Injection simulation device and method
AssigneeNoble International, Inc.
InventorsJeff BAKER, Francis Michael SIEMER, Christopher Wai Yin CHUNG
Life of this patent
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Abstract
An injection simulation device for simulating one or more forces of an injection is provided herein. The device may include a housing and a retractable injection simulation member associated with the housing, wherein the retractable injection simulation member retracts according to a multi-phase force profile. The multi-phase force profile includes a first phase configured to simulate a deformation force of pressing a needle against a subject so as to deform at least a first layer of tissue prior to traversing at least the first layer of tissue of the subject, a second phase configured to simulate a puncture rebound force, and a third phase configured to simulate an insertion force.
Claims83
An injection simulation device comprising a housing and a retractable injection simulation member, said injection simulation member configured to simulate a needle of an injection device with a determined gauge (G) and which device is configured such that the injection simulation member retracts from an extended position to a first retracted position under application of a force1 (N), to simulate a deformation force (Forced) according to the following formula:
- Forced=C(−0.046(G)+1.83)
- wherein the force value ranges between +/−1%-30% and every integer in between, and wherein C comprises a coefficient, said coefficient being a factor of the deformation force of the injection simulation device.
An injection simulation device for simulating one or more forces of an injection, the device comprising:
- a housing;
- and
- a retractable injection simulation member associated with the housing, configured to simulate a needle of an injection device with a determined gauge, and which device is configured such that the injection simulation member retracts from an extended position to a retracted position upon application of a force according to a multi-phase force profile, said multi-phase force profile comprising:
- at least a first phase configured to simulate a deformation force, said deformation force simulating the force of pressing a needle against a subject so as to deform at least a first layer of tissue prior to puncturing at least the first layer of tissue of the subject;
- and
- at least a second phase configured to simulate a puncture rebound force.
An injection simulation device configured to simulate forces applied to an injection device during an injection event, said injection simulation device comprising:
- a housing;
- an injection simulation member, said injection simulation member configured to be retracted from an extended position to a first and/or second retracted position in response to a force on said injection simulation member;
- and
- a resistance mechanism, wherein the resistance mechanism provides one or more resistance values as the injection simulation member is retracted, to simulate one or more forces applied during an injection event wherein the resistance increases as the injection simulation member is retracted to simulate a deformation force until at least a first retracted position is reached, wherein upon reaching the first retracted position, the resistance decreases to simulate a puncture rebound force, following the decrease in resistance, the resistance increases as the injection simulation member is retracted to simulate an insertion force until at least a second retracted position is reached, wherein said one or more forces are configured to simulate one or more variables affecting one or more forces during an injection, comprising needle gauge, needle length, needle bevel, needle coating, needle sharpness, lubrication of the needle, angle of the needle relative to a target site, or one or more characteristics of a tissue traversed by a needle, or a combination thereof.
An injection simulation device configured to simulate forces applied to an injection device during an injection event, said injection simulation device comprising:
- a device housing;
- an injection simulation member slidably engaged with the device housing, said injection simulation member having a proximal end and a distal end, the distal end for interacting with a target area of a user, and the proximal end comprising at least one protrusion, said injection simulation member configured to be retracted from an extended position to a first and/or second retracted position in response to a force on the injection simulation member;
- a resistance mechanism to simulate one or more forces applied during an injection event, wherein as the injection simulation member is retracted, a resistance increases, to simulate a deformation force until at least the first retracted position is reached, wherein upon reaching the first retracted position, the resistance decreases to simulate a puncture rebound force;
- and
- a biasing member disposed within the device housing, wherein following the decrease in resistance, the biasing member causes an increase in resistance as the injection simulation member is further retracted to simulate an insertion force until at least a second retracted position is reached.
A method for simulating an injection, comprising:
- providing an injection device comprising a housing and an injection simulation member slidably engaged with the housing;
- applying a force to a distal end of the injection simulation member to retract the injection simulation member from an extended position;
- wherein the force applied to the distal end of the injection simulation member is sufficient to overcome differential resistances of the injection device, and said force is representative of a force required for application on an injection medicament delivery device;
- and
- wherein the differential resistances are provided based on a multi-phase profile configured to simulate a first phase configured to simulate a deformation force of pressing a needle against a subject so as to deform at least a first layer of tissue prior to traversing at least the first layer of tissue of the subject, a second phase configured to simulate a puncture rebound force, and a third phase configured to simulate an insertion force.
An injection simulation device configured to simulate one or more forces applied to an injection device during an injection event, said injection simulation device comprising:
- a housing;
- an injection simulation member, said injection simulation member configured to be retracted from an extended position to a retracted position in response to a force on said injection simulation member;
- and
- a resistance mechanism, wherein the resistance mechanism provides one or more resistance values as the injection simulation member is retracted to simulate one or more forces applied during an injection event wherein the resistance increases as the injection simulation member is retracted to simulate an insertion force according to:
- F(x)=K*XP
- wherein F(x) is a force value at a point between the extended position and the retracted position, K is a resistance value comprising a resistance of the injection simulation device, X is a displacement value, and P is an exponential power value greater than zero.
An injection simulation device comprising a housing and a retractable injection simulation member, said injection simulation member configured to simulate a needle of an injection device with a determined gauge (G) and which device is configured such that the injection simulation member retracts from an extended position to a retracted position under application of a force, (N), to simulate an insertion force (Force) according to the following formula:
- Forcei=2[C(−0.046(G)+1.83)*E]
- wherein the force value ranges between +/−1%-30% and every integer in between, E comprises a variable factor, and wherein C comprises a coefficient, said coefficient being a factor of the insertion force of the injection simulation device.
Dependencies are inferred from the claim text.