Drug delivery system and method including injection site identification and tracking

Abstract

The drug delivery system includes a housing and a drug delivery assembly supported by the housing. The drug delivery assembly delivers the drug to the target injection site through an injection opening. An ultrasonic transducer is supported by the housing in close proximity to the injection opening. The ultrasonic transducer emits ultrasound into the target tissue at the injection site and receives reflected ultrasound from the target tissue. The processor determines whether the reflected ultrasound indicates the presence of bone in the target tissue. (1) If bone is present in the tissue, the processor determines that the injection site is located in an accessory organ of the target; (2) Otherwise, the processor determines that the injection site is located in the abdomen of the target.

Description

Technical Field

[0001] The present disclosure relates to drug delivery systems, and more particularly to drug delivery systems including an ultrasonic transducer that facilitates determination of an injection site on a patient's body.

Background Art

[0002] Patients suffering from various diseases often have to inject themselves with drugs. To enable patients to conveniently and accurately self-administer drugs, various drug delivery systems, including injection pens, have been developed. Using such systems at repeated injection sites on the body (e.g., the arm, thigh, and abdomen) can cause lipohypertrophy and may inhibit proper absorption of the drug into the subcutaneous tissue. Therefore, patients typically avoid continuous use of an injection site and instead alternate between various injection sites. However, remembering or tracking the use of injection sites can be burdensome for patients. Thus, it would be desirable to provide a drug delivery system that tracks the use of injection sites and facilitates alternating between different injection sites.

Summary of the Invention

[0003] Embodiments of the present disclosure provide a drug delivery device. The system includes a housing and a drug delivery assembly supported by the housing. The drug delivery assembly is configured to deliver a drug to a target injection site through an injection opening. An ultrasonic transducer is supported by the housing in proximity to the injection opening. The ultrasonic transducer is configured to emit ultrasonic waves into the target tissue at the injection site and to receive reflected ultrasonic waves from the target tissue. A processor is operably coupled to the ultrasonic transducer. The processor is configured to determine whether the reflected ultrasonic waves indicate the presence of bone in the target tissue. (1) If bone is present in the tissue, the processor determines that the injection site is located in an accessory organ of the target; (2) Otherwise, the processor determines that the injection site is located in the abdomen of the target.

[0004] Another embodiment of the present disclosure provides a drug delivery device. The drug delivery system includes a housing including an injection opening and a drug delivery assembly supported by the housing. The drug delivery assembly extends through the injection opening and is configured to deliver a drug to a target injection site. Multiple ultrasonic transducers are supported by the housing and arranged around the injection opening. The multiple ultrasonic transducers are configured to emit ultrasound into the target tissue at the injection site and to receive reflected ultrasound from the target tissue. A processor is operably coupled to the multiple ultrasonic transducers and is configured to determine the body location of the target injection site based on the reflected ultrasound.

[0005] A further embodiment of the present disclosure provides a method for delivering a drug to a target. The method includes: emitting ultrasound into the tissue of a target at an injection site via an ultrasonic transducer carried by a drug delivery device; receiving reflected ultrasound from the tissue of a target via the ultrasonic transducer; determining, via a processor operably coupled to the ultrasonic transducer, whether the reflected ultrasound indicates the presence of bone in the tissue of a target; (1) if the presence of bone in the tissue is determined, determining that the injection site is located in an accessory organ of the target; (2) otherwise, determining that the injection site is located in the abdomen of the target; and injecting the drug into the tissue of a target at the injection site via the drug delivery device. [Brief explanation of the drawing]

[0006] The features and advantages described above and other advantages of this disclosure, as well as the manner in which they are achieved, will become more apparent and better understood by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings. [Figure 1] This is a side view of a drug delivery system according to an embodiment of the disclosure. [Figure 2] Figure 1 is a schematic diagram of the drug delivery system. [Figure 3] Figure 1 is a detailed perspective view of the distal end of the drug delivery device in the system. [Figure 4] This is an illustrative diagram of ultrasound emitted by a drug delivery device including six ultrasonic transducers according to embodiments of the present disclosure. [Figure 5] This is an illustrative plot of pixel intensity versus tissue depth, corresponding to the magnitude of reflected ultrasound received by the drug delivery system in Figure 1. [Figure 6] Figure 1 shows an example electrocardiogram (ECG) signal determined by the drug delivery system. [Figure 7]This is an exemplary plot of the difference between the maximum R-wave voltage and the minimum Q-wave voltage, experimentally perceived in a laboratory environment by the drug delivery system shown in Figure 1. [Figure 8] This is an exemplary plot of cardiac cycle pattern voltage, specifically minimum Q-wave voltage, experimentally detected by the drug delivery system shown in Figure 1 in a laboratory environment. [Figure 9] Figure 1 is a flowchart illustrating a method for delivering a drug to a target using the drug delivery system. [Figure 10] This is another part of the flowchart for the method of delivering the drug to the target in Figure 9.

[0007] Throughout the drawings, corresponding reference numerals indicate corresponding parts. The examples described herein illustrate exemplary embodiments of the invention, and such examples should not be construed as limiting the scope of the invention in any manner. [Modes for carrying out the invention]

[0008] The drug delivery systems of this disclosure carry and deliver one or more drugs, which may also be referred to as therapeutic agents or drugs. Such drugs may include, for example, epinephrine, anesthetics, analgesics, steroids, insulin, insulin analogs, insulin derivatives, GLP-1 receptor agonists, therapeutic antibodies, or any other drugs that can be delivered by the systems of this disclosure. The drug delivery devices of this disclosure are generally operated by a user (e.g., a healthcare professional, caregiver, or another person) in the manner described herein to deliver one or more drugs to a target (e.g., another person or user).

[0009] Figure 1 illustrates a drug delivery system 10 according to an exemplary embodiment of the present disclosure. The drug delivery system 10 includes a drug delivery device 12. The drug delivery device 12 is exemplary in shape, but other shapes may be used instead. The drug delivery device 12 includes a housing 14 having a proximal end 16 and a distal end 18 on the opposite side. During use of the drug delivery device 12, the proximal end 16 is located away from the patient and is configured to be operated by the user, while the distal end 18 is located closer to the patient and is configured to deliver the drug (illustrated elsewhere) to the patient. The drug delivery device 12 also includes a longitudinal axis A extending between the proximal end 16 and the distal end 18.

[0010] Continuing to refer to Figure 1, the housing 14 houses the drug delivery assembly 20. Generally, the drug delivery assembly 20 includes a drug-carrying reservoir 22 and a needle 24 that is in fluid communication with the reservoir 22. The needle 24 is selectively movable from a stowed configuration (as illustrated) to a deployed configuration (not illustrated) in which the needle 24 extends through an injection opening 26 located at the distal end 18 of the housing 14. In the deployed configuration, the needle 24 is configured to puncture the target skin, thereby delivering the drug from the reservoir 22 to the target. The drug delivery assembly 20 can take various forms. For example, the drug delivery assembly 20 may include a mechanical, hydraulic, pneumatic, or electric drive mechanism for moving the needle 24, or the needle 24 and reservoir 22, from the stowed configuration to the deployed configuration and vice versa. The drug delivery assembly 20 may additionally or alternatively include a mechanical, hydraulic, pneumatic, or electric drive mechanism for delivering the drug from the reservoir 22 to the needle 24 and target. In a specific example, the reservoir 22 may be a syringe receiving a piston, which is driven within the syringe to deliver the drug from the reservoir 22 to the needle 24 and target. In another specific example, the reservoir 22 may be a compressible bladder that is hydraulically or pneumatically compressed to deliver the drug from the reservoir 22 to the needle 24 and target. The drug delivery assembly 20 may be configured as a wearable infusion device for delivering the drug over a long period (e.g., minutes or hours) or for delivering the drug over a relatively short period (e.g., seconds). In some embodiments, the drug delivery assembly 20 may initiate a chemical reaction to drive the injection by using a gas produced by a chemical reaction to move a piston, lever, or compressible bladder to deliver the drug.

[0011] In some embodiments, device 12 is a reusable device. More specifically, the drug delivery assembly 20, or one or more of its components, is replaceable after the drug is depleted from the reservoir 22, and device 12 can be reused to deliver the drug to the target. In other embodiments, device 12 is a single-use device. More specifically, device 12 is discarded after the drug is depleted from the reservoir 22.

[0012] Continuing to refer to Figure 1, and further to Figure 2, the system 100 also includes various other components that facilitate the delivery of drugs to a target. For example, device 12 includes a processor 28 that is operably coupled to various components, thereby facilitating the delivery of drugs to a target. The processor 28 may be, or include, one or more field programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors). The processor 28 may be operably coupled to a drug delivery assembly 20 and user input 30, and the user input 30 may be operably coupled to actuate the drug delivery assembly 20. In other embodiments, the processor 28 is not operably coupled to one or more of the drug delivery assembly 20 and user input 30. The processor 28 is also operably coupled to a power supply 32 (not shown - such as one or more batteries), memory 34, and transmitter 36, operably coupling the device 12 to one or more remote devices 38, such as a smartphone. In addition, the processor 28 is operably coupled to one or more ultrasonic transducers 40 (e.g., capacitive micromachined ultrasonic transducers (CMUTs)), a first electrode 42, and a second electrode 44. As will be described in more detail below, the ultrasonic transducers 40 and electrodes 42, 44 facilitate the determination and tracking of injection sites used by the subject.

[0013] Figure 3 illustrates an exemplary embodiment of the distal end 18 of a drug delivery device 12, although some parts of the housing 14 are obscured to allow other features of the device 12 to be visible. In some embodiments, as illustrated, the distal end 18 of the device 12 carries a plurality of ultrasonic transducers 40 (exemplarily, three ultrasonic transducers 40) arranged around an injection opening 26. Alternatively, drug delivery devices according to embodiments of the present disclosure may have a different number of ultrasonic transducers (e.g., one, two, four, five, six, or more ultrasonic transducers). The ultrasonic transducers 40 may be arranged around the injection opening 26 at substantially equal angles α (i.e., equal ±5 degrees). The ultrasonic transducers may be coupled to pulse-generating components or circuits (not shown) that generate high-frequency, high-voltage electrical pulses to the transducers in order to cause the transducers to emit ultrasound. Furthermore, the ultrasonic transducer may include a sensor for detecting reflected or returning ultrasonic signals, and an amplifier for boosting the returned signals for processing by a processor.

[0014] One or more of the ultrasonic transducers 40 may be positioned to emit ultrasound at an acute angle β away from the longitudinal axis A of the housing 14. As illustrated in Figure 4 illustrating ultrasounds 41A, 41B, 41C, 41D, 41E, and 41F emitted by an exemplary drug delivery device comprising six ultrasonic transducers, the acute angle provides the ultrasonic transducers with a relatively high probability of collectively emitting ultrasound toward the bone B within the target S. In some embodiments, the acute angle β is substantially 10 degrees (i.e., 10 degrees ± 2.5 degrees). Alternatively, drug delivery devices according to embodiments of the present disclosure may have different arrangements of ultrasonic transducers (e.g., one, two, four, five, six, or more ultrasonic transducers).

[0015] Referring again to Figures 1 and 2 in their entirety, the ultrasonic transducer 40 is configured to emit ultrasound into the target tissue at the injection site and to receive reflected ultrasound from the target tissue. Based on the reflected ultrasound received by the ultrasonic transducer 40, the processor 28 determines the location of the injection site. More specifically, the processor 28 determines whether the reflected ultrasound indicates the presence of bone in the target tissue. Referring further to Figure 5, the presence of bone is indicated by receiving high magnitude reflected ultrasound from a certain tissue depth (for example, about 16 mm) and low magnitude reflected ultrasound from deeper tissue (for example, about 17 mm to 30 mm). If the processor 28 determines that (1) bone is present in the tissue, the processor 28 determines that the injection site is located in the appendage of the target; otherwise, the processor 28 determines that the injection site is located in the abdomen of the target (because it is unlikely that the ultrasound will be reflected by the spine of the target). In the former situation, the processor 28 may determine that the injection site is located in an accessory by determining whether the accessory is the arm or the thigh of the target. More specifically, the processor 28 may determine whether the accessory is the arm or the thigh of the target by determining the bone depth of the tissue, (1A) if the bone depth is greater than a threshold (e.g., 15 mm), the processor 28 determines that the accessory is the thigh of the target, and (1B) if the bone depth is less than the threshold, the processor 28 determines that the accessory is the arm of the target.

[0016] In the case of a device 10 including multiple ultrasonic transducers 40, the processor 28 can analyze the reflected ultrasound received by each transducer 40 in various ways. For example, the processor 28 can analyze the average magnitude of the reflected ultrasound received by all of the transducers 40. As another example, referring further to Figure 4, the processor 28 can analyze the reflected ultrasound received by transducers 40 (e.g., transducers emitting ultrasounds 41C, 41D, and 41E) that indicate the presence of bone near the injection site, and ignore any transducers (e.g., transducers emitting ultrasounds 41A, 41B, and 41F) that do not indicate the presence of bone near the injection site.

[0017] Referring again to Figures 1 and 2 in general terms, the processor 28 determines, based on the electrical signals received via electrodes 42 and 44, whether the injection site is on the right or left side of the target. In some embodiments, electrodes 42 and 44 may be coupled to a differential amplifier (not shown) before being routed to the processor 28. More specifically, the first electrode 42 is in contact with a first skin surface of the target (e.g., the skin at the injection site), and the second electrode 44 is in contact with a second skin surface of the target (e.g., the skin of the target's hand), thereby allowing the processor 28 to receive electrical signals corresponding to the target's cardiac cycle pattern. Referring further to Figure 6, the processor 28 thereby determines the electrocardiogram (ECG) signal. The processor 28 may determine all parts of the ECG signal for one or more cardiac cycles, including P, Q, R, S, and T waves, or the processor 28 may determine only the relevant parts of the ECG signal for one or more cardiac cycles, specifically the parts including the Q and R waves, as will be described in more detail below.

[0018] Continuing with reference to Figure 6, and further to Figures 7 and 8, the processor 28 may analyze one or more portions of the ECG signal to determine whether the injection site is on the right or left side of the subject. Figures 7 and 8 illustrate values ​​of the ECG signal experimentally observed by the device 12 in a laboratory setting. As illustrated, the values ​​can be distinguished to different levels or to various thresholds based on (1) whether the injection site is on the right or left side of the subject, and (2) whether the subject's right or left hand held the device relative to the injection site. More specifically, the processor 28 determines the maximum amplitude of the R wave and the minimum amplitude of the Q wave. Such amplitudes may be for a single cardiac cycle, an averaged or smoothed value over multiple cardiac cycles, etc. As shown in Figure 7 by the voltage value in the first box 110, if the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than a first threshold (e.g., 2mV) and less than a second threshold (e.g., 3mV), the subject is likely holding the device 12 against the right side of their body using their right hand. As shown in Figure 7 by the voltage value in the second box 112, if the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than a second threshold, the subject is likely holding the device 12 against the left side of their body using their right hand. As shown in Figure 7 by the voltage value in the third box 114, if the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is less than a first threshold, the subject is likely holding the device 12 against either the left or right side of their body using their left hand. If the subject is holding the device 12 with their left hand, it can be determined whether the subject is pressing the device 12 against the left or right side of their body by calculating the minimum amplitude of the Q wave. For example, if the subject is holding device 12 with their left hand, and the minimum amplitude of the Q wave is greater than the third threshold (e.g., -0.5mV) as shown in Figure 8 by the voltage value in the fourth box 116, then the subject is likely holding device 12 against the left side of their body with their left hand.Also, as shown in FIG. 8 according to the voltage value in the fifth box 118 or the sixth box 120, when the minimum amplitude of the Q wave is smaller than the third threshold value, the subject is likely holding the device 12 against the right side of the body using the left hand.

[0019] Therefore, in summary, by considering the signal received from the ultrasonic transducer 40, the processor 28 can determine which body part (e.g., arm, leg, or abdomen) the injection site is located at. By considering the signals from the electrodes 42 and 44, the processor 28 can determine on which side of the body the injection site is located (e.g., the left side or the right side of the body). By considering both signals received from the ultrasonic transducer 40 and the electrodes 42 and 44, the processor 28 can distinguish six specific injection sites on the subject's body, specifically, the right thigh, the left thigh, the right arm, the left arm, the right side of the abdomen, and the left side of the abdomen. The processor 28 provides the injection site data to the remote device 12 via the transmitter 36, and the remote device 12 can incorporate the data into an injection site tracking application. Alternatively, the device 12 can present the injection site data via a display.

[0020] Figures 9 and 10 illustrate flowcharts of a method for delivering a drug to a target using the drug delivery system 10. As shown in Figure 9, in block 210, the processor 28 determines that the device 12 is in contact with the target's skin. Such contact may be determined via electrodes 42, 44, more specifically by detecting the presence of a closed circuit defined together by the device 12 and the target. In block 212, the processor 28 determines, via electrodes 42, 44, which side of the target's body is in contact with the device 12. More specifically, the processor 28 determines which side of the target's body is in contact with the device 12 by analyzing one or more portions of the ECG signal. Even more specifically, referring to Figure 10, in subblock 310, the processor 28 determines the maximum amplitude of the R wave in the ECG signal, the minimum amplitude of the Q wave in the ECG signal, and the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave. In subblock 312, the processor 28 compares the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave to a first threshold and a second threshold. If the difference is greater than the first threshold and less than the second threshold (for example, similar to the injection voltage value depicted in box 110 in Figure 7), in subblock 314, the processor 28 determines that the injection site is on the right side of the target. Otherwise, the method proceeds to subblock 316. In subblock 316, the processor 28 compares the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave to a second threshold. If the difference is greater than the second threshold (for example, similar to the injection voltage value depicted in box 112 in Figure 7), in subblock 318, the processor 28 determines that the injection site is on the left side of the target. Otherwise, the method proceeds to subblock 320. In subblock 320, the processor 28 compares the minimum amplitude of the Q wave to a third threshold. If the minimum amplitude of the Q wave is greater than a third threshold (for example, the injection voltage value depicted in box 116), in subblock 322, processor 28 determines that the injection site is on the left side of the target. Otherwise, more specifically, if the minimum amplitude of the Q wave is less than a third threshold, in subblock 324, processor 28 determines that the injection site is on the right side of the target.Referring again to Figure 9, in block 214, the processor 28 determines the location of the body in contact with the device 12 via the ultrasonic transducer 40. More specifically, the processor 28 determines whether bone is present in the tissue near the injection site and the depth of any such bone, as described in relation to Figure 5. In this way, the processor 28 can determine where the injection site is located on the target arm, thigh, or abdomen. The device 12 then transmits the injection site data to the remote device 12, and in block 216, the device 12 delivers the drug to the target via the drug delivery assembly 20.

[0021] The systems and methods according to embodiments of this disclosure can be modified in various ways. For example, device 12 can transmit signals from ultrasonic transducer 40 and / or electrodes 42, 44 to remote device 12, and the processor of remote device 12 can then determine the location of the injection site using any of the methods contemplated herein. Furthermore, the blocks of Figure 9 can be rearranged in any logical order. For example, block 216 (drug delivery) can occur simultaneously with or before blocks 212 and 214. Block 214 can occur simultaneously with or before block 212.

[0022] While the present invention has been illustrated and described in terms of a preferred design, the invention may be modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover all variations, uses, or adaptations of the invention using its general principles. Furthermore, this application is intended to cover any such deviations from this disclosure that exist in known or customary practices in the art to which the invention relates.

Claims

1. A drug delivery system, Housing and A drug delivery assembly, supported by the housing and configured to deliver a drug to a target injection site via an injection opening, An ultrasonic transducer is supported by the housing in close proximity to the injection opening and is configured to emit ultrasonic waves into the target tissue at the injection site and to receive reflected ultrasonic waves from the target tissue. A drug delivery system comprising: a processor operably coupled to the ultrasonic transducer, configured to determine whether the reflected ultrasonic waves indicate the presence of bone in the tissue of the target, and (1) if bone is present in the tissue, determine that the injection site is located in an accessory organ of the target, and (2) otherwise determine that the injection site is located in the abdomen of the target.

2. The drug delivery system according to claim 1, wherein, when bone is present in the tissue, the processor is configured to determine whether the accessory organ is the arm or the thigh of the target.

3. The drug delivery system according to claim 2, wherein the processor is configured to determine whether the appendage is the arm or the thigh of the target by determining the bone depth of the tissue, (1A) determining that the appendage is the femur of the target when the bone depth is greater than a threshold, and (1B) determining that the appendage is the arm of the target when the bone depth is less than a threshold.

4. A first electrode supported by the housing and operably coupled to the processor, configured to contact the skin of the target, The system further comprises a second electrode supported by the housing and operably coupled to the processor, the second electrode configured to contact the skin of the target, The drug delivery system according to any one of claims 1 to 3, wherein the processor is configured to determine an electrocardiogram (ECG) signal via the first electrode and the second electrode, and to determine, based on the ECG signal, whether the injection site of the target is on the right or left side of the target.

5. The processor is further configured to determine the maximum amplitude of the R wave of the ECG signal and the minimum amplitude of the Q wave of the ECG signal. (1) The processor is configured to determine that the tissue is located to the right of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than a first threshold and less than a second threshold. (2) The processor is configured to determine that the tissue is located to the left of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than the second threshold, (3) The processor is configured to determine that the tissue is located to the left of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is less than the first threshold and the minimum amplitude of the Q wave is greater than the third threshold. (4) The drug delivery system according to claim 4, wherein the processor is configured to determine that the tissue is to the right of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is less than the first threshold and the minimum amplitude of the Q wave is less than the third threshold.

6. The drug delivery system according to any one of claims 1 to 5, wherein the processor is supported by the housing.

7. A drug delivery system, A housing equipped with an injection opening, A drug delivery assembly is supported by the housing, extends through the injection opening, and is configured to deliver the drug to the target injection site. A plurality of ultrasonic transducers, supported by the housing and arranged around the injection opening, are configured to emit ultrasonic waves into the target tissue at the injection site and to receive reflected ultrasonic waves from the target tissue. A drug delivery system comprising: a processor operably coupled to the plurality of ultrasonic transducers, configured to determine the body location of the target injection site based on the reflected ultrasonic waves.

8. The drug delivery system according to claim 7, wherein the processor is configured to determine whether the reflected ultrasound received by at least one of the plurality of ultrasonic transducers indicates the presence of bone in the tissue, and to determine the body location of the injection site by (1) if it is determined that bone is present in the tissue, determining that the body location is an accessory organ, and (2) otherwise determining that the tissue is abdominal tissue.

9. The drug delivery system according to claim 8, wherein the processor is configured to determine whether the body location is an accessory organ by determining whether the accessory organ is the arm or the thigh of the target.

10. The drug delivery system according to claim 8, wherein the processor is configured to determine the bone depth of the tissue, (1A) when the bone depth is greater than a threshold, determine that the appendage is the femur of the target, and (1B) when the bone depth is less than a threshold, determine that the appendage is the arm of the target, thereby determining that the body location is an appendage.

11. The drug delivery system according to any one of claims 7 to 10, wherein the housing has a longitudinal axis, and the ultrasonic transducer is positioned to emit ultrasonic waves at an acute angle away from the longitudinal axis.

12. The drug delivery system according to claim 11, wherein the acute angle is substantially 10 degrees.

13. The drug delivery system according to any one of claims 7 to 12, wherein the plurality of ultrasonic transducers are spaced at substantially equal angles around the injection opening.

14. A first electrode supported by the housing and operably coupled to the processor, configured to contact the skin of the target, The system further comprises a second electrode supported by the housing and operably coupled to the processor, the second electrode configured to contact the skin of the target, The drug delivery system according to any one of claims 7 to 12, wherein the processor is configured to determine an electrocardiogram (ECG) signal via the first electrode and the second electrode, and to determine, based on the ECG signal, whether the injection site of the target is on the right or left side of the target.

15. The processor is further configured to determine the maximum amplitude of the R wave of the ECG signal and the minimum amplitude of the Q wave of the ECG signal. (1) The processor is configured to determine that the tissue is located to the right of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than a first threshold and less than a second threshold. (2) The processor is configured to determine that the tissue is located to the left of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than the second threshold, (3) The processor is configured to determine that the tissue is located to the left of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is less than the first threshold and the minimum amplitude of the Q wave is greater than the third threshold. (4) The drug delivery system according to claim 12, wherein the processor is configured to determine that the tissue is to the right of the target when it determines that the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is less than the first threshold and the minimum amplitude of the Q wave is less than the third threshold.

16. A method for delivering a drug to a target, The device emits ultrasound waves into the target tissue at the injection site via an ultrasonic transducer supported by a drug delivery device. The ultrasonic transducer receives reflected ultrasonic waves from the target tissue, A processor operably coupled to the ultrasonic transducer determines whether the reflected ultrasound indicates the presence of bone in the target tissue, (1) if it is determined that bone is present in the tissue, it is determined that the injection site is located in an accessory organ of the target, and (2) otherwise, it is determined that the injection site is located in the abdomen of the target. A method comprising injecting the drug into the target tissue at the injection site via the drug delivery device.

17. The method according to claim 16, wherein determining that the injection site is located in the accessory organ of the target includes determining whether the accessory organ is the arm or the thigh of the target.

18. The method according to claim 16, wherein determining that the injection site is located in the appendage of the target includes determining the bone depth of the tissue, (1A) determining that the appendage is the femur of the target when the bone depth is greater than a threshold, and (1B) determining that the appendage is the arm of the target when the bone depth is less than the threshold.

19. The processor determines the first electrode supported by the drug delivery device, the second electrode supported by the drug delivery device, and the electrocardiogram (ECG) signal. The method according to any one of claims 16 to 18, further comprising determining, via the processor, whether the injection site is on the right or left side of the target based on the ECG signal.

20. Determining whether the injection site is on the right or left side of the target, based on the ECG signal via the processor, is equivalent to determining the maximum amplitude of the R wave and the minimum amplitude of the Q wave of the ECG signal. (1) When the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than a first threshold and less than a second threshold, it is determined that the tissue is located to the right of the target. (2) When the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is greater than the second threshold, it is determined that the tissue is located to the left of the target, (3) When the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is smaller than the first threshold, and the minimum amplitude of the Q wave is larger than the third threshold, it is determined that the tissue is located to the left of the target. (4) The method according to claim 19, which includes determining that the tissue is located to the right of the target when the difference between the maximum amplitude of the R wave and the minimum amplitude of the Q wave is less than the first threshold and the minimum amplitude of the Q wave is less than the third threshold.

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