Cartridge insertion mechanism for a fluid delivery device

Abstract

The fluid delivery device includes a drive unit including an actuator and one or more first structural elements, and a cartridge filled with a fluid before being inserted into a housing. The cartridge has a fluid reservoir sealed at one end by a movable piston and sealed at the other end by a pierceable septum. The cartridge includes one or more second structural elements configured to align and cooperate with the one or more first structural elements to allow the cartridge to be inserted into the drive unit. Once the cartridge is inserted into the drive unit, the piston can be moved by the actuator.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 063,979, filed on October 15, 2014, entitled "Cartridge Insertion Mechanism for a Fluid Delivery Device", the entire content of which is incorporated herein by reference. BACKGROUND OF THE INVENTION

[0003] The present invention generally relates to a cartridge insertion mechanism for a fluid delivery device, and more particularly, to a cartridge insertion mechanism for a flow-through fluid delivery pump for delivering a drug to a patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The following detailed description of embodiments of a cartridge insertion mechanism for a fluid delivery device will be better understood when read in conjunction with the accompanying drawings of exemplary embodiments. However, it should be understood that the invention is not limited to the precise arrangements and instrumentalities shown.

[0005] In the figures:

[0006] Figure 1 is an isometric view of a fluid delivery device;

[0007] Figure 2 is a top sectional view of the fluid delivery device shown in Figure 1 taken along the plane indicated by line 2-2;

[0008] Figure 3A is a front sectional view of the fluid delivery device shown in Figure 1 taken along the plane indicated by line 3A-3A and shown in an initial position;

[0009] Figure 3B is a front sectional view of the fluid delivery device shown in Figure 1 shown in a deployed position;

[0010] Figure 4 is an isometric view of a fluid delivery device with an insertable cartridge according to an exemplary embodiment of the invention showing the cartridge inserted;

[0011] Figure 5 is an isometric view of the fluid delivery device and cartridge shown in Figure 4 with the housing removed;

[0012] Figure 6 is an isometric view of the fluid delivery device and cartridge shown in Figure 4 showing the cartridge inserted;

[0013] Figure 7 is an isometric view of the fluid delivery device and cartridge shown in Figure 4 showing the cartridge inserted and the housing door closed.Oblique view of the fluid delivery device and the cartridge;

[0014] Figure 8 is Figure 4 Oblique cross-sectional view of the fluid delivery device and the cartridge;

[0015] Figure 8A is Figure 8 Enlarged cross-sectional view of the piston end of the cartridge shown in;

[0016] Figure 9 is Figure 7 Oblique cross-sectional view of the fluid delivery device and the cartridge;

[0017] Figure 9A is Figure 9 Enlarged cross-sectional view of the piston end of the cartridge in the fluid delivery device shown in;

[0018] Figure 10 is a view showing the hydraulic fluid path open Figure 7 Oblique cross-sectional view of the fluid delivery device and the cartridge;

[0019] Figure 11 is a view showing the hydraulic fluid path open and the septum punctured by the delivery needle Figure 7 Oblique cross-sectional view of the fluid delivery device and the cartridge; and

[0020] Figure 12 is an oblique view of a fluid delivery device having an insertable cartridge according to an exemplary embodiment of the present invention, having a lid door connected to the cartridge. Detailed Description

[0021] Referring to Figures 1 - 3B , an exemplary fluid delivery device 110 is shown. In one embodiment, the fluid delivery device 110 is a discrete flow-type insulin delivery pump. The fluid delivery device 110 can be single-use, disposable, and non-reusable. The fluid delivery device 110 can provide treatment capabilities in the form of small single-use disposable packages and can be produced using high-volume manufacturing (e.g., injection molding) and assembly processes, thus allowing low-cost commodities. The devices of the present invention can be used in a wide range of applications, including but not limited to clinical applications (e.g., administration of drugs, etc.) and biomedical research (e.g., microinjection into cells, nuclear or organelle transplantation, isolation of single cells or hybridomas, etc.).

[0022] In one embodiment, the fluid delivery device 110 is a device for dispensing, delivering, or administering a fluid or formulation to a user or patient. The fluid can be a low-viscosity gel and / or a therapeutic agent. In one embodiment, the fluid is an analgesic. In one embodiment, the fluid is any type of insulin. In one embodiment, the fluid is U100 insulin. In another embodiment, the fluid is U200 insulin. In another embodiment, the fluid is U300 insulin. In another embodiment, the fluid is U500 insulin. In another embodiment, the fluid is any insulin between U100 and U500. In other embodiments, the fluid can be, but is not limited to, anesthetic and / or other mitigants or analgesics, hormones, psychopharmacological therapeutic compositions, or any other drug or chemical the continuous administration of which is desired or effective for treating a patient. The fluid delivery device 110 can be used to deliver a single fluid and a composition of two or more fluids (mixed or co-administered). As used herein, "patient" or "user" can be a human or non-human animal; the use of the fluid delivery device 110 is not limited to human medicine and can equally apply to veterinary medicine.

[0023] The fluid delivery device 110 can dispense the fluid over a continuous period of time (i.e., basal delivery). In one embodiment, the fluid delivery rate is delivered continuously or near continuously to the user over a continuous period of time. The fluid delivery device 110 can be under patient control (i.e., bolus delivery) and be capable of dispensing a supplemental amount of fluid in addition to the basal amount as needed. In one embodiment, the bolus amount to be delivered in a single optional administration is pre-determined. In a preferred embodiment, the fluid delivery device 110 is hydraulically actuated and includes one or more reservoirs or chambers containing a hydraulic fluid of appropriate viscosity to transfer power from one or more actuators to the fluid and control the delivery rate, as further discussed below.

[0024] Reference Figure 1 , for example, the illustrated fluid delivery device 110 includes a housing 112 and a sticky bottom surface 114, such as a foam pad.

[0025] Reference Figure 2 , the fluid delivery device 110 includes a cartridge 222 having a fluid reservoir 220 containing a drug. The fluid delivery device 110 can include one or more actuators 226 (such as a basal actuator), 228 (such as a bolus actuator) acting on a piston 224 within the cartridge 222.

[0026] Reference Figure 3A and 3B, the needle 330 can be deployed to fluidly couple the fluid reservoir 220 and the patient. The needle 330 can be coupled to a button 332, and the needle 330 can be bent such that translation of the button 332 towards the patient causes the fluid coupling end 330a to be fluidly coupled to the fluid reservoir 220 and causes the delivery end 330b to project from the bottom surface 114.

[0027] Liquid medications for subcutaneous delivery are typically packaged in cartridges or vials having a fluid reservoir. It is desirable to be able to load these pre-filled cartridges into a fluid delivery device for easy manipulation without having to fill a reservoir already inside the device.

[0028] Cartridges typically have a septum seal at one end and a piston or plunger inside at the opposite end. The medication is delivered by fluidly connecting the contents inside the cartridge through the septum to the patient's body and then pressing on the piston.

[0029] In most fluid delivery systems, and particularly in hydraulically driven fluid delivery devices, accurate and effective delivery of the medication requires a small (preferably no) compressible gap between the drive mechanism and the piston, a small (and preferably no) pre-delivery pressure acting on the piston, and the needle to be accurately inserted into the septum.

[0030] Inserting the cartridge into the delivery device can result in performance issues due to length tolerances of the cartridge, which lead to an unacceptably large compressible gap between the drive mechanism and the piston and a misaligned needle insertion system.

[0031] In addition, temperature variations during storage and transportation can cause changes in component dimensions and liquid volumes. If there are significant differences in the coefficients of thermal expansion between components, there can be significant changes in component positions, which can exacerbate tolerance issues. This is particularly evident in hydraulically driven systems where the fluid may have much greater thermal expansion characteristics than the solid components of the device.

[0032] Accordingly, it is desirable to have an easy-to-use mechanism that allows a pre-filled fluid reservoir or cartridge to be inserted into a delivery device, creating a fluid seal in the device to minimize the compressible gap between the drive mechanism and the piston. In one embodiment, the length tolerance of the cartridge that can be used with the delivery device is at least + / -0.4 mm. The delivery device may allow a minimum pressure in the system due to the insertion or the insertion mechanism. The delivery device can allow proper alignment between the cartridge septum seal and the needle mechanism. It would also be beneficial if the delivery device could compensate for thermal expansion effects.

[0033] Specific reference is made to the accompanying drawings, in which like reference numerals denote like elements throughout all the drawings, Figures 4 - 12Shows a fluid delivery device according to an exemplary embodiment of the present invention. Embodiments of the cartridge configuration can be used with a variety of fluid delivery devices 110 (see Figures 1 - 3B ), such as the fluid delivery devices disclosed in U.S. Patent No. 9,101,706, U.S. Patent No. 8,740,847, and U.S. Patent No. 7,481,792, the entire contents of which are incorporated herein by reference.

[0034] In some embodiments, the fluid delivery devices 110, 400 include a housing and a bottom surface configured to be coupled to a skin surface in an engagement position. In one embodiment, a cartridge having a fluid reservoir is connected to the housing and has a septum. In one embodiment, the septum seals one end of the fluid reservoir, and a piston (see Figure 2 ) seals the other end. In one embodiment, the patient inserts a pre-filled cartridge into the fluid delivery device prior to use. The septum of the cartridge may have a pierceable portion that is pierced by a needle during use. In one embodiment, the cartridge is made of glass or has an internal glass coating, although other materials for the cartridge may be used, such as plastic.

[0035] In some embodiments, a needle assembly having a needle can be used to fluidly couple the septum to the skin surface by a desired motion taken by the user or is configured to automatically deploy during use of the device. The needle may have a delivery end and a fluid coupling end. Initially, the fluid coupling end may be fluidly separated from the fluid reservoir (e.g., an initial or pre-fluid delivery position). The delivery end of the needle may also be spaced above the bottom surface of the fluid delivery device such that both ends of the needle are received within the housing in the initial position. After the fluid delivery device is attached to the skin surface in the engagement position, the delivery end of the needle may extend through the bottom surface of the fluid delivery device, and the fluid connection end of the needle may simultaneously, at an offset time, or separately extend through the pierceable portion of the septum such that the fluid reservoir is fluidly coupled to the patient during use (e.g., deployed, in-use, or fluid delivery position).

[0036] In some embodiments, in the case where the system is fluid-driven, the fluid must be reliably contained within the device prior to installing the cartridge. Once installed, the fluid or fluid driving element is operable to advance or push the cartridge piston with a minimal and preferably no compressible space therebetween.

[0037] Reference Figures 4 - 11, showing a first exemplary embodiment of a fluid delivery device 400. The fluid delivery device 400 may include two main components, namely a hydraulic drive unit 401 and an insertable pre-filled cartridge 420. In one embodiment, the cartridge 420 includes a fluid reservoir 415 that holds a drug, one end of which is sealed with a pierceable element 416 (such as a diaphragm held in place by a crimped cap 417) and the other end is sealed by an internally movable piston 419 (see Figure 9 ). The cartridge 420 may also include a bonding structure element 418 at one end. In other embodiments, the bonding structure element 418 is near the middle and / or the other end of the cartridge 420. In one embodiment, as Figures 4 - 11 shown, the bonding structure element 418 is part of a sleeve at the piston end of the fluid reservoir 415, which is attached to the outer surface of the cartridge 420 and is configured to cooperate with the hydraulic drive unit 401 when the cartridge 420 is inserted into the hydraulic drive unit 401. In one embodiment, the bonding structure element 418 has one or more structural elements 418a, such as radially protective depressions and / or protrusions, which are unique to the cartridge model and cooperate with one or more corresponding structural elements of the hydraulic drive unit 401. The bonding configuration between the cartridge 420 and the drive unit 401 can help prevent a cartridge 420 not intended for a particular drive unit 401 (such as a cartridge containing an undesired type or volume of drug) from being inserted into a particular drive unit 401.

[0038] In Figures 4 - 11 the embodiment shown, the structural element 418a of the cartridge 420 includes one or more grooves corresponding to a structural element 421 (such as a protrusion of the drive unit 401). In other embodiments, the structural element 418a of the cartridge 420 also includes or alternatively includes protrusions corresponding to the structural element 421 (such as a depression) of the drive unit 401. In one embodiment, one or more structural elements 418a of the bonding structure element 418 protrude radially inwardly and / or outwardly relative to the longitudinal axis A of the cartridge 420 and extend around the entire outer periphery of the bonding structure element 418, such that the cartridge 420 can be inserted into the hydraulic drive unit 401 at any radial position about the axis A. In other embodiments, one or more structural elements 418a, 421 only partially extend around the outer periphery of the bonding structure element 418 and / or the drive unit, such that the cartridge 420 can only be inserted into the drive unit 401 at one or more discrete radial positions about the axis A.

[0039] In one embodiment, the structural element 421 of the drive unit 401 is near the seal socket 408 within the hydraulic drive unit. The drive unit 401 may include an actuator configured to drive the hydraulic fluid that drives the piston 419. The drive unit 401 may be positioned within a housing 402.

[0040] Reference Figure 8A , in one embodiment, the bonding structure element 418 is a separate component that is bonded to the cartridge 420 with sufficient strength to resist the maximum force applied to the reservoir by the hydraulic system. In one embodiment, the bonding structure element 418 is fixed to the cartridge 420 using an adhesive. In one embodiment, the bonding structure element 418 is fixed to the cartridge 420 by a press fit. In one embodiment, the bonding structure element 418 is fixed to the cartridge 420 by swaging the two components, where the outer annular component compresses the inner annular component around the reservoir when its inner component is axially pressed into the outer annular component. In one embodiment, the bonding structure element 418 is fixed to the cartridge 420 by welding. In one embodiment, the bonding structure element 418 is fixed to a prepared surface on the cartridge 420, such as a film, an etched surface, or an adhesive label. In one embodiment, the bonding structure element 418 is fixed to the cartridge 420 by a sleeve that slides over the end of the cartridge 420 and at least partially over a portion of the seal 418b. In one embodiment, the bonding structure element 418 is integrally formed into the cartridge 420.

[0041] Figure 5 The fluid delivery device 400 is shown with the housing removed to expose the seal socket space 408. Figure 6 The cartridge 420 is shown inserted into the available space within the hydraulic drive unit 401. In one embodiment, the door 406 is coupled to the housing 402 and is configured to close over the cartridge 420 once the cartridge 420 is in place to hold the cartridge 420 within the drive unit 401. As Figure 7 shown, the door 406 can be configured to push the cartridge 420 into its fully seated position when the user closes the door 406. In one embodiment, there is an interlock that prevents the door 406 from closing without the cartridge 420 being at least partially inserted.

[0042] Figure 9 and Figure 9AShows a cross-section of an embodiment where substantially the bonding structural element 418 is pressed into the sealing socket space 408 when the cartridge 420 is inserted. In this embodiment, there is a compliant portion or seal 418b that slides along the rear surface 408a of the sealing socket space 408. At the opposite end of the sealing socket space 408, there is a shoulder 408b that mates with the corresponding end of the bonding structural element 418 to push the bonding structural element 418 and thus press the seal 418b against the rear surface 408a, creating a seal between the rear surface 408a and the piston end of the cartridge 420. In one embodiment, the distance between the rear surface 408a and the front surface shoulder 408b of the sealing socket space 408 is approximately equal to the distance between the front and rear portions of the bonding structural element 418. In one embodiment, the distance between the rear surface 408a and the front surface shoulder 408b of the sealing socket space 408 is less than the distance between the front and rear portions of the bonding structural element 418, such that once the cartridge is inserted into the drive unit, the seal 418b is pressed against the rear surface 408a.

[0043] In one embodiment, the structural element 421 is spaced from the rear surface 408a by a distance approximately equal to the distance by which the structural element 418a is spaced from the end of the seal 418b. In one embodiment, the structural element 421 is spaced from the rear surface 408a by a distance less than the distance by which the structural element 418a is spaced from the end of the seal 418b, such that once the cartridge is inserted into the drive unit, the seal 418b is pressed against the rear surface 408a. Since the sealing force is generated by the mating of the bonding structural elements 418, 421, the length of the cartridge 420 is independent of the formation of the hydraulic fluid seal. In one embodiment, the seal 418b is continuous with the bonding structural element 418, and the compliance is the result of a thin structural element at the end of the bonding structural element 418. In one embodiment, the seal 418b is an O-ring. In one embodiment, the seal 418b is a secondary injection of a compliant material co-molded or overmolded with the bonding structural element 418. In one embodiment, the seal 418b is a second part placed in the structural element of the bonding structural element 418. In one embodiment, the seal 418b is integrally formed with the rear surface 408a of the sealing socket space. In one embodiment, there is no compliant material, and the mating and surface characteristics of the bonding structural element 418 and the surface 408a of the sealing socket space 408 are sufficient to affect the seal for the hydraulic fluid.

[0044] In one embodiment, the bonding structure element 418 comprises a material with less compliance than the seal 418b. In one embodiment, the bonding structure element 418 is made of polycarbonate. In other embodiments, the bonding structure element 418 is composed of plastic materials such as acrylonitrile butadiene styrene (ABS), polypropylene, polysulfone, polyether ether ketone (PEEK), nylon, polyethylene, acrylic, PVC, and polystyrene. In one embodiment, the seal 418b is composed of a thermoplastic elastomer (TPE) with a durometer less than Shore A 70, such as In other embodiments, the seal 418b is composed of rubbers including butyl, nitrile, and silicone.

[0045] In one embodiment, as Figure 9 shown, the hydraulic fluid has not yet contacted the rear end of the piston 419. The fluid is still contained within the hydraulic fluid manifold 404 via the hydraulic fluid valve 407. In one embodiment, to bring the pressurized hydraulic fluid into contact with the rear of the piston 419, the hydraulic valve 407 is opened by aligning the fluid path through the valve stem 407a with the fluid path leading to the cartridge seal socket seal, as Figure 10 shown.

[0046] In one embodiment, to connect the drug delivery path to the patient, the supply end of the needle 430 is pressed through the pierceable element 416, as Figure 11 shown, thereby forming a fluid connection between the interior of the cartridge 420 and the delivery needle 430.

[0047] Referring Figure 12 , a second exemplary embodiment of the fluid delivery device 1200 is shown. In one embodiment, the door 1206 is fixed to the bonding structure element 1218 and is part of the cartridge assembly 1220. In one embodiment, the door 1206 and the bonding structure element 1218 are integrally connected. In one embodiment, the door 1206 and the bonding structure element 1218 are two components, but are joined together before being inserted into the hydraulic drive unit 1201.

[0048] In an alternative embodiment, the needle 430 and the needle support system are fixed to the door 1206 and the door is fixed to the bonding structure element 1218 before being inserted into the hydraulic drive unit 1201.

[0049] Those skilled in the art will understand that changes can be made to the exemplary embodiments shown and described above without departing from their broad inventive concept. Accordingly, it should be understood that the present invention is not limited to the exemplary embodiments shown and described, but is intended to cover modifications within the spirit and scope of the invention as defined by the claims. For example, the specific features of the exemplary embodiments may or may not be part of the claimed invention, and the various features of the disclosed embodiments may be combined. Unless specifically stated herein, the terms "a," "an," and "the" are not limited to one element and should be construed to mean "at least one."

[0050] It should be understood that at least some of the drawings and descriptions of the present invention have been simplified to focus on elements relevant to a clear understanding of the present invention, and other elements that those of ordinary skill in the art would anticipate may also form part of the present invention have been eliminated for clarity. However, since these elements are well known in the art and since they do not necessarily contribute to a better understanding of the present invention, a description of these elements is not provided herein.

[0051] Furthermore, to the extent that the methods of the present invention are not dependent on a particular order of the steps set forth herein, the particular order of the steps should not be construed as a limitation on the claims. Any claims regarding the methods of the present invention should not be limited to performing their steps in the order written, and those skilled in the art can readily understand that the steps can be varied and still remain within the spirit and scope of the present invention.

Claims

1. A fluid delivery device, comprising: a drive unit comprising an actuator and one or more first structural elements; and a cartridge filled with a fluid prior to insertion into the housing and having a fluid reservoir sealed at one end by a movable piston and at another end by a pierceable septum, the cartridge comprising one or more second structural elements configured to align with and cooperate with one or more first structural elements to allow the cartridge to be inserted into the drive unit, the piston being movable by the actuator once the cartridge is inserted into the drive unit; Wherein the drive unit comprises a housing having a door, the door being rotatable relative to the housing to cover the cartridge and seat the cartridge in the drive unit.

2. The fluid delivery device of claim 1, wherein the actuator is a hydraulically driven actuator and the cartridge is sealed to the drive unit via a seal.

3. The fluid delivery device of claim 2, wherein the seal is secured to the fluid reservoir by a sleeve that slides over the cartridge and at least partially over a portion of the seal.

4. The fluid delivery device of claim 3, wherein the sleeve comprises the one or more second structural elements.

5. The fluid delivery device of claim 2, wherein the seal is coupled to the one or more second structural elements.

6. The fluid delivery device of claim 2, wherein the seal is an annular member secured to the exterior of the cartridge.

7. The fluid delivery device of claim 2, wherein the seal is an integrally formed structural element of the cartridge.

8. The fluid delivery device of claim 2, wherein the seal comprises at least two components that are coupled together from opposing lateral sides of the cartridge and form a friction fit with the cartridge.

9. The fluid delivery device of claim 2, wherein the seal comprises a first compliant portion proximate an end of the cartridge and a second compliant portion, the second compliant portion being less compliant than the first compliant portion and comprising the one or more second structural elements.

10. The fluid delivery device of claim 2, wherein at least one of the one or more first structural elements and / or at least one of the one or more second structural elements comprises a tapered lead-in end configured to help guide the cartridge into position and press the seal against the cartridge during insertion.

11. The fluid delivery device according to any one of claims 1-10, wherein the cartridge comprises a longitudinal axis and one or more first structural elements, and the one or more second structural elements comprise one or more radially protruding projections and / or recesses relative to the longitudinal axis.

12. The fluid delivery device of any one of claims 1-10, wherein the one or more first structural elements are generally rectangular protrusions, and the one or more second structural elements are grooves configured to interengage with the generally rectangular protrusions.

13. The fluid delivery device of any one of claims 1-10, wherein the one or more first structural elements are grooves, and the one or more second structural elements are generally rectangular protrusions configured to interengage with the grooves.

14. The fluid delivery device of any one of claims 1-10, wherein the cartridge comprises a cap structure configured to be substantially flush with a housing of the drive unit when the cartridge is fully inserted into the drive unit.

15. The fluid delivery device according to any one of the preceding claims 1-10, further comprising: A needle assembly having a needle having a delivery end and a fluid coupling end, the fluid coupling end being fluidly separated from the fluid reservoir in an initial position, the delivery end extending through the bottom surface of the housing in a deployed position and the fluid coupling end extending through the pierceable septum and being fluidly coupled to the fluid reservoir in the deployed position.

16. A cartridge for insertion into a fluid delivery device, the cartridge comprising: a fluid-filled reservoir, the reservoir being sealed at one end by a movable piston and at the other end by a pierceable septum; and one or more radially projecting and circumferentially extending keying features configured to align and mate with one or more corresponding keying features of the fluid delivery device to thereby allow the cartridge to be inserted into the fluid delivery device; The drive unit of the fluid delivery device includes a housing having a door, the door being rotatable relative to the housing to cover the cartridge and seat the cartridge in the drive unit.

Images