The present technology is generally related to wearable devices and components, such as medical devices, and more particularly, to the removal of wearable devices that are adhered to the skin.
Certain chronic diseases can be monitored and treated in a continuous manner or at particular times throughout the day using medical devices that externally attach to the body. Medical devices that are connected to the body externally require a robust and stable connection that can last for one or more days of wear while providing consistent and accurate monitoring or treatment.
For example, a patient can utilize external sensor devices that connect a sensor to the body to monitor his or her condition. The connection of external sensor devices to the body must be stable to obtain accurate physiological readings of the patient. Delivery devices can also be externally connected to the body to deliver medication. The connection of external delivery devices to the body must be steady enough to allow consistent fluid-flow communication of the medication from the device to the body. If the attachment of the delivery device to the body is disrupted, loss of medication can occur or inaccurate dosages of medication can be delivered to the body.
As a non-limiting example, diabetic patients monitor their blood glucose (BG) levels and deliver insulin continuously or at certain times throughout the day utilizing external devices. The diabetic patient measures his or her BG level using a BG measurement device to determine if treatment is needed, be it with glucose to raise glucose levels or insulin to lower glucose levels. The diabetic patient may use a continuous glucose measurement or monitoring system to monitor sensor glucose (SG) throughout the day. To deliver the insulin to the body, the diabetic patients use insulin delivery devices, including external infusion pumps or patches. Both monitoring and delivery devices should be connected to the body in a stable manner to obtain accurate sensor readings and provide correct delivery dosages.
Current methods of attaching medical devices to the skin or body of the patient utilize adhesive. The adhesive is applied on the device and adheres to the body. Adhesive methods of attachment alone can lose effectiveness in adhering to the body for patients living in geographical areas of high humidity or for patients living active lifestyles. Because of the instability of the attachment of the external device to the body, the operation of devices, which are sensitive to movement, can be compromised. The devices can detach and fall off the body due to lack of adhesion and the patients are thus not able to utilize the important diagnostic and therapeutic tools. Again, the devices can provide inaccurate sensor readings and send erroneous data to a delivery device, or could result in loss of medication at the delivery site into the body. The current methods of attachment of external devices also do not address the problems associated with anchoring a rigid inflexible device to the body for the desired length of time and easily removing the device thereafter.
Accordingly, it is desirable to provide removable wearable devices and methods that improve performance and provide ease of use.
The subject matter of this discloses generally relates to removable devices wearable on a user's skin and methods for using such devices. In one aspect, the present disclosure provides an exemplary removable device including a skin adhesive configured to adhere to the skin, a durable component, and an interface component interconnecting the durable component and the skin adhesive. The device separates at the interface component to remove the durable component from the skin adhesive upon application of a removal force to the device.
In another aspect, the present disclosure provides a removable device wearable on a user's skin includes a skin adhesive configured to adhere to the skin, the skin adhesive having a periphery, a first region with a first adhesive strength, and a second region with a second adhesive strength less than the first adhesive strength that is directly adjacent to the periphery. The removable device further includes a durable component and an interface component interconnecting the durable component and the skin adhesive. The device separates at the interface component to remove the durable component from the skin adhesive upon application of a removal force to the device.
In another aspect, the present disclosure provides a method for using a removable medical device. The method includes adhering the device to a user's skin. The device includes a skin adhesive in direct contact with the user's skin, a durable component, and an interface component interconnecting the durable component and the skin adhesive. The method further includes separating the device at the interface component and removing the durable component from the skin adhesive. Also, the method includes treating the skin adhesive and removing the skin adhesive from the user's skin.
The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures.
The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.
In addition, certain terminology may also be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as “underlying”, “upper”, “lower”, “above”, and “below” refer to directions in the drawings to which reference is made. Terms such as “top”, “bottom”, “front”, “back”, “rear”, “side”, “outboard”, and “inboard” describe the orientation and/or location of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second”, and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.
Embodiments herein are drawn to a removable device including a plurality of nonwoven and fastener material layers. In certain embodiments, adhesive bonding, backing adhesive, transfer adhesive, pressure sensitive adhesive, polyurethane medical tape, humidity-resistant adhesive, UV cure adhesive, ultrasonic welding, and/or other like attachment methods can be used to attach the plurality of layers of the device to one another. Apparent from the accompanying figures, the drawings of the device are not drawn to scale.
For use with certain types of wearable devices, the skin adhesive must be necessarily strong to provide for adhesion times of two weeks or more. As a result, it can be difficult and painful to remove a device secured with such skin adhesive from the skin. As described herein, a removable device is provided with an engineered “weakness” between the skin adhesive and other portions of the device. Specifically, an interface component is located between a rigid component (such as a durable component) and the skin adhesive that provides for the use of less force to first remove the durable component while the skin adhesive remains on the skin. In particular, the durable component is secured to the skin adhesive with less adhesive force than the skin adhesive is secured to the skin with. With the durable component removed, greater access to the skin adhesive is provided. Thus, it may be easier to peel the skin adhesive from the skin. Further, the skin adhesive may be treated to reduce the adhesive force, such as by UV light or solvents.
Embodiments described herein may be utilized in conjunction with medical devices, such as wearable, portable electronic medical devices. The medical device can be configured to provide monitoring or treatment operation on a user while attached to the body. Medical devices that can utilize various embodiments described herein include, but are not limited to, sensors, physiological characteristic monitors and infusion medium delivery systems, devices and methods that can include cannula or needle inserting devices and methods. Although many different applications are possible, exemplary embodiments are used in applications that incorporate a continuous glucose monitoring (CGM) system. That said, the subject matter described herein is not limited to use with such system (or any particular configuration or realization thereof).
Devices according to embodiments herein can be used with, connectable to and disconnectable from or incorporated in a portion of a medical device system. As a non-limiting example, a needle inserting device can be connected to a base structure of an infusion delivery device for insertion of a needle, after which the needle inserting device can be removed from the base and replaced with a different device component such as, but not limited to a reservoir and pump or drive device can be coupled to the base for operation. For example, a sensor or delivery medical device and method may operate to insert a cannula or needle through a user's skin to convey a fluid from the user to one or more sensor elements and/or to provide a fluid flow path for conveying an infusion medium through a hollow channel in the cannula or needle and into the user. Embodiments can also be configured to provide a contiguous fluid-flow passage for fluid transfer between a reservoir and the user when the hollow needle or cannula is inserted in the user. For example, the user could use the device and method with infusion delivery systems. As a non-limiting example, the device can be used with any insulin infusion pump, patch, insulin infusion set and the like that is used externally on the body of a user. The device could also be used with patch devices generally described by way of example in U.S. Pat. No. 8,323,250 filed Feb. 7, 2008, entitled “Adhesive patch systems and methods,” the disclosure of which is herein incorporated by reference in its entirety.
In some embodiments, the medical device can include one or more components. In embodiments, at least a portion of a medical device can be adapted to be secured to the user during operation of the medical monitoring or treatment device and another portion of the medical device may be removable during operation of the device. Certain embodiments may be directed to use of the device and method with a sensor monitoring system. Such embodiments can be used with a sensor having a sensor base with a cannula that can be inserted into the skin of a user and a sensor transmitter that is connectable to and disconnectable from the sensor base while the base remains attached to the skin. The sensor can provide a signal indicative of a characteristic of a user and may be implanted in and/or through subcutaneous, dermal, sub-dermal, inter-peritoneal or peritoneal tissue. Embodiments of a surface mounted sensor could utilize interstitial fluid harvested from underneath the skin. In specific embodiments, the sensor can determine glucose levels in the blood and/or body fluids of the user. However, it will be recognized that further embodiments may be used to determine the levels of other agents, characteristics or compositions, such as hormones, cholesterol, medication concentrations, pH, oxygen saturation, viral loads (e.g., HIV), or the like. Embodiments may provide sensor readings on an intermittent or continuous basis.
The sensor can be an electrode-type sensor, or other type of sensor, such as chemical based, optical based or the like. The sensor transmitter can store and provide sensor readings to other devices or other components of a sensor system. For example, the transmitter can process and wirelessly transmit sensor signals to a remotely located data receiving device. Some embodiments can allow a user or a physician to disconnect the sensor transmitter from the sensor base to retrieve sensor readings. In other embodiments, the sensor controller and/or sensor transmitter used with the device need not be disconnected from the sensor base during operation and can be connected for the entire duration of wear. In further embodiments, the sensor base and sensor transmitter can be manufactured as one medical device instead of multiple components.
Referring now to
The exemplary device 100 further includes an adhesive 30 for adhering the device 100 to a user's skin, i.e., a skin adhesive 30. The skin adhesive 30 has a top side 31 and an opposite bottom side (not shown in
Also, the device 100 includes a sensor 40 extending downward from the durable component 20 to a distal end 44. The central opening 25 may receive a needle or probe to insert the sensor 40 into the user's skin, i.e., for subcutaneous implantation.
Above the top side 31 of the skin adhesive 30 and below the bottom side 22 of the durable component 20, the device 100 includes an adhesive 50 for adhering the durable component 20 to the skin adhesive 30, i.e., an intermediate adhesive 50. The intermediate adhesive 50 includes a top side 51 and an opposite bottom side 52. An exemplary intermediate adhesive 50 is a double-sided pressure sensitive adhesive.
Also, above the top side 31 of the skin adhesive 30 and below the bottom side 22 of the durable component 20, the device 100 includes an interface component 60. The interface component 60 includes a top side 61 and an opposite bottom side 62.
The device 100 is designed to separate along the interface component 60 to allow the durable component 20 to be removed from the skin adhesive 30 before the skin adhesive 30 is removed from the skin 19.
Further, the exemplary interface component includes a substrate 64 and an interface adhesive 65. An exemplary substrate 64 is a substrate such as a synthetic tear resistant paper. An exemplary interface adhesive 65 is a double-sided pressure sensitive adhesive. In the illustrated embodiment, the interface adhesive 65 is located on the top and bottom of the substrate 64 such that the interface adhesive 65 forms both the top side 61 and the bottom side 62 of the interface component 60. Alternatively, the interface adhesive 65 may be located on only one side of the substrate 64 such that the substrate 64 forms one of the sides 61 or 62 of the interface component 60. In exemplary embodiments, each side of the substrate 64 is in contact with an adhesive—either with both sides in contact with the interface adhesive 65, as shown, or with one side in contact with the interface adhesive 65 and the other side in contact with the intermediate adhesive 50.
Further, in
As may be understood from
Cross-referencing
In
Then, the skin adhesive 30 may be treated to reduce the strength of the adhesive force between the skin adhesive 30 and the skin. For example, UV light or other energy may be applied to the skin adhesive to reduce the adhesive force, or a composition, such as a solvent like isopropyl alcohol or other suitable solvent, may be applied to the skin adhesive 30. In either case, the removal of the durable component 20 from the skin adhesive 30 may allow for treatment of an increased area, and possibly the entirety, of the skin adhesive 30 and protects the durable component 20 from damage from such treatment.
It is noted that in certain embodiments of the device 100, the interface component 60 may incorporate a stretch-releasing adhesive. Specifically, the substrate 64 may be a stretchable foam, i.e., the substrate 64 may be an initial length in the longitudinal direction and may be pulled in the longitudinal direction to a greater length. As a result, the strength of the interface adhesive 65 may be reduced. Thus, the method described in
In
For the sake of brevity, conventional techniques related to glucose sensing and/or monitoring and other functional aspects of the subject matter may not be described in detail herein. In addition, certain terminology may also be used in the herein for the purpose of reference only, and thus is not intended to be limiting.
While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.
Number | Name | Date | Kind |
---|---|---|---|
4755173 | Konopka et al. | Jul 1988 | A |
5391250 | Cheney, II et al. | Feb 1995 | A |
5485408 | Blomquist | Jan 1996 | A |
5522803 | Teissen-Simony | Jun 1996 | A |
5665065 | Colman et al. | Sep 1997 | A |
5772623 | Conte | Jun 1998 | A |
5800420 | Gross et al. | Sep 1998 | A |
5807375 | Gross et al. | Sep 1998 | A |
5925021 | Castellano et al. | Jul 1999 | A |
5954643 | Van Antwerp et al. | Sep 1999 | A |
6017328 | Fischell et al. | Jan 2000 | A |
6175752 | Say et al. | Jan 2001 | B1 |
6186982 | Gross et al. | Feb 2001 | B1 |
6246992 | Brown | Jun 2001 | B1 |
6248067 | Causey, III et al. | Jun 2001 | B1 |
6248093 | Moberg | Jun 2001 | B1 |
6355021 | Nielsen et al. | Mar 2002 | B1 |
6379301 | Worthington et al. | Apr 2002 | B1 |
6544212 | Galley et al. | Apr 2003 | B2 |
6558351 | Steil et al. | May 2003 | B1 |
6591876 | Safabash | Jul 2003 | B2 |
6641533 | Causey, III et al. | Nov 2003 | B2 |
6736797 | Larsen et al. | May 2004 | B1 |
6749587 | Flaherty | Jun 2004 | B2 |
6766183 | Walsh et al. | Jul 2004 | B2 |
6801420 | Talbot et al. | Oct 2004 | B2 |
6804544 | Van Antwerp et al. | Oct 2004 | B2 |
7003336 | Holker et al. | Feb 2006 | B2 |
7029444 | Shin et al. | Apr 2006 | B2 |
7066909 | Peter et al. | Jun 2006 | B1 |
7137964 | Flaherty | Nov 2006 | B2 |
7303549 | Flaherty et al. | Dec 2007 | B2 |
7399277 | Saidara et al. | Jul 2008 | B2 |
7442186 | Blomquist | Oct 2008 | B2 |
7602310 | Mann et al. | Oct 2009 | B2 |
7647237 | Malave et al. | Jan 2010 | B2 |
7699807 | Faust et al. | Apr 2010 | B2 |
7727148 | Talbot et al. | Jun 2010 | B2 |
7785313 | Mastrototaro | Aug 2010 | B2 |
7806886 | Kanderian, Jr. et al. | Oct 2010 | B2 |
7819843 | Mann et al. | Oct 2010 | B2 |
7828764 | Moberg et al. | Nov 2010 | B2 |
7879010 | Hunn et al. | Feb 2011 | B2 |
7890295 | Shin et al. | Feb 2011 | B2 |
7892206 | Moberg et al. | Feb 2011 | B2 |
7892748 | Norrild et al. | Feb 2011 | B2 |
7901394 | Ireland et al. | Mar 2011 | B2 |
7942844 | Moberg et al. | May 2011 | B2 |
7946985 | Mastrototaro et al. | May 2011 | B2 |
7955305 | Moberg et al. | Jun 2011 | B2 |
7963954 | Kavazov | Jun 2011 | B2 |
7977112 | Burke et al. | Jul 2011 | B2 |
7979259 | Brown | Jul 2011 | B2 |
7985330 | Wang et al. | Jul 2011 | B2 |
8024201 | Brown | Sep 2011 | B2 |
8100852 | Moberg et al. | Jan 2012 | B2 |
8114021 | Robertson | Feb 2012 | B2 |
8114268 | Wang et al. | Feb 2012 | B2 |
8114269 | Cooper et al. | Feb 2012 | B2 |
8137314 | Mounce et al. | Mar 2012 | B2 |
8181849 | Bazargan et al. | May 2012 | B2 |
8182462 | Istoc et al. | May 2012 | B2 |
8192395 | Estes et al. | Jun 2012 | B2 |
8195265 | Goode, Jr. et al. | Jun 2012 | B2 |
8202250 | Stutz, Jr. | Jun 2012 | B2 |
8207859 | Enegren et al. | Jun 2012 | B2 |
8226615 | Bikovsky | Jul 2012 | B2 |
8257259 | Brauker et al. | Sep 2012 | B2 |
8267921 | Yodfat et al. | Sep 2012 | B2 |
8275437 | Brauker et al. | Sep 2012 | B2 |
8277415 | Mounce et al. | Oct 2012 | B2 |
8292849 | Bobroff et al. | Oct 2012 | B2 |
8298172 | Nielsen et al. | Oct 2012 | B2 |
8303572 | Adair et al. | Nov 2012 | B2 |
8305580 | Aasmul | Nov 2012 | B2 |
8308679 | Hanson et al. | Nov 2012 | B2 |
8313433 | Cohen et al. | Nov 2012 | B2 |
8318443 | Norrild et al. | Nov 2012 | B2 |
8323250 | Chong et al. | Dec 2012 | B2 |
8343092 | Rush et al. | Jan 2013 | B2 |
8352011 | Van Antwerp et al. | Jan 2013 | B2 |
8353829 | Say et al. | Jan 2013 | B2 |
8592640 | Zepeda et al. | Nov 2013 | B2 |
10010675 | Cabiri | Jul 2018 | B2 |
10285617 | Toth et al. | May 2019 | B2 |
10335302 | Perez et al. | Jul 2019 | B2 |
20040116866 | Gorman | Jun 2004 | A1 |
20060211970 | Sciulli | Sep 2006 | A1 |
20070123819 | Mernoe et al. | May 2007 | A1 |
20080214914 | Say et al. | Sep 2008 | A1 |
20100160861 | Causey, III et al. | Jun 2010 | A1 |
20140378799 | Chattaraj | Dec 2014 | A1 |
20160058380 | Lee | Mar 2016 | A1 |
20160361015 | Wang et al. | Dec 2016 | A1 |
20170258402 | Acquista et al. | Sep 2017 | A1 |
20200109314 | Merrill et al. | Apr 2020 | A1 |
20200155050 | Pryor et al. | May 2020 | A1 |
Number | Date | Country |
---|---|---|
2019210240 | Oct 2019 | WO |
2019222615 | Nov 2019 | WO |
Entry |
---|
Qilan Li, A Practical Fabrication Method of the Gecko-Inspired Easy-Removal Skin Adhesives, University of Twente, Department of Engineering Technology, Laboratory for Surface Technology and Tribology, Dec. 7, 2016, https://www.sciencedirect.com/science/article/pii/S2405451816300502. |
Vitalconnect, VistaPoint 2.1 QuickStart and Instructions for Use, VitalConnect, Inc., Nov. 2019, https://vitalconnect.com/docs/ifu015/revB/IFU-15,%20VistaPoint%202.1,%20Rev.%20B.pdf. |
Bryan Laulicht, et. al., Quick-Release Medical Tape, PNAS, vol. 109, No. 46, Nov. 30, 2012, pp. 18803-18808, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3503228/pdf/pnas.201216071.pdf. |
Number | Date | Country | |
---|---|---|---|
20220133988 A1 | May 2022 | US |