Patent Grant
9327077
The invention relates generally to medical devices, and more particularly to medical systems, medicament delivery devices and methods for delivering a medicament into a body of a patient and outputting an electronic signal in response to such delivery.
Self-administered medicament delivery devices, such as, for example pre-filled medical injectors, inhalers, transdermal delivery devices and the like are often used as a part of a patient's medication regimen. For example, known self-administered medicament delivery devices can be used as a part of a patient's emergency care regimen. Emergency care regimens can include, for example, using an auto-injector to rapidly self-administer a medicament in response to an allergic reaction or for the treatment of other emergency conditions (e.g., nerve-agent poisoning on the battlefield). Known self-administered medicament delivery devices can also be used as a part of a patient's chronic care regimen. Chronic care regimens can include, for example, using a pen injector to self-administer a medicament according to a prescribed plan. Examples of chronic care regimens can include, for example, the injection of insulin, the injection of human growth hormone (HGH), erythropoiesis-stimulating agents (ESA), DeMab, Interferons and other chronic therapies, or the like. Furthermore, self-administered medicament delivery devices can also be used for preventive/prophylactic therapies. Examples of preventive/prophylactic therapies include certain vaccines, such as an influenza vaccine.
In the pharmaceutical industry, it can be important to understand patient compliance with self-administered medicament delivery devices. Patient compliance can include any measure of a patient's conformance to a particular therapeutic drug delivery regimen or other indication as mandated by a health care provider or pharmaceutical manufacturer. More particularly, patient compliance measures can include the location where the device was activated, time of day, dose regimen, dosage and route of administration, frequency of device usage, functionality of the device once used, expiration date of the device, device status, medicament status, and any adverse event experienced by the user following the use of the device. Patient compliance can also include providing communication to the patient regarding their therapy (e.g., a notification of when to take their medication, etc.). Understanding patient compliance with medicament delivery devices can enhance the ability of a health care provider to effectively manage a patient's medication regimen, which can lead to improved patient outcomes. Patient compliance data can also be used to inform the manufacturer of the device about potential issues with the device (e.g., data demonstrating poor compliance with a particular device may trigger a manufacturer to investigate the cause of poor compliance and/or change the design or functionality of the device to improve patient care and outcome), alert emergency contacts (including family members, patient guardians, and individuals with Power of Attorney privileges), and aid the patient with adhering to their prescribed therapy. Increasing patient compliance can also generate considerable cost savings for health care providers, pharmaceutical benefits managers (PBM), specialty pharmacies, clinical trial administrators, insurance companies and/or payors.
Ensuring patient compliance with some known medicament delivery devices can be problematic. For example, some known medicament delivery devices (e.g., emergency care devices, as described above and/or chronic care devices) can be bulky and conspicuous, which can make carrying them inconvenient and undesirable. Accordingly, the patient may not carry the medicament delivery device at all times, resulting in the failure to use the medicament delivery device as prescribed.
Similarly, to actuate some known medicament delivery devices, the user may be required to execute a series of operations. For example, to actuate some known auto-injectors, the user must remove a protective cap, remove a locking device, place the auto-injector in a proper position against the body and then press a button to actuate the auto-injector. Failure to complete these operations properly can result in an incomplete injection and/or injection into an undesired location of the body.
The likelihood of improper use of known medicament delivery devices can be compounded by the nature of the user and/or the circumstances under which such devices are used. For example, many users are not trained medical professionals and may have never been trained in the operation of such devices. Moreover, in certain situations, the user may not be the patient, and may therefore have no experience with the medicament delivery device. Similarly, because some known medicament delivery devices are configured to be used relatively infrequently in response to an allergic reaction or the like, even those users familiar with the device and/or who have been trained may not be well practiced at operating the device. Finally, such devices often can be used during an emergency situation, during which even experienced and/or trained users may be subject to confusion, panic and/or the physiological effects of the condition requiring treatment.
Monitoring the patient's compliance with known medicament delivery devices can also be problematic. For example, some known medicament delivery systems include a medicament delivery device and an electronic system to assist the user in setting the proper dosage and/or maintaining a compliance log. Such known medicament delivery systems and the accompanying electronic systems can be large and therefore not conveniently carried by the user. Such known medicament delivery systems and the accompanying electronic systems can also be complicated to use and/or expensive to manufacture.
Thus, a need exists for medicament delivery systems and/or devices that can provide compliance information associated with the use of the device. Moreover, a need exists for medicament delivery systems and/or devices that can communicate electronically with other communications devices.
Medicament delivery systems and devices are described herein. In some embodiments, a system includes a medicament delivery device and a container configured to receive at least a portion of the medicament delivery device. The medicament delivery device includes an actuator and a first electronic circuit system. The actuator is configured to initiate delivery of a medicament into a body when the actuator is moved from a first position to a second position. The first electronic circuit system is configured to output a first electronic signal when the actuator is moved from the first position to the second position. The container includes a second electronic circuit system configured to receive the first electronic signal. The second electronic circuit system is configured to output a second electronic signal associated with the first electronic signal.
In some embodiments, a system includes a medicament delivery device and a container configured to receive at least a portion of the medicament delivery device. The medicament delivery device, which can be, for example, a single-use medical injector, includes an actuator and a first electronic circuit system. The actuator is configured to initiate delivery of a medicament into a body when the actuator is moved from a first position to a second position. The first electronic circuit system is configured to output a first electronic signal when the actuator is moved from the first position to the second position. The first electronic signal can be, for example, a short-range radio frequency signal having a range of approximately 100 meters or less. The container includes a second electronic circuit system configured to receive the first electronic signal. The second electronic circuit system is configured to output a second electronic signal associated with the first electronic signal.
In some embodiments, an apparatus includes a medicament delivery device and an electronic circuit system coupled to the medicament delivery device. The medicament delivery device includes an actuator configured to initiate delivery of a medicament into a body when the actuator is moved from a first position to a second position. The electronic circuit system includes a first radio frequency identification tag configured to output a first electronic signal and a second radio frequency identification tag configured to output a second electronic signal. The second electronic signal has a characteristic (e.g., a frequency) different than a characteristic of the first electronic signal. The actuator is configured to prevent the second radio frequency identification tag from outputting the second electronic signal when the actuator is moved from the first position to the second position. In some embodiments, for example, the actuator is configured to sever at least a portion of the second radio frequency identification tag when the actuator is moved from the first position to the second position.
In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing, a needle, and an electronic circuit system. The needle has a proximal end and a distal end, and is configured to be in fluid communication with the medicament container. The needle is configured to be moved between a first position and a second position. The distal end of the needle is disposed within the housing when the needle is in the first position. At least a portion of the distal end of the needle is disposed outside of the housing when the needle is in the second position. The electronic circuit system is configured to be coupled to the housing. The electronic circuit system is configured to output an electronic signal associated with an impedance between the distal end of the needle and a portion of the housing.
In some embodiments, a method includes moving an actuator of a medicament delivery device to initiate delivery of a medicament into a body. The actuator can be, for example, a mechanical actuator configured to release a spring, an energy storage member, or the like to initiate medicament delivery when the actuator is moved from the first position to the second position. A first electronic signal is output from a first electronic circuit system in response to the movement of the actuator between the first position and the second position. The first electronic signal is a short-range radio frequency signal having a range of approximately 100 meters or less. A second electronic signal associated with the first electronic signal is output from a second electronic circuit system.
As used herein, the term “regimen” or “medication regimen” can include any program, schedule and/or procedure to enhance, improve, sustain, alter, and/or maintain a patient's well-being. A regimen can include, for example, a schedule of medicament delivery events (e.g., injections, oral doses, etc.) that are prescribed or otherwise suggested for the patient. For example, a regimen can include daily insulin injections. A regimen can also include a single medicament delivery event that can be prescribed or otherwise suggested for the patient to administer in response to given a set of circumstances. For example, a regimen can include a injection of epinephrine in response to an allergic reaction. A regimen can also include the delivery of a placebo or inactive ingredient. For example, a clinical trial can include a regimen including various injections of a placebo. Finally, a regimen can also include activities other than the delivery of drugs to the patient. For example, a regimen can include certain procedures to be followed to enhance the patient's well-being (e.g., a schedule of rest, a dietary plan, etc.).
The auto-injector 1002 includes a housing 1110 that defines a gas chamber 1120. The housing 1110 has a proximal end portion 1112 and a distal end portion 1114. A base 1520 is movably coupled to the distal end portion 1114 of the housing 1110. A safety lock 1710 is removably coupled to the base 1520. As discussed in more detail herein, when the safety lock 1710 is coupled to the base 1520, the auto-injector 1002 cannot be actuated. When the safety lock 1710 is removed from the base 1520, the base 1520 can be moved relative to the housing 1110, thereby actuating the auto-injector 1002. Accordingly, to inject a medicament into the body, the distal end portion 1114 of the housing 1110 is oriented towards the user such that the base 1520 is in contact with the portion of the body where the injection is to be made. The base 1520 is then moved towards the proximal end 1112 of the housing 1110 to actuate the auto-injector 1002.
The auto-injector 1002 includes a medicament injector 1210 and a system actuator 1510 disposed non-coaxially within the housing 1110. The medicament injector 1210 includes multiple medicament vials 1262, a plunger 1284 movably disposed within each medicament vial 1262, a movable member 1312 engaged with each plunger 1284 and a needle 1212. Retraction springs 1350 located within a portion of the base 1520 and the housing 1110 can push the needle 1212 back within the housing 1110 after injection. The system actuator 1510 includes a compressed spring 1560, a compressed gas cylinder 1412, and a puncturing mechanism 1612 to dispel the contents of the compressed gas cylinder 1412.
In use, when the auto-injector 1002 is actuated, the puncturing mechanism 1612 punctures the compressed gas cylinder 1412 allowing a pressurized gas to flow into the gas chamber 1120. In response to a force produced by the pressurized gas on the movable member 1312, the movable member 1312 moves distally within the housing 1110. As a result, the needle 1212 is extended through the housing 1110. The movement of the movable member 1312 also causes the plungers 1284 to move within the vials 1262, thereby expelling a medicament from the vials 1262.
The auto-injector 1002 includes an electronic circuit system 1920 configured to provide a predetermined sequence of electronic outputs and/or electronic signals during the use of the auto-injector 1002. The electronic circuit system 1920 is powered by a battery (not shown in
The start button 1970 is disposed on the proximal end of the housing 1110 and can be manually actuated by the user to begin the sequence of electronic outputs. The first switch 1972A is disposed on the distal portion 1114 of the housing 1110 adjacent the base 1520 and the locking member 1710. The locking member 1710 is configured to engage the first switch 1972A such that when the locking member 1710 is removed, as shown in
The proximity sensor 1974 is disposed on the base 1520 and is configured to produce an output when the base 1520 engages the body. The proximity sensor can be, for example, a temperature sensor, an optical sensor, pressure sensor, impedance sensor or the like. In this manner, the processor can be prompted to output a predetermined electronic output when the base 1520 is positioned against the body.
Similarly, the second switch 1972B is disposed on the housing 1110 adjacent the medicament injector 1210. The medicament injector 1210 is configured to engage the second switch 1972B such that when the medicament injector 1210 is moved distally within the housing 1110 the second switch 1972B changes states. In this manner, the processor can be prompted to output a predetermined electronic output based on the position of the medicament injector 1210. Said another way, the electronic circuit system 1920 can produce and/or output an electronic signal and/or an electronic output in response to the actuation of the auto-injector 1002.
In some embodiments, the electronic circuit system 1920 can be configured to output an electronic signal and/or an electronic output based on the output of the proximity sensor 1974 and the output from the second switch 1972B. For example, in some embodiments, the electronic circuit system 1920 can output a first electronic signal when the output from the proximity sensor 1974 indicates that the base 1520 of the auto-injector 1002 is in contact with the body when the second switch 1972B changes states, and a second electronic signal when the output from the proximity sensor 1974 indicates that the base 1520 of the auto-injector 1002 is disposed apart from the body when the second switch 1972B changes states. Said another way, in some embodiments, the electronic circuit system 1920 can be configured to output a first electronic signal associated with the occurrence of a valid injection event (i.e., an injection event during which there was a high likelihood that the medicament was properly injected into the body) and a second electronic signal associated with the occurrence of an invalid injection event (i.e., an injection event during which there was a high likelihood that the medicament was not injected into the body).
The first visual output device 1958A is disposed on the locking member 1710. Similarly, the second visual output device 1958B is disposed on the outer surface 1111 of the housing 1110. The visual output devices 1958A and 1958B are in electronic communication with the processor and are configured to produce an output in response to an electronic signal output by the processor. The visual output devices 1958A and 1958B, as well as any other visual output devices referenced herein, can be any suitable visual indicia, such as, light-emitting diodes (LEDs), liquid-crystal display (LCD) screens, optical polymers, fiber optic components or the like. In some embodiments, the visual output devices 1958A and 1958B can be coupled to the housing 1110 and/or the locking member 1710 by a label 1910.
The audio output device 1956 is disposed within the housing 1110 such that it can project sound outside of the housing 1110. The audio output device 1956, as well as any other audio output devices referenced herein, can be any suitable device for producing sound, such as a micro-speaker a piezo-electric transducer or the like. Such sound output can include, for example, an alarm, a series of beeps, recorded speech or the like. The audio output device 1956 is in electronic communication with the processor and is configured to produce an output in response to an electronic signal output by the processor.
The network interface device 1953 is configured to operatively connect the electronic circuit system 1920 to a remote device 1941 (see
In use, the user activates the electronic circuit system by pushing the start button 1970 to activate the processor, thereby causing the processor to output a predetermined sequence of electronic outputs. In some embodiments, the start button 1970 can activate the processor by providing an input to the processor. In other embodiments, the start button 1970 can activate the processor by placing the battery (not shown in
In some embodiments, upon activation, the processor can output an electronic signal to the audio output device 1956 thereby producing a first electronic output instructing the user in how to use the auto-injector 1002. Such a message can state, for example, “please remove the safety tab.” Additionally, the first visual output device 1958A can produce a flashing light to further indicate to the user where the locking member 1710 is located. The processor can be configured to repeat the first audible instruction if the locking member 1710 is not removed within a predetermined time period.
When the user removes the locking member 1710, the first switch 1972A changes states thereby triggering the processor to output an electronic output providing a second instruction to the user. The second instruction can be, for example, an audible speech output instructing the user to “please place the base of the device on the outer portion of your thigh.” The first visual output device 1958A can produce a lighted output during this audible instruction, thereby visually indicating where the base 1520 is located and/or what portion of the base 1520 should be placed on the thigh.
When the user places the base 1520 against the body, the proximity sensor 1974 provides an input to the processor, thereby triggering the processor to output an electronic output providing a third instruction to the user. The third instruction can be, for example, an audible speech output instructing the user to “push down on the top of the device to activate the injector.”
When the injection is completed, the medicament injector 1210 is configured to engage the second switch 1972B, thereby triggering the processor to output an electronic output providing a fourth instruction to the user. Such a post-use instruction can be, for example, an audible speech output instructing the user to seek further medical attention, providing instructions for the safe disposal of the auto-injector 1002 or the like.
In some embodiments, the processor 1950 can output an electrical signal associated with the second switch 1972B that is received by a remote device 1941, which can be, for example, a compliance tracking device. Said another way, in some embodiments, the electronic circuit system 1920 can output, to the remote device 1941, an electrical signal associated with the end of the injection event. In this manner the electronic circuit system 1920 on the auto-injector 1002 can cooperate with the remote device 1941 to electronically and/or automatically track the details of the use of the auto-injector 1002. Similarly stated, the electronic circuit system 1920 on the auto-injector 1002 and the remote device 1941 can electronically and/or automatically track the patient compliance data associated with the use of the auto-injector 1002.
As described above, the electronic circuit system 1920 also includes a network interface 1953 configured to couple the electronic circuit system 1920 to a remote device 1941 and/or a communications network (not shown in
The electronic circuit system 2920 is configured to output an electronic signal of the types shown and described herein. As discussed in more detail herein, the electronic circuit system 2920 can include many components, such as, for example, a processor, a switch, a visual output device and/or an audio output device. The electronic signal can be, for example, an electronic signal communicated to an output device, such as, for example, a visual output device, an audio output device, a haptic output device or the like. In some embodiments, the electrical signal can be a communications signal configured to be received by a remote device, in a manner similar to that described herein.
In some embodiments, the electronic signal can be associated with an aspect of the medical device 2002, such as an instruction associated with an initial use of the medical device 2002. For example, in some embodiments, the electronic circuit system 2920 can output a text message to a display screen (not shown) disposed on the medical device 2002 instructing the user in the use of the medical device 2002. In other embodiments, the electronic circuit system 2920 can produce an audio output, such as recorded speech, instructing the user in the use of the medical device 2002. In yet other embodiments, the electronic circuit system 2920 can produce and/or transmit an electrical signal associated with a medicament delivery event. In this manner, the electronic circuit system 2920 can be used to track the patient compliance data associated with the use of the medicament delivery device 2002.
Although the electronic circuit system 2920 is shown as being disposed on the second surface 2914 of the label 2910, in other embodiments, the electronic circuit system can be disposed on the first surface 2912 of the label 2910. In yet other embodiments, the electronic circuit system 2920 can be disposed between the first surface 2912 and the second surface 2914 of the label 2910. In yet other embodiments, the label 2910 can include multiple discrete layers coupled together, within which portions of the electronic circuit system can be disposed.
The auto-injector 4002 includes a housing 4110 having a proximal end portion 4112 and a distal end portion 4114. The distal end portion 4114 of the housing 4110 includes a protrusion 4142 to help a user grasp and retain the housing 4110 when using the auto-injector 4002. Said another way, the protrusion 4142 is configured to prevent the auto-injector 4002 from slipping from the user's grasp during use. A base 4520 is movably coupled to the distal end portion 4114 of the housing 4110. A needle guard assembly 4810 is removably coupled to the base 4520. Similarly, a safety lock 4710 is removably coupled to the base 4520. To inject a medicament into the body, the distal end portion 4114 of the housing is oriented towards the user such that the base 4520 is in contact with the portion of the body where the injection is to be made. The base 4520 is then moved towards the proximal end 4112 of the housing 4110 to actuate the auto-injector 4002.
The auto-injector 4002 includes a label 4910 coupled to an outer surface 4111 of the housing 4110. The label 4910 includes an outer layer 4911, an intermediate layer 4980 and an electronic circuit system 4920 (see
A portion of the second surface 4914 of the outer layer 4911 can be coupled to the outer surface 4111 of the housing 4110 by any suitable method. For example, in some embodiments, the second surface 4914 of the outer layer 4911 includes an adhesive configured to bond the outer layer 4911 to the outer surface 4111 of the housing 4110. Other portions of the second surface 4914 of the outer layer 4911 are adjacent the intermediate layer 4980 and portions of the electronic circuit system 4920. In this manner, the outer layer 4911 of the label 4910 retains the intermediate, or spacer, layer 4980 and the electronic circuit system 4920 in a predetermined position against the outer surface 4111 of the housing 4110.
The outer layer 4911 of the label 4910 includes multiple openings 4917 adjacent the audio output device 4956. In this manner, sound waves produced by the audio output device 4956 can be transmitted to an area outside of the housing 4110. Similarly, the outer layer 4911 of the label 4910 includes openings 4918 adjacent the light emitting diodes (LEDs) 4958A and 4958B to allow the user to see the visual output. In some embodiments, the outer layer 4911 of the label 4910 can include a transparent portion adjacent the LEDs 4958A and 4958B to allow the user to see the visual output.
The electronic circuit system 4920 includes a printed circuit board 4922 upon which a microprocessor 4950, two LEDs 4958A and 4958B, two switches 4972A and 4972B and various electronic components 4951, such as, for example, resistors, capacitors and diodes, are mounted. The electronic circuit system 4920 also includes an audio output device 4956, such as, for example, a micro-speaker, coupled to the outer surface 4111 of the housing 4110 adjacent the printed circuit board 4922. The printed circuit board 4922 includes a substrate 4924 upon which a series of electrical conductors 4934, such as for example, copper traces, are etched. The substrate 4924 can be constructed from any material having suitable electrical properties, mechanical properties and flexibility, such as, for example Mylar®, Kapton® or impregnated paper.
A mask layer (not shown) is disposed over the substrate 4924 to electrically isolate selected portions of the electrical conductors 4934 from adjacent components. The electrical conductors 4934 operatively couple the above-mentioned circuit components in a predetermined arrangement. In this manner, the electronic circuit system 4920 can be configured to output, via the LEDs 4958A and 4958B and/or the audio output device 4956, a predetermined sequence of electronic outputs during the use of the auto-injector 4002.
Power is supplied to the electronic circuit system 4920 by two batteries 4962 connected in series. The batteries can be, for example, three volt, “watch-style” lithium batteries. As shown in
As shown in
The intermediate, or spacer, layer 4980 is disposed between the outer layer 4911 and the electronic circuit system 4920. The intermediate layer 4980 includes openings (not shown) within which various components of the electronic circuit system, such as, for example, the batteries 4962 are disposed. The intermediate layer 4980 is sized to maintain a predetermined spacing between the various components included in the label 4910. The intermediate layer can be constructed from any suitable material, such as, for example, flexible foam having an adhesive surface, polycarbonate or the like.
The operation of the auto-injector 4002 and the electronic circuit system 4920 is now discussed with reference to
Prior to use, the auto-injector 4002 is first enabled by removing the needle guard 4810 and the safety lock 4710 (see
The sheath retainer 4840 includes an actuator 4864 that is received by an opening 4862 in the isolation tab 4860. Accordingly, when the sheath retainer 4840 is moved distally away from the base 4520, the isolation tab 4860 is removed from the area between the first electrical contact portion 4936 of the printed circuit board 4922 and the first surface 4964 of one of the batteries 4962. In this manner, the batteries 4962 can be operatively coupled to the electronic circuit system 4920 when the needle guard 4810 is removed, thereby actuating the electronic circuit system 4920.
When actuated, the electronic circuit system 4920 can output one or more predetermined electronic outputs. For example, in some embodiments, the processor 4950 can output an electronic signal associated with recorded speech to the audible output device 4956. Such an electronic signal can be, for example, associated with a .WAV file that contains a recorded instruction instructing the user in the operation of the auto-injector 4002. Such an instruction can state, for example, “remove the blue safety tab near the base of the auto-injector.” The processor can simultaneously output an electronic signal to the first LED 4958A, thereby causing the first LED 4958A, which is located near the safety lock 4710, to flash a particular color. In this manner, the electronic circuit system 4920 can provide both audible and visual instructions to assist the user in the initial operation of the auto-injector 4002.
In other embodiments, the electronic circuit system 4920 can output an electronic output associated with a description and/or status of the auto-injector 4002 and/or the medicament contained therein. For example, in some embodiments, electronic circuit system 4920 can output an audible message indicating the type of medicament contained in the auto-injector, the expiration date of the medicament, the dosage of the medicament or the like.
As illustrated by arrow BB in
In some embodiments, the safety lock 4710 includes an actuator 4732 that actuates the electronic circuit 4920 to trigger a predetermined output or sequence of outputs when the safety lock 4710 is moved from the first position to a second (or unlocked) position, as shown in
As shown in
When the actuator 4732 actuates the electronic circuit system 4920 as described above, the electronic circuit system 4920 can output one or more predetermined electronic outputs. For example, in some embodiments, the processor 4950 can output an electronic signal associated with recorded speech to the audible output device 4956. Such an electronic signal can be, for example, associated with a recorded message notifying the user of the status of the auto-injector 4002. Such a status message can state, for example, “The auto-injector is now enabled.” The processor can also simultaneously output an electronic signal to the first LED 4958A, thereby causing the first LED 4958A to stop flashing, change color or the like.
In some embodiments, the electronic circuit system 4920 can be configured to output the status message for a predetermined time period, such as, for example, five seconds. After the predetermined time period has elapsed, the electronic circuit system 4920 can output an audible message further instructing the user in the operation of the auto-injector 4002. Such an instruction can state, for example, “Place the base of the auto-injector against the patient's thigh. To complete the injection, press the base firmly against the patient's thigh.” In some embodiments, the processor can simultaneously output an electronic signal to the second LED 4958B, thereby causing the second LED 4958B, which is located near the base 4520, to flash a particular color. In this manner, the electronic circuit system 4920 can provide both audible and visual instructions to assist the user in the placement and actuation of the auto-injector 4002. In some embodiments, the electronic circuit system 4920 can be configured to repeat the instructions after a predetermined time period has elapsed.
After the auto-injector 4002 is enabled and placed against the body of the patient, the auto-injector 4002 is actuated by moving the base 4520 proximally towards the housing 4110, as illustrated by arrow CC in
When the actuator 4538 actuates the electronic circuit system 4920, the electronic circuit system 4920 can output one or more predetermined electronic outputs. For example, in some embodiments, the processor 4950 can output an electronic signal associated with recorded speech to the audible output device 4956. Such an electronic signal can be, for example, associated with a recorded message notifying the user that the injection is complete, instructing the user on post-injection disposal and safety procedures, instructing the user on post-injection medical treatment or the like. Such a status message can state, for example, “The injection is now complete. Please seek further medical attention from a doctor.” The processor can also simultaneously output an electronic signal to the first LED 4958A, thereby causing the first LED 4958A to stop flashing, change color or the like, to provide a visual indication that the injection is complete.
As described above, the audio output device 4956, can include, for example, a micro-speaker. In some embodiments, for example, the audio output device 4956 can include an RS-1511A micro-speaker manufactured by Regal Electronics, Inc.
Similarly, the microprocessor 4950 can be a commercially-available processing device dedicated to performing one or more specific tasks. For example, in some embodiments, the microprocessor 4950 can be a commercially-available microprocessor, such as the Sonix SNC 12060 voice synthesizer. Alternatively, the microprocessor 4950 can be an application-specific integrated circuit (ASIC) or a combination of ASICs, which are designed to perform one or more specific functions. In yet other embodiments, the microprocessor 4950 can be an analog or digital circuit, or a combination of multiple circuits.
The microprocessor 4950 can include a memory device (not shown) configured to receive and store information, such as a series of instructions, processor-readable code, a digitized signal, or the like. The memory device can include one or more types of memory. For example, the memory device can include a read only memory (ROM) component and a random access memory (RAM) component. The memory device can also include other types of memory suitable for storing data in a form retrievable by the microprocessor 4950, for example, electronically-programmable read only memory (EPROM), erasable electronically-programmable read only memory (EEPROM), or flash memory.
The housing 6110 has a proximal end portion 6112 and a distal end portion 6114. An label 6910, which includes at least a portion of an electronic circuit system 6920, is disposed on an outer surface 6111 of the housing 6110. As described above, a portion of the label 6910 can include a textual indicia 6916. Similar to the electronic circuit systems shown and described above, the electronic circuit system 6920 is configured to output at least one electronic signal associated with the user of the inhaler 6002. The electronic circuit system 6920 includes a microprocessor (not shown), a microspeaker 6956 and an LED 6958. The electronic circuit system 6920 also includes a motion sensor 6976, the function of which is discussed in more detail below.
The distal end portion 6114 of the housing 6110 includes a mouthpiece 6212 about which a protective cap 6710 is disposed. Prior to use, the inhaler 6002 is first enabled by removing the protective cap 6710, as shown by the arrow GG in
When actuated, the electronic circuit system 6920 can output one or more predetermined electronic outputs. For example, in some embodiments, the electronic circuit system 6920 can output an audible message via the microspeaker 6956 instructing the user to “vigorously shake the inhaler for five seconds.” The processor can simultaneously enable the motion sensor 6976.
Upon receiving a predetermined input from the motion sensor 6976, which can be any sensor suitable for detecting the rapid motion of the inhaler 6002, the processor can then send an electronic signal to produce a second audible message. Such a message can state, for example, “the inhaler is now sufficiently shaken and is ready for use.” In some embodiments, the electronic circuit system 6920 can also output an instruction associated with the correct placement of the inhaler 6002. For example, the electronic circuit system 6920 can output an audible message stating “please place the mouthpiece in your mouth and firmly press down on the medicament container.” The electronic circuit system 6920 can also simultaneously output a signal to the LED 6958 to provide a visual indication of where the mouthpiece 6212 is located.
After the inhaler 6002 is enabled and placed within the mouth of the patient, the inhaler 6002 is actuated by moving the medicament container 6262 distally within housing 6110, as illustrated by arrow HH in
As described above, although not explicitly shown in
In some embodiments, for example, a medicament delivery device can include a network interface device configured to send and/or receive electrical signals via a wireless network. For example,
In use, the wireless communications system 7985 can be used to send and/or receive information associated with the medicament delivery device 7002. Such information can include, for example, information associated with the frequency with which medicament delivery device 7002 is used (e.g., a compliance log), the functionality of the medicament delivery device 7002 after use (e.g., the number of doses remaining), the date and/or time of use, a parameter measuring the success of the latest use of the medicament delivery device 7002, an expiration date of the medicament delivery device 7002 and/or the medicament contained therein, a status of the medicament delivery device 7002 and/or the medicament contained therein, instructions for using the medicament delivery device 7002, the need for additional medical devices, the need for additional drug dosages, and/or any other information that may be useful to users and/or medical professionals associated with the medicament delivery device 7002. For example, in some embodiments, the wireless communications system 7985 can send one or more signals S1 including information related to a user's compliance to the user's home computer and/or a compliance monitoring device. In this manner, the user can use their home computer to track their compliance with a prescribed medication regimen or other usage of the medicament delivery device 7002. In other embodiments, the wireless communications system 7985 can send one or more signals S1 including information related to a user's compliance to a third party. Such third parties can include, for example, a health care provider, an emergency contact, a manufacturer of the medicament delivery device 7002, a pharmaceutical benefits manager (PBM), a specialty pharmacy, a payor (e.g., an insurance company), a clinical trial administrator, an on-line support group or forum, and/or a pharmaceutical company. For example, in some embodiments, the wireless communications system 7985 can send one or more signals S1 including information related to a user's compliance to the user's health care provider. In this manner, the health care provider can monitor the user's compliance with the prescribed medication regimen.
The wireless communications system 7985 can include any hardware, software and/or firmware suitable for wireless communication. For example, in some embodiments, the wireless communications system 7985 can include a microprocessor, a transmitter, a receiver, a transceiver, a microchip, a radio chipset, a wireless interface card (WIC), a host controller interface (HCI), a universal asynchronous receiver/transmitter (UART), a power source (e.g., a battery), one or more sensors, a transponder, an antenna, a crystal, a circuit board, a liquid crystal display (LCD), a Small Computer System Interface (SCSI and ports), a FireWire (or other IEEE 1394 interfaces), a data uplink, a data downlink, a point-to-point link, a fiber optic link, a storage device (e.g., hard drive, flash drive or the like), a personal computer cards, a docking stations, a parallel and/or bit-serial connections, a Universal Serial Bus (USB) port or other serial ports, a light emitting diode (LEDs), a speaker, an amplifier, radiofrequency identification (RFID) devices and/or other common electronic components used for wireless communication. The electronic components can be operatively coupled to form the wireless communications system 7985 by any suitable circuitry. In some embodiments, the wireless communications system 7985 can include the components used for wireless communication on a single chip, such as, for example, the Bluetooth™ radio chip LMX9830 manufactured by National Semiconductor.
As described above, the wireless access point WAP is configured to establish the wireless network NW and to transmit electronic signals between the medicament delivery device 7002 (which can be referred to as a wireless client device), wireless communications devices 7990 (which can be referred to as other wireless client devices) and/or other third party devices 7992. In some embodiments, the wireless communications devices 7990 and/or other third party devices 7992 can include, for example, laptops (computers), personal digital assistants (PDAs), wireless IP phones, servers, routers, and other wireless enabled network devices. Although the wireless access point WAP is shown and described as being distinct from the wireless communications system 7985, in some embodiments, the wireless communications system 7985 can include the functionality of a wireless access point. In this manner, the medicament delivery device 7002 can be utilized as a wireless access point. In yet other embodiments, the wireless communications system 7985 can send and/or receive electronic signal S1 without the use of a wireless access point. In such embodiments, which can be referred to as peer-to-peer networks or ad-hoc networks, the wireless communications system 7985 can communicate directly with the wireless communications devices 7990 and/or other third party devices 7992.
The wireless communication system 7985 can employ any suitable protocol or protocols for sending and/or receiving the electronic signals S. Such protocols can include, for example, Wi-Fi, Bluetooth™, Zigbee, Wi-Max, 802.XX, HomeRF, any protocols associated with Radio Frequency Identification (RFID) transmission and/or a combination thereof. In some embodiments, the wireless communications system 7985 can employ a protocol having heightened security, such as for example, varying levels of encryption. In this manner any information associated with the medical records of a user can be protected against unauthorized access.
In addition to encryption, in some embodiments, the information transmitted and/or received by the wireless communication system 7985 can be in a format configured to prevent the identification of the user. For example, in some embodiments, the information transmitted and/or received by the wireless communication system 7985 can be associated with a unique identification number known only by certain parties, such as, for example, the end user and the end user's physician.
The wireless communications network NW can have any suitable range. For example, in some embodiments, the wireless communications network NW can be a wireless local area network (WLAN). A WLAN can be suitable in certain conditions in which the communications devices 7990 are confined to a limited geographical area, such as, for example, within a hospital, a nursing home or a triage unit. In other embodiments, the wireless communications network NW can be a wireless metropolitan area network (WMAN). A WMAN can be suitable in certain conditions in which the communications devices 7990 are used within a predefined area that cannot easily be covered by a WLAN, such as, for example, within a city. In yet other embodiments, the wireless communications network NW can be a wireless wide area network (WWAN).
Although the arrangement shown in
The medicament delivery device 7002 can be any device suitable for delivering one or more doses of a medicament into a patient's body. As described herein, such devices can include, for example, auto-injectors, pen injectors, inhalers, transdermal patches, pre-filled syringes (PFS), syringes, catheters, stents, implantable vehicles, topical vehicles, pill dispensers or the like. In some embodiments, for example, the medicament delivery device 7002 can be a single-dose device typically used in emergency situations. For example, in some embodiments, the medicament delivery device 7002 can be a single-use medical injector, similar to auto-injector 4002 shown and described above with reference to
In other embodiments, the medicament delivery device 7002 can be a chronic-care medicament delivery device containing multiple doses of medicament configured to be delivered on a regular schedule. In some embodiments, for example, the medicament delivery device 7002 can be a chronic-care pen injector used for injectable pharmaceuticals that require daily, weekly and/or monthly injections, such as, for example, insulin or human growth hormone (HgH). In such embodiments, the wireless communication system 7985 can track the usage of the pen injector and transmit the use information to the patient's physician, specialty pharmacy, payor (e.g., an insurance company), PBM, clinical trial administrator or other provider. In this manner, for example, the patient's physician can ensure that the therapy regime is effective.
In yet other embodiments, the medicament delivery device 7002 can be a single-use and/or disposable chronic-care medicament delivery device. As described in more detail herein, in such embodiments the medicament delivery device 7002 can be included within a kit containing the desired number of doses of medicament.
As described above, in some embodiments, a medicament delivery device can be configured to produce and/or output an electrical signal when the medicament delivery device is actuated. In this manner, patient compliance data, such as, for example, the frequency of use, the date and time of use and/or a parameter measuring the success and/or validity of the use of the medicament delivery device can be monitored based on the actuation of the medicament delivery device, rather than on the removal of a safety interlock from the medicament delivery device. For example,
The container 3010 includes an electronic circuit system 3020 configured to output at least electronic signals S2 and S4, as described in more detail herein. The electronic circuit system 3020 can include any suitable electronic components operatively coupled to produce and/or output the electronic signal S2 and S4, and/or to perform the functions described herein. The electronic circuit system 3020 is operatively coupled to the communications network NW, which includes at least a personal computer (PC) 3990 or other processor, and an internet server 3991. In some embodiments, for example, the electronic circuit system 3020 can include a wireless communications device, similar to the wireless communications system 7985 shown and described above with reference to
The medicament delivery device 3002 can be any device for delivering a medicament into a body, such as, for example, a medical injector (which can include an auto-injector, a pen injector, a multiple-use injector, a syringe or the like), an inhaler or the like. The medicament delivery device 3002 includes an actuator 3970 and an electronic circuit system 3920. The actuator 3970 is movable between a first position (
The electronic circuit system 3920 of the medicament delivery device 3002 is configured to output at least an electronic signal S3 (see
The medical system 3000 can be used to manage the patient's medication regimen and/or track the patient's compliance in following the prescribed medication regimen. When the medical system 3000 is in the first configuration (i.e., the “storage configuration”), as shown in
To move the medical system 3000 from the first configuration to the second configuration (i.e., a “pre-delivery” configuration), the medicament delivery device 3002 is removed from the container 3010, as shown by the arrow JJ in
To move the medical system 3000 from the second configuration to the third configuration (i.e., a “post-delivery” configuration), the medicament delivery device 3002 is actuated by moving the actuator 3970 from the first position (
When the actuator 3970 is moved from the first position to the second position, the electronic circuit system 3920 of the medicament delivery device 3002 outputs the second electronic signal S3. Said another way, when actuator 3970 is moved from the first position to the second position, the actuator 3970 actuates the electronic circuit system 3920 of the medicament delivery device 3002 such that the electronic circuit system 3920 produces and/or outputs the second electronic signal S3. In some embodiments, the movement of the actuator 3970 produces an input that is received by the electronic circuit system 3920, thereby triggering the electronic circuit system 3920 to produce and/or out the second electronic signal S3. Said another way, in some embodiments, the movement of the actuator 3970 changes the state of a switch (not shown in
The second electronic signal S3 is received by the electronic circuit system 3020 of the container 3010, which then produces the third electronic signal S4. The third electronic signal S4 is associated with the second electronic signal S3. In this manner, the electronic circuit system 3020 of the container 3010 and the electronic circuit system 3920 of the medicament delivery device 3002 can cooperatively monitor the patient's compliance in using the medicament delivery device 3002. By utilizing two electronic circuit systems, the electronic circuit system 3920 and the electronic circuit system 3020 can be cooperatively designed to provide the desired functionality. For example, in some embodiments, the container 3010 can be a reusable compliance tracking device and the medicament delivery device 3002 can be a single-use, disposable device. In such an arrangement, the electronic circuit system 3020 of the container 3010 can include complicated circuit elements, circuit elements having a higher cost, and/or circuit elements having higher power consumption (e.g., speakers, long-range wireless communications systems and the like). Conversely, the electronic circuit system 3920 of the medicament delivery device 3002 can include fewer circuit elements, circuit elements having a lower cost, and/or circuit elements having lower power consumption. In some embodiments, for example, the electronic circuit system 3920 of the medicament delivery device 3002 can include a transceiver (not shown in
The second electronic signal S3 can be any suitable communications signal (e.g., a radio frequency signal) that can be received by the electronic circuit system 3020 of the container 3010. For example, in some embodiments, the second electronic signal S3 can be a short-range radio frequency signal having a range of approximately 100 meters or less. In some embodiments, the second electronic signal S3 can be a Bluetooth™-compatible electronic signal, including either a class 1, class 2 or class 3 signal. Said another way, in some embodiments, the electronic circuit system 3920 of the medicament delivery device 3002 and the electronic circuit system 3020 of the container 3010 can be Bluetooth™-enabled circuits. In this manner, the medicament delivery device 3002 can electronically communicate with the container 3010 using low-cost circuit elements and/or using circuit elements having minimal power consumption.
The third electronic signal S4 can be any suitable electronic signal that can be produced and/or output by the electronic circuit system 3020 of the container 3010. For example, in some embodiments, the third electronic signal S4 can be output to an audio output device and/or a video output device (not shown in
In some embodiments, the third electronic signal S4 can be a communications signal (e.g., a radio frequency signal) that can be transmitted from the electronic circuit system 3020 of the container 3010 to the PC 3990 and/or the communications network NW. Such transmission can occur using any suitable method and/or protocol. The third electronic signal S4 can be transmitted, for example, in the form of an e-mail, a phone call, a data stream or the like.
In some embodiments, for example, the third electronic signal S4 can be associated with the patient's compliance in using the medicament delivery device 3002. For example, in some embodiments, the third electronic signal S4 can be sent via the communications network NW to the patient's pharmacy to automatically order additional pre-filled medicament delivery devices and/or replacement cartridges for the medicament delivery device. In other embodiments, the third electronic signal S4 can be sent via the communications network NW to a health care provider, thereby allowing the health care provider to remotely monitor the patient's medication regimen. In yet other embodiments, the third electronic signal S4 can be sent via the communications network NW to a clinical trial administrator, thereby allowing the clinical trial administrator to ensure that the clinical trial protocols are being properly followed.
A first electronic signal is then output from a first electronic system in response to the movement of the actuator, 14. The first electronic signal is a short-range radio frequency signal having a range of approximately 100 meters or less. In some embodiments, for example, the first electronic signal can be a Bluetooth™-compatible electronic signal, including either a class 1, a class 2 or a class 3 signal. In other embodiments, the first electronic signal can be a short-range signal produced by a radio frequency identification (“RFID”) tag within the first electronic circuit system. In this manner, the first electronic circuit system can produce and/output the first electronic signal using electronic devices having a low power consumption, as described above. As described in more detail herein, in some embodiments, the first electronic circuit system can be devoid of a battery.
The first electronic circuit system can be any suitable electronic circuit system of the types shown and described herein. For example, in some embodiments, at least a portion of the first electronic circuit system can be disposed on the housing of the medicament delivery device. In other embodiments, at least a portion of the first electronic circuit system can be disposed on a portion of the medicament delivery device that is removably coupled to the housing of the medicament delivery device (e.g., a removable protective sheath, a removable safety lock or the like). In some embodiments, for example, a medicament delivery device can include a protective sheath that includes a first portion of the first electronic circuit system, and a housing that includes a second portion of the first electronic circuit system. In such embodiments, the first portion of the first electronic circuit system can include a processor configured to control the second portion of the first electronic circuit system and/or a battery configured to provide power to the second portion of the first electronic circuit system. Similarly, the second portion of the first electronic circuit system can include a processor configured to control the first portion of the first electronic circuit system and/or a battery configured to provide power to the first portion of the first electronic circuit system.
A second electronic signal is then output from a second electronic circuit system, 16. The second electronic signal is associated with the first electronic signal. Similarly stated, the second electronic circuit system outputs the second electronic signal in response to the first electronic signal. In some embodiments, for example, the second electronic signal can include information associated with and/or included within the first electronic signal, such as, for example, the date and time when the first electronic signal was received by the second electronic circuit system. In other embodiments, the second electronic signal can include information identifying the contents of the medicament delivery device (e.g., the amount and type of medicament contained therein), an expiration date of the medicament delivery device, or the like.
As described above, the second electronic signal can be any suitable electronic signal that can be produced and/or output by the second electronic circuit system. For example, in some embodiments, the second electronic signal can be output to an audio output device and/or a video output device. In other embodiments, the second electronic signal can be a communications signal (e.g., a radio frequency signal) that can be transmitted from the second electronic circuit system to the user's computer, a communications network NW, and/or a remotely located device.
The electronic circuit system 12530 of the compliance monitoring device 12510 is configured to produce and/or output one or more electronic outputs and/or electronic signals of the type described above. As described in more detail below, the electronic circuit system 12530 includes a speaker 12544 and an LCD screen 12542. Moreover, similar to the container 3010 shown and described above with reference to
The hinged lid 12518 has a first position (see
The electronic circuit system 12530 of the compliance monitoring device 12510 is operatively coupled to the first switch 12536 and the second switch 12537. The first switch 12536 is configured to move between a first state (e.g., closed) and a second state (e.g., opened) when the hinged lid 12518 moves between its first position and its second position, as indicated by arrow LL in
The second switch 12537 is configured to move between a first state (e.g., closed) and a second state (e.g., opened) when the medicament delivery device 12002 is removed from the internal region 12512 of the compliance monitoring device 12510, as indicated by the arrow MM in
The medicament delivery device 12002 can be any device for delivering a medicament into a body, of the types shown and described herein. The medicament delivery device 12002 includes an actuator 12970 and an electronic circuit system 12920. The actuator 12970 is movable between a first position (
The electronic circuit system 12920 of the medicament delivery device 12002 is configured to output at least an electronic signal S5 (see
The medical system 12000 can be used to manage the patient's medication regimen and/or track the patient's compliance in following the prescribed medication regimen in a similar manner as described above with reference to the medical system 3000. To move the medical system 12000 from a storage configuration (
To administer the medication (i.e., to move the medical system 12000 to a post-delivery configuration, as shown in
When the actuator 12970 is moved from the first position to the second position, the electronic circuit system 12920 of the medicament delivery device 12002 outputs the electronic signal S5. Said another way, when actuator 12970 is moved from the first position to the second position, the actuator 12970 actuates the electronic circuit system 12920 of the medicament delivery device 12002 such that the electronic circuit system 12920 produces and/or outputs the electronic signal S5. The actuator 12970 can actuate the electronic circuit system 12920 in any manner as described herein. The electronic signal S5 can be any suitable communications signal, as described herein.
In a similar manner as described above with reference to the medical system 3000, the electronic signal S5 is received by the electronic circuit system 12530 of the compliance monitoring device 12510, which then produces the third electronic output OP3. The third electronic output OP3 is associated with the electronic signal S5. For example, the third electronic output OP3 can include a date and time stamp documenting when the electronic signal S5 was received. In some embodiments, the third electronic output OP3 can include information included within the electronic signal S5, such as a unique identification of the medicament delivery device 12002. In this manner, the electronic circuit system 12530 of the compliance monitoring device 12510 and the electronic circuit system 12920 of the medicament delivery device 12002 can cooperatively monitor the patient's compliance in using the medicament delivery device 12002. As described above, in some embodiments, the third electronic output OP3 includes a communications signal (e.g., a radio frequency signal) that can be transmitted from the electronic circuit system 12530 of the of the compliance monitoring device 12510 to the PC 12990.
Although the electronic circuit system 12530 of the compliance monitoring device 12510 is shown and described as receiving the electronic signal S5 from medicament delivery device 12002 in real-time when the medicament delivery device 12002 is actuated, in other embodiments, the electronic signal S5 can be received by the electronic circuit system 12530 of the compliance monitoring device 12510 at any time after the medicament delivery device 12002 has been actuated. For example, in some embodiments, the electronic signal S5 can be a short-range radio frequency signal having a range of approximately 100 meters or less. Accordingly, in certain instances, the medicament delivery device 12002 may be actuated when the medicament delivery device 12002 is out of transmission range for transmitting the electronic signal S5 to the compliance monitoring device 12510. In some such embodiments, for example, the electronic circuit system 12530 of the compliance monitoring device 12510 and/or the electronic circuit system 12970 of the medicament delivery device 12002 can be configured to detect when the medicament delivery device is in range (e.g., when the patient returns home) and then transmit the electronic signal S5. In other such embodiments, the electronic circuit system 12530 of the compliance monitoring device 12510 can include a scanner (e.g., an optical scanner or the like; not shown in
Although the medical system 12000 is shown and described above as including one medicament delivery device 12002, in other embodiments, a medical system can include multiple medicament delivery devices. Such a system can be used, for example, as a part of a chronic-care medication regimen. For example, a medical system having multiple medicament delivery devices can be used to manage insulin delivery or the delivery of other medicaments (e.g., to treat Multiple Sclerosis, anemia, Rheumatoid Arthritis, Osteoporosis or the like), which can require daily, weekly and/or monthly injections.
The medical injectors 14002A-14002G can be, for example, single-use, disposable auto-injectors of the types shown and described herein. In some embodiments, the medical injectors 14002A-14002G can include the same dosage of a medicament, and can be prescribed as a part of a chronic-care medicament regimen, clinical trial, or the like. In other embodiments, the medical injectors 14002A-14002G can include the different dosages and/or different medicament compositions.
Each of the medical injectors 14002A-14002G includes a removable cover 14070A-14070G, a first electronic circuit system 14920A-14920G and a second electronic circuit system 14080A-14080G. The removable covers 14070A-14070G can be, for example, protective needle guards, safety locks, or any other protective device. As shown in
The container 14040 includes an electronic circuit system 14050, and is configured to receive and/or hold at least a portion of each of the medical injectors 14002A-14002G. For example, in some embodiments, the container 14040 can include multiple recessed portions, retainers, and/or any other suitable structure that matingly receives at least a portion of each medical injector 14002A-14002G. In some embodiments, the medical injectors 14002A-14002G can be arranged within the container 14040 in a specific order and/or orientation. Such an arrangement can be used, for example, to facilitate the medication regimen. Said another way, in some embodiments, the medical injectors 14002A-14002G can be arranged in the order reflecting the order in which they are to be administered by the user. In other embodiments, however, the medical injectors 14002A-14002G can be arranged within the container 14040 randomly. Moreover, in some embodiments, the container 14040 can be configured to receive different types of medical injectors. This can allow the container 14040 to be used in both current and future therapeutic regimens for a patient.
The electronic circuit system 14050 of the container 14040 can be similar to the electronic circuit systems shown and described above, and can, for example, transmit and/or receive electronic signals from the electronic circuit system 14020 of the compliance monitor, the first electronic circuit systems 14920A-14920G and/or the second electronic circuit systems 14080A-14080G. In some embodiments, the electronic circuit system 14050 of the container 14040 can include an RFID tag encoded with information associated with the medical injectors 14002A-14002G, the medication regimen or the like. In this manner, the electronic signals output and/or produced by the electronic circuit system 14050 of the container 14040 can include information characterizing the medical injectors 14002A-14002G and/or the medication regimen. Such information can include, for example, the number of medical injectors, the amount and type of medicament contained within each medical injector, an expiration date of each medical injector or the like. In this manner, when a patient receives a container 14040 for use, the electronic circuit system 14050 of the container 14040 can be electronically encoded with information that can received by the compliance tracking device 14010. Accordingly, when the patient electronically couples the container 14040 to the compliance tracking device 14010 (e.g., by wired connection or a wireless connection), the container 14040 and the compliance tracking device 14010 can electronically and/or automatically update the patient compliance data associated with the medication regimen.
In use, a container 14040 can include the medical injectors required to administer a predetermined medication regimen. For example, in some embodiments the container 14040 can be “loaded” by a pharmacy and delivered to the patient. The container 14040 is then operatively coupled to the compliance tracking device 14010. Said another way, the electronic circuit system 14050 of the container 14040 can be electronically coupled to the electronic circuit system 14020 of the compliance tracking device 14010. In this manner, the electronic information included within the electronic circuit system 14050 of the container 14040 can be received by the electronic circuit system 14020 of the compliance tracking device 14010 to initialize and/or update a compliance tracking schedule associated with the patient's medication regimen.
The compliance tracking device 14010 can then produce and/or output one or more electronic outputs, as described above. Such outputs can include, for example, visual and/or audible outputs reminding the patient of the date and time of the next dosage, indicating the expiration date of the medicament delivery device, providing instructions in the use of the medicament delivery device, a status of the compliance tracking device 14010, a use instruction associated with the compliance tracking device 14010 and/or the like.
To administer a dosage, the patient removes the appropriate medical injector (e.g., medical injector 14002A) from the container 14040. In some embodiments, the removal of the medical injector 14002A triggers the electronic circuit system 14050, the first electronic circuit system 14920A and/or the second electronic circuit system 14080A to output an electronic signal, as described above. Similarly, when the patient removes the removable cover 14070A to place the medical injector 14002A in a “ready” position, the first electronic circuit system 14920A and/or the second electronic circuit system 14080A can output an electronic signal, as described above. Finally, when the patient actuates the medical injector 14002A, the first electronic circuit system 14920A and/or the second electronic circuit system 14080A can output an electronic signal, as described above. In this manner, the medical injectors 14002A-14002G, the container 14040 and the compliance tracking device 14010 can cooperatively monitor the patient's compliance in adhering to the medication regimen.
Although the medical system 3000 is shown and described above as including a medicament delivery device 3002 that is removed from a container 3010 during the medicament delivery event, in other embodiments, a medical system can include a medicament delivery device that remains at least partially disposed within the container during a medicament delivery event. For example,
The container 13510 defines an internal region 13512 (see
The cover 13518 is removably coupled to the container 13510. When the cover 13518 is coupled to the container 13510, the distal end portion 13114 of the medicament delivery device 13002 is within the cover 13518. In this manner, the cover 13518 can protect the medicament delivery device 13002 and/or prevent the inadvertent use thereof. In some embodiments, the cover 13518 can be coupled to the container 13510 via an interference fit, a threaded coupling, a mating protrusion and recess coupling, or the like.
The electronic circuit system 13530 of the container 13510 includes at least a switch 13536 and a communications port 13531. The switch 13536, which can be similar to the switch 12536 shown and described above, produces an electronic input to the electronic circuit system 13530 when the cover 13518 is removed from the container 13510. Said another way, the electronic circuit system 13530 is configured to produce and/or output one more electronic signals when the switch 13536 changes states in response to the cover 13518 being removed from the container 13510. For example, as shown in
The communications port 13531 can be any suitable port for operatively coupling the electronic circuit system 13530 of the container 13510 to a remote device, such as a compliance monitoring device, a PC, a battery charger, or the like (not shown in
To move the medical system 13000 from the first configuration to the second configuration (i.e., a “pre-delivery” configuration), the cover 13518 is removed from the container 13510, as shown by the arrow RR in
To move the medical system 13000 from the second configuration to the third configuration (i.e., a “post-delivery” configuration), the medicament delivery device 13002 is actuated by moving the actuator 13970 as shown by the arrow SS in
The second electronic signal S3′ is received by the electronic circuit system 13530 of the container 13510, which then produces the third electronic signal S4′. As described above, the third electronic signal S4′ is associated with the second electronic signal S3′. The electronic signals S3′ and S4′ can be similar to the electronic signals S3 and S4 described above with reference to
In this manner, the electronic circuit system 13530 of the container 13510 and the electronic circuit system 13920 of the medicament delivery device 13002 can cooperatively monitor the patient's compliance in using the medicament delivery device 13002. By utilizing two electronic circuit systems, the electronic circuit system 13920 and the electronic circuit system 13530 can be cooperatively designed to provide the desired functionality. For example, in some embodiments, the container 13530 can be a reusable compliance tracking device and the medicament delivery device 13002 can be a single-use, disposable device. Upon completion of the injection, the patient can subsequent re-load the container 13510 with next medicament delivery device 13002, as prescribed.
Although the electronic circuit systems disposed on the medicament delivery devices are shown and described above as outputting an electronic signal in response to the movement of an actuator, in other embodiments, an electronic circuit system can be configured to prevent, eliminate, reduce and/or alter the transmission of an electronic signal in response to the actuation of the medicament delivery device. For example,
The medicament delivery device 5002, which can be medical injector (e.g., an auto-injector, a pen injector, a multiple-use injector, a syringe or the like), an inhaler or the like, includes an actuator 5970 and an electronic circuit system 5920. The actuator 5970 is movable between a first position (
The electronic circuit system 5920 includes at least a first RFID tag 5921 and a second RFID tag 5923. The first RFID tag 5921 is configured to output a first electronic signal S6, which can be received by a compliance monitoring device (not shown in
To deliver a dose of medicament, the patient moves the actuator 5970 from the first position to the second position, as shown by the arrow OO in
When the actuator 5970 is moved from the first position to the second position, the actuator 5970 eliminates, blocks, and/or alters the second electronic signal S7, as indicated by the arrow PP in
When the actuator 5970 is moved from the first position to the second position, the first electronic signal S6 is not changed. Accordingly, the first electronic signal S6 can function as a validation signal to the receiving device during the actuation of the medicament delivery device 5002. Said another way, the electronic signal S6 can provide feedback associated with the functionality of the electronic circuit system 5920 (e.g., that the first electronic circuit system 5920 is within the transmission range of the receiving device, that the first electronic circuit system is receiving power, etc.).
The actuator 5970 can eliminate, block, and/or alter the second electronic signal S7 by any suitable mechanism. For example, in some embodiments, the movement of the actuator 5970 produces an input that is received by the electronic circuit system 5920, thereby triggering the electronic circuit system 5920 to eliminate, block, and/or alter the second electronic signal S7 output by the second RFID tag 5923. Said another way, in some embodiments, the movement of the actuator 5970 can change the state of a switch (not shown in
In other embodiments, the movement of the actuator 5970 can disrupt at least a portion of the second RFID tag 5923, thereby eliminating, blocking, and/or altering the second electronic signal S7. For example, in some embodiments, the movement of the actuator 5970 can separate, tear, deform and/or sever a portion of the second RFID tag 5923. In other embodiments, the movement of the actuator 5970 can electronically shield a portion of the second RFID tag 5923, thereby eliminating, blocking, and/or altering the second electronic signal S7. For example, in some embodiments, the actuator 5970 can include a shield portion configured to be disposed about the second RFID tag 5923 when the actuator is in the second position. Such a shield can, for example, block the signal S7 from being output by the second RFID tag 5923.
In other embodiments, the movement of the actuator 5970 can electronically decouple a power source (not shown in
As described herein, the first electronic signal S6 and/or the second electronic signal S7 can include information characterizing the first medicament delivery device 5002. For example, in some embodiments, the first electronic signal S6 and/or the second electronic signal S7 can be associated with the contents of the medicament delivery device 5002 (e.g., the amount and type of medicament contained therein), an expiration date of the medicament delivery device 5002, a dosage of the medicament delivery device 5002 and/or a use instruction associated with the medicament delivery device 5002. In this manner, the receiving device (not shown in
In some embodiments, the first RFID tag 5921 and/or the second RFID tag 5923 can be passive RFID tags. In such an arrangement, the first RFID tag 5921 and/or the second RFID tag 5923 can be powered remotely by a parent RFID tag, which can be disposed, for example on a compliance monitoring device (not shown in
Although the medicament delivery devices are shown and described above as outputting an electronic signal in response to the movement of an actuator, in other embodiments, a medicament delivery device can include any suitable means for providing feedback associated with a dosage administration event. Moreover, although the electronic circuit system 1920 shown and described above with reference to
The medical injector 15002, which can be, for example, a single-use, disposable auto-injector of the types shown and described herein, includes a housing 15110, a medicament container 15262, a needle 15212, and an electronic circuit system 15920. The housing 15110 has a proximal end portion 15112 and a distal end portion 15114. The medicament container 15262 is disposed within the housing 15110. Although the medicament container 15262 is shown as being movably disposed within the housing 15110, in other embodiments, the medicament container 15262 can be fixedly disposed within the housing 15110.
The needle 15212 includes a proximal end 15216 and a distal end 15214, and is configured to be in fluid communication with the medicament container 15262. In this manner, the medicament within the medicament container 15262 can be conveyed into a body during an injection event via the needle 15212. The needle 15212 is movably disposed within the housing 15110 between a first position (
The electronic circuit system 15920 is includes at least a first electrode 15030 and a second electrode 15031. The first electrode 15030 is disposed at the distal end 15214 of the needle 15212. The second electrode 15031 is disposed at the distal end portion 15114 of the housing 15110. The electronic circuit system 15920 is configured to output an electronic signal S8 associated with an impedance between the first electrode 15030 and the second electrode 15031. The electronic signal S8 can be any suitable communications signal, of the types described herein, configured to be received by a compliance monitoring device (not shown in
To deliver a dose of medicament, the patient first places the distal end portion 15114 of the housing against the skin S of the body B. In some embodiments, the second electrode 15031 can include a proximity sensor, similar to the proximity sensor 1974 shown and described above with reference to
During the above-described injection event, the electronic circuit system 15920 is configured to measure the impedance Z1 between the first electrode 15030 and the second electrode 15031. The electronic circuit system 15920 can then produce and/or output the electronic signal S8, which is associated with the impedance Z1. In some embodiments, the electronic signal S8 can be processed, either by the electronic circuit system 15920 or by a compliance monitoring device (not shown in
Although the medicament delivery devices, containers and/or compliance tracking devices shown and described above can be configured to send and/or receive electronic signals associated with a wide range of information, in some embodiments, a medicament delivery device, a container and/or a compliance tracking device can include a wireless communications system configured to transmit a location of the medicament delivery device. Such embodiments, can be particularly appropriate, for example, when the medicament delivery device is a single-dose device for use in emergency situations. For example,
In some embodiments, a wireless communications system can be configured to transmit the geographical location of the medicament delivery device to an emergency response dispatcher via a wireless communications device that is GPS-enabled. For example,
Although the wireless communications systems are shown and described above as being configured to send and/or receive electronic signals associated with a wide range of information, in some embodiments, a wireless communications system can be configured to send and/or receive electronic signals associated with the actuation of a medicament delivery device. More particularly, in some embodiments a wireless communications system can be employed to remotely trigger various functions of a medicament delivery device. For example,
In use, the remote actuation feature of the medicament delivery device 10002 can be advantageous in circumstances in which the user of such a device is not able to actuate the medicament delivery device 10002 and/or there are no other individuals present to actuate the medicament delivery device 10002. For example, in certain situations, soldiers on a battlefield can carry the medicament delivery device 10002, which can contain one or more medicaments. Such medicaments can be formulated to relieve acute pain (e.g., morphine), mitigate the effects of exposure to a nerve agent and/or prevent seizures secondary to such exposure. The wireless communications system 10985 can be configured to send information to and/or receive information from a battlefield monitor station 10990B located in a secure area. In this manner, the battlefield monitor station 10990B can monitor and/or be in communication with the soldiers on the battlefield.
When a critical incident occurs requiring the use of the medicament delivery device 10002, monitoring personnel can send a signal from the battlefield monitor station 10990B to the medicament delivery device 10002 on the soldier requiring medical attention. The wireless communications system 10985 can receive the signal and process the signal into “activation” data, which can then be transmitted to the actuator 10995 to trigger the actuation of the medicament delivery device 10002 and subsequent delivery of the required medication and/or agent. To ensure that the medicament is delivered in the desired location within the soldier's body, the medicament delivery device 10002 can be placed in a predetermined orientation relative to the soldier. For example, in some embodiments, the medicament delivery device 10002 can be retained within a specific pocket of the soldier's uniform.
Although the medicament delivery devices have been shown and described above as including a wireless communications system, in some embodiments, a medicament delivery device can send signals to and/or receive signals from various communications devices using a combination of communications networks. For example, in some embodiments, a medicament delivery device can send signals to and/or receive signals from various communications devices using any suitable combination of wireless networks and wired networks. For example,
The electronic communications port 11996 can be any device configured to be operatively coupled to a docking station 11997, which is in turn operatively coupled via a communications network N to a communications device 11990. The docking station 11977 can be, for example, a compliance monitoring device and/or a container of the types shown and described herein. The communications device 11990 can be any communications device of the type shown and described above (e.g., a physician's computer, PDA, an insurer's computer, etc.). In this manner, the electronic circuit system 11920 can send electronic signals to and/or receive electronic signals from the communications device 11990 via the communications network N and the docking station 11997. Moreover, as described herein, the docking station 11997 can include an electronic circuit system (not shown in
In some embodiments, the electronic communications port 11996 can be a serial bus port such as a USB ports or any another method of connecting the electronic circuit system 11920 to the docking station 11997 and/or the communications device 11990 to transfer data. The electronic circuit system 11920, the electronic communications port 11996 and/or the docking station 11997 can include any electronic components (including hardware, firmware and/or software) configured to facilitate electronic communication. For example, in some embodiments, the electronic circuit system 11920, the electronic communications port 11996 and/or the docking station 11997 can include Small Computer System Interface (SCSI and ports), FireWire (or other IEEE 1394 interfaces), data uplink, point-to-point link, fiber optic links, hard drives, pc cards, circuit boards, uplinks, downlinks, docking stations, parallel and bit-serial connections, and the like.
In some embodiments, the use of a wired communication system used as a part of the communications path, can improve the reliability of the information being transferred and could ensure that the information is transferred at the right time and efficiently. For example, after a patient uses the medicament delivery device 11002, the user can place the device into the docking station 11997 connected to the user's workstation (i.e., the communications device 11990 to trigger the transfer of information.
Moreover, as described above, in some embodiments, the communications device 11990 can include software and/or hardware to download the information from the medicament delivery device to the workstation and transmit such information to a third party such as the patient's/user's health care provider (not shown in
The electronic circuit systems shown and described above can include one or more electronic components operatively coupled to perform the functions described herein For example, the electronic circuit systems shown and described herein (including those included as a part of the medicament delivery devices, the containers, and the compliance monitoring devices shown and described herein) can be similar to the electronic circuit system 1920 shown and described above with reference to
While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
For example, although the components included in the electronic circuit system 4920 (e.g., the microprocessor 4950, the LEDs 4958A and 4958B or the like) are shown and described as being operatively coupled by electrical conductors 4934, in other embodiments, the components can be operatively coupled without being physically connected. For example, in some embodiments, at least a portion of the components included in an electronic circuit system can be inductively coupled. In other embodiments, at least a portion of the components included in an electronic circuit system can be evanescently coupled.
Although the switches 4972A and 4972B are shown and described as being “tear-through” switches that are monolithically formed from the electrical conductors 4934, in other embodiments, a switch can be formed separately from the electrical conductors 4934. For example, in some embodiments, an electrical circuit system can include a series of first electrical conductors having a first set of characteristics (e.g., the width, height, material from which the conductor is fabricated or the like) and a switch constructed from a second electrical conductor having a second set of characteristics different than the first set of characteristics. In other embodiments, a switch can be a separate component, such as, for example, a microswitch, that is mounted to the printed circuit board. In yet other embodiments, an electrical circuit system can include a “pop-out” switch that includes a biasing member to bias the switch in a predetermined state. In yet other embodiments, an electrical circuit system can include a switch that is disposed at a location other than on a printed circuit board.
Similarly, although the switches 4972A and 4972B are shown and described as being irreversibly movable from a first state to a second state, in other embodiments, a switch can be reversibly movable between a first state and a second state. Moreover, in yet other embodiments, a switch can have more than two distinct states.
Although the actuators 4732, 4539 are shown and described as being configured to move in a direction substantially parallel to the surface of the substrate 4924, in other embodiments, an actuator can be configured to actuate an electronic circuit system by moving in any direction. For example, in some embodiments a circuit actuator can be moved in a direction substantially normal to a portion of an electronic circuit system.
Similarly, although the actuators 4732, 4539 are shown and described as actuating the switches 4972A and 4972B by tearing and/or deforming a portion of the substrate 4924, in other embodiments, a switch can be moved from a first state to a second state without deforming the substrate. For example, in some embodiments, an electronic circuit system can include a printed circuit board having a substrate and a frangible switch tab disposed on the substrate. An electrical conductor and/or a switch can be disposed on the frangible switch tab, such that when the switch tab is removed from the substrate the switch is moved from a first state to a second state. In this manner, the switch can be actuated without tearing and/or deforming a portion of the substrate.
Although the actuators 4732, 4539 are shown and described as being included on the safety lock 4710 and the base 4520, respectively, in other embodiments, the actuators can be included on any component of a medicament delivery device. For example, in some embodiments, an auto-injector can include a start button having an actuator configured to actuate an electronic circuit system. In other embodiments, an auto-injector can include a movable member configured to move a medicament container and/or a needle within a housing of the auto-injector, the movable member including an actuator configured to actuate an electronic circuit system.
Although the safety lock 4710 is shown and described as being removed from the housing 4110 of the auto-injector 4002 when in its second position, in other embodiments, a safety lock can remain coupled to the housing of an auto-injector when in its second position. For example, in some embodiments, a safety lock can be moved from its first position to its second position by rotating a portion of the safety lock.
Certain components of the auto-injector 4002 are shown and described as being coupled together via protrusions and mating openings. The protrusions and/or openings can be disposed on any of the components to be coupled together and need not be limited to only a certain component. For example, the safety lock 4710 is shown and described as including an actuator 4732 having a protrusion 4730 configured to be received within an opening 4928A defined by the substrate 4924. In some embodiments, however, the protrusions can be disposed on the substrate 4924 and the mating openings can be defined by the actuator 4732. In other embodiments, such components can be coupled together in any suitable way, which need not include protrusions and mating openings. For example, in some embodiments, an actuator can be operatively coupled to an actuation portion of a substrate via mating shoulders, clips, adhesive or the like.
Although the medical system 14000 shown as including a container 14040, a compliance tracking device 14010 and multiple medical injectors 14002A-14002G, each having at least one electronic circuit system (see e.g., electronic circuit systems 14050, 14020, 14080 and 14920), in some embodiments, a medical system can include only a container having multiple medical injectors. In such embodiments, the container can be a tray or other device configured to hold the medical injectors. The container can also perform the functions of the compliance monitoring device 14010, as described above. Moreover, in some embodiments, a medical injector can include a sheath similar to sheath 14070, wherein the sheath performs the electronic functions of the compliance monitoring device 14010 and/or the container 14050, as described above.
Although the electronic circuit systems are shown and described above as outputting recorded speech in English, in other embodiments, the electronic circuit system can output recorded speech in any language. In yet other embodiments, the electronic circuit system can output recorded speech in multiple languages.
Although some of the electronic circuit systems are shown and described above as including a proximity sensor, in other embodiments, an electronic circuit system can include any suitable sensor for providing feedback to the electronic circuit system. For example, in some embodiments, an electronic circuit system can include a pressure sensor configured to sense the internal gas pressure within a gas-powered auto-injector. In this manner, the electronic circuit system can output an instruction, a status message, and/or an electronic signal to a compliance tracking device when the internal gas pressure crosses a predetermined threshold. For example, in some embodiments, when the internal gas pressure rapidly increases, the electronic circuit system can output a message, such as, for example, “Internal gas chamber has been successfully punctured—injection is in process.”
Similarly, in some embodiments, an electronic circuit system can include a temperature sensor configured to sense the temperature of the medicament contained within the medicament delivery device. In this manner, the electronic circuit system can output an instruction, a status message and/or an electronic signal to a compliance tracking device when the medicament is too cold for effective delivery. For example, in some embodiments, when the medicament is too cold for effective delivery (this may occur, for example, if the medicament delivery device has been left outside overnight or refrigerated for storage), the electronic circuit system can output a message, such as, for example, “MEDICAMENT IS TOO COLD—PLEASE BRISKLY RUB THE AUTO-INJECTOR BETWEEN YOUR HANDS.” Similarly, in some embodiments, the electronic circuit system can output a message and/or a signal based upon the feedback from the temperature sensor, for example, indicating when the medicament will be at the appropriate temperature for delivery. For example, in some embodiments, the electronic circuit system can output a message stating “THE CURRENT MEDICAMENT TEMPERATURE IS XX DEGREES. PLEASE ALLOW THE MEDICAMENT TO STAND AT ROOM TEMPERATURE FOR APPROXIMATELY XX MINUTES BEFORE ADMINISTERING THE DOSE. PLEASE DO NOT MICROWAVE OR OTHERWISE HEAT THE MEDICAMENT.” Similarly, in some embodiments, the electronic circuit system can output an electronic signal to a compliance tracking device so that the temperature data can be stored and/or transmitted to a remote device, as described herein.
Although the medicament delivery device 5002 is shown and described above as having an electronic circuit system 5920 including a first RFID tag 5921 and a second RFID tag 5923, in other embodiments, a medicament delivery device can have an electronic circuit system 5920 including only one RFID tag. Similarly, although the signal S6 output by the first RFID tag 5921 is shown and described above as having a characteristic different from the signal S7 output by the second RFID tag 5923, in other embodiments, the signal S6 can be the same as the signal S7.
Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments where appropriate. For example, in some embodiments, a medicament delivery device can include an electronic circuit system configured to produce a first electronic signal when the device is actuated, similar to the medicament delivery device 3002, and a second electronic signal based upon the impedance between various portions of the device, similar to the medicament delivery device 15002.
This application is a continuation of U.S. patent application Ser. No. 12/017,405, entitled “Medical Injector With Compliance Tracking and Monitoring,” filed Jan. 22, 2008, which is a continuation-in-part of U.S. patent application Ser. No. 11/671,025, now U.S. Pat. No. 8,172,082, entitled “Devices, Systems and Methods for Medicament Delivery,” filed Feb. 5, 2007, which is a continuation-in-part of U.S. patent application Ser. No. 11/621,236, now U.S. Pat. No. 7,731,686, entitled “Devices, Systems and Methods for Medicament Delivery,” filed Jan. 9, 2007, which is a continuation-in-part of U.S. patent application Ser. No. 10/572,148, now U.S. Pat. No. 7,749,194, entitled “Devices, Systems and Methods for Medicament Delivery,” filed Mar. 16, 2006, which is a national stage filing under 35 U.S.C. §371 of International Patent Application No. PCT/US2006/003415, entitled “Devices, Systems and Methods for Medicament Delivery,” filed Feb. 1, 2006, which claims priority to U.S. Provisional Application Ser. No. 60/648,822, entitled “Devices, Systems and Methods for Medicament Delivery,” filed Feb. 1, 2005 and U.S. Provisional Application Ser. No. 60/731,886, entitled “Auto-Injector with Feedback,” filed Oct. 31, 2005; each of which is incorporated herein by reference in its entirety. U.S. patent application Ser. No. 12/017,405 also claims priority to U.S. Provisional Application Ser. No. 60/885,969, entitled “Medicament Delivery Devices with Wireless Communication,” filed Jan. 22, 2007, which is incorporated herein by reference in its entirety. U.S. patent application Ser. Nos. 11/671,025 and 11/621,236 each claim priority to U.S. Provisional Application Ser. No. 60/787,046, entitled “Devices, Systems and Methods for Medicament Delivery,” filed Mar. 29, 2006, which is incorporated herein by reference in its entirety.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2960087 | Uytenbogaart | Nov 1960 | A |
| 3055362 | Uytenbogaart | Sep 1962 | A |
| 3115133 | Morando | Dec 1963 | A |
| 3426448 | Sarnoff | Feb 1969 | A |
| 3688765 | Gasaway | Sep 1972 | A |
| 3768472 | Hodosh et al. | Oct 1973 | A |
| 3795061 | Sarnoff et al. | Mar 1974 | A |
| 3945379 | Pritz et al. | Mar 1976 | A |
| 4108177 | Pistor | Aug 1978 | A |
| 4124024 | Schwebel et al. | Nov 1978 | A |
| 4149394 | Sornes | Apr 1979 | A |
| 4226235 | Sarnoff et al. | Oct 1980 | A |
| 4360019 | Portner et al. | Nov 1982 | A |
| 4424057 | House | Jan 1984 | A |
| 4441629 | Mackal | Apr 1984 | A |
| 4484910 | Sarnoff et al. | Nov 1984 | A |
| 4573976 | Sampson et al. | Mar 1986 | A |
| 4596556 | Morrow et al. | Jun 1986 | A |
| 4610666 | Pizzino | Sep 1986 | A |
| 4613328 | Boyd | Sep 1986 | A |
| 4617557 | Gordon | Oct 1986 | A |
| 4624660 | Mijers et al. | Nov 1986 | A |
| 4640686 | Dalling et al. | Feb 1987 | A |
| 4643721 | Brunet | Feb 1987 | A |
| 4666430 | Brown et al. | May 1987 | A |
| 4673657 | Christian | Jun 1987 | A |
| 4689042 | Sarnoff et al. | Aug 1987 | A |
| 4693708 | Wanderer et al. | Sep 1987 | A |
| 4781697 | Slaughter | Nov 1988 | A |
| 4782841 | Lopez | Nov 1988 | A |
| 4784652 | Wikström | Nov 1988 | A |
| 4795433 | Sarnoff | Jan 1989 | A |
| 4853521 | Claeys et al. | Aug 1989 | A |
| 4865582 | Sibalis | Sep 1989 | A |
| 4874382 | Lindemann et al. | Oct 1989 | A |
| 4894054 | Miskinyar | Jan 1990 | A |
| 4906235 | Roberts | Mar 1990 | A |
| 4915695 | Koobs | Apr 1990 | A |
| 4941880 | Burns | Jul 1990 | A |
| 4959056 | Dombrowski et al. | Sep 1990 | A |
| 4968302 | Schluter et al. | Nov 1990 | A |
| 4983164 | Hook et al. | Jan 1991 | A |
| 5000736 | Kaufhold, Jr. et al. | Mar 1991 | A |
| 5024656 | Gasaway et al. | Jun 1991 | A |
| 5037306 | van Schoonhoven | Aug 1991 | A |
| 5038023 | Saliga | Aug 1991 | A |
| 5041088 | Ritson et al. | Aug 1991 | A |
| 5062603 | Smith et al. | Nov 1991 | A |
| 5064413 | McKinnon et al. | Nov 1991 | A |
| 5071353 | van der Wal | Dec 1991 | A |
| 5085642 | Sarnoff et al. | Feb 1992 | A |
| 5092843 | Monroe et al. | Mar 1992 | A |
| 5125898 | Kaufhold, Jr. et al. | Jun 1992 | A |
| 5167641 | Schmitz | Dec 1992 | A |
| 5199949 | Haber et al. | Apr 1993 | A |
| 5224936 | Gallagher | Jul 1993 | A |
| 5240146 | Smedley et al. | Aug 1993 | A |
| 5281198 | Haber et al. | Jan 1994 | A |
| 5286258 | Haber et al. | Feb 1994 | A |
| 5298023 | Haber et al. | Mar 1994 | A |
| 5312326 | Myers et al. | May 1994 | A |
| 5314412 | Rex | May 1994 | A |
| 5343519 | Feldman | Aug 1994 | A |
| 5344407 | Ryan | Sep 1994 | A |
| 5354284 | Haber et al. | Oct 1994 | A |
| 5356376 | Milijasevic et al. | Oct 1994 | A |
| 5363842 | Mishelevich et al. | Nov 1994 | A |
| 5380281 | Tomellini et al. | Jan 1995 | A |
| 5383851 | McKinnon, Jr. et al. | Jan 1995 | A |
| 5394866 | Ritson et al. | Mar 1995 | A |
| 5399163 | Peterson et al. | Mar 1995 | A |
| 5405362 | Kramer et al. | Apr 1995 | A |
| 5417660 | Martin | May 1995 | A |
| 5466217 | Myers et al. | Nov 1995 | A |
| 5505192 | Samiotes et al. | Apr 1996 | A |
| 5514135 | Earle | May 1996 | A |
| 5558679 | Tuttle | Sep 1996 | A |
| 5567160 | Massino | Oct 1996 | A |
| 5568555 | Shamir | Oct 1996 | A |
| 5569192 | van der Wal | Oct 1996 | A |
| 5584815 | Pawelka et al. | Dec 1996 | A |
| 5615771 | Hollister | Apr 1997 | A |
| 5616132 | Newman | Apr 1997 | A |
| 5645534 | Chanoch | Jul 1997 | A |
| 5662612 | Niehoff | Sep 1997 | A |
| 5681291 | Galli | Oct 1997 | A |
| 5692492 | Bruna et al. | Dec 1997 | A |
| 5695476 | Harris | Dec 1997 | A |
| 5697916 | Schraga | Dec 1997 | A |
| 5716338 | Hjertman et al. | Feb 1998 | A |
| 5728074 | Castellano et al. | Mar 1998 | A |
| 5740794 | Smith et al. | Apr 1998 | A |
| 5772635 | Dastur et al. | Jun 1998 | A |
| 5792190 | Olson et al. | Aug 1998 | A |
| 5800397 | Wilson et al. | Sep 1998 | A |
| 5805423 | Wever et al. | Sep 1998 | A |
| 5809997 | Wolf | Sep 1998 | A |
| 5813397 | Goodman et al. | Sep 1998 | A |
| 5814020 | Gross | Sep 1998 | A |
| 5823346 | Weiner | Oct 1998 | A |
| 5823363 | Cassel | Oct 1998 | A |
| 5832488 | Eberhardt | Nov 1998 | A |
| 5837546 | Allen et al. | Nov 1998 | A |
| RE35986 | Ritson et al. | Dec 1998 | E |
| 5846089 | Weiss et al. | Dec 1998 | A |
| 5848988 | Davis | Dec 1998 | A |
| 5852590 | de la Huerga | Dec 1998 | A |
| 5853292 | Eggert et al. | Dec 1998 | A |
| 5868713 | Klippenstein | Feb 1999 | A |
| 5868721 | Marinacci et al. | Feb 1999 | A |
| D407487 | Greubel et al. | Mar 1999 | S |
| 5925021 | Castellano et al. | Jul 1999 | A |
| 5928195 | Malamud et al. | Jul 1999 | A |
| 5941857 | Nguyen et al. | Aug 1999 | A |
| 5964739 | Champ | Oct 1999 | A |
| 5970457 | Brant et al. | Oct 1999 | A |
| 5971953 | Bachynsky | Oct 1999 | A |
| 5991655 | Gross et al. | Nov 1999 | A |
| 6015438 | Shaw | Jan 2000 | A |
| 6030363 | Kriesel | Feb 2000 | A |
| 6039713 | Botich et al. | Mar 2000 | A |
| 6045534 | Jacobsen et al. | Apr 2000 | A |
| 6062901 | Liu et al. | May 2000 | A |
| 6063053 | Castellano et al. | May 2000 | A |
| 6074213 | Hon | Jun 2000 | A |
| 6077106 | Mish | Jun 2000 | A |
| 6084526 | Blotky et al. | Jul 2000 | A |
| 6086562 | Jacobsen et al. | Jul 2000 | A |
| 6096002 | Landau | Aug 2000 | A |
| 6099504 | Gross et al. | Aug 2000 | A |
| 6102896 | Roser | Aug 2000 | A |
| 6119684 | Nöhl et al. | Sep 2000 | A |
| 6149626 | Rachynsky et al. | Nov 2000 | A |
| 6158613 | Novosel et al. | Dec 2000 | A |
| 6161281 | Dando et al. | Dec 2000 | A |
| 6165155 | Jacobsen et al. | Dec 2000 | A |
| 6175752 | Say | Jan 2001 | B1 |
| 6179812 | Botich et al. | Jan 2001 | B1 |
| 6192891 | Gravel et al. | Feb 2001 | B1 |
| 6193695 | Rippstein, Jr. | Feb 2001 | B1 |
| 6202642 | McKinnon et al. | Mar 2001 | B1 |
| 6210359 | Patel et al. | Apr 2001 | B1 |
| 6210369 | Wilmot et al. | Apr 2001 | B1 |
| 6219587 | Ahlin et al. | Apr 2001 | B1 |
| 6221045 | Duchon et al. | Apr 2001 | B1 |
| 6221055 | Shaw et al. | Apr 2001 | B1 |
| 6245046 | Sibbitt | Jun 2001 | B1 |
| 6249717 | Nicholson et al. | Jun 2001 | B1 |
| 6258063 | Haar et al. | Jul 2001 | B1 |
| 6259654 | de la Huerga | Jul 2001 | B1 |
| 6264629 | Landau | Jul 2001 | B1 |
| 6270455 | Brown | Aug 2001 | B1 |
| 6285757 | Carroll et al. | Sep 2001 | B1 |
| 6312412 | Saied et al. | Nov 2001 | B1 |
| 6317630 | Gross et al. | Nov 2001 | B1 |
| 6321654 | Robinson | Nov 2001 | B1 |
| 6334070 | Nova et al. | Dec 2001 | B1 |
| 6364866 | Furr et al. | Apr 2002 | B1 |
| 6371939 | Bergens et al. | Apr 2002 | B2 |
| 6377848 | Garde et al. | Apr 2002 | B1 |
| 6387078 | Gillespie, III | May 2002 | B1 |
| 6398760 | Danby | Jun 2002 | B1 |
| 6405912 | Giannou | Jun 2002 | B2 |
| 6411567 | Niemiec et al. | Jun 2002 | B1 |
| 6413236 | Van Dyke | Jul 2002 | B1 |
| 6425897 | Overes et al. | Jul 2002 | B2 |
| 6428517 | Hochman et al. | Aug 2002 | B1 |
| 6428528 | Sadowski | Aug 2002 | B2 |
| 6475181 | Potter et al. | Nov 2002 | B1 |
| 6478769 | Parker | Nov 2002 | B1 |
| 6482185 | Hartmann | Nov 2002 | B1 |
| 6494863 | Shaw et al. | Dec 2002 | B1 |
| 6500150 | Gross et al. | Dec 2002 | B1 |
| 6514230 | Munk et al. | Feb 2003 | B1 |
| 6529446 | de la Huerga | Mar 2003 | B1 |
| 6530900 | Daily et al. | Mar 2003 | B1 |
| 6530904 | Edwards et al. | Mar 2003 | B1 |
| 6535714 | Melker et al. | Mar 2003 | B2 |
| 6540672 | Simonsen et al. | Apr 2003 | B1 |
| 6540675 | Aceti et al. | Apr 2003 | B2 |
| 6544234 | Gabriel | Apr 2003 | B1 |
| 6551276 | Mann et al. | Apr 2003 | B1 |
| 6551298 | Zhang | Apr 2003 | B1 |
| 6554798 | Mann et al. | Apr 2003 | B1 |
| 6558320 | Causey, III et al. | May 2003 | B1 |
| 6560471 | Heller | May 2003 | B1 |
| 6569123 | Alchas | May 2003 | B2 |
| 6572584 | Shaw et al. | Jun 2003 | B1 |
| 6574166 | Niemiec | Jun 2003 | B2 |
| 6575939 | Brunel | Jun 2003 | B1 |
| RE38189 | Walker et al. | Jul 2003 | E |
| 6585685 | Staylor et al. | Jul 2003 | B2 |
| 6585698 | Packman et al. | Jul 2003 | B1 |
| 6589158 | Winkler | Jul 2003 | B2 |
| 6595956 | Gross et al. | Jul 2003 | B1 |
| 6633796 | Pool et al. | Oct 2003 | B1 |
| 6641566 | Douglas et al. | Nov 2003 | B2 |
| 6645181 | Lavi et al. | Nov 2003 | B1 |
| 6648850 | Landau | Nov 2003 | B2 |
| 6659980 | Moberg et al. | Dec 2003 | B2 |
| 6676630 | Landau et al. | Jan 2004 | B2 |
| 6679862 | Diaz et al. | Jan 2004 | B2 |
| 6689093 | Landau | Feb 2004 | B2 |
| 6702778 | Hill et al. | Mar 2004 | B2 |
| 6707763 | Osberg et al. | Mar 2004 | B2 |
| 6708050 | Carim | Mar 2004 | B2 |
| 6722916 | Buccinna et al. | Apr 2004 | B2 |
| 6723077 | Pickup et al. | Apr 2004 | B2 |
| 6726661 | Munk et al. | Apr 2004 | B2 |
| 6736796 | Shekalim | May 2004 | B2 |
| 6743635 | Neel et al. | Jun 2004 | B2 |
| 6749437 | Chan | Jun 2004 | B2 |
| 6752781 | Landau et al. | Jun 2004 | B2 |
| 6767336 | Kaplan | Jul 2004 | B1 |
| 6770052 | Hill et al. | Aug 2004 | B2 |
| 6770056 | Price et al. | Aug 2004 | B2 |
| 6783509 | Landau et al. | Aug 2004 | B1 |
| 6786875 | Barker et al. | Sep 2004 | B2 |
| 6786885 | Hochman et al. | Sep 2004 | B2 |
| 6793646 | Giambattista et al. | Sep 2004 | B1 |
| 6803856 | Murphy et al. | Oct 2004 | B1 |
| 6808514 | Schneider et al. | Oct 2004 | B2 |
| 6809653 | Mann et al. | Oct 2004 | B1 |
| 6817986 | Slate et al. | Nov 2004 | B2 |
| 6830560 | Gross et al. | Dec 2004 | B1 |
| 6839304 | Niemiec et al. | Jan 2005 | B2 |
| 6872200 | Mann et al. | Mar 2005 | B2 |
| 6875195 | Choi | Apr 2005 | B2 |
| 6923764 | Aceti et al. | Aug 2005 | B2 |
| 6936029 | Mann et al. | Aug 2005 | B2 |
| 6937150 | Medema et al. | Aug 2005 | B2 |
| 6942646 | Langley et al. | Sep 2005 | B2 |
| 6946299 | Neel et al. | Sep 2005 | B2 |
| 6949082 | Langley et al. | Sep 2005 | B2 |
| 6952604 | DeNuzzio et al. | Oct 2005 | B2 |
| 6953445 | Wilmot et al. | Oct 2005 | B2 |
| 6953693 | Neel et al. | Oct 2005 | B2 |
| 6958691 | Anderson et al. | Oct 2005 | B1 |
| 6959247 | Neel et al. | Oct 2005 | B2 |
| 6961285 | Niemiec et al. | Nov 2005 | B2 |
| 6964650 | Alexandre et al. | Nov 2005 | B2 |
| 6969259 | Pastrick et al. | Nov 2005 | B2 |
| 6979316 | Rubin et al. | Dec 2005 | B1 |
| 6979326 | Mann et al. | Dec 2005 | B2 |
| 6985870 | Martucci et al. | Jan 2006 | B2 |
| 6997911 | Klitmose | Feb 2006 | B2 |
| 7014470 | Vann | Mar 2006 | B2 |
| 7048141 | Abdulhay | May 2006 | B2 |
| 7072738 | Bonney et al. | Jul 2006 | B2 |
| 7093595 | Nesbitt | Aug 2006 | B2 |
| 7104972 | Moller et al. | Sep 2006 | B2 |
| 7113101 | Petersen et al. | Sep 2006 | B2 |
| 7116233 | Zhurin | Oct 2006 | B2 |
| 7126879 | Snyder | Oct 2006 | B2 |
| 7158011 | Brue | Jan 2007 | B2 |
| 7191916 | Clifford et al. | Mar 2007 | B2 |
| 7229458 | Boecker et al. | Jun 2007 | B2 |
| 7278983 | Ireland et al. | Oct 2007 | B2 |
| 7299981 | Hickle et al. | Nov 2007 | B2 |
| 7343914 | Abrams et al. | Mar 2008 | B2 |
| 7351223 | Call | Apr 2008 | B2 |
| 7416540 | Edwards et al. | Aug 2008 | B2 |
| 7544188 | Edwards et al. | Jun 2009 | B2 |
| 7630788 | Reese | Dec 2009 | B1 |
| 7648482 | Edwards et al. | Jan 2010 | B2 |
| 7648483 | Edwards et al. | Jan 2010 | B2 |
| 7670328 | Miller | Mar 2010 | B2 |
| 7731686 | Edwards et al. | Jun 2010 | B2 |
| 7731690 | Edwards et al. | Jun 2010 | B2 |
| 7749194 | Edwards et al. | Jul 2010 | B2 |
| 7871393 | Monroe | Jan 2011 | B2 |
| 7918823 | Edwards et al. | Apr 2011 | B2 |
| 7938802 | Bicknell et al. | May 2011 | B2 |
| 7947017 | Edwards et al. | May 2011 | B2 |
| 8021344 | Edwards et al. | Sep 2011 | B2 |
| 8123719 | Edwards et al. | Feb 2012 | B2 |
| 8149111 | Monroe | Apr 2012 | B2 |
| 8172082 | Edwards et al. | May 2012 | B2 |
| 8206360 | Edwards et al. | Jun 2012 | B2 |
| 8212658 | Monroe | Jul 2012 | B2 |
| 8231573 | Edwards et al. | Jul 2012 | B2 |
| 8424517 | Sutherland et al. | Apr 2013 | B2 |
| 8544645 | Edwards et al. | Oct 2013 | B2 |
| 8556865 | Krulevitch et al. | Oct 2013 | B2 |
| 8556867 | Krulevitch et al. | Oct 2013 | B2 |
| 8622973 | Edwards et al. | Jan 2014 | B2 |
| 8627816 | Edwards et al. | Jan 2014 | B2 |
| 8789748 | Waugh et al. | Jul 2014 | B2 |
| 8849449 | Waugh et al. | Sep 2014 | B2 |
| 20010005781 | Bergens et al. | Jun 2001 | A1 |
| 20020016567 | Hochman et al. | Feb 2002 | A1 |
| 20020072784 | Sheppard, Jr. et al. | Jun 2002 | A1 |
| 20020074345 | Schneider et al. | Jun 2002 | A1 |
| 20020076679 | Aman | Jun 2002 | A1 |
| 20020090601 | Strupat et al. | Jul 2002 | A1 |
| 20020096543 | Juselius | Jul 2002 | A1 |
| 20020183721 | Santini, Jr. et al. | Dec 2002 | A1 |
| 20020188419 | Slate et al. | Dec 2002 | A1 |
| 20030028145 | Duchon et al. | Feb 2003 | A1 |
| 20030040717 | Saulenas et al. | Feb 2003 | A1 |
| 20030060765 | Campbell et al. | Mar 2003 | A1 |
| 20030106824 | Wilmot et al. | Jun 2003 | A1 |
| 20030130853 | Maire | Jul 2003 | A1 |
| 20030132128 | Mazur | Jul 2003 | A1 |
| 20030135388 | Martucci et al. | Jul 2003 | A1 |
| 20030233070 | De La Serna et al. | Dec 2003 | A1 |
| 20040015125 | Alexandre et al. | Jan 2004 | A1 |
| 20040019326 | Gilbert et al. | Jan 2004 | A1 |
| 20040039336 | Amark et al. | Feb 2004 | A1 |
| 20040039337 | Letzing | Feb 2004 | A1 |
| 20040039368 | Reilly et al. | Feb 2004 | A1 |
| 20040054327 | Gillespie, III | Mar 2004 | A1 |
| 20040069667 | Tomellini et al. | Apr 2004 | A1 |
| 20040084047 | Hickle | May 2004 | A1 |
| 20040116854 | Abulhaj et al. | Jun 2004 | A1 |
| 20040138611 | Griffiths et al. | Jul 2004 | A1 |
| 20040143298 | Nova et al. | Jul 2004 | A1 |
| 20040159364 | Landau et al. | Aug 2004 | A1 |
| 20040215369 | Rosenblum | Oct 2004 | A1 |
| 20040220524 | Sadowski et al. | Nov 2004 | A1 |
| 20040225255 | Ono | Nov 2004 | A1 |
| 20040249358 | McWethy et al. | Dec 2004 | A1 |
| 20040267204 | Brustowicz | Dec 2004 | A1 |
| 20050027255 | Lavi et al. | Feb 2005 | A1 |
| 20050033234 | Sadowski et al. | Feb 2005 | A1 |
| 20050033386 | Osborn et al. | Feb 2005 | A1 |
| 20050055014 | Coppeta et al. | Mar 2005 | A1 |
| 20050062603 | Fuerst et al. | Mar 2005 | A1 |
| 20050088289 | Rochkind | Apr 2005 | A1 |
| 20050090781 | Baba et al. | Apr 2005 | A1 |
| 20050134433 | Sweeney, II | Jun 2005 | A1 |
| 20050137530 | Campbell et al. | Jun 2005 | A1 |
| 20050148931 | Juhasz | Jul 2005 | A1 |
| 20050148945 | Chen | Jul 2005 | A1 |
| 20050159705 | Crawford et al. | Jul 2005 | A1 |
| 20050165360 | Stamp | Jul 2005 | A1 |
| 20050168337 | Mahoney | Aug 2005 | A1 |
| 20050171477 | Rubin et al. | Aug 2005 | A1 |
| 20050182358 | Veit et al. | Aug 2005 | A1 |
| 20050183982 | Giewercer | Aug 2005 | A1 |
| 20050192530 | Castellano | Sep 2005 | A1 |
| 20050197654 | Edman et al. | Sep 2005 | A1 |
| 20050203466 | Hommann et al. | Sep 2005 | A1 |
| 20050209569 | Ishikawa et al. | Sep 2005 | A1 |
| 20050261742 | Nova et al. | Nov 2005 | A1 |
| 20050267403 | Landau et al. | Dec 2005 | A1 |
| 20050277891 | Sibbitt | Dec 2005 | A1 |
| 20060030819 | Young et al. | Feb 2006 | A1 |
| 20060053036 | Coffman et al. | Mar 2006 | A1 |
| 20060058848 | Piraino et al. | Mar 2006 | A1 |
| 20060074519 | Barker et al. | Apr 2006 | A1 |
| 20060089592 | Kadhiresan et al. | Apr 2006 | A1 |
| 20060111666 | Hommann et al. | May 2006 | A1 |
| 20060111671 | Klippenstein | May 2006 | A1 |
| 20060116639 | Russell | Jun 2006 | A1 |
| 20060129089 | Stamp | Jun 2006 | A1 |
| 20060129090 | Moberg et al. | Jun 2006 | A1 |
| 20060169611 | Prindle | Aug 2006 | A1 |
| 20060189938 | Hommann et al. | Aug 2006 | A1 |
| 20060200077 | Righi et al. | Sep 2006 | A1 |
| 20060204939 | Bardsley et al. | Sep 2006 | A1 |
| 20060247578 | Arguedas et al. | Nov 2006 | A1 |
| 20060247579 | Friedman | Nov 2006 | A1 |
| 20060265186 | Holland et al. | Nov 2006 | A1 |
| 20070008113 | Spoonhower et al. | Jan 2007 | A1 |
| 20070074722 | Giroux et al. | Apr 2007 | A1 |
| 20070149954 | Hood et al. | Jun 2007 | A1 |
| 20070184847 | Hansen et al. | Aug 2007 | A1 |
| 20070210147 | Morrone et al. | Sep 2007 | A1 |
| 20070213598 | Howard et al. | Sep 2007 | A1 |
| 20070233001 | Burroughs et al. | Oct 2007 | A1 |
| 20070239116 | Follman et al. | Oct 2007 | A1 |
| 20070239140 | Chechelski et al. | Oct 2007 | A1 |
| 20070260210 | Conroy | Nov 2007 | A1 |
| 20080059133 | Edwards et al. | Mar 2008 | A1 |
| 20080111685 | Olson et al. | May 2008 | A1 |
| 20080160492 | Campbell et al. | Jul 2008 | A1 |
| 20080230057 | Sutherland | Sep 2008 | A1 |
| 20090024112 | Edwards et al. | Jan 2009 | A1 |
| 20090030285 | Andersen | Jan 2009 | A1 |
| 20090062728 | Woo | Mar 2009 | A1 |
| 20090131875 | Green | May 2009 | A1 |
| 20090143761 | Cantor et al. | Jun 2009 | A1 |
| 20090194104 | Van Sickle | Aug 2009 | A1 |
| 20090240200 | Heneveld et al. | Sep 2009 | A1 |
| 20100111066 | Mehta | May 2010 | A1 |
| 20100160894 | Julian et al. | Jun 2010 | A1 |
| 20100192948 | Sutherland et al. | Aug 2010 | A1 |
| 20100211005 | Edwards et al. | Aug 2010 | A1 |
| 20100250280 | Sutherland | Sep 2010 | A1 |
| 20100268303 | Mitchell et al. | Oct 2010 | A1 |
| 20100286612 | Cirillo et al. | Nov 2010 | A1 |
| 20100318035 | Edwards et al. | Dec 2010 | A1 |
| 20110046698 | Kivi et al. | Feb 2011 | A1 |
| 20110144574 | Kamen et al. | Jun 2011 | A1 |
| 20110264033 | Jensen et al. | Oct 2011 | A1 |
| 20110295215 | Nielsen et al. | Dec 2011 | A1 |
| 20120071819 | Bruggemann et al. | Mar 2012 | A1 |
| 20120081225 | Waugh et al. | Apr 2012 | A1 |
| 20120083666 | Waugh et al. | Apr 2012 | A1 |
| 20120101444 | Muller-Pathle et al. | Apr 2012 | A1 |
| 20120107783 | Julian et al. | May 2012 | A1 |
| 20120165747 | Lanin et al. | Jun 2012 | A1 |
| 20120226226 | Edwards et al. | Sep 2012 | A1 |
| 20130023822 | Edwards et al. | Jan 2013 | A1 |
| 20130023825 | Edwards et al. | Jan 2013 | A1 |
| 20130079725 | Shang | Mar 2013 | A1 |
| 20130184649 | Edwards et al. | Jul 2013 | A1 |
| 20130190692 | Edwards et al. | Jul 2013 | A1 |
| 20130266919 | Baker et al. | Oct 2013 | A1 |
| 20130280687 | Edwards et al. | Oct 2013 | A1 |
| 20130317477 | Edwards et al. | Nov 2013 | A1 |
| 20130323699 | Edwards et al. | Dec 2013 | A1 |
| 20140031789 | Edwards et al. | Jan 2014 | A1 |
| 20140052069 | Edwards et al. | Feb 2014 | A1 |
| 20140243749 | Edwards et al. | Aug 2014 | A1 |
| 20140276414 | Baker et al. | Sep 2014 | A1 |
| 20140296824 | Edwards et al. | Oct 2014 | A1 |
| 20140371714 | Edwards et al. | Dec 2014 | A1 |
| 20150011973 | Edwards et al. | Jan 2015 | A1 |
| 20150190591 | Edwards et al. | Jul 2015 | A1 |
| 20150294551 | Edwards et al. | Oct 2015 | A1 |
| Number | Date | Country |
|---|---|---|
| 2004231230 | Jun 2006 | AU |
| 1287840 | Mar 2003 | EP |
| 1462134 | Sep 2004 | EP |
| 1712178 | Oct 2006 | EP |
| 2006-034845 | Feb 2006 | JP |
| WO9302720 | Feb 1993 | WO |
| WO 9526009 | Sep 1995 | WO |
| WO 9625965 | Aug 1996 | WO |
| WO 9730742 | Aug 1997 | WO |
| WO 9852632 | Nov 1998 | WO |
| WO 9907425 | Feb 1999 | WO |
| WO 9910031 | Mar 1999 | WO |
| WO 9943283 | Sep 1999 | WO |
| WO 0103758 | Jan 2001 | WO |
| WO 0124690 | Apr 2001 | WO |
| WO 0126020 | Apr 2001 | WO |
| WO 0141849 | Jun 2001 | WO |
| WO 0188828 | Nov 2001 | WO |
| WO 0193926 | Dec 2001 | WO |
| WO 03057283 | Jul 2003 | WO |
| WO 03095001 | Nov 2003 | WO |
| WO 2004041330 | May 2004 | WO |
| WO 2005050526 | Jun 2005 | WO |
| WO 2005077441 | Aug 2005 | WO |
| WO 2006045525 | May 2006 | WO |
| WO 2006085175 | Aug 2006 | WO |
| WO 2006109778 | Oct 2006 | WO |
| WO 2006123956 | Nov 2006 | WO |
| WO2006125692 | Nov 2006 | WO |
| WO 2007088444 | Aug 2007 | WO |
| WO 2008005315 | Jan 2008 | WO |
| WO 2008148864 | Dec 2008 | WO |
| WO 2010114392 | Oct 2010 | WO |
| WO 2012063172 | May 2012 | WO |
| WO 2013043063 | Mar 2013 | WO |
| WO 2013044172 | Mar 2013 | WO |
| Entry |
|---|
| “Solutions for Medical Devices,” 3M Brochure, © 3M 2006. |
| “Flexible circuits / Flex circuits / Flexible Technology Ltd.,” Flexible Technology Limited [online] [retrieved on Aug. 28, 2006] Retrieved from the Internet <URL: http://www.flexibletechnology.com/ >. |
| “Flexible circuits capabilities of Flexible Technology Limited,” Our Flexible Circuits Capabilities [online] [retrieved on Aug. 28, 2006] Retrieved from the Internet <URL: http://www.flexibletechnology.com/Flexible circuits Capability.htm >. |
| “Flex Circuits/flexible circuits design guide,” [online] [retrieved on Aug. 28, 2006] Retrieved from the Internet <URL: http://flexiblecircuit.co.uk/Flex Circuits Design Guide.htm >. |
| “Insect Stings Auto-injector Pouches and Carry Cases,” The Insect Stings On-Line Shop, [online] [retrieved on Jan. 24, 2007] Retrieved from the Internet <URL: http://www.insectstings.co.uk/acatalog/Auto Injector Pouches.html >. |
| “Microfluidics Device Provides Programmed, Long-Term Drug Dosing,” nano techwire.com [online] [retrieved on Nov. 28, 2006] Retrieved from the Internet <URL: http://nanotechwire.com/news.asp?nid=3141&ntid=124&pg=1 >. |
| RFID Gazette, “Smart Labels in Healthcare,” Sep. 29, 2005 [online] [retrieved on Nov. 28, 2006] Retrieved from the Internet <URL: http://www.rfidagazeete.org/2005/09/smart labels in.html >. |
| “Merck Serono Launches easypod(R), First Electronic Growth Hormone Injection Device,” Jan. 30, 2007 [online] [retrieved on Feb. 5, 2007] Retrieved from the Internet <URL: http://www.biz.yahoo.com/prnews/070130/ukm028.html?.v=8. |
| Dr. Oliver Scholz, “Drug depot in a tooth,” [online] [retrieved on Feb. 6, 2007] Retrieved from the Internet <URL: http://www.fraunhofer.de/fhg/EN/press/pi/2007/02Mediendienst22007Thema2.jsp?print=true. |
| Heartsine Technology, samaritan™ Pad Accessories [online] [retrieved on Jun. 1, 2007] Retrieved from the Internet <URL: http://www.heartsine.com/aboutsam-accessories.htm>. |
| CliniSense Corporation, “Drug delivery devices A potentially harsh environment for drugs,” Stability [online] [retrieved on Jun. 1, 2007] Retrieved from the Internet <URL: http://www.clinisense.com/devices.htm>. |
| CliniSense Corporation, “LifeTrack Technology A new method to detect improper storage.” Stability [online] [retrieved on Jun. 1, 2007] Retrieved from the Internet <URL: http://www.clinisense.com/tech.htm>. |
| AED Professionals™ Brochure [online] [retrieved on Jun. 1, 2007] Retrieved from the Internet <URL: http://www.aedprofessionals.com/>. |
| Daniel Ruppar, “Implant Technologies Expected to Remain a Niche but Effective Method of Drug Delivery,” Drug Delivery Technology, Feb. 2007, vol. 7, No. 2 [online] [retrieved on Jun. 1, 2007] Retrieved from the Internet <URL: http://www.drugdeliverytech-online.com/drugdelivery/200702/templates/pageviewer—print?pg=44&pm=8 >. |
| Meridian Medical Technologies, Inc., “Pralidoxime Chloride Trainer,” 2006. [retrieved on Feb. 16, 2007] Retrieved from the Internet <URL: http://www.meridianmeds.com/auto-injectors/2pamcl—trainer.html/>. |
| Laura Lin Gosbee, “Nuts! I Can't Figure Out How to Use My Life-Saving Epinephrine Auto-Injector,” Joint Commision Journal on Quality and Safety, vol. 30, No. 4, Apr. 2004. |
| Amgen, “Using Aranesp prefilled SureClick autoinjector is a simple 3-step process,” 2006. [retrieved on Feb. 16, 2007] Retrieved from the Internet <URL: http://www.aranesp.com/patient/cia/sureclick/using—three—steps.jsp/>. |
| “Bluetooth Accessory Design Guidelines for Apple Products,” Release R7, Apple, Inc. © 2012. |
| Stuart “Cellnovo's Mobile Health Approach to Diabetes Care,” In Vivo: The Business & Medicine Report, Dec. 2010. |
| Search Report and Written Opinion for International Patent Application No. PCT/US06/03415 mailed Jul. 13, 2006, 10 pages. |
| Search Report and Written Opinion for International Patent Application No. PCT/US2008/051612, mailed Dec. 9, 2008. |
| Office Action for U.S. Appl. No. 11/621,236, mailed Feb. 3, 2009. |
| Examination Report for British Patent Application No. GB 0818178.6, mailed Mar. 23, 2009. |
| Examination Report for British Patent Application No. GB 0905194.7, mailed May 8, 2009. |
| Office Action for U.S. Appl. No. 10/572,148, mailed Jun. 19, 2009. |
| Final Office Action for U.S. Appl. No. 11/621,236, mailed Jul. 1, 2009. |
| Examination Report for British Patent Application No. GB 0818178.6, mailed Jul. 9, 2009. |
| Office Action for U.S. Appl. No. 11/621,236, mailed Jan. 11, 2010. |
| Final Office Action for U.S. Appl. No. 10/572,148, mailed Feb. 3, 2010. |
| Search Report and Written Opinion for International Patent Application No. PCT/US09/63983, mailed Feb. 25, 2010. |
| Search Report for European Patent Application No. 09150135.3, mailed Mar. 15, 2010. |
| Final Office Action for U.S. Appl. No. 11/679,331, mailed Feb. 15, 2011. |
| Search and Examination Report for British Patent Application No. 1104754.5, mailed May 18, 2011. |
| English Translation of Office Action for Japanese Patent Application No. JP2009-502964, mailed May 23, 2011. |
| Search and Examination Report for British Patent Application No. 1108993.5, mailed Jun. 17, 2011. |
| Office Action for European Patent Application No. 09150135.3, mailed Jul. 11, 2011. |
| Office Action for Israel Patent Application No. 184552, mailed Jul. 28, 2011. |
| Final Office Action for U.S. Appl. No. 11/671,025, mailed Sep. 8, 2011. |
| Office Action for U.S. Appl. No. 12/794,020, mailed Oct. 25, 2011. |
| Office Action for U.S. Appl. No. 12/119,016, mailed Nov. 3, 2011. |
| Office Action for U.S. Appl. No. 12/017,405, mailed Dec. 7, 2011. |
| Office Action for U.S. Appl. No. 12/615,636, mailed Jan. 25, 2012. |
| Examination Report for British Patent Application No. 1019599.8, mailed Feb. 7, 2012. |
| English Translation of Office Action for Japanese Patent Application No. 2009-502964, mailed May 17, 2012. |
| Search and Examination Report for British Patent Application No. 1213906.9, mailed Sep. 21, 2012. |
| Non-Final Office Action for U.S. Appl. No. 13/924,037, mailed Feb. 14, 2014. |
| International Search Report and Written Opinion for International Patent Application No. PCT/US2013/078071, mailed May 6, 2014. |
| Office Action for U.S. Appl. No. 14/470,165, mailed May 26, 2015. |
| Office Action for U.S. Appl. No. 14/664,426, mailed Jun. 9, 2015. |
| Office Action for U.S. Appl. No. 14/665,659, mailed Jun. 23, 2015. |
| Number | Date | Country | |
|---|---|---|---|
| 20130184649 A1 | Jul 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60787046 | Mar 2006 | US | |
| 60648822 | Feb 2005 | US | |
| 60731886 | Oct 2005 | US | |
| 60885969 | Jan 2007 | US | |
| 60787046 | Mar 2006 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12017405 | Jan 2008 | US |
| Child | 13550999 | US |
| Number | Date | Country | |
|---|---|---|---|
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