Reducing probability of glass breakage in drug delivery devices

Patent metadata

Field	Value
Publication number	US-2019050375-A1
Application number	US-201716070224-A
Country	US
Kind code	A1
Filing date	Mar 14, 2017
Priority date	Mar 15, 2016
Publication date	Feb 14, 2019
Grant date	—

Abstract

A method for determining predicted failure rates of drug injection devices includes receiving a set of parameters that specify physical properties of (i) a syringe, and (ii) a liquid drug, and (iii) a drug injection device configured to deliver the liquid drug to a patient via the syringe. The method further includes receiving failure rate data that specifies a measured rate of failure of the drug injection device in response to various peak pressures within the syringe, applying the received set of parameters to a kinematic model of the drug injection device to determine a predicted peak pressure within the syringe, including determining the predicted peak pressure as a function of impact velocity of the liquid drug, determining a probability of failure of the drug injection device using (i) the received failure rate data and (ii) the predicted peak pressure, and providing an indication of the determined probability of failure to an output device.

First claim

1 . A non-transitory computer-readable medium storing thereon instructions that, when executed on one or more processors, implement a method for determining predicted failure rates of drug injection devices, the method comprising:
receiving a set of parameters that specify physical properties of (i) a syringe, and (ii) a liquid drug, and (iii) a drug injection device configured to deliver the liquid drug to a patient via the syringe; receiving failure rate data that specifies a measured rate of failure of the drug injection device in response to various peak pressures within the syringe; applying the received set of parameters to a kinematic model of the drug injection device to determine a predicted peak pressure within the syringe, including determining the predicted peak pressure as a function of impact velocity of the liquid drug; determining a probability of failure of the drug injection device using (i) the received failure rate data and (ii) the predicted peak pressure; and providing an indication of the determined probability of failure to an output device.

2 . The computer-readable medium of claim 1 , wherein the implemented method further comprises modeling a fluid column in the syringe as an acoustic medium.

3 . The computer-readable medium of claim 1 , wherein the implemented method further comprises modeling a fluid column in the syringe using a Korteweg equation.

4 . The computer-readable medium of claim 1 , wherein the drug injection device includes a mechanism configured to drive a plunger rod toward a plunger of the syringe encased in a syringe carrier, wherein the plunger rod advances the syringe carrier toward a front shell of the drug delivery device; the implemented method further comprising:
using a one-dimensional (1D) kinematic model to model interactions between at least the mechanism, the plunger rod, the plunger, the syringe carrier.

5 . The computer-readable medium of claim 4 , wherein using the 1D kinematic model includes (A) modeling the mechanism as a linear spring with an equilibrium length, and/or (B) modeling (i) a pre-impact stage at which the plunger rod has not come in contact with the plunger, (ii) a first impact stage at which the plunger rod comes in contact with the plunger, and (iii) a third impact stage at which the syringe carrier comes in contact with the front shell.

6 . (canceled)

7 . The computer-readable medium of claim 1 , wherein receiving the set of parameters to the kinematic model includes receiving geometric parameters related to at least one of the syringe or the drug injection device, including at least one of: (i) plunger depth, (ii) plunger rod wall thickness, (iii) plunger rod activation length, (iv) syringe barrel diameter, (v) syringe wall thickness, (vi) fluid volume, (vii) syringe carrier activation length, (viii) plunger rod depth, (ix) length of the guide rod, (x) length of guide rod base, (xi) length of needle insertion, (xii) needle length, (xiii) needle, or (xiv) un-sprung length of spring.

8 . (canceled)

9 . The computer-readable medium of claim 1 , wherein receiving the set of parameters to the kinematic model includes receiving parameters indicative of masses of components, including at least one of: (i) mass of syringe carrier, (ii) mass of pre-filled syringe with drug, (iii) mass of plunger, (iv) mass of rod, or (iv) mass of spring.

10 . (canceled)

11 . The computer-readable medium of claim 1 , wherein receiving the set of parameters to the kinematic model includes receiving at least one of the following (a) through (f):
(a) a parameter indicative of plunger elasticity, (b) a parameter indicative of front shell elasticity, (c) a parameter indicative of fluid sound speed, (d) a parameter indicative of viscosity of the drug, (e) a spring constant, and/or (f) experimental data indicative of a plurality of test runs of an actual drug injector device that shares at several physical properties with the drug injection device being modeled, and deriving one or more of (i) syringe driver friction, (ii) internal plunger damping, (iii) plunger-syringe friction, and (iv) a shell damping constant from the experimental data.

12 - 16 . (canceled)

17 . The computer-readable medium of claim 1 , wherein determining the probability of failure of the drug injection device includes applying a two-term Weibull distribution function.

18 . A method for manufacturing drug injection devices, the method comprising:
receiving, by one or more processors, a fixed set of parameters that specify physical properties of a syringe and a liquid drug; determining a set of parameters that specify physical properties of a drug injection device configured to deliver the liquid drug to a patient via the syringe, including: (i) generating, by the one or more processors, a candidate set of parameters for the drug injection device; (ii) applying, by the one or more processors, the fixed set of parameters and the candidate set of parameters to a kinematic model of the drug injection device to determine a predicted peak pressure within the syringe, including determining the predicted peak pressure as a function of impact velocity of the liquid drug, (iii) determining, by the one or more processors, a probability of failure of the drug injection device using the determined predicted peak pressure, (iv) if the probability of failure is above a threshold value, repeating the steps (i)-(iii) with a modified candidate set of parameters, and (v) selecting the candidate set of parameters if the probability of failure is not above the threshold value; and manufacturing the drug injection device using the determined set of parameters.

19 . The method of claim 18 , further comprising modeling a fluid column in the syringe as an acoustic media.

20 . The method of claim 18 , further comprises modeling a fluid column in the syringe using a Korteweg equation.

21 . The method of claim 18 , wherein the drug injection device includes a mechanism configured to drive a plunger rod toward a plunger of the syringe encased in a syringe carrier, wherein the plunger rod advances the syringe carrier toward a front shell of the drug delivery device; the method further comprising:
using a one-dimensional (1D) kinematic model to model interactions between at least the mechanism, the plunger rod, the plunger, the syringe carrier.

22 . The method of claim 21 , wherein using the 1D kinematic model includes (A) modeling the mechanism as a linear spring with an equilibrium length, and/or (B) modeling (i) a pre-impact stage at which the plunger rod has not come in contact with the plunger, (ii) a first impact stage at which the plunger rod comes in contact with the plunger, and (iii) a third impact stage at which the syringe carrier comes in contact with the front shell.

23 . (canceled)

24 . The method of claim 18 , wherein receiving the set of parameters that specify the physical properties of the drug injection device includes receiving at least one of the following (a) through (h):
(a) geometric parameters for one or several components of the drug injection device, (b) parameters indicative of masses of components of the drug injection device (c) a parameter indicative of front shell elasticity, (d) a parameter indicative of plunger elasticity, (e) a parameter indicative of fluid sound speed, (f) a parameter indicative of viscosity of the drug, (g) a spring constant, and/or (h) experimental data indicative of a plurality of test runs of an actual drug injector device

Assignees

• Amgen Inc

Inventors

• Fitzgibbon Sean
• Folk Christopher R
• Jazayeri Julian

Classifications

• A61M5/315

  Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod {or piston}; Appliances on the rod for facilitating dosing {; Dosing mechanisms} · CPC title

• A61M2205/3327

  Measuring · CPC title

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• G06F2111/10

  Numerical modelling · CPC title

• A61M5/3202

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title