Drug delivery device with bidirectional oscillating rotary pump

Abstract

A rotary metering pump for a drug delivery device having a reservoir and a downstream fluid path includes a sleeve defining a chamber, a manifold housing in fluid communication with the chamber, and a first valve system partially defined by the manifold housing. The first valve system is in selective fluid communication with the chamber. The rotary metering pump further includes a second valve system partially defined by the manifold. The second valve system is in selective fluid communication with the chamber and the first valve system.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to metering pumps for drug delivery devices. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 415,080, filed October 11, 2022, entitled "Drug Delivery Device Having a Bidirectional Oscillatory Rotary Pump," the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Wearable medical devices, such as auto-injectors, have the advantage of providing treatment to patients at locations remote from clinical facilities and / or while worn individually under the patient's clothing. The wearable medical device can be applied to the patient's skin and can be configured to automatically administer a dose of a pharmaceutical composition within a predetermined period of time after applying the wearable medical device to the patient's skin, such as after a 27-hour delay. After the device delivers the pharmaceutical composition to the patient, the patient can subsequently remove and discard the device.

[0004] Current auto-injectors utilize pump architectures that provide unidirectional flow. Many applications require multidirectional flow, necessitating the use of multiple pumps. Therefore, there is a need for an auto-injector that provides multidirectional flow with a single pump. Therefore, those skilled in the art continue their research and development efforts in the area of ​​metering pumps for drug delivery devices. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2015 / 157174 Brochure Summary of the Invention

[0006] A rotary metering pump for a drug delivery device having a reservoir and a downstream fluid path is disclosed.

[0007] In one example, a rotary metering pump includes a sleeve defining a chamber, a manifold housing in fluid communication with the chamber, and a first valve system partially defined by the manifold housing. The first valve system is in selective fluid communication with the chamber. The rotary metering pump further includes a second valve system partially defined by the manifold housing. The second valve system is in selective fluid communication with the chamber and the first valve system.

[0008] The manifold housing may house a first manifold in fluid communication with the first valve system and a second manifold in fluid communication with the second valve system.

[0009] The first valve system may include a first port and a second port, and the second valve system may include a third port and a fourth port. The first port of the first valve system and the third port of the second valve system may be in fluid communication with a reservoir. The second port of the first valve system and the fourth port of the first valve system may be in fluid communication with a downstream fluid path. One of the first valve system and the second valve system may be in fluid communication with a fill port.

[0010] The rotary metering pump may include a piston at least partially received within a sleeve, the piston and sleeve defining a chamber, the piston having a first position in which the chamber has a first volume and a second position in which the chamber has a second volume, the first volume being greater than the second volume.

[0011] The sleeve can be rotatable about a central axis between at least a first rotational position and a second rotational position. The channel can be in fluid communication with a first port of the first valve system when the sleeve is in the first rotational position. The channel can be in fluid communication with a second port of the first valve system when the sleeve is in the second rotational position.

[0012] The sleeve may be rotatable about the central axis between at least a third rotational position and a fourth rotational position. The channel may be in fluid communication with a third port of the second valve system when the sleeve is in the third rotational position, and the channel may be in fluid communication with a fourth port of the second valve system when the sleeve is in the fourth rotational position. The sleeve may be further rotatable to an isolated position such that the first valve system and the second valve system are isolated from the chamber.

[0013] The first valve system may include at least one elastomeric seal, and the second valve system may include at least one elastomeric seal.

[0014] The piston may be configured to rotate and move axially relative to the housing and sleeve, and the piston may be configured to rotate with the sleeve relative to the housing.

[0015] Rotation of the piston in a first rotational direction can be configured to aspirate fluid in the chamber and move the sleeve from the first rotational position to a second rotational position, and rotation of the piston in a second rotational direction can be configured to pump fluid in the chamber and move the sleeve from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction.

[0016] In another configuration, rotation of the piston in a third rotational direction is configured to aspirate fluid in the chamber and move the sleeve from the third rotational position to a further rotational position, and rotation of the piston in a further rotational direction is configured to pump fluid in the chamber and move the sleeve from a fourth rotational position to the third rotational position, the further rotational direction being opposite to the third rotational direction. [Brief explanation of the drawings]

[0017] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings. [Figure 1A] FIG. 1A is an exploded view of a rotary metering pump of a drug delivery device. [Figure 1B] FIG. 1B is an exploded view of a rotary metering pump of a drug delivery device. [Figure 2] FIG. 2 is a perspective view of a rotary metering pump. [Figure 3] 3 is a perspective cross-sectional view of a portion of the rotary metering pump of FIG. 2. FIG. [Figure 4A] FIG. 4A is a schematic diagram of a portion of a drug delivery device. [Figure 4B] FIG. 4B is a schematic diagram of a portion of a drug delivery device. [Figure 5] FIG. 5 is a schematic diagram of a series of fluid movements within the rotary metering pump of FIG.

[0018] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION

[0019] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting as the present invention may assume various alternative orientations.

[0020] All numbers used in the specification and claims should be understood as modified in all instances by the term "about." By "about" is meant a range of plus or minus ten percent of the stated value. As used in the specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The terms "first," "second," etc. are not intended to refer to any particular order or chronology, but instead refer to different states, properties, or elements. "At least" means "greater than or equal to."

[0021] 1A and 1B, a metering pump 10 for a medical syringe or drug delivery device 12 is shown. The metering pump 10 is a rotary metering pump and is described in U.S. Patent Application Publication No. 2009 / 0129994, which is incorporated herein by reference in its entirety. The rotary metering pump 10 is connected to a DC motor and gearbox assembly (not shown) to rotate a sleeve 14 within a housing 16. The sleeve 14 is provided with a helical groove 32. A coupling pin 34 connected to a piston 18 translates along the helical groove 32 to guide the retraction and insertion of the piston 18 within the sleeve 14 as the sleeve 14 rotates in one direction and then the opposite direction, respectively. The sleeve 14 has an end plug 36. Two seals 30 on each end of the piston 18 and the end plug 36 within the sleeve 14 define a cavity or chamber 28 when the piston 18 is retracted following a suction stroke and thus ready to dispense. The volume of the chamber 28 changes depending on the degree to which the piston 18 is retracted. When the piston 18 is fully inserted and the seals 30 are substantially in contact with each other after the dispensing stroke, the volume of the chamber 28 is negligible or essentially zero and is therefore ready to draw.

[0022] In one example, the disclosed rotary metering pump 10 can be characterized as an oscillating rotary pump 10 with an integrated valve architecture having at least two valve systems 22, 24. The disclosed architecture of the rotary metering pump 10 allows for pumping fluids through different channels independently via a single pump. One exemplary application of the disclosed pump 10 is to use the rotary metering pump 10 to fill the reservoir 6 of a drug delivery device 12, enabling a vial-to-device transfer system via the fill port 4, while using a single motor to control the valve system and actuate the rotary metering pump 10.

[0023] A series of ports 22a, 22b, 24a, and 24b are provided to housing 16 via manifold housing 20. Each port 22a, 22b, 24a, and 24b is configured to allow fluid, such as a medication, to flow from fill port 4 to rotary metering pump 10 and then to reservoir 6. The fluid can then return to rotary metering pump 10 and exit another port where the fluid or medication was drawn into chamber 28 (e.g., by retracting piston 18 during a suction phase). Fluid can be dispensed from chamber 28 into a fluid pathway 8, for example, to a patient cannula, by reinserting piston 18 into chamber 28.

[0024] 1-5, the disclosed rotary metering pump 10 is configured for use with a drug delivery device 12, such as a medical syringe. The drug delivery device 12 includes a reservoir 6 and a downstream fluid path 8, such as a cannula (see FIGS. 4A and 4B). The rotary metering pump 10 includes a housing 16 (see FIG. 1B). The housing 16 defines a chamber 28 configured to receive the sleeve 14.

[0025] Referring to FIG. 1B, rotary metering pump 10 includes a manifold housing 20 coupled to housing 16. Manifold housing 20 is configured to be in fluid communication with chamber 28 and two or more valve systems 22, 24 for the selective passage of a fluid, such as a drug. In one example, manifold housing 20 partially defines a first valve system 22 (see FIG. 2) in fluid communication with first manifold 20a. First valve system 22 is in selective fluid communication with chamber 28 based on the alignment of features within rotary metering pump 10, as described below. First valve system 22 includes a first port 22a and a second port 22b. It will be understood that first port 22a may also be referred to as a manifold seal inlet 22a, and second port 22b may be referred to as a manifold seal outlet 22b. In one example, first valve system 22 includes at least one elastomeric seal 30. The elastomeric seal 30 may be overmolded.

[0026] 2, the manifold housing 20 partially defines a second valve system 24 in fluid communication with the second manifold 20b. The second valve system 24 is in selective fluid communication with the chamber 28 and the first valve system 22 based on the alignment of features within the rotary metering pump 10, as described below. The second valve system 24 includes a third port 24a and a fourth port 24b. It is understood that the third port 24a may be referred to as the manifold seal inlet 24a and the fourth port 24b may be referred to as the manifold seal outlet 24b. In one example, the second valve system 24 includes at least one elastomeric seal 30. The elastomeric seal 30 may be overmolded onto the piston 18.

[0027] 4A and 4B , in one or more examples, the first port 22 a of the first valve system 22 and the third port 24 a of the second valve system 24 are in fluid communication with the reservoir 6. Additionally, the second port 22 b of the first valve system 22 and the fourth port 24 b of the first valve system 24 are in fluid communication with the downstream fluid pathway 8. Additionally, in one or more examples, one or more of the first port 22 a and the second port 22 b of the first valve system 22 and / or the third port 24 a and the fourth port 24 b of the second valve system 24 may be in fluid communication with a fill port 4 for filling the reservoir 6 with a fluid, such as a drug.

[0028] 2, rotary metering pump 10 further includes a sleeve 14 at least partially received within housing 16. Sleeve 14 extends along central axis A. C The rotation of the sleeve 14 may be facilitated by a piston 18. The sleeve 14 is rotatable about a central axis A. C The sleeve 14 defines a channel 26 configured to align with the first port 22a, the second port 22b, the third port 24a, and the fourth port 24b upon rotation of the sleeve 14 about the axis.

[0029] The sleeve 14 is rotated along the central axis A between the plurality of positions. C In one example, the sleeve 14 is rotatable 360° about the central axis A between at least a first rotational position and a second rotational position. C The channel 26 is in fluid communication with the first port 22a of the first valve system 22 when the sleeve 14 is in the first rotational position. Additionally, the channel 26 is in fluid communication with the second port 22b of the first valve system 22 when the sleeve 14 is in the second rotational position.

[0030] Furthermore, the sleeve 14 rotates about the central axis A at least between the third rotational position and the fourth rotational position. CWhen the sleeve 14 is in the third rotational position, the channel 26 is in fluid communication with the third port 24a of the second valve system 24. When the sleeve 14 is in the fourth rotational position, the channel 26 is in fluid communication with the fourth port 24b of the second valve system 24.

[0031] The sleeve 14 is further configured to rotate to an isolated position such that the first valve system 22 and the second valve system 24 are isolated from the chamber 28. The isolated position may be located between the first valve system 22 and the second valve system 24, or may be located between the first valve system 22 and the port of one of the second valve systems 24. The isolated position may be anywhere such that the channel 26 is not aligned with a port and therefore is not in fluid communication with the first valve system 22 or the second valve system 24.

[0032] The manifold housing 20 may include a sealing surface that continuously contacts the outer surface of the sleeve 14 such that the manifold housing 20 maintains continuous closure of the chamber 28 during rotation of the sleeve 14 between the manifold ports to maintain a fluid-tight seal.

[0033] 1B , in one or more examples, rotary metering pump 10 further includes piston 18 at least partially received within sleeve 14. Piston 18 and sleeve 14 define a chamber 28 within housing 16. Piston 18 is movable between at least a first position, in which chamber 28 has a first volume, and a second position, in which chamber 28 has a second volume, the first volume being greater than the second volume. Piston 18 is configured to move rotationally and axially relative to housing 16 and sleeve 14. In one example, piston 18 is configured to rotate with sleeve 14 relative to housing 16. In another example, piston 18 is configured to rotate independently of sleeve 14 relative to housing 16.

[0034] In one non-limiting example, rotation of piston 18 in a first rotational direction is configured to aspirate fluid within chamber 28 and move sleeve 14 from the first rotational position to a second rotational position. Further rotation of piston 18 in a second rotational direction is configured to pump fluid within chamber 28 and move sleeve 14 from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction.

[0035] 1 and 2 , in one or more examples, piston 18 is configured to rotate and move axially relative to housing 16 and sleeve 14, with piston 18 configured to rotate with sleeve 14 relative to housing 16 to enable pumping of fluid within multiple channels defined by manifold housing 20. Piston 18 is connected to sleeve 14 via a coupling pin 34 received within a helical groove 32 defined by sleeve 14. First valve system 22 and second valve system 24 are configured to selectively fluidly communicate with both reservoir 6 of drug delivery device 12 and downstream fluid path 8 of drug delivery device 12 via rotation of sleeve 14.

[0036] First valve system 22 and / or second valve system 24 may further be in fluid communication with fill port 4 for filling reservoir 6 with a fluid, such as a medication. Rotation of piston 18 in a first rotational direction may be configured to aspirate fluid in chamber 28 and move sleeve 14 from the first rotational position to a second rotational position, and rotation of piston 18 in a second rotational direction is configured to pump fluid in chamber 28 and move sleeve 14 from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction. Furthermore, rotation of the piston 18 in a third rotational direction is configured to suck fluid in the chamber 28 and move the sleeve 14 from the third rotational position to a fourth rotational position, and rotation of the piston 18 in a fourth rotational direction is configured to pump fluid in the chamber 28 and move the sleeve 14 from the fourth rotational position to the third rotational position, the fourth rotational direction being opposite to the third rotational direction.

[0037] FIG. 5 illustrates, in a series of exemplary schematic diagrams, how rotation and movement of piston 18 and sleeve 14 facilitates fluid movement within rotary metering pump 10. Rotary metering pump 10 can be configured such that fluid can be pumped through first valve system 22 from manifold seal inlet or first port 22a to manifold seal outlet or second port 22b, and from second valve system 24 from manifold seal inlet or third port 24a through chamber 28 to manifold seal outlet or fourth port 24b. The exemplary schematic diagrams shown in FIG. 5 are merely one example of how fluid can flow through a fluid circuit via rotary metering pump 10. Fluid flow contemplated from rotary metering pump 10 is not limited to the schematic sequence shown in FIG. 5.

[0038] As shown in the example of FIG. 5, movement of piston 18 between Position 1 and Position 2 facilitates the aspiration of fluid from first valve system 22 via first port 22a. In Positions 1 and 2, sleeve 14 is positioned such that channel 26 is aligned with first port 22a, thus placing chamber 28 in fluid communication with first port 22a. In one example, first port 22a is simultaneously in fluid communication with reservoir 6 such that, based on movement of piston 18, fluid may travel between reservoir 6 and chamber 28 via first port 22a and channel 26. Retraction and insertion of piston 18 within sleeve 14 may occur simultaneously with rotation of piston 18 and / or sleeve 14, or may occur independently of rotation of the piston and / or sleeve.

[0039] 5, positions 3 and 4 illustrate the movement of fluid from chamber 28 through second port 22b via channel 26. Sleeve 14 is oriented along central axis A such that channel 26 is aligned with second port 22b of first valve system 22. C , thus placing second port 22b in fluid communication with chamber 28. In one example, second port 22b is simultaneously in fluid communication with downstream fluid pathway 8. In another example, second port 22B is simultaneously in fluid communication with the injection site or needle hub (see FIGS. 4A and 4B). Aspiration from first port 22a may then be repeated, as shown in position 5.

[0040] Upon completion of positions 1-5, in one or more examples, sleeve 14 may be rotated to an orientation such that channel 26 is proximate third port 24a and fourth port 24b to facilitate alignment with third port 24a and fourth port 24b. Referring to position 6 in FIG. 4, piston 18 may be retracted to aspirate fluid through third port 24a. Third port 24a may be in fluid communication with fill port 4 to draw fluid from fill port 4 into chamber 28 for transfer to reservoir 6 via fourth port 24b (see position 7). Position 8 illustrates inserting piston 18 into sleeve 14 to dispense fluid from chamber 28 to reservoir 6 via fourth port 24b. Sleeve 14 may then be rotated or oscillated such that channel 26 is again aligned with first port 24a, and aspirate / dispense positions 6-8 are repeated.

[0041] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A rotary metering pump (10) for a drug delivery device (12), comprising a reservoir (6) and a downstream fluid path (8), said rotary metering pump (10) comprising: a sleeve (14) defining a chamber (28); a manifold housing (20) in fluid communication with said chamber (28); a first valve system (22) defined in part by the manifold housing (20), the first valve system (22) being in selective fluid communication with the chamber (28); a second valve system (24) defined in part by the manifold (20) housing, the second valve system (24) being in selective fluid communication with the chamber (28) and the first valve system (22).

2. 2. The rotary metering pump (10) of claim 1, wherein the manifold housing (20) contains a first manifold (20a) in fluid communication with the first valve system (22) and a second manifold (20b) in fluid communication with the second valve system (24).

3. the first valve system (22) comprises a first port (22a) and a second port (22b); The rotary metering pump (10) of claim 1, wherein the second valve system (24) comprises a third port (24a) and a fourth port (24b).

4. 4. The rotary metering pump of claim 3, wherein the manifold housing includes a sealing surface that continuously contacts an outer surface of the sleeve such that the manifold housing maintains continuous closure of the chamber during rotation of the sleeve between manifold ports.

5. 4. The rotary metering pump (10) of claim 3, wherein the first port (22a) of the first valve system (22) and the third port (24a) of the second valve system (24) are in fluid communication with the reservoir (6).

6. 4. The rotary metering pump (10) of claim 3, wherein the second port (22b) of the first valve system (22) and the fourth port (24b) of the first second valve system (24) are in fluid communication with the downstream fluid path (8).

7. 4. The rotary metering pump of claim 3, further comprising: a piston (18) at least partially received within the sleeve (14), the sleeve (14) defining a channel (26), the piston and the sleeve defining the chamber (28), the piston (18) having a first position in which the chamber (28) has a first volume and a second position in which the chamber (28) has a second volume, the first volume being greater than the second volume.

8. The sleeve (14) rotates about a central axis (A) at least between a first rotation position and a second rotation position. Ｃ ) and when the sleeve (14) is in the first rotational position, the channel (26) is in fluid communication with the first port (22a) of the first valve system (22); 8. The rotary metering pump (10) of claim 7, wherein the channel (26) is in fluid communication with the second port (22b) of the first valve system (22) when the sleeve (14) is in the second rotational position.

9. The sleeve (14) rotates about a central axis (A) at least between a third rotation position and a fourth rotation position. Ｃ ) and when the sleeve (14) is in the third rotational position, the channel (26) is in fluid communication with the third port (24a) of the second valve system (24); 8. The rotary metering pump of claim 7, wherein the channel is in fluid communication with the fourth port of the second valve system when the sleeve is in the fourth rotational position.

10. 8. The rotary metering pump of claim 7, wherein the sleeve (14) is rotatable to an isolated position such that the first valve system (22) and the second valve system (24) are isolated from the chamber (28).

11. The rotary metering pump (10) of claim 7, wherein the first valve system (22) comprises at least one elastomeric seal.

12. The rotary metering pump (10) of claim 7, wherein the second valve system (24) comprises at least one elastomeric seal.

13. 8. The rotary metering pump (10) of claim 7, wherein at least one of the first valve system (22) and the second valve system (24) is in fluid communication with a fill port (4).

14. 8. The rotary metering pump of claim 7, wherein the piston is configured to rotate and move axially relative to the housing and the sleeve, and the piston is configured to rotate with the sleeve relative to the housing.

15. 15. The rotary metering pump of claim 14, wherein rotation of the piston in a first rotational direction is configured to aspirate fluid in the chamber and move the sleeve from the first rotational position to the second rotational position, and rotation of the piston in a second rotational direction is configured to pump fluid in the chamber and move the sleeve from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction.

16. 15. The rotary metering pump of claim 14, wherein rotation of the piston in a third rotational direction is configured to aspirate fluid in the chamber and move the sleeve from the third rotational position to the fourth rotational position, and rotation of the piston in a fourth rotational direction is configured to pump fluid in the chamber and move the sleeve from the fourth rotational position to the third rotational position, the fourth rotational direction being opposite to the third rotational direction.

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