# Patent

## Title
Remote controls configured to prevent unintended signal transmission and ambulatory medical systems including the same

## Abstract

Remote controls including a first button, a second button, transmission means, associated with the housing, for transmitting a signal to the ambulatory infusion device, and a controller associated with the housing and adapted to prevent signal transmission by the transmission means unless the second button has been actuated, to allow signal transmission by the transmission means in response to actuation of the second button, and to control the transmission means to transmit a signal in response to the first button being pressed concurrently with actuation of the second button or during a predetermined period after actuation of the second button.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 11/564,219, filed Nov. 28, 2007, now U.S. Pat. No. 8,352,041, which is incorporated herein by reference in its entirety.
This application is related to commonly-owned U.S. application Ser. No. 11/932,856, filed Oct. 31, 2007 and entitled “Method, Apparatus and System for Assigning Remote Control Device to Ambulatory Medical Device.”


BACKGROUND OF THE INVENTIONS
1. Field of Inventions
The present inventions relate generally to remote controls and ambulatory medical systems including remote controls.
2. Description of the Related Art
Many medical systems include a therapeutic device and a remote control with a plurality of buttons that allows a physician, technician or patient to provide an instruction to the therapeutic device by way of a telemetric signal. A remote control may, for example, be provided in combination with an ambulatory medical device such as an implantable infusion device or an implantable stimulation device. Implantable infusion devices frequently include a housing, a medication reservoir, a catheter with a discharge end, a pump or other fluid transfer device that moves the medication from the reservoir to the discharge end of the catheter, a telemetric communication device and a therapeutic device. Implantable stimulation devices may include a housing, electrodes, a source of stimulation energy, a telemetric communication device and a therapeutic device. In either case, the controller may be configured to provide basal delivery of medication or stimulation energy in accordance with instructions provided by the physician. The controller may also be configured to provide bolus delivery in response to an instruction from the patient. Such a “bolus” instruction, which can be communicated to the implantable device by way of a remote control, may come in response to a high glucose level measurement in the case of a diabetic patient, an increase in pain level in the case of a pain management patient, or some other symptom that is associated with the particular medical condition that the therapeutic device is intended to treat.
The present inventors have determined that one issue associated with the use of remote controls in medical systems, especially remote controls carried by patients, is inadvertent actuation and the resulting undesirable delivery of medication, stimulation energy, or other therapies. More specifically, the present inventors have determined that the buttons on the remote control in a conventional ambulatory medical device system may be inadvertently pressed while the remote control is being carried in the patient's hand, pocket, purse or the like, or is being stored in a location where it is at risk of being inadvertently contacted. In addition to the user simply unintentionally pressing the button, keys carried within a pocket or purse can, for example, also press a button. In other situations, such as when a remote control is placed on a bed or chair, the user may sit on the remote and cause buttons to be pressed.
SUMMARY OF THE INVENTIONS
A remote control in accordance with one invention includes a button, apparatus for communicating with a medical device in response to pressing of the button, and apparatus for preventing inadvertent communication with the medical device.
A remote control in accordance with another invention includes a button, a button control element movable between a first position where the button is substantially prevented from being pressed and a second position where the button is not substantially prevented being pressed, and apparatus for communicating with a medical device in response to the button being pressed.
A remote control in accordance with another invention includes a button, a button control element, a communication device adapted to transmit a signal, and a controller adapted to prevent signal transmission by the communication device unless the button control element has been actuated.
A remote control in accordance with another invention includes a single button, apparatus for maintaining the remote control in a locked state in which a signal will not be transmitted to a medical device in response to the single button being pressed, and apparatus for unlocking the remote control in response to a predetermined sequence of presses of the single button.
A remote control in accordance with another invention includes a communication device, an actuator operably connected to the communication device, and a depressible member, movable between a first position where the depressible member is prevented from being depressed and a second position where the depressible member is substantially aligned with the actuator and is not prevented being depressed.
A method of operating a remote control in accordance with another invention includes the step of maintaining the remote control in locked state where pressing the button will not result in signal transmission to a medical device and the step of unlocking the remote control when the user takes an action that demonstrates an intent to transmit a signal.
Such remote controls and methods, which are particularly advantageous because they greatly reduce the likelihood of inadvertent actuation, may also be part of medical systems that include a remote control and a therapeutic device. For example, the remote controls may be part of an ambulatory medical device system that includes an ambulatory medical device such an implantable infusion device or implantable stimulation device.
The above described and many other features of the present inventions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
Detailed descriptions of exemplary embodiments will be made with reference to the accompanying drawings.
FIG. 1 is a plan view of a remote control in a locked state in accordance with one embodiment of a present invention.
FIG. 2 is partial section view taken along line 2-2 in FIG. 1.
FIG. 3 is a plan view of the remote control illustrated in FIG. 1 in an unlocked state.
FIG. 4 is a side view of the remote control illustrated in FIG. 1 in an unlocked state.
FIG. 5 is a side view of the remote control illustrated in FIG. 1 in an unlocked state and actuated state.
FIG. 6 is a partially exploded view of the remote control illustrated in FIG. 1.
FIG. 7 is a side, partial section view of the remote control illustrated in FIG. 1 in a locked state.
FIG. 8 is a plan view of the underside of an exemplary housing top member in a locked state.
FIG. 9 is a plan view of an exemplary housing bottom member.
FIG. 10 is a plan view of the remote control illustrated in FIG. 1 in an unlocked state.
FIG. 11 is a plan view of the underside of the housing top member illustrated in FIG. 8 in an unlocked state.
FIG. 12 is a side, partial section view of the remote control illustrated in FIG. 1 in an unlocked state.
FIG. 13 is a side, partial section view of a portion the remote control illustrated in FIG. 1 in an unlocked and actuated state.
FIG. 14 is a plan view of a remote control with one portion in a locked state, and another portion in an unlocked state, in accordance with one embodiment of a present invention.
FIG. 15 is a plan view of a remote control in a locked state in accordance with one embodiment of a present invention.
FIG. 16 is a plan view of the remote control illustrated in FIG. 15 in an unlocked state.
FIG. 17 is a plan view of a remote control in a locked state in accordance with one embodiment of a present invention.
FIG. 18 is a plan view of the remote control illustrated in FIG. 17 in an unlocked state.
FIG. 19 is a side view of a remote control in a locked state in accordance with one embodiment of a present invention.
FIG. 20 is a side view of the remote control illustrated in FIG. 19 in an unlocked state.
FIG. 21 is a side view of the remote control illustrated in FIG. 19 in an unlocked and actuated state.
FIG. 22 is a side view of a remote control in a locked state in accordance with one embodiment of a present invention.
FIG. 23 is a plan view of a remote control in a locked state in accordance with one embodiment of a present invention.
FIG. 24 is partial section view taken along line 24-24 in FIG. 23.
FIG. 25 is a section view of a portion of the remote control illustrated in FIG. 23.
FIG. 26 is a section view of a portion of the remote control illustrated in FIG. 23 in the unlocked state.
FIG. 27 is a partial section view of the remote control illustrated in FIG. 23 in an unlocked and actuated state.
FIG. 28 is a top plan view of a remote control in accordance with one embodiment of a present invention.
FIG. 29 is a bottom plan view of the remote control illustrated in FIG. 28.
FIG. 30 is an enlarged view of a portion of the remote control illustrated in FIG. 28.
FIG. 31 is a block diagram showing certain aspects of the remote control illustrated in FIG. 28.
FIG. 32 is a block diagram showing certain aspects of a remote control in accordance with one embodiment of a present invention.
FIG. 33 is a plan view of a remote control in accordance with one embodiment of a present invention.
FIG. 34 is a plan view of a remote control in accordance with one embodiment of a present invention.
FIG. 35 is a top plan view of a remote control in accordance with one embodiment of a present invention.
FIG. 36 is a bottom plan view of the remote control illustrated in FIG. 35.
FIG. 37 is a top plan view of a remote control in accordance with one embodiment of a present invention.
FIG. 38 is a cutaway view of an energy generator that may be used in combination with the remote control illustrated in FIG. 37.
FIG. 39 is a circuit diagram in accordance with one embodiment of a present invention.
FIG. 40 is a flow chart in accordance with one embodiment of a present invention.
FIG. 41 is a plan view of an ambulatory medical device system in accordance with one embodiment of a present invention.
FIG. 42 is a block diagram of the ambulatory medical device system illustrated in FIG. 41.



DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
The following is a detailed description of the best presently known modes of carrying out the inventions. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the inventions. The detailed description is organized as follows:
I. Exemplary Remote Controls
II. Exemplary Ambulatory Medical Device Systems
The section titles and overall organization of the present detailed description are for the purpose of convenience only and are not intended to limit the present inventions.
The present remote controls have application in a wide variety of medical device systems. One example of such a system is an implantable infusion device system and the present inventions are discussed in the context of implantable infusion device systems. The present inventions are not, however, limited to implantable infusion device systems and are instead also applicable to other medical device systems that currently exist, or are yet to be developed. For example, the present inventions are applicable to other ambulatory medical device systems. Such systems include, but are not limited to, externally carried infusion pump systems, implantable pacemaker and/or defibrillator systems, implantable neural stimulator systems, and implantable and/or externally carried physiologic sensor systems.
I. Exemplary Remote Controls
One exemplary embodiment of a remote control in accordance with one of the present inventions is generally represented by reference numeral 100 in FIGS. 1-5. The exemplary remote control 100 includes a housing 102 and a button 104. The housing 102 carries a movable button control element 106 with a depressible member 108 that is positioned over the button 104. As discussed in greater detail below, the remote control 100 will generate a signal when the button 104 is pressed and, depending on its position, the button control element 106 will control the operation of the button by either preventing or allowing the button to be pressed.
The exemplary remote control 100 is shown in the locked state, i.e. the state in which the button 104 may not be pressed, in FIGS. 1 and 2. More specifically, when the movable button control element 106 is in the position illustrated in FIGS. 1 and 2, the depressible member 108 will be aligned with a barrier 110 (FIG. 3) on the housing 102. The barrier 110, which may include abutments 112, prevents the depressible member 108 on the button control element 106 from being depressed, thereby preventing the button 104 from being pressed.
The exemplary remote control 100 may be adjusted to the unlocked state illustrated in FIGS. 3 and 4, i.e. the state in which the button 104 may be pressed, by moving the button control element 106 in the direction of arrow A until the depressible member 108 is no longer aligned with the barrier 110 and is instead aligned with a housing aperture 114 that is adjacent to the barrier. To that end, the housing 102 in the exemplary embodiment includes a surface 116 that is shaped to receive the user's forefinger and the button control element 106 includes a raised area 118 that combines with the depressible member 108 to form a region that is shaped to receive the user's thumb. This configuration allows the user to easily hold the remote control 100 between his or her thumb and forefinger and slide the button control element 106 with the thumb. The depressible member 108 and raised area 118 also include ridges 120 which prevent the user's thumb from slipping. Once the button control element 106 has reached the unlocked position illustrated in FIGS. 3 and 4, the user will be able to press the button 104 by moving the depressible member 108 in the direction indicated by arrow B in FIG. 5. This may be easily accomplished by simply pressing downwardly with the thumb.
The housing 102 and button control element 106 perform the advantageous function of preventing inadvertent communication between the exemplary remote control 100 and the associated medical device by preventing the button 104 from being pressed unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100, by sliding the button control element 106 from the locked position (FIGS. 1 and 2) to the unlocked position (FIGS. 3 and 4) prior to pressing the button 104.
There are a variety of structural configurations that would allow a remote control to move from a locked state to an unlocked state in the manner illustrated in FIGS. 1-4, and then be actuated in the manner illustrated in FIG. 5. One example of such a configuration is described below with reference to FIGS. 6-13.
Referring first to FIGS. 6-9, the exemplary housing 102 includes a bottom member 122 and a top member 124. The bottom member 122 has a main wall 126, an outer wall 128 that extends around the perimeter of the main wall, and inner walls 130 and 132. The inner walls 130 and 132 define storage regions for a circuit board 134 and a battery 136. The circuit board 134 carries a controller 138, a communication device 140 (including an antenna), an actuator 142 with a movable element 144, and a pair of LEDs 146 (or other light emitting elements). The LEDs 146, which may be the same color or different colors (e.g. green and red), may be used to communicate various diagnostic issues (e.g. a low battery) as well as the other issues described below. The movable element 144 is aligned with the housing aperture 114 and, in the illustrated embodiment, the housing aperture is covered by a resilient cover 148 that keeps dirt and moisture out of the closed interior space within the housing 102. The actuator 142 may be, for example, a normally open switch that is biased to the open state and is closed in response to downward (in the illustrated orientation) movement of the movable element 144, as is discussed in greater detail below with reference to FIG. 13.
The exemplary button 104, which consists of the actuator 142 and the resilient cover 148, may be pressed by depressing the depressible member 108 when the remote control 100 is in the unlocked state (FIGS. 3-5). Specifically, the depressible member 108 will press the resilient cover 148 which, in turn, will press the movable element 144 of the actuator 142 and close the switch. In some alternative embodiments, the housing aperture 114 will be uncovered and the depressible member 108 will come into direct contact with the actuator 142. In either case, the controller 138 will instruct the communication device 140 to transmit a signal when the switch is closed. Additional information concerning functionality of the controller 138 as well as the other elements carried by the circuit board 134 is provided below in the context of FIGS. 41 and 42.
As illustrated in FIGS. 6-8, the top member 124 of the exemplary housing 102 covers the bottom member 122, thereby defining a closed interior space, and also includes the housing aperture 114. The top member 124 may, for purposes of this description, be divided into a first section 150 that is generally aligned with the button control element 106, and a second section 152 that is located below the button control element. The barrier 110 and housing aperture 114 are part of the second section 152 and the barrier is located between the housing aperture and the first section 150. The second section 152 includes light apertures 154 that allow light from the LEDs 146 to pass through the housing 102. To that end, it should also be noted here that the button control element 106 in the illustrated embodiment is translucent. As such, light from the LEDs 146 that passes through the light apertures 154 will be visible to the user.
With respect to its other structural elements, the top member 124 illustrated in FIGS. 6-8 has a main wall 156 that forms the first and second sections 150 and 152, an outer wall 158, and inner walls 160 and 162. The outer and inner walls 128-132 of the bottom member 122 abut the outer and inner walls 158-162 of the top member 124. The bottom member 122 may also be provided with a plurality of holes (not shown), and the top member 124 may also be provided with a corresponding plurality of posts (not shown) that are configured to be interference fit into the holes to secure the top member to the bottom member.
Turning to the exemplary movable button control element 106, and referring to FIGS. 6-8, the button control element includes a main wall 164 and an outer wall 166. The button control element 106 is also configured to slide along the second section 152 of the housing top member 124. To that end, the button control element 106 is provided with a pair of longitudinally extending inner walls 168 that are in close proximity to, as well as parallel to, the two longitudinally extending portions of the top member inner wall 160. The button control element 106 also has transversely extending inner walls 170 that are positioned such that they abut transversely ending walls 172 (FIGS. 4-6) on the top member 124, thereby limiting the range of movement of the button control element relative to the housing 102. The button control element 106 also includes covers 174 (FIG. 8) that extend inwardly from the outer wall 166. The wide portions 176 (FIG. 6) of the top member second section 152 slide within the spaces defined by the covers 174 and the button control element main and outer walls 164 and 166. The button control element 106 is provided with a pair of guides 178 which slide within a corresponding pair of slots 180 (FIG. 8) that are located within the first section 150 of the housing top member 124. Finally, the button control element 106 includes a plurality of stop members 181 that engage the curved portion of the inner wall 160 on the housing top member 124.
The longitudinally extending portions of the top member inner wall 160, the movable portion inner walls 168, the covers 174, the top member wide portions 176, the guides 178 and slots 180 individually and collectively prevent the movable button control element 106 from sliding in any direction other than along the longitudinal axis of the housing 102. The orientation of the longitudinal axis is the same as the orientation of arrow A in FIG. 3. As a result, even in those instances where the user applies a pushing force to the button control element 106 which has a component that is transverse to longitudinal axis, the button control element will move in the longitudinal direction indicated by arrow A. The guides 178 also prevent debris from entering the housing 102 when the button control element 106 is in the unlocked position.
The covers 174 and the top member wide portion 176 also prevent the button control element 106 from being moved upwardly (in the orientation illustrated in FIG. 7) and pulled off the housing top member 124. Similarly, the alignment of the housing first section 150 with the button control element 106 (including the depressible member 108) prevents a fingernail or object from getting under, and lifting, the depressible member when the remote control 100 is in the locked state.
Forward movement of the button control element 106 relative to the housing 102, i.e. movement toward the unlocked position, is limited by a pair of pins 182 (FIG. 8) that extend downwardly from the covers 174 and engage a pair of stop members 184 (FIG. 9) on the housing bottom member 122 when the button control element reaches the unlocked position illustrated in FIG. 3. Rearward movement is limited by the transversely extending walls 170 and 172, as well as the stop members 181 and the curved portion of the inner wall 160.
The button control element 106 is biased to the locked position illustrated in FIGS. 1, 2, 7 and 8. Thus, unless the user is applying force to button control element 106 in the direction of arrow A (FIG. 3), the button control element will remain in the locked position and the depressible member 108 will remain on the barrier 110. Although the present inventions are not limited to any particular biasing arrangement, the exemplary remote control 100 includes a pair of tension springs 186. The tension springs 186 may be attached to the button control element 106 and to the housing top member 124. The tension springs 186 also help prevent the button control element 106 from being pulled off of the housing 102.
As noted above, the depressible member 108 is part of the button control element 106 and rests on the barrier abutments 112 when the exemplary remote control 100 is in the locked state. More specifically, in the illustrated embodiment, the depressible member 108 is secured to the remainder of the button control element 106 by a living hinge 188 (FIG. 7) and includes a pair of downwardly extending protrusions 190 that rest on the barrier abutments 112. The living hinge 188 allows the depressible member 108 to pivot from the position illustrated in FIG. 4 to the position illustrated in FIG. 5. The living hinge 188 also biases the depressible member 108 to the position illustrated in FIG. 4. The living hinge bias provides an additional level of safety in that simply overcoming the biasing force on the button control element 106 and moving the button control element to the unlocked position will not, in and of itself, result in the button 104 being pressed and a signal being generated. The user must also press the depressible member 108 while maintaining the button control element 106 in the unlocked position.
The manner in which some of the structural elements described above with reference to FIGS. 6-9 operate, as the exemplary remote control 100 is moved from the locked state to the unlocked state, are described below with reference to FIGS. 10-13. With respect to the interaction between the housing 102 and the button control element 106, the longitudinally extending inner walls 168 on the button control element slide along the longitudinally extending portions of the housing inner wall 160, and the transversely extending inner walls 170 on the button control element pull away from the transversely ending walls 172 on the housing. The spaces defined by the button control element main wall 164 and covers 174 will no longer completely enclose the wide portions 176 of the housing second section 152, and the button control element guides 178 will no longer be completely within the housing slots 180. The springs 186, which bias the button control element 106 to the locked position, will also stretch.
The exemplary remote control 100 is shown in the unlocked and actuated state (i.e. with the button 104 pressed) in FIG. 13. The depressible member 108 is aligned with the aperture 114 and pivoted about the living hinge 188 into contact with the resilient cover 148. As a result of the downward force applied by the depressible member 108, the resilient cover 148 is collapses and presses the movable element 144 on the actuator 142, thereby causing the remote control 100 to generate a signal.
The exemplary housing 102 is also provided with an opening 192 that allows the remote control 100 to be secured to, for example, a band of material and worn like a necklace or to a connector ring that facilitates connection to a key chain or a belt loop. The housing top and bottom members 122 and 124 may respectively include sealing walls 194 and 196 (FIGS. 8 and 9) that contact one and other and prevent dirt and moisture from entering the housing 102 by way of the opening 192.
Although the present inventions are not limited to any particular sizes, the exemplary remote control 100 may be sized such that it can be conveniently held between the thumb and forefinger and/or placed in the user's pocket. In one exemplary implementation, the remote control 100 is about 7.5 cm long, 3.5 cm wide and, at its thickest region, about 1.5 cm thick.
Another exemplary remote control is generally represented by reference numeral 100a in FIG. 14. Remote control 100a is substantially similar to remote control 100 and similar elements are represented by similar reference numerals. The remote control 100a also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that operate in the manner described herein in the context of remote control 100. Unlike remote control 100, however, remote control 100a includes a pair of buttons (not shown) that may be individually pressed by the user. To that end, the exemplary housing 102a includes a pair of barriers 110 and a pair apertures 114. The remote control 100a is provided with a corresponding pair of independently operable button control elements 106a, each with a depressible member 108 and a living hinge 188. The exemplary button control elements 106a are mechanically keyed to one another such that they can slide relative to one another, in the directions indicated by arrows C and D, between the locked and unlocked positions illustrated in FIG. 14. Viewed as a single unit, the button control elements 106a are also secured to the housing 102a, and biased to the locked position, in essentially the same way that the button control element 106 is secured to the housing 102.
The housing 102a and button control elements 106a perform the advantageous function of preventing inadvertent communication between the exemplary remote control 100a and the associated medical device by preventing the buttons (not shown) from being pressed unless the user has demonstrated his/her intent to press a particular button. Such intent is demonstrated, in the context of the exemplary remote control 100a, by sliding the button control element 106a associated with that button from the locked position to the unlocked position.
Still another exemplary remote control 100b is illustrated in FIGS. 15 and 16. Remote control 100b is substantially similar to remote control 100 and similar elements are represented by similar reference numerals. The remote control 100b also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that operate in the manner described herein in the context of remote control 100. Unlike the remote control 100, which has a button control element 106 that slides longitudinally, the remote control 100b has a button control element 106b that pivots relative to the housing 102b in the direction indicated by arrow E. More specifically, the button control element 106b is pivotably secured to the housing 102b by a pin 107b and is biased to the locked position illustrated in FIG. 15. The button control element 106b includes a depressible member 108 and a living hinge 188. The housing aperture 114 and button 104 are offset from the depressible member 108 in a substantially transverse direction when the button control element 106b is in the locked position (FIG. 15). Here, the depressible member 108 rests on the top surface of the housing 102b and the button control element 106b covers the button 104. Rotation of the button control element 106b about the pin 107b to the unlocked position illustrated in FIG. 16 aligns the depressible member 108 with the housing aperture 114 and button 104. The depressible member 108 may then be depressed to cause the remote control 100b to generate a signal. It should also be noted that top surface of housing 102b and underside of the button control element 106b are substantially flat in order to facilitate the movement illustrated in FIGS. 15 and 16.
The button control element 106b performs the advantageous function of preventing inadvertent communication between the exemplary remote control 100b and the associated medical device by preventing the button 104 from being pressed unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100b, by rotating the button control element 106b from the locked position (FIG. 15) to the unlocked position (FIG. 16).
Yet another exemplary remote control is generally represented by reference numeral 100c in FIGS. 17 and 18. Remote control 100c is similar to remote control 100 and similar elements are represented by similar reference numerals. The remote control 100c also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that, but for the differences described below, operate in the manner described herein in the context of remote control 100. Here, however, the housing 102c includes a recessed area 198 and the aperture 114c is located within the recessed area. A button 104c, which consists of a resilient cover 148c and an actuator (not shown), is associated with the aperture 114c. The remote control 100c also includes a button control element 106c that is movable between the locked position illustrated in FIG. 17, where it extends over the button, and the unlocked position illustrated in FIG. 18, where it does not extend over the button.
The exemplary button control element 106c is a thin, wire-like structure that pivots about a pivot pin (not shown) associated with the pivot end 202. The free end 204 slides within a groove 206 formed in the surface of the housing 102c. The exemplary button control element 106c is also biased to the position illustrated FIG. 17. The biasing force may, for example, be provided by a spring or other resilient device that is connected to pivot pin.
The controller and communication device may be configured such that the remote control 100c transmits a signal whenever the button 104c is pressed. The remote control 100c is, in the illustrated embodiment, configured to determine whether or not the button control element 106c is in the unlocked position illustrated in FIG. 18 and to prevent signal transmission unless the button control element is in the unlocked position. For example, a sensor 208, which senses when the button control element free end 204 has reached the unlocked position illustrated in FIG. 18 and sends an “unlock” signal to the controller 138 in response, may be provided. A Hall effect sensor is, in those instances where the button control element 106 is formed entirely or partially from metal, one suitable example of such a sensor. Alternatively, or in addition, the angular position of the pivot end 202 may be used to indicate when the button control element free end 204 has reached the position illustrated in FIG. 18. A switch 210, which is associated with the pivot pin and closes when the free end 204 has reached the position illustrated in FIG. 18, is one example of an angular position sensor that may be used in conjunction with the pivot pin. In either case, the controller 138 may, in turn, be configured to prevent the remote control 100c from generating a signal when the button 104c is pressed unless the “unlock” signal from a sensor has been received.
Accordingly, inadvertent communication between the exemplary remote control 100c and the associated medical device may be accomplished by preventing transmission unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100c, by rotating the button control element 106c from the locked position (FIG. 17) to the unlocked position (FIG. 18). The inadvertent communication prevention function may be performed by the button control element 106c alone or, in some embodiments, by the button control element in combination with the controller 138 and sensors 208 and/or 210.
Turning to FIGS. 19-21, another exemplary remote control is generally represented by reference numeral 100d. Remote control 100d is substantially similar to remote control 100 and similar elements are represented by similar reference numerals. The remote control 100d also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that operate in the manner described herein in the context of remote control 100. Unlike remote control 100, which has a housing 102 that is shaped to be held between the thumb and forefinger, remote control 100d includes a housing 102d with a long, thin shape that may be held between one or more fingers and the palm. A button 104d, which consists of an actuator 142 and a cover 148d, is positioned at one end of the housing 102d. 
The exemplary remote control 100d also includes a movable button control element 106d that is carried by the housing 102d and is movable in the direction indicated by arrow F, which is generally transverse to the longitudinal axis of the housing. The exemplary remote control 100d is shown in the locked state, i.e. the state in which the button 104d may not be pressed because it is covered by the button control element 106d, in FIG. 19. Typically, the button control element 106d will be biased to the locked position illustrated in FIG. 19. The user may use his/her thumb to move the button control element 106d to the unlocked position shown in FIG. 20, thereby placing the remote control 100d in the unlocked state. The button 104d may then be pressed (FIG. 21) to cause the remote control 100b to generate a signal.
The button control element 106d performs the advantageous function of preventing inadvertent communication between the exemplary remote control 100d and the associated medical device by preventing the button 104d from being pressed unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100d, by sliding the button control element 106d from the locked position (FIG. 19) to the unlocked position (FIG. 20).
The exemplary remote control 100e illustrated in FIG. 22 is essentially identical to the remote control 100d illustrated in FIGS. 19-21. Here, however, the shape of the housing 102e and the slidable button control element 106e are such that the remote control 100e has an overall shape similar to that of a conventional pen. To that end, the housing 102e also includes a clip 105e. The exemplary remote control 100e may be moved from the locked state (solid lines) to the unlocked state (dashed lines) by sliding the button control element 106e relative to the housing 102e. Here too, this may be accomplished using the thumb. The user will then be able to generate a signal by pressing the button 104e. 
Another exemplary remote control is generally represented by reference numeral 100f in FIGS. 23-27. Remote control 100f is substantially similar to remote control 100 and similar elements are represented by similar reference numerals. The remote control 100f also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that operate in the manner described herein in the context of remote control 100. Unlike remote control 100, where the button 104 is pressed by pressing the resilient cover 148 inwardly relative to the housing 102, the button 104f on the exemplary remote control 100f is pressed by moving a slidable cover 148f longitudinally. To that end, the lateral edges of the slidable cover 148f may be carried by supports (not shown) that hold the slidable cover against the inner surface of the housing top member 124f. The slidable cover 148f also includes an upper portion 214 that is shorter (in the longitudinal direction) than the housing aperture 114f, and a lower portion 216 that is longer and wider than the housing aperture. The slidable cover upper portion 214 has a raised area 118 to engage the user's thumb, while the lower portion has a protrusion 218 that will contact the movable element 144 on the actuator 142 when the button 104f is pressed (FIG. 27). A tension spring 220 biases the slidable cover 148f to the non-pressed and locked position illustrated in FIGS. 23 and 24.
The remote control 100f is also provided with a button control element 106f that consists of a protrusion and a detent that is configured to receive the protrusion. As illustrated for example in FIG. 24, and although the locations of the detent and protrusion may be reversed, a protrusion 222 extends inwardly from the inner surface of the housing top member 124f and a detent 224 is formed in the slidable cover lower portion 216. The protrusion 222 rests in the detent 224, thereby preventing the button 104f from being pressed (i.e. by sliding the slidable cover 148f), when the remote control 100f is in the locked state illustrated in FIGS. 23 and 24. The remote control 100f may be unlocked by moving the slidable cover 148f in the direction indicated by arrow H. The downward movement (in the illustrated orientation) of the slidable cover 148f causes the detent 224 to move away from the protrusion 222, thereby unlocking the remote control 100f, as is illustrated in FIG. 26. Prior to ceasing the application of the downward force, the button 104f may be pressed by sliding the slidable cover 148f in the direction of arrow I to the position illustrated in FIG. 27 until the protrusion 218 engages the movable element 144 on the actuator 142. The spring 220 will return the slidable cover 148f to the locked position illustrated in FIGS. 23 and 24 when the button 104f is released.
It should be noted here that the aforementioned supports for the slidable cover 148f are configured to allow the slidable cover to move slightly inwardly from the locked position illustrated in FIGS. 23 and 24, to the unlocked position illustrated in FIG. 26, and back. Additionally, the housing aperture 114f and slidable cover upper portion 214 are sized and arranged such that the longitudinal ends of the housing aperture will contact the upper portion, and prevent further movement thereof, when the slidable cover 148f reaches the pressed position (FIG. 27) and the locked position (FIGS. 23 and 24).
The button control element 106f performs the advantageous function of preventing inadvertent communication between the exemplary remote control 100f and the associated medical device by preventing the button 104f from being pressed unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100f, by moving the slidable cover 148f downwardly from the locked position (FIGS. 23 and 24) to the unlocked position (FIG. 26), prior to pressing the button 104f by sliding it longitudinally.
Yet another exemplary remote control is generally represented by reference numeral 100g in FIGS. 28-31. Remote control 100g is substantially similar to remote controls 100 and 100c and similar elements are represented by similar reference numerals. The remote control 100g also includes various similar elements that are not shown such as, for example, a circuit board with a controller 138 and a communication device 140 that, but for the differences described below, operate in the manner described herein in the context of remote controls 100 and 100c. For example, remote control 100g includes a housing 102g with an opening 114g1 and an indentation 198 in the housing top member 124g, and a button 104g that is associated with opening. The button 104g includes a resilient cover 148g1 and an actuator 142 (FIG. 31), and the remote control 100g will transmit a signal if the button 104g is pressed when the remote control is in an unlocked state. Here, however, the button control element 106g does not cover the button 104g and is instead associated with the side of the housing 102g opposite the button 104g. 
More specifically, the button control element 106g in the exemplary embodiment is in the form of a button, with a resilient cover 148g2 and an actuator 142 (FIG. 31), that is associated with an opening 114g2 on the housing bottom member 122g. The actuators of the button 104g and the button control element 106g are connected to the controller 138 (FIG. 31). During use, the controller 138 will not instruct the communication device 140 to transmit a signal in response to the user pressing button 104g unless the user also presses the button control element 106g, thereby unlocking the remote control 100g. The requisite pressing of button control element 106g may either be just prior to (e.g. within 1-5 seconds), or concurrent with, the pressing of button 104g. Thus, although the button control element 106g does not cover or physically prevent the button 104g from being pressed, the button control element is used to selectively prevent and allow the transmission of the signal associated with the button 104g. 
The exemplary remote control 100g may also be provided with tactile and/or visible indicia that distinguishes one button from the other. Referring more specifically to FIGS. 28 and 30, in the illustrated embodiment, the housing top member 124g and resilient cover 148g1 have smooth surfaces, while housing bottom member 122g and the resilient cover 148g2 are provided with roughened exterior surfaces. The top-bottom, rough-smooth aspect of the exemplary remote control may also be reversed. The resilient cover 148g2 also has the word “UNLOCK” thereon.
The button control element 106g and controller 138 perform the advantageous function of preventing inadvertent communication between the exemplary remote control 100g and the associated medical device by preventing the button 104g from causing a signal to be sent unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100g, by pressing the button control element 106g. 
Another exemplary remote control is generally represented by reference numeral 100h in FIG. 32. Viewed from the exterior, remote control 100h is identical to the remote control 100g illustrated in FIGS. 28-30. The buttons 104h and button control element 106h, for example, have covers 148h1 and 148h2 that are on opposite sides of the housing. Here, however, the button control element 106h does not include an actuator that is connected to the controller 138 and the covers 148h1 and 148h2 are rigid. The button control element 106h has a mechanical button lock 226 that is operably connected to the cover 148h2 and to the button 104h. The mechanical lock 226 will typically be biased to the locked state where a portion of the lock is positioned so as to prevent the cover 148h1 from being pressed. The mechanical lock 226 may be unlocked by pressing the cover 148h2, thereby moving the aforementioned portion of the lock and allowing the first button 104h1 to be pressed and a signal to be transmitted.
The button control element 106h performs the advantageous function of preventing inadvertent communication between the exemplary remote control 100h and the associated medical device by preventing the button 104h1 from being pressed unless the user has demonstrated his/her intent to press the button. Such intent is demonstrated, in the context of the exemplary remote control 100h, by pressing the button 104h2.
It should be noted here that, in the context of the present inventions, buttons are not limited to cover and actuator type devices employed in the exemplary embodiments described above. As illustrated for example in FIG. 33, the exemplary remote control 100i includes a housing 102i and a touch screen 228. A controller and a communication device (not shown) are also provided. The touch screen 228 may be used to display one or more button configurations in order to allow the user to accomplish various tasks. At least one of the displayed buttons is a bolus delivery button 104i. The housing 102i may also be provided with one or more button control elements 106i (e.g. buttons), which are operably connected to the controller, and an power on/off button 230. In order to conserve power, the remote control 100i has a sleep mode where the touch screen 228 is turned off despite the power being turned on. The remote control 100i may be awoken by pressing one of the button control elements 106i or any portion of the touch screen 228.
Although the remote control 100i may be used to perform other functions when the button control elements 106i are not being pressed, the remote control 100i will not transmit a bolus delivery signal unless the button control elements are being pressed when the bolus delivery button 104i is pressed. Accordingly, when bolus delivery is desired, the user may hold the remote control 100i in one hand, press the button control elements 106i with the thumb and forefinger, and press the bolus delivery button 104i with the other hand using a finger or a stylus. If the button control elements 106i are not being pressed when the bolus delivery button 104i is pressed, the controller will not cause the communication device to transmit a signal, but may cause a message to be displayed on the touch screen 228 which indicates that the bolus delivery signal was not transmitted. The message may also remind the user that that the button control elements 106i must be pressed in combination with the bolus delivery button if he or she does, in fact, desire a bolus delivery.
One or more button control elements may, alternatively, be provided on a touch screen. Turning to FIG. 34, the exemplary remote control 100j includes a housing 102j, a touch screen 228 that may be used to, among other things, display a bolus delivery button 104j and a pair of button control elements 106j, and a power on/off button 230. The remote control 100j also has a sleep mode. Although the remote control 100j may be used to perform other functions without the button control elements 106j being pressed, the remote control 100j will not transmit a bolus delivery signal unless the button control elements have been pressed just prior to (e.g. 1-5 seconds), or when, the bolus delivery button 104j is pressed. Accordingly, when bolus delivery is desired, the user may hold the remote control 100j in one hand, press the button control elements 106j with the other hand, and then the bolus delivery button 104j with the same hand. If the button control elements 106j have not been pressed prior to or concurrently with the bolus delivery button 104j, the controller will not cause the communication device to transmit a signal, but may cause a message to be displayed on the touch screen 228 which indicates that the bolus delivery signal was not transmitted. The message may also remind the user that that the button control elements must be pressed in combination with the bolus delivery button if he or she does, in fact, desire a bolus delivery.
The remote control controllers and the button control elements 106i and 106j perform the advantageous function of preventing inadvertent communication between the exemplary remote controls 100i and 100j and the associated medical devices by preventing the transmission of a signal unless the user has demonstrated his/her intent to press the bolus delivery buttons 104i and 104j. Such intent is demonstrated, in the context of the exemplary remote controls 100i and 100j, by pressing the button control elements 106i and 106j. 
Still another exemplary remote control is generally represented by reference numeral 100k in FIGS. 35 and 36. Remote control 100k is similar to remote controls 100 and 100g and similar elements are represented by similar reference numerals. The remote control 100k also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that, but for the differences described below, operate in the manner described herein in the context of remote controls 100 and 100g. For example, the housing 102k includes a top member 124k with a recessed area 198 and an aperture 114k. A button 104k, which consists of a resilient cover 148k and an actuator (not shown), is associated with the aperture 114k. Here, however, the remote control 100k includes a single button 104k and there is no structure that physically or mechanically prevents the single button from being pressed.
As used herein, the phrase “a single button” means that the associated remote control has only one button. With respect to the exemplary remote control 100k, there are no other buttons on the housing top portion 124k (FIG. 35) and there are no buttons on the housing bottom portion 122k. 
The button 104k may be used to cause the remote control 100k to transmit a signal in the manner described above. The button 104k may also be used as a button control element. More specifically, the controller may be configured such that the default state of the remote control 100k is the lock state and simply pressing the button 104k will not, in and of itself, result in the transmission of a signal. The remote control 100k must be unlocked using the button 104k prior to transmitting a signal. Once the remote control is unlocked, the user will have a brief period (e.g. about 3 seconds) to press the button 104k and transmit a signal. Once the unlocked period has expired or the signal has been transmitted, whichever occurs first, the remote control 100k will revert back to the locked state.
There are a variety of ways to use the button 104k to unlock the remote control 100k. There may, for example, be a predetermined unlocking sequence of button presses that would not be typically associated with an unintentional pressing of the button 104k. One such unlocking sequence is a prolonged press (e.g. 1-2 seconds) and release, followed immediately by a quick press and release, followed immediately by a prolonged press and release. The unlocking sequence may, alternatively, be a single prolonged press (e.g. 5 seconds). The LEDs 146 that are visible through the light apertures 154 may be used to indicate that the user is attempting to unlock the remote control 100k and/or that the remote control has been successfully unlocked and/or that the attempt to unlock the remote control was unsuccessful. Once the unlocking sequence has been received, the controller will cause the communication device to transit a signal in response to a pressing of the button 104k that is indicative of a bolus deliver request and occurs within the unlocked period. For example, one quick press and release, which is not followed by any additional presses, may be used to initiate a bolus delivery signal. The LEDs 146 may be used to indicate that a bolus delivery signal has been sent. Additionally, should any pressing of the button 104k other than an unlock sequence occur while the remote control 100k is in the locked state, the user will be made aware that no signal has been transmitted to the associated medical device though the use of, for example, the LEDs 146.
The button 104k and the controller perform the advantageous function of preventing inadvertent communication between the exemplary remote control 100k and the associated medical device by preventing the transmission of a signal unless the user has demonstrated his/her intent to press the button 104k for the purpose of transmitting a bolus delivery signal. Such intent is demonstrated, in the context of the exemplary remote control 100k, by imputing an unlocking sequence with the button 104k. 
Yet another exemplary remote control is generally represented by reference numeral 100l in FIG. 37. Remote control 100l is similar to remote control 100k and similar elements are represented by similar reference numerals. The remote control 100l also includes various similar elements that are not shown such as, for example, a circuit board with a controller and a communication device that operate in the manner described herein in the context of remote control 100k, but for the differences described below. For example, the housing 102l includes a top member 124l with a recessed area 198 and an aperture 114l. A button 104l, which consists of a resilient cover 148l and an actuator 142l (FIG. 39), is associated with the aperture 114l. The remote control 100l also includes LEDs 146 that may be used to communicate with the user in the manner described in the context of remote control 100k. Here, however, the remote control 100l does not include a battery (e.g. battery 136 in FIG. 9). Instead, as illustrated in FIGS. 38 and 39 power for the remote control 100l is provided by an energy generator 232 that converts movement of the remote control into energy and a capacitor 234 that may be used to store the energy generated by the energy generator 232.
Referring first to FIG. 38, the exemplary energy generator 232 includes one or more coils 236 (only one is shown for purposes of clarity), a permanent, relatively high strength magnet 238 that is positioned within the coil, and a non-conductive housing 240. Electrical contacts 242, which are connected to the coil 236, are positioned on the exterior of the housing 240. The magnet 238 will move back and forth within the coil 236 when the user shakes the remote control 100l. As the magnet 238 moves through the coil 236, a voltage is induced on the coil and a charge is compelled to move through wires that are connected to the generator contacts 242. The charge is stored by the capacitor 234.
Turning to FIG. 39, the exemplary energy generator 232 and capacitor 234 are part of a power generation and control system 244, which also includes a diode 246, a normally closed switch 248, a normally open switch 250, and a power control circuit 252. The diode 246 is employed in the illustrated embodiment because the flow of current from the energy generator 232 alternates with the direction of movement of the magnet 238. The diode 246 allows charge to flow into the capacitor 234 when the magnet 238 is moving in one direction, and prevents charge from being removed from the capacitor when the magnet is moving in the other direction. The actuator 142l (i.e. a normally open switch) associated with the button 148l is also part of the power generation and control system 244. The circuit consisting of the energy generator 232 and the capacitor 234 is completed when the button 148l is pressed and the actuator 142l is closed. Accordingly, in order to charge the capacitor 234 with the energy generator 232, the user must press the button 148l while shaking the remote control 100l. Shaking and/or other motion that occurs when button 148l is not pressed is simply lost.
It should be noted here that the other operations of the button 148l, e.g. causing a bolus delivery signal to be transmitted, are not effected by the connection of the button to the power generation and control system 244. The exemplary power generation and control system 244 operates as follows. As noted above, the capacitor 234 is charged by shaking the remote control 100l while the button 148l is being pressed. Power for the power control circuit 252 is also provided by the energy generator 232 at this time. When the charge on the capacitor 234 is sufficient to supply the system Vcc, the power control circuit 252 sends a signal that opens switch 248 and closes switch 250 in order to disconnect the energy generator 232 from the capacitor and connect the capacitor to the system Vcc. The user may, in some implementations, be provided with a visible and/or audible indication that the remote control 100l has been fully charged. The remote control 100l will boot up after the user releases the button 148l, and the remote control will operate in the manner described above, albeit with the capacitor 234 as the energy source instead of a battery. For example, the user may transmit a bolus delivery signal by pressing the button 148l after the remote control 100l has booted up.
The power control circuit 252, which is powered by the capacitor 234 once the remote control 100l has been charged, may also be configured to discharge any energy in the capacitor in predetermined situations in order to further prevent inadvertent signal transmission. For example, the power control circuit 252 may be configured to discharge any energy in the capacitor 234 after a predetermined period (e.g. two minutes) has elapsed subsequent to the shaking/charging, regardless of whether or not a signal has been transmitted. Alternatively, or in addition, the power control circuit 252 may be configured to discharge any energy in the capacitor 234 immediately after any signal has been transmitted, or only after a predetermined signal has been transmitted. For example, the power control circuit 252 may be configured to discharge any energy in the capacitor 234 immediately after a bolus delivery signal has been transmitted.
The button 104l and the power control circuit 252 perform the advantageous function of preventing inadvertent communication between the exemplary remote control 100l and the associated medical device by preventing the transmission of a signal unless the user has demonstrated his/her intent to press the button 104l for the purpose of transmitting a bolus delivery signal. Such intent is demonstrated, in the context of the exemplary remote control 100l, by shaking the remote control while pressing the button 104l in order to charge the remote control.
Turning to FIG. 40, the operational methodology of the exemplary remote controls 100-100l may be summarized as follows.
The exemplary remote controls 100-100l are maintained in a default, locked state where the remote controls prevent signal transmission (Step 01). This may be accomplished, in the context of the illustrated embodiments, by (1) maintaining the button control element 106 in the position illustrated in FIGS. 1 and 2, thereby preventing the button 104 from being pressed; (2) maintaining the button control elements 106a in the position illustrated in the top half of FIG. 14, thereby preventing the associated buttons from being pressed; (3) maintaining the button control element 106b in the position illustrated in FIG. 15, thereby preventing the button 104 from being pressed; (4) maintaining the button control element 106c in the position illustrated in FIG. 17, thereby preventing the button 104c from being pressed; (5) maintaining the button control element 106d in the position illustrated in FIG. 19, thereby preventing the button 104d from being pressed; (6) maintaining the button control element 106e in the solid-line position illustrated in FIG. 22, thereby preventing the button 104e from being pressed; (7) maintaining the button control element 106f in the position illustrated in FIG. 24, thereby preventing the button 104f from being pressed; (8) blocking signal transmission that would otherwise result from the pressing of the buttons 104g, 104i and 104j; (9) maintaining the button control element 106h in the locked state, thereby preventing the button 104h from being pressed; (10) blocking signal transmission that would otherwise result from the pressing of the button 104k; and (11) withholding the energy necessary for the remote control 100l to operate.
The exemplary remote controls 100-100l may be unlocked when the user takes an action that demonstrates his or her intent to transmit a signal (Step 02). This may be accomplished, in the context of the illustrated embodiments, by actuating the button control element by (1) moving the button control element 106 to the position illustrated in FIGS. 3 and 4, thereby unlocking the remote control 100; (2) moving the desired the button control element 106a to the position illustrated in the bottom half of FIG. 14, thereby unlocking the remote control 100a with respect to the corresponding button; (3) moving the button control element 106b to the position illustrated in FIG. 16, thereby unlocking the remote control 100b; (4) moving the button control element 106c to the position illustrated in FIG. 18, thereby unlocking the remote control 100c; (5) moving the button control element 106d to the position illustrated in FIG. 20, thereby unlocking the remote control 100d; (6) moving the button control element 106e in the dashed-line position illustrated in FIG. 22, thereby unlocking the remote control 100e; (7) pushing the cover 148f in the direction of arrow H (FIG. 24) so as to move dislodge one portion of the button control element 106f from the other (FIG. 26), thereby unlocking the remote control 100f; (8) pressing the button control elements 106g, 106i and 106j, thereby unlocking the remote controls 100g, 100i and 100j; (9) pressing the button control element 106h, thereby unlocking the remote control 100h; (10) imputing an unlocking sequence with the button 104k, thereby unlocking the remote control 100k; and (11) shaking the remote control 100l while pressing the button 104l. It should be noted here that, in the context of the present application, demonstrating the intent to transmit a signal is not simply turning a remote control on with an on/off button or waking up a remote control that is in a low power sleep mode.
Once unlocked, exemplary remote controls 100-100l may be used to transmit a signal (Step 03). This may be accomplished, in the context of the illustrated embodiments, by pressing the buttons 104-104l. 
Additional steps may also be performed. For example, the exemplary remote controls 100-100l may also be returned to the locked state in response to user action or inaction. The return to the locked state may occur whether or not the remote controls are used to transmit a signal while unlocked. This may be accomplished, in the context of the illustrated embodiments, by (1) releasing the button control element 106 so that it will return the position illustrated in FIGS. 1 and 2; (2) releasing the desired the button control element 106a so that it will return to the position illustrated in the top half of FIG. 14; (3) releasing the button control element 106b so that it will return to the position illustrated in FIG. 15; (4) releasing the button control element 106c so that it will return to the position illustrated in FIG. 17; (5) releasing the button control element 106d so that it will return to the position illustrated in FIG. 19; (6) releasing the button control element 106e so that it will return in the solid-line position illustrated in FIG. 22; (7) releasing the cover 148f so that it will return to the position illustrated in FIGS. 23 and 24; (8) transmitting a signal by pressing the buttons 104g, 104i and 104j or not transmitting a signal within a predetermined period; (9) releasing the button control element 106h; (10) transmitting a signal by pressing the button 104k or not transmitting a signal within a predetermined period; and (11) transmitting a signal by pressing the button 104l or not transmitting a signal within a predetermined period.
Finally, the remote controls 100-100l may also be unlocked in other ways (and in additional ways) for reasons other than transmitting a bolus delivery signal. For example, there may be a different predetermined unlocking sequence of button presses (e.g. three quick presses) that is used to unlock a remote control for purposes of mating a remote control with an implanted medical device. Such functionality is discussed in commonly assigned application Ser. No. 60/867,580, which is entitled “Method, Apparatus and System for Assigning Remote Control Device to Ambulatory Medical Device.” For example, the exemplary remote control 100 may be unlocked for the purpose of simply pressing the button 104 by moving the button control element 106 to the unlocked position, and then unlocked for the purpose of mating the remote control with an implanted medical device by using the button 104 to input the unlocking sequence.
II. Exemplary Ambulatory Medical Device Systems
One example of an ambulatory medical device system in accordance with the present inventions is an implantable infusion device system. The implantable infusion device system may include any one of the remote controls 100-100l in combination with an implantable infusion device. The implantable infusion device system 10 illustrated in FIGS. 41 and 42, for example, includes a remote control 100 and an implantable infusion device 300.
As noted above, the exemplary remote control 100 includes a battery or other power source 136, a controller 138, such as a microprocessor, microcontroller or other control circuitry, memory 139, an actuator 142 with a movable element 144, and LEDs 146. A communication device 140 (including an antenna if necessary) is also provided. Although the present inventions are not limited to any particular communication device, the exemplary communication device 140 is telemetry device that transmits an RF signal at a specified frequency. The RF signal may, in some instances, be a carrier signal that carriers bit streams. The communication device 140 is also configured to receive signals from the implantable infusion device 300. Other exemplary communication devices include oscillating magnetic field communication devices, static magnetic field communication devices, optical communication devices, ultrasound communication devices and direct electrical communication devices.
The exemplary implantable infusion device 300 illustrated in FIGS. 41 and 42 includes a medication reservoir 302 and a pump or other fluid transfer device 304 within a housing 306. The pump 304 transfers medication from the reservoir 302 through a catheter 308 to the target region within the body. Operation of the implantable infusion device 300 is controlled by a controller 310, such as a microprocessor, microcontroller or other control circuitry, in accordance with instructions stored in memory 312. Power is provided by a battery or other power source 314. An audible alarm 316 may also be provided in order to inform the patient, for example, when the amount of medication in the reservoir 302 is low or when the amount of energy stored in the battery 314 is low. A refill port 318, which allows the reservoir to be refilled while the implantable infusion device 300 is within the patient, is positioned on the exterior of the housing 306.
A communication device 320 is also provided. The communication device 320 in the exemplary implantable infusion device 300 is configured to receive signals from, and transmit signals to, the remote control 100. To that end, the exemplary communication device 320 may be a telemetry device that transmits and receives RF signals at a specified frequency. The RF signal may, in some instances, be a carrier signal that carriers bit streams.
The remote control 100 may be used, for example, to send a “bolus delivery” request to the implantable infusion device 300 by way of the communication devices 140 and 320 when the button 104 is pressed. The remote control controller 138 may actuate one or more of the LEDs 146 in order to confirm to the patient that the “bolus delivery” request has been transmitted. The implantable infusion device controller 310 may respond to the receipt of the “bolus delivery” request in a variety of ways. For example, the controller 310 may accept the request, actuate the fluid transfer device 304, and transmit an “acceptance” signal to the remote control 100. In response to the “acceptance” signal, the remote control controller 138 may actuate one or more of the LEDs 146 so as to indicate that that the “bolus delivery” request has been accepted.
The controller 310 may, alternatively, deny the “bolus delivery” request because the fluid transfer device 304 is already in the process of transferring medication to the catheter 308, the patient has already reached the maximum permissible number of bolus deliveries for a particular time period, or there has not been sufficient time since the last delivery of medication. A “denial” signal may also be transmitted from the infusion device 300 to the remote control 100 and, in response, the remote control controller 138 may actuate one or more of the LEDs 146 so as to indicate that that the “bolus delivery” request has been denied.
Although the inventions disclosed herein have been described in terms of the preferred embodiments above, numerous modifications and/or additions to the above-described preferred embodiments would be readily apparent to one skilled in the art. By way of example, but not limitation, in an audible communication device (e.g. a buzzer) may be provided in place of, or in addition to, the LEDs 146 on the remote controls 100-100h. The inventions also include any combination of the elements from the various species and embodiments disclosed in the specification that are not already described. It is intended that the scope of the present inventions extend to all such modifications and/or additions and that the scope of the present inventions is limited solely by the claims set forth below. Additionally, the present inventions include systems that comprise an ambulatory medical device (such as an implantable infusion device) in combination with any of the remote controls described above or claimed below.

## Claims

1. A remote control for use with an ambulatory infusion device, the remote control comprising:
a housing having a first side and a second side opposite the first side;
a first button carried by the housing and associated with the first side;
a second button carried by the housing and associated with the second side;
visible and/or tactile indicia that distinguishes the first button from the second button;
transmission means, associated with the housing, for transmitting a bolus delivery request signal to the ambulatory infusion device; and
a controller associated with the housing and adapted to always prevent communication between the remote control and the ambulatory infusion device in response to the first button being pressed unless the first button is being pressed concurrently with the second button being pressed or during a predetermined period after the second button has been pressed, to allow transmission of the bolus delivery request signal by the transmission means in response to the second button being pressed, and to only control the transmission means to transmit the bolus delivery request signal in response to the first button being pressed concurrently with the second button being pressed or during a predetermined period after the second button has been pressed.

2. A remote control as claimed in claim 1, wherein the housing is sized and shaped such that it may be carried by a human hand.

3. A remote control as claimed in claim 1, wherein at least one of the first and second buttons comprises an actuator and a cover.

4. A remote control as claimed in claim 1, wherein the ambulatory infusion device comprises an implantable infusion device; and the transmission means comprises transmission means for transmitting a signal to the implantable infusion device.

5. A remote control for use with an ambulatory infusion device, the remote control comprising:
a housing having a first side and a second side opposite the first side;
a first button carried by the housing and associated with the first side;
a second button carried by the housing and associated with the second side;
visible and/or tactile indicia that distinguishes the first button from the second button;
transmission means, associated with the housing, for transmitting a signal to the ambulatory infusion device; and
a controller associated with the housing and adapted to prevent signal transmission by the transmission means unless the second button has been actuated, to allow signal transmission by the transmission means in response to actuation of the second button, and to control the transmission means to transmit a signal in response to the first button being pressed concurrently with actuation of the second button or during a predetermined period after actuation of the second button;
wherein the only buttons on the remote control are the first and second buttons.

6. A remote control as claimed in claim 5, wherein the housing is sized and shaped such that it may be carried by a human hand.

7. A remote control as claimed in claim 5, wherein the ambulatory infusion device comprises an implantable infusion device; and the transmission means comprises transmission means for transmitting a signal to the implantable infusion device.

8. A method of operating a remote control, the remote control including a housing having a first side and a second side opposite the first side, a signal generation button carried by the housing and associated with the first side, a button, which is not a signal generation button and is not an on/off button, carried by the housing and associated with the second side, and visible and/or tactile indicia that distinguishes the signal generation button from the button associated with the second side, the method comprising the steps of:
maintaining the remote control in a locked state where a pressing of any button on the remote control by a patient in which an implantable infusion device is implanted does not result in transmission of a generated medication delivery signal that instructs the medication delivery device to deliver medication from the remote control to the implantable infusion device;
unlocking the remote control in response to a pressing of the button associated with the second side of the housing
wirelessly transmitting a generated medication delivery signal to the implantable infusion device in response to a pressing of the signal generation button by the patient while the remote control is unlocked; and
returning the remote control to the locked state, without any additional user action.

9. A method as claimed in claim 8, wherein the remote control is returned to the locked state in response to the passage of a predetermined time period during which the medication delivery signal is not transmitted to the implantable infusion device.

10. A method as claimed in claim 9, wherein the predetermined time period is a period of 1 to 5 seconds after the button associated with the second side is pressed.

11. A method as claimed in claim 8, wherein the remote control is returned to the locked state in response to the medication delivery signal being transmitted to the implantable infusion device.

12. A method as claimed in claim 8, wherein the remote control is returned to the locked state immediately upon release of the button associated with the second side of the housing.