Receiving, activating, deploying and integrating functionality of flexible elongate elements

Abstract

Exemplary embodiments provide methods, devices, and support structures for deploying flexible elongate elements, such as catheters or subcutaneous sensors, into user tissue, such as skin tissue. A first embodiment utilizes rotational motion to deploy the element while constraining the element to prevent buckling. A second embodiment utilizes linear motion to deploy a flexible elongate element with assistance of an introducer element to provide support. Other embodiments provide a support feature; for example, a sacrificial sleeve may temporarily secure or wrap the elongate element to temporarily increase its structural stiffness. Another support structure may be used to tension the tissue of the user, such as by bulging the skin at an area that facilitates deployment of the elongate element. The cannula or sensor itself may also be constructed or configured to support deployment.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Application No. 63 / 434,243, filed on December 21, 2022, the entire content of which is incorporated herein by reference. Background Art

[0003] Advances in miniaturization technology have enabled the manufacture of wearable devices that can perform therapeutic drug delivery, as well as sense and report physiological characteristics. Examples of such devices include (but are not limited to) devices for dispensing insulin, glucagon - like peptide (GLP - 1), combinations of insulin and GLP - 1, fertility drugs, leukocyte - stimulating drugs, or other drugs.

[0004] Such devices typically deploy needles, catheters, cannulas, or other elements that connect the wearable device to the user's tissue (such as the skin). Here, such deployable elements are generally referred to as "catheters", but it should be understood that the term "catheter" encompasses needles, cannulas, and other similar deployable elements. To determine how much therapeutic drug to dispense, the device may include sensors (such as glucose or ketone sensors), which can be part of the catheter or separate from the catheter.

[0005] The catheter must be large enough to effectively perform the above - mentioned functions, but within those constraints, it is preferably as small as possible. Smaller catheters generally mean less pain for the user when the element penetrates the skin and during long - term deployment (such as may be required for an automated insulin delivery (AID) device). This also means that the entire device can be made smaller, enabling it to be worn unobtrusively under clothing and improving the user's comfort when worn.

[0006] At the same time, the catheter needs to have sufficient rigidity to penetrate the skin without buckling. As these catheters become narrower or more flexible and / or more slender, due to the inherent physical properties of the material (such as the elastic modulus) as well as very small physical dimensions and geometries (such as geometric cross - section stiffness), they tend to become insufficiently rigid. Thin, flexible, and slender elements that naturally have low geometric stiffness are notoriously difficult to deploy to an appropriate penetration depth in a deformable material (such as human skin tissue). For example, under critical load conditions, or when inserted or penetrating the human skin, they instead tend to structurally fail due to axial compressive forces, which may result in undesired lateral displacements of the structure (such as buckling or deflection, e.g., bouncing off the top surface of the skin when the catheter is inserted at an angle and unable to penetrate). Summary of the Invention

[0007] Exemplary embodiments provide a unique catheter deployment assembly that is configured to mitigate deployment failure during penetration and allow for proper usage functions after initial penetration.

[0008] In one aspect, a device includes: a deployable element configured for subcutaneous deployment; a rotating mechanism having an outer circumference around which at least a portion of the deployable element is wound, the rotating mechanism being configured to rotate the deployable element around the outer circumference; and a base having an opening through which the deployable element is configured to extend, wherein the deployable element is selectively constrained such that rotation of the deployable element is converted into linear motion.

[0009] In some embodiments, the rotating mechanism can be a pulley or flywheel assembly.

[0010] The device may further include a torsion spring configured to provide energy to rotate the rotating mechanism.

[0011] The device may further include a stop plate configured to control the extent to which the deployable element extends beyond the opening.

[0012] The device may further include a fluid conduit configured to connect the deployable element to a reservoir.

[0013] Use of the rotating mechanism as described above may allow the device to be effective while still being relatively small (i.e., less than 0.5 inches × 0.5 inches × 0.375 inches).

[0014] The deployable element may be selected from the group consisting of a cannula, a catheter, a needle, or a sensor. In some embodiments, the deployable element is a glucose sensor or a ketone sensor configured for continuous glucose monitoring.

[0015] The device may further include at least one housing configured to enclose the device. In some embodiments, the device deploys a sensor and the at least one housing only encloses the device. In other embodiments, the device can be part of an automated insulin delivery (AID) device and the at least one housing encloses both the device and the AID device.

[0016] The device may further include at least one convex or concave protrusion disposed on the base, wherein the size and shape of the protrusion are designed to cause the user's skin to be tightened near the opening when the base is pushed against or adhered to the skin.

[0017] In some embodiments, the deployable element has a circular cross-section (e.g., laminated or coated wire). In other embodiments, the deployable element may have a rectangular cross-section (as in the case of a catheter). In some embodiments, the deployable element has a laminated composite structure, including at least one polymer, at least one metal, and a coating. In some embodiments, the deployable element includes one or more conductive signal traces connected to embedded electronic hardware.

[0018] In another aspect, a device includes: a deployable element linearly extending in a first direction and configured for subcutaneous deployment; a guide extending in a first direction parallel to the deployable element; a base having an opening through which the deployable element is configured to extend; and a linear deployment mechanism configured to extend the deployable element and the guide in the first direction.

[0019] The guide may include a geometric interface having an angled structure and further includes a suspension member having a suspension opening through which the deployable element and the guide pass, wherein the shape of the suspension opening is designed to allow the deployable element to continue extending on its original linear trajectory until a set stop point is reached, and the guide is pushed through a portion of the suspension opening by the angled structure, which releases the guide from the driving force of the linear deployment mechanism.

[0020] The device may further include a tension spring connected to an end of the guide, wherein the tension spring is configured to reverse the displacement direction of the guide to fix the sharp end of the guide within a protected structure.

[0021] The device may further include a sacrificial sleeve connecting the deployable element and the guide.

[0022] Other technical features may be immediately apparent to those skilled in the art from the following drawings, description, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] To facilitate identification of the discussion of any particular element or action, one or more of the most significant digits in the reference numerals refer to the drawing number in which the element is first introduced.

[0024] Figure 1A is a perspective view of an exemplary rotary sleeve deployment mechanism according to a first embodiment.

[0025] Figure 1B is a side view of an exemplary rotary sleeve deployment mechanism according to a first embodiment.

[0026] Figure 1CIs a perspective view of an exemplary rotary cannula deployment mechanism according to a second embodiment.

[0027] Figure 1D Shows an exemplary damper applicable to an exemplary embodiment.

[0028] Figure 1E Shows an internal view of an exemplary damper applicable to an exemplary embodiment.

[0029] Figure 1F Is a side view of an exemplary rotary cannula deployment mechanism having a damper.

[0030] Figure 2 Is a perspective view showing a pulley assembly in a first undeployed state.

[0031] Figure 3 Is a perspective view showing a pulley assembly in a second deployed state.

[0032] Figures 4A - 4D Provides various close-up views of the pulley assembly of the first embodiment.

[0033] Figure 5 Provides various views of the deployment mechanism of the first embodiment enclosed in a separate housing.

[0034] Figure 6 Provides various views of the deployment mechanism of the first embodiment enclosed in a housing capable of accommodating other components (such as an automatic insulin delivery (AID) device).

[0035] Figure 7A Is an exploded perspective view of an exemplary rotary cannula deployment mechanism according to the first embodiment.

[0036] Figure 7B Shows compared with Figure 8 A perspective view seen from the opposite side.

[0037] Figure 8 Is a side view showing the deployable element 102 of the first embodiment in more detail.

[0038] Figure 9 Is a side view showing an alternative configuration of the deployable element 102 of the first embodiment.

[0039] Figure 10A Is a perspective view showing the pulley assembly of the first embodiment as seen from the front and side in more detail.

[0040] Figure 10B Is a perspective view showing the pulley assembly of the first embodiment as seen from the side and rear in more detail.

[0041] Figure 11Is a perspective view showing the electrical connection between the sensor and the on-board front-end electronics, as well as the electrical service loop for connecting the front-end electronics to the back-end electronics in the drug delivery device body.

[0042] Figures 12A - 12D Shows an alternative release mechanism suitable for an exemplary embodiment.

[0043] Figure 13 Is an exploded perspective view of an exemplary linear cannula deployment mechanism according to a second embodiment.

[0044] Figure 14 Is a perspective view from the side and bottom of the assembled linear cannula deployment mechanism of the second embodiment in a first undeployed state.

[0045] Figure 15 Is a perspective view from the side and bottom of the assembled linear cannula deployment mechanism of the second embodiment in a second deployed state.

[0046] Figure 16 Shows the guide of the second embodiment in more detail.

[0047] Figure 17 Is a side view of a structure for tightening the user's epidermis suitable for any of the described embodiments.

[0048] Figure 18 Is a side view of an alternative epidermis tightening structure suitable for any of the described embodiments.

[0049] Figure 19 Is a perspective view of the epidermis tightening structure.

[0050] Figure 20 Is Figure 17 A side view of the epidermis tightening structure of, showing different possible protrusion profile shapes.

[0051] Figure 21A Is a perspective view showing an exemplary cannula structure suitable for any of the described embodiments.

[0052] Figure 21B Shows one aspect of the subject matter according to one embodiment.

[0053] Figure 21C Shows one aspect of the subject matter according to one embodiment.

[0054] Figure 22 Is Figure 21A A side view of the exemplary cannula structure of. [[ID=……]]

[0055] Figure 23 Is a perspective view showing an exemplary sensor structure suitable for any of the described embodiments.

[0056] Figure 24A Shows an exemplary rotary cannula deployment mechanism for penetrating the outermost layer of skin using a guide.

[0057] Figure 24B Shows Figure 24A a rotary cannula deployment mechanism with an exemplary housing.

[0058] Figure 25A -B shows an exemplary guide suitable for Figure 24A a rotary cannula deployment mechanism.

[0059] Figure 26A -C shows exemplary guides according to various embodiments.

[0060] Figure 27A Shows the way a guide is positioned relative to housing features in an exemplary rotary cannula deployment mechanism.

[0061] Figures 27B - 27C Provides various views of a pulley for a rotary cannula deployment mechanism.

[0062] Figures 28A - 28D Shows an exemplary retaining block for a rotary cannula deployment mechanism at various assembly stages.

[0063] Figure 29A -C shows a rotary cannula deployment mechanism with the guide moving at various stages of deployment and retraction.

[0064] Figures 30A - 30B Shows a rotary cannula deployment mechanism in a pre-deployment state and a fully inserted state, respectively.

[0065] Figure 31 Shows the interface between a guide and a spring according to an exemplary embodiment.

[0066] Figure 32A Is a side view showing a rotary cannula deployment mechanism in a pre-deployment state.

[0067] Figure 32B Is a side view showing a rotary cannula deployment mechanism in a fully inserted state. Detailed Description

[0068] Exemplary embodiments provide methods, devices, and support structures for deploying a flexible elongate element (such as a catheter or a subcutaneous sensor) into user tissue (such as skin tissue).

[0069] A first embodiment deploys an element using a rotational motion while constraining the element to prevent buckling. The constraint may allow the element to be deployed without the assistance of a guide element that supports the flexible element.

[0070] Use rotational motion derived from a harnessed potential energy source (such as a torsion spring), and utilize the torque applied to a selectively constrained thin element at the radius of a flywheel or pulley. The thin element is guided with minimal frictional resistance in a circular-to-linear motion and is pressed into the skin tissue layer at the distal sharp end of the elongate element. This circular winding and initial containment provides a method for deploying sensor elements in a compact package (minimal spatial volume of the mechanism) for deployment to a subcutaneous tissue depth beneath the outer surface of the skin (in some embodiments, approximately 4 - 7 millimeters deep).

[0071] A second embodiment utilizes linear motion to deploy a flexible elongate element with the assistance of a guide element that provides support. Use linear motion derived from a harnessed potential energy source (such as a helical compression spring), and utilize the force applied to a selectively constrained configuration of a single or multiple thin elements. The thin elements are guided in a linear motion with minimal frictional resistance and begin to be pressed into the skin tissue layer at the distal sharp end of the elongate element (a subcutaneous guide in this embodiment). This linear containment provides a method for deploying sensor elements in a compact package (minimal spatial volume of the mechanism) for deployment to a subcutaneous tissue depth (4 - 7 millimeters) beneath the outer surface of the skin.

[0072] Other embodiments provide support features that improve the functionality of the above embodiments. For example, a sacrificial sleeve may temporarily hold or surround the elongate element to temporarily increase the structural stiffness of the elongate element.

[0073] Another support structure may provide for tensioning the user's tissue, such as by causing the skin to bulge in an area facilitating the deployment of the elongate element. The structure may include a protruding annular structure on a wearable or applicator device that contacts and / or adheres to the skin during insertion of the elongate element to be deployed into the human skin layer.

[0074] The cannula or the sensor itself may also be constructed or configured to support the deployment. For example, laminated composite structures of polymers, metals, and other materials may be combined into various cross-sectional shapes. These elements can be used to form the desired directional stiffness to improve the deployment penetration effect and / or maintain conductive signal conduits / traces leading to the embedded electronic hardware.

[0075] Exemplary embodiments

[0076] As an aid to understanding, a series of examples will first be presented before the detailed description of the underlying implementation. Note that these examples are for illustrative purposes only and the invention is not limited to the embodiments shown.

[0077] Reference is now made to the accompanying drawings, in which like reference numerals are used to refer to like elements throughout. In the following description, numerous specific details are set forth for purposes of illustration. However, the new embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form to facilitate description. The aim is to cover all modifications, equivalents, and alternatives consistent with the claimed subject matter.

[0078] In the drawings and the accompanying description, the names "a", "b", and "c" (and similar names) are intended to represent variables that stand for any positive integer. Thus, for example, if an embodiment sets the value of a to a = 5, the complete set of components 122 denoted as components 122-1 to 122-a may include components 122-1, 122-2, 122-3, 122-4, and 122-5. The embodiments are not limited to this.

[0079] Rotating cannula deployment mechanism without a guide

[0080] A first embodiment provides a rotating catheter deployment assembly 100 without a guide, as Figures 1A - 4D shown. The catheter deployment assembly 100 can be used to deploy a catheter, a sensor, or both, as appropriate.

[0081] Figure 1A [[ID=1(5]]And Figure 1B shows the assembled catheter deployment assembly 100. The catheter deployment assembly 100 includes a deployable element 102, which can be a cannula, a needle, a catheter, a sensor, etc. For example, the deployable element 102 can be a cannula or a needle for delivering a drug (such as insulin). The deployable element 102 can be a glucose sensor or a ketone sensor (such as an electrochemical sensor, an optical fiber sensor, a wire sensor, a fluorescence sensor, etc.), a temperature sensor, or an activity sensor. In some embodiments, multiple sensors can be combined into a single deployable element 102, such as a situation where one side of the deployable element 102 serves as a glucose sensor while the opposite side serves as a ketone sensor.

[0082] In this example, the deployable element 102 rotates along the outer radius of a flywheel or a pulley until the rotational motion is converted into linear motion, and the deployable element 102 linearly moves into or out of an opening 114 in a base 108 that supports the catheter deployment assembly 100 (e.g., on a user's skin). The deployable element 102 can be selectively constrained by a housing 104 that surrounds the deployable element and the pulley. Additionally or alternatively, the housing 104 can take the form of the outer shell of the catheter deployment assembly 100.

[0083] The catheter deployment assembly 100 can be positioned and / or retained on the base 108 using one or more base protrusions 126 and / or ribs 128, which fit into corresponding cutouts in the bottom of the cover 104, and the bottom of the cover 104 can be opened outward to allow a connection to be established between the catheter deployment assembly 100 and the base 108.

[0084] Using rotational motion derived from a constrained potential source (in this embodiment, a torsion spring controlled by a release member 110 engaged in the support block 106), and using a torque applied to the deployable element 102 at the radius of the pulley sub-opening 804B, the deployable element 102 is guided to perform circular to linear motion with minimal frictional resistance and is pressed into the skin tissue layer at the distal sharp end of the deployable element 102 (in this application, a subcutaneous sensor, but alternatives may be used as explained above and below). This circumferential winding and initial stowage allows the formation of a mechanism with a relatively small spatial volume (e.g., less than approximately 0.25 inches by 0.25 inches by 0.375 inches).

[0085] The catheter deployment assembly 100 allows for the deployment of sensors or other components to a depth in the subcutaneous tissue below the outer surface of the skin (e.g., approximately 4-7 mm). The penetration depth can be controlled by the shape of the stop plate 112 mounted to the pulley. Figure 1B 、 Figure 1C 、 Figure 7A and Figure 7B As shown, the stop plate 112 includes a protrusion 116 that fits into a groove 118 in the housing 104 and also includes an opening that allows the stop plate 112 to be mounted to the pulley. As the pulley rotates, the stop plate 112 rotates and the protrusion 116 moves within the groove 118 until it strikes a stop point at the end of the groove 118, which prevents the pulley from rotating further (and thus stops the linear motion of the deployable element 102).

[0086] In the case where deployable element 102 is a sensor, the sensor can relay a signal back to integrated front-end electronics 124 on catheter deployment assembly 100. Integrated front-end electronics 124 can include a processor, which may be a relatively weak processor compared to the processor on the larger wearable device to which catheter deployment assembly 100 belongs or is attached. Integrated front-end electronics 124 can perform some limited front-end processing on the sensor signal. The resulting data can be transmitted to the processor on the wearable device via service portion 120.

[0087] exist Figure 1A and Figure 1B In the embodiment of FIG. 1 , the release member 110 is secured in the support block 106 until it is pulled away from the stop plate 112 . Figure 1CAn alternative construction is shown in which the release member 110 is secured within a housing support 122 formed in the housing 104. The housing support 122 can be simply a raised ring formed from the material of the housing 104 or can be a separate element attached to the housing 104.

[0088] Figures 1D - 1F An alternative damper 130 applicable to the exemplary embodiment is shown. For example, the damper 130 can be an electro-viscous damper attached to the housing 104 and filled with a viscous medium to absorb energy from the catheter deployment assembly 100. The damper 130 can include one or more ridges 132 or feather elements through which the deployable element 102 can be wound, where the size and shape of the ridges 132 are configured to slow the movement of the spring deploying the deployable element 102. In some embodiments, the ridges 132 can be arranged to act only on a portion of the stroke of the deployable element 102 (e.g., the last 1 / 2 - 1 / 4).

[0089] Figure 1F An exemplary structure of the deployable element 102 is also shown. As shown, an outer tubular structure (e.g., a thin-walled extruded polymer) can surround a core including sensor elements. The tubular structure can be completely straight or can have an open (or other shaped) end geometry for integration. This tubular structure can provide additional protection to the outermost coating of the deployable element 102 when rotation of the pulley drives the sensor to move linearly (downward) relative to the static housing and housing components. The tubular sleeve can remain stationary while the sensor travels through the inner diameter of the tube. Thus, a low-friction polymer may be a suitable material choice.

[0090] In addition, a low radial force / compression seal can be selectively provided at the interface of the housing encapsulation with the exit location (i.e., opening 114) of the deployable element 102 where it contacts the body. The seal can be a low-hardness silicone polymer (or compatible elastomer) that can be molded in or it can be in the shape of a small O-ring or a more complex "duckbill" or "tapered funnel" type geometry. Such a seal can prevent liquid from entering at this interface.

[0091] Figure 2 、 Figure 3 and Figures 4A - 4D The deployment of the deployable element 102 is shown. In the initial state ( Figure 2 and Figure 4C ), the deployable element 102 is not deployed and is retracted through the opening 114 (e.g., as shown in Figure 17 ). When the pulley assembly 1000 rotates, it drives the deployable element 102 to move linearly (in Figure 2, Figure 3 and Figure 4A downward in (e.g., as shown in Figure 3 and Figure 4A ) until the deployable element 102 reaches its fully deployed extent ( Figure 3 and Figure 4A ).

[0092] Figure 2 , Figure 3 , Figure 4A , Figure 4B and Figure 4D An optional fluid conduit 202 is also shown, which can be used when the deployable element 102 is a cannula, catheter, or needle for delivering a drug (e.g., liquid insulin). The fluid conduit 202 is connected to the deployable element 102 (e.g., via a flexible, elastic, tapered, or extensible portion that allows the interface between the deployable element 102 and the fluid conduit 202 to move as the pulley rotates, or by moving the length of the fluid conduit 202 into / out of an attached reservoir). The fluid conduit 202 can be connected to a reservoir and allows fluid to be delivered from the reservoir through the deployable element 102. When the deployable element 102 is in its undeployed or initial state, the fluid conduit 202 can form a bend ( Figure 2 and Figure 4C ), and this bend can have the necessary slack to allow the deployable element 102 to deploy without interrupting the fluid connection from the reservoir to the fluid conduit 202 and then to the deployable element 102. The deployable element 102 can have a sharp distal end, an open lumen that is fluidly connected to the fluid conduit 202 at its distal end, and / or one or more holes near its distal end (e.g., as shown in Figure 4C ) for delivering a drug (e.g., insulin).

[0093] Due to the use of rotational motion to drive the deployable element 102, the catheter deployment assembly 100 can be kept so small in size. Thus, it can be arranged for use alone in a relatively small housing ( Figure 5 ) or in combination with other elements of a drug delivery device (e.g., an automated insulin delivery or "AID" device, see Figure 6 ).

[0094] In the stand-alone example of Figure 5 , the catheter deployment assembly 100 is mounted within its own catheter assembly housing 502. In this form factor, the catheter deployment assembly 100 can be used, for example, to deploy a stand-alone sensor (e.g., a glucose sensor for continuous glucose monitoring).

[0095] In the combined example of Figure 6 , the catheter deployment assembly 100 is included within a larger integral device housing 602, which can also house other components of a drug delivery device. For example, the catheter deployment assembly 100 can be used to deploy a glucose sensor or a ketone sensor (as shown inFigure 5 As shown, the glucose sensor or ketone sensor is used to control the delivery of a quantified insulin from the AID device. The AID device may also be incorporated within an integral device housing 602. When used separately or in combination with a blood glucose monitor, the AID device may also utilize a catheter deployment assembly 100 to deploy a needle, cannula, or catheter for delivering insulin or other drugs.

[0096] Figures 7A - 7B An exploded view of the components of the catheter deployment assembly 100 is shown from different perspectives.

[0097] As previously described, the catheter deployment assembly 100 sits on a base 108, which is shaped to hold a pulley assembly 1000. Specifically, the base 108 includes a semi-circular resting portion configured to support the pulley assembly 1000.

[0098] The pulley assembly 1000 can be controlled by a release member 110, which includes a bent portion fitted within a support block 106. The support block 106 is connected to a first support plate 702 fixed to the first end of the housing 104, thereby fixing the support block 106 in place. The release member 110 restrains a protrusion 116 of a stop plate 112. When the release member 110 is pulled (see Figure 1A ), the bent portion is pulled out of the support block 106 to near the protrusion 116, thereby releasing the restraint of the release member 110 on the protrusion 116 (and thus on the stop plate 112).

[0099] The release member 110 (in this embodiment and the second embodiment) can be actuated by a shape memory alloy (SMA) wire, which changes length in response to an external stimulus (such as the application of an electric current or a temperature change). The SMA wire can be actuated by a circuit (such as when it responds to a transmitter / receiver within the catheter deployment assembly 100 indicating that it is time to deploy a deployable element 102, as in the case where the catheter deployment assembly 100 is part of a drug delivery device and is controlled, for example, by a signal from a mobile phone or similar device), or by a button press or the like. Alternatively, the release member 110 can be manually triggered by a user, for example, by pressing a button at the outer surface of the integral device housing 602 (such as an insulin pump housing) or pulling a protrusion or the release member 110 itself (which can be reached by the user at the outer surface of the integral device housing 602). In the latter example, the release member 110 can be completely removed by the user when the user triggers the insertion of the deployable element 102 and can be discarded by the user. In an alternative embodiment, the release member 110 can be connected to a gear mechanism and / or a plunger element in a reservoir of a drug delivery device driven by a gear mechanism. As the gear mechanism advances, it can reach a threshold point at which the release member 110 is pulled or pushed, thereby causing the deployment of the deployable element 102.

[0100] The stop plate 112 is fixed to a pulley 706 (details seeFigure 10A and Figure 10B ), the pulley obtains energy from a spring 704 (a torsion spring or a helical spring in this example). When the stop plate 112 is released, the pulley 706 rotates under the action of the spring 704, so that the protrusion 116 rotates within the groove of the housing 104. When the protrusion 116 reaches the end of the groove, the stop plate 112 is constrained and stops moving.

[0101] The deployable element support 712 is also mounted to the pulley 706. The deployable element support 712 includes a deployable element 102 (a sensor in the form of a laminated wire in this example), which is wound circumferentially around the pulley 706 and is optionally inserted into the ridges of the deployable element support 712 (as Figure 11 shown). The deployable element 102 is further constrained by the housing 104 such that it rotates within a smaller channel within the catheter deployment assembly 100. For example, when deploying a sensor in the form of a wire with a diameter of 0.004 inches, the channel width is approximately 0.040 inches.

[0102] As Figure 1B shown in the example, the structures of the housing 104 and the base 108 control the shape of this channel. The channel is designed such that the rotational movement of the deployable element 102 is converted into linear movement near the opening of the base 108. The opening is positioned to receive the end of the deployable element 102 when the deployable element 102 moves linearly towards the user's skin.

[0103] The pulley 706 is mounted to the second end of the housing 104 through a second support plate 710. The pulley 706 can be correctly positioned relative to the support plate 710 by using a spacer 708.

[0104] The catheter deployment assembly 100 can be mounted to a support 714, which can form part of a housing or serve as a bracket or tray for a drug delivery device (such as an integral device housing 602) or a blood glucose sensing device.

[0105] Figure 8 The deployable element support 712 is shown in more detail.

[0106] The deployable element support 712 provides support for the deployable element 102 and connects the deployable element 102 to the pulley 706, so that the deployable element 102 is correctly positioned around the outer circumference of the pulley 70%.

[0107] The deployable element support 712 includes a circular body 802 (to correspond to the shape and approximate dimensions of the pulley 706). It also includes a pulley main opening 806, which is sized and shaped to receive a main support post extending from the pulley. To further support and properly orient the deployable element support 712, the body 802 also includes pulley sub-openings 804a, 804b, and 804c. These sub-openings correspond to sub-support portions on the pulley 706.

[0108] The deployable element support 712 may also include circuitry 808, such as embedded electronic hardware for collecting data from sensors or controlling the flow of liquid medication into the cannula. In some embodiments, the deployable element 102 may include conductive traces that connect, for example, sensors through the deployable element 102 to the deployable element support 712 and associated circuitry 808.

[0109] In one example, the deployable element support 712, service section 120, and / or deployable element 102 may be made of a multi-layer circuit board, such as a printed circuit board (PCB). An example of the composition of different layers of the circuit board is shown in Table 1 below:

[0110]

[0111]

[0112] Table 1

[0113] Figure 9 An alternative embodiment of the deployable element support 712 is shown. In addition to the foregoing elements, Figure 9 the deployable element support 712 of also includes a service section 120.

[0114] Figure 10A and Figure 10B more particularly shows the pulley assembly 1000.

[0115] In the pulley assembly 1000, the pulley 706 is connected to the deployable element support 712 by a set of pulley support portions that pass through corresponding openings in the deployable element support 712. The pulley main front support portion 1004 passes through the pulley main opening 806 in the deployable element support 712, while the pulley front sub-support portions 1002a, 1002b, 1002c pass through the pulley sub-openings 804a, 804b, 804c. The pulley main front support portion 1004 then passes through the spacer 708 and is received in a corresponding opening in the support plate 710 that supports the pulley 706.

[0116] On the opposite side, similarly configured sub-support portions pass through corresponding openings in the stop plate 112. The main rear support portion 1008 of the pulley is surrounded by a spring 704, the spring including bent ends that are connected through openings in the pulley 706 and the stop plate 112 to transmit energy to the pulley 706. The main rear support portion 1008 of the pulley then enters a corresponding opening in the support plate 702, which supports the pulley 706.

[0117] Figure 11 Is a perspective view showing the electrical connection between the sensor included in (or forming) the deployable element 102 and the integrated front-end electronics 124, and the electrical service portion 120 for connecting the integrated front-end electronics 124 to the back-end electronics in the drug delivery device body.

[0118] The sensor in the deployable element 102 can be electrically connected to the deployable element support 712 and can transmit an electrical sensor signal to one or more contact points 1104a, 1104b on the deployable element support 712. One or more conductive contacts 1102a, 1102b can be attached to the contact points 1104a, 1104b respectively to transmit the signal to the integrated front-end electronics 124. After preliminary processing, the integrated front-end electronics 124 can transmit the processed data to the main processor of the wearable device through the circuit in the service portion 120. The service portion 120 can be connected to the circuit on the wearable device to transmit the processed data (and / or optional raw sensor signals).

[0119] This configuration allows the data to be preliminarily processed as close as possible to the sensor, which improves the calculation time and reduces the workload of the main processor (back-end electronics) of the wearable device.

[0120] The above embodiments employ a release member 110 that can be pulled to release the protrusion 116 on the stop plate 112, which causes the pulley 706 to rotate under the action of the spring. In these embodiments, the release member 110 is used to hold the stop plate 112 in place until activation. Figures 12A - 12D Shows an alternative release mechanism suitable for an exemplary embodiment, which is useful in space-constrained situations.

[0121] In this release mechanism, the protrusion 116 on the stop plate 112 is held in place by two pins mounted to the base 108. The first pin 1202 is L-shaped and is mounted to the first pin pivot 1206. The first pin 1202 can be configured to hold the protrusion 116 in place until it rotates about the first pin pivot 1206 to move the first pin 1202 out of the path of the protrusion 116.

[0122] To this end, the second pin 1204 is C-shaped and is mounted at one end to the second pin pivot 1208. At the other end, the second pin 1204 is attached to the release trigger 1210 (e.g., an SMA wire).

[0123] Before the trigger 1210 is actuated, the release mechanism is in the Figure 12A and Figure 12C configuration shown. In this configuration, the protrusion 116 presses on the first pin 1202 (as indicated by the Figure 12C downward arrow in). The force applied by the protrusion 116 will cause the first pin 1202 to rotate about the first pin pivot 1206 unless the rotation of the first pin 1202 is blocked by the second pin 1204.

[0124] When the trigger 1210 is actuated (e.g., by manually pulling on the trigger 1210, or by applying a current to the trigger 1210 when the trigger is implemented as an SMA wire). This causes the second pin 1204 to rotate about the second pin pivot 1208 ( Figure 12D ), which releases the first pin 1202. At this time, the first pin 1202 is free to rotate about the first pin pivot 1206, causing the first pin 1202 to move away from the protrusion 116. Without the first pin 1202 being blocked, the pulley 706 rotates freely under the action of the spring 704.

[0125] Linear deployment mechanism with optional guide

[0126] An alternative to the first embodiment uses linear motion instead of rotational motion. Examples of these embodiments are shown in Figures 13 to 16 .

[0127] In this embodiment, the deployable element 102 is not constrained by the housing and the base, and thus may be more prone to buckling than the first embodiment. Therefore, to increase the stiffness of the deployable element 102, an optional guide 1318 is provided. The guide 1318 can be placed parallel to the deployable element 102 so that the guide 1318 supports the deployable element 102 during deployment.

[0128] However, it may not be desirable to embed the guide 1318 in the user's skin for the duration of the deployment of the deployable element 102. This may increase the size of the entry location into the user's skin, resulting in discomfort (among other drawbacks). Therefore, the exemplary embodiment provides a design that allows the guide 1318 to automatically retract after it has served its purpose of assisting in the deployment of the deployable element 102.

[0129] Figure 13 is an exploded view showing the various components of the linear catheter deployment assembly 1300.

[0130] The anti-rotation pin 1302 connects the harness 1304 to the housing of the retention catheter deployment assembly 1300. The anti-rotation pin 1302 prevents the harness 1304 from rotating (e.g., due to the force applied by the deployment spring 1306). The harness 1304 may be connected to the base 1326 at the base of its legs. The size and shape of the base may be designed to be complementary to an opening in the base 1326 that forms the bottom of the housing in which the catheter deployment assembly 1300 is received.

[0131] The harness 1304 may be configured to support other elements of the catheter deployment assembly 1300, including the deployment spring 1306, the support cup 1308, the deployable element 102, the buffer plate 1312, and the suspension member 1314.

[0132] The deployment spring 1306 (e.g., a helical compression spring) stores and releases energy that allows the deployable element 102 to be linearly driven into the user's skin. The deployment spring 1306 pushes against the support cup 1308, which is sized and shaped to press against the deployable element 102, thereby transferring the energy from the deployment spring 1306 to the deployable element 102. The support cup 1308 is constrained by the release member 1310, which prevents the deployment spring 1306 from deploying the deployable element 102 until the release member 1310 is removed. The support cup 1308 may include a protrusion that allows the guide 1318 to retract, as described in more detail below in connection with Figure 15 a more detailed description.

[0133] The buffer plate 1312 mates with or on a complementary-shaped opening in the suspension member 13, and supports the deployable element 102. The opening in the suspension member 1314 has an opening with a first narrower side and a second wider side. The narrower side allows the deployable element 102 and the guide 1318 to deploy. Due to the shape of the recoil spring 1324, the guide 1318 is then pushed towards the second wider side of the suspension member 1314 and retracts due to the action of the retraction spring 1316 (see the description in connection with Figure 14 and Figure 15 .

[0134] The sacrificial sleeve 1320 may temporarily fix the guide 1318 and the deployable element 102 together, allowing them to move as a unit. For a more detailed description of the sacrificial sleeve 1320, see Figure 16 .

[0135] The recoil spring 1324 and the support tube 1322 may be directly attached to the base 1326. The remaining elements of the catheter deployment assembly 1300 may be attached to the harness 1304, which is then attached to the base at the bottom of the legs of the harness 1304.

[0136] As Figure 14As shown, during operation, the deployment spring 1306 is initially held in a compressed state by the release member 1310 so that it stores energy. When the release member 1310 is removed, the energy stored in the deployment spring 1306 is released and transferred to the support cup 1308. The support cup 1308 then pushes the deployable element 102 together with the guide 1318 (the guide may be connected to the deployable element 102) through an opening in the suspension member 1314. This causes a combined linear translation of the deployable element 102 and the guide 1318 by a first predetermined distance. This action causes the retraction spring 1316 attached to the guide 1318 to extend, thereby storing energy in the retraction spring 1316.

[0137] After the first predetermined distance, both the deployable element 102 and the guide 1318 move through an opening in the recoil spring 1324. The tip of the guide 1318 forms an opening in the user's skin through which the deployable element 102 can pass.

[0138] The opening in the recoil spring 1324 is complementary in shape to the guide 1318, so that when the guide 1318 moves downward through the opening in the recoil spring 1324, the guide is pushed towards the side of the recoil spring 1324 (see Figure 15 ). The guide 1318 includes a geometric portion having an angled structure 1402, the width of which is greater than the first portion of the opening in the suspension member 1314 through which the guide 1318 initially passes. The second portion of the opening in the suspension member 1314 is oriented towards the side of the suspension member 1314 in the same direction as the direction in which the recoil spring 1324 pushes the guide 1318, and has a larger opening corresponding in size and shape to the angled structure 1402.

[0139] When the angled structure 1402 moves towards the second portion of the opening due to the interaction of the recoil spring 1324 on the guide 1318, two things occur. First, the guide 1318 moves towards the side of the support cup 1308 where a groove is cut in the support cup 1308. This releases the guide 1318 from the action of the deployment spring 1306. Second, the retraction spring 1316, which was previously restricted from pulling back the guide 1318 by the suspension member 1314, is free to pull the guide 1318 back above the suspension member 1314. This pulls the guide 1318 back into the base 1326, thereby providing it with a safety housing that prevents the tip of the guide 1318 from contacting the user's skin again.

[0140] As described above, the guide 1318 and the deployable element 102 may be connected together such that they move linearly together. Figure 16An example of a sacrificial sleeve 1320 configured to temporarily connect the two components is shown. The sacrificial sleeve 1320 temporarily increases the structural stiffness of these components during combined translation in a desired direction, but then cuts, peels, collapses, or otherwise separates from these components after reaching the desired translation amount or position. This allows the independent elongate components to move differently and unconnected relative to each other in the same or opposite directions.

[0141] For example, the sacrificial sleeve 1320 can be a thin-walled element formed of a polymeric material. When the suspension member 1314 moves downward under the action of the deployment spring 1306, the sacrificial sleeve 1320 can be compressed against the recoil spring 1324. At this time, it may collapse, cut, or separate along a predetermined separation line. The sacrificial sleeve 1320 can remain within the catheter deployment assembly 1300, for example, be captured in the support tube 1322.

[0142] Similar to the above embodiments, the deployable element 102 can be a cannula or needle for delivering a drug (such as insulin), or can be a glucose sensor or a ketone sensor (such as an electrochemical sensor, an optical fiber sensor, a pull-wire sensor, a fluorescence sensor, etc.), a temperature sensor, or an activity sensor.

[0143] Epidermal tensioning structure

[0144] Since the above embodiments can be used in conjunction with particularly thin and flexible elements, these elements may be particularly prone to buckling or deflection. Any of these embodiments can benefit from deploying the cannula or sensor (or the deployable element 102) into pre-tensioned tissue to reduce the likelihood of buckling. Figures 17 to 20 An exemplary structure is shown that allows the user's tissue (such as epidermal tissue) to be tensioned before deploying the cannula / sensor.

[0145] Figure 17 and Figure 19 An example of a tensioning structure that can be present on the base 108 of the catheter deployment assembly 100 is shown. The tensioning structure includes an annular ring 1702 that is centered on an opening in the base of the catheter deployment assembly 100 or the catheter deployment assembly 1300 (through which the deployable element 102 passes). The annular ring 1702 can be any suitable size; in the example shown, the outer diameter of the annular ring 1702 is approximately 0.25 inches.

[0146] The annular ring 1702 forms a gap 1706 at the center of the annular ring 1702. When the base of the catheter deployment assembly is pressed into the user's skin 1704, the skin slightly bulges into the gap 1706, thereby tensioning the skin 1704.

[0147] Figure 17The example in Figure 20 shows annular loops with different cross - sectional shapes: a triangular cross - section 2002, a trapezoidal cross - section 2004, an oval cross - section 2006, and a rectangular cross - section 2008.

[0148] Figure 18 shows an alternative construction of the tensioning element. In this case, the tensioning element causes the skin 1704 to be indented inwardly rather than bulging outwardly as in Figure 17 . To achieve this, the bottom surface of the base 108 projects outwardly with a convex protrusion 1802 that can be centered over the opening 114. This pushes the skin 1704 away from the base 108, which causes the skin to be tensioned against the base 108. If the deployable element 102 is deployed at an angle, the opening 114 can be positioned such that the deployable element 102 is nearly perpendicular to the tensioned skin surface where the deployable element 102 is to be inserted, or more perpendicular than would be the case if the opening were centered on the protrusion 1802.

[0149] Exemplary cannula and sensor structures

[0150] The cannula or the sensor itself can also be constructed or configured to support deployment, as shown by the exemplary deployable element 102 in Figures 21A to 23 .

[0151] For example, Figures 21A to 22 shows an exemplary sensor formed from a laminated composite structure of polymers, metals, and other materials. These materials can be combined into various cross - sections and can be used to form the desired directional stiffness (usually axial stiffness, but not necessarily). This can improve the deployment of thin, flexible, and elongated elements into the human skin during multi - day implant use. Additionally, it can maintain conductive signal conduits / traces to the embedded electronic hardware.

[0152] Figure 21A Two different deployable elements 102 are shown at the top; the deployable element on the left corresponds to the deployable element of the first rotational embodiment, while the deployable element on the right corresponds to the deployable element of the second linear embodiment. The close - up at the bottom of the page represents a structure that can be applied to either of these embodiments.

[0153] The deployable element 102 can be composed of a core layer 2102, an outer layer 2104, a first conductor / electrode 2106, a second conductor / electrode 2108, and / or a support 2110.

[0154] The core layer 2102 can be formed of a material that is rigid enough or has a high enough modulus to prevent the deployable element 102 from buckling or deflecting (e.g., stainless steel, titanium, or other metals). The support member 2110 can further improve the directional stiffness of the deployable element 102 to improve deployment penetration and can be made of a material similar to the core layer 2102 and / or a polymer, such as polyimide, FEP, PTFE, PP, PCL, PGA, PGLA, PLA, silicone, etc. The support member 2110 can also be or alternatively a biocompatible coating.

[0155] The outer layer 2104 can be a coating, such as an enzyme or other bioengineered compound, that protects the other layers while protecting the penetration point into the user's skin. It can also be electrically insulating to retain the electrical signals traveling along the conductors / electrodes 2106, 2108.

[0156] The first and second conductors / electrodes 2106, 2108 can form traces that transmit electrical signals from the distal end of the deployable element 102 to an embedded circuit for processing the signals. The conductors / electrodes 2106, 2108 can be made of a conductive material such as copper alloy, nickel, silver, gold, etc. The conductors / electrodes 2106, 2108 can extend along the entire length of the deployable element 102.

[0157] After assembly, the multi-layered structure can be modified at the distal tip to support penetration into the user's skin. For example, the material at the distal end can be ablated to remove all materials except the core layer 2102 and allow the core layer 2102 to become sharp.

[0158] Figure 21B and Figure 21C Additional examples of deployable elements in the form of thin, flexible, multi-layered laminated wires are shown. In these embodiments, different layers 2114a, 2114b, 2114c, 2114d, 2114e... can be sequentially coated on top of the core 2116. For example, the core 2116 can be a piece of wire (e.g., 5 / 1000 inches in diameter) made of tungsten or stainless steel. The layers 2114a... can be insulators, conductors, enzymes, etc., coated along the length of the wire. The final layer can be a protective biocompatible coating 2112.

[0159] In some embodiments (e.g., Figure 21B as shown), different layers can be ablated away to expose each layer in sequence. Alternatively ( Figure 21C ), individual layers can be ablated in specific regions along the length of the wire to selectively expose them.

[0160] Figure 23An exemplary structure suitable for a catheter is shown. The catheter may include a reinforced tip 2304 at the distal end, which is configured to penetrate the user's skin. The tip 2304 may be pointed or sharp to facilitate penetration.

[0161] The catheter may be hollow to allow the dispensing of liquid drugs through the catheter. To this end, one or more ports 2302 may be provided at the distal end of the catheter, near the tip 2304. The ports 2302 may face the side of the catheter to allow the dispensing of liquid drugs.

[0162] As in the example shown, the catheter may have a substantially rectangular cross-section 2306. This cross-section 2306 provides strength to the catheter and prevents it from collapsing, which would prevent the catheter from dispensing liquid drugs. Other suitable shapes may be used as needed. The proximal end of the catheter may include an interface, thereby allowing the catheter to be connected to a fluid conduit 202, which is connected to a reservoir for supplying liquid drugs.

[0163] Figures 1A - 12D The rotational deployment mechanism shown in [the reference] was previously described as "needleless". Such a system is capable of deploying an elongate or deployable element to a depth of, for example, 2 to 10 millimeters as measured perpendicular to the outer surface of the skin or alternatively linearly along the length of the deployable element. This "needleless" feature helps to minimize trauma and wound size during penetration. It is known that minimizing these factors can improve the functional efficacy of the elongate element residing within the tissue (typically at a subcutaneous depth).

[0164] Figures 24A - 32B The embodiment shown in [the reference] includes a guide that is capable of minimally penetrating the outermost and toughest layer of skin (from the stratum corneum to the dermis) (penetration depth is only 1 to 3 millimeters), and then retracting from the skin during or after the further downward penetration of the deployable element 102 (for example, see Figures 32A - 32B ) into the subcutaneous tissue. Thus, the accompanying deployable element will only need to independently slide into the softer subcutaneous layer or the least tough layer of the skin (mainly fat and connective tissue) and remain there during use. Of course, the assist system may be configured to drive an auxiliary sharp element to the full depth together with the deployable element; nonetheless, reducing penetration may be desired for minimizing trauma and wound size.

[0165] These embodiments are particularly useful when combined with elongate or deployable elements that are very small in size or diameter, or have certain geometries or are made of specific materials such that their inherent stiffness (e.g., Young's modulus) makes them too weak to be independently delivered through the skin into the tissue medium without buckling.

[0166] The following figures include many of the same features as previously discussed in Figures 1A - 12D Therefore, redundant descriptions are omitted.Figure 24A illustrates an exemplary rotational cannula deployment mechanism for penetrating the outermost layer of the skin using a introducer, while Figure 24B illustrates Figure 24A the rotational cannula deployment mechanism having an exemplary housing 704.

[0167] The housing 704 is provided with integrated channels, which in this embodiment include a first channel 2406 and a second channel 2408. These channels are configured to adapt, align, and guide an introducer (such as shown in Figures 25A - 26C ) that serves as a primary tissue penetration element.

[0168] The deployment mechanism further includes a retaining block 2402 and an introducer spring 2404 within the housing. The design and function of these elements are described in conjunction with Figures 28A - 28D and FIGS. 30A - 31.

[0169] Figure 25A and 25B illustrates an exemplary introducer 2502 suitable for the described embodiment. The introducer 2502 may include a tapered tip 2504 having a sharp edge 2506.

[0170] The introducer 2502 further includes a flexible portion 2508 that provides a spring - like portion that allows longitudinal bending without yielding. When the introducer is in the pre - deployment configuration, the flexible portion 2508 bends around the housing 104 and is driven by the rotational movement of the above - mentioned pulley 706. When the introducer is deployed, the flexible portion 2508 straightens, driving the tip 2504 into the skin.

[0171] Interface feature structures 2510 such as protrusions, grooves, flanges, or hooks allow the introducer 2502 to be connected to the introducer spring 2404, as shown in more detail in Figure 31 FIGS. A - 31B.

[0172] Alignment feature structures 2512 may be bends or curves that allow the portion of the introducer 2502 closest to the tip 2504 (referred to herein as the introducer guide portion 2514) to be positioned close to or flush with the deployable element 102. Thus, the introducer can penetrate the outermost layer of the skin and guide the deployable element 102 into the body.

[0173] As shown in Figures 26A - 26C , it can be foreseen that some embodiments of the introducer 2502 may include various shapes and end structures 2516, 2518 specifically configured for particular applications. Only a few variants are shown here as examples, but these do not cover many possible options.

[0174] Figure 27A-C shows how the exemplary guide 2502 is positioned relative to the first channel 2406 and the second channel 2408 of the housing 104 and relative to the pulley 706. The interface feature 2510 of the guide 2502 is configured to rest in the corresponding groove 2702 of the pulley 706. During assembly, the interface feature 2510 extends through the first channel 2406 of the housing 104, while the flexible portion 2508 is outside the housing 104 and extends around the housing 104. The alignment feature 2512 bends the guide 2502 back towards the deployable element 102 and through the second channel 2408 of the housing 104.

[0175] During assembly, the flexible portion 2508 of the guide 2502 is bent to the geometry of the pulley 706, and the interface feature 2510 is fed into the groove 2702 on the pulley 706.

[0176] The major length of the guide 2502 (corresponding to the flexible portion 2508) is tangentially positioned to the outermost surface of the housing 104, while the shorter length (corresponding to the guide portion 2514 of the guide) fits within the second channel 2408 integrated within the housing 104.

[0177] The construction also includes several other components, which can be separate components combined by assembly. Alternatively or additionally, some elements can be integrated into a single combined component. Figures 28A - 28D Show these additional components.

[0178] During the assembly process, with the guide 2502 positioned in its desired location, the retaining block 2402 is added to fix the guide 2502 to the housing 104 and the pulley 706. The retaining block 2492 can be, for example, an injection molded part made of a low friction polymer material to reduce the mechanical energy loss during the functional movement of the relative sliding action of the guide 2502. The retaining block 2402, together with any attached (or integrated) components, is directly attached to the housing 104 or other static elements of the system by snap fit, press fit, crimping or other suitable attachment methods.

[0179] The retaining block 2402 can include a recess 2802 configured and positioned for positioning, constraining and holding an escapement clip 2804 or similar element, which provides low force deflection and is used to set the position of the guide spring 2402 and the locking element within the system. The guide spring 2402 can provide sufficient force to retract the guide 2502 during system operation. Figure 31 A-31B shows the exemplary guide spring 2402 in more detail.

[0180] The escapement clip 2804 can be composed of thin metal parts formed by stamping. This escapement clip 2804 can also be part of the housing 104 or attached to the housing 104. Similarly, the structure includes a retaining flexure 2806. The main function of the retaining flexure 2806 is to provide a light normal force radially inwardly directed towards the center of the housing 104, which force is applied (e.g., directly) to the outward-facing surface of the guide 2502. The retaining flexure 2806 also establishes an initial escapement position that allows the guide 2502 to spring back from its temporarily held bent shape and flex to its original straight beam shape. In this embodiment, the retaining flexure 2806 is composed of thin metal formed by stamping and has a flexure cantilever beam section with attachment features and geometries. This element can also be directly attached to the housing 104.

[0181] Figure 29A -C shows an exemplary sequence of positions of the guide 2502 during deployment and before retraction. Figure 29A Shows the initial position of the guide 2502 at the start of the rotational movement of the contact pulley 706. Figure 29B Shows the position where the guide 2502 is released from the restraining force of the retaining flexure 2806 and the rotation of the pulley 706. Figure 29C Shows an instantaneous state in which the guide 2502 springs back to its straight shape at the time of manufacture and just before it is retracted by the guide spring 2404.

[0182] During its fully inserted (deployed) position, the guide 2502 engages with geometric features integrated within or assembled to the guide spring 2404 through interface features 2510. Figure 30B Shows the guide 2502 in the fully inserted position, which shows the point at which the guide 2502 is released from its static holding position under the escapement clip 2804 when the guide spring 2404 is now connected to the guide 2502 and thus allows the guide 2502 to retract from the penetrated tissue.

[0183] Figure 30A Shows the guide 2502 in the pre-deployment state, which shows that the load of the guide spring 2404 (a constant force type in this embodiment) is held by the escapement clip 2804 and is thus isolated (or separated) from the main drive energy source during the main angle of the driving rotational movement. This system configuration helps to reduce the force capacity required for the guide spring 2404 such that it is only slightly greater than the frictional forces generated by the contact of the guide 2502 with the tissue and the surfaces of the housing 104 and the retaining block 2402. Thus, this spring force will also minimize the obstruction to the main force and inertia of the rotational movement of the pulley 706.

[0184] Figure 31Exemplary interface feature structures of the introducer 2502 and the interface spring 2404 are shown. These feature structures allow these elements to be connected so that the introducer 2502 can be retracted during the rotational movement cycle of the system. The introducer interface feature structure 2510 has been described above. Meanwhile, the spring interface 3102 has a corresponding geometry, such as a hook for connecting to the hook end of the introducer interface feature structure 2510 and a central hole through which the introducer 2502 passes. In some embodiments, the ends of the introducer spring 2404 can be easily formed into a fine "U" shape or hook shape, which will lock onto the flat edge shape of the introducer interface feature structure 2510. This embodiment represents the most basic functional configuration. However, it will be immediately apparent to those skilled in the art that alternative features for providing interface functionality can be achieved by varying the nuances of the components as well as the interface geometry and materials.

[0185] The opposite ends of the introducer spring 2404 can be formed into coils 3104, which can be used to reduce the overall size of the system.

[0186] Figure 32A -B respectively correspond Figure 30A and 30B and show a comparison of the exemplary "pre-deployment state" with the state when the introducer 2502 and the deployable element 102 are in the "fully inserted" position.

[0187] These figures show that before deployment, the tip positions of the introducer 2502 and the deployable element 102 remain at approximately the same distal position, although in alternative embodiments the introducer can extend distally beyond the deployable element 102. Upon triggering a deployment event, the introducer 2502 and the deployable element 102 move tangentially adjacent to each other at the same offset or insertion rate. When reaching its escapement position during the rotational movement, the introducer 2502 reaches its maximum insertion depth (Di) within the skin tissue, which, as described above, can be 1 to 3 millimeters below the outermost surface of the skin. At this point in the rotation, the introducer 2502 is pulled and retracted by the introducer spring 2404, travels in the opposite direction and returns to reside within the package of the deployment device, where the tip of the introducer 2502 stops and remains at its initial position.

[0188] Meanwhile, the rotational movement of the pulley 706 continues in its forward direction, and the deployable element 102 (directly attached to the pulley 706 at the end of the deployable element 102 opposite its tip in this embodiment) continues its trajectory into the tissue until its tip reaches a final depth (Ds) of, for example, 2 to 10 millimeters, or more preferably 4 to 6 millimeters, which is measured perpendicularly from the outer surface of the skin or alternatively linearly along the length of the deployable element 102 (e.g., when the insertion angle is designed not to be perpendicular to the skin surface). When the rotational movement reaches its stop position, the deployable element 102 remains within the tissue during its use.

[0189] These figures also show a fixed point 3202 (axially shaped in this embodiment, although other configurations are possible), which holds the coil portion 3104 of the guide spring 2404, allowing it to unwind and then retract. Similar functionality can be configured with other suitably constructed elastic, spring-like elements. The insertion angle can also be adjusted from perpendicular to, for example, 30 - 60 degrees.

[0190] A guide element that does not penetrate as deeply into the tissue as the deployable element 102 (e.g., an infusion cannula or a sensor element as described above) achieves a number of objectives. The guide element is capable of penetrating the tougher layers of the skin (e.g., the stratum corneum) to create a hole or an entry path for the more flexible deployable element 102, and then retracting into the delivery device (e.g., within a drug delivery device or a continuous glucose monitor housing). This results in less pain for the user and less trauma at the insertion site. Consequently, the design and method require less "wound healing". For example, for a sensor such as a continuous glucose sensor, this reduced wound healing allows the sensor to "warm up" faster and, compared to a situation where the guide or needle element penetrates to a depth greater than or approximately equal to the penetration depth of the sensor (or deployable element), allows the sensor to provide readings faster or more accurately. Less trauma is also beneficial when, for example, the cannula is the deployable element 102 and a drug such as insulin or GLP - 1 or a similar drug is infused through the cannula into the patient's body. The reduced trauma and less wound healing can also reduce the likelihood of blockage at or near the distal end of the cannula. Thus, having a guide (which does not remain beneath the skin surface) that does not penetrate as deeply as the deployable element (which does remain beneath the skin surface) is very beneficial for both the patient and the functionality of the medical device (e.g., whether it is a drug delivery device or a continuous glucose monitor (CGM)).

[0191] Those of ordinary skill in the art will understand that the concepts described above can be applied to a needle used as a guide and an infusion cannula or an analyte sensor used as a deployable element, as described above. More specifically, in some embodiments, the guide described above can be in the form of a needle. The needle can be positioned within the lumen of a hollow deployable element. In other embodiments, the needle can be hollow, and the deployable element can be positioned within the lumen of the needle. And as described above, the needle can penetrate the outermost (toughest) layer of the skin and then retract outside the skin into the medical device housing (from which the needle is deployed), and the deployable element can continue to penetrate further into the softer layer of the subcutaneous tissue (either when the needle retracts backward or before the needle retracts backward, but after the needle stops penetrating distally further). In this way, the needle does not penetrate distally further than the deployable element, resulting in less pain for the user and less trauma at the insertion site.

[0192] It should be understood that the exemplary devices shown in the above block diagrams may represent a functional description example of many potential embodiments. Therefore, the division, omission, or inclusion of the block functions shown in the drawings does not mean that the hardware components, circuits, software, and / or elements for implementing these functions must be divided, omitted, or included in the embodiments.

[0193] Some embodiments may be described using "one embodiment" or "embodiments" and their derivatives. These terms mean that the specific features, structures, or characteristics described in connection with the embodiment are included in at least one embodiment. The phrase "in one embodiment" appearing throughout the specification does not necessarily refer to the same embodiment. Additionally, unless otherwise stated, the above features are considered to be used in any combination together. Thus, any feature discussed separately can be used in combination with each other unless it is indicated that the features are incompatible with each other.

[0194] Generally referring to the symbols and terms used herein, the detailed description herein may be presented in the form of program processes executed on a computer or a computer network. These process descriptions and representations are used by those skilled in the art to most effectively convey the substance of their work to other persons skilled in the art.

[0195] Some embodiments may be described using "coupled" and "connected" and their derivatives. These terms are not necessarily intended to be synonyms of each other. For example, some embodiments may use the terms "connected" and / or "coupled" to describe so as to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements do not directly contact each other but still cooperate or interact with each other.

[0196] It is emphasized that the abstract of the present disclosure is provided to allow the reader to quickly determine the nature of the technical disclosure. It should be understood that it is not used to interpret or limit the scope or meaning of the claims. Additionally, in the above detailed description, it can be seen that for the sake of simplifying the disclosure, various features are grouped together in a single embodiment. This method of disclosure should not be construed as reflecting an intention that the claimed embodiments require more features than those expressly recited in each claim. On the contrary, as reflected in the following claims, the inventive subject matter lies in less than all the features of a single disclosed embodiment. Therefore, the following claims are hereby incorporated into the detailed description, with each claim standing alone as a separate embodiment. In the appended claims, the terms "comprising" and "wherein" are used as the ordinary English equivalents of the respective terms "including" and "wherein". Additionally, the terms "first", "second", "third", etc. are used only as labels and are not intended to impose a numerical requirement on their objects.

[0197] The foregoing description includes examples of the disclosed architecture. Of course, it is not possible to describe every conceivable combination of components and / or methods, but one of ordinary skill in the art will recognize that many further combinations and permutations are possible. Accordingly, the novel architecture is intended to embrace all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims.

[0198] Exemplary embodiments may include, but are not limited to:

[0199] 1. A device comprising: a deployable element configured for subcutaneous deployment; a guide configured to remain adjacent to the deployable element during deployment of the deployable element to support the deployable element during deployment; and a base having an opening, wherein the deployable element and the guide are configured to extend through the opening, and wherein the deployable element is configured to extend a first amount within the user's skin during deployment, and the guide is configured such that the guide penetrates into the user's skin and extends a second amount within the user's skin that is less than the first amount.

[0200] 2. The device of (1) above, wherein the deployable element is configured to extend to a depth of 4 - 7 millimeters within the user's skin.

[0201] 3. The device of (1) or (2) above, wherein the guide is configured to penetrate the outermost layer of the user's skin including the stratum corneum to the dermis.

[0202] 4. The device of any one of (1) - (3) above, wherein the guide is configured to extend to a depth of 1 - 3 millimeters within the user's skin.

[0203] 5. The device of any one of (1) - (4) above, wherein the guide is configured to automatically retract through the opening in the base after reaching a maximum deployment distance.

[0204] 6. The device of any one of (1) - (5) above, wherein the deployable element is configured to continue to extend after the guide reaches a maximum deployment distance.

[0205] 7. The device of any one of (1) - (6) above, wherein the deployable element is selected from the group consisting of a cannula, a catheter, a needle, or a sensor.

[0206] 8. The device of any one of (1) - (7) above, wherein the deployable element is: a glucose sensor configured to perform continuous blood glucose monitoring, or a ketone sensor.

[0207] 9. The device according to any one of (1)-(8) above further includes a rotating mechanism having an outer circumference around which at least a portion of the deployable element is wound, the rotating mechanism configured to rotate the deployable element around the outer circumference and configured to selectively restrain the deployable element such that rotation of the deployable element is converted into linear motion.

[0208] 10. The device according to (9) above further includes a guide spring coiled around a fixed point on the device.

[0209] 11. The device according to (10) above further includes: a housing surrounding at least a portion of the rotating mechanism; a holding block configured to fix the guide to the housing; and one or more escapement clips disposed in corresponding recesses of the holding block and configured to fix the guide spring.

[0210] 12. The device according to any one of (10)-(11) above, wherein the guide spring includes a guide spring interface configured to cooperate with a corresponding interface on the guide.

[0211] 13. The device according to any one of (9)-(12) above, wherein the rotating mechanism is a pulley assembly.

[0212] 14. The device according to any one of (9)-(13) above further includes a torsion spring configured to provide energy to rotate the rotating mechanism.

[0213] 15. The device according to any one of (9)-(14) above further includes a stop plate configured to control the extent to which the deployable element extends beyond the opening.

[0214] 16. The device according to any one of (9)-(15) above further includes a fluid conduit configured to connect the deployable element to a reservoir.

[0215] 17. The device according to any one of (1)-(8) above further includes a linear deployment mechanism configured to cause the deployable element and the guide to extend.

[0216] 18. The device according to any one of (1)-(17) above further includes at least one convex or concave protrusion provided on the base, wherein the size and shape of the protrusion are designed to tighten the user's skin near the opening when the base is pushed against the skin.

[0217] 19. The device according to any one of (1)-(18) above, wherein the deployable element has a laminated composite structure including at least one polymer, at least one metal, and a coating.

[0218] 20. The device according to any one of (1)-(19) above, wherein the deployable element includes one or more conductive signal traces connected to embedded electronic hardware.

Claims

1. An apparatus, comprising: A deployable element configured for subcutaneous deployment; A guide configured to remain adjacent to the deployable element during deployment of the deployable element to support the deployable element during deployment; And A base having an opening, the deployable element and the guide being configured to extend through the opening, Wherein the deployable element is configured to extend a first amount within the user's skin during the deployment, and the guide is configured such that the guide penetrates the user's skin and extends a second amount within the user's skin, the second amount being less than the first amount.

2. The device according to claim 1, wherein, The deployable element is configured to extend to a depth of 4 - 7 millimeters within the user's skin.

3. The device according to claim 1, wherein, The guide is configured to penetrate the outermost layer of the user's skin including the stratum corneum to the dermis.

4. The device according to claim 1, wherein, The guide is configured to extend to a depth of 1 - 3 millimeters within the user's skin.

5. The device according to claim 1, wherein, The guide is configured to automatically retract through the opening in the base after reaching a maximum deployment distance.

6. The device according to claim 1, wherein The deployable element is configured to continue to extend after the guide reaches the maximum deployment distance.

7. The device according to claim 1, wherein The deployable element is selected from the group consisting of a cannula, a catheter, a needle, or a sensor.

8. The apparatus according to claim 1, wherein, The deployable element is: A glucose sensor configured to perform continuous glucose monitoring, or A ketone sensor.

9. The apparatus according to claim 1, further comprising a rotating mechanism having an outer circumference, the deployable element being wound around at least a portion of the outer circumference, the rotating mechanism being configured to rotate the deployable element around the outer circumference and being configured to selectively constrain the deployable element such that rotation of the deployable element is converted into linear motion.

10. The apparatus according to claim 9, further comprising a guide spring coiled around a fixed point on the apparatus.

11. The apparatus according to claim 10, further comprising: A housing surrounding at least a portion of the rotating mechanism; A retaining block configured to fix the guide to the housing; And One or more escapement clips, the one or more escapement clips being disposed in corresponding recesses of the retaining block and configured to fix the guide spring.

12. The apparatus according to claim 10, wherein, The guide spring includes a guide spring interface configured to cooperate with a corresponding interface on the guide.

13. The device according to claim 9, wherein, The rotating mechanism is a pulley assembly.

14. The apparatus according to claim 9, further comprising a torsion spring configured to provide energy to rotate the rotating mechanism.

15. The apparatus according to claim 9, further comprising a stop plate configured to control the extent to which the deployable element extends beyond the opening.

16. The apparatus according to claim 9, further comprising a fluid conduit configured to connect the deployable element to a reservoir.

17. The apparatus according to claim 1, further comprising a linear deployment mechanism configured to cause the deployable element and the guide to extend.

18. The device according to claim 1 further includes at least one convex or concave protrusion disposed on the base, wherein, The protrusion is sized and shaped to cause the user's skin near the opening to be tightened when the base is pushed against the user's skin.

19. The device according to claim 1, wherein, The deployable element has a laminated composite structure including at least one polymer, at least one metal, and a coating.

20. The apparatus according to claim 1, wherein The deployable element includes one or more conductive signal traces connected to embedded electronic hardware.

Images