Cartridge adapter for drug delivery device

The cartridge adapter with integrally formed clamping members and dovetail connection interface addresses the challenge of maintaining device contact during extended infusions, enabling self-administration of larger medication volumes by securely engaging differently sized cartridges.

JP7766130B2Active Publication Date: 2025-11-07BECTON DICKINSON & CO
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Patent Information

Application Number
JP2024067563
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-05-30
Filing Date
2024-04-18
Publication Date
2025-11-07
Estimated Expiration
2040-05-29

AI Technical Summary

Technical Problem

Existing drug delivery devices face challenges in maintaining contact between the device and the target site on the patient's skin for volumes exceeding 1 mL, especially when the injection time extends beyond 10 to 15 seconds, making self-administration difficult and requiring hospital or outpatient settings for slow infusion.

Method used

A cartridge adapter with integrally formed clamping members and a dovetail connection interface that can engage differently sized cartridges, allowing for secure attachment to drug delivery devices, facilitating the use of varying cartridge sizes and ensuring stable engagement during infusion.

Benefits of technology

Enables secure attachment of cartridges of varying sizes, ensuring consistent and stable infusion over extended periods, allowing self-administration of larger medication volumes without the need for hospital settings.

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Abstract

To provide a drug delivery device, especially, a cartridge adapter for a drug delivery device.SOLUTION: A cartridge adapter 50 for a drug delivery device, the cartridge adapter includes a body 60 having a first end 62 and a second end 64 positioned opposite the first end, with the body including a first clamp member 66, a second clamp member 68 spaced from the first clamp member, and a connection interface 72 configured to engage a corresponding connection interface of a drug delivery device. The first and second clamp members are moveable relative to each other and configured to receive and engage a plurality of different sized cartridges 74 for a drug delivery device.SELECTED DRAWING: Figure 17
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Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 62 / 854,411, filed May 30, 2019, entitled "Cartridge Adapter for Drug Delivery Device," the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THE INVENTION The present invention relates generally to drug delivery devices and, more particularly, to cartridge adapters for drug delivery devices. [Background technology]

[0003] Various types of automatic injectors or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic formulations to be administered or self-injected by untrained personnel. These devices typically include a container prefilled with the liquid therapeutic formulation and some type of automatic needle injection mechanism that can be released by the user. Automatic injectors are typically used when the volume of fluid or medication to be administered is less than a certain volume, typically 1 mL, and typically have an injection time of approximately 10 to 15 seconds. When the volume of fluid or medication to be administered exceeds 1 mL, the injection time generally becomes longer, resulting in difficulties for the patient in maintaining contact between the device and the target site on the patient's skin. Furthermore, as the volume of medication administered increases, it becomes desirable to increase the injection time. The conventional method for slowly infusing medication into a patient is to start an intravenous (IV) injection and slowly infuse the medication into the patient's body. Such procedures are typically performed in a hospital or outpatient setting.

[0004] Certain devices allow for self-injection in the home setting, allowing the liquid therapeutic formulation to be gradually infused into a patient's skin. In some cases, these devices are small enough (both in height and overall size) to be "worn" by the patient while the liquid therapeutic formulation is being infused into the patient's body. These devices typically include a pump or other type of release mechanism to force the liquid therapeutic formulation from a reservoir into an infusion needle. Such devices also typically include a valve or flow control mechanism to initiate the flow of the liquid therapeutic formulation at the appropriate time, and a release mechanism to initiate the infusion. Summary of the Invention [Means for solving the problem]

[0005] In one aspect, a cartridge adapter for a drug delivery device includes a body having a first end and a second end disposed opposite the first end, the body including a first clamping member, a second clamping member spaced from the first clamping member, and a connection interface configured to engage a corresponding connection interface of the drug delivery device, the first and second clamping members being movable relative to each other and configured to receive and engage a plurality of different sized cartridges for the drug delivery device.

[0006] The first clamping member may extend from a first end of the body to a second end of the body, and the second clamping member may extend from the first end of the body to a second end of the body. The body and the first and second clamping members may be integrally formed with one another. The connection interface may be a dovetail. The first and second clamping members may be arcuate. The body, the first and second clamping members, and the connection interface may be integrally formed with one another.

[0007] In a further aspect, a drug delivery device includes a housing including a first connection interface, a first cartridge having a first diameter configured to receive a medicament, a drive assembly received within the housing and configured to engage the cartridge to dispense the medicament from the cartridge, a needle actuation assembly received within the housing and including a patient needle configured to pierce the skin of a patient, and a cartridge adapter including a body having a first end and a second end disposed opposite the first end, the body comprising a first clamp member, a second clamp member spaced from the first clamp member, and the second connection interface configured to engage with the first connection interface, the first and second clamp members being movable relative to each other to receive and engage the first cartridge.

[0008] The drug delivery device may further include a second cartridge configured to receive the medicament, the second cartridge having a second diameter. The second diameter is larger than the first diameter, and the first and second clamp members are configured to receive and engage the second cartridge. The first clamp member may extend from the first end of the body to the second end of the body, and the second clamp member may extend from the first end of the body to the second end of the body. The body and the first and second clamp members may be integrally formed with each other. The first connection interface may be a recess, and the second connection interface may be a dovetail received by the recess. The first and second clamp members may be arc-shaped. The body, the first and second clamp members, and the connection interface may be integrally formed with each other.

[0009] The above-mentioned and other aspects 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 the embodiments of the disclosure taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of a conventional drug delivery system. [Figure 2] FIG. 2 is a partial cross-sectional perspective view of the drug delivery system of FIG. 1. [Figure 3] FIG. 2 is a partial cross-sectional front view of the drug delivery system of FIG. 1. [Figure 4] 2 is a top view of the drug delivery system of FIG. 1 with the top portion of the housing removed and showing the drug delivery system in a pre-use position. [Figure 5] 2 is a top view, partially in section, of the drug delivery system of FIG. 1, showing the drug delivery system in a pre-use position. [Figure 6] 2 is a partial cross-sectional front view of the drug delivery system of FIG. 1, showing the drug delivery system in a pre-use position. [Figure 7] 2 is a top view of the drug delivery system of FIG. 1 with the top portion of the housing removed and showing the drug delivery system in an initial actuated position. [Figure 8] 2 is a partial cross-sectional top view of the drug delivery system of FIG. 1 showing the drug delivery system in an initial actuated position. [Figure 9] 2 is a partial cross-sectional front view of the drug delivery system of FIG. 1 showing the drug delivery system in an initial actuated position. [Figure 10] 2 is a top view of the drug delivery system of FIG. 1 with the top portion of the housing removed and showing the drug delivery system in the use position. [Figure 11] 2 is a top view, partially in section, of the drug delivery system of FIG. 1, showing the drug delivery system in the use position. [Figure 12] 2 is a partial cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position for use. [Figure 13] 2 is a top view of the drug delivery system of FIG. 1 with the top portion of the housing removed and showing the drug delivery system in a post-use position. [Figure 14] 2 is a top view, partially in section, of the drug delivery system of FIG. 1, showing the drug delivery system in a post-use position. [Figure 15]2 is a partial cross-sectional front view of the drug delivery system of FIG. 1 showing the drug delivery system in a post-use position. [Figure 15A] 2 is a partial cross-sectional front view of the drug delivery system of FIG. 1 showing a pad with the drug delivery system in a pre-use position. [Figure 15B] 2 is a partial cross-sectional perspective view of the drug delivery system of FIG. 1 showing a pad with the drug delivery system in a pre-use position. [Figure 15C] 2 is a partial cross-sectional perspective view of the drug delivery system of FIG. 1 showing a pad with the drug delivery system in a pre-use position. [Figure 16] FIG. 2 is a partial cross-sectional view of the drug delivery system of FIG. 1 showing the valve assembly. [Figure 17] 1 is an exploded perspective view of a cartridge adapter for a drug delivery device according to one embodiment of the present invention. FIG. [Figure 18] FIG. 18 is a perspective view of the cartridge adapter of FIG. 17, shown connected to a drug delivery device with a cartridge received within the cartridge adapter, according to one embodiment of the present invention. [Figure 19] FIG. 18 is a perspective view of the cartridge adapter of FIG. 17 according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] The following description is provided to enable any person skilled in the art to make and use the embodiments contemplated and described for practicing the invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to those skilled in the art. All such modifications, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0012] For purposes of the remainder of this specification, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives will refer to the present invention in the orientation of the drawings. However, it should be understood that the present invention may contemplate alternative variations unless expressly stated to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0013] 1-16 , a conventional drug delivery system 10 includes a drive assembly 12, a reservoir 14, a valve assembly 16, and a needle drive assembly 18. The drive assembly 12, the reservoir 14, the valve assembly 16, and the needle drive assembly 18 are at least partially disposed within a housing 20. The housing 20 includes a top portion 22 and a bottom portion 24, although other suitable arrangements for the housing 20 may be used. In one embodiment, the drug delivery system 10 is an injector device configured to be worn or secured to a user and to deliver a predetermined dose of medication provided in the reservoir 14 to the user via injection. The system 10 may be used to deliver a "bolus injection," which delivers the medication within a set time period. The medication may be delivered over a period of up to 45 minutes, although other suitable injection volumes and durations may be used. The bolus injection or delivery may be performed with or without any specific rate control. The system 10 may deliver medication to a user at a fixed pressure and at variable rates. The general operation of the system 10 is described below with reference to FIGS.

[0014] 1-16 , system 10 is completed through user engagement of activation button 26, causing needle 28 of needle assembly 18 to pierce the user's skin, actuation of drive assembly 12, placing needle 28 in fluid communication with container 14 and expelling fluid or medication from container 14, and removal of needle 28 after medication infusion is complete. The general operation of drug delivery systems is shown and described in International Publication Nos. 2013 / 155153 and 2014 / 179774, which are incorporated herein by reference in their entireties. The operation of system 10 is shown and described in U.S. Patent Application Publication No. 2017 / 0354788, which is incorporated herein by reference in its entirety. Housing 20 of system 10 includes an indicator window 30 for viewing an indicator arrangement 32 configured to provide a user with an indication regarding the status of system 10, and a container window 31 for viewing container 14. The indicator window 30 may be a magnifying lens that provides a clear view of the indicator arrangement 32. The indicator arrangement 32 moves along the needle actuator assembly 18 during use of the system 10 to indicate the pre-use, in-use, and post-use status of the system 10. The indicator arrangement 32 provides a visual indication of the status, although other suitable indications, such as audible or tactile, may be provided as alternative or additional indications.

[0015] 4-6 , while system 10 is in the pre-use position, container 14 is spaced apart from drive assembly 12 and valve assembly 16, and needle 28 is in a retracted position. As shown in FIGS. 7-9 , during initial actuation of system 10, drive assembly 12 engages container 14 and moves container 14 toward valve assembly 16, which is configured to puncture closure 36 of container 14 and place medicament within container 14 in fluid communication with needle 28 via tubing (not shown) or other suitable arrangement. Drive assembly 12 is configured to engage stopper 34 of container 14, which initially can move the entire container 14 into engagement with valve assembly 16 due to the incompressibility of the fluid or medicament within container 14. Initial actuation of system 10 is triggered by a user's engagement of actuator button 26, which releases needle drive assembly 18 and drive assembly 12, as described in more detail below. During initial actuation, needle 28 is still in the retracted position and is about to move to the extended position to inject into a user of system 10 .

[0016] While system 10 is in the use position, as shown in FIGS. 10-12 , needle 28 is in an extended position at least partially outside housing 20, and drive assembly 12 moves stopper 34 within container 14 to deliver medicament from container 14, through needle 28, and to the user. In the use position, valve assembly 16 has already punctured closure 36 of container 14, placing container 14 in fluid communication with needle 28 and allowing drive assembly 12 to move stopper 34 relative to container 14 so that fluid can be dispensed from container 14. In the post-use position of system 10, shown in FIGS. 13-15 , needle 28 is in a retracted position and engaged with pad 38 to seal needle 28 and prevent any residual flow of fluid or medicament from container 14.

[0017] 17-19, a cartridge adapter 50 for a drug delivery device 52 is shown. The drug delivery device 52 may be the same as the system 10 shown in FIGS. 1-16 and described above. The cartridge adapter 50 may be integrated into the system 10, which operates in the same manner as described above. The cartridge adapter 50 includes a body 60 having a first end 62 and a second end 64 opposite the first end 62. The body 60 includes a first clamping member 66 and a second clamping member 68 spaced apart from the first clamping member 66. A connection interface 70 is configured to engage a corresponding connection interface 72 of the drug delivery device 52. The first and second clamping members 66, 68 are movable relative to each other and configured to receive and engage a plurality of differently sized cartridges 74 for the drug delivery device 52. The cartridge 74 may be the same as the container 14 described above and shown in FIGS. 1-16. Cartridge adapter 50 is configured to receive cartridges 74 having different size diameters and different lengths.

[0018] 17 and 18, cartridge 74 may be inserted into cartridge adapter 50 by engaging first and second clamping members 66, 68 with cartridge 74, which moves first and second clamping members 66, 68 further apart from one another, thereby creating a biasing force that engages and secures cartridge 74 between first and second clamping members 66, 68. First and second clamping members 66, 68 are arcuate such that the shape of first and second clamping members 66, 68 generally corresponds to the outer surface of cartridge 74, although other suitable shapes and configurations may be used.

[0019] The first clamp member 66 extends from the first end 62 of the body 60 to the second end 64 of the body 60. The second clamp member 68 also extends from the first end 62 of the body 62 to the second end 64 of the body 60. The connection interface 70 is dovetailed and is received and engaged by a corresponding connection interface 72, which is formed by a dovetail recess defined by a housing 82 of the drug delivery device 52, although other suitable connection interfaces may be used. The connection interface 70 includes a first flange 76 extending from the first clamp member 66 and a second flange 78 extending from the second clamp member 68, with a connection portion 80 extending between the first and second flanges 76, 78. The first and second flanges 76, 78 may be planar, and the connection portion 80 may be arcuate. The connection interface 70 may be flexible, facilitating connection between the connection interface 70 of the cartridge adapter 50 and the corresponding interface 72 of the drug delivery device 52. The cartridge adapter 50 allows the cartridge 74 to be attached to the drug delivery device 52 from outside the housing 82. The body 60, the first and second clamping members 66, 68, and the connection interface 70 are integrally formed with one another, although other suitable arrangements may be used. In particular, the first and second clamping members 66, 68, and the connection interface 70 are formed from a single sheet of material. The body 60 may be formed from a polymeric material, although other suitable materials or combinations of materials may be used.

[0020] Elements of one disclosed embodiment can be combined with elements of one or more other disclosed embodiments to form different combinations, all of which are considered to be within the scope of the present invention.

[0021] While this disclosure has been described as having exemplary designs, the disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations using the general principles of the disclosure. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.

Claims

1. 1. A cartridge adapter for a drug delivery device, comprising: a body having a first end and a second end disposed opposite the first end; the body comprising a first clamping member, a second clamping member spaced from the first clamping member, and a connection interface configured to engage a corresponding connection interface of a drug delivery device; the first and second clamping members are integrally formed with one another, are flexibly movable relative to one another, and are configured to receive and engage a plurality of different sized cartridges for a drug delivery device; When the cartridge is engaged, the first and second clamp members generate a biasing force against both the cartridge and the second clamp member. Cartridge adapter.

2. 2. The cartridge adapter of claim 1, wherein the first clamping member extends from the first end of the body to the second end of the body, and the second clamping member extends from the first end of the body to the second end of the body.

3. The cartridge adapter of claim 1 , wherein the connection interface includes a dovetail.

4. 2. The cartridge adapter of claim 1, wherein the first and second clamping members are arcuate.

5. The cartridge adapter of claim 1 , wherein the body, the first and second clamping members, and the connection interface are integrally formed with one another.

6. 1. A drug delivery device comprising: a housing including a first connection interface; a first cartridge having a first diameter configured to receive a medicament; a second cartridge configured to receive a medicament and having a second diameter greater than the first diameter; a drive assembly received within the housing and configured to engage the first or second cartridge to dispense medicament from the first or second cartridge; a needle drive assembly including a patient needle received within the housing and configured to pierce the skin of a patient; 1. A cartridge adapter including a body having a first end and a second end disposed opposite the first end, the body includes a first clamping member, a second clamping member spaced from the first clamping member, and a second connection interface configured to engage with the first connection interface; the first and second clamping members are integrally formed with one another, are flexibly movable relative to one another, and are configured to receive and engage at least one of a first cartridge and a second cartridge; a cartridge adapter configured such that when the cartridge is engaged, the first and second clamp members generate a biasing force on both the cartridge; A drug delivery device comprising:

7. 7. The drug delivery device of claim 6, wherein the first clamping member extends from the first end of the body to the second end of the body, and the second clamping member extends from the first end of the body to the second end of the body.

8. The drug delivery device of claim 6 , wherein the first connection interface includes a recess and the second connection interface includes a dovetail that is received by the recess.

9. The drug delivery device of claim 6 , wherein the first and second clamping members are arcuate.

10. The drug delivery device of claim 6 , wherein the body, the first and second clamping members, and the second connection interface are integrally formed with one another.

Citation Information

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