Embodiments relate generally to medical devices, and more particularly to subcutaneous insertion systems comprising a device to be applied to a patient and an insertion system for applying the device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods.
A variety of devices can be applied to a patient to provide a treatment or monitor a patient condition. Some can do both. One example is an infusion system used to deliver substances such as fluids and medications into the subcutaneous layer of skin of a patient. Typically, a subcutaneous infusion system includes a site applied to the surface of the skin of a patient, the site having a cannula that is introduced into the skin, as well as a tube extending from the site to, for example, an infusion pump to deliver the substance. Another example is a patient monitoring system used to check or monitor one or more conditions of a patient (e.g., blood levels, such as glucose or oxygen), which also can include a device applied to the skin of the patient and comprising a cannula, filament, wire or other device introduced at least partially subcutaneously. For convenience, surface devices generally, whether for infusion, monitoring or some other purpose, will generally be referred to herein as sites. In some embodiments, sites refer to sensors or “patch pumps”.
In current designs, it is typically necessary to introduce the cannula or other device of the site into the skin of the patient while maintaining the site at a given orientation. The orientation of the cannula is also fixed, extending perpendicularly from a bottom surface of the site and therefore inserted straight into, or perpendicularly to, the surface of the skin. While this perpendicular orientation can require a shorter cannula and a shorter needle for insertion of the cannula while also being easy and convenient for user self-application using an insertion aid device, perpendicular insertion can be inconvenient for some users, such as those with low body fat or who are active and desire a more secure placement of the infusion device and cannula. Additionally, some users may wish to control the angle of insertion of the cannula, depending on location and anatomy, to increase comfort and placement efficacy. Still others may find the perpendicular orientation difficult to administer when applying the site to some locations on the body.
In addition, devices for assisting in insertion of the cannula of an infusion device into the skin of the patient are known. For example, some devices utilize springs to automatically drive a needle into the skin of a patient to introduce the cannula of the site into the subcutaneous layer. Because a needle is used to introduce the cannula of the infusion device into the subcutaneous layer of skin, there is a risk associated with inadvertent exposure to the needle. Further, patients may react adversely to viewing the needle prior to insertion and may, for example, be reluctant to self-insert the needle into the skin. Prior devices may not adequately shroud the needle prior to and/or after introduction of the site.
Other issues of concern in the design and use of insertion devices include ease of use by the patient and sterility. For example, some patients may have difficulty loading an infusion device into an insertion device.
It is therefore desirable to provide new designs for subcutaneous inserter devices and other devices used to assist in the introduction of a device into the skin of a patient.
Embodiments described or otherwise contemplated herein substantially meet the aforementioned needs; for example, an insertion device comprising a housing comprising a first end; a sleeve slidably arranged at least partially in the housing; a cylinder hub at least partially arranged in the sleeve and the housing and comprising a shoulder portion and a body portion, the shoulder portion proximate to the first end of the housing; a needle hub slidably arranged in the cylinder hub and comprising a needle; and a site comprising a patient side surface and a subcutaneous element, the subcutaneous element coupled to the site at an angle greater than 0 degrees and less than 90 degrees with respect to the patient side surface, the site arranged within the housing such that the needle can pass through at least a portion of the site to enter the subcutaneous element at the angle.
In an embodiment, a method comprises providing an insertion device comprising a housing comprising a first end, a sleeve slidably arranged at least partially in the housing, a cylinder hub at least partially arranged in the sleeve and the housing and comprising a shoulder portion and a body portion, the shoulder portion proximate to the first end of the housing, and a needle hub slidably arranged in the cylinder hub and comprising a needle; providing a site to be applied by the insertion device, the site comprising a patient side surface and a subcutaneous element to be inserted by the insertion device, the subcutaneous element coupled to the site at an angle greater than 0 degrees and less than 90 degrees with respect to the patient side surface; and configuring the insertion device and the site to be coupled with one another such that the needle can pass through at least a portion of the site to enter the subcutaneous element at the angle to insert the subcutaneous element during use.
In an embodiment, an insertion device comprises a housing comprising a first end; a sleeve slidably arranged at least partially in the housing; a cylinder hub at least partially arranged in the sleeve and the housing and comprising a shoulder portion and a body portion, the shoulder portion proximate to the first end of the housing; and a needle hub slidably arranged in the cylinder hub and comprising a needle; wherein the insertion device is configured to be coupled with a site to insert a subcutaneous element of the site subcutaneously, the subcutaneous element coupled to the site at an angle greater than 0 degrees and less than 90 degrees with respect to a patient-contacting surface of the site, the site coupled with the insertion device such that the needle can pass through at least a portion of the site to enter the subcutaneous element at the angle.
The above summary is not necessarily 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 these embodiments.
Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments of the subject matter in connection with the accompanying drawings, in which:
While 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 subject matter hereof 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 subject matter hereof in accordance with the appended claims.
Embodiments relate to subcutaneous insertion systems comprising a site or other surface device to be applied to a patient and an insertion system for applying the site or other surface device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods. The site or other surface device can comprise a device applied to the skin of the patient and comprising a cannula, filament, wire, sensor or other subcutaneous element to be introduced at least partially subcutaneously into the skin of a patient. For convenience, sites and other surface devices generally, whether for infusion, monitoring or some other purpose, will generally be referred to herein as sites. In some embodiments, sites may refer to sensors or “patch pumps”.
In an embodiment, a subcutaneous insertion system comprises a site and an insertion device for applying the site to the skin of a user. The site comprises a surface for application to the skin of a patient and a subcutaneous element, such as a cannula, filament, wire, sensor or other subcutaneous element to be introduced at least partially subcutaneously into the skin of a patient, extending from the surface at an angle greater than 0 degrees and less than 90 degrees. The site can be preloaded in the insertion device, which comprises a needle configured to interact with the cannula or other subcutaneous element to insert the cannula or other subcutaneous element into the skin of the patient at an angle greater than 0 degrees and less than 90 degrees with respect to the surface of the skin of the patient as the site is applied to the surface of the skin of the patient by the insertion device. The insertion device is configured to retract and securely retain the needle in an inaccessible portion of the insertion device after insertion of the cannula or other subcutaneous element. In embodiments, the subcutaneous insertion system can further comprise a set comprising tubing and configured to be removably coupled to the site while on the skin of the patient in order to convey fluid from a source coupled to the set to the patient via the tubing, site and cannula. In still other embodiments, devices and elements other than tubing sets can be mechanically, electrically and/or communicatively coupled with the site following application to the skin of the patient. The site (or “payload”) can be circular, elliptical, rectangular, or modifications of those general shapes.
While the type of surface device and subcutaneous element can vary in embodiments, examples discussed herein generally relate to an infusion site comprising a cannula. These examples are used without limitation or effect on the scope of the claims, as various other types of devices and elements are contemplated and may or may not fall within the scope of the claims. Some of these other devices and elements include patient monitoring systems and devices used to check or monitor one or more conditions of a patient (e.g., blood levels such as glucose, carbon dioxide, or oxygen) or body temperature, which also can include a device applied to the skin and comprising a cannula, filament, wire, sensor or other device introduced at least partially subcutaneously. Still other devices can be used in embodiments for application in or on the skin of a patient, including those with a different type of or without a subcutaneous element, with a plurality of subcutaneous elements, or with a subcutaneous element as well as surface elements (e.g., sensors or other devices configured to monitor a patient condition at the surface of the skin, independent of or in combination with a subcutaneous element). In some embodiments, a site may comprise a “patch pump” or similar device which may include its own fluid reservoir, power mechanism, power supply, electronic circuitry and cannula insertion system.
Referring to
Lock pin 170 secures cap 160 to housing 110 via an aperture 172 in housing 110 and an aperture 174 in cap 160 and can also abut or otherwise interact with sleeve 150 to prevent sleeve 150 from moving within housing 110 and cap 160. This can prevent inadvertent activation of insertion device 100, such as if insertion device was inadvertently dropped or jarred, while also providing a child safety feature. Lock pin 170 can form part of or be coupled with a tear-away band 176 that can be part of cap 160 or housing 172, such that removing tear-away band 176 removes lock pin 170 and enables cap 160 to be decoupled from housing 110 while also freeing sleeve 150 for movement. Cap 160 can comprise a label 161 in embodiments, wherein the label identifies at least one of a manufacturer of insertion device 100, name of insertion device 100, a serial number of insertion device 100, a barcode or other computer-readable identifier, instructions or warnings with respect to use of insertion device 100, and the like. Cap 160 can include a raised annular rib around its inner surface near the proximal end. This rib can be continuous or discontinuous. In some embodiments, the choice of cap design could be influenced by the sterilization method used on the device.
Insertion device 100 can be preloaded with or otherwise comprise a site 180 including a central hub 181 extending upwardly from a top surface or side of site 180. In still other embodiments, site 180 is not pre-loaded within insertion device 100 and instead can be coupled with insertion device 100 just prior to application of site 180 to the skin of the patient. Site 180 can be coupled with a site pad 182 and sleeve pad 184 on a bottom surface or side opposing its top surface. In other embodiments in which site 180 is differently configured and/or comprises a different type of device, the configuration of site pad 182 and/or sleeve pad 184 can vary, or one or both could be omitted or replaced by a different element. Here and elsewhere in this document unless otherwise specified, a “top” surface generally refers to an upper surface as the drawing is oriented on the page, while a “bottom” surface generally refers to the opposite, lower surface in the drawing, without limitation with respect to how the device or element may be oriented in use and operation or other situations. This convention is used for other elements and features herein throughout as well, unless otherwise specified.
Site pad 182 can couple or interface between site 180 and sleeve pad 184, while sleeve pad 184 can be configured to removably secure site 180 to sleeve 150 before application of site 180 to the skin of a patient. Sleeve pad 184 can comprise an adhesive layer, such as one comprising TEGADERM or another similar adhesive suitable for application to human skin or tissue, to removably couple site 180 to the skin of a patient after activation of device 100, which separates sleeve pad 184 from sleeve 150 as site 180 is applied to the skin of the patient. The adhesive layer can be applied to or coupled with a bottom surface of sleeve pad 184, or in another embodiment the adhesive layer can be applied to or coupled with a different surface of or coupled to site 180. In
One, some or all of site 180, site pad 182 and sleeve pad 184 can be precoupled with one another within insertion device 100 (i.e., combined or assembled together during manufacturing of insertion device 100), or in some embodiments they can be separate components combined upon activation of device 100. For example, in one embodiment site 180 and site pad 182 are precoupled with one another within insertion device 100 during manufacturing, and subsequently the combination is coupled with sleeve pad 184, via an additional adhesive layer on a top surface of sleeve pad 184 and/or on a bottom surface of site pad 182, only upon activation of device 100 to apply site 180, along with site pad 182 and sleeve pad 184, to the skin of a patient. The perimeter 191 of each of site 180, site pad 182 and sleeve pad 184 can be a variety of shapes. As shown in
Site pad 182 and sleeve pad 184 each comprise an aperture 183 and 185 (see
Site 180 is also supported or held in place within insertion device 100 by an end portion 132 of cylinder hub 130 and trigger rib 152 of sleeve 150. End portion 132 and trigger rib 152 can abut and/or support at least a portion of a central hub 181 of site 180. In one embodiment, end portion 132 can further be configured to abut and/or support at least a portion of the top surface of site 180. Thus, like the end of cap post 162 having first and second portions 166 and 168, end portion 132 of cylinder hub 130 is also configured to support site 180 in an orientation in which the top and bottom surfaces of site 180 are neither parallel nor perpendicular with the sidewalls of housing 110 and cap 160. The bottom surface of site 180 is generally parallel to the top surface of sleeve pad 184. In an embodiment shown in
Referring also to
Cylinder hub 130 further comprises apertures 136 (see
Body portion 133 comprises an aperture 137 configured to interact with a corresponding tab on needle hub 120. Body portion 133 also comprises a needle guide 138 and previously mentioned end portion 132 that abuts site 180 as discussed above.
Referring to
Referring to
Referring to
Accordingly, the channel 177 formed within the septum 190 provides angled access for a cannula 188 that is inserted through a site 180 at various angles. The contours of the arch shaped aperture 199 and channel 177 provide a versatile and functional passage and arrangement for cannula insertion. Accordingly, the when the cannula 188 is inserted through the aperture 196, wall 179, and channel 177 of lower portion 192, a convenient seal is made possible by the septum 190.
Sleeve 150 is depicted in
Biasing element 140 can comprise a spring, such as a coil spring, in embodiment. In other embodiments, some other type or form of biasing element can be used. As discussed below, biasing element 140 is compressed during application of site 180, and release of the compression retracts needle 122 during use and operation of insertion device 100.
Referring to
In
Once housing 110, cylinder hub 130 and needle hub 120 advance sufficiently toward the patient's skin so that snap arm 126 (see
Referring to
Once site 180 has been applied to the skin of a patient, an infusion set can be coupled to site 180 to enable an infusion pump or other fluid source to deliver a fluid to the patient via site 180, in an embodiment in which site 180 is used for infusion. Examples of infusion sets are disclosed in U.S. Pat. No. 9,192,717 to Cote et al., which is incorporated herein by reference in its entirety. In embodiments, the set can be coupled to site 180 in a plurality of different relative positions (i.e., to change the side or angle from which infusion tubing of the set extends from site 180 to increase comfort and convenience to the patient). In one embodiment, an infusion set can be coupled to site 180 in at least different relative positions, such as with the needle of the set entering site 180 from one of four different sides spaced apart from another by about 90 degrees. In other embodiments, more or fewer relative coupling relationships between site 180 and the set are possible. Upon being coupled to site 180, a needle within the set passes through a side of central hub 180 and pierces septum 190, establishing fluid communication between the needle (and medical tubing coupled thereto via the rest of the set, such as from an infusion pump) and cannula 188.
In still other embodiments, devices other than infusion sets and tubing can be coupled to site 180. In embodiments, this coupling can be mechanical, electrical, communicative or some combination of these coupling modalities. A set or other type of mechanical coupler can be used in embodiments, or a set can be omitted. To accommodate a variety of different coupling types and configurations, the configuration of site 180 can vary in embodiments, as can the configuration, size and orientation of some or all of the components of insertion device 100. For example, in embodiments the configuration of portions of sleeve 150, cylinder hub 130 and/or needle hub 120, which can interact with site 180 to abut and/or support site 180 within insertion device 100, can vary from those depicted as the configuration or type of payload (e.g., site 180) of insertion device 100 varies. In various embodiments, however, insertion device 100 can be used to apply, including subcutaneously, at least a portion of a site or other device at an angle between 0 degrees and 90 degrees to the skin of a patient. In some embodiments, the insertion needle passageway through the site can always be used for attachment of a set buckle to the site after placement onto the skin of a patient.
Additionally, site 180 can comprise additional elements or devices that communicate, cooperate or support the subcutaneous element or that otherwise provide a desired function. For example, in embodiments site 180 can comprise a radio-frequency identification (RFID) tag, chip, circuit, memory, sensor, light-emitting diode (LED), user interface, or other device or feature. These various devices and features can collect data, such as via the subcutaneous element or independently, and provide information to a user, clinician, other caregiver, computer or system. In still other embodiments, one or more components of site 180 can communicate with an external device, such as a meter, smartphone, smart watch, tablet, handheld or bodyworn computer or device, laptop, network, computer terminal, data reader or virtually any other device. The communications can be wired or wireless and can utilize one or more communication techniques including WIFI, BLUETOOTH, near- or far-field communications, or other techniques.
Housing 212 is shown with a generally planar top housing surface 224 and an angled side housing surface 226 along at least one side. The remaining side surface(s) 228 may be perpendicular to the top housing surface 224 or may gradually slope down to the bottom surface 218, as depicted in
Another type of site that may be provided by an insertion device is a “patch pump”. For purposes of this application, “patch pumps” refer to small infusion pumps that can be adhered directly to the skin for wear. Such patch pumps can be used to infuse a variety of fluids or medicaments. Patch pumps include insulin pumps which can provide insulin to diabetic users; however, their usefulness can extend beyond insulin delivery to the delivery of other medicaments. In some embodiments, patch pumps involve no tubing, readily adhere to the body, are small, lightweight, completely or partially disposable, and are capable of being worn and manipulated discreetly under clothing. Some patch pumps are controlled wirelessly by a separate controller.
Although not depicted in
Referring to
Site pad 182 and sleeve pad 184 each comprise an aperture that enables cannula 388 to pass through site pad 182 and sleeve pad 184 when patch pump 380 is applied to the skin of a patient. Patch pump 380 is preloaded in insertion device 300, and cap 160 is secured to housing 110 by lock pin 170 and includes tear-away band 176. In some embodiments, as shown in
End portion 132 of cylinder hub 130 is also configured to support patch pump 380 in an orientation in which the top surface 354 and bottom surface 356 of patch pump 380 are neither parallel nor perpendicular with the sidewalls of housing 110 and cap 160. In an embodiment shown in
Once housing 110, cylinder hub 130 and needle hub 120 advance sufficiently toward the skin that snap arm 126 of needle hub 120 reaches trigger rib 152, trigger rib 152 causes snap arm 126 to disengage from aperture 137. Because biasing element 140 has been compressed during the movement of housing 110 and cylinder hub 130 toward the skin and relative to sleeve 150, disengagement of snap arm 126 from aperture 137 by trigger rib 152 causes needle hub 120 and needle 122 to be retracted upwardly away from the skin within cylinder hub 130 and housing 110 by the released force of compressed biasing element 140, which engages with tabs 123 (See
Once patch pump 380 has been applied to the skin of a patient, the needle 122 is retracted, leaving the cannula 388 of the patch pump 380 inserted in the desired patient location. As the needle 122 is retracted from the passageway in the pump, retention fingers 350 of the cylinder hub 130 are permitted to disengage from the patch pump 380. This disengagement results in the patch pump 380 being separated from the rest of the insertion device 300. Accordingly, retraction of the needle allows the retention fingers 350 to move inward during removal. Operation of the retention fingers 350 is described in greater detail in
The angled passageway 358 begins to extend inward from the attachment aperture 352 in an angled manner with a smooth surface diameter. Partially into the angled passageway 358 an annular constriction 360 protrudes inward from the perimeter before the angled passageway 358 again widens to a section 362 of smooth diameter that houses a self-sealing septum 364. The angled passageway 358 is reduced to a final, narrow diameter passage 366 leading to the bottom housing surface 356, out of which cannula 388 extends in an angled manner from the housing 312.
In
It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with an enabling disclosure for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of the subject matter hereof as set forth in the appended claims and the legal equivalents thereof.
The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. Although subject matter hereof has been described with reference to particular embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the subject matter.
Various modifications to subject matter hereof may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant art will recognize that the various features described for the different embodiments of the invention can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations, within the spirit of the subject matter. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the subject matter. Therefore, the above is not contemplated to limit the scope of the subject matter.
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.
This application is a continuation of application Ser. No. 16/097,449 filed Oct. 29, 2018, which is a National Phase entry of PCT Application No. PCT/US2017/029353 filed Apr. 25, 2017, which claims the benefit of U.S. Provisional Application No. 62/329,352 filed Apr. 29, 2016, each of which is incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3094989 | Stauffer | Jun 1963 | A |
3547119 | Hall et al. | Dec 1970 | A |
4235234 | Whitney et al. | Nov 1980 | A |
4378015 | Wardlaw | Mar 1983 | A |
4531937 | Yates | Jul 1985 | A |
4563177 | Kamen | Jan 1986 | A |
4645495 | Vaillancourt | Feb 1987 | A |
4747831 | Kulli | May 1988 | A |
4755173 | Konopka et al. | Jul 1988 | A |
4781695 | Dalton | Nov 1988 | A |
4805791 | Begley | Feb 1989 | A |
4813939 | Marcus | Mar 1989 | A |
4994042 | Vadher | Feb 1991 | A |
5092853 | Couvertier, II | Mar 1992 | A |
5122119 | Lucas | Jun 1992 | A |
5129884 | Dysarz | Jul 1992 | A |
5135496 | Vetter et al. | Aug 1992 | A |
5135502 | Koenig, Jr. et al. | Aug 1992 | A |
5137516 | Rand et al. | Aug 1992 | A |
5167632 | Eid et al. | Dec 1992 | A |
5176650 | Haining | Jan 1993 | A |
5176662 | Bartholomew et al. | Jan 1993 | A |
5248301 | Koenig, Jr. et al. | Sep 1993 | A |
5257980 | Van Antwerp et al. | Nov 1993 | A |
5391151 | Wilmot | Feb 1995 | A |
5451210 | Kramer et al. | Sep 1995 | A |
5522803 | Teissen-Simony | Jun 1996 | A |
5545143 | Fischell et al. | Aug 1996 | A |
5573510 | Isaacson | Nov 1996 | A |
5575777 | Cover et al. | Nov 1996 | A |
5584813 | Livingston et al. | Dec 1996 | A |
5591188 | Waisman | Jan 1997 | A |
5676156 | Yoon | Oct 1997 | A |
5738641 | Watson et al. | Apr 1998 | A |
5817058 | Shaw | Oct 1998 | A |
5833666 | Davis et al. | Nov 1998 | A |
5848989 | Villani | Dec 1998 | A |
5848990 | Cirelli et al. | Dec 1998 | A |
5851197 | Marano et al. | Dec 1998 | A |
5865842 | Knuth et al. | Feb 1999 | A |
5873856 | Hjertman et al. | Feb 1999 | A |
5947931 | Bierman | Sep 1999 | A |
5954643 | Van Antwerp et al. | Sep 1999 | A |
5968011 | Larsen et al. | Oct 1999 | A |
5971950 | Lopez et al. | Oct 1999 | A |
5980506 | Mathiasen | Nov 1999 | A |
6017328 | Fischell et al. | Jan 2000 | A |
6056718 | Funderburk et al. | May 2000 | A |
6056726 | Isaacson | May 2000 | A |
6074369 | Sage et al. | Jun 2000 | A |
6077244 | Botich et al. | Jun 2000 | A |
6086575 | Mejslov | Jul 2000 | A |
6093172 | Funderburk et al. | Jul 2000 | A |
6123690 | Mejslov | Sep 2000 | A |
6159181 | Crossman et al. | Dec 2000 | A |
6191338 | Haller | Feb 2001 | B1 |
6293925 | Safabash et al. | Sep 2001 | B1 |
6302866 | Marggi | Oct 2001 | B1 |
6355021 | Nielson et al. | Mar 2002 | B1 |
6419699 | Schuessler | Jul 2002 | B1 |
6428515 | Bierman et al. | Aug 2002 | B1 |
6447482 | Ronborg et al. | Sep 2002 | B1 |
6450992 | Cassidy, Jr. | Sep 2002 | B1 |
6517517 | Farrugia et al. | Feb 2003 | B1 |
6520938 | Funderburk et al. | Feb 2003 | B1 |
6549810 | Leonard et al. | Apr 2003 | B1 |
6572586 | Wojcik | Jun 2003 | B1 |
6579267 | Lynch et al. | Jun 2003 | B2 |
6607509 | Bobroff et al. | Aug 2003 | B2 |
6613064 | Rutynowski et al. | Sep 2003 | B2 |
6620136 | Pressly, Sr. et al. | Sep 2003 | B1 |
6685674 | Douglas et al. | Feb 2004 | B2 |
6736797 | Larsen et al. | May 2004 | B1 |
6749589 | Douglas et al. | Jun 2004 | B1 |
6830562 | Mogensen et al. | Dec 2004 | B2 |
6923791 | Douglas | Aug 2005 | B2 |
6926694 | Morano-Ford et al. | Aug 2005 | B2 |
6991620 | Marano-Ford et al. | Jan 2006 | B2 |
7018344 | Bressler et al. | Mar 2006 | B2 |
7022108 | Marano-Ford et al. | Apr 2006 | B2 |
7052483 | Wojcik | May 2006 | B2 |
7056302 | Douglas | Jun 2006 | B2 |
7129389 | Watson | Oct 2006 | B1 |
7297138 | Fangrow, Jr. | Nov 2007 | B2 |
7303543 | Maule et al. | Dec 2007 | B1 |
7407493 | Cane′ | Aug 2008 | B2 |
D576267 | Mogensen et al. | Sep 2008 | S |
7520867 | Bowman et al. | Apr 2009 | B2 |
7585287 | Bresina et al. | Sep 2009 | B2 |
7594902 | Horisberger | Sep 2009 | B2 |
7699807 | Faust et al. | Apr 2010 | B2 |
7699808 | Marrs et al. | Apr 2010 | B2 |
7731691 | Cote et al. | Jun 2010 | B2 |
7850658 | Faust et al. | Dec 2010 | B2 |
7879010 | Hunn et al. | Feb 2011 | B2 |
7931615 | Fangrow, Jr. | Apr 2011 | B2 |
7985199 | Kornerup | Jul 2011 | B2 |
7993306 | Marrs et al. | Aug 2011 | B2 |
8029460 | Rush | Oct 2011 | B2 |
8152769 | Douglas et al. | Apr 2012 | B2 |
8157773 | Turner | Apr 2012 | B2 |
8226614 | Turner | Jul 2012 | B2 |
8317759 | Moberg et al. | Nov 2012 | B2 |
8343115 | Lynch et al. | Jan 2013 | B2 |
8795309 | Lacy | Aug 2014 | B2 |
9192717 | Cote et al. | Nov 2015 | B2 |
9227013 | Lacy | Jan 2016 | B2 |
9662440 | Yodfat | May 2017 | B2 |
9795777 | Sonderegger | Oct 2017 | B2 |
9993595 | Michaud et al. | Jun 2018 | B2 |
10076606 | Ambruzs | Sep 2018 | B2 |
10307532 | Pearson | Jun 2019 | B2 |
10434285 | Schoonmaker et al. | Oct 2019 | B2 |
20010039387 | Rutynowski et al. | Nov 2001 | A1 |
20010053889 | Marggi et al. | Dec 2001 | A1 |
20020010423 | Gross et al. | Jan 2002 | A1 |
20020022855 | Bobroff et al. | Feb 2002 | A1 |
20020045867 | Nielson et al. | Apr 2002 | A1 |
20020077599 | Wojcik | Jun 2002 | A1 |
20020082543 | Park et al. | Jun 2002 | A1 |
20020123724 | Douglas et al. | Sep 2002 | A1 |
20020123740 | Flaherty et al. | Sep 2002 | A1 |
20020161332 | Ramey | Oct 2002 | A1 |
20020173769 | Gray et al. | Nov 2002 | A1 |
20030014018 | Giambattista et al. | Jan 2003 | A1 |
20030060776 | Heiniger | Mar 2003 | A1 |
20030060781 | Mogensen et al. | Mar 2003 | A1 |
20030060798 | Fischer et al. | Mar 2003 | A1 |
20030109829 | Mogensen et al. | Jun 2003 | A1 |
20030125669 | Safabash et al. | Jul 2003 | A1 |
20030130619 | Safabash et al. | Jul 2003 | A1 |
20030158520 | Safabash et al. | Aug 2003 | A1 |
20030181863 | Ackley | Sep 2003 | A1 |
20030199823 | Bobroff et al. | Oct 2003 | A1 |
20030225373 | Bobroff et al. | Dec 2003 | A1 |
20030225374 | Mathiasen | Dec 2003 | A1 |
20030236498 | Gross et al. | Dec 2003 | A1 |
20040002682 | Kovelman et al. | Jan 2004 | A1 |
20040116866 | Gorman et al. | Jun 2004 | A1 |
20040138612 | Shermer et al. | Jul 2004 | A1 |
20040143216 | Douglas et al. | Jul 2004 | A1 |
20040147877 | Heuser | Jul 2004 | A1 |
20040158207 | Hunn et al. | Aug 2004 | A1 |
20040162521 | Bengtsson | Aug 2004 | A1 |
20040199123 | Nielsen | Oct 2004 | A1 |
20040204687 | Mogensen et al. | Oct 2004 | A1 |
20040215151 | Marshall et al. | Oct 2004 | A1 |
20040236284 | Hoste et al. | Nov 2004 | A1 |
20040260250 | Harris et al. | Dec 2004 | A1 |
20050043687 | Mogensen et al. | Feb 2005 | A1 |
20050075606 | Botich et al. | Apr 2005 | A1 |
20050090779 | Osypka | Apr 2005 | A1 |
20050101910 | Bowman et al. | May 2005 | A1 |
20050101932 | Cote et al. | May 2005 | A1 |
20050101933 | Marrs | May 2005 | A1 |
20050107743 | Fangrow, Jr. | May 2005 | A1 |
20050113761 | Faust et al. | May 2005 | A1 |
20050119611 | Marano-Ford et al. | Jun 2005 | A1 |
20050131346 | Douglas | Jun 2005 | A1 |
20050215979 | Kornerup et al. | Sep 2005 | A1 |
20050240154 | Mogensen | Oct 2005 | A1 |
20050283114 | Bresina et al. | Dec 2005 | A1 |
20060041224 | Jensen | Feb 2006 | A1 |
20060129090 | Moberg et al. | Jun 2006 | A1 |
20060173413 | Fangrow | Aug 2006 | A1 |
20070066955 | Sparholt | Mar 2007 | A1 |
20070142776 | Kovelman et al. | Jun 2007 | A9 |
20070276355 | Nielsen | Nov 2007 | A1 |
20080071156 | Brister et al. | Mar 2008 | A1 |
20080103450 | Marrs et al. | May 2008 | A1 |
20080154205 | Wojcik | Jun 2008 | A1 |
20080243051 | DeStefano | Oct 2008 | A1 |
20090012472 | Ahm | Jan 2009 | A1 |
20090076453 | Mejlhede | Mar 2009 | A1 |
20090124979 | Raymond et al. | May 2009 | A1 |
20090143763 | Wyss et al. | Jun 2009 | A1 |
20090215979 | Dorwald | Aug 2009 | A1 |
20090216215 | Thalmann et al. | Aug 2009 | A1 |
20090264825 | Cote et al. | Oct 2009 | A1 |
20090287153 | Bresina et al. | Nov 2009 | A1 |
20100049129 | Yokoi et al. | Feb 2010 | A1 |
20100063453 | Theander | Mar 2010 | A1 |
20100137829 | Nielsen | Jun 2010 | A1 |
20100217105 | Yodfat et al. | Aug 2010 | A1 |
20110028982 | Lacy | Feb 2011 | A1 |
20110125106 | Giambattista et al. | May 2011 | A1 |
20120179106 | Cote et al. | Jul 2012 | A1 |
20130012881 | Lacy | Jan 2013 | A1 |
20130274576 | Amirouche | Oct 2013 | A1 |
20140039453 | Sonderegger | Feb 2014 | A1 |
20140088555 | Li | Mar 2014 | A1 |
20160296695 | Hassaman et al. | Oct 2016 | A1 |
20160339172 | Michaud et al. | Nov 2016 | A1 |
Number | Date | Country |
---|---|---|
2004289184 | Nov 2010 | AU |
2005264927 | Mar 2011 | AU |
2004289183 | Apr 2011 | AU |
2004289185 | Jun 2011 | AU |
1272423 | Aug 1990 | CA |
2446976 | Jan 2002 | CA |
2544293 | Jan 2012 | CA |
2544303 | Jun 2013 | CA |
2570868 | May 2014 | CA |
2544299 | Jan 2016 | CA |
2792489 | Mar 2016 | CA |
100506310 | Jul 2009 | CN |
100571799 | Dec 2009 | CN |
101018578 | Apr 2010 | CN |
1878592 | Jul 2011 | CN |
29905072 | Sep 1999 | DE |
20220543 | Oct 2003 | DE |
0397951 | May 1989 | EP |
0239244 | Sep 1991 | EP |
0451040 | Oct 1991 | EP |
0290176 | Feb 1996 | EP |
0615768 | Dec 1999 | EP |
1329233 | Sep 2004 | EP |
1687046 | Sep 2008 | EP |
2380620 | Oct 2011 | EP |
2383011 | Nov 2011 | EP |
1789116 | May 2013 | EP |
2596821 | May 2013 | EP |
1691877 | Dec 2013 | EP |
1684840 | Oct 2017 | EP |
2752164 | Feb 1998 | FR |
H 11-347120 | Dec 1999 | JP |
2000-254225 | Sep 2000 | JP |
2004-524926 | Aug 2004 | JP |
2007-510497 | Apr 2007 | JP |
4685024 | May 2011 | JP |
4891086 | Dec 2011 | JP |
2013-039416 | Feb 2013 | JP |
5575084 | Aug 2014 | JP |
5976091 | Jul 2016 | JP |
WO 1996032981 | Oct 1996 | WO |
WO 1998058693 | Dec 1998 | WO |
WO 1999034739 | Jul 1999 | WO |
WO 1999033504 | Nov 1999 | WO |
WO 2002081012 | Oct 2002 | WO |
WO 2002083206 | Oct 2002 | WO |
WO 2002100457 | Dec 2002 | WO |
WO 2002100467 | Dec 2002 | WO |
WO 2002102442 | Dec 2002 | WO |
WO 2004101071 | Nov 2004 | WO |
WO 2005046767 | May 2005 | WO |
WO 2005046780 | May 2005 | WO |
WO 2005046781 | May 2005 | WO |
WO 2005049117 | Jun 2005 | WO |
WO 2006009665 | Jan 2006 | WO |
WO 2006020851 | Feb 2006 | WO |
WO 2008022476 | Feb 2010 | WO |
WO 2011014492 | Feb 2011 | WO |
Entry |
---|
“Technical Information Sheet Product No. 1538L, 3M™ Medical Rayon Woven Tape on Liner,” 3M, 2 pages (2003). |
Inset®Visual Guide, Unomedical, 16 pages, 2004. |
Smiths Medical MD, Inc., “Infusion Sets Overview,” 2009, 2 pages. |
Mike H., “New FreeStyle Libre ‘Hybrid’ Glucose Monitor Approved in Europe,” Sep. 5, 2014, 6 paegs. |
Application and File history for U.S. Appl. No. 10/705,719, filed Nov. 10, 2003. Inventors: Cote et al. |
Application and File history for U.S. Appl. No. 10/705,725, filed Nov. 10, 2003. Inventors: Faust et al. |
Application and File history for U.S. Appl. No. 10/705,736, filed Apr. 20, 2010. Inventors: Marrs et al. |
Application and File history for U.S. Appl. No. 10/869,181, filed Jun. 16, 2004. Inventors: Bresina et al. |
Application and File history for U.S. Appl. No. 10/918,212, filed Dec. 14, 2010. Inventors: Faust et al. |
Application and File history for U.S. Appl. No. 11/554,835, filed Oct. 31, 2006. Inventors: Marrs et al. |
Application and File history for U.S. Appl. No. 12/509,063, filed Jul. 24, 2009. Inventors: Bresina et al. |
Application and File history for U.S. Appl. No. 12/844,402, filed Jul. 27, 2010. Inventors: Lacy. |
Application and File history for U.S. Appl. No. 13/351,993, filed Jan. 17, 2012. Inventors: Cote et al. |
Application and File history for U.S. Appl. No. 13/619,396, filed Sep. 14, 2012. Inventors: Lacy. |
Transcript of Diabetando Diabetando YouTube video “FreeStyle Libre Getting Start,” https://www.youtube.com/watch?v=0cXw09YBJxE, Sep. 2, 2014, 39 pages. |
International Search Report for corresponding International Application No. PCT/US2017/029353 dated Aug. 3, 2017; 12 pages. |
Written Opinion of the International Searching Authority for corresponding International Application No. PCT/US2017/029353 dated Aug. 3, 2017; 10 pages. |
FreeStyle Libre https://www.freestylelibre.us/support/overview.html Getting Started introduction video. © 2018 Abbott Laboratories. |
Examination Report corresponding to Australia Patent Application No. 2017257665 dated Nov. 24, 2021. |
Number | Date | Country | |
---|---|---|---|
20220096757 A1 | Mar 2022 | US |
Number | Date | Country | |
---|---|---|---|
62329352 | Apr 2016 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 16097449 | US | |
Child | 17549373 | US |