Medication delivery device for administering fluid to patients

Abstract

The present invention relates to a medication delivery device for administering fluid to patients. The device comprises a patch designed to be applied to the patient's skin, equipped with a flexible cannula that penetrates the skin to deliver fluid from a reservoir. A fluid delivery channel connects the cannula, while a valve along the channel prevents retrograde flow of the fluid, ensuring precise administration. The valve can be an umbrella, reed, or duckbill valve. The device may include a balloon bladder to buffer and release fluid at a controlled rate after injection. A luer fitting enables connection with an external syringe for fluid delivery. The device also features a deployment system with a spring-loaded mechanism for controlled cannula deployment and retraction. Designed with low-profile body, the device can accommodate fluids of varying viscosities through adaptable components.

Description

Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSCROSS REFERENCE TO RELATED APPLICATIONSThis application claims the benefit of U.S. Provisional Application No. 63 / 778,390, filed March 27, 2025, the entire contents of which are hereby incorporated by reference in their entirety.TECHNICAL FIELD

[0001] This disclosure relates generally to medication delivery devices, and more particularly to devices for administering therapeutic fluids to patients through a wearable patch or injection system. The disclosed invention focuses on improving fluid flow control, ensuring one-way delivery of medication, and preventing backflow, while optimizing the compactness and efficiency of the device.BACKGROUND

[0002] Medication delivery devices have been widely used in modem healthcare to administer various therapeutic fluids, such as insulin, pain relievers, or antibiotics, directly into a patient's body. These devices come in various forms, including syringes, infusion pumps, and wearable patches. Among these, wearable drug delivery devices are gaining prominence due to their ability to administer controlled doses of medication over time without restricting the patient’s mobility. These devices play a crucial role in chronic disease management, enabling patients to receive ongoing treatment without frequent hospital visits.

[0003] Despite the advancements in medication delivery devices, there are still significant challenges associated with ensuring precise and reliable drug administration, especially in devices designed for self-administration. Current devices often struggle with preventing backflow of medication, controlling dosage accuracy, and minimizing the space required for packaging the fluid control mechanisms. Devices that combine inflow and outflow conduits in a compact form can suffer from leakage, inadequate valve control, and complex operation, which can result in unreliable delivery' and pose risks to patient safety. For instance, several prior art references, including US 9486575, US 8221361, US 8216208, and US 7524300, all require a septum for the medication delivery channel. These designsDocket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSintroduce additional challenges related to sealing, leakage, and compatibility with various components. Other patents in the Medtronic patent family, such as US 8221386, US 8262627, US 8221362, US 7935090. US 8366683, US 7731680, and US 8777925, similarly require a septum for fluid delivery, which complicates the device's design and operation. Devices that incorporate inflow and outflow conduits in a compact form factor may also suffer from leakage or inadequate valve control, further complicating the operation for end users.

[0004] Furthermore, existing designs often struggle with effectively accommodating different fluid viscosities, controlling the fluid flow rate, and preventing retrograde flow in a compact and user-friendly form. For example, Medtronic's US 7338465 patent discloses a device that also requires a septum for the medication delivery channel, which can introduce potential leakage points and increase design complexity, making it less suitable for selfadministration or home care settings. Additionally, devices incorporating a septum necessitate the use of a needle on the drug-containing syringe, which limits the volume flow rate of medication delivery. For instance, when injecting insulin directly with a syringe, the presence of a needle restricts the flow rate, requiring the user to inject slowly. By eliminating the septum, the disclosed invention enables needle-less delivery, allowing a higher volume flow rate through a syringe without a needle, thereby providing a faster and more efficient drug administration process.

[0005] Therefore, there is a need for a medication delivery device that can overcome these limitations, particularly by eliminating the requirement for a septum in the fluid delivery channel. The proposed design of a flexible cannula does not include a septum, thereby simplifying the design and avoiding the complications associated with prior art. By removing the septum, the disclosed device reduces the risk of leakage, enhances reliability, and improves the user experience. Additionally, eliminating the need for a needle on the medication-containing syringe simplifies the disposal process. Traditional needle syringes require users to either trim the needle with a needle cutter, which is an extra step in the workflow, or dispose of it in a sharps container, adding to disposal complexity. A patch that enables needle-less medication delivery improves ease of use and reduces ecological impact by eliminating the need for specialized needle disposal.Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSSUMMARY OF THE INVENTION

[0006] The invention relates to an advanced medication deliver, device designed for precise, safe, and user-friendly administration of therapeutic fluids to patents. The device features a patch that adheres to the patient's skin and incorporates a flexible cannula for subcutaneous delivery of medication from a reservoir. The device is equipped with a fluid delivery' channel containing a valve — such as an umbrella, reed, or duckbill valve — to ensure unidirectional fluid flow and prevent backflow, enhancing the accuracy and reliability of drug delivery.

[0007] A balloon bladder within the patch serves as a reservoir, buffering the fluid during injection and enabling controlled release into the patient's tissue. The device integrates a luer fitting for secure connection to external syringes, facilitating seamless bolus injections. A spring-loaded mechanism within the deployment system ensures controlled extension and retraction of the cannula, prioritizing user and patient safety7.

[0008] The design eliminates the need for a septum in the fluid delivery channel, reducing complexity and risk of leakage commonly seen in conventional devices. The compact, low- profile form factor accommodates fluids of vary ing viscosities, with adaptable components to optimize performance in diverse clinical scenarios. This innovation addresses challenges associated with leakage, backflow prevention, and dosage accuracy, providing an effective solution for self-administration and chronic disease management.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate exemplary7embodiments and, together with the description, serve to explain the disclosed principles.

[0010] FIG. 1A-1C illustrates a side view of a medication delivery device, which is used to deliver a medical patch to a patient’s skin, in accordance with an embodiment of present disclosure.Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0011] FIG.2 illustrates a side view of the medication delivery device after a user has initiated deployment, in accordance with an embodiment of the present disclosure.

[0012] FIG.3 A illustrates a side view of the medication delivery device, focusing on elements that enable retraction of the cannula support needle (via a needle carrier) after the patch is placed on the patient’s skin, in accordance with an embodiment of the present disclosure.

[0013] FIG.3B illustrates a side view of the medication delivery device, showing the separation of the device from the patch once the support needle has been fully retracted, in accordance with an embodiment of the present disclosure.

[0014] FIG.4 illustrates an isometric top view of the medication delivery' device, highlighting the external components and internal arrangement visible through cut-outs in the outer sleeve, in accordance with an embodiment of the present disclosure.

[0015] FIG.5 illustrates an isometric top view of the medication delivery' device in an intermediate stage of its deployment sequence, similar to that described in FIG.2, in accordance with an embodiment of the present disclosure.

[0016] FIG.6A illustrates an isometric top view of the medication delivery device in its final retracted configuration, emphasizing that the support needle is fully withdrawn into the housing prior to device removal, in accordance with an embodiment of the present disclosure.

[0017] FIG.6B illustrates an isometric top view of the medication delivery' device in its final state after it has been lifted aw ay from the patch, which remains adhered to the patient's skin, in accordance with an embodiment of the present disclosure.

[0018] FIG.7 illustrates an isometric bottom view of the medication delivery device, with a cutaway of the outer sleeve to provide visibility into the internal components and their movement, in accordance with an embodiment of the present disclosure.Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0019] FIG.8 illustrates an isometric bottom view of the medication delivery device, with the cutaway of the outer sleeve to reveal the internal mechanisms and their movement, in accordance with an embodiment of the present disclosure.

[0020] FIG.9A illustrates an isometric bottom view of the medication delivery device show n with a cutaway section of the outer sleeve, illustrating the delivery of the patch on the user’s skin.

[0021] Fig.9B illustrates an isometric bottom view of the medication delivery device (similar to FIG. 3B), showing the device lifted off and separated from the patch after the support needle is fully retracted, in accordance with an embodiment of the present disclosure.

[0022] FIG. 10 illustrates a cross-sectional side view of the patch in its deployed state is show n, in accordance with an embodiment of the present disclosure.

[0023] FIG. 11 illustrates a cross-sectional side view of the patch during the preparation for bolus injection, in accordance with an embodiment of the present disclosure.

[0024] FIG. 12 illustrates a cross-sectional side view of the patch during bolus injection, in accordance with an embodiment of the present disclosure.

[0025] FIG. 12A illustrates a cross-sectional side view' of the patch during the bolus injection phase, with the additional inclusion of a skin layer for contextual illustration, in accordance with a preferred embodiment of the present disclosure.

[0026] FIG. 13 illustrates a cross-sectional side view' of the patch during the post-injection phase, where the syringe has been removed and the patch bladder is gradually returning to its contracted state, in accordance with a preferred embodiment of the present disclosure.

[0027] FIG. 14 illustrates a cross-sectional side view' of the patch, depicting an alternative embodiment of the patch in which a reed valve replaces the umbrella valve used in earlier embodiments, in accordance with an embodiment of the present disclosure.Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0028] FIG. 15 illustrates a cross-sectional side view of the patch, illustrating the screw-fit attachment of the luer to the patch, in accordance with an embodiment of the present disclosure.

[0029] FIG. 16A illustrates a cross-sectional view of the patch, specifically showing the outflow path of the bolus injection into the patch bladder, in accordance with an embodiment of the present disclosure.

[0030] FIG. 16B illustrates a cross-sectional view of the patch, focusing on the inflow path from the patch bladder (after the bolus is delivered) and emphasizing the reed valve’s role in preventing backflow, in accordance with an embodiment of the present disclosure.

[0031] from the patch bladder after the bolus has been delivered into the patch bladder, in accordance with an embodiment of the present disclosure.

[0032] FIG. 17 illustrates a cross-sectional view of the patch during the phase where the user has removed the syringe from the luer after delivering the bolus of medication, in accordance with an embodiment of the present disclosure.

[0033] FIG. 18 illustrates an isometric view of the patch, providing a more comprehensive visual representation of the key components described in earlier figures, in accordance with an embodiment of the present disclosure.

[0034] FIG. 19 illustrates an isometric view of the patch which provides a clearer depiction of how the cannula interfaces with the patch, which includes the reed valve, in accordance with an embodiment of the present disclosure.

[0035] FIG.20 illustrates an isometric view of the patch depicting the relationship between the cannula, the reed valve, and the patch components during the medication delivery process, in accordance with an embodiment of the present disclosure.

[0036] FIG.21 illustrates an isometric view of the patch illustrating the embodiment that incorporates the reed valve to ensure unidirectional flow of medication, in accordance with an embodiment of the present disclosure.Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0037] FIG.22 illustrates a cross-sectional side view of the patch which includes a patch bladder of cylindrical shape, which is oriented vertically and is depicted in its contracted state, in accordance with an embodiment of the present disclosure.

[0038] FIG.23 illustrates a cross-sectional side view of the patch, highlighting the screw fit attachment of a syringe to the patch prior to delivering a bolus of medication, as well as the configuration of the patch bladder of cylindrical shape and the duckbill valve in a vertical orientation, in accordance with an embodiment of the present disclosure.

[0039] FIG.24 illustrates a detailed cross-sectional view of the patch, illustrating the injection process where medicine is administered into the patch, in accordance with an embodiment of the present disclosure.

[0040] FIG.25 illustrate a detailed cross-sectional view of the patch, illustrating the stage after the user has removed the syringe and the patch bladder begins to relax, expelling the medicine through the cannula, in accordance with an embodiment of the present disclosure.DETAILED DESCRIPTION OF THE DRAWINGS

[0041] Exemplary embodiments are described with reference to the accompanying drawings. Wherever convenient, the same reference numbers are used throughout the drawings to refer to the same or like parts. While examples and features of disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the scope of the disclosed embodiments.

[0042] Further, the phrases “in some embodiments,” “in accordance with some embodiments,” “in the embodiments shown,” “in other embodiments,” and the like mean a particular feature, structure, or characteristic following the phrase is included in at least one embodiment of the present disclosure and may be included in more than one embodiment. In addition, such phrases do not necessarily refer to the same embodiments or different embodiments.

[0043] Referring now to FIG. 1A -1C, an isometric half-sectional view of medication delivery system 100 consisting of a patch delivery device 101, with installed patch 112 andDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSconfigured in preparation for deployment of the patch, is illustrated in accordance with an embodiment of the present disclosure. The patch delivery device 101 is composed of several key components that interact during the deployment process. The patch delivery' device 101, as shown in FIG. 1A- IB, may include a deployment system that comprises an outer sleeve 102, an inner carrier 104, and a needle carrier 106. The patch delivery device 101 may further include an inner carrier spring 108, an inner carrier spring perch 116, a needle carrier spring 110, and a support needle 122.

[0044] The cannula 114 is part of the patch 112 and not the delivery- system. During deployment, the support needle 122, housed yvithin the needle carrier 106, provides structural support to the cannula 114 to prevent kinking as it is inserted into the patient's skin. Once the patch 112 is applied, the support needle 122 retracts into the device, leaving the cannula 114 in position for medication delivery.

[0045] The outer sleeve 102 houses and encloses the internal components. This outer sleeve 102 acts as the external casing of the medication delivery device 100, providing a protective outer structure. Inside the outer sleeve, the inner carrier 104 is depicted, which moves within the outer sleeve 102 during the deployment process, under the influence of force exerted by spring 108 and communicated through inner carrier spring perch 116. The inner carrier 104 is responsible for advancing the patch 112 into position during deployment.

[0046] Within the inner carrier 104, we see the needle carrier 106, yvhich houses the support needle and is loaded yvith a spring that controls the retraction of the support needle after the patch 112 has been deployed. Specifically, there are two critical springs involved in the deployment process of the patch: the inner carrier spring 108, positioned between the inner carrier 104 and the outer sleeve 102, and the needle carrier spring 110. Inner carrier spring 108 supplies the energy to advance the patch into position on the patient, and needle carrier spring supplies the energy to retract and safe support needle 122 once the patch has been deployed. Both of these springs are initially compressed and are storing potential energy prior to deployment. Inner carrier spring 108 would like to expand and drive inner carrier 104 in the downward direction; however, it cannot because stopper 124 is bearing against a slot in outer 102, preventing its motion. Stopper 124 and button 126 are incorporated into a cantilever arm feature in inner carrier 104. A radially inward deflection of button 126 wouldDocket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSallow stopper 124 to clear its slot so that spring 108 could expand. In similar design, needle carrier spring 110 would like to expand and drive needle carrier 106 in the upward direction; however, it likewise cannot because stopper 128 is bearing against a lip 130 in inner carrier 104. preventing its motion. Stopper 128 functions as a cantilever feature incorporated into needle carrier 106. A radially inward deflection of 128 would allow it to clear slot 130 so that spring 110 could expand. Stopper 128 is, in this state of the mechanism, inaccessible from the outside of Patch Delivery device 101 so that a deflecting force cannot be applied to it.

[0047] At the open end of the Patch Delivery device 101, patch 112 is loaded and prepared for deployment. Patch 112 is inserted so that the support needle 122 and the nose of the needle carrier 118 insert into and through the body of patch 112. Patch 112 is inserted and ultimately brought to contact a locating rib 120 on the distal face of inner carrier 104. so that patch 112 is seated in a stable position and support needle 122 fills the interior lumen of patch cannula 114. FIG. 1C depicts a magnified view of support needle 122 and patch cannula 114, illustrating that support needle 122 fills the entire lumen of patch cannula 114 so as to provide support for the entire length of patch cannula 114, thus discouraging it from buckling when the patch is inserted into the patient’s skin.

[0048] The user initiates deployment of patch 112 by depressing deploy ment button 126 radially inward. This action flexes stopper 124 inward until it clears lip 132, allowing inner carrier spring 108 to expand and drive inner carrier 104 downward. The downward motion of inner carrier 104 advances patch 112 into the patient’s skin surface. As spring 108 expands, stopper 124 displaces under lip 132 and then recovers into pocket 134. Shortly thereafter, the bottom edge of button 126 lands against lip 132, stopping further expansion of inner carrier spring 108 and movement of inner carrier 104. This movement brings Patch Delivery device 101 to its deployed state.

[0049] Only inner carrier spring 108 drives the movement of inner carrier 104 and patch 112 into position. Needle carrier spring 110 does not contribute to this deployment but functions solely to retract support needle 122 after patch 112 has been applied. This ensures that support needle 122 is safely withdrawn into the device, preventing accidental exposure to the user when handling the patch delivery system after deployment.Docket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0050] Referring now to FIG. 2, an isometric half-sectional view 200 of the patch delivery device 101 after the user has initiated deployment, in accordance with an embodiment of the present disclosure. The side view 200 depicts how the patch delivery device 101 moves from its loaded state into action, positioning the patch 112 onto the patient’s skin. The outer sleeve 102 continues to house the internal components, maintaining structural integrity. The inner carrier 104 is displaced forward as a result of an expansion of the inner carrier spring 108, which is now shown partially expanded compared to its compressed state in FIG. 1.Button 126 now lands on lip 132, preventing further movement of inner carrier 104. The forward displacement of the inner carrier pushes the patch 112 into place against the patient's skin.

[0051] The patch 112 has now moved forward so that cannula 114 has penetrated the patient’s skin and the distal tip of cannula 114 is at an appropriate subcutaneous depth for the deliver}' of medication to the patient. The support needle 122 continues to support cannula 114 and prevent it from buckling during insertion. Patch 112 features an adhesive on its bottom layer, which secures patch 112 to the patient’s skin so that once the patch delivery’ system has been removed, patch 112 remains in place. The needle carrier spring 110 remains compressed in this stage, holding the needle carrier 106 in place abutted against inner carrier 104. The support needle 122 within needle carrier 106 continues to provide structural support to cannula 114 until retraction. In this state, stopper 128 continues to bear against lip 130 and prevent expansion of needle earner spring 110.However, the simultaneous downw ard movement of inner carrier 104 and needle carrier 106 during this stage has brought stopper 128 to locate radially underneath button 702. At this point, a force applied to button 702 w ill displace stopper 128 and allow7needle carrier spring 110 to release, moving needle carrier 106 in the upward direction.

[0052] Referring now to FIG. 3A, a side view 300 of the medication delivery7device, focusing on elements that enable retraction of the needle carrier 106 after deployment of patch 112 and prior to removal of patch delivery device 101, is illustrated in accordance with an embodiment of the present disclosure. In this step, the outer sleeve 102 continues to provide an external structure for the patch delivery device 101. The user has now activated a safety7mechanism by pressing needle retraction button 702, which deflects a cantilever snapDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSon the needle cassette to the right, as shown in the image. This action releases the needle carrier 106, allowing needle carrier spring 110 to retract support needle 122 into the device.

[0053] Once the user depresses needle retraction button 702 on the outer sleeve 102, button 702 displaces stopper 128 on the needle carrier, allowing stopper 128 to clear lip 130 and enabling needle carrier 106 to retract. As the needle carrier retracts, stopper 128 flexes back and recovers into slot 132, withdrawing support needle 122 into the device.

[0054] Needle carrier 106 retracts, drawing support needle 122 into a bore 304 located within the outer sleeve 102. This retraction mechanism is crucial for protecting the user and patient from accidental needle exposure post-injection, ensuring that support needle 122 is safely housed within the Patch Delivery device 101 after use. The inner carrier 104 maintains its position after completing its forw ard displacement to deploy the patch 112. The inner carrier spring 108 remains expanded, reflecting its role in driving the deployment sequence earlier in the process.

[0055] Referring now to FIG. 3B, a side view 300 of the patch delivery device 101, focusing on separation of Patch Deliver}' device 101 from patch 112. At this stage, the user lifts Patch Delivery' device 101 in a vertical direction away from patch 112, which is now affixed to the patient's skin. No internal motion of components occurs within this stage. This figure illustrates how support needle 122 has been withdrawn into bore 304. Because needle 122 has been withdrawn, Patch Delivery device 101 presents minimal risk to the user during handling, post-use. At this point, the user may safely discard Patch Delivery' device 101.

[0056] Referring now to FIG. 4, an isometric top view 400 of the Patch Delivery device 101, show casing the external components and internal arrangement visible through slots in the outer sleeve 102, is illustrated, in accordance w ith an embodiment of the present disclosure. The outer sleeve 102 forms a main cylindrical housing of the Patch Delivery¬ device 101. Within the outer sleeve 102, the inner carrier 104 is positioned along the interior of the outer sleeve 102.

[0057] The inner earner 104 is responsible for holding and advancing the patch 112 during the deployment process. Although the patch 112 is not directly visible in this isometric topDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSview 400, the design and positioning of the inner carrier 104 within the outer sleeve 102 is crucial for the proper functioning of the patch delivery’ device 101. FIG. 4 suggests that the inner carrier 104 moves longitudinally within the outer sleeve 102 during operation, guided by a slot that controls its travel, consistent with the descriptions provided in FIGS. 1-3. Fig.4 illustrates the exterior view of the patch delivery device 101 in a state prior to or during the deployment sequence. The slots in the outer sleeve 102 allow partial visibility7of the underlying mechanical components, providing a clearer understanding of the device’s operation. Additionally, the outer sleeve 102 provides structural support while allowing for controlled movement of the internal components.

[0058] Referring now to FIG. 5, an isometric top view 500 of the medication delivery7system 100 at the deployment stage of its sequence, similar to that described in FIG.2. is illustrated, in accordance with an embodiment of the present disclosure. The outer sleeve 102 remains a main cylindrical housing while the inner carrier 104. This isometric view 500 provides insight into the internal arrangement of the patch delivery device 101 as it progresses through its activation.

[0059] The inner carrier 104 is partially visible through the cut-out in the outer sleeve 102. The inner carrier 104 is responsible for advancing the patch 112. In this stage, the patch 112 is deployed at the front of the patch delivery device 101, with its cannula extending from its central portion and supported by support needle 122. This configuration suggests that the inner carrier 104 has moved forward, causing the patch 112 to be contacting the patient’s skin surface and the patch cannula inserted to a subcutaneous depth in preparation for fluid delivery7. The outer sleeve 102 remains stationary7, while the internal components move relative to it during the device operation. This figure illustrates the end-stage deployment configuration from an external perspective, with the internal components having completed their forw ard motion to deliver the patch. The cut-out in the outer sleeve allows visibility into the internal mechanism and its movements. FIG. 5 shows the device during the stage where the patch 112 and the cannula 114 are fully deployed, ready for medication delivery, providing a clear external perspective on the deployment process.

[0060] Referring now to FIG. 6A / 6B, isometric top views 600 of the patch delivery' device 101 in its final retracted configuration, as seen from a perspective similar to that in FIG. 3,Docket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSis illustrated, in accordance with an embodiment of the present disclosure. The outer sleeve 102 and the inner carrier 104 remain stationary. The support needle 122, which was previously extended in FIG. 5, has now been fully retracted into the Patch Delivery device 101.

[0061] The outer sleeve 102 forms the main cylindrical body of the patch delivery device 101 and is labelled as part of the outer sleeve 102. The inner carrier 104 has completed its role in deploying the patch 112, and needle carrier 106 has completed its role of retracting support needle 122 (neither show n); as demonstrated in earlier figures. In this state, the support needle 122 is housed safely inside the outer sleeve 102, ensuring protection after the patch has been deployed. FIG. 6A depicts Patch Delivery7device 101 prior to removal of patch 112. FIG. 6B depicts Patch Delivery device 101 after the user has lifted it and separated it from patch 112. This figure represents the final stage in the patch delivery sequence.

[0062] Referring now to FIG. 7, an isometric bottom view 700 of the patch delivery device 101, with a cutaway of the outer sleeve 102 to provide visibility into the internal components and their movement, is illustrated, in accordance with an embodiment of the present disclosure. This isometric bottom view 700 corresponds to the same state as seen in FIG. 1, showing the progression of deployment of the patch delivery device 101.

[0063] The outer sleeve 102 forms the outer sleeve 102 of the patch delivery device 101, while the inner carrier 104 showing its displacement relative to the outer sleeve 101 as the patch delivery7device 101 progresses through its operation. Support needle 122 is in place inside the cannula 114 of patch 112. The inner carrier spring (108, not visible here) is compressed, awaiting activation from button 126.

[0064] Referring now to FIG. 8, an isometric bottom view 800 of the patch delivery7device 101, with a cutaway of the outer sleeve 102 to reveal the internal mechanisms and their movement, is illustrated, in accordance with an embodiment of the present disclosure. This isometric bottom view 800 corresponds to the same state as seen in FIG. 2, showing progression of deployment of the patch delivery7device 101.Docket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0065] The user has depressed button 126. The inner carrier spring 108 has expanded and pushed the inner carrier 104 forward, positioning the patch 112 at the patient’s skin for deployment. The needle carrier 106 remains in its same relative position to patch 112. The button 702 can be seen clearly in this figure. At this state, button 702 lies immediately over stopper 128. Support needle 122 remains in place inside the cannula 114 of patch 112. The needle carrier spring (110, not visible here) is compressed, awaiting activation from button 702.

[0066] Referring now to FIG. 9A, an isometric bottom view 900 of the patch delivery device 101, with a cutaway of the outer sleeve 102 to reveal the internal mechanisms and their movement, is illustrated, in accordance with an embodiment of the present disclosure. This isometric bottom view 900 corresponds to the same state as seen in FIG. 3A, showing progression of deployment of the patch delivery device 101.

[0067] The user has depressed button 702. The needle carrier spring 110 has expanded and pushed the needle carrier 106 rearward, withdrawing the needle from inside patch 112. Stopper 128 has moved from its previous location, to recover in a slot just above lip 130.

[0068] The support needle 122 is now retracted into the bore 304 within the outer sleeve 102, ensuring that it is fully protected. This retraction mechanism is vital for user and patient safety, as it prevents accidental needle sticks by securely housing the support needle 122 inside the device.

[0069] Referring now to FIG. 9B, an isometric bottom view 900 of the patch delivery' device 101. with a cutaway of the outer sleeve 102 to reveal the internal mechanisms and their movement, is illustrated, in accordance with an embodiment of the present disclosure. This isometric bottom view 900 corresponds to the same state as seen in FIG. 3B, showing progression of deployment of the patch delivery device 101.

[0070] Patch 112 (not shown) is now adhered to the patient’s skin. The user has lifted Patch Delivery device 101 vertically off patch 112, thus separating the two components. This sketch reveals more clearly the protected location of support needle 122 inside bore 304 of patch delivery’ device 101.Docket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0071] Referring now to FIG. 10, a cross-sectional side view 1000 of patch 112 in its deployed state is shown, is illustrated, in accordance with an embodiment of the present disclosure. In this figure, the patch 112 is deployed and adhered to the patient's skin, while the cannula 114 is extended, to an appropriate subcutaneous depth to deliver medication into the patient. The patch 112 is depicted in its operational position on the patient's skin, functioning as the interface between a standard medical syringe (not shown) and the patient. The patch 112 employs adhesive 136 to adhere to the patient’s skin for an appropriate duration. Notably, the patch 112 includes a balloon or bladder mechanism, which is illustrated here in its contracted state, indicating that it is not currently pressurized. This contracted state occurs after the deployment of the patch 112 but before or after the fluid has been administered, depending on the sequence of events.

[0072] The cannula 114, which extends downward from patch 112, is in its deployed position, penetrates the patient's skin to facilitate the delivery of medication.

[0073] Referring now to FIG. 11, a cross-sectional side view 1100 of the patch 112 during the preparation for bolus injection, is illustrated, in accordance with an embodiment of the present disclosure. In this step, the user is preparing to deliver a bolus of medication by connecting a syringe 1102 to the patch 112. The syringe 1102 is depicted as slip-fitted into the luer 1104 of patch 112, providing a fluid-tight connection for the administration of medication. The user manually attaches the syringe 1102 to top of the patch 112, preparing patch 112 for fluid transfer. The patch 112 is already adhered to the patient's skin, as described in the previous figure, with the cannula 114 fully deployed and inserted into the patient’s skin for medication delivery. The cannula 114, which penetrates the patient's skin, ensures direct access to the subcutaneous tissue for fluid injection. The syringe 1102 interface at the top of the patch 112 serves as the entry point for delivering the bolus of medication. This allows the user to manually control the medication dosage through the external syringe or fluid source connected via the syringe 1102.

[0074] The patch 112 provides structural support during the delivery process, ensuring that the cannula 114 remains stable while the bolus is administered. The connection between the syringe 1102 and the patch 112 must be secure to prevent leaks or disconnection during use.Docket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSThe cannula 114 is a permanent part of patch 112 and remains in place for the duration of the injection.

[0075] Referring now to FIG. 12A, a cross-sectional side view 1200 of the patch 112 during the bolus injection phase is illustrated, in accordance with an embodiment of the present disclosure. This figure shows the user administering a bolus of medication to the patch 112 via the connected syringe 1102. In this stage, the luer 1104 serves as a conduit for the medication, delivering the bolus into the patch 112. The bolus is partially administered into the patient's skin through the cannula 114, which remains deployed and inserted subcutaneously. Simultaneously, the remaining volume of the bolus is buffered within the expandable patch bladder 1202, integrated into the patch 112. The patch bladder 1202, depicted in an expanded state, accommodates excess fluid that is not immediately delivered into the patient’s tissue. This design ensures that the bolus injection process is smooth and controlled, preventing undue pressure buildup and medicine leakage at the injection site and allowing gradual release of the stored fluid from the bladder into the skin over time.

[0076] The cannula 114 remains securely positioned within the skin during this process, ensuring efficient transfer of medication. The structural integrity of the patch 112 and the secure attachment of the syringe 1102 ensure that no fluid leakage occurs during the injection. The expandable patch bladder 1202 may provide a visual indication of the bolus injection if the cap is made from a clear material. However, if the cap is opaque, the bladder would not be visible. Tactile feedback may also be present depending on the type of syringe used, though insulin syringes provide a high mechanical advantage that could make pressure changes difficult to detect. The filling process is primarily designed as a quick plug-and-push action, with product testing needed to verify whether users can perceive a filling indication. Referring now to FIG. 12B, a cross-sectional side view 1200A of the patch 112 during the bolus injection phase, with the additional inclusion of a skin layer 1204 for contextual illustration, is illustrated, in accordance with a preferred embodiment of the present disclosure. This figure provides further clarity by showing the device in contact with the patient's skin during the injection process. The syringe 1102 is shown securely connected to the patch 112, facilitating the administration of a bolus of medication. The cannula 114, deployed subcutaneously into the skin layer 1204, delivers a portion of theDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSbolus directly into the patient’s tissue. Meanwhile, the remaining fluid is accommodated within the patch bladder 1202 of the patch 112, which is shown in an expanded state.

[0077] The skin layer 1204 emphasizes the low-profde design of the device, which minimizes vertical protrusion from the patient’s skin, ensuring comfort and reducing potential interference with patient activities. The patch 112 adheres securely to the skin, providing stability for the device during the injection phase. The patch bladder 1202 manages the fluid dynamics by buffering the excess bolus volume, which is gradually delivered into the patient’s tissue over time. The inclusion of the skin layer 1204 further illustrates the interaction between the device and the patient, highlighting the precise alignment of the cannula 114 for effective subcutaneous deliver}7. The syringe 1102 remains securely attached, ensuring a seamless flow of medication and preventing fluid leakage.

[0078] Referring now to FIG. 13, a cross-sectional side view 1300 of the patch 112 during the post-injection phase, where the syringe has been removed and the patch bladder 1202 is gradually returning to its contracted state, is illustrated, in accordance with a preferred embodiment of the present disclosure.

[0079] The patch 112 is shown with the patch bladder 1202 still partially expanded, containing the remaining volume of medication that is slowly delivered through the cannula 114 into the patient's tissue. The umbrella valve 1302 at the base of luer 1104 ensures that medication flows only in the desired direction (into the patient) and prevents any retrograde How back through the luer 1104.

[0080] As the patch bladder 1202 gradually contracts, the remaining fluid is steadily administered, ensuring a controlled and complete delivery of the bolus. The cannula 114 remains inserted into the patient's skin, facilitating the ongoing infusion until the bladder 1202 has fully returned to its relaxed state, at which point the medication delivery7is complete. Umbrella valve 1302, bladder 1202. and cannula 114 cooperate to provide a buffering mechanism, wherein a patient may rapidly deliver a dose to the patch and be done; the internal elements of the patch subsequentially deliver the medicine to the patient with no leakage between the cannula and the skin and no leakage out of the patch itself.Docket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS

[0081] This figure, in combination with the earlier stages shown in FIGs. 10-12A, illustrates the entire process of medication delivery from the patch 112. Once the patch bladder 1202 has fully contracted, the deployment system returns to the state shown in FIG.10, ensuring that all medication has been safely and effectively delivered to the patient.

[0082] Referring now to FIG. 14, a cross-sectional side view 1400 of the patch 112, depicting an alternative embodiment of the patch in which a reed valve 1402 replaces the umbrella valve 1302 used in earlier embodiments, is illustrated, in accordance with an embodiment of the present disclosure. In this figure, the patch 112 is in its deployed state, and the patch bladder 1202 (not fully shown here) remains in its contracted form, ready to receive medication.

[0083] This design differs from the previously discussed design in that it employs a reedlike valve, residing in the volume of the bladder; to prevent backflow. This valve resides outboard of the centerline of the patch (defined by the long axis through the patch cannula). The off-centerline location of the valve conserves overall patch height, thereby improving patient ergonomics and comfort. The location of the reed valve in this design necessitates the use of separate conduits for the inflow and outflow of the medication into and out of the patch bladder 1202.

[0084] The figure highlights how the reed valve 1402 facilitates one-way flow while accommodating the compact nature of the device. This is particularly important for maintaining a low vertical profile, similar to the earlier designs seen in FIGs. 10-13, but with improved fluid control by segregating the inflow and outflow- pathways.

[0085] The cannula 114 remains deployed into the patient’s skin, enabling direct fluid delivery' when the patch bladder 1202 expands with medication. The reed valve 1402 ensures that the pressure within the patch bladder 1202 drives the medication out into the patient without any backflow, supporting controlled and safe fluid administration.

[0086] Referring now to FIG. 15, a cross-sectional side view 1500 of the patch 112, illustrating the screw-fit attachment of the syringe 1102 to the patch 112, is illustrated, in accordance with an embodiment of the present disclosure. This embodiment features a screw-fit mechanism, which provides a secure and stable connection for administeringDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSmedication. The screw-fit syringe 1102 is aligned and fastened to the patch 112 using mating threads on syringe 1102 and luer 1104, ensuring a tight seal and preventing accidental detachment during the fluid delivery process. As the user prepares to deliver a bolus of medication, the cannula 114 is already deployed and inserted into the patient's skin, ready to facilitate the transfer of medication. The patch bladder 1202 remains in its contracted state before the bolus injection, awaiting the introduction of the medication. The compact design of this embodiment makes it ideal for minimizing the overall profile while still delivering the necessary functions, including secure fluid deliver}’ and backflow prevention. The reed valve 1402 adds an additional layer of protection, ensuring that medication delivety is efficient and controlled within the compact form factor of the patch 112.

[0087] Referring now to FIG. 16A, a cross-sectional view 1600A of the patch 112, specifically showing the inflow path of the bolus injection into the patch bladder 1202, is illustrated, in accordance with an embodiment of the present disclosure. This embodiment features the syringe 1102 connected to the patch 112, facilitating the administration of medication. Upon injection, the medicine flows through the inflow conduit into the patch bladder 1202, which expands to accommodate the incoming volume. The design incorporates the reed valve 1402, which ensures unidirectional flow; preventing backflow' of the medicine once inside the bladder. The reed valve 1402 allow s the medication to flow freely into the bladder while maintaining separation between the inflow and outflow conduits. The cannula 114 is shown already deployed, positioned to deliver the medication from the patch bladder into the patient's tissue upon further contraction of the patch bladder 1202.

[0088] Referring now to FIG. 16B, a cross-sectional view 1600B of the patch 112, focusing on the outflow path from the patch bladder 1202 after the bolus has been delivered into the patch bladder 1202, is illustrated, in accordance with an embodiment of the present disclosure. The inflow path connect from the centerline of the product up high, whereas the outflow channels connect from farther out and feed in below the other lines. This embodiment, like FIG. 16A, features the syringe 1102 connected to the patch 112, allowing for secure attachment of the injection system. Once the medication has been injected intoDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSthe patch bladder 1202, the reed valve 1402 prevents any backflow into the luer, maintaining one-way flow. The medicine is stored within the bladder and gradually flows out through a separate outflow conduit as the patch bladder 1202 contracts, expelling the remaining fluid into the cannula 114 for delivery into the patient's tissue. The separation between the inflow and outflow channels is achieved through this distinct conduit design, allowing for efficient and controlled release of the medication. The reed valve 1402 ensures that medicine cannot return through the inflow conduit, thereby improving the reliability of the device 101. The cannula 114 remains positioned to deliver the medication to the intended site after it passes through the outflow conduit, demonstrating how the design supports a controlled and sequential drug delivery process.

[0089] Referring now to FIG. 17, a cross-sectional view 1700 of the patch 112 during the phase where the user has removed the syringe from the luer after delivering the bolus of medication, is illustrated, in accordance with an embodiment of the present disclosure. The patch bladder 1202 is shown partially contracted, with the medicine being gradually expelled into the cannula 114 for delivery to the patient. The reed valve 1402 in this embodiment plays a critical role in preventing any backflow of medication into the inflow channel once the syringe is detached. This ensures that the medicine flows in a single direction from the patch bladder 1202 through the outflow conduit and is delivered in a controlled manner via the cannula 114. The device 101 directs the expelled medication into a manifold or collection volume before it enters the cannula for injection into the patient’s tissue. The design emphasizes the distinct separation of inflow and outflow paths within the small, compact profile of the device, enabling efficient and continuous the medication delivery while preventing retrograde flow. As the patch bladder 1202 continues to relax, the remaining medication is completely dispensed through the outflow channel, utilizing the contracting force of the patch bladder 1202 and the backflow-prevention mechanism of the reed valve 1402.

[0090] Referring now to FIG. 18, an isometric view 1800 of the patch 112, providing a more comprehensive visual representation of the key components described in earlier figures, is illustrated, in accordance with an embodiment of the present disclosure. The patch body 112 is depicted in a deployed configuration, with the reed valve 1402 positionedDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTScentrally, serving as the primary backflow prevention mechanism. In this embodiment, the reed valve 1402 replaces the umbrella valve 1302 utilized in earlier designs, ensuring unidirectional flow of medication. The reed valve 1402 is located at the junction between the inflow and outflow channels, preventing retrograde flow after the medication enters the patch bladder 1202 (not fully shown here). The cannula 114, extending downward from the patch, is shown in position, ready to deliver medication directly into the patient’s tissue once the patch bladder expands. The hub and seal refer to structural elements near the valve assembly that stabilize the connection between the luer fitting and the patch 112. These components ensure a secure and leak-free attachment, providing both mechanical support and sealing at the interface between the patch and the delivery device 101. Referring now to FIG. 19, an isometric view 1900 of the patch 112, w hich provides a clearer depiction of how- the syringe 1102 interfaces with the patch 112, including the reed valve 1402, is illustrated in accordance with an embodiment of the present disclosure. The cannula 114 extends from the patch 112 and is connected securely to it, ensuring a stable attachment while preventing any fluid leakage. The reed valve 1402 serves as the primary mechanism to prevent backflow-, directing fluid flow into or out of the patch bladder (not fully depicted) in a controlled manner. The patch 112 remains compact in design, with sufficient space allocated for both the inflow and outflow^ conduits. The use of the reed valve 1402 mandates that inflow and outflow follow^ separate paths, as the valve structure does not allows bidirectional flow' through a single conduit. The positioning of the luer 1104 on the patch 112 ensures easy alignment and engagement with the syringe 1102 or medication delivery apparatus. This embodiment highlights the significance of integrating inflow and outflow¬ channels into the design while maintaining a low vertical profile, as seen in previous figures. The space-efficient packaging and functionality of the reed valve 1402 contribute to the reliable operation of the patch during the medication delivery process. Referring now to FIG. 20, an isometric view 2000 of the patch 112 depicting the relationship between the cannula 114, the reed valve 1402, and the patch components during the medication delivery process, is illustrated in accordance with an embodiment of the present disclosure. The cannula 114 is seen as a central component, aligned through the patch 112 and connecting to the underside of patch 112. The reed valve 1402, a crucial element of this embodiment, ensures unidirectional flow, preventing any retrograde movement of fluid. This reed valveDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTS1402 structure allows fluid to be injected into the patch bladder 1202 of the patch 112 through specific inflow conduits while blocking any backflow once the fluid has entered. In this figure, the reed valve 1402 is in a position to maintain separation between the inflow and outflow paths, safeguarding the controlled delivery of medication. The patch 112 incorporates both inflow and outflow conduits. The patch bladder 1202, though visually represented as transparent, is actually in an inflated state, as indicated by the thin line near the tip of the arrow coming from 1202. This ensures a one-way flow of medication into the patch bladder 1202, aided by the pressure applied via the delivery device 101.

[0091] Referring now to FIG. 21, an isometric view 2100 of the patch 112 illustrating the embodiment that incorporates the reed valve 1402 to ensure unidirectional flow of medication, is illustrated, in accordance with an embodiment of the present disclosure. This figure provides a detailed view of the patch design, focusing on the critical relationship between the reed valve 1402, the patch bladder 1202, and the cannula 114 within the patch 112.

[0092] The reed valve 1402 remains a central feature, preventing the backflow of medication after it has entered the patch bladder 1202 through the inflow conduits. The patch bladder 1202, visible here in its contracted form, is designed to receive and store medication, which will later be expelled in a controlled manner through the outflow pathways. The conduit on the left highlights the outflow channel, which directs the fluid out of the patch bladder 1202 and towards the cannula 114 for administration to the patient.

[0093] The patch 112 efficiently integrates both inflow and outflow channels, allowing for the separation of these pathways. This compact design maintains a low vertical profile while optimizing the flow of fluid through the patch 112, ensuring effective fluid delivery without compromising space. The cannula 114, extending from the patch, provides a direct channel for medication delivery into the patient's body. The syringe 1102 supports this connection, ensuring secure attachment to the external delivery’ mechanism.

[0094] Referring now to FIG. 22, a cross-sectional side view 2200 of the patch 112 which includes the patch bladder 1202 of cylindrical shape, which is oriented vertically and is depicted in its contracted state, is illustrated, in accordance with an embodiment of theDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSpresent disclosure. The design features a duckbill valve 2202, which replaces other valve designs, such as the reed valve 1402 or the umbrella valve 1302 used in earlier embodiments. The duckbill valve 2202 is particularly advantageous because it provides a reliable, self-sealing mechanism without requiring precise surface interfaces, which are necessary for the proper function of the umbrella valve 1302.

[0095] This embodiment showcases the vertically positioned patch bladder, which inflates during fluid delivery and contracts once the medication has been administered. The duckbill valve 2202 ensures unidirectional flow; allowing medication to pass through while preventing backflow, thereby maintaining the integrity of fluid delivery. The cannula 114 remains deployed through the patch 112, providing a direct pathway for the medication to flow from the patch bladder 1202 of cylindrical shape into the patient’s tissue. The simplicity of the duckbill valve 2202 design ensures that the cannula 114 or needle can penetrate the duckbill valve 2202 cleanly without compromising the seal or the integrity of the patch 112. This valve 2202 also offers advantages in terms of reliability, as it does not rely on the same fine tolerances or material properties required by the reed valve 1402.

[0096] Referring now to FIG. 23, a cross-sectional side view 2300 of the patch 112, highlighting the configuration of the patch bladder 1202 of cylindrical shape and the duckbill valve 2202 in a vertical orientation, is illustrated, in accordance with an embodiment of the present disclosure. This embodiment further illustrates the connection between the patch 112 and the syringe 1102, preparing for the administration of a bolus of medication. The patch bladder of cylindrical shape, in its contracted state, is positioned vertically within the patch 112, designed to inflate as the medication is delivered and contract after the fluid has been administered. The duckbill valve 2202 ensures one-way flow of medication into the patch bladder 1202 of cylindrical shape and prevents any backflow. This duckbill valve 2202 provides a reliable self-sealing mechanism wdthout the need for finely tuned surface interfaces, which are required in other designs, such as the umbrella valve 1302 or the reed valve 1402. The user connects the syringe 1102 to the patch 112 in a screw-fit manner, ensuring a secure connection before administering the medication. The syringe 1102 supports the cannula 114, which penetrates through the duckbill valve 2202 and into the patient’s tissue. The duckbill valve's design is particularlyDocket No. 10106-002PCT MEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSbeneficial for facilitating smooth passage of the cannula 114 through the valve 2202, reducing the risk of leakage or compromising the seal during drug delivery.

[0097] Referring now to FIG. 24, a detailed cross-sectional view 2400 of the patch 112, illustrating the injection process where medicine is administered into the patch 112, is illustrated, in accordance with an embodiment of the present disclosure. This embodiment features the patch bladder 1202 in cylindrical form, which is oriented vertically and positioned beneath the duckbill valve 2202, facilitating the controlled inflow of medication through syringe 1102. As depicted, the user injects medication via the syringe 1102, which is securely attached to the patch 112. The syringe 1102 channels the medication through the duckbill valve 2202, which is designed to ensure unidirectional flow' and prevent backflow. The valve's self-sealing characteristics eliminate the need for precisely designed interface surfaces, which are typically required for other valve designs like the umbrella or reed valves. Additionally, when this particular design embodiment is loaded into position in patch delivery device 101, the duckbill valve’s design allows support needle 122 to pass smoothly through the body of patch 112 and into cannula 114. The patch bladder 1202 in the cylindrical form is shown in its contracted state before being inflated by the medication. Upon the injection of medicine, the patch bladder 1202 expands, accommodating the delivered fluid. This patch bladder 1202 acts as a reservoir for the medication until it is fully administered to the patient through the cannula 114.

[0098] Referring now to FIG. 25, a detailed cross-sectional view 2500 of the patch 112, illustrating the stage after the user has removed the syringe and the patch bladder 1202 begins to relax, expelling the medicine through the cannula 114, is illustrated, in accordance with an embodiment of the present disclosure. This embodiment, similar to the previous figures, employs the vertically oriented patch bladder 1202 of cylindrical shape in conjunction with the duckbill valve 2202 to manage fluid flow. As depicted in FIG. 25, the user has already administered the medication by injecting it through the syringe 1102 and duckbill valve 2202, causing the patch bladder 1202 to expand. After the syringe is removed, the patch bladder 1202 of cylindrical shape contracts or relaxes, forcing the stored medication to exit through the cannula 114, delivering the fluid to the target site. The duckbill valve 2202 plays a critical role during this phase. Its self-sealing design ensuresDocket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSthat while medication flows outward from the patch bladder 1202 through the cannula 114, no backflow occurs. This feature is particularly advantageous over alternatives like umbrella or reed valves, which may require precisely designed surfaces or materials to function effectively. In contrast, the duckbill valve maintains a reliable seal without needing additional interfacing parts or adjustments.

[0099] Thus, the disclosed patch delivery' device 101 tries to overcome the technical problem of preventing backflow and ensuring precise, reliable medication delivery to a patient. Traditional delivery devices often encounter issues related to valve performance, such as leakage, inconsistent sealing, and the requirement for finely machined surfaces to ensure proper function. These problems can result in ineffective medication delivery', contamination, or patient safety’ concerns. Additionally, managing both inflow and outflow of medication within a compact device has posed design challenges, particularly when using conventional valves such as umbrella valve or reed valves, which may not always provide reliable sealing or may require additional components to function optimally.As will be appreciated by those skilled in the art, the techniques described fin the various embodiments discussed above are not routine, or conventional, or well-understood in the art.

Claims

Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSCLAIMSWhat is Claimed is:

1. A medication delivery device for administering a fluid to a patient, comprising:a patch configured to be applied to skin of the patient;a cannula formed from a flexible material, wherein the cannula is attached to the patch and is configured to penetrate the skin of the patient and establish fluid communication between a fluid reservoir and the patient to deliver fluid;a fluid delivery channel connected to the cannula and configured to deliver fluid through cannula; anda valve positioned along the fluid delivery channel, wherein the valve is configured to prevent retrograde flow of the fluid through the fluid delivery channel.

2. The device of claim 1, wherein the valve is selected from a group consisting of an umbrella valve, a reed valve, and a duckbill valve.

3. The device of claim 1, further comprising a balloon bladder in fluid communication with the cannula, wherein the balloon bladder is configured to expand upon injection of the fluid to buffer a portion of the fluid volume.

4. The device of claim 3, wherein the balloon bladder is configured to contract after injection to release buffered fluid into the cannula at a controlled rate.

5. The device of claim 1, further comprising a luer fitting in fluid communication with the fluid delivery channel, the luer fitting configured to connect with an external syringe, wherein the luer fitting is selected from a group consisting of a slip-fit luer, and a luer-lock.

6. The device of claim 1 , further comprising a deployment system, the deployment system comprising:Docket No. 10106-002PCTMEDICATION DELIVERY DEVICE FOR ADMINISTERING FLUID TO PATIENTSan outer sleeve;an inner carrier; anda needle carrier, wherein the needle carrier is configured to protectively withdraw the needle after fluid delivery.

7. The device of claim 7, wherein the deployment system further comprises a spring mechanism configured to displace the inner carrier for patch deployment and retract the needle carrier after deployment.

8. The device of claim 7, wherein the septum includes a cruciform slot to facilitate entry of the fluid del i x ery instrument.

9. The device of claim 1, wherein the patch further comprises a low-profile body, and wherein the body being designed to minimize vertical height during use.

10. The device of claim 1, wherein the device is configured to accommodate different fluid viscosities by varying at least one of:the size of the fluid delivery channel;the material properties of the balloon bladder; andthe material properties of the cannula.

Images