Source: http://www.google.com/patents/US20040158207?dq=7565338
Timestamp: 2016-10-21 14:16:53
Document Index: 26055510

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

Patent US20040158207 - Infusion set - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA 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...http://www.google.com/patents/US20040158207?utm_source=gb-gplus-sharePatent US20040158207 - Infusion setAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS20040158207 A1Publication typeApplicationApplication numberUS 10/679,925Publication dateAug 12, 2004Filing dateOct 6, 2003Priority dateApr 6, 2001Also published asEP1383560A2, US7879010, US8469929, US8801660, US20110087196, US20130281931, WO2002081012A2, WO2002081012A3Publication number10679925, 679925, US 2004/0158207 A1, US 2004/158207 A1, US 20040158207 A1, US 20040158207A1, US 2004158207 A1, US 2004158207A1, US-A1-20040158207, US-A1-2004158207, US2004/0158207A1, US2004/158207A1, US20040158207 A1, US20040158207A1, US2004158207 A1, US2004158207A1InventorsMarcel Hunn, Jurg Liniger, Patrik Denoth, Marc Oesch, Markus Butikofer, Rudolf Zihlmann, Simon ScheurerOriginal AssigneeMarcel Hunn, Jurg Liniger, Patrik Denoth, Marc Oesch, Markus Butikofer, Rudolf Zihlmann, Simon ScheurerExport CitationBiBTeX, EndNote, RefManPatent Citations (6), Referenced by (368), Classifications (22), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetInfusion set
DETAILED DESCRIPTION [0064] [0064]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 6 a. 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. [0065] [0065]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 1 d of the foundation body 1 engages with a channel 5 a 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. [0066] The outer area of the holder 5, which is guided in the interior of the guiding element 6, can exhibit a surface structure or comprise one or more elements projecting outwards which enable the holder 5 to move in the expelling direction but prevent or hamper it from moving in the restoring direction, such that incorrect use may be prevented. Accordingly, corresponding structures or elements can be provided on the inner side of the guiding element 6, in order to enable movement only in a predetermined direction. [0067] If the brackets 6 a of the guiding element 6 are moved by pressing the operating elements 6 b together, such that the latching projections 6 c of the guiding element 6 no longer engage with the latching projections 1 a 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 6 d of the guiding element 6 via a circumferential groove 7 a 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 7 a of the operating element 7 is positioned below the circumferential protrusion 6 d, 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. [0068] [0068]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 9 a 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 1 b of the foundation body 1 via the edge 9 b 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 9 b protruding from the plug 9 is inserted into the gap defined by the upper side of the foundation body 1 and the jutting edge 1 c 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 9 b of the plug 9 engages with the gap defined by the edge 1 c 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. [0069] 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 1 b of the foundation body 1, such that the plug cannula 10 can always be securely introduced into the casing 5. [0070] 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 1 b of the foundation body 1, shown in FIG. 2, which connects the plug 9 securely to the foundation body 1. [0071] [0071]FIG. 8 shows an alternative embodiment of the present invention. A swivel 16, rotationally mounted in the foundation body 1, can be moved to a position in which the opening 18 of the swivel 16 points upwards. In this position, a cannula can be inserted into the foundation body 1 with the aid of the guiding needle 8 which is protected by a frame serving as a protective element 6, as described above. Once the cannula has been inserted, the guiding needle 8 can be removed again. The swivel 16 can then be rotated on its side, as shown in FIG. 8, and preferably latches to a latching projection 17 pointing upwards and arranged on the base plane of the foundation body 1, which holds the swivel 16 securely in its tilted down position. In this alternative embodiment, a plug 9 can be attached laterally to the completely tilted down swivel 16, such that the plug cannula 10 running in the linear extension of the tube 12 can be inserted into the opening 18, pointing to the side, of the swivel 16. A latching device 15 attached to the plug 9 can then latch with suitable counter pieces of the swivel 16. [0072] In each of the embodiments described above, the plug 9 can be disconnected again from the foundation body 1 by laterally pressing on the regions lying above or to the side of the latching devices 15 of the plug 9. Once the plug 9 has been disconnected, the sealing element 4 again completely closes access to the cannula 3. [0073] [0073]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 28 a, in the expelling direction of the cannula 3. The holding element 28 a 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 28 b 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 27 a 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 28 a 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 27 a of the needle carrier 27 abuts the holding ring 23. [0074] [0074]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 28 b 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 27 a 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. [0075] In general, the holding element 28 a and/or the holding element 28 b can be formed as a tipping or sliding mechanism or as any other securing mechanism. [0076] [0076]FIG. 11 shows the cannula inserting device shown in FIG. 10, once the needle carrier 27 has been retracted. The guiding needle 8 has thus been retracted back out of the expelled cannula 3 and inserted back into the guiding element 6, in order to avoid injuries. [0077] As an exemplary alternative to the embodiment shown, the needle carrier 27 can be retracted fully automatically, once the cannula 3 has been inserted, by operating a triggering mechanism for the restoring spring 22 via the underside of the needle carrier 27, which retracts the needle carrier 27 back immediately after the cannula 3 has been inserted. In this case, the second triggering button 25 can be omitted. [0078] 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 6 b in order to release the latch between the latching projections 6 c of the guiding element 6 and the latching projections 1 a of the foundation body 1. [0079] 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 6 b, and the latch between the guiding element 6 and the foundation body 1 cannot therefore be released in the position shown in FIG. 10. [0080] [0080]FIG. 12 shows the cannula inserting device, detached from the foundation body 1, with the guiding needle 8 retracted. The cannula inserting device can now be safely disposed of, since the guiding needle 8 is covered by the surrounding guiding element 6 and the danger of unintentional pricking injury is minimized. Alternatively, the cannula inserting device can be moved back to the position shown in FIG. 9 using tensing devices (not shown), for example by pushing the holding ring 23 from its upper position back into a lower position, wherein the restoring spring 22 is re-tensed. It is equally possible to expel the needle carrier 27 from the guiding element 6 and thus tense the restoring spring 22, wherein the inserting spring 21 is then re-tensed in a second step. In the case of a reusable device, the used guiding needle is preferably exchanged and replaced with a new guiding needle, and a new cannula 3 and corresponding holder 5 including sealing element 4 as the case may be. [0081] [0081]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 39 a and other connecting elements (not shown). Within the connector sleeve 38, the guiding sleeve 33 is provided with tongues 33 a, 33 b and 33 c protruding inwards from it. The tongues 33 a to 33 c 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 33 a to 33 c 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 37 a, fixedly connected to the triggering button 37, is provided within the guiding sleeve 33, said triggering sleeve 37 a comprising indentations in the axial direction which are assigned to the tongues 33 b and 33 c. Furthermore, special triggering surfaces, such as chamfers, are provided on the triggering sleeve 37 a in order to press away the tongues 33 a to 33 c in a predetermined order when the triggering sleeve 37 a 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 33 b arranged symmetrically above the spring 31 and a pair of tongues 33 a 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 38 a with a bore 38 b is provided on the upper side of the connector sleeve 38, wherein the diameter of the bore 38 b 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 38 a lies opposite a securing clip 38 c comprising an elastic element on the upper side of the connector sleeve 38, wherein a tongue 38 d provided on the securing clip 38 a can latch with the securing clip 38 c when the securing clip 38 a and the securing clip 38 c are pressed together. The bore 38 b shown in FIG. 13, arranged eccentrically with respect to the cannula axis, prevents the triggering button 37 from being pressed. If the securing clip 38 a and the securing clip 38 c are pressed together such that the securing clip 38 c locks in for example with the tongue 38 d, then the bore 38 b 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. [0082] [0082]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 33 a, which the cannula sub-assembly 35 has been pressed onto by the spring 31, are deformed by the triggering sleeve 37 a 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 33 c. 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. [0083] 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 33 c, arranged symmetrically with respect to each other, which makes it possible to re-position the set. [0084] 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 33 c. In the position shown, the spring 31 is held by the tongues 33 b. In general, the spring can also be held in the position shown for example by the upper end of the needle part 34. [0085] [0085]FIG. 15 shows the device from FIG. 14 once the operating button 37 has been completely pressed in. This pushes the triggering sleeve 37 a over the tongues 33 b and 33 c, 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. [0086] [0086]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 37 a arranged within the connector sleeve 38. The triggering sleeve 37 a recesses and lower and upper chamfers on the inner side along its axial direction, using which a lower and an upper slaving ring 32 a and 32 b can be uncoupled when the triggering sleeve 37 a 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. [0087] The lower slaving ring 32 a 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 32 b 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 32 a and 32 b, 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. [0088] [0088]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 32 a is laterally shifted away from the stopper sleeve 36 by a lower oblique inner surface of the triggering sleeve 37 a and thus uncoupled from the stopper sleeve 36. The lower slaving ring 32 a 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 32 b which is still held fixedly by the guiding sleeve 33 and presses the lower slaving ring 32 a 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. [0089] [0089]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 32 b is laterally shifted by a upper oblique area of the triggering sleeve 37 a 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 32 b, 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. [0090] In the foregoing description, embodiments of the invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled. 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