Patent Application
20200372995
The present invention relates to medical pumps for delivering medicament to a patient, and more specifically, to systems in which a user-wearable pump wirelessly communicates with other devices.
There are a wide variety of medical treatments that include the administration of a therapeutic fluid in precise, known amounts at predetermined intervals. Devices and methods exist that are directed to the delivery of such fluids, which may be liquids or gases, are known in the art.
One category of such fluid delivery devices includes insulin injecting pumps developed for administering insulin to patients afflicted with type I, or in some cases, type II diabetes. Some insulin injecting pumps are configured as portable or ambulatory infusion devices can provide continuous subcutaneous insulin injection and/or infusion therapy as an alternative to multiple daily injections of insulin via a syringe or an insulin pen. Such pumps are worn by the user and may use replaceable cartridges. In some embodiments, these pumps may also deliver medicaments other than, or in addition to, insulin, such as glucagon, pramlintide, and the like. Examples of such pumps and various features associated therewith include those disclosed in U.S. Patent Publication Nos. 2013/0324928 and 2013/0053816 and U.S. Pat. Nos. 8,287,495; 8,573,027; 8,986,253; and 9,381,297, each of which is incorporated herein by reference in its entirety.
Another type of pump that has been developed is a patch pump also known as a micro pump. Patch pumps are small pumps, typically ambulatory, that may be carried directly on the skin under the user's clothing. In some cases, the pumps are situated directly on, or very near to, the injection site such that little or no tubing is required to deliver the insulin or other medicament to the patient. Some patch pumps include a single button on the pump to initiate delivery of medicament and do not include a built-in display or user interface. These pumps are therefore primarily remote-controlled.
With the proliferation of handheld electronic devices, such as mobile phones (e.g., smartphones), there is a desire to be able to remotely utilize such devices to optimize usage of infusion pumps, including both patch pumps and pumps having their own user interfaces. These remote controllers would enable a pump to be monitored, programmed and/or operated more privately, more conveniently and more comfortably. Accordingly, one potential use of dedicated remote devices and handheld consumer electronic devices (such as smartphones, tablets and the like) is to utilize such devices as controllers for remotely programming and/or operating infusion pumps. In addition to mobile control devices such as smartphones and dedicated remote controllers, it may be beneficial to enable infusion pumps to communicate with other devices, such as continuous glucose monitors, glucose meters, and other health monitoring devices, for example.
To use a smartphone or dedicated remote control device to control an infusion pump, the device must be paired with the particular pump in order to enable the pump to execute commands sent by the remote device. Other devices, such as continuous glucose monitors must also be paired in order to be used in conjunction with the pump. Due to security requirements, a simple Bluetooth pairing is typically not sufficient to pair devices with a pump and an additional step, such as entering a complex code displayed on the pump into the phone or other device must be undertaken to securely pair the devices. In a system that includes multiple devices such as a phone, dedicated remote control and a CGM, such a process can therefore be time consuming.
Disclosed herein are methods for establishing communication protocols between wireless devices in infusion pump systems. Infusion pump systems can include a number of components capable of wireless communication with one or more other components including an infusion pump, a continuous glucose monitoring (CGM) system, a smartphone or other remote consumer electronic device and/or a dedicated remote controller for the infusion pump. The present disclosure provides various methods for simplifying connections among these devices.
In embodiments, a system and method simplify the connection of additional devices into an infusion pump system having multiple devices. After a pump is securely paired with a primary device such as, for example, a smartphone, the primary device can be enabled to share the secure connection information with one or more secondary devices. The one or more secondary devices can then automatically be paired with the pump when connecting to the pump because the required secure connection information is already present on the secondary device and therefore does not need to be manually entered or otherwise acquired as was done with the primary device. By enabling the security feature such as a complex security code to be shared with secondary devices from the primary device rather than reenacting the initial pairing procedure on the secondary devices, significant time and effort can be saved while still ensuring secure connections.
In an embodiment, a method of pairing devices in an ambulatory infusion pump system, can include initiating a pairing procedure to pair a user-wearable infusion pump with a primary device, receiving secure connection information for pairing the user-wearable infusion pump with the primary device at the primary device and verifying the secure connection information to pair the user-wearable pump with the primary device. If a pairing procedure to pair the user-wearable infusion pump with a secondary device is initiated, the primary device can share the secure connection information with the secondary device. The secondary device can then be paired with the user-wearable infusion pump using the secure connection information received from the primary device.
In an embodiment, a method of pairing devices in an ambulatory infusion pump system can include initiating a pairing procedure to pair a user-wearable infusion pump with a primary device and executing the pairing procedure including executing a security protocol on the primary device. If a pairing procedure to pair the user-wearable infusion pump with a secondary device is initiated, the primary device can share secure connection information with the secondary device. The secondary device can then be paired with the user-wearable infusion pump using the secure connection information received from the primary device without executing the security protocol on the secondary device.
In embodiments, systems that may include more than one individual having a device capable of communicating with and/or controlling an infusion pump can be configured to provide different individuals with different levels of access and/or control of pump functions and/or data. A primary device can be securely paired with an infusion pump and provided with a master key giving full pump access to the primary device, including the ability to provide other devices with varying levels of access to the pump. If a secondary device of another user is to be given a different level of access to the pump, the user of the primary device can select a level of access for the secondary device and share a different, secondary security key with the secondary device rather than the master key. The pump can then be capable of being controlled and/or accessed by multiple devices having different levels of access based on the specific security key that was provided by the primary device and used to pair the secondary device with the pump.
In embodiments, the pairing process between an infusion pump and a device including a camera, such as a smartphone, can be simplified. When a security code is displayed on the pump such as a complex, e.g., 16 digit, security key as a part of the pairing process, rather than the user manually entering the security key into the phone, the user can employ the camera of the phone to scan the security key while it is displayed on the screen of the pump. This can be done, for example, by using the camera to take a picture of the code and the phone automatically recognizing the characters in the code. The scanned security data is then used by the phone to complete the pairing process. This enables a user to quickly pair the phone with the pump while also eliminating the possibility of typographical errors in transposing the security key into the phone.
The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.
Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:
While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
In one embodiment, the medical device can be an ambulatory insulin pump configured to deliver insulin to a patient. Further details regarding such pump devices can be found in U.S. Pat. No. 8,287,495, which is incorporated herein by reference in its entirety. In other embodiments, the medical device can be an infusion pump configured to deliver one or more additional or other medicaments to a patient.
In one embodiment, pump 102 includes a processor that controls operations of the pump and, in some embodiments, may receive commands from a separate device for control of operations of the pump. Such a separate device can include, for example, a dedicated remote control or a smartphone or other consumer electronic device executing an application configured to enable the device to transmit operating commands to the processor of pump 102. In some embodiments, processor can also transmit information to one or more separate devices, such as information pertaining to device parameters, alarms, reminders, pump status, etc. In one embodiment pump 102 does not include a display but may include one or more indicator lights 174 and/or one or more input buttons 172. Pump 102 can also incorporate any or all of the features described with respect to pump 12 in
Referring to
Embodiments of the present disclosure include components capable of and methods using wired and wireless transmission and receipt of signals for exchange of information and commands between and among any of the components as described herein, including, e.g., between a pump and a smartphone; among a pump, a CGM and a smartphone; between a dedicated remote controller and a pump; among a dedicated remote controller, a CGM and a pump; among a dedicated remote controller, a BGM and a pump, and other combinations as would be contemplated by those of skill in the art.
For a pump to be able to be controlled by a remote control device such as a smartphone 170 operating a software application for controlling the pump or dedicated remote controller 171 via wireless communication such as, for example, Bluetooth, the pump must be paired with the control device to establish the mutual connection between the devices. Similarly, for the pump and/or remote 170, 171 to communicate with additional devices such as a CGM, the devices must also be paired. One embodiment of such a pairing procedure 300 is depicted in
Pumps can be paired with remote control devices and other devices through various other secure means and/or through communication of various other types of secure information. One example of a pairing procedure for a pump having no display such that no security code or other information could be viewed on or entered into the pump is described in U.S. patent Publication Ser. No. 16/507,146, which is hereby incorporated herein by reference in its entirety.
Pairing multiples devices with a pump and with each other via a process such as that described with respect to
At step 406, the secondary device can seek to be paired with the pump by wirelessly communicating with the pump. Alternatively, the pump can initiate the connection with the secondary device or the primary device can initiate the connection between the pump and the secondary device. For example, if a phone is the primary device and is already connected to an electronic watch as the secondary device, the phone can initiate pairing between the electronic watch and pump by sharing the secure connection information with the watch. The secondary device can then automatically be paired with the pump at step 408 because the required secure connection information (e.g., complex security code) is already present on the secondary device and/or has already been communicated to the pump and therefore does not need to be manually entered or otherwise obtained by the secondary device as was done with the primary device. A number of secondary devices can be paired in this manner. In an embodiment where the primary device is a smartphone, secondary devices can include, for example, a dedicated remote controller, a continuous glucose monitor, a glucose meter, a fitness tracking device, a tablet or laptop computer and an electronic watch. In various embodiments, any device described herein or known in the art as pairing with an infusion pump can function as the primary device.
The system and method of
In systems that may employ multiple devices capable of communicating with an infusion pump, there may be more than one individual having a device capable of communicating with and/or controlling the pump. Such individuals can include for example, healthcare providers, caregivers such as parents or grandparents, and patients, including minor patients. Given the varied needs and sophistication levels of different individuals, it may be desirable to provide different individuals with different levels of access and/or control of pump functions and/or data. Such levels can include, for example, read only access to data, bolus only capability for pump programming and full programming access. In addition, an individual user may have more than one device capable of interacting with a pump and it may be desirable to provide different devices with different levels of access and/or functionality. For example, it may be desirable to provide a user's phone with full control of the pump and only enable display only, bolus only, etc. access for another device such as an electronic watch. In an embodiment, wireless pairing procedures as described herein can be utilized to provide such varying access.
The embodiments above disclose various options for enabling easier and more versatile pairing of multiple devices in an infusion pump system by employing a primary device to pair secondary devices with a pump and the ability to provide such secondary devices with varying levels of access to the pump. However, the initial primary device must still be securely paired with the pump. When this pairing is done using the complex security key of
Also incorporated herein by reference in their entirety are commonly owned U.S. Pat. Nos. 6,999,854; 8,133,197; 8,287,495; 8,408,421 8,448,824; 8,573,027; 8,650,937; 8,986,523; 9,173,998; 9,180,242; 9,180,243; 9,238,100; 9,242,043; 9,335,910; 9,381,271; 9,421,329; 9,486,171; 9,486,571; 9,492,608; 9,503,526; 9,555,186; 9,565,718; 9,603,995; 9,669,160; 9,715,327; 9,737,656; 9,750,871; 9,867,937; 9,867,953; 9,940,441; 9,993,595; 10,016,561; 10,201,656; 10,279,105; 10,279,106; 10,279,107; 10,357,603; 10,357,606; 10,492,141; 10/541,987; and 10,569,016. commonly owned U.S. Patent Publication Nos. 2009/0287180; 2012/0123230; 2013/0053816; 2014/0276423; 2014/0276569; 2014/0276570; 2018/0021514;
2018/0071454; 2019/0240398; 2019/0307952; 2019/0365997 and 2020/0114076 and commonly owned U.S. patent application Ser. Nos. 16/507,146; 16/725,278; 16/725,337; 16/793,662 and 16/830,415.
Various embodiments of systems, devices, and methods have been described herein.
These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.
Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.
Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.
Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
The present application claims the benefit of U.S. Provisional Application No. 62/850,811 filed May 21, 2019, which is hereby incorporated herein in its entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62850811 | May 2019 | US |
