WO2022066854A1

WO2022066854A1 - Cartridge holder with snap component and medical injection device including the same

Info

Publication number: WO2022066854A1
Application number: PCT/US2021/051677
Authority: WO
Inventors: Roger Groskopf; Stephen C. SIMMONS; Paul Paia MARICI; Michael Vincent Quinn; Anthony HAN
Original assignee: Becton, Dickinson And Company
Priority date: 2020-09-25
Filing date: 2021-09-23
Publication date: 2022-03-31

Abstract

Provided herein is a cartridge holder subassembly for a medical injection device, including a cartridge holder having an open proximal end, a closed distal end, and a sidewall therebetween defining a cartridge holder interior, a cartridge having an open proximal end, a closed distal end having a collar having a proximal end and a distal end, and a sidewall therebetween defining a cartridge interior configured to hold a composition therein, the cartridge received in the cartridge holder interior, and a snap component extending inwardly from the sidewall and/or distal end of cartridge holder, the snap component arranged at the distal end of the cartridge about the collar and configured to limit relative movement between the cartridge and the cartridge holder.

Description

CARTRIDGE HOLDER WITH SNAP COMPONENT AND MEDICAL INJECTION DEVICE INCLUDING THE SAME

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Application Serial No. 63/083,490, entitled “Cartridge Holder with Snap Component and Medical Injection Device Including the Same”, filed September 25, 2020, the entire disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] The present disclosure relates generally to components useful as replacements for helical coil springs for medical devices, and, in particular embodiments or aspects, to injection devices including cartridge holder subassemblies with snap components.

Description of Related Art

[0003] Medical injection devices often utilize resilient members, such as springs, placed between various components, to bias the components in order to ensure more accurate drug delivery. However, there are shortcomings to the use of current resilient members used in medical injection devices, such as a lack of control and load recovery. Accordingly, there is a need in the art for a more robust component to allow for greater load recovery.

SUMMARY OF THE INVENTION

[0004] Provided herein is a cartridge holder subassembly for a medical injection device, including a cartridge holder having an open proximal end, a closed distal end, and a sidewall therebetween defining a cartridge holder interior, a cartridge having an open proximal end, a closed distal end having a collar having a proximal end and a distal end, and a sidewall therebetween defining a cartridge interior configured to hold a composition therein, the cartridge received in the cartridge holder interior, and a snap component extending inwardly from the sidewall and/or distal end of cartridge holder, the snap component arranged at the distal end of the cartridge about the collar and configured to limit relative movement between the cartridge and the cartridge holder.

[0005] The snap component may include one or more protrusions extending radially inward from the sidewall of the cartridge holder adjacent the distal end thereof. The one or more protrusions may be one or more annular rings about an interior circumference of the cartridge holder interior. A distance between the one or more protrusions and the distal end of the cartridge holder may be less than or equal to a distance between a proximal end and a distal end of the collar. The one or more protrusions may be an angled proximal-facing and/or distal- facing surface. The one or more protrusions may include a rounded proximal-facing surface. The one or more protrusions may be a planar distal-facing surface. The planar distal-facing surface may be perpendicular to a longitudinal axis defined by the proximal end and the distal end of the cartridge holder. The collar may be formed from a metal or metal alloy. The snap component may be formed of a polymeric material. The polymeric material may be thermoplastic. The cartridge may be formed of glass. The cartridge may include a stopper sealing the proximal end. The cartridge holder may be formed of plastic. The cartridge holder may include threads arranged at the distal end, with the threads configured for removable coupling to a needle hub. Threading of a needle hub onto the cartridge holder is configured to tighten the one or more protrusions around the collar of the cartridge.

[0006] The snap component may be formed separately from the cartridge holder, with the snap component received by an opening defined by the cartridge holder. The snap component may include a wedge-shaped protrusion and a stop surface, with the stop surface of the snap component configured to engage the sidewall of the cartridge holder to secure the snap component to the cartridge holder. The opening may be an annular groove, where the snap component includes a body having a ridge, with the ridge configured to engage the annular groove to secure the snap component to the cartridge holder

[0007] Also provided herein is a medical injection device including a cartridge holder subassembly, the cartridge holder subassembly including a cartridge holder having an open proximal end, a closed distal end, and a sidewall therebetween defining a cartridge holder interior, a cartridge having an open proximal end, a closed distal end having a collar having a proximal end and a distal end, and a sidewall therebetween defining a cartridge interior configured to hold a composition therein, the cartridge received in the cartridge holder interior, and a snap component extending inwardly from the sidewall and/or distal end of cartridge holder, the snap component arranged at the distal end of the cartridge about the collar and configured to limit relative movement between the cartridge and the cartridge holder.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 shows an exploded view of a cartridge holder subassembly with a snap component according to a non-limiting embodiment or aspect as described herein; [0009] FIG. 2 is a cross-sectional view of a cartridge holder subassembly with a snap component according to a non-limiting embodiment or aspect as described herein;

[0010] FIG. 3 is an exploded view of a medical injection device including a cartridge holder subassembly with a snap component according to a non-limiting embodiment or aspect as described herein;

[0011] FIG. 4 is a cross-sectional view of a medical injection device including a cartridge holder subassembly with a snap component according to a non-limiting embodiment or aspect as described herein;

[0012] FIG. 5 is a cross-sectional view of a cartridge holder subassembly with a snap component according to a further non-limiting embodiment or aspect as described herein;

[0013] FIG. 6 is cross-sectional view of a cartridge holder of the cartridge holder subassembly of FIG. 5;

[0014] FIG. 7 is a cross-sectional view of the cartridge holder subassembly of FIG. 5;

[0015] FIG. 8 is perspective view of a snap component according to a further non-limiting embodiment or aspect as described herein;

[0016] FIG. 9 is a cross-sectional view of a cartridge holder subassembly with a snap component according to a further non-limiting embodiment or aspect as described herein;

[0017] FIG. 10 is a cross-sectional view of a cartridge holder of the cartridge holder subassembly of FIG. 9; and

[0018] FIG. 11 is a cross-sectional view of the cartridge holder subassembly of FIG. 9.

DESCRIPTION OF THE INVENTION

[0019] The use of numerical values in the various ranges specified in this application, unless expressly indicated otherwise, are stated as approximations as though the minimum and maximum values within the stated ranges are both preceded by the word “about”. As used herein, the term “about” means the stated value ± 10%. In this manner, slight variations above and below the stated ranges can be used to achieve substantially the same results as values within the ranges. Also, unless indicated otherwise, the disclosure of these ranges is intended as a continuous range including every value between the minimum and maximum values. For definitions provided herein, those definitions refer to word forms, cognates and grammatical variants of those words or phrases.

[0020] The figures accompanying this application are representative in nature, and should not be construed as implying any particular scale or directionality, unless otherwise indicated. For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal” and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. [0021] Provided herein is a cartridge holder, and cartridge holder subassembly, with a snap component for use as a replacement for a spring in a medical device.

[0022] Turning to FIGS. 1 and 2, shown is a non-limiting embodiment or aspect of a cartridge holder subassembly for a medical injection device. Cartridge holder subassembly includes cartridge 15 and cartridge holder 14. When arranged inside a medical injection device, cartridge 15 is received within cartridge holder 14.

[0023] Cartridge 15 has a proximal end, a distal end, and a sidewall therebetween defining an interior configured to hold one or more medications to be delivered with the medical injection device. Cartridge 15 can have an open proximal end. In non-limiting embodiments or aspects, open proximal end is sealed by a stopper configured to cooperate with a piston rod to eject one or more medications from the cartridge through distal end, for example through a needle arranged at a distal end of cartridge 15 that is in fluid communication with the cartridge interior. Cartridge 15 can assume any useful configuration, and can be formed of any suitable material. In non-limiting embodiments or aspects, cartridge 15 is glass or plastic.

[0024] Cartridge holder 14 has an open proximal end, a distal end, and a sidewall therebetween defining a cartridge holder interior. Cartridge holder interior can be configured to receive a cartridge, such as cartridge 15, for example by inserting a cartridge into cartridge holder 14 interior through open proximal end of cartridge holder 14. In non-limiting embodiments or aspects, distal end of cartridge holder 14 includes one or more features to allow for a needle to be attached thereto.

[0025] In non-limiting embodiments or aspects, distal end of cartridge holder 14 includes one or more of threads, protrusions, and/or recesses to cooperate with opposite features on a needle hub. Cartridge holder 14 can assume any useful configuration, and can be formed of any suitable material. In non-limiting embodiments or aspects, cartridge holder 14 is plastic.

[0026] With continuing reference to FIG. 2, cartridge holder 14 includes snap component 11. In non-limiting embodiments or aspects, snap component 11 is configured to engage distal end of cartridge 15 to limit and/or prevent relative movement between cartridge 15 and cartridge holder 14 during device actuation, thereby ensuring a more accurate delivery of a composition from cartridge 15. [0027] In non-limiting embodiments or aspects, snap component 11 is one or more protrusions extending from sidewall and/or distal end of cartridge holder 14 into cartridge holder interior. In non-limiting embodiments or aspects, snap component 11 includes one or more protrusions extending from the sidewall of cartridge holder 14. In non-limiting embodiments or aspects, snap component 11 is one or more annular rings extending from sidewall of cartridge holder 14, and arranged about a distal end of cartridge 15, for example as shown in FIG. 2. In non-limiting embodiments or aspects, snap component 11 can be arranged within cartridge holder 14 interior, such that when a cartridge holder subassembly (cartridge holder 14 and cartridge 15) is received within a medical injection device, the neck and/or collar of cartridge 15 are positioned distally of snap component 11, for example as shown in FIG. 2. In this way, snap component 11 limits and/or prevents, by contacting the proximal end of the collar of cartridge 15, unwanted proximal movement of cartridge 15. In non-limiting embodiments or aspects, a distance between snap component 11 and distal end of cartridge holder 14 is equal to or less than a distance between a proximal end and a distal end of collar of cartridge 15.

[0028] In non-limiting embodiments or aspects, cartridge 15 includes a crimped metal and/or metal alloy collar. In non-limiting embodiments or aspects, snap component 11 can be arranged within cartridge holder interior such that when a cartridge holder subassembly (cartridge holder 14 and cartridge 15) is received within a medical injection device, the crimped metal and/or metal alloy collar of cartridge 15 is positioned distally of snap component 11, for example as shown in FIG. 2.

[0029] Snap component 11 can be integral to cartridge holder 14, or a distinct element. In non-limiting embodiments, snap component 11 is integral to cartridge holder, for example the sidewall of cartridge holder 14. In non-limiting embodiments or aspects, snap component 11 is formed of the same material as cartridge holder 14. In non-limiting embodiments or aspects, snap component 11 is formed of a different material than cartridge holder 14. In non-limiting embodiments or aspects, snap component 11 is formed of a plastic, metal, or elastomer. It is within the abilities of those of skill in the art to select a material for snap component 11 that allows for the assembly of a medical injection device including a subassembly including a cartridge 15 and cartridge holder 14, allowing collar of cartridge 15 to bypass snap component 11, while at the same time providing sufficient resilience to limit movement of cartridge 15 and cartridge holder 14 relative to one another. In non-limiting embodiments or aspects, snap component is attached to cartridge holder 14 with an adhesive, such as, for example, a hot melt adhesive or UV curing glue. [0030] Snap component 11 can assume any useful shape, for example by having an angled and/or rounded proximal surface configured to allow the collar of cartridge 15 to slide distally by snap component 11 during assembly. Snap component can also include a planar distal surface, extending radially inward from sidewall of cartridge holder 14, configured to abut the collar of cartridge 15, thereby preventing the collar, and cartridge 15, from sliding proximally and bypassing snap component 11.

[0031] In one aspect or embodiment, in addition to the snap component 11, an additional feature may be provided that interacts with an attached needle such that when the needle is screwed on it acts to tighten the grip of the internal features on the collar of cartridge 15 like a collet.

[0032] Also provided herein is a medical injection device including a cartridge holder subassembly with a snap component as described above. Such devices, such as injection pens, are described in U.S. Patent No. 9,421,334, incorporated herein by reference in its entirety. With reference to FIGS. 3 and 4, shown are an exploded (FIG. 3) and cross-sectional (FIG. 4) view of an injection pen 51 for delivery of a composition to a user. As shown, injection pen 51 includes a pen upper body or housing 1, which houses a plurality of dose setting and injection components. Pen upper body 1 is connected to a cartridge housing 14, which houses cartridge 15. Injection pen 51 can also include a lower pen cap 12 to cover the cartridge 15 and cartridge housing 14 when injection pen 51 is not in use. As shown, injection pen 51 can include a dose set knob 2 that includes a knob-like portion that is rotated by a user to set a desired dose. Dose set knob 2 can also include a plurality of numerals, corresponding to a number of dosage units that is visible through a window 13 provided on pen upper body 1. A user rotates dose set knob 2 until the desired dose is visible in window 13. Pen upper body 1 can include an arrow or other indicator 53 to precisely indicate the set dose. Once the desired dose is set, a user presses a button 3 until the set dosage amount is completely injected. An outer shield 69 can cover a needle 56 to prevent accidental needle sticks upon removal of the lower pen cap 12.

[0033] Injection pen 51 can include push button 3, provided at a proximal end, closest to a user and farthest from needle 56, of pen upper body 1. Push button 3 can include an annular bead or rim 57 that engages with a corresponding annular groove (not shown) provided on the internal surface of dose set knob 2. The annular rim and groove connection can be a friction fit that maintains push button 3 in a biased position on dose set knob 2 under the force of a button spring 10, but allows push button 3 to be pushed into dose set knob 2 for injecting a set dose. The interior of push button 3 can accommodate a setback bearing insert 8 that rests on an internal surface at a proximal end of a setback member or driver 9. Push button 3 can be designed to rotate freely on setback bearing insert 8.

[0034] Setback member or driver 9 can be a cylindrical member, coaxial with and surrounded by dose set knob 2. Setback member 9 can be provided co-axially around brake tower 5 as described above. Brake tower 5 can be axially and rotatably fixed to pen upper body 1. In non-limiting embodiments or aspects, brake tower 5 co-axially surrounds a piston rod 6. Piston rod 6 can include a set of keys (not shown) that engage a slot (not shown) internal to brake tower 5 (as described above) to rotatably lock piston rod 6 to brake tower 5. Piston rod 6 can include a plurality of threads (not shown) provided on the interior surface thereof. Piston rod 6 can co-axially surround a lead screw 4 that includes a series of threads 42 at least at its distal end. Lead screw threads 42 can be configured to be in threaded engagement with the internal threads (not shown) provided on the interior of piston rod 6. Due to its threaded engagement with lead screw 4, piston rod 6 can be moved into cartridge 15 during injection to press on a stopper 16 provided inside cartridge 15 to expel a dose of medication.

[0035] With reference to the present disclosure, injection pen 51 includes a cartridge holder subassembly as described above. Cartridge holder subassembly includes cartridge 15, received within cartridge holder 14, and snap component 11 arranged within cartridge holder 14, to reduce and/or prevent movement of cartridge 15 during injection, and thus ensuring that an accurate dose is injected. As shown in FIG. 2, snap component 11 can be arranged about a distal end of cartridge 15.

[0036] Following assembly, and when injection pen 51 is ready to be used, a dose for drug delivery can be set. To set a dose using injection pen 51 as described herein, a user rotates the knob portion of dose set knob 2 relative to pen upper body 1. An outer surface 59 of the dose set knob 2 can include a thread 23, which is in threaded engagement with a plurality of threads 17 provided on the internal surface of the pen upper body 1, as shown in FIGS. 3 and 4. Accordingly, as dose set knob 2 is rotated relative to pen upper body 1, dose set knob 2 screws or advances a distance out of pen upper body 1, as shown in FIG. 4. Dose set knob 2 can include an annular shoulder or rim 21 on the interior surface thereof near the proximal end, as shown in FIG. 4. This annular shoulder 21 can engage with an enlarged portion or head 91 of setback member 9, as shown in FIG. 4. Annular shoulder 21 of dose set knob 2 can include a series of teeth or ridges 22 that engage with a plurality of similarly shaped teeth or ridges (not shown) provided on enlarged head 91 of setback member 9. Dose set knob teeth 22 and setback member teeth can extend in opposite axial directions. During dose setting, dose set knob 2 can be free to rotate with respect to setback member 9 in both clockwise and counter-clockwise directions. As this occurs, the plurality of teeth or ridges 22 on dose set knob 2 can slip past the teeth provided on head portion 91 of setback member 9, thus providing a tactile signal or clicking noise to indicate the setting of a dosage amount.

[0037] With regard to the injection mechanism, as described above, lead screw 4 can include a plurality of threads 42 at its distal end that are in threaded engagement with a plurality of threads 64 that can be provided along the entire length of a hollow piston rod 6 as shown in FIG. 3. Piston rod 6 can be held non-rotatably with respect to pen upper body 1 due to a non- rotatable coupling with brake tower 5, which can be held axially and rotatably fixed with respect to the pen upper body 1. Piston rod 6 can include a key or set of keys 62 at its distal end that engage with a slot (not shown) provided on the internal surface of the brake tower 5 to prevent relative rotation therebetween while permitting piston rod 6 to move axially with respect thereto. Threads 42 of lead screw 4 can include a flat portion (not shown) corresponding to a flat portion 65 of piston rod 6, such that axial movement of the lead screw during dose setting does not result in axial movement of the piston rod 6. Accordingly, rotation of lead screw 4 during injection of a dose can cause the threads 42 of lead screw 4 to engage threads 64 of the piston rod 6, thereby axially moving piston rod 6. Because piston rod 6 can be non-rotatable with respect to body 1, as lead screw 4 is caused to rotate during injection, as described above due to its rotational coupling setback member 9, piston rod 6 through its threaded engagement with lead screw 4 can be caused to move in the distal direction to press against stopper 16 provided in cartridge 15, thus expelling a liquid medication therefrom.

[0038] Referring to FIGS. 5-7, in a further non-limiting embodiment or aspect, the snap component 11 is formed separately from the cartridge holder 14. In one non-limiting embodiment or aspect, four snap components 11 are provided, although one or more snap components 11 may be utilized. The snap component(s) 11 may be arcuate to correspond to the shape or arc of the cartridge holder 14. The snap component s) 11 include a wedge-shaped protrusion 24 and a stop surface 26. As shown in FIGS. 6 and 7, the cartridge 15 is assembled inside the cartridge holder 14 and the snap component s) 11 is inserted into an opening(s) 28 defined by the cartridge holder 14 with the wedge-shaped protrusion 24 flexing during insertion and snapping back such that the stop surface 26 engages the wall of the cartridge holder 14 to prevent removal of the snap component(s) 11 from the cartridge holder 14. The snap component s) 11 of FIG. 5 operate in the same manner as the snap component 11 shown in FIG. 2 to limit and/or prevent relative movement between cartridge 15 and cartridge holder 14 during device actuation. [0039] Referring to FIGS. 8-11, in a further non-limiting embodiment or aspect, the snap component s) 11 is formed separately from the cartridge holder 14. The snap component(s) 11 are provided on a body 30 having a circumferential ridge 32. The body 30 is C-shaped, although other suitable shapes may be utilized. The circumferential ridge 32 may extend around the entire circumference of the body 30 or only a portion of the circumference of the body 30. As shown in FIGS. 10 and 11, the body 30 with the snap component(s) 11 is pushed onto the neck of the cartridge 15 prior to assembly of the cartridge 15 with the cartridge holder 14. The body 30 is biased open as the body 30 is positioned onto the cartridge 15 and snaps back to secure the body 30 to the cartridge 15. The cartridge 15 with the body 30 and snap component s) 11 is inserted into the cartridge holder 14 with the ridge 32 being received by a groove 34 defined by the cartridge holder 14 to secure the body 30 and the snap component(s) 11 relative to the cartridge holder 14. The snap component(s) 11 of FIGS. 8-11 engage the cartridge 15 operate in the same manner as the snap component 11 shown in FIG. 2 to limit and/or prevent relative movement between cartridge 15 and cartridge holder 14 during device actuation.

[0040] Although the devices have been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the systems and methods are not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present systems and methods contemplate 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

THE INVENTION CLAIMED IS:

1. A cartridge holder subassembly for a medical injection device, comprising: a cartridge holder comprising an open proximal end, a closed distal end, and a sidewall therebetween defining a cartridge holder interior; a cartridge comprising an open proximal end, a closed distal end comprising a collar having a proximal end and a distal end, and a sidewall therebetween defining a cartridge interior configured to hold a composition therein, the cartridge received in the cartridge holder interior; and a snap component extending inwardly from the sidewall and/or distal end of cartridge holder, the snap component arranged at the distal end of the cartridge about the collar and configured to limit relative movement between the cartridge and the cartridge holder.

2. The cartridge holder subassembly according to claim 1, wherein the snap component comprises one or more protrusions extending radially inward from the sidewall of the cartridge holder adjacent the distal end thereof.

3. The cartridge holder subassembly according to claim 2, wherein the one or more protrusions comprise one or more annular rings about an interior circumference of the cartridge holder interior.

4. The cartridge holder subassembly according to claim 2 or claim 3, wherein a distance between the one or more protrusions and the distal end of the cartridge holder is less than or equal to a distance between a proximal end and a distal end of the collar.

5. The cartridge holder subassembly according to any of claims 2-4, wherein the one or more protrusions comprise an angled proximal-facing and/or distal-facing surface.

6. The cartridge holder subassembly according to any of claims 2-5, wherein the one or more protrusions comprise a rounded proximal-facing surface.

7. The cartridge holder subassembly according to any of claims 2-6, wherein the one or more protrusions comprise a planar distal-facing surface.

8. The cartridge holder subassembly according to claim 7, wherein the planar distal-facing surface is perpendicular to a longitudinal axis defined by the proximal end and the distal end of the cartridge holder.

9. The cartridge holder subassembly according to any of claims 1-8, wherein the collar comprises a metal or metal alloy.

10. The cartridge holder subassembly according to any of claims 1-9, wherein the snap component is formed of a polymeric material.

11. The cartridge holder subassembly according to claim 10, wherein the polymeric material comprises a thermoplastic.

12. The cartridge holder subassembly according to claim 1, wherein the snap component is formed separately from the cartridge holder, the snap component received by an opening defined by the cartridge holder.

13. The cartridge holder subassembly according to claim 12, wherein the snap component comprises a wedge-shaped protrusion and a stop surface, the stop surface of the snap component configured to engage the sidewall of the cartridge holder to secure the snap component to the cartridge holder.

14. The cartridge holder subassembly according to claim 12, wherein opening comprises an annular groove, and wherein the snap component comprises a body having a ridge, the ridge configured to engage the annular groove to secure the snap component to the cartridge holder.

15. The cartridge holder subassembly according to any of claims 1-14, wherein the cartridge holder comprises threads arranged at the distal end, the threads configured for removable coupling to a needle hub.

16. The cartridge holder subassembly according to claim 15, wherein threading of a needle hub onto the cartridge holder is configured to tighten the one or more protrusions around the collar of the cartridge.

17. A medical injection device comprising a housing having a distal end and a proximal end; a cartridge holder subassembly according to any of claims 1-16 received within the housing an injection needle at a distal end of the housing and in fluid communication with the cartridge; and an actuation member at a proximal end of the housing, the actuation member configured to actuate the medical injection device to deliver a composition through the injection needle, wherein the snap component limits movement of the cartridge relative to the cartridge holder.