Drug delivery device with bi-directional swing-rotary pump

Abstract

A rotary metering pump for a drug delivery device having a reservoir and a downstream fluid path, the rotary metering pump comprising: 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. A first valve system is selectively in fluid communication with the chamber. The rotary metering pump also includes a second valve system partially defined by the manifold. The second valve system is selectively in fluid communication with the chamber and the first valve system.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 415,080, filed on October 11, 2022, and entitled “Drug Delivery Device with Bi-Directional Oscillo-Rotative Pump,” the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present disclosure generally relates to metering pumps for use with drug delivery devices.

[0006] Description of Related Technology

[0007] A wearable medical device (e.g., an auto-injector) has the advantage of providing treatment to a patient at a location remote from a clinical facility and / or while the wearable medical device is discretely worn under the patient's clothing. The wearable medical device can be applied to the patient's skin and configured to automatically deliver a dose of a pharmaceutical composition within a predefined time period (e.g., after a 27-hour delay) after the wearable medical device is applied to the patient's skin. After the device delivers the pharmaceutical composition to the patient, the patient can then remove and dispose of the device.

[0008] Current auto-injectors use pump structures that provide unidirectional flow. Many applications require multidirectional flow, which requires the use of multiple pumps. Therefore, there is a need for an auto-injector that uses a single pump to provide multidirectional flow. Therefore, those skilled in the art continue to conduct research and development work in the field of metering pumps for drug delivery devices. Summary of the invention

[0009] A rotary metering pump for use with a drug delivery device having a reservoir and a downstream fluid path is disclosed.

[0010] In one example, the rotary metering pump includes: a sleeve defining a chamber; a manifold housing, the manifold housing being in fluid communication with the chamber; and a first valve system, the first valve system being partially defined by the manifold housing. The first valve system is selectively in fluid communication with the chamber. The rotary metering pump also includes: a second valve system, the second valve system being partially defined by the manifold housing. The second valve system is selectively in fluid communication with the chamber and the first valve system.

[0011] 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.

[0012] 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 the reservoir. The second port of the first valve system and the fourth port of the first second 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.

[0013] The rotary metering pump may include: a piston, which is at least partially accommodated in the sleeve, the piston and the sleeve define the chamber, the piston has a first position and a second position, the chamber has a first volume in the first position, and the chamber has a second volume in the second position, the first volume is greater than the second volume.

[0014] The sleeve may be rotatable about a central axis between at least a first rotational position and a second rotational position. When the sleeve is in the first rotational position, the passage may be in fluid communication with the first port of the first valve system. When the sleeve is in the second rotational position, the passage may be in fluid communication with the second port of the first valve system.

[0015] The sleeve may be rotatable about the central axis between at least a third rotational position and a fourth rotational position. When the sleeve is in the third rotational position, the passage may be in fluid communication with the third port of the second valve system, and when the sleeve is in the fourth rotational position, the passage may be in fluid communication with the fourth port of the second valve system. The sleeve may also be rotatable to an isolation position such that the first valve system and the second valve system are isolated from the chamber.

[0016] The first valve system may include at least one elastic seal. Further, the second valve system may include at least one elastic seal.

[0017] The piston may be configured to rotate and move axially relative to the housing and the sleeve, and the piston may be configured to rotate with the sleeve relative to the housing.

[0018] Rotation of the piston in a first rotational direction may be configured to draw fluid into 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 may 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.

[0019] In another configuration, rotation of the piston in the third rotational direction is configured to draw fluid into the chamber and move the sleeve from the third rotational position to the further rotational position. Rotation of the piston in the further rotational direction is configured to pump fluid in the chamber and move the sleeve from the fourth rotational position to the third rotational position, wherein the further rotational direction is opposite to the third rotational direction. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above-mentioned features and other features and advantages of the present disclosure, as well as the manner in which these features and advantages are achieved, will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0021] Figure 1A is an exploded view of a rotary metering pump for a drug delivery device;

[0022] Figure 1B is an exploded view of a rotary metering pump for a drug delivery device;

[0023] Figure 2 It is a three-dimensional diagram of a rotary metering pump;

[0024] Figure 3 yes Figure 2 A perspective cross-sectional view of a portion of a rotary metering pump;

[0025] Figure 4A is a schematic diagram of a portion of a drug delivery device;

[0026] Figure 4B is a schematic diagram of a portion of a drug delivery device; and

[0027] Figure 5 yes Figure 2 Schematic diagram of the series of fluid movements within a rotary metering pump.

[0028] Corresponding reference numerals refer to corresponding parts throughout the several views.The exemplifications set forth herein illustrate exemplary embodiments of the disclosure, and such exemplifications should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0029] Spatial or directional terms such as "left," "right," "inner," "outer," "above," and "below" should not be considered limiting as the invention may assume various alternative orientations.

[0030] All numbers used in the specification and claims are to be understood as being modified in all cases by the term "about". "About" refers to a range of plus or minus 10% of the stated value. As used in the specification and claims, the singular forms "a", "an", and "the" include plural references unless the context clearly indicates otherwise. The terms "first", "second", etc. are not intended to refer to any particular order or sequence, but to different conditions, characteristics, or elements. "At least" means "greater than or equal to".

[0031] Overall reference Figure 1A and Figure 1B , Figure 1A and Figure 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, which is described in the international publication text of publication number WO 2015 / 157174, which is incorporated herein by reference in its entirety. The rotary metering pump 10 is configured to be connected to a direct current (DC) motor and a gearbox assembly (not shown) to rotate a sleeve 14 in a housing 16. A spiral groove 32 is provided on the sleeve 14. A coupling pin 34 connected to the piston 18 translates along the spiral groove 32 to guide the piston 18 to retract into the sleeve 14 and insert the sleeve when the sleeve 14 rotates in one direction and then rotates in the opposite direction. The sleeve 14 has an end plug 36. When the piston 18 retracts after the suction stroke and is therefore ready to be dispensed, two seals 30 on the ends of the piston 18 and the end plug 36 respectively located inside the sleeve 14 define a cavity or chamber 28. The volume of the chamber 28 varies according to the degree of retraction of the piston 18. When the piston 18 is fully inserted and the seals 30 are substantially in contact with each other after the dispensing stroke and are therefore ready for aspiration, the volume of the chamber 28 is negligible or substantially zero.

[0032] In one example, the disclosed rotary metering pump 10 can be characterized as a swing-rotary pump 10 with an integrated valve structure having at least two valve systems 22, 24. The structure of the disclosed rotary metering pump 10 enables fluid to be pumped through different channels independently by a single pump. An exemplary application of the disclosed pump 10 is to use the rotary metering pump 10 to fill the reservoir 6 of the drug delivery device 12, and to implement a vial-to-device transfer system via the filling port 4, while using a single motor to control the valve system and actuate the rotary metering pump 10.

[0033] A series of ports 22a, 22b, 24a and 24b are provided relative to the housing 16 via the manifold housing 20. Each port 22a, 22b, 24a and 24b is configured so that a fluid (e.g., a drug) can flow from the fill port 4 to the rotary metering pump 10 and then to the reservoir 6. The fluid can then move back to the rotary metering pump 10 and out of a port different from the port through which the fluid or drug has been drawn into the chamber 28 (e.g., by retraction of the piston 18 during the aspiration phase of operation). By reinserting the piston 18 into the chamber 28, the fluid can be dispensed from the chamber 28 to, for example, a fluid path in the patient's body leading to a downstream fluid path 8 (e.g., a cannula).

[0034] Generally, refer to Figures 1 to Figure 5 The disclosed rotary metering pump 10 is configured to be used in a drug delivery device 12 (e.g., a medical syringe). The drug delivery device 12 includes a reservoir 6 and a downstream fluid path 8 (e.g., a cannula), see Figure 4A and Figure 4B The rotary metering pump 10 includes a housing 16 (see Figure 1B The housing 16 , which is configured to receive the sleeve 14 , defines a chamber 28 .

[0035] refer to Figure 1B The rotary metering pump 10 includes a manifold housing 20 coupled to the housing 16. The manifold housing 20 is configured to be in fluid communication with the chamber 28 and two or more valve systems 22, 24 to selectively allow fluid (e.g., medication) to pass therethrough. In one example, the manifold housing 20 partially defines a first valve system 22 (see Figure 2 ), the first valve system is in fluid communication with the first manifold 20a. Based on the alignment of features within the rotary metering pump 10 as described below, the first valve system 22 is selectively in fluid communication with the chamber 28. The first valve system 22 includes a first port 22a and a second port 22b. It should be understood that the first port 22a may also be referred to as a manifold seal inlet 22a, and the second port 22b may be referred to as a manifold seal outlet 22b. In one example, the first valve system 22 includes at least one elastomeric seal 30. The elastomeric seal 30 may be over-molded.

[0036] Still reference Figure 2, the manifold housing 20 partially defines a second valve system 24 in fluid communication with the second manifold 20b. Based on the alignment of features within the rotary metering pump 10 as described below, the second valve system 24 is selectively in fluid communication with the chamber 28 and the first valve system 22. The second valve system 24 includes a third port 24a and a fourth port 24b. It should be understood that the third port 24a can be referred to as a manifold seal inlet 24a, and the fourth port 24b can be referred to as a manifold seal outlet 24b. In one example, the second valve system 24 includes at least one elastomeric seal 30. The elastomeric seal 30 can overmold the piston 18.

[0037] refer to Figure 4A and Figure 4B In one or more examples, 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. Further, the second port 22b of the first valve system 22 and the fourth port 24b of the first and second systems 24 are in fluid communication with the downstream fluid path 8. Still further, in one or more examples, one or more of the first port 22a and the second port 22b of the first valve system 22 and / or one or more of the third port 24a and the fourth port 24b of the second valve system 24 may be in fluid communication with the filling port 4 to fill the reservoir 6 with a fluid (e.g., a drug).

[0038] Return to reference Figure 2 The rotary metering pump 10 further includes a sleeve 14 at least partially contained within the housing 16. The sleeve 14 is capable of rotating about a central axis A. C Rotation. The rotation of the sleeve 14 may be facilitated by the piston 18. The sleeve 14 defines a passage 26 that is configured to be rotatable about the central axis A based on the sleeve 14. C The first port 22a, the second port 22b, the third port 24a and the fourth port 24b are aligned with each other by rotation.

[0039] The sleeve 14 is arranged around the central axis A between a plurality of positions. C Can rotate 360 ​​degrees. In one example, the sleeve 14 can rotate around the central axis A. C The sleeve 14 rotates between at least a first rotational position and a second rotational position. When the sleeve 14 is in the first rotational position, the passage 26 is in fluid communication with the first port 22a of the first valve system 22. Further, when the sleeve 14 is in the second rotational position, the passage 26 is in fluid communication with the second port 22b of the first valve system 22.

[0040] In addition, the sleeve 14 may be capable of surrounding the central axis A. CWhen the sleeve 14 is in the third rotational position, the passage 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 passage 26 is in fluid communication with the fourth port 24b of the second valve system 24.

[0041] The sleeve 14 is also configured to rotate to an isolation position such that the first valve system 22 and the second valve system 24 are isolated from the chamber 28. The isolation position may be between the first valve system 22 and the second valve system 24, or the isolation position may be between the ports of one of the first valve system 22 and the second valve system 24. The isolation position may be any position such that the passage 26 is not aligned with the port and is not in fluid communication with the first valve system 22 or the second valve system 24.

[0042] The manifold housing 20 may include a sealing surface that is in continuous contact with an 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 manifold ports to maintain a fluid tight seal.

[0043] refer to Figure 1B In one or more examples, the rotary metering pump 10 further includes a piston 18 that is at least partially contained within the sleeve 14. The piston 18 and the sleeve 14 define a chamber 28 within the housing 16. The piston 18 is movable between at least 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, wherein the first volume is greater than the second volume. The piston 18 is configured to rotate and move axially relative to the housing 16 and the sleeve 14. In one example, the piston 18 is configured to rotate relative to the housing 16 together with the sleeve 14. In another example, the piston 18 is configured to rotate relative to the housing 16 independently of the sleeve 14.

[0044] In one non-limiting example, rotation of the piston 18 in a first rotational direction is configured to draw fluid into the chamber 28 and move the sleeve 14 from the first rotational position to the second rotational position. Further rotation of the piston 18 in a second rotational direction is configured to pump the fluid within the chamber 28 and move the sleeve 14 from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction.

[0045] Refer to Figure 1 and Figure 2In one or more examples, the piston 18 is configured to rotate and move axially relative to the housing 16 and the sleeve 14, wherein the piston 18 is configured to rotate with the sleeve 14 relative to the housing 16 to allow fluid to be pumped in a plurality of channels defined by the manifold housing 20. The piston 18 is connected to the sleeve 14 via a coupling pin 34, which is received within a helical groove 32 defined by the sleeve 14. The first valve system 22 and the second valve system 24 are configured to selectively fluidly connect the reservoir 6 of the drug delivery device 12 and the downstream fluid path 8 of the drug delivery device 12 via rotation of the sleeve 14.

[0046] The first valve system 22 and / or the second valve system 24 may also be in fluid communication with the fill port 4 to fill the reservoir 6 with a fluid (e.g., a drug). The rotation of the piston 18 in the first rotational direction is configured to draw the fluid into the chamber 28 and move the sleeve 14 from the first rotational position to the second rotational position, and the rotation of the piston 18 in the second rotational direction is configured to pump the fluid in the chamber 28 and move the sleeve 14 from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction. Further, the rotation of the piston 18 in the third rotational direction is configured to draw the fluid into the chamber 28 and move the sleeve 14 from the third rotational position to the fourth rotational position, and wherein the rotation of the piston 18 in the fourth rotational direction is configured to pump the 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.

[0047] Figure 5 In a series of exemplary schematic diagrams, it is shown how the rotation and movement of the piston 18 and sleeve 14 facilitates the movement of fluid within the rotary metering pump 10. The rotary metering pump 10 can be configured so that fluid can be pumped from the manifold seal inlet or first port 22a to the manifold seal outlet or second port 22b through the first valve system 22 via the chamber 28, and from the manifold seal inlet or third port 24a to the manifold seal outlet or fourth port 24b through the second valve system 24. Figure 5 The exemplary schematic diagram shown in FIG. 1 is only one example of how fluid may flow through a fluid circuit via the rotary metering pump 10. The flow of fluid out of the rotary metering pump 10 is not limited to Figure 5 Schematic sequence shown.

[0048] In such Figure 5In the example shown, movement of the piston 18 between position 1 and position 2 facilitates drawing fluid from the first valve system 22 via the first port 22a. At positions 1 and 2, the sleeve 14 is positioned so that the passage 26 is aligned with the first port 22a, thereby placing the chamber 28 in fluid communication with the first port 22a. In one example, the first port 22a is simultaneously in fluid communication with the reservoir 6, so that fluid can travel between the reservoir 6 and the chamber 28 via the first port 22a and the passage 26 based on the movement of the piston 18. The retraction and insertion of the piston 18 within the sleeve 14 can occur simultaneously with the rotation of the piston 18 and / or the sleeve 14, or can occur independently of the rotation of the piston and / or the sleeve.

[0049] Still refer to Figure 5 , positions 3 and 4 show the movement of fluid from chamber 28 through passage 26 through second port 22b. Sleeve 14 is circumferentially oriented around central axis A C The first valve system 22 is rotated or swung so that the channel 26 is aligned with the second port 22b of the first valve system 22, thereby connecting the second port 22b to the chamber 28. In one example, the second port 22b is simultaneously connected to the downstream fluid path 8. In another example, the second port 22b is simultaneously connected to the injection site or needle hub (see Figure 4A and Figure 4B ). Then, as shown in position 5, suction from the first port 22a may be repeated.

[0050] After positions 1 to 5 are completed, in one or more examples, the sleeve 14 can be rotated to an orientation that brings the channel 26 close to the third port 24a and the fourth port 24b to facilitate alignment with the third port 24a and the fourth port 24b. Referring to position 6 of Figure 4, the piston 18 can be retracted to aspirate fluid through the third port 24a. The third port 24a can be in fluid communication with the filling port 4 so that the fluid is drawn from the filling port 4 to the chamber 28 to be transferred to the reservoir 6 via the fourth port 24b (see position 7). Position 8 shows that the fluid is dispensed from the chamber 28 to the reservoir 6 via the fourth port 24b by inserting the piston 18 into the sleeve 14. Then, the sleeve 14 can be rotated or swung to an orientation that aligns the channel 26 with the first port 24a again, and the aspiration / dispensing positions 6 to 8 can be repeated.

[0051] Although the present invention has been described in detail based on what is currently considered to be the most practical and preferred embodiments for the purpose of illustration, it should be understood that such detail is for that purpose only and that the present invention is not limited to the disclosed embodiments, but on the contrary, the present invention 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 may be combined with one or more features of any other embodiment.

Claims

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

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

3. The rotary metering pump (10) according to claim 1, wherein: The first valve system (22) includes a first port (22a) and a second port (22b); and The second valve system (24) includes a third port (24a) and a fourth port (24b).

4. The rotary metering pump (10) according to claim 3, wherein: The manifold housing (20) includes a sealing surface that is in continuous contact with an 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 manifold ports.

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

7. The rotary metering pump (10) according to claim 3, further comprising: A piston (18) is at least partially received in the sleeve (14), the sleeve (14) defines a passage (26), the piston and the sleeve define the chamber (28), the piston (18) has a first position and a second position, in the first position the chamber (28) has a first volume, in the second position the chamber (28) has a second volume, the first volume is greater than the second volume.

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

9. The rotary metering pump according to claim 7, wherein: The sleeve (14) is capable of rotating about a central axis (A C ) rotates between at least a third rotational position and a fourth rotational position; When the sleeve (14) is in the third rotational position, the passage (26) is in fluid communication with the third port (24a) of the second valve system (24); and When the sleeve (14) is in the fourth rotational position, the passage (26) is in fluid communication with the fourth port (24b) of the second valve system (24).

10. The rotary metering pump according to claim 7, wherein: The sleeve (14) is rotatable to an isolation 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) according to claim 7, wherein: The first valve system (22) includes at least one elastic seal.

12. The rotary metering pump (10) according to claim 7, wherein: The second valve system (24) includes at least one elastic seal.

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

14. The rotary metering pump (10) according to claim 7, wherein: The piston (18) is configured to rotate and move axially relative to the housing (16) and the sleeve (14); and wherein the piston (18) is configured to rotate relative to the housing (16) together with the sleeve (14).

15. The rotary metering pump (10) according to claim 14, wherein: Rotation of the piston (18) in a first rotational direction is configured to draw fluid into the chamber (28) and move the sleeve (14) from the first rotational position to the second rotational position; and wherein rotation of the piston (18) in a second rotational direction is configured to pump fluid in the chamber (28) and move the sleeve (14) from the second rotational position to the first rotational position, the second rotational direction being opposite to the first rotational direction.

16. The rotary metering pump (10) according to claim 14, wherein: Rotation of the piston (18) in a third rotational direction is configured to draw fluid into the chamber (28) and move the sleeve (14) from the third rotational position to the fourth rotational position; and wherein 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.

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