Fluid systems that contain materials to improve the performance and lifespan of medical devices

Abstract

A medical device operable to deliver a fluid to a patient includes a base having a base body and a hollow cannula for insertion into the patient, the hollow cannula being one of fixed to the base and movable relative to the base to an insertion position in the patient. The base body includes a fluid pathway that is one of fluidly connected to the hollow cannula and fluidly connectable to the hollow cannula. The fluid pathway includes a pathway portion sealed with a sealant, the pathway portion including an adsorbent operable to modify fluid passing through the pathway 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

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 63 / 018401, filed with the U.S. Patent and Trademark Office on April 30, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present 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 that can remove selected compounds from the fluid immediately prior to administration of the fluid to the patient. In one embodiment, the medical device is suitable for delivering controlled doses of insulin formulations associated with an adsorbent for removing stabilizers and / or selected compounds from the insulin formulation prior to delivery to the patient. [Background technology]

[0003] Injectable medications such as insulin are commonly administered with patch syringes and infusion sets.

[0004] Drugs and pharmaceuticals often contain preservatives and / or stabilizers to extend their shelf life. For example, insulin often contains phenol and / or m-cresol as stabilizers. These stabilizers often cause side effects such as injection site irritation, inflammation, scarring, and lipohypertrophy.

[0005] Existing infusion sets are disclosed in PCT application PCT / US2019 / 028248, filed June 28, 2019, the entire contents of which are incorporated herein by reference.

[0006] While conventional devices have been suitable for their intended uses, there is a continuing need in the industry for improved medical devices to reduce irritation and inflammation at the injection site. Summary of the Invention [Problem to be solved by the invention]

[0007] It is therefore an aspect of the present invention to provide a medical device that reduces irritation and inflammation at the injection site. [Means for solving the problem]

[0008] The above and / or other aspects of the present invention are achieved by providing a medical device operable to deliver a 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 one of fixed to the base body and movable relative to the base body to an insertion position in the patient. The base body includes a fluid pathway that is one of fluidly connected to the hollow cannula and fluidly connectable to the hollow cannula. The fluid pathway includes a pathway portion sealed with a sealant, the pathway portion including an adsorbent operable to modify a fluid passing through the pathway 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.

[0009] The above and / or other aspects of the present invention can also be achieved by providing a medical device including 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 also includes a pump connector connectable to a pump. The base body, fluid connector, pump connector, and tubing each have a fluid pathway therethrough. Each fluid pathway is fluidly connectable. At least one fluid pathway of the base body, fluid connector, and pump connector includes a pathway portion sealed with a sealant, the pathway portion including an adsorbent configured to remove one or more compounds or substances from the fluid to modify the fluid passing through the pathway portion before delivering the fluid to the patient.

[0010] The above and / or other aspects of the present invention are also achieved by providing a method for manufacturing a medical device, the method including providing at least one of a patch syringe, a base, a fluid connector, and a pump connector, the method including a groove recessed from a surface of at least one of the patch syringe, the base, the fluid connector, and the pump connector, the method also including providing an adsorbent material in the groove and sealing the groove with a sealant to form at least a portion of a fluid pathway through at least one of the patch syringe, the base, the fluid connector, and the pump connector.

[0011] Additional and / or other aspects and advantages of the invention will be set forth in the description that follows, or will be obvious from the description, or may be learned by practice of the invention. [Brief explanation of the drawings]

[0012] The above and / or other aspects and advantages of embodiments of the present invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a diagram illustrating an infusion set according to one embodiment of the present invention. [Figure 2] 2 is an exploded perspective view of the fluid connector of the infusion set of FIG. 1. FIG. [Figure 3] FIG. 3 is a perspective view of the fluid connector of FIG. 2 in an assembled state. [Figure 4] FIG. 4 is a plan bottom view showing the fluid path portion of the fluid connector of FIG. [Figure 5] 5 is a cross-sectional view of the fluid connector of FIG. 2. FIG. [Figure 6] 6 is a cross-sectional view showing the fluid connector of FIG. 2 connected to the base of FIG. 2. [Figure 7] FIG. 7 is a cross-sectional view of a base according to one embodiment of the present invention. [Figure 8] FIG. 8 is an enlarged view of the base of FIG. [Figure 9] FIG. 9 is an enlarged cross-sectional view of a base 108 according to another embodiment of the present invention. [Figure 10] FIG. 10 is a cross-sectional view showing a pump connector according to one embodiment of the present invention. [Figure 11] FIG. 11 is a perspective view of a patch injector according to another embodiment of the present invention. [Figure 12] FIG. 12 is a partial perspective view of the patch syringe of FIG. 11 with the seal removed for illustrative purposes. [Figure 13] FIG. 13 is a flowchart of a method according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0013] Reference will now be made to the embodiments of the present invention as illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein illustrate, by way of example only and not by way of limitation, the present invention.

[0014] The embodiments are not intended to be mutually exclusive, and features of one embodiment can be combined with other embodiments unless they are mutually inconsistent.

[0015] It will be understood by those skilled in the art that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth below or illustrated in the drawings. The embodiments herein are capable of other embodiments and of being practiced or carried out in various ways. Moreover, the phraseology and terminology used herein are for purposes of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0016] Unless otherwise limited, the terms "connected," "coupled," and "mounted," and variations thereof, are used broadly herein and encompass both direct and indirect connections, couplings, and mountings. Additionally, the terms "connected" and "coupled," and variations thereof, are not limited to physical or mechanical connections or couplings. Furthermore, terms such as "up," "down," "bottom," "top," "front," "rear," "top," "bottom," "upward," "downward," and other directional descriptors are intended to facilitate the description of exemplary embodiments of the present invention and are not intended to limit the structures of exemplary embodiments of the present invention to any particular location or orientation. Terms of degree, such as "substantially" or "about," are understood by those skilled in the art to refer to a reasonable range around and including a given value, as well as to a range outside the given value, e.g., a typical tolerance range associated with the manufacture, assembly, and use of an embodiment. The term "substantially," when referring to a structure or characteristic, includes a characteristic that is largely or completely within the structure.

[0017] Embodiments of the present invention are directed to medical devices or medical delivery devices and methods of making same that receive or carry a fluid such as insulin, a drug, or a medication for delivery to a patient, remove one or more compounds or substances from the insulin, drug, or medication, and then deliver the improved fluid to the patient.

[0018] The medical device is particularly suitable for use in delivering insulin that includes a stabilizer or preservative, at least a portion of which can be removed from the insulin prior to delivery of the improved insulin to a patient. The medical device for introducing an insulin formulation into a patient is used in association with an adsorbent that contacts the insulin formulation prior to introduction into the patient.

[0019] The medical device can deliver fluids, such as insulin, to a patient by bolus and / or basal delivery. In one embodiment, the drug is an insulin formulation or solution delivered to the patient in a selected and controlled dose at an injection or infusion site.

[0020] Insulin formulations are typically solutions containing preservatives and stabilizers to extend the shelf life of the insulin solution until ready for use. In one embodiment, the stabilizer is phenol, m-cresol, or a mixture thereof. Most patients with type 1 diabetes and some patients with type 2 diabetes manage their condition by administering multiple daily insulin injections. Daily injections can lead to side effects, including irritation, inflammation, scarring, lipohypertrophy, and accumulation of subcutaneous fat at insulin injection or infusion sites. Incorporation of phenol or m-cresol into insulin formulations is effective in providing bacteriostatic effects and stabilizing the insulin formulation. However, the presence of phenol or m-cresol in insulin following repeated or sustained injections at the injection or infusion site may cause inflammation and irritation to the patient, reduce insulin absorption at the site, and reduce the persistence of insulin administration at the site.

[0021] The phenolic excipients m-cresol and phenol, present in insulin analog formulations as bacteriostatic and stabilizing factors, are cytotoxic in in vitro test systems and contribute to adverse tissue reactions when administered topically at formulation concentrations. These adverse tissue reactions result in elevated proinflammatory cytokine levels and altered subcutaneous insulin pharmacokinetics. Adverse reactions are often dose-dependent; as the excipient dose increases, as in insulin infusion devices, pharmacokinetics increasingly shift relative to initial values. Data suggest that excipient-induced inflammation in models adversely affects insulin administration and absorption. This may lead to poor adherence.

[0022] One feature of the medical device of the present invention is the selective removal of phenolic excipients from insulin formulations without interfering with the efficacy of the insulin upon administration to patients. Experiments using activated carbon as an adsorbent have shown that phenol and m-cresol can be effectively removed from insulin formulations, maintaining the insulin effluent at formulation concentrations. Treated insulin with reduced concentrations of phenolic excipients can be administered to patients within a time period that does not substantially result in denaturation or loss of insulin potency. In one embodiment, the adsorbent is selected to remove only phenolic excipients.

[0023] The adsorbents can be used in conjunction with medical devices to remove at least a portion of the stabilizers, particularly phenolic stabilizers, from insulin formulations prior to introduction into a patient.

[0024] In one embodiment, the adsorbent is activated charcoal, which may be in granular, extruded, or powder form to provide a contact surface area for insulin sufficient to remove a selected amount of phenolic stabilizers to reduce inflammation at the delivery site without denaturing or losing efficacy of the insulin upon delivery to the patient. In describing the device and method, the terms activated charcoal and activated carbon are used interchangeably. Acid-treated activated charcoal, such as phosphoric acid-activated charcoal, is particularly suitable for removing phenol and m-cresol from insulin formulations. In one embodiment, the activated charcoal is chemically activated carbon obtained by treatment with phosphoric acid. Activation can be performed with phosphoric acid, e.g., at pH 6.7. However, those skilled in the art will appreciate that other pH levels can be employed. Commercially available phosphoric acid-treated activated charcoal can be used to remove phenol and m-cresol from insulin formulations. An example of commercially available acid-treated activated charcoal is available from Cabot Corporation under the trade name CN5-20. The activated charcoal has a surface area that provides sufficient contact with insulin to remove a sufficient amount of phenolic compounds to minimize irritation and inflammation at the injection site.

[0025] Activated carbon can be obtained from a variety of carbon sources, including, for example, wood, coconut shells, olive kernels, peat, lignite, coal, or other suitable carbon sources. In one embodiment, activation is accomplished 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 1,000 m 2 Activated carbon has a surface area of ​​approximately 0.26 to 1.16 cm / g. 3 / g, and generally about 0.40 to 0.70 cm 3 In other embodiments, the activated carbon may have a pore volume of 1500 m 2 In a further embodiment, the activated carbon can have a surface area of ​​2300 m / g or more, depending on the activation method. 2 / g and in some cases 3,000 m 2 / g.

[0026] The sorbent is present in an amount that provides a contact time with the insulin formulation sufficient to remove a desired amount of phenol, m-cresol, or other stabilizers contained in the insulin formulation without denaturing insulin potency and to reduce irritation and inflammation at the injection site. The sorbent is located in the insulin formulation flow path as close to the injection element or delivery site as reasonably possible to reduce degradation of the insulin formulation before introduction into the patient.

[0027] The amount of activated carbon in the assembly complements the insulin dosage and flow rate for basal or bolus delivery and provides the desired adsorption rate of the phenolic stabilizer. In one embodiment, the amount of adsorbent provides about 95% m-cresol removal after 4 days and about 60% after 7 days at a basal flow rate.

[0028] FIG. 1 illustrates an infusion set 100 according to one embodiment of the present invention. As shown, the infusion set 100 includes a fluid connector 102 that connects to tubing 104, which is also connected to a pump connector 106 for connection to a pump. The infusion set 100 also includes a base 108 having a base body 109 and a hollow cannula 111 (best seen in FIG. 7) for insertion into a patient. The fluid connector 102 is connectable to the top of the base 108, as shown in FIG. 6. The base body 109, fluid connector 102, pump connector 106, and tubing 104 each have a fluid pathway therethrough.

[0029] According to one embodiment, the fluid connector 102 is a breakaway fluid connector 102. As shown in Figure 2, the fluid connector 102 includes two components: a fluid path portion 110 and a latch portion 112. The latch portion 112 includes an activation lever 114, a fluid connector latch 116, and a rigid stop 118.

[0030] According to one embodiment, the activation lever 114, the fluid connector latch 116, and the rigid stop 118 are integrally formed as a unitary structure. Furthermore, the activation lever 114 forms an arm with each of the fluid connector latches 116. These arms are displaceable relative to the fluid path portion 110. The fluid connector latches 116 are displaceable to a latched position in which at least a portion of the fluid connector latch 116 of the base 108 is disposed within the fluid path portion 110 (see FIG. 6). Furthermore, the arms are resiliently biased toward the latched position.

[0031] The fluid path portion 110 includes a tube connector portion 120 for connecting the fluid connector 102 and the tubing 104. The fluid path portion 110 may be secured to the latch portion 112 via a snap-fit ​​engagement, and according to one embodiment, the fluid path portion 110 and the latch portion 112 may be made from the same material. While an exemplary embodiment of a separate fluid connector is shown, those skilled in the art will understand that a one-piece fluid connector or a fluid connector consisting of two or more pieces may be employed without departing from the scope of the present invention.

[0032] FIG. 4 is a planar bottom view (with latching portions omitted for clarity) of a fluid path portion 110 according to an embodiment of the present invention, and FIG. 5 is a cross-sectional view of a fluid connector 102 according to an embodiment of the present invention. As shown in FIGS. 4 and 5 , the fluid path of the fluid path portion 110 of the fluid connector 102 includes a fluid connector path portion 150 including a groove 152 in an upper interior ceiling or dome portion or roof interior dome portion of the fluid path portion 110 and a sealant 154, such as a pressure-sensitive adhesive or membrane or film 154, that covers the groove 152 to form a fluid-tight path portion or fluid connector path portion 150. Those skilled in the art will appreciate that other sealants can be employed, such as a molded part that is ultrasonically or chemically welded onto the groove 152. For simplicity, in describing this and other embodiments, a film is employed as the sealant. According to one embodiment, the film 154 is a pressure-sensitive adhesive or film 154, such as Mylar, that can fluid-seal the groove 152.

[0033] Preferably, a sorbent, such as activated carbon sorbent, is placed in the groove 152 before sealing the groove 152 with the film 154. As best shown in FIG. 4 , the groove 152 has a tortuous path. The groove 152 is configured so that the insulin formulation passing through the sorbent has a residence time within the fluid connector pathway portion 150 sufficient to remove phenolic stabilizers from the insulin formulation before delivery to the patient, but also to result in substantially no denaturation or loss of potency of the insulin formulation before delivery to the patient. Those skilled in the art will appreciate that other shapes and lengths of the groove 152 can be employed without departing from the scope of the present invention. The objective is to provide sufficient contact with the sorbent to remove a sufficient amount of the irritating stabilizer without compromising the efficacy of the insulin formulation.

[0034] As shown in FIG. 6, when the fluid connector 102 is connected to the base 108, a blunt cannula 156 forming the ceiling of the dome-shaped portion of the fluid connector 102 penetrates a septum 158 of the base 108 to connect the fluid passages of the fluid connector 102 with the fluid passages of the base 108.

[0035] FIG. 7 is a cross-sectional view of a base 108 according to another embodiment of the present invention, and FIG. 8 is an enlarged view of FIG. 7. As shown in FIGS. 7 and 8, a hollow cannula 111 forms a distal portion of a base body 109. The base body 109 includes a proximal seal member 158 that fluidly seals the proximal end of a cylindrical portion 160 of the base body 109. According to one embodiment, the proximal seal member 158 is a septum 158, although other seal members may be employed without departing from the scope of the present invention. The base body 109 also includes an inner seal member 162 that fluidly seals the interior portion of the cylindrical portion 160, forming a first chamber 164 between the proximal and inner seal members 158, 162 and a second chamber 166 between the inner seal member 162 and the proximal portion of the hollow cannula 111. According to one embodiment, the inner seal member 162 is a septum 162, although other seal members may be employed without departing from the scope of the present invention.

[0036] First chamber 164 includes a first end port 170, and second chamber 166 has a second end port 172. First end port 170 and second end port 172 are connected by a groove 174 provided in the inner wall of cylindrical portion 160, and groove 174 is covered with a sealing material 176 such as film 176. Preferably, an adsorbent such as activated carbon adsorbent is placed in groove 174 before sealing groove 174 with film 176.

[0037] The sealant 176 is preferably a pressure-sensitive adhesive or film 176, such as Mylar, that can fluidly seal the groove 174. According to one embodiment, the groove 174 is a spiral groove 174. Those skilled in the art will appreciate that multiple end ports and connecting grooves, or a pair of end ports with multiple connecting grooves, or multiple end ports each with multiple connecting grooves, can be disposed within the barrel without departing from the scope of the present invention. However, for clarity, only one pair of end ports with one connecting groove is shown in the depicted embodiment.

[0038] Figure 9 is an enlarged cross-sectional view of a base 108 according to another embodiment of the present invention. As with the previous embodiment, as shown in Figure 9, the base body 109 includes a proximal seal member 158 that fluidly seals the proximal end of the cylindrical portion 160 of the base body 109. The base body 109 also includes an inner seal member 162 that fluidly seals the interior portion of the cylindrical portion 160, forming a first chamber 164 between the proximal and inner seal members 158, 162 and a second chamber 166 between the inner seal member 162 and the proximal portion of the hollow cannula 111.

[0039] 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 groove 184 provided in the inner wall of the cylindrical portion 160, and the groove 184 is covered with a sealing material 186, such as a film 186. In this manner, the groove 184 fluidly connects the first and second chambers 164, 166. Preferably, an adsorbent, such as an activated carbon adsorbent, is disposed in the groove 184 before sealing the groove 184 with the film 186.

[0040] The sealant 186 is preferably a pressure-sensitive adhesive or film 186, such as Mylar, that can fluidly seal the groove 184. According to one embodiment, the groove 184 is a linear groove 184. While FIG. 9 depicts multiple linear grooves 184, those skilled in the art will understand that a single linear groove 184 could be employed without departing from the scope of the present invention. Furthermore, those skilled in the art will understand that the groove 184 need not be linear and can have other shapes without departing from the scope of the present invention. For example, the groove 184 could have a curved and / or zigzag shape, or could be a serpentine path without a geometric shape.

[0041] 10 is a cross-sectional view of a pump connector 190 according to one embodiment of the present invention. The connector 190 includes a main body 192 having an inner seal member 194, a proximal seal member 196, and a connector needle 198 proximally spaced from the proximal seal member 196 for fluid communication with a pump. The connector needle 198 is in fluid communication with a first chamber 200 disposed between the inner seal member 194 and the proximal seal member 196. The connector 190 also includes a second chamber 202 disposed distal (toward the patient) of the inner seal member 194. The second chamber 202 is in fluid communication with a tubing port 204 for connection to tubing of a drug delivery device.

[0042] The connector 190 also includes a first end port 206 disposed in the first chamber 200, a second end port 208 disposed in the second chamber 202, and a groove 210 connecting the first end port 206 and the second end port 208. The groove 210 fluidly connects the first and second chambers 200 and 202. The groove 210 is recessed from the inner wall of the connector 190 and is covered with a sealing material 212 such as a film. Preferably, an adsorbent such as activated carbon adsorbent is placed in the groove 210 before sealing the groove 210 with the film 212. The film 212 is preferably a pressure-sensitive adhesive such as Mylar, and can fluidly seal the groove 210.

[0043] According to one embodiment, the groove 210 is linear. According to another embodiment, the groove 210 is spiral. According to another embodiment shown in Figure 10, the groove 210 is a meandering path without a specific geometric shape. Such a path is advantageous for increasing the residence time of the drug within the groove 210.

[0044] Although FIG. 10 shows only one pair of end ports 206, 208 and one recessed groove 210, those skilled in the art will understand that multiple end ports and connecting grooves, or a pair of end ports with multiple connecting grooves, or multiple end ports each with multiple connecting grooves, can be arranged within the connector of the present invention without departing from the scope of the present invention.

[0045] FIG. 11 is a bottom perspective view of a patch injector 300 according to another embodiment of the present invention. The patch injector 300 includes a cover 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 includes a sharp insertion needle for inserting the hollow cannula 308 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 306 from a retracted position in which the hollow cannula 308 does not extend distally beyond the base body 306 to a patient insertion position in which the hollow cannula 308 extends distally beyond the base body 306, as shown in FIGS. 11 and 12 .

[0046] According to one embodiment, the patch injector 300 includes a reservoir for holding a fluid, such as insulin. The patch injector 300 includes a fluid pathway fluidly connecting the reservoir to the hollow cannula 308. According to one embodiment, the base body 306 includes one or more grooves 310, 312 recessed from the surface of the base body 306, and a sealing material 314, such as a film 314, seals the grooves 310, 312, which form a path portion of the fluid pathway. The manufacturer preferably provides an adsorbent, such as activated carbon adsorbent, in the grooves 310, 312 before sealing the grooves 310, 312 with the sealing material 314, such as a film 314.

[0047] The sealant 314 is preferably a pressure-sensitive adhesive film 314 such as Mylar, and is capable of fluidly sealing the groove or grooves 310, 312.

[0048] 12 , the film 314 is omitted to better illustrate the channels 310, 312. According to one embodiment shown in FIGS. 11 and 12 , the channels are recessed proximally from the distal surface of the base body 306. In such an embodiment, a channel portion is disposed on the exterior of the cover 302, so that the fluid pathway passes from the interior to the exterior; in the embodiment of FIGS. 11 and 12 , the fluid pathway passes back into the interior of the patch syringe 300 before reaching the hollow cannula 308. According to another embodiment, the channels are recessed distally from the proximal surface of the base body 306 within the cover 302. The size and shape of the channel or channels 310, 312 can be manipulated to provide a residence time within the channels for a fluid, such as an insulin formulation passing through an activated carbon adsorbent, to minimize or prevent denaturation and / or loss of efficacy prior to delivery to a patient.

[0049] As with the other depicted and described embodiments, during operation of the patch injector 300, the sorbent removes one or more compounds or substances from the fluid before delivering the fluid to the patient via the hollow cannula 308.

[0050] 13 is a flowchart of a method 400 according to one embodiment of the present invention. In an initial operation, for illustrative purposes, the method is described as being performed by a manufacturer, although it will be understood that other entities may perform the method without departing from the scope of the present invention. In operation 402, the manufacturer provides at least one of an infusion set base, a fluid connector, and a pump connector, where 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 a sorbent material within the groove. Then, in operation 406, the manufacturer seals the groove with a film to form at least a portion of a fluid pathway.

[0051] The method can include additional operations. For example, in the base or pump connector, the method can include inserting an inner sealing member between the first and second end ports of the recessed channel. The method can also include inserting another sealing member that seals or at least limits access to the first end port from the external environment.

[0052] Although embodiments of the present invention have been described with respect to multi-part infusion sets and patch syringes, embodiments of the present invention may also include other drug delivery devices, such as one-part infusion sets, however, for the sake of brevity, these embodiments have been omitted.

[0053] While only a few embodiments of the present invention have been shown and described, the present invention is not limited to the described embodiments. Instead, it will be understood by those skilled in the art that changes can be made to these embodiments without departing from the principles and spirit of the present invention. Any of the embodiments and / or elements disclosed herein can be combined with one another, unless they are mutually inconsistent, to form various additional embodiments not specifically disclosed. It is particularly noted that those skilled in the art can easily combine various technical aspects of the various elements of the various exemplary embodiments described above in many other ways, all of which are considered to be within the scope of the present invention, as defined by the appended claims and their equivalents.

[0054] The various aspects of the present embodiment may be used independently or in combination.

Claims

1. 1. A medical device operable to deliver a fluid to a patient, comprising: a base having a hollow cannula for insertion into a patient and a base body attached to the hollow cannula; a fluid connector connectable to the base; a pump connector connectable to a pump; a tube connecting the fluid connector and the pump connector; each of the base body, the fluid connector, the pump connector, and the tube has a fluid path therein, and each of the fluid paths is fluidly connectable; the fluid path of at least one of the base body, the fluid connector, and the pump connector includes a path portion sealed with a sealant; the pathway portion includes a sorbent operable to modify a fluid passing through the pathway portion by removing one or more compounds or substances from the fluid prior to delivery of the fluid to the patient; the path portion is a recessed groove recessed from the inner surface of the fluid connector, the recessed groove is recessed from a roof of an interior dome portion of the fluid connector; the fluid connector includes the hollow cannula depending from the roof of the inner dome portion; The medical device, wherein the recess fluidly connects the incoming fluid path with a cannula fluid path of the fluid connector.

2. 1. A medical device operable to deliver a fluid to a patient, comprising: a base having a hollow cannula for insertion into a patient and a base body attached to the hollow cannula; a fluid connector connectable to the base; a pump connector connectable to a pump; a tube connecting the fluid connector and the pump connector; each of the base body, the fluid connector, the pump connector, and the tube has a fluid path therein, and each of the fluid paths is fluidly connectable; the fluid path of at least one of the base body, the fluid connector, and the pump connector includes a path portion sealed with a sealant; the pathway portion includes a sorbent operable to modify a fluid passing through the pathway portion by removing one or more compounds or substances from the fluid prior to delivery of the fluid to the patient; The path portion is a recessed groove recessed from the inner surface of the base body, the hollow cannula depends from a distal portion of the base body; the base body includes a proximal seal member fluidly sealing a proximal end of the barrel of the base body, and an inner seal member fluidly sealing an inner portion of the barrel, forming a first chamber between the proximal seal member and the inner seal member and a second chamber between the inner seal member and a proximal portion of the hollow cannula; The recessed groove is recessed from the inner surface of the cylindrical portion, The medical device, wherein the recess fluidly connects the first and second chambers.

3. 1. A medical device operable to deliver a fluid to a patient, comprising: a base having a hollow cannula for insertion into a patient and a base body attached to the hollow cannula; a fluid connector connectable to the base; a pump connector connectable to a pump; a tube connecting the fluid connector and the pump connector; each of the base body, the fluid connector, the pump connector, and the tube has a fluid path therein, and each of the fluid paths is fluidly connectable; the fluid path of at least one of the base body, the fluid connector, and the pump connector includes a path portion sealed with a sealant; the pathway portion includes a sorbent operable to modify a fluid passing through the pathway portion by removing one or more compounds or substances from the fluid prior to delivery of the fluid to the patient; the passage portion is a recessed groove recessed from the inner surface of the pump connector, the pump connector includes an inner seal member fluidly separating an inlet chamber and an outlet chamber within the pump connector; The groove is recessed from an inner wall of the pump connector, The medical device, wherein the recess fluidly connects the inlet chamber and the outlet chamber of the pump connector.

4. The medical device according to claim 1 , wherein the groove is sealed with the sealing material.

5. The medical device of claim 4 , wherein the adsorbent comprises an activated carbon adsorbent.

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

7. 7. The medical device of claim 6, wherein the size and shape of the grooves are operable to provide a residence time within the grooves of the insulin formulation passing through the activated carbon adsorbent to minimize or prevent at least one of denaturation and loss of efficacy prior to delivery to the patient.

8. 7. The medical device of claim 6, wherein the activated carbon adsorbent comprises a phosphoric acid-treated activated carbon adsorbent.

9. 7. The medical device of 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 claim 1 , wherein the sealing material is made of a film.

11. 1. A method of manufacturing a medical device, comprising: providing at least one of the patch syringe, the base, the fluid connector, and the pump connector with a recessed groove recessed from a surface of said at least one; providing an adsorbent in the groove; and sealing the recessed groove with a sealant to form at least a portion of a fluid pathway through at least one of the patch syringe, the base, the fluid connector, and the pump connector.

12. The method of claim 11 , wherein the sealant comprises a film.

Images