Curved reservoir for medical syringes
The curved barrel and plunger rod design in wearable medical devices address the space constraints of wearable medical devices by enabling efficient and compact fluid delivery, allowing for larger volumes of pharmaceutical compositions.
Patent Information
- Application Number
- JP2024521106
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-10-07
- Filing Date
- 2022-10-03
- Publication Date
- 2025-10-16
AI Technical Summary
Wearable medical devices face limitations in reservoir volume and length due to the impact on overall package size, which affects the administration of pharmaceutical compositions.
A curved barrel and plunger rod design with integrated actuators and an electric motor or rotational spring mechanism to dispense fluid efficiently, allowing for a compact and efficient fluid delivery system.
The curved design conserves space, enabling a larger volume of fluid delivery while maintaining a compact size and efficient fluid movement, facilitating controlled medication administration.
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Abstract
Description
[Technical Field]
[0001] The present disclosure relates to a curved reservoir for a medical injector. [Background technology]
[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 253,321, entitled "Curved Reservoir for Medical Injector," filed October 7, 2021, the entire disclosure of which is incorporated herein by reference in its entirety.
[0003] Wearable medical devices, such as auto-injectors, have the advantage of providing treatment to patients remotely from clinical facilities and / or while worn individually under the patient's clothing. The wearable medical device can be applied to the patient's skin and can be configured to automatically administer a dose of a pharmaceutical composition within a predetermined period of time after application of the wearable medical device to the patient's skin, such as after a 27-hour delay. After the device administers the pharmaceutical composition to the patient, the patient can subsequently remove and discard the device. The wearable medical device can use a cylindrical barrel-type reservoir. The use of a barrel-type reservoir can limit the volume and / or length of the reservoir due to the impact that the reservoir length has on the overall package size of the wearable medical device. Summary of the Invention
[0004] In one aspect or embodiment, a reservoir and drive assembly for a medical injector includes a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid, a stopper received within the interior space configured to move within the curved barrel to dispense the fluid from the curved barrel, a curved plunger rod having a first end connected to the stopper and a second end disposed opposite the first end, and at least one actuator, such as a gear configured to drive the curved plunger rod, to guide movement of the stopper within the curved barrel.
[0005] At least a portion of the curved plunger rod and the stopper may be integrally formed. The curved barrel may be curved along its entire length extending from the first end of the curved barrel to the second end of the curved barrel. The curved plunger rod may be curved along its entire length extending from the first end of the curved plunger rod to the second end of the curved plunger rod.
[0006] The assembly may further include an electric motor configured to drive at least one gear. The at least one gear may include a worm gear, a pinion gear, and a planetary gear set. The electric motor may include a drive shaft with the worm gear fixed thereto and the pinion gear engaged with the worm gear and the planetary gear set. A drive arm may be connected to the planetary gear set, and the drive arm may be connected to the curved plunger rod.
[0007] The assembly may further include a printed circuit board assembly, the printed circuit board assembly being C-shaped. The curved barrel may have a circular cross-section along a direction extending perpendicular to a curved central axis extending from the first end to the second end of the curved barrel.
[0008] In a further aspect or embodiment, a medical injector includes the reservoir and drive assembly of any of the above aspects or embodiments, a power source, and a cannula configured to be inserted into the skin of a patient.
[0009] In a further aspect or embodiment, a reservoir and drive assembly for a medical injector includes a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid, a stopper received within the interior space configured to move within the curved barrel to dispense the fluid from the curved barrel, a curved plunger rod having a first end connected to the stopper and a second end disposed opposite the first end, and a drive assembly for the curved plunger rod including a rotational spring configured to drive the curved plunger rod and move the stopper within the curved barrel.
[0010] In a further aspect or embodiment, a reservoir and drive assembly for a medical injector includes a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid, a stopper received within the interior space configured to move within the curved barrel to dispense the fluid from the curved barrel, a curved plunger rod having a first end connecting the curved plunger rod to the stopper and a second end disposed opposite the first end, and the drive assembly includes an electric motor directly connected to the curved plunger rod via a drive arm, the electric motor configured to drive the curved plunger rod to move the stopper within the curved barrel. [Brief explanation of the drawings]
[0011] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a schematic diagram of a drug delivery device according to one aspect or embodiment of the present application. [Figure 2] FIG. 2 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to one aspect or embodiment of the present application. [Figure 3] 3 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 4] FIG. 4 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 5] FIG. 5 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 6] FIG. 6 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 7] FIG. 7 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 8] FIG. 8 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 9] FIG. 9 is a schematic diagram of a reservoir and drive assembly of the drug delivery device of FIG. 1 according to a further aspect or embodiment of the present application.
[0012] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION
[0013] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting as the present invention may assume various alternative orientations.
[0014] All numbers used in the specification and claims should be understood as modified in all instances by the term "about." By "about" is meant a range of plus or minus ten percent of the stated value. As used in the specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The terms "first," "second," etc. are not intended to refer to any particular order or chronology, but instead refer to different conditions, characteristics, or elements. "At least" means "greater than or equal to."
[0015] Referring to FIG. 1 , medical injector 10 includes reservoir 12, power source 14, and control electronics 18. In one aspect or embodiment, medical injector 10 is a wearable auto-injector configured to deliver a dose of medication. Medical injector 10 can be attached to a patient's skin and triggered to inject the medication from reservoir 12 into the patient. Medical injector 10 can be pre-filled with a medication or pharmaceutical composition or can be filled with a medication or pharmaceutical composition by a patient or medical professional prior to use. In one aspect or embodiment, medical injector 10 is utilized for injection of a medication.
[0016] The medical injector 10 is configured to deliver a dose of a pharmaceutical composition, e.g., any desired medication, into a patient's body via subcutaneous injection at a controlled injection rate. Exemplary time durations for delivery achieved by the medical injector 10 can range from about 5 minutes to about 60 minutes, but are not limited to this exemplary range. Exemplary volumes of the pharmaceutical composition delivered by the medical injector 10 can range from about 0.1 milliliters to about 10 milliliters, but are not limited to this exemplary range. The amount of pharmaceutical composition administered to the patient can be adjusted.
[0017] In one aspect or embodiment, power supply 14 is a DC power supply including one or more batteries. In one aspect or embodiment, control electronics 18 includes a microcontroller 24, sensing electronics 26, a valve controller 28, sensing electronics 30, and deployment electronics 32 that control operation of medical injector 10. In one aspect or embodiment, medical injector 10 includes a fluidics subsystem including reservoir 12, a volume sensor 34 for reservoir 12, a reservoir fill port 36, and a metering system 38 including a drive assembly 40 and a valve mechanism 42. The fluidics subsystem may further include an occlusion sensor 44, a deployment actuator 46, a cannula 48 for insertion into the patient's skin, and a fluid line 50 in fluid communication with reservoir 12 and cannula 48. In an alternative aspect or embodiment, the occlusion sensor is a system for measuring motor current. In one aspect or embodiment, the insertion mechanism (not shown) is configured to move the cannula 48 from a retracted position, where the cannula 48 is fully disposed within the device 10, to an extended position, where the cannula 48 extends outside the device 10.
[0018] Referring to FIG. 2 , in one aspect or embodiment, the reservoir 12 and drive assembly 40 of the medical injector 10 include a curved barrel 52, a stopper 54, a curved plunger rod 56, and at least one actuator, such as gears 58, 60, and 62. The curved barrel 52 has a first end 64 and a second end 66 disposed opposite the first end 64, and the curved barrel 52 defines an interior space 68 configured to receive a fluid. The stopper 54 is received within the interior space 68, and the stopper 54 is configured to move within the curved barrel 52 to dispense the fluid from the curved barrel 52. The curved plunger rod 56 has a first end 70 and a second end 72 disposed opposite the first end 70, and the curved plunger rod 56 is connected to the stopper 54. At least one gear 58, 60, 62 is configured to drive the curved plunger rod 56 and move the stopper 54 within the curved barrel 52. The length of the curved plunger rod 56 from the first end 70 to the second end 72 can be equal to or greater than the length of the curved barrel 52 from the first end 64 to the second end 66 plus the thickness of the stopper 54 so as to dispense the entire contents of the curved barrel 52.
[0019] The curved plunger rod 56 and stopper 54 may be integrally formed or separately formed, with the curved plunger rod 56 connected to the stopper 54 via any suitable connection configuration. The curved barrel 52 is curved along its entire length extending from a first end 64 of the curved barrel 52 to a second end 66 of the curved barrel 52, although other suitable arrangements may be utilized. The curved plunger rod 56 is curved along its entire length extending from a first end 70 of the curved plunger rod 56 to a second end 72 of the curved plunger rod 56, although other suitable arrangements may be utilized. The drive assembly 40 further includes an electric motor 80 configured to drive the at least one gear 58, 60, 62. In one aspect or embodiment, the at least one gear 58, 60, 62 includes a worm gear 58, a pinion gear 60, and a planetary gear set 62. The electric motor 80 includes a drive shaft 82 with a worm gear 58 fixed thereto and a pinion gear 60 engaged with the worm gear 58 and a planetary gear set 62. A drive arm 84, connected to the planetary gear set 62, is connected to the curved plunger rod 56. Thus, upon actuation of the electric motor 80, the drive shaft 82 rotates the worm gear 58, which rotates the pinion gear 60 and the planetary gear set 62, thereby rotating the drive arm 84. Rotation of the drive arm 84 moves the curved plunger rod 56, which in turn moves the stopper 54 within the curved barrel 52 to dispense fluid from the curved barrel 52 into the cannula 48 or other configuration. In one aspect or embodiment, the curved plunger rod 56 includes a plurality of gear teeth along its length (not shown), which engage one or more gears driven by the electric motor 80. The curved barrel 52 may be used to infuse or deliver fluids using a gearing mechanism with rate adjustment using an active actuator, or may be powered by a passive system for bolus or basal delivery.
[0020] 2 , in one aspect or embodiment, medical injector 10 includes a C-shaped printed circuit board assembly 86. Curved barrel 52 has a circular cross-section along a direction extending perpendicular to a curved central axis 88 that extends from first end 64 to second end 66 of curved barrel 52.
[0021] The curved barrel 52 and / or curved plunger rod 56 conserve space and allow the overall size of the medical injector 10 to be minimized while still holding a sufficient volume of fluid. The curved barrel 52 and / or curved plunger rod 56 also conserves the movement required to dispense fluid from the medical injector 10 while allowing the use of gearing mechanisms with high efficiency. The curved barrel 52 allows the reservoir 12 to have a large arc length while maintaining an overall length less than the axial length, allowing the reservoir 12 to have a relatively small cross-sectional area, thereby advantageously reducing surface friction and the force required to drive against back pressure during delivery of the medication.
[0022] In one aspect or embodiment, the cross section of the curved barrel 52 is circular, oval, or other closed loop structure. In one aspect or embodiment, the stopper 54 is pushed and / or pulled using an internal structure such as a cable or rod. The height and cross-sectional area of the curved barrel 52 can be varied to accommodate different volumetric injection targets for various products. In one aspect or embodiment, the internal space 68 of the curved barrel 52 has a volume of 3 to 10 mL. In a further aspect or embodiment, the internal space 68 of the curved barrel 52 has a volume of 10 to 50 mL.
[0023] Referring to FIG. 3 , in a further aspect or embodiment, the electric motor 80 is connected to a bevel gear 90, which rotates a gear of the planetary gear set 62, which rotates the drive arm 84 to displace the curved plunger rod 56.
[0024] 4 , in a further aspect or embodiment, the drive assembly 40 of the medical injector 10 includes a gearbox 92 connected to the electric motor 80, which rotates a lead screw 94, which in turn translates a slider nut 96. The slider nut 96 moves the curved plunger rod 56, and a rack support bar 98 guides and / or aligns the movement of the curved plunger rod 56.
[0025] 5 , in a further aspect or embodiment, the electric motor 80 is connected to a worm gear 58, which in turn rotates a pinion gear 60. The pinion gear 60 engages a rack 100 disposed on the curved plunger rod 56, which moves the curved plunger rod 56, and a rack support bar 98 guides and / or aligns the movement of the curved plunger rod 56. The rack 100 may be integrally formed with the curved plunger rod 56.
[0026] Referring to FIG. 6, in a further aspect or embodiment, the drive assembly 40 may be similar to that shown in FIG. 5, except that the spur gear set 102 is disposed between the worm gear 58 and the pinion gear 60.
[0027] 7 , in a further aspect or embodiment, drive assembly 40 of medical injector 10 includes a bevel gear 104 connected to electric motor 80, which rotates spur gear set 106. A gear of spur gear set 106 engages pinion gear 60, which in turn engages rack 100 of curved plunger rod 56.
[0028] 8 , in a further aspect or embodiment, electric motor 80 of drive assembly 40 of medical injector 10 is directly connected to drive arm 84, which moves curved plunger rod 56. Electric motor 80 may be a pancake-style electric motor. A rotary joint 108 may be disposed between motor 80 and drive arm 84.
[0029] 9 , in a further aspect or embodiment, the drive assembly 40 of the medical injector 10 includes a wound rotational spring 110 held by a pin 112. When the pin 112 is removed, either manually by the patient or automatically by the medical injector 10, the spring 110 is released, urging the drive arm 84 to move the curved plunger rod 56. One end of the spring 110 is fixed to a structure of the medical injector 10, and a moving end of the spring 110 is fixed to the drive arm 84. The drive arm 84 is fixed to the medical injector 10 via a pivot 114, such as a rotary joint.
[0030] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
[0031] The present invention includes the following embodiments: [Configuration 1] 1. A reservoir and drive assembly for a medical injector, comprising: a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid; a stopper received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel; a curved plunger rod having a first end and a second end disposed opposite the first end, the curved plunger rod connected to the stopper; and at least one actuator that directs movement of the stopper within the curved barrel. [Configuration 2] 2. The reservoir and drive assembly of claim 1, wherein the curved plunger rod and at least a portion of the stopper are integrally formed. [Configuration 3] 3. The reservoir and drive assembly of configuration 1 or 2, wherein the curved barrel is curved along an entire length extending from the first end of the curved barrel to the second end of the curved barrel. [Configuration 4] 4. The reservoir and drive assembly of any one of configurations 1 to 3, wherein the curved plunger rod is curved along its entire length extending from the first end of the curved plunger rod to the second end of the curved plunger rod. [Configuration 5] 5. The reservoir and drive assembly of any one of configurations 1 to 4, further comprising an electric motor configured to drive the at least one actuator. [Configuration 6] 6. The reservoir and drive assembly of claim 5, wherein the at least one actuator comprises a worm gear, a pinion gear, and a planetary gear set. [Configuration 7] 7. The reservoir and drive assembly of claim 6, wherein the electric motor includes a drive shaft, the worm gear is fixed to the drive shaft, and the pinion gear is engaged with the worm gear and the planetary gear set. [Configuration 8] 8. The reservoir and drive assembly of configuration 7, further comprising a drive arm connected to the planetary gear set, the drive arm connected to the curved plunger rod. [Configuration 9] 9. The reservoir and drive assembly of any one of configurations 1 to 8, further comprising a printed circuit board assembly, said printed circuit board assembly being C-shaped. [Configuration 10] 10. The reservoir and drive assembly of any one of configurations 1 to 9, wherein the curved barrel has a circular cross-section along a direction extending perpendicular to a curved central axis extending from the first end to the second end of the curved barrel. [Configuration 11] A medical syringe, 11. The reservoir and drive assembly of any one of configurations 1 to 10; Power supply and a cannula configured to be inserted into the patient's skin; A medical syringe comprising: [Configuration 12] 1. A reservoir and drive assembly for a medical injector, comprising: a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid; a stopper received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel; a curved plunger rod having a first end and a second end disposed opposite the first end, the curved plunger rod connected to the stopper; a rotational spring configured to drive the curved plunger rod and move the stopper within the curved barrel. [Configuration 13] 1. A reservoir and drive assembly for a medical injector, comprising: a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid; a stopper received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel; a curved plunger rod having a first end and a second end disposed opposite the first end, the curved plunger rod connected to the stopper; a drive assembly comprising an electric motor directly connected to the curved plunger rod via a drive arm, the electric motor configured to drive the curved plunger rod and move the stopper within the curved barrel;
Claims
1. 1. A reservoir and drive assembly for a medical injector, comprising: a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid; a stopper received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel; a curved plunger rod having a first end and a second end disposed opposite the first end, the curved plunger rod connected to the stopper; and at least one actuator that directs movement of the stopper within the curved barrel.
2. The reservoir and drive assembly of claim 1 , wherein the curved plunger rod and at least a portion of the stopper are integrally formed.
3. 2. The reservoir and drive assembly of claim 1, wherein the curved barrel is curved along an entire length extending from the first end of the curved barrel to the second end of the curved barrel.
4. 2. The reservoir and drive assembly of claim 1, wherein the curved plunger rod is curved along an entire length extending from the first end of the curved plunger rod to the second end of the curved plunger rod.
5. The reservoir and drive assembly of claim 1 , further comprising an electric motor configured to drive the at least one actuator.
6. The reservoir and drive assembly of claim 5 , wherein the at least one actuator comprises a worm gear, a pinion gear, and a planetary gear set.
7. 7. The reservoir and drive assembly of claim 6, wherein the electric motor includes a drive shaft, the worm gear is fixed to the drive shaft, and the pinion gear is engaged with the worm gear and the planetary gear set.
8. The reservoir and drive assembly of claim 7 further comprising a drive arm connected to said planetary gear set, said drive arm connected to said curved plunger rod.
9. 10. The reservoir and drive assembly of claim 1, further comprising a printed circuit board assembly, said printed circuit board assembly being C-shaped.
10. 2. The reservoir and drive assembly of claim 1, wherein the curved barrel has a circular cross-section along a direction extending perpendicular to a curved central axis extending from the first end to the second end of the curved barrel.
11. A medical syringe, The reservoir and drive assembly of claim 1; Power supply and a cannula configured to be inserted into the patient's skin; A medical syringe comprising:
12. 1. A reservoir and drive assembly for a medical injector, comprising: a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid; a stopper received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel; a curved plunger rod having a first end and a second end disposed opposite the first end, the curved plunger rod connected to the stopper; a rotational spring configured to drive the curved plunger rod and move the stopper within the curved barrel.
13. 1. A reservoir and drive assembly for a medical injector, comprising: a curved barrel having a first end and a second end disposed opposite the first end, the curved barrel defining an interior space configured to receive a fluid; a stopper received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel; a curved plunger rod having a first end and a second end disposed opposite the first end, the curved plunger rod connected to the stopper; a drive assembly comprising an electric motor directly connected to the curved plunger rod via a drive arm, the electric motor configured to drive the curved plunger rod and move the stopper within the curved barrel;