Filling assist assembly

Abstract

A filling aid assembly (1) for filling a liquid into a reservoir (101) of a patch pump (100), the patch pump comprising a piston (102) arranged within the reservoir (101), the filling aid assembly comprising a cover member (2) configured to be arranged on top of the patch pump (100), the cover member having an opening (21), the cover part (2) has an opening for access to the reservoir when the cover part (2) is arranged on top of the patch pump (100) for fluid exchange between the reservoir (101) and the pre-filled container (10) containing the liquid. The filling aid assembly further comprises a dial ring (4) and a transfer gear assembly (5) engaged with the internal toothing (41) of the dial ring (4) to convert rotational movement of the dial ring (4) into displacement of the piston (102) within the reservoir (101).

Description

Technical Field

[0001] The present invention relates to a filling auxiliary assembly for filling a liquid into a reservoir of a patch pump, and to a medical assembly comprising the filling auxiliary assembly. Background Art

[0002] Certain diseases, such as diabetes, require that a liquid, such as a solution containing insulin, be regularly applied to the patient's body through the patient's skin. In order to facilitate application, patch-like medical devices are known, which are configured to be applied to the patient's skin and are preferably worn by the patient for a long period of time. Such a patch-like device generally includes a hollow needle (cannula) configured to pierce the patient's skin, and the liquid substance is delivered to the patient's body through the needle. In particular, if the liquid substance is to be applied slowly and / or regularly over a long period of time, the needle is advantageously connected to a delivery system including an automatic pump mechanism, wherein the pump mechanism is contained in the patch-like medical device. In particular, the pump mechanism generally includes a reservoir for containing the liquid, and the needle is ideally directly connected to the reservoir.

[0003] Different methods known in the art are to initially fill the reservoir and / or refill the reservoir with the liquid to be administered. A first method involves the use of pre-filled cartridges that are inserted directly into the patch-like medical device.

[0004] Another method comprises a reservoir with a syringe shape, which can be removed from a patch-like medical device, and the reservoir comprises an input adapter for a bottle, so that once the bottle is taken out from the patch, the bottle can be attached to the reservoir. In this case, the reservoir comprises a piston, and once the bottle is placed in an adapter, the piston can be manually actuated to suck liquid out of the bottle. The shortcoming that this method has is that the reservoir needs to be removed from the patch-like medical device to be refilled, which may increase the risk of contamination. In addition, the reservoir and the mechanism for actuating the piston need to be built in a sturdy manner to avoid damage or wear when taking out the reservoir, manually actuating the piston and repeatedly inserting the reservoir back into the patch-like medical device.

[0005] In the case where the reservoir cannot be removed from the patch-like medical device, it is known in the prior art to use a separate transfer syringe to first draw the liquid from the prefilled container and then inject the liquid into the reservoir. However, this method has the disadvantage of requiring a separate transfer syringe, which must be properly sterilized. In addition, if the user, such as a patient, is not properly trained or does not have the motor skills to properly operate the syringe, the liquid may be wasted in the transfer. Summary of the invention

[0006] In a first aspect, the object of the present invention is therefore to provide a filling aid which enables the reservoir of a patch pump to be filled with a liquid in a hygienically safe, simple and rapid manner.

[0007] This first object is achieved by a filling aid according to claim 1. Further embodiments of the invention are listed in the dependent claims.

[0008] The present invention provides a filling auxiliary assembly for filling a liquid into a reservoir of a patch pump, the patch pump comprising a piston arranged in the reservoir, the piston being movable to push the fluid out of the reservoir by displacement in a forward direction and to allow the fluid to fill the reservoir by displacement in a rearward direction,

[0009] Filling aid components include:

[0010] a cover member configured to be arranged on top of the patch pump, the cover member having an opening for accessing the reservoir when the cover member is arranged on top of the patch pump to enable fluid exchange between the reservoir and a prefilled container containing a liquid;

[0011] a shift ring, which surrounds the cover component and can rotate relative to the cover component, and a transmission gear assembly, which is arranged in the cover component,

[0012] The shift ring includes an internal toothing arrangement.

[0013] The transmission gear assembly engages with the internal gear device of the dial ring, and the transmission gear assembly includes an output element, which is used to connect with the drive mechanism of the patch pump to convert the rotational movement of the dial ring into the displacement of the piston in the forward direction and / or rearward direction in the reservoir.

[0014] Particularly since the patch pump is intended as a wearable device, the drive mechanism of the patch pump may be small and delicate. By providing a filling aid comprising a dial ring and a transmission gear assembly according to the present invention, operation becomes easier and the risk of damage to the drive mechanism of the patch pump is minimized, since the user does not need to directly contact the drive mechanism of the patch pump to move the piston.

[0015] The filling aid assembly may further comprise a holder configured to receive a prefilled container containing a liquid, the prefilled container being in particular a vial or a cartridge, wherein the holder may comprise a hollow needle defining a lumen, the needle having a sharp first end for piercing the prefilled container, and wherein the holder may have a holder insertion portion which is insertable into the opening of the cover member to engage with the patch pump, thereby enabling fluid exchange between the reservoir and the prefilled container via the lumen.

[0016] The holder may include a holder base and an adapter configured to receive a cartridge having a displaceable stopper that closes the cartridge at a first end. The adapter may include a safety cover to prevent the stopper from being ejected when the cartridge is received in the adapter. Such a safety cover may be particularly useful during the first stage of the filling process, in which a gas such as air may be pushed into the cartridge to create a positive pressure, which then facilitates the extraction of the liquid in the second stage of the filling process. In the absence of a safety cover, the stopper may be ejected from the cartridge due to the positive pressure, which may cause injury to the user and / or cause spillage of the liquid contained in the cartridge.

[0017] In addition, the adapter is removable from the holder base to allow the holder base to receive a vial having a diameter greater than the diameter of the cartridge when the adapter is removed. Providing a removable adapter allows for greater flexibility in the choice of pre-filled containers that can be used by the user to fill the reservoir of the patch pump. Preferably, the adapter is reusable.

[0018] Preferably, the needle is fixedly attached to the holder base. In this case, the holder base may be intended for single use and is therefore disposable.

[0019] The liquid contained in the prefilled container may in particular be a solution containing insulin. In the present disclosure, the terms "vial" and "cartridge" both refer to a bottle-like member closed at a first end by a pierceable septum. "Vial" is understood to be a closed bottom-closed. "Cartridge" is used in this context to describe a bottom-open cylindrical bottle-like member that closes the second end of the bottle-like member with a removable stopper. The diameter of the vial may be larger than the diameter of the cartridge.

[0020] Before filling the liquid into the reservoir, fluid that may have been contained in the reservoir, in particular gas, more specifically air or an inert gas such as nitrogen or argon, can be pushed out when the pre-filled container is fluidly connected to the reservoir to create a positive pressure in the pre-filled container, thereby facilitating the subsequent extraction of the liquid.

[0021] The cover part preferably has a window through which the reservoir can be seen when the cover part is arranged on top of the patch pump. The window can be a cutout in the cover part, which cutout can have the shape of the reservoir. It is also conceivable that the cutout is covered by a transparent window cover.

[0022] The cover member may also include indicia disposed adjacent the window that indicates different fill volumes of the reservoir to aid the user when the cover member is disposed on top of the patch pump.

[0023] The cover part protects the patch pump during the filling process when arranged on top of the patch pump. The prefilled container can be safely connected to the patch pump by having an opening in the cover part and a holder for the prefilled container that can be inserted into the opening. Ideally, the holder is inserted into the opening in the cover part before the prefilled container is placed in the holder to avoid liquid spilling once the septum of the prefilled container is pierced by the sharp first tip of the needle.

[0024] The filling aid assembly may further comprise a base member, wherein the cover member and the base member are connectable to form a cavity inside which the patch pump may be received.

[0025] The base component and / or the cover component may include alignment features that allow the base component and the cover component to be connected only when the cover component is in a predetermined orientation relative to the base component. These alignment features may be box-like alignment features, male features and female features that match the male features, or any other suitable features.

[0026] Ideally, the cover and base components form a cavity that is sealed when the components are connected in order to prevent dirt from entering the cavity and protect the patch pump.

[0027] The base member may be provided as part of a packaging that protects the patch pump prior to use. The base member may include means for securing the patch pump to the base member in a predetermined orientation relative to the base member. In particular, the base member may include a securing arm configured to engage with an edge of the patch pump to hold the patch pump in place.

[0028] Preferably, the cover part with the dial ring and / or the base part of the filling aid are reusable.

[0029] The cover member may include a cover and a support member that are separately manufactured and rigidly connected to each other, wherein the transmission gear assembly is arranged between the support member and the cover member. In particular, the transmission gear assembly can be at least partially mounted on the support member. In particular, the transmission gear assembly can be retained on the support member by a mounting plate that is screwed onto the support member. The cover member is preferably used to protect the transmission gear assembly, and preferably includes an opening for accessing the reservoir when the cover member is arranged on the top of the patch pump. The cover member and the support member can be connected to each other via a set of screws.

[0030] The shift ring can be held between the cover and the support member while being rotatable relative to the cover and the support member. This prevents the shift ring from being disengaged from the cover member, and in particular prevents the internal toothing of the shift ring from being disengaged from the transmission gear assembly.

[0031] The dial ring preferably has a peripheral outer surface, which is configured to be accessible to the user's hand to manually rotate the dial ring, and the peripheral outer surface is preferably textured. In this case, "textured" can refer to any surface modification that helps grip, in particular the outer surface can be grooved or roughened. Such a textured outer surface provides a good grip when manually operating the dial ring.

[0032] The transmission gear assembly may include a safety clutch configured to disconnect the rotational motion of the dial ring from the displacement of the piston when a torque above a predefined torque threshold is applied to the dial ring. As already mentioned, the drive mechanism of the piston in the patch pump may be fragile and may be easily damaged when excessive torque is applied to the drive mechanism. The safety clutch prevents the excessive torque from damaging the drive mechanism. Therefore, the user does not have to worry about having to self-regulate the amount of torque applied to the dial ring, which facilitates manipulation.

[0033] The safety clutch may comprise a first gear and a second gear which share a common central axis and are arranged one on top of the other along the common axis so as to form a friction connection, wherein the first gear preferably engages with an internal toothing of the shift ring.

[0034] Preferably, the first gear and the second gear are configured to rotate in unison due to the friction connection as long as the torque applied to the shift ring is lower than or equal to a predefined torque threshold, and the first gear is configured to slip relative to the second gear when the torque applied to the shift ring is higher than the predefined torque threshold.

[0035] The safety clutch may comprise a shaft extending along a common central axis, on which the first gear and the second gear are arranged. The shaft may have an end cap at a first end and a threaded portion at a second end, wherein the first gear may have a recess in which the end cap may be received so as to rotate with the first gear. The safety clutch may further comprise at least one nut which is screwed onto the threaded portion, thereby pressing the second gear against the first gear to produce a friction connection. In order to ensure a consistent predefined torque threshold, the safety clutch may further comprise a tensioning device, in particular at least one disc spring, arranged on the shaft between the at least one nut and the second gear, which is preferably combined with a keyed washer.

[0036] The output element of the transmission gear assembly may be an output gear mechanism engaged with the second gear of the safety clutch, wherein the output gear mechanism is configured to engage with a drive mechanism of the patch pump to achieve displacement of the piston in the reservoir.

[0037] The output gear mechanism may include an output gear engaged with the second gear of the safety clutch and a sliding sleeve extending vertically from the surface of the output gear. The sliding sleeve may be attached to the output gear, preferably attached to the output gear in an elastic manner via a spring. Preferably, the sliding sleeve is configured to receive the pin of the drive mechanism of the patch pump so that when the pin is received in the sliding sleeve, the pin rotates in unison with the output gear to drive the drive mechanism. Preferably, the cross section of the pin is star-shaped or any other shape suitable for handling high torque, particularly any non-circular symmetrical shape, and therefore can be form-fitted in the circumferential direction, and the sliding sleeve has a receiving portion with a matching cross section. The spring preferably allows the sliding sleeve to retract when the cover member is placed on the top of the patch pump to ensure that the output gear mechanism does not prevent the cover member from being fully assembled to the base member, even when the cross section of the pin is not initially aligned with the cross section of the receiving portion of the sliding sleeve.

[0038] In a second aspect, the present invention provides a medical assembly comprising:

[0039] a filling auxiliary component, the filling auxiliary component being as described above;

[0040] A patch pump is used to deliver fluid through the patient's skin. The patch pump includes:

[0041] a liquid reservoir for containing liquid;

[0042] a piston disposed within the reservoir, the piston being movable to push fluid out of the reservoir by displacement in a forward direction and to allow fluid to fill the reservoir by displacement in a rearward direction, and

[0043] The driving mechanism, in particular a piston gear system, is used to drive the piston.

[0044] The transmission gear assembly of the filling aid is engaged with the drive mechanism to convert the rotational movement of the dial ring into displacement of the piston in the forward direction and / or the rearward direction within the reservoir.

[0045] The reservoir of the patch pump may include an input nozzle, wherein the needle is received inside the input nozzle when the holder insertion portion is inserted into the opening of the cover member, and wherein the insertion portion is preferably configured to connect to the input nozzle via a releasable snap-fit ​​connection. In particular, the holder insertion portion may include a cantilever that engages with a notch on the input nozzle. The input nozzle may be covered by a nozzle diaphragm. The needle may have a sharp second end for piercing the nozzle diaphragm.

[0046] The reservoir may have an annular shape, whereby the piston preferably moves along a circle within the reservoir, wherein the circle and the dial ring are concentric when the filling aid assembly and the patch pump are assembled. Such an annular shape may enable a compact arrangement of components in the patch pump, resulting in a smaller overall size, which increases the comfort of the patient wearing the patch pump.

[0047] In a preferred embodiment, rotating the dial ring in a first rotational direction, in particular clockwise, causes the piston to move in a forward direction and thereby pushes fluid, in particular gas, more particularly air or an inert gas, out of the reservoir before the reservoir is filled with liquid, thereby generating a positive pressure in particular in a prefilled container containing liquid in fluid exchange with the reservoir, and wherein rotating the dial ring in a second rotational direction opposite to the first rotational direction, in particular counterclockwise, causes the piston to move backward and thereby allows liquid to flow through the lumen of the needle into the reservoir when the prefilled container is arranged in fluid exchange with the reservoir. In particular, the backward movement of the piston can allow liquid to flow through the lumen of the needle into the reservoir by the effect of the positive pressure previously generated in the prefilled container by the forward movement of the piston. Additionally or alternatively, the backward movement of the piston can cause a negative pressure in the reservoir, which draws liquid into the reservoir through the lumen of the needle. In order to eliminate gas bubbles in the liquid filled into the liquid reservoir, the dial ring can be slowly rotated backward and forward in the second rotation direction and the first rotation direction, respectively, so that the piston produces a small backward displacement and forward displacement. In order to make the piston optimally prepared for the subsequent process, which includes delivering at least a portion of the liquid to the user, the backward and forward displacement of the piston is preferably ended with a displacement in the forward direction.

[0048] Preferably, the reservoir is transparent or translucent to allow visual detection of gas bubbles in the liquid that has been filled into the reservoir. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The preferred embodiments of the present invention are described below with reference to the accompanying drawings, which are for the purpose of illustrating the preferred embodiments of the present invention, rather than for the purpose of limiting the present invention.

[0050] Figure 1 shows a partially exploded perspective view of a medical assembly including a filling aid assembly according to an embodiment of the present invention;

[0051] Figure 2 Shown according to Figure 1 A first perspective view of a retainer base of an embodiment of ;

[0052] Figure 3 Shows Figure 2 A second perspective view of the retainer base;

[0053] Figure 4 Shows Figure 2 A front view of a retainer base;

[0054] Figure 5 A patch pump is shown;

[0055] Figure 6 Shown along Fig.11 The section plane AA marked in the assembled state Figure 1 A cross-sectional view of a medical component;

[0056] Figure 7 Shown according to Figure 1 A top view of a cover member having a dial ring according to an embodiment of the present invention;

[0057] Figure 8 Shows Figure 7 A side view of a cover member with a dial ring;

[0058] Fig. 9 Shows Figure 7 A three-dimensional view of a cover component with a dial ring;

[0059] Fig.10 The assembled state without the retainer is shown according to Figure 1 A perspective view of a medical assembly of an embodiment of the present invention;

[0060] Fig.11 Shows Fig.10 A top view of an embodiment of the invention;

[0061] Fig.12 Shows Figure 1 An exploded perspective view of a cover member, a shift ring and a transmission gear assembly according to an embodiment of the present invention;

[0062] Fig.13 Shown according to Figure 5 A top view of a patch pump according to an embodiment of the present invention;

[0063] Fig.14 Shown according to Figure 5 A stereogram of a patch pump and an exploded stereogram of an output gear mechanism according to an embodiment of the present invention;

[0064] Fig.15 Shown according to Figure 1 A cross-sectional view of a safety clutch of an embodiment of the present invention;

[0065] Fig.16 Shows Fig.15 An exploded perspective view of a safety clutch;

[0066] Fig.17 Shown according to Figure 1 A cross-sectional view of an output gear mechanism of an embodiment of the present invention;

[0067] Fig.18 Shows Fig.17 An exploded perspective view of the output gear mechanism;

[0068] Fig.19 Shown according to Figure 1 A cross-sectional view of a shift ring, a safety clutch and an output gear mechanism of an embodiment of the present invention;

[0069] Fig. 20 Shown according to Figure 1 An exploded cross-sectional view of the dial ring, the safety clutch and the base component of an embodiment of

[0070] Fig.21 Shown along Fig.11 The section plane BB is marked in Figure 6 A cross-sectional view of an embodiment of the present invention. DETAILED DESCRIPTION

[0071] Figure 1 A medical assembly according to an embodiment of the present invention is illustrated. The medical assembly comprises a filling aid assembly 1 and a patch pump 100 .

[0072] The filling aid assembly 1 includes a cover member 2 and a base member 6 that can be connected to form a cavity, and a patch pump 100 having a reservoir 101 to be filled can be as follows Figure 1 The filling auxiliary component 1 also includes a dial ring 4 surrounding the cover part 2, and the dial ring 4 can rotate relative to the cover part 2. The cover part 2 has an opening 21, which is used to access the reservoir 101 of the patch pump 100 when the cover part 2 is arranged on the top of the patch pump 100. In order to be able to fill the reservoir 101 through the opening 21, the opening 21 needs to be correctly aligned with the reservoir 101. When assembling this embodiment of the medical assembly, the patch pump 100 is first placed on the base part 6 in the correct direction. To this end, the base member 6 may include a fixed arm 64, and the patch pump 100 may include a flat piece 106 attached to the bottom surface of the patch pump 100, wherein the flat piece 106 has an alignment hole 107 to be aligned so that the fixed arm 64 can reach the alignment hole 107 through the flat piece and engage with the edge 108 of the patch pump 100 to hold the patch pump 100 in place on the base member 6.

[0073] To then facilitate alignment of the cover component 2 relative to the base component 6, and therefore also relative to the alignment of the patch pump 100 with the reservoir 101, the base component 6 may include box-shaped alignment features 61 distributed along the inner edge of the base component 6. Preferably, at least one box-shaped alignment feature 61 includes a snap arm 62, which is used to make a "click" sound when engaged with the cover component 2 to inform the user that the cover component 2 and the base 6 are correctly connected. In addition, the cover component 2 may include a male feature 24 that engages with a corresponding notch 63 of the outer edge of the base component 6.

[0074] The filling aid assembly 1 also includes a holder 3 for receiving a prefilled container containing a liquid to be filled into the patch pump 100. The prefilled container is closed at a first end by a pierceable septum. The holder 3 shown here includes a holder base 33 and an adapter 34. The holder base 33 is configured to directly receive a vial 11 having a specific standardized vial diameter, while the adapter 34 can be inserted into the holder base 33 to receive a prefilled container, in particular a cartridge 10, having a diameter smaller than the standardized vial diameter. Figure 1 The adapter 34 shown in FIG. 3 is particularly suitable for receiving a cartridge having a first end closed by a pierceable septum and a second end closed by a bung 12, because the adapter 34 includes a safety cover 35 that covers the second end of the cartridge 10 when the cartridge is located in the adapter 34, thereby preventing the bung from being ejected from the cartridge 10 when a gas, such as air, is pumped into the cartridge before extracting the liquid contained in the cartridge 10. In particular, the adapter 34 may have a receiving portion configured to receive and hold the cartridge 10, and an arm portion extending from the receiving portion along the cartridge 10 when the cartridge 10 is placed in the adapter 34. The safety cover 35 may protrude from the arm portion at a certain angle so as to extend above and parallel to the second end of the cartridge 10 when the cartridge 10 is located in the adapter 34, so that the second end is covered. The adapter 34 may be configured to only partially surround the cartridge 10 in the circumferential direction, i.e. the adapter 34 may be open to one side so that the cartridge can be inserted into the adapter from said side, i.e. in a direction parallel to the safety cover, such as Figure 1 as shown in .

[0075] The holder 3 , in particular, the holder base 33 has an insertion portion 32 that can be inserted into the opening 21 of the cover member 2 . Figures 2 to 4 An enlarged view of the retainer base 33 is shown in FIG. Figure 2 and Figure 3 is a stereogram, and Figure 433 is a front view of the holder base 33. The holder base 33 includes a hollow needle 31 defining a lumen. The needle 31 has a sharp first end 311 arranged to pierce the septum of the prefilled container and a sharp second end 312 arranged in the insertion portion 32. Figure 5 1 shows a perspective view of a patch pump 100. The reservoir 101 includes an input nozzle 105, Figure 5 An enlarged view of the input nozzle 105 can be seen in the inset of FIG. The input nozzle 105 has a substantially cylindrical shape extending vertically upward in a direction perpendicular to the displacement direction of the piston 102 in the reservoir 101, and is arranged at the end of the reservoir 101 and fluidly connected to the end of the reservoir 101. The insertion portion 32 has a cantilever 321, and the input nozzle 105 has a matching indentation, which enables the insertion portion 32 to be connected to the input nozzle 105 in a releasable snap-fit ​​manner when the holder insertion portion 32 is inserted into the opening 21 of the cover member 2. The input nozzle 105 may be covered by a septum, in which case the sharp second end 312 of the needle 31 pierces the septum when the insertion portion 32 is engaged with the input nozzle 105. The sharp second end 312 of the needle 31 preferably does not protrude beyond the cantilever 21 to prevent damage to the needle 31 and injury to the user.

[0076] Figure 6 Shown along Figure 1 The cross-sectional plane A'-A' of the medical component (such as Fig.11 ), wherein all parts are assembled. The sharp first end 311 of the needle 31 reaches the cartridge 10 arranged in the adapter 34 entering the holder 3, and the sharp second end 312 of the needle reaches the input nozzle 105 entering the reservoir 101 to achieve fluid exchange between the cartridge 10 and the reservoir 101.

[0077] Figures 7 to 9 The cover part 2 and the dial ring 4 surrounding the cover part 2 are shown. Figure 7 A top view is shown, in which the opening 21 is clearly visible, and Figure 8 A side view is shown and Fig. 9 The cover part 2 also has a window 27, through which the reservoir can be ideally viewed when the cover part 2 is arranged on top of the patch pump. The window 27 can be a cutout in the cover part 2, which has the shape of the reservoir 101, such as Figure 7 It is also conceivable that the cutout is covered by a transparent window cover (not shown here).

[0078] Fig.10 In stereogram and Fig.11 Shown in top view Figure 1 A medical component without a retainer 3. Fig.10 and Fig.11 As can be seen in FIG, the patch pump includes a piston 102 arranged in a reservoir 101. The piston 102 is movable to push the fluid out of the reservoir 101 through the input nozzle 105 by displacement in the forward direction, and to allow the fluid to fill the reservoir 101 by displacement in the rearward direction. The piston 102 in the reservoir 101 can be moved forward and backward by rotating the dial ring 4. Preferably, the piston 102 includes a piston head 1022, the cross-section of which matches the cross-section of the reservoir 101, and the piston 102 includes a sealing element surrounding the piston head 1022, which slides along the inner wall of the reservoir 101 when the piston head 1022 moves forward and backward, thereby sealing the reservoir 101 at one end.

[0079] In the preferred embodiment shown here, the reservoir has an annular shape, and the piston 102 therefore moves along a circle inside the reservoir 101 , wherein the circle and the dial ring 4 are concentric.

[0080] Preferably, when the prefilled container 10, 11 is installed in the holder 3, rotating the dial ring 4 in the clockwise direction causes the piston 102 to move in the forward direction, and thus pushes the gas, especially the air of the reservoir 101, into the prefilled container 10, 11 through the lumen of the needle 31 to generate a positive pressure in the prefilled container. Then, rotating the dial ring 4 in the counterclockwise direction causes the piston 102 to move backward, and thus generates a negative pressure, so as to allow the liquid to flow out of the prefilled container 10, 11 through the lumen of the needle 31 into the reservoir 101. Preferably, the reservoir 101 is as shown in FIG. Fig.10 and Fig.11 2 is transparent or translucent, so that the user can observe the piston 102 and the filling state through the window 27 in the cover 22 of the cover part 2. If the user observes gas bubbles in the liquid filled into the reservoir 101, the user can slowly rotate the dial ring back and forth to cause a small forward and backward displacement of the piston to remove the bubbles. The reciprocating displacement of the piston preferably ends with a displacement in the forward direction. Ending with the displacement in the forward direction causes the sealing element surrounding the piston head 1022, which can be made of a flexible material, to be oriented in a defined starting position, which enables a more reliable and more accurate application of the first dose of liquid to the user than when the sealing element is in an undefined twisted state after the displacement in the backward direction.

[0081] In some embodiments, a portion of the cover member 2 may be provided adjacent to the window 27, in particular as Fig.11 In the embodiment shown in FIG. 1 , a mark 28 is arranged on the cover 22 of the cover part 2 , thereby indicating different filling volumes to the user. Alternatively, the mark 28 can also be arranged on the reservoir 101 .

[0082] Fig.12 An exploded view of the cover part 2 and the shift ring 4 and the transmission gear assembly 5 is shown. The cover part 2 comprises a cover 22 and a support part 23 which are connected to each other in the assembled state, in particular via screws 29. The cover 22 comprises an opening 21 into which a retainer insertion portion 32 can be inserted. The shift ring 4 is held between the cover 22 and the support part 23 and can rotate relative to the cover 22 and the support part 23. In particular, the cover 22 has a cover edge 25 which rests on an inner edge 43 of the shift ring 4 when the cover part is assembled, the inner edge 43 protruding radially inwards.

[0083] In this preferred embodiment, the dial ring has a peripheral outer surface 42 which is textured, in particular presenting a plurality of grooves arranged adjacent to each other around the entire peripheral outer surface 42, so as to facilitate gripping the dial ring 4 so as to rotate the dial ring 4 with one hand while preferably holding the base part 6 with the other hand.

[0084] The shift ring 4 includes a radially inward internal tooth device 41, which is engaged with the transmission gear assembly 5. The transmission gear assembly 5 is arranged between the support member 23 and the cover member 22. Fig.12 As shown in , the transmission gear assembly can be mounted on the support member 23 and held in place by a mounting plate 53 which is screwed to the support member 23 using screws 29.

[0085] The transmission gear assembly 5 includes an output element, which is used to connect with the driving mechanism of the patch pump to convert the rotational movement of the dial ring 4 into the displacement of the piston 102 in the reservoir 101 in the forward direction and / or the backward direction.

[0086] In the embodiment shown here, the output element is an output gear mechanism 52, which is configured to engage with the piston gear system 103 of the patch pump 100 to achieve displacement of the piston 102 in the reservoir 101. Fig.13 It is visible in the top view.

[0087] exist Fig.14, a patch pump 100 is shown in a perspective view together with an output gear mechanism 52. In addition to the output gear 521, the output gear mechanism 52 also includes a sliding sleeve 522 extending vertically from the surface of the output gear 521, the sliding sleeve 522 being elastically attached to the output gear via a spring 523 and configured to slide along the rotation axis of the output gear 521. The piston gear system 103 of the patch pump 100 includes a pin 104, and the sliding sleeve 522 is configured to receive the pin 104, in particular to establish a form fit with respect to the circumferential direction, so that the pin 104 rotates in unison with the output gear 521 to drive the piston gear system 103. The pin 104 in the embodiment shown here has a star-shaped cross section, and the sliding sleeve 522 has a receiving portion with a matching cross section. The spring 523 allows the sliding sleeve 522 to retract when the cover part 2 is placed on top of the patch pump 100, to ensure that the output gear mechanism 52 will not prevent the cover part 2 from being fully assembled onto the base part 6, even if the cross section of the pin 104 is not initially aligned with the cross section of the receiving portion of the sliding sleeve 522. In this case, once the cover part 2 and the base part 6 are assembled, the receiving portion of the sliding sleeve 522 can first be rotated slightly by rotating the dial ring 4 until the cross sections are aligned and the sliding sleeve 422 slides onto the pin 104.

[0088] like Fig.13 As shown in , the pin 104 can be attached to a first piston gear 109, which in turn can transmit the rotation of the first piston gear 109 to at least the second piston gear 110, which engages with an internal tooth arrangement (not visible here) of the arm 1021 of the piston 102 to convert the rotation of the second piston gear 110 into a circular displacement of the piston 102. The arm 1021 of the piston 102 extends beyond the reservoir 101 along the edge 108 of the patch pump 100, thereby following the curvature of the edge 108. A clamping element 111 can be arranged on the arm 1021 of the piston 102 so as to hold the arm 1021.

[0089] like Fig.12 As shown in Fig.15 and Fig.16 As shown in more detail in , the transmission gear assembly 5 comprises a safety clutch 51 configured to decouple the rotational movement of the dial ring 4 from the displacement of the piston 102 when a torque above a predefined torque threshold is applied to the dial ring 4 .

[0090] Fig.15 A cross-sectional view of the safety clutch 51 is shown, and Fig.16The safety clutch 51 is shown in an exploded view. The safety clutch 51 comprises a first gear 511 and a second gear 512 which share a common central axis A and are arranged one on top of the other along the common axis A. In the present embodiment, the first gear 511 has a larger diameter than the second gear 512 and is directly engaged with the internal toothing 41 of the shift ring 4, while the second gear 512 is engaged with the output gear 521 of the output mechanism 52.

[0091] The cross-sectional view of the output mechanism 52 is as follows: Fig.17 As shown in Fig.18 An exploded view of the output mechanism 52 is shown having an output gear 521 , a sliding sleeve 522 and a spring 523 .

[0092] The safety clutch 51 includes a shaft 513 extending along a common central axis, the shaft 513 having an end cap 514 at a first end and a threaded portion 515 at a second end. The shaft has a D-shaped cross-section as it approaches the first end (i.e., where there is no thread). A first gear 511 and a second gear 512 are arranged on the shaft 513. The first gear 511 has a recess for receiving the end cap. The end cap may have at least one straight edge or another key feature that matches the corresponding shape of the recess, so that the end cap is forced to rotate with the first gear 511 when received in the recess. In addition, the first gear 511 has a D-shaped center hole, the shape of which is fitted to the cross-section of the shaft 513, so that the first gear 511 rotates in unison with the shaft 513. However, the second gear 512 has a center hole that allows the shaft to rotate freely, so that the rotation of the shaft does not automatically drive the rotation of the second gear 512. The safety clutch 51 includes at least one nut 516, which is screwed into the center hole of the shaft 513. Fig.13In the embodiment shown, two nuts 516 are screwed onto the threaded portion of the shaft 515 to press the second gear 512 against the first gear so as to produce a friction connection between the first gear 511 and the second gear 511. To improve the tensioning, the safety clutch 51 may include a keyed washer 517 with a D-shaped hole and a disc spring 518 arranged on the shaft 513 between the second gear 512 and the nut 516. Due to the friction connection, the second gear 512 rotates in unison with the first gear 511 as long as the torque applied to the dial ring 4 is lower than or equal to a predefined torque threshold. The predefined torque threshold depends on the force with which the first gear 511 and the second gear are pressed against each other, i.e., in this case, on the degree to which the nut 516 is tightened. When the torque applied to the dial ring 4 and transmitted to the first gear 511 is higher than the predefined torque threshold, the first gear 511 slips relative to the second gear 512 and the rotation is no longer transmitted to the second gear 512. Since the second gear 512 is engaged with the output gear 521, the rotational movement of the dial ring will no longer be converted into the displacement of the piston 102 of the patch pump 100. Therefore, the safety clutch 51 prevents excessive torque from being applied to the piston gear system 103, thereby protecting the piston gear system 103 from potential damage.

[0093] Fig.19 A cross-sectional view of the shift ring 4 , the safety clutch 51 and the output gear mechanism 52 is shown, wherein the engagement of the first gear 511 with the internal toothing 41 of the shift ring 4 and the engagement of the second gear 512 with the output gear 521 can be seen.

[0094] Fig. 20 The cover part 2, the dial ring 4, the patch pump 100 and the base part 6 are shown in a cross-sectional view. The dashed arrows indicate how these parts are assembled. As can be seen in this cross-sectional view, the transmission gear assembly 5 is basically arranged on the support part 23 of the cover part 2, wherein the sliding sleeve 522 of the output gear mechanism 52 protrudes into the recess 26 defined by the support part 23, and the recess 26 forms a cavity with the base part 6, and the patch pump 100 is received in the cavity when the cover part 2 and the base part 6 are connected. In addition, the snap arm 62 and the fixed arm 64 of the base part 6 described above can be seen in this cross-sectional view.

[0095] Fig.21 Shows Figure 6 A cross-sectional view of a medical component, but at a different angle, i.e. along Fig.11 The cross-sectional plane BB marked in FIG. 1 shows a cross-sectional view of the medical assembly to show the engagement of the transmission mechanism 5 with the piston gear system 103 of the patch pump 100. In particular, Fig.21It is shown that the pin 104 of the piston gear system 103 is received in the sliding sleeve 522 of the output gear mechanism 52, thus depicting how the rotation of the dial ring 4 causes the rotation of the first gear 511 of the clutch 51. If the torque is higher than the above-mentioned predefined threshold, the rotation of the first gear 511 will carry the rotation of the second gear 512 due to the friction connection, and the rotation of the second gear 512 will in turn cause the rotation of the output gear 521, and thus cause the rotation of the sliding sleeve 522, which then drives the displacement of the piston by rotating the pin 104.

[0096] Reference numerals

[0097] 1 Filling auxiliary assembly 516 Nut

[0098] 2 Cover assembly 517 Key joint washer

[0099] 21 Opening 518 Disc spring

[0100] 22 Covering member 52 Output gear mechanism

[0101] 23 Support component 521 Output gear

[0102] 24 convex feature 522 sliding sleeve

[0103] 25 Cover edge 523 Spring

[0104] 26 Recess 53 Mounting plate

[0105] 27 Window 6 Base part

[0106] 28 Mark 61 Box Alignment Feature

[0107] 29 Screw 62 Clip arm

[0108] 3 Retainer 63 Cutout

[0109] 31 Hollow needle 64 Fixed arm

[0110] 311 sharp first end 10 cartridge

[0111] 312 sharp second end 11 vial

[0112] 32 Retainer insert portion 12 Plug

[0113] 321 Cantilever 100 Patch Pump

[0114] 33 holder base 101 reservoir

[0115] 34 Adapter 102 Piston

[0116] 35 Safety cover 1021 Piston arm

[0117] 4 Shifter 1022 Piston head

[0118] 41 Internal gearing 103 Piston gear system

[0119] 42 peripheral outer surface 104 pin

[0120] 43 inner edge 105 input nozzle

[0121] 5 Transmission gear assembly 106 Flat parts

[0122] 51 Safety clutch 107 Alignment hole

[0123] 511 first gear 108 edge

[0124] 512 Second gear 109 First piston gear

[0125] 513 shaft 110 second piston gear

[0126] 514 end cap 111 clamping element

[0127] 515 Threaded part

Claims

1. A filling auxiliary component (1), the filling auxiliary component (1) being used to fill a liquid into a reservoir (101) of a patch pump (100), the patch pump (100) comprising a piston (102) arranged in the reservoir (101), the piston (102) being movable to push the fluid out of the reservoir by displacement in a forward direction, and to allow the fluid to fill the reservoir (101) by displacement in a backward direction, The filling auxiliary component (1) comprises: a cover member (2), the cover member (2) being configured to be arranged on the top of the patch pump, the cover member having an opening (21), the opening (21) being used to access the liquid reservoir when the cover member (2) is arranged on the top of the patch pump (100), so as to achieve fluid exchange between the liquid reservoir (101) and the prefilled container (10) containing the liquid; a dial ring (4), the dial ring (4) surrounding the cover member (2) and being rotatable relative to the cover member (2); and a transmission gear assembly (5), wherein the transmission gear assembly (5) is arranged inside the cover component (2), Wherein, the shift ring (4) comprises an internal tooth device (41), wherein the transmission gear assembly (5) engages with the internal tooth device (41) of the shift ring (4), and The transmission gear assembly (5) includes an output element, which is used to connect to the driving mechanism of the patch pump to convert the rotational movement of the dial ring (4) into the displacement of the piston (102) in the forward direction and / or backward direction in the liquid reservoir (101).

2. The filling aid assembly according to claim 1 further comprises a holder (3) configured to receive the prefilled container containing the liquid, the prefilled container being in particular a vial (11) or a cartridge (10), the holder (3) comprising a hollow needle (31) defining a lumen, the needle (31) having a sharp first end (311) for piercing the prefilled container (10), in, The holder (3) has a holder insertion portion (32) which can be inserted into the opening (21) of the cover member (2) to engage with the patch pump (100), thereby enabling fluid exchange between the reservoir (101) and the prefilled container (10) via the lumen.

3. The filling aid assembly according to claim 2, wherein: The retainer (3) comprises: a retainer base (33), and an adapter (34) configured to receive a cartridge (10) having a displaceable stopper (12) closing the cartridge (10) at a first end, wherein the adapter (34) comprises a safety cover (35) configured to cover the first end of the cartridge to prevent the stopper (12) from being ejected when the cartridge is received in the adapter (34), and Wherein the adapter (34) is removable from the holder base (34) to allow the holder base (33) to receive a vial (11) having a diameter greater than the diameter of the cartridge (10) when the adapter (34) is removed.

4. The filling aid assembly according to any one of the preceding claims, further comprising a base member (6), wherein: The cover member (2) and the base member (6) are connectable to form a cavity configured to receive the patch pump (100).

5. A filling aid assembly according to any one of the preceding claims, wherein: The cover member (2) comprises a cover member (22) and a support member (23) which are separately manufactured and rigidly connected to each other. Wherein, the transmission gear assembly (5) is arranged between the supporting component (23) and the covering component (22).

6. The filling aid assembly according to claim 5, wherein: The dial ring (4) is held between the cover (22) and the support member (23), and is rotatable relative to the cover (22) and the support member (23), and / or The dial ring (4) has a peripheral outer surface (42), which is configured to be accessible by a user's hand for manually rotating the dial ring, and the peripheral outer surface (42) is preferably textured.

7. A filling aid assembly according to any one of the preceding claims, wherein: The transmission gear assembly (5) comprises a safety clutch (51) configured to decouple the rotational movement of the dial ring (4) from the displacement of the piston (102) when a torque above a predefined torque threshold is applied to the dial ring (4).

8. The filling aid assembly according to claim 7, in, The safety clutch (51) comprises a first gear (511) and a second gear (512), the first gear (511) and the second gear (512) sharing a common central axis (A) and arranged one on top of the other along the common axis (A) so as to form a friction connection, wherein the first gear (511) is engaged with the internal gear device (41) of the shift ring (4), wherein the first gear (511) and the second gear (512) are configured to rotate in unison due to the friction connection as long as the torque applied to the shift ring (4) is lower than or equal to the predefined torque threshold, and Wherein, the first gear (511) is configured to slide relative to the second gear (512) when the torque applied to the shift ring is higher than the predefined torque threshold.

9. The filling aid assembly according to claim 8, wherein: The safety clutch (51) comprises a shaft (513) extending along the common central axis, the first gear (511) and the second gear (512) being arranged on the shaft (513), the shaft (513) having an end cap (514) at a first end and a threaded portion (515) at a second end, wherein the first gear (511) has a recess in which the end cap is received so as to rotate together with the first gear, and Wherein, the safety clutch (51) further comprises at least one nut (516), wherein the at least one nut (516) is screwed onto the threaded portion (515), thereby pressing the second gear (512) against the first gear (511) to generate the friction connection.

10. The filling aid assembly according to claim 8 or 9, wherein: The output element of the transmission gear assembly (5) is an output gear mechanism (52) engaged with the second gear (512) of the safety clutch (5), wherein the output gear mechanism (52) is configured to engage with the drive mechanism of the patch pump (100) to achieve the displacement of the piston (102) in the fluid reservoir (101).

11. The filling aid assembly according to claim 10, wherein: The output gear mechanism (52) comprises: an output gear (521) engaged with the second gear (512) of the safety clutch (51), and a sliding sleeve (522) extending vertically from the surface of the output gear (521) and attached to the output gear (521), preferably elastically attached to the output gear (521) via a spring (523), The sliding sleeve (522) is configured to receive a pin (104) of a driving mechanism of the patch pump (100), so that when the pin (104) is received in the sliding sleeve (522), the pin (104) rotates in unison with the output gear (521) to drive the driving mechanism of the patch pump.

12. A medical component, comprising: A filling aid assembly (1) according to any one of the preceding claims; as well as A patch pump (100) is used to deliver a liquid through the skin of a patient, the patch pump (100) comprising: A liquid reservoir (101), the liquid reservoir (101) being used to contain liquid; a piston (102) disposed within the reservoir (101), the piston being movable to push fluid out of the reservoir by displacement in a forward direction and to allow fluid to fill the reservoir (101) by displacement in a rearward direction; a drive mechanism, in particular a piston gear system (103), wherein the piston gear system (103) is used to drive the piston (102); Wherein, the transmission gear assembly (5) of the filling auxiliary assembly (1) is engaged with the driving mechanism of the patch pump to convert the rotational movement of the dial ring (4) into the displacement of the piston (102) in the fluid reservoir (101) in the forward direction and / or the backward direction.

13. The medical assembly according to claim 12, wherein: The liquid reservoir (101) of the patch pump (100) comprises an input nozzle (105), wherein the needle (31) is received inside the input nozzle (105) when the retainer insertion portion (32) is inserted into the opening (21) of the cover member (2), and wherein the insertion portion (32) is preferably configured to be connected to the input nozzle (105) via a releasable snap-fit ​​connection.

14. The medical assembly according to claim 12 or 13, wherein: The reservoir (101) has an annular shape, whereby the piston (102) moves along a circle within the reservoir (101), wherein the circle and the dial ring (4) are concentric when the filling auxiliary assembly (1) and the patch pump (100) are assembled.

15. The medical assembly according to any one of claims 12 to 14, wherein Rotating the dial ring (4) in a first rotational direction, in particular rotating the dial ring (4) clockwise, causes the piston (102) to move in the forward direction and thereby push fluid, in particular gas, out of the reservoir (101) before filling with the liquid, thereby in particular causing a positive pressure in a pre-filled container containing the liquid in fluid communication with the reservoir, and Wherein, rotating the dial ring (4) in a second rotational direction opposite to the first rotational direction, in particular rotating the dial ring (4) counterclockwise, causes the piston (102) to move backward, thereby allowing the liquid to flow through the lumen of the needle (31) and enter the reservoir when the prefilled container (10) is arranged to exchange fluid with the reservoir.

16. The medical assembly according to any one of claims 12 to 14, wherein The reservoir is transparent or translucent to allow visual detection of gas bubbles in the liquid that has been filled into the reservoir.

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