Wearable medicament delivery device with compressible reservoir and method of use thereof

Abstract

A wearable drug delivery device and related methods are described. The wearable drug delivery device can include: a housing; a flexible bag disposed within the housing; a cannula in fluid communication with the flexible bag; and a pumping mechanism for forcing a drug from the flexible bag and into the cannula, wherein the pumping mechanism is proximate the flexible bag and includes a spring-loaded paddle or a driving bag.

Claims

1. A wearable drug delivery device comprising: a housing; a flexible bag disposed within the housing; a cannula in fluidic communication with the flexible bag, the cannula comprising: a proximal end connected to the flexible bag; and a distal end that exits the housing; a support disposed between the flexible bag and at least a portion of the cannula; a pumping mechanism for forcing a drug from the flexible bag and into the cannula, the pumping mechanism proximate the flexible bag and comprising a spring-loaded paddle, wherein the spring-loaded paddle comprises a hinged connection, and wherein the flexible bag is compressed between the support and the spring-loaded paddle; and a valve positioned inside the housing and between the proximal end of the cannula and the distal end of the cannula, wherein the valve is configured to open and close to control a flow of the drug through the cannula.

2. The device of claim 1, wherein the spring-loaded paddle is driven by a torsion spring or a compression spring.

3. The device of claim 1, wherein the housing comprises at least one of: a flexible outer shell or a housing height less than 12 mm.

4. The device of claim 1, wherein the valve is configured to crimp or squeeze the cannula.

5. A method of delivering a drug, the method comprising: providing a wearable drug delivery device comprising: a housing; a flexible bag disposed within the housing; a cannula in fluidic communication with the flexible bag, the cannula comprising: a proximal end connected to the flexible bag; and a distal end that exits the housing; a support disposed between the flexible bag and at least a portion of the cannula; a valve positioned inside the housing and between the proximal end of the cannula and the distal end of the cannula; and a pumping mechanism comprising a spring-loaded paddle, wherein the spring-loaded paddle comprises a hinged connection; activating the pumping mechanism to force a drug from the flexible bag and into the cannula, wherein the flexible bag is compressed between the support and the spring-loaded paddle; and opening and closing the valve to control a flow of the drug through the cannula.

6. The method of claim 5, wherein the step of activating the pumping mechanism comprises pivoting the spring-loaded paddle about the hinged connection.

7. The method of claim 6, wherein the step of pivoting the spring-loaded paddle comprises driving the spring-loaded paddle with a torsion spring or a compression spring.

8. The method of claim 5, wherein the housing comprises at least one of: a flexible outer shell or a housing height less than 12 mm.

9. The method of claim 5, wherein the step of opening and closing the valve comprises crimping or squeezing the cannula.

10. The method of claim 5, wherein the drug comprises pegfilgrastim.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:

(2) FIG. 1 is a schematic, perspective view of a known drug delivery device.

(3) FIG. 2 is a schematic, bottom view of the device of FIG. 1 being filled with a drug.

(4) FIGS. 3 and 4 are images of functional components of the device of FIG. 1 in which an exterior housing of the device has been removed.

(5) FIG. 5A is a schematic, perspective view of a drug delivery device having a paddle and a torsion spring, in accordance with certain embodiments of the invention.

(6) FIG. 5B is a schematic, side view of the drug delivery device of FIG. 5A.

(7) FIG. 6A is a schematic, perspective view of a drug delivery device having a paddle and a compression spring, in accordance with certain embodiments of the invention.

(8) FIG. 6B is a schematic, side view of the drug delivery device of FIG. 6A.

(9) FIG. 7A is a schematic, perspective view of a drug delivery device having a driving bag, in accordance with certain embodiments of the invention.

(10) FIG. 7B is a schematic, side view of the drug delivery device of FIG. 7A in which the driving bag is in an unexpanded state.

(11) FIG. 7C is a schematic, side view of the drug delivery device of FIG. 7A in which the driving bag is in an expanded or inflated state.

(12) FIG. 8 is a flowchart of a method of delivering a drug, in accordance with certain embodiments of the invention.

DETAILED DESCRIPTION

(13) It is contemplated that apparatus, systems, methods, and processes of the claimed invention encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and/or modification of the apparatus, systems, methods, and processes described herein may be performed by those of ordinary skill in the relevant art and are considered to be within the scope of the disclosed invention.

(14) It should be understood that the order of steps or order for performing certain actions is immaterial, so long as the invention remains operable. Moreover, two or more steps or actions may be conducted simultaneously.

(15) Referring to FIGS. 5A and 5B, in some examples, an on-body or wearable drug delivery device 100 includes a housing 102, an adhesive pad 104, a flexible bag 106 containing a drug (e.g., a liquid drug), a cannula 108 in fluid communication with the flexible bag 106, and a paddle 110 disposed on or proximate to the flexible bag 106. While this disclosure may describe the drug delivery device 100 as delivering a liquid drug, in general and in various embodiments the device 100 can be adapted to deliver any medicament (e.g., drug, biologic, etc.) in any form (e.g., liquid, gel, powder, etc.). In general, the housing 102 is attached to the adhesive pad 104, which can be used to secure the device 100 to a patient. The flexible bag 106 and the paddle 110 can be disposed within the housing 102. The flexible bag 106 can be substantially flat and/or arranged in a plane that is substantially parallel to a plane defined by the adhesive pad. In other embodiments, the flexible bag 106 can be arranged in different orientations. In the depicted example, the flexible bag 106 is disposed between a support 112 and the paddle 110. The support 112 can be or include a flat plate and/or one or more other components disposed within the housing 102. In some examples, the support 112 can be or include a portion of the housing 102 and/or the adhesive pad 104. A proximal end 114 of the cannula 108 can be connected to the flexible bag 106 (e.g., at an end or edge), and a distal end 116 of the cannula 108 exits the housing 102 (e.g., through the adhesive pad 104) for insertion into the patient's skin.

(16) In certain implementations, the paddle 110 can be used to pump the drug from the flexible bag 106, through the cannula 108, and into the patient. The paddle 110 can be attached at one end to a hinge 118, which allows the paddle 110 to rotate or pivot about the hinge 118. A torsion spring 120 may be provided to press the paddle 110 towards and/or into the flexible bag 106. In such embodiments, the pivoting action of the paddle 110 compresses or squeezes the flexible bag 106 between the paddle 110 and the support 112, thereby increasing a pressure inside the flexible bag 106. The increased pressure can pump the drug from the flexible bag 106 and into the cannula 108.

(17) In various implementations, the device 100 includes a valve 122 for regulating fluid flow from the flexible bag 106 and/or through the cannula 108. The valve 122 can be mechanically and/or electrically actuated to open and close, as needed, to deliver desired amounts of drug to the patient. For example, while the paddle 110 may be continuously squeezing the flexible bag 106, the drug may be permitted to flow from the flexible bag 106 only when the valve 122 is open. The device can include a controller or processor and battery power, as needed, to regulate the opening and closing of the valve 122. In some examples, the valve 122 can stop the flow by crimping or squeezing the cannula 108.

(18) Referring to FIGS. 6A and 6B, in an alternative example, the device 100 utilizes a compression spring 124 (in addition to or instead of the torsion spring 120) to pivot or press the paddle 110 towards and/or into the flexible bag 106. The compression spring 124 can be positioned between the paddle 110 and a top portion of the housing 102, as shown. Other types of springs or forcing mechanisms for pivoting or pressing the paddle 110 are contemplated. For example, the device 100 can utilize or include, an extension spring, a Belleville spring, a drawbar spring, a volute spring, a garter spring, a flat spring, a gas spring, and/or an air spring. Additionally or alternatively, the paddle 110 can be pivoted or forced using one or more pneumatic components, hydraulic components, and/or electrical components (e.g., a motor).

(19) Referring to FIGS. 7A, 7B, and 7C, in certain implementations, a wearable drug delivery device 130 includes the housing 102, the adhesive pad 104, the flexible bag 106 containing the drug, the cannula 108 in fluid communication with the flexible bag 106, the valve 122 for regulating fluid flow through the cannula 108, and a driving bag 132 disposed on or proximate to the flexible bag 106. In some embodiments, the driving bag 132 includes a first chamber 134 and a second chamber 136 separated by a frangible baffle 138. The first chamber can include one or more first reactants and the second chamber can include one or more second reactants, and the frangible baffle 138 can serve as a barrier to prevent contact between the one or more first reactants and the one or more second reactants. To pump the drug from the flexible bag 106, a user of the device 130 (e.g., the patient) can press a button 140 on the device 130, which can act as a trigger for breaking the frangible baffle 138. The button 140 can be or include, for example, a mechanically, electrically, and/or remotely actuated trigger that is capable of breaking or rupturing the frangible baffle 130. In one example, the button 140 can compress the driving bag 132 and cause the frangible baffle 130 to rupture and/or detach from an inner surface of the driving bag 138, such that the one or more first reactants and the one or more second reactants can come into contact and/or mix with one another. The frangible baffle 130 can be constructed of or include one or more brittle materials and/or thin portions that are configured to break or rupture when subjected to stress introduced by the button 140. Once the one or more first reactants and the one or more second reactants come into contact, a chemical reaction can take place that causes the driving bag 132 to expand or inflate. For example, the one or more first reactants and the one or more second reactants can react to generate gas and/or produce a foam. As the driving bag 132 expands, the flexible bag 106 can be compressed or squeezed between the driving bag 132 and the support 112, which increases the pressure in the flexible bag 106 and causes the drug to flow from the flexible bag 106 and into the cannula 108. FIG. 7B shows the driving bag 132 in an initial, unexpanded state, with the flexible bag 106 full or nearly full of the drug. FIG. 7C shows the driving bag 132 in a final, expanded state, with the flexible bag 106 empty or nearly empty of the drug. The valve 122 can be opened and closed to regulate flow through the cannula 108, as needed.

(20) In various examples, the one or more first reactants and the one or more second reactants can include any combination of reactants that, when mixed, react with one another to expand in volume or size (e.g., in a one-way chemical reaction). A product of the reaction can be or include, for example, a gas (e.g., in a gas evolution reaction) and/or a foam, such as an expanding foam (e.g., an expanding polyurethane foam). In one example, the one or more first reactants include an isocyanate and/or a polyisocyanate, and the one or more second reactants include a mix of polyol, water, surfactant, and/or catalyst, for producing a polyurethane foam. In another example, the gas evolution reaction can occur between an acid and a carbonate. When choosing the reactants and products for the reaction, an amount of expansion relative to starting volumes should be assessed, along with safety considerations related to use of such materials in a wearable device.

(21) In other embodiments, the driving bag 132 can be expanded to compress the flexible bag 106 using other techniques. For example, the driving bag 132 can be inflated using a pump, an air compressor, a cannister or cartridge of compressed air or other gas, or other known inflation techniques or devices, which can be in fluidic communication with the driving bag 132. The flexible bag 106 and/or the driving bag 132 can be made of a variety of flexible and/or nonpermeable materials, including, for example, polyethylene, polypropylene, polyester, other polymeric materials, aluminum, other metallic materials, or any combination thereof. In one example, the flexible and/or nonpermeable materials include a laminated film in which at least one layer includes aluminum or other impermeable material.

(22) Advantageously, use of the flexible bag 106 and the pumping mechanisms described herein (e.g., including the paddle 110 and the driving bag 132) can allow the housing 102 to be more compact and/or have a lower profile compared to existing or previous designs. Referring again to FIGS. 5A and 5B, the housing 102 can have a length L, a width W, and a height H, any of which can be less than corresponding dimensions for existing or previous designs. For example, the height H of the housing 102 can be 10% less, 25% less, or 50% less than corresponding heights of existing or previous designs, such as the design shown in FIG. 1. The lower profile of the housing 102 can make the devices described herein less likely to be caught on clothing and/or dislodged, which can lead to leakage.

(23) Example low, high, and typical values for the length L, the width W, the height H, and other parameters for the drug delivery devices described herein are provided in Table 1. The listed values can be minimum, maximum, or average dimensions. Various embodiments include any parameter value (e.g., integer or decimal value) within the cited ranges. For example, the length L of the housing 102 can be 25, 26, 27, . . . , 74, or 75 mm. Express support and written description of these values for each parameter are hereby represented.

(24) TABLE-US-00001 TABLE 1 Exemplary parameters for medicament delivery device. Parameter Low Typical High Housing Length L (mm) 25 50 75 Housing Width W (mm) 20 40 60 Housing Height H (mm) 6 12 18 Flexible Bag Capacity (cm.sup.3) 0.1 1 5 Flexible Bag Pumping Pressure (kPa, gauge) 10 100 1000

(25) Additionally or alternatively, use of flexible components (e.g., the flexible bag 106) can allow the housing 102 to be made of or include soft or flexible materials. For example, the housing 102 can be constructed of thin or flexible plastic materials that allow the housing 102 to be more comfortable to wear and/or capable of bending or deforming, as needed, in response to movement of the patient's body. In some instances, for example, the housing 102 can be made of a flexible polymeric material (e.g., polypropylene or polyethylene), silicone, a thermoplastic elastomer, and/or a woven or non-woven fabric. A wall thickness for the housing 102 can depend on a desired stiffness or flexibility. In some examples, the wall thickness can be about 2 mm, 1 mm, 0.5 mm, or less, or can range from about 0.5 mm to about 1.5 mm (e.g., for a small injection molded part). The housing materials and/or wall thicknesses can allow the stiffness of the housing 102 to be as much as 25%, 50%, 75%, or 90% lower than the housing stiffness of existing or previous designs.

(26) Further, in some embodiments, the pumping mechanisms described herein (e.g., including the paddle 110 and the driving bag 132) do not utilize motors, electrical components, or any electrical energy to force or pump the drug through a cannula and into a patient. The energy to pump the drug can instead be provided by springs or chemical energy, as described herein. By comparison, previous or existing devices generally include electrical or battery-powered pumps, which can be more complicated and generally less reliable or more prone to failure.

(27) FIG. 6 is a flowchart of a method 150 of delivering a drug. A wearable drug delivery device is provided (step 152). The device includes: a housing; a flexible bag disposed within the housing; a cannula in fluid communication with the flexible bag; and a pumping mechanism having a spring-loaded paddle or a driving bag (e.g., including a plurality of reactants). The pumping mechanism is activated (step 154) to force a drug from the flexible bag and into the cannula. Activating the pumping mechanism can include, for example, compressing the flexible bag with the spring-loaded paddle or the driving bag and/or opening or closing a valve.

(28) The teachings herein may be used to implement methods for delivering various medicaments or drugs, including but not limited to pegfilgrastim as well as other liquids, such as solutions, which may comprise any of adalimumab, rituximab, risankizumab, etanercept, trastuzumab, ado-trastuzumab emtansine, trastuzumab deruxtecan, bevacizumab, infliximab, pegfilgrastim, filgrastim, tocilizumab, golimumab, interferon beta-la, ranibizumab, denosumab, pembrolizumab, nivolumab, aflibercept, eculizumab, ocrelizumab, pertuzumab, secukinumab, omalizumab, ustekinumab, vedolizumab, daratumumab, dupilumab, atezolizumab, natalizumab, bortezomib, ipilimumab, durvalumab, emicizumab, palivizumab, guselkumab, mepolizumab, panitumumab, ramucirumab, belimumab, abatacept, certolizumab pegol, ixekizumab, romiplostim, benralizumab, evolocumab, canakinumab, obinutuzumab, cetuximab, erenumab, blinatumomab, romosozumab, mirikizumab, inotuzumab, sacituzumab govitecan, enfortumab vedotin, brentuximab vedotin, or any combination thereof.

(29) Each numerical value presented herein, for example, in a table, a chart, or a graph, is contemplated to represent a minimum value or a maximum value in a range for a corresponding parameter. Accordingly, when added to the claims, the numerical value provides express support for claiming the range, which may lie above or below the numerical value, in accordance with the teachings herein. Absent inclusion in the claims, each numerical value presented herein is not to be considered limiting in any regard.

(30) The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention.

(31) The features and functions of the various embodiments may be arranged in various combinations and permutations, and all are considered to be within the scope of the disclosed invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive. Furthermore, the configurations, materials, and dimensions described herein are intended as illustrative and in no way limiting. Similarly, although physical explanations have been provided for explanatory purposes, there is no intent to be bound by any particular theory or mechanism, or to limit the claims in accordance therewith.