Fluid reservoirs and associated devices and methods

Abstract

A fluid reservoir system is disclosed herein. In accordance with some embodiments, the present technology includes a reservoir defining a cavity and a plunger slidably received within the cavity. The plunger includes a vial interface, a plunger rod extending distally from the vial interface, and a needle extending longitudinally through the plunger rod. The needle has an inlet end at the vial interface and an outlet end proximate a distal portion of the plunger rod. When an outlet end of a vial of fluid medicament is coupled to the vial interface, the needle extends through a septum of the vial such that the inlet end of the needle is disposed within the vial. When the plunger is fluidly coupled to the vial, proximal movement of the plunger and vial relative to the reservoir draws the fluid drug from the vial through the needle and into the interior region of the reservoir.

Description

[0001] Cross - reference to Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 625,757, filed on January 26, 2024, and U.S. Provisional Application No. 63 / 702,074, filed on October 1, 2024, which are hereby incorporated by reference in their entireties. Technical Field

[0003] The present technology relates to fluid delivery systems. In particular, the present technology relates to fluid reservoirs and associated devices and methods for filling fluid reservoirs with liquid medications. Background Art

[0004] According to modern medical techniques, certain diseases or disorders can be treated by delivering a drug fluid or other substance to a patient's body in a continuous manner or at specific times or intervals over a period of time. For example, diabetes is typically treated by delivering a limited amount of insulin to a patient at appropriate times. Some common modes of providing insulin treatment to patients include delivering insulin via manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., continuous insulin infusion devices such as insulin pumps) to deliver a controlled amount of insulin or other medications to a patient.

[0005] Persistent problems associated with systems designed for infusing medications include having components that are difficult for some patients to use, and the body's natural reaction to foreign objects introduced into the body such as implanted cannulas. Among the various responses of the body to foreign objects, inflammation and fibrous tissue accumulation at the infusion site significantly shorten the duration that an infusion device can remain at a single infusion site (i.e., "site failure"). In addition, tissue encapsulation and blockage of the implanted cannula or catheter (i.e., "occlusion") often occur, preventing or stopping the infusion of the medication. Inflammation may be exacerbated by insulin aggregation when insulin is stored in the reservoir within the pump at ambient temperature. Thus, frequent repositioning of the infusion site is required to continue using the infusion pump. Currently, the wear time of all commercial insulin infusion devices is marked as ≤3 days.

[0006] Infusion systems often include a fluid infusion device (e.g., a pumping device) and an infusion set, including a connector that couples the infusion set to the pumping device, a cannula or needle implanted in a user, and a tubing segment between the connector and the cannula or needle to carry a drug from a reservoir in the pumping device to the user. There are many types of infusion sets that can be coupled to a single pumping device, and each infusion set is often selected by the user based on personal preference. Other difficulties with existing infusion systems arise from the user having to fill the pump reservoir with insulin provided in a separate vial. The process of transferring insulin from the vial to the reservoir is both difficult and error-prone. Challenging aspects include the need to maintain sterility of multiple components and contact surfaces, the dispensing using an intermediate transfer device (such as a syringe), the incorrect measurement of insulin, and the inadvertent introduction of air into the reservoir. While these difficulties may be inconvenient, the resulting errors can lead to more serious problems, such as an incorrect insulin dose, which can result in acute hypoglycemia or chronic hyperglycemia.

[0007] Accordingly, there is a need for improved fluid reservoirs and associated devices and methods for filling fluid reservoirs. SUMMARY OF THE INVENTION

[0008] The present technology includes a fluid transfer assembly having a reservoir and a plunger. The reservoir includes a sidewall having a proximal end and a distal end, the sidewall surrounding and defining an inner lumen. The sidewall has an opening at the proximal end. The reservoir is configured to receive and contain a fluid drug within the inner lumen. The plunger has a proximal end portion and a distal end portion. The plunger includes a vial interface at the proximal end portion, the vial interface being configured to receive an outlet end of a vial containing the fluid drug, a plunger rod extending distally from the vial interface and slidably disposed within the inner lumen of the reservoir, and a needle extending longitudinally through the plunger rod. The needle has an inlet end at the vial interface and an outlet end near a distal portion of the plunger rod. The needle defines a lumen extending through the needle. The fluid transfer assembly is configured to be coupled to a vial such that when the outlet end of the vial is coupled to the vial interface of the plunger, the needle extends through a septum of the vial such that the inlet end of the needle is disposed within the vial and in fluid communication with the fluid drug. When the needle is fluidly coupled to the vial, proximal movement of the plunger and the vial relative to the reservoir draws the fluid drug out of the vial through the needle and into an interior region of the reservoir.

[0009] In some embodiments, the vial interface of the plunger includes an annular sidewall that defines a cavity therein, and wherein the inlet end of the needle is disposed within the cavity, distal to the proximal end of the annular sidewall. In several such embodiments, the annular sidewall includes a flange that extends around at least a portion of the circumference of the inner surface of the annular sidewall. The flange projects into the cavity and is configured to engage the outlet end of the vial to secure the outlet end within the cavity.

[0010] According to several embodiments, the plunger includes a plunger head coupled to the distal portion of the plunger rod, and the plunger head extends between the outer surface of the distal portion of the plunger rod and the inner surface of the sidewall of the reservoir, thereby creating a seal between the plunger and the reservoir. The plunger head may include a diaphragm, and the needle extends through the diaphragm such that the outlet end of the needle is distal to the distal end of the diaphragm. In several embodiments, the plunger head extends circumferentially around the distal portion of the plunger rod and includes an inner surface that defines a plurality of threads configured to engage a plurality of threads at the outer surface of the distal portion of the plunger rod. In some examples, the reservoir is configured to be received within a fluid infusion pump. According to some embodiments, the distal portion of the reservoir includes a filter configured to filter particles from the fluid drug when dispensing the fluid drug from the fluid reservoir.

[0011] The present technology includes a method for transferring a fluid drug from a vial to a reservoir. The method includes providing a fluid transfer assembly that includes a reservoir defining an inner cavity configured to receive and contain a fluid drug and a plunger. The plunger has a proximal end portion and a distal end portion. The plunger includes a vial interface at the proximal end portion, a plunger rod extending distally from the vial interface, and a needle. The plunger rod is slidably positioned within the inner cavity of the reservoir. The needle extends longitudinally through the plunger and has an inlet end at the vial interface and an outlet end proximal to the distal portion of the plunger rod. The needle defines a lumen extending therethrough. The method further includes coupling the outlet end of the vial containing the fluid drug to the vial interface of the plunger, thereby piercing the diaphragm of the vial with the inlet end of the needle and establishing a fluid connection between the vial and the lumen of the needle. When the vial remains engaged with the vial interface of the plunger, the method includes moving the vial and the plunger together in a proximal direction away from the reservoir, thereby creating a negative pressure within the inner region of the reservoir and withdrawing the fluid drug from the vial and into the inner region of the reservoir through the needle. In some embodiments, coupling the outlet end of the vial to the vial interface includes inserting the outlet end of the vial distally into a cavity at the proximal end of the plunger.

[0012] The method may also include separating the vial from the plunger after aspirating a desired amount of the fluid medicament into the interior region of the reservoir. In some cases, the method also includes removing the plunger from the reservoir after aspirating a desired amount of the fluid medicament into the interior region of the reservoir. The plunger may also include a plunger head that is coupled to the distal portion of the plunger rod and extends between the outer surface of the plunger rod and the inner surface of the reservoir. In such an embodiment, the method may also include separating the plunger rod from the plunger head to effect removal of the plunger from the reservoir, and removing the plunger from the reservoir while the plunger head remains within the reservoir and prevents expulsion of the fluid medicament. In some cases, separating the plunger rod from the plunger head includes rotating the plunger rod relative to the plunger head. Any of the above methods may include placing the reservoir in a fluid infusion pump.

[0013] Some embodiments of the present technology include a reservoir for use with a liquid infusion system for delivering a liquid medicament to a user. The reservoir may include a barrel portion defining a lumen configured to receive the liquid medicament and a dispensing portion including a septum. The dispensing portion extends distally from the barrel portion and defines a passageway therein. The passageway has a proximal end fluidly coupled to the barrel portion and terminates distally at the septum. When the fluid medicament is dispensed from the reservoir, the fluid medicament flows along a flow path beginning at the barrel portion and extending through the passageway and into a needle extending through the septum. The reservoir also includes a filter disposed in the flow path within the passageway of the dispensing portion, the filter being configured to trap particles in the fluid medicament.

[0014] In some embodiments of the reservoir, the dispensing portion includes a neck extending distally from the barrel portion and a head extending distally from the neck. The head has a cross-sectional dimension that is greater than the cross-sectional dimension of the neck, and at least a portion of the filter is positioned within a portion of the passage extending through the neck. In some examples, the septum is disposed within the head of the dispensing area, the head further includes a receiving cavity that includes a portion of the passage between the distal end of the filter and the proximal end of the septum, and the receiving cavity is configured to receive the inlet end of a needle extending proximally through the septum. According to some embodiments, the reservoir may further include a cap configured to be positioned above the dispensing area to secure the septum within the dispensing area. The receiving cavity is configured to receive the inlet end of a needle extending proximally through the septum. In a particular embodiment, the filter is a first filter, and the reservoir further includes a second filter disposed within the dispensing area in the flow path. In certain examples, the dispensing portion includes a neck extending distally from the barrel portion and a head extending distally from the neck, and the head has a cross-sectional dimension that is greater than the cross-sectional dimension of the neck. The filter is a first filter and is positioned within a portion of the passage extending through the neck, and the dispensing portion further includes a second filter disposed within the passage and downstream of the first filter. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0016] Figure 1A and Figure 1B are a front view and a cross-sectional view, respectively, of a fluid transfer assembly constructed in accordance with several embodiments of the present technology.

[0017] Figure 2A are Figure 1A and Figure 1B are enlarged cross-sectional views of the distal portion of the fluid transfer assembly shown in.

[0018] Figure 2B is an enlarged cross-sectional view of the distal portion of another embodiment of a fluid transfer assembly constructed in accordance with the present technology.

[0019] Figure 3 are Figure 1A , Figure 1B and an isolated view of the plunger rod of the fluid transfer assembly shown in FIG. 2.

[0020] Figures 4A to 4D illustrates a method of filling a fluid reservoir with a fluid transfer assembly in accordance with several embodiments of the present technology using Figures 1A to 3 .

[0021] Figure 5A and Figure 5B show the distal portion of a fluid transfer assembly according to several embodiments of the present technology, where the plunger is in a partially advanced and fully advanced position.

[0022] Figure 6A , Figure 6B and Figure 6C show various plunger heads for use with the fluid transfer assembly of the present technology.

[0023] Figure 7 show a fluid transfer assembly of the present technology coupled to a vial and including a gripping member according to several embodiments of the present technology.

[0024] Figure 8 show an infusion pump coupled to an infusion set, where a reservoir of the present technology is received within the infusion pump. DETAILED DESCRIPTION

[0025] The present technology relates to certain components and features of a fluid infusion system for treating a medical condition of a patient. In particular, the present technology relates to a fluid reservoir and associated devices and methods for filling the fluid reservoir with a liquid medicament. The non-limiting examples described below relate to a medical device for treating diabetes (more specifically, an insulin pump), but the embodiments of the disclosed subject matter are not limited thereto. Thus, in certain embodiments, the fluid medicament is insulin. However, in other embodiments, fluid medicaments other than insulin, such as drugs for treating pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, drugs, vitamins, hormones, etc., can also be administered through the fluid infusion system described.

[0026] Figure 1A and Figure 1B are a front view and a cross-sectional view, respectively, of a fluid transfer assembly 100 (or "transfer assembly 100") constructed according to the present technology. The fluid transfer assembly 100 is configured to facilitate the transfer of a fluid medicament from a vial (not shown) to a fluid reservoir 102 before coupling the reservoir 102 to a fluid infusion device to deliver the fluid medicament to a patient. As Figure 1A and Figure 1B shown, the fluid transfer assembly 100 includes a reservoir 102 and a plunger 104. The plunger 104 includes a plunger rod 105 and a plunger head 150 located at the distal end of the plunger rod 105. Before the reservoir filling process, the plunger 104 is disposed within the barrel of the reservoir 102 (as depicted). At the end of the process, the plunger rod 105 is removed from the plunger head 150 of the plunger 104, and the reservoir 102 is operatively coupled to an infusion pump or other fluid delivery system (e.g., as shown in FIG. 5 below).

[0027] The reservoir 102 extends longitudinally between a proximal end region 102a and a distal end region 102b, and the plunger 104 extends longitudinally between a proximal end portion 104a and a distal end portion 104b. As used herein, "proximal" refers to a position along the longitudinal axis of the delivery assembly 100 that is closer to the open end of the plunger rod 105 (where the fluid drug vial is received), and "distal" refers to a position along the longitudinal axis of the delivery assembly 100 that is farther from the open end of the plunger rod 105. When the reservoir 102 is subsequently coupled to a fluid delivery system for dispensing a fluid drug, the fluid drug flows in a proximal-to-distal direction.

[0028] Figure 2A is an enlarged view of the distal end region 102b of the reservoir 102. Refer to Figures 1A to 2A , the fluid reservoir 102 may include a barrel portion 110 and a dispensing portion 111 extending distally from the barrel portion 110. The barrel portion 110 defines an internal region 118 that is configured to receive and store a fluid drug and to slidably receive the plunger 104 therein. The internal region 118 is bounded by a sidewall having a body portion 164 and an end portion 166. The body portion 164 has an opening 168 at its proximal end ( Figure 4B best visible in), and the end portion 166 extends distally from the distal end of the body portion 164. -- The plunger 104 is configured to be received through the opening 168 during assembly. The cross-sectional dimensions of the outer surface 167 of the sidewall along the end portion 166 may taper distally. The inner surface 169 of the sidewall along the end portion 166 may also taper distally (as Figures 1A to 2A shown), generally following the contour of the outer surface 167 and / or the distal face of the plunger 104. By at least mirroring the distal face of the plunger 104, once the plunger 104 is fully advanced into the barrel portion 110, the dead space within the reservoir 102 (as Figure 1A and Figure 1B shown) is reduced or eliminated. In some embodiments, the contour of the inner surface 169 of the sidewall along the end portion 166 may not follow the contour of the outer surface 167, such as, for example, as discussed below with reference to Figures 5A to 6C .

[0029] The dispensing portion 111 includes the narrow portion of the reservoir 102 and defines a channel 109 (see Figure 2A ), through which the fluid drug travels when being dispensed from the barrel portion 110 to an infusion device and ultimately to the user. Optionally, in a patch infusion device, the liquid drug may travel from the reservoir 102 to a cannula that is directly inserted into the user. The internal region 118 of the barrel portion 110 and the channel 109 of the dispensing portion 111 are in communication via a passageway 115 extending therebetween (see Figure 2A)Fluid coupling. The dispensing portion 111 may also include a diaphragm 122 at the distal end of the channel 109. Thus, the channel 109 may extend from the distal end of the passageway 115 to the diaphragm 122.

[0030] The dispensing portion 111 may include a neck region 112 extending distally from the barrel portion 110 and a head region 114 extending distally from the neck region 112. As shown, the cross-sectional dimensions of the head region 114 may be greater than the cross-sectional dimensions of the neck region 112. In some embodiments, the distal end region 102b of the reservoir 102 also includes a cap 116 coupled to the head region 114 to help secure the diaphragm 122 to the head region 114. The cap 116 may have an opening 117 that covers a portion of the diaphragm 122 and through which a needle for piercing the diaphragm 122 may be received.

[0031] The reservoir 102 also includes a filter 120 that is disposed within the passageway 109 of the dispensing portion 111 and is configured to filter out particles from the fluid medicament (such as insulin aggregates) as the fluid medicament passes through the passageway 109. Filtering particles from the fluid medicament reduces the likelihood of inflammation occurring at the patient infusion site and facilitates extending the duration of cannula implantation (e.g., up to 7 days or longer). The filter 120 can include a single filter (as shown) or multiple filters (e.g., two filters, three filters, four filters, etc.). The filter 120 can include a porous hydrophilic structure formed from one or more of the following: polyvinyl alcohol (PVA), polyurethane, polyester, polyether, polyacrylate, nylon, cellulose, cellulose acetate, cellulose nitrate, polyethylene, polyvinyl acetate, polysulfone, polyethersulfone (PES), collagen, polycaprolactone, acrylic copolymer, mixed cellulose ester, polytetrafluoroethylene (PTFE), polycarbonate, and other hydrophilic materials. In some embodiments, one, some, or all of the filters can include hydrophilic additives such as glycerin. Additional detailed information regarding the filter assembly can be found in U.S. Provisional Application No. 63 / 625,721, entitled "Fluid Delivery Filters," filed on January 26, 2024, U.S. Patent No. 11,197,949, entitled "Medication Infusion Components and Systems," filed on January 18, 2018, and U.S. Patent No. 10,279,126, entitled "Fluid Conduit Assembly with Gas Trapping Filter in the Fluid Flow Path," filed on October 7, 2014, the entire disclosures of which are incorporated herein by reference in their entirety.

[0032] In some embodiments, the reservoir 102 includes a first filter (such as Figure 2AThe filter shown in [[ ]] and a second filter (not shown). The first filter may include an expandable porous structure having a first average pore size and a first height, and the second filter may include a second porous structure having a second average pore size and a second height. The second average pore size may be smaller than the first average pore size, and the second height may be smaller than the first height. For example, the second filter may be configured to trap smaller aggregates that pass through the larger pores of the first filter. In some embodiments, the first filter may include PVA, cellulose, polyurethane, polyester, polyether, or collagen, and may have an average pore size of about 0.1 mm to about 0.5 mm, while the second filter may include at least one of an acrylic copolymer membrane, a polyethersulfone membrane, a mixed cellulose ester membrane, a cellulose acetate membrane, a nitrocellulose membrane, a nylon membrane, a hydrophilic polytetrafluoroethylene (PTFE) membrane, and / or a polycarbonate membrane, and may have an average pore size of about 0.1 μm to about 10 μm.

[0033] Figure 2B An enlarged cross-sectional view of the distal portion of another embodiment of a reservoir constructed in accordance with the present technology. In addition to Figure 2B the reservoir includes a plurality of filters, Figure 2B the reservoir represented by the distal portion in [[ ]] may be the same as Figures 1A to 2A the reservoir having the same components and features. Each of the filters may include a porous hydrophilic structure formed from; one or more of polyvinyl alcohol (PVA), polyurethane, polyester, polyether, polyacrylate, nylon, cellulose, cellulose acetate, nitrocellulose, polyethylene, polyvinyl acetate, polysulfone, polyethersulfone (PES), collagen, polycaprolactone, acrylic copolymer, mixed cellulose ester, polytetrafluoroethylene (PTFE), polycarbonate, and other hydrophilic materials. In some embodiments, one, some, or all of the filters may include a hydrophilic additive, such as glycerol.

[0034] In [[ ]] Figure 2BIn the depicted embodiment, reservoir 102 includes three filters: a first filter 121 disposed within channel 109 proximate to channel 115; a second filter 123 disposed within channel 109 distal to the first filter 121; and a third filter 125 disposed within channel 109 distal to the second filter 123. Each of the filters generally spans the width of channel 109 such that fluid medication is forced to travel through the filter when dispensed. The first, second, and third filters 121, 123, 125 may be formed of the same or different materials, have the same or different pore sizes, have the same or different porosities, have the same or different widths, and have the same or different heights. In other examples, the filter assembly 120 may include a single filter, two filters, four filters, etc. Additional details regarding the filter assembly can be found in U.S. Provisional Application No. 63 / 625,721, filed Jan. 26, 2024, entitled “FLUID DELIVERY FILTERS”; U.S. Patent No. 11,197,949, filed Jan. 18, 2018, entitled “MEDICATION INFUSION COMPONENTS AND SYSTEMS”(); and U.S. Patent No. 10,279,126, filed Oct. 7, 2014, entitled “FLUID CONDUIT ASSEMBLY WITH GAS TRAPPING FILTER IN THE FLUID FLOW PATH”, the entire disclosures of which are incorporated herein by reference in their entireties.

[0035] The dispensing portion 111 may also include a receiving area 127 that includes a portion of channel 109 between the distal end of the filter 120 and the proximal end of the septum 122. When a needle (e.g., the needle of an infusion cap or other fluid conduit assembly) is positioned across the septum 122 and receives fluid from channel 109 during a fluid dispensing operation, the piercing / entry end of the needle may be positioned within the receiving area 127 distal to the filter 120 to avoid the needle piercing or otherwise contacting any portion of the filter 120. The dispensing portion 111 may be configured to ensure that the filter 120 remains proximal to the distal tip of the needle upon insertion of the needle such that the dispensed fluid medication passes through (and is filtered by) the filter 120 before flowing through the needle. In this way, the needle is not clogged by insulin aggregates or other particles.

[0036] Referring again to Figure 1A and Figure 1B, the plunger 104 includes a plunger rod 105 and a plunger head 150 located at the distal end portion of the plunger rod 105. The plunger rod 105 may include a vial interface 124 that mates with the proximal end portion 104a of the plunger 104, a shaft 126 that extends distally from the vial interface 124, and a plunger head coupling region 142 that mates with the distal end portion 104b of the plunger 104. The shaft 126 is configured to be slidably positioned within the inner region 118 of the barrel portion 110 of the reservoir 102 during fluid transfer operations, while the vial interface 124 remains proximal and external to the barrel portion 110.

[0037] The vial interface 124 may be configured to receive and secure the outlet end of a fluid drug vial during fluid transfer (shown in detail below in Figures 4A to 4D ). The vial interface 124 may include an annular sidewall 129 that extends proximally from the base 131 ( Figure 1B ) of the shaft 126, and the annular sidewall 129 and the base 131 together define a cavity 128 at the proximal end portion 104a of the plunger 104. In some embodiments, the vial interface 124 may include means for releasing the secured outlet end of the vial within the cavity 128. For example, as shown in Figure 1B , in some examples, the annular sidewall 129 includes a flange 130 that extends around at least a portion of the circumference of the inner surface of the annular sidewall 129. The flange 130 may project inwardly into the cavity 128, and when the outlet end of the vial has been inserted distally beyond the flange 130, the flange 130 resists the proximal movement of the vial, thereby securing the vial within the cavity 128. In these and other embodiments, the annular sidewall 129 may selectively include one or more windows 132 that enable a user to view the position of the needle and the outlet end of the vial during and after insertion of the vial, and that enable the annular sidewall to bend outwardly when the vial is inserted into the cavity 128.

[0038] The plunger 104 also includes a plunger head 150 that is coupled to the plunger head coupling region 142 at the distal portion of the shaft 126. The plunger head 150 extends between the outer surface of the plunger 104 and the inner surface of the sidewall of the reservoir 102, thereby creating a fluid seal between the plunger 104 and the reservoir 102. In some embodiments, the plunger head 150 includes a plunger head body 134 that extends around the circumference of the plunger head coupling region 142 and above the distal surface of the plunger head coupling region 142. The plunger head body 134 includes a distal face 135 that, in some embodiments, may bulge toward the dispensing portion 111. The distal face 135 may have other configurations, as described below. The plunger head 150 also includes a diaphragm 138 that extends through the distal face 135, and during fluid transfer operations, the needle 140 (discussed below) of the plunger extends through the diaphragm. The diaphragm 138 may be positioned distally of the plunger head body 134. Optionally, the plunger head 150 may include one or more O-rings 136 positioned between the plunger head body 134 and the inner surface of the reservoir 102. The inner surface of the plunger head 150 and / or the plunger head body 134 (e.g., facing the plunger 104) may define one or more threads 151 that are configured to mate with one or more threads 143 on the outer surface of the plunger head coupling region 142. When the fluid transfer process is complete (e.g., when the fluid has been successfully loaded into the reservoir 102, as described below), the plunger rod 105 of the plunger 104 may be rotated relative to the plunger head 150 to decouple the plunger rod 105 from the plunger head 150 and enable removal of the plunger rod 105, leaving the plunger head 150 within the reservoir. It should be understood that other methods of detachably coupling the plunger rod 105 to the plunger head 150 are possible.

[0039] Figure 3 An isolated view of the plunger rod 105 of the plunger 104. Refer Figure 1A 、 Figure 1B and Figure 3 , the shaft 126 of the plunger 104 may include a hollow frame formed by a plurality of longitudinally extending struts 152 ( Figure 3 ) that are circumferentially spaced apart by windows 154 ( Figure 3 ). In other examples, the shaft 126 includes a tubular structure that is circumferentially continuous along its entire length. As Figure 3 shows, the plunger 104 may include a needle 140 that extends longitudinally through the plunger rod 105 and defines a lumen extending therethrough. When the plunger rod 105 is coupled to the plunger head 150, the needle 140 may have an inlet end 140a (visible only in Figure 1B ) disposed at the vial interface 124 and an outlet end 140b distal to the diaphragm 138. The needle 140 may be fixed to a portion of the plunger rod 105 (in this example, at position 160, visible only in Figure 1BAs shown, the needle 140 and the plunger rod 105 are prevented from moving axially relative to each other. When the plunger rod 105 is removed from the plunger head 150, the needle 140 is withdrawn proximally through the septum 138, and subsequently the septum 138 is configured to be self-sealing.

[0040] When the outlet end of the vial is coupled to the vial interface 124 of the plunger 104, the needle 140 extends through the septum of the vial such that the inlet end of the needle 140a is disposed within the vial and in fluid communication with the fluid medicament. The proximal movement of the plunger 104 and the vial relative to the reservoir 102 draws the fluid medicament out of the vial through the needle 140 and into the interior region 118 of the reservoir 102. Thus, the fluid transfer assembly 100 of the present technology is configured to draw the fluid medicament into the reservoir 102 through the needle 140 extending from the proximal end of the reservoir 102 to the interior region of the reservoir, unlike existing transfer assemblies that place the transfer needle into the interior region through a septum at the distal end portion of the reservoir. Filling from the proximal end of the reservoir 102 also eliminates the challenges associated with filling from the distal end, such as residual fluid medicament blocking the connector and the outlet on the distal end of the reservoir.

[0041] In some embodiments, in addition to or instead of including one or more filters in the reservoir 102, the transfer assembly 100 may include one or more filters contained within the plunger rod 105 and in internal fluid communication with the needle 140. Figure 1B An example filter 133 is schematically shown. Such an arrangement enables filtering of the fluid medicament (such as insulin) during filling of the reservoir 102. The filter 133 can be any filter disclosed herein.

[0042] Figures 4A to 4D A method of transferring a fluid medicament from a vial V to a reservoir 102 using the fluid transfer assembly 100 is shown. As Figure 4A shown, at the vial interface 124 of the plunger 104, the outlet end O of the vial V can be inserted into the cavity 128. When the vial V is inserted, the sharp inlet end 140a of the needle 140 (see Figure 1B ) pierces the septum at the outlet end O of the vial V and passes through the septum into the interior region of the vial V, thereby establishing a fluid connection between the interior region of the fluid vial V and the lumen of the needle 140. In some embodiments, the outlet end O of the vial V can be advanced into the cavity 128 until the end face of the liquid vial abuts the base 131 of the shaft 126 ( Figure 1B ), or at least until the bottom edge of the cap at the outlet section O of the vial V is distal to the annular flange 130 within the cavity 128 ( Figure 1B ), thereby temporarily fixing the outlet end O of the vial V within the cavity 128.

[0043] As Figure 4BAs shown, the user can move the vial V and the plunger 104 proximally away from the barrel portion 110 of the reservoir 102, thereby creating a negative pressure in the inner region 118 of the barrel portion 110 and forcing the fluid medicament in the vial V to flow through the needle 140 and into the inner region 118 of the barrel portion 110. Once the reservoir 102 is filled (or at least filled to the satisfaction of the user), the vial V can be decoupled from the vial interface 124 by removing the vial V proximally from the cavity 128, as Figure 4C depicted. The plunger rod 105 can then be decoupled from the plunger head 150, for example, by rotating the plunger rod 105 relative to the plunger head 150. Other coupling / decoupling mechanisms are possible. As Figure 4D shown, the plunger rod 105 can then be removed from the reservoir 102, leaving only the plunger head 150 within the inner region 118 of the barrel portion 110.

[0044] According to some embodiments of the present technology, the plunger head 150 can be configured to address the unique challenges posed by pulling fluid into the reservoir 102 through the needle 140 in the plunger 104 when the plunger 104 is in an inverted position (e.g., pulling the plunger 104 upward to fill the reservoir 102). As discussed above, in some embodiments, the distal face 135 of the plunger head 150 protrudes towards the dispensing portion 111 of the reservoir 102. Based on this, during the filling operation, the tip of the needle 140 is positioned below the annular space 119 (at an elevation lower than the elevation of the annular space) (see Figure 4B and Figure 4C ), between the plunger head 150 and the inner surface of the barrel portion 110. In this way, air bubbles that may be generated during filling (from the air in the vial being pulled into the reservoir 102) travel upward and remain trapped within the annular space 119. The air bubbles can remain trapped within the reservoir such that when insulin is dispensed from the dispensing end of the reservoir 102 during the dispensing operation, the air bubbles are expelled along with the insulin, which can affect the dosage of the fluid medicament among other complications.

[0045] To address the above issues and reduce the presence of air bubbles within the reservoir, in some embodiments, the shape of the plunger head can be such that the elevation of the needle extending from the distal face of the plunger head during fluid transfer is higher than the elevation of the most distal end of the plunger head, thereby funneling potential air bubbles into the needle for removal prior to dispensing the fluid medicament. For example, Figure 5A and Figure 5BShows a distal portion of a fluid delivery assembly 500, which is generally similar to the fluid delivery assembly 100, except that the plunger 504 of the fluid delivery assembly 500 includes a plunger head 550 having an inverted and / or concave distal face 535. As shown, the distal face 535 has an annular region 572 that coincides with the most distal end of the plunger head 550, and a cavity 574 that extends proximally from the annular region 572 to the plunger head body 534. The surface 576 at the distal face 535 that defines the cavity 574 may taper proximally such that the cavity 574 forms a funnel. The distal tips of the diaphragm 538 and the needle 540 are disposed at the proximal end of the cavity 574. Thus, during filling, the distal tip of the needle 540 is positioned at an elevation higher than the elevation of the most distal end of the plunger head 550. Thus, any air bubbles that may be generated during filling collect upward to the needle tip and are discharged from the reservoir 502 before dispensing the fluid medicament from the reservoir 502.

[0046] The shape of the inner surface 569 at the end portion 566 of the barrel portion 510 may be mirrored to the inner surface of the plunger distal face 535 to eliminate any dead space between the two. As Figure 5A and Figure 5B shown, in some embodiments, the inner surface 569 may extend into the inner region 518 towards the plunger head 550 such that the inner surface 569 bulges towards the plunger head 550.

[0047] The slope of the surface 576 that defines the cavity 574 may vary. For example, as Figure 5A and Figure 5B shown, the diameter of the cavity 574 may decrease substantially linearly until it decreases exponentially near the diaphragm 538. As Figure 6A shown, in some embodiments, the diameter d of the cavity 574 first decreases exponentially and then decreases substantially linearly as the surface 576 approaches the diaphragm (not shown in Figure 6A ). As Figure 6B depicted, the diameter d of the cavity 574 may decrease logarithmically. As Figure 6C shown, in some embodiments, the diameter d of the cavity 574 first decreases sharply and then gradually decreases substantially linearly such that a portion of the surface 576 has a nominal slope, thereby creating a shallower cavity 574. Reducing the volume of the cavity 574 can be beneficial as it can provide more space within the reservoir 502 as long as the tip of the needle 540 remains proximal to the most distal end of the plunger head 550. In any of the embodiments disclosed herein, the surface 576 may have one or more inflection points.

[0048] The fluid delivery assembly of the present technology may optionally include a gripping member that is configured to be detachably coupled to the reservoir and provides a surface for the user to grip during a fluid delivery operation. Figure 7An example grip member 700 coupled to reservoir 102 of fluid transfer assembly 100 is shown. Reservoir 102 is filled by pulling upwardly away from plunger 104, which requires the user to grasp reservoir 102, which is difficult to do without squeezing barrel portion 110 (which may result in an incorrect amount of insulin being drawn into the reservoir). The additional grip member alleviates this problem by enabling the patient to grasp reservoir 102 during the filling operation without contacting barrel portion 110. In some embodiments, for example as Figure 7 shown, grip member 700 is configured to be coupled to dispensing portion 111 of reservoir 102 by any suitable coupling means (e.g., a rotary / screw arrangement, a locking clamp, a snap fit, etc.)( Figure 1A ). At least a portion of grip member 700 may have a diameter greater than the diameter of barrel portion 110 to facilitate user gripping.

[0049] Once filled, reservoir 102 is then operatively coupled to an infusion pump. For example, Figure 8 infusion pump 800 is shown, in which reservoir 102 is received. As described, in some examples, connector 802 may be coupled to dispensing portion 111 of reservoir 102( Figure 1A ) to fluidly couple reservoir 102 to infusion set 804. Infusion set 804 may include, for example, tubing 806 and infusion unit 808. Tubing 806 extends between connector 802 and infusion unit 808 and fluidly couples the two, and infusion unit 808 may include a cannula configured to be inserted into a patient's skin. In certain embodiments, connector 802 is coupled to reservoir 102 before reservoir 102 is coupled to pump 800. In other embodiments, connector 802 is attached after reservoir 102 is coupled to pump 800. In another example, reservoir 102 may be operatively coupled to a patch infusion device. Such a device attaches to the user's skin and utilizes a cannula that is inserted directly into the user's body, without the need for an infusion set. By residing a filter within the reservoir, various infusion systems can be designed to interchangeably use a single reservoir design, enabling the user to move, for example, between a tethered infusion device and a patch pump without having to have multiple types of reservoirs on hand. Similarly, the user may switch between various infusion sets for use with a tethered pump, not being limited to only infusion sets that contain filters. Thus, positioning the filter within the reservoir better protects the user in various treatment modalities.

[0050] Examples

[0051] For convenience, various examples of aspects of the present subject matter are described as numbered examples (1, 2, 3, etc.). These are provided as examples and do not limit the present subject matter.

[0052] Example 1: A fluid transfer assembly, the fluid transfer assembly comprising: a reservoir including a sidewall having a proximal end and a distal end and surrounding and defining an inner cavity, the sidewall having an opening at the proximal end, and wherein the reservoir is configured to receive and contain a fluid medicament within the inner cavity; a plunger having a proximal end portion and a distal end portion, the plunger comprising: a vial interface located at the proximal end portion, the vial interface being configured to receive an outlet end of a vial containing a fluid medicament; a plunger rod extending distally from the vial interface, wherein the plunger rod is slidably disposed within the inner cavity of the reservoir, and a needle longitudinally extending through the plunger rod, the needle having an inlet end at the vial interface and an outlet end near a distal portion of the plunger rod, wherein the needle defines a lumen extending through the needle; wherein the fluid transfer assembly is configured to be coupled to a vial such that when the outlet end of the vial is coupled to the vial interface of the plunger, the needle extends through a septum of the vial such that the inlet end of the needle is disposed within the vial and in fluid communication with the fluid medicament, and wherein when the needle is fluidly coupled to the vial, proximal movement of the plunger and the vial relative to the reservoir draws the fluid medicament out of the vial through the needle and into an interior region of the reservoir.

[0053] Example 2: The fluid transfer assembly according to Example 1, wherein the vial interface of the plunger includes an annular sidewall defining a cavity therein, and wherein the inlet end of the needle is disposed within the cavity, distal to a proximal end of the annular sidewall.

[0054] Example 3: The fluid transfer assembly according to Example 2, wherein the annular sidewall includes a flange extending around at least a portion of a circumference of an inner surface of the annular sidewall, wherein the flange projects into the cavity, and wherein the flange is configured to engage the outlet end of the vial to secure the outlet end within the cavity.

[0055] Example 4: The fluid transfer assembly according to Example 1 or Example 2, wherein the plunger includes a plunger head coupled to the distal portion of the plunger rod, the plunger head extending between an outer surface of the distal portion of the plunger rod and an inner surface of the sidewall of the reservoir, thereby creating a seal between the plunger and the reservoir.

[0056] Example 5: The fluid transfer assembly according to Example 4, wherein the plunger head includes a septum, and wherein the needle extends through the septum such that the outlet end of the needle is distal to a distal end of the septum.

[0057] Example 6: The fluid transfer assembly according to Example 4, wherein the plunger head circumferentially extends around the distal portion of the plunger rod and includes an inner surface defining a plurality of threads configured to engage a plurality of threads at the outer surface of the distal portion of the plunger rod.

[0058] Example 7: The fluid transfer assembly according to any one of Examples 1 to 6, wherein the reservoir is configured to be received within a fluid infusion pump.

[0059] Example 8: The fluid transfer assembly according to any one of Examples 1 to 7, wherein a distal portion of the reservoir includes a filter configured to filter out particles from the fluid medicament when dispensing the fluid medicament from the fluid reservoir.

[0060] Example 9: A method for transferring a fluid medicament from a vial to a reservoir, the method comprising: providing a fluid transfer assembly including: a reservoir defining an inner cavity and configured to receive and contain a fluid medicament; a plunger having a proximal end portion and a distal end portion, the plunger including: a vial interface at the proximal end portion, a plunger rod extending distally from the vial interface, wherein the plunger rod is slidably positioned within the inner cavity of the reservoir, and a needle longitudinally extending through the plunger, the needle having an inlet end at the vial interface and an outlet end near the distal portion of the plunger rod, wherein the needle defines a lumen extending therethrough; coupling an outlet end of a vial containing the fluid medicament to the vial interface of the plunger, thereby piercing a septum of the vial with the inlet end of the needle and establishing a fluid connection between the vial and the lumen of the needle; and while the vial remains engaged with the vial interface of the plunger, moving the vial and the plunger together in a proximal direction away from the reservoir, thereby creating a negative pressure within the inner region of the reservoir and withdrawing the fluid medicament from the vial through the needle and into the inner region of the reservoir.

[0061] Example 10: The method according to Example 9, wherein coupling the outlet end of the vial to the vial interface includes distally inserting the outlet end of the vial into a cavity at the proximal end of the plunger.

[0062] Example 11: The method according to Example 9, further comprising: separating the vial from the plunger after a desired amount of the fluid medicament has been drawn into the inner region of the reservoir.

[0063] Example 12: The method according to Example 9, further comprising: removing the plunger from the reservoir after a desired amount of the fluid medicament has been drawn into the inner region of the reservoir.

[0064] Example 13: The method according to Example 12, wherein the plunger further includes a plunger head, the plunger head being coupled to the distal portion of the plunger rod and extending between the outer surface of the plunger rod and the inner surface of the reservoir; separating the plunger rod from the plunger head to effect removal of the plunger from the reservoir, and removing the plunger from the reservoir while the plunger head remains within the reservoir and preventing the fluid medicament from being discharged.

[0065] Example 14: The method according to Example 13, wherein separating the plunger rod from the plunger head includes rotating the plunger rod relative to the plunger head.

[0066] Example 15: The method according to Example 12, the method further including placing the reservoir in a fluid infusion pump.

[0067] Example 16: A reservoir for use with a fluid infusion system for delivering a fluid medicament to a user, the reservoir comprising: a barrel portion defining an inner cavity, the barrel portion being configured to receive the fluid medicament; a dispensing portion including a septum, the dispensing portion extending distally from the barrel portion and defining a passageway therein, the passageway having a proximal end fluidly coupled to the barrel portion, and wherein the passageway terminates distally at the septum, and wherein when the fluid medicament is dispensed from the reservoir, the fluid medicament flows along a flow path starting from the barrel portion and extending through the passageway and into a needle extending through the septum; and a filter disposed in the flow path within the passageway of the dispensing portion, the filter being configured to trap particles in the fluid medicament.

[0068] Example 17: The reservoir according to Example 16, wherein the dispensing portion includes a neck extending distally from the barrel portion and a head extending distally from the neck, wherein the head has a larger cross-sectional dimension than the cross-sectional dimension of the neck, and wherein at least a portion of the filter is positioned within a portion of the passageway extending through the neck.

[0069] Example 18: The reservoir according to Example 17, wherein the septum is disposed within the head of the dispensing region, the head further including a receiving cavity, the receiving cavity including a portion of the passageway between the distal end of the filter and the proximal end of the septum, and the receiving cavity being configured to receive the inlet end of a needle extending proximally through the septum.

[0070] Example 19: The reservoir according to Example 16, the reservoir further including a cap portion configured to be positioned above the dispensing region to secure the septum within the dispensing region.

[0071] Example 20: The reservoir according to Example 16, wherein the filter is a first filter, and the reservoir further includes a second filter disposed within the dispensing region in the flow path.

[0072] Example 21: The reservoir according to Example 20, wherein the dispensing portion includes a neck extending distally from the barrel portion and a head extending distally from the neck, wherein the head has a cross-sectional dimension larger than that of the neck, the filter is a first filter and is positioned within a portion of the passage extending through the neck, and the dispensing portion further includes a second filter disposed within the passage and downstream of the first filter.

[0073] Example 22: A fluid delivery assembly, the fluid delivery assembly comprising: a reservoir defining an internal region configured to receive a fluid medicament, the reservoir having a proximal end portion and a distal end portion, wherein the reservoir is configured to dispense the fluid medicament from the distal end portion; and a plunger having a proximal end portion and a distal end portion, the plunger including: a plunger rod configured to be slidably disposed within the internal region of the reservoir; a plunger head configured to be coupled to the distal portion of the plunger rod and disposed within the internal region of the reservoir such that the plunger head provides a seal between the plunger and the reservoir, wherein the plunger head includes a distal face facing the distal inner surface of the reservoir such that the fluid medicament contained in the reservoir is longitudinally confined between the distal face of the plunger head and the distal inner surface of the reservoir, and wherein the distal face of the plunger head defines a cavity extending proximally from the farthest distal end of the plunger head into the plunger head, wherein when the reservoir contains the fluid medicament, movement of the plunger head relative to the distal end of the reservoir dispenses the fluid medicament from the distal end portion of the reservoir.

[0074] Example 23: The fluid delivery assembly according to Example 22, the fluid delivery assembly further including a needle extending longitudinally through the plunger rod, the needle having an inlet end at the proximal end portion of the plunger and an outlet end at the proximal end portion of the cavity such that the outlet end is proximal to the farthest distal end of the plunger head.

[0075] Example 24: The fluid delivery assembly according to Example 22, wherein the cross-sectional diameter of the cavity tapers proximally.

[0076] Example 25: The fluid delivery assembly according to Example 22, wherein the shape of the distal inner surface of the reservoir complements the profile of the distal face of the plunger head.

[0077] Example 26: The fluid transfer assembly according to Example 22, wherein the distal inner surface of the reservoir bulges toward the plunger head.

[0078] Conclusion

[0079] It should be understood that embodiments other than those described herein are also within the scope of the present technology. Additionally, several other embodiments of the present technology may have different configurations, components, or procedures from those described herein. Accordingly, one of ordinary skill in the art will understand that the present technology may have other embodiments with additional elements, or the present technology may have other embodiments without several of the features referenced Figures 1A to 8 shown and described above.

[0080] The description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the exact forms disclosed above. Where context permits, the singular term or plural term may also include the plural term or the singular term, respectively. While specific embodiments and examples of the present technology have been described above for illustrative purposes, those skilled in the relevant art will recognize that various equivalent modifications can be made within the scope of the present technology. For example, while steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide additional embodiments.

[0081] As used herein, the terms "substantially", "essentially", "about" and similar terms are used as approximate terms and not as terms of degree, and are intended to account for the inherent deviations of the measured or calculated values that would be recognized by one of ordinary skill in the art.

[0082] Furthermore, unless the word "or" is explicitly limited to only mean a single item that excludes the other items when referring to a list of two or more items, the use of "or" in such a list should be construed to include (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited features, such that any greater number of the same features and / or additional types of other features are not excluded. It should also be understood that specific embodiments have been described herein for purposes of illustration, but various modifications can be made without departing from the present technology. Additionally, while advantages associated with certain embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need to exhibit such advantages to fall within the scope of the present technology. Accordingly, the present disclosure and associated technologies may cover other embodiments not expressly shown or described herein.

Claims

1. A fluid transfer assembly, the fluid transfer assembly comprising: A reservoir, the reservoir including a sidewall having a proximal end and a distal end and surrounding and defining an inner cavity, the sidewall having an opening at the proximal end, and wherein the reservoir is configured to receive and contain a fluid medicament within the inner cavity; A plunger, the plunger having a proximal end portion and a distal end portion, the plunger including: A vial interface located at the proximal end portion, the vial interface being configured to receive an outlet end of a vial containing a fluid medicament; A plunger rod extending distally from the vial interface, wherein the plunger rod is slidably disposed within the inner cavity of the reservoir, and A needle longitudinally extending through the plunger rod, the needle having an inlet end at the vial interface and an outlet end near the distal portion of the plunger rod, wherein the needle defines a lumen extending through the needle, Wherein the needle has an inlet end at the proximal end portion of the plunger and an outlet end at the proximal end portion of the cavity, such that the outlet end is proximal to the farthest distal end of the plunger head, Wherein the fluid transfer assembly is configured to be coupled to a vial such that when the outlet end of the vial is coupled to the vial interface of the plunger, the needle extends through a septum of the vial such that the inlet end of the needle is disposed within the vial and in fluid communication with the fluid medicament, and Wherein when the needle is fluidly coupled to the vial, proximal movement of the plunger and the vial relative to the reservoir draws the fluid medicament out of the vial through the needle and into an inner region of the reservoir.

2. The fluid transfer assembly according to claim 1, wherein the vial interface of the plunger includes an annular sidewall defining a cavity therein, and wherein the inlet end of the needle is disposed within the cavity and distal to the proximal end of the annular sidewall.

3. The fluid transfer assembly according to claim 2, wherein the annular sidewall includes a flange extending around at least a portion of a circumference of an inner surface of the annular sidewall, wherein the flange projects into the cavity, and wherein the flange is configured to engage the outlet end of the vial to secure the outlet end within the cavity.

4. The fluid transfer assembly according to claim 1, wherein: The plunger includes a plunger head coupled to the distal portion of the plunger rod, The plunger head extends between an outer surface of the distal portion of the plunger rod and an inner surface of the sidewall of the reservoir, thereby creating a seal between the plunger and the reservoir.

5. The fluid transfer assembly according to claim 4, wherein the plunger head includes a septum, and wherein the needle extends through the septum such that the outlet end of the needle is distal to the distal end of the septum.

6. The fluid transfer assembly according to claim 4, wherein the plunger head circumferentially extends around the distal portion of the plunger rod and includes an inner surface defining a plurality of threads configured to engage a plurality of threads at the outer surface of the distal portion of the plunger rod.

7. The fluid transfer assembly according to claim 1, wherein the reservoir is configured to be received within a fluid infusion pump.

8. The fluid transfer assembly according to claim 1, wherein a distal portion of the reservoir includes a filter configured to filter particles from the fluid medicament when dispensing the fluid medicament from the fluid reservoir.

9. The fluid transfer assembly according to claim 1, wherein a distal inner surface of the reservoir bulges towards the plunger head.

10. A method for transferring a fluid medicament from a vial to a reservoir, the method comprising: providing a fluid transfer assembly comprising: a reservoir defining a lumen and configured to receive and contain a fluid medicament; a plunger having a proximal end portion and a distal end portion, the plunger comprising: a vial interface at the proximal end portion, a plunger rod extending distally from the vial interface, wherein the plunger rod is slidably positioned within the lumen of the reservoir, and a needle longitudinally extending through the plunger, the needle having an inlet end at the vial interface and an outlet end near the distal portion of the plunger rod, wherein the needle defines a lumen extending through the needle; coupling an outlet end of a vial containing the fluid medicament to the vial interface of the plunger, thereby piercing a septum of the vial with the inlet end of the needle and establishing a fluid connection between the vial and the lumen of the needle; and while the vial remains engaged with the vial interface of the plunger, moving the vial and the plunger together in a proximal direction away from the reservoir, thereby creating a negative pressure within the interior region of the reservoir and withdrawing the fluid medicament from the vial through the needle and into the interior region of the reservoir.

11. The method according to claim 10, wherein coupling the outlet end of the vial to the vial interface includes distally inserting the outlet end of the vial into a cavity at the proximal end of the plunger.

12. The method according to claim 10, wherein the method further comprises: After drawing a desired amount of the fluid medicament into the interior region of the reservoir, separating the vial from the plunger.

13. The method according to claim 10, the method further comprising: After drawing a desired amount of the fluid medicament into the interior region of the reservoir, removing the plunger from the reservoir.

14. The method according to claim 13, wherein: the plunger further includes a plunger head coupled to the distal portion of the plunger rod and extending between the outer surface of the plunger rod and the inner surface of the reservoir, separating the plunger rod from the plunger head to effect removal of the plunger from the reservoir, and Remove the plunger from the reservoir while the plunger head remains within the reservoir and prevents the fluid medicament from being discharged.

15. The method according to claim 14, wherein separating the plunger rod from the plunger head comprises rotating the plunger rod relative to the plunger head.

16. The method according to claim 13, the method further comprising placing the reservoir in a fluid infusion pump.

17. A reservoir for use with a fluid infusion system for delivering a fluid medicament to a user, the reservoir comprising: A barrel portion defining an inner cavity, the barrel portion being configured to receive a fluid medicament; A dispensing portion including a septum, the dispensing portion extending distally from the barrel portion and defining a channel therein, the channel having a proximal end fluidly coupled to the barrel portion, and wherein the channel terminates distally at the septum, and wherein when dispensing the fluid medicament from the reservoir, the fluid medicament flows along a flow path starting from the barrel portion and extends through the channel and into a needle extending through the septum; And A filter disposed in the flow path within the channel of the dispensing portion, the filter being configured to trap particles in the fluid medicament.

18. The reservoir according to claim 17, wherein the dispensing portion includes a neck extending distally from the barrel portion and a head extending distally from the neck, wherein the head has a cross-sectional dimension larger than the cross-sectional dimension of the neck, and wherein at least a portion of the filter is positioned within a portion of the channel extending through the neck.

19. The reservoir according to claim 18, wherein: The septum is disposed within the head of the dispensing region, The head further includes a receiving cavity, the receiving cavity including a portion of the channel between the distal end of the filter and the proximal end of the septum, and The receiving cavity is configured to receive the inlet end of a needle extending proximally through the septum.

20. The reservoir according to claim 17, the reservoir further comprising a cap configured to be positioned above the dispensing region to secure the septum within the dispensing region.

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