Patent Grant
11311666
The present disclosure generally relates to drug delivery devices and, more particularly, a drug delivery device capable of being worn by a patient while the drug delivery device delivers a drug to the patient.
Delivery of medicaments, e.g., liquid drugs, to a patient via injection using a needle or syringe is well-known. More recently, devices that automate the delivery of medicaments have been introduced. These devices (which are commonly referred to as “on-body devices” or “on-body injectors”) are mounted or otherwise secured to the body of the patient (e.g., to the arm or abdomen) and remain in place for an extended amount of time (on the order of hours or days), injecting an amount of the medicament into the body of the patient at one or more scheduled times. For example, a device may be configured to deliver a medicament over the span of 45 minutes, with delivery beginning 27 hours after the device has been activated and applied to a patient (to ensure that the medicament is not delivered sooner than 24 hours after a medical procedure or treatment). These devices improve upon manual methods by obviating the need for the patient to inject themselves with the medicament (which carries heightened risks of the patient improperly administering the injection or injecting the medicament at an inappropriate time) or to return to a medical facility for one or more injections by a technician or medical professional.
One known on-body device 10 is shown in
The internal components of the device 10 include a reservoir 14 that is configured to be filled with a medicament to be delivered to the patient. An upper surface of the housing 12 includes a fill indicator 16 that provides a visual indication of the amount of fluid in the reservoir 14. In addition to the fill indicator 16, the upper surface of the housing 12 may include printed information, such as information regarding the medicament to be delivered. The upper surface of the housing 12 may be formed of a translucent material, which allows light from a status light 18 (which may be configured as a light-emitting diode) mounted within the housing 12 (
The medicament is injected into the reservoir 14 using a (typically pre-filled) syringe 22 via a port 24 incorporated into the bottom or underside of the housing 12 (
A piston or plunger 28 (
When the device 10 has been activated, it is mounted or secured to the body of the patient. The applicator 26 is first removed from the underside of the housing 12 and discarded, followed by a pull tab 30 being manipulated to remove a release film from an adhesive pad 32 associated with the underside of the housing 12. The housing 12 is then pressed against the body of the patient, with the adhesive pad 32 facing the body. An adhesive present on the adhesive pad 32 causes the adhesive pad 32 (and, hence, the housing 12) to adhere to the body.
Some predetermined time after the device 10 has been activated (which may be on the order of three to five minutes, for example), a distal end portion of a cannula 34 is introduced into the skin of the patient via a cannula window 36 defined in the housing 12 (
As the cannula 34 is not itself configured to pierce the skin, an associated needle 38 is provided within the lumen of the cannula 34, with a sharp or beveled distal end of the needle 38 extending out of a distal end of the cannula 34. A midsection of the needle 38 is mounted within a needle carriage 40, while a proximal end 42 of the cannula 34 is mounted within a cannula carriage 44 that is initially positioned directly adjacent to the needle carriage 40. The needle carriage 40 is pivotally connected to an end of a linkage or crank arm 46, with an opposite end of the linkage 46 being associated with a torsion spring 48. At the designated time (e.g., 3-5 minutes after the device 10 has been activated), the controller causes a lever (not visible) to be released, which allows the spring 48 to recoil, in turn rotating the linkage 46, which rotation causes the needle carriage 40 to move along a linear track 50 from a first position adjacent to the spring 48 (
Continued recoiling of the spring 48 causes further rotation of the linkage 46, which has the effect of moving the needle carriage 40 back toward the spring 48 (i.e., back toward its first position). Rather than moving along with the needle carriage 40, the cannula carriage 44 is held in its second position (
Movement of the needle carriage 40 in a proximal direction away from the cannula carriage 44 causes the needle 38 to partially (but not fully) retract from the cannula 34. In the final condition shown in
As for the mechanism by which the medicament is advanced out of the reservoir 14, the device 10 includes a lever 54 mounted to a pivot point 56 (
A first wire or filament 72 extends from the lever 54, around a first pulley 74, and into association with a first electrical contact 76. A second wire or filament 78 extends from the lever 54 in the opposite direction of the first wire 72, around a second pulley 80, and into association with a second electrical contact 82. The wires 72 and 78 allow the lever 54 to stay electrically coupled to the electrical contacts 76 and 82 (which are electrically coupled to the above-referenced printed circuit board) as the lever 54 pivots about the pivot point 56.
At the designated time (e.g., 27 hours after the device 10 has been activated), the controller provides commands that cause the lever 54 to be alternately pivoted about the pivot point 56 in opposite first and second directions. Pivotal movement of the lever 54 in the first direction will cause the first arm 58 of the lever 54 to engage and rotate the first gear 60 an incremental amount, while pivotal movement of the lever 54 in the second direction will cause the second arm 62 of the lever 54 to engage and rotate the second gear 64 an incremental amount (in the same direction in which the first gear 60 is rotated by the first arm 58). Both gears 60 and 64 are contained within a single part and are associated with a common shaft 84 (
After the medicament has been delivered (e.g., over the course of a 45-minute session), the controller alerts the patient via a visual cue from the status light 18 and/or an audible cue from the buzzer that medicament delivery is complete. Subsequently, the patient removes the device 10 from their skin and discards the device 10.
While devices of the type described above have proven adequate, there is room for improvement of them. For example, existing devices have a relatively large profile that can inhibit patient activities and/or cause embarrassment. Accordingly, patients often seek to minimize the time that existing devices are worn, which can limit the time during which data can be collected from the devices.
Applicants have invented an improved wearable delivery device that facilitates increased collection of biometric data from patients. Although some biometric data measurement is helpful during delivery of a medicament, a significant amount of useful data is available post-injection (e.g., related to patient acceptance and/or reaction to the medicament, as well as other general biometric data related to patient health and otherwise). The ability to measure such post-injection data is limited, however, to the amount of time patients are willing to wear the device. As mentioned above, the large profile of the device often motivates patients to wear devices for as short a time as possible. However, the components of the device needed for biometric sensing have a significantly smaller profile, than the components required for cannula injection and drug delivery. As such, Applicants have invented a device that allow the larger profile components to be decoupled from the biometric sensing elements, thereby allowing the larger profile components to be removed from the patients once they are no longer needed, while leaving the biometric sensing elements behind. This enables collection of biometric patient data over a far longer period, which can have significant health and other benefits.
In general, in one an aspect, embodiments of the invention relate to a[GM1] medicament delivery device including a sensor module having a sensor housing with one or more sensors disposed in the sensor housing, and an adhesive patch adapted for connecting the sensor module to a skin surface. An injector module includes an injector module housing, and a reservoir disposed in the injector module housing and adapted to be filled with a medicament to be delivered to a patient. The injector module also includes a cannula adapted to (i) fluidically connect with the reservoir and (ii) pass into a subcutaneous tissue, and a needle initially disposed in a lumen defined by the cannula and is adapted to pass into the subcutaneous tissue. The injector module also includes a coupling mechanism adapted to couple the injector module to the sensor module. The injector module is adapted to (i) be coupled to the sensor module during injection of the cannula and the needle into the subcutaneous tissue and during delivery of the medicament and (ii) be removed from the sensor module after the delivery of the medicament.
One or more of the following features may be included. The at least one sensor may include a temperature sensor, an accelerometer, a gyroscope, a pulse oximeter, a blood pressure sensor, a hydration sensor, a pH sensor, glucose sensor, and/or a UV exposure sensor. The at least one sensor may be disposed on a bottom surface of the sensor module and is configured to be in contact with the skin surface when the adhesive patch is connected thereto.
The coupling mechanism may include a latch. The sensor module may define a recess adapted to mate with the latch. The coupling mechanism may include a push button adapted to move the latch between an engaged position and a disengaged position. The push button may extend through a portion of the injector module housing. The push button may be adapted to initiate cannula insertion when the push button is pressed into a depressed position.
The injector module may include an injector timer, and the push button may be adapted to start the injection timer when the push button is pressed into a depressed position. The push button may be adapted to move from the depressed position to a released position after a predetermined time is measured by the injector timer.
The push button may be adapted to move the latch to the disengaged position when the push button is in the released position, thereby uncoupling the injector module from the sensor module.
The sensor housing of the sensor module may define a needle port. The cannula may be adapted to pass through the needle port of the sensor module. The needle may be adapted to pass through the needle port. The injector module may be adapted to be removed from the sensor module after withdrawal of the cannula and the needle from the subcutaneous tissue.
The needle may include a sensing component.
In another aspect, embodiments of the invention relate to a method for delivering a medicament, the method including connecting to a skin surface a medicament delivery device including an injector module coupled to a sensor module including at least one sensor, with the injector module including a reservoir containing the medicament. The medicament is delivered from the injector module into a subcutaneous tissue. After delivery of the medicament, the injector module is removed from the sensor module while leaving the sensor module in contact with the skin surface.
One or more of the following features may be included. The injector module may include a cannula in fluidic communication with the reservoir, and delivering the medicament may include passing the cannula into the subcutaneous tissue.
The cannula may be left in the subcutaneous tissue after delivery of the medicament. The injector module may include a needle disposed in a lumen in the cannula, and delivering the medicament may include piercing the skin surface with the needle prior to passing the cannula into the subcutaneous tissue. The needle may include a sensing component, and a biometric component may be monitored with the needle while the needle contacts the skin.
A biometric parameter may be monitored with the sensor module, e.g., after the injector module is removed. The biometric parameter may be temperature, oxygen level, blood pressure, hydration, pH, glucose, and/or UV exposure.
The injector module may include a coupling mechanism adapted to couple the injector module to the sensor module. The coupling mechanism may include a latch. The sensor module may define a recess adapted to mate with the latch.
The coupling mechanism may include a push button adapted to move the latch between an engaged position and a disengaged position. Delivering the medicament may include pushing the push button into a depressed position. Pushing the push button into the depressed position may initiate insertion of a cannula into the subcutaneous tissue.
The injector module may include an injector timer, and delivering the medicament may include pushing the push button into a depressed position to start the injection timer.
Delivering the medicament may include the push button moving to a released position after a predetermined time measured by the injector timer. Moving the push button to the released position may move the latch to the disengaged position, thereby uncoupling the injector module from the sensor module.
The medicament may include pegfilgrastim.
These and other objects, along with advantages and features of embodiments of the present invention herein disclosed, will become more apparent through reference to the following description, the figures, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations.
In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:
It is contemplated that apparatus, systems, methods, and processes of the claimed invention encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and/or modification of the apparatus, systems, methods, and processes described herein may be performed by those of ordinary skill in the relevant art and are considered to be within the scope of the disclosed invention.
It should be understood that the order of steps or order for performing certain actions is immaterial, so long as the invention remains operable. Moreover, two or more steps or actions may be conducted simultaneously.
Embodiments of the invention include medicament delivery devices that include a combination of an injector module and a sensor module. This configuration enables removal of the injector module after delivery of a medicament, while leaving in place a low-profile sensor housing. This configuration provides the advantage of enabling sensing one or more biometric parameters for days after treatment, e.g., tracking temperature to catch febrile neutropenia. Sensors that may be included in the device are, e.g., thermometers, accelerometers, gyroscopes, pulse oximeters, blood pressure sensors, hydration sensors, pH sensors, glucose sensors, and UV exposure sensors. By incorporating the sensor into a separable module, the user needs to wear only a minimal patch for biometric sensing after the infusion is complete to continue health monitoring, The device thereby enables performing two related functions in a single application.
Referring to
An adhesive patch 125 is disposed on a bottom surface of the sensor module 100. The adhesive patch is adapted for connecting the sensor module to a skin surface during use, i.e., it includes an adhesive that causes the adhesive pad (and, hence, the sensor module) to adhere to the body. The adhesive patch may define an opening for the sensor if contact to the skin by the sensor is required. Alternatively, if the sensor does not require skin contact, e.g., an accelerometer, an opening in the adhesive patch may not be required.
In various embodiments, the injector module 105 includes an injector module housing 127. The reservoir 14 (described above) is disposed in the injector module housing, with the reservoir 14 being adapted to be filled with a medicament to be delivered to a patient. The cannula 34 (described above) is adapted to be fluidically connected to the reservoir 14. In an embodiment, the cannula 34 is also adapted to pass through the needle port 115 of the sensor module 100 and into a subcutaneous tissue. The needle 38 (described above) is initially disposed in a lumen defined by the cannula 34 and adapted to pass through the needle port and into the subcutaneous tissue. In some embodiments (not shown), the cannula 34 may be adapted to pass to a side of the sensor module 100 and through a pass-through access hole defined by the adhesive patch 125.
Referring to
In some embodiments, the sensor module defines a recess 135 adapted to mate with the latch 130. The coupling mechanism may include a spring-loaded push button 140 adapted to move the latch between an engaged position and a disengaged position. In the engaged position, the injector module 105 is connected to the sensor module 100 by the latch being disposed in the recess. In some instances, this is the position of the modules 100, 105 during delivery of a medicament. In the disengaged position, the latch 130 is removed from the recess 135, thereby uncoupling the injector module 105 from the sensor module 100, so that that the injector module 105 may be removed from the sensor module 100. The push button 140 may extend through a portion of the injector module housing. The push button 140 may be adapted to initiate cannula insertion when the push button 140 is pressed into a depressed position. In other embodiments, the injector module 105 and sensor module 100 can have other corresponding structure to enable attachment and detachment. As a few examples, the structure can include a snap connection, a hook and loop connection, an interference fit connection, a magnetic connection, an adhesive, a tear-away strip, a bayonette connection, or a ¼ turn connection.
The injector module 105 may include an injector timer (not shown). The push button 140 (or other attachment structure) may be adapted to start the injection timer when the push button 140 is pressed into the depressed position. Furthermore, the push button 140 may be adapted to move from the depressed position to a released position after a predetermined time is measured by the injector timer. The predetermined time can be correlated to medicament delivery to the patient. For example, the predetermined time can be equal to (or within some percentage of) the amount of time required to complete a desired medicament dosage.
Referring to
Referring to
Exemplary dimensions of the medicament delivery device are provided below:
In accordance with various embodiments of the invention, a medicament may be delivered to a patient as follows. The medicament delivery device 90 may be connected to a skin surface of a patient, e.g., with the adhesive patch. As described above, the medicament delivery device 90 may include the injector module 105 coupled to the sensor module 100 that includes a sensor. The medicament is disposed in the reservoir 14 of the injector module 105. The medicament is delivered from the injector module 105 into a subcutaneous tissue. For example, the needle 38 disposed in the cannula 34 may piece the skin surface and the cannula 34 may be passed through the needle port 115 of the sensor module 105 into the subcutaneous tissue. The medicament may then be delivered through the cannula 34. After delivery of the medicament, the injector module 105 is removed from the sensor module 100 while leaving the sensor module 100 in contact with the skin surface.
Decoupling the injector module 105 from the sensor module 100 enables a biometric parameter to be monitored (e.g. by the patient and/or a healthcare professional), both during the delivery of the medicament and after removal of the injector module. The biometric parameter may be, e.g., temperature, oxygen level, activity level (e.g., steps), heart rate, and/or blood pressure.
As described above, in various embodiments, the injector module 105 includes a coupling mechanism adapted to couple the injector module to the sensor module 110. For example, the injector module 105 may include a latch 130 adapted to mate with a recess 135 defined by the sensor module 110 and a push button 140 adapted to move the latch 130 between an engaged position and a disengaged position. Delivering the medicament may include pushing the push button 140 into a depressed position, which initiates insertion of the cannula 34 into the subcutaneous tissue. The injector module may include an injector timer, such that pushing the push button 140 into a depressed position starts the injection timer. Then, after a predetermined time in which the medicament is delivered, the push button moves to a released position. This moves the latch 130 to the disengaged position, thereby uncoupling, i.e., unlocking, a connection of the injector module 105 to the sensor module 110. The injector module 105 may be then be removed by the user, while the sensor module 110 remains in contact with the skin surface, thus enabling monitoring a biometric parameter or parameters after medicament delivery.
The teachings herein may be used to implement methods for delivering various medicaments, including but not limited to liquids, such as solutions, which may comprise any of adalimumab, rituximab, risankizumab, etanercept, trastuzumab, ado-trastuzumab emtansine, trastuzumab deruxtecan, bevacizumab, infliximab, pegfilgrastim, filgrastim, tocilizumab, golimumab, interferon beta-1a, ranibizumab, denosumab, pembrolizumab, nivolumab, aflibercept, eculizumab, ocrelizumab, pertuzumab, secukinumab, omalizumab, ustekinumab, vedolizumab, daratumumab, dupilumab, atezolizumab, natalizumab, bortezomib, ipilimumab, durvalumab, emicizumab, palivizumab, guselkumab, mepolizumab, panitumumab, ramucirumab, belimumab, abatacept, certolizumab pegol, ixekizumab, romiplostim, benralizumab, evolocumab, canakinumab, obinutuzumab, cetuximab, erenumab, blinatumomab, romosozumab, mirikizumab, inotuzumab, sacituzumab govitecan, enfortumab vedotin, and/or brentuximab vedotin.
Each numerical value presented herein, for example, in a table, a chart, or a graph, is contemplated to represent a minimum value or a maximum value in a range for a corresponding parameter. Accordingly, when added to the claims, the numerical value provides express support for claiming the range, which may lie above or below the numerical value, in accordance with the teachings herein. Absent inclusion in the claims, each numerical value presented herein is not to be considered limiting in any regard.
The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention.
The features and functions of the various embodiments may be arranged in various combinations and permutations, and all are considered to be within the scope of the disclosed invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive. Furthermore, the configurations, materials, and dimensions described herein are intended as illustrative and in no way limiting. Similarly, although physical explanations have been provided for explanatory purposes, there is no intent to be bound by any particular theory or mechanism, or to limit the claims in accordance therewith.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5620312 | Hyman | Apr 1997 | A |
| 5897530 | Jackson | Apr 1999 | A |
| 6589229 | Connelly et al. | Jul 2003 | B1 |
| 7147615 | Wariar et al. | Dec 2006 | B2 |
| 8088096 | Lauchard et al. | Jan 2012 | B2 |
| 9061097 | Holt et al. | Jun 2015 | B2 |
| 10569014 | Hanson et al. | Feb 2020 | B2 |
| 10583245 | McCullough et al. | Mar 2020 | B2 |
| 10625018 | Destefano et al. | Apr 2020 | B2 |
| 10646664 | Lee et al. | May 2020 | B2 |
| 10682474 | Ring et al. | Jun 2020 | B2 |
| 10758683 | Gibson et al. | Sep 2020 | B2 |
| 20020123735 | Rake et al. | Sep 2002 | A1 |
| 20020123740 | Flaherty et al. | Sep 2002 | A1 |
| 20030009131 | Van Antwerp et al. | Jan 2003 | A1 |
| 20030187395 | Gabel et al. | Oct 2003 | A1 |
| 20110105872 | Chickering, III et al. | May 2011 | A1 |
| 20120010594 | Holt et al. | Jan 2012 | A1 |
| 20120310175 | Vedrine et al. | Dec 2012 | A1 |
| 20140100522 | Nie et al. | Apr 2014 | A1 |
| 20150374919 | Gibson | Dec 2015 | A1 |
| 20160038689 | Lee et al. | Feb 2016 | A1 |
| 20160199574 | Ring et al. | Jul 2016 | A1 |
| 20160296704 | Gibson | Oct 2016 | A1 |
| 20160354555 | Gibson et al. | Dec 2016 | A1 |
| 20170147787 | Albrecht et al. | May 2017 | A1 |
| 20170182253 | Folk et al. | Jun 2017 | A1 |
| 20170361015 | McCullough | Dec 2017 | A1 |
| 20170368260 | McCullough et al. | Dec 2017 | A1 |
| 20180001021 | Wu et al. | Jan 2018 | A1 |
| 20180021508 | Destefano et al. | Jan 2018 | A1 |
| 20180028747 | Hanson et al. | Feb 2018 | A1 |
| 20180036476 | McCullough et al. | Feb 2018 | A1 |
| 20180085517 | Laurence et al. | Mar 2018 | A1 |
| 20180133447 | McAllister et al. | May 2018 | A1 |
| 20180256823 | Nazzaro et al. | Sep 2018 | A1 |
| 20180304014 | Knudsen et al. | Oct 2018 | A1 |
| 20190022306 | Gibson et al. | Jan 2019 | A1 |
| 20190050375 | Fitzgibbon et al. | Feb 2019 | A1 |
| 20190060562 | Olivas et al. | Feb 2019 | A1 |
| 20190134296 | Barbedette et al. | May 2019 | A1 |
| 20190143043 | Coles et al. | May 2019 | A1 |
| 20190151544 | Stonecipher | May 2019 | A1 |
| 20190167908 | Fitzgibbon et al. | Jun 2019 | A1 |
| 20190192766 | Stonecipher | Jun 2019 | A1 |
| 20190247579 | Damestani et al. | Aug 2019 | A1 |
| 20190275235 | Barmaimon | Sep 2019 | A1 |
| 20190275241 | Ring et al. | Sep 2019 | A1 |
| 20190307958 | Yang | Oct 2019 | A1 |
| 20190328965 | Moberg | Oct 2019 | A1 |
| 20190365986 | Coiner et al. | Dec 2019 | A1 |
| 20190381238 | Stonecipher et al. | Dec 2019 | A1 |
| 20200069875 | Nazzaro | Mar 2020 | A1 |
| 20200179609 | Tan-Malecki et al. | Jun 2020 | A1 |
| 20200188585 | Petisce et al. | Jun 2020 | A1 |
| 20200253525 | Zhang et al. | Aug 2020 | A1 |
| 20210069411 | Demers | Mar 2021 | A1 |
| Number | Date | Country |
|---|---|---|
| 2796157 | Sep 2016 | EP |
| 2014143770 | Sep 2014 | WO |
| 2015187797 | Dec 2015 | WO |
| 2016100055 | Jun 2016 | WO |
| 2016130679 | Aug 2016 | WO |
| 2016133947 | Aug 2016 | WO |
| 2016145094 | Sep 2016 | WO |
| 2016130679 | Nov 2016 | WO |
| 2017120178 | Jul 2017 | WO |
| 2017200989 | Nov 2017 | WO |
| 2018081234 | May 2018 | WO |
| 2018151890 | Aug 2018 | WO |
| 2018164829 | Sep 2018 | WO |
| 2018165499 | Sep 2018 | WO |
| 2018183039 | Oct 2018 | WO |
| 2018226515 | Dec 2018 | WO |
| 2018226565 | Dec 2018 | WO |
| 2018236619 | Dec 2018 | WO |
| 2018237225 | Dec 2018 | WO |
| 2019014014 | Jan 2019 | WO |
| 2019018169 | Jan 2019 | WO |
| 2019022950 | Jan 2019 | WO |
| 2019022951 | Jan 2019 | WO |
| 201932101 | Feb 2019 | WO |
| 2019032482 | Feb 2019 | WO |
| 2019070472 | Apr 2019 | WO |
| 2019070552 | Apr 2019 | WO |
| 2019074579 | Apr 2019 | WO |
| 2019089178 | May 2019 | WO |
| 2019090303 | May 2019 | WO |
| 2019143753 | Jul 2019 | WO |
| WO-2020112515 | Jun 2020 | WO |
| Entry |
|---|
| U.S. Appl. No. 17/178,799, filed Feb. 18, 2021. |
| U.S. Appl. No. 17/178,795, filed Feb. 18, 2021. |
