Braking tower with elastic member and medical injection device comprising the same

Abstract

Provided herein is a brake tower for a medical injection device, the brake tower having a proximal end, a distal end having a distal face, a sidewall defining a longitudinal axis between the proximal end and the distal end, and one or more resilient protrusions disposed on the distal face. Also provided herein is a medical injection device comprising a brake tower.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 083,622, filed on September 25, 2020, entitled “Brake Tower with Elastomeric Component and Medical Injection Device Including the Same”, the entire disclosure of which is incorporated herein by reference.

[0003] Background Art of the Invention

[0004] Technical Field of the Invention

[0005] This disclosure generally relates to components used as alternatives to helical springs in medical devices, and in certain embodiments or aspects, to injection devices including a brake tower-like member with an elastic component.

[0006] Description of the prior art

[0007] Medical injection devices typically utilize elastic components (e.g., springs) placed between parts to bias these parts, ensuring more precise drug delivery. However, the elastic components currently used in medical injection devices suffer from drawbacks such as a lack of control and a lack of load recovery. Therefore, there is a need in the art for a more robust component that allows for greater load recovery. Summary of the Invention

[0008] This document provides a brake tower-shaped member for use in a medical injection device. The brake tower-shaped member has a proximal end, a distal end, and a sidewall. The distal end has a distal face, and the sidewall defines a longitudinal axis between the proximal and distal ends. The brake tower-shaped member also includes one or more resilient protrusions disposed on the distal face.

[0009] The one or more elastic protrusions may be formed from an elastic polymer. The one or more elastic protrusions may be formed from rubber. The rubber may be natural rubber or synthetic rubber. The one or more elastic protrusions may be formed from silicone resin. The silicone resin may be a room temperature vulcanizing silicone resin.

[0010] A proximal end, a distal end, and sidewalls may define a cylinder. The distal end may have a larger outer perimeter than the proximal end and / or the sidewalls. The sidewalls may define at least a partially hollow interior. The distal end face may include two to ten resilient protrusions arranged on the distal end face. The one or more resilient protrusions may have a circular shape. The one or more protrusions may have a polygonal shape.

[0011] This article also provides a medical injection device including a brake tower having a proximal end, a distal end, a sidewall, and one or more resilient protrusions, the distal end having a distal face, the sidewall defining a longitudinal axis between the proximal and distal ends, and the one or more resilient protrusions disposed on the distal face. Attached Figure Description

[0012] Figure 1 This is a perspective view of a brake tower-like member with an elastic component according to a non-limiting embodiment or aspect described herein;

[0013] Figure 2 This is a partial cross-sectional view of a medical injection device including a brake tower-like member according to a non-limiting embodiment or aspect described herein, showing the position before engagement;

[0014] Figure 3 This is a partial cross-sectional view of a medical injection device including a brake tower-like member according to a non-limiting embodiment or aspect described herein, showing the engagement position;

[0015] Figure 4 This is an exploded view of a medical injection device according to a non-limiting embodiment or aspect described herein, the medical injection device including a brake tower-like member with an elastic component; and

[0016] Figure 5 This is a cross-sectional view of a medical injection device according to a non-limiting embodiment or aspect described herein, the medical injection device including a brake tower-like member with an elastic component. Detailed Implementation

[0017] Unless otherwise explicitly stated, the use of numerical values ​​within the various ranges specified in this application is to describe approximate values, as the minimum and maximum values ​​within the stated ranges are preceded by the word "approximately". As used herein, the term "approximately" means ±10% of the stated value. In this way, substantially the same result as the values ​​within the stated range can be achieved using small variations above and below the stated range. Furthermore, unless otherwise stated, the disclosure of these ranges is intended as a continuous range including each value between the minimum and maximum values. For the definitions provided herein, these definitions refer to the lexical form, cognates, and grammatical variations of these words or phrases.

[0018] Unless otherwise stated, the accompanying drawings are representative in nature and should not be construed as implying any particular scale or orientation. For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives will refer to the invention as oriented in the drawings. However, it should be understood that the invention can take various alternative variations and sequences of steps unless explicitly stated to the contrary. Therefore, specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0019] This article provides a brake tower-shaped component with elastic elements, which can be used as a replacement for springs in medical devices.

[0020] Go to Figures 1 to 3 These figures illustrate non-limiting embodiments or aspects of a brake tower 5 for a medical injection device. The brake tower can employ any useful construction used in medical injection devices. In a non-limiting embodiment or aspect, the brake tower 5 is cylindrical and has a proximal end, a distal end, and a sidewall defining a longitudinal axis between the proximal and distal ends. In a non-limiting embodiment or aspect, the brake tower 5 is at least partially hollow, and the proximal end, distal end, and sidewall define an interior that can accommodate one or more other components of the medical injection device as described below. In a non-limiting embodiment or aspect, the interior of the brake tower 5 includes one or more features for interacting with components housed within the brake tower, for example, by reversibly or irreversibly locking. For example, but not limited to, such features may include slots, lugs, recesses, and / or openings. Such features can, for example, prevent relative rotation between the brake tower 5 and components housed within the brake tower, such as the brake tower core, lead screw, and / or piston rod.

[0021] In a non-limiting embodiment or aspect, the sidewall of the brake tower 5 may include one or more splines or teeth configured to allow the brake tower 5 to rotate when engaged with another component within a medical injection device (e.g., a setback member). In a non-limiting embodiment or aspect, the one or more splines or teeth are configured to allow the brake tower 5 to rotate in only a single direction.

[0022] In a non-limiting embodiment or aspect, the distal end of the brake tower 5 is enlarged, for example, enlarged so that the outer periphery is larger than the proximal end. In a non-limiting embodiment or aspect, the distal end of the brake tower 5 includes one or more features for interacting with another component (e.g., a housing) of a medical injection device, for example, through reversible or irreversible locking. For example, but not limited to, such features may include one or more slots, lugs, recesses, and / or openings, and may prevent relative rotation between the brake tower and the component.

[0023] The brake tower 5 can be formed of any suitable material. In a non-limiting embodiment or aspect, the brake tower 5 is formed of a polymer material (e.g., plastic). In a non-limiting embodiment or aspect, the brake tower 5 is formed of a thermoplastic. In a non-limiting embodiment or aspect, the brake tower 5 is formed of a metal or metal alloy.

[0024] Continue to refer to Figures 1 to 3 The distal end of the brake tower-shaped member 5 includes a distal face with one or more resilient protrusions 11 extending distally from the distal face along a longitudinal axis. The one or more resilient protrusions 11 are used to bias the cartridge housed within a medical injection device, minimizing component displacement and thus ensuring more precise delivery of the composition from the cartridge. Figure 2 As shown, prior to assembly and insertion of the tube 15, one or more resilient protrusions 11 have a first length and are neither compressed nor biased. Figure 3 As shown, after assembling and inserting the cylinder 15, the cylinder 15 engages with one or more resilient protrusions 11 to compress and bias the one or more resilient protrusions 11 such that the one or more resilient protrusions 11 have a second length, wherein the second length is less than the first length. In a non-limiting embodiment or aspect, the distal face of the brake tower 5 includes 2, 3, 4, 5, 6, 7, 8, 9, 10 or more resilient protrusions. In one non-limiting embodiment or aspect, the distal face of the brake tower 5 includes 5 to 10 protrusions.

[0025] One or more elastic protrusions 11 may be formed of any suitable elastic material, provided that the material can provide the required compressibility / expansion. In a non-limiting embodiment or aspect, the elastic material is a highly elastic material. In a non-limiting embodiment or aspect, one or more elastic protrusions 11 are formed of rubber. In a non-limiting embodiment or aspect, the rubber is polyisoprene rubber, silicone rubber, and / or butyl rubber. In non-limiting embodiments or aspects, the rubber is butyl rubber (IIR), isoprene rubber (IR), butadiene rubber (BR), styrene-butadiene rubber (SBR), ethylene-propylene rubber (EPM), ethylene-propylene-diene rubber (EPDM), chlorosulfonated polyethylene (CSM), ethylene-vinyl acetate copolymer (EVA), styrene-isoprene rubber (SIR), thermoplastic elastomers, and / or natural rubber. To some extent, this rubber is not inherently sticky, and one or more elastic protrusions 11 can be adhered to the distal face of the brake tower member 5 by any suitable adhesive known to those skilled in the art.

[0026] In non-limiting embodiments or aspects, one or more elastic protrusions 11 are formed of an elastic copolymer, including but not limited to thermoplastic elastomers, thermoplastic vulcanizates, or styrene copolymers. The styrene copolymer is, for example, a styrene-butadiene (SBR or SBS) copolymer, a styrene-isoprene (SIS) block polymer, or a styrene-isoprene / butadiene (SIBS) block copolymer, wherein the styrene content in the styrene block copolymer is in the range of about 10% to about 70%, and preferably in the range of about 20% to about 50%. The elastomer composition may include, but is not limited to, antioxidants and / or inorganic reinforcing agents, vulcanizing agents, vulcanization accelerators, vulcanization activators, processing aids, fillers, etc., for maintaining the stability of the elastomer composition, to maintain and improve the physical properties and heat resistance of the rubber material. To some extent, such a copolymer is not inherently sticky, and one or more elastic protrusions 11 can be adhered to the distal face of the brake tower 5 by any suitable adhesive known to those skilled in the art.

[0027] In a non-limiting embodiment or aspect, one or more elastic protrusions 11 are formed of a material with a Shore A value of 20 to 40, optionally 30 to 40, the range including all values ​​and sub-ranges therebetween. In a non-limiting embodiment or aspect, one or more elastic protrusions 11 are formed of a material comprising ethylene propylene diene monomer (EPDM) rubber. In a non-limiting embodiment or aspect, one or more elastic protrusions 11 are formed of a material comprising EPDM rubber and various fillers / additives. In a non-limiting embodiment or aspect, one or more elastic protrusions 11 are formed of ultra-high molecular weight EPDM rubber (e.g., KELTAN 9565Q), various fillers (e.g., MISTRON Vapor), mineral oil, zinc oxide, stearic acid, antioxidants (e.g., SONGNOX 1076), curing accelerators (e.g., TBzTD), vulcanizing agents (e.g., VULTAC 710), and sulfur (e.g., wettable sulfur).

[0028] In a non-limiting embodiment or aspect, one or more resilient protrusions 11 are formed of foam. To some extent, this foam is not inherently adhesive, and one or more resilient protrusions 11 can be adhered to the distal face of the brake tower 5 by any suitable adhesive known to those skilled in the art.

[0029] In a non-limiting embodiment or aspect, the elastic material is silicone. In a non-limiting embodiment or aspect, the elastic silicone is a room-temperature vulcanized (RTV) silicone. RTV silicone is available from many manufacturers, such as NuSil (Carpinteria, CA, USA). Although those skilled in the art may utilize additional adhesive materials as needed, because RTV silicone can have adhesive properties, in a non-limiting embodiment or aspect, it is not necessary to apply additional adhesive to the distal surface of the brake tower 5 for applying one or more elastic protrusions 11 thereto.

[0030] In non-limiting embodiments or aspects, one or more elastic protrusions 11 are formed from a mixture of various materials, such as, but not limited to, polymers, rubber, foams and / or silicone resins.

[0031] Continue to refer to Figure 1One or more resilient protrusions 11 may take any useful shape, configuration, and / or orientation on the distal face of the brake tower 5. In a non-limiting embodiment or aspect, one or more resilient protrusions may have a circular or polygonal shape (e.g., triangular, quadrilateral, etc.). One or more resilient protrusions 11 may be randomly oriented or oriented in a specific manner on the distal face of the brake tower 5.

[0032] This document also provides a medical injection device comprising a brake tower-like member having one or more resilient protrusions as described above. Such a device (e.g., an injection pen) is described in U.S. Patent No. 9,421,334, the entire contents of which are incorporated herein by reference. References Figure 4 and Figure 5 An exploded view of the injection pen 51 used to deliver the composition to the user is shown. Figure 4 ) and cross-sectional view ( Figure 5 As shown, the injection pen 51 includes an upper pen body or housing 1 that houses multiple dosage setting and injection components. The upper pen body 1 is connected to a cartridge housing 14 that houses a cartridge 15. The injection pen 51 may also include a lower pen cap 12 to cover the cartridge 15 and cartridge housing 14 when the injection pen 51 is not in use. As shown, the injection pen 51 may include a dosage setting knob 2, which includes a knob-like portion that the user rotates to set the desired dosage. The dosage setting knob 2 may also include multiple numbers corresponding to multiple dosage units visible through a window 13 provided on the upper pen body 1. The user rotates the dosage setting knob 2 until the desired dosage is visible in the window 13. The upper pen body 1 may include an arrow or other indicator 53 to precisely indicate the set dosage. Once the desired dosage is set, the user presses a button 3 until the set dosage is fully injected. The outer shield 69 can cover the needle 56 to prevent accidental needle pricks when removing the lower pen cap 12.

[0033] The injection pen 51 may include a push button 3 located at the proximal end of the upper pen body 1, closest to the user and furthest from the needle 56. The button 3 may include an annular flange or edge 57 that engages with a corresponding annular groove (not shown) on the inner surface of the dose setting knob 2. The connection between the annular edge and the groove may be a friction fit, which, under the force of the button spring 10, holds the button 3 in a biased position on the dose setting knob 2, but allows the button 3 to be pushed into the dose setting knob 2 to inject the set dose. The button 3 may internally accommodate a setback bearing insert 8, which rests on the inner surface of the proximal end of the rear member or drive member 9. The button 3 may be designed to rotate freely on the setback bearing insert 8.

[0034] The rear component or drive component 9 may be a cylindrical component, coaxial with and surrounded by the dose setting knob 2. As described above, the rear component 9 may be coaxially arranged around the brake tower 5. The brake tower 5 may be axially and rotatably fixed to the upper pen body 1. In a non-limiting embodiment or aspect, the brake tower 5 surrounds and is coaxial with the piston rod 6. The piston rod 6 may include a set of keys (not shown) that engage (as described above) with slots (not shown) inside the brake tower 5 to rotatably lock the piston rod 6 to the brake tower 5. The piston rod 6 may include a plurality of threads (not shown) disposed on the inner surface of the piston rod. The piston rod 6 may surround and be coaxial with the lead screw 4, which includes a series of threads 42 at least at its distal end. The threads 42 of the lead screw may be configured to engage with internal threads (not shown) disposed inside the piston rod 6. Because the piston rod 6 is threadedly engaged with the lead screw 4, during the injection process, the piston rod can move into the cylinder 15 to press against the stopper 16 located inside the cylinder 15, thereby discharging a dose of drug.

[0035] Referring to this disclosure, the injection pen 51 includes a brake tower 5 as described above. The brake tower 5 includes a distal face that includes one or more resilient protrusions as described above, located between the brake tower 5 and the cartridge 15 to bias the cartridge 15 in the distal direction, thereby preventing any movement of the cartridge 15 during injection and ensuring an accurate dosage.

[0036] After assembly, and when the injection pen 51 is ready for use, the dosage for drug delivery can be set. To set the dosage using the injection pen 51 as described herein, the user rotates the knob portion of the dosage setting knob 2 relative to the upper pen body 1. Figure 4 and Figure 5As shown, the outer surface of the dosage setting knob 2 may include a thread 23, which engages with a plurality of threads 17 on the inner surface of the upper pen body 1. Therefore, when the dosage setting knob 2 rotates relative to the upper pen body 1, the dosage setting knob 2 rotates out or forward a certain distance from the upper pen body 1, such as... Figure 5 As shown. Figure 5 As shown, the dose setting knob 2 may include an annular shoulder or edge 21 located on the inner surface near the proximal end of the dose setting knob. Figure 5 As shown, the annular shoulder 21 can engage with the enlarged portion or head 91 of the rear member 9. The annular shoulder 21 of the dose setting knob 2 may include a series of teeth or ridges that engage with a plurality of similarly shaped teeth or ridges (not shown) disposed on the enlarged head 91 of the rear member 9. The teeth of the dose setting knob and the teeth of the rear member may extend in opposite axial directions. During dose setting, the dose setting knob 2 can rotate freely relative to the rear member 9 in both clockwise and counterclockwise directions. When this occurs, the plurality of teeth or ridges on the dose setting knob 2 may slide over the teeth disposed on the head 91 of the rear member 9, thereby providing a tactile signal or click to indicate the dose setting.

[0037] Regarding the injection mechanism, as described above, the lead screw 4 may include a plurality of threads 42 at its distal end, which threadly engage with a plurality of threads 64 that may be arranged along the entire length of the hollow piston rod 6, such as... Figure 5 As shown. Because it is non-rotatably coupled to the brake tower 5, which can be axially and rotatably fixed relative to the upper pen body 1, the piston rod 6 can remain non-rotatable relative to the upper pen body 1. The piston rod 6 may include a key or set of keys 62 at its distal end, which engages with a slot (not shown) provided on the inner surface of the brake tower 5 to prevent relative rotation between the piston rod and the brake tower while allowing axial movement of the piston rod 6 relative to the brake tower. The thread 42 of the lead screw 4 may include a flat portion (not shown) corresponding to the flat portion 65 of the piston rod 6, such that axial movement of the lead screw during dose setting does not cause axial movement of the piston rod 6. Therefore, rotation of the lead screw 4 during injection dose can cause the thread 42 of the lead screw 4 to engage with the thread 64 of the piston rod 6, thereby allowing axial movement of the piston rod 6. Because the piston rod 6 can be non-rotatable relative to the upper pen body 1, as the lead screw 4 is driven to rotate during injection due to its rotational coupling with the rear member 9 as described above, the piston rod 6 can be driven to move in the distal direction through its threaded engagement with the lead screw 4 to press against the stop 16 provided in the cylinder 15, thereby discharging the liquid drug therefrom.

[0038] Although these apparatuses have been described in detail based on embodiments currently considered most practical and preferred for illustrative purposes, it should be understood that such details are for that purpose only, and the systems and methods are not limited to the disclosed embodiments, but are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the systems and methods are contemplated 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

1. A braking tower-shaped component, the braking tower-shaped component being used in a medical injection device, the braking tower-shaped component comprising: A proximal end, a distal end, and a sidewall, the distal end having a distal face, the sidewall defining a longitudinal axis between the proximal end and the distal end, wherein the proximal end, the distal end, and the sidewall define an elongated cylinder; and A plurality of elastic protrusions are arranged on the distal surface and located between the brake tower and the cylinder of the medical injection device to bias the cylinder in the distal direction, thereby preventing any movement of the cylinder during injection, wherein each elastic protrusion includes a columnar body fixed to the distal surface.

2. The brake tower-shaped member according to claim 1, wherein, The plurality of elastic protrusions comprise an elastic polymer.

3. The brake tower-shaped member according to claim 2, wherein, The plurality of elastic protrusions comprise rubber.

4. The brake tower-shaped member according to claim 3, wherein, The rubber in question is natural rubber.

5. The brake tower-shaped member according to claim 3, wherein, The rubber in question is synthetic rubber.

6. The brake tower-shaped member according to any one of claims 1 to 5, wherein, The plurality of elastic protrusions comprise silicone resin.

7. The brake tower-shaped member according to claim 6, wherein, The silicone resin is a room temperature vulcanizing silicone resin.

8. The brake tower-shaped member according to claim 1 or 2, wherein, The distal end has a larger periphery than the proximal end and / or the sidewall.

9. The brake tower-shaped member according to claim 1 or 2, wherein, The sidewall defines an interior that is at least partially hollow.

10. The brake tower-shaped member according to claim 1 or 2, wherein, The distal end face includes two to ten elastic protrusions arranged on the distal end face.

11. The brake tower-shaped member according to claim 1 or 2, wherein, The plurality of elastic protrusions include those in a circular shape.

12. The brake tower-shaped member according to claim 1 or 2, wherein, The plurality of elastic protrusions include polygonal shapes.

13. A medical injection device, comprising: A housing having a distal end and a proximal end; Brake tower-shaped member according to any one of claims 1 to 12; A cylinder, which is housed within the housing on the distal side of the brake tower-like member, and contains a composition therein; A cylinder housing, which is received within the housing on the distal side of the brake tower-like member and configured to hold the cylinder within the cylinder housing; An injection needle is located at the distal end of the housing and is in fluid communication with the cylindrical body; as well as An actuating member, located at the proximal end of the housing, is configured to actuate the medical injection device to deliver the composition via the injection needle. The plurality of elastic protrusions arranged on the distal end face of the brake tower-shaped member cause the cylinder to be biased distally.

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