the cannula 3. Latching the holder 5 into the foundation body 1 fixedly anchors the holder 5 in the foundation body 1 if an upward force relative to the guiding element 6, which is still connected to the foundation body 1 during the removing process, acts on the guiding needle 8, and thus enables the drag on the cannula 3 to be relieved during the needle 8 removing process.
If the brackets 6a of the guiding element 6 are moved by pressing the operating elements 6b together, such that the latching projections 6c of the guiding element 6 no longer engage with the latching projections 1a of the foundation body 1, then the cannula inserting device can be detached from the foundation body 1. In its most extreme upper position, the operating element 7 is fixedly latched to a circumferential protrusion 6d of the guiding element 6 via a circumferential groove 7a in the lower region of the operating element 7 and thus ensures that, once the cannula inserting device has been disconnected, the guiding needle 8 can no longer be unintentionally expelled from the guiding element 6. In the basic pre-assembled state of the cannula inserting device on the foundation body 1, as may be seen from FIG. 1, the operating element 7 is retracted far enough into the guiding element 6 that the circumferential groove 7a of the operating element 7 is positioned below the circumferential protrusion 6d, such that the operating element 7 only latches to the guiding element 6 once the cannula 3 has been inserted. FIG. 3 shows a partial section of the inserted cannula 3, with the holder 5 latched in the foundation body 1, wherein a sealing element 4 is arranged in said holder 5.
FIG. 4 shows a sectional image of the plug 9 of the liquid supply device shown in FIG. 1. The coupling part 13 of the tube 12 is connected to a liquid conveying means (not shown). The entire liquid space of the coupling part 13, the tube 12 and the plug 9 is then flooded. The plug comprises a plug cannula 10 which is connected to the tube 12 by the conduit 9a running through the plug 9. The plug 9 is moved to a position above the foundation body 1 as shown in FIG. 5 and brought into contact with the edge 1b of the foundation body 1 via the edge 9b running along the lower rear side of the plug 9. The plug 9 is preferably tipped slightly upwards for this, as shown in FIG. 6, such that the edge 9b protruding from the plug 9 is inserted into the gap defined by the upper side of the foundation body 1 and the jutting edge 1c of the foundation body 1. The plug 9 can thus be moved to a first contact position with the foundation body 1 in a relatively simple and user-friendly way. If the edge 9b of the plug 9 engages with the gap defined by the edge 1c of the foundation body 1, then the plug 9 can be tilted downwards about the point of rotation defined by this engagement, in order to introduce the plug cannula 10 into the casing 5 through the sealing element 4 and thus to enable a liquid to flow from the liquid conveying means through the coupling part 13, the tube 12, the plug 9 and the plug cannula 10 into the cannula 3 and thus into the surrounding tissue.
If the plug 9 is tilted downwards from the position shown in FIGS. 6 and 7, it is guided via guiding cams 14 in order to introduce the plug cannula 10 into the casing 5 positionally exactly. By guiding the plug 9 as it is tilted, by means of the guiding cams 14, it is possible to correct a lateral offset of the plug 9 relative to the foundation body 1 such as may arise as the plug 9 is attached to the edge 1b of the foundation body 1, such that the plug cannula 10 can always be securely introduced into the casing 5.
When the plug 9 is completely tilted down, the plug cannula 10 having been introduced into the casing 5, the latch devices 15 provided laterally on the plug 9 latch with the latching projections 1b of the foundation body 1, shown in FIG. 2, which connects the plug 9 securely to the foundation body 1.
FIG. 9 shows an automatic cannula inserting device in accordance with the invention. With respect to describing the foundation body 1, together with the corresponding latch connections, and inserting the cannula 3, together with its holder 5 and sealing element 4, reference is made to the description above. A needle carrier 27 which may be moved in the longitudinal direction of the guiding element 6 is provided in the guiding element 6, said needle carrier 27 being fixedly connected to the guiding needle 8. Alternatively, the guiding needle 8 can also be designed such that it can be coupled to the needle carrier 27, in order for example to be able to exchange the guiding needle 8. The needle carrier 27 is situated in a retracted position and is biased by an inserting spring 21 abutting the front side of the needle carrier 27, said inserting spring 21 being supported against a supporting element 20 provided roughly in the middle part of the guiding element 6 and biasing the needle carrier 27, which is secured by the holding element 28a, in the expelling direction of the cannula 3. The holding element 28a can be released by a first triggering button 24. On the opposite side of the supporting element 20, a restoring spring 22 is provided which presses against a holding ring 23 which is secured by a holding element 28b and can be released by a second triggering button 25. The needle carrier 27 runs in the longitudinal direction of the guiding element 6, through the two springs 21 and 22 and may be shifted through the supporting element 20 and the holding ring 23 and comprises a holding element 27a at its rear end in order to prevent it from being able to pass completely through the holding ring 23. If the triggering button 24 is pressed, then the schematically drawn holding element 28a is slide or tilted radially outwards in the direction of the arrow, the tilting mechanism preferably being formed completely within the guiding element 6, wherein the needle carrier 27 is then no longer held in the expelling direction of the cannula 3 and is accelerated downwards by the force of the inserting spring 21 in order to expel the cannula 3 from the guiding element 6 via the guiding needle 8 and to insert it through the plaster 2 into a tissue. The expelling movement is continued until the holding element 27a of the needle carrier 27 abuts the holding ring 23.
FIG. 10 shows the cannula inserting device shown in FIG. 9, once the process of expelling the cannula 3 has been completed. The inserting spring 21 has transferred the energy stored in it to the needle carrier 27 and is relieved. The holder 5 can, for example, be latched to the foundation body 1 as described above. If the second triggering button 25 is then operated by the user, the holding element 28b which may be radially shifted (FIG. 9) is pushed out of the holding ring 23 and the holding ring 23—which has so far been secured against moving axially in the guiding element 6—is released, such that the restoring spring 22 presses against the holding ring 23 and the holding element 27a of the needle carrier 27 and a restoring force thus acts on the needle carrier 27. In the embodiment shown, the restoring spring 22 is preferably designed such that it can apply a stronger force than the inserting spring 21, since the latter is pressed together again as the needle carrier 27 is retracted. Alternatively, the needle carrier 27 can also be formed such that, once the cannula 3 has been inserted, there is no longer a coupling between the lower side of the needle carrier 27 and the inserting spring 21, such that the inserting spring 21 no longer has to be tensed as the needle carrier 27 is retracted.
In general, the holding element 28a and/or the holding element 28b can be formed as a tipping or sliding mechanism or as any other securing mechanism.
In accordance with another alternative embodiment, the restoring spring 22 can be triggered automatically by releasing the holding ring 23, when the cannula inserting device is removed from the foundation body 1, e.g., by simultaneously releasing the holding ring 23 when pressing in the buttons 6b in order to release the latch between the latching projections 6c of the guiding element 6 and the latching projections 1a of the foundation body 1.
The cannula inserting device is advantageously designed such that the latch between the guiding element 6 and the foundation body 1 cannot be released if the guiding needle 8 is in the position shown in FIG. 9 before the cannula 3 is expelled and/or in the expelled position shown in FIG. 10. This can be achieved if, for example, the underside of the needle carrier 27 is sufficiently wide that the underside of the guiding element 6 is prevented from being pressed together at the buttons 6b, and the latch between the guiding element 6 and the foundation body 1 cannot therefore be released in the position shown in FIG. 10.
FIG. 13 shows a first embodiment of an automatic cannula inserting and restoring device, in its initial state before a cannula 3 on a cannula sub-assembly 35 has been inserted using a guiding needle 8. The cannula inserting device comprises a connector sleeve or guiding element 38 which has connector elements 39 at its lower end, in order for example to be fastened on a foundation or base body 1, as shown for one of the embodiments in the figures above. Said connector elements 39 for connecting the connector sleeve 38 to a predetermined base body comprise for example latching tongues 39a and other connecting elements (not shown). Within the connector sleeve 38, the guiding sleeve 33 is provided with tongues 33a, 33b and 33c protruding inwards from it. The tongues 33a to 33c are arranged at various positions in the axial direction of the guiding sleeve 33 and can be arranged as individual protruding elements or also over a large part of the circumference of the guiding sleeve 33. The tongues can also for example lie opposite each other and/or can be formed symmetrical with respect to each other as a number of individual tongue elements. The three tongues 33a to 33c shown by way of example are arranged offset with respect to each other in the axial direction of the guiding sleeve 33, in order to fulfil various functions when an expelling and restoring process is triggered, as will be explained below. A triggering sleeve 37a, fixedly connected to the triggering button 37, is provided within the guiding sleeve 33, said triggering sleeve 37a comprising indentations in the axial direction which are assigned to the tongues 33b and 33c. Furthermore, special triggering surfaces, such as chamfers, are provided on the triggering sleeve 37a in order to press away the tongues 33a to 33c in a predetermined order when the triggering sleeve 37a in the embodiment shown in FIG. 13 is shifted downwardly, initiating the expelling and restoring process of the cannula sub-assembly 35. Furthermore, a needle part or needle carrier 34 is arranged, such that it may be shifted, within the connector sleeve 38, and is coupled to the cannula sub-assembly 35 via a fixedly connected guiding needle 8 and a direct contact area or is latched to the cannula sub-assembly 35 via a suitable latching device (not shown). In the initial state shown, the completely biased spring 31 presses on the cannula sub-assembly 35, wherein a pair of tongues 33b arranged symmetrically above the spring 31 and a pair of tongues 33a of the guiding sleeve 33 arranged below the cannula sub-assembly 35 hold the biased spring 31 pressing on the cannula sub-assembly 35 in position. A securing clip 38a with a bore 38b is provided on the upper side of the connector sleeve 38, wherein the diameter of the bore 38b roughly corresponds to the diameter of the triggering button 37 and is preferably a little larger in order to enable the triggering button 37 to pass easily through. The approximately L-shaped securing clip 38a lies opposite a securing clip 38c comprising an elastic element on the upper side of the connector sleeve 38, wherein a tongue 38d provided on the securing clip 38a can latch with the securing clip 38c when the securing clip 38a and the securing clip 38c are pressed together. The bore 38b shown in FIG. 13, arranged eccentrically with respect to the cannula axis, prevents the triggering button 37 from being pressed. If the securing clip 38a and the securing clip 38c are pressed together such that the securing clip 38c locks in for example with the tongue 38d, then the bore 38b is moved to a concentric position with respect to the position of the triggering button 37, such that the triggering button 37 can be pressed.
FIG. 14 shows the device shown in FIG. 13 once the operating button 37 has been pressed in by about a half length. The lower tongues 33a, which the cannula sub-assembly 35 has been pressed onto by the spring 31, are deformed by the triggering sleeve 37a extending along the inner side of the connector sleeve 38, which releases the cannula sub-assembly 35 together with the needle carrier 34, the spring 31 pressing on a lower end stopper which can be provided in the cannula inserting device or on a base body 1. The upper end of the needle carrier 34 thus leads over the tongues 33c. The cannula 3 of the cannula sub-assembly 35, connected to the guiding needle 8, is expelled downwards, out of the device, by the force of the spring 31, preferably at high speed, and can be inserted into a tissue as desired.
In the position shown in FIG. 14, the cannula sub-assembly 35 is latched to a foundation body or base body of an infusion set (not shown) and the needle carrier 34 is unlatched by tongues in the foundation body of the infusion set, such that the needle carrier 34 and the cannula sub-assembly are no longer connected (not shown in FIG. 14). In this position, the needle carrier 34 is latched by the two tongues 33c, arranged symmetrically with respect to each other, which makes it possible to re-position the set.
The semi-relieved spring 31 presses downwards against the expelled cannula sub-assembly 35 and abuts a protruding element of the needle part 34 on the opposite side, the needle part 34 being secured against shifting axially by the tongues 33c. In the position shown, the spring 31 is held by the tongues 33b. In general, the spring can also be held in the position shown for example by the upper end of the needle part 34.
FIG. 15 shows the device from FIG. 14 once the operating button 37 has been completely pressed in. This pushes the triggering sleeve 37a over the tongues 33b and 33c, which are pressed outwards and away and thus release the needle part 34 which is pushed back into the connector sleeve 38 again by the spring 31 which can now be fully relieved. This retracts the guiding needle 8 connected to the needle part 34 out of the cannula and the cannula sub-assembly 35 into the connector sleeve 38, wherein the cannula 3 can remain in a tissue. The needle part 34 is held in the retracted position by the spring 31, such that the guiding needle 8 cannot unintentionally exit the connector sleeve 38, which minimises the risk of injury. The connector sleeve 38 can then be removed from a base body by detaching the connector elements 39.
FIG. 16 shows a second embodiment of an automatic cannula inserting and restoring device in its initial state, comprising a connector sleeve 38 which is connected to a foundation body 1. A triggering button 37 passes into the triggering sleeve 37a arranged within the connector sleeve 38. The triggering sleeve 37a recesses and lower and upper chamfers on the inner side along its axial direction, using which a lower and an upper slaving ring 32a and 32b can be uncoupled when the triggering sleeve 37a is shifted axially, in order to expel the guiding needle 8, together with the cannula 3 arranged around it and the corresponding cannula sub-assembly 35, out of the connector sleeve 38 and to then retract the guiding needle 8 out of the cannula 3 and the cannula sub-assembly 35, as will be described below.
The lower slaving ring 32a abuts a stopper sleeve 36 and is held in position by the stopper sleeve 36 against the pressure of the spring 31. The spring 31 presses on the upper side against the upper slaving ring 32b which is held in position, for example in a channel or recess, by the guiding sleeve 33. The needle carrier 34 is designed such that it can be moved in the axial direction of the connector sleeve 38, through the slaving rings 32a and 32b, up to the end of the needle carrier 34 which exhibits a larger diameter than the inner diameter of the slaving rings in order for example to prevent the needle carrier 34 from falling out. The needle carrier 34 is in turn fixedly connected to the guiding needle 8.
FIG. 17 shows the device shown in FIG. 16 once the securing cap arranged over the triggering button 37 has been removed and the triggering button 37 has been pressed in by about a half length. The lower slaving ring 32a is laterally shifted away from the stopper sleeve 36 by a lower oblique inner surface of the triggering sleeve 37a and thus uncoupled from the stopper sleeve 36. The lower slaving ring 32a can either already be coupled to the needle carrier 34 or can be coupled to the needle carrier 34 by this shifting process. The spring 31 then presses against the upper slaving ring 32b which is still held fixedly by the guiding sleeve 33 and presses the lower slaving ring 32a coupled to the needle carrier 34 downwards and thus inserts the guiding needle 8, together with the cannula 3, into a tissue lying below the foundation body 1, wherein the cannula sub-assembly 35 is in turn moved as far as a lower end stopper. In this position, the needle carrier 34 remains latched to the foundation body 1, which makes it possible to re-position the entire set.
FIG. 18 shows the device shown in FIG. 17 once the triggering button 37 has been pressed in further. This firstly unlatches the needle carrier 34 completely from the cannula sub-assembly 35. The upper slaving ring 32b is laterally shifted by a upper oblique area of the triggering sleeve 37a and thus uncoupled from the guiding sleeve 33 and couples into the needle carrier 34, such that the spring 31 can press the needle carrier 34 upwards via the upper slaving ring 32b, as far as an upper end stopper. This retracts the guiding needle 8 out of the cannula 3 and the cannula sub-assembly 35, which is held in the retracted position by the spring 31 pressing against the needle carrier 34, which minimises the risk of injury. In general, one or more operating elements, e.g., buttons, can be provided for triggering the expelling and restoring processes, wherein said operating elements trigger, e.g., by releasing a spring, the corresponding process directly or indirectly, e.g., by shifting an element in the cannula inserting device.
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