JP5165025B2 - Inhaler with air flow regulation - Google Patents

Description

  The present invention relates generally to the field of inhalers that deliver appropriate materials to a user, typically during inspiration, and more particularly to the size of the air flow path to obtain / maintain a constant flow rate. It relates to an inhaler that regulates.

  Respiratory delivery systems, such as metered dose inhalers, dry powder inhalers, and nebulizers, generally allow substances to be taken into the lung tissue of the body, usually by simple inhalation. Metered dose inhalers generally mix a drug and propellant in a pressurized aerosol container with a valve, thereby releasing a certain amount of aerosol into the inhaled air stream when the container is activated. . A dry powder inhaler typically fluidizes powdered medications using inhalation jets and draws these powdered medications into the respiratory tract. Nebulizers generally form an aerosol by nebulizing a drug in a substantially continuous carrier gas stream that can be inhaled.

  Regardless of the respiratory delivery system used, conventional drug introduction into the pulmonary tissue of the human body allows a selected / predetermined amount of drug to be delivered to the individual's lung tissue relative to that person's respiratory system. There are many points to be improved in the convenient delivery regardless of the strength / weakness. For example, currently used metered dose inhalers generally require at least some synchronization between valve actuation and user inhalation (which has proven difficult for some users). Metered dose inhalers generally rely on a minimum threshold inhalation by the user, so if the inhalation is less than this minimum threshold, the amount of drug that can successfully reach the lung tissue may be less than the required drug amount . Accordingly, various attempts have been made to develop a metered dose inhaler that “senses” the amount of inhalation hollow airflow and changes the amount of drug dispensed based on the inhalation flow rate. In other words, in an exemplary situation where two individuals use a metered dose inhaler with such a “sensor”, the first individual (which is less capable of inhaling than the second individual) For each actuation, a higher concentration of drug will be dispensed than the concentration obtained by the second individual. However, such attempts to adjust the amount of drug according to the user's inhalation intensity vary in the degree of success, all of which tend to be a significant price for the consumer.

  Dry powder inhalers, at least generally, tend to avoid synchronization problems with metered dose inhalers. However, the dry powder inhaler cannot solve the problem that the size of inhalation varies among users and also varies depending on the situation (even the same user). That is, an individual may not be able to perform inhalation with sufficient force to “fluidize” and inhale the entire amount of powdered drug. Accordingly, the dose of the powdered drug that actually reaches the lung tissue tends to change based on the suction input.

  With respect to nebulizers, inhalation generally tends to reduce the pressure at the nebulizer nozzle. Thus, desirable drug administration is generally affected by the duration and intensity of the user's inhalation. Many nebulizers operate on the basis of a “continuous flow of steam”, but there is a control system that directs the atomized gas stream from the nebulizer to a “holding chamber” (from which a user can draw a charge). Has been used. However, these “charges” also generally depend on the user being able to inhale the entire amount of vaporized drug from the holding chamber. Thus, a user with a relatively weak inhalation capability may not accept the entire “charge” of the drug. Accordingly, it is observed that the degree of success also varies for nebulizers that attempt to control the amount of drug dispensed with respect to the user's inhalation intensity.

  In summary, the accuracy of medication delivery in conventional respiratory delivery systems is inconveniently inaccurate. In each of the systems discussed above, the desired amount of drug to be delivered to the intended lung tissue generally depends (at least to some extent) on the user's inhalation intensity, generally on a per-dose basis and / or Or it varies between individuals. That is, between the lack (or fluctuation) of the user's breathing ability and the lack (or fluctuation) that the user consistently accepts sufficient, prescribed and / or desirable amounts of medication. It is recognized that a correlation exists. Accordingly, an improved respiratory delivery system that efficiently incorporates an invariant of dispensed drug into the air stream and successfully delivers such invariant of dispensed drug to the target lung tissue. It would be desirable to develop a respiratory delivery system that shows.

  The claims in this patent application generally relate to the first set of embodiments discussed in the introduction to the detailed description section of this patent application.

FIG. 1 is a cross-sectional view of one embodiment of an inhaler. FIG. 2 is a side view of the inhaler of FIG. 3A is an end view of the droplet ejection device used by the inhaler of FIG. 1, and FIG. 3B is a cross-sectional view of the droplet ejection device of FIG. 1 along line 3B-3B of FIG. 3C is a cross-sectional view of one embodiment of droplet ejection that may be used with the inhaler of FIG. 1, according to the cross-section indicated by line 3C-3C in FIG. 3A. FIG. 4 is a side view of another embodiment of an inhaler. FIG. 5 is a side cross-sectional view of one embodiment of an air flow adjustment assembly that may be used with an inhaler. FIG. 6 is a schematic diagram of another embodiment of an inhaler that uses the operative interconnection of the inhaler controller assembly and the air flow regulation assembly. FIG. 7 is a schematic diagram of one embodiment of an inhaler having a controller assembly, which controller assembly is an operational test for controlling the transmission of one or more signals to a plurality of ejection actuators useful for the inhaler. Having both a module and a dosing action execution module, the controller assembly also includes a dosing action setup module for establishing various parameters of the dosing action. FIG. 8 is one embodiment of a manufacturing protocol for the inhaler of FIG. FIG. 9 is one embodiment of an inhaler actuator operational test protocol that may be used by the inhaler operational test module of FIG. 10 is one embodiment of a dosing setup protocol that may be used by the dosing setup module of the inhaler of FIG. FIG. 11 is another embodiment of a dosing setup protocol that may be used by the dosing setup module of the inhaler of FIG.

(preface)
As an overview to the group of various embodiments of the present invention, oral and nasal inhalation are generally encompassed by the present invention. One common substance that can be dispensed, discharged, or otherwise ejected by the inhaler of the present invention is a liquid drug, which is in the form of a plurality of individual discrete droplets, Typically, it can be jetted into a stream of air flowing through the inhaler somewhere upstream of the discharge outlet of the inhaler. However, the present invention is not limited to any particular type of material ejected by the inhaler and is not limited to any particular form in which this material can be ejected from the inhaler.

  The first group of embodiments of the present invention generally relates to an inhaler used to release a suitable substance for inhalation by a user. The first aspect of this first group of embodiments includes at least one air inlet, at least one outlet (eg, mouthpiece, nasal mask), and at least extending between the air inlet and outlet. It is embodied by an inhaler including one air flow path. The inhaler also includes at least one ejection actuator and an air flow adjustment assembly. In general, the ejector actuators release the appropriate material into the air flow, while the air flow adjustment assembly allows the size of the passage to direct all of the air flow to a constant flow rate through the inhaler. Adjust to achieve / maintain.

  There are various improvements in the above features relating to the first aspect of the first group of embodiments. Additional features may also be incorporated into the first aspect of the first group of embodiments. These refinements and additional features may exist individually or in any combination. Any type of ejection actuator can be used with the inhaler of the first aspect. Multiple ejection actuators can also be used. These multiple ejection actuators may be independently operable. These multiple ejection actuators can also be separated into multiple groups, and each individual group of ejection actuators can be operated independently.

  In one embodiment, the air flow adjustment assembly includes a flow adjustment port having a length, the port having an inner diameter that varies over the length of the port. For example, the flow control port converges at least generally in the direction of the airflow flowing through the port. All of the air flow is directed through this flow control port. A baffle, piston, or the like is movably disposed within the inlet port and spaced from the inner wall of the air intake port over at least a portion of the length of the air intake port. Any structure that “flow-throttling” can be used. Movement of the baffle relative to the flow control port changes the amount of space between the baffle and the inner wall of the flow control port.

  The above change in the magnitude of the distance between the baffle and the inner wall of the flow control port can be used to achieve a constant flow rate of the air flow flowing through the inhaler. In order to increase the delivery of inhaled material, it may be preferred that a constant flow of air is drawn into the inhaler. More specifically, delivery of inhaled material provides some relationship between the flow rate of air being drawn into the inhaler and the rate at which the material (eg, drug) is ejected or released into the air stream. Can be increased. Assuming that the user can generate at least a certain threshold level of suction input, the baffle provides a constant flow to the flow control port regardless of the suction input being generated by the user. Can be arranged to

  The movement of the baffle can be realized by a purely mechanical system. For example, a biasing member (e.g., a coil spring) can act on the baffle to oppose the suction input being applied to the baffle. That is, the baffle can be biased in the “upstream” direction. A suction force below a certain level does not compress the biasing member to maintain the maximum spacing between the baffle and the inner wall of the converging flow control port. However, if the suction force exceeds a certain level, the biasing member begins to compress so as to reduce the distance between the baffle and the inner wall of the air intake port. Thus, this reduction in the size of the air flow path through which all the air flow should pass will only allow a certain maximum flow rate through the inhaler. As the suction input further increases, the distance between the baffle and the inner wall of the converging flow control port is further reduced so that the flow rate through the inhaler is maintained at least substantially at the constant maximum flow rate. It will be. That is, as long as the suction input exceeds a certain threshold, the suction input by the user changes the size of the air flow path through which all airflow is directed (e.g., the baffle in the converging flow control port). As a result (by changing position), this results in at least substantially the same flow through the inhaler. There may be other methods for adjusting the size of the air flow path that directs all the air flow by a purely mechanical system, these methods being the first aspect of this first group of embodiments. It is in the range. However, the structure described herein may also provide one or more benefits or advantages based on its unique design.

  Movement of the baffle relative to the flow control port can also be accomplished in response to certain types of signals. For example, the first aspect described above may further include an air flow monitoring assembly that allows determination of the flow rate through at least a portion of the inhaler. Flow rate information can be used to determine the amount of space between the baffle and the inner wall of the converging flow control port. One or more signals may be sent to the appropriate driver. This signal is a signal for moving the baffle to a position for realizing a “derived” or “calculated” magnitude of the distance between the baffle and the flow control port. In this case, any suitable type of drive can be used. Furthermore, these “signal-based” air flow conditioning principles can be moved in response to signals to adjust the size of the air flow path that directs all air flow. It can be used with any type of flow regulation structure, so that at least a substantially uniform flow rate is obtained regardless of the suction input being generated by the user of the inhaler (again, the suction input is at least As long as the value exceeds a certain threshold).

  The second group of embodiments of the present invention generally relates to an inhaler with an operational test capability of an actuator used in the inhaler to eject or release a suitable substance. The first aspect of this second group of embodiments is embodied by an inhaler, in which a test signal is preferably used at least by the current inhaler (e.g. control of the inhaler). Sent to each actuator or group of actuators (currently operable by logic) to eject or eject material from the inhaler. An “actuator group” is a plurality of jetting actuators that are actuated by a single common signal, and an inhaler is capable of separating a plurality of these actuator groups, each of these actuator groups being independent. It can be included in an operable state. The test signal of this first aspect preferably does not cause any release of the substance from the inhaler, and therefore preferably activates an activation signal (eg, “functioning activation signal”) that causes the release from the inhaler. Is different in at least some respects from sending to a “working” ejection actuator. The response of each ejection actuator or group of actuators to the test signal for the first aspect is evaluated in some way, for example to evaluate the operability of the actuator.

  There are various improvements in the above features regarding the first aspect of the second group of embodiments. Additional features may also be incorporated into the first aspect of the second group of embodiments. These refinements and additional features may exist individually or in any combination. Assessing the response of the ejection actuator or actuator group to the test signal for the first aspect may require assessing the electrical performance of each ejection actuator or actuator group. Consider the case where each ejection actuator is a resistor (as well as any given actuator group) having a relatively constant resistance to the ejection signal used by the inhaler. This resistance can be calculated using the relationship R = V / I. In this equation, an electrical signal of known voltage (V) or current (I) is sent to a particular ejection actuator or actuator group, and the other of voltage (V) or current (I) can be measured. Any change in the resistance (R) of the ejection actuator or actuator group, determined according to the test signal for the first aspect, greater than a predetermined amount will cause some type of disqualification for the particular ejection actuator or actuator group. May be considered or equivalent. For actuator groups, any suitable criteria for defining a “failed condition” (including the case where only one actuator in the group has failed) may be used. More typically, however, the first aspect is a condition in which a plurality of predetermined ejection actuators within a given actuator group are disqualified before the actuator group is deemed disqualified according to the first aspect. Can be implemented to allow to become. It will be appreciated that other types of actuators, such as piezoelectric material based actuators, can also be evaluated by the electrical properties of the actuator.

  One method for performing the first aspect with respect to an ejection actuator or actuator group that is “disqualified” with respect to evaluating the response of the actuator to the test signal is to place the ejection actuator or actuator group in some way with respect to the next dosing action. Would disable the feature. Alternatively, the inhaler control logic would at least provide input regarding the presence of these jetting actuators or actuator groups that “disqualified” the self-test for the first aspect. This is particularly true when each jetting actuator or actuator group is independently operable, and at least substantially a predetermined amount of material is determined by each jetting actuator or actuator group by a predetermined actuation signal. Relevant when released in response to. Disabling a jetting actuator or actuator group means that all such actuators or actuator groups are not valid for use in subsequent delivery actions or “dosing events” by the inhaler. Means. The inhaler is “computer controlled” in some way (eg, including a programmable memory to control the operation of the inhaler at least in relation to the manner in which the actuation signal is provided to the inhaler ejection actuator I think). An “administration action” may require sending the same actuation signal to each of the ejection actuators or groups of actuators multiple times over a period of time (eg, 8 pulses in 2 seconds), but one or more actuation signals are 1 It includes any predetermined protocol for delivery to the above jetting actuators or actuator groups. Disabling all jet actuators or actuator groups disqualified for self-testing according to the first aspect can all be recognized / counted by the control logic of the inhaler of the first aspect, and specific administration actions Can be used by this control logic to modify or adjust the execution of. One method is that each individual actuation signal that would have been sent to a "disabled" jet actuator or actuator group for a particular dosing action "passed" the self-test of the first aspect ( “Passed”) to be sent to a jetting actuator or actuator group. This can be done in various ways. For example, it can be done by adding one or more actuation signals to the “end” of the first dosing action (ie, before being changed). Thus, even if one or more of the jetting actuators or actuator groups in the inhaler is inoperable (or disabled as a whole by the ineffective function described above), the inhaler is still in the second group of implementations. As a result of the first aspect of the configuration, at least substantially the same predetermined release amount could be accurately delivered for a given administration action.

  Another method that may be implemented in addressing a particular jet actuator or actuator group that is “disqualified” according to the first aspect is that any jet of the inhaler that has been temporarily disabled with respect to the control logic used for the inhaler “Re-activate” an actuator or group of actuators. That is, the inhaler for the first aspect may actually include a greater number of ejecting actuators or actuator groups than the number of actually desired / needed ejecting actuators or actuator groups for the inhaler at any one time. Thereby, the control logic of the inhaler of the first aspect can be “programmed” to use only some of the ejection actuators or actuator groups, and actuators that are not currently needed can be temporarily disabled ( For example, the control logic is programmed not to send actuation signals to the actuators that are not currently needed throughout the dosing action). The ejection actuators or actuator groups “disqualified” and so identified according to the first aspect are in a one-to-one relationship with the corresponding “excess” ejection actuators or actuator groups of the inhaler. Can be exchanged. That is, the control logic of the inhaler can be reprogrammed to preferentially use one of the surplus ejection actuators or actuator groups rather than using one ejection actuator or actuator group that is “disqualified” according to the first aspect. . Such “excess” jetting actuators or actuator groups are preferably first tested for operational capability (including testing according to the first aspect) before engaging in the actual dosing action.

  The first aspect may be performed as part of a test procedure before the inhaler is distributed for use in a respiratory delivery operation. Preferably, however, the first aspect is performed to at least allow the self-test of the first aspect to be performed after the inhaler has been sold for distribution to the user of the inhaler. This can be left to the user's decision by the user manually starting the self-test of the first aspect. Alternatively, the self-test can be incorporated into the inhaler control logic program so that the self-test of the first aspect is automatically performed on some principle. In the latter case, it may be desirable to perform the self-test of the first aspect before each dosing action is performed by the inhaler or at least in some type of cycle.

  The second aspect of the second group of embodiments adds to the first aspect described above the monitoring of the performance of each ejection actuator or actuator group. This is done using the actual actuation signal, i.e. the signal that results in the release from the inhaler, and at least generally in the same way as the method discussed above with respect to the "test signal" of the first and first aspects. Is called. That is, the performance of each ejection actuator or actuator group in the second aspect is typically monitored / evaluated with respect to the operating performance of the actuator based on the actual signal transmitted to the actuator in the actual dosing action.

  There are various improvements in the above features relating to the second aspect of the second group of embodiments. Additional features may also be incorporated into the second aspect of the second group of embodiments. These refinements and additional features may exist individually or in any combination. Initially, as discussed above, the basic principles discussed with respect to the first aspect are equally applicable to the second aspect. However, there are many areas that admit specific discussions regarding the second aspect. Any ejection actuator or actuator group identified as disqualified with respect to the second aspect may be addressed in a number of ways. One way would be to retransmit each actuation signal that was initially sent to a “disqualified” jet actuator or actuator group to another jet actuator or actuator group that was not “disqualified” in accordance with the second aspect. . This may be difficult to perform on a “real-time” basis or during a given dosing action. A more possible practice is to provide the inhaler user some notification about the “disqualified” dosing action and improve disqualification for the next dosing action. This is done using any of the previously described methods (eg, using a pre-existing jet actuator or actuator group that “passed” evaluation, using a jet actuator or actuator that was “disqualified” in a previous dosing action. Receiving an additional number of actuation signals equal to the number of actuation signals sent to the group; to replace a disqualified ejection actuator or actuator group, a “surplus” ejection actuator or actuator group is given a given “administration”. By "adding" to an "active" jetting actuator or actuator group useful for the inhaler for "action").

  Another possibility for the above content is to inform the user that the “make-up” dosing action should be performed, and perhaps also inform the time when the dosing action should be performed. I will. This is possible based on a number of factors with the inhaler of the second aspect. Having independently actuable jetting actuators or groups of actuators allows for very precise control of the amount of substance released by the inhaler at a given dosing action. For precise control over the signal (also with respect to the number of signals applied), and also because a single actuator or group of actuators dispenses a certain amount in response to a certain signal. The amount of substance released by the inhaler of the second aspect in a given administration action can be accurately determined. The inhaler of the second aspect will have already determined the specific ejection actuator or actuator group that was disqualified for a given dosing action. Further, the inhaler of the second aspect may be configured to track how many actuation signals have been sent to these jetting actuators or actuator groups when the actuators are in a “disqualified” state. . Accordingly, the inhaler of the second aspect may be configured to define a “refill” administration action as follows. That is, a “replenishment” dosing action sends a new actuation signal to one or more other ejection actuators or actuator groups (eg, “surplus” actuators) that were operable or were operable in the immediately preceding dosing action. The number of these new actuation signals is equal to the number of actuation signals transmitted to the ejection actuator or actuator group “disqualified” in the previous dosing action according to the second aspect.

  The third group of embodiments of the present invention relates generally to inhalers that are used to cause a user to release a suitable substance. The first aspect of the third group of embodiments is embodied by an inhaler including a plurality of ejection actuators or actuator groups. Such multiple actuator groups all include at least one, typically multiple actuators, that are actuated simultaneously by a single common signal. Preferably, each ejection actuator or group of actuators is independently operable and processable by what can be viewed as inhaler control logic. That is, an actuation signal (or any signal for actuation, eg, a self-test signal) can be sent to any designated ejection actuator or actuator group. These ejection actuators or actuator groups may be attached to a common ejection head or the like, or may reside in these heads. Alternatively, the inhaler can include a number of independent ejection heads, each of which includes at least one, more typically a plurality of ejection actuators or actuator groups. In either case, the number of currently “active” ejection actuators is less than the total number of ejection actuators present for the inhaler. That is, the inhaler does not use all of the ejection actuators to achieve a given dosing action at any time. That is, at least some of the ejection actuators present for the inhaler are temporarily or permanently disabled so that no substance can be released from the inhaler at least at the present time.

  There are various improvements in the above features relating to the first aspect of the third group of embodiments. Additional features may also be incorporated into the first aspect of the third group of embodiments. These refinements and additional features may exist individually or in any combination. One method characterizing the first aspect is a method for manufacturing the inhaler as described above, wherein a greater number of ejection actuators than desired / necessary are installed for the inhaler. In this case, at least some, and more preferably all of the jetting actuators or actuator groups are installed before or after installing the actuator in the inhaler and before selling the inhaler for distribution to the user. A test can be performed. Assume that the inhaler is designed to have “x” operable jetting actuators or actuator groups. More than “x” jetting actuators or actuator groups are manufactured and installed in the inhaler. Testing the inhaler ejection actuator or actuator group may be terminated when it is determined that at least “x” ejection actuators or actuator groups are properly operable. However, preferably all jetting actuators or actuator groups are tested for operability. This may be done to determine or confirm whether there are any surplus operable jetting actuators or actuator groups, or for other purposes (eg, any of the jetting actuators or actuator groups that were initially operable If it fails later and is determined to be disqualified according to the self-test protocol described in the text, it is "to reactivate").

  Testing the various ejection actuators or actuator groups can be considered as determining the operability of the ejection actuators or actuator groups individually. Testing the operability of individual ejection actuators or actuator groups can be accomplished in any suitable manner for the first aspect of the third group of embodiments. For example, optical test techniques can be used to determine: That is, optical test techniques are used to determine whether a given ejection actuator or actuator group is providing proper ejection when a representative actuation signal is sent to a particular ejection actuator or actuator group. Obtain (e.g., optically inspect a nozzle through which material passes when a particular ejection actuator releases material from the inhaler, or a nozzle through which material passes when a particular ejection actuator group releases material from the inhaler By). Another method would be to evaluate the electrical performance of a particular ejection actuator or actuator group. Evaluation of electrical performance does not necessarily require the use of actual actuation signals or ejection signals, but instead may use test signals that are different from the actuation signals used by the inhaler for a given dosing action. For example, the test signal need not cause any discharge by a particular jetting actuator or actuator group that receives the test signal. Consider the case where each of the various ejection actuators is a resistor having a relatively constant resistance with respect to the ejection signal commonly used by the inhaler. This resistance can be calculated using the relationship R = V / I. In this equation, an electrical signal of known voltage (V) or current (I) can be sent to a particular ejection actuator and the other of voltage (V) or current (I) can be measured. Any change in the resistance (R) of the ejection actuator or actuator group, determined according to the test signal for this variant of the first aspect, may indicate some type of disqualification for a particular ejection actuator or actuator group. Other types of actuators, such as piezoelectric material based actuators, can also be evaluated by the electrical properties of the actuator.

  One method for carrying out the above variant of the first aspect is to provide a jet actuator or group of actuators “disqualified” for evaluation in response to the operational test, either permanently or temporarily with respect to the control logic of the inhaler. Would be to disable. This is especially true when each jetting actuator or actuator group is independently operable and a predetermined amount of material is released by each jetting actuator or actuator group in response to a predetermined actuation signal. If you are concerned. Disabling the function of the ejection actuator or actuator group means that all such actuators or groups of actuators will at least control the inhaler for use in subsequent delivery operations or “dosing actions” by the inhaler. Means not valid in the current state of the logic. An “administration action” may require sending the same actuation signal to a certain number of jetting actuators or groups of actuators multiple times over a period of time (eg, 8 pulses per 2 seconds), but one or more actuations Includes any predetermined protocol for delivering signals to one or more jetting actuators or actuator groups. In accordance with the first aspect, disabling all of the ejecting actuators or actuator groups due to at least some deficiencies in the operability of the actuators means that these ejecting actuators or actuator groups are in the control logic of the inhaler. It means not involved in all administration actions based on the current state.

  Disabling one or more ejection actuators or one or more actuator groups for a given inhaler can be done permanently or temporarily. All such disabling of the ejection actuators or actuator groups is also performed after it has been determined, according to the first aspect, that a predetermined number of ejection actuators or actuator groups are operable for the inhaler. . Permanently disabling one or more jetting actuators or actuator groups is probably by sending a constant signal to the desired jetting actuator or actuator group (eg, passing a high current through a resistance-based actuator). Can be achieved). This method of disabling any surplus ejection actuator or actuator group does not require inhaler control logic to “know” the invalid state of any of the ejection actuators or actuator groups. That is, even though the inhaler control logic still sends a signal to each of the ejection actuators or actuator groups installed for the inhaler, the deactivated ejection actuators or actuator groups are not It does not respond to any of the signals to produce an emission. Another way would be to “program” the control logic of the inhaler as follows: That is, for any dosing action, control logic is programmed to not send any actuation signal to the “disabled” ejection actuator or group of actuators. The advantage of the latter programming would be to save power for the inhaler, especially when the inhaler is configured for portable use and includes an “onboard” power supply.

  The fourth group of embodiments of the present invention generally relates to controlling the manner in which the inhaler performs the dosing action (the appropriate substance is ejected from the inhaler or otherwise dispensed). The first aspect of the fourth group of embodiments is generally that at least one, and more preferably, the operability of each of the inhaler's ejection actuators or actuator groups is at least (before, during, Or embodied in an inhaler determined after administration). An “actuator group” is a plurality of jetting actuators that are actuated simultaneously by a single common signal or in some other predetermined manner. The inhaler can include a plurality of these actuator groups, each of which is independently operable. One or more parameters that control the execution of a given dosing action for the inhaler (hereinafter “dosing action control logic” for the dosing action) are determined by the inhaler at least in some manner by the ejection actuator or actuator group. Based on this information regarding at least some operability, established or defined according to the principles of the first aspect.

  There are various improvements to the above features regarding the first aspect of the fourth group of embodiments. Additional features may also be incorporated into the first aspect of the fourth group of embodiments. These refinements and additional features may exist individually or in any combination. An “administration action” may require that the same actuation signal be transmitted multiple times over a period of time to one or more individual ejection actuators, to one or more actuator groups, or to some combination of actuators. Includes any predetermined protocol for delivering one or more actuation signals to one or more jetting actuators, to one or more actuator groups, or to some combination of actuators. Typically, the pattern of actuation signals is repeated multiple times, and each execution of the pattern can be considered as a dosing action cycle, a dosing action control logic cycle, a jetting actuator / actuator group injection cycle, and the like. In some cases, there is a delay between the time of the last activation signal in one cycle of a given administration action and the time of the first activation signal in the next-in-time cycle of the same administration action. This delay may be considered “dead time”. Dead time may not necessarily be present in every dosing action that can be performed by an inhaler according to the fourth group of embodiments.

  Each execution of the dosing action by the inhaler according to the fourth group of embodiments will cause a relatively constant amount of a given substance to be ejected or released (eg, a change in dose may occur at each execution of the same dosing action). And within an acceptable relatively small range so that there is little or no change in the total dose delivered). The basic premise of dose delivery control that can be incorporated into an inhaler according to the fourth group of embodiments is that a determinable and fixed amount of a given substance is a given jet actuator or actuator group of the inhaler. To be ejected for a given actuation signal. This is of course premised on that each of the ejection actuators or actuator groups used for a given administration action is operable. By determining the operability of the ejection actuator, the actuator group, or both the ejection actuator and the actuator group according to the fourth group of embodiments, the inhaler according to this fourth group of embodiments allows a given dosing action Control, and this control is done to at least improve the consistency of the total amount of substance dispensed by the inhaler at each execution of a given dosing action control logic. That is, the inhalers of the fourth group of embodiments can change a given dosing action control logic over time and change the total dose delivered by the inhaler with each execution of the dosing action control logic. May be at least reduced.

  In the following, a fourth group of embodiments will be discussed with regard to dosing action control logic using only individual ejection actuators. However, the following discussion is equally applicable to any dosing action control logic using only actuator groups or any combination of individual ejection actuators and actuator groups.

  A fourth group of embodiments may be used to change the dosing action control logic based on this dosing action control logic for subsequent execution of the dosing action. Consider the case where the dosing action control logic having the first configuration in question uses a certain number of jetting actuators and if a determination is made that one or more of these jetting actuators are not operational. The inhalers of the fourth group of embodiments may initially determine the number of actuation signals that all inoperable ejection actuators are scheduled to receive in the first configuration dosing action control logic. Subsequently, the dosing action control logic could be changed from the first configuration to the second configuration, which specified that these actuation signals be used by the dosing action control logic of the first configuration. Send to one or more operable jetting actuators. Another method simply identifies a non-operational ejection actuator designated to be used by the first configuration of the dosing action control logic, and the dosing action control logic from the first configuration to the second configuration. Which replaces each of these jetting actuators with a jetting actuator that has been determined to be operational and that has not been designated for use by the dosing action control logic of the first configuration. That is.

  Based on the above, the inhaler for the fourth group of embodiments may actually include a greater number of ejection actuators than the number of ejection actuators used by a given dosing action control logic useful for the inhaler. . Thereby, the administration action control logic of the inhaler according to the fourth group of embodiments can be “configured” to use only some of the ejection actuators, and depending on the current form of administration action control logic Blowing actuators that are not currently used may be temporarily disabled (e.g., dosing action control logic is configured not to send an actuation signal to the jetting actuator during execution of a dosing action based on this dosing action control logic) By doing). The ejection actuators determined to be inoperable according to the fourth group of embodiments and so confirmed can be replaced in a one-to-one relationship by corresponding “surplus” ejection actuators of the inhaler. That is, the dosing action control logic of the inhaler according to the fourth group embodiment gives priority to the “surplus” ejection actuator without using one ejection actuator that has been determined to be inoperable, and the fourth group implementation. It can be reconfigured according to the form. Any such "extra" jetting actuators are preferably first tested for actuator operability before being incorporated into the subject's dosing action control logic.

  Another method for changing the dosing action control logic and later performing any dosing action according to the dosing action control logic is to read the dosing action control logic in its current form or first configuration and then operate Determining whether there is a jetting actuator that is possible and not currently used by this first configuration of the dosing action control logic. These steps can be performed in any order. There are many ways to change the dosing action control logic to the second configuration when there are one or more operable jetting actuators that are not currently used by the dosing action control logic of the first configuration. One method for changing the dosing action control logic according to the fourth group of embodiments from the first configuration to the second configuration when there is a surplus ejection actuator is to One configuration of dosing action control logic would incorporate any dead time between adjacent cycles. This will keep the injection frequency per actuator the same for the dosing action performed according to the second configuration of dosing action control logic, but is necessary to fully perform such dosing action. The total time spent will be reduced. This is because there will be more squirt signals, so that more material will be delivered in each cycle of dosing. That is, in the above case, additional jetting actuators can be incorporated into each cycle of the dosing action by changing the associated dosing action control logic, which is required for execution of each cycle of the dosing action. It does not extend the entire time. Less cycles may be required to complete the execution of the dosing action according to this second configuration of dosing action control logic and to provide the desired total dose for the related dosing action It will be understood that it includes only the execution part of the cycle.

  By changing the dosing action control logic from the first configuration to the second configuration, all of the operable surplus ejection actuators can be administered without extending the total time required to execute each cycle of the dosing action. May not be possible to incorporate into each cycle (ie, the injection frequency per jet actuator or actuator group may actually be reduced when changing the dosing action control logic from the first configuration to the second configuration). ). However, the fourth group of embodiments includes changing the dosing action control logic from the first configuration to the second configuration to extend each cycle of the dosing action, which is at least one additional operable. This is done by using a simple ejection actuator for each cycle. As previously mentioned, fewer cycles may be required to complete the execution of the dosing action according to the second configuration of dosing action control logic.

  The fourth group of embodiments may also be viewed as establishing or defining dosing action control logic based on identifying operable ejection actuators. In this case, the information required to define the dosing action control logic according to the fourth group of embodiments is required to be delivered with the dosing action performed according to the currently prescribed dosing action control logic. And a dose that is at least considered to be delivered per actuation signal by each operable jetting actuator. For example, a representative number of jetting actuators can be evaluated to determine the amount of material released from the actuator based on some predetermined actuation signal. The average discharge from each such actuator can be used by the fourth group of embodiments. In any case, to be used by the corresponding dosing action control logic by dividing the desired total dose for the intended dosing action by the dose delivered by one ejection actuator per actuation signal. Resulting in the total number of actuation signals required. Then, dividing the total number of actuation signals by the total number of operable ejection actuators determines the number of cycles to be used by the dosing action control logic. The injection pattern within each cycle can then be established by any suitable method.

  Embodiments of the fourth group include that one or more of the ejection actuators designated to be used for a given dosing action by the control logic of that dosing action is actually subject to the subject dosing action. May determine that it was not involved to the extent required by the control logic (e.g., the specific ejector actuator operability specified to be used for a given dosing action is evaluated during the execution of the dosing action Can be). There are a number of ways to deal with this situation. One method is to actually determine the total number of actuation signals transmitted to the inoperable ejection actuator while performing the subject's dosing action according to its dosing action control logic, and then this same number. Will be sent to one or more operable jetting actuators. This is included in the fourth group of embodiments, but may be difficult to perform on a “real-time” basis, ie while the subject's dosing action is being performed according to its dosing action control logic. . A more possible practice is to give the inhaler user some notification about the “disqualified” dosing action and to improve this disqualification for the next dosing action. This is done using any of the previously described methods (e.g., using an existing jetting actuator that has been determined to be operable, and a jetting actuator that is inoperable upon prior execution of the subject's dosing action) Or receiving an additional number of actuation signals equal to the number of actuation signals transmitted to the actuator group; in order to replace a disqualified ejection actuator or actuator group, a “surplus” ejection actuator may be "By" adding "to the" active "ejection actuator useful for the inhaler).

  Another possibility for the above content is that the user is informed that a “make-up” dosing action should be performed, and the time at which the “make-up” dosing action should be performed. Probably to inform. This is possible based on a number of factors by the inhalers of the fourth group of embodiments. Having independently actuable jetting actuators or groups of actuators allows for very precise control of the amount of substance released by the inhaler at a given dosing action. Because of the precise control over the signal (and also with respect to the number of signals applied), and because the single ejection actuator dispenses a certain amount in response to a certain actuation signal, the fourth The amount of substance released in a given administration action by the group of inhalers can be determined relatively accurately. The inhalers of the fourth group of embodiments will have already determined the specific ejection actuator that was disqualified for the performance of a given dosing action. In addition, the inhalers of the fourth group of embodiments track how many actuation signals are sent to these jetting actuators when the actuators are “disqualified” or inoperable. Can be configured. Accordingly, the inhalers of the fourth group of embodiments can be configured to define a “refill” administration action as follows. That is, a “replenishment” dosing action may cause a new actuation signal to be activated in the execution of the immediately preceding subject dosing action or to other operable (eg, “surplus” actuators) one or more ejection actuators. The number of these new actuation signals is defined as transmitting, and according to the fourth group of embodiments, the actuation transmitted to the ejection actuator or actuator group that was “disqualified” or disabled in the last dosing action. Equal to the number of signals.

(Description of Embodiment)
The present invention will now be described with reference to the accompanying drawings, which at least assist in showing various features related to the invention. A system 10 that is one embodiment of a respiratory delivery system is shown in FIGS. 1-3C. The delivery system 10 is in the form of a portable inhaler 14 in the illustrated embodiment. The inhaler 14 is portable and delivers orally any type of flowable substance to an individual. Most commonly, this material will be a type of drug that is stored in the inhaler 14 in liquid form. Hereinafter, the respiratory delivery system 10 will be described with respect to the application of such agents. However, gaseous substances can also be delivered using the inhaler 14, and non-drug substances can also be delivered in both liquid or gaseous form and in the form of powder in suspension. Is possible. Furthermore, the inhaler 14 can also be used for local or nasal delivery of these types of substances.

  Two basic assemblies define the inhaler 14. One is the handpiece 16 and the other is the cartridge assembly 28. In general, handpiece 16 includes a number of electronic elements for controlling the operation of inhaler 14 and for recording information regarding the use of inhaler 14. On the other hand, the cartridge assembly 28 includes a medication supply and a type of “head” that is threaded when the medication is ejected from the inhaler 14 in the form of droplets.

  One part of the handpiece 16 of the inhaler 14 is a housing 18 that is at least approximately cylindrical. The illustrated embodiment is cylindrical throughout the inhaler housing 18, but different shapes are also contemplated. Release from the inhaler 14 occurs through an end 22 of the housing 18 that defines a discharge outlet. In general, the discharge end 22 of the housing 18 is inserted into the mouth of an individual using the inhaler 14. If necessary, a mouthpiece or the like may be formed at the discharge end 22 of the inhaler 14 (not shown). The opposite end of the inhaler housing 18 is indicated with a reference numeral 26.

  Preferably, several electrical components are used for the inhaler 14. Airflow through these electrical components can have a detrimental effect on the operation of the electrical components. Thus, in one embodiment, the end 26 of the inhaler housing 18 is closed. Rather, air is drawn into the housing 18 to introduce a plurality of droplets into the housing 18 for inhalation by an individual using the inhaler 14. This method is described in more detail below. Air is drawn through a plurality of air intake (intake) slots 82. The intake slots 82 extend into the inhaler housing 18 as shown in FIG. 2, and each define an inhaler inlet. Generally, the electrical components described above are located at a location within the inhaler housing 18 between the inhalation slot 82 and the closed end 26 of the inhaler housing 18, and thus using the inhaler 14. During inhalation of an individual, the inhaled air flow is not directed at the electrical components. Regardless of which slot 82 would have such advantages, one or more air intake orifices are located at the end 26 of the inhaler housing 18 or at other suitable locations in the inhaler housing 18. It is also possible. Further, although the shape of these slots 82 is shown to be rectangular, the shape of the slots 82 can be any shape that allows air to flow into the inhaler housing 18.

  The cartridge assembly 28 is detachably interconnected to the inhaler housing 18 of the handpiece 16 so that one cartridge assembly 28 is removed by the individual from the inhaler housing 18 to a structurally similar cartridge assembly 29. Can be replaced. Interconnection by a “snap fit” between the cartridge assembly 28 and the inhaler housing 18 may be used (not shown). Appropriate buttons or other mechanisms may be used to remove the cartridge assembly 28 from within the inhaler housing 18 or to disconnect the "snap fit". Insertion and removal of the cartridge assembly 28 can both be done through the discharge end 22 of the inhaler housing 18, but the inhaler housing 18 can be inserted and removed to provide insertion and removal (not shown) of the cartridge assembly 28. It can also be formed from possible interconnected (eg, threaded interconnect) parts. In either case, the reason for providing an easily removable cartridge assembly 28 is to allow an individual to release multiple medications using the same inhaler 14. Two or more individuals can use the same inhaler 14 to release one or more medications contained in one or more cartridge assemblies 28 owned by an individual.

  The cartridge assembly 28 includes a drug container 46 that houses a supply of drug. Multiple drug containers 46 may be used in the cartridge assembly 28 to release multiple drugs simultaneously as needed, or to release any one drug (not shown). Various types of information regarding this medication and / or container 46 for this particular medication are stored electronically on chip 48. The chip 48 is attached to the drug container 46 or formed integrally with the drug container 46. Information that may be included in the chip 48 is as follows. That is, 1) the identity of a specific drug in the drug container 46; 2) the type of this specific drug; 3) the concentration of this specific drug; 4) the specific drug is still not released to the individual at all. The total volume initially contained in the drug container 46 in an undisclosed state; 5) the identity of the individual designated to use the drug stored in the drug container 46; 6) in the drug container 46 Restrictions on the use of drugs stored in (for example, should not be used to administer different drugs that may be contained in separate cartridge assemblies 28 and released from the same inhaler 14 within a certain period of time): 7 ) Protocol for controlling the release of the drug from the drug container 46 (eg activation signal, the required time interval between each “dosing action” being a single or predetermined number of releases from the inhaler 14); 8) Inhaler 14 is special An access code that must be entered to be operable using the cartridge assembly 28; and 9) how the drug dispensing and / or drug dispensing amount is changed A “protocol” regarding what to do (based on patient requirements or otherwise). Data regarding the use of the cartridge assembly 28 may also be stored in the chip 48, such as in a suitable database structure (eg, the chip 48 may also include one or more electronic memories). For example, the time and date of each “dosing action” or each single release from the inhaler 14 may be recorded on the chip 48 for future use / evaluation. Furthermore, information regarding the operability of any actuator 42 of the droplet ejection device 30 used by the inhaler 14 can also be stored on the chip 48. Information on the number and arrangement of all actuators of the droplet ejection device 30 used by the inhaler 14 determined to be “not operated” according to any of the protocols discussed below with respect to FIGS. Can be stored.

  The drug exiting the drug container 46 is discharged from the portable inhaler 14, preferably in the form of a plurality of droplets, which are inhaled by the inhaler flow / while the inhalation flow is flowing. 18 through the discharge end 22. In this regard, each of the cartridge assemblies 28 for the inhaler 14 also includes a droplet ejection device 30 that is fluidly connected to each other by a corresponding container 46 and a suitable fluid interconnect 54. Has been. Any method of fluidly connecting the droplet ejection device 30 and the drug container 46 to each other can be used. The droplet ejection device 30 protrudes at least substantially toward the discharge end 22 of the inhaler housing 18 when loaded into the inhaler 14.

  Various types of delivery or ejection techniques / components may be used with the inhaler 14 and these techniques / parts are disclosed in U.S. Pat. No. issued to Voges, issued Apr. 20, 1999. No. 5,894,841 is incorporated, and this patent is incorporated herein by reference. Details of one embodiment of the droplet ejection device 30 are shown in FIGS. 3A-3C. The droplet ejection device 30 includes a plurality of droplet ejection assemblies 32. The droplet ejection assemblies 32 each include an actuator 42 that is aligned with a corresponding discharge orifice 34 and separated from these orifices 34 by a space 38. The drug exiting the drug container 46 is placed in this space 38 at least just prior to release (eg, drug may be continuously present in the space 38; in the space 38 associated with a particular droplet ejection assembly 32) All or substantially all of the drug can be released upon actuation of the droplet ejection assembly 32, and thereafter the droplet can be refilled again after such actuation). Actuation of the portable inhaler 14 causes each actuator 42 that receives the actuation signal to release the drug through the corresponding discharge orifice 34 in the form of a single drop and typically multiple drops. All of the actuators 42 can be actuated simultaneously, or multiple actuators 42 can be actuated in some type of sequence or spray pattern. Preferably, each actuator 42 is operable independently. The illustrated embodiment shows a one-to-one relationship between the actuator 42 and the discharge orifice 34, but there may be multiple actuators 42 discharging from a common discharge orifice 34, or a given actuator 42 Can be discharged from a plurality of discharge orifices 34 (not shown).

  In one embodiment, the actuator 42 is a resistor, and an actuation signal provided to the resistor acts to rapidly increase the temperature of the actuator 42 that receives such a signal. This rapid temperature rise of each “activated” actuator 42 forms / generates a bubble in direct contact with the actuator 42. The expansion of the bubbles by a rapid temperature rise in the direction of the corresponding discharge orifice 34 facilitates the movement of the drug disposed between the bubble and the corresponding discharge orifice 34, and the drug is discharged from the discharge orifice 34. 34 through.

  Operation of the droplet ejection assembly 32 of the droplet ejection device 30 may be accomplished by a controller assembly 62 that is part of the handpiece 16 of the inhaler 14. In this regard, a suitable operational interconnect 70 extends between the droplet ejection device 30 and the controller assembly 62 and interconnects the droplet ejection device 30 and the controller assembly 62. Another operational interconnect 72 extends between the tip 48 of the drug container 46 and the controller assembly 62 to interconnect the tip 48 and the controller assembly 62. Any method of properly interconnecting the operation of the controller assembly 62 and the cartridge assembly 28 of the handpiece 16 may be used. Indeed, one or more aspects of the “electronic element” or controller assembly 62 can actually be incorporated into the structure of the droplet ejection device 30. In any case, controller assembly 62 may include one or more microprocessors, programmable logic controls, electronic memory, and one or more clocks. In general, the controller assembly 62 reads the operating protocol stored on the chip 48 of the cartridge assembly 28 and causes the droplet ejection device 30 of the cartridge assembly 28 to operate on this protocol (e.g. According to the elapsed time required during the administration period, the elapsed time required between the administration actions). Various types of data may also preferably be stored in / via controller assembly 62. For example, the time and date of each operation of the inhaler 14 may be recorded / retained for future use / evaluation. In addition, information for controlling access (eg, security) to the portable inhaler 14 or information regarding the inhaler 14 is communicated to / via the controller assembly 62 as well as information regarding operation control of the inhaler 14. Can be remembered.

  The components of the controller assembly 62 are powered by an on-board power supply 74 (eg, a rechargeable battery) that is operatively / electrically interconnected with these components, which is also part of the handpiece 16. . Other components of the inhaler 14 can also be electrically interconnected with the power source 74. The operation of the inhaler 14 can be automated via suitable sensors 58 (eg, airflow, pressure). The sensor 58 is operatively interconnected with the controller assembly 62 and thereby connected to the power source 74 via the controller assembly 62. Sensor 58 is also part of handpiece 16. The sensing of a constant air flow in the inhaler housing 18 can cause the sensor 58 to send a signal to the controller assembly 62, which then sends an actuation signal (eg, a single pulse or a series of Can be transmitted to the droplet ejection device 30 via the operational interconnect 70. The drug droplets can then be ejected from the droplet ejection device 30 in the manner previously described. Inclusion of the activation switch 86 of the handpiece 16 in the outer portion of the inhaler housing 18 allows manual operation of the inhaler 14. The activation switch 86 is operably interconnected with the controller assembly 62 and thereby interconnected with the power source 74. Actuating the switch 86 sends a signal to the controller assembly 62 that sends an actuation signal (eg, a single pulse or a series of predetermined pulses) via the operational interconnect 70 to eject droplets. To device 30. Flowable material droplets can then be ejected from the droplet ejection device 30 in the manner previously described. One or both of sensor 58 and actuation switch 86 may be used in the design of inhaler 14.

  Another embodiment is shown in the form of an inhaler 100 in FIG. The inhaler 100 generally includes a cartridge / mouthpiece subassembly 102 that is preferably removably interconnected to the handpiece 132. A suitable interconnect 124 operatively interconnects the cartridge / mouthpiece subassembly 102 and the handpiece 132 so that one or more signals (eg, electrical signals) can be transmitted between the subassembly 102 and the handpiece 132. Allows to be exchanged between. The cartridge / mouthpiece subassembly 102 generally includes any suitable shaped housing 106 that defines at least one air flow path 130 therein. Air is drawn into the air flow path 130 through an intake assembly 104 (eg, one or more inlets) located at appropriate locations on the housing 106. In the illustrated embodiment, the air intake assembly 104 is disposed at one end of the cartridge / mouthpiece subassembly 102. An air flow path 130 directs airflow to the discharge assembly 128 (eg, mouthpiece). The discharge assembly 128 is also located at a suitable location on the housing 106. In the illustrated embodiment, the discharge assembly 128 is disposed at the opposite end of the cartridge / mouthpiece subassembly 102 relative to the intake assembly 104.

  Within the cartridge / mouthpiece subassembly 102 is an ejection assembly 112. The components of the ejection assembly 112 include a head 116 having one or more ejection actuators that deliver a suitable material for inhalation to the air stream (at least generally through the air flow path 130 to the discharge assembly 128. (In the direction of heading)). There can be a one-to-one relationship between the ejection actuators and their corresponding discharge orifices. Alternatively, multiple actuators can discharge from a common discharge orifice. Alternatively, a given ejection actuator can be ejected from multiple ejection orifices. Any direction of discharge from the ejection head 116 can be used for the air flow through the air flow path 130 (eg, the material can be directed parallel to the air flow by the head 116; or Can be oriented perpendicular to the air flow by the head 116). The above supply of material is stored in the tank 120 of the ejection assembly 112. Accordingly, there is a suitable fluid interconnection between the tank 120 and the ejection head 116. A certain amount of material being ejected can be stored in the ejection head 116 and can be replenished via the tank 120. The head 116 can also be configured to eject material directly from the tank 120.

  The handpiece 132 generally includes an electronic element or controller assembly 136 for controlling the operation of the inhaler 100 and also includes an ejection assembly 112. In one embodiment, the controller assembly 136 is programmable with respect to at least one item. Other components of handpiece 132 include a suitable display 140, a power supply 144 (eg, a rechargeable battery), and one or more switches 148. The switch 148 may allow manual actuation of the ejection assembly 112, allow at least some types of data entry, and / or allow entry by other users. The start of the dosing action by the inhaler 100 has reached a specific flow rate automatically (eg, a specific flow rate) via information received from one or more sensors 108 (eg, pressure transducers) that monitor the flow rate through the air flow path 130. When) can also be achieved. These sensors 108 are preferably attached to the handpiece 132, in contact with at least a portion of the air flow through the air flow path 130, and operatively interconnected with the controller assembly 136.

  Between the flow rate of the air stream flowing through the inhaler and the rate at which the inhaled substance is released into this air stream, to increase the efficiency of a given administration action (e.g. There may be some relationship between the locations (for more efficient delivery). The air flow through the inhaler is controlled in a purely mechanical manner (ie, no electronics are required to control / regulate the air flow and any type of controller assembly is operatively interconnected. One embodiment is shown in FIG. 5 in the form of an airflow adjustment assembly 228. The air flow adjustment assembly 228 may be used in any inhaler design including the inhaler 14 of FIGS. 1-3B and the inhaler 100 of FIG.

  The inhaler includes an air flow conduit 204. Within this air flow conduit 204 is disposed a flow adjustment port or throat 208 of an air flow adjustment assembly 228 through which substantially all air flow for the inhaler is directed. While it may be desirable to place this flow control port 208 at least substantially at the inlet of the inhaler, it may be possible to place it near the middle of the inhaler. In either case, the flow regulation port 208 is defined by a side wall 212 that converges at least approximately in the direction of air flow (indicated by arrow “A”) flowing through the air flow conduit 204. That is, the first end 216 of the air intake port 208 has a larger inner diameter than the second end 220 of the air intake port 208 that is spaced apart in the longitudinal direction. In the illustrated embodiment, the convergence is linear.

  The air flow adjustment assembly 228 further includes a baffle 232 that is movably disposed within the flow adjustment port 208. The baffle 232 generally includes a head 236 and a shaft 240. The baffle 232 is biased by an appropriate biasing member 244, for example, a coil spring, in the upstream direction (the direction opposite to the direction indicated by the arrow “A”). Coil spring 244 acts on the side of head 236 of baffle 232 opposite to the side in contact with the air drawn into air flow conduit 204 during inhalation by the user of the inhaler. The opposite end of the spring 244 is located in a suitable abutment 224 that is suitably secured to the airflow conduit 204. The abutment 224 is configured to allow airflow to pass through the abutment 224 in the direction of arrow “A” and further includes a guide for movably receiving the shaft 240 of the baffle 232. obtain. The guide further supports the baffle 232 in the flow adjustment port 208. Any method that supports the baffle 232 to move relative to the flow control port 208 may be used.

  When inhalation is performed by a user of an inhaler in which an airflow adjustment assembly 228 is used, an airflow generally in the direction of arrow “A” flowing through the flow adjustment port 208 and the airflow conduit 204 is formed. By this inhalation, a force in the direction of arrow “A” is also applied to the head 236 of the baffle 232. However, the spring 244 resists these forces. Basically, the size of the head 236 of the baffle 232, the size / contour of the flow adjustment port 208, and the biasing force provided by the spring 244 automatically adjusts the desired flow rate through the inhaler airflow conduit 204. This is independent of the degree of inhalation generated by the user (even if a predetermined threshold is exceeded). At least a certain amount of suction force will cause the spring 244 to compress at least somewhat. Movement of the baffle 232 causes the spring 244 to compress in the direction of arrow “A”, thereby reducing the distance between the head 236 of the baffle 232 and the inner wall of the flow control port 208. The reduction in the distance between the head 236 of the baffle 232 and the inner wall of the flow control port 208 ultimately reduces the flow rate of the air flow through the air flow conduit 204. Thus, there is some relationship between the amount of suction input being generated by the user of the inhaler that includes the air flow adjustment assembly 228 and the position of the baffle 232 relative to the flow adjustment port 208, which position is the inhaler. Control the flow rate of the air flow through. In general, as the suction input increases and exceeds a certain threshold of suction input, the spacing between the head 236 of the baffle 232 and the inner wall of the flow control port 208 decreases.

  Considering the operation of the intake air flow adjustment assembly 228 with respect to three different users, the operating principle of the air flow adjustment assembly 228 is further illustrated. Assume that the force that the air flow that user A can apply to the head 236 of the baffle 232 is equal to the biasing force applied to the head 236 by the spring 244. Thereby, the baffle 232 maintains the “rest” position of the baffle 232 in the maximum state in which the distance between the head 236 of the baffle 232 and the inner wall of the flow control port 208 is possible. Let F1 be the flow rate of the air flow through the air flow conduit 204.

  Here, it is assumed that the user B can generate a larger suction input than the user A. As a result, the baffle 232 moves against the biasing force applied by the spring 244, thereby reducing the distance between the head 236 of the baffle 232 and the inner wall of the flow control port 208. More particularly, the baffle 232 moves relative to the flow control port 204, where the distance between the head 236 of the baffle 232 and the inner wall of the flow control port 208 is within the air flow conduit 204. A flow rate at least substantially equal to F1 flowing through the airflow conduit 204 (realized by user A, which is the same as the flow rate in this example, but the suction capacity is user B Lower than).

  Finally, suppose that user C can generate a larger suction input than user B. As a result, the baffle 232 moves against the biasing force applied by the spring 244, thereby further reducing the distance between the head 236 of the baffle 232 and the inner wall of the flow control port 208. More specifically, for user C, baffle 232 moves to a position relative to air intake port 204, where the distance between head 236 of baffle 232 and the inner wall of flow control port 208 is A flow rate at least substantially equal to F1 flowing in the air flow conduit 204 is generated at least substantially (the flow rate flowing through the air flow conduit 204, realized by both user A and user B, is Same, but inhalation capability is lower than user C).

  The airflow adjustment assembly 228 of FIG. 5 is automatically “activated” and “driven” only by a suction input generated by the user. That is, the air flow regulation assembly 228 of FIG. 5 is a purely mechanical system. The principle of the air flow regulation assembly 228 can be implemented in a more sophisticated (eg, electronic or electromechanical) system, which will be described below with respect to the inhaler 160 schematically illustrated in FIG. explain. The inhaler 160 generally includes an airflow assembly 164 that includes an air intake assembly 168 (eg, one or more air intakes), a discharge assembly 172 (eg, a mouthpiece, one that covers the nose, ie, Mask) and at least one airflow conduit 170 extending between the air intake assembly and the discharge assembly. Any suitable substance (eg, drug) may be introduced by the ejection actuator assembly 180 into the air flow being drawn into the air flow assembly 164. Any type of ejection actuator design (including designs with only a single ejection actuator and designs with multiple ejection actuators) may be used by the ejection actuator assembly 180. Typically, the ejection actuator assembly 180 introduces the desired material into the air stream at any location upstream from the discharge assembly 172. The ejection actuator assembly 180 may actually be disposed in the air flow conduit 170, but the ejection actuator assembly 180 may be disposed outside the air flow conduit 170. In this case, however, the ejection actuator assembly 180 is fluidly interconnected or at least fluidly interconnectable with the airflow conduit 170 to introduce the desired material into the airflow.

  The inhaler 160 also includes a controller assembly 176 for controlling the operation of the inhaler 160 with respect to at least one item. For example, the controller assembly 176 can be operatively interconnected with the ejection actuator assembly 180 (eg, to control the ejection sequence of each ejection actuator of the ejection actuator assembly 180 at a given dispensing action). However, this is not required for adjustment of the air flow through the inhaler 160. In this regard, the controller assembly 176 of the inhaler 160 is also operatively interconnected with the air flow monitoring assembly 184 and the air flow regulation assembly 188. In general, the air flow monitoring assembly 184 monitors the air flow flowing through at least a portion of the air flow conduit 204 to allow determination of a corresponding flow rate. Any suitable sensor (eg, pressure transducer) may be used by the air flow monitoring assembly 184 for this purpose. The actual flow rate determination can be accomplished in any manner, including by the controller assembly 176 (eg, via a microprocessor) based on the input provided by the air flow monitoring assembly 184.

  Also in this inhaler, to increase the efficiency of a given dosing action between the flow rate of air flow drawn into the air flow assembly 164 and the rate at which the desired substance is released from the ejection actuator assembly 180. It is thought that there is some kind of relationship. Accordingly, it may be desirable to provide a predetermined flow rate that flows through the inhaler 160 as described above, which directs all of the air flow (typically at or near the inlet). This can be realized by adjusting the size of the adjustment port. In the case of the inhaler 160, this adjustment is provided by an operative interconnection of the controller assembly 176 and the airflow adjustment assembly 188. In general, the controller assembly 176 sends a signal or set of signals to the airflow adjustment assembly 188. This signal moves the flow adjuster of the air flow adjustment assembly 188 to a fixed position to adjust the size of the flow control port that directs all of the air flow. This adjustment of the size of the flow adjustment port provides a certain desired flow rate of the air flow flowing through the air flow assembly 164 in generally the same manner as discussed above with respect to the intake air flow adjustment assembly 228.

  Any structure may be used for the flow adjustment portion of the air flow adjustment assembly 188. For example, the airflow adjustment assembly 188 can use the baffle 232 and air intake port 208 used by the airflow adjustment assembly 228 of FIG. Instead of using a suction input to move the baffle 232, the airflow adjustment assembly 188 can determine several types of devices for moving the baffle 232 in response to signals from the controller assembly 176. Method / amount used. Also, any type of device suitable for moving the flow adjustment portion of the air flow adjustment assembly 188 in the inhaler 160 could be used. Finally, any type of flow regulation port could be used for the air flow regulation assembly 188. What is important with respect to the air flow adjustment assembly 188 is that the user adjusts the size of the air flow path through which all the air flow passes, thereby generating a flow rate of the air flow drawn into the inhaler 160 by the user. Regardless of the suction input (again, assuming that these suction inputs are above a certain threshold), at least substantially maintain a constant level.

  FIG. 7 shows a schematic of an inhaler 320, another embodiment of a “computer controlled” inhaler. Inhaler 320 includes an inhaler controller assembly 310 that controls the operation of inhaler 320. One component of the inhaler controller assembly 310 is an operational test module 312. Another component of the inhaler controller assembly 310 is a dosing action execution module 314. Both the action test module 312 and the dosing action execution module 314 send signals to one or more of the ejection actuators 316 or one or more actuator groups used by the inhaler 320, so that these actuators Are released through an inhaler release assembly 318 (eg, mouthpiece for oral delivery, mask for nasal delivery). There may be a one-to-one relationship between the ejection actuators 316 and their corresponding discharge orifices, or there may be multiple actuators 316 discharging from a common discharge orifice, or multiple given actuators 316 Can be discharged from the discharge orifice. The inhaler 320 shows that four ejection actuators 316a-d are used, but any number of ejection actuators 316, including multiple groups of ejection actuators 316, can be used, each of these groups independently Operable and each of the ejection actuators 316 in a given group can be activated simultaneously by a single common signal. What is important about the inhaler 320 is that each of the ejection actuators 316 or actuator groups can be independently operable by both the operational test module 312 of the inhaler controller assembly 310 and the dosing action execution module 314 ( For example, a plurality of ejection actuators 316 can be separated into a plurality of groups, each group having a plurality of ejection actuators 316, each of the groups of ejection actuators 316 being an operational test of the inhaler controller assembly 310. Both the module 312 and the dosing action execution module 314 are independently operable, and each ejection actuator 316 of a given group is activated by a single common signal). After referring to the following, the operational test module 312, the dosing action execution module 314, or both of these modules can be integrated with the inhaler controller assembly 310 in any number of ways, and inhalation It should be understood that this need not necessarily be considered as part of the instrument controller assembly 310.

  In general, the operational test module 312 of the inhaler 320 of FIG. 7 provides a signal or series of signals, preferably to each of the ejection actuators 316, or to each actuator group, thereby evaluating the performance of the actuator in some way. To do. In one embodiment, this signal does not release any substance through the inhaler discharge assembly 318, in which case the signal can be considered a test signal. However, a signal that releases a substance can also be used by the operational test module 312. In this case, the signal can be characterized as an actuation signal suitable for the dosing action. On the other hand, the dosing action execution module 314 sends an actuation signal or series of actuation signals to one or more of the ejection actuators 316 or to one or more actuator groups in a predetermined manner, thereby preferably A predetermined amount of the desired substance is provided through the inhaler discharge assembly 318 ("dosing event"). It should be understood that any type of actuator that can be actuated independently (eg, resistor-based, piezoelectric material-based) can be used as the ejection actuator 316. Furthermore, any method that incorporates the functionality of the operational test module 312 and the dosing action execution module 314 may be used by the inhaler controller assembly 310.

  Typically, the inhaler 320 will include a significant number of ejection actuators 316. In one embodiment, the inhaler 320 includes at least 10 ejection actuators 316 or actuator groups that are independently operable. Not all of the ejection actuators 316 or actuator groups need be available by the inhaler 320 for a given dosing action. One of the reasons that the inhaler 320 has an extra jet actuator 316 or actuator group is to increase the revenue associated with the production of the jet actuator 316 for the inhaler 320. Typically, a plurality of jetting actuators 316 or actuator groups are mounted on a common structure to define a jetting head 330 as shown in FIG. For the inhaler 320 shown in FIG. 7, only one ejection head 330 is identified. With respect to the inhaler 320, it may also be performed to attach a plurality of ejection heads 330 to a common structure. In any case, incorporating more jetting actuators 316 into the design of the inhaler 320 than necessary requires that all of the jetting actuators 316 (or actuator groups) on a given jetting head 330 be ejected by the jetting head 330. It means that it need not be operable to be useful for use of the inhaler 320.

  One embodiment of a method for manufacturing an inhaler 320 having surplus ejection actuators 316 or actuator groups is shown in FIG. 8 in the form of an inhaler manufacturing protocol 430. The protocol 430 begins at step 422, where a desired number of operable ejection actuators 316 or actuator groups for the inhaler 320, or at least a minimum number of operable ejection actuators 316 or actuator groups. Is specified. Step 424 of protocol 430 indicates that more than the desired number / minimum number of operable ejection actuators 316 or actuator groups are actually manufactured to be included in inhaler 320. This typically includes the ejection head 330 for the inhaler 320 and the desired / required amount that the total number of ejection actuators 316 or actuator groups included in the inhaler 320 is shown in step 422 of the protocol 430. (The number of ejection heads 330 is one or two or more). Assume that the desired number of operable ejection actuators 316 is 90 and one ejection head 330 can be manufactured to include 100 of these ejection actuators 316. Only 90 jetting actuators 316 are desirable / necessary for use with the inhaler 320, but a jet head 330 having 100 jetting actuators 316 is nevertheless installed within the inhaler 320.

  Before or after a given ejection head 330 is physically installed in the inhaler 320, at least some (more preferably all) ejection actuators 316 or actuator groups of the ejection head 330 may be Tested as shown at 426. Any suitable method for testing the operational capabilities of various jetting actuators 316 or actuator groups may be used. One method for evaluating the operational capability of a given jetting actuator 316 or actuator group is by evaluating the electrical performance of the actuator. Assume that the ejection actuator 316 is a resistor of the type discussed above with respect to the inhaler 14 of FIGS. 1-3C. Any signal that evaluates the electrical performance of the ejection actuator 316 or actuator group in this case in any way can be used by step 426 of protocol 430. Another method sends an electrical signal to each of the resistor-based ejection actuators 316 or actuator groups so that the resistance of either the resistor-based ejection actuator 316 or the actuator group is a previously known value. (Eg, using the principle of V = IR). Any resistance value that has changed more than a predetermined amount can be associated with the execution of step 426 of protocol 430. There may be other methods for evaluating the electrical performance of the ejection actuator 316 or group of actuators. This includes that the ejection actuator 316 or group of actuators is other than a resistance base (eg, a piezoelectric material base). There are also other methods for assessing the overall performance of the ejection actuator 316 or group of actuators, which are within the scope of step 426 of protocol 430. Another way to evaluate the performance of the ejection actuator 316 or group of actuators is to use optical test techniques to determine: That is, when an actuation signal is sent to a given jetting actuator 316 or group of actuators, an optical test technique can be used to determine whether a release from the inhaler 320 was actually from this particular jetting actuator 316 or group of actuators. (E.g., determine whether there has been a discharge from a nozzle associated with a particular ejection actuator 316 or from a nozzle associated with a particular actuator group).

  Not all of the ejection actuators 316 or actuator groups incorporated in the structure of the inhaler 320 need be tested by performing step 426 of protocol 430. For example, a test by performing step 426 of manufacturing protocol 430 of a jetting actuator 316 or actuator group included or to be included in a given inhaler 320 is specified at least in step 422 of protocol 430. A number of ejection actuators 316 or actuator groups may be terminated when the test associated with step 426 of protocol 430 “passes”. More preferably, however, all of the ejection actuators 316 or actuator groups on each ejection head 330 to be installed or initially installed in the inhaler 320 are actually tested by performing step 426 of protocol 430. The The reason for this will be described below with respect to the ejection actuator operation test protocol 500 of FIG.

  The manufacturing protocol 430 of FIG. 8 ends at step 428. Step 428 is for designating the ejection actuator 316 or actuator group that the inhaler 320 should be available at least initially (such actuator 316 or actuator group is installed in the inhaler 320). . There are various ways in which this “designation” can be performed. For example, surplus ejection actuators 316 or actuator groups (ie, more operable ejection actuators 316 or actuator groups than specified in step 422) can be permanently disabled. . By sending an “excess” electrical signal (eg, a voltage or current higher than a typical actuation signal to achieve release from the inhaler 320), the ejection actuator 316 or actuator group is permanently inoperable Can be. This is possible because each of the ejection actuators 316 or actuator groups is preferably operable independently. Another method is simply to program the inhaler controller assembly 310 to use only some of the ejection actuators 316 or actuator groups for the dosing action. One advantage of this method is that if one or more of the “active” ejection actuators 316 or actuator groups are disabled at some point during the lifetime of the inhaler 320, step 426 of protocol 430. Any excess ejection actuators 316 or actuator groups that have passed the tests associated with can be “activated” via the operational test module 312 for the inhaler controller assembly 310.

  One embodiment of an inhaler actuator operational test protocol 500 that may be used by the operational test module 312 is shown in FIG. Protocol 500 is optional using at least one, and more preferably multiple, independently operable devices or groups of devices (each device in a given group being operated simultaneously by a single common signal). These devices are devices for releasing any substance (eg, a plurality of droplets) from the associated inhaler. Thus, the protocol 500 can be used by the respiratory delivery system 10 of FIG. 1 discussed above (again, a plurality of independently operable resistors 42 are used). However, the protocol 500 can also be used for inhalers that use a plurality of independently operable piezoelectric material-based inhaler ejection actuators.

  The operational test protocol 500 of FIG. 9 will be described in connection with the inhaler of FIG. The protocol 500 includes a step 502 in which a signal is transmitted by / via the operational test module 312 to at least each of the ejection actuator 316 or actuator group of the inhaler 320. These actuators are currently “active” with respect to the inhaler controller assembly 310 (ie, are useful for involvement in dosing actions controlled by the inhaler controller assembly 310). All of the ejection actuators 316 or actuator groups installed in the inhaler 320 can also be tested. Typically, this is limited to cases where the signal is a test signal that does not cause release from the inhaler 320 so as not to change the desired dose. In any case, the response of each such ejection actuator 316 or actuator group to the corresponding signal is evaluated by / via execution of step 504 of protocol 500. Any ejection actuator 316 or actuator group that is disqualified from the test is identified in some way through the execution of step 506 of protocol 500. Input from the operational test module 312 for all of the “failed” ejection actuators 316 or actuator groups is then provided to the dosing action execution module 314 via execution of step 508 of the protocol 500.

  Any signal suitable for evaluating the performance of a given ejection actuator 316 or actuator group may be used by step 502 of the inhaler ejection actuator operational test protocol 500 of FIG. One method for evaluating the performance of a given ejection actuator 316 or actuator group is by evaluating the electrical performance of the actuator. Consider that the ejection actuator 316 or actuator group is a resistor of the type discussed above with respect to the inhaler 14 of FIGS. 1-3C. In this case, any signal that evaluates the electrical performance of the actuator 316 or actuator group in any way may be used by the protocol 500. Another method is to send an electrical signal to each of the resistor-based ejection actuator 316 or actuator group so that the resistance of either the resistor-based ejection actuator 316 or actuator group is known previously. One would determine whether it changed from the value (eg, using the relationship R = V / I). Any change in resistance greater than a predetermined amount can be associated with a “disqualification” of the evaluation in the execution of step 506 of protocol 500. There may be other methods for evaluating the electrical performance of the ejection actuator 316 or actuator group. This includes the case where the ejection actuator 316 or actuator group is an actuator other than a resistor base (eg, a piezoelectric material base). There are also other methods for evaluating the performance of an actuator 316 or actuator group, which are within the scope of step 504 of protocol 500.

  Identifying any ejection actuator 316 or actuator group that has been “disqualified” with respect to the signal provided by execution of step 502 of the operational test protocol 500 of FIG. 9 prevents further operation of the “disqualified” actuator 316 or actuator group. Can be used to That is, the input provided by the operational test module 312 to the dosing action execution module 314 via execution of step 508 of the protocol 500 causes the dosing action execution module 314 to cause all of the “disqualified” actuators 316 or actuator groups to be Any further use may be suspended altogether (i.e., if the identification was made through execution of steps 502-506 of protocol 500, the "disqualified" ejection actuator 316 or actuator group no longer has An activation signal to achieve release at the dosing action is not sent by the dosing action execution module 314). Minimally, preferably, the dosing action execution module 314 provides the dosing action execution module 314 to each of the ejection actuators 316 or actuator groups that have been identified as “disqualified” through execution of steps 502-506 of the protocol 500. Will be addressed in subsequent dosing actions initiated / controlled through.

  There are various ways in which the dosing action execution module 314 can handle the input provided by the operational test protocol 500 of FIG. Consider the case where the signal of step 502 of protocol 500 is a test signal that does not result in any release from inhaler 320. One way is to “program” the inhaler controller assembly 310 to send an activation signal such as: That is, the actuation signal that would have been sent to the ejection actuator 316 or actuator group that was “disqualified” for a given dosing action “passed” the evaluation considered by steps 502-506 of protocol 500 of FIG. It transmits to the ejection actuator 316 or an actuator group. This is done for all subsequent dosing actions that are initiated / controlled via the dosing action execution module 314. Another method is that one of the surplus ejection actuators 316 or actuator groups according to the inhaler manufacturing protocol 430 of FIG. 8 is “active” for each of the ejection actuators 316 or actuator groups that disqualified the operational test protocol 500 of FIG. “Activate”. This is because it may not be desirable to permanently disable or disable the ejection actuator 316 or actuator group that exceeds the amount specified in step 422 of the inhaler manufacturing protocol 430 of FIG.

  Now consider the case where the signal of step 502 of the operational test protocol 500 of FIG. There are many ways that the dosing action execution module 314 can address the identification of any actuator 316 or actuator group that is disqualified (in this case, as a result of the input provided by step 508). One method is that the dosing action execution module 314 does not “disqualify” each actuation signal originally transmitted to the “disqualified” ejection actuator 316 or actuator group according to the execution of steps 500-506 of the protocol 500. Is transmitted to the ejection actuator 316 again. This can be difficult to perform on a “real time” basis or during a given dosing action. That is, during the actual dosing action, the “disqualified” ejection actuator 316 or actuator group is identified, how to deal with this disqualification in the same dosing action, and this disqualification is subject to the subject's dosing action It would be difficult to achieve an “additional” release that is addressed before the end of the period. A more possible practice is to provide the user of the inhaler 320 with some notification regarding the “disqualified” dosing action and improve the disqualification for the next dosing action. This is done using any of the previously described methods (eg, “disqualified” in a previous dosing action using an existing jet actuator 316 or actuator group that “passed” the evaluation of step 504, for example. Receiving an additional number of actuation signals equal to the number of actuation signals transmitted to the ejection actuator 316 or actuator group; in order to replace a failed ejection actuator 316 or actuator group, the “surplus” ejection actuator 316 or actuator group , By "adding" to an "active" jetting actuator 316 or actuator group useful for inhaler 320 for a given "dosing action").

  Yet another possibility for how the dosing action execution module 314 may handle the input that is the subject of step 508 of the protocol 500 of FIG. 9 is that the user can perform a “make-up” dosing action. It will probably tell you what should be done and also tell you when the supplementary dosing action should be performed. This is made possible by the inhaler 32 based on a number of factors. Having independently actuated jetting actuators 316 or actuator groups allows for very precise control of the amount of material released by the inhaler 320 in a given dosing action. Because of the precise control over the actuation signal (and also the number of actuation signals applied), and in addition, a single actuator 316 or group of actuators dispenses a certain amount in response to a certain actuation signal. Thus, the amount of substance released by the inhaler 320 in a given administration action can be accurately determined. The inhaler 320 would have already determined the particular ejection actuator 316 or actuator group that was disqualified for a given dosing action by performing steps 502 and 504 of the protocol 500. Further, the controller assembly 310 of the inhaler 320 is configured to track how many actuation signals have been sent to these ejection actuators 316 or actuator groups when the actuators are in a “disqualified” state. Can be done. Accordingly, the inhaler 320 may be configured to define a “refill” administration action as follows. That is, a “replenishment” dosing action can cause a new activation signal to be activated in the previous dosing action or other operable (eg, “surplus” actuator 316) one or more ejection actuators 316 or actuator groups. The number of these new actuation signals is the number of actuation signals sent to the “disqualified” ejection actuator 316 or actuator group determined according to steps 502 and 504 in the previous dosing action. Is equal to

  The ejection actuator operation test protocol 500 of FIG. 9 may be performed as part of a test procedure prior to the distribution of the inhaler 320 for use in a respiratory delivery operation. Preferably, however, the protocol 500 is implemented to allow the protocol 500 to be executed one or more times after the inhaler 320 has been sold for distribution to the inhaler user. If the signal of step 502 of protocol 500 of FIG. 9 is a test signal, execution of protocol 500 is left to manual start of operation test protocol 500 at the discretion of the user. Another method would be to have the operational test protocol 500 run automatically based on some predetermined criteria. For example, it may be desirable to run the operational test protocol 500 before execution of each dosing action initiated / controlled by the dosing action execution module 314. It may also be desirable to run the operational test protocol 500 based on a certain period.

  In both the manufacturing protocol 430 of FIG. 8 and the operation test protocol 500 of FIG. 9, the “failed condition” for the actuator group is defined (when only one ejection actuator in the group is disqualified) Any suitable criteria can be used. More typically, however, both the manufacturing protocol 430 and the operational test protocol 500 are considered to be in a given actuator group before the actuator group is deemed disqualified according to either of these protocols 430, 500. A plurality of predetermined jetting actuators are implemented to allow disqualification.

  The previously described method by which the dosing action execution module 314 can address the input that is the subject of step 508 of the protocol 500 of FIG. 9 is provided via the dosing action setup module 328 of the inhaler 320 of FIG. obtain. In general, the dosing action setup module 328 is considered to provide electronic dosing delivery control capability to the inhaler 320 of FIG. Electronic medication delivery control methods other than those previously discussed may also be used via the dosing action setup module 328. Consider an administration setup protocol 600 shown in FIG. 10 that may be used by the administration setup module 328 of the inhaler 320 of FIG. The dosing action setup protocol 600 includes reading 602 the dosing action control logic. It will be appreciated that multiple dosing action control logic may be utilized in the dosing action execution module 314 of the inhaler 320 of FIG. In this case, protocol 600 will include appropriate steps or methods for reading the desired dosing action control logic.

  The dosing action control logic read in step 602 of protocol 600 is either a specific ejection actuator 316 or actuator group currently designated for use by the dosing action control logic or, in the first configuration, The number of actuation signals currently designated to be transmitted to each of these ejection actuators 316 or actuator groups, and in this first configuration, these actuation signals are transmitted to these ejection actuators 316 or actuator groups. Recognizing a method (e.g., the frequency of the actuation signal per jet actuator 316 or actuator group). In a single dosing action, one pattern or set of actuation signals will be repeated multiple times according to the associated dosing action control logic. Each of these iterations may be considered a “cycle”. Each ejection actuator 316 or actuator group used by a given dosing action logic is in any given full cycle all other jetting actuators 316 or actuator groups used by this same dosing action logic in the same full cycle. Receive the same number of activation signals as. In one embodiment, there is only one actuation signal per jet actuator 316 or actuator group per cycle, but this is not essential. Consider the case where there are 200 currently designated ejection actuators 316 to be used by a given dosing action control logic. A “cycle” may include continuously sending the same actuation signal to these 200 ejection actuators 316. Accordingly, the time between when the actuation signal is transmitted to the first ejection actuator 316 and when it is transmitted to the 200th ejection actuator 316 constitutes one cycle. The same actuation signal can be sent continuously to the group of ejection actuators 316, thereby sending the actuation signal to the first group of ejection actuators 316 and the last group of ejection actuators 316. It should be understood that the time between the set times also constitutes a cycle. In fact, any combination of actuation signals transmitted to one or more individual ejection actuators 316, one or more groups of ejection actuators 316, or both, can make one cycle in a given dosing action control logic. Can be configured.

  Inhaler 320 may have more ejection actuators 316 or actuator groups than are currently used by the dosing action control logic for step 602. That is, the dosing action control logic for step 602 may be used only for a limited number of ejection actuators 316 or actuator groups for performing dosing actions. Step 604 of protocol 600 determines whether there are more ejection actuators 316 or actuator groups for the inhaler than are currently used by the dosing action control logic for step 602. One way in which this can be done is by performing the operational test protocol 500 of FIG. If the number of operable jetting actuators 316 or actuator groups is less than or equal to the number of jetting actuators 316 or actuator groups designated for use by the dosing action control logic for step 602, the protocol 600 is step 604-step. Continue with 606. Step 606 simply provides the end function of protocol 600.

  The dosing action setup protocol 600 proceeds from step 604 to step 608 if there are more operable ejection actuators 316 or actuator groups than are currently used by the dosing action control logic for step 602. Step 608 relates to “dead time”. The time at which the activation signal is sent to the last ejection actuator 316 or actuator group in one cycle and the activation signal is the first ejection in the next-in-time cycle of the dosing action control logic for step 602 There may be a delay between the time of transmission to the actuator 316 or actuator group. This can be considered “dead time”. Dead time allows the ejection actuator 316 or actuator group to be completely “recharged” for the next activation signal cycle in performing the dosing action according to the dosing action control logic for step 602. May be needed to There may be other reasons for providing dead time between adjacent cycles of dosing. In any case, step 608 of the dosing action setup protocol 600 queries whether there is dead time between adjacent cycles of dosing action logic for step 602.

  The dosing action setup protocol 600 performs step 614 if there is a dead time between adjacent cycles of dosing action control logic for step 602 and adds at least some of the surplus ejection actuators 316 or actuator groups to this dead time. . This changes the dosing action control logic for step 602. There may be a limit to the actual number of surplus ejection actuators 316 or actuator groups that can be added to the dead time without changing the frequency with which a given ejection actuator 316 or actuator group receives an actual signal during the performance of a dosing action. . For example, there can be a maximum number of ejection actuators 316 or actuator groups that can be actuated simultaneously in a given cycle of dosing. Thus, if it is desirable to maintain the current cycle time and thereby the injection frequency of the jetting actuator 316 or actuator group, only a limited number of surplus jetting actuators 316 or actuator groups for step 604 will be used. In addition to the dosing action control logic for step 602, it may be possible to change the dosing action control logic. However, the total execution time of the dosing action control logic for step 602 will then be reduced if the dosing action control logic for step 602 is changed in this way. That is, each execution of the dosing action according to the dosing action control logic for step 602 delivers at least relatively the same total dose (ie, the change between dosing actions is relatively small, preferably within a small range. ). Each ejection actuator 316 or group of actuators delivers a determinable amount of desired material for a given actuation signal. The total number of actuation signals required to deliver the desired total dose for the dosing action associated with the dosing action control logic for step 602 is calculated as the desired total dose for the dosing action, the ejection actuator 316 or the actuator. It can be derived by dividing by the dose the group delivers per actuation signal. Since more actuation signals are being sent to the ejection actuator 316 or actuator group per cycle, the required cycle (cycle of cycles) is changed by a change in the dosing action control logic for step 602 as described above. Will contain less).

  If there is a dead time and all of the surplus ejection actuators 316 or actuator groups will be added to the dosing action control logic for step 602, it will still extend the time for each of its cycles. The logic may indicate that the dosing action control logic for step 602 is to be changed by adding all of the excess ejection actuators 316 or actuator groups to each of the cycles. Thereby, the injection frequency of the ejection actuator 316 or actuator group may be reduced with respect to the administration action control logic for step 602 at the current time of the change. This is because there will be more delay between actuation signals provided to a given ejection actuator 316 or actuator group between adjacent cycles. However, the total time of dosing should be reduced. This is because, in accordance with the above method, more actuation signals are given per cycle and thereby shortening the entire injection cycle.

  Now consider the case where there is no dead time between actuator injection cycles in the dosing action control logic for step 602. In this case, the dosing setup protocol 600 of FIG. Step 610 provides that at least some of the operable surplus ejection actuators 316 or actuator groups are added to the dosing action control logic injection cycle for step 602. Again, the actual number of surplus ejection actuators 316 or actuator groups that can be added to a given injection cycle without changing the frequency with which a given ejection actuator 316 or actuator group receives an ejection signal throughout the dosing operation is There can be a limit. For example, there can be a maximum number of ejection actuators 316 or actuator groups that can be actuated simultaneously in a given cycle. Therefore, if it is desirable to maintain the current cycle time and thereby the injection frequency of the ejection actuator 316 or actuator group, only a limited number of excess ejection actuators 316 or actuator groups are stepped. In addition to the dosing action control logic for 602, it would be possible to change the dosing action control logic. However, the total execution time for the dosing action according to this now changed dosing action control logic will in this case be reduced according to the method described above.

  If there is no dead time and all of the surplus ejection actuators 316 or actuator groups are incorporated into the dosing action control logic for step 602, the time for each of the cycles will be extended, step 610 of protocol 600. May still indicate that all of the excess ejection actuators 316 or actuator groups are incorporated into each cycle of dosing action control logic for step 602. Thereby, the ejection frequency of the ejection actuator 316 or actuator group may be reduced with respect to the dosing action control logic for step 602, which has now been changed. This is because there is more delay between actuation signals provided to a given jetting actuator 316 or actuator group between adjacent cycles. However, the total time of dosing will be reduced. This is because, according to the method described above, more actuation signals are given per cycle, thereby shortening the entire injection cycle.

  Another protocol that may be used by the dosing action setup module 328 of the inhaler 320 of FIG. 7 is shown in FIG. In general, protocol 718 can be viewed as establishing dosing action control logic for a given dosing action. Steps 720, 724, and 726 of protocol 718 are essentially preliminary and can be performed in any order. Execution of step 720 of protocol 718 determines the number of ejector actuators 316 or actuator groups of inhaler 320 that are currently operable. One way in which this can be done is by performing the operational test protocol 500 of FIG. Execution of step 724 of protocol 718 determines the desired / required total dose for the dosing action whose dosing action control logic is currently defined. Typically, this information will be specified by the attending physician or the like, but can be input to the inhaler 320 in any suitable manner. Execution of step 726 of the dosing action setup protocol 718 determines the volume of material that is considered to be delivered at least for one actuation signal per jet actuator 316 or group of actuators 316. One way in which this can be done is to simultaneously provide an actuation signal to the ejection actuator 316, or group of ejection actuators 316, and measure the weight dispensed by such actuation signal, thereby providing a dispensed volume. Can be determined. Another method would be to measure droplet size and count the number of droplets. The ejection amount per group of one ejection actuator 316 or ejection actuator 316 may be measured for each ejection actuator 316 or actuator group in any head 330 and recorded for each ejection actuator 316 or actuator group, A more appropriate method would be to evaluate a statistically significant number of jetting actuators 316 or actuator groups 316 and assume that other actuators are operating as well. That is, after the evaluation, an average value is associated with each of the ejection actuators 316 or each of the groups of ejection actuators 316 related to the target actuation signal. In any case, the desired release information can be stored as a number, such as in a look-up table or in the control logic of the inhaler 320, this number being one per activation signal. It is a number that identifies the ejection amount per ejection actuator 316 or group of actuators 316. The look-up table, or stored number, can be generated when programming the dosing action setup protocol 718, or each self-test is completed and operable jet actuator 316 or group of jet actuators 316 Can be updated after being confirmed.

  Information determined or otherwise provided by the execution of steps 720, 724, and 726 is used, at least in part, to define dosing action control logic. Execution of step 728 determines the number of actuation signals that will be required for the dosing action. One way in which this determination can be made is to divide the number of actuation signals determined by performing step 728 by the number of operable ejection actuators 316 determined by performing step 720. It will be appreciated that the total number of cycles required for the current administration action specified may use a portion of one cycle.

  The last parameter of the dosing action control logic currently defined by protocol 718 of FIG. 11 includes establishing the injection frequency of the jetting actuator 316 for each cycle of this dosing action by execution of step 732. This can be done in any suitable way. For example, operable jet actuators 316 may be fired continuously at a time, groups of jet actuators 316 may be fired continuously at a time, or a combination thereof. Again, there may be a minimum time between successive injections of a given ejection actuator 316. This will then affect the frequency of injections performed.

  Those skilled in the art will appreciate that several changes can be made to the devices and methods disclosed herein with respect to the illustrated embodiments without departing from the spirit of the invention. Also, while the present invention has been described above with reference to preferred embodiments, it is to be understood that the invention is amenable to various configuration changes, modifications, and alterations, and that such configurations, modifications, and changes are appended. It will be understood that it is intended to be within the scope of the following claims.

Claims (22)

A respiratory delivery system for at least assisting in introducing a first substance into lung tissue,
At least one air inlet;
At least one exit,
At least one air flow path extending between the at least one air inlet and the at least one outlet;
A plurality of ejection actuators;
At least one air flow adjustment assembly adapted to adjust the size of the passage through which the air flow is directed so as to obtain a single air flow rate substantially independent of the size of the inhalation; viewing including the one of the air flow adjustment assembly,
Among the plurality of ejection actuators, at least one inoperable ejection actuator is specified, and an operation signal to be transmitted to the at least one inoperative ejection actuator is an at least one inoperative ejection actuator. The respiratory delivery system is sent to at least one operable jetting actuator by disabling .   The respiratory delivery system according to claim 1, wherein the respiratory delivery system is selected from the group consisting essentially of an oral inhaler and a nasal inhaler.   The respiratory delivery system of claim 1, wherein the first substance is selected from the group consisting essentially of a liquid drug and a powder drug. Before Ki噴 exits actuator, respiratory delivery system according to the first substance to claim 1, which is adapted to at least assist in releasing the air stream.   The respiratory delivery system of claim 1, wherein each of the ejection actuators is independently operable. Before Ki噴 out actuator includes a first and second groups of said ejection actuators, including said ejection actuators, each of the plurality of the first and second groups, the first group The respiratory delivery system of claim 1, wherein the respiratory delivery system is operable independently of the second group. The respiratory delivery system of claim 1, wherein the at least one air flow conditioning assembly is disposed at or near the at least one air inlet of the air flow path .   The at least one air flow path includes a flow control port, and a first inner diameter of the flow control port disposed toward the at least one air inlet is disposed toward the at least one outlet. The respiratory delivery system of claim 1, wherein the respiratory delivery system is larger than a second inner diameter of the flow control port.   The respiratory delivery system according to claim 1, wherein a side wall of the at least one air flow path converges linearly in a direction of the air flow toward the at least one outlet. Each of the air flow regulation assemblies includes a baffle;
The baffle includes a first main surface and a second main surface arranged substantially perpendicular to the direction of the air flow, and an outer peripheral portion;
When the baffle is in a first position disposed toward the at least one air inlet, the outer periphery of the baffle is spaced a first distance from the sidewall;
When the baffle is in a second position disposed toward the at least one outlet, the outer periphery of the baffle is separated from the side wall by a second distance that is less than the first distance. The respiratory delivery system of claim 9 . Each of the air flow regulation assemblies includes a baffle;
The respiratory delivery system of claim 1, wherein the baffle includes a first major surface and a second major surface disposed substantially perpendicular to the direction of air flow. A first position of the baffle in response to a first suction force is defined by the baffle being separated from the at least one outlet by a first distance;
A second position of the baffle in response to a second suction input that is greater than the first suction input is such that the baffle is spaced from the at least one outlet by a second distance that is less than the first distance. The respiratory delivery system of claim 11 , defined by: A first position of the baffle in response to a first suction force is defined by the baffle being separated from the at least one air inlet by a first distance;
The second position of the baffle in response to a second suction input that is greater than the first suction input is separated from the air inlet by a second distance that is greater than the first distance. The respiratory delivery system of claim 11 , defined by The baffle avoids suppression of the air flow at a first position disposed toward the at least one air inlet;
The respiratory delivery system of claim 11 , wherein the baffle at least partially inhibits the air flow at a second position disposed toward the at least one outlet. The respiratory delivery system of claim 11 , wherein the baffle has a flat plate shape . The air flow adjustment assemblies each include a biasing member including a first end and a second end;
The first end is disposed in contact with the baffle;
The second end is disposed at a fixed position with respect to the at least one air flow path, and the biasing member is directed to the baffle in a direction substantially opposite to the direction of the air flow. The respiratory delivery system according to claim 11 , wherein a biasing force is applied to the breathing system. The respiratory delivery system according to claim 16 , wherein a magnitude of a user's minimum suction input is substantially equal to a magnitude of the biasing force applied to the baffle by the biasing member. Normal suction force of the user, the greater than the minimum suction force of the user, the baffle of claim 17 which is moved toward the user when under the action of the normal suction force Respiratory delivery system. The respiratory delivery system of claim 16 , wherein the biasing member is a spring.   The respiratory delivery system of claim 1, further comprising at least one air flow monitoring assembly adapted to monitor flow data. The at least one air flow monitoring assembly is communicatively interconnected with the at least one air flow adjustment assembly, and the at least one air flow monitoring assembly is connected to the at least one air flow adjustment assembly; 21. A respiratory delivery system according to claim 20 , wherein a signal relating to the flow data is transmitted. The at least one air flow adjustment assembly includes at least one passage adjustment;
The respiratory delivery system according to claim 21 , wherein the at least one passage adjusting unit adjusts the size of the at least one air flow path in response to the signal.

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