INFUSION SYSTEM HAVING AN INFUSION PUMP AND HAVING A PUMP MODULE THAT CAN BE COUPLED THERETO

Abstract

An infusion system includes a pump and a replaceable pump module. The pump module can be arranged in a mount of the pump and includes a plunger-barrel unit operatively connectable to a drive mechanism of the pump. The pump module includes a plunger that can be coupled to the drive mechanism by a coupling structure operatively connected to the plunger and a counter-coupling structure for connecting engagement in the coupling structure and operatively connected to the drive mechanism. In a securing position, the infusion system includes a securing member which locks the coupling structure and the counter-coupling structure to each other. In addition or in the alternative, the infusion pump includes a control link operatively connected to the pump module.

Claims

1. An infusion system comprising an infusion pump and a pump module being separate therefrom and provided as a disposable product and thus replaceable which is configured to be arranged in a mount of the infusion pump and includes a plunger-barrel unit operatively connectable to a drive mechanism of the infusion pump comprising a plunger translationally movable within a barrel, the plunger being adapted to be coupled to the drive mechanism by coupling structure operatively connected to the plunger and by a counter-coupling structure configured for connecting engagement in the coupling structure and being operatively connected to the drive mechanism, wherein the infusion pump has a control link which is operatively connected or operatively connectable to the pump module so that, when the pump module is arranged in the mount, the control link is positioned by force in a release position in which pumping action of the plunger is enabled, and that, when the pump module is not arranged in the mount, the control link is positioned by force in a blocking position in which pumping action of the plunger.

2. The infusion system according to claim 1, wherein the infusion pump includes a cover member configured to be positioned in a closing position closing the mount for the pump module, wherein the cover member, the mount and the pump module are adapted to each other and designed so that, when the pump element is not arranged in the mount, the cover member cannot be positioned in the closing position closing the mount.

3. The infusion system according to claim 2, wherein the cover member is operatively connected to the control link in such a way that the control link is positioned by force into the release position when the cover member is provided in the closing position and is positioned by force into the blocking position when the cover member is not provided in the closing position.

4. The infusion system according to claim 11, wherein the securing member is operatively connected to the control link in such a way that the securing member fixes the coupling structure and the counter-coupling structure when the control link is provided in the release position, and the securing member releases the coupling structure and the counter-coupling structure when the control link is provided in the blocking position.

5. The infusion system according to claim 1, wherein the infusion system includes a toggle lever mechanism which is operatively connected to the pump module and operatively connected to the control link.

6. The infusion system according to claim 1, wherein the control link is biased to the blocking position.

7. The infusion system according to claim 11, wherein the securing member is a sleeve-shaped hollow body comprising a longitudinal axis oriented in parallel to an axis of the plunger, and the securing member is positionable relative to the coupling structure and the counter-coupling structure in a direction of the axis of the plunger between the securing position and a release position.

8. The infusion system according to claim 11, wherein the securing member is biased to the securing position.

9. The infusion system according to claim 11, wherein the infusion system includes an emergency release comprising an actuating element coupled to the securing member so as to manually actuate the securing member and to move the securing member from the securing position to a securing member release position.

10. The infusion system according to claim 9, wherein the actuating element is coupled to the control link so that, when the control link is provided in the release position, the control link will block and cannot be actuated for moving the securing member from the securing position to the securing member release position.

11. The infusion system according to claim 1, wherein the infusion system further comprises a securing member configured for locking the coupling structure and the counter-coupling structure in the coupled state to each other in a securing position.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0038] Further features and advantages of the invention will be resulting from the following exemplary and non-limiting description of the figures. They are merely schematic and serve only for the comprehension of the invention, wherein:

[0039] FIG. 1 shows a perspective view of the rear side of an infusion system comprising an infusion pump and a pump module inserted in the latter,

[0040] FIG. 2 shows the infusion system of FIG. 1 in a sectional view, while the pump housing is partially cut free, in a coupling position or infusion position,

[0041] FIG. 3 shows a sectional view of the infusion pump of FIGS. 1 and 2 with a pump module inserted in the same in an uncoupling position,

[0042] FIG. 4 shows a sectional view transversely to the section plane of FIGS. 2 and 3 of the infusion pump with a pump module inserted therein,

[0043] FIG. 5 shows another sectional view transversely to the section plane of FIGS. 2 and 3 of the infusion pump with an inserted pump module during actuation of an emergency release,

[0044] FIG. 6 shows an embodiment of the pump module with a connected shift clamp for squeezing one of the fluid lines, and

[0045] FIG. 7 shows a perspective view of the front side of an infusion system comprising an infusion pump and a pump module inserted in the latter.

DETAILED DESCRIPTION

[0046] FIGS. 1 and 7 illustrate an exemplary embodiment of an infusion system according to the invention comprising an infusion pump 1 and comprising a pump module 2 inserted in the latter (FIG. 1 rear side, FIG. 7 front side). The pump 1 includes a housing 3 which preferably consists substantially of a lower housing part 4 including a housing cover 5 and a cover member 6 in the form of a cover flap 6 here. The lower housing part 4 and the housing cover 5 are connectable/connected to each other, for example via a locking connection or screwed connections not shown in the Figures, and in the assembled state form the housing 3. The lower housing part 4 has a housing bottom 7. In or at the housing cover 5 display elements 8, operating elements 9 and a display 10 of the pump 1 are disposed. In the lower housing part 4 an actuating element 16 is arranged in the form of a shift latch 16 in this case. In the housing 3 a mount 30 for the pump module 2 is configured (see especially in FIG. 2) which can be closed by means of the cover member 6. The mount 30 is open in the distal direction, is closed in the proximal direction by means of a bottom wall 32 and is enclosed by a sidewall 33 (sidewalls 33) corresponding to the external shape of the plunger-barrel unit. In total, the mount 30 is formed to match the plunger-barrel unit 11 (shown in FIG. 6) so that the latter can be arranged therein in a defined position. In the bottom wall 32 of the mount 30 a central through-hole is formed through which a coupling rod 38 and a clamping sleeve 39 as a securing member 39 are passed for coupling the plunger 15 to the drive 26, as will be described below.

[0047] The pump module 2 is schematically shown separately in FIG. 6. A more detailed representation of the pump module 2 is found in FIGS. 3, 4 and 5. It includes a plunger-barrel unit 11, a first elastically deformable tube portion 12 and a second elastically deformable tube portion 13. The pump module 2 is in the form of a single-use article (disposable). The tube portions 12, 13 may especially be configured as a PVC tube.

[0048] The plunger-barrel unit 11 includes a barrel 14 which may be made especially from plastic material and/or may be manufactured as an injection-molded part, and includes a plunger 15 to be reciprocated therein which may equally be made especially from plastic material and/or may be manufactured as an injection-molded part. The barrel 14 includes a bottom wall 17, a circumferential wall 18 and a cover wall 19. The plunger 15 is sealed against the circumferential wall 18 by means of seals 20a, 20b arranged on both sides so that the plunger-barrel unit 11 has a fluid compartment/dosing compartment 21. The plunger 15 has a coupling structure 34 on its proximal side, i.e. on the side opposed to the fluid compartment 21. Said coupling structure is formed by a central blind hole 35 introduced to the plunger 15 at the proximal edge of which coupling hooks 36 provided with locking contours are disposed. In the bottom wall 17 a fluid passage 31 is formed. The plunger-barrel unit 11 includes at its distal end area a barrel head 24 at which in turn a handle member 25 is distally arranged for user-side handling of the pump module 2, especially when inserting the infusion pump 1 into or removing the infusion pump 1 from the mount 30. An annular bead 52 located in the side wall 18 constitutes an axial stop for the plunger 15 so that the maximum stroke of the plunger-barrel unit 11 is fixed and the plunger 15 is form-fit prevented from falling out of the barrel 14.

[0049] The plunger 15 is preferably arranged/formed/fixed as a smooth-running plunger and at its distal end and at its proximal end includes a seal 20a, 20b in the form of a movable sealing lip. The distance along the longitudinal direction L between the distal seal 20a and the proximal seal 20b of the plunger 15 exceeds the plunger stroke of the plunger-barrel unit 11 in the shown exemplary embodiment. This guarantees that the barrel wall of the fluid compartment dosing compartment 21 contacts exclusively the one distal seal 20a so that the sterility thereof is safeguarded. Preferably, the excess between the distance along the longitudinal direction L between the distal seal 20a and the proximal seal 20b of the plunger 15 and the plunger stroke amounts to at least 2 mm.

[0050] In the barrel head 24 an inlet bore 22 and an outlet bore 23 are formed (cf. FIG. 6) which are fluid-connected, on the one hand, to the fluid passage 31 and are fluid-connected, on the other hand, to the first tube portion 12 and the second tube portion 13. In this way, the fluid compartment 21 is fluid-connected via the fluid passage 31 and the inlet bore 22 to the first tube portion 12 and is fluid-connected via the fluid passage 31 and the outlet bore 23 to the second tube portion 13. The tube portions 12, 13 may be molded especially onto the barrel 14 and, resp., the barrel head 24. They may be configured especially like common infusion tubes. The first tube portion 12 is provided, in the embodiment of FIG. 3, with an inlet Luer lock connection (not shown) at its end facing away from the plunger-barrel unit 11. The second tube portion 13 is provided with an outlet Luer lock connection (not shown) at its end facing away from the plunger-barrel unit 11. In this way, the pump module 2 can be easily connected to common infusion units.

[0051] FIGS. 2 to 5 show that the pump 1 includes a drive 26 for the plunger-barrel unit 11 (inherent to the pump), here in the form of a linear motor 26. The motor 26 is arranged to be congruent to the longitudinal axis L of the plunger-barrel unit 11 so that forces for reciprocating the plunger 15 can be transmitted centrally and without any twists/transverse forces. The drive 26 is arranged to be fixed in position at the lower housing part 4 by being mounted in an intermediate wall 27.

[0052] The drive 26 can be operatively coupled to the plunger 15 via a drive rod 37 and a coupling rod 38. Both the drive rod 37 and the coupling rod 38 are constituent parts of the infusion pump 1 and are coupled permanently to each other and to the drive motor 26, viz. are not intended to be uncoupled from the latter by a user. The drive rod 37 is driven by means of the drive motor 26 and therefore may perform a reciprocating movement in the direction of the longitudinal axis L. At its distal end, the coupling rod 38 has a counter-coupling structure 40 which is formed to match the coupling structure 34 of the plunger 15. The counter-coupling structure 40 here is provided in an area of reduced diameter with a possibly peripheral deepening 41 or groove 41 which is suited and intended for coupling engagement in the coupling hooks 36 of the plunger 15.

[0053] On the coupling rod 38 a securing member 39, here in the form of a clamping sleeve 39, is arranged to be positioned relative to the coupling rod 38 in the direction of the longitudinal axis L between a distal clamping position and a proximal release position. In the clamping position (see FIG. 4), the clamping sleeve 39 engages the coupling hooks 36 engaging in the deepening 41 by its distal end portion so that the coupling hooks cannot detach from the deepening by deformation radially outwardly and the connection of the coupling structure 34 and the counter-coupling structure 40 is secured. In the release position (FIG. 5), the distal end portion of the clamping sleeve 39 releases the coupling hooks 36 so that they can deform outwardly in the radial direction and can detach from the deepening 41, when a user seizes the pump module 2 at the handle member 25 and removes the same from the mount 30 in the distal direction. The clamping sleeve 39 is biased into the distal direction, viz. into its clamping position, by means of a compression spring 42.

[0054] The infusion pump 2 moreover includes a control link 43. The latter is received to be positioned within a frame 46 of the lower housing part 4 in a direction transversely to the longitudinal direction L between an uncoupling position/blocking position (FIG. 2) and a release position/pumping position (FIG. 3). The control link 43 is coupled to a toggle lever mechanism 47 substantially consisting of a first lever arm 48 and a second lever arm 50 connected to the latter via a free joint 49. The first lever arm 48 is substantially L-shaped and is pivotally arranged at the lower housing part 4 by means of a pivot joint 51 fixed relative to the lower housing part 4. It is coupled by its end opposed to the free joint 49 to an actuating rod 53 interacting with the cover member 6. The second lever arm 50 is rotatably coupled to the control link 43 by its end opposed to the free joint 49.

[0055] The control link 43 has a lower wall 54 on the side of the lower housing part, an upper wall 55 on the side of the upper housing part opposed to the lower wall and two sidewalls 56 connecting the upper wall 55 and the lower wall 54. The second lever arm 50 is coupled to the one sidewall 56, while the other sidewall 56 is coupled to a compression spring 57 bearing against the frame 46, the compression spring biasing the control link 43 in the direction of the second lever arm 50 (in the FIGS. 1, 2 and 3 to the right, in the FIGS. 4 and 5 out of the projection plane). In the lower wall 54 (and identically in the upper wall 55) a control groove 58 is configured. It includes a release portion 59 extending in the longitudinal direction L (cf. FIG. 2) and a blocking portion 60 extending initially tilted and then transversely to the longitudinal direction L (see FIG. 3).

[0056] The clamping sleeve 39 includes two diametrically opposed control cams 61 engaging in the control grooves 58 of the upper wall 55 and the lower wall 54.

[0057] It is resulting from FIGS. 2 to 5 that the cover element 6 in the form of the cover flap 6 is arranged to be pivoting between an opened position (FIG. 3) and a closed position (FIGS. 2, 4 and 5) by means of a hinge joint 62 at the lower housing part 4. Said hinge joint is provided with a positioning pin 63 which interacts with the second tube portion 13 and ensures the latter to be placed at an air sensor 44 as intended when the cover flap 6 is closed.

[0058] For using the pump 1 a user first opens the cover flap 6 of the pump 1, for example by inserting a special wrench laterally into a dedicated bore and thus unlocks the cover flap 6. When the front flap 6 is opened, the control link 43 is provided in the uncoupling or blocking position and the coupling rod 38 is provided in the extended state. Thus, the actuating rod 53 has been shifted outwardly (distally) by means of the two lever arms 48, 50. When the infusion line including the two tube portions 12, 13 is filled free from air bubbles, the second tube portion 13 is closed in a fluid-tight manner by means of a shift clamp 45. Then the user shifts the pump module 2 into the intended mount 30 of the pump 1 which in the condition shown in FIG. 2 is provided with the control link 43 in the uncoupling or blocking position (shifted to the right in FIG. 2) and with the clamping sleeve 39 in the release position (shifted to the proximal direction) until the coupling structure 34 engages in the counter-coupling structure 40, i.e. the coupling hooks 36 engage in the deepening 41 preferably in an audible and/or feelable manner and the plunger-barrel unit 11 is connected to the drive 26.

[0059] After that, the cover flap 6 is closed. In so doing, the cover flap 6 interacts with the actuating rod 53 and shifts the latter in the proximal direction. As a consequence, the first lever arm 48 carries out a pivoting movement (anti-clockwise in FIGS. 2 and 3) about the fixed pivot joint 51, which causes the control link 43 to be moved against the bias of the compression spring 57 within the frame 46 by means of the second lever arm 50 (from the blocking position shown in FIG. 2 to the left into the release or pumping position shown in FIG. 3). The clamping sleeve 39 is moved, by means of the control cams 61 engaging in the control groove 58, in the distal direction into its clamping position in which the coupling structure 34 and the counter-coupling structure 40 are secured relative to each other. The compression spring 42 located at the clamping sleeve 39 ensures safe connection during operation.

[0060] A locking mechanism located in the upper housing part 5 ensures safe locking of the flap 6 in the closed position. At the same time, the second tube portion 13 is placed toward the air sensor as intended and, for example, is pressed against the same. This ensures detection and appropriate communication of possibly present or introduced air bubbles during infusion.

[0061] Now the user enters the desired delivery rate via the display elements 8 and the operating elements 9. The delivery rate is shown on the display 10 which may be a touch screen according to one embodiment so that input may also be carried out via the display 10 (operation via a cell phone or tablet App is further possible and is within the scope of the invention). Directly after release the pump 1 will start. As soon as the user has started the infusion, the drive rod 37 of the linear motor 46 will reciprocate with the coupled coupling rod 38 including the clamping sleeve 39 and the plunger 15 within the release portion 59 of the control groove 58 of the control link 43 and, in so doing, will pump infusion solution in the direction of the patient.

[0062] After completion of the infusion, the pump 1 is turned off. The drive rod 37 of the linear motor 46 returns the coupling rod 38 with the plunger 15 to the starting position. As soon as the user opens the cover member 6, the compression spring 57 forces the control link 43 back in the direction of the blocking position (to the right in FIGS. 2 and 3). The actuating rod 53 is moved outwardly (distally) again via the toggle mechanism 47. By moving the control link 43 back into the blocking position, as the control cams 61 engage in the control groove 58 the clamping sleeve 39 is positioned in the proximal direction relative to the coupling structure 34 and the counter-coupling structure 40 and releases the latter so that the plunger 15 can be released from the coupling rod 38 while the coupling hooks 36 are rebounding. Now the user may remove the pump module 2 from the mount 30 of the infusion pump 1.

[0063] In an emergency case or if the infusion pump 1 has a technical defect, the plunger 15 can be unlocked via an emergency release with the aid of the actuating element 16. Accordingly (cf. FIGS. 4 and 5), the actuating element 16 is manually pushed in the proximal direction (cf. also the arrow on the actuating element 16 in FIG. 1). A driving cam 64 which is in mesh with the control cam 61 of the clamping sleeve 39 slides said control cam with the clamping sleeve 39 to the rear (in the proximal direction) so that the coupling structure 34 and the counter-coupling structure 40 are released and the plunger 15 can be disconnected from the coupling rod 38. For preventing the emergency release from working in the release or pumping position (shown in FIG. 3) and permitting the same to work in the uncoupling or blocking position only (shown in FIG. 2), a web 65 or cam 65 which, when the control link 43 is in the release or pumping position, interacts with the driving cam 64 and prevents a user from inadvertently triggering the emergency release during infusion is provided on the control link 43 (cf. especially FIG. 5). Alternatively, the control link 43 can be controlled via a further linear motor.