WO2022066904A1

WO2022066904A1 - Biasing member for medical injection device

Info

Publication number: WO2022066904A1
Application number: PCT/US2021/051750
Authority: WO
Inventors: Bradley M. Wilkinson
Original assignee: Becton, Dickinson And Company
Priority date: 2020-09-25
Filing date: 2021-09-23
Publication date: 2022-03-31

Abstract

A biasing member for a medical injection device having a housing, a brake member, a cartridge, and an injection needle, wherein the biasing member includes a body having a first end, a second end positioned opposite the first end, a top surface, and a bottom surface positioned opposite the top surface, and a raised portion extending from the body in a direction extending from the bottom surface of the body to the top surface of the body. The raised portion is resilient.

Description

BIASING MEMBER FOR MEDICAL INJECTION DEVICE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Application Serial No. 63/083,524, entitled “Biasing Member for Medical Injection Device”, 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 a biasing member for a medical injection device.

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] In one aspect or embodiment, a biasing member for a medical injection device having a housing, a brake member, a cartridge, and an injection needle, includes a body having a first end, a second end positioned opposite the first end, a top surface, and a bottom surface positioned opposite the top surface, and a raised portion extending from the body in a direction extending from the bottom surface of the body to the top surface of the body. The raised portion is resilient.

[0005] The extension portion may extend from the top surface of the body. The body may be arcuate. The raised portion may be curved. The raised portion may extend from the second end of the body. The biasing member may be C-shaped. The body may include a protrusion extending from the bottom surface of the body, with the protrusion configured to be received by a corresponding recess of the brake member. The bottom surface of the body may be configured to engage a portion of the brake member. The biasing member may be formed from a metallic material. The body may be integrally formed with the raised portion. The body and the raised portion may be equal in thickness.

[0006] In another aspect or embodiment, a medical injection device includes a housing having a distal end and a proximal end, a brake member received within the housing, a cartridge received within the housing, with the cartridge configured to receive a medicament, a cartridge housing received within the housing distally of the brake member and configured to hold the cartridge, a biasing member as described in any of the aspects or embodiments above, with the biasing member received within the housing and positioned between the brake member and the cartridge, an injection needle at the distal end of the housing and in fluid communication with the cartridge, and an actuation member configured to actuate the medical injection device to deliver the composition through the injection needle.

[0007] The bottom surface of the body of the biasing member may be engaged with the brake member. The biasing member may be secured to the brake member via an ultrasonic weld. The biasing member may be first and second biasing members.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a perspective view of a medical injection device according to one aspect or embodiment of the present application.

[0009] FIG. 2 is an exploded view of the medical injection device of FIG. 1.

[0010] FIG. 3 is a partial perspective view of a brake member and first and second biasing members of the medical injection device of FIG. 1.

[0011] FIG. 4 is a perspective view of a first and second biasing member according to one aspect or embodiment of the present application.

[0012] FIG. 5 is a partial cross-sectional view of the medical injection device of FIG. 1, showing a pre-engagement position of first and second biasing members.

[0013] FIG. 6 is a partial cross-sectional view of the medical injection device of FIG. 1, showing an engagement position of first and second biasing members.

DESCRIPTION OF THE INVENTION

[0014] 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.

[0015] 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. [0016] Referring to FIGS. 1-6, according to one aspect or embodiment of the present application, a medical injection device 10 includes a button 12, button spring 14, dose set knob 16, bearing insert 18, driver 20, housing 22, first and second biasing members 24, 26, brake member 28, lead screw 30, piston rod 32, stopper 34, cartridge 36, cartridge housing 38, cap 40, outer shield 42, and needle 44. The medical injection device 10 is utilized to deliver a medicament or composition contained within the cartridge 36 to a person. The medical injection device 10 may be similar and operate in the same manner as the injection device shown and described in U.S. Patent No. 9,421,334, which is incorporated herein by reference in its entirety.

[0017] Referring to FIGS. 1-3, the housing 22 receives a plurality of dose setting and injection components. The housing 22 is connected to the cartridge housing 38, which receives the cartridge 36. The cap 40 covers the cartridge 36 and the cartridge housing 38 when the injection device 10 is not in use. The dose set knob 16 includes a knob-like portion that is rotated by a person to set a desired dose. The dose set knob 16 can also include a plurality of numerals or markings 46 that correspond to a number of dosage units that are visible through a window 48 provided on the housing 22. The dose set knob 16 is rotated until the desired dose is visible in the window 48. The housing 22 can include an arrow or other indicator 50 to precisely indicate the set dose. Once the desired dose is set, the button 12 is pressed until the set dosage amount is completely injected. The outer shield 42 can cover the needle 44 to prevent accidental needle sticks upon removal of cap 40.

[0018] The button 12 can include an annular bead or rim 52 that engages with a corresponding annular groove (not shown) provided on the internal surface of the dose set knob 16. The annular rim 52 and groove connection can be a friction fit that maintains the push button 12 in a biased position on the dose set knob 16 under the force of the button spring 14, but allows the button 12 to be pushed into the dose set knob 16 for injecting a set dose. The interior of the button 12 can accommodate the bearing insert 18 that rests on an internal surface at a proximal end of the driver 20. The push button 12 can be designed to rotate freely on the bearing insert 18.

[0019] The driver 20 can be a cylindrical member, coaxial with and surrounded by the dose set knob 16. The driver 20 can be provided co-axially around the brake member 28, which is axially and rotatably fixed to the housing 22. The brake member 28 co-axially surrounds the piston rod 32. The piston rod 32 includes a set of keys (not shown) that engage a slot (not shown) internal to the brake member 28 to rotatably lock the piston rod 32 to the brake member 28. The piston rod 32 can include a plurality of threads (not shown) provided on the interior surface thereof. The piston rod 32 co-axially surrounds the lead screw 30, which includes a series of threads 54 at least at its distal end. The lead screw threads 54 are configured to be in threaded engagement with the internal threads (not shown) provided on the interior of the piston rod 32. Due to its threaded engagement with the lead screw 30, the piston rod 32 can be moved into the cartridge 36 during injection to press on the stopper 34 provided inside the cartridge 36 to expel a dose of medication from the cartridge 36. To set a dose using the injection device 10 as described herein, a user rotates the knob portion of the dose set knob 16 relative to the housing 22. An outer surface of the dose set knob 16 can include a thread 56 that is in threaded engagement with a plurality of threads 58 provided on the internal surface of the housing 22. Accordingly, as the dose set knob 16 is rotated relative to the housing 22, the dose set knob 16 screws or advances a distance out of the housing 22.

[0020] With regard to the injection mechanism, as described above, the lead screw 30 includes the plurality of threads 54 at its distal end that engage with a plurality of threads (not shown) provided along the entire length of a hollow piston rod 32. The piston rod 32 is held non-rotatably with respect to the housing 22 due to a non-rotatable coupling with the brake member 28, which can be held axially and rotatably fixed with respect to the housing 22. The piston rod 32 can include a key or set of keys 60 at its distal end that engage with a slot (not shown) provided on the internal surface of the brake member 28 to prevent relative rotation therebetween while permitting the piston rod 32 to move axially with respect thereto. The threads 54 of the lead screw 30 can include a flat portion (not shown) corresponding to a flat portion 62 of the piston rod 32, such that axial movement of the lead screw 30 during dose setting does not result in axial movement of the piston rod 32. Accordingly, rotation of the lead screw 30 during injection of a dose can cause the threads 54 of the lead screw 30 to engage the threads of the piston rod 32, thereby axially moving the piston rod 32. Because the piston rod 32 can be non-rotatable with respect to the housing 22, as the lead screw 30 is caused to rotate during injection, as described above due to its rotational coupling with the driver 20, the piston rod 32 through its threaded engagement with the lead screw 30 can be caused to move in the distal direction to press against the stopper 34 provided in the medicament cartridge 36, thus expelling a liquid medication therefrom.

[0021] Referring to FIGS. 2-6, the first and second biasing members 24, 26 of the injection device 10 are positioned between a distal end 70 of the brake member 28 and the cartridge 36 in an axial direction to bias the cartridge 36 in a distal direction to prevent any movement of the cartridge 36 during injection thereby ensuring an accurate dose is injected. As shown in FIGS. 5 and 6, during assembly of the device 10 and prior to insertion of the cartridge 36 (FIG.

5), the first and second biasing members 24, 26 have an unbiased position where the first and second biasing members 24, 26 have a maximum length. After assembly of the device 10 with the cartridge 36 inserted and engaged with the first and second biasing members 24, 26 (FIG.

6), the first and second biasing members 24, 26 are in a biased position where the first and second biasing members 24, 26 are compressed with a length less than the maximum length of the first and second biasing members 24, 26.

[0022] In one aspect or embodiment, as shown in FIG. 3, a bottom surface 88 of each biasing member 24, 26 is engaged with the distal end 70 of the brake member 28, although other suitable positions and arrangements may be utilized. The biasing members 24, 26 are secured to the brake member 28 via one or more ultrasonic welds 72, although other suitable securing arrangements, such as adhesive, fasteners, etc., may be utilized. Further, the biasing members 24, 26 may each include a protrusion 74 extending from the bottom surface 88 of each biasing member 24, 26, with each protrusion 74 received by a corresponding recess 76 of the brake member 28. The first and second biasing members 24, 26 may be one or more biasing members, as discussed in more detail below.

[0023] Referring to FIG. 4, the first and second biasing members 24, 26 each include a body 80 having a first end 82, a second end 84 positioned opposite the first end 82, a top surface 86, and the bottom surface 88 positioned opposite the top surface 86. Each biasing member 24, 26 also includes a raised portion 90 extending from the body 80 in a direction extending from the bottom surface 86 of the body 80 to the top surface 88 of the body 80. The raised portion 90 is resilient. The raised portion 90 may be resilient due to the geometry and/or material of the raised portion 90. The raised portion 90 extends from the top surface 88 of the body 80. The body 80 is arcuate, although other suitable shapes may be utilized. The arcuate shape of the body 80 of each biasing member 24, 26 is configured to conform to the outer surface of the brake member 28 and the inner surface of the housing 22. The raised portion 90 is curved, although other suitable configurations may be utilized. The raised portion 90 extends from the second end of the body, although the raised portion 90 may be positioned intermediate the first and second ends 82, 84 of the body 80. The biasing members 24, 26 are C-shaped, although other suitable shapes and configurations may be utilized.

[0024] In one aspect or embodiment, each biasing member 24, 26 is manufactured or formed from a metallic material, such as spring steel, although other suitable materials may be utilized. [0025] In one aspect or embodiment, the body 80 is integrally formed with the raised portion 90. Each biasing member 24, 26 is configured to be formed as a single, unitary piece. The body 80 and the raised portion 90 are equal in thickness, although other suitable configurations may be provided.

[0026] Although the first and second biasing members 24, 26 are provided, a single biasing member may be utilized. In one aspect or embodiment, the single biasing member may be the same as the first and second biasing members 24, 26 shown in in FIG. 4 and described above or may be wider with the arcuate body 80 extending a larger number of degrees to ensure a consistent axial biasing force is applied between the brake member 28 and the cartridge 36.

[0027] 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 biasing member for a medical injection device having a housing, a brake member, a cartridge, and an injection needle, the biasing member comprising: a body having a first end, a second end positioned opposite the first end, a top surface, and a bottom surface positioned opposite the top surface; and a raised portion extending from the body in a direction extending from the bottom surface of the body to the top surface of the body, wherein the raised portion is resilient.

2. The biasing member of claim 1, wherein the raised portion extends from the top surface of the body.

3. The biasing member of claim 1 or claim 2, wherein the body is arcuate.

4. The biasing member of any of claims 1-3, wherein the raised portion is curved.

5. The biasing member of any of claims 1-4, wherein the raised portion extends from the second end of the body.

6. The biasing member of any of claims 1-5, wherein the biasing member is C- shaped.

7. The biasing member of any of claims 1-6, wherein the body comprises a protrusion extending from the bottom surface of the body, the protrusion configured to be received by a corresponding recess of the brake member.

8. The biasing member of any of claims 1-7, wherein the bottom surface of the body is configured to engage a portion of the brake member.

9. The biasing member of any of claims 1-8, wherein the biasing member comprises a metallic material.

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10. The biasing member of any of claims 1-9, wherein the body is integrally formed with the raised portion.

11. The biasing member of any of claims 1-10, wherein the body and the raised portion are equal in thickness.

12. A medical injection device comprising: a housing having a distal end and a proximal end; a brake member received within the housing; a cartridge received within the housing, the cartridge configured to receive a medicament; a cartridge housing received within the housing distally of the brake member and configured to hold the cartridge; a biasing member according to any of claims 1-11, the biasing member received within the housing and positioned between the brake member and the cartridge; an injection needle at the distal end of the housing and in fluid communication with the cartridge; and an actuation member configured to actuate the medical injection device to deliver the composition through the injection needle.

13. The medical injection device of claim 12, wherein the bottom surface of the body of the biasing member is engaged with the brake member.

14. The medical injection device of claim 13, wherein the biasing member is secured to the brake member via an ultrasonic weld.

15. The medical injection device of any of claims 12-14, wherein the biasing member comprises first and second biasing members.

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