Patent Grant
10595900
Field of the Invention
Systems and methods for measuring an analyte in a host are provided. More particularly, systems and methods are provided for applying a transcutaneous analyte measurement system to a host.
Description of the Related Technology
Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.
Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are spread so far apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. Glucose levels may be alternatively monitored continuously by a sensor system including an on-skin sensor assembly. The sensor system may have a wireless transmitter which transmits measurement data to a receiver which can process and display information based on the measurements.
The process of applying the sensor to the person is important for such a system to be effective and user friendly. The application process should result in the sensor assembly being attached to the person in a state where it is capable of sensing glucose level information, communicating the sensed data to the transmitter, and transmitting the glucose level information to the receiver.
Exemplary prior art systems are disclosed in, e.g., US PGP 2014/0088389 and US PGP 2013/0267813, owned by the assignee of the present application and herein incorporated by reference in their entireties. Such systems tended to rely on particular configurations of a spring and a seal. These configurations resulted in certain disadvantages. For example, portions of the movement occurred when the spring was at its lowest force, e.g., at the end of its extension or compression, i.e., at its equilibrium position. In addition, as the spring was maintained in a compressed or extended or otherwise preloaded condition, between the time of manufacture and the time of activation, the same could undergo mechanical fatigue during this time. Such may in addition result in cause mechanical “creep”, particularly in plastic components.
Other issues include that certain elements, particularly seals, were subject to “slingshotting” as insertion elements underwent movements caused by the insertion routine such effects resulting in inaccurate sensor wire placement, as the amount of slingshotting is unpredictable. In addition, where a single spring was suggested in prior implementations, the same would generally have to be a large spring to accommodate all the motion required in insertion and retraction, and such a large spring may be expected to deleteriously cause tissue trauma as the needle and sensor were forcefully inserted into a host.
This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. This Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above.
The present systems and methods relate to systems and methods for measuring an analyte in a host, and for applying a transcutaneous analyte measurement system to a host. The various embodiments of the present systems and methods for applying the analyte measurement system have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the present embodiments as expressed by the claims that follow, their more prominent features now will be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the present embodiments provide the advantages described herein.
In a first aspect, an applicator is provided for applying an on-skin sensor assembly to skin of a host, the device including: an applicator housing configured to secure a disposable housing, where the disposable housing is configured to receive an electronics unit, and where the electronics unit is configured to generate analyte information based on a signal from a sensor, the sensor including a sensor wire with an electrode contact portion, the electrode contact portion configured for use in powering the sensor and transmitting a signal from the sensor to the electronics unit when the electronics unit is received in the disposable housing; and a sensor insertion drive configured to insert an indwelling portion of the sensor wire into a host and to mount the disposable housing to a portion of the sensor wire and the electrode portion that is not indwelling, the indwelling portion of the sensor wire inserted into skin of a host using a needle configured to provide support and structure to the sensor wire during insertion, the sensor insertion drive configured to perform an insertion step where the needle is inserted into skin of the host to deploy the sensor wire, and a retraction step where the needle is retracted from the skin of the host, thereby leaving the sensor wire deployed in the host, and where the needle insertion step and the needle retraction step are performed so as to provide a predetermined force profile during the needle insertion and retraction steps.
Implementations of the embodiments may include one or more of the following. The predetermined force profile during the needle insertion step may be defined by an equation such that F=f(x), where x is a distance the sensor wire is translated from an initial position. The function f(x) may be defined to be an envelope between ax2+bx+c and dx2+gx+h. The function f(x) may be a bimodal curve. The sensor insertion drive may include a crank slider component, a rack and pinion component, or a barrel cam. The applicator may further include a trigger configured to, in response to being activated, cause the insertion component, e.g., a needle and/or cannula, to insert the sensor into the host. A needle may be employed to provide column strength to the sensor, e.g., sensor wire, and a cannula may be employed to provide column strength to the needle. The trigger may be an activatable button configured to be operated by a user, such as one mechanically linked to the insertion component, such that activation of the button forms a portion of the insertion step or the retraction step, or a portion of both.
A spring may be used to perform the insertion step, and activation of the button may perform the retraction step. The spring may be a torsion spring. Activation of the button may perform the insertion step, and a spring may be used to perform the retraction step. Activation of the button may include depressing a plunger. The trigger may be an electromechanical element configured to be activated by a signal received from a transmitter. The transmitter may include a smartphone running an insertion application. The insertion component may further include a cannula to provide additional column strength and isolation to the needle, where the cannula is disposed within and through at least one seal in the housing during the insertion step, and where the cannula is configured to be removed from the seal and housing as part of the retraction step.
The sensor insertion drive may include a primary operating component and a booster component, such that the booster component is configured to insert additional stored energy into the primary operating component to remove the cannula from the seal and housing during the retraction step. The booster component may be a booster spring. The housing may define at least one hole for passage of the sensor wire, and the seal may be configured to substantially isolate the indwelling portion of the sensor wire from the portion of the sensor wire that is not indwelling. The applicator may further include a seal carrier in which the at least one seal is disposed, where the seal is adhered to the seal carrier, including by overmolding or gluing. The seal carrier may include sidewall ribs to reduce seal deformation during cannula removal. The seal carrier may include a spring couple to the seal to reduce seal deformation during cannula removal. The seal may be bonded to the seal carrier to inhibit movement of the seal during removal of the cannula. The seal or the seal carrier or both may define voids configured to reduce friction between the seal or seal carrier and the cannula during removal of the cannula.
At least two pucks may be disposed within the housing to electrically couple areas of the electrode contact portion to respective electrodes on the electronics unit, and the pucks may be configured to reduce friction between the seal or seal carrier and the cannula, the configuration to reduce friction defined by shaved or hollowed out portions of the pucks or by voids within the pucks.
The seal may be a hybrid seal included of silicone and TPE. The seal may be a stack seal, where the stack seal is configured to decouple movement of the sensor wire from movement of the cannula. The seal may be a sandwich seal, and the sandwich seal may include a first seal component and a second seal component, where the cannula is disposed between the first and second seal components. The seal may be a flow seal, where the flow seal defines a channel by a channel wall, the cannula being disposed in the channel, and may further include a lubricant disposed between the channel wall and an exterior of the cannula. The seal may be an O-ring seal.
The applicator may further include a seal support, where the seal support is configured to inhibit movement of the seal during removal of the cannula. The seal support may be a spring. The applicator may further include a sensor wire support, where the sensor wire support is configured to inhibit movement of the sensor wire during removal of the cannula. The sensor wire support may be a spring. The applicator may further include a motor rotationally coupled to the cannula, such that the motor is configured to rotate the cannula prior to and during removal of the cannula. The applicator may further include a cam rotationally coupled to the cannula, such that the cam is configured to rotate the cannula prior to and during removal of the cannula, the cam being coupled to the insertion component and receiving a linear force therefrom. The linear force may be received from a spring. The linear force may be received from user activation of a button. The cam may be configured to rotate the cannula with a cycle time of less than 500 ms.
The insertion component may be configured to retract the cannula prior to retraction of the needle, such that a slingshot effect of the flexible seal causes the seal to strike the needle rather than the sensor wire. During the insertion step, the insertion component may be configured such that the needle is deployed to a first depth and then the sensor wire is deployed to a second depth, where the second depth is deeper than the first depth. The applicator may further include an electronics unit placement spring configured to snap the electronics unit into the housing during the retraction step. The electronics unit placement spring may be configured to draw the electronics unit into the housing. The housing may be configured to secure the electronics unit by a mechanical connection to an electronics unit bay, and the electronics unit and electronics unit bay may be configured such that the electronics unit cannot be removed from the electronics unit bay without destruction of a portion of the electronics unit bay, the destruction also destroying the mechanical connection. The electronics unit may be configured, in response to the trigger being activated and/or the electrical connection of the sensor to the electronics unit, to generate analyte information. The housing may be configured such that the electronics unit cannot be removed from the housing while the housing is adhered to the skin of the host.
A time between sensor insertion into the host and the electronics unit securing to the housing may be less than about 1 second. At least one contact on the electronics unit may be more rigid than the sensor, and the electronics unit may be configured such that, when fully secured to the housing, the at least one contact presses the sensor into an elastomeric seal such that the elastomeric seal is compressed and conforms to the sensor.
The sensor may be configured, after insertion into the host, to be surrounded by an elastomeric seal, and the electronics unit may be configured, in response to the electronics unit being released from a lock, to compress the elastomeric seal to secure the sensor and to form a seal around the sensor.
The device may be configured to disengage from the housing and from the electronics unit in response to the electronics unit being released from a lock. The device may be configured to provide one or more tactile, auditory, or visual indications that the electronics unit has been inserted into the housing to the extent permitted by a lock. The applicator may further include a trigger lock configured to prevent activation of the trigger. The applicator may further include a protective cover configured to cover the electronics unit and the housing after sensor insertion and to secure the electronics unit to the housing.
In a second aspect, a device is provided for applying an on-skin sensor assembly to a host, including: a needle containing a removable sensor, the sensor including a sensor wire with at least two conductive contact points at an ex vivo portion and a sensing portion at an in vivo portion, the needle configured to be inserted into a host to deploy the sensor, including to be inserted into a host to deploy the sensing portion in vivo in the host, and where the needle is configured to be retracted out of the host following deployment; a cannula traversing a seal within a disposable housing, where the needle is configured to be inserted into the host after passing at least partially through the cannula in a first direction when deploying the sensor in the host, and where the needle is configured to at least partially pass through the cannula in a direction opposite the first direction when the needle is being retracted out of the host, and where the cannula is configured to be retracted out of the seal at least partially during the time the needle is being retracted out of the host; where the needle insertion and retraction requires a first portion of a force profile, and where the cannula retraction requires a second portion of a force profile; and further including one or more drive components to provide or enable a force exceeding the force profile during both the first portion and the second portion.
Implementations of the embodiments may include one or more of the following. The one or more of the drive components may convert rotational force to a linear force. The drive component may be a scotch yoke, a crank slider, a barrel cam, or a rack and pinion. The drive component for the first portion of the force profile may be a scotch yoke, a crank slider, a barrel cam, or a rack and pinion, and a drive component for the second portion of the force profile may be a spring. A source of energy for the rotational force may be a torsion spring. The spring may be configured to store energy for the second portion of the force profile by compression or tension. The needle retraction may cause the cannula retraction. The second portion may have a maximum greater than a maximum of the first portion. The first and second portions may be normal curves.
The disposable housing further may include a septum, where the sensor wire passes through the septum, and where the septum provides the sensor wire with a force against removal from the host. The first and second portions together may form a bimodal distribution. The one or more drive components may include a first helical spring configured to perform the first portion of the force profile, and a second helical spring configured to perform a second portion of the force profile. A drive component for the first portion of the force profile may be a scotch yoke coupled to a torsion spring, and a drive component for the second portion of the force profile may be a spring, where the device is configured such that when motion corresponding to the first portion of the force profile is completed, the wheel of the scotch yoke is prevented from rotating any further. The wheel of the scotch yoke may be prevented from rotating any further, neither forwards nor backwards. The applicator may further include a ratchet component, where the wheel of the scotch yoke is prevented from rotating any further due to the ratchet component.
The seal carrier may include one or more elements configured to prevent slingshotting of the seal when the cannula is retracted. The one or more elements may include ribs mounted to the seal carrier and penetrating at least a portion of the seal.
The seal may be a hybrid seal. The hybrid seal may include a first component having a first durometer and a second component having a second durometer, the second durometer higher than the first durometer. The material of the first component may be a thermoplastic elastomer and a material of the second component may be silicone. The seal may define an empty volume at least partially surrounding the cannula before the cannula is retracted, and the seal may be configured such that the empty volume can be at least partially filled with a lubricant such as petroleum jelly.
The seal may be configured to define an injection port for the lubricant, the injection port in pressure communication with the empty volume. The empty volume may be substantially the shape of a rectangular solid. The seal may further define two puck voids, the puck voids substantially cylindrical in shape, and the device further may include two pucks, the pucks essentially cylindrical in shape, each puck occupying one of the puck voids, and the cannula may be situated so as to traverse each puck prior to cannula retraction. The puck voids may be defined by cored-out sections of the pucks.
In a third aspect, a device is provided for depositing a sensor within a disposable housing, the sensor not pre-connected to the disposable housing, including: a needle configured to house an implantable sensor configured to be deposited into a host, the sensor constituted by a wire and having a proximal end and a distal end, the sensor held against movement in one direction when disposed in the needle by a push rod; an applicator in which the needle is situated, the applicator including at least one latch; a drive situated within the applicator to insert the needle into the host, and to retract the needle following insertion; where at a distal end of travel of the needle, the push rod engages the latch such that the push rod is maintained in a stationary position during needle retraction, such that the distal end of the sensor is deposited into the host and the proximal end of the sensor is disposed in the disposable housing.
Implementations of the embodiments may include one or more of the following. The applicator may further include a cannula, and the device may be configured such that the needle travels at least partially through the cannula at least during a portion of the insertion and retraction. The cannula may be situated within the disposable housing. The drive may be configured to remove the cannula during the retraction of the needle. The drive may include a torsion spring or a booster spring, for example, e.g., and the booster spring may be configured to perform the retraction. The drive further may include a rack and pinion, a crank slider, a barrel cam, or any other suitable mechanism for converting rotary motion into linear motion. The sensor may be further held against movement in the needle, in two directions, by a definition of a kink in the sensor, where the kink provides a frictional point of contact between an inner wall of the needle and the sensor, e.g., in one implementation one or more wires constituting the sensor.
The device may further include a seal in the disposable housing, such that the proximal end of the sensor is disposed in the seal in the disposable housing upon insertion and retraction. The sensor wire may be a coaxial wire having a first exposed portion and a second exposed portion. The seal may define two voids, and may further include first and second conductive pucks, each puck disposed in a respective void, such that the first conductive puck is in signal communication with the first exposed portion when the sensor wire is inserted in the seal, and such that the second conductive puck is in signal communication with the second exposed portion when the sensor wire is inserted in the seal. The applicator may further include a seal carrier in which the seal is disposed. The applicator may further include a pushrod back spring configured to bias the push rod during movement of the push rod, whereby ambiguity in movement of the pushrod is removed.
In a fourth aspect, a wearable portion of a device for monitoring an analyte is provided, including: a disposable housing in which a seal carrier may be located, the seal carrier configured to support at least one seal and to connect to at least one implantable sensor wire; and a transmitter configured to frictionally or mechanically couple to the disposable housing, the transmitter configured to conductively couple to a proximal portion of the sensor wire; where the disposable housing further includes a frangible portion, such that once the transmitter frictionally or mechanically couples to the disposable housing, the transmitter cannot be removed without removal of the frangible portion. In other words, once the frangible portion is removed, the transmitter can no longer be secured to the disposable housing, and a new disposable housing must be employed.
Implementations of the embodiments may include one or more of the following. The frangible portion may form an exterior perimeter of the seal carrier, and the transmitter may be inserted adjacent the exterior perimeter.
In a fifth aspect, a device is provided for depositing a sensor within a disposable housing, the sensor not pre-connected to the disposable housing, including: a needle configured to house an implantable sensor configured to be deposited into a host, the needle passing through a seal, the sensor constituted by a wire and having a proximal end and a distal end, the sensor held against movement in one direction when disposed in the needle by a push rod; an applicator in which the needle is situated; a drive situated within the applicator to insert the needle into the host, and to retract the needle following insertion; and a spring configured to engage the sensor wire at least when the needle is removed, such that, upon removal of the needle and the push rod, the sensor wire is secured against movement caused by movement of the needle through the seal.
A number of advantages may be seen by implementation of arrangements according to present principles. For example, the implementations lead to consistency in insertion, retraction, and speed, leading in turn to a more reproducible sensor environment and in vivo wound response. This in turn may reduce sensor-to-sensor performance variability, including due to the effects of outliers, dip and recover faults, and end-of-life faults. This further enables reduced factory calibration, including more predictable signal trends at start up, as well as reduced pain for the patient.
As one example, a more rapid insertion and retraction step reduces the potential for the user to move while the needle and/or the deployment mechanism are in the body. While the time required for a user to react to pain has been found to be about 0.40 to 1.0 seconds, systems and methods according to present principles may insert and retract the needle within, e.g., 0.25 seconds, so that the needle has exited the skin before a user can begin to react. Systems and methods according to present principles further prevent variability in the needle/sensor angle due to motion of the user. In addition, systems and methods according to present principles reduce the potential for tissue damage and pain due to motion perpendicular to the needle axis, e.g., that could be imparted by motion of the user.
In one aspect, an applicator for applying an on-skin sensor assembly to skin of a host comprises an applicator housing operatively coupled to a disposable housing, the disposable housing being configured to receive an electronics unit, the electronics unit being configured to generate analyte information based on a signal from a sensor. The applicator further comprises an insertion assembly comprising an insertion member, the insertion member being configured to insert the sensor into the skin of the host, a resistance member releasably coupled to the insertion assembly, a first drive assembly containing a first amount of stored energy, the first drive member being configured to drive the insertion member in a distal direction to an inserted position, and a second drive assembly containing a second amount of stored energy. The second drive member is configured to drive the insertion member in a proximal direction, and the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly. In one embodiment, the first drive assembly is configured to drive the insertion member in the proximal direction after the insertion member reaches the inserted position. In another embodiment, the first drive assembly is configured to activate the second drive assembly after the first drive assembly begins driving the insertion member in the proximal direction. In another embodiment, the first drive assembly is configured to activate the second drive assembly when the first drive assembly reaches a trigger position, the trigger position being proximal of the inserted position. In another embodiment, the second drive assembly is configured to decouple the resistance member from the insertion assembly. In another embodiment, the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly. In another embodiment, the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly and drive the insertion member in a proximal direction to a retracted position. In another embodiment, the proximal direction and the distal direction extend along an axis of the insertion member. In another embodiment, the proximal direction and the distal direction extend at an angle to a plane of the disposable housing. In another embodiment, the resistance member is operatively coupled to the disposable housing. In another embodiment, the resistance member is frictionally engaged with the insertion assembly. In another embodiment, the resistance member is slidably coupled with the insertion assembly. In another embodiment, the resistance member comprises an elastomer. In another embodiment, the resistance member comprises a seal. In another embodiment, the applicator further comprises a carrier operatively coupled to the disposable housing, the resistance member being operatively coupled to the carrier. In another embodiment, the carrier is movably coupled to the disposable housing. In another embodiment, the insertion member comprises a needle. In another embodiment, the insertion assembly comprises a cannula. In another embodiment, the insertion member is configured to travel through the cannula as the insertion member moves distally. In another embodiment, the resistance member is releasably coupled to the cannula. In another embodiment, the cannula is fixed relative to the disposable housing as the insertion member moves distally. In another embodiment, the seal comprises a first portion and a second portion, the first portion having a first durometer and the second portion having a second durometer, the second durometer being higher than the first durometer. In another embodiment, the first portion comprises silicone and the second portion comprises TPE. In another embodiment, the cannula is disposed between the first and second seal components. In another embodiment, the resistance member defines a channel configured to receive a fluid or gel. In another embodiment, the applicator further comprises a cam configured to rotate the cannula about an axis of the cannula. In another embodiment, a distal end of the insertion member extends distal of the cannula when the resistance member is decoupled from the insertion assembly. In another embodiment, the resistance member comprises a contact surface configured to engage with the cannula, the contact surface defining one or more voids between the contact surface and the cannula. In another embodiment, the applicator further comprises a plurality of conductive elastomeric contacts disposed within the resistance member, the conductive elastomeric contacts defining one or more voids between the contact surface and the cannula. In another embodiment, at least a portion of the insertion assembly extends through the two conductive elastomeric contacts. In another embodiment, the resistance member comprises a contact surface configured to engage with the cannula, and wherein the conductive elastomeric contacts define one or more voids between the contact surface and the cannula. In another embodiment, the resistance member is coupled directly to the insertion member. In another embodiment, the insertion assembly comprises a support configured to inhibit proximal movement of the sensor, at least after the insertion assembly reaches the inserted position. In another embodiment, the support comprises a pushrod. In another embodiment, the support comprises a spring. In another embodiment, the disposable housing comprises a first portion coupled to a second portion by a frangible member. In another embodiment, the disposable housing comprises a receptacle configured to receive a corresponding key of a compatible electronics unit. In another embodiment, the disposable housing comprises an interference structure configured to prevent installation of an incompatible electronics unit in the disposable housing. In another embodiment, the applicator further comprises a trigger configured to activate the first drive assembly. In another embodiment, the trigger comprises an electromechanical element configured to be activated by a signal received from a transmitter. In another embodiment, the transmitter comprises a smartphone running an insertion application. In another embodiment, the applicator further comprises a safety lock configured to prevent operation of the trigger. In another embodiment, the safety lock comprises a tab coupled to the trigger by at least one frangible member. In another embodiment, the first amount of stored energy exceeds about ¼ lbf and the second amount of stored energy exceeds about ⅛ lbf. In another embodiment, at least one of the first drive assembly and the second drive assembly is configured to convert rotational motion into linear motion. In another embodiment, at least one of the first drive assembly and the second drive assembly includes a scotch yoke, a crank slider, a barrel cam, or a rack and pinion. In another embodiment, at least one of the first drive assembly and the second drive assembly includes a spring. In another embodiment, at least one of the first drive assembly and the second drive assembly includes a torsion spring. In another embodiment, the second amount of stored energy is greater than the first amount of stored energy. In another embodiment, the applicator further comprises a ratchet member configured to prevent backdriving of the first drive assembly. In another embodiment, the sensor comprises a sensor wire. In another embodiment, the resistance member is configured to substantially isolate a first portion of the sensor wire from a second portion of the sensor wire. In another embodiment, the disposable housing defines at least one opening configured to allow passage of the sensor. In another embodiment, the carrier comprises a securement member configured to inhibit proximal movement of the resistance member. In another embodiment, the securement member comprises glue. In another embodiment, the securement member comprises one or more inwardly-extending ribs. In another embodiment, the securement member comprises a spring. In another embodiment, the disposable housing is configured such that the electronics unit, once installed, cannot be removed from the disposable housing while the housing is adhered to the skin of the host. In another embodiment, the disposable housing is configured such that the electronics unit, once installed, cannot be removed from the disposable housing without breaking the frangible member. In another embodiment, the sensor comprises a bend configured to frictionally engage with the insertion member. In another embodiment, the insertion assembly comprises a needle hub, a cannula, and a cannula hub, and wherein engagement of the needle hub with the cannula hub causes the cannula to move in a proximal direction.
In another aspect, an applicator for applying an on-skin sensor assembly to skin of a host comprises an applicator housing operatively coupled to a disposable housing, the disposable housing being configured to receive an electronics unit, and the electronics unit being configured to generate analyte information based on a signal from a sensor. The applicator further comprises an insertion assembly comprising an insertion member, the insertion member being configured to insert the sensor into the skin of the host, a first drive assembly containing a first amount of stored energy, the first drive member being configured to drive the insertion member in a distal direction during a first phase and in a proximal direction during a second phase, and a second drive assembly containing a second amount of stored energy, the second drive member being configured to drive the insertion member in the proximal direction. The first drive assembly is configured to activate the second drive assembly during the second phase. In one embodiment, the drive assembly is self-reversing from the first phase to the second phase. In another embodiment, a distal end of the insertion member extends distal of the cannula during the second phase. In another embodiment, the first drive assembly is configured to drive the insertion member in the proximal direction after the insertion member reaches an inserted position. In another embodiment, the first drive assembly is configured to activate the second drive assembly during the second phase. In another embodiment, the first drive assembly is configured to activate the second drive assembly in response to the first drive assembly reaching a trigger position during the second phase. In another embodiment, the applicator further comprises a resistance member, the resistance member being operatively coupled to the insertion assembly during the first phase, wherein the second drive assembly is configured to decouple the resistance member from the insertion assembly during the second phase. In another embodiment, the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly. In another embodiment, the insertion assembly comprises a cannula. In another embodiment, the insertion member is configured to travel through the cannula during the first phase. In another embodiment, the resistance member is releasably coupled to the cannula. In another embodiment, the cannula is fixed relative to the disposable housing as the insertion member moves distally. In another embodiment, at least one of the first drive assembly and the second drive assembly is configured to convert rotational motion into linear motion. In another embodiment, at least one of the first drive assembly and the second drive assembly includes a scotch yoke, a crank slider, a barrel cam, or a rack and pinion. In another embodiment, at least one of the first drive assembly and the second drive assembly includes a spring. In another embodiment, at least one of the first drive assembly and the second drive assembly includes a torsion spring. In another embodiment, the second amount of stored energy is greater than the first amount of stored energy. In another embodiment, the applicator further comprising a ratchet member configured to prevent backdriving of the first drive assembly.
In another aspect, a sensor inserter assembly for applying an on-skin device to a skin of a host, the assembly comprises an applicator body, a disposable housing releasably coupled to the applicator body, a sharp configured to place a sensor at least partially into the skin of the host, a resistance member operatively coupled to the disposable housing, a separation member releasably coupled to the resistance member, the separation member being configured to prevent contact of the sharp with the resistance member, a deployment assembly configured to cause the sharp to move from a proximal starting position to a distal insertion position during a first phase and then to a proximal retracted position during a second phase, the deployment assembly being further configured to release the separation member from the resistance member during the second phase, a first stored energy component storing sufficient energy to drive the first phase and at least a first part of the second phase, and a second stored energy component storing sufficient energy to drive at least a second part of the second phase. In one embodiment, the second stored energy component stores sufficient energy to drive the second phase. In another embodiment, the second stored energy component stores more energy than the first stored energy component. In another embodiment, the disposable housing is configured to automatically release from the applicator body after the separation member is released from the resistance member. In another embodiment, the disposable housing is configured to automatically release from the applicator body in response to the separation member being released from the resistance member. In another embodiment, the resistance member is moveable relative to the disposable housing, at least after the separation member is released from the resistance member. In another embodiment, the deployment assembly is self-reversing from the first phase to the second phase. In another embodiment, the deployment assembly is configured to activate the second stored energy component during the second phase. In another embodiment, the separation member is frictionally engaged with the resistance member. In another embodiment, the separation member is slidably coupled to the resistance member. In another embodiment, at least one of the first drive assembly and the second drive assembly is configured to convert rotational motion into linear motion.
In another aspect, a method of applying an on-skin sensor assembly to skin of a host comprises providing an assembly comprising an applicator housing operatively coupled to a disposable housing, an insertion assembly comprising an insertion member, a first drive assembly containing a first amount of stored energy, and a second drive assembly containing a second amount of stored energy. The method further comprises activating a trigger of the assembly, wherein activating the trigger causes the first drive assembly to drive the insertion member in a distal direction during a first phase, wherein a sensor is inserted into the skin of the host, the first drive assembly to drive the insertion member in a proximal direction during a second phase, wherein the first drive assembly activates the second drive assembly, and the second drive assembly to drive the insertion member in the proximal direction during the second phase. In one embodiment, the method further comprises installing an electronics unit in the disposable housing, the electronics unit being configured to generate analyte information based on a signal from the sensor. In another embodiment, the assembly further comprises a resistance member coupled to the insertion assembly. In another embodiment, activating the trigger causes the second drive to decouple the resistance member from the insertion assembly during the second phase. In another embodiment, the second amount of stored energy is sufficient to decouple the resistance member from the insertion assembly. In another embodiment, the resistance member comprises a seal. In another embodiment, the insertion assembly comprises a cannula. In another embodiment, the second amount of stored energy is greater than the first amount of stored energy. In another embodiment, at least one of the first drive assembly and the second drive assembly is configured to convert rotational motion into linear motion. In another embodiment, the first drive assembly activates the second drive assembly in response to the first drive assembly reaching a trigger position during the second phase.
In further aspects and embodiments, the above method features of the various aspects are formulated in terms of a system as in various aspects, having an applicator configured to carry out the method features. Any of the features of an embodiment of any of the aspects, including but not limited to any embodiments of any of the first through fifth aspects referred to above, is applicable to all other aspects and embodiments identified herein, including but not limited to any embodiments of any of the first through fifth aspects referred to above. Moreover, any of the features of an embodiment of the various aspects, including but not limited to any embodiments of any of the first through fifth aspects referred to above, is independently combinable, partly or wholly with other embodiments described herein in any way, e.g., one, two, or three or more embodiments may be combinable in whole or in part. Further, any of the features of an embodiment of the various aspects, including but not limited to any embodiments of any of the first through fifth aspects referred to above, may be made optional to other aspects or embodiments. Any aspect or embodiment of a method can be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of a system or apparatus can be configured to perform a method of another aspect or embodiment, including but not limited to any embodiments of any of the first through fifth aspects referred to above.
This Summary is provided to introduce a selection of concepts in a simplified form. The concepts are further described in the Detailed Description section. Elements or steps other than those described in this Summary are possible, and no element or step is necessarily required. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in any part of this disclosure.
These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.
The following description and examples illustrate some example embodiments of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present invention.
Sensor System and Applicator
The on-skin sensor assembly 600 may be attached to the host with use of an applicator adapted to provide convenient and secure application. Such an applicator may also be used for inserting the sensor 200 through the host's skin. Once the sensor 200 has been inserted, the applicator detaches from the sensor assembly.
In general, the continuous analyte sensor system 100 includes any sensor configuration that provides an output signal indicative of a concentration of an analyte. The output signal including (e.g., sensor data, such as a raw data stream, filtered data, smoothed data, and/or otherwise transformed sensor data) is sent to receiver which may be e.g., a smart phone, smart watch, dedicated device and the like. In one embodiment, the analyte sensor system 100 includes a transcutaneous glucose sensor, such as is described in US Patent Publication No. US-2011-0027127-A1, the contents of which are hereby incorporated by reference in its entirety. In some embodiments, the sensor system 100 includes a continuous glucose sensor and comprises a transcutaneous sensor such as described in U.S. Pat. No. 6,565,509 to Say et al., for example. In another embodiment, the sensor system 100 includes a continuous glucose sensor and comprises a subcutaneous sensor such as described with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al. or U.S. Pat. No. 6,484,046 to Say et al., for example. In another embodiment, the sensor system 100 includes a continuous glucose sensor and comprises a subcutaneous sensor such as described with reference to U.S. Pat. No. 6,512,939 to Colvin et al. In another embodiment, the sensor system 100 includes a continuous glucose sensor and comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,477,395 to Schulman et al., for example. In another embodiment, the sensor system 100 includes a continuous glucose sensor and comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,424,847 to Mastrototaro et al. Other signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publication No. US-2005-0203360-A1 and U.S. Patent Publication No. US-2009-0192745-A1, the contents of which are hereby incorporated by reference in their entireties. The sensor extends through a housing, which maintains the sensor on the skin and provides for electrical connection of the sensor to sensor electronics, provided in the electronics unit.
In still further embodiments, the system 100 can be configured for use in applying a drug delivery device, such an infusion device, to the skin of a patient. In such embodiments, the system can include a catheter instead of, or in addition to, a sensor, the catheter being connected to an infusion pump configured to deliver liquid medicines or other fluids into the patient's body. In embodiments, the catheter can be deployed into the skin in much the same manner as a sensor would be, for example as described herein.
In one embodiment, the sensor is formed from a wire or is in a form of a wire. For example, the sensor can include an elongated conductive body, such as a bare elongated conductive core (e.g., a metal wire) or an elongated conductive core coated with one, two, three, four, five, or more layers of material, each of which may or may not be conductive. The elongated sensor may be long and thin, yet flexible and strong. For example, in some embodiments, the smallest dimension of the elongated conductive body is less than about 0.1 inches, less than about 0.075 inches, less than about 0.05 inches, less than about 0.025 inches, less than about 0.01 inches, less than about 0.004 inches, or less than about 0.002 inches. The sensor may have a circular cross-section. In some embodiments, the cross-section of the elongated conductive body can be ovoid, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-Shaped, irregular, or the like. In one embodiment, a conductive wire electrode is employed as a core. To such a clad electrode, one or two additional conducting layers may be added (e.g., with intervening insulating layers provided for electrical isolation). The conductive layers can be comprised of any suitable material. In certain embodiments, it can be desirable to employ a conductive layer comprising conductive particles (i.e., particles of a conductive material) in a polymer or other binder.
In certain embodiments, the materials used to form the elongated conductive body (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, and/or the like) can be strong and hard, and therefore are resistant to breakage. For example, in some embodiments, the ultimate tensile strength of the elongated conductive body is from about 80 kPsi to about 500 kPsi. In another example, in some embodiments, the Young's modulus of the elongated conductive body is from about 160 GPa to about 220 GPa. In still another example, in some embodiments, the yield strength of the elongated conductive body is from about 60 kPsi to about 2200 kPsi. In some embodiments, the sensor's small diameter provides (e.g., imparts, enables) flexibility to these materials, and therefore to the sensor as a whole. Thus, the sensor can withstand repeated forces applied to it by surrounding tissue.
In addition to providing structural support, resiliency and flexibility, in some embodiments, the core (or a component thereof) provides electrical conduction for an electrical signal from the working electrode to sensor electronics (not shown). In some embodiments, the core comprises a conductive material, such as stainless steel, titanium, tantalum, a conductive polymer, and/or the like. However, in other embodiments, the core is formed from a non-conductive material, such as a non-conductive polymer. In yet other embodiments, the core comprises a plurality of layers of materials. For example, in one embodiment the core includes an inner core and an outer core. In a further embodiment, the inner core is formed of a first conductive material and the outer core is formed of a second conductive material. For example, in some embodiments, the first conductive material is stainless steel, titanium, tantalum, a conductive polymer, an alloy, and/or the like, and the second conductive material is conductive material selected to provide electrical conduction between the core and the first layer, and/or to attach the first layer to the core (e.g., if the first layer is formed of a material that does not attach well to the core material). In another embodiment, the core is formed of a non-conductive material (e.g., a non-conductive metal and/or a non-conductive polymer) and the first layer is a conductive material, such as stainless steel, titanium, tantalum, a conductive polymer, and/or the like. The core and the first layer can be of a single (or same) material, e.g., platinum. One skilled in the art appreciates that additional configurations are possible.
In the illustrated embodiments, the electronics unit 500 is releasably attachable to the sensor 200. The electronics unit 500 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, and is configured to perform algorithms associated with processing and calibration of the sensor data. For example, the electronics unit 500 can provide various aspects of the functionality of a sensor electronics module as described in U.S. Patent Publication No. 2009-0240120-A1 and U.S. Patent Publication No. 2012-0078071-A1 the contents of which are hereby incorporated by reference in their entireties. The electronics unit 500 may include hardware, firmware, and/or software that enable measurement of levels of the analyte via a glucose sensor, such as an analyte sensor 200. For example, the electronics unit 500 can include a potentiostat, a power source for providing power to the sensor 200, other components useful for signal processing and data storage, and preferably a telemetry module for one- or two-way data communication between the electronics unit 500 and one or more receivers, repeaters, and/or display devices, such as devices 110-113. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor. The electronics unit 500 may include sensor electronics that are configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time corresponding measured analyte values, analyzing a variation of estimated analyte values, and the like. Examples of systems and methods for processing sensor analyte data are described in more detail herein and in U.S. Pat. Nos. 7,310,544, 6,931,327, U.S. Patent Publication No. 2005-0043598-A1, U.S. Patent Publication No. 2007-0032706-A1, U.S. Patent Publication No. 2007-0016381-A1, U.S. Patent Publication No. 2008-0033254-A1, U.S. Patent Publication No. 2005-0203360-A1, U.S. Patent Publication No. 2005-0154271-A1, U.S. Patent Publication No. 2005-0192557-A1, U.S. Patent Publication No. 2006-0222566-A1, U.S. Patent Publication No. 2007-0203966-A1 and U.S. Patent Publication No. 2007-0208245-A1, the contents of which are hereby incorporated by reference in their entireties.
One or more repeaters, receivers and/or display devices, such as key fob repeater 110, medical device receiver 111 (e.g., insulin delivery device and/or dedicated glucose sensor receiver), smart phone 112, portable computer 113, and the like are operatively linked to the electronics unit, which receive data from the electronics unit 500, which is also referred to as the transmitter and/or sensor electronics body herein, and in some embodiments transmit data to the electronics unit 500. For example, the sensor data can be transmitted from the sensor electronics unit 500 to one or more of key fob repeater 110, medical device receiver 111, smart phone 112, portable computer 113, and the like. In one embodiment, a display device includes an input module with a quartz crystal operably connected to an RF transceiver (not shown) that together function to transmit, receive and synchronize data streams from the electronics unit 500. However, the input module can be configured in any manner that is capable of receiving data from the electronics unit 500. Once received, the input module sends the data stream to a processor that processes the data stream, such as described in more detail below. The processor is the central control unit that performs the processing, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time corresponding measured analyte values, analyzing a variation of estimated analyte values, downloading data, and controlling the user interface by providing analyte values, prompts, messages, warnings, alarms, and the like. The processor includes hardware that performs the processing described herein, for example read-only memory (ROM) provides permanent or semi-permanent storage of data, storing data such as sensor ID (sensor identity), receiver ID (receiver identity), and programming to process data streams (for example, programming for performing estimation and other algorithms described elsewhere herein) and random access memory (RAM) stores the system's cache memory and is helpful in data processing. An output module, which may be integral with and/or operatively connected with the processor, includes programming for generating output based on the sensor data received from the electronics unit (and any processing that incurred in the processor).
In some embodiments, analyte values are displayed on a display device. In some embodiments, prompts or messages can be displayed on the display device to convey information to the user, such as reference outlier values, requests for reference analyte values, therapy recommendations, deviation of the measured analyte values from the estimated analyte values, or the like. Additionally, prompts can be displayed to guide the user through calibration or trouble-shooting of the calibration.
Additionally, data output from the output module can provide wired or wireless, one- or two-way communication between the receiver and an external device. The external device can be any device that interfaces or communicates with the receiver. In some embodiments, the external device is a computer, and the receiver is able to download current or historical data for retrospective analysis by a physician, for example. In some embodiments, the external device is a modem, and the receiver is able to send alerts, warnings, emergency messages, or the like, via telecommunication lines to another party, such as a doctor or family member. In some embodiments, the external device is an insulin pen, and the receiver is able to communicate therapy recommendations, such as insulin amount and time, to the insulin pen. In some embodiments, the external device is an insulin pump, and the receiver is able to communicate therapy recommendations, such as insulin amount and time to the insulin pump. The external device can include other technology or medical devices, for example pacemakers, implanted analyte sensor patches, other infusion devices, telemetry devices, or the like. The receiver may communicate with the external device, and/or any number of additional devices, via any suitable communication protocol, including radio frequency, Bluetooth, universal serial bus, any of the wireless local area network (WLAN) communication standards, including the IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communication protocols, ZigBee, wireless (e.g., cellular) telecommunication, paging network communication, magnetic induction, satellite data communication, GPRS, ANT, and/or a proprietary communication protocol.
Certain aspects of applicators systems are described in U.S. Patent Publication No. 2013-0267811-A1 and U.S. Pat. No. 7,497,827; both of which are owned by the assignee of the present application and herein incorporated by reference in their entireties.
In particular, the implementations described in the applications incorporated by reference above depict systems and methods of applying a transcutaneous sensor into a patient and situating sensor wires within a housing to which the transmitter is attached. In some cases a torsion spring provides the force required for the system to perform the steps, and energy is similarly stored in the torsion spring, which is preloaded prior to shipping. However, in other implementations, it may be desirable to add to the force provided by the torsion spring, or to replace the torsion spring altogether with another source of force. One reason for doing so is that in the above implementation the torsion spring is shipped and stored in the preloaded or constrained configuration, and is thus subject to loss of spring force over time. In addition, use of a previously-constrained torsion spring (or any similar single spring) leads to a reduced spring force at the end of the spring movement due to Hooke's Law, F=−kx, where x is the distance from the equilibrium position. That is, at the end of the spring movement, x is close to zero, and thus so is the force.
The below described implementations generally discuss sensors constituted by one or more sensor wires. However, it will be understood that the sensors are not limited to such wire shaped or linear arrangements. Rather, the sensors may be implemented as planar sensors, volumetric sensors, point sensors, or in other shapes as will be understood given this description.
For example, and referring to
Various other types of applicators may thus be employed, and are described below. Such applicators endeavor to tailor the applied force such that the stored force is available and applied as required. Specific examples will be given below with regard to specific applicators. In general it will be desired to have more force available than is required by any given force profile. It is also noted that a typical force profile has a bimodal distribution, e.g., has at least two maxima, as may be seen by the bimodal distribution of
In one implementation, as shown in
A force profile for the device of
The applicator of
Referring in more detail now to
The device 20 is intended to perform steps of inserting a sensor, generally embodied by a sensor wire, into a patient, in vivo, the sensor wires extending out of the patient and coupled to an ex vivo disposable housing, the ex vivo disposable housing adhered to the skin of a patient. A transmitter (not shown in
A seal carrier 26 is illustrated in
Two holes 34a and 34b are defined within the seal 24, and within the holes are situated the conductive pucks (not shown in
Referring now to
A user may situate the applicator 20 in a desired location on their skin, and may remove protective tab 42, allowing access to button 44. Depression of the button 44 then starts the process of insertion.
In particular, depression of the button 44 operates to disengage the trigger tab 46 from a corresponding stop 49 on a torsion spring housing 52. With reference to
In embodiments, the protective tab 42 can function as a safety mechanism or lock, preventing depression of the button 44 (and thus, activation of the system) until after the protective tab 42 is separated and/or removed from the housing 30. In embodiments, the protective tab can include one or more members which extend beyond the perimeter of the button 44, over the surface of the applicator housing 30, so as to prevent depression of the button 44 until after the protective tab (or at least the portions which extend beyond the perimeter of the button 44) is removed. In embodiments, the protective tab can be coupled to the applicator housing 30 by one or more frangible elements which are configured to break when the tab is pressed up, down, sideways, or when the protective tab is twisted or pulled. The frangible element(s) can be configured to break upon application of a force between about 1.0 and 1.8 pounds. In some embodiments, the frangible element(s) can be configured to break upon application of a force between about 1.3 and 1.5 pounds. Depending on the desired user interaction, the protective tab can be configured to be removed via a twisting motion, a sweeping motion, a bending motion, or a pulling motion. In some embodiments, for example as illustrated in
In some embodiments, the protective tab and/or the button can include one or more visual or tactile features configured to indicate to a user the appropriate method of removal. For example, the protective tab can include arrows, protrusions, ridges, and/or tacky grips to indicate the location and direction in which the user should press on (or pull or twist) the tab to break the frangible member.
With reference again to
The sensor wire may have a kink defined so as to allow a friction fit within the needle. In this way, the sensor wire is held within the needle while still able to be translated through the needle by the force of the push rod. Generally, the kink may be configured so as to hold the wire within the needle, but in the case where the wire is external of the needle, and in the cannula, the kink would not be able to hold the sensor wire within the cannula, or would only be able to hold it to a minimal degree.
The push rod 86 is inserted in the needle proximal of the sensor, and after sensor insertion, holds the sensor in place (e.g., in position) while the needle and cannula are retracted. The push rod 86 can hold the sensor in place, e.g., in vivo, as the push rod is caused to be stationary at the distal end of its travel, i.e., the push rod stays in place (e.g., remains fixed or in the same position) while the needle and cannula move proximally around it. The push rod hub 84 is described in greater detail below.
In use the force of the torsion spring causes the yoke/needle hub assembly 64 including the outer needle hub 66, to move downward, i.e., distally, i.e., towards the seal carrier 26. The inner needle hub moves along with the outer needle hub in this downstroke because of the engagement of tab 91a and 93a with slot 94a (and a corresponding tab with a corresponding slot on the opposite side of the assembly 64). By engaging the tab 91a and 93a of the inner needle hub 68 with the locking features of the slot 94a in the outer needle hub 66 (and engaging a corresponding tab with a corresponding slot on the opposite side of the assembly 64) during assembly of the component, the spring 74 becomes compressed and thus preloaded during assembly. When the inner needle hub is caused to disengage from the outer needle hub, as will be described, the force of the spring 74 expanding causes the inner needle hub to move away from the outer needle hub in a proximal direction.
Referring to
At or near the lowest point of travel of the scotch yoke mechanism, two tabs 106 of the push rod hub 84 (only one is shown in
In some embodiments, push rod backspring elements 112 (
The torsion spring continues to rotate the wheel, causing the yoke to begin to move in the proximal direction, while the push rod hub remains fixed. The motion of the yoke in the proximal direction, in combination with the arrested push rod hub, activates the booster spring to retract the needle and cannula in the following fashion. In one implementation the amount of rotation remaining in the torsion spring after the pin 58 reaches its lowest point is 5% to 20% of its overall rotation, e.g., 10%.
First, and referring to
Next, two ramps 116 (see
As described above, at this point the scotch yoke mechanism is now beginning to drive in a proximal direction. However, as the initial preloading of the torsion spring caused the distal movement of the yoke, in some cases the force of the booster spring can act to re-load or “back drive” the torsion spring. Accordingly, in such implementations a ratchet mechanism can be employed to arrest movement of the torsion spring. In particular, and referring to
Engagement of the ratchet pawl 48 is with the ratchet teeth 136 inhibits or prevents clockwise rotation or back driving of the torsion spring housing 52. Similarly, abutment of the stop 49 against the hard stop 47 inhibits or prevents further counterclockwise rotation of the torsion spring housing 52. Motion of the pin 58 is thus also arrested, stopping movement of the scotch yoke mechanism, including the outer needle hub. The needle, however, continues to retract, as the same is driven by the booster spring on the inner needle hub. As described above, movement of the inner needle hub further causes retraction of the cannula hub. In this way the cannula and the needle are fully retracted through the seal by the booster spring. As the cannula hub and cannula are no longer supporting the seal carrier, the same is free to rotate (by the effect of gravity) into the disposable housing. In many cases, it is desirable to include a push spring 38 to assist this motion, the push spring held up by the cannula hub 32 until the same is removed and the seal carrier is ready to drop down into the disposable housing 36, as described in greater detail below. In some embodiments, one or more retention features 166 of the lower housing 40 can be employed to prevent the disposable housing 36 from being released from the housing 40 until after the cannula has been retracted from the seal. In some embodiments, the rotation of the seal carrier can facilitate the release of the retention feature(s) 166, allowing the disposable housing to separate from the device 20. Once the inner needle hub is in a fully retracted position, the sensor has been placed in the body and the applicator can be removed leaving the disposable housing assembly.
Advantages of implementations of the device of
With reference now to
With reference now to
With reference now to
The sensor wire itself may have one or more contact regions, e.g., corresponding to an outer silver layer and an inner platinum layer, separated by a polyurethane layer. It will be understood that the specific constituents of these conductive and insulator layers may vary according to implementation. The conductive regions may be accessed either directly (in the case of contact with the outer silver layer) or via removal of the silver and polyurethane layers to obtain access to the platinum layer.
The wire may include a generally ex vivo portion and a generally in vivo section, both of which being about and approximately ½ inch in length. The ex vivo portion may include electrical contact points, and the in vivo portion may include a sensing portion, which may be at the distal tip of the in vivo portion or may be proximal of the distal tip of the in vivo portion. A transmitter may be employed which has electrical contacts (not shown) which contact first and second pucks. As the wire also contacts the pucks, the wire is in signal communication with the transmitter. To ensure that each puck contacts a separate portion of the wire, the insulated portion of the wire may be disposed between the pucks. In this way, a first contact, e.g., the silver portion, makes contact with the first puck, and a second contact, e.g., the platinum portion, makes contact with the second puck. In one implementation, the diameter of the pucks is about 80 mils, and the distance between the pucks is about 215 mils.
The implementation of
In one alternate implementation of an applicator according to present principles, a wearable device, such as is embodied in the disposable housing 36 and transmitter (described below), may be deployed in a host using systems and methods described in the applications incorporated by reference above, and in particular as disclosed in the applications incorporated by reference above. For example, in the applications incorporated by reference, a sensor wire is inserted through the cannula into a host, and the wire is sealed with an elastomeric seal which is compressed by transmitter insertion.
In the above implementation of
In embodiments employing a booster spring, the booster spring can be fired when the needle is fully inserted, and can be configured to facilitate the retraction of the needle/cannula assembly, leaving the sensor behind and installed in the sensor pod. A considerable amount of force, however, may be released upon firing of the booster spring. This force can result in a large acceleration of the inner needle hub against the cannula hub, possibly creating vibrations or amplifying any existing oscillation in the mechanism. In embodiments, various design parameters of the booster spring can be adjusted to change the acceleration curve of the spring and thereby reduce or avoid any sudden acceleration when it is fired. Embodiments can thus reduce or avoid any vibration imparted to the mechanism by the booster spring during retraction and provide safe and reliable retraction. For example, some embodiments can employ a variable pitch booster spring, a variable diameter (e.g., cone-shaped) booster spring, a variable diameter wire booster spring, or multiple booster springs (e.g., one inside another, or multiple springs in series) to achieve these goals. In addition, different materials and/or material processing techniques can be used to obtain the desired spring constant and thereby achieve these goals.
Generally, the implementation of
As an example of a system configured to obviate any need for an additional force, and referring in particular to
One difference between the implementation of
As an example of the use of manual or semi-manual or user-supplied force, and referring in particular to
Once the button 146 is moved in a proximal direction, the bar 154 no longer arrests rotation of the wheel 144, and in the same way as described above, the needle and sensor wire may be inserted into the host using the force of a torsion spring (not shown) coaxial with the wheel 144. In particular, a yoke 158 is illustrated which may be driven downward by rotation of the wheel 144, propelling the needle and sensor into the host. This aspect is also illustrated in
The button 146 may be provided with indentations biased in a way to assist the user in moving the button in the direction indicated by arrow 152 (see
Other ways may also be employed of converting rotational energy stored in a torsion spring (and thus resulting in a rotational force) into the more linear translation required in a sensor deposition system. Put another way, one basic requirement of an applicator system is that the same be configured to perform an insertion of a sensor transcutaneously, such that a portion of the sensor is in vivo in the interstitial space in a host (the distal portion) and a portion of the sensor (the proximal portion) is ex vivo. In some cases the sensor may have sufficient column strength and a sharpened end so as to be able to penetrate the skin itself using systems and methods disclosed here or in applications incorporated by reference. In other cases, including in most implementations disclosed here, a needle is used for insertion of the sensor, and the sensor travels with the needle during insertion and is maintained in vivo while the needle retracts, i.e., leaving the sensor in place. In other cases as will be described the needle is used to perform insertion but the sensor wire has sufficient column strength to penetrate even deeper than the needle, through the patient's interstitial area.
Thus a general required motion applicable to most embodiments is that of insertion and retraction, i.e., insertion to insert the needle and sensor assembly, and retraction to remove the needle. In some cases, greater column strength is provided to the needle, and the needle motion itself is significantly eased, by incorporation of a cannula, which is generally a hypotube. For example, and as in
As an example of an implementation in which overall efficiency is increased, thus negating the need for an additional force or driving mechanism or source of stored energy, and referring to
Without wishing to be bound by theory, it is believed that crank slider mechanisms are generally more efficient than scotch yoke mechanisms, and subsequently result in a reduction of energy losses during the deployment cycle. In some implementations, crank slider mechanisms may be employed without a booster spring, because of the reduction of energy losses. As in
In the same way, and for the same purpose of increasing efficiency of the device, and referring to the device 242 in
One exemplary benefit to the rack and pinion mechanism is that the same may in some implementations have benefits over the scotch yoke mechanism. For example, scotch yoke mechanisms typically have points in their cycles of low torque and high torque, which can make them susceptible to stalling in places where a large amount of torque is required. A rack and pinion mechanism generally provides a more constant torque and may overall be more efficient in transferring the torsional spring energy to linear motion.
As another example of an implementation in which additional force is supplied,
Activation of the trigger may then cause the release and subsequent extension of the spring 272, driving the needle with sensor into the host. In the same way as described above, with regard to activation of the booster spring e.g., using a push rod hub which latches into a portion of the applicator housing, the spring 274 may be activated, causing retraction of the needle out of the host, while leaving a portion of the sensor within.
Besides manual retraction, another implementation includes a step of user preload. This implementation may be a variant of the single compression spring. However, for manual insertion, the spring may be placed on the shelf in the half loaded state. The initial input of the force by the user pressing the plunger fully loads the spring. Then the release is identical to the single spring implementation described above with respect to
One benefit to the implementation of manual insertion is that only a single coaxial spring is required, thus significantly reducing costs. In use, a user would depress the plunger against the resistance of the spring, in the same way as a button on a ballpoint pen is compressed against a spring. No activation of a needle occurs until the bottom of travel is reached by the plunger. When at the bottom of travel, the spring releases, and the needle and push rod are pushed forward under the skin. This position is maintained until the user releases the plunger at which time the plunger retracts, pulling the needle and cannula back and depositing the sensor. As in the other implementations, the push rod may stay in the distal or bottom position, causing the sensor to be deposited into the host. The user may then remove the applicator and install a transmitter.
Advantages to the implementation of user preload insertion include lower-cost and fewer components, as well as the avoidance of partial deployments, as no activation occurs until the user fully depresses the plunger. Another significant advantage to manual insertion is that the spring is not fully preloaded, but rather half-loaded by the user right before activation. In this way, problems with sizing components for sustained loads in plastic components, such as creep, are avoided.
An exemplary force profile is illustrated by the graph 210 in
A method of use is illustrated by the flowchart 214 of
The implementations of
The barrel cam 306 performs the conversion of rotational force to linear or translational or longitudinal force. The barrel cam 306 includes one or more channels, shown as channels 308, 312, and 314. Parts such as the outer needle hub, inner needle hub, a cannula hub, push rod hub, and the like, are driven by corresponding nubs which a ride within the channels or tracks of the barrel 306. In particular, nub 316 is driven by rotation of the channel 308. Nub 318 is driven by rotation of the channel 312. Nub 322 is driven by rotation of the channel 314. The linear positions of the needle hub, push rod hub, and cannula hub, can be controlled by the shapes of the tracks in the barrel cylinder. In this way, component parts may be inserted and retracted as needed, without the need for hub drop offs. As the cylinder rotates, each of the hubs move linearly independently from one another.
In the embodiment illustrated in
Referring now to
During the insertion process, the outer needle hub 66c, the inner needle hub 68c, and the push rod 86c move together in a distal direction, along with the second portion 29 of the two-part seal carrier 26c. The second portion 29 slidingly engages with the first portion 27 and ultimately snaps into engagement with the first portion 27. At this stage, the needle 72 and the sensor wire are deployed into the patient's skin.
In configurations with a two part seal carrier negative interactions affecting force required or sensor positioning (e.g. friction or seal recoil) are prevented. This is accomplished by negating relative movement between the sealing member and needle during the insertion phase of the cycle. This also has the additional benefit of lowering component count (e.g. deleting the cannula) and holding a smaller lumen in the seal which may have sealing benefits.
In all of the implementations noted, when the cannula 78 is removed from the seal 24, a deleterious phenomenon termed “slingshotting” may occur, and many of the efforts of systems and methods according to present principles are directed towards reduction or elimination of slingshotting. In particular, when the cannula is removed, the seal, which is generally made of an elastomer, is pulled by the cannula due to friction at the point of contact (actually a cylinder of contact). Thus, a cylindrical portion of the seal, generally in the interior of the seal and adjacent the cannula, is temporarily pulled by the cannula during cannula removal.
As the cannula emerges from the seal, the lack of frictional “pull” of the cannula on the seal causes the seal to rebound in the distal direction. Depending on configuration, the rebounding (“slingshotting”) seal may frictionally contact the sensor wire and/or needle and force the same forward, having a deleterious effect on placement of the contact points on the sensor wire vis-a-vis the contact pucks. For example, the slingshotting can result in a change of position of over 100 mils, and to this is compared the diameter of the pucks, which may be, e.g., 80 mils, and the distance between the pucks, which may be, e.g., 215 mils.
Some ways to combat seal slingshotting include modification of the seal to reduce its frictional contact with the cannula. These ways are discussed below. Another way to combat seal slingshotting is to perform an action with the cannula to ease its removal from the seal, or at least to perform an action that causes the seal to slingshot less. Referring to
The amount of rotation required may be small, and the same need only rotate during the time immediately before cannula removal up to the time most or all of the cannula is removed. In one implementation, and without wishing to be bound by theory, it is believed that, in the absence of rotation, the static friction and adhesion between the cannula and the seal must be overcome for the seal to not be pulled by the cannula. If the cannula is caused to rotate, the static friction and adhesion has already been overcome, and the only force required is that caused by the kinetic friction. Assuming the normal force is the same, as the kinetic friction is generally less than static friction, the cannula force is much less on the seal during removal. Relative motion between the seal and the cannula about the rotational axis does not cause deformation of the seal elastomer about the longitudinal axis. Therefore slingshotting effects can be minimized by breaking static friction and adhesion in the rotational axis.
It will be understood that the cannula drive may be constituted by a number of devices, including those driven by the same sources of energy performing the insertion and/or retraction, devices specifically dedicated for this purpose, or the like. Such devices may include cams, motors, and so on.
Besides rotating the cannula (or causing the cannula to perform another like motion, e.g., vibrating the cannula) to accomplish the goal of lessening seal slingshotting, another way to specifically reduce the effect of seal slingshotting on the sensor wire is to retract the cannula prior to retraction of the needle. In this way, the seal slingshotting or “snapback” contacts the needle and not the sensor wire itself. The needle shields the sensor wire from the slingshotting effect.
Referring to the flowchart 414 of
The implementation of
In yet another implementation, and referring to
In
This implementation may be implemented by modifying the implementation of
In embodiments, the needle can be a single-lumen needle with a single bevel at its point, such as the needle 450 illustrated in
In some embodiments, the needle can be a multi-lumen needle, such as the needle 456 illustrated in
In some embodiments, the needle can be a curved, C-shaped, or Tuohy needle. For example, as shown in
The term “needle” as used herein should be construed to cover any delivery device that can contain the sensor 1018 for delivery to the appropriate depth. The “needle” can have any of a variety of shapes with regard to its wall structure 1012. For example, the wall shape can be cylindrical with a circular cross-section or can have a V-shaped, square or rectangular, or even some irregular, cross-section. The wall shape also need not be an extruded shape with the same cross-section along its axis. For example, the wall shape may start as a cylindrical tube with a circular cross-section at a proximal end and then change to a V-shape (in cross section) as it approaches the distal end. The wall shape may also have defined along its length slots or various openings—such as a slot that gives it a C-shape in cross-section. (The open cross-section of the C or V-shapes affords clearance for attachment of wiring, for example.)
Generally, however, the wall structure 1012 defines some inner (relative to some outer surface of the wall) dimension (width or diameter for example) that supports or contains the sensor 1018 for subcutaneous delivery. For example, in a V-shaped cross-section, the inner part of the V near its base has a diameter that is occupied by the sensor lodged between the two inner wall surfaces. Thus, the “dimension” is defined by the position that the sensor occupies (or would occupy) during delivery in or on the needle wall structure 1012. The term “needle” also covers other devices (with different names) that share similar wall structures and functions (e.g., delivery of an implantable device), such as, for example, a tube, channel, cannula, catheter or blunt dilator with a recess or opening for deployment of an implantable device (e.g., a sensor).
The wall structure 1012 of the needle 1010 has, in the embodiment of
In some embodiments, the outer diameter of the wall structure 1012 at the proximal end, for example, may be about 0.0135 plus 0.001 or minus 0.0002 inches. The outer diameter and thickness of the wall structure 1012 reflects a balance of columnar stiffness and minimization of the wound size for clearance of the needle through the patient's skin. In certain embodiments, the diameter of the wall structure 1012 is minimized, but not to the point where the needle 1010 is susceptible to buckling under the expected axial load from needle insertion.
In one aspect, the wall structure 1012 has a length configured to retain and protect the sensor 1016. In the case of one type of subcutaneously delivered glucose sensor, for example, the wall structure 1012 has a length of about 2.31±0.02 inches.
The strength of the wall structure 1012 (e.g., column strength) is determined in part by its material composition. A range of materials can be used, for example, steel (e.g., stainless steel), ceramics, titanium, tantalum, nickel, nickel-titanium, iridium, silver, palladium, platinum-iridium, iridium, ceramics, composites, and combinations or alloys thereof, and/or the like. Polymers that may be used include, but are not limited to, polycarbonate, polymethacrylic acid, ethylene vinyl acetate, polyesters, fluoropolymers including polytetrafluorethylene (TEFLON®), polyethylene, polypropylene, high density polyethylene, nylons, polyethylene terephthalate, and polyesters, combinations thereof, and the like. Stiffer materials like stainless steel (SS304 with a full hard temper) can store more deformation energy and have a higher modulus (190-203 GPa Young's modulus) and elastic limit (205-310 MPa) than many other materials and thus have good stiffness and resistance to buckling and permanent (plastic) deformation. This helps to keep the shape of the needle (and its ability to deliver the sensor) through penetration of the skin to the sensor depth. Also, steel has the advantage that it can be machined (formed, filed, ground, etc.) to create a sharper edge than many other materials. Further, steel tends to hold its edge well—the aforementioned modulus and energy storage capability keep the edge sharp through its use.
The insertion force and buckling strength of the needle 1010 has been determined. The needle 1010 is inserted at 45 degrees into 10N Syndaver at 1 in/min. Peak insertion force was measured using a 10N load cell. Insertion forces were measured for 8 attempts at an average of 0.22 b lbf with a minimum of 0.156 lbf and a maximum of 0.298 lbf and a standard deviation of 0.0505. Insertion forces were also measured for conventional needles and averaged 0.191 lbf with a range of 0.163 lbf and 0.237 lbf and a standard deviation of 0.0239.
Buckling strength was tested by compressing the needle 1010 against a non-pierceable (metal plate) and measuring the axial force required to buckle the needle using the 10N load cell. The buckling strength of the needle 1010 was (for 8 samples) 2.505 lbf on average with a minimum of 2.185 lbf and a maximum of 2.280 lbf and a standard deviation of 0.2189. For conventional needles, 2.458 lbf on average with a minimum of 2.158 lbf and a maximum of 2.755 lbf was measured.
The ratios of buckling strength as a ratio to insertion force ranged from about 7.3 to 14.6 times the insertion force. Thus, the needle 1010 is capable of withstanding buckling even with presentation of some relatively high percentage of blunt contour for dilation of the skin opening.
The “central axis” is a reference point for an amount and positioning of the cutting edge 1014 and blunt contours relative to the proximal portion of the sensor 1016 (or where the sensor would be if it were within the needle 1010). For example, the central axis of the wall structure 1012 in the implementation of
The central axis 1020 is not limited to a linear shape. Generally, the central axis will be defined by a line through a series of points wherein the points are the centroids of a series of cross-sectional slices of the proximal end of the sensor 1018. Thus, as the path of the sensor 1018 bends or curves, the central axis 1020 will follow. (The “centroid” is an average position of all of the points in a shape. For a cylindrical sensor it is the center of the circular cross-section. However, the sensor need not have any particular cross-sectional shape to define a central axis—even an irregular cross-sectional shape has a centroid.) Generally, then, the central axis defines a central location of the composite pathway of the sensor 1018 proximal the edges and blunt contours as a reference point for the positioning of the edges and blunt contours 1014, 1016.
The central opening 1022 is an opening in the center defined by a closed boundary wall structure—such as the one defined by the tubular portion of the needle 1010 wall structure 1012 in
Referring back to
The bend may be any of a variety of angles depending on the desired angle of entry of the tip of the cutting edge. Preferably, the bevel angle of the cutting edge 1014 is balanced to the amount of blunt contour 1016 seen by the skin as it is penetrated. The amount of blunt contour and cutting edge “seen” by the skin for example is the projected area occupied by the blunt contour and cutting edge when viewed along the central axis 1020. (This captures a measure of what proportion of the blunt and cutting edges impacts the skin as the needle is advanced along the central axis line.) The blunt surface area is the amount of area occupied by the blunt contours of the needle from this view and the cutting surface area is the amount of surface area positioned opposite the blunt contours starting with the cutting edge, again as viewed along the central axis 1020.
Generally, a design with a greater bend (and a larger blunt contour area seen at the insertion site) is more advantageous for reducing wound size. However, the extent of the bend (and size of the blunt contour seen at the insertion site) is limited by the need for some aspect of the cutting edge 1014 to be positioned to penetrate the skin surface and form a hole large enough for expansion of the hole without further tearing. Thus the bevel angle or other angle of the cutting edge 1014 relative to the central axis balances the amount of bend 1030's angle.
Lubricants or other materials may be added into the lumen of the needle 1010 to facilitate sensor withdrawal. For example, silane, silicone, parylene or other material with a low coefficient of friction may be added to the luminal surface of the needle. Coating the lumen walls with lubricious fluid improves the ease of release of the sensor without damaging the sensor membrane or otherwise inhibiting sensor operation.
The cutting edge 1014 may include several sharpened edges or portions thereof in composite or a single planar facet forming a single sharpened edge. In any case, the cutting edge 1014 in the embodiment of
The beveled surfaces may include a primary or proximal bevel 1024 and a pair of secondary or distal bevels 1026, as shown in
In one implementation, the cutting edge 1014 could be defined on a single, primary bevel 1024 having an angle in the angle ranges described above, such as the angle shown in
In certain embodiments, such as the one illustrated
The secondary bevels 1026 may be varied in their angle from the outer surface line. However, a range of about 8 to 24 degrees balances the proportion of cutting edges 1014 and blunt contours 1016 for wound reduction. In some embodiments, the needle may have a 17 degree bend 30, 7 degree primary bevel 1024 and 16 degree secondary bevel 1026.
In
Although the set of bevels 1024, 1026 form several axially oriented edges on the distal end of the wall structure 1012, not all of those edges are necessarily sharpened. Instead, the cutting edge 1014 is formed only on more distal portions of the secondary bevels 1026. In particular, for example, on
In the illustrated embodiment of
The remainder of the edges of the bevels 1024, 1026 may be rounded into smoothed, non-cutting edges having about 2 to 3 thousandths of an inch radius or greater. For example, the heel and other edges of the primary bevel 1024 may be blasted with media to smooth them. Blasting the heel of the bevel (the proximal, inner edge defining the central opening 1022) may smooth it to reduce or eliminate coring, which occurs when the skin is picked up during needle 1010 insertion (also sometimes referred to as “coring”).
As shown in
In one embodiment, the bend 1030 advantageously repositions or offsets the leading point (and initial contacting cutting feature) of a conventional needle to the opposite side of the circular cross-section by 0.0112 inches, as shown by comparison of
It should be noted, however, that an advantage of presenting a blunt contour 1016 starts with any sized bend 1030 (or other structure or modification) that moves the point and other cutting edges 1014 within the outermost periphery of the circumscribed wall structure 1012. Offsetting the cutting edge away from the outermost periphery and closer to (or past) the central axis than the adjacent outer edge by even 1% therefore results in some benefit of reduced invasiveness. Such positioning presents a blunt contour to the skin during insertion of the needle. Generally, the further the positioning across the dimension of the needle 1010, the larger the proportion of the area presented to the skin that is made up by a blunt contour (versus cutting edge). For example, in some embodiments, the cutting edge can be repositioned across the dimension from about 5% to about 65% of the dimension in intervals of 5%. At the same time, some amount of cutting edge must be presented or no initial opening in the skin will be formed large enough to be dilated without tearing by the blunt dissection—hence the concept of “balance” between cutting and blunt dissection described above.
Although sometimes referred to as a diameter for the purposes of the round tubing used for wall structure 1012 in the illustrated embodiments, the relevant “dimension” is any major dimension across the portion of the wall structure 1012—or “cross dimension”—configured to hold the sensor. Another metric that can be used to characterize the proportion of cutting edge 1014 to blunt contour 1016 is the projected area dedicated to blunt contours 1016 projected along from a perspective viewed along the central axis 1020. For example, as shown in a view along the central axis in
The various degrees of bend and bevel angles disclosed herein are not arbitrary. Rather, they impact wound size (and consequently dip-and-recover and other foreign body responses) and sensor deployment amongst other things. For example,
The relationship of the ratio (blunt surface area/cutting surface area) versus needle bend and primary bevel angle can be defined by an equation: Ratio (BSA/CSA)=0.1895+0.2266*(Bend Angle)−0.004952*(Bend Angle)2 for a primary bevel angle of 5 degrees. The constants change with each of the primary bevel angle changes. Ratio=0.171+0.1379*Bend Angle)−0.003095*(Bend Angle)2 for a primary bevel angle of 7 degrees. Ratio=0.1329+0.09457*Bend Angle)−0.002286*(Bend Angle)2 for a primary bevel angle of 9 degrees. The changing constants can be determined via curve fit to the data above in Table 1 for different bevel angles.
Referring now to
Sensor delivery systems that employ a needle without a slot are typically unable to deliver a pre-connected sensor (i.e., a sensor connected to sensor electronics prior to sensor insertion). With these systems, electrical connection between the sensor and the sensor electronics occurs after the sensor has been inserted and often after the needle has been retracted. In some embodiments, such as the embodiment illustrated in
In short, the C-shape or V-shape or other shape formed by a slot 1034 extending through the distal end of the needle 1010 may provide for delivery of pre-connected sensors 1018. The wires from the sensor can extend through the slot 1034 while the rest of the sensor is held within the opening 1022. More than one slot could be used, such as for several electrical connectors. In addition, the slots may vary in size, shape and positioning depending upon the desired use and/or reduction of invasiveness.
The windows and slots may be combined with the bend and other characteristics of the needles illustrated in
Embodiments can incorporate various additional or alternative features to avoid or limit tissue trauma. For example, some embodiments can be configured to reduce vibration and/or lateral motion of the needle tip during the insertion and retraction phases of sensor deployment by de-coupling at least a portion of the device from the needle. For example, some embodiments can include additional bearing features operatively coupled to the inner needle hub, so as to decouple the inner needle hub from the outer needle hub or other portions of the device and minimize transfer of any vibrational forces to the needle. Additionally or in the alternative, some embodiments can include features configured to counteract any moments placed on the needle during the insertion or retraction phases, or to otherwise limit or constrain the path of the needle during the insertion and retraction phases to a straight line and thereby avoid or reduce the likelihood of tissue trauma. In some embodiments, the needle hub itself can comprise a semi-rigid or somewhat compliant material, to provide damping of high frequency vibrations and/or lateral movement during actuation and ensure that the needle follows the prescribed path. In some embodiments, the needle itself can comprise a relatively low temper (e.g. less than full hard stainless steel), to allow the needle shaft to flex during the insertion and retraction phases.
Other aspects of systems and methods according to present principles are now described.
If the seal carrier 26 falls into place in the disposable housing 36 upon removal of the cannula hub, it is generally apparent to users how the transmitter 500 is to be snapped into the disposable housing. However, when the seal carrier 26 is left at a significant angle with respect to the disposable housing 36, it may not be apparent to all users how the transmitter is to be snapped into the disposable housing, particularly where the angled position of the seal carrier obscures the user view of the slot 442. Accordingly, it is desirable to have a component that serves to exert a force to rotate (or otherwise push) the seal carrier 26 down into place in the disposable housing 36.
In some embodiments, as illustrated in
Referring now to
Referring to
Referring back to
In more detail, the disposable housing 36 includes a breakaway section 432 which is attached to a remainder of the disposable housing 36 via frangible portions 436 and 438. An access strip 434 may be employed in some implementations to further ease the removal of the breakaway section 432 from the remainder of the disposable housing 36. For example, a user may grab, push, or pull on the access strip 434 and twist or pull so as to remove the breakaway section 432 from the remainder. That is, the breakaway section 432 can be used to bend or break out of the way in order to remove the transmitter from the disposable housing once the same has been removed from the body. In some embodiments, a breakaway section can be configured to break away from the remainder of the disposable housing 36 under a force of between about 2-4 pounds. Also in some embodiments, a breakaway section can be configured to break away from the remainder of the disposable housing 36 at a break angle of between about 30-60 degrees.
Additional advantages ensue to the disposable housing 36 including a breakaway section 432. The same allows a minimization of insertion forces required to latch the transmitter onto the disposable housing. This system minimizes deflection of the disposable housing due to compression of the seal. The system maintains compression of the seal over time and temperature, acting against deleterious consequences including creep. The same provides a user-friendly removal process to separate the transmitter from the disposable housing after the wearable has been removed from the body.
Referring back to
As noted above, many of the implementations described provide ways to make available additional power and force to perform the steps of insertion or retraction. In some cases, the additional force does not result in an increase of overall force, but a better distribution of force, so that force is available when needed to perform the desired steps. In some cases, and as described below, systems and methods according to present principles relate to ways to decrease the force required, e.g., to lower the force required in a given force profile. Many systems and methods as described below achieve this effect by modification of the seal component 24 discussed generally above, as well as modifications to its associated seal carrier 26. In addition, besides easing force requirements on insertion and retraction components, systems and methods according to present principles also relate to reducing the effect of seal slingshotting as described above, again by modification of the seal 24 and/or by other means of arresting movement of the sensor wire.
In particular,
In more detail,
In this implementation, various ribs may be provided to reduce seal deformation during cannula removal. The ribs may be adhered to the seal during the overmolding process to even more fully situate the seal in place. One or more pillar ribs 602 at least partially surround the conductive pucks (not shown). The pillar ribs 602 may completely surround the pucks or may only partially surround the pucks. Sidewall ribs may also be provided in some configurations to reduce seal deformation during cannula removal. A continuous wall rib 604 is illustrated which extends from one side of the seal carrier to the other, e.g., along the distal/proximal axis. The ribs as described may be formed of materials similar or the same as the seal carrier 626, and may moreover be integral therewith. The ribs may also be formed of a different material, but in general the material should be of higher durometer than that of the seal 624. An additional rib 606 is illustrated, and the same may either be a “floating” rib, situated within the seal 624 but not directly connected to the seal carrier 626, or the additional rib 606 may be directly connected to the seal carrier 626.
Variations of these configurations of ribs will also be understood to help reduce seal slingshotting, e.g., by prohibiting motion of the seal in and along the distal/proximal axis. Certain of these configurations are described below. For example, to even further lessen the effect or possibility of seal slingshotting, voids 608 may be defined in the seal 624 to reduce the amount of seal material in contact with the cannula, thus reducing the effect of seal slingshotting.
Another way of easing force requirements on insertion and retraction is described with respect to
In more detail, a first material 634, which may be a high durometer material such as an elastomer, e.g., silicone, may be disposed in locations in which significant contact is made with a cannula, needle, and sensor wire. A second lower durometer material 632 may then be placed to constitute the rest of the seal 628, and in particular in locations where a sealing function is desired. The second material 632 may be, e.g., a thermoplastic elastomer (TPE). As noted the second material 632 typically has a lower durometer than that of the silicone, allowing the same to achieve a better seal.
The implementation of
In particular, the cannula 78 passes through a channel 646 formed between a seal portion 638 and the seal carrier 644. During manufacture, a fluid such as grease, e.g., petroleum jelly, is injected into the channel 646. Following injection, it need not occupy the entirety of the channel. However, when the transmitter is placed on top of the seal and forced onto the seal and seal carrier, making contact with the pucks 123 and 125, the seal portion 638 will be significantly compressed, forcing the grease throughout the channel. The grease provides a moisture barrier and significantly reduces the retraction force required for the cannula, consequently reducing slingshotting.
The grease may be inserted through a septum 642, e.g., with a needle. A front septum 648 may be provided, and the same may advantageously be employed to help retain the sensor wire in place via friction. The septum 648 (and septum 642) may be made of seal material, e.g., an elastomer, and the same generally is pre-stressed to “close up” when the cannula or needle is removed. In some implementations, the septum may be made of a more rigid elastomer, to allow a more rigid hold on the wire. Because of this there may still be an increase in force required when the cannula begins to be retracted from the septum, but in many of the applicator implementations, the beginning of cannula retraction is at a point when the retraction drive, e.g., spring, has considerable energy with which to exert a force, e.g., the spring is not at the end of its movement, and thus such retraction is easily performed.
The pucks 123 and 125 may be “floating”, in the sense that they are held by the seal 638 and are not penetrated by the cannula (nor is the seal 638), except at the septum 648. However, the pucks 123 and 125 may be held within the seal 638 by the use of annular tabs 652 moving within cylindrical channels 654.
Various advantages inure to the implementation of
Alternatives of the system of
In another alternative, rather than piercing the septum, the cannula could be held just proximal to it. During deployment, i.e., needle insertion, the needle pierces the septum and performs sensor insertion. The cannula still serves the purpose of preventing needle contact with the grease inside the flow seal. This implementation has the benefit that the septum remains in an unstressed state during sterilization and storage. This aspect eliminates the compression set that would otherwise reduce sensor retention by the septum post sterilization and after storage.
In yet another implementation, as shown in
This implementation may reduce the amount of force needed to remove the cannula from the seal. In addition, the same allow for seal breaches to occur, e.g., in one ring, without affecting the seal integrity of the other ring(s). (Seal breaches may occur due to surface defects, tolerances, and the like.) In variations of the implementation of
Another implementation which may be employed to reduce the normal force on the cannula by the seal, and thus to make the cannula easier to remove, is by use of the sandwich seal. Such a sandwich seal is illustrated by
In particular, as noted the force required to remove the cannula from the seal typically stresses the components of the seal and applicator system. Efforts have been attempted at reducing the required force to remove the cannula by slitting the seals, but such seal slitting operations are typically undesirable and deleterious.
A sandwich seal employs a two-part design in which the cannula is sandwiched between the two parts. This results in a generally much lower cannula pull force requirement because along the length of the cannula the frictional force of the seal thereon is less. Other advantages include that no grease is required for sealing, and sensor retention is decoupled from the seal and can be made much more robust. Ideal sealing materials, such as low durometer elastomers, can be employed because the sealing function is decoupled from other functions such as sensor placement.
In more detail, a sandwich seal may be employed which increases the gap spacing between the seal and the cannula. Instead of a single block of elastomeric material, two blocks may be employed and the cannula can pass through in-between the blocks. The cannula thus has a larger opening through which to pass, minimizing resistance and slingshotting.
Referring first to
A top sandwich component 678 is illustrated, having a top frame 682 and a top seal 684. The top sandwich component 678 may be hinged to the bottom component 672 (see hinge 692 in
In use, and during insertion, the system may be in the unlatched position, as illustrated in
In one implementation, the bottom seal material 672 may have a higher durometer than the seal material 684. In another implementation, the opposite may be true. Having a higher durometer bottom seal material 672 allows support of the sensor wire in a way so as to produce a reliable connection to the pucks but which also allows good sealing when sandwiched to the lower durometer material snapping down from above it. In some cases, the frame 682 and the top seal 684 may both be made of an overmolded low durometer seal material.
Variations of the implementation of
In yet another variation, the top portion of the seal (frame 682 and seal 684) may be held above the needle, and the septum (described above) is not pierced in its manufactured state. Rather, the needle pierces the septum upon activation of the applicator. In this variation, the cannula can be eliminated, reducing parts and increasing manufacturability. The septum beneficially remains in an unstressed state during sterilization and storage. This aspect has the advantage of a limited compression set that would otherwise reduce sensor retention by the septum post sterilization and after storage. In this variation, the top portion of the seal may be held out of the way of the needle before and during deployment as well as during storage, which may be accomplished by putting snaps on the top seal component or incorporating features into the carrier that hold the seal in the applicator and prevent the top seal from compressing on the needle.
Advantages of the implementation of
In implementations according to these principles, a seal housing 704 includes a septum 705 for use in holding a sensor wire as described above, the septum 705 located at a distal portion of the seal subassembly. A material 706 is illustrated, which is overmolded onto a rigid plastic component 703. The material 706 may be a low durometer component, e.g., TPE or silicone or other sealing material. The material 706 also contacts a bottom portion of the rigid plastic component 703, as shown in
When the cannula is removed during retraction, the spring element 738, and in particular the contact element 744, no longer abuts the cannula but rather it abuts the sensor wire, providing additional force against sensor wire movement. In one variation, spring element 738 may be configured to provide a greater force when contacting the sensor wire then when contacting the cannula. In another variation, the spring element 738 may be arrested from movements such that the contact element 744 does not even abut the cannula until such time as the cannula is removed, and then the arresting of movement may be removed and the spring element caused to contact and provide a force against the sensor wire.
The implementations of
In more detail, and referring first to
In more detail, the seal housing 812 includes one or more glue wells 814. In
It will be understood that in any of the implementations of
Variations of the above will also be understood. For example, in some cases users may find it difficult or inconvenient to hold the applicator flat on their skin and push the activation button at the same time. Such may be particularly true if the user is inserting the sensor on their side or back. For these reasons, and referring to
The activating device 906 and the activated device 902, i.e., the applicator, may be communicatively coupled in a number of ways, including wirelessly or via a wired link. Wireless communication schemes may include RF links such as may be enabled by Bluetooth protocols, WiFi, or the like. Other communication schemes will also be understood. Advantages of such systems and methods according to present principles are described above, but also include that the user may situate the applicator on their body in a more stable fashion, rather than having to use one of their fingers to also push the activation button (or manipulate another activator, such as a slider or the like disclosed here).
The activating device 906 may be, e.g., a smart phone, a smart watch, a computing device, a dedicated receiver or transmitter, e.g., similar to a garage door opener or other remote control, or the like. The same may incorporate timers or other time delay devices, as well. In alternative implementations, a button on the applicator may be employed, as in
In another variation, and referring to
In another embodiment, and referring to
In contrast to the transmitter 500 and disposable housing 36 illustrated in
In embodiments, a sensor insertion device can generally include an upper housing, a lower housing, a protective tab (e.g., a safety frangible), a trigger button, a torsion spring housing or wheel cam, a torsion spring, an outer needle hub, an inner needle hub, a needle, a sensor, a push rod hub, a push rod, a cannula hub, a cannula, a compression spring, a seal carrier, a seal, a disposable housing, and an adhesive patch, for example as described herein. In some embodiments, a sensor insertion device can be configured to deploy generally as follows. In an initial configuration, for example as manufactured and provided to the consumer, the upper housing and lower housing are coupled together to house the inner components of the device. The torsion spring and the compression spring are pre-energized or pre-loaded. The outer needle hub, inner needle hub, cannula hub, and push rod hub are fixedly coupled to one another in an initial, pre-deployed configuration, with the needle and push rod in an initial proximal position. The cannula is in an initial distal position, and is operatively coupled to the disposable housing via the seal. In some embodiments, the cannula extends through the elastomeric seal in frictional engagement with the elastomeric seal. The seal carrier is hingedly coupled to the disposable housing, but disposed at an angle with respect to the disposable housing, in line with an angle of insertion. In the initial configuration, the cannula hub cooperates with ribs of the lower housing to secure the seal carrier in this angled position. Also in the initial configuration, a tab or other protrusion of the trigger is disposed so as to block or prevent rotation of the torsion spring housing, and thereby prevent activation of the torsion spring. The sensor is disposed fully within the lumen of the needle, distal of the push rod. The push rod, needle, and cannula are arranged telescopically along the axis of insertion of the sensor.
In order to enable deployment of the device, the user first decouples or otherwise removes the protective tab, which is initially coupled to the trigger to prevent unintentional deployment of the device. The user then presses down on the trigger. The trigger slides through a track in the upper housing, and the tab is displaced from its blocking engagement with the torsion spring housing, thereby releasing or activating the torsion spring and causing the torsion spring housing to rotate about its center axis.
The torsion spring housing includes a pin configured to engage with a slot or yoke in the outer needle hub. As the torsion spring housing begins to rotate (under the force of the activated torsion spring), the pin pushes the slot and, thus, the outer needle hub, in a distal direction. Since the inner needle hub and push rod hub are both fixed to the outer needle hub at this stage, but the cannula hub is fixed in the distal direction (e.g., prevented from moving distally by the positioning of the seal carrier and disposable housing), the inner needle hub and push rod hub both move distally with respect to the cannula hub. With this movement, the inner needle hub moves from a first engagement position with the cannula hub, travelling to a second engagement position with the cannula hub. The needle, sensor, and push rod travel together to their most distal positions, and the needle and sensor are inserted into the skin.
After (or at the same time as) the outer needle hub, the inner needle hub, and the push rod hub reach their most distal position, arms or other features of the push rod hub engage with corresponding tabs or other positional engagement features of the lower housing to lock the push rod hub in its distal position (e.g. to prevent proximal movement of the push rod hub). Backspring features forming part of (or coupled to) the push rod hub deform as the push rod hub reaches its distal position to bias the push rod hub against the positional engagement features of the lower housing, thereby fixing the position of the push rod hub (and the push rod) in the axial direction.
As the torsion spring housing continues to rotate (still under the force of the activated torsion spring), the drive mechanism self-reverses, and the engagement of the pin with the slot begins to move the outer needle hub back in a proximal direction, initiating retraction of the needle. Since the push rod hub is fixed in a distal position at this stage (e.g., prevented from moving proximally by its engagement with the lower housing), the push rod provides a backstop to the sensor in the distal position and prevents proximal movement of the sensor as the needle moves in the proximal direction.
The movement of the outer needle hub in the proximal direction causes the outer needle hub to decouple from the push rod hub (e.g., by causing the disengagement or interengaging features of the outer needle hub and the push rod hub). As the outer needle hub continues to move proximally with respect to the push rod hub, tabs or protrusions of the push rod hub engage with tabs or protrusions of the inner needle hub, to release the inner needle hub from engagement with the outer needle hub. At or about the same time, the torsion spring housing rotates into a section of the upper housing containing one or more ratchet engagement teeth and a hard stop. This structure engages the ratchet arm of the torsion spring housing and arrests rotational movement of the torsion spring housing, as well as and linear movement of the outer needle hub. The decoupling of the inner needle hub from the outer needle hub serves to release or otherwise activate the compression spring, which drives the inner needle hub further in the proximal direction. As the inner needle hub is driven proximally, it couples with second engagement feature of the cannula hub. The movement of the inner needle hub pulls the needle, the cannula hub, and the cannula in the proximal direction. This drives the cannula out of the seal and the cannula and needle to the fully retracted proximal position.
Once the cannula hub is moved out from under the seal carrier to a proximal position, the seal carrier is free to rotate about its hinged coupling with the disposable housing, from its initial angled orientation to a flat or other final orientation within the disposable housing, in which the disposable housing can receive a transmitter. In some embodiments, this rotation is assisted with the addition of, for example, a spring-like arm biased against the seal carrier. At this stage, the disposable housing is also decoupled from the remainder of the device, such that the device need only be lifted away by the user to leave the disposable housing applied to the skin and ready to receive the transmitter.
It should be appreciated that all methods and processes disclosed herein may be used in any glucose monitoring system, continuous or intermittent. It should further be appreciated that the implementation and/or execution of all methods and processes may be performed by any suitable devices or systems, whether local or remote. Further, any combination of devices or systems may be used to implement the present methods and processes.
Methods and devices that are suitable for use in conjunction with aspects of the preferred embodiments are disclosed in U.S. Pat. Nos. 4,757,022; 4,994,167; 6,001,067; 6,558,321; 6,702,857; 6,741,877; 6,862,465; 6,931,327; 7,074,307; 7,081,195; 7,108,778; 7,110,803; 7,134,999; 7,136,689; 7,192,450; 7,226,978; 7,276,029; 7,310,544; 7,364,592; 7,366,556; 7,379,765; 7,424,318; 7,460,898; 7,467,003; 7,471,972; 7,494,465; 7,497,827; 7,519,408; 7,583,990; 7,591,801; 7,599,726; 7,613,491; 7,615,007; 7,632,228; 7,637,868; 7,640,048; 7,651,596; 7,654,956; 7,657,297; 7,711,402; 7,713,574; 7,715,893; 7,761,130; 7,771,352; 7,774,145; 7,775,975; 7,778,680; 7,783,333; 7,792,562; 7,797,028; 7,826,981; 7,828,728; 7,831,287; 7,835,777; 7,857,760; 7,860,545; 7,875,293; 7,881,763; 7,885,697; 7,896,809; 7,899,511; 7,901,354; 7,905,833; 7,914,450; 7,917,186; 7,920,906; 7,925,321; 7,927,274; 7,933,639; 7,935,057; 7,946,984; 7,949,381; 7,955,261; 7,959,569; 7,970,448; 7,974,672; 7,976,492; 7,979,104; 7,986,986; 7,998,071; 8,000,901; 8,005,524; 8,005,525; 8,010,174; 8,027,708; 8,050,731; 8,052,601; 8,053,018; 8,060,173; 8,060,174; 8,064,977; 8,073,519; 8,073,520; 8,118,877; 8,128,562; 8,133,178; 8,150,488; 8,155,723; 8,160,669; 8,160,671; 8,167,801; 8,170,803; 8,195,265; 8,206,297; 8,216,139; 8,229,534; 8,229,535; 8,229,536; 8,231,531; 8,233,958; 8,233,959; 8,249,684; 8,251,906; 8,255,030; 8,255,032; 8,255,033; 8,257,259; 8,260,393; 8,265,725; 8,275,437; 8,275,438; 8,277,713; 8,280,475; 8,282,549; 8,282,550; 8,285,354; 8,287,453; 8,290,559; 8,290,560; 8,290,561; 8,290,562; 8,292,810; 8,298,142; 8,311,749; 8,313,434; 8,321,149; 8,332,008; 8,346,338; 8,364,229; 8,369,919; 8,374,667; 8,386,004; 8,394,021; 8,527,025; 7,896,809; 9,119,528; and U.S. Pat. No. 9,119,529.
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The above description presents the best mode contemplated for carrying out the present invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this invention. This invention is, however, susceptible to modifications and alternate constructions from that discussed above that are fully equivalent. Consequently, this invention is not limited to the particular embodiments disclosed. On the contrary, this invention covers all modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the invention. While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive.
All references cited herein are incorporated herein by reference in their entirety. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.
Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meaning to a person of ordinary skill in the art, and are not to be limited to a special or customized meaning unless expressly so defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being re-defined herein to be restricted to include any specific characteristics of the features or aspects of the disclosure with which that terminology is associated. Terms and phrases used in this application, and variations thereof, especially in the appended claims, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing, the term ‘including’ should be read to mean ‘including, without limitation,’ ‘including but not limited to,’ or the like; the term ‘comprising’ as used herein is synonymous with ‘including,’ ‘containing,’ or ‘characterized by,’ and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps; the term ‘having’ should be interpreted as ‘having at least;’ the term ‘includes’ should be interpreted as ‘includes but is not limited to;’ the term ‘example’ is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; adjectives such as ‘known’, ‘normal’, ‘standard’, and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass known, normal, or standard technologies that may be available or known now or at any time in the future; and use of terms like ‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words of similar meaning should not be understood as implying that certain features are critical, essential, or even important to the structure or function of the invention, but instead as merely intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention. Likewise, a group of items linked with the conjunction ‘and’ should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as ‘and/or’ unless expressly stated otherwise. Similarly, a group of items linked with the conjunction ‘or’ should not be read as requiring mutual exclusivity among that group, but rather should be read as ‘and/or’ unless expressly stated otherwise.
Where a range of values is provided, it is understood that the upper and lower limit, and each intervening value between the upper and lower limit of the range is encompassed within the embodiments.
With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. The indefinite article ‘a’ or ‘an’ does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.
It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases ‘at least one’ and ‘one or more’ to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles ‘a’ or ‘an’ limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases ‘one or more’ or ‘at least one’ and indefinite articles such as ‘a’ or ‘an’ (e.g., ‘a’ and/or ‘an’ should typically be interpreted to mean ‘at least one’ or ‘one or more’); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of ‘two recitations,’ without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to ‘at least one of A, B, and C, etc.’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., ‘a system having at least one of A, B, and C’ would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to ‘at least one of A, B, or C, etc.’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., ‘a system having at least one of A, B, or C’ would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase ‘A or B’ will be understood to include the possibilities of ‘A’ or ‘B’ or ‘A and B.’
All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification are to be understood as being modified in all instances by the term ‘about.’ Accordingly, unless indicated to the contrary, the numerical parameters set forth herein are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims in any application claiming priority to the present application, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.
Furthermore, although the foregoing has been described in some detail by way of illustrations and examples for purposes of clarity and understanding, it is apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather to also cover all modification and alternatives coming with the true scope and spirit of the invention.
Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application claims the benefit of U.S. Provisional Application No. 62/244,520, filed Oct. 21, 2015. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.
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