Fluid delivery filter

Abstract

A filter for use with a fluid infusion device is disclosed herein. In accordance with some embodiments, the present technology includes a system for delivering a fluid drug to a patient at an infusion site, the system comprising: a fluid conduit configured to deliver the fluid drug along at least a portion of a fluid path, the fluid path extends between a reservoir containing the fluid drug and a cannula inserted subcutaneously into a patient at an infusion site; and a filter disposed within the fluid conduit and configured to trap particles formed in the fluid drug, where the filter comprises a porous structure comprising glycerol.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 625,721, filed on January 26, 2024, the entire disclosure of which is incorporated herein by reference. Technical field

[0003] The present technology generally relates to fluid infusion devices for delivering a pharmaceutical fluid to a user's body. Background art

[0004] According to modern medical techniques, certain diseases or disorders can be treated by delivering a pharmaceutical fluid or other substance to a patient's body in a continuous manner or at specific times or time 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 therapy to a patient include delivering insulin via a manually operated syringe and an insulin pen. 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 pharmaceuticals to a patient.

[0005] Fluid infusion devices suitable for use as insulin pumps can be implemented as external devices or implantable devices that are surgically implanted into a patient's body. External fluid infusion devices include devices designed for a generally fixed location (e.g., for a hospital or clinic), and devices constructed for mobile or portable use (carried by a patient). An external fluid infusion device can establish a fluid flow path from a fluid reservoir via, for example, a suitable hollow tube to the patient. The hollow tube can be connected to a hollow fluid delivery needle or cannula that is designed to pierce the patient's skin to deliver the infusion fluid to the body.

[0006] Persistent problems associated with systems designed for infusing pharmaceuticals 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 set can remain at a single infusion site (i.e., "site failure"). In addition, tissue encapsulation and blockage of implanted cannulas or catheters (i.e., "occlusion") often occur, preventing or stopping the infusion of the pharmaceutical. Inflammation can be exacerbated by insulin aggregation when insulin is stored in a reservoir within the pump at ambient temperature. Therefore, it is necessary to frequently re - position the infusion site to continue using the infusion pump. Currently, the wear time of all commercial insulin infusion sets is marked as ≤ 3 days.

[0007] Therefore, there is a need for improved fluid delivery systems. Summary of the Invention

[0008] This disclosure relates to filters for use with fluid infusion devices. According to some embodiments, the technology includes a system for delivering a fluid medicament to a patient at an infusion site, the system including: a fluid conduit configured to convey the fluid medicament along at least a portion of a fluid path extending between a reservoir containing the fluid medicament and a cannula subcutaneously inserted into the patient at the infusion site; and a filter disposed within the fluid conduit and configured to trap particles formed in the fluid medicament, wherein the filter includes a porous structure containing glycerol and / or may have an absorption rate between 0 seconds and 30 seconds, in some cases less than six seconds, or less than five seconds. In several embodiments, the fluid medicament is insulin, and the filter is configured to trap insulin aggregates formed in the insulin. The system may be configured to infuse the fluid medicament to the patient at the infusion site over a period of greater than four days, greater than five days, greater than six days, or greater than seven days. In some examples, the porous structure includes polyvinyl alcohol, cellulose, polyurethane, polyester, polyether, or collagen and has an average pore size of from about 0.1 mm to about 0.5 mm. According to several cases, the porous structure includes at least one of an acrylic copolymer membrane, a polyethersulfone membrane, a mixed cellulose ester membrane, a cellulose acetate membrane, a cellulose nitrate membrane, a nylon membrane, a hydrophilic polytetrafluoroethylene (PTFE) membrane, and / or a polycarbonate membrane and has an average pore size of from about 0.1 μm to about 10 μm. In some embodiments, the fluid conduit includes a tube and a connector configured to fluidly couple the tube to the reservoir, and the filter is disposed within the connector. According to several examples, the system includes a second filter disposed within the fluid conduit.

[0009] A system for delivering a fluid medicament to a patient at an infusion site, the system comprising a fluid conduit having a first end configured to be fluidly coupled to a reservoir containing the fluid medicament and a second end configured to be fluidly coupled to an infusion cannula. The fluid conduit can be configured to deliver the fluid medicament from the reservoir to the patient through the infusion cannula. The system can further include a connector and a filter, the connector being configured to fluidly couple the first end of the fluid conduit to the reservoir, the filter being disposed within the connector and configured to trap particles formed in the fluid medicament. The filter can include a porous structure comprising glycerol, and / or can have an absorption rate between 0 seconds and 30 seconds, in some cases less than six seconds, or less than five seconds. In several embodiments, the fluid medicament is insulin, and the filter is configured to trap insulin aggregates formed in the insulin. The system can be configured to infuse the fluid medicament to the patient at the infusion site over a period of greater than four days, greater than five days, greater than six days, or greater than seven days. In some examples, the porous structure comprises polyvinyl alcohol, cellulose, polyurethane, polyester, polyether, or collagen and has an average pore size of about 0.1 mm to about 0.5 mm. Depending on several cases, the porous structure comprises at least one of an acrylic copolymer membrane, a polyethersulfone membrane, a mixed cellulose ester membrane, a cellulose acetate membrane, a cellulose nitrate membrane, a nylon membrane, a hydrophilic polytetrafluoroethylene (PTFE) membrane, and / or a polycarbonate membrane, and has an average pore size of about 0.1 μm to about 10 μm. In some embodiments, the fluid conduit includes tubing. According to several examples, the system includes a second filter disposed within the fluid conduit.

[0010] A system for delivering a fluid medicament to a patient at an infusion site, the system comprising an infusion pump, a reservoir, a cannula, and a fluid conduit, the reservoir being configured to store the fluid medicament and being configured to be received by the infusion pump, the cannula being configured for subcutaneous insertion into the tissue of the patient at the infusion site, the fluid conduit having a first end configured to be fluidly coupled to the reservoir and a second end configured to be fluidly coupled to the cannula. The fluid conduit may be configured to deliver the fluid medicament from the reservoir to the patient. The system may further include a connector and one or more filters, the connector being configured to fluidly couple the first end of the fluid conduit to the reservoir, the one or more filters being disposed in at least one of the reservoir, the fluid conduit, or the connector. Each of the one or more filters is configured to trap particles formed in the fluid medicament. The one or more filters may include a porous structure comprising glycerol, and / or may have an absorption rate between 0 seconds and 30 seconds, in some cases less than six seconds, or less than five seconds. In several embodiments, the fluid medicament is insulin, and the filter is configured to trap insulin aggregates formed in the insulin. The system may be configured to infuse the fluid medicament to the patient at the infusion site over a period of greater than four days, greater than five days, greater than six days, or greater than seven days. In some examples, the porous structure comprises polyvinyl alcohol, cellulose, polyurethane, polyester, polyether, or collagen and has an average pore size of from about 0.1 mm to about 0.5 mm. In some instances, the porous structure comprises at least one of an acrylic copolymer membrane, a polyethersulfone membrane, a mixed cellulose ester membrane, a cellulose acetate membrane, a cellulose nitrate membrane, a nylon membrane, a hydrophilic polytetrafluoroethylene (PTFE) membrane, and / or a polycarbonate membrane and has an average pore size of from about 0.1 μm to about 10 μm. In some examples, the system includes a second filter disposed in at least one of the reservoir, the fluid conduit, or the connector. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Many aspects of the present disclosure may 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.

[0012] Figure 1 is a schematic view of a fluid delivery system according to several embodiments of the present technology.

[0013] Figure 2 is a plan view of a fluid delivery system including a fluid infusion device and an infusion assembly according to several embodiments of the present technology.

[0014] Figure 3A is Figure 2 an exploded view of the connector shown, and Figure 3B is Figure 2 and Figure 3A an assembled view of the connector shown.

[0015] Figure 4A is an exploded view of another connector for use with the fluid delivery system of the present technology, and Figure 4B is Figure 4A an assembled view of the connector shown.

[0016] Figure 5 is a perspective view of a fluid delivery system according to several embodiments of the present technology, the fluid delivery system including a fluid infusion device configured to adhere to a user's skin.

[0017] Figure 6 is a graph showing survival curves of fluid delivery systems using different filter materials.

[0018] Figure 7 is a table showing the survival rates of fluid delivery systems using different filter materials. DETAILED DESCRIPTION

[0019] The subject matter described herein relates to certain components, parts, and features of a fluid infusion system configured to treat a medical condition of a patient. The fluid infusion system is used to infuse a fluid medicament into a user's body. 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 medicaments for treating pulmonary hypertension, iron chelating medicaments, pain medications, cancer treatments, drugs, vitamins, hormones, etc., may also be administered through the described fluid infusion system. Additionally, the filters of the present technology can be used with fluid delivery systems other than the fluid delivery systems described herein.

[0020] Figure 1FIG. 0 is a schematic illustration of a fluid delivery system 100 configured to administer a fluid medicament, such as insulin, to a patient. The fluid delivery system 100 includes a reservoir 102 configured to contain and supply the fluid medicament, and a fluid conduit assembly 104 configured to be fluidly coupled to the reservoir 102 and to convey the fluid medicament from the reservoir 102 to the patient along a fluid path 108. The fluid path 108 may terminate at an cannula 107 configured to be implanted within a subcutaneous region of the patient for an extended period of time, such as at least four days. As detailed herein, the fluid conduit assembly 104 may include one structure or a series of structures defining all or a portion of the fluid path 108. In some examples, the fluid conduit assembly 104 may include tubing and one or more connectors (not shown) for fluidly coupling the ends of the tubing to the reservoir 102 and the cannula 107. The fluid delivery system 100 also includes at least one filter 106 disposed at one or more locations along the fluid path 108 (e.g., within a downstream portion of the fluid reservoir 102, along the fluid conduit assembly 104, or both). As described below, the filter 106 is configured to filter out undesirable particles present in the fluid medicament as the fluid medicament flows along the fluid path 108, thereby reducing the likelihood of inflammation at the infusion site and advantageously extending the duration of cannula implantation. The filter 106 is also configured to enable the fluid medicament to effectively pass through the filter 106, thereby providing improved delivery volume accuracy of the fluid medicament.

[0021] The filter 106 includes a porous structure defining a plurality of interconnected pores through which the fluid medicament flows during a fluid delivery operation. The average pore size may be small enough to inhibit the flow of particles such as insulin aggregates, silicone oil, and other foreign substances. The filter 106 may have, for example, an average pore size of from about 0.1 mm to about 5.0 mm, from about 0.3 mm to about 1 mm, or not greater than about 0.5 mm. In some embodiments, the filter 106 may have a smaller pore size, such as from about 1 μm to about 5 μm, or a pore size not greater than about 3 μm. In some embodiments, the filter 106 has a porosity of 50% to 95%, and in some cases 90% to 95%. In some examples, the filter 106 may include a material that expands when contacted with a liquid, such as a foam.

[0022] The filter 106 and / or the porous structure can be formed from one or more materials that have sufficient hydrophilicity to absorb the fluid medicament and swell at a rate that avoids clogging of the fluid path 108 at the location of the filter 106. For example, the filter 106 can have an absorption rate between 0 seconds and 30 seconds, and in some cases between 0 seconds and 5 seconds, or less than 5 seconds. The absorption rate can be measured by placing the unused filter 106 in water and measuring the time it takes for the filter to reach full swelling.

[0023] In some embodiments, the porous structure is formed from a first hydrophilic material that forms the majority of the porous structure and a second or additive hydrophilic material that is more hydrophilic than the first material. The first hydrophilic material can include one or more of polyvinyl alcohol (PVA), polyurethane, polyester, polyether, polyacrylate, nylon, cellulose, cellulose acetate, cellulose nitrate, polyethylene, polyvinyl acetate, polysulfone, polyethersulfone (PES), collagen, polycaprolactone, acrylic copolymers, mixed cellulose esters, polytetrafluoroethylene (PTFE), polycarbonate, and other hydrophilic materials. In some embodiments, the first hydrophilic material includes a polymer having a hydrophobic backbone and hydrophilic functional groups (such as PVA). The hydrophobic backbone can attract silicone oil that may be present in the fluid reservoir. In any case, when combined with the first hydrophilic material, the additive hydrophilic material increases the rate of water absorption and the rate at which the filter swells upon contact with water. Without being bound by theory, it is believed that when the additive hydrophilic material is present, the increased hydrophilicity of the filter 106 improves the ability of the filter to filter out unwanted particles such as insulin aggregates and other particles, thereby improving the in vivo viability of the cannula 107. In addition, the increased wettability of the filter 106 can reduce or eliminate pulsatile flow through the filter 106, which not only increases the fluid delivery volume accuracy but also requires less power from the pumping mechanism of the infusion device.

[0024] In several embodiments, the second hydrophilic material can include glycerol (also known as "glycerin"). In addition to being very hydrophilic, glycerol is naturally present in the human body and is advantageously also present in currently commercially available insulin formulations. The filter 106 can include, for example, from about 0.01 mg to about 50 mg, or from about 1 mg to about 25 mg, or from about 0.01 mg to about 10 mg of glycerol. Experimental data showing an extended wear duration of the transdermal delivery system due to the glycerol additive in the filter are referenced Figure 6 and Figure 7Described in the following embodiments. Other second hydrophilic materials include humectants such as butylene glycol, erythritol, sorbitol, mannitol, etc. In any case, the porous structure may include a ratio of the first hydrophilic material to the second hydrophilic material of about 10:1 to about 1:1, or about 5:1 to about 1:1. As one of several exemplary combinations provided only for the purpose of providing examples, the porous structure may include a ratio of PVA (the first hydrophilic material) to glycerol (the second hydrophilic material) of 10:1 to 1:1 or about 5:1 to 1:1. If the ratio of PVA to glycerol is 1:1 and the glycerol is 0.01 mg, then the PVA will be 0.01 mg; if the ratio of PVA to glycerol is 10:1 and the glycerol is 0.01 mg, then the PVA will be 0.1 mg; if the ratio of PVA to glycerol is 1:1 and the glycerol is 50 mg, then the PVA will be 50 mg; if the ratio of PVA to glycerol is 10:1 and the glycerol is 50 mg, then the PVA will be 500 mg, and so on.

[0025] The filter 106 can have a height measured along the axis of the fluid path, a width measured perpendicular to the height, and a volume. In some cases, the filter 106 can have a height of about 0.05 inches to about 0.2 inches.

[0026] Although Figure 1 A single component is shown as being used as the filter 106, but the fluid delivery system 100 of the present technology can utilize a plurality of physically different elements that together serve as the filter 106. As previously mentioned, the fluid delivery system 100 can include a plurality of filters 106 positioned along the fluid path 108. The filter 106 can be positioned at, for example, one, some, or all of the following locations: within a portion of the reservoir 102; within a conduit extending between the reservoir 102 and the cannula 107; within a connector configured to fluidly couple an upstream end of the conduit to the reservoir 102; within a connector configured to fluidly couple a downstream end of the conduit to the cannula 107. One or more filters 106 can be disposed at any of the aforementioned locations.

[0027] When multiple filters 106 are used, the filters 106 can have the same or different material properties. For example, in some embodiments, the fluid delivery system 100 can include a first filter and a second filter. The first filter can include a first hydrophilic material and a hydrophilic additive (such as glycerol), and have a first pore size and a first height. The second filter can include a hydrophilic additive (such as glycerol) and a second hydrophilic material different from the first hydrophilic material, and have a second pore size smaller than the first pore size and a second height smaller than the first height.

[0028] In some embodiments, the filter 106 is also used to absorb and / or adsorb certain substances, chemicals, or suspended elements in the fluid drug. For example, the filter 106 can comprise a material that is configured or treated to absorb / adsorb lubricating oil or manufacturing oil associated with the manufacture, assembly, or maintenance of one or more components of the fluid delivery system. In this regard, a fluid reservoir for insulin can be manufactured with trace amounts of silicone oil that serves as a lubricant for the plunger of the reservoir. Accordingly, the filter 106 can include a material, layer, or treatment that reduces, traps, or otherwise removes some or all of the silicone oil in the drug fluid as the drug fluid passes through the filter 106.

[0029] In certain embodiments, the filter 106 optionally serves as a drug reservoir during operation of the fluid delivery system. For this purpose, the filter 106 can include a drug, medicament, chemical, or composition that is impregnated therein (or coated thereon, or otherwise carried by the filter 106). When fluid flows through the filter 106 during a fluid delivery operation, an amount of the drug is released into the fluid drug. In fact, unless the filter 106 or the fluid conduit assembly 104 is replaced before depletion, the drug carried by the filter 106 will eventually be depleted. The drug carried by the filter 106 can be selected to address the needs of a particular patient, fluid delivery system, fluid drug, etc. According to the exemplary insulin infusion system described herein, the filter 106 can optionally be impregnated with a drug that treats the infusion site to extend the service life of the fluid infusion set. For example, the filter 106 can be treated with an anticoagulant such as heparin or dextran. As another example, the filter 106 can be impregnated or infused with an anti-proliferative drug such as rapamycin. It should be understood that these examples are neither exhaustive nor limiting, and the filter 106 can be impregnated, treated, or infused with any drug that may be suitable and appropriate for a particular medical condition, fluid delivery system, or application.

[0030] Figure 2 is a plan view of an exemplary embodiment of a fluid delivery system 200 that includes a portable fluid infusion device 202 for the controlled dispensing of a drug fluid and an infusion assembly 204 that is configured to be fluidly coupled to the infusion device 202. The infusion device 202 is configured to be carried or worn by a patient and includes a fluid reservoir 203 (hidden and not visible in Figure 2 ). The fluid reservoir 203 can be removed from or secured to the housing of the infusion device 202. The infusion device 202 can also include a plunger that is slidably disposed within the fluid reservoir, and an associated drive system for moving the plunger to dispense the fluid drug from the fluid reservoir 203 into the infusion assembly 204. The infusion device 202 can also include a power source and one or more electronic components (e.g., a processor, a transmitter, etc.).

[0031] As Figure 2 shown, the infusion assembly 204 includes a tube 210, an infusion unit 212 fluidly coupled to the distal (i.e., downstream) end of the tube 210, and a connector 214 configured to be fluidly coupled to the proximal (i.e., upstream) end of the tube 210. The infusion unit 212 is configured to temporarily adhere to a patient's body (e.g., via an adhesive patch) and includes a cannula (not shown) configured to be implanted within a subcutaneous region of the patient for an extended period of time (e.g., more than four days). The connector 214 mates with and is coupled to a portion of the fluid reservoir 203 and / or the infusion device housing, thereby forming a fluid path from the fluid reservoir 203 to the tube 210 and securing the infusion assembly 204 to the infusion device 202. Thereafter, actuation of the drive system of the fluid infusion device 202 causes fluid medication to be expelled from the fluid reservoir 203, through the connector 214, through the tube 210, and into the patient's body via the cannula of the infusion unit 212.

[0032] According to some examples, the connector 214 includes a removable reservoir cap and / or fitting sized and configured to accommodate replacement of the fluid reservoir (which is typically disposable) as needed. Figure 3A And Figure 3B show an exploded view and an assembled view of the connector 214, respectively. As Figure 3A and Figure 3B shown, the connector 214 includes a body 220 that includes a distal (upstream) portion 220a and a proximal (downstream) portion 220b, the distal (upstream) portion being configured to receive a mating portion of the fluid reservoir 203 (e.g., via threaded engagement, snap fit, tabs, etc.), the proximal (downstream) portion defining a passage 228 and being configured to receive the upstream end of the tube 210. The connector 214 may also include a coupling element 224, a needle 222, and a filter 206, the coupling element being configured to be received within the passage 228, the needle having an upstream end configured to penetrate a septum of the fluid reservoir 203. The filter 206 is positioned within the passage 228, where a first filter 206a and a second filter 206b are upstream of a third filter 206c. The filter 206 may include a porous structure formed from a hydrophilic material (such as any of the hydrophilic materials disclosed herein) and a hydrophilic additive (such as glycerol), as detailed above.

[0033] As Figure 3BAs best shown in, the needle 222 can be fixed within the body 220 such that the upstream end of the needle 222 is positioned within the internal cavity of the lower portion 220a, and the downstream end of the needle 222 is positioned within the channel 228, upstream of or aligned with the upstream end of the filter 206. During fluid delivery operations, the fluid drug is forced out of the fluid reservoir 203, into the hollow needle 222, then through the first filter 206, and then flows into the upstream end of the tube 210 that is coupled to the upper portion 220b of the body 220.

[0034] Figure 4A is an exploded view of another connector 314 for use with the fluid delivery system of the present technology, and Figure 4B is Figure 4A the assembled view of the connector shown. As Figure 4A and Figure 4B shown, the connector 314 includes a body 220 that includes a lower (upstream) portion 220a and an upper (downstream) portion 220b. The lower (upstream) portion is configured to receive a mating portion of the fluid reservoir 203 (e.g., via threaded engagement, snap fit, tabs, etc.). The upper (downstream) portion defines a channel 228 and is configured to receive the upstream end of the conduit 210. The connector 214 may also include a coupling element 224, a needle 222, and a filter 206. The coupling element is configured to be received within the channel 228. The needle has an upstream end configured to penetrate the septum of the fluid reservoir 203. The filter includes a first filter 206a, a second filter 206b, and a third filter 206c. The filter 206 is positioned within the channel 228, where the first filter 206a and the second filter 206b are located upstream of the third filter 206c. As Figure 4A visible in, the height and volume of each of the first filter 206a and the second filter 206b are greater than the height and volume of the third filter 206c. The first filter 206a and the second filter 206b may include a porous structure formed of a first hydrophilic material having a first pore size, and the third filter 206c may include a porous structure formed of a second hydrophilic material different from the first hydrophilic material and having a pore size smaller than the pore sizes of the first filter 206b and the second filter 206c. One, some, or all of the first filter 206a, the second filter 206b, and the third filter 206c may contain hydrophilic additives such as glycerin, as detailed above.

[0035] As Figure 4BAs best shown in , the needle 222 can be fixed within the body 220 such that the upstream end of the needle 222 is positioned within the internal cavity of the lower portion 220a, and the downstream end of the needle 222 is positioned within the channel 228, upstream of or aligned with the upstream end of the first filter 206a. During fluid delivery operations, the fluid drug is forced out of the fluid reservoir 203, into the hollow needle 222, and then successively through the first filter 206a, the second filter 206b, and the third filter 206c, after which it flows into the upstream end of the conduit 210 that is coupled to the upper portion 220b of the body 220.

[0036] Figure 5 FIG. 4 is a perspective view of another embodiment of a fluid delivery system 500 that includes a fluid infusion device 502 that is configured to adhere to a user's skin (e.g., via an adhesive patch) and deliver a fluid drug to the user via a cannula 507 associated with the infusion device 502. The fluid infusion device 502 also includes: a fluid reservoir 503 (hidden and not visible in Figure 5 ), a plunger slidably disposed within the fluid reservoir 503, a drive system for moving the plunger to dispense the fluid drug from the fluid reservoir 503 into the cannula 507, a power source, one or more electronic components (e.g., a processor, a transmitter, etc.), and an insertion device for inserting the cannula 507 into the patient's body. All of the foregoing components may be partially or fully housed within the housing 404.

[0037] The infusion device 502 may also include one or more filters of the present technology (not visible) disposed at one or more locations along the fluid flow path. For example, the infusion device 502 may include a filter positioned within the reservoir and / or within the internal structure of the infusion device 502 to define the portion of the fluid path between the fluid reservoir 503 and the cannula 507. Other locations are possible. The filters included within the infusion device 502 may include hydrophilic additives such as glycerol detailed above.

[0038] Embodiment

[0039] The present technology is further illustrated by the following non-limiting examples.

[0040] The inventors conducted animal studies to evaluate the performance of different filters within the reservoir-to-tube connector (or “RT connector”) of fluid delivery systems such as the tethered delivery system Figure 2 shown above. Each of the fluid delivery systems being tested was placed on the abdomen of a pig, with the cannula of the system inserted into the subcutaneous space of the pig. The delivery systems were operated continuously to deliver insulin (via a Medtronic MiniMed TMThe 770G pump was run until system failure or for 1 week (≥7 days). The dosing regimen included adjusting the basal / bolus rate to control blood glucose (BG) within the range of 100 mg / dL - 400 mg / dL. The time to system failure was determined based on: (1) the BG level did not decrease by at least 50 mg / dL one hour after a corrective bolus for BG > 400 mg / dL in pigs (in humans, this limit is typically set at 250 mg / dL - 300 mg / dL), or (2) signs of infection at the infusion site. The cause of each delivery system failure was analyzed, and these causes included pump / fluid path blockage due to catheter kinking, other mechanical problems, accidental device separation / removal due to animal rubbing / other movement, or infusion site loss due to a decreasing insulin absorption rate over time.

[0041] The control group used in this study utilized an RT connector, where the PVA filter had been die-cut to a certain size. The control filter did not contain a glycerol additive.

[0042] This study included two test products, each of which included a modified form of the control group product. The first group of test products utilized the same RT connector as the control connector, but was modified to include a PVA filter that had been laser-cut to a certain size. The first test group did not contain a glycerol additive. The second group of test products utilized the same RT connector as the control connector, but was modified to include a PVA filter that had been laser-cut to a certain size and contained a glycerol additive.

[0043] After installing the RT connector in the control group and the two RT connectors in the test groups on pigs, they were fluidly connected to the same pump model (Medtronic MiniMed TM 770G pump).

[0044] Kaplan-Meier curves using log-rank statistics were used to evaluate the survival rates of the control delivery system and the test delivery systems. The survival rates of the delivery systems that failed due to various reasons (including site loss, mechanical problems, or accidental catheter removal) are shown in Figure 6 .

[0045] The summary results of the survival rates of the control group and the first and second test groups are shown in Figure 7 . The 7-day survival rate of the first test group (laser-cut, without glycerol) was 55%, and trended lower than the 7-day survival rate of the second test group (laser-cut, with glycerol) (82%) and the 7-day survival rate of the control (die-cut, without glycerol) (78%). Thus, between the test products that were laser-cut, adding glycerol to the filter improved the survival rate.

[0046] Conclusion

[0047] Certain other embodiments of the present technology may have configurations, components, or procedures different from those described herein. Accordingly, those of ordinary skill in the art should understand that the present technology may have other embodiments with additional elements, or the present technology may have other embodiments without some of the features shown and described above with reference to Figures 1 to 7 illustrated and described.

[0048] 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 respectively include the plural term or the singular term. While specific embodiments and examples of the present technology have been described above for illustrative purposes, those skilled in the relevant art should 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 execute the steps in a different order. The various embodiments described herein can also be combined to provide additional embodiments.

[0049] 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 those of ordinary skill in the art.

[0050] In addition, 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 the 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 the 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 are required to exhibit such advantages to fall within the scope of the present technology. Accordingly, the present disclosure and the associated technology may cover other embodiments not expressly shown or described herein.

Claims

1. A system for delivering a fluid drug to a patient at an infusion site, the system comprising: A fluid conduit configured to deliver the fluid drug along at least a portion of a fluid path extending between a reservoir containing the fluid drug and a cannula subcutaneously inserted into the patient at the infusion site; And A filter disposed within the fluid conduit and configured to trap particles formed in the fluid drug, wherein the filter comprises a porous structure containing glycerol.

2. The system according to claim 1, wherein the fluid drug is insulin, and wherein the filter is configured to trap insulin aggregates formed in the insulin.

3. The system according to claim 1 or claim 2, wherein the system is configured to infuse the fluid drug into the patient at the infusion site over a period of greater than four days.

4. The system according to any one of claims 1 to 3, wherein the porous structure comprises polyvinyl alcohol, cellulose, polyurethane, polyester, polyether or collagen.

5. The system according to any one of claims 1 to 4, wherein the porous structure has an average pore size of from about 0.1 mm to about 0.5 mm.

6. The system according to any one of claims 1 to 5, wherein the porous structure comprises at least one of: an acrylic copolymer membrane, a polyethersulfone membrane, a mixed cellulose ester membrane, a cellulose acetate membrane, a cellulose nitrate membrane, a nylon membrane, a hydrophilic polytetrafluoroethylene (PTFE) membrane, and / or a polycarbonate membrane.

7. The system according to any one of claims 1 to 6, wherein the porous structure has an average pore size of from about 0.1 μm to about 10 μm.

8. The system according to any one of claims 1 to 7, wherein the fluid conduit comprises a tube and a connector configured to fluidly couple the tube to the reservoir, and wherein the filter is disposed within the connector.

9. The system according to any one of claims 1 to 8, wherein the filter is a first filter, and wherein the system comprises a second filter disposed within the fluid conduit.

10. A system for delivering a fluid drug to a patient at an infusion site, the system comprising: A fluid conduit having a first end configured to be fluidly coupled to a reservoir containing the fluid drug and a second end configured to be fluidly coupled to a cannula, wherein the fluid conduit is configured to deliver the fluid drug from the reservoir to the patient through the cannula; A connector configured to fluidly couple the first end of the fluid conduit to the reservoir; And A filter disposed within the connector and configured to trap particles formed in the fluid drug, the filter comprising a porous structure containing glycerol.

11. The system according to claim 10, wherein the fluid drug is insulin, and wherein the filter is configured to trap insulin aggregates formed in the insulin.

12. The system according to claim 10 or claim 11, wherein the system is configured to infuse the fluid drug at the infusion site into the patient over a period of time greater than four days.

13. The system according to any one of claims 10 to 12, wherein the porous structure comprises polyvinyl alcohol, cellulose, polyurethane, polyester, polyether or collagen.

14. The system according to any one of claims 10 to 13, wherein the porous structure has an average pore diameter of from about 0.1 mm to about 0.5 mm.

15. The system according to any one of claims 10 to 14, wherein the porous structure comprises at least one of the following: 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.

16. The system according to any one of claims 10 to 15, wherein the porous structure has an average pore diameter of from about 0.1 μm to about 10 μm.

17. The system according to any one of claims 10 to 16, wherein the fluid conduit comprises a tube.

18. The system according to any one of claims 10 to 17, wherein the filter is a first filter, and wherein the system comprises a second filter disposed within the fluid conduit.

19. A system for delivering a fluid drug to a patient at an infusion site, the system comprising: an infusion pump; a reservoir configured to store the fluid drug, the reservoir configured to be received by the infusion pump; a cannula configured for subcutaneous insertion into the tissue of the patient at the infusion site; a fluid conduit having a first end configured to be fluidly coupled to the reservoir and a second end configured to be fluidly coupled to the cannula, wherein the fluid conduit is configured to transport the fluid drug from the reservoir to the patient; and a connector configured to fluidly couple the first end of the fluid conduit to the reservoir; and one or more filters disposed in at least one of the reservoir, the fluid conduit, or the connector, wherein each filter of the one or more filters is configured to trap particles formed in the fluid drug, and wherein the filter comprises a porous structure comprising glycerol.

20. The system according to claim 19, wherein the fluid drug is insulin, and wherein the filter is configured to trap insulin aggregates formed in the insulin.

21. A system for delivering a fluid drug to a patient at an infusion site, the system comprising: a fluid conduit having a first end configured to be fluidly coupled to a reservoir containing the fluid drug and a second end configured to be fluidly coupled to a cannula, wherein the fluid conduit is configured to transport the fluid drug from the reservoir to the patient through the cannula; A connector configured to fluidly couple the first end of the fluid conduit to the reservoir; and A filter disposed within the connector and configured to trap particles formed in the fluid medicament, the filter including a porous structure having an absorption rate between 0 seconds and 30 seconds.

22. A system for delivering a fluid medicament to a patient at an infusion site, the system comprising: A fluid conduit configured to transport the fluid medicament along at least a portion of a fluid path extending between a reservoir containing the fluid medicament and a cannula subcutaneously inserted into the patient at the infusion site; and A filter disposed within the fluid conduit and configured to trap particles formed in the fluid medicament, wherein the filter includes a porous structure having an absorption rate between 0 seconds and 30 seconds.

23. A system for delivering a fluid medicament to a patient at an infusion site, the system comprising: An infusion pump; A reservoir configured to store the fluid medicament, the reservoir being configured to be received by the infusion pump; A cannula configured for subcutaneous insertion into the tissue of the patient at the infusion site; A fluid conduit having a first end configured to be fluidly coupled to the reservoir and a second end configured to be fluidly coupled to the cannula, wherein the fluid conduit is configured to transport the fluid medicament from the reservoir to the patient; and A connector configured to fluidly couple the first end of the fluid conduit to the reservoir; and One or more filters disposed in at least one of the reservoir, the fluid conduit, or the connector, wherein each of the filters is configured to trap particles formed in the fluid medicament, and wherein the filter includes a porous structure having an absorption rate between 0 seconds and 30 seconds.

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