Transdermal analyte sensors, applicators, and related methods

Abstract

The present embodiments relate generally to applicators for on-skin sensor assemblies for measuring an analyte in a host, and methods of use and manufacture thereof. In some aspects, an applicator for applying an on-skin sensor assembly to a host's skin is provided. The applicator includes an applicator housing; a needle carrier assembly including an insertion element configured to insert a sensor of the on-skin sensor assembly into the host's skin; a holder detachably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly when coupled to the needle carrier assembly; and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position and from the distal insertion position to a proximal retraction position.

Description

[0001] Incorporate the relevant application by reference. The scope of any and all priorities identified in the application data sheet, or any correction thereof, is hereby incorporated by reference in accordance with 37 CFR 1.57. This application claims the benefits of U.S. Provisional Application No. 62 / 524,247, filed June 23, 2017, and U.S. Provisional Application No. 62 / 658,486, filed April 16, 2018. Each of the foregoing applications is incorporated herein by reference in its entirety, and each thereby expressly forms a part of this specification. Technical Field

[0002] Systems and methods for measuring analytes within a host are provided. More specifically, systems and methods for applying a transdermal analyte measurement system to a host are provided. Background Technology

[0003] Diabetes is a condition in which the pancreas cannot produce enough insulin (type 1 or insulin-dependent) and / or insulin is ineffective (type 2 or non-insulin-dependent). In a diabetic state, the patient suffers from hyperglycemia, which can cause a range of physiological disturbances associated with the deterioration of small blood vessels, such as kidney failure, skin ulcers, or vitreous hemorrhage. Hypoglycemia can be induced by unintentional overdose of insulin, or by excessive exercise or insufficient food intake of insulin or a glucose-lowering agent.

[0004] Conventionally, diabetic patients wear self-monitoring blood glucose (SMBG) monitors, which typically require an uncomfortable finger prick method. Due to this lack of comfort and convenience, diabetic patients usually only measure their glucose levels two to four times a day. Disadvantageously, these intervals are so long that it may be too late for diabetic patients to detect symptoms of hyperglycemia or hypoglycemia, sometimes leading to dangerous side effects. An alternative is continuous glucose monitoring via a sensor system that includes sensor components on the skin. The sensor system may have a wireless transmitter that transmits measurement data to a receiver, which can process and display the information based on the measurement.

[0005] The method of applying sensors to a person is crucial for the effectiveness and user-friendliness of such systems. The application method should ensure that the sensor component attached to the person is in a state where it can sense glucose levels, transmit the sensed data to a transmitter, and transmit the glucose level information to a receiver.

[0006] This background information is provided to briefly introduce the following summary and detailed description of the invention. This background information is not intended to help define the scope of the claimed subject matter, nor is it intended to limit the claimed subject matter to solutions to any or all of the aforementioned drawbacks or problems. Summary of the Invention

[0007] The systems and methods of the present invention relate to systems and methods for measuring analytes within a host and for applying a transdermal analyte measurement system to a host. Various embodiments of the systems and methods of the present invention for applying an analyte measurement system have several features, none of which individually is responsible for their desired properties. Without limiting the scope of the embodiments as set forth in the following claims, their more prominent features will now be briefly discussed. After considering this discussion, and especially after reading the section entitled “Detailed Description,” it will become clear how the features of this embodiment provide the advantages described herein.

[0008] An applicator is provided for applying an on-skin sensor assembly to the skin of a host. The applicator includes an applicator housing; a needle holder assembly including an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of a host; a retainer detachably coupled to the needle holder assembly and configured to guide the on-skin sensor assembly when coupled to the needle holder assembly; and a drive assembly configured to drive the insertion element from a proximal initiation position to a distal insertion position and from the distal insertion position to a proximal retraction position.

[0009] In some embodiments, the on-skin sensor assembly includes an electronic unit. In some embodiments, the sensor is connected to the electronic unit in the applicator housing. In some embodiments, the retainer is configured to release the on-skin sensor assembly after the sensor has been at least partially inserted into the host's skin. In some embodiments, the applicator further includes an activation element configured to activate a drive assembly. In some embodiments, the activation element includes a deflectable feature. In some embodiments, the deflectable feature is configured to provide resistance to activation. In some embodiments, the deflectable feature is configured to return the activation element to a starting position. In some embodiments, the activation element includes one of a button, switch, toggle switch, slider, trigger, and knob. In some embodiments, the applicator further includes a safety element configured to prevent operation of the activation element. In some embodiments, the safety element includes a tab coupled to the activation element via at least one fragile component. In some embodiments, distal and proximal directions extend along the insertion axis of the insertion element. In some embodiments, the retainer includes an elastomer.

[0010] In a first aspect, the applicator housing includes a guide. The drive assembly includes a rotary drive element coupled to the needle carriage assembly and includes a pin configured to travel in the guide during rotation of the rotary drive element; and a spring configured to rotate the rotary drive element in a single rotational direction upon activation of the drive assembly, thereby driving the insertion element from a proximal initiation position to a distal insertion position and from the distal insertion position to a proximal retraction position. In some embodiments, the rotary drive element is configured to convert rotational motion into linear motion. In some embodiments, the rotary drive element includes a wheel cam. In some embodiments, the pin is radially offset from the rotation axis of the rotary drive element. In some embodiments, when the insertion element is in the proximal initiation position, the pin is positioned approximately 30 degrees from the bottom center relative to the rotation axis of the rotary drive element. In some embodiments, when the insertion element is in the distal insertion position, the pin is positioned approximately 180 degrees from the bottom center relative to the rotation axis of the rotary drive element. In some embodiments, when the needle carriage assembly is in the proximal retraction position, the pin is positioned approximately 330 degrees from the bottom center relative to the rotation axis of the rotary drive element. In some embodiments, the pin travels in the guide in a direction perpendicular to the extension direction of the insertion element. In some embodiments, the guide includes a slot. In some embodiments, the slot is fixed during sensor insertion. In some embodiments, the slot includes a horizontal slot. In some embodiments, the slot includes a vertical slot configured to receive at least the pin of the rotary drive element when loaded through the bottom of the applicator housing. In some embodiments, the applicator housing is fixed. In some embodiments, the rotary drive element further includes a protrusion that contacts a retaining element configured to prevent rotation of the rotary drive element. In some embodiments, the applicator further includes an activation element configured to deflect the retaining element, thereby causing the rotary drive element to rotate. In some embodiments, the rotary drive element further includes a protrusion configured to decouple the on-skin sensor assembly from the needle holder assembly. In some embodiments, the protrusion is configured to apply force to the on-skin sensor assembly during rotation of the rotary drive element. In some embodiments, the protrusion of the rotary drive element is configured to pass through a slot in the needle holder assembly as the rotary drive element rotates.

[0011] In a second aspect, the drive assembly includes a torsion spring. The torsion spring includes a first end coupled to the applicator housing and a second end coupled to the needle carriage assembly. Upon activation of the drive assembly, the first and second ends unwind in opposite directions, thereby driving the insertion element from a proximal initiation position to a distal insertion position and from the distal insertion position to a proximal retraction position. In some embodiments, the unwinding first and second ends in opposite directions drive the torsion spring in an arc. In some embodiments, the arc extends in a direction perpendicular to both the distal and proximal directions. In some embodiments, a spool is coupled to the torsion spring. In some embodiments, the torsion spring is wound around the spool. In some embodiments, the second end of the torsion spring is configured to drive the insertion element. In some embodiments, the torsion spring is a double torsion spring. In some embodiments, the first end of the torsion spring is coupled to a protrusion of the applicator housing. In some embodiments, the second end of the torsion spring is coupled to a protrusion of the needle carriage assembly.

[0012] In a third aspect, the drive assembly further includes a linkage element comprising a first end coupled to a first end of a torsion spring; a second end coupled to a second end of the torsion spring; and a hinge substantially aligned with the winding axis of the torsion spring. In some embodiments, the linkage element comprises a flexible linkage mechanism.

[0013] In a fourth aspect, the drive assembly includes a linkage element having a first end connected to the applicator housing and a second end connected to the needle carriage assembly and a hinge disposed between the first and second ends. The drive assembly further includes a torsion spring having a first end connected to the needle carriage assembly and a second end connected to the linkage element between the second end and the hinge. Upon activation of the drive assembly, the second end is configured to drive the linkage element such that the insertion element is driven from a proximal initiation position to a distal insertion position and from the distal insertion position to a proximal retraction position.

[0014] In a fifth aspect, the drive assembly includes a linkage element comprising a first end connected to the applicator housing, a second end connected to the needle holder assembly, and a hinge disposed between the first and second ends. The drive assembly further includes a torsion spring comprising a first end connected to the applicator housing and a second end connected to the linkage element between the first end and the hinge. Upon activation of the drive assembly, the second end is configured to drive the linkage element such that the insertion element is driven from a proximal initiation position to a distal insertion position, and from the distal insertion position to a proximal retraction position.

[0015] In a sixth aspect, the drive assembly includes a linkage element comprising a first end coupled to the applicator housing; a second end coupled to the needle holder assembly; and a hinge disposed between the first and second ends. The drive assembly further includes a tension spring coupled to the linkage element. Upon activation of the drive assembly, the tension spring is configured to drive the linkage element such that the insertion element is driven to a distal insertion position in the distal direction and from the distal insertion position in the proximal direction.

[0016] In a seventh aspect, the drive assembly includes a leaf spring having a first end coupled to the applicator housing and a second end coupled to the needle carriage assembly. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element to a distal insertion position, at least in the distal direction.

[0017] In an eighth aspect, the drive assembly includes a linkage element comprising a first end coupled to an applicator housing; a second end coupled to a needle carriage assembly; and a hinge disposed between the first and second ends. The drive assembly further includes a leaf spring comprising a first end coupled to the needle carriage assembly and a second end coupled to the linkage element between the second end and the hinge. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element to a distal insertion position in the distal direction and driving the insertion element from the distal insertion position in the proximal direction.

[0018] In a ninth aspect, the drive assembly includes a leaf spring having a first end coupled to the applicator housing and a second end coupled to the needle carriage assembly. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element to a distal insertion position, at least in the distal direction.

[0019] In a tenth aspect, the drive assembly includes a linkage element comprising a first end coupled to an applicator housing; a second end coupled to a needle carriage assembly; and a hinge disposed between the first and second ends. The drive assembly further includes a leaf spring comprising a first end coupled to the needle carriage assembly and a second end coupled to the linkage element between the second end and the hinge. Upon activation of the drive assembly, the leaf spring is configured to decompress, thereby driving the insertion element to a distal insertion position in the distal direction and driving the insertion element from the distal insertion position in the proximal direction.

[0020] In an eleventh aspect, the drive assembly includes an insertion spring configured to drive an insertion element in a distal direction to a distal insertion position upon activation of the drive assembly; and a retraction spring contacting the needle carriage assembly and configured to retract the insertion element from the distal insertion position to a proximal retraction position. In some embodiments, the insertion spring comprises a compression spring. In some embodiments, the retraction spring comprises a leaf spring. In some embodiments, the retraction spring is configured to retract the insertion element from the host's skin. In some embodiments, upon activation of the drive assembly, a portion of the energy stored in the insertion spring is transferred to the retraction spring as the insertion spring drives the insertion element in the distal direction. In some embodiments, the insertion spring includes a first end coupled to an applicator housing and a second end coupled to a retainer, the retainer being coupled to the needle carriage assembly when the insertion spring drives the insertion element in the distal direction to the distal insertion position and decoupled from the needle carriage assembly when the retraction spring drives the insertion element in the proximal direction from the distal insertion position. In some embodiments, the insertion element is configured to travel in an arc when driven in both the distal and proximal directions.

[0021] In a twelfth aspect, the drive assembly includes a rotary drive element comprising a ridge configured to slide along a channel in the needle carriage assembly, the ridge defining a variable cam path around at least a portion of the circumference of the rotary drive element; and a torsion spring configured to rotate the rotary drive element based on the variable cam path upon activation of the drive assembly, thereby driving the insertion element to a distal insertion position in the distal direction and from the distal insertion position in the proximal direction. In some embodiments, the torsion spring is configured to rotate the rotary drive element by an angle greater than zero degrees and less than 360 degrees in a single direction upon activation of the drive assembly. In some embodiments, the rotary drive element comprises a barrel cam. In some embodiments, the rotary drive element is configured to rotate in a plane substantially perpendicular to both the proximal and distal directions.

[0022] In a thirteenth aspect, the drive assembly includes a guide member coupled to the applicator housing, and a hub configured to slide along the guide member, the hub contacting a reversing element via a first traveling portion along the guide member and a needle carriage assembly via a second traveling portion along the guide member. The reversing element includes a fulcrum; a first end contacting the hub via the first traveling portion of the guide member; and a second end coupled to the needle carriage assembly. The drive assembly further includes a spring configured to, upon activation of the drive assembly, drive the hub in a proximal direction via the first traveling portion of the guide member, thereby driving the insertion element to a distal insertion position in a proximal direction, and to drive the hub in a proximal direction from the distal insertion position in a proximal direction via the second traveling portion of the guide member.

[0023] In a fourteenth aspect, the drive assembly includes a first spring configured to drive the needle carriage assembly to a distal insertion position in a distal direction after activation of the drive assembly, and a second spring configured to drive the needle carriage assembly from the distal insertion position in a proximal direction. In some embodiments, the first and second springs are pre-compressed prior to activation of the drive assembly. In some embodiments, when the needle carriage assembly is driven to the distal insertion position in the distal direction, at least a portion of the energy stored in the first spring is transferred to the second spring.

[0024] In some embodiments, the retainer includes at least one retaining element configured to secure the retainer to the applicator housing after the needle carriage assembly reaches the distal insertion position. In some embodiments, the retainer further includes a retaining element configured to detachably engage the on-skin sensor assembly to the retainer as the needle carriage assembly travels in the distal direction to the distal insertion position, and to decouple the retainer from the on-skin sensor assembly as the needle carriage assembly travels in the proximal direction from the distal insertion position.

[0025] In some embodiments, the retainer includes a retaining element having a first end and a second end. The first end is secured in a guide of the needle carriage assembly so that, as the needle carriage assembly travels in the distal direction to the distal insertion position, the second end is detached from the guide of the needle carriage assembly, and as the needle carriage assembly travels in the proximal direction from the distal insertion position and separates from the retainer, the second end is decoupled from the on-skin sensor assembly.

[0026] In some embodiments, the needle carriage assembly includes a retaining element that, as the needle carriage assembly travels in the distal direction to a distal insertion position, detachably engages the on-skin sensor assembly to a retainer, and the retaining element is configured to deform sufficiently to decouple from the on-skin sensor assembly as the needle carriage assembly travels in the proximal direction from the distal insertion position and separates from the retainer.

[0027] In some embodiments, the retainer includes a deformable retaining element that detachably engages the on-skin sensor assembly to the retainer. The needle carriage assembly contacts the deformable retaining element to prevent deformation of the deformable retaining element as the needle carriage assembly travels distally to the distal insertion position. As the needle carriage assembly travels proximally from the distal insertion position, the needle carriage assembly disengages from the retainer, allowing the retaining element to deform sufficiently to decouple from the on-skin sensor assembly.

[0028] In some embodiments, the needle holder assembly includes a first retaining element configured to detachably attach a retainer to the needle holder assembly and a second retaining element configured to detachably attach a sensor assembly on the skin to one of the retainer and the needle holder assembly.

[0029] In some embodiments, the insertion element includes a C-needle with a flared edge. In some embodiments, the insertion element includes a needle with a deflected tip. In some embodiments, the insertion element includes a needle tip with a curved profile configured to substantially follow the insertion path of the needle tip. In some embodiments, the insertion element includes a needle, and the needle carrier assembly further includes a needle hub configured as a channel for the needle during sensor insertion and further configured to close the needle tip after sensor insertion. The insertion element further includes a needle spring configured to drive the needle hub to the needle tip after sensor insertion.

[0030] In some embodiments, the on-skin sensor assembly includes a loading port configured to receive fluid or gel and a cannula configured to deliver fluid or gel through the host's skin.

[0031] In some embodiments, the applicator further includes a resilient sensor holding element whose first end is coupled to the applicator housing and to at least one of the insertion element and the sensor. The resilient sensor holding element is configured to hold the sensor within the insertion element before activation of the drive assembly. In some embodiments, upon activation, the insertion element is configured to advance in a proximal direction such that the resilient sensor holding element decouples from at least one of the insertion element and the sensor.

[0032] In some embodiments, the applicator further includes a sensor holding element comprising tabs configured to hold the sensor within the insertion element prior to activation of the drive assembly.

[0033] In some embodiments, the applicator further includes a sensor holding element, which is positioned in a first position against at least one of the insertion element and the sensor and configured to rotate away from the insertion element and the sensor in a second position.

[0034] In some embodiments, the applicator further includes a sensor retaining sleeve disposed around at least a portion of the insertion element and the sensor. The needle carriage assembly includes a tapered needle hub configured to separate the sensor retaining sleeve during sensor insertion.

[0035] In some embodiments, the sensor includes a strain relief feature configured to limit sensor bending with a bending radius smaller than a predetermined bending radius. In some embodiments, the strain relief feature comprises an elastic material.

[0036] In some embodiments, the on-skin sensor assembly includes an open cavity configured to receive a sensor and provide the sensor with a curved region extending from a generally horizontal direction to a generally vertical direction. In some embodiments, the open cavity is configured to guide bodily fluids released from the host due to at least partial insertion of the sensor into the host's skin. In some embodiments, the on-skin sensor assembly includes a wicking material configured to absorb bodily fluids released from the host due to at least partial insertion of the sensor into the host's skin.

[0037] In a fifteenth aspect, a method for applying an on-skin sensor assembly to the skin of a host is provided. The method includes providing an applicator including an applicator housing, a needle holder assembly including an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of a host, and a retainer detachably coupled to the needle holder assembly and configured to guide the on-skin sensor assembly when coupled to the needle holder assembly, a drive assembly, and an activation element. The method includes activating the activation element, wherein activating the activation element causes the drive assembly to drive the insertion element to a distal insertion position in a distal direction and to drive the insertion element from the distal insertion position to a proximal retraction position in a proximal direction, thereby inserting the sensor of the on-skin sensor assembly at least partially into the skin of the host. In some embodiments, the distal and proximal directions extend along the insertion axis of the insertion element.

[0038] In some embodiments, the applicator housing includes a guide. The drive assembly includes a rotary drive element coupled to the needle carriage assembly and includes a pin configured to travel in the guide during rotation of the rotary drive element; and a spring configured to rotate the drive element in a single rotational direction upon activation of the drive assembly, thereby driving the insertion element from a proximal initiation position to a distal insertion position and from the distal insertion position to a proximal retraction position. In some embodiments, the rotary drive element is configured to convert rotational motion into linear motion. In some embodiments, the rotary drive element includes a wheel cam. In some embodiments, the pin is radially offset from the rotation axis of the rotary drive element. In some embodiments, when the insertion element is in the proximal initiation position, the pin is positioned approximately 30 degrees relative to the rotation axis of the rotary drive element from its bottom center. In some embodiments, when the insertion element is in the distal insertion position, the pin is positioned approximately 180 degrees relative to the rotation axis of the rotary drive element from its bottom center. In some embodiments, when the needle carriage assembly is in the proximal retraction position, the pin is positioned approximately 330 degrees relative to the rotation axis of the rotary drive element from its bottom center. In some embodiments, the guide includes a slot.

[0039] In some embodiments, the drive assembly includes a torsion spring having a first end coupled to the applicator housing and a second end coupled to the needle holder assembly. Upon activation of the drive assembly, the first and second ends unwind in opposite directions, thereby driving the insertion element from a proximal initiation position to a distal insertion position and from the distal insertion position to a proximal retraction position. In some embodiments, the unwinding first and second ends in opposite directions drive the torsion spring in an arc. In some embodiments, the arc extends in a direction perpendicular to both the distal and proximal directions.

[0040] In some embodiments, the drive assembly includes an insertion spring configured to drive an insert element in a distal direction to a distal insertion position upon activation of the drive assembly, and a retraction spring contacting the needle carriage assembly and configured to drive the insert element from the distal insertion position to a proximal retraction position. In some embodiments, the insertion spring comprises a compression spring. In some embodiments, the retraction spring comprises a leaf spring. In some embodiments, upon activation of the drive assembly, a portion of the energy stored in the insertion spring is transferred to the retraction spring as the insertion spring drives the insert element in the distal direction. In some embodiments, the insertion spring includes a first end coupled to the applicator housing and a second end coupled to a retainer. The retainer is coupled to the needle carriage assembly when the insertion spring drives the insert element in the distal direction to the distal insertion position, and decouples from the needle carriage assembly when the retraction spring drives the insert element in the proximal direction from the distal insertion position. In some embodiments, the insert element is configured to travel in an arc when driven in both the distal and proximal directions.

[0041] In some embodiments, the drive assembly includes a rotary drive element comprising a ridge configured to slide along a channel in the needle carriage assembly, the ridge defining a variable cam path around at least a portion of the circumference of the rotary drive element; and a torsion spring configured to rotate the rotary drive element upon activation of the drive assembly, thereby driving the insertion element to a distal insertion position in the distal direction and from the distal insertion position in the proximal direction based on the variable cam path. In some embodiments, the torsion spring is configured to rotate the rotary drive element by an angle greater than zero degrees and less than 360 degrees in a single direction upon activation of the drive assembly. In some embodiments, the rotary drive element comprises a barrel cam. In some embodiments, the rotary drive element is configured to rotate in a plane substantially perpendicular to both the proximal and distal directions.

[0042] In some embodiments, the drive assembly includes a guide member coupled to the applicator housing, a hub configured to slide along the guide member, the hub contacting a reversing actuating element via a first portion traveling along the guide member and a needle carriage assembly via a second portion traveling along the guide member. The reversing actuating element includes a fulcrum, a first end contacting the hub via the first portion traveling along the guide member, and a second end coupled to the needle carriage assembly; the drive assembly further includes a spring configured to, upon activation of the drive assembly, drive the hub proximally upward via the first portion traveling along the guide member, thereby driving the insertion element to a distal insertion position, and to drive the hub proximally via the second portion traveling along the guide member, thereby driving the insertion element from the distal insertion position proximally.

[0043] In some embodiments, the drive assembly includes a first spring configured to drive the needle carriage assembly to a distal insertion position in a distal direction upon activation of the drive assembly, and a second spring configured to drive the needle carriage assembly from the distal insertion position in a proximal direction. In some embodiments, when the needle carriage assembly is driven to the distal insertion position in the distal direction, at least a portion of the energy stored in the first spring is transferred to the second spring.

[0044] In a sixteenth aspect, an applicator is provided for applying an on-skin sensor assembly to the skin of a host. The applicator includes an insertion component configured to translate a needle holder assembly and the on-skin sensor assembly in a distal direction from an initial proximal position to a distal insertion position. The applicator includes a retraction component configured to translate the needle holder assembly in a proximal direction from the distal insertion position to a proximal retraction position. The retraction component is configured to activate in response to contact of the on-skin sensor assembly with the host's skin.

[0045] In some embodiments, the insertion assembly includes a first spring. In some embodiments, the retraction assembly includes a second spring. In some embodiments, the insertion assembly further includes a retainer configured to guide the needle carriage assembly at least during translation from an initial proximal position to a distal insertion position. In some embodiments, the retainer further includes at least one retaining element configured to retain the second spring at least during insertion. In some embodiments, the at least one retaining element is disposed outside the second coil and configured to contact and retain the coil of the second spring. In some embodiments, the needle carriage assembly further includes at least one backstop feature configured to prevent lateral deflection of the at least one retaining element at least during insertion. In some embodiments, the at least one backstop feature is configured not to contact the at least one retaining element in the distal insertion position, thereby causing the second spring to deflect the at least one retaining element and activate the retraction assembly. In some embodiments, the second spring is configured to apply a force sufficient to deflect the at least one retaining element in the distal insertion position when the sensor assembly on the skin contacts the host's skin. In some embodiments, the applicator further includes an inner housing. In some embodiments, the applicator further includes an outer housing containing an activation element configured to activate the insertion assembly. In some embodiments, the activation element is prevented from activating the insertion assembly until the outer housing is translated a predetermined distance in the distal direction relative to the inner housing. In some embodiments, the inner housing further includes an engagement element and the needle carriage assembly includes a protrusion. The engagement element is configured to engage with the protrusion after the needle carriage assembly has translated in the distal direction beyond a predetermined threshold, thereby preventing the needle carriage assembly from translating in the distal direction beyond the predetermined threshold. In some embodiments, the engagement feature includes a hook. In some embodiments, the needle carriage assembly further includes a hub configured to engage an insertion element to the needle carriage assembly. In some embodiments, the hub is further configured to engage with a sensor assembly on the skin.

[0046] In some embodiments, both the insertion assembly and the retraction assembly include a first spring. In some embodiments, the first spring is configured to apply a force between the retainer and the deployment sleeve. In some embodiments, the retainer includes at least one retaining element configured to secure the retainer to the deployment sleeve. In some embodiments, the applicator further includes a housing and an activation element configured to deflect at least one retaining element, thereby enabling the first spring to translate the retainer, the needle carriage assembly, and the on-skin sensor assembly from a proximal position to a distal insertion position. In some embodiments, the housing further includes at least one protrusion, and the deployment sleeve includes at least one retaining element configured to contact at least one protrusion of the housing. In some embodiments, the first spring is configured to apply a force sufficient to deflect at least one retaining element of the deployment sleeve when the on-skin sensor assembly contacts the host's skin, thereby releasing at least one retaining element of the deployment sleeve from at least one protrusion of the housing. In some embodiments, the first spring is further configured to translate the deployment sleeve in a proximal direction. In some embodiments, the needle carriage assembly further includes a protrusion configured to contact the deployment sleeve, thereby translating the needle carriage assembly in a proximal direction.

[0047] In a seventeenth embodiment, a needle hub is provided for applying an on-skin sensor assembly to the skin of a host. The needle hub includes at least one upper arm. The needle hub includes a base including anti-rotation features. The base is configured to be at least partially disposed within an aperture of the on-skin sensor assembly. The needle hub is configured to engage with an insertion element.

[0048] In some embodiments, an anti-rotation feature is configured to prevent the base from rotating within the orifice. In some embodiments, the anti-rotation feature includes a key having a shape complementary to at least a portion of the orifice. In some embodiments, at least one upper arm is configured to be disposed through an orifice in the needle holder assembly of the applicator. In some embodiments, at least one upper arm is configured to contact the upper surface of the needle holder assembly adjacent to the orifice in the needle holder assembly. In some embodiments, at least one upper arm is configured to be disposed in a groove in the upper surface of the needle holder assembly to secure the needle hub relative to the needle holder assembly. In some embodiments, at least one upper arm is flexible. In some embodiments, at least one upper arm is configured to retract radially inward. In some embodiments, the needle hub further includes at least one lower arm. In some embodiments, at least one lower arm is configured to contact the lower surface of the needle holder assembly adjacent to the orifice in the needle holder assembly. In some embodiments, the insertion element includes a needle. In some embodiments, the needle includes an open side configured to receive a sensor of a sensor assembly on the skin. In some embodiments, the base includes a flat surface configured to engage with the top surface of the sensor assembly on the skin to hold the insertion element in a substantially perpendicular orientation to the top surface of the sensor assembly on the skin.

[0049] In an eighteenth embodiment, a method of applying an on-skin sensor assembly to the skin of a host is provided. The method includes providing an applicator. The applicator includes a housing comprising an activation element. The applicator includes an insertion assembly. The applicator includes a retraction assembly. The method includes activating the activation element. Activating the activation element causes the insertion assembly to translate a needle holder assembly and the on-skin sensor assembly in a distal direction from a proximal position to a distal insertion position, thereby at least partially inserting the sensor of the on-skin sensor assembly into the host's skin. Activating the activation element causes the retraction assembly to translate the needle holder assembly in a proximal direction from the distal insertion position to a proximal retraction position. The retraction assembly is configured to activate in response to contact of the on-skin sensor assembly with the host's skin.

[0050] In some embodiments, the insertion assembly includes a first spring. In some embodiments, the retraction assembly includes a second spring. In some embodiments, the insertion assembly further includes a retainer configured to guide the needle carriage assembly at least during translation from a proximal position to a distal insertion position. In some embodiments, the retainer further includes at least one retaining element configured to retain the second spring at least during insertion. In some embodiments, the at least one retaining element is disposed outside the second coil and configured to contact and retain the coil of the second spring. In some embodiments, the needle carriage assembly further includes at least one backstop feature configured to prevent lateral deflection of the at least one retaining element at least during insertion. In some embodiments, the at least one backstop feature is configured not to contact the at least one retaining element in the distal insertion position, thereby causing the second spring to deflect the at least one retaining element and activate the retraction assembly. In some embodiments, the second spring is configured to apply a force sufficient to deflect the at least one retaining element in the distal insertion position when the sensor assembly on the skin contacts the host's skin. In some embodiments, the second spring includes a shank extending along the diameter of the second spring, and wherein the at least one retaining element is disposed inside the second spring and configured to retain the shank of the second spring. In some embodiments, the housing is an outer housing and the applicator further includes an inner housing. In some embodiments, activating the activation element involves translating the outer housing a predetermined distance in the distal direction relative to the inner housing. In some embodiments, the inner housing further includes an engagement element and the needle carriage assembly includes a protrusion. The engagement element is configured to engage with the protrusion after the needle carriage assembly has been translated in the distal direction beyond a predetermined threshold, thereby preventing the needle carriage assembly from translating in the distal direction beyond the predetermined threshold. In some embodiments, the engagement feature includes a hook. In some embodiments, the needle carriage assembly further includes a needle hub configured to engage an insertion element to the needle carriage assembly.

[0051] In some embodiments, both the insertion assembly and the retraction assembly include a first spring. In some embodiments, the first spring is configured to apply a force between the retainer and the deployment sleeve. In some embodiments, the retainer includes at least one retaining element configured to secure the retainer to the deployment sleeve. In some embodiments, activating the activation element includes deflecting at least one retaining element of the retainer, thereby enabling the first spring to translate the retainer, the needle carriage assembly, and the on-skin sensor assembly from a proximal position to a distal insertion position. In some embodiments, the housing further includes at least one protrusion, and the deployment sleeve includes at least one retaining element configured to contact at least one protrusion of the housing. In some embodiments, the first spring is configured to apply a force sufficient to deflect at least one retaining element of the deployment sleeve when the on-skin sensor assembly contacts the host's skin, thereby releasing at least one retaining element of the deployment sleeve from at least one protrusion of the housing. In some embodiments, the first spring is further configured to translate the deployment sleeve in a proximal direction. In some embodiments, the needle carriage assembly further includes a protrusion configured to contact the deployment sleeve, thereby translating the needle carriage assembly in a proximal direction.

[0052] In a nineteenth aspect, an applicator is provided for applying a sensor assembly onto the skin of a host. The applicator includes a first body detachably coupled to a needle. The applicator further includes a second body detachably coupled to the first body via frictional engagement. The applicator further includes a spring configured to provide a first force to the first and second bodies. The first force can drive the first and second bodies in a distal direction. The frictional engagement can be configured to decouple by a reaction force applied to the sensor assembly on the skin in the opposite direction of the first force.

[0053] In some embodiments, the applicator further includes at least one retaining element configured to frictionally engage the second body to the first body. In some embodiments, the at least one retaining element is integrally formed with the second body. In some embodiments, the at least one retaining element frictionally engages against a wall of the first body. In some embodiments, a reaction force disengages the frictional engagement by displacing the at least one retaining element from the wall of the first body. In some embodiments, the wall is a backstop. In some embodiments, the wall is configured to prevent deflection of the at least one retaining element.

[0054] In some embodiments, frictional engagement is disengaged by a reaction force exceeding a force threshold. In some embodiments, the force threshold is determined by the frictional force between at least one retaining element and the first body. In some embodiments, the threshold is at least 0.5 lbf. In some embodiments, the threshold is at least 1 lbf.

[0055] In some embodiments, the first body is configured to retract in the proximal direction after decoupling friction engagement. In some embodiments, the applicator further includes a second spring. The second spring may be configured to drive the first body in the proximal direction. In some embodiments, the second spring is held released by at least one retaining element of the second body.

[0056] In some embodiments, the decoupling of the friction engagement is configured to be independent of the distance between the sensor assembly on the skin and the distal end of the applicator. In some embodiments, the first body is configured to retract independently of the distance between the sensor assembly on the skin and the distal end of the applicator. In some embodiments, the reaction force applied to the sensor assembly on the skin is provided by the host skin, the reaction force being opposite to the first force. In some embodiments, the interior of the applicator is configured to allow the host skin to reside within the interior. In some embodiments, the needle is configured to be inserted into the skin at a predetermined depth. In some embodiments, the friction engagement is configured to decouple within a distance range between the sensor assembly on the skin and the distal end of the applicator.

[0057] This summary is provided to introduce a series of concepts further described in the Detailed Description section. Elements or steps other than those described in this summary are possible, and no element or step is essential. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to embodiments that address any or all of the shortcomings stated in any part of this disclosure. Attached Figure Description

[0058] These and other features, aspects, and advantages are described below with reference to the accompanying drawings, which are intended to illustrate and not limit the invention. In the drawings, similar reference numerals denote corresponding features throughout the similar embodiments.

[0059] Figure 1 A schematic diagram illustrating a continuous analyte sensor system according to some embodiments.

[0060] Figures 2A to 2B A perspective view illustrating a sensor assembly on the skin according to some embodiments.

[0061] Figures 3A to 3B A perspective view illustrating another on-skin sensor assembly according to some embodiments.

[0062] Figure 4 Description according to some embodiments Figures 3A to 3B A cross-sectional view of the sensor assembly on the skin.

[0063] Figure 5 Description according to some embodiments Figure 5 An exploded perspective view of the applicator.

[0064] Figures 6A to 6H Description according to some embodiments Figure 5 Sectional and perspective views of several features of the applicator.

[0065] Figures 7A to 7F Description of operation during some embodiments Figure 5 Several cross-sectional views of the applicator.

[0066] Figure 8 Description of some embodiments similar to Figure 5 The applicator, but a cross-sectional view of the applicator containing the activation element on the upper side of the applicator housing.

[0067] Figure 9 Description of some embodiments similar to Figure 5 The applicator, but a cross-sectional view of the applicator containing the activation element on the inside of the applicator housing.

[0068] Figure 10 Description of some embodiments similar to Figure 5 The applicator, but a cross-sectional view of the applicator containing the activation element on the lower side of the applicator housing.

[0069] Figures 11A to 11D 11J describes the assembly according to some embodiments. Figure 5 A perspective view of the steps of the applicator, while Figures 11E to 11H A side sectional view illustrating the steps described.

[0070] Figure 12 An exploded perspective view illustrating another applicator for a sensor assembly on the skin in an analytical material sensor system according to some embodiments.

[0071] Figures 13A to 13F Description according to some embodiments Figure 12 Perspective and sectional views of several features of the applicator.

[0072] Figures 14A to 14E Description of operation during some embodiments Figure 12 Several cross-sectional views of the applicator.

[0073] Figure 15 This illustration shows a perspective view of an exemplary dual torsion spring used in an applicator for a skin sensor assembly in an analytical material sensor system according to some embodiments.

[0074] Figure 16 This illustration shows a perspective view of another exemplary double torsion spring used in the applicator of a skin sensor assembly for an analytical material sensor system according to some embodiments.

[0075] Figure 17 This illustration shows a perspective view of yet another exemplary double torsion spring used in the applicator of a skin sensor assembly for an analytical material sensor system according to some embodiments.

[0076] Figure 18 Description of some embodiments including for Figure 12 A cross-sectional view of the alternative drive mechanism of the torsion spring and movable hinge of the applicator.

[0077] Figure 19 Description of some embodiments including for Figure 12 A cross-sectional view of an alternative drive mechanism for the torsion spring and movable hinge of the actuator.

[0078] Figure 20 Description of some embodiments including for Figure 12 A cross-sectional view of another alternative drive mechanism for the torsion spring and movable hinge of the actuator.

[0079] Figure 21 Description of some embodiments including for Figure 12 A cross-sectional view of another alternative drive mechanism for the applicator's tension spring and movable hinge.

[0080] Figure 22 Description of some embodiments including for Figure 12 A cross-sectional view of another alternative drive mechanism for the leaf spring of the applicator.

[0081] Figure 23 Description of some embodiments including for Figure 12 A cross-sectional view of another alternative drive mechanism for the applicator's leaf spring and movable hinge.

[0082] Figures 24A to 24F 24H, 24J, and 24L to 24M illustrate the assembly according to some embodiments. Figure 12 A cross-sectional view of the steps of the applicator, while Figure 24G and 24K A perspective view illustrating the steps described.

[0083] Figure 25 This is an exploded perspective view illustrating yet another applicator for a skin sensor assembly in an analytical material sensor system according to some embodiments.

[0084] Figures 26A to 26D Description according to some embodiments Figure 25 Several cross-sectional perspective views and bottom views of several features of the applicator.

[0085] Figures 27A to 27E Description of operation during some embodiments Figure 25Several cross-sectional views of the applicator.

[0086] Figures 28A to 28C 28H describes the assembly according to some embodiments. Figure 25 Several perspective views of the applicator, simultaneously Figures 28D to 28G A cross-sectional view illustrating the assembly of the applicator.

[0087] Figure 29 An exploded perspective view illustrating an applicator for a sensor assembly on the skin of an analytical material sensor system according to some embodiments.

[0088] Figure 30 Description according to some embodiments Figure 29 A cross-sectional view of a portion of the applicator.

[0089] Figure 31 This illustration shows a cross-sectional view of another applicator for a skin sensor assembly in an analytical material sensor system according to some embodiments.

[0090] Figures 32A to 34B This is an exploded perspective view illustrating yet another applicator for a skin sensor assembly in an analytical material sensor system according to some embodiments.

[0091] Figures 33A to 33E Several perspective cross-sectional views illustrating several features of the applicator of FIG32 according to some embodiments.

[0092] Figures 34A to 34D Several cross-sectional views of the applicator of FIG32 during operation according to some embodiments are shown.

[0093] Figures 35A to 35C A cross-sectional view illustrating the skin sensor assembly retention mechanism of the applicator according to some embodiments of FIG32.

[0094] Figures 36A to 36C A cross-sectional view illustrating another on-skin sensor assembly retention mechanism of the applicator of FIG32 according to some embodiments.

[0095] Figures 37A to 37C A cross-sectional view illustrating another on-skin sensor assembly holding mechanism of the applicator of FIG32 according to some embodiments.

[0096] Figure 38 The illustration shows a perspective view of an applicator similar to the one shown in FIG32, according to some embodiments, which includes an activation element on one side of the housing.

[0097] Figure 39 Description according to some embodiments Figure 38 A cross-sectional perspective view of a portion of the applicator.

[0098] Figures 40A to 40G Several perspective views illustrate the steps for assembling the applicator of FIG32 according to some embodiments.

[0099] Figures 41A to 41B A cross-sectional view illustrating an exemplary skin-on sensor assembly retention mechanism for an applicator of an analytical material sensor system according to some embodiments.

[0100] Figures 42A to 42B A cross-sectional view illustrating another exemplary on-skin sensor component retention mechanism for an applicator of an analytical material sensor system according to some embodiments.

[0101] Figures 43A to 43B This is a cross-sectional view illustrating yet another exemplary on-skin sensor assembly retention mechanism for an applicator of an analytical material sensor system according to some embodiments.

[0102] Figure 44 A perspective view illustrating a portion of another exemplary skin-on sensor component retention mechanism for an applicator for an analytical material sensor system according to some embodiments.

[0103] Figure 45 A perspective view illustrating a portion of an exemplary skin sensor assembly retention mechanism for an applicator of an analytical material sensor system according to some embodiments.

[0104] Figure 46 This is a perspective view illustrating a portion of an exemplary skin-on sensor assembly retention mechanism for an applicator of an analytical material sensor system according to some embodiments.

[0105] Figure 47 This describes the cross-section of a kink needle used in an applicator for an analytical material sensor system according to some embodiments.

[0106] Figures 48A to 48B Cross-sectional and plan views of the flared C-shaped needle used in the applicator of an analytical material sensor system according to some embodiments are described respectively.

[0107] Figure 49 This illustration shows a perspective view of a deflecting tip needle used in an applicator for an analytical analyte sensor system according to some embodiments.

[0108] Figure 50 This illustration shows a perspective view of a curved needle used in an applicator for an analytical material sensor system according to some embodiments.

[0109] Figures 51A to 51B This illustration shows a cross-sectional view of the needle hub of an applicator for an analytical material sensor system according to some embodiments.

[0110] Figures 52A to 52BCross-sectional and plan views of the infusion cannula integrated into the skin sensor assembly of an analyte sensor system according to some embodiments are described respectively.

[0111] Figure 53 A cross-sectional view illustrating the sensor holding mechanism of an applicator for an analytical material sensor system according to some embodiments.

[0112] Figure 54 A perspective view illustrating another sensor holding mechanism for an applicator in an analytical material sensor system according to some embodiments.

[0113] Figure 55 A cross-sectional view illustrating another sensor holding mechanism for an applicator in an analytical material sensor system according to some embodiments.

[0114] Figures 56A to 56B This is a perspective view illustrating another sensor holding element of an applicator for an analytical material sensor system according to some embodiments.

[0115] Figure 57 This illustration shows a cross-sectional view of another sensor holding element of an applicator for an analytical material sensor system according to some embodiments.

[0116] Figure 58 This illustration shows a cross-sectional view of another sensor holding element of an applicator for an analytical material sensor system according to some embodiments.

[0117] Figures 59A to 59B This illustration shows a cross-sectional view of another sensor holding element of an applicator for an analytical material sensor system according to some embodiments.

[0118] Figure 60 This illustration shows a cross-sectional view of a skin sensor assembly having at least a portion of a sensor encapsulated in a flexible material, according to some embodiments.

[0119] Figure 61 The illustration shows a cross-sectional view of a skin sensor assembly including an open cavity, according to some embodiments, the open cavity being configured to allow for a large bending radius in the sensor.

[0120] Figure 62 The illustration shows a cross-sectional view of a skin sensor assembly including an open cavity according to some embodiments, the open cavity being configured to allow for a large bending radius in the sensor.

[0121] Figure 63 The illustration shows a cross-sectional view of a skin sensor assembly including an open cavity, according to some embodiments, the open cavity being configured to allow for a large bending radius in the sensor.

[0122] Figures 64A to 64BThis describes battery bonding features for a sensor assembly on the skin according to some embodiments.

[0123] Figure 65 A flowchart illustrating a method for applying a sensor assembly to the skin of a host, according to some embodiments.

[0124] Figure 66 This describes an exemplary mechanism, according to some embodiments, for configuring an applicator to apply sensor components on the skin of a host.

[0125] Figure 67 This describes exemplary sterilization, encapsulation, and sealing features of an applicator configured, according to some embodiments, to apply sensor components on the skin to the skin of a host.

[0126] Figure 68 This illustration shows a top perspective view of a sensor assembly on the skin according to some embodiments.

[0127] Figure 69 Description according to some embodiments Figure 68 Bottom perspective view of the sensor assembly on the skin.

[0128] Figure 70 Description according to some embodiments Figure 68 A cross-sectional view of the sensor assembly on the skin.

[0129] Figure 71 This describes yet another applicator for a skin sensor assembly in an analytical material sensor system, according to some embodiments.

[0130] Figure 72 Description according to some embodiments Figure 71 An exploded perspective view of the applicator.

[0131] Figures 73A to 73C Description of some embodiments during operation along Figure 71 The section line A-A' intercepts Figure 71 and 72 Several cross-sectional views of the applicator.

[0132] Figures 74A to 74C Description of some embodiments during operation along Figure 71 The section line B-B' intercepts Figure 71 and 72 Several cross-sectional views of the applicator.

[0133] Figure 75A and 75B Description according to some embodiments Figure 71 and 72 Enlarged view of some features of the applicator.

[0134] Figure 76A and 76B Description according to some embodiments Figure 71 and 72 Enlarged view of some features of the applicator.

[0135] Figure 77 Description according to some embodiments Figure 71 and 72 Partial perspective sectional view of the needle holder assembly, hub, and sensor assembly on the skin of the applicator.

[0136] Figure 78 Description according to some embodiments Figure 71 and 72 A cross-sectional view of the hub of the applicator and the sensor assembly on the skin.

[0137] Figure 79 Description according to some embodiments Figure 71 and 72 A top view of the needle holder assembly and part of the hub.

[0138] Figure 80A and 80B A perspective view illustrating the locking feature of a needle used in an applicator for an analytical material sensor system according to some embodiments.

[0139] Figures 81A to 81C This illustration shows several cross-sectional views of another applicator for a skin sensor assembly in an analytical material sensor system according to some embodiments, as well as various features and operating positions.

[0140] Figure 81D Description according to some embodiments Figures 81A to 81D A perspective view of multiple features of the applicator.

[0141] Figures 82A to 82D This illustration shows several cross-sectional views of another applicator for a skin sensor assembly in an analytical material sensor system according to some embodiments, as well as various features and operating positions.

[0142] Figure 83 This illustration shows a cross-sectional view of an applicator, including a deformable layer disposed above an activation element, according to some embodiments.

[0143] Figure 84 This is a perspective view illustrating an applicator using a torsion activation mechanism according to some embodiments.

[0144] Figure 85 This illustration shows a cross-sectional view of an applicator including a top-mounted activation element, according to some embodiments.

[0145] Figure 86The description, according to some embodiments, describes the shaft, insertion element, and at least... Figure 26C The relationship between the arcs of the inserted element's travel.

[0146] Figure 87 Description according to some embodiments Figure 3A , 3B A cross-sectional view of the sensor assembly on the skin of 4, which further includes an upper patch 328.

[0147] Figures 88A to 88B A perspective view illustrating another optional battery connection feature for a sensor assembly on the skin, according to some embodiments.

[0148] Figure 89 A flowchart illustrating another method for applying a sensor assembly on the skin to the skin of a host, according to some embodiments.

[0149] Figure 90 Description according to some embodiments Figure 71 and 72 Enlarged view of some features of the applicator.

[0150] Figure 91 A perspective view illustrating a sensor assembly on the skin according to some embodiments. Detailed Implementation

[0151] The following description and examples detail some exemplary embodiments. Those skilled in the art will recognize that many variations and modifications of this disclosure exist that are within the scope of this disclosure. Therefore, the description of a particular exemplary embodiment should not be considered to limit the scope of this disclosure.

[0152] System Introduction Figure 1This is a schematic diagram depicting an example continuous analyte monitoring system 100, which includes an analyte sensor system 102 comprising an on-skin sensor assembly 160 configured to be fastened to the skin of a host via a base (not shown). According to certain aspects of this disclosure, the analyte sensor system 102 is operatively connected to a host and a plurality of display devices 110 to 114. Example display devices 110 to 114 may include computers, such as smartphones, smartwatches, tablets, laptops, and desktop computers. In some embodiments, display devices 110 to 114 may be Apple Watches, iPhones, and iPads manufactured by Apple Inc., or Microsoft (Windows) or Google devices. It should be noted that alternatively, or in addition to being a display device, display device 114 may be a drug delivery device that can cooperate with the analyte sensor system 102 to deliver a drug to the host. The analyte sensor system 102 may include a sensor electronics module 140 and a continuous analyte sensor 138 associated with the sensor electronics module 140. Sensor electronics module 140 can directly communicate wirelessly with one or more of the plurality of display devices 110 to 114 via wireless communication signals. As will be discussed in more detail below, display devices 110 to 114 can also communicate with each other and / or with the analyte sensor system 102 via each other. For ease of reference, the wireless communication signal from the analyte sensor system 102 to the display devices 110 to 114 can be referred to as “uplink” signal 128. The wireless communication signal from, for example, the display devices 110 to 114 to the analyte sensor system 102 can be referred to as “downlink” signal 130. The wireless communication signal between two or more of the display devices 110 to 114 can be referred to as “crosslink” signal 132. In addition, the wireless communication signal may include data transmitted by one or more of the display devices 110 to 113 via a “remote” uplink signal 136 (e.g., cellular signal) to one or more remote servers 190 or network entities (e.g., cloud-based servers or databases), and receiving remote downlink signals 142 transmitted by the remote servers 190.

[0153] In the Figure 1In the illustrated embodiments, one of the plurality of display devices may be a custom display device 111 specifically designed to display certain types of displayable sensor information associated with analytical values ​​(e.g., numerical values ​​and arrows in some embodiments) received from sensor electronics module 126. In some embodiments, one of the plurality of display devices may be a handheld device 112, such as a mobile phone, handheld computer, etc., based on Android, iOS or other operating systems, wherein the handheld device 112 may have a relatively large display and be configured to display a graphical representation of continuous sensor data (e.g., including current and historical data). Other display devices may include other handheld devices, such as tablet computer 113, smartwatch 110, drug delivery device 114, blood glucose meter and / or desktop computer or laptop computer.

[0154] It should be understood that, in the case of display device 134e (which may be a drug delivery device other than or in place of display device), warnings and / or sensor information provided by continuous analyte sensor 122 relative to sensor electronics module 126 may be used to initially and / or regulate drug delivery to host 120.

[0155] During use, the sensing portion of sensor 138 can be placed under the host's skin, and the contact portion of sensor 138 can be electrically connected to electronic unit 140. Electronic unit 140 can engage with a housing (e.g., a base) of an adhesive patch attached to and fastened to the host's skin. In some embodiments, electronic unit 140 is integrally formed with the housing. Alternatively, electronic unit 140 can be disposable and directly coupled to the adhesive patch.

[0156] The continuous analyte sensor system 100 may include a sensor configuration that provides an output signal indicating the concentration of the analyte. The output signal, containing (e.g., sensor data, such as raw data streams, filtered data, smoothed data, and / or additionally transformed sensor data), is sent to a receiver.

[0157] In some embodiments, the analyte sensor system 100 includes a transdermal glucose sensor, such as that described in U.S. Patent Publication No. US-2011-0027127-A1, the entire contents of which are incorporated herein by reference. In some embodiments, the sensor system 100 includes a continuous glucose sensor and includes a transdermal sensor (e.g., as described in U.S. Patent No. 6,565,509, U.S. Patent No. 6,579,690, and / or U.S. Patent No. 6,484,046). The contents of U.S. Patent Nos. 6,565,509, 6,579,690, and 6,484,046 are incorporated herein by reference in their entirety.

[0158] Various signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publications US-2005-0203360-A1 and US-2009-0192745-A1, the contents of which are incorporated herein by reference in their entirety. A sensor may extend through a housing that may hold sensor 138 on, in, or under the skin and / or provide electrical connection of sensor 138 to sensor electronics in electronics unit 140.

[0159] In some embodiments, the descriptions of the base, housing, wearable, and / or transmitter of the on-skin sensor assembly 160 may be interchangeable. In other embodiments, the base and housing of the on-skin sensor assembly 160 may be different in meaning and may be separate components from the sensor electronics module 140 (e.g., from the transmitter or receiver).

[0160] In several embodiments, sensor 138 is in the form of a wire. The distal end of the wire may be formed, for example, with a tapered shape (to facilitate insertion of the wire into the host's tissue). Sensor 138 may include an elongated conductor, such as an elongated conductive core (e.g., a metal wire) or an elongated conductive core coated with one, two, three, four, five, or more layers of material, each layer of material may be conductive or may not be conductive. The elongated sensor may be long and thin, but flexible and robust. For example, in some embodiments, the minimum size of the elongated conductor is less than 0.1 inch, less than 0.075 inch, less than 0.05 inch, less than 0.025 inch, less than 0.01 inch, less than 0.004 inch, less than 0.002 inch, less than 0.001 inch, and / or less than 0.0005 inch.

[0161] Sensor 138 may have a circular cross-section. In some embodiments, the cross-section of the elongated conductor may be oval, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, or similar in shape. In some embodiments, the conductive wire electrode serves as the core. In other embodiments, sensor 138 may be mounted on a generally flat substrate. For such electrodes, one or two additional conductive layers may be added (e.g., providing an intermediate insulating layer for electrical isolation). The conductive layer may be composed of any suitable material. In some embodiments, a conductive layer comprising a polymer or other binder containing conductive particles (i.e., particles of conductive material) may be required.

[0162] In some embodiments, the material used to form the elongated conductor (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, and / or the like) may be strong and rigid, and therefore resistant to fracture. For example, in several embodiments, the ultimate tensile strength of the elongated conductor is greater than 80 kPsi and less than 140 kPsi, and / or the Young's modulus of the elongated conductor is greater than 160 GPa and less than 220 GPa. The yield strength of the elongated conductor may be greater than 58 kPsi and less than 2200 kPsi.

[0163] Electronic unit 140 may be detachably or permanently coupled to sensor 138. Electronic unit 140 may include electronic circuitry associated with measuring and processing continuous analyte sensor data. Electronic unit 140 may be configured to perform algorithms associated with processing and calibrating sensor data. For example, electronic unit 140 may provide several aspects of the functionality of sensor electronics modules as described in U.S. Patent Publication No. US-2009-0240120-A1 and U.S. Patent Publication No. US-2012-0078071-A1, the entire contents of which are incorporated herein by reference. Electronic unit 140 may include hardware, firmware, and / or software capable of measuring analyte content via a glucose sensor (e.g., sensor 138).

[0164] For example, electronic unit 140 may include a potentiostat, a power supply for providing power to sensor 138, signal processing components, data storage components, and a communication module (e.g., a telemetry module) for unidirectional or bidirectional data communication between electronic unit 140 and one or more receivers, transponders, and / or display devices (e.g., devices 110 to 114). The electronic components may be mounted to a printed circuit board (PCB) or the like and may take various forms. The electronic components may take the form of integrated circuits (ICs) (e.g., application-specific integrated circuits (ASICs)), microcontrollers, and / or processors. Electronic unit 140 may include sensor electronics configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, evaluating analyte values, comparing estimated analyte values ​​with analyte values ​​measured at corresponding times, analyzing changes in estimated analyte values, and the like. Examples of systems and methods for processing sensor analyte data are described in more detail in U.S. Patent Nos. 7,310,544, 6,931,327, 2005-0043598-A1, 2007-0032706-A1, 2007-0016381-A1, and 2008-0033254-A1. The contents of the patents described in U.S. Patent Publication No. 2005-0203360-A1, U.S. Patent Publication No. 2005-0154271-A1, U.S. Patent Publication No. 2005-0192557-A1, U.S. Patent Publication No. 2006-0222566-A1, U.S. Patent Publication No. 2007-0203966-A1, and U.S. Patent Publication No. 2007-0208245-A1 are incorporated herein by reference in their entirety. Electronic unit 140 can communicate with devices 110 to 114 and / or any number of additional devices via any suitable communication protocol. Example communication methods or protocols include radio frequency; Bluetooth; Universal Serial Bus; any of the following wireless local area network (WLAN) communication standards, including IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communication protocols; ZigBee; wireless (e.g., cellular) telecommunications; paging network communication; magnetic induction; satellite data communication; proprietary communication protocols, open-source communication protocols and / or any suitable wireless communication method.

[0165] Additional sensor information is described in U.S. Patent Nos. 7,497,827 and 8,828,201. The entire contents of U.S. Patent Nos. 7,497,827 and 8,828,201 are incorporated herein by reference.

[0166] Any sensor shown or described herein may be an analyte sensor; a glucose sensor and / or any other suitable sensor. The sensor described in the context of any embodiment may be any sensor described herein or incorporated herein by reference. The sensors shown or described herein may be configured to sense, measure, detect any analyte and / or interact with any analyte.

[0167] As used herein, the term "analyte" is a broad term and has the common and conventional meaning given to those skilled in the art (and not limited to a particular or customary meaning), and refers to (but not limited to) a substance or chemical component in an analyzable biological fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, urine, sweat, saliva, etc.). Analytes may include naturally occurring substances, man-made substances, metabolites, or reaction products.

[0168] In some embodiments, the analyte used for measurement by the sensing area, device, system, and method is glucose. However, other analytes are also considered, including (but not limited to) ketone bodies; acetyl-CoA; acarboxyprothrombin; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); andrenostenedione; antipyrine; arabinose enantiomers; arginase; benzoyl succinate (cocaine); biotinylate; biopterin; C-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid. acid); chloroquine; cholesterol; cholinesterase; cortisol; testosterone; choline; creatine kinase; creatine kinase MM isoenzyme; cyclosporine A; d-penicillamine; deethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetyltransferase polymorphism, alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy neuropathy), MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycine; triglycerides; glycerol; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free methyladenosine triiodide (FT3); fumarylacetoacetase; galactose / gal-1-phosphate; galactose-1-phosphate uridine transferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione catalase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosamine enzyme A; human erythrocyte carbonic anhydrase I; 17-α-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead;Lipoproteins ((a), B / A-1, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanoic acid / norphytanoic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse triiodinated methyladenosine (rT3); selenium; serum pancreatic lipase; sissomicin; somatostatin C; specific antibodies (adenovirus, antinuclear antibody, antizeta antibody, arbovirus, Aujeszky's diseasevirus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia lamblia). Hepatitis B virus (HBV), Helicobacter pylori, Hepatitis B virus, Herpes simplex virus, HIV-1, IgE (atopic disease), Influenza virus, Leishmania donovani, Leptospira, Measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, Parainfluenza virus, Plasmodium falciparum, Poliovirus, Pseudomonas aeruginosa, Respiratory syncytial virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii Plasmodium gondii, Plasmodium pallidium, Trypanosoma cruzi / rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus; specific antigens (hepatitis B virus, HIV-1); acetone (e.g., succinylated acetone); acetoacetic acid; sulfadoxine; theophylline; thyroid-stimulating hormone (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; leukocytes and zinc protoporphyrin.

[0169] In some embodiments, salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or interstitial fluid may also constitute analytes. Analytes may be naturally present in biological fluids or endogenous, such as metabolites, hormones, antigens, antibodies, or similar substances. Alternatively, analytes may be, for example, contrast agents for imaging, radioactive isotopes, chemical reagents, fluorocarbon-based synthetic blood, or pharmaceutical or medical compositions, including (but not limited to): insulin; glucagon; ethanol; cannabinoids (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (crack cocaine). Cocaine); Stimulants (amphetamine, methamphetamine, Ritalin, Cyert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); Depressants (barbiturates, methylquinone, sedatives (e.g., Valium, Librium, Miltown, Serax), Equanil, Tranxene); Hallucinogens (phencyclidine, lysergic acid). (acid), mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, pethidine, percocet, percodan, tussionex, fentanyl, darvon, talwin, lomotil); synthetic drugs (designer) Drugs (analytes of fentanyl, pethidine, amphetamine, methamphetamine, and phencyclohexylpiperidine, such as ecstasy); anabolic steroids and nicotine. Metabolites of drugs and pharmaceutical compositions are also considered analytes. Analytes produced in the body, such as neurochemicals and other chemicals, such as ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), serotonin (5HT), 5-hydroxyindoleacetic acid (FHIAA), and intermediates in the citric acid cycle, may also be analyzed.

[0170] Many embodiments described herein may use adhesives to attach a base or housing, sensor module, transmitter or electronics unit, and / or sensor to a host (e.g., to the host's skin). The adhesive may be configured for adhesion to the skin. The adhesive may include a liner (e.g., the liner is located between the adhesive and the base). Additional adhesive information, including adhesive liner information, is described in U.S. Patent Application No. 14 / 835,603, filed August 25, 2015. The entire contents of U.S. Patent Application No. 14 / 835,603 are incorporated herein by reference.

[0171] As noted above, the system can apply an on-skin sensor assembly to the host's skin. The on-skin sensor assembly may include a base comprising an adhesive for attaching a glucose sensor to the skin. Other methods, such as strips or watchbands, are also considered.

[0172] At least Figure 1 Any of the features described in the context of this document may be applied to all aspects and embodiments identified herein. Furthermore, any of the features of an embodiment may be independently, in any way, combined partly or entirely independently with other embodiments described herein; for example, one, two, three, or more embodiments may be combined wholly or partially. Additionally, any of the features of an embodiment may be optional for other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system may be configured to perform the method of another aspect or embodiment.

[0173] Throughout this disclosure, the references can also be described as on-skin sensor assemblies for wearable devices. Such on-skin sensor assemblies (see...) Figures 1 to 4 (and 68 to 70) can be disposable or reusable and may include (see) Figures 68 to 70 (See Figures 2 to 4) or may not include (a base or base plate) a sensor assembly on the skin with a base plate (e.g. Figures 68 to 70 The base plate can be reusable; however, on-skin sensor assemblies without a base plate (e.g., Figures 2 to 4) can be disposable. Although Figure 1 The sensor assembly 160 on the skin has already been discussed, but Figures 2A to 4 68 to 70 describe at least some other embodiments of the sensor assembly on the skin.

[0174] Figure 2A This illustration shows a perspective view of a skin sensor assembly 260 according to some embodiments. The skin sensor assembly 260 may include an outer housing comprising a first top portion 292 and a second lower portion 294. In some embodiments, the outer housing may include a flip-top design. The skin sensor assembly 260 may include the features described above. Figure 1The electronic unit 140 described herein is similar to the components described above (e.g., a potentiostat, a power supply for providing power to the sensor 138, a signal processing component, a data storage component, and a communication module (e.g., a telemetry module) for one-way or two-way data communication, a printed circuit board (PCB), an integrated circuit (IC), an application-specific integrated circuit (ASIC), a microcontroller, and / or a processor). The outer housing may have a large circular body with a tapered end opposite to the large circular body. The outer housing may further include an aperture 296 disposed at the tapered end of the outer housing and adapted for sensor 238 and needle insertion. The aperture 296 may be an opening having a U-shaped channel extending through the tapered end of the outer housing. The on-skin sensor assembly 260 may further include an adhesive patch 226 configured to secure the on-skin sensor assembly 260 to the host's skin. As shown, the adhesive patch 226 may have an aperture 298 having a similar shape to and substantially aligned with aperture 296. Sensor 238 may be configured to extend at least partially through apertures 296 and 298. In some embodiments, adhesive patch 226 may include an adhesive suitable for skin adhesion, such as a pressure-sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) that adheres to a carrier substrate for skin adhesion (e.g., spun lace polyester, polyurethane film, or other suitable type), but any suitable type of adhesive is also contemplated.

[0175] The sensor assembly 260 can be attached to the host skin using an applicator suitable for providing convenient and secure application. This applicator can also be used to insert the sensor 238 through the host skin and / or to connect the sensor 238 to the electronics unit. Once the sensor 238 is inserted into the skin (and connected to the electronics unit), the sensor assembly can be removed from the applicator.

[0176] Figure 2B illustrate Figure 2A Bottom perspective view of the sensor assembly 260 on the skin. Figure 2B The description includes orifices 296 and 298 located on the side of the outer housing, each orifice being suitable for sensor 238 and needle insertion.

[0177] Figure 3A This illustration shows a perspective view of a skin sensor assembly 360 according to some embodiments. The skin sensor assembly 360 may include an outer housing comprising a first top portion 392 and a second lower portion 394. In some embodiments, the outer housing may include a flip-top design. The skin sensor assembly 360 may include the same as described above. Figure 1The electronic unit 140 described herein is similar to components such as a potentiostat, a power supply for providing power to the sensor 138, a signal processing component, a data storage component, and a communication module (e.g., a telemetry module) for one-way or two-way data communication, a printed circuit board (PCB), an integrated circuit (IC), an application-specific integrated circuit (ASIC), a microcontroller, and / or a processor. As shown, the outer housing may have a generally elliptical shape. The outer housing may further include a sensor assembly aperture 396 that is disposed generally through the central portion of the outer housing and is adapted for insertion of a sensor 338 and a needle through the bottom of the on-skin sensor assembly 360. In some embodiments, the sensor assembly aperture 396 may be a channel or an elongated slot. The on-skin sensor assembly 360 may further include an adhesive patch 326 configured to secure the on-skin sensor assembly 360 to the host's skin. In some embodiments, the adhesive patch 326 may include an adhesive suitable for skin adhesion on its underside for skin attachment, such as a pressure-sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) for bonding to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type), but any suitable type of adhesive is also contemplated. In some embodiments, the adhesive patch 326 may further include an adhesive on its top side (e.g., the non-skin contact side) to help bond the adhesive patch 326 to a portion of the associated applicator during manufacturing and / or to hold the adhesive patch 326 in a generally flat orientation before placement on the host's skin. In some embodiments, the adhesive applied to the top side may be weaker than the adhesive applied to the inside side to ensure proper transfer of the sensor assembly on the skin to the host's skin. As shown, the adhesive patch 396 may have an aperture 398 aligned with the sensor assembly aperture 396, such that the sensor 338 can pass through the bottom of the sensor assembly 360 on the skin and through the adhesive patch 396.

[0178] Figure 3B illustrate Figure 3A A 360° bottom perspective view of the sensor components on the skin. Figure 3B Further explanation is given of sensor assembly orifices 396 and 398, which are generally located in the central portion of the bottom of the sensor assembly 360 on the skin, both of which are suitable for sensor 338 and needle insertion.

[0179] Figure 91This illustration shows a perspective view of an on-skin sensor assembly 9160 according to some embodiments. The on-skin sensor assembly 9160 may be generally similar to other on-skin sensor assemblies described herein, such as on-skin sensor assemblies 160, 260, and 360. Similar to on-skin sensor assembly 360, on-skin sensor assembly 9160 may have an adhesive patch 9126 and a flip-top design including a top shell and a bottom shell. Additionally, similar to on-skin sensor assembly 160, on-skin sensor assembly 9160 may include a plurality of attachment points 9162a and 9162b. On-skin sensor assembly 9160 may include an aperture 9296. The aperture 9296 may be a through-hole extending through the on-skin sensor assembly 9160. The aperture 9296 may be configured to allow needles and / or sensors to pass through. In some embodiments, on-skin sensor assembly 9160 may further include an aperture 9294. The aperture 9294 may extend a depth through the on-skin sensor assembly 9160 from the top surface of the on-skin sensor assembly 9150. In some embodiments, the aperture 9294 is configured with anti-rotation features, such as Figure 78 The base 7152 of the needle hub 7150 described herein is engaged.

[0180] In some embodiments, the skin sensor assembly 9160 includes an identification tag 9150. The identification tag 9150 may be located on the top surface of the skin sensor assembly 9150 (as shown) or on the side surface of the skin sensor assembly. The identification tag 9150 may be an image resembling an icon or mark identifying the manufacturer of the skin sensor assembly. Additionally, the identification tag 9150 may be configured to be scanned by a user to pair the skin sensor assembly with a device (e.g., handheld device 112). In some embodiments, the identification tag 9150 is a code, such as (but not limited to) a QR code, matrix code, 2D barcode, or 3D barcode. The code may be embedded in the image of the identification tag 9150.

[0181] Figure 4 illustrate Figure 3A and 3B A 360° cross-sectional view of the sensor assembly on the skin. Figure 4 This describes the first top portion 392 and the second bottom portion 394 of the outer housing, the adhesive patch 326, the sensor assembly aperture 396 in the central portion of the skin sensor assembly 360, the aperture 398 in the central portion of the adhesive patch 326, and the sensor 338 passing through the sensor assembly aperture 396. (Previously combined) Figure 3A The described electronic unit may further include a circuit board 404 and a battery 402 configured to provide power to at least the circuit board 404.

[0182] Figure 87 Description according to some embodiments Figure 3A , 3BA cross-sectional view of the skin-on sensor assembly 360 of patch 4, further comprising an upper patch 328. The upper patch 328 may include an adhesive suitable for skin adhesion, device adhesion, or a combination thereof on its underside, such as a pressure-sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) for adhesion to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin and / or device adhesion, but any suitable type of adhesive is also contemplated. In some embodiments, this adhesive may be the same as the adhesive applied to the underside of patch 326. In some other embodiments, the adhesive may be different from the adhesive applied to the underside of patch 326. In some embodiments, the upper patch 328 may be shaped as circular, elliptical, strip-shaped, X-shaped, or any other shape or form suitable for securing the upper patch 328 to the lower patch 326 and / or the host's skin. The upper patch 328 may completely or partially cover the skin-on sensor assembly 360. The upper patch 328 can improve the adhesive lifespan of the on-skin sensor assembly 360 on the host's skin 130 by increasing the additional adhesive contact area on the surface of the skin 130 and / or providing a single surface covering the wearable, which reduces the risk of accidental mechanical removal (e.g., trapping, snagping, tearing) by reducing the capture surface / edge on the on-skin sensor assembly 360. Reducing the surface of the on-skin sensor assembly 360, which is generally perpendicular to the body surface, is considered to improve capture resistance. This increased wearable lifespan provided by the upper patch 328 can be a valuable feature, especially as systems evolve towards and exceed 10-14 days of wearable adhesive solutions.

[0183] In some embodiments, the upper patch 328 may be assembled into any applicator in this specification, above the on-skin sensor assembly 360 and exposing the underlying adhesive. After the on-skin sensor assembly 360 is deployed via the applicator, the patch 326 may adhere to the host's skin 130 and may be adhered to the upper patch 328 above the on-skin sensor assembly 360 and to the host's skin 130 by one or more features of the applicator, such as a retainer and / or needle holder assembly as described in conjunction with any of the figures herein.

[0184] Applicator Examples Figure 5This is an exploded perspective view illustrating an applicator 500 for applying an on-skin sensor assembly 160 to host skin 130 according to some embodiments. In some embodiments, the applicator 500 may include an applicator housing 502 having an opening at its bottom and configured to receive at least one or more mechanisms for applying the on-skin sensor assembly 160 to host skin 130. The applicator housing 502 may be formed of any suitable material, such as polymers, polycarbonate, ABS, nylon, polyethylene, polypropylene, etc. In some embodiments, the applicator housing 502 may be configured to cover at least one feature of the applicator housing 502, such as a guide for a reciprocating or back-and-forth mechanism (e.g., a scotch-yoke mechanism) (see [link]). Figure 6B ).

[0185] The applicator 500 includes an activation element 504 configured to activate a drive assembly of the applicator 500. In some embodiments, the activation element 504 may be a button, switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable component, or any other suitable mechanism for activating the drive assembly of the applicator 500.

[0186] The applicator 500 may further include a needle holder assembly 508, the needle holder assembly including a sensor assembly 160 configured to be placed on the skin (e.g., Figure 1 The sensor 138 is at least partially inserted into the host's skin 130 of the insertion element. Figure 5 (Not shown in the image). Inserted components are in... Figure 6H The description further clarifies that it is attached to the needle carriage assembly 508 and extends generally along the insertion axis in the distal direction. In some embodiments, the needle carriage assembly 508 includes a needle carriage or shuttle. In some embodiments, the insertion element includes a needle, such as a side-opening needle, a deflected-tip needle with a deflected tip, a curved needle, a polymer-coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as one that is at least combined with... Figures 47 to 50 The following are described in more detail with references to 80A to B. In other embodiments, the insertion element may include the sensor 138 itself, which is rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support, as described in U.S. Patent No. 9,357,951, filed September 29, 2010; U.S. Patent Publication No. 2014 / 0107450, filed February 28, 2013; and U.S. Patent Publication No. 2015 / 0289788, filed April 10, 2014. The entire contents of U.S. Patent Publications No. 9,357,951, 2014 / 0107450, and 2015 / 0289788 are incorporated herein by reference.

[0187] The applicator 500 may further include a drive assembly 510 configured to drive the insertion element of the needle carriage assembly 508 to a distal insertion position in a distal direction and to drive the insertion element from the distal insertion position to a proximal retraction position in a proximal direction. The distal direction may be defined as extending toward an open side of the applicator 500 along a path configured to travel on the needle carriage assembly 508. The distal direction may also be defined as toward the user's skin. The proximal direction may be defined as a direction extending in a direction generally opposite to the distal direction. In some embodiments, the distal and proximal directions extend along the insertion axis of the insertion element and the needle carriage assembly 508.

[0188] The drive assembly 510 may include a rotary drive element 514 coupled to the needle carriage assembly 508 via a shaft 526. In some embodiments, the rotary drive element 514 includes a cam feature having a generally circular or oval circumference, such as a wheel cam. The rotary drive element 514 may be configured to rotate relative to the needle carriage assembly 508 about a rotation axis 518 that coincides with the centerline of the shaft 526. The rotary drive element 514 may further include a pin 516 disposed on a surface of the rotary drive element 514 that is radially displaced from the rotation axis 518. The pin 516 is configured to be in a guide of the applicator housing 502 (see...). Figure 6B Proceeding in the middle.

[0189] The drive assembly 510 may further include a spring 512. The spring 512 may be a torsion spring, clock spring, power spring, or any other suitable type of spring. The spring 512 may be formed of any suitable material, including (but not limited to) plastic or metal, such as stainless steel. In some embodiments, the spring 512 is pre-compressed before the applicator is activated. In some embodiments, the spring 512 is configured to be additionally loaded during applicator activation. The spring 512 may have a first end 520 coupled to the needle carriage assembly 508 and a second end 522 coupled to the rotary drive element 514. The spring 512 may be coaxially arranged with the shaft 526. The spring 512 may be configured to rotate the rotary drive element 514 in a single direction relative to the needle carriage assembly 508 after the drive assembly 510 is activated. In some embodiments, the spring 512 is configured to unwind by rotating greater than zero degrees and less than 360 degrees after the drive assembly 510 is activated. In some embodiments, the spring 512 is pre-wound between 30 and 1440 degrees.

[0190] By means of a rotary drive element 514 configured to rotate relative to the needle carriage assembly 508 about a rotation axis 518 and a pin 516 constrained to travel in a guide within the applicator housing 502, the rotational motion of the rotary drive element 514, driven by a spring 512, is converted into a linear reciprocating motion of the needle carriage assembly 508 along axis 590 and thus a linear reciprocating motion of the insertion element (not shown). More specifically, the rotation of the rotary drive element 514 drives the insertion element 508 to a distal insertion position in the distal direction and from the distal insertion position to a proximal retraction position in the proximal direction. Such embodiments may omit the cross-region switching mechanism between aspects of the drive assembly 510, which drives the needle carriage assembly 508 independently in the distal and proximal directions by a single mechanism that converts rotational motion into reciprocating linear motion.

[0191] The applicator 500 may further include a retainer 524 detachably coupled to the needle holder assembly 508 and configured to guide the sensor assembly 160 on the skin when coupled to the needle holder assembly 508. In some embodiments, the retainer 524 may also be referred to as a carrier or transport component.

[0192] Figures 6A to 6H Description according to some embodiments Figure 5 Sectional and perspective views of several features of the applicator 500. Figure 6A The illustration shows a cross-sectional view of an applicator 500, which includes an applicator housing 502, an activation element 504, a needle holder assembly 508, a rotary drive element 514, a pin 516, and a retainer 524. Each of these components may have at least the following combined features as previously described. Figure 5 The described functionality.

[0193] Figure 6B The guide 582 in the applicator housing 502 is described. In some embodiments, the guide 582 may include a Scottish yoke track, wherein the pin 516 is configured to travel as the rotary drive element 514 rotates after the drive assembly 510 is activated.

[0194] Figure 6C The applicator housing 502 is described with a plurality of tracks 622a, 622b, 622c, wherein a corresponding one of a plurality of protrusions or ribs 624a, 624b, 624c of the needle carriage assembly 508 is configured to slide. Therefore, tracks 622a-622c in the applicator housing 502 define a travel path for the needle carriage assembly 508. In some embodiments, this travel path is generally linear and longitudinal. Although Figure 6C The diagram shows three orbits and protrusions, but any number of orbits and corresponding protrusions are considered. For ease of understanding, Figure 6CThe illustration shows a partial bottom view of the applicator 500, which also shows portions of the sensor assembly 160 and the retainer 524 on the skin.

[0195] Figure 6D The description describes an embodiment of the needle carriage assembly 508 that includes a locking element 632 configured to prevent rotation of the rotary drive element 514. Specifically, the rotary drive element 514 includes a protrusion 634 that contacts the retaining element 632, preventing the protrusion 634 from traveling along a path it would otherwise take as the spring 512 releases at least a portion of its stored energy within the rotary drive element 514. In some embodiments, the retaining element 632 includes a deflectable tab formed of a material such as a polymer, polycarbonate, ABS, nylon, polyethylene, polypropylene, or any other suitable material. The activation element 504 includes a protrusion 640 configured to deflect the retaining element 632 such that the protrusion 634 is no longer held by the retaining element 632, thereby causing the rotary drive element 514 to rotate and activating the drive assembly 510. The rotary drive element 514 further includes a ridge 636 configured to limit rotation of the rotary drive element 514 when the rotary drive element 514 rotates and the ridge 636 contacts the retaining element 632.

[0196] Figure 6E The retaining element 642 of the retainer 524 and the stop element 644 of the applicator housing 502 are described, the retaining element and the stop element being configured to secure the retainer 524 to the applicator housing 502 after the needle carriage assembly 508 reaches the distal insertion position. In some embodiments, the retaining element 642 is a deflectable arm or any other type of protrusion or latch. For example, as the needle carriage assembly 508 travels in the distal direction, the retaining element 642 slides along the inner surface of the applicator housing 502 until it is slightly deflected by the stop element 644 due to the rotational drive element 514 rotated by the spring 512, and then engages in the outward direction under the stop element 644. At this point, the needle carriage assembly 508 can advance freely in the proximal direction as the spring 512 further rotates the rotational drive element 514. The stop element 644 will prevent the retaining element 642 and the retainer 524 from traveling in the proximal direction. In this way, after reaching the distal insertion position, the movement of the needle holder assembly 508 in the proximal direction releases the retainer 524 from the needle holder assembly 508 and / or the sensor assembly 160 on the skin.

[0197] Figure 6FThe protrusion 652 of the retainer 524 and the protrusion 654 of the applicator housing 502 are described, the protrusions being configured to prevent the retainer 524 from traveling further in the distal direction than the distal insertion position. For example, when the retainer 524 is driven in the distal direction by the needle carriage assembly 508, the protrusion 652 travels along the inner surface of the applicator housing 502 until the protrusion 652 contacts the protrusion 654, at which point further travel of the retainer 524 in the distal direction is prevented.

[0198] Figure 6G The description includes a skin sensor assembly 160 comprising multiple attachment points 662a to 662f, which are configured to mate with corresponding retaining elements on a needle holder assembly 508 and / or retainer 524, while traveling at least partially toward a distal insertion position in a distal direction during applicator activation. In some embodiments, attachment points 662a to 662f are small notches or recesses. Although multiple attachment points 662a to 662f are described, any number of attachment points is contemplated. In some embodiments, the corresponding retaining elements may include a snap-fit, friction fit, interference feature, resilient clamp, and / or adhesive configured to engage the skin sensor assembly 160 with the needle holder assembly 508 and / or retainer 524.

[0199] Furthermore, during pressure fluctuations, such as at high altitudes or under vacuum during a disinfection process, air present within the skin sensor assembly 160 can exert a deformation force from within the cavity of the skin sensor assembly 160. Although Figure 6G Not shown herein, but in some embodiments, the on-skin sensor assembly 160 may have at least a portion formed of a reduced thickness or a second material (e.g., an elastomer) and thus reduced strength and stiffness, such that when the applicator 500 is exposed to such pressure fluctuations, the portion having the reduced thickness or second material deforms in a controlled manner, thereby reducing or eliminating additional damage to the on-skin sensor assembly 160 due to unintended and uncontrolled expansion of the on-skin sensor assembly 160. The portion formed of the reduced thickness or second material may be selected to guide controlled expansion away from reference and / or retaining features that secure the on-skin sensor assembly to the applicator assembly. This feature may be present in any applicator described herein.

[0200] Figure 6HThe retaining elements 672a and 672b of the retainer 528 are described. These retaining elements are configured to detachably connect the skin sensor assembly 160 to the retainer 528 when the needle carriage assembly 508 travels in the distal direction to the distal insertion position, and to decouple the skin sensor assembly 160 from the retainer 528 when the needle carriage assembly 508 travels in the proximal direction from the distal insertion position toward the proximal retraction position. Specifically, each of the retaining elements 672a and 672b may include a first end 676a and 676b, a second end 678a and 678b, and pivot points 680a and 680b. As the needle carriage assembly 508 travels in the distal direction to the distal insertion position, the first ends 676a, 676b of each of the retaining elements 672a, 672b are secured in the corresponding guides 674a, 674b of the needle carriage assembly 508, and each of the retaining elements 672a, 672b is secured against interference points 682a, 682b of the needle carriage assembly 508, thereby detachably connecting the second ends 678a, 678b to attachment points 662a, 662b of the sensor assembly 160 on the skin. In some embodiments, the guides 674a, 674b include slots or stop elements. Because the retaining elements 642, 644 and / or protrusions 652, 654 secure the retainer 524 in the distal insertion position (e.g., Figure 6E (As described in the text), therefore, as the needle carriage assembly 508 travels rearward in the proximal direction, the needle carriage assembly 508 separates from the retainer 524, thereby separating the first ends 676a, 676b of the retaining elements 672a, 672b from the corresponding slots 674a, 674b, such that when the retaining elements 672a, 672b rotate about the pivot points 680a, 680b, the first ends 676a, 676b deflect inward from the attachment points 662a, 662b of the sensor assembly 160 on the skin and the second ends 678a, 678b deflect outward. Although two retaining elements are described, any number of retaining elements are considered. Furthermore, the following incorporates at least Figures 35A to 37C Some alternative mechanisms for performing such hold and release actions are further described. Any of these alternative mechanisms used with the applicator 500 are considered.

[0201] The following is relative to Figures 7A to 7F A brief description of the operation of the applicator 500 is provided, the figures illustrating in sequence the operation according to some embodiments. Figure 5 Several perspective views of the applicator.

[0202] Figure 7AThis describes the pre-activated state of the applicator 500. The applicator housing 502 and slot 582 remain fixed relative to the host skin during activation. The activation element 504 is in the pre-activated position. The insertion assembly 508 is also in the pre-activated position, coupled to the retainer 524, which is detachably coupled to the sensor assembly 160 on the skin, such as when combined with at least... Figures 6A to 6H As described. At least a portion of the insertion element 674 of the needle holder assembly 508 is described as protruding in the distal direction below the sensor assembly 160 on the skin. The insertion element 674 may include a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer coating needle, a hypodermic needle, a deflecting tip, or any other suitable type of needle or structure, as will be combined with at least Figures 47 to 50 And 80A to B are described in more detail. Insertion element 674 is configured to guide at least a portion of sensor 138 of sensor assembly 160 on the skin. Rotational drive element 514 of drive assembly 510 is shown in a pre-activated position, the rotational drive element having a pin 516 at a first position within guide 582 of applicator housing 502 and a protrusion 634 that contacts retaining element 632. Figure 7A In the middle, pin 516 is positioned at approximately 30 degrees (clockwise, but counterclockwise is also considered) relative to the bottom dead center of the rotational axis of the rotary drive element 514, which passes through the center of the surface on which pin 516 is mounted.

[0203] Figure 7B The state of the applicator 500 when activated is described. The activation element 504 is described as being in the activated position, for example, when the activation element has been pushed longitudinally in the distal direction by the user. In the activated position, the activation element 504 deflects the holding element 632, allowing the protrusion 634 of the rotary drive element 514 to move unimpeded, thereby causing the rotary drive element 514 to rotate via the unwinding of the spring 512. Because... Figure 7B The applicator 500 is currently activated, therefore the rotary drive element 514, pin 516, needle holder assembly 508, insertion element 674, retainer 524, and skin sensor assembly 160 still exhibit orientation as shown. Figure 7A The pre-activation and positioning are as follows. However, the rotational drive element 514 will rotate in the direction of the circular arrow, and the needle holder assembly 508, insertion element 674, retainer 524, and skin sensor assembly 160 will be driven to the distal insertion position by the pin 516 in the distal direction under the rotation of the rotational drive element 514. However, this disclosure is not so limited, and the rotational drive element 514 may be configured to rotate in a direction opposite to the direction of the circular arrow.

[0204] Figure 7CThis describes the state of the applicator 500 during activation. The activation element 504 is described as being in... Figure 7B In the activated position, the rotary drive element 514 is shown as part of the rotated body (indicated by a circular arrow), with the protrusion 634 having advanced beyond the retaining element 632. The pin 516 is shown as having moved to a second position within the guide 582. This second position is shown to the left of the first pre-activated position. As the rotary drive element 514 rotates by the force generated by the spring 512, it drives the insertion assembly 508, insertion element 674, retainer 524, and skin sensor assembly 160 toward the distal insertion position in the distal direction.

[0205] Figure 7D This describes the applicator 500 at the distal insertion position during activation. The activation element 504 is described as being in... Figure 7B and 7C In the activated position. Rotary drive element 514 is shown as... Figure 7C Compared to a further clockwise rotation (indicated by the circular arrow), protrusion 634 has advanced further beyond retaining element 632. Pin 516 is shown as having moved to a third position within guide 582, indicating it is in... Figure 7C The first pre-activated position is to the right of the second activated position. As the rotary drive element 514 rotates further by the force generated by the spring 512, the insertion assembly 508, insertion element 674, retainer 524, and skin sensor assembly 160 are driven to the distal insertion position in the distal direction. In this distal insertion position, at least a portion of the insertion element 674 and at least a portion of the sensor 138 of the skin sensor assembly 160 can be inserted into the host's skin 130. At this position, retaining elements 642, 644 (see FIG. 6) can be engaged, and protrusions 652 and 654 (see FIG. 6) can contact each other. Figure 7D In the middle, pin 516 is positioned approximately 180 degrees (clockwise, but counterclockwise is also considered) relative to the lower dead center of the rotation axis of rotary drive element 514.

[0206] Figure 7E Description of the applicator 500 during activation. Activation element 504 is described as being used during... Figures 7B to 7D In the activated position. Rotary drive element 514 is shown as... Figure 7DCompared to the further rotation indicated by the circular arrow, pin 516 is shown as having moved to a fourth position within guide 582. This fourth position is shown to the right of the previously discussed first to third positions. Insertion assembly 508 and insertion element 674 are now shown as driven from the distal insertion position in the proximal direction when rotational drive element 514 is further rotated by the force generated by spring 512. Holder 524 and skin sensor assembly 160 are shown as detached from needle holder assembly 508 because retaining elements 642, 644 (see FIG. 6) are engaged and protrusions 652 and 654 (see FIG. 6) are accessible to each other. Figure 7E In the demonstrated position, the sensor assembly 160 on the skin can also be decoupled from the holder 524, as previously combined. Figure 6H As described.

[0207] Figure 7F Description of the activated applicator 500. Activation element 504 is described as being in... Figures 7B to 7E In the activated position. Rotary drive element 514 is shown as... Figure 7E Compared to a further rotation (indicated by the circular arrow), this causes the ridge 636 to contact the retaining element 632, thereby limiting further rotation of the rotation drive element 514. The pin 516 is shown moved to a fifth position within the guide 582, the position shown to the left of the fourth rightmost position as the pin 516 travels in the reverse direction along the guide 582. The insertion assembly 508 and the insertion element 674 are shown in the proximal retracted position. The retainer 524 and the skin sensor assembly 160 are shown separated from the needle holder assembly 508. Figure 7F In the shown location, the sensor assembly 160 on the skin can also be decoupled from the holder 524, as previously combined. Figure 6H As described. In Figure 7F In the middle, pin 516 is positioned approximately 330 degrees (clockwise, but counterclockwise is also considered) relative to the rotation axis of the rotary drive element 514 at the bottom center.

[0208] Figures 8 to 10 The description is similar to Figure 5The cross-sectional views of applicators 800, 900, and 1000 of applicator 500 are shown; however, the applicators alternatively have activation elements 804, 904, and 1004 respectively disposed on the upper, inner, and lower sides, rather than on the top, of applicator housings 802, 902, and 1002. Applicators 800, 900, and 1000 may include substantially all the features of applicator 500 and have substantially the same operation. For example, the applicator housings 802, 902, 1002; the activation elements 804, 904, 1004; the needle carriage assemblies 808, 908, 1008; the rotary drive elements 814, 914, 1014 (including pins 816, 916, 1016 and protrusions 834, 934, 1034) and the retaining elements 832, 932, 1032 may respectively correspond substantially to the applicator housing 502, the activation element 504, the needle carriage assembly 508, the rotary drive element 514 (including pins 516 and protrusions 504), and the retaining element 502 of the applicator 500.

[0209] However, in Figure 8 In this configuration, the activation element 804 is positioned on the upper side rather than the top of the applicator housing 802 and is configured to deflect the holding element 832 upon activation, such that the protrusion 834 no longer restricts the rotational drive element 814 in a spring similar to the spring 512 of the applicator 500. Figure 8 Rotating under a force (not shown in the image). Figure 9 In this configuration, the activation element 904 is located on the middle side of the applicator housing 902 rather than on the top and is configured to deflect the holding element 932 upon activation, such that the protrusion 934 no longer restricts the rotational drive element 914 in a spring similar to the spring 512 of the applicator 500. Figure 9 Rotation under force (not shown). As shown, due to the middle side position of the activation element 904, the holding element 932 can be located substantially on one side of the rotation drive element 914.

[0210] exist Figure 10 In this configuration, the activation element 1004 is positioned on the lower side of the applicator housing 1002 rather than on the top and is configured to deflect the holding element 1032 upon activation, such that the protrusion 1034 no longer restricts the rotational drive element 1014 in a spring similar to the spring 512 of the applicator 500. Figure 10 Rotation under force (not shown). As shown, due to the lower position of the activating element 1004, the holding element 1032 can be substantially located on one side of the rotation driving element 1014. 50 Now combined Figures 11A to 11H Discussion of applications for assembling applicators, for example Figure 5 and 8 Examples of steps for applicators 500, 800, 900, and 1000 up to 10.

[0211] Figure 11A The first end 520 of the spring 512 is connected to the needle carriage assembly 508. The first end 520 may be connected to or abutted against the protrusion 1102 of the needle carriage assembly 508, and the spring 512 may be inserted around the hub 1104 of the needle carriage assembly 508 such that the spring 512 and the hub 1104 are coaxially arranged with each other.

[0212] Figure 11B The diagram illustrates connecting the second end 522 of spring 512 to rotary drive element 514 and inserting shaft 526 into hub 1104 of needle carriage assembly 508, within which shaft 526 is rotatable. Shaft 526, hub 1104, and spring 512 may be coaxially arranged relative to each other. As shown by the circular arrow, rotary drive element 514 may rotate about shaft 526 in a circular direction opposite to the direction of rotation of rotary drive element 514 during activation, thereby pre-storing energy in spring 512. Shaft 524 may be fully inserted into a portion of needle carriage assembly 508 such that protrusion 634 contacts retaining element 632, thereby preventing rotary drive element 514 from rotating until activation. In some embodiments, rotary drive element 514 may rotate about shaft 504 such that spring 512 is only partially wound. In such embodiments, spring 512 may be fully wound in a later stage of assembly. Although Figure 11B The rotary drive element 514 is described as having a convex aspect configured to mate with the concave aspect of the hub 1104, but this disclosure also contemplates the rotary drive element 514 having a concave aspect configured to mate with the convex aspect of the hub 1104.

[0213] Figure 11C The retaining elements 672a and 672b are pushed toward the center of the holder 524 and the holder 524 is connected to the needle carriage assembly 508 by placing the first ends 676a and 676b of the retaining elements 672a and 672b into the corresponding slots 674a and 674b of the needle carriage assembly 508.

[0214] Figure 11D This explains how the second terminals 678a and 678b of retaining elements 672a and 672b are connected. Figure 11D (Not shown) The skin sensor assembly 160 is attached to the attachment points 662a, 662b of the skin sensor assembly 160 to connect the skin sensor assembly 160 to the retainer 524. In some embodiments, the retaining elements 672a, 672b may include a snap-fit ​​engagement, a friction engagement, an interference feature, an elastic clamp, and / or an adhesive.

[0215] Figure 11E The description is provided by the opening in the bottom of the applicator housing 502 and through the vertical portion of the guide 582 (see...). Figure 11FThe assembled needle holder assembly 508, rotary drive element 514, retainer 524, and skin sensor assembly 160 are inserted into the applicator housing 502. During this insertion, the pin 516 of the rotary drive element 514 is inserted along at least the vertical portion of the guide 582 in the applicator housing 502, as shown. Figure 11F As shown in the diagram. Therefore, at this time, spring 512 ( Figure 11E , 11F (Not shown in the image) It may not be fully wound, but rather partially wound to the extent that the pin 516 of the rotary drive element 514 is positioned to be inserted along the guide 582 in the applicator housing 502.

[0216] Figure 11G The assembled needle holder assembly 508, rotary drive element 514, retainer 524, and skin sensor assembly 160 are further positioned in the proximal direction into the applicator housing 502 such that the pin 516 of the rotary drive element 514 follows the guide 582 of the applicator housing 502, thereby rotating the rotary drive element 514 completely wrapping around the spring 512. Figure 11G (Not shown in the image), and the protrusion 634 is positioned to contact the retaining element 632 such that the loading includes at least a rotary drive element 514, a drive assembly with a pin 516 and a spring 512 for activation.

[0217] Figure 11H illustrate Figure 11G An enlarged cross-sectional view of region 1106 illustrates the relationship between the rotary drive element 514, pin 516, guide 582, protrusion 634, and retaining element 632.

[0218] Figure 11J The instructions state that the activation element 504 is inserted into the applicator housing 502.

[0219] Figure 12 An exploded perspective view illustrating another applicator 1200 for applying an on-skin sensor assembly to the skin of a host, according to some embodiments. Applicator 1200 may include an applicator housing 1202 having an opening at its bottom and configured to accommodate at least one or more mechanisms for applying an on-skin sensor assembly 160 to the skin 130 of a host (see FIG. 2).

[0220] The applicator 1200 includes an activation element 1204 configured to activate a drive assembly of the applicator 1200. In some embodiments, the activation element 1204 may be a button, switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable component, or any other suitable mechanism for activating the drive assembly of the applicator 1200. The applicator 1200 may further include a needle holder assembly 1208, which includes a sensor 138 configured to hold a sensor assembly 160 on the skin (e.g., a sensor 138). Figure 1 Insertion element inserted into the host's skin 130 Figure 12 (Not shown in the image). In some embodiments, the insertion element includes a needle, such as a C-shaped needle, as will be combined with at least Figures 47 to 50 And 80A to B are described in more detail.

[0221] The applicator 1200 may further include a drive assembly 1210 configured to drive the insertion element of the needle carriage assembly 1208 to a distal insertion position in a distal direction and to drive the insertion element from the distal insertion position to a proximal retraction position in a proximal direction. The distal direction may be defined as extending toward an open side of the applicator 1200 along a path configured to travel on the needle carriage assembly 1208. The distal direction may also be defined as toward the user's skin. The proximal direction may be defined as a direction extending in a direction generally opposite to the distal direction. In some embodiments, the distal and proximal directions extend along the insertion axis of the insertion element and the needle carriage assembly 1208.

[0222] The drive assembly 1210 may include a spring 1212 having a first foot 1220 (e.g., one end) and a second foot 1222 (e.g., one end). The spring 1212 may be a torsion spring, a double torsion spring, or any other suitable type of spring. The spring 1212 may be supported by a spring reel 1250 including a first portion 1250a and optionally a second portion 1250b. In some embodiments, the spring 1212 is self-supporting and not supported by a spring reel. The first portion 1250a may be configured to engage with the second portion 1250b such that the spring reel 1250 is coaxially positioned with the spring 1212 and provides support for the spring 1212 along its axis of rotation 1218. As will be shown in more detail in conjunction with FIG13, the first foot 1220 of the spring 1212 may be coupled to the applicator housing 1202, for example, by a hook or protrusion. The second shank 1222 can be attached to the needle carriage assembly 1208, such as a hook or protrusion of the needle carriage assembly 1208. Upon activation of the drive assembly 1210, the first shank 1220 and the second shank 1222 of the spring 1212 unwind in opposing clockwise or counterclockwise directions, thereby driving the spring 1212 and the insertion element 1208 in the arc to the distal insertion position in the distal direction and driving the spring from the distal insertion position in the proximal direction. The arc traversed by the drive assembly 1210 can extend in directions substantially perpendicular to the distal and proximal directions, or extend in an arc defined by the shank and the point of rotation of the spring.

[0223] The applicator 1200 may further include a retainer 1224 detachably coupled to the needle holder assembly 1208 and configured to guide the on-skin sensor assembly 160 upon coupling to the needle holder assembly 1208. In some embodiments, the retainer 1224 may include a peeling plate. As will be described in more detail below, once the on-skin sensor assembly 160 is placed on the host's skin 130, the on-skin sensor assembly 160 can be peeled off from the retainer 1224 and / or the needle holder assembly 1208.

[0224] Figures 13A to 13F Description according to some embodiments Figure 12 Perspective and sectional views of several features of the applicator 1200. Figure 13AThe illustration shows a cross-sectional view of an applicator 1200, which includes an applicator housing 1202 with a retaining element 1334, an activation element 1204, a spring coil 1250, a spring 1212 with a first handle 1220 and a second handle 1222, a needle holder assembly 1208 with the retaining element 1332, a retainer 1224, and a skin sensor assembly 160. In some embodiments, the retaining element 1332 may include a snap-fit, friction fit, interference feature, resilient clamp, and / or adhesive configured to engage the skin sensor assembly 160 with the needle holder assembly 1208 and / or the retainer 1224. Each of these components may have at least as previously described. Figure 12 The functions described. Furthermore, the first handle 1220 is configured to rotate about the rotation point 1336 after the drive assembly is activated. The second handle 1222 is similarly configured.

[0225] Figure 13F This illustration shows an enlarged perspective view of the retaining element 1342 of the retainer 1224 and the stop element 1344 of the applicator housing 1202, the elements being configured to secure the retainer 1228 to the applicator housing 1202 after the needle carriage assembly 1208 reaches the distal insertion position. In some embodiments, the retaining element 1342 is a deflectable arm. For example, as the needle carriage assembly 1208 travels in the distal direction, the retaining element 1342 slides along the inner surface of the applicator housing 1202 and is deflected by the stop element 1344 until the retaining element 1342 engages under the stop element 1344 due to the partial unwinding of the spring 1212. In some embodiments, the functions of the retaining element 1342 and the stop element 1344 are interchangeable; for example, the stop element 1344 may be configured to be deflected by the retaining element 1342 and engage above the retaining element. At this point, although the needle carriage assembly 1208 can move freely in the proximal direction, the stop element 1344 will prevent the retaining element 1342 and the retainer 1224 from moving backward in the proximal direction due to the further unwinding of the spring 1212. In this way, the movement of the needle carriage assembly 1208 in the proximal direction after reaching the distal insertion position causes the retainer 1224 and / or the needle carriage assembly 1208 to be released from the sensor assembly 160 on the skin.

[0226] Figure 13B The illustration shows an enlarged cross-sectional view of a portion of the needle carriage assembly 1208, including a retaining element 1332 configured to interlock with a retaining element 1334 of the applicator housing 1202 and prevent the needle carriage assembly 1208 from separating from the applicator housing 1202 in a loaded pre-activated position. An activation element 1204 is configured to deflect the retaining element 1332 such that the retaining element 1334 no longer holds the retaining element 1332, thereby causing a spring 1212 to separate the needle carriage assembly 1208 from the applicator housing 1202 and activate the drive assembly 1210.

[0227] Figure 13C An enlarged view illustrating the second shank 1222 of the spring, which is connected to the needle carriage assembly 1208, for example, via a hook 1348 configured to secure the second shank 1222 to the needle carriage assembly 1208. Figure 13C The fixing concept described in the second foot 1222 can also be used for the first foot 1220.

[0228] Figure 13D A sensor assembly 160 on the skin is described, comprising a plurality of attachment points 662a to 662c configured to mate with corresponding retaining elements 1372a to 1372c on a needle holder assembly 1208 and / or retainer 1224, while traveling at least partially toward a distal insertion position in a distal direction during applicator activation. In some embodiments, where retainer 1224 includes a release plate, retainer 1224 may function similarly to a release plate in die making or injection molding processes. Although a plurality of attachment points 662a to 662c are described, any number of attachment points is contemplated. In some embodiments, retaining elements 1372a to 1372c may include a snap-fit ​​engagement, a friction engagement, an interference feature, a resilient clamp, and / or an adhesive.

[0229] The retaining elements 1372a to 1372c of the needle carriage assembly 1208 and / or retainer 1224 are configured to detachably engage the skin sensor assembly 160 to the retainer 1228 when the needle carriage assembly 1208 travels in the distal direction to the distal insertion position, and to decouple the skin sensor assembly 160 from the needle carriage assembly 1208 and / or retainer 1228 when the needle carriage assembly 1208 travels in the proximal direction from the distal insertion position toward the proximal retraction position. Specifically, because the retaining elements 1342 and 1344 prevent the retainer 1224 from traveling in the proximal direction at the distal insertion position, the needle carriage assembly 1208 travels rearward in the proximal direction. This separates the needle holder assembly 1208 from the retainer 1224 and the on-skin sensor assembly 160, thereby decoupling the retaining elements 1372a to 1372c from the attachment points 662a to 662c of the on-skin sensor assembly 160. Although two retaining elements are described, any number of retaining elements is considered. Furthermore, the following incorporates at least... Figures 35A to 37C Alternative mechanisms for performing such hold and release actions are further described. Any of these alternative mechanisms used with the applicator 1200 are considered.

[0230] Figure 13EThe illustration shows a perspective view of an applicator housing 1202 containing multiple tracks 1322a, 1322b, 1322c, with corresponding multiple protrusions 1324a, 1324b, 1324c of the needle carriage assembly 1208 configured to slide within the multiple tracks. Therefore, tracks 1322a to 1322c in the applicator housing 1202 define a travel path for the needle carriage assembly 1208. In some embodiments, this travel path is generally linear and longitudinal. Although... Figure 13E The image shows three orbits and protrusions, but it considers either a single orbit or multiple orbits and their corresponding protrusions.

[0231] The following is relative to Figures 14A to 14E The operation of the applicator 1200 is briefly described, and the figures illustrate the operation during some embodiments. Figure 12 Several cross-sectional views of the applicator.

[0232] Figure 14A This describes the state of the applicator 1200 when activated. The activation element 1204 is shown in the activated position, for example, when the activation element has been pushed longitudinally in the distal direction by the user. In the activated position, the activation element 1204 deflects the retaining element 1332 such that when the spring 1212 unwinds from its pre-wound state, the retaining element 1334 of the applicator housing 1202 does not prevent the needle carriage assembly 1208 from moving. Because... Figure 14A The applicator 1200 is shown in its newly activated state, with the spring 1212, needle holder assembly 1208, retainer 1224, and skin sensor assembly 160 displayed in their pre-activated orientation and position. However, the spring 1212 will partially unwind, and this unwinding will drive the needle holder assembly 1208, retainer 1224, and skin sensor assembly 160 to the distal insertion position in the distal direction.

[0233] Figure 14B This describes the state of the applicator 1200 during activation. The activation element 1204 is described as being in [a certain state]. Figure 14A In the activated position, the spring 1212 has been partially unwound, such that the first shank 1220 is unwound in a first arc direction and the second shank 1222 is unwound in a second arc direction opposite to the first arc direction. The spring 1212 travels through an arc direction generally perpendicular to the distal and proximal directions, or in an arc defined by the shank of the spring 1212 and its associated point of rotation. Thus, the force generated by the spring 1212 drives the needle holder assembly 1208, the insertion element 1374, the retainer 1224, and the skin sensor assembly 160 toward the distal insertion position in the distal direction.

[0234] Figure 14C This describes the applicator 1200 at the distal insertion position during activation. The activation element 1204 is described as being in... Figure 14A and14B In the activated position. Spring 1212 is already relative to its... Figure 14A and 14B The position described is generally further unwound in the direction of the horizontal arrow. The insertion assembly 1208, retainer 1224, and skin sensor assembly 160 are driven to the distal insertion position by the force generated by spring 1212. In this distal insertion position, a position similar to that shown in Figure 6 can be... Figures 14A to 14E (Not shown) At least a portion of the insertion element connected to the needle holder assembly 1208 and at least a portion of the sensor 138 of the skin sensor assembly 160 (e.g., not shown) Figure 1 It is inserted into the host's skin 130. At this location, although not shown, retaining elements 1342, 1344 (see Figure 13) can engage with each other.

[0235] Figure 14D Description of the applicator 1200 during activation. Activation element 1204 is described as being used during... Figures 14A to 14C In the activated position. Spring 1212 has been further unwound and is traveling in roughly the same direction as indicated by the arrow. Figures 14A to 14C Unwinding of spring 1212 causes needle carriage assembly 1208 to move distally because spring 1212 is now located on opposite sides of the points anchored to the first foot 1220 and the second foot 1222. Further unwinding of spring 1212 causes needle carriage assembly 1208 to move proximally toward a proximal retracted position. Due to engagement of the retaining element (see Figure 13), retainer 1224 and skin sensor assembly 160 are shown as detached from needle carriage assembly 1208. Figure 14D In the position shown, the sensor assembly 160 on the skin can also be decoupled from the holder 1224, as previously described with reference to label 1330 in FIG13.

[0236] Figure 14E Description of the activated applicator 1200. Activation element 1204 is described as being in... Figures 14A to 14D In the activated position. Spring 1212 is described as being in conjunction with... Figure 14D The position described herein is further retracted and generally travels in the direction indicated by the arrow. The insertion assembly 1208 travels to the proximal retraction position in the proximal direction indicated by the vertical arrow. The retainer 1224 and the skin sensor assembly 160 are shown as separate from the needle holder assembly 1208.

[0237] Figures 15 to 17 Perspective views illustrating several exemplary dual torsion springs in different configurations of the support applicator 1200 according to some embodiments. Therefore, by Figures 15 to 17 Any of the described springs can be used in the previous connection. Figures 12 to 14EThe spring 1212 discussed. For example... Figures 15 to 17 As shown, crosslinking bridges 1522c, 1622c, and 1722c of different shapes and / or sizes can be provided for springs 1512, 1612, and 1712 by flaring one or more shank feet in a specific direction.

[0238] For example, Figures 15 to 17 The double torsion springs 1512, 1612, and 1712 are described, each comprising a first winding 1512a, 1612a, 1712a and a second winding 1512b, 1612b, 1712b. The double torsion springs 1512, 1612, and 1712 can be formed from individual segments of a suitable material (e.g., metal or plastic). The first windings 1512a, 1612a, and 1712a each include first legs 1520a, 1620a, 1720a and second legs 1522a, 1622a, 1722a. The second windings 1512b, 1612b, and 1712b each include first legs 1520b, 1620b, 1720b and second legs 1522b, 1622b, 1722b. For each spring 1512, 1612, 1712, the second handles 1522a, 1522b; 1622a, 1622b; 1722a, 1722b can be connected to each other via crosslinking bridges 1522c, 1622c, 1722c. Figure 15 The crosslinking bridge 1522c may have a length substantially equal to the distance 1530 between the first winding 1512a and the second winding 1512b, the distance being defined by the extensions of the second shanks 1522a and 1522b from the first winding 1512a and the second winding 1512b, respectively. Figure 16 The crosslinking bridge 1622c may have a length exceeding the distance 1630 between the first winding 1612a and the second winding 1612b, the distance being defined by the extension of the second legs 1622a, 1622b from the first winding 1612a and the second winding 1612b, respectively, as the second legs 1622b of the second winding 1612b open toward the first legs 1620b of the second winding 1612b. Figure 17 The crosslinking bridge 1722c may have a length exceeding the spacing 1730 between the first winding 1712a and the second winding 1712b, the spacing being defined by the extensions of the second legs 1722a and 1722b from the first winding 1712a and the second winding 1712b, respectively. This is because the second legs 1722a of the first winding 1712a are open toward the first legs 1720a of the first winding 1712a, and the second legs 1722b of the second winding 1712b are open toward the first legs 1720b of the second winding 1712b, providing and displaying [the crosslinking bridge]. Figure 15 Crosslinking bridge 1522c or shown in Figure 16Compared to the crosslinking bridge 1622c, the crosslinking bridge 1722c has an increased length.

[0239] Figures 18 to 23 Description of an applicator according to some embodiments, such as Figure 12 An alternative drive component for the applicator 1200. Figure 18 The description includes a drive assembly for the linkage element 1850. In some embodiments, the linkage element 1850 may include a retractable link. The retractable link may contain one or more movable hinges. In other embodiments, the linkage element 1850 may include at least two discrete portions configured to pivot about a hinge connecting the at least two discrete portions.

[0240] A retractable link is a type of hinge assembly formed from an extension of a base material (such as polypropylene plastic). The retractable link is a thin sheet of the base material that acts as a bending connection to two larger portions of the base material. Typically, the larger portions of the base material, as well as the hinge, are made from a single continuous piece of base material. Due to its relatively thinness and often being made of a flexible material, a retractable link can also rotate up to 180 degrees or more about an axis—potentially cycling thousands or even millions of times. Unlike most hinges that involve multiple parts assembled using a traditional pivot mechanism, a retractable link is not a separate entity. It can be described as a deliberate fault line at a predetermined point in the material, designed so that it does not fail after repeated bending.

[0241] The linkage element 1850 has a first end 1852 connected to the applicator housing 1802, a second end 1854 connected to the needle holder assembly 1808, and a hinge 1856 disposed between the first end 1852 and the second end 1854.

[0242] The drive assembly further includes a spring 1812, which in some embodiments may be a single torsion spring or a double torsion spring. The spring 1812 includes a first foot 1820, which is coupled to the applicator housing 1802 and / or the linkage element 1850 at a first end 1852 and / or at a position between the first end 1852 and the hinge 1856. The spring 1812 further includes a second foot 1822, which is coupled to the needle holder assembly 1808 and / or the linkage element 1850 at a second end 1854 or at a position between the second end 1854 and the hinge 1856. In some embodiments, the hinge 1856 may be aligned with the axis of rotation 1818 of the spring 1812 to provide smooth operation and reduce any stress caused by incompatible movement between the linkage element 1850 and the spring 1812.

[0243] The applicator 1200 of the drive component 1810 can be used to substantially achieve the following: Figure 12The applicator 1200 is described to function as described, however, it further includes, during activation, the first end 1852, the second end 1854 and the hinge 1856 of the linkage element 150 moving generally aligned with the first foot 1820, the second foot 1822 and the rotation axis 1818 of the spring 1812, respectively.

[0244] Figure 19 The description includes another drive assembly including the linkage element 1950. The linkage element 1950 has a first end 1952 connected to the applicator housing 1902, a second end 1954 connected to the needle carriage assembly 1908, and a hinge 1956 disposed between the first end 1952 and the second end 1954. The drive assembly further includes a spring 1912, which in some embodiments may be a single torsion spring or a double torsion spring. The spring 1912 includes a first foot 1920 connected to the linkage element 1950 between the second end 1954 and the hinge 1956. The spring 1912 further includes a second foot 1922 connected to the needle carriage assembly 1908. Upon activation, the spring 1912 unwinds and the first foot 1952 sweeps an arc, while the second foot 1954 remains substantially fixed relative to the needle carriage assembly 1908. As the first lever 1952 sweeps across its arc, it drives the connecting element 1950 from the shown bent position, causing the hinge 1956 to pivot until the connecting element 1950 is substantially vertical, and then continues to pivot until the connecting element 1950 is in contact with... Figure 19 The orientation is generally mirrored as shown in the diagram. This movement drives the needle carriage assembly 1908 in the distal direction, reaching the distal insertion position when the linkage element 1950 is generally vertical, and subsequently as the linkage element 1950 is further driven from a generally vertical orientation to a position consistent with... Figure 19 The orientation shown is generally mirror-image, gradually increasing in the proximal direction.

[0245] Figure 20The description includes another drive assembly including the linkage element 2050. The linkage element 2050 has a first end 2052 connected to the applicator housing 2002, a second end 2054 connected to the needle holder assembly 2008, and a hinge 2056 disposed between the first end 2052 and the second end 2054. The drive assembly further includes a spring 2012, which in some embodiments may be a single torsion spring or a double torsion spring. The spring 2012 includes a first shank 2020 connected to the linkage element 2050 between the first end 2052 and the hinge 2056. The spring 2012 further includes a second shank 2022 connected to the applicator body 2002. Upon activation, the spring 2012 unwinds and the first shank 2052 sweeps in an arc, while the second shank 2054 remains substantially fixed relative to the applicator body 2002. As the first lever 2052 sweeps across its arc, it drives the connecting element 2050 from the shown bent position, causing the hinge 2056 to pivot until the connecting element 2050 is substantially vertical, and then continues to pivot until the connecting element 2050 is in contact with... Figure 20 The orientation shown is generally mirror-image. This movement drives the needle carriage assembly 2008 in the distal direction, reaching the distal insertion position when the linkage element 2050 is generally vertical, and subsequently when the linkage element 2050 is further driven from the generally vertical direction to the distal insertion position. Figure 20 The orientation shown is generally mirror-image, gradually increasing in the proximal direction.

[0246] Figure 21The description includes another drive assembly including link element 2150. Link element 2150 has a first end 2152 coupled to applicator housing 2102, a second end 2154 coupled to needle carriage assembly 2108, and a hinge 2156 disposed between the first end 2152 and the second end 2154. The drive assembly further includes a spring 2112, which in some embodiments may be a tension spring. Compression springs are also contemplated. However, a compression spring may be coupled between hinge 2156 and the proximal side of applicator housing 2102. Spring 2112 includes a first end 2120 coupled to link element 2150 and a second end 2122 coupled to applicator body 2102. In some embodiments, the first end 2120 is coupled to link element 2150 between the first end 2152 and hinge 2156. In other embodiments, the first end 2120 is coupled to link element 2150 at hinge 2156. In another embodiment, the first end 2120 is coupled to a link element 2150 between the hinge 2156 and the second end 2154. Upon activation, the spring 2112 drives the link element 2150 from the illustrated bent position by unwinding in an arc extending generally perpendicular to the distal and proximal directions, or in an arc defined by the spring's shank and its corresponding pivot point. The hinge 2156 pivots until the link element 2150 is substantially vertical, and then continues to pivot until the link element 2150 is coupled to the hinge 2156. Figure 21 The orientation shown is generally mirror-image. This movement drives the needle carriage assembly 2108 in the distal direction, reaching the distal insertion position when the linkage element 2150 is generally vertical, and subsequently as the linkage element 2150 is further driven from a generally vertical orientation to a position similar to... Figure 21 The orientation shown is generally mirror-image, gradually increasing in the proximal direction.

[0247] Figure 22 The description includes another drive assembly for the leaf spring 2212. The leaf spring 2212 includes a first end 2220 coupled to the applicator housing 2202 and a second end 2222 coupled to the needle carriage assembly 2208. Upon activation, the leaf spring 2212 unloads in a direction generally parallel to the insertion axis, driving the needle carriage assembly 2208 to the distal insertion position as the leaf spring 2212 unloads.

[0248] Figure 23The description includes another drive assembly including link element 2350. Drive assembly 2310 is substantially the same as drive assembly 1910, except that a leaf spring 2312 is used instead of torsion spring 1912. Link element 2350 has a first end 2352 connected to applicator housing 2302, a second end 2354 connected to needle carriage assembly 2308, and a hinge 2356 disposed between the first end 2352 and the second end 2354. The drive assembly further includes a leaf spring 2312 having a first end 2320 connected to link element 2350 between the second end 2354 and hinge 2356, and a second end 2322 connected to needle carriage assembly 2308. Upon activation, spring 2312 is unloaded, and the first end 2320 sweeps an arc, while the second end 2322 remains substantially fixed relative to needle carriage assembly 2308. As the first end 2320 sweeps across its arc, the first end 2320 drives the link element 2350 from the shown curved position, the hinge 2356 pivots, until the link element 2350 is substantially vertical, and then continues to pivot until the link element 2350 is in a position with... Figure 23 The orientation shown is essentially a mirror image. This movement drives the needle carriage assembly 2308 in the distal direction, reaching the distal insertion position when the linkage element 2350 is generally vertical, and subsequently as the linkage element 2350 is further driven from the generally vertical direction to the distal insertion position... Figure 23 The directions shown are roughly mirror images, gradually increasing towards the proximal end.

[0249] Now combined Figures 24A to 24M Discussions are used to assemble the applicator, for example Figure 12 An example of the steps in the applicator 1200. To the extent that it is compatible with any step, Figures 24A to 24M The assembly steps can also be applied to utilizing the combination Figures 18 to 23 Any applicator of the described driving component.

[0250] Figure 24A This indicates that the first part 1250a and the second part 1250b of the spring drum 1250 are connected together inside the winding of the spring 1212. Figure 24B This describes the assembled spring drum 1250 and spring 1212. The spring drum 1250 and spring 1212 are arranged coaxially with each other. Figure 24C The spring 1212, which is wound in the direction indicated by the circular arrow, has a first foot 1220 and a second foot 1222 in the illustrated position. Figure 24D The spring 1212 after winding is described, which has a first foot 1220 and a second foot 1222 in the described position.

[0251] Figure 24EThe description describes the connection of the wound spring 1212 to the needle carriage assembly 1208. In some embodiments, this includes a hook 1348 for connecting a first foot 1220 to the needle carriage assembly 1208 and for connecting a second foot 1222 to or abutting the needle carriage assembly to the needle carriage assembly 1208. Figure 24F A side view illustrating the wound spring 1212 connected to the needle carriage assembly 1208, while... Figure 24G Description shown Figure 24F A perspective view of the layout.

[0252] Figure 24H The description indicates that the holder 1224 is connected to the needle holder assembly 1208 and the skin sensor assembly 160 is connected to the holder 1224. Figure 24J This illustration shows a side view of the assembled skin sensor assembly 160, retainer 1224, and needle holder assembly 1208. Figure 24K Description shown Figure 24J A perspective view of the layout.

[0253] Figure 24L The description describes how a composite comprising a skin sensor assembly 160, a retainer 1224, a needle holder assembly 1208, and a spring 1212 is assembled into the applicator housing 1202 through an opening in the bottom of the applicator housing 1202, and how an activation element 1204 is inserted into the applicator housing 1202. Figure 24M Description shown Figure 24L The results of the components in.

[0254] Figure 25 This illustration shows an exploded perspective view of another applicator 2500 for a skin sensor assembly 160 of an analyte sensor system according to some embodiments. The applicator 2500 may include an applicator housing 2502 configured to house one or more mechanisms for applying the skin sensor assembly 160 to the host skin 130. The applicator housing 2502 may be formed of any suitable material, such as polymers, polycarbonate, ABS, nylon, polyethylene, polypropylene, etc.

[0255] The applicator 2500 includes an activation element 2504 configured to activate a drive assembly of the applicator 2500. In some embodiments, the activation element 2504 may be a button, switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable component, or any other suitable mechanism for activating the drive assembly of the applicator 2500. The applicator 2500 may further include a needle holder assembly 2508, which includes components configured to hold a sensor assembly 160 (e.g., on the skin) on the skin. Figure 1 Sensor 138 (e.g.) Figure 1 ) Inserted into the host's skin 130 (e.g. Figure 1 Insertion element 2574 in the [missing information]. In some embodiments, insertion element 2574 includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as one that will be combined with at least [missing information]. Figures 47 to 50 And 80A to B are described in more detail. In other embodiments, the insertion element may include a sensor 138, which is rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0256] The applicator 2500 may further include a drive assembly 2510 configured to drive the insertion element 2574 of the needle carriage assembly 2508 to a distal insertion position in a distal direction and to drive the insertion element from the distal insertion position to a proximal retraction position in a proximal direction.

[0257] The applicator 2500 may further include a retainer 2524 detachably coupled to the needle holder assembly 2508 and configured to guide the on-skin sensor assembly 160 when coupled to the needle holder assembly 2508. As will be described in more detail below, once the on-skin sensor assembly 160 is placed on the host's skin 130, the on-skin sensor assembly 160 can be detached from the retainer 2524 and / or the needle holder assembly 2508.

[0258] The drive assembly 2510 may include a spring 2512, which may be any suitable type of spring, such as a compression spring, tension spring, leaf spring, retraction arm spring, etc. The spring 2512 may have a first end 2520 coupled to the applicator housing 2502 and a second end coupled to the needle carriage assembly 2508. The spring 2520 may be configured to drive the needle carriage assembly 2508 in a distal direction upon activation of the drive assembly 2510. In some embodiments, the spring 2512 may be preloaded, for example, at the factory. In some other embodiments, the spring 2512 may be loaded by the action of a user of the applicator 2500.

[0259] The drive assembly 2510 further includes a spring 2528 that can be coupled to an applicator base 2530 of the applicator 2500. In some embodiments, the spring 2528 may be a compression spring, a tension spring, a leaf spring, a retraction arm spring, etc. In some embodiments, the spring 2528 may be preloaded, for example, at the factory. In some other embodiments, the spring 2528 may be loaded by a user's action. In still other embodiments, the spring 2528 may be loaded by unloading the spring 2512. As will be described in more detail below, the spring 2528 may include one or more portions of the needle carriage assembly 2508 configured to drive the needle carriage assembly 2508 from the distal insertion position in a proximal direction.

[0260] Figures 26A to 26DDescription according to some embodiments Figure 25 Several cross-sectional and bottom views of several features of the applicator 2500. Figure 26A The illustration shows a perspective sectional view of an applicator 2500, which includes an applicator housing 2502, an activation element 2504, an applicator base 2530 including a protrusion 2602, a spring 2512, a leaf spring 2528, a needle holder assembly 2508, a retainer 2524, and a skin sensor assembly 160. Each of these components may have at least as previously described... Figure 25 The described functionality.

[0261] Figure 26B A perspective view illustrating several features of the retainer 2524, the applicator base 2530, and the activation element 2504. A spring 2512 is configured to be coupled at a first end to the applicator housing 2502 and at a second end to the retainer 2524. In a pre-activated state, the spring 2512 is configured to store energy to drive the retainer 2512 (and the needle carriage assembly 2508) to a distal insertion position in a distal direction upon activation. The retainer 2524 includes a shaft 2614 configured to engage with the applicator base 2530, such that the retainer 2524 is configured to pivot about the shaft 2614 in a generally circular arc. Figure 26B In the illustration, the activation element 2504 is described as including a protrusion 2612 configured to guide the holder 2524 in the shown pre-activated position until the activation element 2504 is activated, thereby displacing the protrusion 2612 relative to the holder 2524 from its pre-activated orientation and releasing the holder 2524. Figure 26B Further clarification: The leaf spring 2528 is not coupled to the retainer 2524. Instead, the leaf spring 2528 is coupled to the needle carriage assembly 2508 and configured to drive the needle carriage assembly 2508 from the distal insertion position in the proximal direction. Although the activation element 2504 is shown as a button, this disclosure further contemplates the activation element 2504 as a switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable assembly, or any other suitable mechanism for activating the drive assembly of the applicator 2500. Furthermore, although the activation element 2504 is described as being positioned on one side of the applicator housing 2502, this disclosure contemplates any other location, such as on the top, bottom, or other side of the applicator housing 2502, and / or any other positioning angle relative to the applicator housing 2502.

[0262] Figure 26C An exploded perspective view illustrating the needle holder assembly 2508, insertion element 2674, and retainer 2524. Insertion element 2674 is coupled to the needle holder assembly 2508. In some embodiments, insertion element 2674 includes a sensor 138 of a sensor assembly 160 on the skin (e.g., ...). Figure 1A side-opening needle is guided and inserted into the host's skin 130. An insertion assembly 2508 is coupled at its first end to a shaft 2614 of a retainer 2524. The insertion assembly 2508 further includes a retaining element 2622 configured to detachably couple a second end of the needle holder assembly 2508 to the retainer 2524. The insertion assembly 2508 further includes a retaining element 2604 configured to detachably couple a skin sensor assembly 160 to the needle holder assembly 2508 and the retainer 2524. In some embodiments, the retaining element 2604 may include a snap-fit ​​engagement, friction engagement, interference feature, resilient grip, and / or adhesive configured to couple the skin sensor assembly 160 to the needle holder assembly 2508 and / or the retainer 2524. A spring 2512 is configured to drive the needle holder assembly 2508 and the retainer 2524 to a distal insertion position along an arc defined by the shaft 2614 in the distal direction upon activation of the applicator 2500. When the needle carriage assembly 2508 is driven in an arc in the distal direction, the spring 2512 transfers at least a portion of its stored energy to the leaf spring 2528. In some other embodiments, the leaf spring 2528 may be preloaded such that the spring 2512 does not transfer its stored energy to the leaf spring 2528. When the needle carriage assembly 2508 is driven in the distal direction, the protrusion 2602 of the applicator base 2530 is configured to sufficiently deflect the retaining element 2622 to disengage the needle carriage assembly 2508 from the retainer 2524 substantially at the distal insertion position, thereby decoupling the second end of the needle carriage assembly 2508 from the retainer 2524. Therefore, the leaf spring 2528, now loaded from the distal insertion position, is configured to drive the needle carriage assembly 2508 in an arc in the proximal direction from the distal insertion position to the proximal retraction position.

[0263] Figure 26D Describe portion 2632 of the activation element 2504, which is coupled to the applicator housing 2502 and configured to act as a return spring, returning the activation element 2504 to its pre-activated position after activation. For example, as Figure 26D As shown, when the activation element 2504 is pressed to the right, part 2632 deforms against the applicator housing 2502, thereby essentially acting as a spring. When the spring is unloaded, the activation element 2504 returns to its pre-activated position.

[0264] Figures 27A to 27E Description of operation during some embodiments Figure 25 Several cross-sectional views of the applicator 2500. Figure 86 This describes the relationship between the shaft 2614, the insertion element 2674, and the arc 8602 traveling through the insertion element 2674 during insertion and retraction, according to some embodiments. Figure 27AThe applicator 2500 is illustrated during activation. For example, the activation element 2504 is illustrated in the activation position, such as being pushed inward, which releases the retainer 2524 from its fixed pre-activated state. The spring 2512, needle holder assembly 2508, insertion element 2674, retainer 2524, and skin sensor assembly 160 are all shown in their pre-activated positions.

[0265] Figure 27B Description of the applicator 2500 during activation. Spring 2512 extends in the distal direction along an arc 8602 defined by shaft 2614 (see...). Figure 86 The drive retainer 2524 and the detachably connected needle holder assembly 2508, insertion element 2674, and skin sensor assembly 160 are also described. In some embodiments, the radius 8604 of the arc 8602 (see...) Figure 86 The range is between 20 mm and 80 mm (inclusive), but radii larger or smaller than this range are also taken into account.

[0266] Compared to Figure 86 The radius 8604 of this arc 8602 may depend on one or more of the following: the distance 8606 from the host's skin 130 to the axis 2614; the height 8608 of the sensor assembly 160 on the skin from the bottom opening or surface of the applicator 2500 or from the axis 2614; and / or the position of the sensor 138 within the sensor assembly 160 on the skin. The radius 8604 may be selected at least partially to minimize tissue trauma, optimize the deployment of the sensor 138, and minimize insertion and / or retraction friction between the insertion member and the host's tissue.

[0267] For example, relative to Figure 27A and 86 An angle 2710 between the needle shaft and the bottom plane of the sensor assembly on the skin can be calculated to achieve minimal offset between the straight needle path and the ideal curved profile 8602. In some embodiments, an angle of approximately 71 degrees between the needle shaft and the bottom plane of the sensor assembly on the skin has been determined to produce less lateral movement of the tip of the insertion element 2674 within the host's skin, compared to an approximately 90-degree angle. However, this angle may depend on at least some of the same factors that affect the ideal radius of the arc.

[0268] In addition, various needle geometries can be used, including (but not limited to) straight needle geometries, kinked needle geometries (e.g., two or more generally straight portions with one or more bends disposed therebetween), and fully or partially curved needle geometries (e.g., a curved distal portion configured to at least partially puncture the host's skin using or not using a straight proximal portion), such as in combination with at least Figures 47 to 50And 80A to B are described in more detail.

[0269] Figure 27C The applicator 2500 is described in the distal insertion position. Spring 2512 has driven the retainer 2524, along with the detachably coupled needle carriage assembly 2508, insertion element 2674, and skin sensor assembly 160, to the distal insertion position in the distal direction. Additionally, the protrusion 2602 of the applicator base 2530 has fully deflected the retaining arm 2622 to release the second end of the needle carriage assembly 2508 from the retainer 2524, preparing for movement from the distal insertion position in the proximal direction.

[0270] Figure 27D The applicator 2500 is described during retraction. Spring 2512 retains the unloaded position, pinning retainer 2524 in the distal insertion position. However, leaf spring 2528 remains in contact with the now-released needle carriage assembly 2508, driving the needle carriage assembly 2508 and the coupled insertion element 2674 from the distal insertion position to the proximal retraction position in the proximal direction. Spring 2512 is released from the skin sensor assembly 160 by means of retaining element 2604, pinning retainer 2524 and the skin sensor assembly 160 disposed thereunder in the distal insertion position. In some embodiments, retaining element 2604 may include a snap-fit ​​engagement, friction engagement, interference features, resilient clamps, and / or adhesives.

[0271] Figure 27E The applicator 2500 is described in the proximal retraction position. A leaf spring 2528 has driven the needle holder assembly 2508 and the insertion element 2674 to the proximal retraction position. The applicator 2500 can then be released from the host's skin, thereby removing the sensor assembly 160 from the skin and the sensor 138 (e.g., now at least partially inserted into the host's skin). Figure 1 In addition to this, all parts of the applicator 2500 will be removed from the host's skin.

[0272] Figures 28A to 28H Assembly according to some embodiments Figure 25 The steps of the applicator 2500. Figure 28A The description describes how the insertion element 2674 is coupled to the needle carriage assembly 2508. In some embodiments, the insertion element 2674 may be coupled to the needle carriage assembly 2508 at an angle that substantially coincides with the circular path insertion element 2674, and the needle carriage assembly 2508 traverses it during activation. Figure 28B The needle carriage assembly 2524 is connected to the needle carriage assembly 2508 by connecting the needle carriage assembly 2508 to the shaft 2614 of the holder 2524 and connecting the retaining element 2622 to the holder 2524. Figure 28CThe description explains that the skin sensor assembly 160 is connected to the holder 2524 and the needle holder assembly 2508 by engaging the retaining element 2604 of the needle holder assembly 25089 with the skin sensor assembly 160.

[0273] Figure 28D Instructions: Insert the activation element 2504 into the applicator housing 2502. Figure 28E The first end of the spring 2512 is connected to the applicator housing 2502 through an opening in the bottom of the applicator housing 2502. Figure 28F The explanation will be provided by Figure 28C The steps described herein produce component 2800c which is inserted into the applicator housing 2502. (As shown in...) Figure 28F In component 2800c, spring 2512 is positioned to contact retainer 2524, and retainer 2524 is secured by protrusion 2612 of activation element 2504.

[0274] Figure 28G The applicator base 2530 is connected to the applicator housing 2502. The shaft 2614 of the retainer 2524 is connected to the applicator base 2530, and the leaf spring 2528 is positioned to contact the needle holder assembly 2508. Figure 28H The applicator 2500 is described as an assembly. In this step, the applicator base 2530 can be attached to the applicator housing 2502 by, for example, acoustic welding, press-fit, snap-fit, adhesive, or any other suitable method of fixing plastic materials together.

[0275] Figure 29 This is an exploded perspective view illustrating another applicator 2900 for applying an on-skin sensor assembly to the skin 130 of a host, according to some embodiments. The applicator 2900 may include an applicator housing 2902 having an opening at its bottom and configured to accommodate at least one or more mechanisms for applying the on-skin sensor assembly 160 to the skin 130 of the host.

[0276] The applicator 2900 includes an activation element 2904 configured to activate a drive assembly of the applicator 2900. In some embodiments, the activation element 2904 may be a button, switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable assembly, or any other suitable mechanism for activating the drive assembly of the applicator 2900. The applicator 2900 may further include a needle holder assembly 2908, which includes a sensor 138 (e.g., a sensor from the sensor assembly 160 on the skin) configured to receive a sensor from the sensor assembly 160 on the skin. Figure 1 Insertion element inserted into the host's skin 130 (see) Figure 30In some embodiments, the insertion element includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer-coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as one that incorporates at least Figures 47 to 50 And 80A to B are described in more detail. In other embodiments, the insertion element may include the sensor 138 itself, which is rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0277] The applicator 2900 may further include a drive assembly 2910 configured to drive the insertion element of the needle carriage assembly 2908 to a distal insertion position in a distal direction and to drive the insertion element from the distal insertion position to a proximal retraction position in a proximal direction. The distal direction may be defined as extending toward the open side of the applicator 2900 along a path configured to travel on the needle carriage assembly 2908. The distal direction may also be defined as toward the user's skin. The proximal direction may be defined as a direction extending in a direction generally opposite to the distal direction. In some embodiments, the distal and proximal directions extend along the insertion axis of the insertion element and the needle carriage assembly 2908.

[0278] The drive assembly 2910 may include a rotary drive element 2914 disposed within the needle carriage assembly 2908 and configured to rotate relative to the needle carriage assembly 2908 about a rotation axis 2918 parallel to the centerline of the needle carriage assembly 2908. In some embodiments, the rotary drive element 2914 is configured to rotate in a plane substantially perpendicular to the proximal and distal directions. In some embodiments, the rotary drive element 2914 includes a barrel cam. The rotary drive element 2914 includes a ridge 2916 defining a variable cam path around at least a portion of the circumference of the rotary drive element. The ridge 2916 is configured to travel along a channel on the inner surface of the needle carriage assembly 2908 as the rotary drive element 2914 rotates (see [link to documentation]). Figure 30 The needle carriage assembly 2908 is slid, thereby driving it to a distal insertion position in the distal direction and subsequently to a proximal retraction position as defined by the variable cam path of the ridge 2916.

[0279] The drive assembly 2910 may further include a spring 2912 disposed within the rotary drive element 2914. The spring 2912 may be a torsion spring or any suitable type of spring. The spring 2912 may have a first end 2920 coupled to the applicator housing 2902 and a second end 2922 coupled to the rotary drive element 2914. The spring 2912 may be coaxially disposed with the rotary drive element 2914 and the needle carriage assembly 2908. The spring 2920 may be configured to rotate the drive element 2914 in a single direction relative to the needle carriage assembly 2908 after the drive assembly 2910 is activated.

[0280] By configuring the rotary drive element 2914 to rotate about the rotation axis 2918 relative to the needle carriage assembly 2908 and restricting the ridge line 2916 to travel in the channel of the needle carriage assembly 2908, the rotational motion of the rotary drive element 2914 caused by the spring 2912 is converted into the needle carriage assembly 2908 and thus the insertion of the element (see Figure 30 The linear reciprocating motion of the rotary drive element 2914. More specifically, the rotation of the rotary drive element 2914 drives the insertion element 2908 to the distal insertion position in the distal direction and drives the insertion element from the distal insertion position to the proximal retraction position in the proximal direction.

[0281] The applicator 2900 may further include a retainer 2924, which is detachably coupled to the needle holder assembly 2908 via a retaining element 2980 and configured to guide the on-skin sensor assembly 160 upon coupling to the needle holder assembly 2908. In some embodiments, the retaining element 2980 may include a snap-fit, friction fit, interference feature, resilient clamp, and / or adhesive configured to engage the on-skin sensor assembly 160 with the needle holder assembly 2908 and / or the retainer 2924. Once the on-skin sensor assembly 160 is placed on the host skin 130, the on-skin sensor assembly 160 can be detached from the retainer 2924 and / or the needle holder assembly 2908.

[0282] Figure 30 Description according to some embodiments Figure 29 A perspective section view of a portion of the applicator 2900. Figure 30 This describes at least one protrusion 3024 of the needle carriage assembly 2908, the protrusion being configured as a track on the inner surface of the applicator housing 2902 defining a linear travel path of the needle carriage assembly 2908. Figure 30 (Not shown in the figure) Slides within the tracks 622a to 622c in Figure 6. Figure 30 Further describing channel 3002, the ridge 2916 of the rotary drive element 2914 is configured to slide when the spring 2912 rotates the rotary drive element 2914 relative to the needle carriage assembly 2908. Figure 30 Further explanation of the insertion element 3074 connected to the needle carriage assembly 2908.

[0283] In some embodiments, the retainer 2924 further includes a retaining element 3042, the retaining element being configured to engage with a retaining element of the applicator housing 2902. Figure 30 (Not shown in the figure) (similar to the stop element 644 of the applicator housing 462 in Figure 6) engages and secures the retainer 2924 to the applicator housing 2902 after the needle carriage assembly 2908 reaches the distal insertion position. Although Figure 30Not shown, but retainer 2928 may further include a protrusion and applicator housing 2902 may further include a protrusion configured to prevent retainer 2924 from traveling in the distal direction beyond the distal insertion position, similar to the previously combined Figure 6F The protrusions 652 and 654 are described.

[0284] Figure 31 This illustration shows a cross-sectional view of another applicator 3100 for an on-skin sensor assembly of an analyte sensor system according to some embodiments. In some embodiments, the applicator 3100 may include an applicator housing 3102 configured to house one or more mechanisms for applying the on-skin sensor assembly 160 to the skin 130 of a host. The applicator 3100 may further include a base 3130 coupled to the applicator housing 3102 and configured to form the bottom of the applicator 3100.

[0285] The applicator 3100 further includes an activation element of the drive assembly 3110 configured to activate the applicator 3100. Figure 31 (Not shown). In some embodiments, the activation element may be a button, switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable assembly, or any other suitable mechanism for activating the drive assembly of the applicator 3100. Additionally, the activation element of the applicator 3100 may be positioned in any location and orientation relative to the applicator housing 3102, such as at the top, any portion of the side, or the bottom of the applicator housing 3102 and / or at any angle relative to the portion of the applicator housing 3102 in which the activation element is housed. The applicator 3100 may further include a needle holder assembly 3108 comprising a sensor 138 detachably coupled to the skin sensor assembly 160 and configured to hold the sensor 138 (e.g., ...) of the skin sensor assembly 160. Figure 1 An insertion element 3174 is inserted into the host's skin 130. In some embodiments, the insertion element includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer coating needle, a hypodermic needle, a deflecting tip, or any other suitable type of needle or structure, such as one that is combined with at least Figures 47 to 50 And 80A to B are described in more detail. In other embodiments, the insertion element may include the sensor 138 itself, which is rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0286] The drive assembly 3110 is configured to drive the insertion element 3174 of the needle carriage assembly 3108 to a distal insertion position in a distal direction and to drive the insertion element from the distal insertion position to a proximal retraction position in a proximal direction. The drive assembly 3110 may include a guide member 3138, a spring 3112, a hub 3132, and a reversing element 3136. The guide member 3138 may be coupled to at least one of the applicator housing 3102 and the base 3130, respectively, at a first end and / or a second end. The spring 3112 may be disposed around the guide member 3138 such that the guide member 3138 extends generally along the centerline of the spring 3112. The spring 3112 may be any suitable type of spring, such as a compression spring, and may have a first end coupled to the base 3130 and a second end coupled to the hub 3132, which is disposed on the guide member 3138 and configured to travel along the guide member. Spring 3120 can be configured to drive hub 3132 in the proximal direction along guide member 3138, as shown by the arrow, after activation of drive assembly 3110. Reverse actuation element 3136 can generally function as a lever, with a fulcrum at or near its midpoint, said fulcrum being rotatably coupled to base 3130 or applicator housing 3102. A first end of reverse actuation element 3136 can contact a protrusion 3134 of hub 3132 for travel of at least a first portion of hub 3132 in the proximal direction, and a second end of reverse actuation element 3136 can contact needle carriage assembly 3108. Insertion assembly 3108 can be slidably coupled to guide member 3138 on one side of hub 3132 opposite to spring 3112.

[0287] In operation, after activation of the drive assembly 3110, the spring 3112 drives the hub 3132 along the guide member 3138 in the proximal direction. For the first portion of travel along the guide member 3138, the protrusion 3134 of the hub 3132 contacts the first end of the reverse actuating element 3136, causing the second end of the reverse actuating element 3136 to drive the needle carriage assembly 3138, insertion element 3174, and skin sensor assembly 160 in the distal direction. After the first portion of travel along the guide member 3138, the protrusion 3134 of the hub 3132 clears the first end of the reverse actuating element 3136 and contacts a portion of the needle carriage assembly 3138 slidably connected to the guide member 3138. At this point, the needle carriage assembly 3108, insertion element 3174, and skin sensor assembly 160 are in the distal insertion position. For the second portion traveling along the guide member 3138 in the proximal direction, the hub 3132, still driven by the spring 3112, drives the needle carriage assembly 3108 and the insertion element 3174 from the distal insertion position to the proximal retraction position in the proximal direction. In this way, the drive assembly 3110 converts the linear motion of the spring 3112 in a single direction (e.g., the proximal direction) into a reciprocating linear motion in the distal direction and subsequently in the proximal direction.

[0288] Figure 32A This illustration shows an exploded perspective view of another applicator 3200 for an on-skin sensor assembly of an analyte sensor system according to some embodiments. Applicator 3200 may include an applicator housing 3202 configured to receive at least one or more mechanisms for applying the on-skin sensor assembly 160 to the skin 130 of a host. Applicator 3200 may further include a base 3230 coupled to a bottom opening of the applicator housing 3202. Base 3230 defines a bottom surface of applicator 3200 and a plane for applying the on-skin sensor assembly 160 to the skin 130 of the host.

[0289] The applicator 3200 includes an activation element 3204 configured to activate the drive assembly of the applicator 3200. In some embodiments, the activation element 3204 may be a button, switch, toggle switch, slider, trigger, knob, rotating component, deformable and / or retractable component, or any other suitable mechanism for activating the drive assembly of the applicator 460.

[0290] The applicator 3200 may further include a needle holder assembly 3208, the needle holder assembly including a sensor 138 configured to insert the on-skin sensor assembly 160 into the host's skin 130 (e.g., Figure 1 Insertion element 3274 in ). In some embodiments, the insertion element includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as one that will be combined with at least Figures 47 to 50 And 80A to B are described in more detail. In other embodiments, the insertion element may include a sensor 138, which is rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0291] The applicator 3200 may further include a retainer 3224 detachably coupled to the needle holder assembly 3208 and configured to guide the on-skin sensor assembly 160 when coupled to the needle holder assembly 3208. As will be described in more detail below, once the on-skin sensor assembly 160 is placed on the host's skin 130, the on-skin sensor assembly 160 can be detached from the retainer 3224 and / or the needle holder assembly 3208.

[0292] The applicator 3200 may further include a drive assembly configured to drive the insert element 3274 and the needle carriage assembly 3208 to a distal insertion position in a distal direction and to drive the insert element and the needle carriage assembly from the distal insertion position to a proximal retraction position in a proximal direction. The drive assembly 3210 may include a first spring 3212 and a second spring 3228. The first spring 3212 may be a compression spring or any suitable type of spring and may have a first end coupled to the applicator housing 3202 and a second end coupled to the retainer 3224. The first spring 3212 is configured to drive the retainer 3224, along with the coupled needle carriage assembly 3208, insert element 3274, and skin sensor assembly 160, to the distal insertion position in a distal direction upon activation of the drive assembly 3210. Generally, at the distal insertion position, the needle carriage assembly 3208 can be decoupled from the retainer 3224 and the skin sensor assembly 160.

[0293] The second spring 3228 may be a compression spring or any suitable type of spring, and may have a first end coupled to the retainer 3224 and a second end coupled to the needle carriage assembly 3208. The second spring 3228 is configured to drive the needle carriage assembly 3208 and the insertion element 3274 from a distal insertion position to a proximal retraction position in a proximal direction. In some embodiments, the first spring and / or the second spring may be preloaded, partially loaded, or unloaded.

[0294] Figure 32B An exploded perspective view 3250 illustrating the needle holder assembly 3208 connected to the insertion element 3274, the second spring 3228, the retainer 3224, and the skin sensor assembly 160.

[0295] Figures 33A to 33E Description according to some embodiments Figures 32A to 32B A perspective sectional view of several features of the applicator 3200. Figure 33A The illustration shows a perspective sectional view of the entire applicator 3200, which includes an applicator housing 3202, an activation element 3204, a first spring 3212, a needle holder assembly 3208 coupled to an insertion element 3274, a retainer 3224 coupled to a skin sensor assembly 160, and a base 3230. Each of these components may have at least as previously described... Figures 32A to 32B The described functionality.

[0296] Figure 33BAn enlarged perspective cross-sectional view illustrating the retaining element 3312 of the holder 3224, which is detachably coupled to the applicator housing 3202. The retaining element 3312 is configured to prevent the holder 3224 from traveling in the distal direction and thus prevent the spring 3212 from being unloaded. When activated, the activation mechanism 3204 is configured to fully deflect the retaining element 3312 to decouple it from the applicator housing 3202, thereby releasing the holder 3224 from traveling in the distal direction driven by the spring 3212.

[0297] Figure 33C This illustration shows an enlarged perspective cross-sectional view of the retaining element 3342 of the needle carriage assembly 3208, configured to detachably connect the needle carriage assembly 3208 to the retainer 3224. As shown, the retaining element 3342 may have an inclined surface configured to contact a protrusion (not shown in FIG. 33) of the applicator housing 3202 or base 3230 (not shown in FIG. 33), the inclined surface being configured to sufficiently deflect the retaining element 3342 to decouple the needle carriage assembly 3208 from the retainer 3224 when the needle carriage assembly 3208 is in or near the distal insertion position.

[0298] Figure 33D A perspective view illustrating a plurality of retaining elements 3372a, 3372b of the needle holder assembly 3208 is shown, the retaining elements being configured to pass through the retainer 3224 and detachably connect the on-skin sensor assembly 160 to the retainer 3224 and the needle holder assembly 3208. As previously described, at the distal insertion position, a deflected retaining element 3342 decouples the needle holder assembly 3208 from the retainer 3224, such that a second spring 3228 actuates the needle holder assembly 3208 in the proximal direction. When the needle holder assembly 3208 is actuated in the proximal direction, the retaining elements 3372a, 3372b disengage from the on-skin sensor assembly 160. Although two retaining elements are shown, any number of retaining elements are contemplated. In some embodiments, the retaining elements 3372a, 3372b may include a snap-fit, friction fit, interference feature, resilient clamp, and / or adhesive configured to connect the on-skin sensor assembly 160 to the needle holder assembly 3208 and / or the retainer 3224. In addition, the following text combines at least Figures 35A to 37C Further describe alternative mechanisms that can perform these hold and release actions.

[0299] Figure 33E The illustration shows a perspective cross-sectional view of the retaining element 3346 of the retainer 3224 and the retaining element 3348 of the applicator housing 3202, the retaining elements being configured to secure the needle carriage assembly 3208 to the retainer 3346 after the needle carriage assembly 3208 has reached the distal insertion position. This interaction secures the insertion element 3274 in the proximal retracted position, thereby ensuring that the end of the insertion element 3274 is not exposed outside the bottom of the applicator 3200.

[0300] The following is relative to Figure 34A The operation of the applicator 3200 is briefly described up to 34F, and the figures illustrate several perspective views of the applicator of FIG32 during operation according to some embodiments.

[0301] Figure 34A This describes the state of the applicator 3200 when activated. For example, the activation element 3204 is shown as being activated after being pushed down by the user. The activation element 3204 deflects the retaining element 3312 so as not to prevent the holder 3224 from traveling in the distal direction. The holder 3224, the needle carriage assembly 3208, the insertion element 3274, the first spring 3212, and the second spring 3228 are all shown in the pre-activated position.

[0302] Figure 34B The applicator 3200 is described during activation. The activation element 3204 is described as being in the activation position. The spring 3212 drives the retainer 3224, the needle holder assembly 3208, the insertion element 3274, and the skin sensor assembly 160 toward the distal insertion position in the distal direction.

[0303] Figure 34C The applicator 3200 is described during activation when the needle holder assembly 3208 approaches the distal insertion position. The activation element 3204 is illustrated in the activation position. The insertion assembly 3208, insertion element 3274, retainer 3224, and on-skin sensor assembly 160 are driven to the distal insertion position in the distal direction. At or near this distal insertion position, at least a portion of the insertion element 3274 and at least a portion of the sensor 138 of the on-skin sensor assembly 160 can be inserted into the host's skin. At this position, the retaining element 3342 is deflected by a portion of the applicator housing 3302 or base 3230, thereby decoupling the needle holder assembly 3208 from the retainer 3224.

[0304] Figure 34D The applicator 3200 is described during activation. The activation element 3204 is shown in the activated position. A second spring 3228 drives the needle holder assembly 3208 and the insertion element 3274 from the distal insertion position in the proximal direction. Although... Figure 34D Not shown, but once the needle carriage assembly reaches the proximal retracted position, retaining elements 3346 and 3348 can engage with each other to secure the needle carriage assembly 3208 and the insertion element 3274 in the proximal retracted position, thereby holding the insertion element 3274 in the locked retracted position.

[0305] Figures 35A to 35C Several cross-sectional views illustrating the skin sensor assembly holding mechanism of the applicator 3200 of FIG32 according to some embodiments are shown. Figures 35A to 35CThe described retention mechanism is similar to that of the previous binding. Figures 6A to 6H The retention mechanism described. Figure 35A The retention mechanism when the applicator 3200 is in a pre-activated state is described. The retaining element 3372a is described as part of the retainer 3224 and is configured to detachably engage the on-skin sensor assembly 160 to the retainer 3224 when the needle carriage assembly 3208 travels in the distal direction to the distal insertion position, and to decouple the on-skin sensor assembly 160 from the retainer 3224 when the needle carriage assembly 3208 travels in the proximal direction from the distal insertion position toward the proximal retraction position. Specifically, the retaining element 3372a may include a first end 3376a and a second end 3378a. The second end may be detachably engaged with the on-skin sensor assembly 160 in the pre-activated state. As previously described, the retaining elements 3372a, 3372b may include snap-fit, friction fit, interference features, resilient clamps, and / or adhesives configured to engage the on-skin sensor assembly 160 with the needle carriage assembly 3208 and / or the retainer 3224. Figure 35A Further description of the applicator housing 3202 includes an optional reinforcing element 3510 configured to prevent lateral movement of the retaining element 3372a in a proximal starting position, thereby supporting a detachable connection of a second end 3378a of the retaining element 3372a to the sensor assembly 160 on the skin.

[0306] Figure 35B The applicator 3200 is described in the activated distal insertion position. When the needle carriage assembly 3208 travels in the distal direction to the distal insertion position, the retaining element 3342 of the needle carriage assembly 3208 is released from the retainer 3224. The second end of the retaining element 3372a can still be detachably coupled to the sensor assembly 160 on the skin. Figure 35B Further explanation of the optional reinforcing element 3510 is provided because it no longer has physical contact with the retaining element 3372a at the distal insertion position, thereby decoupling the second end 3378a of the retaining element 3372a from the sensor assembly 160 on the skin.

[0307] Figure 35C The applicator 3200 is described, wherein the needle carriage assembly 3208 moves in the proximal direction from a distal insertion position. Since the retaining element 3342 of the needle carriage assembly 3208 is decoupled from the retainer 3224 at the distal insertion position, the needle carriage assembly 3208 disengages from the retainer 3224 as it travels rearward in the proximal direction. As the needle carriage assembly 3208 travels in the proximal direction, the first end 3376a of the retaining element 3372a is deflected by the needle carriage assembly 3208, thereby decoupling the second end 3378a of the retaining element 3372a from the skin sensor assembly 160. Figure 35CFurther explanation of the optional reinforcing element 3510 is given, as it no longer has physical contact with the retaining element 3372a at the distal insertion position.

[0308] Figures 36A to 36C Several cross-sectional views illustrating another on-skin sensor assembly holding mechanism of the applicator 3200 of FIG32 according to some embodiments. Figure 36A The retention mechanism when the applicator 3200 is in the pre-activated state is described. The retention element 3372a is described as part of the needle carriage assembly 3208 and configured to detachably engage the on-skin sensor assembly 160 to the retainer 3224 when the needle carriage assembly 3208 travels in the distal direction to the distal insertion position, and to decouple the on-skin sensor assembly 160 from the retainer 3224 when the needle carriage assembly 3208 travels in the proximal direction from the distal insertion position toward the proximal retraction position. Specifically, the retention element 3372a is detachably engaged with the on-skin sensor assembly 160 when the needle carriage assembly 3208 travels in the distal direction to the distal insertion position. Figure 36A Further description of the applicator housing 3202 includes an optional reinforcing element 3610 configured to prevent lateral movement of the retaining element 3372a and / or retaining element 3342 in the proximal starting position, thereby supporting a detachable connection of the retaining element 3372a to the sensor assembly 160 on the skin.

[0309] Figure 36B The applicator 3200 is described at the distal insertion position. The retaining element 3342 of the needle carriage assembly 3208 is decoupled from the retainer 3224 at the distal insertion position. The retaining element 3224 is sufficiently deflected by a portion of the applicator housing 3202 or the applicator base of the applicator housing 3202 to clear the stop element of the needle carriage assembly. Therefore, as the needle carriage assembly 3208 travels rearward in the proximal direction by the force provided by the spring 3228, the needle carriage assembly 3208 separates from the retainer 3224. The retaining element 3372a is configured to be easily deflected or deformed by the separation of the retainer 3224 from the needle carriage assembly 3208, rather than physically deflected as the needle carriage assembly 3208 travels in the proximal direction. Figure 36B Further explanation of the optional reinforcing element 3610 is given because it is no longer in physical contact with retaining element 3372a and / or retaining element 3342 in the distal insertion position, thereby decoupling retaining element 3372a from the skin sensor assembly 160 and / or decoupling retainer 3224 from the needle holder assembly 3208.

[0310] Figure 36C This indicates that in the proximal direction from Figure 36BThe needle carriage assembly 3208 moves to the distal insertion position. As shown, by separating the needle carriage assembly 3208 from the retainer 3224, the retaining element 3372a is released from the sensor assembly 160 on the skin and the needle carriage assembly 3208 is driven in the proximal direction by the force provided by the spring 3228. Figure 36C To further clarify, the optional reinforcing element 3610 no longer has physical contact with retaining element 3372a and / or retaining element 3342 in the proximal retracted position.

[0311] Figures 37A to 37C Several cross-sectional views illustrating another skin sensor assembly holding mechanism of the applicator 3200 of FIG32 according to some embodiments. Figure 37A Description of the applicator 3200 in the pre-activated position. Holding element 3372a in... Figure 37A The description refers to the retainer 3208 as an integral part of it, and it is configured to detachably connect the skin sensor assembly 160 to the retainer 3224 when the needle carriage assembly 3208 travels in the distal direction to the distal insertion position, and to decouple the skin sensor assembly 160 from the retainer 3224 when the needle carriage assembly 3208 travels in the proximal direction from the distal insertion position to the proximal retraction position. Specifically, when the needle carriage assembly 3208 travels in the distal direction to the distal insertion position, the retaining element 3372a is detachably connected to the skin sensor assembly 160. Figure 37A Further description of the applicator housing 3202 includes an optional first reinforcing element 3710 configured to prevent lateral movement of the retaining element 3342 in the proximal retracted position. Figure 37A Further description of the needle holder 3208 includes an optional second reinforcing element 3712 configured to prevent lateral movement of the retaining element 3372a, thereby supporting a detachable connection of the retaining element 3372a to the sensor assembly 160 on the skin.

[0312] Figure 37B The needle carriage assembly 3208 is described in the distal insertion position. The retaining element 3342 of the needle carriage assembly 3208 is engaged with the retainer 3224 at the distal insertion position. Therefore, when the spring 3228 is unloaded, under the force provided by the spring 3228, as the needle carriage assembly 3208 travels rearward in the proximal direction, the needle carriage assembly 3208 separates from the retainer 3224 and is pushed against the retainer 3224 and the needle carriage assembly 3208. Figure 37B Further explanation of the optional first reinforcing element 3710 is provided, as it no longer physically contacts the retaining element 3342 in the distal insertion position, thereby decoupling the retainer 3224 from the needle carriage assembly 3208. The optional second reinforcing element 3712 is also described as physically contacting the retaining element 3372a in the distal insertion position.

[0313] Figure 37C This explains that after the retaining element 3372a of the needle carriage assembly 3208 is decoupled from the retainer 3224, the needle carriage assembly begins to travel in the proximal direction. When the needle carriage assembly 3208 travels in the proximal direction, the retaining element 3372a does not... Figures 35A to 35C Instead of physical deflection in orientation, the applicator 3200 is simply separated from the on-skin sensor assembly 160 by the user removing it from the skin. In some embodiments, when the applicator 3200 is removed from the skin, an adhesive patch holding the on-skin sensor assembly 160 to the host skin provides sufficient bonding strength to decouple the on-skin sensor assembly 160 from the host skin. Figure 37C Further explanation of the optional first reinforcing element 3710 is that it no longer has physical contact with the retaining element 3372a in the proximal retracted position, thereby supporting the decoupling of the retaining element 3372a from the sensor assembly 160 on the skin.

[0314] Figure 38 The description, based on a perspective view similar to that shown in FIG. 32 of some embodiments of the applicator 3800, indicates that the applicator includes an activation element 3804 on one side of the applicator housing 3802. Except that the activation element 3804 is located on one side of the applicator housing 3802 rather than on the top of the applicator housing, the applicator 3800 may have substantially the same features as any of the applicators 3200 of FIG. 32. This arrangement can provide an applicator with a reduced height compared to a top-activated applicator, but with a potentially increased width or diameter compared to a top-activated applicator.

[0315] Figure 39 Description according to some embodiments Figure 38 A cross-sectional view of a portion of the applicator 3800. The activation element 3804 is configured to deflect the retaining element 3902 of the retainer 3824 upon activation, the retaining element being configured to prevent the retainer 3824 from traveling in the distal direction. All other features of the applicator 3800 not discussed are substantially the same as those previously described with respect to either applicator 3200 of FIG. 32.

[0316] Figures 40A to 40G Several perspective views illustrate the assembly process of the applicator for FIG32 according to some embodiments. Figure 40A The instructions state that the second spring 3228 is inserted into the retainer 3224. Figure 40B The description then explains that the insertion element 3274 is inserted into the needle carriage assembly 3208, and subsequently, the insertion element 3274 inserted into the needle carriage assembly 3208 is inserted into the retainer 3224. In some embodiments, the insertion element 3274 inserted into the needle carriage assembly 3208 is inserted into the retainer 3224 to pre-compress the second spring 3228. Figure 40C This describes the retention element ( ) of the retainer 3224 or the needle carriage assembly 3208. Figure 40C (Not shown in the image) The attachment point of the sensor assembly 160 on the skin ( Figure 40C (Not shown) The skin sensor assembly 160 is connected to at least one of the holder 3224 and the needle holder assembly 3208.

[0317] Figure 40D The instructions specify that the activation element 3204 is connected to the applicator housing 3202. Figure 40D In this embodiment, the activation element 3204 is attached to the top of the applicator housing 3202. In some embodiments, the activation element 3204 may be pressed into an opening in the applicator housing 3202 configured to receive the activation element 3204. However, in other embodiments, the applicator housing 3202 may accommodate the activation element 3204 in other locations, such as the upper, middle, or lower side of the applicator housing. Figure 40E The instructions state that the first spring 3212 is inserted into the applicator housing 3202. Figure 40F The explanation will be in the future. Figure 40C The components described herein (including retainer 3224, second spring 3228, needle holder assembly 3208, insertion element 3274, and skin sensor assembly 160) are inserted into the applicator housing 3202. In some embodiments, the insertion... Figure 40C The component described herein pre-compresses the first spring 3212. Figure 40G This describes how to connect the base 3230 to the applicator housing 3202.

[0318] Skin sensor component retention mechanism In some embodiments of the applicator described herein, the on-skin sensor assembly 160 is held in situ during travel, at least in the distal direction, to the distal insertion position. In some such embodiments, the on-skin sensor assembly 160 is then released or decoupled from a portion of the applicator during application to the host's skin, allowing the needle holder assembly and insertion element to travel rearward in the proximal direction. Figures 41A to 45 This describes several alternative retention mechanisms that can be used with any of the applicators described herein.

[0319] Figures 41A to 41B This describes an exemplary skin-on sensor assembly retention mechanism for an applicator in an analytical material sensor system, according to some embodiments. Figures 41A to 41B The described retention mechanism can be viewed as maintaining the configuration of the sensor components on the first skin, and is similar to the previously described combination. Figure 5 The retention mechanism described.

[0320] Figure 41A This explains the holding mechanism of the sensor assembly 160 while it is held in place on the skin. Figure 41B Explain the retention mechanism when the sensor assembly 160 is decoupled from the skin.

[0321] Figure 41A The retaining elements 4172a and 4172b of the retainer 4124 are described, and these retaining elements are configured to detachably engage the skin sensor assembly 160 to the retainer 4124 when the needle carriage assembly 4108 (and the insertion element 4172, the retainer 4124, and the skin sensor assembly 160) travels in the distal direction to the distal insertion position. Specifically, the retaining elements 4172a and 4172b may each include a first end 4176a and 4176b, a second end 4178a and 4178b, and a pivot point 4180a and 4180b. The first ends 4176a and 4176b are fixed in the corresponding guides 4174a and 4174b of the needle holder assembly 4108, and each of the retaining elements 4172a and 4172b is fixed relative to the interference points 4182a and 4182b of the needle holder assembly 4108, so that when the needle holder assembly 4108 travels in the distal direction to the distal insertion position, the second ends 4178a and 4178b are detachably connected and fixed to the attachment points 4162a and 4162b of the sensor assembly 160 on the skin. In some embodiments, the contours of the slots 4174a, 4174b allow the sides of the slots 4174a, 4174b to apply force to the first ends 4176a, 4176b of the retaining elements 4172a, 4172b, sufficient to hold the second ends 4178a, 4178b of the retaining elements 4172a, 4172b engaged with the attachment points 4162a, 4162b of the sensor assembly 160 on the skin. Although two retaining elements have been described, any number of retaining elements is contemplated.

[0322] Figure 41B The retention mechanism is explained as the needle carriage assembly 4108 and the insertion element 4174 travel from the distal insertion position to the proximal retraction position in the proximal direction. As the needle carriage assembly 4108 travels rearward in the proximal direction, it separates from the retainer 4124, thereby removing the first ends 4176a, 4176b of the retaining elements 4172a, 4172b from the corresponding slots 4174a, 4174b. This causes the first ends 4176a, 4176b of the retaining elements 4172a, 4172b to deflect inward from the attachment points 4162a, 4162b of the sensor assembly 160 on the skin, and the second ends 4178a, 4178b to deflect outward, as the retaining elements 4172a, 4172b rotate about the pivot points 4180a, 4180b.

[0323] Figures 42A to 42B This describes an exemplary skin-on sensor assembly retention mechanism for an applicator in an analytical material sensor system, according to some embodiments. Figures 42A to 42B The retention mechanism described can be viewed as the sensor assembly on the second skin being kept in a fixed configuration, and is similar to the retention mechanism previously described in conjunction with Figure 36. Figure 42A This explains the holding mechanism of the sensor assembly 160 while it is held in place on the skin. Figure 42B Explain the retention mechanism when the sensor assembly 160 is decoupled from the skin.

[0324] Figure 42A It is noted that retaining elements 4272a and 4272b are portions of the needle carriage assembly 4208 that pass through or surround the needle carriage assembly 4208, rather than being portions of the retainer 4224. Retaining elements 4272a and 4272b are configured to detachably connect the supra-skin sensor assembly 160 to the retainer 4228 as the needle carriage assembly 4208 (along with the insertion element, retainer 4224, and supra-skin sensor assembly 4224) travels in the distal direction to the distal insertion position.

[0325] Figure 42B This describes the retention mechanism when the needle carriage assembly 4208 and the insertion element 4274 travel in the proximal direction from the distal insertion position to the proximal retraction position. During the proximal travel of the needle carriage assembly 4208, the needle carriage assembly 2508 separates from the retainer 4224, and the retaining elements 4272a, 4272b decouple from the corresponding attachment points 4262a, 4262b of the skin sensor assembly 160. When the needle carriage assembly 4208 travels in the proximal direction, the retaining elements 4272a, 4272b do not... Figures 41A to 41B The retaining elements 4172a and 4172b are not physically deflected in orientation, but rather pulled out of the attachment points 4262a and 4262b by retraction energy.

[0326] Figures 43A to 43B This describes an exemplary skin-on sensor assembly retention mechanism for an applicator in an analytical material sensor system, according to some embodiments. Figures 43A to 43B The retention mechanism described can be considered a passive buckle design. Figure 43A This explains the holding mechanism of the sensor assembly 160 while it is held in place on the skin. Figure 43B Explain the retention mechanism when the sensor assembly 160 is decoupled from the skin.

[0327] Figure 43A It is explained that retaining elements 4372a and 4372b are part of retainer 4324. Retaining elements 4372a and 4372b are configured to detachably connect the skin sensor assembly 160 to retainer 4324 when the needle carriage assembly 4308 (and the insertion element, retainer 4324 and skin sensor assembly 4324) travels in the distal direction to the distal insertion position. Figure 43AFurther explanation is provided regarding the protrusions 4380a and 4380b of the needle holder assembly 4308, which are configured to physically contact the retaining elements 4372a and 4372b of the retainer 4324, thereby preventing the retaining elements 4372a and 4372b from disengaging from the sensor assembly 4324 on the skin when the needle holder assembly 4308 contacts the retainer 4324.

[0328] Figure 43B This describes the retention mechanism of the needle carriage assembly 4308 as it travels in the proximal direction from the distal insertion position to the proximal retraction position. During the proximal travel of the needle carriage assembly 4308, the needle carriage assembly 4308 separates from the retainer 4324. Although Figures 43A to 43B Not shown in the text, but can be accessed through similar methods. Figure 6E One or more retaining elements 642, 644 secure the retainer 4324 to the applicator housing or base. Therefore, when the applicator is removed from the host's skin, the retaining elements 4372a, 4372b can be decoupled from the corresponding attachment points 4362a, 4362b of the on-skin sensor assembly 160. In some embodiments, when the applicator is removed from the skin, the adhesive patch holding the on-skin sensor assembly 160 to the host's skin provides sufficient bonding strength to decouple the on-skin sensor assembly 160 from the host's skin.

[0329] Figure 44 This describes another part of an exemplary skin-on sensor assembly retention mechanism for an applicator in an analytical material sensor system, according to some embodiments. Figure 44 The needle holder assembly 4408, retainer 4424, and on-skin sensor assembly 160 are described. Contrary to several prior embodiments of the retention mechanism for the on-skin sensor assembly 160, the needle holder assembly 4408 includes at least one retaining element 4472a, and the retainer 4424 includes at least one alignment element 4473a, wherein the retaining element 4472a is configured to be detachably coupled to the on-skin sensor assembly 160, and the alignment element 4473a is configured to align the on-skin sensor assembly 160 within the applicator. This distribution of retaining elements between the needle holder assembly and the retainer can be implemented for any on-skin sensor assembly retention mechanism described herein.

[0330] Figure 45 and 46 This section describes a portion of an exemplary skin-on sensor assembly retention mechanism for an applicator of an analytical material sensor system according to some embodiments. Figure 45 and 46 This description is similar to the previous combination. Figure 5 The described needle holder assemblies 4508 and 4608; rotation drive elements 4514 and 4614; and skin sensor assembly 160. Therefore, Figure 45 and Figure 46 The retention mechanism can be similar to Figure 5 It functions as described herein. The rotary drive elements 4514, 4614 may be wheel cams and may include cam lobes 4518 (e.g., ramps or protrusions) disposed along at least a portion of the circumference of the rotary drive elements 4514, 4614. Figure 46 Not shown in the text, see below. Figure 45 ).exist Figure 45 In the process, as the rotary drive element 4514 rotates, the protrusion 4518 can travel side by side with the needle holder assembly 4508, and contact the skin sensor assembly 160 and gradually apply force to it, so that the skin sensor assembly 160 is decoupled from the needle holder assembly 4508. Figure 46 As the rotary drive element 4614 rotates, the protrusion can travel at least partially through the guide or slot 4620 in the needle holder assembly 4608 and contact the skin sensor assembly 160, gradually applying force to it, thereby decoupling the skin sensor assembly 160 from the needle holder assembly 4608. In this way, the rotary drive elements 4514, 4614 can be used to drive the needle holder assemblies 4508, 4608 in both distal and proximal directions, as previously described. Figure 5 As described, and after being deposited onto the host's skin, the sensor assembly 160 is released onto the skin.

[0331] In some embodiments, the on-skin sensor assembly retention mechanism may include features for attaching the on-skin sensor assembly to a needle holder assembly and / or a retainer. Methods for attaching the on-skin sensor assembly are described in U.S. Patent Application No. 15 / 387088, the entire contents of which are incorporated herein by reference. For non-limiting examples, the on-skin sensor assembly retention mechanism may include a fragile release element (e.g., Figures 137-140), a fragile elastomer (e.g., Figures 134-136), a removable adhesive (e.g., Figures 123-125), or a removable friction-fit connection (e.g., Figures 126-133).

[0332] For example, in the current embodiment, a fragile release element can be implemented via a structure attached between a sensor assembly (e.g., 160), a retainer (e.g., 524), a needle holder (e.g., 508), and / or an applicator housing (e.g., 502) on the skin. The fragile component may include features having a weakened portion or a portion designated to break during release of the sensor assembly from the applicator. The fragile component configured to break may comprise a patch material (e.g., spun lace) or a molded component (e.g., ABS, PC, polymers, elastic polymers, etc.).

[0333] For example, in the current embodiment, the removable adhesive can be implemented by a removable adhesive that is detachably attached between the sensor assembly (e.g., 160), the retainer (e.g., 524), the needle holder (e.g., 508), and / or the applicator housing (e.g., 502) on the skin. The removable adhesive may be made of double-sided tape, glue, or a hot melt polymer. The removable adhesive is configured to detach during the release of the sensor assembly from the applicator by an applicator mechanism (e.g., a retraction mechanism) or user force.

[0334] For example, in the current embodiment, a detachable friction-fit connection can be implemented through surface contact between a skin sensor assembly (e.g., 160), a retainer (e.g., 524), a needle holder (e.g., 508), and / or an applicator housing (e.g., 502). The detachable friction-fit connection can be made of rigid or elastic materials (e.g., silicone, TPE, TPU, rubber, etc.) or combinations thereof. The connection components (e.g., skin sensor assembly 160 and retainer 524) have frictional material interactions (e.g., interference fit, deformable fit, etc.). The detachable friction-fit connection is configured to disengage during the release of the skin sensor assembly from the applicator by an applicator mechanism (e.g., a retraction mechanism) or user force.

[0335] Among other things, the following is relative to Figures 71 to 89 The discussion may involve applicators that take into account skin bulges (e.g., skin that bends in a generally convex manner when the host pushes the applicator against the skin). Figures 71 to 89 This could further involve preventing the insertion mechanism, components, or springs from stopping due to such skin bulges, or, in other aspects, initiating retraction after insertion based on sensor components on the skin and / or other features of the applicator that press against the host's skin with a force sufficient to initiate retraction, rather than being triggered by the sensor components on the skin and / or other features of the applicator reaching a predetermined physical displacement in the distal direction. Such a force-based retraction trigger is contemplated to allow insertion to be converted into retraction at multiple distal displacement locations, at least in part, based on the position of the host's skin surface during application.

[0336] Figure 71This describes an applicator 7100 for a skin sensor assembly in an analyte sensor system according to some embodiments. As will be described below, the applicator 7100 may include an activation element 7104 disposed on one side of the applicator 7100, for example, on one side of the outer housing 7101 of the applicator 7100. In some embodiments, the activation element 7104 may be a button, switch, toggle switch, slider, trigger, knob, rotating component, part of the deforming and / or retracting applicator 7100, or any other suitable mechanism for activating the insertion and / or retraction assembly of the applicator 7100. In some embodiments, the activation element 7104 may be disposed in a position, such as the top, upper side, lower side, or any other position of the applicator 7100. The applicator 7100 may be large enough that the body can be held by hand and the activation element 7104 can be activated by pushing or otherwise using, for example, the thumb or index and / or middle finger.

[0337] The applicator 7100 can be configured to have one or more safety features that prevent activation of the applicator 7100 until the safety features are deactivated. In one instance, one or more safety features prevent the applicator 7100 from activating unless the applicator 7100 is pressed against the host's skin with sufficient force. Furthermore, as will be discussed below... Figures 72 to 80B As described in more detail in one or more of the descriptions, the applicator 7100 may be further configured such that one or more of its components retract at least in part based on one or more components being pushed toward the host skin with a force exceeding a predetermined threshold, rather than based on one or more components being translated beyond a predetermined static distal position. In other words, the applicator 7100 may implement force-based retraction triggering, but is not limited to displacement-based retraction triggering.

[0338] Figure 72 Description according to some embodiments Figure 71 An exploded perspective view of the applicator 7100. The applicator 7100 may include an outer applicator housing 7101, which includes an activation element 7104. The outer applicator housing 7101 may be configured to translate in a distal direction by a force applied by the host to the applicator 7100, particularly the inner housing 7102, thereby aligning the activation element 7104 at a position that allows the applicator 7100 to be activated. Further explanation of the alignment process will be provided below.

[0339] The applicator 7100 further includes an inner housing 7102 configured to receive at least one or more mechanisms for applying the on-skin sensor assembly 360 to the host's skin 130. A distal surface 7130 of the bottom opening of the inner housing 7102 may define a bottom surface of the applicator 7100. In some embodiments, after the applicator 7100 is pressed onto the host's skin 130, the skin 130 may deform substantially convexly at the distal surface 7130, such that at least a portion of the surface of the skin 130 disposed at the bottom opening of the applicator housing 7102 extends into the bottom opening of the inner housing 7102 beyond the plane defined by the distal surface 7130 in the proximal direction.

[0340] In some embodiments, a first barrier layer 7192 may be disposed over one or more openings (e.g., opening 7106) in the inner housing 7102, and at least a portion of the activation element 7104 may be configured to extend through the openings during activation of the applicator 7100. In such embodiments, a portion of the activation element 7104 may be configured to pierce or deform the first barrier layer 7192 after activation of the applicator 7100. The first barrier layer 7192 may comprise a gas-permeable material, such as Tyvek, or a non-gas-permeable material, such as a metal foil, polymer film, elastomer, or any other suitable material.

[0341] The applicator 7100 may further include a needle holder assembly 7108, which includes a needle hub 7150 configured to engage the insertion element 7174 to the needle holder assembly 7108. In some other embodiments, the insertion element 7174 may be directly engaged to the needle holder assembly 7108. The insertion element 7174 is configured to engage the sensor 338 of the sensor assembly 360 on the skin (see...). Figures 3A to 4 ) Inserted into the host's skin 130 (e.g., Figure 1 In some embodiments, the insertion element includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer-coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as in combination with at least Figures 47 to 50 As described in 80A to B. In other embodiments, the insertion element 7174 may be integrally formed with the sensor 338 and may be rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0342] The applicator 7100 may further include a retainer 7124 detachably coupled to the needle carriage assembly 7108 and configured to guide the needle carriage assembly 7108 and the on-skin sensor assembly 360 when coupled to the needle carriage assembly 7108, for example, at least during translation from a proximal position to a distal insertion position. As will be described in more detail below, once the on-skin sensor assembly 360 is placed on the host's skin 130, the on-skin sensor assembly 360 can be peeled off or released from the retainer 7124 and / or the needle carriage assembly 7108.

[0343] The applicator 7100 may further include an insertion assembly configured to translate the insertion element 7174, needle hub 7150, needle carriage assembly 7108, and skin sensor assembly 360 from a proximal position to a distal insertion position in a distal direction. This insertion assembly may include a first spring 7112. The first spring 7112 may be a compression spring or any suitable type of spring and may have a first end that contacts or engages with the internal applicator housing 7102 and a second end that contacts or engages with the retainer 7124. The first spring 7112 is configured to translate the retainer 7124, needle carriage assembly 7108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 to the distal insertion position in a distal direction upon activation of the insertion assembly. Generally, at the distal insertion position, the needle carriage assembly 7108 can be decoupled from the retainer 7124 and the skin sensor assembly 360.

[0344] The applicator 7100 may further include a retraction assembly configured to translate the needle carriage assembly 7108, needle hub 7150, and insertion element 7174 from a distal insertion position to a proximal retraction position in a proximal direction. In some embodiments, the initial proximal position may be the same as the proximal retraction position. In other embodiments, the initial proximal position may be different from the proximal retraction position. This retraction assembly may include a second spring 7128. The second spring 7128 may be a compression spring or any suitable type of spring, and may have a first end that contacts or engages with the retainer 7124 and a spring retaining element (e.g., Figures 74A to 75B 7442a, 7442b) of the second spring 7128 contacts or engages with the second end at least until retraction. The second spring 7128 is configured to respond to contact of the sensor assembly 360 on the skin with the host's skin 130 and / or to such extent that the first end of the second spring 7128 overcomes at least one spring retaining element (e.g., Figures 74A to 75BThe force exceeding a predetermined threshold (7442a, 7442b) reaches the travel limit, thereby translating the needle carriage assembly 7108, needle hub 7150, and insertion element 7174 from the distal insertion position to the proximal retraction position in the proximal direction. In some embodiments, a backstop feature (not shown) may be disposed at the bottom of the applicator 7100, for example, on the distal portion of the inner housing 7102. This backstop feature may be configured to contact one or more of the sensor assembly 360, needle carriage 7108, or retainer 7124 on the skin in the distal insertion position.

[0345] In some embodiments, the transfer of the skin sensor assembly 360 between insertion and retraction can be combined as previously described, for example... Figures 35A to 37C Any of the events described in the text will occur.

[0346] In some embodiments, a second barrier layer 7194 may be disposed above the bottom opening of the inner housing 7102. The second barrier layer 7194 may comprise a gas-permeable material such as Tyvek, or a non-gas-permeable material such as a metal foil or membrane. In some embodiments, the second barrier layer 7194 may be removed by the host prior to the use of the applicator 7100. In embodiments including one or both of the first barrier layer 7192 and the second barrier layer 7194, such layers may provide a sterile environment between the applicator 7100 and the external environment and / or may allow the entry and exit of gases, for example, during sterilization.

[0347] although Figures 71 to 72 Not shown, but in some embodiments, the applicator 7100 may include a cap configured to be secured to the distal surface 7130 of the inner housing 7102 and removable prior to use. In some embodiments, such a cap may also serve as a sterile barrier, as described in U.S. Patent Application No. 16 / 011527, which is incorporated herein by reference in its entirety.

[0348] The following is relative to Figures 73A to 73C Briefly describe some aspects of the operation of the applicator 7100, the figures illustrating operation according to some embodiments. Figure 71 and 72 Several cross-sectional views of the applicator 7100. Figures 73A to 73C For example, it can correspond to along Figure 71 The applicator 7100 for cutting the section line A-A' shown in the image.

[0349] Figure 73AThis describes the state of the applicator 7100 before activation. The retainer 7124 includes an insertion component retaining element 7332 configured to contact the inner housing 7102, thereby securing the retainer 7124, needle holder assembly 7108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 in the pre-activated state.

[0350] The needle holder assembly 7108 includes a plurality of wearable retention and / or alignment elements 7372a, 7372b configured to extend through the retainer 7124 and detachably attach the on-skin sensor assembly 360 to the retainer 7124 and / or the needle holder assembly 7108. The wearable retention elements 7372a, 7372b may include, for example, arms, deflection elements, tabs, pawls, hooks, or any other features with retention functionality. In some embodiments, the wearable retention elements 7372a, 7372b may extend around rather than through the retainer 7124. Although two wearable retention elements are described, any number of wearable retention elements are contemplated. In some embodiments, the wearable retention elements 7372a, 7372b may include hook-and-loop engagements, friction engagements, interference features, resilient clamps, and / or adhesives configured to attach the on-skin sensor assembly 360 to the needle holder assembly 7108 and / or the retainer 7124.

[0351] The inner housing 7102 may include a spring 7320, the spring being configured to... Figure 73A The pre-activated orientation contacts the outer housing 7101 and maintains a predetermined distance between the outer housing 7101 and the inner housing 7102. The spring 7320 may be a compression spring, a leaf spring, a retractable arm spring, a piece of foam, or rubber, etc. In some other embodiments, the outer housing 7101 may include the spring 7320, and the spring 7320 may be configured to interact with... Figure 73A The internal housing 7102 is contacted in the opposite manner.

[0352] The activation applicator 7100 may involve the host pressing the applicator 7100 onto their skin with sufficient force to cause the outer housing 7101 to translate distally (as indicated by arrow 7302) toward and relative to the inner housing 7102 until the activation element 7104 is aligned with the aperture 7106 of the inner housing 7102 and the insertion assembly retaining element 7332 of the retainer 7124. The insertion assembly retaining element 7332 may include, for example, an arm, a deflecting element, a tab, a pawl, a latch, or any other feature with a retaining function. Once this alignment is achieved, the host may initialize (e.g., push) the activation element 7104, as indicated by arrow 7304, thereby fully deflecting the insertion assembly retaining element 7332 to release the retainer 7124 from the inner housing 7102. In some other embodiments, the applicator 7100 may be configured such that the activation element 7104 may be activated initially, but actual insertion is not triggered until the outer housing 7101 has been sufficiently translated toward and relative to the inner housing 7102 in the distal direction. In still other embodiments, the activation element 7104 may be biased toward the center of the applicator 7100 such that the activation element 7104 does not require explicit activation by the host, and instead the activation element 7104 may be configured to automatically initiate insertion after the outer housing 7101 has been sufficiently translated toward and relative to the inner housing 7102 in the distal direction.

[0353] This configuration offers several benefits. First, the translation of the outer housing 7101 relative to the inner housing 7102 before activation provides drop protection, ensuring that the applicator 7100 will not activate prematurely if it is accidentally dropped. Second, the spring 7320 provides a force bias that the host must overcome by pressing the applicator 7100 into their skin before activation, thus reducing the likelihood of activation before the applicator 7100 is properly positioned. Additionally, the host can choose not to activate the applicator 7100 and interrupt pressing it onto their skin, in which case the spring 7320 will bias relative to the outer housing 7101, causing the outer housing 7101 to return to its initial state.

[0354] The retainer 7124, needle holder assembly 7108, needle hub 7150, insertion element 7174, skin sensor assembly 360, first spring 7112, and second spring 7128 are all shown in the image. Figure 73A In the pre-activation position.

[0355] Figure 73B The applicator 7100 is described during insertion of the skin sensor assembly 360 but before retraction of the needle carriage assembly 7108. A first spring 7112 drives the retainer 7124, needle carriage assembly 7108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 in the distal direction toward the distal insertion position. Figure 73BThis indicates that the skin sensor assembly 360 is in contact with the host's skin 130, but the holder 7124 has not yet been fully driven by the first spring 7112 to a position in contact with the skin sensor assembly 360 or the host's skin 130.

[0356] In some embodiments, the mass of each of the retainer 7124, needle carriage assembly 7108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 may be specifically designed to reduce or substantially eliminate the tendency for the needle carriage assembly 7108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 to separate due to inertial forces from the retainer 7124 when driven in the distal direction during insertion. In some embodiments, the force applied by the first spring 7112 may be selected to be sufficient to properly operate the applicator 7100 without being too large to further exacerbate the aforementioned inertial-triggered separation. In some embodiments, the spring (not shown) may be configured to apply a force, for example, in the distal direction relative to a portion of the needle carriage assembly 7108, sufficient to prevent the needle carriage assembly 7108 from inertially triggering separation from the retainer 7124 during insertion.

[0357] Figure 73C The description refers to the applicator 7100 during activation, at which time the needle carriage assembly 7108, needle hub 7150, and insertion element 7174 retract in the proximal direction via the second spring 7128. Figure 73C In this position, the first spring 7112 has fully driven the sensor assembly 360 on the skin into the host's skin. From this position, the spring-retaining element (e.g., Figures 74A to 75B 7442a and 7442b) release the second spring 7128 and drive the needle carriage assembly 7108, needle hub 7150, and insert element 7174 from the distal insertion position in the proximal direction. After the needle carriage assembly 7108 reaches the proximal retracted position, the needle carriage retaining element 7334 of the retainer 7124 engages with the needle carriage assembly 7108, thereby maintaining the needle carriage assembly 7108, needle hub 7150, and insert element 7174 in a locked retracted position that restricts access to the insert element 7174. The needle carriage retaining element 7334 may include, for example, an arm, deflection element, tab, pawl, hook, or any other feature with a retaining function. In this retracted position, travel of the needle carriage assembly 7108, needle hub 7150, and insert element 7174 in the distal direction is prevented.

[0358] The following is relative to Figures 74A to 74C Further description of some aspects of the operation of the applicator 7100, the figures illustrating operation according to some embodiments Figure 71 and 72 The applicator 7100 has several cross-sectional views. Figures 74A to 74C For example, it can correspond to along Figure 71The applicator 7100 for cutting the section line B-B' shown in the image. For ease of explanation, Figures 74A to 74C The needle hub 7150 and the insertion element 7174 are not shown in the image.

[0359] Figure 74A This describes the state of the applicator 7100 before activation. For ease of explanation, Figure 74A The skin sensor assembly 360 is not described. The retainer 7124 includes spring-retaining elements 7442a and 7442b configured to contact and retain the first end of the second spring 7128 in a pre-activated state, such as during insertion, when the second end of the spring 7128 contacts the needle holder assembly 7108. The spring-retaining elements 7442a and 7442b may include, for example, arms, deflection elements, tabs, pawls, hooks, or any other features with a retention function. Although two spring-retaining elements 7442a and 7442b are shown, at least one spring-retaining element is contemplated. In some embodiments, such as Figures 81A to 81D As shown, the applicator 7100 may include one spring-retaining element. In some embodiments, the applicator 7100 may include three spring-retaining elements. In some embodiments, the applicator 7100 may include four spring-retaining elements. In some embodiments, the spring-retaining elements 7442a, 7442b are deflectable arms, rigid arms, deformable features, latches, snaps, or hooks. In some embodiments, the spring-retaining elements 7442a, 7442b may be actively deflected by one or more features within the applicator 7100.

[0360] The needle carriage assembly 7108 includes backstop features 7444a and 7444b configured to prevent lateral deflection of the spring retaining elements 7442a and 7442b in the proximal starting position, for example, at least during insertion, thereby supporting the retention of the second spring 7128 between the spring retaining elements 7442a and 7442b and the retainer 7124 until retraction. Although two backstop features are described, any number of backstop features is considered. The number of backstop features may be equal to the number of spring retaining elements.

[0361] Figure 75A Enlarged views illustrating the spring retaining element 7442b and the backstop feature 7444b. Figure 75A In this configuration, the first spring 7112 drives the retainer 7124, the needle holder assembly 7108, and the skin sensor assembly 360 in a distal insertion position. A backstop feature 7444b is shown engaging with a spring retainer element 7442b to prevent lateral deflection of the spring retainer element 7442b, thereby preventing the second spring 7128 from releasing. Figure 75AAs shown, the proximal end of the spring retaining element 7442b can be offset from the distal end of the backstop feature 7444b by a distance α. In some embodiments, the distance α is the length required for the spring retaining element 7442b to traverse the backstop feature 7444b such that the spring retaining element 7442b passes over the backstop feature 7444b. The backstop feature 7444b may have a ramp guiding the spring retaining element 7442b. The distal ends of the needle carriage assembly 7108 and the retainer 7124 can be offset from each other by at least the same distance α to allow the spring retaining element 7442b to pass distally over the backstop feature 7444b.

[0362] It is understood that the frictional force between the corresponding contact surface of the backstop feature 7444b and the spring retaining element 7442b can at least partially determine the amount of force that releases the spring retaining element 7442b from the backstop feature 7444b. This force allows lateral deflection of the spring retaining element 7442b, and thus allows expansion of the second spring 7128. In some embodiments, the amount of force is at least 0.1 lb. In some embodiments, the amount of force is at least 0.5 lb. In some embodiments, the amount of force is at least 1 lb. In some embodiments, the amount of force is at least 2 lb. In some embodiments, the amount of force is at least 3 lb. In some embodiments, the amount of force is at least 4 lb. In some embodiments, the amount of force is at least 5 lb.

[0363] Although the figure shows a backstop feature 7444b that prevents the spring retaining element 7442b from deflecting laterally in the radially outward direction, the opposite structural relationship is considered. For example, the inclined surface of the spring retaining element 7442b can be reversed to face as... Figure 75A The relative directions are shown in the figure. Additionally, the inclined surface of the spring retaining element 7442b can be biased against the backstop feature 7444b in a radially inward direction by the second spring 7128. In this type of embodiment, the backstop feature 7444b may be located radially inward of the spring retaining element 7442b.

[0364] Therefore, in some embodiments, the materials used to form the retainer 7124 and the pin carriage assembly 7108 may be selected based on the desired amount of force required for lateral deflection of the release spring retaining element 7442b. Examples of such materials may include polycarbonate, ABS, PC / ABS, polypropylene, high-impact polystyrene (HIPS), polybutylene terephthalate (PBT), polyoxymethylene (POM), acetal, polyacetal, polyoxymethylene, PTFE, high-density polyethylene (HDPE), nylon, polyethylene terephthalate (PET), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), TPSiv, cyclic olefin polymers (COP), cyclic olefin copolymers (COC), and / or liquid crystal polymers (LCP).

[0365] The angle θ of the portion of the spring retaining element 7442b in contact with the second spring 7128 can also affect the amount of frictional force that causes the spring retaining element 7442b to deflect laterally, thereby releasing the second spring 7128. Therefore, the angle θ can be selected based on the desired amount of force that causes the spring retaining element 7442b to deflect laterally sufficiently to release the second spring 7128. In some embodiments, the angle θ relative to the vertical axis of the spring retaining element 7442b is at least 1 degree. In some embodiments, the angle θ is at least 5 degrees. In some embodiments, the angle θ is at least 10 degrees. In some embodiments, the angle θ is at least 15 degrees. In some embodiments, the angle θ is at least 20 degrees. In some embodiments, the angle θ is about 30 to 45 degrees. Additionally, the force distribution of the second spring 7128 can affect the target amount of frictional force that causes the spring retaining element 7442b to deflect laterally. Therefore, in some embodiments, the force distribution of the second spring 7128 can be taken into account when selecting one or both of the materials used to form the retainer 7124 and the needle holder assembly 7108, as well as the angle θ of the portion of the spring retaining element 7442b that contacts the second spring 7128.

[0366] The angle β of the spring retaining element 7442b relative to the vertical axis also affects the amount of lateral deflection of the spring retaining element 7442b, thereby releasing the frictional force of the second spring 7128. By contacting the spring retaining element 7442b, the second spring 7128 can apply a force to the spring retaining element 7442b at a distance d from the bottom of the spring retaining element 7442b, the force causing a torque sufficient to cause lateral deflection of the spring retaining element 7442b.

[0367] Figure 75A Further describing the needle carriage assembly 7108, it includes a deflection element 7522 configured to contact the spring retaining element 7442b and hold it in a lateral deflection orientation once the second spring 7128 has initially deflected the spring retaining element 7442b and sufficiently actuated the needle carriage assembly 7108 in the proximal direction. Figure 75B The deflection element 7522 prevents the spring retaining element 7442b from contacting the winding of the second spring 7128 as the second spring 7128 extends, thus facilitating the operation of the applicator 7100 and preventing the energy released by the second spring 7128 and designed to drive the needle carriage assembly 7128 in the proximal direction from being absorbed by unwanted contact with the spring retaining element 7442b during the release of the second spring 7128.

[0368] In some embodiments, the angle θ of the portion of the spring retaining element 7442b that contacts the second spring 7128 may be substantially 90° (e.g., flat), and the deflecting element 7522 may have a... Figure 75AThe inclined or angled surface that contacts the spring retaining element 7442b in the position described herein. In such embodiments, in addition to the functions described above, the deflection element 7522 may be configured to, in addition to the functions described above, deflect the retainer 7124 from the first spring 7112. Figure 75A Position driven as described in the text Figure 75B When the position is as described, the spring retaining element 7442b is initially deflected.

[0369] In some embodiments, the inner housing 7102 may include a protrusion 7546 extending distally from the inner housing 7102. The protrusion 7546 may be configured to contact at least one of the spring retaining elements 7442a, 7442b and the backstop features 7444a, 7444b in a pre-activated state, thereby preventing the spring retaining elements 7442a, 7442b from laterally deflecting until the retainer 7124 and the needle holder assembly 7108 have been translated distally by at least a predetermined minimum distance. Therefore, the protrusion 7546 provides drop protection, allowing the applicator 7100 to be activated prematurely without responding to a shock impact from a fall before intentional activation.

[0370] Return to Figure 74A The inner housing 7102 may further include an engagement element 7448 configured to engage a protrusion 7449 of the needle carriage assembly 7108 after the needle carriage assembly 7108 has translated in the distal direction beyond a predetermined threshold, thereby preventing the needle carriage assembly 7108 from translating in the distal direction beyond the predetermined threshold. This ensures that the needle carriage assembly retracts in the event of air firing or dry firing, wherein the applicator 7100 is activated in some way when not held to the host's skin. In some embodiments, the predetermined threshold may correspond to a point where the distal end of the needle carriage assembly 7108 extends beyond a point near the distal end of the inner housing 7102, extends to a point substantially coincident with the distal end of the inner housing 7102, or is the distal end point of the distal end of the inner housing 7102. In some embodiments, the engagement element 7448 includes a hook, a U-shaped structure, a loop, a protrusion, or any other structure as described above capable of engaging the protrusion 7449.

[0371] Figure 74B The description refers to the applicator 7100, which, upon activation, initiates a force retraction feature process at or near the distal insertion position, where the on-skin sensor assembly 360 can contact the host's skin. A first spring 7112 has driven the retainer 7124, needle holder assembly 7108, needle hub 7150, insertion element, and on-skin sensor assembly 360 in the distal direction toward the distal insertion position. During proper operation, the retainer 7124 and on-skin sensor assembly 360 should press against the host's skin. However... Figure 74BThe dry activation conditions can also be described, wherein the applicator 7100 is not properly pressed onto the host's skin before triggering the applicator 7100. Therefore, after the first spring 7112 drives the retainer 7124 and the needle carriage assembly 7108 in the distal direction beyond a predetermined threshold, the engagement element 7448 contacts the protrusion 7449. This prevents the needle carriage assembly 7108 from traveling further in the distal direction, while sufficiently further driving the retainer 7124 in the distal direction such that the backstop features 7444a, 7444b of the needle carriage assembly 7108 no longer contact the spring retaining elements 7442a, 7442b in the distal insertion position, thereby releasing the first end of the second spring 7128 and initiating retraction even when the applicator 7100 is dry activated. The insertion force provided by the first spring 7112 is sufficient to further overcome the frictional force between the corresponding contact surfaces of the backstop feature 7444b and the spring retaining element 7442b.

[0372] Turn Figure 75B The first spring 7112 has driven the retainer 7124, needle holder assembly 7108, and on-skin sensor assembly 360 to the host's skin in a distal direction. When the first spring 7112 drives the retainer 7124, needle holder assembly 7108, and on-skin sensor assembly 360 against the host's skin, the skin provides a reaction force to the force generated by the first spring 7112. The skin resists the force of the first spring 7112 and biases the distal end of the on-skin sensor assembly 360. Due to... Figure 75A As shown, the distal end of the retainer 7124 is offset from the distal end of the sensor assembly 360 on the skin, so that when the first spring 7112 continues to drive the retainer 7124 towards the skin while the sensor assembly 360 presses against the skin, the reaction force provided by the skin is transferred to the retainer 7124. The reaction force provided by the skin allows the spring retaining element 7442b to displace through the backstop feature 7444b. Once the spring retaining element 7442b has passed the backstop feature 7444b by a distance α, the second spring 7128 can laterally deflect the spring retaining element 7442b, thereby releasing the second spring 7128 that drives the needle holder assembly 7108 in the proximal direction. Alternatively, as combined above... Figure 75A As described, the angle θ of the portion of the spring retaining element 7442b that contacts the second spring 7128 is approximately 90° (e.g., flat), and the inclined or angled surface of the deflecting element 7522 that contacts the spring retaining element 7444b sufficiently deflects the spring retaining element 7442b to release the second spring 7128 that drives the needle carriage assembly 7108 in the proximal direction.

[0373] In some embodiments, the engagement element 7448 may engage the protrusion 7449 even when the applicator 7100 is pressed against the user's skin. In such embodiments, the engagement element 7448 engages the protrusion 7449 when the first spring 7112 actuates the retainer 7124, the needle carriage assembly 7108, and the on-skin sensor assembly 360 against the host's skin. As explained above, when the engagement element 7448 engages the protrusion 7449, the engagement element 7448 prevents the needle carriage assembly 7108 from moving distally. This allows the spring retaining elements 7442a, 7442b to disengage from the backstop features 7444a, 7444b and allows the release of the second spring 7128. The engagement of the engagement element 7448 and the protrusion 7449 adds additional force to the reaction force provided by the skin, thereby increasing the energy required to overcome the frictional engagement of the spring retaining elements 7442a, 7442b and the backstop features 7444a, 7444b. In some cases, the engagement of the engagement element 7448 and the protrusion 7449 provides an immediate pulse force that converts at least some of the initial energy of the first spring 7112 into the energy required to overcome the frictional engagement of the spring retaining elements 7442a, 7442b and the backstop features 7444a, 7444b. Such embodiments are considered potentially beneficial for users with soft skin or a higher percentage of body fat.

[0374] Return to Figure 74C This illustrates that during activation, the applicator 7100 and needle carriage assembly 7108 retract in the proximal direction via a second spring 7128, as indicated by arrow 7402. Figure 74C In the case where the backstop features 7444a and 7444b no longer secure the spring retaining elements 7442a and 7442b, when the sensor assembly 360 on the skin contacts the host's skin 130, the first end of the second spring 7128 pushes the spring retaining elements 7442a and 7442b with sufficient force to deflect the spring retaining elements 7442a and 7442b in the distal insertion position, thereby allowing the second spring 7128 to clear the spring retaining elements 7442a and 7442b and drive the needle carriage assembly 7108 in the proximal direction, so that even in the case of dry start-up, the needle carriage assembly 7108, the needle hub 7150 (see needle hubs 73A to 73C) and the insertion element 7174 (see...) will also be activated. Figures 73A to 73C It remains in the locked retracted position.

[0375] Figure 76A and 76B Enlarged views illustrating some features of an applicator (e.g., applicator 7100) according to some embodiments.

[0376] exist Figure 76A In the middle, the first spring 7112 (see Figures 72 to 74CThe retainer 7124, needle holder assembly, and on-skin sensor assembly 360 are driven toward the distal insertion position in the distal direction (indicated by arrow 7602). The retaining element 7372b of the needle holder assembly is detachably coupled to the on-skin sensor assembly 360. As illustrated, during insertion and near the distal insertion position, the retainer 7124 contacts the spring retaining element 7372b to prevent lateral deflection of the spring retaining element 7372b and thereby rigidly secure the on-skin sensor assembly 360 to the needle holder assembly.

[0377] exist Figure 76B In the middle, the second spring 7128 (see...) Figures 72 to 74C The needle holder assembly 7108 is driven proximally from the distal insertion position. Since the retainer 7124 has been sufficiently driven distally, at the distal insertion position, the retainer 7124 is no longer in contact with the wearable retention element 7372b. Therefore, the wearable retention element 7372b is freely deflected laterally, thereby releasing the on-skin sensor assembly 360 from the wearable retention element 7372b, and thus from the needle holder assembly 7108. The needle holder assembly 7108 is now driven proximally by the second spring 7128, simultaneously securing the on-skin sensor assembly 360 to the host's skin. Furthermore, in some embodiments, since the retainer 7124 is driven to the distal insertion position by the first spring 7112 and is substantially held in said position, the retainer 7124 can press against one or both of the on-skin sensor assembly 360 or its adhesive patch, supporting one or both during attachment to the host's skin.

[0378] Figure 90 Description according to some embodiments Figure 71 and 72Enlarged view of some features of the applicator. As shown, the applicator 7100 is in a pre-activated state. In this state, spring retaining elements 7442a, 7442b can be held against backstop features 7444a, 7444b. A second spring 7128 can bias the spring retaining elements 7442a, 7442b relative to the backstop features 7444a, 7444b. As mentioned above, sufficient force is required to deflect the spring retaining elements 7442a, 7442b through the backstop features 7444a, 7444b. Sufficient force can be determined, or at least partially determined, by the frictional force between the spring retaining elements 7442a, 7442b and the backstop features 7444a, 7444b. It is understood that the backstop features 7444a and 7444b may have grooves 7446a and 7446b, respectively, to engage with the spring retaining elements 7442a, 7442b. The grooves 7446a and 7446b can increase the drag force between the spring retaining elements 7442a and 7442b and the backstop features 7444a and 7444b. In such embodiments, the grooves 7446a and 7446b can increase the force required to deflect the spring retaining elements 7442a and 7442b from the backstop features 7444a and 7444b, while the materials of the spring retaining elements 7442a and 7442b and / or the backstop features 7444a and 7444b have a lower or even lower coefficient of friction. Furthermore, the grooves 7446a and 7446b can increase the force required to deflect the spring retaining elements 7442a and 7442b from the backstop features 7444a and 7444b, while the second spring 7128 has a smaller or even smaller diameter or a lower or even lower spring constant. In some embodiments, the grooves 7446a and 7446b may each have a concave channel. The concave shape of the channel may have angled surfaces configured to drag along multiple edges of the spring retaining elements 7442a, 7442b. In such embodiments, the spring retaining elements 7442a, 7442b may be wedge-shaped, configured to drag within the grooves 7446a, 7446b. In some embodiments, the applicator 7100 may include as many grooves 7446 as the backstop feature 7444.

[0379] Figure 77 Description according to some embodiments Figure 71 and 72 A partial perspective cross-sectional view of the needle holder assembly 7108, needle hub 7150, and skin sensor assembly 360 of the applicator 7100. Figure 78 The illustration shows a cross-sectional view of a needle hub 7150 and a skin sensor assembly 360 according to some embodiments. Figure 79 This is a top view illustrating a portion of the needle carriage assembly 7108 and needle hub 7150 according to some embodiments. Reference is made below. Figures 77 to 79 Describe these characteristics.

[0380] The skin sensor assembly 360 includes a sensor assembly aperture 396. The hub 7150 is configured to engage the insertion element 7174 with the needle holder assembly 7108 and substantially maintain the desired orientation of the insertion element 7174 during insertion of the sensor of the skin sensor assembly 360 into the skin of the host.

[0381] The needle hub 7150 includes a plurality of upper arms 7156a, 7156b, a plurality of lower arms 7154a, 7154b, and a base 7152. Although two upper arms and two lower arms are described, any number of arms comprising a single upper and lower arm is contemplated. In some embodiments, the upper arms 7156a, 7156b and the lower arms 7154a, 7154b may be flexible such that when the needle hub 7150 is coupled to the needle carriage assembly 7108, the upper arms 7156a, 7156b and the lower arms 7154a, 7154b secure the needle hub 7150 relative to the needle carriage assembly 7108 in a desired orientation. For example, the upper arms 7156a, 7156b can be configured to taper radially inward, such that when positioned through the frame aperture 7712 in the needle carriage assembly 7108, the upper arms 7156a, 7156b contact the upper surface of the needle carriage assembly 7108 adjacent to the frame aperture 7712, and the lower arms 7154a, 7154b contact the lower surface of the needle carriage assembly 7108 adjacent to the frame aperture 7712. This arrangement allows for a compliant fit between the needle carriage assembly 7108 and the needle hub 7150, wherein the lower arms 7154a, 7154b deflect to allow the upper arms 7156a, 7156b to expand after the surface of the frame aperture 7712 has been cleared. The lower arms 7154a, 7154b can be partially or completely relaxed to bias the needle hub in the distal direction and reduce the gap between the needle hub and the needle carriage, which would otherwise exist in a non-compliant fit. In addition, the upper arms 7156a, 7156b and the lower arms 7154a, 7154b also help maintain contact between the base 7152 and the top surface of the sensor assembly 360 on the skin.

[0382] The base 7152 includes anti-rotation features. These anti-rotation features may include a key having a shape complementary to at least a portion of the sensor assembly aperture 396 of the on-skin sensor assembly 360, and may be configured to substantially prevent the needle hub 7150 from rotating relative to the on-skin sensor assembly 360 about an axis 7702 parallel to the insertion element 7174, for example, preventing the base 7152 from rotating within the sensor assembly aperture 396. Alternatively, the upper surface of the needle holder assembly 7108 adjacent to the holder aperture 7712 may include a groove 7910 configured to receive the upper arms 7156a, 7156b when they are positioned through the holder aperture 7712 in an orientation complementary to the orientation of the groove 7910, such as... Figure 79 As explained in the document, this fixes the needle hub 7150 relative to the needle carriage assembly 7108.

[0383] In some embodiments, the base 7152 further includes a generally flat surface, which, in some cases, when the anti-rotation feature of the base 7152 engages within the sensor assembly hole 396 of the skin sensor assembly 360, is configured to engage with the top surface of the skin sensor assembly 360 and hold the insertion element 7174 in a generally perpendicular orientation to the top surface of the skin sensor assembly 360.

[0384] Based at least on the aforementioned features of the needle hub 7150, the skin sensor assembly 360, and / or the needle holder assembly 7108, the base 7152 allows for easy assembly during manufacturing, including (but not limited to) properly aligning and pre-assembling the insertion element 7174 onto the skin sensor assembly 360, and / or enabling easy engagement of the components of the needle hub 7150, the insertion element 7174, the sensor 338, and the skin sensor assembly 360 to other parts of the assembled applicator 7100.

[0385] Figure 80A and 80B This is a perspective view illustrating the locking feature of needles 8074a, 8074b used in an applicator for an analyte sensor system according to some embodiments. For example, Figure 80A The needle 8074a includes a locking feature comprising a ridge 8076 configured to engage, for example, a complementary feature within the needle hub 7150. Alternatively, Figure 80B The needle 8074b includes a locking feature, which includes a groove 8078 configured to engage, for example, with a complementary feature within the needle hub 7150.

[0386] In yet another alternative, any insert element described in this disclosure may include, for example, a locking feature that heat-fuses the selected insert element to the needle hub 7150. In yet another alternative, any insert element described in this disclosure may include a locking feature comprising, for example, one or more friction-fitting or snap-fitting needle hub elements that secure the selected insert element to the needle hub 7150. In yet another alternative, any insert element described in this disclosure may include a locking feature comprising, for example, complementary flap elements configured to mate with each other on the selected insert element and the needle hub 7150. In yet another alternative, any insert element described in this disclosure may include a locking element comprising, for example, one or more insert-molded elements configured to engage the selected insert element to the needle hub 7150.

[0387] During manufacturing, the applicator 7100 can be assembled in sections. For example (and not limitingly), if present, a first barrier layer 7192 can be secured to the inner housing 7102. An insertion element 7174 can be coupled to the needle hub 7150, which can then be coupled to the skin sensor assembly 360. A second spring 7128 can be placed in the holder 7124 or the needle carriage assembly 7108, and the needle carriage assembly 7108 can then be positioned in the holder 7124 and attached to the needle hub 7150 and the skin sensor assembly 360 via wearable retaining elements 7372a, 7372b. A first spring 7112 can be placed in the holder 7124, which can then be installed in the inner housing 7102. The inner housing 7102 can be inserted into and secured to the outer housing 7102. If present, a second barrier layer 7194 can be secured to the inner housing 7102. If it is a separate component, then the activation element 7104 can then be placed into the outer housing 7101. Any labels, sterilization and / or encapsulation can then be applied to the applicator 7100.

[0388] Figures 81A to 81C This illustration shows several cross-sectional views of another applicator 8100 for a skin sensor assembly of an analytical material sensor system according to some embodiments, as well as various features and operating positions.

[0389] The applicator 8100 may include an external applicator housing 7101 including an activation element 7104. The external applicator housing 7101 may be configured to translate in a distal direction under a force applied by the host of the applicator 8100, thereby aligning the activation element 7104 in a position that allows the applicator 8100 to be activated. Figure 81A The alignment is as described above. As previously described in conjunction with the applicator 7100, in some embodiments, the activation element 7104 may be positioned in any location, such as the top, upper, lower, or any other location of the applicator 8100.

[0390] The applicator 8100 further includes an inner housing 7102 configured to receive one or more mechanisms for applying the on-skin sensor assembly 360 to the host's skin. A distal surface 7130 of the bottom opening of the inner housing 7102 may define a bottom surface of the applicator 8100. In some embodiments, after the applicator 8100 is pressed onto the host's skin, the skin may deform into a generally convex shape at the distal surface 7130, such that at least a portion of the surface of the skin disposed at the bottom opening of the applicator housing 7102 extends proximally into the bottom opening of the inner housing 7102, beyond the plane defined by the distal surface 7130.

[0391] although Figures 81A to 81CNot specified, the inner housing 7102 may include a spring 7320 configured to contact the outer housing 7101 and maintain a predetermined distance between the outer housing 7101 and the inner housing 7102 in a pre-activated orientation (see [reference]). Figure 73A Spring 7320 may be a compression spring, leaf spring, retractable arm spring, a piece of foam or rubber, etc. In some other embodiments, outer housing 7101 may include spring 7320, and spring 7320 may be configured to contact inner housing 7102.

[0392] The applicator 8100 may further include a needle holder assembly 8108. The needle holder assembly 8108 includes wearable retention and / or alignment elements 7372a, 7372b, configured to pass through the holder 8124 and detachably connect the on-skin sensor assembly 360 to the holder 8124 and / or the needle holder assembly 8108. Although two wearable retention and / or alignment elements are described, any number of wearable retention and / or alignment elements are contemplated.

[0393] The applicator 8100 further includes a needle hub 7150 configured to engage the insertion element 7174 to the needle holder assembly 8108. The insertion element 7174 is configured to insert the sensor 338 of the on-skin sensor assembly 360 into the host's skin 130 (e.g., Figures 3A to 4 In some embodiments, the insertion element 7174 includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as in combination with at least Figures 47 to 50 As described in 80A to B. In other embodiments, the insertion element 7174 may be integrally formed with the sensor 338, wherein the insertion element 7174 may be rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0394] The applicator 8100 may further include a retainer 8124 detachably coupled to the needle holder assembly 8108 and configured to guide the on-skin sensor assembly 360 when coupled to the needle holder assembly 8108, for example, at least during translation from a proximal position to a distal insertion position. As previously described in conjunction with the applicator 7100, once the on-skin sensor assembly 360 is placed on the host's skin, the on-skin sensor assembly 360 can be peeled off or released from the retainer 8124 and / or the needle holder assembly 8108.

[0395] The applicator 8100 may further include an insertion assembly configured to translate the insertion element 7174, needle hub 7150, and needle carriage assembly 8108 in a distal direction from a proximal position to a distal insertion position. This insertion assembly may include a first spring 7112. The first spring 7112 may be a compression spring or any suitable type of spring, with a first end contacting or engaging with the internal applicator housing 7102 and a second end contacting or engaging with the retainer 8124. The first spring 7112 is configured to, upon activation of the insertion assembly, translate the retainer 8124, needle carriage assembly 8108, needle hub 7150, insertion element 7174, and on-skin sensor assembly 360 in a distal direction to the distal insertion position. Generally, at the distal insertion position, the needle carriage assembly 8108 can be decoupled from the retainer 8124 and the on-skin sensor assembly 360.

[0396] The applicator 8100 may further include a retraction assembly configured to translate the needle carriage assembly 8108, needle hub 7150, and insertion element 7174 in a proximal direction from a distal insertion position to a proximal retraction position. In some embodiments, the initial proximal position may be the same as the proximal retraction position. In other embodiments, the initial proximal position may be different from the proximal retraction position. Such a retraction assembly may include a second spring 8128. The second spring 8128 may be a compression spring or any suitable type of spring and may have a first end that contacts or engages with the retainer 8124 and a second end that includes a foot 8129 (e.g., a spring portion or spring end) disposed generally along the diameter of the second spring 8128, contacting or engaging with a spring retaining element 8142 of the retainer 8124 at least before retraction. The spring retaining element 8142 may include, for example, an arm, a deflection element, a tab, a pawl, a hook, or any other feature with a retention function. Except as described below, the spring retaining element 8142 may have substantially the same form and function as the spring retaining elements 7442a, 7442b of the applicator 7100. The second spring 8128 is configured to translate the needle carriage assembly 8108, needle hub 7150, and insertion element 7174 from the distal insertion position to the proximal retraction position in the proximal direction. When the spring retaining element 8142 is not supported by the backstop element 8144 and in response to the shank 8129 of the second spring 8128 pressing the spring retaining element 8142 with a force exceeding a predetermined threshold sufficient to overcome and deflect the spring retaining element 8142, the shank 8129 of the second spring 8128 is released from the spring retaining element 8142 in the distal insertion position.

[0397] In some embodiments, the transfer of the skin sensor assembly 360 between insertion and retraction can be combined as previously described, for example... Figures 35A to 37C Any of the events described in the text will occur.

[0398] The needle carriage assembly 8108 further includes a backstop feature 8144 configured to prevent lateral movement of the spring retaining element 8142 of the retainer 8124 in at least a proximal pre-activated position, thereby supporting the retention of the second spring 8128 between the spring retaining element 8142 and the retainer 8124 until retraction. Figure 81A In the orientation shown, the second spring 8128 applies a force to the spring retaining element 8142, but the backstop feature 8144 prevents the retaining element 8142 from deflecting laterally.

[0399] The retainer 8124 further includes a needle carriage retaining element 7334, which may include a deflectable arm, a rigid arm, a deformable feature, a latch, a snap, or a hook. After the needle carriage assembly 8108 reaches a proximal retracted position upon activation, the needle carriage retaining element 7334 is configured to engage with the needle carriage assembly 8108, thereby holding the needle carriage assembly 8108, the needle hub 7150, and the insertion element 7174 in a locked retracted position, restricting access to the insertion element 7174.

[0400] although Figures 81A to 81C Not specified, but the inner housing 7102 of the applicator 8100 may further include an engagement element 7448, and the needle carriage assembly 8108 may further include a protrusion 7449 and may be substantially engaged as previously described at least Figures 74A to 74C The description is effective.

[0401] although Figures 81A to 81C Not specified, but the inner housing 7102 of the applicator 8100 may further include a protrusion extending distally from the inner housing 7102, generally as previously described, protrusion 7546. Similar to the previously described combination. Figure 75A As described, this protrusion can be configured to contact at least one of the spring-retaining element 8142 and the backstop feature 8144 in a pre-activated state, such that the spring-retaining element 8142 is prevented from laterally deflecting until the retainer 8124 and the needle holder assembly 8108 have been translated in the distal direction by at least a predetermined minimum distance. Therefore, the protrusion provides drop protection, allowing the applicator 8100 to be activated prematurely without responding to a shock from a fall prior to activation.

[0402] The applicator 8100 functions largely similarly to the applicator 7100, except that it uses a spring retaining element 8142 disposed along the interior of the second spring 8128 and configured to contact and retain the shank 8129 of the second spring 8128 along its diameter, instead of using spring retaining elements 7442a, 7442b disposed along the exterior of the second spring 7128 and configured to contact and retain the coil of the second spring 7128. In contrast to the outer side of the second spring 8128, placing the spring retaining element 8142 within the center of the second spring 8128 and generally along its center further ensures that the spring retaining element 8142 does not contact the coil of the second spring 8128 when the second spring 8128 extends during retraction, thus making the operation of the applicator 8100 smoother. In addition, unlike the spring retaining elements 7442a and 7442b, the arrangement including the spring retaining element 8142 reduces the risk and difficulty of ensuring that multiple spring retaining elements are triggered or overcome substantially simultaneously.

[0403] although Figures 81A to 81C Not shown in the original document, in some embodiments, the applicator 8100 may include a cap configured to be secured to the distal surface 7130 of the inner housing 7102, and removable prior to use. In some embodiments, such a cap may also serve as a sterile barrier, as described in U.S. Patent Application No. 16 / 011527, which is incorporated herein by reference in its entirety.

[0404] Figure 81A This illustration shows the state of the applicator 8100 before activation, according to some embodiments. The retainer 8124, needle holder assembly 8108, needle hub 7150, insertion element 7174, skin sensor assembly 360, first spring 7112, and second spring 7128 are all shown in the pre-activated position.

[0405] The retaining element 7332 of the retainer 8124 contacts the inner housing 7102, thereby securing the retainer 8124, needle holder assembly 8108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 in the pre-activated state.

[0406] The backstop feature 8144 of the needle carriage assembly 8108 contacts the spring retaining element 8142 and prevents it from deflecting laterally, thereby ensuring that the spring retaining element 8142 holds the shank 8129 of the second spring 8128 in the shown loaded or pre-activated position.

[0407] Activating the applicator 8100 may involve the host pressing the applicator 8100 onto their skin with sufficient force to cause the outer housing 7101 to translate distally toward and relative to the inner housing 7102 until the activating element 7104 is aligned with the insertion assembly retaining element 7332 of the retainer 8124. Figure 81A As shown in the diagram. Once this alignment is achieved, the host can initialize the activation element 7104, thereby causing the insertion assembly retaining element 7332 to be sufficiently deflected to release the retainer 8124 from the inner housing 7102. In some other embodiments, the applicator 8100 may be configured such that the activation element 7104 can be activated initially, but actual insertion is not triggered until the outer housing 7101 has been sufficiently translated toward and relative to the inner housing 7102 in the distal direction. In still other embodiments, the activation element 7104 may be biased toward the center of the applicator 8100, such that the activation element 7104 does not need to be explicitly activated by the host, but instead the activation element 7104 may be configured to automatically initialize insertion after the outer housing 7101 has been sufficiently translated toward and relative to the inner housing 7102 in the distal direction.

[0408] Figure 81B The description describes the applicator 8100 after activation and during insertion according to some embodiments. A first spring 7112 drives the retainer 8124, needle holder assembly 8108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 in the distal direction toward the distal insertion position. Figure 81B This indicates that the sensor assembly 360 on the skin is in contact with the host's skin 130, but the retainer 8124 has not yet been fully driven by the first spring 7112 to contact the sensor assembly 360 on the skin or the host's skin 130.

[0409] In some embodiments, the mass of each of the retainer 8124, needle carriage assembly 8108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 may be specifically designed to reduce or substantially eliminate the tendency of the needle carriage assembly 8108, needle hub 7150, insertion element 7174, and skin sensor assembly 360 to separate from the retainer 8124 when driven in the distal direction during insertion. In some embodiments, the force applied by the first spring 7112 may be further selected to be sufficient to properly operate the applicator 7100 without being too large to further exacerbate the aforementioned inertial-triggered separation. In some embodiments, the spring (not shown) may be configured to apply a force, for example, to a portion of the needle carriage assembly 8108 in the distal direction, sufficient to prevent the needle carriage assembly 7108 from inertial-triggered separation from the retainer 8124 during insertion.

[0410] Figure 81CThe description describes the applicator 8100 after activation according to some embodiments, at or near the distal insertion position. A first spring 7112 has driven the retainer 8124, the needle carriage assembly 8108, and the skin sensor assembly 360 to the distal insertion position in the distal direction. Since the first spring 7112 has driven the retainer 8124 further distally than the needle carriage assembly 8108, the backstop feature 8144 no longer contacts the spring retainer element 8142, causing the second spring 8128 (e.g., the shank 8129) to laterally deflect the spring retainer element 8142, thereby releasing the second spring 8128 that drives the needle carriage assembly 8108 in the proximal direction. Alternatively, similar to the above description... Figure 75A As described in the applicator 7100, the angle θ of the portion of the spring retaining element 8142 that contacts the shank 8129 of the second spring 7128 is approximately 90° (e.g., flat). Once the backstop feature 8144 is no longer in contact with the spring retaining element 8142, the spring retaining element 8142 can be biased to automatically and fully deflect to release the second spring 7128, thereby releasing the second spring 8128 to drive the needle carriage assembly 8108 in the proximal direction. Although Figures 81A to 81C Not shown, but the inner housing 7102 may further include a engagement element 7448 configured to engage with a protrusion 7449 of the needle carriage assembly 8108, and substantially as previously engaged at least Figures 74A to 74C The described function is effective. In some embodiments, a backstop feature (not shown) may be disposed on the bottom of the applicator 8100, for example, on the distal portion of the inner housing 7102. This backstop feature may be configured to contact one or more of the sensor assembly 360, needle holder 8108, or retainer 8124 on the skin in the distal insertion position.

[0411] After the second spring 8128 is released, the second spring 8128 is configured to drive the needle carriage assembly 8108, the needle hub 7150, and the insertion element 7174 in the proximal direction. Although Figure 81C Not shown, but when the needle carriage assembly 8108 travels to the proximal retracted position, the needle carriage retaining element 7134 can engage with the needle carriage assembly 8108, thereby holding the needle carriage assembly 8108, the needle hub 7150 and the insertion element 7174 in a locked retracted position that restricts access to the insertion element 7174.

[0412] Figure 81D Perspective views illustrating the holder 8124, the first spring 7112, and the second spring 8128 of the applicator 8100 according to some embodiments. Figure 81D The description includes the orientation of the spring retaining element 8142 and the retaining foot 8129 of the second spring 8128 within the applicator 8100 before retraction.

[0413] During manufacturing, the applicator 8100 can be assembled in segments. For example (and not limitingly), as previously described in conjunction with the applicator 7100, if present, then the first barrier layer 7192 (see [link to documentation]) can be applied. Figure 72 The insertion element 7174 can be attached to the inner housing 7102. The insertion element 7174 can be coupled to the needle hub 7150, which can then be coupled to the skin sensor assembly 360. A second spring can be placed in the holder 8124 or the needle carriage assembly 8108, and the needle carriage assembly 8108 can then be placed in the holder 8124 and attached to the needle hub 7150 and the skin sensor assembly via wearable retaining elements 7372a, 7372b. A first spring 7112 can be placed in the holder 8124, which can then be installed in the inner housing 7102. The inner housing 7102 can be inserted into and secured to the outer housing 7102. As previously described in conjunction with the applicator 7100, if present, a second barrier layer 7194 (see [link to applicator]) can be applied. Figure 72 It is fixed to the inner housing 7102. If it is a separate element, then the activation element 7104 can then be placed in the outer housing 7101. Any labels, sterilization and / or encapsulation can then be applied to the applicator 8100.

[0414] Figures 82A to 82D This illustration shows several cross-sectional views of another applicator 8200 for a skin sensor assembly in an analytical substance sensor system according to some embodiments, as well as various features and operating positions. Unlike applicators 7100 and 8100, applicator 8200 utilizes a single spring to insert and retract insert element 8274 to place the associated sensor 338 and skin sensor assembly 360.

[0415] The applicator 8200 includes a housing 8202 and an activation element 8204 disposed on the top of the applicator 8200. However, the activation element 8204 may be disposed on one side of the applicator 8200 or at any other location.

[0416] The applicator 8200 may further include a needle holder assembly 8208. The needle holder assembly 8208 includes wearable retention and / or alignment elements 8272a, 8272b, configured to pass through the retainer 8224 and detachably couple the on-skin sensor assembly 360 to the retainer 8224 and / or the needle holder assembly 8208. In some embodiments, the wearable retention elements 8272a, 8272b may extend around rather than through the retainer 8224. The wearable retention elements 8272a, 8272b may include, for example, an arm, a deflection element, a tab, a pawl, a hook, or any other feature with a retention function. Although two wearable retention and / or alignment elements are described, any number of wearable retention and / or alignment elements are contemplated. As will be described in more detail below, the needle carriage assembly 8208 further includes a protrusion 8266 configured to contact or hook the deployment sleeve 8206 during retraction, thereby causing the needle carriage assembly 8208 to translate in the proximal direction during retraction.

[0417] The applicator 8200 further includes an insertion element 8274 configured to insert a sensor 338 of the on-skin sensor assembly 360 into the host's skin 130 (e.g., Figure 1 In some embodiments, the insertion element 8274 includes a needle, such as a side-opening needle, a needle with a deflecting tip, a curved needle, a polymer coating needle, a hypodermic needle, or any other suitable type of needle or structure, such as in combination with at least Figures 47 to 50 As described in 80A to 80B. In other embodiments, the insertion element 8274 may include a sensor 338 that is rigid enough to be partially inserted into the host's skin 130 with minimal or no structural support.

[0418] although Figures 82A to 82D Not described herein, but in some embodiments, the applicator 8200 may further include a needle hub 7150 configured to couple the insertion element 8274 to the needle carriage assembly 8208, as previously described, at least Figures 77 to 79 As described. In some other embodiments, the insertion element 8274 may be directly coupled to the needle carriage assembly 8208, such as... Figures 82A to 82D As shown in the image.

[0419] The applicator 8200 may further include a retainer 8224, which is detachably coupled to the deployment sleeve 8206 and the needle carriage assembly 8208 via retainer retaining elements 8232a, 8232b. The retainer retaining elements 8232a, 8232b may include, for example, arms, deflection elements, tabs, pawls, hooks, or any other features with a retention function. The retainer 8224 is configured to guide the on-skin sensor assembly 360 during insertion, for example, at least during translation from a proximal position to a distal insertion position, upon coupling to the needle carriage assembly 8208. As previously described in conjunction with applicators 7100 and 8100, once the on-skin sensor assembly 360 is placed on the host's skin, it can be peeled off or released from the retainer 8224 and / or the needle carriage assembly 8208.

[0420] The applicator 8200 may further include an insertion assembly configured to translate the retainer 8224, the insertion element 8274, and the needle carrier assembly 8208 in a distal direction from a proximal position to a distal insertion position. This insertion assembly may include a spring 8212. The first spring 8212 may be a compression spring or any suitable type of spring and may have a first end that contacts or engages with the deployment sleeve 8206 and a second end that contacts or engages with the retainer 8224. The first spring 8212 is configured to translate the retainer 8224, the needle carrier assembly 8208, the insertion element 8274, and the skin sensor assembly 360 in a distal direction to the distal insertion position after activation of the insertion assembly. Generally, at the distal insertion position, the needle carrier assembly 8208 can be decoupled from the retainer 8224 and the skin sensor assembly 360.

[0421] The applicator 8200 may further include a retraction assembly configured to translate the needle carriage assembly 8208 and the insertion element 8274 from a distal insertion position to a proximal retraction position in a proximal direction. In some embodiments, the initial proximal position may be the same as the proximal retraction position. In other embodiments, the initial proximal position may be different from the proximal retraction position. Such a retraction assembly may also include a spring 8212. The first spring 8212 is also configured to translate the deployment sleeve 8206, the needle carriage assembly 8208, and the insertion element 8274 from the distal insertion position to the proximal retraction position in a proximal direction in response to the sensor assembly 360 contacting the host's skin 130 and / or reaching a travel limit by a force exceeding a predetermined threshold. For example, although not described, the housing 8202 may further include an engagement element 7448 configured to engage with a protrusion 7449 of the needle carriage assembly 8208, and substantially engage at least as previously described. Figures 74A to 74CThe description is effective. In some embodiments, a backstop feature (not shown) may be positioned at the bottom of the applicator 8200, such as on the distal portion of the housing 8202. Such a backstop feature may be configured to contact one or more of the on-skin sensor assembly 360, needle holder 8208, retainer 8224, or deployment sleeve 8206 in the distal insertion position. The spring 8212 is configured to apply a force sufficient to deflect the deployment sleeve retaining elements 8262a, 8262b of the deployment sleeve 8206 when the on-skin sensor assembly 360 contacts the host skin 130, thereby disengaging the deployment sleeve retaining elements 8262a, 8262b of the deployment sleeve 8206 from the protrusions 8264a, 8264b of the housing 8202 (see figure). Figures 82C to 82D Released from the distal insertion position, the spring 8212 allows the deployment sleeve 8206 to be translated in the proximal direction, and thus the needle carriage assembly 8208 and the insertion element 8274. The deployment sleeve retaining elements 8262a, 8262b may include, for example, arms, deflecting elements, tabs, pawls, hooks, or any other features with a retaining function.

[0422] In some embodiments, the transfer of the sensor assembly 360 on the skin between insertion and retraction can be as previously combined with any existing diagram (e.g., Figures 35A to 37C The occurrence described by any one of them.

[0423] This dual insertion / retraction operability of spring 8212 is possible during insertion, where the deployment sleeve 8206 is secured by deployment sleeve retaining elements 8262a, 8262b, contacting corresponding protrusions 8264a, 8264b of housing 8202. Therefore, when spring 8212 applies force between deployment sleeve 8206 and retainer 8224, spring 8212 drives retainer 8224 and the coupled needle carriage assembly 8208, insertion element 8274, and on-skin sensor assembly 360 to a distal deployment position, where on-skin sensor assembly 360 contacts the host's skin 130. Once on-skin sensor assembly 360 contacts the host, retainer 8224 is secured to on-skin sensor assembly 360, the travel restriction features of applicator 8200, and / or the host's skin. Therefore, with the retainer 8224 fixed, the force applied by the spring 8212 between the fixed retainer 8224 and the deployment sleeve 8206 is used to push the deployment sleeve 8206 with sufficient force in the proximal direction, so that the deployment sleeve retaining elements 8262a, 8262b are sufficiently deflected to clear the protrusions 8264a, 8264b of the housing 8202, thereby releasing the deployment sleeve 8206 for further actuation by the spring 8212 in the proximal direction. Since the protrusions 8266 of the needle carriage assembly 8208 are configured to contact, engage, or hook the deployment sleeve 8206 when it translates in the proximal direction, the action of the spring 8212 translating the deployment sleeve 8206 in the proximal direction also translates the needle carriage assembly 8208 and the coupled insertion element 8274 in the proximal direction to the proximal retracted position. Now, relative to Figures 82A to 82D Discuss the location of the aforementioned features.

[0424] although Figures 82A to 82D Not shown, but in some embodiments, the applicator 8200 may include a cap configured to be secured to the distal surface of the inner housing 8202 or the activation element 8204, and removable prior to use. In some embodiments, such a cap may create a sealed volume providing a sterile barrier, as previously described in U.S. Patent Application No. 16 / 011527, which is incorporated herein by reference in its entirety.

[0425] Figure 82AThe state of the applicator 8200 before activation is illustrated according to some embodiments. Before activation, retainer holding elements 8232a, 8232b secure the retainer 8224 to the deployment sleeve 8206. The retainer holding elements 8232a, 8232b may include, for example, arms, deflection elements, tabs, pawls, hooks, or any other features with a retention function. The needle holder assembly 8208 is coupled to the retainer 8224. The insertion element 8274 is coupled to the needle holder assembly 8208. The on-skin sensor assembly 360 is coupled to the needle holder assembly 8208 via wearable retaining elements 8272a, 8272b. The illustrated positions may correspond to proximal positions.

[0426] Figure 82B This describes the state of the applicator 8200 when activated according to some embodiments. The activati...

Claims

1. An applicator for applying a sensor assembly on skin to the skin of a host, the applicator comprising: An insertion assembly configured to translate the needle holder assembly and the on-skin sensor assembly from an initial proximal position to a distal insertion position in a distal direction; Internal casing; An outer housing includes an activation element configured to activate the insertion assembly, wherein the activation element is prevented from activating the insertion assembly until the outer housing is translated a predetermined distance in a distal direction relative to the inner housing, wherein the inner housing includes an aperture, and the activation element is configured to align with the aperture when the outer housing is translated the predetermined distance in a distal direction relative to the inner housing; as well as A retraction assembly configured to translate the needle holder assembly from the distal insertion position to the proximal retraction position in a proximal direction, wherein the retraction assembly is configured to be activated in response to contact of a sensor assembly on the skin with the host's skin.

2. The applicator of claim 1, wherein the insertion assembly includes a first spring.

3. The applicator of claim 1, wherein the retraction assembly includes a second spring.

4. The applicator of claim 3, wherein the insertion assembly further includes a retainer configured to guide the needle carriage assembly at least during translation from the initial proximal position to the distal insertion position.

5. The applicator of claim 4, wherein the retainer further comprises at least one retaining element configured to retain the second spring at least during insertion.

6. The applicator of claim 5, wherein the at least one retaining element is disposed along the outside of the second spring and configured to contact and retain the coil of the second spring.

7. The applicator of claim 6, wherein the needle carriage assembly further includes at least one backstop feature configured to prevent lateral deflection of the at least one retaining element at least during insertion.

8. The applicator of claim 7, wherein the at least one backstop feature is configured not to contact the at least one retaining element in the distal insertion position, thereby allowing the second spring to deflect the at least one retaining element and activate the retraction assembly.

9. The applicator of claim 6, wherein the second spring is configured to apply a force sufficient to deflect the at least one retaining element in the distal insertion position when the sensor assembly on the skin contacts the skin of the host.

10. The applicator of claim 5, wherein the second spring includes a shank extending along the diameter of the second spring, and wherein the at least one retaining element is disposed along the interior of the second spring and configured to retain the shank of the second spring.

11. The applicator according to any one of claims 1-10, wherein the activation element is disposed on one side of the outer housing.

12. The applicator according to any one of claims 1-11, wherein the activation element is configured to be pushed by the host toward the interior of the outer housing once the alignment is achieved.

13. The applicator according to any one of claims 1-12, wherein the activation element is biased toward the center of the applicator to automatically initiate insertion when the outer housing is translated the predetermined distance in the distal direction relative to the inner housing.

14. The applicator of claim 1, wherein the inner housing further includes an engagement element, and the needle carriage assembly includes a protrusion, the engagement element being configured to engage with the protrusion after the needle carriage assembly has translated in the distal direction beyond a predetermined threshold, thereby preventing the needle carriage assembly from translating in the distal direction beyond the predetermined threshold.

15. The applicator of claim 14, wherein the engaging element comprises a hook.

16. The applicator of claim 1, wherein the needle carriage assembly further includes a hub configured to engage an insertion element to the needle carriage assembly.

17. The applicator of claim 16, wherein the hub is further configured to be coupled to a sensor assembly on the skin.

18. The applicator of claim 2, wherein both the insertion assembly and the retraction assembly comprise the first spring.

19. The applicator of claim 18, wherein the first spring is configured to apply a force between the retainer and the deployment sleeve.

20. The applicator of claim 19, wherein the retainer includes at least one retaining element configured to secure the retainer to the deployment sleeve.

21. The applicator of claim 20, further comprising a housing and an activation element configured to deflect the at least one retaining element such that the first spring can translate the retainer, the needle holder assembly, and the on-skin sensor assembly from the proximal position to the distal insertion position.

22. The applicator of claim 21, wherein the housing further includes at least one protrusion, and the deployment sleeve includes at least one retaining element configured to contact the at least one protrusion of the housing.

23. The applicator of claim 22, wherein the first spring is configured to apply a force sufficient to deflect the at least one retaining element of the deployment sleeve when the sensor assembly on the skin contacts the skin of the host, thereby releasing the at least one retaining element of the deployment sleeve from the at least one protrusion of the housing.

24. The applicator of claim 23, wherein the first spring is further configured to translate the deployment sleeve in the proximal direction.

25. The applicator of claim 24, wherein the needle carriage assembly further includes a protrusion configured to contact the deployment sleeve, thereby translating the needle carriage assembly in the proximal direction.

Images