Manifold combined with insertion mechanism of a fluid delivery device for filling and large volume direct injection

Abstract

An injection mechanism for a fluid delivery device has a manifold configured to cooperate with a button for slidable engagement within a frame. The manifold and frame have openings for selective fluidic connection to other components related to the fluid delivery device such as a monodirectional pump, a reservoir and a primary container for storing fluid used to full the reservoir. Some manifold openings have a fluid channel connected therebetween. At least one manifold opening has a fluid channel connected between it and a fluid channel of a needle or catheter that is inserted into a patient. The manifold openings are arranged along the manifold such that a subset of the manifold openings are aligned with the frame openings when the button is in a first position, and a different subset of the manifold openings are aligned with the frame openings when the button is in a second position.

Description

MANIFOLD COMBINED WITH INSERTION MECHANISM OF A FLUID DELIVERYDEVICE FOR FILLING AND LARGE VOLUME DIRECT INJECTIONBACKGROUNDField:

[0001] Illustrative embodiments relate generally to an injection module with an integrated manifold that allows filling a fluid delivery' device reservoir directly from a primary container and for large volume manual direct injection.Description of Related Art:

[0002] Bolus and / or infusion pump therapy generally requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the patient's skin and through which infusion of a medicament takes place. Infusion pump therapy offers the advantages of continuous infusion, precision dosing, and programmable delivery schedules.

[0003] To facilitate drug delivery therapy, there are generally two types of pumps, namely, conventional pumps and patch pumps. Conventional pumps require the use of a disposable component, typically referred to as an infusion set, tubing set or pump set, which conveys the medicament from a reservoir within the pump into the skin of the user. The infusion set consists of a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal infusion needle or flexible plastic catheter extends. The base typically has an adhesive that retains the base on the skin surface during use. The cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit required by the user.

[0004] Another type of insulin pump is a patch pump. Unlike a conventional infusion pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism and mechanism for automatically inserting the cannula, in a single housing which is adhesively attached to an infusion site on the patient's skin, and does not require the use of a separate infusion or tubing set. A patch pump containing a medicament adheres to the patient’s skin and delivers the medicament over a period of time or at a selected time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separatecontroller device, while others are completely self-contained. Such devices can be replaced on a frequent basis, such as every three days, when the medicament reservoir is exhausted or when complications may otherwise occur, such as restriction in the cannula or the infusion site.

[0005] As patch pumps are designed to be a self-contained unit that is worn by the user (e.g., patient), it is preferable to be as small as possible so that it does not interfere with the activities of the user. Thus, in order to minimize discomfort to the user, it would be preferable to minimize the overall thickness of the patch pump. However, in order to minimize the thickness of the patch pump, the constituent parts of the patch pump should be reduced in size and possibly in number as much as possible.

[0006] Some patch pumps can be designed with reservoirs that are integrated as opposed to a patch pump in which a pre-fdled cartridge is inserted into the patch pump housing. Patch pumps with integrated reservoirs may require fdling after patch pump assembly at the manufacturing stage, or at the end user stage wherein a healthcare provider or patch pump wearer provides a medicament to the patch pump reservoir using a filling method. A need exists for a mechanism and / or process to improve automatic filling of a reservoir in a patch pump.SUMMARY

[0007] The above and other problems are overcome, and additional advantages are realized, by illustrative embodiments.

[0008] It is an aspect of illustrative embodiments to provide an injection mechanism for a fluid delivery device that delivers a fluid medicament to a patient, the fluid delivery device having a pump for providing a controlled amount of the medicament from a reservoir to the injection mechanism. The injection mechanism comprises: a patient interface fluid channel member comprising a fluid channel, at least a portion of the patient interface fluid channel member being insertable into the patient’s skin; a button; a frame; and a manifold. The frame side walls that define a frame interior space, the frame having a proximal frame end configured to receive at least a portion of the button into the frame interior space, and adistal frame end from which the patient interface fluid channel member can be configured to extend for insertion into the patient’s skin. The frame has a plurality of frame openings in the frame side walls. The manifold comprises a manifold housing with manifold side walls that define a manifold interior space, the manifold housing having a throughway within the manifold interior space that is configured to receive at least a portion of the patient interface fluid channel member. The manifold housing has a proximal manifold end coupled to a distal button end of the button and a distal manifold end with a distal opening from which the patient interface fluid channel member can be configured to extend. The button is slidably- engaged with respect to the frame to translate along a longitudinal axis of the frame and configured to be placed in at least a first button position with respect to the frame whereby the button is inserted a first distance into the frame interior space and along the longitudinal axis of the frame, and a second button position with respect to the frame whereby the button is inserted a second distance into the frame interior space along the longitudinal axis of the frame that is different from the first distance. The manifold housing is slidably engaged with respect to the frame to translate with the button along the longitudinal axis of the frame and comprises a plurality of manifold fluid openings in the manifold side walls, and a plurality of fluid channels comprising manifold fluid channels arranged between selected ones of the manifold fluid openings, and at least one manifold fluid channel arranged between one of the manifold fluid openings and the fluid channel of the patient interface fluid channel member.

[0009] In accordance with aspects of illustrative embodiments, the first subset of the manifold openings are arranged in the manifold housing at first positions along a longitudinal axis of the manifold, and the second subset of the manifold openings are arranged in the manifold housing at second positions along the longitudinal axis of the manifold that are distanced from the first positions and closer to the proximal manifold end.

[0010] In accordance with aspects of illustrative embodiments, the plurality of manifold fluid openings are arranged such that a first subset of the plurality of manifold fluid openings align with respective ones of the frame openings when the button is in the first button position, and a second subset of the plurality of manifold fluid openings align within respective ones of the frame openings when the button is in the second button position, the second subset having at least one of the plurality of manifold fluid openings that is not also inthe first subset and the second button position utilizing at least one of the plurality of manifold fluid channels in the manifold that is not also utilized in the first button position.

[0011] In accordance with aspects of illustrative embodiments, the medicament is provided in a container from which the reservoir in the fluid delivery device can be filled, the plurality of manifold fluid openings in the manifold housing comprising two pairs of openings employed with the button in the first button position, each of the two pairs of openings being fluidically connected by a corresponding one of the manifold fluid channels therebetween.

[0012] In accordance with aspects of illustrative embodiments, the pump has an inlet and an outlet that are respectively connected to one of the openings in each of the two pairs of openings, and the reservoir and the container are respectively connected to other ones of the openings in each of the two pairs of openings.

[0013] In accordance with aspects of illustrative embodiments, the medicament is provided in a container from which the reservoir in the fluid delivery device can be filled, the plurality of manifold fluid openings in the manifold housing comprising a pair of openings employed with the button in the second buton position, and a third opening, the pair of openings being fluidically connected by a one of the manifold fluid channels therebetween, the third opening being fluidically connected to the at least one manifold fluid channel arranged between one of the manifold fluid openings and the fluid channel of the patient interface fluid channel member.

[0014] In accordance with aspects of illustrative embodiments, the pump has an inlet and an outlet, the reservoir and the inlet are fluidically connected to respective ones of the pair of openings, and the outlet is fluidically connected to the third opening.

[0015] In accordance with aspects of illustrative embodiments, the button comprises at least one clip member extending from a button side wall, and the frame has a depression dimensioned to receive the at least one clip, the clip member and the depression being arranged along a longitudinal axis of the manifold and the longitudinal axis of the frame such that the depression engages the clip and prevents further sliding of the button relative to the frame when the button is in the second buton position.

[0016] In accordance with aspects of illustrative embodiments, the patient interface fluid channel member is disposed within the frame when the button is in the first button position, and at least a portion of the fluid channel of the patient interface fluid channel member extends beyond the distal frame end when the button is in the second button position.

[0017] In accordance with aspects of illustrative embodiments, the patient interface fluid channel member comprises at least one of a hollow needle, and a needle and catheter assembly.

[0018] In accordance with aspects of illustrative embodiments, the patient interface fluid channel member comprises the needle and catheter assembly, the needle and catheter assembly having a cannula dimensioned to receive at least part of a needle therein, at least part of the fluid channel in the patient interface fluid channel member comprising the cannula. The injection mechanism further comprises: the button having button side walls defining a button interior space and at least one cam guide in the button side walls, the at least one cam guide having a proximal cam guide end and a distal cam guide end relative to a longitudinal axis of the button; a guiding member dimensioned to be slidably received wi thin the button interior space, and having the needle connected to a distal end of the guiding member and the cannula releasably connected to the distal end of the guiding member, and a follower member dimensioned to travel along the cam guide. The guiding member, the needle and the cannula being disposed at a corresponding first guide position relative to the frame when the button is in the first button position and the patient interface fluid channel member is disposed within the frame, and when the button is in the second button position and the at least a portion of the fluid channel of the patient interface fluid channel member extends beyond the distal frame end, and the follower member being disposed at the distal cam guide end. The guiding member and the needle being disposed at a second guide position relative to the frame when the follower member travels along the cam guide and is disposed at the proximal cam guide end.

[0019] In accordance with aspects of illustrative embodiments, the cannula remains in the corresponding first guide position relative to the frame when the guiding member and the needle are disposed at the second guide position relative to the frame.

[0020] In accordance with aspects of illustrative embodiments, the pump is a monodirectional pumping mechanism.

[0021] Additional and / or other aspects and advantages of illustrative embodiments will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the illustrative embodiments. The illustrative embodiments may comprise apparatuses and methods for operating same having one or more of the above aspects, and / or one or more of the features and combinations thereof. The illustrative embodiments may comprise one or more of the features and / or combinations of the above aspects as recited, for example, in the attached claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above and / or other aspects and advantages of the illustrative embodiments will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, of which:

[0023] FIGs. 1 and 2 are, respectively, a top perspective and a side view of an example patch pump as a wearable fluid delivery' device;

[0024] FIG. 3 is a block diagram of example components of an example fluid delivery device constructed in accordance with an example embodiment;

[0025] FIGs. 4A and 4B are a block diagram of example wearable delivery patch components employed, respectively, for filling a reservoir, and injecting from the reservoir, using a manifold constructed in accordance with an example embodiment and a monodirectional pump;

[0026] FIGs. 5A, 5B and 5C are cross-section views of an insertion mechanism constructed in accordance with an example embodiment and deployed, respectively, in a preliminary position with manifold placement for storage and filling, in an activated button position with manifold placement for injection and the needle and catheter extended, and in a activated button position with manifold placement for injection and the needle retracted from the extended catheter;

[0027] FIGs. 6A and 6B are respective exploded views of an insertion mechanism constructed in accordance with an example embodiment and depicting opposing sides of a manifold;

[0028] FIGs. 7A and 7B are, respectively, a fluid pathway schematic of a components in a fluid delivery device, and a cross-section of a manifold, in the preliminary position of FIG. 5 A and constructed in accordance with an example embodiment;

[0029] FIGs. 8A and 8B are, respectively, a fluid pathway schematic of components in a fluid delivery device, and a cross-section of a manifold, in the activated button position of FIGs. 5B and 5C and constructed in accordance with an example embodiment;

[0030] FIG. 9 illustrates a perspective view of a button with its end cap removed that is constructed for deployment in an insertion mechanism in accordance with an example embodiment;

[0031] FIG. 10A is a perspective view of a subassembly comprising a button, manifold with catheter, and guiding part with needle constructed in accordance with an example embodiment;

[0032] FIG. I0B is a cross-section of a frame constructed in accordance with an example embodiment;

[0033] FIG. 10C is a partial view of the subassembly in FIG. 10A disposed within the frame in FIG. 9B; and

[0034] FIG. 11 is a cross-sectional view of an insertion mechanism constructed in accordance with an example embodiment showing fluid pathways within the manifold.

[0035] Throughout the drawing figures, like reference numbers will be understood to refer to like elements, features and structures.DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0036] Reference will now be made in detail to illustrative embodiments, which are depicted in the accompanying drawings. The embodiments described herein exemplify, but do not limit, the illustrative embodiments by referring to the drawings.

[0037] As will be appreciated by one skilled in the art, there are numerous ways of carrying out the examples, improvements, and arrangements of a fluid delivery device in accordance with embodiments disclosed herein. Although reference will be made to the illustrative embodiments depicted in the drawings and the following descriptions, the embodiments disclosed herein are not meant to be exhaustive of the various alternative designs and embodiments that are encompassed by the disclosed technical solutions, and those skilled in the art will readily appreciate that various modifications can be made, and various combinations can be made without departing from the scope of the disclosed technical solutions.

[0038] In accordance with example embodiments of the present disclosure, an improved patch pump design for a wearable fluid delivery device is provided that employs fluid pathways in an insertion mechanism for filling a reservoir with medicament and injection of the medicament into a patient. In accordance with an advantageous aspect of the example embodiments, the improved patch pump design allows for a method of filling the reservoir in the patch pump using a pump of the fluid delivery device and components of the insertion mechanism. As described further herein, example embodiments of an insertion mechanism employ a manifold configured to cooperate with other components of the patch pump to operate in a filling position (e.g., to facilitate fluid flow from a primary container such as a vial to the reservoir), and in an injection position (e.g., to facilitate fluid flow from the reservoir to the needle and / or catheter) using the pump, allowing a user such as the patient or the patient’s caregiver the autonomy to automatically fill the patch pump in a convenient manner and thereby obviating the need, expense and inconvenience of going to a clinical setting for a healthcare provider to fill the patch pump.

[0039] FIGs. 1 and 2 illustrate an example patch pump 10 for use as a wearable fluid delivery device. The patch pump comprises an enclosure or housing 12 with activation buttons 20 and an insertion mechanism 22. The housing 12 can have an adhesive pad 16 provided on its baseplate 14 and a liner 18 that are configured to allow a user to remove the liner 18 and place a tacky side of the adhesive pad 16 on a patient’s skin to adhere the patch pump 10 to the patient. The insertion mechanism 22 is shown in an undeployed position in FIG. 1. In FIG. 2, the adhesive pad 16 and liner 18 are not shown for clarity to depict theinsertion mechanism in a deployed position whereby a needle 26 and / or catheter 24 extend from the housing 12 for insertion into a patient’s skin. As described herein, an example patch pump has a catheter 24 and needle 26 assembly for insertion of the catheter and needle into a patient and then retraction of the needle. An example insertion mechanism is described in PCT international application WO 2015 / 164653 which is incorporated herein by reference. It is to be understood that the insertion mechanism can alternatively employ a hollow needle, for example.

[0040] The patch pump 10 comprises other components arranged in the enclosure 12. FIG. 3 is an example block diagram of example components of the patch pump. The patch pump 10 comprises a reservoir 28, the insertion mechanism 22, and a fluid displacement module 30 that can include a motor 32 with associated motor housing and gearbox, gear train 36, a pump mechanism 38 (e.g., a positive displacement pump), and inlet and outlet fluid paths (e.g., 40a, 40b). The patch pump 10 further comprises electrical components such as a power module (e.g., battery 42), and an electrical module 44 comprising a controller 46, a motor driver 48, optional sensing module 50 to sense fluid flow conditions (e.g. occlusion), optional audio driver 52 (e.g., to indicate dosing in progress, low reservoir, occlusion, successful pairing with external device, or other condition), and an optional visual driver 54, and an optional wireless driver 56 for wireless communication between the fluid delivery device and an optional remote pump control device 58 (e.g., a smartphone or dedicated controller). As described below, the controller 46 can be programmed or otherwise configured to control the motor and therefore the pump mechanism 38 for perform filling and injection operations via example embodiments of the technical solution described herein. The initiating of the pump mechanism 38, also after referred to herein as the pump 38, to either commence filling the reservoir 28 from a primary container 60, or to commence injecting by controllably moving fluid from the reservoir 28 to the needle 26 and / or catheter 24 inserted into the patient’s skin can be automatic (e.g., in response to a sensor that detects position of a component in the insertion mechanism 22) or manual (e.g., controlled by the user via a user interface to the patch pump such as the wireless controller 58 or using the activation buttons 20 or other control device provided on the patch pump housing 12).

[0041] FIGs. 4A and 4B illustrate example patch pump 10 components employed for filling a reservoir 28 and for injecting from the reservoir 28 using a manifold 70 con struct cd in accordance with an example embodiment to be operational with a monodirectional pump. The manifold 70 has fluid pathways indicated generally at 72 whereby use of various ones of the pathways is selectable depending on stage of use (e.g., storage, filling, injection). The manifold 70 can be fluidically connected to patch pump 10 components such as the pump 38, the reservoir 28 (e.g., a flexible reservoir as described in PCT international application WO 2017 / 053284 which is incorporated herein by reference), a catheter / needle hub or assembly indicated as 94, and a primary container 60 (e.g., a syringe, or vial or other container with a Luer lock). The example schematic of the fluid pathways 72 in the manifold 40 shown in FIG. 4A illustrates a filling stage whereby fluid from the primary container 60 is provided to an inlet of the pump 38 via a fluid channel 72a in the manifold 70, and the pump 38 provides fluid from its outlet through a fluid channel 72b in the manifold 70 to the reservoir 28. The example schematic of the fluid pathways 72 in the manifold 40 shown in FIG. 4B illustrates an injec tion stage whereby fluid from the reservoir 28 is provided to an inlet of the pump 38 via a fluid channel 72c in the manifold 70, and the pump 38 provides fluid from its outlet through a fluid channel 72d in the manifold 70 to the catheter and'or needle hub 94.

[0042] Reference is now made to FIGs. 5A, 5B and 5C and FIGs. 6A and 6B which illustrate an example embodiment of an improved injection mechanism 80 having a manifold 70. FIGs. 5A, 5B and 5C are cross-section views of an insertion mechanism 80 constructed in accordance with an example embodiment and deployed, respectively, in a preliminary position with manifold 70 placement for storage and filling, in an activated button position with manifold placement for injection and the needle and catheter extended, and in a activated button position with manifold 70 placement for injection and the needle retracted from the extended catheter. FIGs. 6A and 6B are respective exploded views of an insertion mechanism constructed in accordance with an example embodiment and depicting opposite sides of a manifold 70 and related components described below.

[0043] Tire injection mechanism 80 has a button 82 shown with a button cap 82a.The injection mechanism 80 further comprises a frame 84 having frame side walls that define a frame interior space. As shown in FIGs. 5A and 10B, the frame interior space can have adistal portion 84b that is narrower than a proximal portion 84a (e.g., the diameter of the distal portion 84b is dimensioned to slidably receive the manifold 70 but smaller than the diameter of the proximal portion 84a). The proximal portion 84a is dimensioned to slidably receive the button 82, but the button 82 is dimensioned to be too large to fit into the distal portion 84b of the frame 84. The distal end of the frame 84 is configured to allow the catheter 94 and / or needle 88 to extend therefrom. The proximal portion 84a of the frame 84 is configured to slidably receive at least a portion of the button 82 into the interior space of the frame 84. The distal end of the button 82 is coupled to a proximal end of the manifold 70.

[0044] The manifold 70 has a manifold housing with side walls that define a manifold interior space comprising a throughway 96 along its longitudinal axis that is configured to receive at least a portion of the catheter 94 and / or needle 88 via its proximal opening 96a (FIG. 6A). The distal end of the throughway 96 has a distal opening 96b from which the catheter 94 and / or needle 88 can extend. The proximal end 70a of the manifold 70 has a depression to receive a septum 92. The manifold 70 housing has openings 70c therein to respective ends of fluid pathways 72 that terminate at the manifold housing (e.g., fluid pathways 72a, 72b, 72c and the manifold end of fluid pathway 72d, in contrast to the end of fluid pathway 72d that is fluidically connected to catheter 94). In accordance with an example embodiment, the exterior of the manifold 70 housing has planar surface area(s) 70b in which the openings 70c are arranged. The frame 84 has fluid path openings 110 in its sidewalls that can be selectively aligned with different groups or subsets of the openings 70c in the manifold 70 housing, depending on the position of the manifold 70 and button 82 relative to the frame 84 for different operations such as filling and injection. For example, the openings 70c in the manifold 70 can be on opposite sides of the manifold 70 housing.The openings 110 in the frame 84 can be on opposite sides of the frame side walls, and can be radially aligned with selected ones of the openings 70c in the manifold 70 depending on the position of the button 82. Tightness between the manifold 70 and the frame 84 and therefore seal between their respective openings 70c and 110 can be ensured using an O-ring or overmolding with respect to the manifold openings 70c, for example.

[0045] With continued reference to FIGs. 5A through 6B, the button 82 is configured with an interior space dimensioned to slidably receive a guiding part 86 therein. The button82 is pro vided with an exterior ring 106 that is arranged along the longitudinal axis of the button 82 to be flush with the proximal end of the frame 84 when the button 82 is in an undeployed positon as shown in FIG. 5A. The undeployed position of the button 82 shown in FIG. 5 A can be used in a storage stage or filling stage of the insertion mechanism 80. The proximal end of the guiding part 86 is arranged to be proximal to the exterior ring 106 of the button 82 and the proximal end of the frame 84 when the button 82 is in the undeployed positon shown in FIG. 5A. The catheter 94 is stowed within the frame 84 when the button 82 is in the undeployed positon shown in FIG. 5A. As described below, a subset of the openings 70c on the manifold are aligned with the openings 110 in the frame to allow filling. For example, a pair of the openings 110a, 110b on one side of the frame 84 can be fluidically coupled to an inlet and an outlet of the pump 38, and a pair of the openings 110c and ! lOd on an opposite side of the frame 84 can be fluidically coupled to the reservoir 28 and the primary' container 60, respectively, as shown in FIGs. 7A and 7B. During filling, the pump 36 can draw fluid from the primary' container 60 via fluid channel 72a in the manifold 70 and output fluid to the reservoir 28 via the fluid channel 72b in the manifold 70.

[0046] The guiding part 86 has a hub 118 with integral tongues 120 that are configured to be slidably engaged in respective cam guides 98 provided in the side walls of the button 82. The cam guides 98 are arranged to be opposite each other in the button 82 side walls. It is to be understood that a different number of a tongue 120 and cam guide 98 can be used. A cam guide 98 has an angled recess 100 at its distal end that is arranged to release the guiding part 86 from a first position relative to the button 82 as shown in FIG. 5B to a second position relative to the button 82 as shown in FIG. 5C, when the button 82 is pressed relative to the frame 84 (e.g., manually by a user) for the injection position or stage shown in FIGs. 5B and 5C. When the insertion mechanism 80 is configured for the injection stage shown in FIGs. 5B and 5C, the catheter 94 extends from the distal end of the frame 84, but the needle extends from the frame 84 or can be retracted into the frame 84 and button, depending on whether or not the guiding part 86 is released. The interior of the frame 84 is provided with corresponding interior protrusions 114, as shown in FIGs. 10A and 10C, that are positioned within the frame 84 to cooperate with the respective tongues 120 in their respective angled recesses 100 to ensure rotation of the guiding part 86 relative to the button 82 by moving thetongues 120 toward the remainder of the cam guides 98 to release the needle 88 from the catheter 94.

[0047] With reference to FIGs. 5A through 6B and FIG. 9, the button 82 is provided with clips 108 on the exterior of the button 82 housing that are configured to be engaged with corresponding clip openings 112 provided in the frame 84. The cooperation of the clips 108 with the clip openings 112 fixes the positon of the button 82 relative to the frame 84 and thereby the extension of the catheter 94 from the frame 84 to ensure injection depth and position during the injection stage illustrated in FIGs. 5B and 5C.

[0048] As stated above with reference to FIGs. 7A and 7B illustrating an insertion mechanism during a filling stage, a pair of the openings 110a, 110b on one side of the frame 84 can be fluidically coupled to the inlet and the outlet of the pump 38, and a pair of the openings 110c and 1 lOd on an opposite side of the frame 84 can be fluidically coupled to the reservoir 28 and the primary container 60, respectively. During filling, the pump 36 can draw fluid from the primary container 60 via fluid channel 72a in the manifold 70 and output fluid to the reservoir 28 via the fluid channel 72b in the manifold 70.

[0049] With reference to the FIGs. 8A and 8B, after the button 82 is depressed and moved from an undeployed position shown in FIGs. 5A and 7A to a deployed position for injection as shown in FIGs. 5B, 5C and 8 A, the openings 110a, 110b in the frame 84 can be fluidically coupled to the inlet and the outlet of the pump 38, and opening 110c in the frame 84 can be fluidically coupled to the reservoir 28, to allow the pump 38 to draw fluid from the reservoir 28 via a fluid channel 72c and to output fluid to the catheter via a fluid channel 72d. The opening 1 lOd in the frame 84 is not used during the injection stage and therefore no opening 70c relative to the opening 1 lOd in the frame 84 is needed as illustrated in FIG. 8B, and the arrangement of the three openings 70c illustrated on one side of the manifold 70 in FIG. 6A in contrast with the arrangement of the four openings 70c on the other side of the manifold 70 in FIG. 6B. The manifold 70 is illustrated schematically in FIG. 7A (storage and filling stages) and FIG. 8A (injection stage). Opposing pairs of the openings 70c arranged at the distal end of the manifold 70 are fluidically coupled to the openings 110a through 1 lOd in the frame 84 when the button 82 is undeployed and in the filling stage. Three openings 70c arranged closed to the proximal end of the manifold 70 are fluidically coupled to theopenings 110a through 110c in the frame 84 when the button 82 is pressed for injection. FIG. 11 illustrates the placement of the fluid paths 72a and 72b used for the filling stage as more distal relative to the more proximal placement of the fluid paths 72c and 72d used for the injection stage such that selection of the corresponding fluid paths 72 for filling or an injection is simplified by merely pressing the button 82 and translating it until the clips 108 engage with the openings 112 in the frame 84.

[0050] In accordance with example embodiments, connection from the frame 84 to other subsystems in the device 10 (e.g., pump 30, reservoir 32, or a primary' container 60) is implemented as holes. The connection from the openings 110 in the injection mechanism 80 to these other subsystems can be done using tubing for example. In that case, the frame 84 can be dimensioned or configured so that the openings 110 each have a circumferential edge extending from the side wall of the frame 84 and the tubes are directly connected within or over these edges by gluing. Alternatively, the openings 110 are smooth at the exterior side wall of the frame and the tubing is glued within the opening 110 and at least partially within the side wall of the frame. Alternatively, a barbed connection can be integrated to the frame 84 for connecting to tubing at the openings 110 at the exterior side wall of the frame 84.

[0051] The manifold 70 and the catheter 94 can be implemented as a single kinematical group. For example, the catheter 94 and the manifold 70 can be glued together on the internal diameter of the manifold 70, or the catheter 94 can be assembled on a a wedge (e.g., a metallic part) to secure internal diameter of the catheter, and the wedge is coupled to the manifold 70 via gluing or stamping or other method. The connections between the wedge and manifold and between the wedge and catheter are tight.

[0052] The insertion mechanism 80 described and illustrated herein in accordance with an example embodiment advantageously combines a catheter insertion mechanism with a manifold 70 in order to reduce user steps. It is also a compaction in space of generally two subsystems, that is, a manifold and a catheter insertion mechanism. It is of interest to reduce space of a fluid delivery device (e.g., device 10) that needs to integrate these functions. The manifold 70 allows automatic filling of a reservoir 28 in a fluid delivery device 10 using a monodirectional pump and filling directly from the primary container 60 when insertion mechanism 80 is in a first position (e.g., the button 82 is undeployed as shown in FIGs. 5Aand 7A) and allows for simple configuration of the insertion mechanism 80 into a second position for injection (e.g., the button 82 is pressed as shown in FIGs. 5B, 5C and 8A) due to the arrangement of openings 70c and fluid channels 72 in the manifold. The insertion mechanism 80 therefore employs a relatively simple translation and monostable operation to switch from a storage and filling stage to an injection stage of use.

[0053] The insertion mechanism 80 constructed in accordance with example embodiments of the present disclosure is also advantageous because the insertion mechanism 80 reduces dead volume of fluid in the fluid channels between the reservoir 28, pump 38 and catheter 94, as compared with fluid volume that can exist in the baseplate fluid channels, and the flexible tube deployed from a downstream point in the fluid path from the pump to the insertion mechanism, as described in PCT international applications WO 2015 / 164653 and WO2015157174, for example. Also, the manifold 70 allows automatic switching of the direction of the fluid to or from the reservoir 28 when an operator pushes on the button 82 to begin an injection as illustrated by the pathways 72 in FIG. 7B as compared with FIG. 8B.

[0054] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the above description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0055] The above-presented description and figures are intended by way of example only and are not intended to limit the illustrative embodiments in any way except as set forth in the following claims. It is particularly noted that persons skilled in the art can readily combinethe various technical aspects of the various elements of the various illustrative embodiments that have been described above in numerous other ways, all of which are considered to be within the scope of the claims.

Claims

CLAIMS:

1. An injection mechanism for a fluid delivery device that delivers a fluid medicament to a patient, the fluid delivery device having a pump for providing a controlled amount of the medicament from a reservoir to the injection mechanism, the injection mechanism, comprising: a patient interface fluid channel member comprising a fluid channel, at least a portion of the patient interface fluid channel member being insertable into the patient’s skin; a button; a frame with frame side walls that define a frame interior space, the frame having a proximal frame end configured to receive at least a portion of the button into the frame interior space, and a distal frame end from which the patient interface fluid channel member can be configured to extend for insertion into the patient’s skin, the frame having a plurality of frame openings in the frame side walls; and a manifold comprising a manifold housing with manifold side walls that define a manifold interior space, the manifold housing having a throughway within the manifold interior space that is configured to receive at least a portion of the patient interface fluid channel member, the manifold housing having a proximal manifold end coupled to a distal button end of the button and a distal manifold end with a distal opening from which the patient interface fluid channel member can be configured to extend; wherein the button is slidably engaged with respect to the frame to translate along a longitudinal axis of the frame and configured to be placed in at least a first button position with respect to the frame whereby the button is inserted a first distance into the frame interior space and along the longitudinal axis of the frame, and a second button position with respect to the frame whereby the button is inserted a second distance into the frame interior space along the longitudinal axis of the frame that is different from the first distance; and wherein the manifold housing is slidably engaged with respect to the frame to translate with the button along the longitudinal axis of the frame and comprises a plurality of manifold fluid openings in the manifold side walls, and a plurality of fluid channels comprising manifold fluid channels arranged between selected ones of the manifold fluidopenings, and at least one manifold fluid channel arranged between one of the manifold fluid openings and the fluid channel of the patient interface fluid channel member.

2. The injection mechanism of claim 1 , wherein the first subset of the manifold openings are arranged in the manifold housing at first positions along a longitudinal axis of the manifold, and the second subset of the manifold openings are arranged in the manifold housing at second positions along the longitudinal axis of the manifold that are distanced from the first positions and closer to the proximal manifold end.

3. The injection mechanism of claim 1 , wherein the plurality of manifold fluid openings are arranged such that a first subset of the plurality of manifold fluid openings align with respective ones of the frame openings when the button is in the first button position, and a second subset of the plurality of manifold fluid openings align within respective ones of the frame openings when the button is in the second button position, the second subset having at least one of the plurality of manifold fluid openings that is not also in the first subset and the second button position utilizing at least one of the plurality of manifold fluid channels in the manifold that is not also utilized in the first button position.

4. The injection mechanism of claim 3, wherein the medicament is provided in a container from which the reservoir in the fluid delivery device can be filled, the plurality of manifold fluid openings in the manifold housing comprising two pairs of openings employed with the button in the first button position, each of the two pairs of openings being fluidically connected by a corresponding one of the manifold fluid channels therebetween.

5. The injection mechanism of claim 4, wherein the pump has an inlet and an outlet that are respectively connected to one of the openings in each of the two pairs of openings, and the reservoir and the container are respectively connected to other ones of the openings in each of the two pairs of openings.

6. The injection mechanism of claim 3, wherein the medicament is provided in a container from which the reservoir in the fluid delivery device can be filled, the plurality of manifold fluid openings in the manifold housing comprising a pair of openings employed with the button in the second button position, and a third opening, the pair of openings being fluidically connected by a one of the manifold fluid channels therebetween, the third opening being fluidically connected to the at least one manifold fluid channel arranged between one of the manifold fluid openings and the fluid channel of the patient interface fluid channel member.

7. The injection mechanism of claim 6, wherein the pump has an inlet and an outlet, the reservoir and the inlet are fluidically connected to respective ones of the pair of openings, and the outlet is fluidically connected to the third opening.

8. Hie injection mechanism of claim 1 , wherein the button comprises at least one clip member extending from a button side wall, and the frame has a depression dimensioned to receive the at least one clip, the clip member and the depression being arranged along a longitudinal axis of the manifold and the longitudinal axis of the frame such that the depression engages the clip and prevents further sliding of the button relative to the frame when the button is in the second button position.

9. The injection mechanism of claim 2, wherein the patient interface fluid channel member is disposed within the frame when the button is in the first button position, and at least a portion of the fluid channel of the patient interface fluid channel member extends beyond the distal frame end when the button is in the second button position.

10. The injection mechanism of claim 2, wherein the patient interface fluid channel member comprises at least one of a hollow needle, and a needle and catheter assembly.

11. The injection mechanism of claim 10, wherein the patient interface fluid channel member comprises the needle and catheter assembly, the needle and catheter assembly having a cannula dimensioned to receive at least part of a needle therein, at least part of the fluid channel in the patient interface fluid channel member comprising the cannula, and the injection mechanism further comprises: the button having button side walls defining a button interior space and at least one cam guide in the button side walls, the at least one cam guide having a proximal cam guide end and a distal cam guide end relative to a longitudinal axis of the button; a guiding member dimensioned to be slidably received within the button interior space, and having the needle connected to a distal end of the guiding member and the cannula releasably connected to the distal end of the guiding member, and a follower member dimensioned to travel along the cam guide, the guiding member, the needle and the cannula being disposed at a corresponding first guide position relative to the frame when the button is in the first button position and the patient interface fluid channel member is disposed within the frame, and when the button is in the second button position and the at least a portion of the fluid channel of the patient interface fluid channel member extends beyond the distal frame end, and the follower member being disposed at the distal cam guide end; the guiding member and the needle being disposed at a second guide position relative to the frame when the follower member travels along the cam guide and is disposed at the proximal cam guide end.

12. The injection mechanism of claim 11 , wherein the cannula remains in the corresponding first guide position relative to the frame when the guiding member and the needle are disposed at the second guide position relative to the frame.

13. The injection mechanism of claim 1, wherein the pump is a monidirectional pumping mechanism.

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