Channel system for placing performance-enhancing and long-lasting materials in medical devices

Abstract

A medical device configured to deliver fluid to a patient includes a base having a base body and a hollow cannula for insertion into the patient, the hollow cannula being fixed to the base or movable relative to the base to a patient insertion position. The base body includes a fluid passageway that is in fluid connection or is capable of being in fluid connection with the hollow cannula. The fluid passageway includes a passageway portion sealed with a seal, the passageway portion including a sorbent configured to modify fluid passing through the passageway portion by removing one or more compounds or substances from the fluid prior to delivery of the fluid to the patient through the hollow cannula.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 018401, filed April 30, 2020, with the United States Patent and Trademark Office, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This invention generally relates to a medical device for delivering a fluid to a patient and filtering or removing selected compounds from the fluid prior to delivery to the patient. The medical device includes an adsorbent material disposed within the device to remove selected compounds from the fluid prior to delivery to the patient. In one embodiment, the medical device is adapted to deliver a controlled dose of an insulin formulation, wherein the device is associated with an adsorbent for removing stabilizers and / or selected compounds from the insulin formulation prior to delivery to the patient. Background Technology

[0004] Insulin and other injectable drugs are typically delivered with patch syringes and infusion kits.

[0005] Drugs and pharmaceuticals often contain preservatives and / or stabilizers to extend their shelf life. For example, insulin typically contains phenol and / or m-cresol as stabilizers. These stabilizers can often cause side effects such as irritation, inflammation, scarring, and lipotrophy at the injection site.

[0006] The existing infusion kit is disclosed in PCT application PCT / US2019 / 028248, filed on June 28, 2019, the entire contents of which are incorporated herein by reference.

[0007] Although existing devices are suitable for their intended use, the industry still needs to continuously improve medical devices to reduce irritation and inflammation at the injection site. Summary of the Invention

[0008] Therefore, one aspect of the present invention is to provide a medical device for reducing irritation and inflammation at the injection site.

[0009] The above and / or other aspects of the present invention are achieved by providing a medical device configured to deliver fluid to a patient. The medical device includes a base having a base body and a hollow cannula for insertion into a patient, the hollow cannula being fixed to the base body or movable relative to the base body to a patient insertion position. The base body includes a fluid passage that is fluidly connected to or capable of being fluidly connected to the hollow cannula. The fluid passage includes a passage portion sealed with a sealant, the passage portion including an adsorbent configured to modify the fluid passing through the passage portion by removing one or more compounds or substances from the fluid prior to delivery of the fluid to the patient via the hollow cannula.

[0010] The foregoing and / or other aspects of the present invention are further achieved by providing a medical device comprising a base having a hollow cannula for insertion into a patient and a base body attached to the hollow cannula. The device also includes a fluid connector connectable to the base. The device further includes a pump connector connectable to a pump. Each of the base body, fluid connector, pump connector, and cannula has a fluid passage therethrough. Each fluid passage is fluidly connectable. The fluid passage of at least one of the base body, fluid connector, and pump connector includes a passage portion sealed with a seal; and the passage portion includes an adsorbent configured to modify the fluid passing through the passage portion by removing one or more compounds or substances from the fluid prior to delivery to the patient.

[0011] The foregoing and / or other aspects of the present invention are also achieved by providing a method of manufacturing a medical device. The method includes providing at least one of a patch injector, a base, a fluid connector, and a pump connector, said at least one including a groove recessed from a surface of said at least one of the patch injector, the base, the fluid connector, and the pump connector. The method further includes providing an adsorbent in the groove and sealing the groove with a seal to form at least a portion of a fluid path through said at least one of the patch injector, the base, the fluid connector, and the pump connector.

[0012] Further and / or other aspects and advantages of the invention will be set forth in the description which follows, or will become apparent from the description, or may be learned by practice of the invention. Attached Figure Description

[0013] The above and / or other aspects and advantages of embodiments of the invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, wherein:

[0014] Figure 1 An infusion kit according to an embodiment of the present invention is shown;

[0015] Figure 2 yes Figure 1 Exploded view of the fluid connector of the infusion kit;

[0016] Figure 3 yes Figure 2 A perspective view of the fluid connector in its assembled state;

[0017] Figure 4 yes Figure 2 A plan view of the fluid path section of the fluid connector;

[0018] Figure 5 yes Figure 2 A cross-sectional view of the fluid connector;

[0019] Figure 6 Is with Figure 2 base connection Figure 2 Cross-sectional view of the fluid connector

[0020] Figure 7 This is a cross-sectional view of the base according to an embodiment of the present invention;

[0021] Figure 8 yes Figure 7 The amplified portion of the base;

[0022] Figure 9 This is an enlarged cross-sectional view of the base 108 according to another embodiment of the present invention;

[0023] Figure 10 This is a cross-sectional view of a pump connector according to an embodiment of the present invention;

[0024] Figure 11 This is a perspective view of a patch syringe according to another embodiment of the present invention;

[0025] Figure 12 yes Figure 11 A partial perspective view of the patch syringe, in which the seal has been removed for illustration; and

[0026] Figure 13 This is a flowchart of a method according to an embodiment of the present invention. Detailed Implementation

[0027] Reference will now be made in detail to embodiments of the invention illustrated in the accompanying drawings, wherein similar reference numerals denote similar elements. The embodiments described herein are illustrated with reference to the accompanying drawings but do not limit the invention.

[0028] The embodiments are not intended to be mutually exclusive, such that features of one embodiment can be combined with other embodiments, as long as they do not contradict each other.

[0029] Those skilled in the art will understand that this disclosure, in its application, is not limited to the details of the construction and arrangement of the components illustrated in the following description or the accompanying drawings. The embodiments described herein can be other embodiments and can be practiced or performed in various ways. The phrases and terms used herein are for descriptive purposes only and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof, herein is intended to include items listed below and their equivalents, as well as additional items.

[0030] Unless otherwise limited, the terms “connection,” “link,” and “installation,” and their variations thereof, used herein, are used in a broad sense to include direct and indirect connections, links, and installations. Furthermore, the terms “connection” and “link,” and their variations thereof, are not limited to physical or mechanical connections or links. Additionally, terms such as “upper,” “lower,” “bottom,” “top,” “front,” “rear,” “upper,” “lower,” “upward,” and “downward,” as well as other directional descriptors, are intended to facilitate the description of exemplary embodiments of the invention and are not intended to limit the structure of exemplary embodiments of the invention to any particular location or orientation. Degree terms such as “substantially” or “approximately” are understood by those skilled in the art to refer to a reasonable range around a given value and include both the given value and ranges beyond it, such as general tolerances associated with the manufacture, assembly, and use of the embodiments. When referring to a structure or feature, the term “substantially” includes most or all of the feature.

[0031] Embodiments of the present invention relate to a medical device or medical delivery device and a method of manufacturing the medical device, the medical device receiving or carrying a fluid, such as insulin, a drug, or a medicine, for delivery to a patient, removing one or more compounds or substances from the insulin, drug, or medicine, and then delivering the modified fluid to the patient.

[0032] This medical device is particularly suitable for delivering insulin containing stabilizers or preservatives, such that at least a portion of the stabilizer or preservative is removed from the insulin before the modified insulin is delivered to the patient. The medical device for introducing insulin formulations into a patient is used in conjunction with an adsorbent material that contacts the insulin formulation before the insulin formulation is introduced into the patient.

[0033] Medical devices can deliver fluids (e.g., insulin) to a patient via bolus flow and / or basal delivery. In one embodiment, the drug is an insulin formulation or solution that is delivered to the patient at the injection or infusion site in a selected and controlled dose.

[0034] Insulin preparations are typically solutions containing preservatives and stabilizers to extend the shelf life of the insulin solution until it is ready for use. In one embodiment, the stabilizer is phenol, m-cresol, or mixtures thereof. Most people with type 1 diabetes and a portion of people with type 2 diabetes manage their condition by injecting insulin multiple times a day. Daily injections can cause side effects, including irritation, inflammation, scarring, lipomatosis, and subcutaneous fat accumulation at the insulin injection or infusion site. The presence of phenol and m-cresol in insulin preparations is effective as antibacterial agents and for stabilizing the insulin preparation. However, when insulin is repeatedly or continuously injected at the injection or infusion site, the presence of phenol and m-cresol in the insulin can cause inflammation and irritation in patients, and can reduce insulin absorption at that site and decrease the persistence of insulin delivery.

[0035] Phenolic excipients m-cresol and phenol, which act as antibacterial and stabilizing factors in insulin analogs, are cytotoxic in in vitro systems and can cause adverse tissue reactions when delivered locally at formulation concentrations. Adverse tissue reactions lead to elevated levels of pro-inflammatory cytokines and altered subcutaneous insulin pharmacokinetics. Adverse reactions are typically dose-dependent, thus the pharmacokinetic changes relative to the initial values ​​become increasingly significant with the delivery of more excipients (e.g., excipients in the insulin infusion device). Trial data suggest that excipient-induced inflammation models negatively impact insulin administration and absorption pathways. This can lead to problems with inadequate adherence.

[0036] A feature of the medical device of the present invention is the selective removal of phenolic excipients from insulin formulations without interfering with the effectiveness of insulin delivery to the patient. Experiments using activated charcoal as an adsorbent have shown that phenol and m-cresol can be effectively removed from insulin formulations while maintaining the efflux insulin at formulation concentrations. The resulting treated insulin with reduced phenolic excipient concentrations is delivered to the patient for a period of time during which insulin denaturation or loss of potency occurs substantially. In one embodiment, the adsorbent is selected to remove only the phenolic excipients.

[0037] The adsorbent can be used with medical devices to remove at least a portion of the stabilizer, particularly to remove at least a portion of the phenolic stabilizer from the insulin formulation before it is introduced into the patient.

[0038] In one embodiment, the adsorbent is activated carbon, which may be granular, extruded, or powdered, to provide a contact surface area sufficient to remove a selected amount of phenolic stabilizer to suppress inflammation at the delivery site without denaturing or deactivating the insulin upon delivery to the patient. In the description of this apparatus and method, the terms activated carbon and activated charcoal are used interchangeably. Acid-treated activated carbon (e.g., phosphoric acid activated carbon) is particularly suitable for removing phenol and m-cresol from insulin formulations. In one embodiment, the activated carbon is a chemically activated carbon obtained by treatment with phosphoric acid. Activation can be carried out with phosphoric acid, such as phosphoric acid at pH 6.7. However, those skilled in the art will understand that other pH levels may be used. Commercially available phosphoric acid-treated activated carbon can be used to remove phenol and m-cresol from insulin formulations. Examples of commercially available acid-treated activated carbon are available from Cabot Corporation under the trade name CN5-20. Activated carbon has a surface area that provides sufficient contact with insulin to remove an amount of phenolic compounds sufficient to minimize irritation and inflammation at the injection site.

[0039] Activated carbon can be obtained from a variety of carbon sources, including, for example, wood, coconut shells, olive pits, peat, lignite, coal, or other suitable carbon sources. In one embodiment, activation is carried out by chemical activation with phosphoric acid to provide beneficial porosity, pore volume, surface area, surface chemistry, and pore size distribution. Activated carbon typically has a porosity greater than 1000 m³ / s. 2 The surface area per g. The pore volume of activated carbon can be approximately 0.26-1.16 cm³. 3 / g, typically approximately 0.40-0.70cm 3 / g. In other embodiments, the activated carbon may have 1500m 2 / g or greater surface area. In another embodiment, the activated carbon can have a surface area greater than 2300m². 2 / g surface area, and in some cases, depending on the activation method, the surface area of ​​activated carbon can be greater than 3000m². 2 / g.

[0040] The amount of adsorbent present is sufficient to provide contact time with the insulin formulation, sufficient to remove the desired amount of phenol, m-cresol, or other stabilizers contained in the insulin formulation to reduce irritation and inflammation at the injection site without denaturation or reduced insulin efficacy. The adsorbent is located in the flow path of the insulin formulation, as close as possible to the injection component or delivery site to limit the degradation of the insulin formulation before it is introduced into the patient.

[0041] The amount of activated charcoal in the component is complemented by the insulin dose and flow rate (which depends on delivery via a minimum flow or bolus flow) to provide the desired phenolic stabilizer adsorption rate. In one embodiment, at the minimum flow rate, the amount of adsorbent provides approximately 95% removal of m-cresol after 4 days and approximately 60% removal after 7 days.

[0042] Figure 1 An infusion kit 100 according to an embodiment of the present invention is shown. As shown, the infusion kit 100 includes a fluid connector 102 connected to a conduit 104, which is also connected to a pump connector 106 for connection to a pump. The infusion kit 100 also includes a base 108, which includes a base body 109 and a hollow cannula 111 for insertion into a patient's body. Figure 7 (Clearly visible in the image). The fluid connector 102 can be connected to the top of the base 108, as shown below. Figure 6 As shown. Each of the base body 109, fluid connector 102, pump connector 106, and pipe 104 has a fluid passage passing through it.

[0043] According to one embodiment, the fluid connector 102 is a two-part fluid connector 102. For example... Figure 2 As shown, the fluid connector 102 includes two components: a fluid path portion 110 and a latch portion 112. The latch portion 112 includes an actuating rod 114, a fluid connector latch 116, and a rigid stop 118.

[0044] According to one embodiment, the actuating rod 114, the fluid connector latch 116, and the rigid stop 118 are integrally formed as a single structure. Furthermore, the actuating rod 114 and its respective fluid connector latch 116 form arms. These arms are displaceable relative to the fluid path portion 110. The fluid connector latch 116 can be displaced to a latched position where at least a portion of the fluid connector latch 116 at the base 108 is located within the fluid path portion 110 (see...). Figure 6 In addition, the arm is elastically biased toward the latch position.

[0045] The fluid path portion 110 includes a pipe connector portion 120 for connecting the fluid connector 102 to the pipe 104. The fluid path portion 120 can be secured to the latch portion 112 via a snap-fit ​​engagement, and according to one embodiment, the fluid path portion 112 and the latch portion 112 can be made of the same material. Although an exemplary embodiment of a two-piece fluid connector has been shown, those skilled in the art will understand that a single-piece fluid connector or a fluid connector made of more than two pieces can be used without departing from the scope of the invention.

[0046] Figure 4This is a plan view of the fluid path portion 110 according to an embodiment of the present invention (the latch portion is omitted for clarity). Figure 5 This is a cross-sectional view of a fluid connector 102 according to an embodiment of the present invention. Figure 4 and Figure 5 As shown, the fluid passage of the fluid path portion 110 of the fluid connector 102 includes a passage portion 150 and a seal 154. The passage portion includes a recess 152 recessed in the top inner ceiling or dome portion or the top inner dome portion of the fluid path portion 110. The seal is, for example, a pressure-sensitive adhesive or a diaphragm or film 154 that covers and fluid-seales the recess 152 to form the passage portion or fluid connector passage portion 150. Those skilled in the art will understand that other seals can be used, such as molded parts ultrasonically or chemically welded to the recess 152. For simplicity, a film is used as the seal in the description of this embodiment and other embodiments. According to one embodiment, the film 154 is a pressure-sensitive adhesive or film 154, such as a polyester film, which can fluid-seal the recessed groove 152.

[0047] Preferably, the adsorbent (e.g., activated carbon adsorbent) is placed in the groove 152 before the groove 152 is sealed with the film 154. Figure 4 As clearly shown, groove 152 is a tortuous path. Groove 152 is configured such that the insulin formulation passing through the adsorbent has sufficient residence time in the pathway portion 150 to remove the phenolic stabilizer from the insulin formulation before delivery to the patient, and substantially no denaturation or loss of efficacy of the insulin formulation before delivery to the patient. Those skilled in the art will understand that other shapes and lengths of groove 152 may be employed without departing from the scope of the invention. The aim is to provide sufficient contact with the adsorbent to remove a sufficient amount of irritating stabilizer without causing loss of insulin formulation efficacy.

[0048] like Figure 6 As shown, when the fluid connector 102 is connected to the base 108, a blunt sleeve 156 suspended from the top of the dome portion of the fluid connector 102 passes through the diaphragm 158 of the base 108 to connect the fluid passage of the fluid connector 102 to the fluid passage of the base 108.

[0049] Figure 7 This is a cross-sectional view of the base 108 according to another embodiment of the present invention. Figure 8 yes Figure 7 The magnified portion. For example... Figure 7 and Figure 8As shown, the hollow cannula 111 is suspended at the distal portion of the base body 109. The base body 109 includes a proximal sealing member 158 that fluidly seals the proximal end of the column portion 160 of the base body 109. According to one embodiment, the proximal sealing member 158 is a diaphragm 158, but other sealing members may be used without departing from the scope of the invention. The base body 109 also includes an intermediate sealing member 162 that fluidly seals the intermediate portion of the column portion 160 and forms a first chamber 164 located between the proximal sealing member 158 and the intermediate sealing member 162, and a second chamber 166 located between the intermediate sealing member 164 and the proximal portion of the hollow cannula 111. According to one embodiment, the intermediate sealing member 162 is a diaphragm 162, but other sealing members may be used without departing from the scope of the invention.

[0050] The first chamber 164 includes a first end port 170, and the second chamber 166 has a second end port 172. The first end port 170 and the second end port 172 are connected by a recess 174 in the inner wall of the column portion 160, which is covered by a seal 176 (e.g., a membrane 176). Preferably, an adsorbent (e.g., activated carbon adsorbent) is placed in the recess 174 before sealing the recess 174 with the membrane 176.

[0051] The seal 176 is preferably a pressure-sensitive adhesive or a film 176, such as a polyester film, which fluidly seals the recessed groove 174. According to one embodiment, the recessed groove 174 is a spiral groove 174. Those skilled in the art will understand that, without departing from the scope of the invention, multiple end ports and connecting grooves, a pair of end ports having multiple connecting grooves, or multiple end ports each having multiple connecting grooves may be provided within the column portion. However, for clarity, only a set of end ports with a single connecting groove is shown in the illustrated embodiment.

[0052] Figure 9 This is an enlarged cross-sectional view of the base 108 according to another embodiment of the present invention. Similar to the previous embodiment, as... Figure 9 As shown, the base body 109 includes a proximal sealing member 158 at the proximal end of the column portion 160 of the fluid-sealed base body 109. The base body 109 also includes an intermediate sealing member 162, which fluid-seales the middle portion of the column portion 160 and forms a first chamber 164 located between the proximal sealing member 158 and the intermediate sealing member 160, and a second chamber 166 located between the intermediate sealing member 164 and the proximal portion of the hollow cannula 111.

[0053] The first chamber 164 includes a first end port 180, and the second chamber 166 has a second end port 182. The first end port 180 and the second end port 182 are connected by a recess 184 in the inner wall of the column portion 160, which is covered by a seal 186 (e.g., a membrane 186). Thus, the recess 1840 fluidly connects the first chamber 164 and the second chamber 166. Preferably, an adsorbent (e.g., activated carbon adsorbent) is placed in the recess 184 before sealing it with the membrane 186.

[0054] The seal 186 is preferably a pressure-sensitive adhesive or a film 186, such as a polyester film, which can fluidly seal the recessed groove 184. According to one embodiment, the recessed groove 184 is a linear groove 184. Although in Figure 9 Multiple linear grooves 184 are depicted, but those skilled in the art will understand that a single linear groove 184 may be used without departing from the scope of the invention. Furthermore, those skilled in the art will understand that the groove 184 need not be linear, and it may have other shapes without departing from the scope of the invention. For example, the groove 184 may have a curved shape and / or a zigzag shape, or it may be a wandering path without geometric shape.

[0055] Figure 10 This is a cross-sectional view of a pump connector 190 according to an embodiment of the present invention. The connector 190 includes a body 192 having an intermediate sealing member 194, a proximal sealing member 196, and a connector pin 198 suspended proximally from the proximal sealing member 196 for fluid communication with a pump. The connector pin 198 is in fluid connection with a first chamber 200 disposed between the intermediate sealing member 194 and the proximal sealing member 196. The connector 190 also has a second chamber 202 disposed distal to the intermediate sealing member 194 (facing the patient). The second chamber 202 is in fluid connection with a conduit port 204 for connection to a conduit of a drug delivery device.

[0056] The connector 190 also includes a first end port 206 disposed in a first chamber 200, a second end port 208 disposed in a second chamber 202, and a recessed groove 210 connecting the first end port 206 and the second end port 208. The recessed groove 210 fluidly connects the first chamber 200 and the second chamber 202. The recessed groove 210 is recessed from the inner wall of the connector 190 and is covered by a seal 212 (e.g., a membrane 212). Preferably, an adsorbent (e.g., activated carbon adsorbent) is placed in the groove 210 before sealing the groove 210 with the membrane 212. The membrane 212 is preferably a pressure-sensitive adhesive or a film 212, such as a polyester film, which can fluidly seal the recessed groove 210.

[0057] According to one embodiment, the recessed groove 210 is linear. According to another embodiment, the recessed groove 210 is helical. Figure 10 In another embodiment shown, the recessed groove 210 is a travel path without a specific geometry. Such a path is advantageous for increasing the residence time of the drug within the recessed groove 210.

[0058] although Figure 10 Only a pair of end ports 206, 208 and a recessed groove 210 are depicted in the figure. However, those skilled in the art will understand that, without departing from the scope of the invention, multiple end ports and multiple connection grooves, or a pair of connectors having multiple connection grooves, or multiple end ports each having multiple connection grooves, can be provided in the connector of the present invention.

[0059] Figure 11 This is a bottom perspective view of a patch injector 300 according to another embodiment of the present invention. The patch injector 300 includes a cap 302 and a base 304 having a base body 306 and a hollow cannula 308 for insertion into a patient. According to one embodiment, the hollow cannula 308 is rigid and sharp. According to another embodiment, the hollow cannula 308 is flexible, and the patch injector 300 further includes a sharp insertion needle for inserting the hollow cannula 306 into a patient. According to one embodiment, the hollow cannula 308 is fixed relative to the base body 306. However, preferably, the hollow cannula 308 is movable relative to the base body 308 from a withdrawn position to a patient insertion position, in which the hollow cannula 308 does not extend distally beyond the base body 306, and in the patient insertion position, the hollow cannula 308 extends distally beyond the base body 306, such as... Figure 11 and Figure 12 As shown.

[0060] According to one embodiment, the patch injector 300 includes a reservoir for holding fluid (e.g., insulin). The patch injector 300 includes a fluid passage connecting the reservoir to a hollow cannula 308. According to one embodiment, a base body 306 includes one or more recesses 310, 312 recessed from a surface of the base body 306, and a seal 314 (e.g., a film 314) seals the recesses 310 and 312, thereby forming a passage portion of the fluid passage. The manufacturer preferably provides an adsorbent (e.g., activated carbon adsorbent) in the recesses 310, 312 before sealing them with the seal 314 (e.g., the film 314).

[0061] The seal 314 is preferably a pressure-sensitive adhesive film 314, such as Mylar, which can fluidly seal the recess or multiple recesses 310, 312.

[0062] Figure 12 Thin film 314 is omitted to better illustrate grooves 310 and 312. According to... Figure 11 and Figure 12 In one embodiment shown, the groove is recessed from the distal surface of the base body 306 towards the proximal surface. In such an embodiment, because the passage portion is located on the exterior of the cover 302, the fluid passage flows from the interior to the exterior, and... Figure 11 and Figure 12 In one embodiment, the fluid pathway returns to the interior of the patch injector 300 before reaching the hollow cannula 308. According to another embodiment, a recess is provided inside the cap 302, recessed distally from the proximal surface of the base body 306. The size and shape of the recess or plurality of recesses 310, 312 are configured to provide a residence time for fluid (e.g., insulin formulation) passing through the activated charcoal adsorbent in the recess to minimize or prevent denaturation and / or loss of efficacy before delivery to the patient.

[0063] As in other depicted and described embodiments, during operation of the patch injector 300, the adsorbent removes one or more compounds or substances from the fluid before delivering the fluid to the patient via the hollow cannula 308.

[0064] Figure 13 This is a flowchart of method 400 according to an embodiment of the present invention. In a first operation, for illustrative purposes, the method is described as being implemented by a manufacturer, but it should be understood that other entities may also practice the method without departing from the scope of the invention. In operation 402, the manufacturer provides at least one of a base, a fluid connector, and a pump connector for an infusion kit, and said at least one of the base, fluid connector, and pump connector includes a groove recessed from its inner surface. In operation 404, the manufacturer provides an adsorbent in the groove. And in operation 406, the manufacturer seals the groove with a thin film to form at least a portion of the fluid path.

[0065] The method may include other operations. For example, in a base or pump connector, the method may include inserting an intermediate sealing member between a first end port and a second end port of the recess. The method may also include inserting another sealing member to seal or at least restrict access from the external environment to the first end port.

[0066] Embodiments of the invention have been described with respect to multi-part infusion kits and patch injectors; however, embodiments of the invention may also include other drug delivery devices, such as single-piece infusion kits. For the sake of brevity, however, these embodiments have been omitted.

[0067] Although only a few embodiments of the invention have been shown and described, the invention is not limited to the described embodiments. Rather, those skilled in the art will understand that changes can be made to these embodiments without departing from the principles and spirit of the invention. Any embodiments and / or elements disclosed herein can be combined with each other to form various additional embodiments not specifically disclosed, provided that they do not contradict each other. It is particularly noteworthy that those skilled in the art can readily combine various technical aspects of the various elements of the various exemplary embodiments described above in a variety of other ways, all of which are considered to fall within the scope of the invention as defined by the appended claims and their equivalents.

[0068] Various aspects of the embodiments may be used independently or in combination thereof.

Claims

1. A medical device configured to deliver fluid to a patient, comprising: The base has a hollow cannula for insertion into a patient and a base body attached to the hollow cannula; A fluid connector capable of being connected to the base; A pump connector, which is capable of being connected to a pump; and A conduit connecting the fluid connector and the pump connector; in: Each of the base body, the fluid connector, the pump connector, and the pipe has a fluid passage therethrough, and the respective fluid passage is capable of fluid connection; The fluid passage of at least one of the base body, the fluid connector, and the pump connector includes a passage portion sealed with a seal. The pathway portion includes an adsorbent configured to modify the fluid passing through the pathway portion by removing one or more substances from the fluid prior to delivery of the fluid to the patient; The passage portion includes a groove recessed from the inner surface of the fluid connector; The groove is recessed from the top of the inner dome portion of the fluid connector; The fluid connector includes a hollow cannula suspended from the top of the internal dome portion; and The groove fluidly connects the inflow fluid path to the sleeve fluid path of the fluid connector.

2. A medical device configured to deliver fluid to a patient, comprising: The base has a hollow cannula for insertion into a patient and a base body attached to the hollow cannula; A fluid connector capable of being connected to the base; A pump connector, which is capable of being connected to a pump; and A conduit connecting the fluid connector and the pump connector; in: Each of the base body, the fluid connector, the pump connector, and the pipe has a fluid passage therethrough, and the respective fluid passage is capable of fluid connection; The fluid passage of at least one of the base body, the fluid connector, and the pump connector includes a passage portion sealed with a seal. The pathway portion includes an adsorbent configured to modify the fluid passing through the pathway portion by removing one or more substances from the fluid prior to delivery of the fluid to the patient; The passage portion includes a groove recessed from the inner surface of the base body; The hollow cannula is suspended from the distal portion of the base body; The base body includes a proximal sealing member that fluid-seals the proximal end of the column portion of the base body and an intermediate sealing member that fluid-seals the middle portion of the column portion, thereby forming a first chamber between the proximal sealing member and the intermediate sealing member and a second chamber between the intermediate sealing member and the proximal portion of the hollow cannula. The groove is recessed from the inner surface of the column portion; and The groove fluidly connects the first chamber and the second chamber.

3. A medical device configured to deliver fluid to a patient, comprising: The base has a hollow cannula for insertion into a patient and a base body attached to the hollow cannula; A fluid connector capable of being connected to the base; A pump connector, which is capable of being connected to a pump; and A conduit connecting the fluid connector and the pump connector; in: Each of the base body, the fluid connector, the pump connector, and the pipe has a fluid passage therethrough, and the respective fluid passage is capable of fluid connection; The fluid passage of at least one of the base body, the fluid connector, and the pump connector includes a passage portion sealed with a seal. The pathway portion includes an adsorbent configured to modify the fluid passing through the pathway portion by removing one or more substances from the fluid prior to delivery of the fluid to the patient; The passage portion includes a groove recessed from the inner surface of the pump connector; The pump connector includes an intermediate sealing member that fluidly separates the inflow chamber and the outflow chamber within the pump connector; The groove is recessed from the inner wall of the pump connector; and The groove fluidly connects the inflow chamber and the outflow chamber of the pump connector.

4. The medical device according to any one of claims 1 to 3, wherein, The groove is sealed with a sealant.

5. The medical device according to claim 4, wherein, The adsorbent includes activated carbon adsorbent.

6. The medical device according to claim 5, wherein, The fluid comprises an insulin formulation containing a phenolic stabilizer, and wherein the activated charcoal adsorbent is adapted to remove the phenolic stabilizer from the insulin formulation prior to delivery to a patient.

7. The medical device according to claim 6, wherein, The size and shape of the groove are configured to provide a residence time of the insulin formulation passing through the activated charcoal adsorbent in the groove, in order to minimize or prevent at least one of denaturation and loss of efficacy before delivery to the patient.

8. The medical device according to claim 6, wherein, The activated carbon adsorbent includes activated carbon adsorbent treated with phosphoric acid.

9. The medical device according to claim 6, wherein, The phenolic stabilizer is selected from the group consisting of phenol, m-cresol and mixtures thereof.

10. The medical device according to any one of claims 1 to 3, wherein, The seal includes a thin film.

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